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1091 Cards in this Set
- Front
- Back
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What schedule drugs require one-inch red "C" on the lower right corner of a prescription when the hardcopy for the controlled substance is integrated into the nonscheduled drug prescription files?
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Schedule III, IV, V
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What is required when dispensing a drug with an estrogenic component?
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Package insert
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What is the default container for a prescription unless the patient has specifically requested not to receive their medications in this manner?
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Child-resistant safety containers
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What is a DEA Form 222?
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Form required for ordering Schedule II controlled substances
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What are the 4 sections of the California Pharmacy Law Text?
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1. The California Business and Professions Code
2. The California Code of Regulations from the Administrative Codes 3. The California Health and Safety Codes (includes Uniform Controlled Substances Act) 4. The California Civil Codes (confidentiality) |
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What is the difference between a Statute and a Regulation?
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Statute: Codes found in the California Business and Professions Codes, California Health and Safety Codes, and California Civil Codes; Statutes are passed by the state legislature
Regulations: Codes that make up the California Code of Regulations; Codes are developed by State Agencies (e.g. CA Board of Pharmacy) |
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What is the Preemption Doctrine?
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When a state and federal law conflict, the more stringent law applies. (ex. Paregoric is Schedule III in federal, but Schedule II in CA --> Schedule II prevails in CA because it is more strict)
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What terms are used in a statute or regulation to make it mandatory?
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"must" or "shall"
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What is the difference between a mandatory and permissive law?
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A mandatory law must be followed precisely as stated.
A permissive law only provides guidance on how to proceed. (e.g. pharmacist does not have to be PIC for a second pharmacy if they cannot handle duties for both pharmacies) |
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What terms are used in a statute or reglation to make it permissive?
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"may" or "can"
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A patient requests a refill for a medication that has PRN refills, but the prescription was originally written over one year ago. Are you required, by law, to contact the physician for a new prescription?
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No, you technically have not broken any laws and would not be subject to criminal sanctions. However you have acted outside the standard of practice according to the attorney general. You could be subject to a civil claim if something bad happened to the patient.
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How does the Attorney General's opinion weigh in on a pharmacy related matter?
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It is a GUIDANCE, not a law, but if you do not follow it and something happens to a patient, the patient could file a legal claim stating you were not following the STANDARD OF PRACTICE.
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What are the three common legal actions that can be brought against a pharmacist?
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1. Civil
2. Criminal 3. Administrative |
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What is the potential legal action when an individual wins a civil suit against a pharmacist?
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The pharmacist may be required to compensate the patient
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What is the potential legal action when a governing body wins a criminal suit against a pharmacist?
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The pharmacist could serve time in prison or pay a fine
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What is the potential legal action when a state board of pharmacy wins a criminal suit against a pharmacist?
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The pharmacist could have their license revoked, suspended, or put on probation
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What is the governing body for the CA State Board of Pharmacy?
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Department of Consumer Affairs
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How many board members sit on the CA State Board of Pharmacy?
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13
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How many CA State Board members are required to be pharmacists?
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7
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How many CA State Board members are appointed by the Governor?
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11
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How many CA State Board of Pharmacy members are appointed by the State Senate?
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2
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How many of the State Senate-appointed CA State Board of Pharmacy members are required to be pharmacists?
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0
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How many of the Governor-appointed CA State Board of Pharmacy members are required to be actively practicing pharmacists?
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5
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How many of the Governor-appointed CA State Board of Pharmacy members are required NOT to be pharmacists?
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4
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How many total CA State Board of Pharmacy members are required NOT to be pharmacists?
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8
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How many of the Governor-appointed CA State Board of Pharmacy members are required to be registered pharmacists?
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7
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to work in an acute-care hospital setting?
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1
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to work in an independent community pharmacy?
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1
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to work in a chain community pharmacy?
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1
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to work in a long-term healthcare setting?
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1
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to work in a skilled nursing facility setting?
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1
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What is the minimum number of pharmacists on the CA State Board of Pharmacy required to be a member of a pharmacists' labor union?
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1
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What is the minimum number of pharmacy's a person must own in the state of CA in order to be considered a "chain community pharmacy"?
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75
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What is the maximum number of pharmacy's a person can own in the state of CA in order to be considered an "independent community pharmacy"?
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4
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What is the length of a term for a CA State Board of Pharmacy member?
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4 years
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What is the maximum number of consecutive terms a CA State Board of Pharmacy member can serve?
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2 terms
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What is a quorum for a CA State Board of Pharmacy meeting?
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7 members
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How often are meetings held for the CA State Board of Pharmacy?
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At least once every 4 months
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What is the minimum number of meetings the CA State Board of Pharmacy can get away with in a year?
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3
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What is the role of the pharmacy inspector?
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Inspect, during normal business hours, all pharmacies, medical device retailers, veterinary drug retail operations, dispensaries, wholesalers of drugs or medical devices and operations in which drugs or devices are compounded, stored, dispensed or sold
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Are pharmacy inspectors allowed in physician offices and/or clinics?
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Yes, when the office orders, stores, and dispenses drugs and does not have a pharmacy license issued by the CA State Board of Pharmacy.
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Are pharmacy inspectors required to be registered pharmacists?
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No
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When can a pharmacy inspector arrest someone?
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If they have "reasonable cause" that a person has violated state pharmacy laws, usually constituting a felony or misdemeanor
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Is a pharmacy inspector required to have a warrant if they choose to arrest someone?
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No
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What is required if a pharmacy inspector chooses to remove pharmacy files and prescription records?
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1. Signed receipt itemizing which prescription documents or drugs were removed
2. Photocopies of the prescription records should remain in the pharmacy |
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What is the maximum number of consecutive years a CA State Board of Pharmacy member can serve?
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8 years
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A pharmacy inspector comes in during normal business hours for an inspection. What information is the manager required to provide if the inspector requests it?
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1. Names of the pharmacy owner(s)
2. Names of the pharmacy manager(s) 3. Names of the employees 4. Brief statement of the capacity by which each person works |
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What are the roles of the executive officer of the board?
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Exercise the powers and perform the duties delegated by the Board.
Influence policy changes. Institute accusation proceedings against licensed pharmacists who have broken the law. |
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Does the executive officer of the board have to be a registered pharmacist?
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No
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Who may prescribe or furnish drugs?
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MD
DDS DPM Optometrist Veterinarian DO |
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Who can prescribe in a collaborative practice?
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NP
PA CNM Naturopathic Doctor PharmD/RPh |
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What is another way of saying "collaborative practice"?
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"extended scope of practice legislation"
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In a collaborative practice, who takes the majority of the liability?
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MD
DDS DPM Optometrist Veterinarian DO The prescriber granting the authorization |
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What happens to a prescriber's prescribing privileges if the physician retires and retires their license?
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Physician cannot prescribe drugs
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What happens to a prescriber's prescribing privileges if the physician retires and changes their license to voluntary service?
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Physician can practice medicine and write Rxs
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What is a voluntary service license?
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A license issued to a retired prescriber who provides voluntary, unpaid service
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What is California's ruling on refilling a prescription when the prescriber is deceased?
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Trick question, there is no ruling.
The pharmacis should demonstrate reasonableness |
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What are the roles of the executive officer of the board?
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Exercise the powers and perform the duties delegated by the Board.
Influence policy changes. Institute accusation proceedings against licensed pharmacists who have broken the law. |
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Does the executive officer of the board have to be a registered pharmacist?
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No
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Who may prescribe or furnish drugs?
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MD
DDS DPM Optometrist Veterinarian DO |
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Who can prescribe in a collaborative practice?
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NP
PA CNM Naturopathic Doctor PharmD/RPh |
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What is another way of saying "collaborative practice"?
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"extended scope of practice legislation"
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In a collaborative practice, who takes the majority of the liability?
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MD
DDS DPM Optometrist Veterinarian DO The prescriber granting the authorization |
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What happens to a prescriber's prescribing privileges if the physician retires and retires their license?
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Physician cannot prescribe drugs
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What happens to a prescriber's prescribing privileges if the physician retires and changes their license to voluntary service?
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Physician can practice medicine and write Rxs
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What is a voluntary service license?
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A license issued to a retired prescriber who provides voluntary, unpaid service
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What is California's ruling on refilling a prescription when the prescriber is deceased?
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Trick question, there is no ruling.
The pharmacist should demonstrate reasonableness |
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What is the extent of the prescriptive authority of an optometrist?
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Optometrists have limited prescriptive authority.
Only "qualified" optometrists can prescribe therapeutic pharmaceutical agents |
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How does a pharmacist determine if an optometrist has prescriptive authority?
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TPA-certified optometrists will have a letter T at the end of their license number (e.g. OPT 12345-T).
"TPA" will appear at the right of the prescriber's license number on the prescription |
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How does a pharmacist verify an optometrist is allowed to prescribe therapeutic pharmaceutical agents?
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Check www.optometrist.ca.gov
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What can a TPA-certified optometrist prescribe?
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Topical anti-allergy
Topical anti-inflammatory Oral and topical glaucoma agents in patients >18 yo Oral antihistamines Oral acyclovir Topical antivirals Codeine/hydrocodone combinations Oral antibiotics |
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Under what circumstances would a TPA-certified optometrist need to consult an ophthalmologist?
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When prescribing a topical corticosteroid
Patients condition worsens 72 hours after diagnosis Inflammation still persists after 3 weeks If the patient still needs to take the medication 6 weeks after diagnosis Patients condition reoccurs within 3 months |
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Under what circumstances would a TPA-certified optometrist need to consult an ophthalmologist when prescribing an oral antibiotic?
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Patients condition worsens 72 hours after diagnosis
Patients condition does not resolve within 10 days of diagnosis |
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What oral antibiotics may a TPA-certified optometrist prescribe?
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Dicloxacillin
Amoxicillin Erythromycin Clarithromycin Cephalexin Cephadroxil Cefaclor TMP-SMZ Ciprofloxacin Azithromycin (only for eyelid infections and chlamydial disease manifesting in eyes) |
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When can a TPA-certified optometrist prescribe oral azithromycin?
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Eyelid infections and chlamydial disease manifesting in eyes
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How long can a TPA-certified optometrist prescribe a topical antiviral med?
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3 weeks
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How long can a TPA-certified optometrist prescribe oral acyclovir?
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10 days
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How long can a TPA-certified optometrist prescribe codeine/hydrocodone combinations?
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3 days
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Besides being a certified TPA-optometrist what other registration is required for an optometirst to prescribe codeine/hydrocodone combinations?
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DEA
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What age limits are imposed for the prescriptive authority for a TPA-optometrist?
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Glaucoma agents are only to be prescribed to patients over 18 years old.
All other agents are allowed to be prescribed regardless of age. |
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What schedule controlled substances can a naturopathic doctor (ND) prescibe in a collaborative practice?
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Schedule III, IV, V
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How many maximum Naturopathic Doctors can a licensed physician supervist at one time?
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4
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How would a pharmacist know an Naturopathic Docto has prescribing rights by looking at the prescription?
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The Naturopathic Doctor would have a furnishing number with letters NDF on the prescription (e.g. NDF-704)
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What medications can a Naturopathic Doctor prescribe without a physician-directed protocol?
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Epinephrine for anaphylaxis
Natural or synthetic hormones (e.g. Armour thyroid OK, testosterone NOT OK as it is a Schedule III Controlled Substance) |
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What other registration is required besides physician-directed protocol is necessary for a Naturopathic Doctor to prescibe Controlled Substances?
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Naturopathic Doctor must register with DEA
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A pharmacist receives a prescription from a Naturopathic Doctor, the prescription has an NDF (Naturopathic Doctor Furnishing) prescriber number, but the pharmacist is not sure if the prescription drug can be ordered by the Naturopathic Doctor. What can the pharmacist do to validate the prescription?
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Request a copy of the physician-directed protocol from the authorizing MD
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What prescribing rights does a PA/NP have when bound by a physician directed protocol?
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Administer or provide medications to patient
Call in or write prescription from supervising physician to pharmacy Furnish prescriptions for Schedule II through V Controlled Substances pursuant to physician directed protocol |
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What kind of prescription pad may an authorized Health Care Professional use to write Controlled Substance prescriptions
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State approved prescription security form issued specifically to the PA, NP, CNM or ND
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Can PAs/NPs/CNM prescribe medications?
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No, they can only FURNISH medications pursuant to the physician directed protocol
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What other registration is necessary for a PA/NP/CNM furnish an Rx for a Controlled Susbtance?
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DEA registration
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If a PA/NP/CNM is following a PDP who's signatures are required on the prescription to make it legal?
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Just the PA, NP, or CNM
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What identifying information is required on a prescription written by a PA/NP/CNM/ND?
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Supervising MD Printed Name, Address, Phone Number.
PA/NP/CNM/ND Printed or Stamped Name, License Number, Signature |
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Which types of Health Care Professionals can write prescriptions for Schedule II through V Controlled Substances as long as they are registered with the DEA and write a prescription for a drug contained in the Prescriber Directed Protocol?
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PA
NP CNM |
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A prescriber wants to write a prescription for a schedule II substance what kind of prescription pad is required?
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Special state approved security prescription form
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Are triplicate prescription pads still required for Schedule II prescriptions?
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No
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How can a pharmacist do to ensure a prescription written by a PA/NP/CNM falls in line with the Prescriber Directed Protocol?
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Require a signed copy of the Prescription Directed Protocol be provided
Require the PA/NP/CNM provide their PA/NP/CNM registration number Require PA/NP/CNM provide DEA registration number Speak directly with the supervising physician to validate prescription authenticity |
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Whose name is supposed to be listed on the prescription label for a prescription written by another HCP?
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Either the HCP or the supervising physician
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Are both names required on the prescription label when filling a prescription from an authorized HCP?
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No, just one
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Can a PA/NP/CNM provide a patient with a physical drug?
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Yes, if its prepackaged
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Is PA/NP/CNM authorized to sign for prescription samples?
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Yes
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Can PA/NP/CNM have their own prescription blanks?
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Yes
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What schedule controlled substances can an NP/PA/CNM prescriber with Prescriber Directed Protocols?
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Schedule II through V
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Can a CNM furnish prescriptions from their own practice when they are the sole owner of the practice?
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No
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What registration is required for a CNM to furnish prescriptions with prescriber directed protocol?
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Furnishing number from Board of RNs
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In what scope can a CNM provide Rxs even with the Prescriber Directed Protocol?
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Family planning
Perinatal services Child birth delivery services Routine health care to essentially healthy patients |
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In what instances can a PA/NP/CNM provide prescriptions to a patient without seeing them provided they have a Prescribing Directed Protocol?
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Sexual partner of patient with diagnosed STI (chlamydia)
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Does the prescription for the partner of the person with an STI have to include their name?
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No, the prescription label can say "Jane Smith and Partner"
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Does the HCP have to have license in California and be working with California based clinic in order to prescribe under Prescriber Directed Protocol?
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Yes
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If a pharmacist receives a prescription for Jane Smith & Partner for an antibiotic indicated for a chlamydial infection. How should the pharmacist label the prescription for the partner?
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"Jane Smith (Partner)"
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Who is authorized to sign for sample prescriptions and medical devices, provided they have a prescriber directed protocol?
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PA, NP, CNM, ND
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What responsibilites can a pharmacist engage in that would be considered an "expanding scope of practice"?
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Administer prescriptions according to a prescriber's order
Perform skin punctures for CLIA certified equipment (BGM, cholesterol, etc) Check BP and tell patient if its WNL Administer emergency contraceptive (with prescriber directed protocol Administer immunizations with Prescriber Directed Protocol) Obtain vitals Ordering drug therapy related lab tests Administer drugs/biologicals by injection pursuant to prescriber directed protocol Initiating and adjusting drug regimen of patient according to written protocol standard |
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How long does a pharmacy have to report a change in the PIC, owners, or corporate officers to the Board of Pharmacy?
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30 days
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How many pharmacies can a PIC be in charge of simultaneously?
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2 pharmacies <50 miles apart
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Can a PIC also serve concurrently as an exemptee-in-charge (a.k.a. representative-in-charge) for a wholesaler or veterinary food-animal drug retailer?
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No
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How can a pharmacist who serves as PIC at 2 pharmacies officially step down as PIC at one of the two pharmacies?
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Written statement to owner stating the second pharmacy duties will intervene with primary
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How long can an employee pharmacist act as interim PIC when the PIC resigns?
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120 days
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What are the requirements for an employee pharmacist to act as Interim PIC?
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Employee pharmacist should be actively involved in the pharmacy operation
Interim PIC cannot exceed 120 days Board of Pharmacy should be advised of this interim arrangement The pharmacy should identify a permanent PIC |
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Under what circumstances can a PIC not be found liable for activities of their employees?
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The PIC did not ENGAGE in conduct that violated a pharmacy practice related law
The PIC did not PERMIT, ENCOURAGE, APPROVE of any conduct by another that resulted in the violation of a pharmacy related law The PIC REPORTED the violation to the Board of Pharmacy in a timely manner The PIC took all necessary actions to stop and REMEDY the violation within a reasonable period of time |
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What are the requirements for a Registered Pharmacist to serve as a pharmacist-preceptor?
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Supervises either intern pharmacists or pharmacy students enrolled in IPPE or APPE
The pharmacist preceptor assumes responsibility for all pharmacy related activities performed by the pharmacy intern or student while under the pharmacist's supervision The pharmacist preceptors license must not be revoked, suspended or on probation |
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What are the CE requirements for a California Pharmacist?
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30 hours of CE every 2 years
Retain records for 4 years If pharmacist does not comply, the Board of Pharmacy can put the pharmacist's license on an INACTIVE status |
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How many CE hours are required for a California pharmacist?
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30 CE hours every 2 years
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How long does a California pharmacist need to keep CE records?
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4 years
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What can the California Board of Pharmacy do if a pharmacist does not comply with the CE requirements?
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The BOP can put the pharmacist's license on an INACTIVE status
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What are the requirements of a Pharmacy-Intern?
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Currently enrolled in a pharmacy school or have completed coursework at a recognized school of pharmacy
Require community and institutional pharmacy experience |
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What is the minimum amount a pharmacist intern card is valid?
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5 years
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Under what circumstances (and for how long) can a pharmacist intern card be extended?
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1-2 more year (total maximum of 7 years) for foreign graduates or Out of State Pharmacists
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When is an intern pharmacist licensure not extended?
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Individual who has failed licensure exam 3 times
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How many times can a board applicant take the pharmacist licensure exam?
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4 times
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What happens if a board applicant fails the pharmacist licensure exam four times
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Applicant is required to successfully complete a minimum of 16 semester units of pharmacy education before being allowed to retake the board exam
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How long does a pharmacist intern have to notify the Board of Pharmacy about a change of address or they are no longer eligible to be a pharmacy intern?
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30 days
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How many CE hours are required for a California pharmacist?
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30 CE hours every 2 years
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How long does a California pharmacist need to keep CE records?
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4 years
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What can the California Board of Pharmacy do if a pharmacist does not comply with the CE requirements?
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The BOP can put the pharmacist's license on an INACTIVE status
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What are the requirements of a Pharmacy-Intern?
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Currently enrolled in a pharmacy school or have completed coursework at a recognized school of pharmacy
Require community and institutional pharmacy experience |
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What is the minimum amount a pharmacist intern card is valid?
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5 years
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Under what circumstances (and for how long) can a pharmacist intern card be extended?
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1-2 more year (total maximum of 7 years) for foreign graduates or Out of State Pharmacists
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When is an intern pharmacist licensure not extended?
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Individual who has failed licensure exam 3 times
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How many times can a board applicant take the pharmacist licensure exam?
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4 times
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What happens if a board applicant fails the pharmacist licensure exam four times
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Applicant is required to successfully complete a minimum of 16 semester units of pharmacy education before being allowed to retake the board exam
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How long does a pharmacist intern have to notify the Board of Pharmacy about a change of address or they are no longer eligible to be a pharmacy intern?
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30 days
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What are the responsibilities of the pharmacist intern?
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Can perform all the duties of registered pharmacist
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What can't a pharmacist intern have?
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Pharmacist intern cannot be in posesssion of the key that opens/closes the pharmacy
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What are the Pharmacist licensure requirements for a Pharmacist Intern? (When can a Pharmacist Intern apply for Pharmacist licensure?)
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>1500 hours of experience under registered pharmacist supervision
Community and institutional experience Signed affidavit of completed hours |
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How many Pharmacy Interns can a Preceptor Pharmacist supervise simutaneously?
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2 pharmacist interns
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What's the maximum externship hours a pharmacy intern can be granted by the Board of Pharmacy?
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600 hours
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What's the maximum hours for a first year pharmacy intern can accrue?
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250 hours
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Must all pharmacy technicians be registered with the CA state board of pharmacy?
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Yes, and certified within 1 year unless they work in a correctional facility, State mental health facility, Juvenile Detention, or VA
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What are the 5 tasks a pharmacy technician may perform?
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1. REMOVING a drug or DRUGS FROM STOCK. This also include controlled substances for the filling of controlled substance prescriptions by the pharmacy technician
2. COUNTING, pouring, or MIXING pharmaceuticals 3. PLACING a PRODUCT INTO a CONTAINER 4. AFFIXING a LABEL or labels to the container 5. PACKAGING and repackaging a product |
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When is tech-check-tech activities legal?
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General acute care hospital with ongoing clinical pharmacy program
Techs can check floor and ward stock, unit dose for patients Pharmacy has a description of the clinical program prior to initiating the activity PIC is responsible for ensuring the tech-check-tech functions are carefully monitored Program shall be under the direct supervision of a pharmacist whose supervision will be spelled-out in the hospital's P&Ps along with ongoing evaluations of the program Pharmacy technicians that participate will require specialized advanced training as described by the P&Ps |
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When is tech-check-tech activities illegal?
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Compounded or repackaged products must be checked by the pharmacist
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What are the pharmacy technician educational/training standards?
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Associate of Arts (A.A) degree has been earned in an area of study related to the duties performed by a pharmacy technician
The pharmacy technician candidate has completed programs specified by the Board of Pharmacy (240 hours of instruction) The candidate is eligible to take the board's pharmacist licensing exam A pharmacy technician program accredited by American Society of Health Systems Pharmacists A pharmacy technician program provided by a branch of the federal armed services where the applicant possesses a certificate of completion |
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How many minimum hours of instruction is required for a pharmacy technician to have successfully completed in order to be issued a pharmacy technician certificate from the Board of Pharmacy?
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240 hours
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How long does a pharmacy technician that became a pharmacist have to return their pharmacy technician certificate back to the board?
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15 days of receipt of the pharmacist license
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How many total experiential hours must be satisfied for pharmacy technician trainees?
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320 hours
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How many community experiential hours must be satisfied for a pharmacy technician trainee?
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120 hours
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How long does a pharmacy technician trainee have to complete their required experiential training hours?
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6 consecutive months
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How many hospital experiential hours must be satisfied for a pharmacy technician trainee?
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200 hours
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How long does have a pharmacy technician trainee have to complete their required hospital experiential hours?
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12 consecutive months
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How many pharmacy technician trainees can be in the pharmacy at a time?
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One pharmacy technician trainee for every one pharmacist on duty
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How is a pharmacy technician trainee distinguished in the pharmacy?
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Pharmacy technician trainee must wear identification that indicates that they are a student trainee
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How many pharmacy technicians may be on duty when a single pharmacist is on duty?
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1 pharmacy technician
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How many pharmacy technicians may be on duty when two pharmacists are on duty?
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3 pharmacy technicians (1:1 for the first pharmacist on duty and 2:1 for the second pharmacist on duty)
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What can a pharmacist do if they refuse to supervise two pharmacy technicians simultaneously?
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Inform the PIC in writing indicating the reason for refusal within a reasonable period, not to exceed 24 hours after a job schedule is posted indicating the times when a second technician is to be assigned
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When can two pharmacy technicians be on duty for a single pharmacist in a community pharmacy setting?
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When the community pharmacy engages in the filling of inpatient orders for a licensed health agency
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What happens to the second technician when a community pharmacy that engages in the filling of inpatient orders for a licensed health agency is finished with their inpatient orders for the day?
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The second pharmacy technician can go home for the day
The second pharmacy technician can no longer engage in pharmacy technician activities, but they can assume the duties ordinarily delegated to a pharmacy clerk The second pharmacy technician must remove their badge identifying them as a pharmacy technician when acting as a pharmacy clerk |
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How long does a pharmacy need to keep records showing that the pharmacy technician duties were in compliance with the state job description and the policies and procedures for a pharmacy technician?
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3 years
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What are the board examination or testing requirements for the certification of pharmacy technicians in CA?
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Trick question, there are no requirements for pharmacy technician certification at this time, but the board is seriously considering enacting regulations that will require new pharmacy technician candidates to take a "Certification Examination" and to take continuing education courses similar to the pharmacist requirement in CA
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What is the ratio of pharmacy clerks to pharmacists requirement?
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Trick Question. There are no set ratios regarding the number of pharmacy clerks for each pharmacist
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What duties may a pharmacy clerk engage in?
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Type prescription labels
Enter prescription information into the pharmacy's electronic record-keeping system Request and receive refill authorizations Stock drugs Answer phone calls Ring up prescription sales |
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How many pharmacy interns may a single pharmacist have at any time?
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2 pharmacy interns
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If there are 3 pharmacists on duty what are the maximum number of pharmacy technicians allowed to be on duty?
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5 pharmacy technicians
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What is a "Representative-in-Charge"?
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An individual in charge of a veterinary food-animal drug retail business or Drug wholesaler
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Does a "Representative-in-charge" have to be a pharmacist?
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No
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What is a "Representative"?
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An individual that is an employee at a veterinary food-animal drug retail business or Drug wholesaler
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How frequently is the license renewed for a non-pharmacist "representative" at a veterinary food-animal drug retail business or Drug Wholesaler?
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Annually
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How long does a veterinary food-animal drug retail business of Drug Wholesaler have to notify a change in the representative-in-charge to the Board of Pharmacy?
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30 days
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What are the education requirements for a "representative"?
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High school graduate or equivalent
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What are the training requirements for a "representative"?
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State and federal laws involving the distribution of dangerous drugs, devices and controlled substances
Quality assurance systems USP standards relating to the safe storage and handling of drugs Prescription drug terminology, abbreviations, and dosages Additional information to be determined by the BOP |
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What are the work requirements for a "representative"?
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1 year of paid work experience related to the distribution or dispensing of dangerous drugs or devices or meet all the prerequisites to take the pharmacists licensure exam
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Under what circumstances can a pharmacist dispense prescription drugs or devices to a physical therapist?
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A pharmacist may furnish a dangerous drug or device to a physical therapist as long as that drug or device is common to the specific services these health care professionals render to patients.
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What documentation is required for a pharmacist to furnish a drug or device to a physical therapist?
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The pharmacist must keep a record containing the DATE of the transaction, the NAME and ADDRESS of the physical therapist, NAME and QUANTITY of the drug or device dispensed
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What kind of documentation does a pharmacist need to keep showing the provision of devices from a supplier?
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DATE of the transaction, NAME and ADDRESS of supplier, and the BUYER and a DESCRIPTION of the device and quantity supplied
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Who may phone in the prescription from a prescriber's office?
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Any employee of the prescriber may call in the prescription with the exception of emergency Schedule II controlled substances.
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May prescriptions from prescribers be electonically transmitted to a pharmacy?
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Yes. While CA allows e-prescribring for prescription drugs including controlled substances, the DEA does not encourage it. However, the CA Pharmacy, Dentail and Medical Boards are supporting the activity to increase efficiency and reduce expanses.
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What types of transmission are considered electronic?
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Fax, Data transmission via Internet
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What information is a pharmacist not required to record for an oral or electronic data transmission prescription?
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Address, telephone number, license classification, federal registry number of the prescriber or the address of the patient if the information is readily retrievable in the pharmacy
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Is a pharmacy required to create a hard copy or write an electronic prescription?
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No, if the pharmacy is able, upon request by the Board, to immediately produce a hard copy report of the requested prescription (except Schedules II, IV, or V)
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How long does a pharmacy have to have electronic transmission prescriptions available?
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3 years
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What schedule of controlled substances may be transmitted electronically?
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Schedule II, III, IV, V
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What Schedule Controlled Substances must be producted in hard copy form, signed, and dated by the dispensing pharmacist when the prescription is transmitted orally or electonically?
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Schedules III, IV, or V
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What does a pharmacist need to do when a prescriber electronically transmits a prescription for Schedule II, III, IV, or V controlled substances?
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Produce HARD COPY form, SIGNED and DATED by the dispensing pharmacist
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What is required if a pharmacist needs to change a computerized pharmacy record after the drug has been dispensed?
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The DATE shall be entered when the change was made, the IDENTITY of the person or PHARMACIST MAKING the change, the IDENTITY of the PHARMACIST APPROVING the changes.
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Who may phone in/electronically transmit a prescription order from a health care facility?
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RPh/PharmD, RN, Licensed Vocational Nurse, Licensed Psychiatric Technician, or other Healing Arts licentiates
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Does the person calling in/electronically transmitting the prescription have to be employed by the health care facility?
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No, the person may either be a consultant to the facility or be employed by the facility. The person must be authorized by means of an administrative written procedure to forward prescription orders to a pharmacy.
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Who may receive an orally transmitted prescription order from a licensed prescriber's office?
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Pharmacist, Pharmacy Intern (the pharmacist must initial the prescription indicating they received the prescription)
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Who may receive a refill authorization from a prescriber's office?
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Pharmacy clerk or technician
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Who may request a refill authorization from a prescriber's office?
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Pharmacy clerk or technician
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Who may accept a modification to a prescription order over the phone?
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Pharmacist/Pharmacy Intern
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May a pharmacist fill a prescription from another state?
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A pharmacy in CA may fill prescriptions issued by licensed prescribers located in other states
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Is a CA security prescription form required when a controlled substance prescription is being called in from out of state?
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No, the CA security prescription form need not be used since the prescription can be transferred byt he pharmacist onto the pharmacy's blank prescription pads
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May a pharmacist fill a prescription from out-of-country?
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No, as a general rule, a pharmacist may not fill a prescription from another country. However, there are laws both state and federal that allows for the filling of prescriptions from DC and US territories including PR, the Virgin Islands, Guam, and American Samoa
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What if a prescription drug does not contain an expiration date?
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The drug is considered expired under law and may not be dispensed pursuant to a patient's prescription.
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What should a pharmacy do if they encounter a prescription drug without an expiration date.
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The drug product should not be in the pharmacy's stock and should either be destroyed or sent back to the supplier.
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What Beyond Use date should be used for a compounded non-sterile product?
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6 months unless any of the ingredients used are less than the 6 month expiration date
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What expiration date should be used for extemporaneously prepared unit does drug packaging?
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1 year or less (if manufacturer date is less than 1 year)
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What expiration date should be used for products produced by the drug manufacturer?
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Exact expiration date imprinted on the drug manufacturer's container or possibly a one year expiration date
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May a pharmacist fill a preprinted, multiple check-off prescription that has more than one drug item (not scheduled controlled substance) checked-off?
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Yes, as long as the prescriber indicates the number of drugs they have prescribed
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Under what circumstances can a preprinted, multiple check-off prescription be used for a controlled substance?
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1. It is preprinted on a special security prescription form
2. It is validated by the pharmacist and transferred to a blank pharmacy prescription form |
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What are the refill limits on a prescription that has a PRN refill designation?
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1 year or less for nonscheduled prescriptions, no prescription for controlled substance may be designated refillable as needed
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Under what circumstances may a pharmacist refill a non-controlled substance that has PRN refills beyond 1 year?
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If the prescriber is unavailable to authorize the continuance of the prescription and in the pharmacist's professional judgment, failure to refill the prescription might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well being
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What documentation is required for a pharmacist that decides to refill a prescription for a non-controlled substance with PRN refills after 1 year?
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Pharmacist shall inform the prescriber within a reasonable period of time and maintain a record of providing the refill and the basis for their judgment to provide the patient with the refill prescription
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May a pharmacist deviate from the way a prescription is written?
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No, only if the prescriber is contacted to authorize the change
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May a pharmacist refuse to fill a prescription based upon religious, moral, or ethical concerns?
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A pharmacist shall not obstruct a patient from obtaining a prescription drug or device, that pharmacist may refuse the filling of a given prescription item if that pharmacist originally notifies their employer of the objection and that pharmacy, pharmacist, or employer makes reasonable accomodations to ensure that the patient obtains the prescription item in a timely manner
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What must a pharmacist do if they plan to refuse to fill a prescription for a given class or classes of drugs or devices?
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The pharmacist must notify their employer in writing upon being employed or at a time when such religious, moral, or ethical concerns arise in order for the employer to establish the written policy setting forth the procedures that will ensure that the patient will receive the prescribed drug or device in a timely and reasonable manner
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What must a pharmacist do if they find a prescription to be harmful to a patient?
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The pharmacist must contact the prescriber in an attempt to have the prescribermake any necessary changes
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What must a pharmacist do if the drug in not in the pharmacy's stock and there is otherwise no reason not to fill the prescription?
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Immediately notify the patient and arrange for the drug to be delivered to the patient in a timely manner
Transfer the prescription to another pharmacy Return the prescription to the patient and refer them to another pharmacy that stocks the prescription |
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May a prescription be written an filled for an "off-label" use?
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Yes
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How much should a Medicare beneficiary be charged for a prescription medication (not OTC, not compounded)?
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Medicare beneficiaries are to be charged a price that does not exceed the Medi-Cal reimbursement rate for prescription medications or an amount as set by the State Department of Health Services to cover electronic transmission charges
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What prescription blank must be used for Medi-Cal or Medicaid outpatients?
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All written prescription for Medi-Cal or Medicaid outpatients are required to be written on tamper-resistant prescription blank (even for non-prescription drugs)
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What tamper-resistant elements are required for a prescription pad use for Medicaid prescriptions?
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One or more industry-recognized features designed to prevent:
Unauthorized COPYING of a completed or blank prescription. ERASURE or modification of information written on a prescription by the prescriber Use of COUNTERFEIT prescription forms |
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Which prescription forms have more regulations: Medi-CalMedicaid or CA secure controlled substance forms?
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CA secure controlled substance forms
Controlled substance prescription written on Medi-Cal prescription pads containing only the 3 requirements (Copying, Erasure, Counterfeit-prevention) are in violation of the safety code |
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Does the Medi-Cal tamper resistant form requirements apply to e-prescriptions, faxed prescriptions, or phoned in prescriptions from the prescriber?
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No
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Under what circumstances may a pharmacist place false or misleading information on a prescription label?
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Prescriber writes for it as part of clinical trial or if in the medical judgment of the prescriber labeling is appropriate for the proper treatment of the patient (e.g. patient may have addiction problem, so the prescriber requests placebo with name of active drug)
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When can a pharmacist give rebates or discounts to others for referral?
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The pharmacy cannot provide gifts or morney as an inducement or an award for sending a customer to a pharmacy
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When can a prescriber give a gift or money to a pharmacy or pharmacist for a referral?
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TRICK QUESTION, the prescriber cannot do that
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What is the "Drug Diversion" Law?
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Originally associated with the "Prescription Drug Marketing Act"
Intended to discourage a resale of drugs by a nonprofit pharmacy to a for-profit pharmacy |
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When can a pharmacist purchase a drug at a lower price from another pharmacy and sell the drug on prescription at their usual price?
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When for the persons own use.
Where the lower-cost drugs are sold to a purchaser also eligible for those prices under the Nonprofit Institutions Act When sold to a walk-in customer with a prescription provided that those sales represent less than 1% of the drugs purchased annually by the pharmacy If a specific drug is not readily available for a patient with an emergency prescription, a for-profit pharmacy may borrow the drug from a non-profit pharmacy and dispense it to a patient at the for-profit pharmacy's U&C prescription price. |
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What additional steps are required if a specific drug is not readily available for a patient with an emergency prescription and the for-profit pharmacy borrows a drug from a non-profit pharmacy and dispenses it at the for-profit's U&C price?
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The borrowed drug must be returned to the non-profit pharmacy exactly as it was attained originally (same drug, strength, amount, and manufacturer)
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If a specific drug is not readily available for a patient with an emergency prescription can the for-profit pharmacy purchase the drug from the non-profit pharmacy?
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No, the for-profit pharmacy may NOT pruchase the drug from the non-profit pharmacy
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When can a hospital ER dispense drugs?
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Hospital outpatient pharmacy is closed an there is no pharmacist on duty.
Prescription drug is acquired by the hospital and the dispensing of the drug and amount is recorded by the pharmacy. ER pharmacy staff must believe that an outside pharmacy is not available to provide the prescription drug (only 72 hours supply can be dispensed) |
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If a hospital ER dispenses a drug they believe is not available at another outpatient pharmacy, how much drug can they dispense?
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72 hour supply
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What is an "impaired pharmacist"?
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Impaired pharmacist is one whose competency may be impaired due to the abuse of alcohol or drug substances or mental illness
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What is the "Pharmacist Recovery Program"?
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a.k.a. "Diversion Program"
Rehabilitate pharmacist through treatment programs so that they may return to the practice of pharmacy and not prose a danger to the public health and safety |
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What 4 logs must be in a compounding pharmacy?
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Compounding FORMULA and PROCEDURES
COMPOUNDING ITEM log EQUIPMENT MAINTENANCE records (including refrigerator and freezer temperature) Record of INGREDIENTS PURCHASED |
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What kind of water is ued for compounding?
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Purified water (not tap)
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What kind of alcohol is used if a compounding prescription that calls for alcohol does not specify a type?
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95% EtOH
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What is first order kinetics?
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No difference between groupsMost drugs follow first order kinetics
Drug given is proportional to Plasma concentration |
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What is zero order kinetics?
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Occurs when metabolism becomes saturated
Elimination rate is INDEPENDENT of drug concentration Phenytoin, theophylline, voriconazole follow zero order kinetics once the metabolism becomes saturated small increase in dose is proportional to large increase in drug concentration |
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What is the null hypothesis (Ho)?
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There is no difference between the two groups
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What is the alternative hypothesis (Ha)
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There is a diference between the two arms of the trial
If you reject the null hypothesis you are accepting the alternative hypothesis |
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What is the p-value?
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Likelihood null hypothesis is true
Probability result occurred by chance P<0.05 generally accepted Indicates statistical significance |
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What is a Type I error?
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Null hypothesis is true, yet rejected in error
Represented as alpha Alpha is commonly set at 0.05 5% of the time the null hypothesis will be rejected in error False positive |
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What is a Type II error?
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Null hypothesis is false, but it is accepted in error
It was concluded there was no difference when there was one False negative Beta Measures sensitivity |
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What is sensitivity?
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Test's ability to identify positive results
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What is statistical power?
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Probability test will reject the null hypothesis when the null hypothesis is false (not make Type II error)
1-Beta Higher power provide certainty null hypothesis was not rejected in error |
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What requirements are there for a prescriber to dispense drugs in their office?
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Prescriber is responsible for counting or pouring the drug into a vial or bottle and properly labeling that vial or bottle
Fulfill all labeling requirements Use childproof containers Maintain necessary records |
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What other health care professionals can hand a prescription drug to a patient of the supervising prescriber?
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NP, PA, CNM
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What other health care professionals can provide samples to a patient?
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NP, PA, CNM, ND
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What health care professionals can sign for the receipt of samples?
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NP, PA, CNM, ND
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What written disclosures need to be provided to a patient picking up a prescription at a prescriber's office?
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Patient has a choice to obtain the prescription from either the prescriber or from a pharmacy of their choice
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What are considered acts of unprofessional conduct?
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Violation or attempted violation of the law
Assisting in or abetting the violation of or conspiring to violate any law Acts of gross immorality Incomptence Commision of any act involving moral turpitude, dishonesty, fraud, deceit, or corruption Gross negligence Excessing furnishing of CSs without a prescription, issued on a prescription, but not issued in the usual course of professional treatment, or issued on a prescription with the pharmacist's knowledge that the drug will be used to treat an addiction and is neither a part of any authorized methadone maintenance program nor is for any other legitimate medical purpose Knowingly making or signing any certificate or other document that falsely represents the existence or nonexistence of a state of facts Self administration of any drug in a manner that is dangerous to oneself or to others, Conviction of more than one misdeanor or any felony involving the use of any drug or alcoholic beverage, Conviction of a crime substantially related to the qualifications, functions, and duties of a licensed pharmacist Engaging in any conduct that subverts or attempts to subvert an investigation by the board, Inappropriate exercise of one's education, training and experience as a pharmacist Inappropriate exercise of the pharmacist's best professional judgment or responsibility in the dispensing of controlled substances, dangerous drugs or devices, or provision of pharmacy-related services Failure to consult with patient or prescription records on a prescription drug issue Failure to fully maintain and retain appropriate patient specific information pertaining to performance of any pharmacy-related function |
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Can a pharmacy-related disciplinary action in another state cause this state to take disciplinary action?
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Yes
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What prescription drug forms are required to be placed in child resistant packaging?
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Oral and external use (NOT required for topical or non-oral administration)
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What documentation is required for patients requesting non-childproof containers?
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TRICK QUESTION, the law does not require that such a request be furnished in writing or signed by the patient, but it is HIGHLY RECOMMENDED that written documentation exist if the patient opts to waive the receipt of their prescription in a child resistant safety container
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How many hospital beds require a pharmacist full-time?
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101 beds or more
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Who may oversee the purchase, storage, and provision of drugs in a hospital with 100 or fewer beds?
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Physician
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If a hospital has 100 or less beds and they do not choose to employ a pharmacist, what kind of pharmacist, if any, is required?
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Consultant pharmacist
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What are the inpatient dispensing requirements for a hospital with 100 beds or less?
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Drugs may be dispensed to patients who are being discharged,
For emergency cases under treatment in the hospital |
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What are the outpatient dispensing requirements for a hospital with 100 beds or less?
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The physician determines that it is in the best interest of the patient that a particularly drug regimen be immediately commenced or continued
The physician reasonably believes that no other pharmacy is available and accessible to the patient within 30 min or a 30 mi radius of the hospital Physician provides no more than a 72 hour supply Properly labeled medication |
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What are the maximum number of hours a day a pharmacist with non-exempt status can work in one week?
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9 hours with 1 hour break
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What are the maximum number of hours a week a pharmacist with non-exempt status can work in one week?
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54 hours with 1 hour break over 6 days
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What are the overtime pay requirements for a pharmacist with non-exempt status that works beyond 8 hours per day or 40 hours per week?
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1.5 times pay beyond 8 hours or 40 hours per week
2 times pay beyond 12 hours per day |
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Under what circumstances can the nonexempt status for a pharmacist allow 10 hours per day and 40 hours per week?
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2/3 vote for an alternative workweek
Alternative workweeks is adopted pursuant to a collective bargaining agreement In cases of emergency or where there is a need to protect life Where a pharmacist employee works at one pharmacy for 40 hours per week while working part-time at another unrelated pharmacy) |
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What activities may be performed while a pharmacist leaves for a meal break or other break?
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Pharmacy may remain open
No prescription medication may be provided to a patient unless the prescription medication is for a refill medication that pharmacist has checked Ancillary staff may continue non-discretionary duties authorized to them by pharmacy law |
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How is a pharmacy intern considered when a pharmacist leave for a meal break or other break?
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Ancillary staff and may not perform discretionary duties
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How long can a pharmacist leave for a meal break or other break?
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30 minutes
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Under what circumstances can pharmacist provide a drug to an officer of an ocean vessel?
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With a written prescription
Prescription drugs shall be ordered on the ocean vessel's official stationary and signed by the first officer Drugs shall be maintained on the vessel and dispensed by a registered medical officer Drugs shall be furnished in a sealed container to the ship's first officer or delivered directly on board Controlled substances shall be distributed in accordance with federal requirements |
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How long does a pharmacy have to give notice to the Board of Pharmacy that they are furnishing prescription drugs to officers of an ocean vessel?
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30 days
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How long does a pharmacist or pharmacy have to file a written appeal regarding an issued citation by a board inspector?
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30 days
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How long does a pharmacist or pharmacy have to request an office conference with the Board of Pharmacy regarding an issued citation by a board inspector?
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14 calendar days
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How long does the Board of Pharmacy have to report the findings in writing from the office conference?
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14 days of the office conference
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How long does a pharmacist or pharmacy have to request a formal hearing before an administrative law judge?
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30 days of issuance of the office conference decision
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What does an "Order of Abatement" mean?
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A request by means of citation that something be taken care of or be corrected (e.g sink with hot and cold running water if a sink happens not to be there or is not working properly)
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How long does a cited person or entity who has been issued an "Order of Abatement" have to submit a written request for an extention if they are unable to complete a correction within the time set forth in a citation because of conditions beyond their control?
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Requests for extention must be made within the time set forth for abatement
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What is a pharmacy required to do if they employee someone with a known mental, substance abuse or criminally related problem?
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Procedures must be in place for taking action to protect the public against any potential problems
(e.g. listing signs or symptoms common to impairments and a description of the action to be taken when impairment noted presents itself) |
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How long does a pharmacy have to report to the Board of Phamacy that a licensed employee of the pharmacy engaged in theft or impairment?
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14 days
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What type of information must a pharmacy submit to the Board of Pharmacy regarding a license employee of the pharmacy engaged in theft or impairment?
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Licensee ADMISSION of PHYSICAL IMPAIRMENT affecting the employee's ability to practice
Licensee ADMISSION of THEFT, diversion, or self-use of dangerous drugs Any VIDEO or documentary evidence DEMONSTRATING IMPAIRMENT of a licensee Any VIDEO or documentary evidence DEMONSTRATING THEFT, diversion, or self-use of drugs by licensee Any TERMINATION of licensee BASED ON THEFT, diversion, or self-use of dangerous drugs Sufficient detail to inform the board of the facts upon which the report is based, including an ESTIMATE of the TYPE and QUANTITY of all dangerous drugs involved, the TIMEFRAME over which the LOSSES ARE SUSPECTED, and DATE of the LAST CONTROLLED SUBSTANCE INVENTORY. UPON REQUEST of the Board, the pharmacy shall prepare and submit an AUDIT involving the DRUGS SUSPECTED TO BE MISSING |
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What happens to the party that reports a licensee has engaged in theft or impairment issue?
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The party making the good faith report to the Board is granted immunity from any liability, civil, or criminal
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What happens if a pharmacist forgets to renew his or her license?
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Pharmacist license needs to be renewed every 2 years
If the pharmacist does not renew their license within 3 years, it may not be renewed and canceled at the end of the 3 year perior |
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What would happen to a pharmacist if they failed to renew their license within 3 years?
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Pharmacist would need to retake the board examination and pass in order for reinstatement
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Under what circumstances may a pharmacist license may not be renewed by the Board of Pharmacy?
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Pharmacist is not making court-ordered child support payments or has defaulted on a government issued student loan
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How much minimum settlement money must be reported to the Board of Pharmacy when a Pharmacist loses a pharmacy-related lawsuit?
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$3000.
Settlement or arbitration awards where the pharmacist must pay-out $3000 or more as the result of a pharmacy related matter, must be reported by either the pharmacist or the licensed pharmacist's insurer to the Board |
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How long does a pharmacist or the licensed pharmacist's insurer have to report a settlement of >$3000 to the Board of Pharmacy?
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30 days after the settlement or arbitration award is finalized and provided to all parties
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Can Schedule III, IV, or V controlled substances be sent from a prescriber over the Internet to a pharmacy?
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Yes
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What is an "appropriate prior examination" entail with regards to a prescription submitted over the Internet from a prescriber's office to a pharmacy?
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Existence of a prescriber-patient relationship
Medical records kept by the prescriber on the medical or vetinary care of the patient A physical examination or at least a line of questioning by the prescriber to ascetain the nature of the medical problem |
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What is the fine to a pharmacy or pharmacist for a violation of the requirement for Internet transmission of a prescription?
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$25,000 per occurrence
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How many minimum Medi-Cal fraud convictions are allowed before the Board of Pharmacy can revoke a pharmacist's license?
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2 prior cases
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What happens if a candidate for a license violates the Examination Security Acknowledgement?
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Any applicant for any license issued by the Board who removes all or part of any qualifying examination to any other person may be disqualified as a candidate for a license
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What responsibilities are there for health care professionals that fall under international law?
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Licensed health care professionals are obligated to report the appropriate authorities regarding acts of torture, coercisve interrogation with regards to the treatment of detainees
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Should a pharmacist fill a prescription for a celebrity using a fictitious name entered on the prescription by the prescriber?
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No.
No person shall, in connection with the prescribing, furnishing, administering, or dispensing of a drug, give a false name or false address |
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What is Relative Risk (RR)?
|
Probability of an event occurring in the exposed group vs a non-exposed (or control) group
Expressed as a fraction or percentage of the risk to the control group Relative Risk = 1 indicates no difference between comparison groups RR < 1 means that the intervention reduced the risk of the outcome only provides a measure of what the risk of an event is in one group compared to the risk of that event in a comparison group |
|
|
What does a RR = 1 mean?
|
No difference between comparison groups
|
|
|
What does RR > 1 mean?
|
Intervention reduced the risk of outcome
|
|
|
How do you calculate RR?
|
Disease progression in variable group (16%) over disease progression in control group (28%) = 0.57 RR
Subjects treated with drug X were only 57% as likely as placebo-treated patients to have disease progression |
|
|
What is Relative Risk Reduction (RRR)?
|
1-RR
only provides a measure of what the risk of an event is in one group compared to the risk of that event in a comparison group |
|
|
How do you calculate RRR?
|
1-RR
|
|
|
What does a RRR of 0.43 mean?
|
43% risk reduction in disease progression in patients being treated with drug X
|
|
|
What does a RR of 0.57 mean?
|
Subjects treated with drug X were only 57% as likely as placebo-treated patients to have disease progression
|
|
|
What does RR and RRR not reflect?
|
These data do not reflect how important or large the treatment effection really is in the population at-large
|
|
|
What is Absolute Risk Reduction (ARR)?
|
Absolute difference in outcome rates between the treatment and control groups
|
|
|
What is Relative Risk (RR)?
|
Probability of an event occurring in the exposed group vs a non-exposed (or control) group
Expressed as a fraction or percentage of the risk to the control group Relative Risk = 1 indicates no difference between comparison groups RR < 1 means that the intervention reduced the risk of the outcome only provides a measure of what the risk of an event is in one group compared to the risk of that event in a comparison group |
|
|
What does a RR = 1 mean?
|
No difference between comparison groups
|
|
|
What does RR > 1 mean?
|
Intervention reduced the risk of outcome
|
|
|
How do you calculate RR?
|
Disease progression in variable group (16%) over disease progression in control group (28%) = 0.57 RR
Subjects treated with drug X were only 57% as likely as placebo-treated patients to have disease progression |
|
|
What is Relative Risk Reduction (RRR)?
|
1-RR
only provides a measure of what the risk of an event is in one group compared to the risk of that event in a comparison group |
|
|
How do you calculate RRR?
|
1-RR
|
|
|
What does a RRR of 0.43 mean?
|
43% risk reduction in disease progression in patients being treated with drug X
|
|
|
What does a RR of 0.57 mean?
|
Subjects treated with drug X were only 57% as likely as placebo-treated patients to have disease progression
|
|
|
What does RR and RRR not reflect?
|
These data do not reflect how important or large the treatment effection really is in the population at-large
|
|
|
What is Absolute Risk Reduction (ARR)?
|
Absolute difference in outcome rates between the treatment and control groups
|
|
|
How do you calculate ARR?
|
Disease progression in control group (28%) minus disease progression in variable group (16%) = 12%
|
|
|
What does an ARR of 12% mean?
|
For every 100 patients enrolled, Drug X reduced disease progression by 12%
|
|
|
What is Number Needed to Treat (NNT)?
|
1/ARR
Number of people who would need to be treated with the intervention in order to prevent 1 adverse event Puts the results for a trial in a clinically relevant context |
|
|
What does an NNT=8.3 mean?
|
For every 9 patients who receive Drug X, you would expect disease progression to be prevented in 1 patient
|
|
|
What is Number Needed to Harm (NNH)?
|
1/ARR
Number of people wh would need to be exposed to the harmful agent (e.g. cigarette smoke) in order to cause 1 adverse event |
|
|
What is the Odds Ratio (OR)?
|
Ratio of the odds of an event occurring in the treatment group to the odds of an event occuring in the control group
|
|
|
What does an OR=1 mean?
|
No difference between groups
|
|
|
What does an OR<1 mean?
|
Odds ratios are very similar to the Relative Risk
|
|
|
Correlation
|
Measure of the relation between 2 variables
|
|
|
What is the Pearson Correlation Coefficient (r)?
|
Quantifies the direction and magnitude of the linear correlation
Values range from -1 to 1 |
|
|
What does r=0 mean?
|
No correlation, 2 variables do not vary together at all
|
|
|
What does positive r mean?
|
Positive correlation,directly proportional, the 2 variables tend to increase or decrease together
|
|
|
What does negative r mean?
|
Negative correlation, inversely proportional, the 2 variables tend to increase or decrease together
|
|
|
What does a r=1 mean?
|
data points form a straight line, directly proportional, 2 variables vary together completely
|
|
|
What does a r=-1 mean?
|
data points form a straight line, inversely proportional, 2 variables vary together completely
|
|
|
What does ECHO stand for?
|
Economic, Clinical and Humanistic Outcomes, related to pharmacoeconomic studies
|
|
|
What is the most common pharmacoeconomic methodology seen in literature today?
|
Cost-Effectiveness Analysis
|
|
|
What is a disadvantage of Cost-Effectiveness Analysis?
|
Inability to directly compare different types of outcomes
|
|
|
When is cost-minimization analysis used?
|
2 or more interventions have already demonstrated equivalence in outcomes and the costs of each intervention are being compared
Assumed to be equivalent in comparative groups |
|
|
What is a limitation of cost minimization analysis?
|
Limited given it can only compare alternatives with the same outcome
|
|
|
What is a cost-benefit analysis?
|
Systematic process for calculating and comparing benefits and costs of an interventionin terms of monetary units
Measured in dollars |
|
|
What is a cost-utility analysis?
|
Specialized form of cost-effectiveness analysis that includes a quality of life component associated with morbidity using common health indices such as quality-adjusted life (QALYs) and disability-adjusted life years (DALYs)
Measured in quality-adjusted-life-year (QALY) or other units |
|
|
What is Cost-Effectiveness Analysis?
|
Series of analytical and mathematical procedures that aid in the selection of a course of action from various alternative approaches
Measures natural units (life-years gained, mmHg blood pressure) |
|
|
What is the main advantage of Cost-Effectiveness Analysis?
|
Outcomes are easier to quantify when compared to other analyses
|
|
|
How long does an acknowledment of receipt of privacy practices be kept on file in a helath care organization?
|
6 years
|
|
|
What happens if a patient does not sign the receipt of privacy practices form in a pharmacy?
|
The pharmacist can sign for the patient if the patient received the notice
|
|
|
Under what 3 circumstances may a patient's information be directed without securing further approval from the patient (beyond the receipt of the privacy practices)?
|
Treatment
Payment Health care operations |
|
|
What documentation is required if a patient pays for their antidepressants out of pocket and do not want it reported to their insurance company?
|
An authorization needs to be obtained
|
|
|
When can confidentialy regarding a minor's prescription dissipate ?
|
Minor is under the age of 15 and the patient's parents are paying for the prescription
|
|
|
Can a patient's friend or family member pick up a patient's prescription?
|
Yes. The patient does not need to give the name of the individuals picking up their prescription in advance.
|
|
|
What is the minimum requirement for a quality assurance program?
|
Documents medication errors and attributes them to that pharmacy or their personnel
|
|
|
Are the medication error records subject to discovery in arbitration, civil actions, or other proceedings?
|
No
|
|
|
When can the Board of Pharmacy review a pharmacy's medication error records?
|
As necessary to protect the public health and safety
|
|
|
What is a "medication error"?
|
Any variation from a prescription or drug order not authorized by a prescriber. If there is a significant or unreasonable dealy in the patient receiving their prescription, this can be construed as a medication error.
|
|
|
Who must be notified when there is a medication error?
|
Pharmacist, prescriber, patient
|
|
|
How long does a pharmacy have to investigate a medication error?
|
2 business days from the date the error was discovered
|
|
|
What must a Quality Assurance Report include?
|
Date, location, and participants in the Quality Assurance review
Pertinent data and other information relating to the medication error(s) reviewed and documentation fo any patient contact Findings and determinations generated by the Quality Assurance review Recommended changes to pharmacy policy, procedures, systems, or processes, if any |
|
|
How long does a Quality Assurance record for a given situation have to be stored and immediately retrievable in the pharmacy?
|
1 year from the date the record was created
|
|
|
Which report is discoverable in arbitration: Incident Report or Quality Assurance Report?
|
Incident Report.
Incident report is discoverable in arbitration. |
|
|
Should quality assurance reports be sent to the pharmacy's insurance company?
|
No, quality assurance report is not provided to the pharmacy's insurance company and is maintained in the pharmacy
|
|
|
What is included in an incident report?
|
Incident report provides an account of WHO, WHAT and WHEN was involved in a medication error
|
|
|
Which should include an action plan to prevent a specific medication error from reoccurring: Incident Report or Quality Assurance Report?
|
Quality Assurance Report.
The quality assurance report provides an account of WHO, WHAT, and WHEN as well as what was LEARNED and DONE to AVOID the error in the future |
|
|
Which report requires the names of the parties involved: Incident Report or Quality Assurance Report?
|
Incident Report
Incident report must include the names of the parties involved in the incident |
|
|
Which report only requires the employment classification (e.g. pharmacist, technician, etc) of the parties involved in a medication error: Incident Report or Quality Assurance Report?
|
Quality Assurance Report.
Quality assurance report only needs to include the employment classification of the parties involved in the medication error incident. |
|
|
If a PharmD has a PDP which allows them to prescribe Controlled Substances what additional registration is required?
|
PharmD must register with DEA
|
|
|
Can pharmacists legally participate in immunization programs?
|
Yes with a PDP
|
|
|
What is the minimum amount a patient's medication profile must be kept on file?
|
1 year since the last medication fill
|
|
|
What patient care activities may a pharmacist engage in with a PDP?
|
Ordering or performing routine drug therapy related patient assessment procedures
Obtaining vitals Ordering drug therapy related lab tests Administering drugs and biologicals by injection Initiating and adjusting a drug regimen of a patient |
|
|
Can a pharmacist engage in patient care activities pursuant to a PDP in a community setting?
|
Yes
|
|
|
How many physicians must support the extended scope of practice for a physician to engage in patient care activities?
|
At least 1
|
|
|
How long does a pharmacist have to provide a written report to the supervising physician regarding a change, initiation, adjustment, or modification to an approved preexisting drug therapy?
|
24 hours
|
|
|
What types of skin punctures may a clinical pharmacist perform?
|
Procedure a patient could perform on themselves
CLIA certified |
|
|
If a pharmacist had a PDP to administer immunizations would the prescriber have to be present at the time of injection?
|
No
|
|
|
If a pharmacist had a PDP to administer immunizations would the prescriber have to write individual prescriptions for the patient to receive the immunization?
|
No
|
|
|
What is the National Vaccine Injury Compensation Program (NVICP)?
|
Awards compensation to children who may be injured by an immunization product
|
|
|
What is the maximum compensation per claim for the NVICP?
|
$250,000 per claim
|
|
|
Would adverse reactions from an immunization be covered under the NVICP?
|
Yes
|
|
|
Would negligence be covered under the NVICP?
|
No
|
|
|
What is a pharmacist authorized to do when taking a patient's blood pressure?
|
Inform the patient of the result
Render an opinion as to whether the reading is within high, low, or normal range Advise the patient to consult a physician if necessary |
|
|
What schedule substances may a pharmacist refill a prescription without authorization because the prescriber cannot be immediately reached and failure to refill the prescription might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being?
|
Nonscheduled, Schedule III, IV, and V
|
|
|
How much nonscheduled drug can a pharmacist refill without prescriber authorization?
|
Full refill
|
|
|
How much Schedule III, IV, or V drug can a pharmacist refill without prescriber authorization?
|
Only a reasonable quantity of the drug until the prescriber can be contacted
|
|
|
How much Schedule II drug can a pharmacist refill without prescriber authorization?
|
TRICK QUESTION. Schedule II controlled substances cannot be refilled without the execution of a new written security prescription or an emergency call to the pharmacy by the prescriber to continue the Schedule II drug followed by the issuing of a new security prescription within 7 days after telephoning in the emergency order
|
|
|
How long does a prescriber have to send in security prescription for an emergency Schedule II that was phoned in?
|
7 days
|
|
|
A pharmacist decides to refill a prescription without authorization because they believe that not continuing the medication may pose a hazard to the patient's health. The pharmacist is only providing a reasonable quantity to allow for a prescriber to be contacted. Can the pharmacist put the medication in the old prescription bottle that the patient came in with?
|
No. The reasonable supply of the drug is to placed in a new container that is properly labeled.
|
|
|
What must the pharmacist inform the patient of when they decide to refill a prescription for a reasonable quantity without prescriber authorization?
|
Pharmacist should tell the patient that no additional refills will be dispensed without prescriber authorization and the refill was authorized by the pharmacist without prescriber authorization.
|
|
|
What must a pharmacist document on the back of the prescription that was refilled without prescriber authorization?
|
DATE and REASONABLE AMOUNT of drug dispensed, the REASON for continuing the drug, and the INITIALS of the pharmacist filling the prescription
|
|
|
What happens if there is a government declared "State of Emergency" and a patient that does not have a prescription record at a pharmacy requests a refill without prescriber authorization?
|
Pharmacist may provide reasonable quantities to the patient
|
|
|
What are the ways emergency oral contraception can be obtained?
|
1. Physician prescription
2. Specially trained pharmacist provide the emergency contraception pursuant to the CA State Protocol or by a PDP 3. Sale of Plan B OTC |
|
|
Can a physician write and can a pharmacist fill a prescription for emergency oral contraception for a patient under the age of 18?
|
Yes
|
|
|
Does a pharmacist require specialized training in order to dispense emergency oral contraception to a patient when the prescription was written by a physician?
|
No
|
|
|
Can a pharmacist charge a $10 administrative fee related to dispensing emergency oral contraception to a patient when the prescription was written by a physician?
|
No
|
|
|
Can a pharmacist charge a $10 administrative fee related to dispensing emergency oral contraception to a patient when the prescription was dispensed pursuant to a state or PDP?
|
Yes
|
|
|
Does a pharmacist require specialized training in order to dispense emergency oral contraception to a patient when the prescription was dispensed purusant to a state or PDP ?
|
Yes
|
|
|
How many CE hours must a pharmacist complete to become specially-trained in dispensing emergency contraception?
|
1 hour
|
|
|
What are the specific counseling points that a specialily-trained pharmacist in dispensing emergency contraception must cover?
|
ALLERGIES
TIMING (Emergency contraception should be initiated up to 5 days (120 hours) of unprotected intercourse) FACT SHEET ADJUNCTIVE MEDS to prevent NAUSEA and VOMITING |
|
|
Can a pharmacist dispense Emergency Contraception in advance of the patient's anticipated need for emergency contraception?
|
Yes
|
|
|
Is physician examination required prior to dispensing emergency contraception using a PDP or statewide? standardized protocol
|
No
|
|
|
Are patients who have medical insurance required to pay the $10 administrative fee when emergency contraceptive is dispensed?
|
No
|
|
|
Can a specially-trained pharmacist following a PDP or statewaide protocol provide emergency oral contraception to patients under the age of 18?
|
Yes
|
|
|
Can levonorgestrel be sold in retail businesses?
|
No
|
|
|
Where is OTC levonorgestrel to be stored?
|
Behind the pharmacy counter
|
|
|
How old does a patient have to be to get levonorgestrel OTC?
|
17 or older
|
|
|
Can a male or family memebrs or friends purchase levonorgestrel if they are over 17?
|
Yes
|
|
|
How many packages of levonorgestrel can a person purchase at one time?
|
TRICK QUESTION, there is no limit, a person can purchase more than 1 package of levonorgestrel at a time
|
|
|
Can a pharmacist charge a $10 administrative fee for the dispensing of OTC levonorgestrel?
|
No
|
|
|
What counseling points must a pharmacist or pharmacy intern provide to a patient purchasing levonorgestrel OTC?
|
TRICK QUESTION, there are no counseling points required
|
|
|
Who may transact a sale of OTC emergency contraception?
|
Only the pharmacist or pharmacy intern (under supervision of the pharmacist)
|
|
|
Can a physician write a prescription for levonorgestrel?
|
Yes
|
|
|
Can a physician write a prescription for levonorgestrel for a patient under the age of 18?
|
Yes
|
|
|
What happens when a patient tests positive for HLA-B*5701 gene prior to initiating abacavir (ZIAGEN)?
|
Drug cannot be used
|
|
|
How does hypersensitivity to abacavir (ZIAGEN) present?
|
2 or more of the following symptoms:
Fever Rash GI (n/v/d/abd pain) Constitutional (fatigue, achiness) Respiratory (dyspnea, cough, pharyngitis) |
|
|
What do you do if a patient presents with symptoms of hypersensitivity to abacavir (ZIAGEN)?
|
Discontinue as soon as hypersensitvity reaction is suspected
|
|
|
What happens when an Asian patient tests positive for the HLA-B*1502 gene prior to intiating carbamazepine (TEGRETOL)?
|
Do not use carbamazepine unless the beneits outweigh risk (dermatological reactions: Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS))
|
|
|
What happens when a patient is HER2/neu oncogene positive prior to initating trastuzumab (HERCEPTIN)?
|
Drug can be used. HER2/neu over-expression required for use
|
|
|
What happens when a patient is anaplastic lymphoma kinase (ALK) positive prior to initiating crizotinib (XALKORI)?
|
Drug can be used
|
|
|
What is the indication for crizotinib (XALKORI)?
|
Locally advanced or metastatic NSCLC that is ALK positive
|
|
|
What happens if a patient has a BRAFV600E mutation prior to intiating vemurafenib (ZELBORAF)?
|
Drug can be used
|
|
|
What happens if a patient has a wild-type BRAFV600E gene prior to initiating vemurafenib (ZELBORAF)?
|
Drug cannot be used
|
|
|
What is the indication for vemurafenib (ZELBORAF)?
|
Metastatic melanoma
|
|
|
What happens if a patient has a k-ras mutation prior to initiating cetuximab (ERBITUX)?
|
Drug should not be used as k-ras mutations indicate a poor response to therapy
|
|
|
What happens if a ptient has a k-ras mutation prior to initiating panitumumab (VECTIBIX)?
|
Drug should not be used as k-ras mutations indicate a poor response to therapy
|
|
|
What is the indication for cetuximab (ERBITUX)?
|
Colorectal cancer
|
|
|
What is the indication for panitumumab (VECTIBIX)?
|
Colorectal cancer
|
|
|
What happens if a patient is infected with CCR5-tropic HIV-1 prior to initiating maraviroc (SELZENTRY)?
|
Drug can be used
|
|
|
What happens if a ptient is infected with CXCR-4 tropic HIV-1 disease prior to initiating maraviroc (SELZENTRY)?
|
Drug should not be used
|
|
|
What is the indication for maraviroc (SELZENTRY)?
|
CCR5-tropic HIV-1
|
|
|
What happens if an Asian patient tests positive for HLA-B*1502 gene prior to initiating phenytoin (DILANTIN)?
|
Do not use unless benefit clearly outweighs risk
Strong association between the risk of developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) |
|
|
What happens if a patient is a poor metabolizer of CYP2D6 prior to initiating atomoxetine (STRATTERA)?
|
Increase in adverse events
May have exaggerated response (5 fold increase) to drug due to reduced rate of metabolism No recommendation, but use with caution |
|
|
If a patient is a poor metabolizer of CYP2D6 is that a contraindication to initiating atomoxetine (STRATTERA)?
|
No, there is no recommendaiton, but it should be used with caution
|
|
|
What are the adverse effects associated with atomoxetine (STRATTERA)?
|
Decreased appetite, insomnia, sedation, depression, tremor, early morning awakening, pruritus, and mydriasis
|
|
|
What happens if a patient is HLA-B*5801 positive prior to initiating allopurinol (ZYLOPRIM)?
|
Increased risk of severe cutaneous reactions
|
|
|
What are the pharmacogenomic testing recommendations for the HLA-B*5801 gene prior to initiating allopurinol (ZYLOPRIM)?
|
TRICK QUESTION. No recommendations for testing
|
|
|
What happens if a patient presents to clinic with skin rash or other signs which may indicate an allergic reaction after starting allopurinol (ZYLOPRIM)?
|
Discontinue immediately. In some instances, a skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial, and purpuric lesions as well as SJS (and/or generalized vasculitis, irreversible hepatotoxicity, and on rare occasions, death)
|
|
|
What happens if a patient is an extensive metabolizer of CYP2D6 when taking codeine?
|
Patient may have an exaggerated response to a drug due to extensive conversion to morphine metabolite
|
|
|
What is the pharmacogenomic testing recommendation for CYP2D6 testing in patients taking codeine?
|
There is no recommendation, but use with caution. CYP2D6 extensive metabolizers are common
|
|
|
What are the lactation recommendations for a mother taking codeine that is a CYP2D6 rapid metabolizer?
|
Most opioids are excreted in breast milk
Do not use codeine since rapid metabolizers of CYP2D6 enzyme will produce excessive amounts of morphine which could be fatal to the infant |
|
|
What happens if a patient has loss of function alleles at CYP2C9*2 and CYP2C9*3 prior to initiating warfarin?
|
Increased bleeding risk
More frequent INR monitoring Use lower warfarin doses |
|
|
If a patient has a genetic deficiency of Thiopurine Methyltransferase (TPMT) and is taking azathioprine what are they at risk for?
|
Increased risk of myelosuppressive effects
If patient has low or absent TPMT activity they are at risk for severe myelotoxicity |
|
|
If a patient has a genetic deficiency of Thiopurine Methyltransferase (TPMT) and is taking mercaptopurine what are they at risk for?
|
Increased risk of myelosuppressive effects
If patient has low or absent TPMT activity they are at risk for severe myelotoxicity |
|
|
What is the indication for azathioprine?
|
Solid organ cancers and leukemia
|
|
|
What is the indication for mercaptopurine
|
Solid organ cancers and leukemia
|
|
|
What happens if a patient is homozygous for UGT1A1*28 allele prior to initiating irinotecan (CAMPTOSAR)?
|
Risk of neutropenia
Initial one-level dose reduction should be considered |
|
|
What happens if a patient is heterozygous for UGT1A1*28 allele prior to initiating irinotecan (CAMPTOSAR)?
|
Lower risk of neutropenia
No dose adjustment necessary |
|
|
What happens if a patient has an A haplotype of the VKORC1 gene prior to initiating warfarin?
|
Patient will require a lower dose of warfarin
|
|
|
Who may write the date of issuance on a controlled prescription?
|
Prescriber only
|
|
|
If a pharmacy intern or technician fills a prescription whose initials must also appear on the back of the prescription before it is filed away?
|
Dispensing pharmacist
|
|
|
Is the price charged to the patient required on the back of the prescription before it is filed away?
|
No, but it is considered ethically appropriate
|
|
|
Whose initials are required when a prescription is received orally by one pharmacist and dispensed by another pharmacist, whose initials must appear on the back of the prescription label before it is filed away?
|
Both the transmitting and dispensing pharmacists initials must appear on the back of the prescription label
|
|
|
Is a pharmacist required to provide the indication on the prescription label if provided by the prescriber or requested by the patient?
|
Yes
|
|
|
What descriptive information about the tablet/capsule dispensed must appear on the prescription label?
|
COLOR
SHAPE IDENTIFICATION CODE |
|
|
Under what circumstances does a prescription label not have to include descriptive information?
|
Dispensed by VETERINARIAN
NEW DRUG (<120 days no description in reference files available) NO DESCRIPTION available in any commercially available database INPATIENT USE |
|
|
How long does a national reference file have to add drug description data to their database?
|
90 days
|
|
|
How long does a pharmacy have to add drug description data to their database for a new drug?
|
120 days
|
|
|
Are the initials of the filling pharmacist required on the back of the prescription label?
|
No
|
|
|
Are the initials of the filling pharmacy technician or intern required on the back of the prescription label?
|
Yes
|
|
|
Does the pharmacy lot number have to be on the back of the prescription label for a non-compounded prescription?
|
No
|
|
|
How often does a pharmacy consultant have to provide written reports and pharmaceutical recommendations in a hospital with 100 beds or fewer?
|
At least quarterly
|
|
|
What are the minimum personnel requirements for a P&T within a hospital?
|
1 Physician
1 Pharmacist Director of Nursing Service Hospital Administrator |
|
|
How many hours a day does a hospital have to have access to prescribed medication?
|
24 hours
|
|
|
How often do emergency trays of medication have to be inspected by the pharmacist?
|
Every 30 days
|
|
|
How long does a prescriber have to countersign a verbal order in a patient's chart in a hospital?
|
48 hours
|
|
|
How are standing orders recorded in a patient's chart in a hospital?
|
Copy of the standing order, dated and signed by prescriber should be placed in the patient's record
Specify the circumstances under which the drug is to be administered Specify the types of patient medical conditions for whom the standing orders are intended P&T approved Specific drug, dosage, rout, and frequency of administration Limited duration of therapy for the administration of the drug |
|
|
What medications can be available at the patient's bedside in the hospital?
|
No medication shall be left at the patient's bedside unless authorized by the prescriber.
If meds are allowed at patient bedside they must be kept in a cabinet, drawer or in possession of the patient No schedule II, III, and IV medications allowed |
|
|
What schedule medications are allowed at patient bedside if the prescriber allows medications at patient bedside?
|
Schedule V or below
|
|
|
Under what circumstances may medications brought in by the patient in the hospital be used?
|
The drugs have been ordered by the prescriber as well as approved for use by the prescriber with instruciton to use these medications documented in the patient's medical record
The medication containers are clearly and properly labeled The contents of the containers brought into the hospital by the patient have been examined and positively identified by either the patient's physician or the hospital pharmacist |
|
|
How are medication supplies for ward stock to be ordered in the hospital pharmacy?
|
Printed order form and approved by the P&T, nursing director, and other committees that have an interest in the treatment of patients assigned to a designated area
|
|
|
When is ward stock supposed to be available to registered nurses?
|
At all times, even when pharmacy is closed
|
|
|
What records must be maintained if ward stock is used?
|
Name and strength of drug removed and administered
Amount of drug taken Date and time the medication was taken Name of the patient to whom the drug was administered Name and signature of the registered nuse who procured and administered the medication |
|
|
Who is responsible for the maintenance and assurance that all drugs in ward stock are properly labeled and stored securely with no outdated drugs?
|
Pharmacist
|
|
|
What information should be available at the nursing station and pharmacy when administering an investigational drug?
|
Dosage form
Route of administration Strength Compounding requirements Uses Side effects Drug interactions Symptoms of toxicity |
|
|
When can a patient go home with drugs from the hospital?
|
Prescription required
|
|
|
Who must consult a patient going home from the hospital with take home medications?
|
Discharge nurse, pharmacist or physician
|
|
|
Can external drugs in liquid, tablet, capsule, or powder form be stored with drugs for internal use in hospital setting?
|
No
|
|
|
Can test agents, germicides, disinfectants, and other household substances be stored with medications in hospital setting?
|
No
|
|
|
What are the appropriate refrigerator temperature settings in a hospital to store medications?
|
2.2-7.7C (36-46F)
|
|
|
What are the appropriate room temperature settings in a hospitial to store medications?
|
15-30C (59-86F)
|
|
|
How often do drugs have to be inspected at the nursing units by the pharmacist?
|
30 days
|
|
|
What happens to extra Schedule II, III, IV medication after patient discharge from the hospital?
|
Destroyed in presence of 2 pharmacist or a pharmacist and a registered nurse
Name of the patient, name and strength of the drug, prescription number, amount to be destroyed, date of destruction, and the signatures of the witnesses required above shall be recorded in patient's medical record or in a separate log |
|
|
How long do records related to the destruction of Schedule II, III, or IV medication have to be stored?
|
3 years
|
|
|
What other method can be used for small amounts of Schedule II, III, IV medication that needs to be destroyed?
|
DEA Form 41 sent to regional DEA director who will upon receipt of the form will provide directions on how to proceed with the destruction
|
|
|
How does the regional DEA usually advise the destruction of Schedule II, III, IV medications that require destruction?
|
Return controlled substances to designated disposal site or back to the drug's manufacturer if they allow for return
|
|
|
What happens to non-scheduled drugs or Schedule V drugs not used by the patient prior to discharge?
|
Destroyed in the presence of a pharmacist and should be properly documented and witnessed
|
|
|
How many hypodermic needles or syringes may be provided to a patient over the age of 18 can a pharmacist acting under a county or city authorization program without a prescription?
|
10 hypodermic needles or syringes
|
|
|
Who must approve the selection of a Pharmacist-In-Charge (PIC) besides the owner of the pharmacy?
|
Board of Pharmacy
|
|
|
How long does a pharmacy have to suggest a replacement PIC if disapproved by the Board of Pharmacy?
|
15 days
|
|
|
What happens if a pharmacy is unable to name a PIC within 30 days that is approved by the Board of Pharmacy?
|
The pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis to act as the interim pharmacist-in-charge (for less than 120 days)
|
|
|
What happens if a wholesale or veterinary-drug/food operation is unable to name a Representative In Charge (RIC) within 30 days that is approved by the Board of Pharmacy?
|
The wholesaler/veterinary-drug/food operation may instead provide on that form the name of any representative who is an employee, officer, or administrator of business and who is actively involved in the management of the business on a daily basis to act as the interim representative-in-charge (for less than 120 days)
|
|
|
What happens if a pharmacist fails a CE audit conducted by the Board of Pharmacy?
|
Board shall cancel the active pharmacist license
Pay re-renewal fee Submit satisfactory proof of completion of 30 CE hours |
|
|
Can a pharmacist with an inactive pharmacy license practice pharmacy?
|
No
|
|
|
How does a pharmacist get inactive pharmacy license status?
|
Pharmacist notifies the board that they want an inactive status
|
|
|
Does a pharmacist need to pay the renewal fee to maintain an inactive pharmacy license?
|
Yes
|
|
|
Does a pharmacist have to complete CE requirements while maintaining an inactive pharmacy license?
|
No
|
|
|
How does a pharmacist change their inactive license status back to active?
|
Provide proof of completion of 30 CE hours
Check the ACTIVE box on the license renewal form and attach copies of certificates proving the completion of 30 hours |
|
|
Can a pharmacist who has had their license revoked, suspended, or placed on probation obtain an inactive license?
|
No
|
|
|
How long does a pharmacist have to appeal the Board's decision to put their license on inactive status because of missing renewal or failing to prove completion of CE hours?
|
Within 15 days of Board notification
|
|
|
What is a retired license issued?
|
Pharmacist wishes to retire from the practice of pharmacy
|
|
|
How does a pharmacist with a retired license regain an active license?
|
Retake NAPLEX and CPJE
|
|
|
When is a license canceled?
|
Pharmacist fails to renew their license whether active or inactive within 3 years of the license's expiration date
|
|
|
What are the 2 major changes to the pharmacist license renewal form?
|
Disclosure of prior convictions
Fingerprints for pharmacist's who obtained their license prior to 2002 |
|
|
What prior convictions need to be reported to the Board on the license renewal form?
|
Any conviction in CA or another sate
Omitting traffic infractions under $300 Any traffic infraction involving alcohol, drugs, or controlled substances |
|
|
When does a pharmacy technician or clerk have to make a pharmacist/intern take over a prescriber call for refills?
|
When the prescriber chooses to change the directions, strength, dosing frequency, or the drug itself
|
|
|
Who should take a prescriber call for a refill of a non-scheduled drug?
|
Pharmacist/intern
|
|
|
What is the refill frequency allowed for a Schedule III or IV medication?
|
5 refills or 120 days
|
|
|
Who should take a prescriber call for a refill of a Schedule III or IV drug?
|
Pharmacist/intern
|
|
|
Can a pharmacy technician or clerk request a refill for a Schedule III or IV controlled substance if the prescription has not been refilled up to 5 refills nor within the 120 days for refill within a 6 month period from the date originally written?
|
Yes
|
|
|
Can the Board require a pharmacist not only be placed on probation for a pharmacy-related violation, but also require them to take a pharmacy-related ethics course?
|
Yes
|
|
|
What are the minimum DURATION standards for a pharmacy-related ethics course that will fulfill Board requirements for a pharmacist that is on probation due to a pharmacy-related violation?
|
22 hours (14 contact hours, 8 hours for preparation, evaluation, and assessment)
|
|
|
What are the minimum FACULTY standards for a pharmacy-related ethics course that will fulfill Board requirements for a pharmacist that is on probation due to a pharmacy-related violation?
|
Instructors must have a valid unrestricted CA professional license or otherwise be qualified by virtue of prior training, education and experience, to teach an ethics or professionalism course at a university or teaching institution
|
|
|
What are the minimum CONTENT standards for a pharmacy-related ethics course that will fulfill Board requirements for a pharmacist that is on probation due to a pharmacy-related violation?
|
BACKGROUND ASSESSMENT to familiarize the provider and instructors with the FACTORS THAT LED THE CANDIDATE'S REFERRAL TO THE CLASS
BASELINE ASSESSMENT of candidates knowledge and awareness of ethical and legal issues related to the practice of pharmacy in CA Assessment of PARTICIPANT'S EXPECTATIONS of the program with their desire to change to be in compliance with ethical standards and the law DIDACTIC PRESENTATION of material related to those areas that were problems for the participant BASED UPON RESULTS OF BACKGROUND ASSESSMENT EXPERIENTIAL EXERCISES that allow the participant to practice concepts and newly developed skills they have learned during the didactic portion of the class LONGITUDINAL FOLLOW-UP |
|
|
What are the minimum requirements for LONGITUDINAL FOLLOW-UP for a pharmacy-related ethics course that will fulfill Board requirements for a pharmacist that is on probation due to a pharmacy-related violation?
|
Minimum of 2 CONTACTS at spaced intervals (e.g. 6 months and 12 months) within 1 year after course is completed or prior to completion of the participant's probationary period if probation is less than 1 year to assess the participant's status
STATUS REPORT submitted to the Board or its designee within 10 calendar days after the last contact |
|
|
What is the MAXIMUM CLASS SIZE standard for a pharmacy-related ethics course that will fulfill Board requirements for a pharmacist that is on probation due to a pharmacy-related violation?
|
Shall not exceed 12 participants
|
|
|
What are the minimum requirements for a pharmacy-related ethics course provider to STORE CANDIDATE RECORDS?
|
3 years
|
|
|
What is a pharmacy-related ethics course required to do to indicate a candidate's successful completion of a pharmacy-related ethics course?
|
Issue certificate of completion
Notify the Board in writing of its determination that the participant has successfully completed the program |
|
|
What is a pharmacy-related ethics course required to do to indicate a candidate's UNSUCCESSFUL completion of a pharmacy-related ethics course?
|
Notify Board in writing within 10 calendar days of determination
provide all accompanying documentation supporting the determination Fail the participant |
|
|
What are the consequences for dishonest conduct during a Board examination?
|
Examination will not be graded
Cannot take exam for 3 years Surrender intern license until eligible to take the exam again May not be issued a pharmacy technician license until the applicant is again eligible to take the exam |
|
|
What documentation and additional steps are required of the pharmacist when there is a government declared "State of Emergency" and a patient that does not have a prescription record at a pharmacy requests a refill without prescriber authorization?
|
Date
Patient Name Patient Address Drug Name Drug Strength Quantity Communicate furnishing of drug/device to patient's physician ASAP |
|
|
What documentation and additional steps are required of the pharmacist when there is a government declared "State of Emergency" and a patient that does not have a prescription record at a pharmacy requests a refill without prescriber authorization?
|
Date
Patient Name Patient Address Drug Name Drug Strength Quantity Communicate furnishing of drug/device to patient's physician ASAP |
|
|
What are the mobile pharmacy requirements established during a state of emergency?
|
Share COMMON OWNERSHIP with at least 1 currently license pharmacy in good standing
Retains DISPENSING RECORDS LICENSED PHARMACIST ON PREMISES PHARMACIST in CONTROL AND MANAGEMENT while drugs are dispensed REASONABLE SECURITY MEASURES are taken to safeguard the drug supply LOCATED within the declared or affected emergency area CEASES PROVISION of services within 48 hours following the termination of declared emergency |
|
|
How long does a mobile pharmacy have to cease the provision of services following the termination of the declared emergency?
|
48 hours
|
|
|
What is the minimum age for a patient to receive OTC dextromethorphan?
|
18
|
|
|
What is the maximum fine for a retailer who sells OTC dextromethorphan to an underaged patient?
|
$250
|
|
|
Can a pharmacist's license be renewed if they are over $100,000 delinquent in income tax or government required payments?
|
No
|
|
|
What are the requirements for a printer in CA that provides Security Prescription forms for prescribers?
|
Location, names and titles of any individual, owner, partner, corporate officer, manager, agent, representative, employee or subcontractor of the applicant who has direct access to or management or control of, controlled substance prescription forms and require those persons to submit the signed statement described above.
|
|
|
Under what circumstances can controlled substance prescription forms be provided in person?
|
Prescription forms provided person are restricted to ESTABLISHED CUSTOMERS
|
|
|
How long does a printer in CA that provides Security Prescription forms have to report a theft or loss of controlled substance prescription forms to the department via fax or e-mail?
|
Within 24 hours of the incident
|
|
|
How long does the owner, corporate officer, or manager of an entity licensed by the Board of Pharmacy have to provide records requested by an authorized officer of the law or by an authorized representative of the Board of Pharmacy?
|
3 business days
|
|
|
How long does the owner, corporate officer, or manager of an entity licensed by the Board of Pharmacy have to request an extension of the 3 day timeframe for records requested by an authorized officer of the law or by an authorized representative of the Board of Pharmacy?
|
14 calendar days from the date the records were requested
|
|
|
When is an extension request by a pharmacy deemed approved if the Board fails to deny the extension request?
|
Within 2 business days of the time the extension request was made directly to the Board
|
|
|
Can a nonresident pharmacy permit a pharmacist whose license has been revoked by the CA Board to provide drugs or pharmacy-related services to a person residing in California?
|
No
|
|
|
Can a person sell or obtain hypodermic needles and syringes without a prescription for industrial uses?
|
Yes and they do not need to comply with individual laws for hypodermic needles and syringes
|
|
|
Under what circumstances may a prescriber or pharmacist provide hypodermic needles and syringes to a patient without a prescription?
|
If the person is known to the furinsher and the furnisher has previously been provided a prescription or other proof of a legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment
|
|
|
What are the hypodermic needle and syringe program requirements for a pharmacy that furnishes nonprescription hypodermic needles and syringes?
|
ONE OR MORE of the following options:
ONSITE, safe, hypodermic needle and syringe collection and disposal program that meets state and federal standards Furnish or make available MAIL-BACK SHARPS CONTAINERS authorized by the USPS, that meet applicable state and federal requirements for the transport of medical sharps waste, and shall provide tracking forms to verify destruction at a certified disposal facility Furnish or make available a SHARPS CONTAINER that meets applicable state and federal standards for collection |
|
|
What written information or verbal counseling to consumers are required for a pharmacy that furnishes nonprescription syringes?
|
How to access drug treatment
Access testing and treatment of HIV and Hepatitis C Safely dispose of sharps waste |
|
|
When might a pharmacist choose to put a prescription expiration date of less than one year on the label?
|
Expiration date should be based on the pharmacist's professional judgment
Drugs that run the risk of being contaminated (e.g. nose drops or topical ophthalmological products, oral antibiotic) |
|
|
What is the expiration date for an extemporaneously prepared unit dose form?
|
1 year
|
|
|
What is the expiration date for a compounded product?
|
6 months
|
|
|
Can a prescription for a controlled substance allow PRN refills?
|
No
|
|
|
What information must be recorded every time a prescription is refilled?
|
DATE dispensed
DISPENSING PHARMACIST INITIALS QUANTITY dispensed |
|
|
What information needs to be recorded if a prescription presents for refill that is now available generically?
|
Trade name for the new generic product
|
|
|
What information needs to be recorded if a prescription has no refills and is authorized by the prescriber's office over the phone?
|
Initials of the party authorizing the refill
Number of new refill authorized Date |
|
|
Is a pharmacy legally required to keep a patient drug profile on each patient?
|
Yes
|
|
|
Under what circumstances is a pharmacy not required to have a patient drug profile for a patient?
|
Pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy
|
|
|
Can a pharmacist accept a prescription faxed from a patient?
|
No
|
|
|
What schedule prescriptions can a pharmacy fax to another pharmacy?
|
Non scheduled, Schedule IIII, IV, V
Faxed document is to be treated as a telephonic order |
|
|
What is required for a pharmacy to transfer a prescription to another pharmacy?
|
Receiving pharmacist shall create a written prescription, identifying it as a transferred prescription and record the date of transfer and the original prescription number
Receiving pharmacist notifies transferring pharmacy of the transfer Transferring pharmacy will record the prescription is transferred and the date of transfer |
|
|
A non-scheduled prescription has 9 refills, it has been filled once at the original pharmacy, how many times can the prescription be transferred between pharmacies?
|
9 times
|
|
|
How many times can a Schedule III, IV, or V controlled substance with 5 refills be transferred between pharmacies?
|
Once
|
|
|
What documentation is required for the transfer of a Schedule III, IV, or V controlled substance?
|
Receiving pharmacy must write on the face of the prescription that it is "transferred"
Sending pharmacy must write "void" across the face of the originally filled prescription |
|
|
Which pharmacy may refill the remaining refills on a prescription once it is transferred: receiving or sending?
|
Receiving pharmacy
|
|
|
Which pharmacy may call for refills on a prescription once it is transferred: receiving or sending?
|
Sending pharmacy, Pharmacy that originally SENT the prescription
|
|
|
What information does the receiving pharmacist need to to record when transferring a prescription?
|
Reduce to writing
Identify as TRANSFERRED TRANSFER DATE DATE of LAST FILLING DATE of ORIGINAL FILLING PRESCRIPTION NUMBER from the sending pharmacy TRANSFERRING PHARMACY NAME TRANSFERRING PHARMACY ADDRESS REMAINING REFILLS |
|
|
If transfer is completed electronically, which pharmacist must contact the other to ensure receipt: receiving or sending?
|
Receiving pharmacist
|
|
|
What additional information needs to be recorded when transferring a prescription for a controlled substance?
|
RECEIVING PHARMACY: Forwarding pharmacy DEA and licensed prescriber DEA
TRANSFERRING PHARMACY: Receiving pharmacy DEA number |
|
|
What information does the sending pharmacist need to to record when transferring a prescription?
|
MARK "VOID" on the face of the prescription
TRANSFER DATE RECEIVING PHARMACIST NAME RECEIVING PHARMACY NAME RECEIVING PHARMACY ADDRESS RECEIVING PHARMACY DEA number for controlled substances REMAINING REFILLS TRANSFERRED |
|
|
What is the OTC Hypodermic Needle/Syringe Record Book?
|
No longer required
A book used to keep track of syringes and needles when prescriptions were not required |
|
|
What are the requirements for a pharmacy to provide a patient a syringe or needle for animal use without a prescription?
|
Patient must provide their identify
|
|
|
What records must be kept when a pharmacy prepares extemporaneous unit dosage forms?
|
Ledger with the following information:
DATE PREPARED PARTY PREPARING the extemporaneous supply of unit dose medications LOT NUMBER(S) TOTAL DRUG AMOUNT USED DRUG AMOUNT USED PER LOT NUMBER(S) DRUG NAME DRUG STRENGTH MANUFACTURER'S NAME |
|
|
How must extemporaneous unit dosage forms be labeled?
|
DRUG NAME
DRUG STRENGTH LOT NUMBER EXPIRATION DATE (1 year or less) |
|
|
How many times can a Schedule III, IV, or V controlled substance be transferred between two pharmacies with a common electronic file?
|
Once only
|
|
|
Can a patient request their prescription information not be available in the common electronic file shared between pharmacies?
|
No, the law where a patient could request this was repealed in 2007
|
|
|
Can a prescriber e-mail a prescription to a pharmacy?
|
Yes, if it is transferred in a secure manner which ensure integrity and confidentiality of the prescription
|
|
|
May a pharmacy keep its prescription records in an electronic filling system without reducing such records to writing?
|
Yes. A pharmacy that receives an electronic transmission of a prescription is no longer required to reduce the prescription to writing as long as the pharmacy is able to immediately produce a hard copy upon request. Further, it is required that pharmacy's computer system be programmed to inhibit any changes to or deletions of information electronically stored, unless authorized by the pharmacist.
|
|
|
What is the pharmacy self-assessment survey?
|
Promotes compliance with applicable laws
Every pharmacy in CA will be responsible under the direction of the PIC, to respond to a self-assessment survey of the pharmacy's compliance with both federal and state pharmacy-related laws. Assesses facility's condition and security, nature of drug stock, posting of certificates and notices, PIC responsibilities, pharmacist-intern activities, pharmacy technician tasks, controlled substance prescription dispensing and records, prescription labeling and dispensing practices, prescription refill and transfer practices, methods of ensuring patient confidentiality, prescription drug compounding and repackaging practices, and electronic transmission of prescription procedures |
|
|
How often must a pharmacy complete a self-assessment survey?
|
Must be completed before July 1 of every odd numbered year
|
|
|
How long does a pharmacy have to complete a self-assessment survey when they receive a new pharmacy permit or there is a change in the PIC?
|
30 days
|
|
|
How long does a pharmacy need to keep the results of their self-assessment on file?
|
3 years
|
|
|
What information is to be included when a pharmacy repackages a previously dispensed medication for a patient?
|
All required prescription labeling information
Name and address of pharmacy repackaging the drug and the name and address of the pharmacy that initially dispensed the drug to the patient if such an arrangement was made |
|
|
When is an oral patient consultation rendered?
|
New prescription
Modification to an existing prescription When requested by the patient When deemed necessary by the pharmacist (even if not new or refill prescription) |
|
|
Who may render an oral patient consultation?
|
Pharmacist
Pharmacy intern (Supervising pharmacist within hearing distance) Nurse |
|
|
When is an oral patient consultation not necessary?
|
Refill as written
Patient refuses |
|
|
Who may receive an oral patient consultation?
|
Family member
Nurse Physician |
|
|
Is oral patient consultation necessary for a patient upon discharge from the hospital?
|
Yes
|
|
|
In what settings is oral patient consultation necessary?
|
Community
Outpatient (discharge from inpatient) |
|
|
Why does the patient consultation have to be oral?
|
Written materials may be provided as a supplement, but not a SUBSTITUTE for oral consultation
Written information may provide meaningful direction to a patient, but often fails to answer the patient's specific questions |
|
|
What documentation is required when an oral patient consultation occurs?
|
No, but the pharmacy may choose to keep track of if oral patient consultation occurred and if so, who performed it
|
|
|
What notices must be conspicuously displayed in the pharmacy?
|
Notice to Consumers
Additional Notice to Consumers (regarding prescriptions not being filled due to ethical or religious beliefs) |
|
|
What may a pharmacist choose to do if a patient presents to pharmacy requesting a price for more than 5 prescription drugs and does not have prescriptions available for all or some of the drugs?
|
Pharmacist may request patient request in WRITING
Pharmacist shall respond within 10 DAYS Pharmacy may choose a FEE for each prescription price quotation |
|
|
What is the maximum patient requests for a retail prescription a pharmacy needs to respond to?
|
3 requests from any one person or entity in a 6 month period
|
|
|
When is a pharmacist not required to provide the retail price for a medication?
|
PHONE REQUEST for CONTROLLED SUBSTANCE
COMPETITOR price request OUT-OF-STATE price request |
|
|
What are the 3 additional oral or written information that must accompany a dispensed prescription besides the directions for use?
|
Oral or written statement advising patient of ADVERSE DRUG REACTIONS
AUXILIARY PRESCRIPTION LABELS PATIENT PI (for specific medications required by law or by the manufacturer) |
|
|
Which auxiliary labels are required by law?
|
Drug may cause DROWSINESS
Drug may affect VISION Drug may cause ADVERSE EFFECT WHEN COMBINED WITH ALCOHOL MULTIPLE-DRUG MEDICATION PACKAGE |
|
|
Which drugs or classes must have an auxiliary label indicating they may cause drowsiness alone or with alcohol and operation of a motor vehicle while taking the medication should be avoided?
|
Muscle relaxants
Analgesics with CNS depressant affects Antipsychotics (including phenothiazines) Antidepressants Antihistamines Motion sickness agents Antipruritics Antinauseants Anticonvulsants Antihypertensive agents All Schedule II, III, IV, V depressant or narcotic controlled substances Anticholinergic agents Disulfiram and other drugs (chlorpropamide, metronidazole) MAOIs Nitrates |
|
|
What auxiliary label is required for a multiple-drug medication (patient med pak) package?
|
Store in a cool, dry place
|
|
|
What is a patient med pack (multiple-drug medication package)?
|
Refillable prescription for a non-liquid oral product placed in a clean reusable container used by the same patient and is to only contain no more than 1 month supply
|
|
|
What auxiliary label is required for a controlled substance?
|
Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
|
|
|
What agents must be accompanied with a package insert?
|
Estrogenic agents (alone or in combination with progesterone)
Request of drug manufacturer |
|
|
What black box warning appears on fluoroquinolone antibiotics?
|
Increased risk of tendinitis and tendon rupture
|
|
|
What black box warning appears on sodium phosphate preps?
|
Increased risk of kidney damage
|
|
|
Is a pharmacy required to post a notice that it shares an electronic file networking system with other pharmacies?
|
No
|
|
|
Can pharmacists advertise their services or drug prices?
|
Yes, as long as it is truthful advertising
|
|
|
Is a pharmacy obligated to keep records of retained prescription drugs/medical devices on the premises?
|
Yes, they should also be available for inspection
|
|
|
How long is a pharmacy obligated to keep records of retained prescription drugs/medical devices on site?
|
3 years
|
|
|
Can a pharmacy choose to have electronic records of the retained prescription drugs/medical devices on site?
|
Yes, and it should be made available upon request
|
|
|
Can a pharmacy apply for a waiver where their records of retained prescription drugs/medical devices are held off-site?
|
Yes, the board may waive the requirement to keep records on the premises if the pharmacy requests the waiver in writing and the request is justifiable
|
|
|
What does the FDA require pharmacies to provide patients with in regards to the reporting of adverse side effects while taking their medications?
|
A toll-free number
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1800-FDA-1088 |
|
|
Do you have to be a registered pharmacist in order to own a pharmacy in CA?
|
No
|
|
|
Who must be in charge of all prescription medication transactions?
|
Registered pharmacist in CA
|
|
|
Who may not own a pharmacy in CA?
|
CA licensed prescribers
Person who is married to a CA licensed prescriber seeking ownership of a pharmacy where title is vested in both parties' names Corporation seeking ownership of a pharmacy where 10% or more of the stock is owned by a CA licensed prescriber |
|
|
Can a chiropractor own a pharmacy where medical devices are sold?
|
No
|
|
|
Can a married couple own a pharmacy when one of them is a prescriber?
|
No. If a pharmacist owned a pharmacy before they were married, they would be able to keep the pharmacy as a sole and separate business. However, because California is a community property state, a married pharmacist would have difficulty obtaining a pharmacy when their spouse is a prescriber because the business could be considered "community property," "joint tenacy" or "tenants in common" title vesting.
|
|
|
How much maximum stock can a prescriber(s) have in a pharmacy corporation without being ineligible for permit status?
|
10%, if there is more than one prescriber associated with the corporation, then the total number of shares issued to the collective group of prescribers cannot exceed 10% in order for pharmacy status to be granted
|
|
|
Can a group of physicians own a hospital pharmacy?
|
Yes, without restriction. The group of physicians can own an in-patient and outpatient hospital pharmacy
|
|
|
Can a group of physicians own a pharmacy operated by a Health Management Organization (HMO)?
|
Yes
|
|
|
What are the building standards for a pharmacy?
|
COUNSELING AREA (formerly 5 foot barriers)
SPACE for PRESCRIPTION PREPARATION (formerly 16 feet) SUFFICIENT SPACE (formerly 240 sq ft) EQUIPMENT in CLEAN and WORKING ORDER SINK with HOT and COLD WATER Pharmacist responsible for effective control against THEFT or diversion POSSESSION of KEY to the pharmacy where drugs and controlled substances are stored shall be restricted to the pharmacist Maintain a READILY ACCESSIBLE RESTROOM |
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What security requirements are there for a pharmacy?
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REASONABLE BARRIER sufficient to prevent access by the public with ACCESS TO CONSULTATION
New regulations DO NOT mention floor to ceiling barrier with a lockable door for operations, but this regulation is still upheld Formerly pharmacy separate from merchandising area Formerly minimum height of 5 ft Formerly Locked entry door or gate |
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Who may possess a key to the pharmacy?
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Pharmacist ONLY in community setting
Store manager may have a key in a clearly marked envelope (that must be passed to pharmacist to open the pharmacy the next business day) Nurse in charge in a hospital setting where the pharmacy is not open 24 hours/day Nurse in charge must keep pharmacy key on premises when not on duty |
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Can a pharmacy license be transferred?
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No, if a pharmacy is purchased by another owner, the new owner must apply for a new license.
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For how long can the Board grant a temporary license in the case of pharmacy transfer?
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180 days
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Where must a pharmacy permit be posted within the pharmacy?
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Conspicuous place within the pharmacy area
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When does a pharmacy application have to indicate the number of owners?
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When the number of partners, members or stockholders exceeds 5
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Can a convicted felon apply for a pharmacy?
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No
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How long does a pharmacy owner have to inform the board of a change in ownership?
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30 days
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After what percentage of ownership transferred must the Board be notified within 30 days?
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10%
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After what percentage of ownership is transferred must a pharmacy reapply for pharmacy licensure?
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50%
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What is the minimum amount of days a pharmacy must operate in order to avoid having their permit voided by the Board?
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Pharmacy must operate 1 day every week during any 120 day period
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How long does the Board have to wait to void a pharmacy license when an owner fails to notify the Board that the pharmacy has been closed?
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10 days
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How long does a Pharmacy permit holder have to notify the Board and complete steps necessary to close their pharmacy?
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10 days
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What steps must a pharmacy permit holder complete upon notification that they will no longer be in business?
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Arrange for TRANSFER of all DRUGS and CONTROLLED SUBSTANCES and MEDICAL DEVICES
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How long does a pharmacy permit holder have to notify that the transfer of drugs, controlled substances and medical devices is complete upon pharmacy closure?
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Immediately
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What happens if a pharmacy permit holder closes their pharmacy, but does not transfer drugs, controlled substances, and medical devices?
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Board may enter the pharmacy with court order and transfer, store, and sell the devices.
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How are the proceeds divided if a the Board of Pharmacy conducts a sale of the drugs, controlled substances, and medical devices on an owners behalf?
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Board may retain the proceeds of any sale if conducts equal to the amount of obtaining the court order.
Remaining proceeds must be returned to the permit holder |
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What happens if a pharmacy owner fails to respond to a Board sale of an owner's drugs, controlled substances, and medical devices within 30 calendar days?
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Board has a right to deposit the permit holder's share of the proceeds into the Board's "Contingency Fund"
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What other permits is a pharmacy required to have in order to operate?
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DEA license when dispensing controlled substances
Compounding license when compounding prescriptions |
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How often must a pharmacy license be renewed?
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Annually
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When is a pharmacy exempt from obtaining a compounding license?
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Pharmacy operations licensed by the CA Department of Health Services that are subject to JCAHO accreditation
Community pharmacy that is involved in the reconstitution of a sterile powder obtained from a manufacturer and the drug is reconstituted for administration to patients by a HCP |
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Is a clinic required to obtain a pharmacy license in order to stock and dispense drugs?
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Yes
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How long does a clinic that dispenses medications have to have records regarding all drug purchases, administrations, and dispensing?
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3 years
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Can a Schedule II substance be dispensed by a clinic?
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No, only if dispensed/administered by the physician
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How often must a consulting pharmacist visit a clinic to ensure compliance?
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At least quarterly each year
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How often must a consulting pharmacist certify a clinic is (or is not) in compliance with pharmacy law?
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Quarterly
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How long does a clinic have to keep records of compliance from the consulting pharmacist?
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3 years
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What limitations are there for a surgical clinic?
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Surgical clinic may only dispense drugs for surgical procedure, pain and nausea
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How much take-home medication may a surgical clinic dispense to a patient?
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< 72 hours
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Can a surgical clinic have Schedule II substances on site for administration on premises?
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Yes
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Does a hospital require a permit to order, store, and dispense drugs?
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Yes, regardless of size
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When does a hospital pharmacist have to renew their pharmacy license?
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Annually on or before November 1
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What license is required for out-of-state manufacturers, wholesalers, or pharmacies which sell or distributes drugs (including medical devices) to California?
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Out-of-state drug distribution license
Non-resident pharmacy registration |
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How often do Out-of-State Drug Distribution and Non-Resident Pharmacy Registrations have to be renewed?
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Annually
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What type of pharmacy requires a Non-Resident Pharmacy Registration?
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Mail order pharmacy that does a significant amount of business with California residents
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Does a pharmacy located outside the physical plan of a hospital, serving the hospital, have to be separately licensed?
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No
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How can a Pharmacy-Hospital agreement be structured?
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Reimbursement based on direct billing for the costs of all pharmaceutical products or services rendered to each patient by the contracting pharmacy
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What type of Pharmacy-Hospital agreement is illegal?
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Percentage contract agreement related to patient charges or based on hospital/pharmacy revenues
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What are the Board requirements to grant a pharmacy a waiver for off-site storage of pharmacy records?
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1. Facility is secure from unauthorized access
2. Confidentiality of records should be maintained 3. Pharmacy needs to be able to produce records within 48 hour or 2 business days of request by Board |
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How long does a pharmacy that chooses to keep their records off-site have to produce the records?
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48 hours or 2 business days
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What may a pharmacy do if their request for off-site storage is canceled due to lack of compliance?
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They may reapply upon demonstrating to the Board that the pharmacy is present in compliance with the requirements of the regulation
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If a pharmacy is granted permission for off-site storage of pharmacy records, how long must they keep their prescription records for noncontrolled substances?
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1 year from the last date of dispensing of medications
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If a pharmacy is granted permission for off-site storage of pharmacy records, how long must they keep their prescription records for controlled substances?
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2 years from the last date of dispensing
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What is a wholesaler required to do if they sell an excessive amount of drugs such as Vicodin or Viagra to a closed door pharmacy?
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They must keep track and report this activity to the Board
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What is a medication pedigree?
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Electronic record containing information regarding each transaction resulting in a change of ownership of a given drug. Starting 1/1/2016, a wholesaler or repackager of drugs may not sell, trade, or transfer a prescription drug at wholesale without providing a pedigree. The pedigree ensures that it is obtained from a reliable and FDA licensed manufacturer and is carefully monitored as it proceeds through the distribution chain and is guaranteed to be exactly the drug and strength indicated on the packaging that will be dispensed to the ultimate consumer or patient.
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What are the legal responsibilities of a drug manufacturer or wholesaler?
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LICENSED by the CA State Board of Pharmacy
Ensure PROPER STORAGE, security, ordering, distributing procedures are in place Maintain operational POLICIES and PROCEDURES ensuring that every aspect of their operations are in COMPLIANCE with both federal and state laws REPORT any unusual or larger than normal sales to pharmacies of dangerous drugs SYSTEM to DETECT VARIANCES in ORDERING PATTERNS by the same customer over a 12 month period |
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What system requirements must be set for a drug manufacturer that is detecting variances in ordering patters by the same customer over a 12 month period?
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Purchases exceed 20% as compared to the last 12 months
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How long does a drug wholesaler have to identify a new representative-in-charge?
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30 days
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Does a drug manufacturer that is licensed by the FDA to sell their own drugs and devices have to have a representative-in-charge?
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No
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How long can the Board issue a temporary license if there is a change in wholesale ownership?
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180 days
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How long can the Board issue a temporary license to an out-of-state distributor?
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180 days
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Is a manufacturer that distributes their own product directly into CA required to obtain a Non-Resident Wholesaler license?
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No
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What is the minimum Wholesaler License Surety Bond Requirement?
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$100,000
Lesser amount allowed if the annual gross receipts of the previous tax year for the wholesaler is $10,000,000 or less in which case the surety bond shall be reduced to $25,000 |
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What is the purpose of a Wholesaler Surety Bond?
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Secure payment of any administrative fine imposed by the board and any other legal costs incurred
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When can the Board file a claim against a Wholesaler Surety Bond?
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Licensee fails to pay a fine within 30 days after the order imposing the fine or costs become final
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What is an interoperable electronic system (with regards to medication pedigree)?
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Electronic track and trace system for drugs that uses a unique identification number established at the point of manufacture
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What information must be included in a medication pedigree?
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DRUG SOURCE
DRUG NAME FEDERAL MANUFACTURER'S REGISTRATION NUMBER PRINCIPAL ADDRESS OF SOURCE TRADE/GENERIC DRUG NAME QUANTITY DOSAGE FORM STRENGTH DATE OF TRANSACTION SALES INVOICE NUMBER CONTAINER SIZE NUMBER OF CONTAINERS EXPIRATION DATES LOT NUMBERS RECEIVING BUSINESS NAME RECEIVING BUSINESS ADDRESS RECEIVING BUSINESS NAME and ADDRESS OF each individual certifying delivery or receipt of the drug CERTIFICATION from a responsible party of the source of the drug that information contained in the pedigree is true and accurate Single pedigree shall include every change of ownership of a given drug from its initial manufacture through to its final transaction to a pharmacy regardless of repackaging or assignment of another NDC |
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What transactions are not required to be recorded on a pedigree?
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Samples provided to a prescriber by the manufacturer or manufacturer's employee
Injectable provided directly to the prescriber or other HCP that is responsible for the administration of the injectable drug to a patient Intracompany sale or transfer Drugs delivered by the federal government to a local or state government entity Sale, trade, or transfer of a radioactive drug between any 2 entities licensed by the Radiologic Health Branch of the State Dept of Public Health and the federal Nuclear Regulatory Commission Sale, trade, or transfer of veterinary drugs Sale, trade, or transfer of IV solutions intended for fluids and electrolytes for dialysis or for irrigation or reconstitution as well as sterile water Drug contained in packages combined with medical supplies or equipment to be used for surgical procedures |
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Who may sign for ordered drugs from a wholesaler when they arrive at the pharmacy?
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Only a pharmacist or pharmacist intern
A designated representative may also sign for and receive the delivery (not pharmacy clerk or technician) |
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Who is a designated representative that may sign for and receive a delivery of ordered drugs from a wholesaler when they arrive at the pharmacy?
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Individual to whom a license has been granted to operate a veterinary food-animal drug business and is either a representative-in-charge or a representative of such an operation
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When can the temporary use of a mobile pharmacy be used if the pharmacy is destroyed or made non-accessible?
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1. Mobile pharmacy will PROVIDE SERVICES ON or IMMEDIATELY CONTIGUOUS to the site of the damaged or destroyed pharmacy
2. MOBILE PHARMACY will continue to be UNDER CONTROL and management of a PIC 3. LICENSED PHARMACIST ON DUTY while drugs are being dispensed 4. Reasonable SECURITY MEASURES are taken to to safeguard the drug supply Pharmacy operating the mobile pharmacy shall provide the Board with RECORDS OF THE DESTRUCTION of or damage to the pharmacy and an expected restoration date 5.NOTIFY BOARD WITHIN 3 CALENDAR DAYS OF RESTORATION of the permanent pharmacy |
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How long does a pharmacy have to notify the Board that their previously destroyed pharmacy has been restored and they are no longer operating a mobile pharmacy?
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3 calendar days
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How long can a mobile pharmacy be in operation once the restoration of the permanent pharmacy is complete?
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48 hours
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How long does a hospital have to deliver drugs that were received at a central receiving area to the pharmacy?
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1 working day
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When does a pharmacist have to inventory drugs received from a central receiving area in a hospital that were transferred to the pharmacy?
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Immediately
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Who may sign for a drug or device ordered and provided to a manufacturer, MD, DDS, DPM, Optometrist, Veterinarian, ND, laboratory, PT?
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Person of entity receiving the drug or device or a duly authorized representative of the person or entity sign for the receipt of the delivered drugs or devices
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When can a pharmacy take delivery of drugs and devices when the pharmacy is closed and there is no pharmacist on duty?
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The drugs are placed and locked in a secure storage facility in the same building as the pharmacy
Only the PIC or a pharmacist designated by the PIC has access to the secure storage facility after drugs/devices have been delivered Secure storage facility has a means of indicating whether it has been entered after drugs/devices have been delivered Pharmacy maintains written P&Ps for the delivery of drugs/devices to a secure storage facility Agent delivering drugs/devices leaves documents indicating the name/amt of each drug/device delivered in the secure storage facility |
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What is the difference between a side effect and adverse effects?
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Side effects are more common and less severe
Adverse effects are known complications, but are generally rarer and more severe |
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If a patient is allergic to a beta-lactam antibiotic, what class do they have a 5% chance of having a cross reaction to?
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Cephalosporins
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What drugs have sulfa in them?
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SMX, thiazide diuretics, loop diuretics, sulfonylureas, acetazolamide, zonisamide, celecoxib
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What do you do (for exam purposes) if a patient presents with rhinitis, mild asthmatic/skin type reactions or true allergy to NSAID/ASA?
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Discontinue ASA/NSAID
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Can a pharmacist substitute the dosage form when a prescriber does not check "Do Not Substitute" on the prescription originally written for the trade name?
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Yes, as long as the change benefits the patient's ability to comply with the prescribed drug therapy (ointment may have different absorption rate than cream, run out of one dosage form are NOT reasons to substitute)
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Can a pharmacist substitute a drug when a prescriber does not check "Do Not Substitute" on the prescription and a generic becomes available?
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Yes, but it must be the same salt form
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How can a prescriber prohibit a pharmacist from substituting a prescription?
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1. ORALLY stating
2. WRITING OUT "DO NOT SUBSTITUTE" on the written prescription 3. Checking the box DO NOT SUBSTITUTE AND INITIALING IT on a written prescription 4. Transmitting an ELECTRONIC prescription with DO NOT SUBSTITUTE (NO INITIAL REQUIRED) |
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What should a pharmacist do if a prescriber only checks the DO NOT SUBSTITUTE box on a written prescription an the pharmacist wishes to substitute a drug or dosage form?
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Contact the prescriber for clarification
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Can a pharmacist sell boric acid over the counter?
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Yes
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Does a pharmacist have to maintain a poison registry book keeping track of poisons sold OTC to a patient?
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No
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Can a pharmacy store sample prescription drugs?
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No
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When can a pharmacy store sample prescription drugs?
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Health care entity may transfer a sample drug to a retail pharmacy for an "emergency medical reason." (e.g. regular supplies of a given drug are unavailable due to drug supply shortages)
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Under what conditions may a sample prescription be distributed to a patient?
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Licensed practitioner to a patient
Licensed HCP under PDP Hospital pharmacy or another health care entity acting under the direction of a prescriber (prescriber will be required to authorize in writing to a manufacturer or distributor that the drug samples are to be distributed to a hospital pharmacy or other health care entity) |
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What additional step is required for a prescriber to allow a hospital pharmacy or health care entity to distribute sample prescription drugs?
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Prescriber will be required to authorize in writing to a manufacturer or distributor that the drug samples are to be distributed to a hospital pharmacy or other health care entity
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What is DMSO?
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Dimethyl sulfoxide
Organic solvent that is not available by any drug manufacturer as an FDA approved drugs Used topically in 70s and 80s in the management of arthritis Only available through chemical supply companies |
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What adverse effects are associated with DMSO that led to its decreased usage?
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Blood dyscrasias
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How can a physician prescriber DMSO?
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1. INFORMED CONSENT from patient
2. TREATMENT PROCEDURE 3. BENEFITS/RISKS OF DMSO 4. ALTERNATIVES TO DMSO 5. QUESTIONS/CONCERNS 6. PATIENT SIGNATURE on WRITTEN CONSENT |
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What auxiliary label is required for a pharmacist to affix to a DMSO prescription?
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"Waring: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you, and keep out of the reach of children"
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What are the automated drug delivery system requirements?
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1. Clinic must have P&Ps regarding the use, maintenance, and security of the device
2. Pharmacy must consult with the patient via telecommunications link with 2 way audio/video capabilities 3. Pharmacist must verify prescription 4. Pharmacist must be in CA while operating automated drug delivery system 5. Pharmacist responsible for stocking, inventory control, and review of the operation and maintenance of the system |
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How often must a pharmacist inspect the automated drug delivery system, ensure cleanliness, and review transaction records to ensure security and accountability of the system?
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Once monthly
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What are the requirements for a skilled nursing facility and intermediate care facility when installing an automated drug delivery system?
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1. System must be under supervision by a pharmacist
2. Pharmacist does NOT have to be physically present if the pharmacist surveys the system electronically 3. Pharmacy is responsible for the stocking, upkeep, and general monitoring of the system |
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What is required when a pharmacist handles radioactive drugs?
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Pharmacist must be trained in these areas
Completed nuclear pharmacy course and/or has gained experience in related programs approved by the Board |
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What is required for a pharmacy to furnish radioactive drugs?
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Special permit from the Board
Exempt from counseling |
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What is the limitation the State Dept of Health Services may impose on emergency drug supplies as ward stock in licensed health care facilities?
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4 doses of any separated drug dosage form
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What limit may a licensed health care facility impose with P&Ps in place for emergency supply for oral or suppository dosage forms?
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24 of each oral or suppository dosage forms
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Who is accountable for the automated drug delivery system (ADDS) in an outpatient pharmacy setting?
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Under the pharmacy department's control
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How long do records accounting for the drugs dispensed from an automated drug delivery system (ADDS) in an outpatient pharmacy setting?
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3 years
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What is the dispensing limitation for an ADD system to be used as an emergency drug supply unit?
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72 hours supply or less
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What are the labeling requirements for an automated drug delivery system (ADDS) in an outpatient pharmacy setting?
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Labeling requirement shall not be subject to the same standards of a usual prescription label if the drugs are in unit dose packaging or unit of use packaging and patient information regarding the dispensed drug is readily available at the time of the drug being provided to the patient
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How often do the records for an automated drug delivery system (ADDS) in an outpatient pharmacy setting have to be reviewed and maintained?
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Monthly
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What steps are involved in the review and maintenance of an automated drug delivery system (ADDS)?
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1. PHYSICAL INSPECTION of the drugs in the ADD system
2. Maintain CLEANLINESS 3. Review of all TRANSACTION RECORDS to validate the security and accountability of the system |
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What is an outpatient pharmacy required to do when implementing an automated drug delivery system (ADDS)?
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Notify the Department of Health Services (DHS) in writing prior to using the system
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Who has the authority to revoke the use of an Automated Drug Delivery System (ADDS)?
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Department of Health Services (DHS), if they determine that a facility is not in compliance with the requirements of the statute
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Can a pharmacy store refill prescriptions in a secured container to be picked-up by patients without a pharmacist's intervention?
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Yes
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Can a pharmacy install security containers to allow patients to drop off their prescriptions when the pharmacy is not open?
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Yes, new and refills
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What is required for a patient to be able to pick up their refilled prescription in a secure container without pharmacy consultation?
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1. PATIENT CONSENT
2. Prescription DOES NOT REQUIRE CONSULTATION 3. Security box must have means to IDENTIFY each patient and only release that patient's prescription 4. SECURE from access and removal by unauthorized individuals |
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What next steps are required if there is a medication error or patient complaint when filling a medication that was dispensed using security container?
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Review by quality assurance program
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How long does a pharmacy need to keep P&Ps regarding the use of security containers for prescription refill and drop-off?
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3 years beyond the last use of the security box delivery system
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Can a veterinary drug be dispensed without a prescription?
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No
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What are the requirements for a person to become a "veterinary retailer exemptee", "designated representative", or "representative-in-charge" of a veterinary food-animal drug retailer?
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1. Fill out application with the Board
2. High school graduate or possess equivalent 3. 1 year of paid work experience related to the distribution or dispensing of dangerous drugs 4. Must complete a training course that is Board approved |
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What is required for a veterinary food-drug retailer to dispense a drug for a food-producing animal?
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Prescription
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What additional step is required for a designated representative to dispense a prescription for a controlled substance?
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Labels of the container should be countersigned by the prescribing veterinarian before being dispensed
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How long can a veterinary retailer refill a veterinarian's prescription order?
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6 months after the issuance date of the initial order
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How long do prescription records have to be kept on file in a veterinarian food-animal drug retailer?
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3 years after the last recorded filling of the prescription
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What can a veterinary retailer do if they only have a partial quantity of a prescription?
|
Partially ship a portion so long as the full quantity is shipped within 30 days
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What is required if a veterinary retailer is unable to provide the full prescription within 30 days?
|
New prescription
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What must a veterinary retailer log when a prescription is shipped?
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1. DATE SHIPPED
2. QUANTITY 3. NUMBER of CONTAINERS SHIPPED |
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What must a veterinary food-animal drug retailer do if an exemptee leaves their employ?
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Retailer shall IMMEDIATELY return the certificate of exemption to the Board
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What is required for a pharmacist to dispense contact lenses?
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1. Valid Prescription
2. STATE LICENSE of the prescribing practitioner 3. EXPIRES within 1 YEAR from the date of the last prescribing examination 4. Prescription must explicitly state that it is a prescription for contact lenses and include the lens brand name, type and tint, and other specifications necessary for ordering lenses 5. NO SUBSTITUTIONS. Prescription dispensed must be for the exact contact lenses ordered. |
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What auxiliary labels or written notices must be provided to a patient when a pharmacist chooses to dispense contact lenses?
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Warning: if you are having any unexplained eye discomfort, watering, vision change, or redness - remove lenses immediate and consult with your eyecare practitioner
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What must a pharmacy do before dispensing contact lenses?
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Register with the Medical Board of CA at the time of initiation application for license
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How long is a nonresident pharmacy required to keep records regarding shipments of contact lenses to person in CA?
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3 years
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Who may request records for inspection of pharmacy contact lens records?
|
Medical Board of CA
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What are the requirements for a pharmacy to provide prescription drugs to a home health agency or licensed hospice in a portable container?
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1. Container to be provided by pharmacist
2. Tamper-proof seal 3. Under control of pharmacist, nurse, or delivery person at all times 4. Label on the outside with list of contents 5. Maintain container at proper temperatures |
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Which drugs may a sealed portable container for a home health agency or licensed hospice contain?
|
1000 mL NS
1000 mL D5 2 vials of urokinase 5000 IU > 5 heparin sodium lock flush 100 IU/mL > 5 heparin sodium lock flush 10 IU/mL > 5 epinephrine 1:1000 > 5 epinephrine 1:10000 > 5 diphenhydramine 50 mg/mL > 5 methylprednisolone 125 mg/2 mL > 5 NS (30 mL vial) > 5 naloxone 1 mg/mL, 2 mL > 5 droperidol 5 mg/2 mL > 5 prochlorperazine 10 mg/2 mL > 5 promethazine 25 mg/mL > 5 dextrose 25 g/50 mL > 5 glucagon 1 mg/mL > 5 insulin 100 IU/mL > 5 bumetamide 0.5 mg/2 mL > 5 furosemide 10 mg/mL > 5 EMLA 5 g tube > 5 lidocaine 1% 30 mL vial |
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What requirements for P&Ps must a home health agency or hospice before receiving sealed portable containers?
|
1. STORAGE of the portable container
2. TRANSFER between the pharmacy and the agency 3. ORAL or WRITTEN MD PRESCRIPTION (Method of how drugs within the container is to be administered to a patient) 4. SPECIFIC TREATMENT PROTOCOL for the administration of EACH MEDICATION 5. REVIEWED AND REVISED PRN ANNUALLY by a group of professional personnel including a MD, pharmacist, and RN 6. Provide a COPY to the FURNISHING PHARMACY |
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What next steps are necessary if a drug is administered to a patient from a sealed portable container pursuant to an oral MD order?
|
Furnishing pharmacy must ensure that the oral MD order is immediately written down by the RN or PharmD and sent within 24 hours by written copy or fax to the furnishing pharmacy
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How long does a prescriber have to provide a signed copy of the drugs ordered that were administered to a patient from a sealed portable container?
|
20 days
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How long does a nurse have to return a sealed portable container of drugs that has been broken to the furnishing pharmacy?
|
7 days
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How long can a sealed portable container sit in a home health agency or licensed hospice unused before it has to be returned to the furnishing pharmacy for verification of product quality, quantity, integrity, and expiration dates?
|
60 days
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What must a pharmacy do prior to selling ephedrine-like products OTC?
|
Be "self-certified"
Provide employee training Store the products in controlled and secured areas Require patient photo ID Maintain logbooks accounting for all sales transactions of these products and ensure that there is legitimate use among purchasers who are 18 and over |
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What does "self-certification" mean in regards to a pharmacy selling ephedrine-like products OTC?
|
Self-certificaiton is location-specific, NOT employee-specific
Retailer must register with DEAdiversion.usdoj.gov and provide the following information: 1. DEA number (if applicable) 2. Tax ID number 3. Business name 4. Business address 5. Business telephone number 6. Business e-mail address 7. Number of employees at location 8. Number of trained employees at location 9. Type of establishment (e.g. pharmacy, grocery, etc) 10. Ephedrine-like products to be handled |
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Does a retailer that chooses to self-certify in order to sell ephedrine-like products OTC have to use the DEA materials in their certification program if they have their own materials?
|
Yes
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What must be logged with every transaction where ephedrine is sold OTC?
|
1. PRODUCT NAME
2. STRENGTH 3. QUANTITY 4. CUSTOMER NAME 5. CUSTOMER ADDRESS 6. TRANSACTION DATE/TIME 7. CUSTOMER SIGNATURE |
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What is the age restriction for the sale of ephedrine-like products OTC in CA?
|
18 and over
|
|
|
What is the DAILY sales limit per customer for ephedrine-like products OTC?
|
3.6 g ephedrine-like products
|
|
|
What is the MONTHLY sales limit per customer for ephedrine-like products OTC?
|
9 g ephedrine-like products
|
|
|
Does a customer who comes in to purchase one 60 mg dose of pseudoephedrine have to sign the log book?
|
No
|
|
|
Does a customer who comes in to purchase one dose of ephedrine have to sign the log book?
|
Yes
|
|
|
Does a customer who comes in to purchase one dose of phenylpropylamine have to sign the log book?
|
Yes
|
|
|
What drugs are "ephedrine-like products" that can be sold OTC?
|
Pseudoephedrine
Ephedrine Phenylpropylamine |
|
|
What sales restrictions are there on OTC iodine?
|
< 8 oz of betadine/povidone solutions containing < 1% iodine
< 1 oz of betadine/povidone solutions containing < 2% iodine |
|
|
What is required if someone needs to sell, transfer, or furnish more iodine than the current OTC limit?
|
Provider must submit a report to the Department of Justicefor all such transactions
|
|
|
Can epinephrine auto-injectors be furnished to a school distric by a pharmacy?
|
Yes
|
|
|
What are the requirements for a school to receive epinephrine auto-injectors?
|
1. Order from MD indcating the number of injectors to be furnished
2. Records must be maintained by the school for 3 years regarding the use of such epinephrine auto-injectors 4. Furnishing pharmacy must also keep records of the provision of the drug pursuan t to an order for 3 years |
|
|
How long does a school district or county have to maintain records regarding the administration of epinephrine auto-injectors
|
3 years
|
|
|
How long does a pharmacy have to maintain records of dispensing epinephrine auto injectors to a school district or county?
|
3 years
|
|
|
Can a prescription drug that is returned by the patient to the pharmacy be resold by the pharmacy?
|
No
|
|
|
Is a pharmacy obligated to reimburse a patient for unused portion of returned medication?
|
No, but they may do so as a good faith measure
|
|
|
What is a pharmacy obligated to do with a prescription drug that was sold to a patient that has been returned?
|
Pharmacy is obligated to DESTROY the drug and NOT reuse it for a subsequent prescription
|
|
|
What types of drugs can be redistributed to indigent patients?
|
Drug is acquired from a surplus voluntary drug repository created by donations from pharmacies, SNFs, wholesalers, and county facilities
|
|
|
What are the minimum requirements for county-owned pharmacies or pharmacies that have contracted with the county for providing free prescription drugs to indigent population?
|
1. Establish ELIGIBILITY for medically INDIGENT PATIENTS WHO MAY PARTICIPATE in the program
2. Provide prescription medications AT NO CHARGE 3. Develop a FORMULARY of the medications that will be used in the program |
|
|
What types of drugs may be donated for distribution to indigent population?
|
1. NO CONTROLLED SUBSTANCES
2. STORED PROPERLY 3. NEVER IN PATIENT POSSESSION 4. UNOPENED, TAMPER-EVIDENT PACKAGING 5. MAINTAINED IN DONATED PACKAGING UNITS UNTIL DISPENSED 6. DISPENSE IN NEW, PROPERLY LABELED CONTAINER 7. SEGREGATED FROM REGULAR PHARMACY STOCK 8. NOT EXPIRED |
|
|
What records must a pharmacy keep if they choose to participate in medication distribution program to the indigent?
|
Pharmacy must maintain records regarding the acquisition and disposition of the donated medications
P&Ps regarding medications that require refrigeration |
|
|
Under what circumstances may a mercury fever thermometer be sold OTC?
|
Only with a prescription
|
|
|
Can sharps be disposed of in usual trash or recycling containers?
|
No
|
|
|
Under what circumstances can a pharmacy (if they choose) accept return of used hypodermic needles and syringes from the public?
|
If it is in a sharps container
|
|
|
Is a pharmacy required to accept used hypodermic needles and syringes from the public?
|
No, not at this time
|
|
|
If a pharmacy chooses to compound sterile products, are they required to obtain an additional pharmacy license?
|
Yes
|
|
|
How often does a pharmacy license to compound sterile products have to be renewed?
|
Annually
|
|
|
How often does a pharmacy that engages in the compounding of sterile products have to be inspected?
|
Annually (when license is renewed)
|
|
|
Does a hospital, home care agency, or SNF that engages in compounding of sterile products have to obtain a separate license for the compounding of sterile products?
|
No, specifically if they are JCAHO accredited
|
|
|
How long can the Board issue a cease and desist order to a sterile compounding pharmacy that is found to inappropriately compound sterile products which are a potential threat to the health and welfare of the public?
|
30 days or the date of a hearing seeking an interim suspension order whichever is earlier
|
|
|
How long does an owner of a sterile compounding pharmacy have to contest a cease and desist order from the Board?
|
15 days of receipt of the order notice to request in writing a hearing before the president of the Board
|
|
|
What are the general requirements for a sterile compounding pharmacy to be approved for operation by the Board?
|
1. CLEAN room and work station
2. VENTILATION system 3. COMPOUNDING AREA and LAMINAR AIR FLOW HOODS CERTIFIED ANNUALLY 4. Maintain an aseptic environment 5. SINK 6. REFRIGERATOR/FREEZER in the room |
|
|
How long do certifications of the sterile compounding area and laminar air flow hoods have to be kept on file in a sterile compounding pharmacy?
|
3 years
|
|
|
What are the ISO classifications allowed for a sterile compounding pharmacy that dispenses injectable products?
|
ISO class 5 laminar airflow hood within an ISO class 7 cleanroom with a positive air pressure differential relative to adjacent areas
1. ISO class 5 cleanroom OR 2. A barrier isolator that provides an ISO class 5 environment for compounding |
|
|
How often do surfaces in the sterile compounding area have to be disinfected?
|
Weekly
|
|
|
What are the recordkeeping requirements for a sterile compounding pharmacy?
|
1. Drug name
2. Lot Number 3. Amount 4. Date 5. Employee training and competency evaluation 6. Refrigerator and freezer temperatures 7. Certification records of the sterile compounding environment 8. Cleaning logs for facilities and equipment 9. Inspection for expired or recalled pharmaceutical products or raw materials 10. Preparation records including master worksheet, the preparation worksheet, and records of end-product evaluation results |
|
|
How long does a sterile compounding pharmacy have to keep their records on file?
|
3 years
|
|
|
Can an employee of a sterile compounding pharmacy wear hand, finger, or wrist jewelry?
|
No, if jewelry cannot be removed then it must be thoroughly cleaned and covered with a sterile glove
|
|
|
How often does a sterile compounding pharmacy have to check for proficiency and reassess employees on sterile injectable preparation?
|
Every 12 months
|
|
|
How often must employees complete a validation process on technique?
|
Every 12 months
|
|
|
What happens if an employee is found to have microbial growth in a sample from their validation process on technique?
|
Sterile preparation process must be evaluated, corrective action taken, and the validation process repeated
|
|
|
What license is required for a non-resident pharmacy to transport sterile injectable drug products into CA?
|
They must obtain a separate license for compounding injectable sterile products, renew it annually, and follow the same guidelines as a pharmacy located within CA
|
|
|
What are instances a pharmacist should avoid when compounding so it would not be construed as manufacturing?
|
1. No professional relationship exists among the prescriber, patient, and the pharmacist who dispenses the drug product
2. Pharmacy compounds products which are exact generic copies of FDA approved, commercially available drug products 3. Pharmacy is receiving and using drug substances without obtaining and retaining evidence of the source of such substances or the method of their preparation 4. Pharmacy is compounding drugs in high volume in anticipation of receiving prescriptions 5. Large amounts of compounded drugs are distributed to patients outside of the pharamcy's normal trade area or across state lines 6. Where drugs are being compounded by one pharmacy to be dispensed by another pharmacy 7. Where the pharmacy is compounding drug products not deemed safe/effective and where there is not substantiating scientific literature to support the use of such compounded drug products |
|
|
What are the recordkeeping requirements for a sterile compounding pharmacy?
|
1. Drug name
2. Lot Number 3. Amount 4. Date 5. Employee training and competency evaluation 6. Refrigerator and freezer temperatures 7. Certification records of the sterile compounding environment 8. Cleaning logs for facilities and equipment 9. Inspection for expired or recalled pharmaceutical products or raw materials 10. Preparation records including master worksheet, the preparation worksheet, and records of end-product evaluation results |
|
|
What is an exception to the regulation stating that drugs are not to be compounded by one pharmacy and dispensed by another pharmacy?
|
Manufacturer shall not mean a pharmacy compounding a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy for the purpose of delivering or administering the drug to a patient or patients named in the prescription provided that neither the components for the drug nor the drug are compounded, packaged, or otherwise prepared prior to receipt of the prescription
|
|
|
How long does a sterile compounding pharmacy have to keep their records on file?
|
3 years
|
|
|
Is a compounded product FDA approved if both the ingredients, individually are FDA approved?
|
No
|
|
|
Can an employee of a sterile compounding pharmacy wear hand, finger, or wrist jewelry?
|
No, if jewelry cannot be removed then it must be thoroughly cleaned and covered with a sterile glove
|
|
|
How often does a sterile compounding pharmacy have to check for proficiency and reassess employees on sterile injectable preparation?
|
Every 12 months
|
|
|
How often must employees complete a validation process on technique?
|
Every 12 months
|
|
|
What happens if an employee is found to have microbial growth in a sample from their validation process on technique?
|
Sterile preparation process must be evaluated, corrective action taken, and the validation process repeated
|
|
|
What license is required for a non-resident pharmacy to transport sterile injectable drug products into CA?
|
They must obtain a separate license for compounding injectable sterile products, renew it annually, and follow the same guidelines as a pharmacy located within CA
|
|
|
What are instances a pharmacist should avoid when compounding so it would not be construed as manufacturing?
|
1. No professional relationship exists among the prescriber, patient, and the pharmacist who dispenses the drug product
2. Pharmacy compounds products which are exact generic copies of FDA approved, commercially available drug products 3. Pharmacy is receiving and using drug substances without obtaining and retaining evidence of the source of such substances or the method of their preparation 4. Pharmacy is compounding drugs in high volume in anticipation of receiving prescriptions 5. Large amounts of compounded drugs are distributed to patients outside of the pharamcy's normal trade area or across state lines 6. Where drugs are being compounded by one pharmacy to be dispensed by another pharmacy 7. Where the pharmacy is compounding drug products not deemed safe/effective and where there is not substantiating scientific literature to support the use of such compounded drug products |
|
|
What is an exception to the regulation stating that drugs are not to be compounded by one pharmacy and dispensed by another pharmacy?
|
Manufacturer shall not mean a pharmacy compounding a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy for the purpose of delivering or administering the drug to a patient or patients named in the prescription provided that neither the components for the drug nor the drug are compounded, packaged, or otherwise prepared prior to receipt of the prescription
|
|
|
Is a compounded product FDA approved if both the ingredients, individually are FDA approved?
|
No
|
|
|
Can a pharmacist furnish to a prescriber a reasonable quantity of compounded medication for prescriber's office use?
|
Yes
|
|
|
What is a "reasonable quantity" of compounded medication a pharmacist may provide to a prescriber for office use?
|
Quantity of the compounded drug that is sufficient for that prescriber's office use consistent with the expiration date of the product (usually 180 days)
|
|
|
What does "prescriber's office use" mean in regards to a compounded medication?
|
1. Compounded drug is to be applied/administered in the prescriber's office
2. If dispensed, no more than a 72 hour supply of the compounded drug is to be given by the prescriber to the patient |
|
|
What are the pharmacy recordkeeping requirements on compounding for future furnishing?
|
1. Date of preparation
2. Lot number and expiration date of each of the ingredients 3. Expiration date of the finished product will not exceed 180 days or the shortest expiration date of any of the ingredients whichever is less 4. Signature or initials of the compounding pharmacist 5. Formula for the compounded product 6. Manufacturer name of the raw materials 7. Quantity in units of finished products or grams of raw materials 8. Package size and number of units prepared |
|
|
Can a pharmacy advertise that they compound a specific product?
|
Yes
|
|
|
What schedule is a schedule II controlled substance is compounded with a non-scheduled substance?
|
Schedule III, IV, V
|
|
|
What schedule is alfentanil (ALFENTA)?
|
Schedule II
|
|
|
What schedule is alphaprodine?
|
Schedule II
|
|
|
What schedule is apomorphine?
|
Schedule II (in CA, non-scheduled federal)
|
|
|
What schedule is codeine?
|
Schedule II
|
|
|
What schedule is dihydrocodeine (DROCODE, PARACODIN, DICOGESIC)?
|
Schedule II
|
|
|
What schedule is fentanyl (SUBLIMAZE)?
|
Schedule II
|
|
|
What schedule is hydromorphine (DILAUDID)?
|
Schedule II
|
|
|
What schedule is levoalphacetylmethadol (Levo-Dromoran)?
|
Schedule II
|
|
|
What schedule is meperidine (DEMEROL)?
|
Schedule II
|
|
|
What schedule is methadone?
|
Schedule II
|
|
|
What schedule is morphine?
|
Schedule II
|
|
|
What schedule is opium (OPIUM TINCTURE, CAMPHORATED TINCTURE OF OPIUM, PAREGORIC)?
|
Schedule II in CA (Schedule III Federally)
|
|
|
What schedule is oxycodone (PERCODAN/PERCOCET)?
|
Schedule II
|
|
|
What schedule is oxymorphone (NUMORPHAN, OPANA ER)?
|
Schedule II
|
|
|
What schedule is sufentanil (SUFENTA)?
|
Schedule II
|
|
|
What schedule is nabilone (CESAMET)?
|
Schedule II
|
|
|
What is the indication for nabilone (CESAMET)?
|
Antiemetic
|
|
|
What schedule is amphetamine?
|
Schedule II
|
|
|
What schedule is cocaine?
|
Schedule II
|
|
|
What schedule is cathinone (a.k.a. norephedrone, alkaloid found in KHAT)?
|
Schedule II
|
|
|
What schedule is dextroamphetamine (DEXADRINE)?
|
Schedule II
|
|
|
What schedule is dexmethylphenidate (FOCALIN)?
|
Schedule II
|
|
|
What schedule is khat (from Catha Edulis plant, KHAT or AFRICAN TEA)?
|
Schedule II
|
|
|
What schedule is methamphetamine (DESOXYN, METHADRINE)?
|
Schedule II
|
|
|
What schedule is methylphenidate (RITALIN)?
|
Schedule II
|
|
|
What schedule is phenmetrazine (PRELUDIN)?
|
Schedule II
|
|
|
What is the indication for phenmetrazine (PRELUDIN)?
|
Stimulant
|
|
|
What is the schedule for amobarbital injection (AMYTAL)?
|
Schedule II
|
|
|
What is the schedule for amobarbital suppositories (AMYTAL)?
|
Schedule III
|
|
|
What is the schedule for glutethimide (DORIDEN)?
|
Schedule II in CA (Schedule III Federally)
|
|
|
What is the schedule for pentobarbital injection (NEMBUTAL)?
|
Schedule II
|
|
|
What is the indication for amobarbital (AMYTAL)?
|
Sedative/hypnotic
|
|
|
What is the schedule for pentobarbital suppositories (NEMBUTAL)?
|
Schedule III
|
|
|
What is the schedule for secobarbital oral capsules (SECONAL)?
|
Schedule II
|
|
|
What is the schedule for secobarbital suppositories (SECONAL)?
|
Schedule III
|
|
|
What schedule is dronabinol (MARINOL)?
|
Schedule III
|
|
|
How much codeine/hydrocodeine can be dispensed for the prescription to be considered Schedule III?
|
< 1.8 g codeine/hydrocodeine per 100 mL
OR < 90 mg/dosage unit with 1+ non-narcotic ingredients |
|
|
How much dihydrocodeinonee can be dispensed for a prescription to be considered Schedule III?
|
< 300 mg dihydrocodeinone per 100 mL
OR < 15 mg/dosage unit with 1+ non-narcotic ingredients |
|
|
How much opium can be dispensed for a prescription to be considered Schedule III?
|
< 500 mg opium per 100 mL with 1+ non-narcotic ingredients
OR < 500 mg opium per 100 g with 1+ non-narcotic ingredients |
|
|
How much morphine can be dispensed for a prescription to be considered Schedule III?
|
50 mg per 100 mL with 1+ non-narcotic ingredients
OR 50 mg per 100 g with 1+ non-narcotic ingredients |
|
|
What schedule is buprenorphine?
|
Schedule III
|
|
|
What schedule is buprenorphine with naloxone?
|
Schedule III
|
|
|
What schedule is benzphetamine (DIDREX)?
|
Schedule III
|
|
|
What schedule is mazindol (SANOREX, MAZANOR)?
|
Schedule III in CA (Schedule IV Federally)
|
|
|
What schedule is phendimetrazine (BONTRIL, PLEGINE, PRELU-2)?
|
Schedule III
|
|
|
What schedule is aprobarbital (ALURATE)?
|
Schedule III
|
|
|
What schedule is butabarbital (BUTISOL)?
|
Schedule III
|
|
|
What schedule is gamma hydroxybutyric acid (GHB)?
|
Schedule III if contained in a drug product for which an application has been approved, otherwise its Schedule I
|
|
|
What schedule is ketamine (KETALAR)?
|
Schedule III
|
|
|
What schedule is metharbital (GEMONIL)?
|
Schedule III
|
|
|
What schedule is methyprylon (NOLUDAR)?
|
Schedule III
|
|
|
What schedule is talbutal (LOTUSATE)?
|
Schedule III
|
|
|
What schedule is thyamylal (SURITAL)?
|
Schedule III
|
|
|
What schedule is thiopental (PENTOTHAL)?
|
Schedule III
|
|
|
What schedule are anabolic steroids?
|
Schedule III
|
|
|
What schedule is difenoxin + atropine (MOTOFEN)?
|
Schedule IV
|
|
|
What schedule is pentazocine (TALWIN)?
|
Schedule IV
|
|
|
What schedule is cathine (norpseudoephedrine, derived from KHAT plant)?
|
Schedule IV
|
|
|
What schedule is diethylpropion (TENUATE, TEPANIL)?
|
Schedule IV
|
|
|
What schedule is fenfluramine (PONDIMIN)?
|
Schedule IV
|
|
|
What schedule is phentermine (FASTIN, IONAMIN)?
|
Schedule IV
|
|
|
What schedule is pemoline (CYLERT)?
|
Schedule IV
|
|
|
What schedule is alprazolam (XANAX)?
|
Schedule IV
|
|
|
What schedule is barbital (VERONAL)?
|
Schedule IV
|
|
|
What schedule is chloral betaine (BETA-CHLOR)?
|
Schedule IV
|
|
|
What schedule is chloral hydrate (NOCTEC)?
|
Schedule IV
|
|
|
What schedule is clobazam (MYSTAN)?
|
Schedule IV
|
|
|
What schedule is chlordiazepoxide (LIBRIUM)?
|
Schedule IV
|
|
|
What schedule is clonazepam (KLONOPIN)?
|
Schedule IV
|
|
|
What schedule is clorazepate (TRANXENE)?
|
Schedule IV
|
|
|
What schedule is diazepam (VALIUM)?
|
Schedule IV
|
|
|
What schedule is dichloralphenzone (MIDRIN)?
|
Schedule IV
|
|
|
What schedule is estazolam (PROSOM, DOMNAMID, EURODIN, NUCTALON)?
|
Schedule IV
|
|
|
What schedule is eszopiclone (LUNESTA)?
|
Schedule IV
|
|
|
What schedule is ethchlorvynol (PLACIDYL)?
|
Schedule IV
|
|
|
What schedule is ethinamate (VALMID)?
|
Schedule IV
|
|
|
What schedule is flunitrazepam (ROHYPNOL, NARCOZEP, DARKENE, ROIPNOL)?
|
Schedule IV
|
|
|
What schedule is flurazepam (DALMANE)?
|
Schedule IV
|
|
|
What schedule is halazepam (PAXIPAM)?
|
Schedule IV
|
|
|
What schedule is lorazepam (ATIVAN)?
|
Schedule IV
|
|
|
What schedule is mebutamate (CAPLA)?
|
Schedule IV
|
|
|
What schedule is mephobamate (EQUANIL, MILTOWN)?
|
Schedule IV
|
|
|
What schedule is methohexital (BREVITAL)?
|
Schedule IV
|
|
|
What schedule is midazolam (VERSED)?
|
Schedule IV
|
|
|
What schedule is nitrazepam (MOGADON)?
|
Schedule IV
|
|
|
What schedule is nordiazepam (NORADAZEPAM, DEMADAR, MADAR)
|
Schedule IV
|
|
|
What schedule is oxazepam (SERAX)?
|
Schedule IV
|
|
|
What schedule is oxazolam (SERENAL, CONVERTAL)?
|
Schedule IV
|
|
|
What schedule is paraldehyde (PARAL)?
|
Schedule IV
|
|
|
What schedule is petrichloral (PERICLOR)?
|
Schedule IV
|
|
|
What schedule is phenobarbital (LUMINAL)?
|
Schedule IV
|
|
|
What schedule is prazepam (CENTRAX)?
|
Schedule IV
|
|
|
What schedule is quazepam (DORAL)?
|
Schedule IV
|
|
|
What schedule is temazepam (RESTORIL)?
|
Schedule IV
|
|
|
What schedule is triazolam (HALCION)?
|
Schedule IV
|
|
|
What schedule is zaleplon (SONATA)?
|
Schedule IV
|
|
|
What schedule is zopiclone (LUNESTA)?
|
Schedule IV
|
|
|
What schedule is zolpidem (AMBIEN)?
|
Schedule IV
|
|
|
How much codeine can a prescription have in order to classify as a Schedule V substance?
|
<200 mg codeine/100 mL with 1+ non-scheduled drug
OR <200 mg codeine/100 g with 1+ non-scheduled drugs |
|
|
How much dihydrocodeine can a prescription have in order to classify as a Schedule V substance?
|
100 mg/100 mL with 1+ non-scheduled drug
OR 100 mg/100 g with 1+ non-scheduled drug |
|
|
How much opium can a prescription have in order to classify as a Schedule V substance?
|
100 mg opium per 100 mL with 1+ non-scheduled drug
OR 100 mg opium per 100 g with 1+ non-scheduled drug |
|
|
What schedule is buprenorphine (BUPRENEX)?
|
Schedule V
|
|
|
What schedule is difenoxin 0.5 mg+ atropine (MOTOFEN)?
|
Schedule V
|
|
|
What schedule is diphenoxylate 2.5 mg + atropine (LOMOTIL)?
|
Schedule V
|
|
|
What schedule is pregabalin (LYRICA)?
|
Schedule V
|
|
|
What schedule is gabapentin (NEURONTIN)?
|
Schedule V
|
|
|
What does "compounding" mean?
|
Altering the DOSAGE FORM or delivery system of a drug
Altering the STRENGTH of a drug Preparing a drug product from BULK CHEMICALS |
|
|
Is reconstitution of a drug pursuan tto a manufacturer's direction for oral, rectal, topical, or injectable administration considered "compounding"?
|
No
|
|
|
Is tablet splitting considered "compounding"?
|
No
|
|
|
Is addition of flavoring agents to enhance palatability considered "compounding"?
|
No
|
|
|
What is a self-assessment for compounding pharmacies?
|
Form developed by the Board
Applies to all compounding and sterile compounding Must be completed by PIC before July 1 of odd-numbered years or within 30 days of the start of a new PIC and within 30 days of the issuance of a new pharmacy license |
|
|
How often must a self-assessment for a compounding pharmacy be completed?
|
Before July 1 of odd-numbered years
|
|
|
How long does a PIC have to fill out a self-assessment for a compounding pharmacy if they are a new PIC or have a new pharmacy license?
|
30 days
|
|
|
The pharmacist is counseling the parent of a child who has received an ADHD diagnosis and will begin therapy with methylphenidate sustained release (Ritalin SR). The following counseling points should be conveyed to the parent:
A. Report at once if the child has chest pain, shortness of breath, or fainting. B. Report at once if the child is seeing or hearing things that are not real, believing things that are not real, or are acting suspicious. C. This medicine has the potential to be abused; store the medicine where it cannot be taken by the wrong person or stolen. D. A and C only. E. All of the above. |
E
Explanation Stimulants should not be used in patients with heart problems or serious psychiatric conditions. Report at once if the child has chest pain, shortness of breath, or fainting. Report at once if the child is seeing or hearing things that are not real, believing things that are not real, or are suspicious. All stimulants require a MedGuide. |
|
|
The pharmacist is counseling the parent of a child who has received an ADHD diagnosis and will begin therapy with Focalin XR. The following counseling points should be conveyed to the parent:
A. The capsules can be opened and mixed with any cold juice or cereal. B. The capsule contents can be sprinkled on applesauce (if not warm and used right away—swallow, but do not chew). C. The capsule contents can be sprinkled on applesauce (if not warm and used right away). The medicine, once mixed in applesauce, cannot be stored longer than 4 hours. D. The capsules cannot be opened; if your child cannot swallow the capsule, please ask your doctor for a capsule that can be opened or for a patch formulation. E. None of the above. |
B
Explanation Patient instructions for Focalin XR include the following: Swallow capsules whole with water or other liquids. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing. The instructions also apply to these long-acting ADHD medications: Ritalin LA, Metadate CD and Adderal XR. With Vyvanse, the capsule contents can be mixed in water and must be taken right away (Vyvanse, like the others, cannot be stored if mixed). |
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|
Choose the correct counseling statements for the methylphenidate (Daytrana) patch:
A. Place on hip two hours before desired effect B. Replace weekly C. Alternate the hip where the patch is placed each week D. Hold patch on skin for 7 seconds E. Remove during bathing or showering |
A
Explanation The patch is applied to the hip area in the morning (avoid waistline on pants as it may cause it to rub off—the patch was designed before the popularity of pants that hang around the hips.) It is applied two hours before the desired effect and replaced each morning. The hips are rotated each day: left hip on odd days, right hip on even days. Instruct the patient to hold the patch on the skin for 30 seconds and smooth down the edges. If applied correctly the patch should stay on during bathing & swimming. |
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|
What schedule is modafinil (PROVIGIL)?
|
Schedule IV
|
|
|
Medication Guides, or MedGuides, contain important safety information. They contain FDA-approved patient education and are considered part of a drug's labeling. Choose the correct statement concerning MedGuides:
A. Instruct the patient to review the MedGuide for important safety information—dispense with each new prescription and with each refill. B. Instruct the patient to review the MedGuide for important safety information—dispense with each new prescription—refills do not require a MedGuide. C. Atomoxetine does not require a MedGuide. D. A and C only. E. B and C only. |
A
Explanation The stimulants AND atomoxetine require a MedGuide, with each new prescription and refill. The MedGuide warning for stimulants involves psychiatric and heart-related problems. The MedGuide warning for atomoxetine concerns suicidal thoughts in children and teenagers, worsening psychiatric problems, liver damage and heart problems. MedGuides also contain general information about the drug, including how to take the medicine and side effects. |
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|
A pharmacist is dispensing atomoxetine to an adult patient who has a history of alcohol and drug abuse. The pharmacist should be careful to include this counseling statement:
A. Contact your doctor at once if you experience nausea, loss of appetite, malaise and abdominal pain in the upper right part of your stomach—these could be symptoms of liver disease. B. You should be seen right away if you experience a sustained, painful erection that has lasted at least 4 hours. C. This medication can cause weight gain. D. A and B only. E. All of the above. |
D
Explanation Atomoxetine can cause liver damage (rarely, but possible). Symptoms of liver damage can include nausea, loss of appetite, vomiting, diarrhea, malaise, and abdominal pain in the upper right part of the stomach (near the liver). Yellowed skin (jaundice) indicates (along with light stool and dark urine) a severe liver condition, caused by increased bilirubin in the blood. Priapism can rarely occur with this drug. Atomoxetine does not cause weight gain. It can decrease appetite (anorexia). |
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|
A patient gave the pharmacist a prescription for Strattera. Choose the correct statement/s concerning Strattera:
A. The generic name is atomoxetine. B. A two week wash-out period is required between atomoxetine and monoamine oxidase inhibitors. C. This is a C III medication. D. A and B only. E. All of the above. |
D
Explanation Atomoxetine (Strattera) is not controlled. Stimulants are first-line agents for ADHD, however atomoxetine is sometimes used first if abuse potential is suspected. Or, atomoxetine can be tried if a patient has failed trials of different stimulant agents. |
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|
What is the CURES program abbreviation stand for?
|
Controlled Substance Utilization Review an Evaluation System
|
|
|
What schedule controlled substances must be reported through the CURES program once dispensed by the pharmacy?
|
Schedule II, III, IV
|
|
|
How frequently must reports be submitted to the CURES system?
|
Weekly (no specific day provided by the statute)
|
|
|
When does a pharmacy not need to report a dispensing of a controlled substance?
|
when less than a 48 hours supply of a Schedule IV controlled substance is dispensed
|
|
|
How are reports submitted by the pharmacy to the CURES system?
|
online
|
|
|
Is a prescriber still required to write Schedule II prescriptions on a triplicate form?
|
No
|
|
|
Can a pharmacy accept a Schedule II prescription written on a triplicate form?
|
No
|
|
|
Can a patient with a soy/peanut allergy use Combivent (ipratropium/albuterol)?
|
No
|
|
|
Can a patient with a soy/peanut allergy use Cleviprex (clevidipine)?
|
No
|
|
|
Can a patient with a soy/peanut allergy use Diprivan (propofol)?
|
No
|
|
|
Can a patient with a true egg allergy receive the H1N1 seasonal vaccine?
|
No
|
|
|
Can a patient with a true egg allergy use Cleviprex (clevidipine)?
|
No
|
|
|
Can a patient with a true egg allergy use Diprivan (propofol)?
|
No
|
|
|
Can a patient with a true egg allergy receive the yellow fever vaccine?
|
No
|
|
|
What are the contraindications to using Cleviprex (clevidipine)?
|
soy/peanut allergy, egg allergy
|
|
|
What are the contraindications to using Diprivan (propofol)?
|
soy/peanut allergy, egg allergy
|
|
|
What opioids do not cross react with morphine?
|
Fentanyl, meperidine, and methadone do not cross react with opioids of the morphine-type
|
|
|
What are the contraindications to using Combivent (ipratropium/albuterol)?
|
soy/peanut allergy
|
|
|
What are the contraindications to using Prometrium (progesterone)?
|
soy/peanut allergy
|
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|
When can a pharmacist request and receive in writing from the State Department of Justice the history of a patient's usage of Schedule II, III, or IV controlled substances?
|
1. Information available in CURES database
2. Patient is under the care of the pharmacy/pharmacist requesting the information 3. There is reasonable suspicion of inappropriate or illegal use of a Schedule II, III, or IV controlled substance |
|
|
Can you order security prescription forms from any printer?
|
No, the printer must be approved by the CA Board of Pharmacy
|
|
|
What are the requirements for the special security prescription forms in order for a prescriber to order controlled substances for a patient?
|
1. If the prescription is copied or photocopied the word "void" shall appear in a pattern across the entire front of the prescription
2. Watermark on the backside of the prescription blank "California Security Prescription" 3. Chemical void protection that prevents alteration by chemical washing 4. Feature printed in thermo-chromic ink 5. Area of opaque writing so that the writing disappears if the prescription is lightened 6. A description of the security features included on each prescription form 7. Six quantity check-off boxes shall be printed on the form and the following quantities shall appear: 1-24, 25-49, 50-74, 75-100, 101-150, 150 and over 8. In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in a tablet or capsule form 9. Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered for Schedule III, IV, or V controlled substances 10. The prescription blanks shall contain a statement printed on the bottom of the prescription blank in order to differentiate the security prescription as a single controlled substance entry prescription or as a multiple entry prescription form (2 different prescription forms must be used since multiple controlled substance drugs cannot be entered on a security prescription if it is intended for only one controlled substance drug entry) 11. Unique lot number and each form within that batch shall be numbered sequentially beginning with number one 12. Identification number of the approved security printer by the Department of Justice 13. Refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill |
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|
What are the 6 quantity check-off boxes that must be printed on the controlled substance security prescription form?
|
1. 1-24
2. 25-49 3. 50-74 4. 75-100 5. 101-150 6. 150 and over |
|
|
What words must be printed on the bottom of the controlled substance security prescription form if it is intended for only one controlled substance drug entry?
|
This prescription is void if more than one controlled substance prescription is written per blank
|
|
|
What words must be printed on the bottom of the controlled substance security prescription form if it is intended for multiple controlled substance drug entries?
|
This prescription is void if the number of drugs prescribed is not noted... (the number of controlled substance drugs ordered must be noted after this statement)
|
|
|
Can a prescriber include Schedule II, III, IV, and V controlled substances on a multiple controlled substance security prescription form?
|
Yes
|
|
|
Can a prescriber indicate the dispensing of multiple controlled substances at different dates?
|
Yes, as long as the date when the prescription was written is the true date it was written
|
|
|
Can office staff date a controlled substance security prescription form if a prescriber forgets to put it down?
|
No
|
|
|
Can a prescriber's office with less than 25 prescribers utilize a single security form with a check-off box for each prescriber's name, category of license, license number, DEA registration number?
|
Yes, as long as the prescriber signs their name next to the check box where their name is listed
|
|
|
Can a prescriber's office with 25 or more prescribers in a single office order security prescription forms for controlled substances without the actual prescriber's preprinted name, license and federal registration numbers?
|
Yes, as long as it is handwritten, typed or computer generated on the security prescription form
|
|
|
How long must an office with less than 25 prescribers keep records where controlled substance security prescription forms have been dispensed?
|
3 years
|
|
|
What must occur when preparing a security prescription form for a Schedule II drug?
|
1. Written on special security prescription form
2. Prescriber must sign their name and also place the date issued in ink (these 2 items must be in the prescriber's handwriting) 3. Remainder of information (e.g. patient's name, address, drug name, strength, quantity, directions, DEA number, prescriber's address) placed on the security prescription form may be either typewritten or in the handwriting of the prescriber or their employee |
|
|
When does a prescriber not have to place a Schedule II prescription on a controlled substance security prescription form?
|
When the schedule II substance is for a patient that is terminally ill
|
|
|
What does a prescriber need to add to a non-security prescription blank for a schedule II controlled substance that is for a patient that is terminally ill?
|
Prescriber must have "11159.2 exemption" written or printed on the non-security prescription blank
|
|
|
Can a pharmacist fill a prescription for a Schedule II controlled substance written on a non-secure prescription form if the prescriber forgets to add "11159.2 exemption"?
|
Yes, if the pharmacist knows the patient is terminally ill and the pharmacist subsequently returns the prescription to the prescriber for the clarification to be placed on the prescription within 72 hours
|
|
|
What must a pharmacist do if a prescriber makes an error or omits information (other than their signature and date) on a security prescription form for a controlled substance?
|
The pharmacist may contact the prescriber and receive clarification of what was actually intended or needed to be added, and the pharmacist may incorporate the correct or omitted information onto the security prescription form along with documentation that the prescriber was contacted to rectify the error or omission
|
|
|
What must a pharmacist do if a prescriber omits their signature or date on a security prescription form for a controlled substance?
|
The pharmacist must return the prescription to the prescriber in order to obtain the prescriber's name and date
|
|
|
How long may a prescription for a schedule II controlled substance be filled?
|
6 months (e.g. prescription written January 1 must be filled no later than June 30 of the same year)
|
|
|
What does "terminally ill" mean according to state law?
|
A patient who has a documented diagnosis of an illness or disease that will result in death
|
|
|
How long may a security prescription form for a Schedule II controlled substance be held by the patient before filling?
|
60 days. The schedule II prescription must be tendered for filling or at least partially filled within 60 days following the date of issue
|
|
|
May Schedule II, controlled substance prescription forms be filed with Schedule III, IV, and V prescription forms?
|
No
|
|
|
How must a multiple security prescription form be filed if it includes a Schedule II controlled substance AND a Schedule III, IV, or V controlled substance?
|
Make a copy and place a one inch red C on the lower right hand corner if this second copy is placed with the nonscheduled drug files
|
|
|
When may a prescriber place an order for a Schedule II controlled substance over the phone?
|
"in an emergency where failure to issue a prescription may result in loss of life or intense suffering, an order for a Schedule II controlled substance may be dispensed on an oral, written, or electronic data transmission order"
|
|
|
What should a pharmacist do if an emergency prescription for a Schedule II controlled substance is called in?
|
1. Add "Authorization for Emergency Dispensing"
2. Destroy the temporary prescription once the permanent security prescription is forwarded by the prescriber |
|
|
How long does a prescriber have to submit a permanent security prescription form when they phoned in an emergency Schedule II controlled substance?
|
7 days
|
|
|
What if the prescriber does not send the pharmacy the necessary security prescription for the Schedule II controlled substance within 7 days after an emergency request?
|
Pharmacist has an additional 144 hours (6 days) to notify the DEA/Bureau of Narcotic Enforcement in writing of the situation)
|
|
|
What will the DEA/Bureau of Narcotic Enforcement do once a pharmacist reports a prescriber failed to provide the necessary security prescription form for an emergency Schedule II Controlled Substance that was phoned IN?
|
Keep the following information on file for 3 years
1. Name of the prescriber 2. Name, strength, and quantity of the Schedule II drug dispensed 3. Circumstances under which the emergency prescription was filled 4. Date and method of notification of the DEA/Bureau of Narcotic Enforcement 5. Name or Names of any DEA/Bureau of Narcotic Enforcement agents to whom oral notice was furnished |
|
|
May a prescriber write a prescription for a Schedule III, IV, or V substance on a non-secure prescription form when it is intended for the terminally ill?
|
No
|
|
|
Are oral orders for Schedule II drugs allowed for SNFs?
|
Yes, if the prescription is reduced to handwriting on a form developed by the pharmacy for this purpose.
|
|
|
Are electronic orders for Schedule II drugs allowed for SNFs?
|
Yes, if the pharmacist produces, signs, and dates a hard copy of the prescription
|
|
|
Is an oral or electronic order for a Schedule II controlled substance required to be an emergency in order to be accepted by the dispensing pharmacy?
|
No
|
|
|
Can a prescription for a Schedule II controlled substance be refilled?
|
No
|
|
|
How long does a pharmacy have to fill the remaining quantity of a prescription for a Schedule II controlled substance?
|
72 hours
|
|
|
What happens if a pharmacy fails to fill the remaining quantity of a Schedule II controlled substance?
|
The pharmacist must contact the prescriber for a new secure prescription form
|
|
|
What must a pharmacist do if a patient requests less than the amount originally requested for a Schedule II controlled substance?
|
The pharmacist must notify the prescriber prior to dispensing
|
|
|
Can a pharmacist later fill a prescription for a Schedule II controlled substance if the patient originally did not fill the entire quantity?
|
No, that would constitute as a refill
|
|
|
When can a pharmacist partially fill a prescription for a Schedule II controlled substance?
|
When the prescription is for a patient in a SNF or if the prescription is for a patient that is terminally ill
|
|
|
How long may a Schedule II controlled substance prescription be partially filled for a patient that is terminally ill or in an SNF?
|
60 days
|
|
|
What must the pharmacist document on the security prescription form when a Schedule II controlled substance is partially filled?
|
Record the date and the amount of each partial fill on the security prescription form
|
|
|
When does prescription information for a partially filled Schedule II controlled substance have to be forwarded to the CURES system?
|
Once the prescription has been completely filled, or canceled
|
|
|
What must the person in the SNF do if they partially fill a Schedule II controlled substance?
|
The person receiving the controlled substance must sign for it
|
|
|
How might a situation be handled whereby a patient brings in a Schedule II prescription for a 60 day supply and insurance will pay for only 30 days?
|
The pharmacist may dispense a 30 day supply and bill the insurance carrier accordingly and dispense another 30 day supply in a second container to be paid for by the patient. Each drug supply must be labeled separately and total may not exceed the amount written for on the prescription.
|
|
|
May a pharmacy order Schedule II drugs from an out-of-state wholesaler or supplier?
|
Yes, as long as the pharmacy forwards a copy of the order, contract, or agreement for procurement of such Schedule II drugs to the State's Attorney General's office, via registered mail, within 24 hours of transmitting the order.
|
|
|
What is a DEA Form 222?
|
Department of Justice's order/transfer form for Schedule II drugs or Schedule I drugs being researched to allow pharmacies to procure or purchase such substances from DEA-registered manufacturers, distributors or wholesalers.
|
|
|
Who may sign a DEA Form 222?
|
Same person who signed the most recent DEA registration or by a person having POA that has been previously submitted to the DEA
|
|
|
How must a triplicate DEA Form 222 be separated?
|
Top and middle copies must be sent intact to the manufacturer or wholesaler, otherwise the order will be refused
|
|
|
How many items may be written on each line of a DEA Form 22?
|
1 item per line
|
|
|
How many items may be ordered on a single DEA Form 222?
|
10
|
|
|
What must a wholesaler or supplier do if a DEA Form 222 is submitted with errors, erasures, or alterations from a pharmacy?
|
The wholesaler must return the third copy with an explanation why it was returned to the pharmacy. The pharmacy must keep this copy.
|
|
|
Where must a pharmacy record the number of items received and the date of receipt for Schedule II controlled substances?
|
On the DEA Form 222
|
|
|
How are the DEA Form 222 copies disseminated?
|
Copy 1. Retained by the supplier
Copy 2. Sent by the supplier to the regional administrator of the DEA at the end of the month Copy 3. Retained in the pharmacy |
|
|
How long must DEA Form 222 copies be available for inspection?
|
2 years
|
|
|
What other purposes may a DEA Form 222 be used other than for purchase of Schedule II controlled substances?
|
1. Transfer of Schedule II drugs to a prescriber
2. Transfer of Schedule II drugs to another pharmacy 3. Return of Schedule II drugs to a supplier |
|
|
Under which scenario may the transfer of Schedule II substance does not require the submission of a DEA Form 222, but does require written notification to the DEA and the pharmacy keeping inventory records of such transfers?
|
When a pharmacy engages in a bulk sale of its Schedule II drugs (along with its other prescription drugs) to another pharmacy or to a new owner of the existing pharmacy
|
|
|
How long in advance does the DEA have to be notified in order to discontinue or transfer business regarding Schedule II controlled substances?
|
14 days
|
|
|
May a clinic licensed to dispense drugs also dispense Schedule II controlled substances?
|
No, however a prescriber licensed to prescribe controlled substances may write prescriptions for Schedule II drugs to be administered at the clinic
|
|
|
Who may grant/revoke POA for Schedule II controlled substances?
|
original registrant or someone with POA
|
|
|
What is first line treatment for moderate/severe allergic rhinitis?
|
Intranasal corticosteroids
|
|
|
What is first line treatment for mild/occasional allergic rhinits?
|
Second generation oral antihistamines
|
|
|
What are the brand names for intranasal beclomethasone?
|
Beconase and Vancenase
|
|
|
Under what age does the FDA recommends against the use of cough and cold products?
|
4 years old
|
|
|
What is SLUDGE?
|
Adverse effects for cholinergics
1. Salivation 2. Lacrimation 3. Urination 4. Defecation 5. Gastrointestinal upset 6. Emesis (m = Miosis and Muscle spasm) |
|
|
Why are patients instructed to take donepezil in the evening?
|
Donepezil causes nausea
|
|
|
What is glossitis?
|
Inflamed tongue
|
|
|
What is koilonychias?
|
thin, concave, spoon-shaped nails
|
|
|
What drugs decrease folic acid?
|
CAMMPPOT
Cholestyramine Azathioprine Mercaptopurine Methotrexate Pentamide Phenytoin Primidone OCPs Thioguanine |
|
|
How much iron supplementation does a breast fed baby need at 4-6 mos of age?
|
1 mg/kg/day
|
|
|
Which elements are constipating?
|
Calcium
Iron |
|
|
Which elements cause diarrhea?
|
Magnesium
|
|
|
What is the most common adverse reaction to intravenous iron infusions?
|
Hypotension
|
|
|
How should EPO be injected?
|
SQ (not in the deltoid)
|
|
|
What is the lab presentation of macrocytic anemia?
|
low hemoglobin
low hematocrit MCV>100 |
|
|
What are the causes of macrocytic anemia?
|
folic acid deficiency
vitamin B12 deficiency Chronic alcoholism Lack of intrinsic factor Crohn’s or celiac disease Poor nutritional intake |
|
|
What is the lab presentation of microcytic anemia?
|
low hemoglobin
low hematocrit MCV<80 |
|
|
What are the causes of microcytic anemia?
|
Iron deficiency
Hemodialysis |
|
|
Can a pharmacist fill a prescription for an out-of-state Schedule III, IV, V controlled substance for a California resident?
|
Yes, if it is phoned in or submitted electronically
Written prescriptions would need to be submitted on the security prescription form |
|
|
Can a pharmacist fill a prescription for an out-of-state Schedule II controlled substance for a California resident?
|
No, unless the prescriber has a valid DEA and has written the prescription on a security prescription form
|
|
|
Can a pharmacist fill an out-of-state Schedule III, IV, V controlled substance for an out-of-state resident that is not written on a security prescription form?
|
Yes, as long as the security prescription form is not required by the other state's laws
|
|
|
Can a pharmacist refill an out-of-state prescription for a Schedule III, IV, IV controlled substance for an out-of-state resident?
|
Yes, if refills are authorized and it is refilled within the 6 month period
|
|
|
Can prescriptions for controlled substances be mailed using USPS?
|
Yes
|
|
|
How frequently are pharmacies required to complete an inventory of their Schedule II, III, IV, V controlled substances?
|
Once every 2 years
|
|
|
What is the formula for checking if a DEA is valid?
|
B[first initial of prescriber's last name]
1st, 3rd, and 5th digit + (2nd, 4th and 6th digit) x 2 7th Digit = Last Digit of Sum |
|
|
Does the inventory for Schedule II controlled substances have to be accurate or an estimate?
|
Accurate
|
|
|
Does the inventory for Schedule III, IV, V controlled substances have to be accurate or an estimate?
|
Estimate, unless the drug container holds >1000 units of the drug
|
|
|
When must an exact count of Schedule III, IV, V controlled substances have to be accurate?
|
If the drug container holds >1000 units of the drug
|
|
|
What are the rules regarding the date the biennial inventory of controlled substances needs to be completed?
|
1. On the same day of the year the initial inventory was taken
2. On the usual physical inventory date, if this date does not vary more than 6 months from the biennial date that would otherwise apply (e.g. initial inventory 5/1/2009, next inventory can occur between 11/1/2009 to 11/1/2010) 3. On any other fixed date that does not vary more than 6 months from the biennial date that would otherwise apply |
|
|
How long must a pharmacy keep controlled substance inventory records available for inspection?
|
3 years
|
|
|
Can a prescriber antedate or postdate a prescription for controlled substances?
|
No, this is illegal
|
|
|
What form is required to be filled out when disposing of controlled substances?
|
DEA Form 41
|
|
|
What are the 2 major methods in which controlled substances are disposed of once a DEA official is contacted for advisement?
|
1. Destroyed at designated disposal site
2. Returned to manufacturer for credit |
|
|
What auxiliary label must be affixed on a prescription vial for a controlled substance?
|
"It is a crime to transfer this drug to any person other than the patient for whom the drug was prescribed"
|
|
|
What is required for a pharmacist or their designee to deliver a parenteral controlled substance to a patient's home?
|
1. Currently prescribed
2. Labeled |
|
|
What is required for a pharmacist or their designee to deliver a parenteral non-controlled substance to a patient's home?
|
1. Currently prescribed
2. Labeled or unlabeled |
|
|
Can a pharmacist knowingly dispense a prescription to a patient with an addiction problem?
|
No
|
|
|
Can a prescriber knowingly write a prescription for a patient with an addiction problem?
|
No
|
|
|
What types of facilities may provision controlled substances to patients with an addiction problem?
|
1. In-patient institution approved by the State Department of Mental Health
2. City or county jail 3. State prison 4. Facility licensed by the State Department of Mental Health 5. State or county hospital 6. Facility licensed by the State Department of Mental Health 7. Other types of facilities licensed by the Department of Mental Health as the need arises |
|
|
What controlled substances are used int he treatment of patients addicted to narcotics?
|
1. Methadone (primarily)
2. Opium 3. Morphine 4. Hydromorphone 5. Meperidine |
|
|
How many days does a patient addicted to narcotics typically receive controlled substances at a facility approved to treat patients with an addiction problem?
|
15 days
|
|
|
How much opium does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
8 grains of opium
|
|
|
How much morphine does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
4 grains of morphine
|
|
|
How much hydromorphone does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
1 grains of hydromorphone
|
|
|
How much meperidine does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
400 mg meperidine
|
|
|
How much methadone does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
180 mg methadone (may exceed this amount as of 9/2002)
|
|
|
How much levoalphacetylmethadol (LAAM) does a patient receive per day in a facility approved to treat patients with an addiction problem within the first 15 days of admission?
|
200 mg LAAM (may exceed this amount as of 9/2002)
|
|
|
How much opium does a patient receive per day in a facility approved to treat patients with an addiction problem after 15 days of admission?
|
4 grains opium
|
|
|
How much morphine does a patient receive per day in a facility approved to treat patients with an addiction problem after 15 days of admission?
|
2 grains morphine
|
|
|
How much Pantopon does a patient receive per day in a facility approved to treat patients with an addiction problem after 15 days of admission?
|
3 grains Pantopon
|
|
|
How much hydromorphone does a patient receive per day in a facility approved to treat patients with an addiction problem after 15 days of admission?
|
1/2 grain hydromorphone
|
|
|
How much meperidine does a patient receive per day in a facility approved to treat patients with an addiction problem after 15 days of admission?
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200 mg meperidine
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Which controlled substance(s) may be continued after 30 days of treatment at a state-approved facility for patients with addiction?
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Methadone and levoalphacetylmethadol (LAAM)
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Which health care providers may administer controlled substances at a state-approved facility for patients with addiction?
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1. RN
2. PharmD 3. PA 4. Psychiatric Technician 5. Licensed vocational nurse |
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Under what conditions may a pharmacist dispense Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine)?
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1. Prescriber has completed > 8 hours of CE int he management of opioid-dependent patients addicted to Schedule III-V controlled substances
2. Prescriber's second DEA begins with X instead of A or B 3. Presciber is only treating 100 patients at a time 4. Prescriber may not delegate pursuant to a protocol to a NP or PA |
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How many hours of CE must a physician complete in order to write prescriptions for Suboxone (bupernorphine/naloxone) and Subutex (buprenorphine)?
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> 8 hours
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If a physician has copmleted the necessary course to administer prescriptions for Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) what additional DEA number will they receive?
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A second DEA number idential to their previous number except the first letter (e.g. A or B) is replaced with an X
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How many maximum patients may a prescriber who has completed the CE in order to write prescriptions for Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) allowed to treat at one time?
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100 patients
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Can a physician delegate prescriptive authority for Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) to an NP or PA?
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No
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What is an "injection card system"?
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Enables a facility to authorize an outpatient to receive injections of controlled substances at their facility
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How long does a facility have to make an injection card part of the patient's permanent medical record?
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15 days from the date the last authorized dose is administered
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Within how many days must the board be notified of a change of pharmacy ownership?
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30 days
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Within how many days must the board be notified of a change of an address or name?
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30 days
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Within how many days must the board be notified of a change of the pharmacist-in-charge?
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30 days
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Within how many days must the board be notified of drug loss (by destruction or pilferage)?
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30 days
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Within how many days must the DEA be notified of controlled substance drug loss (by destruction or pilferage)?
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Immediately (within 1 business day)
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Within how many days must the board be notified in the case of a bankruptcy, insolvency, or receivership?
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Immediately in writing
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Within how many days must the board be notified regarding any change in the pharmacy permit?
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30 days
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Within how many days must the Board be notified by the PIC if a licensed employee of the pharmacy is involved in the theft, diversion or self-use of a drug or exhibits behavior representing an impairment that affects that persons ability to practice?
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30 days
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How long must a community pharmacy keep prescription records?
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3 years
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How long must a hospital pharmacy keep prescription records?
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3 years
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How long must a clinic pharmacy keep prescription records?
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3 years
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How long must a pharmacy keep patient medication profile records?
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1 year after date of last entry
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How long must a pharmacy keep pharmacy technician compliance records?
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3 years from time of making
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How long must a pharmacy keep Controlled Substance inventory records?
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3 years
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How long does a pharmacist have to keep CE certificates?
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4 years
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How long does a pharmacy have to keep DEA Form 222 records?
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2 years
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How long does a pharmacy have to keep self-assessment of pharmacy records?
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3 years completed by July 1st each odd year
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How long does a pharmacy need to keep patient medication error documentation records?
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1 year
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What is the pharmacist-intern hour requirement?
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1500 hours
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What is the CE hour requirement?
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30 hours every 2 years
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What date does the Self-Assessment of Pharmacy record have to be completed by?
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July 1 each odd year
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What is the interim period for a temporary PIC?
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120 days
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What is the frequency for Controlled Substances Inventory?
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2 years
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What is the number of days in which a prescription for a Schedule II controlled substance must be filled?
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Within 6 months of the date the Rx was written
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What is the number of days in which a prescription for a Schedule II controlled substance must be filled if written fora terminally ill patient in a SNF and time limit for filling total Rx if Rx is partially filled at intervals?
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Within 60 days of the date Rx was written
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What is the time period in which to electronically submit info on Schedule II, III, IV Rxs per the CURES program?
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Weekly
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How long does a prescriber have to submit a written prescription per an emergency oral order for a Schedule II controlled substance by the prescriber?
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7 days from date written
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How long does a pharmacist have to report a prescriber who fails to submit a written prescription after they call in an emergency oral order for a Schedule II controlled substance?
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144 hours after 7 days of the emergency oral order
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What is the time period a Schedule III or IV prescription must be filled or refilled before it is voided?
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6 months from date written. Refills not to exceed 120 days
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How many maximum days of refills may a Schedule III or IV prescription have on it?
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120 days
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What is the expiration date for any compounded prescription?
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6 months or less (if any ingredients expires before 6 months)
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What is the expiration date for extemporaneously prepared unit doses?
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1 year or less if manufacturer's expiration date is less than 1 year
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What is the renewal time period on a pharmacy permit?
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Annually
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What is the renewal time period on a sterile compounding license?
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Annually
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What is the time period for a temporary permit issued upon transfer of ownership?
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180 days
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What is the time period one must renew license to continue to practice pharmacy?
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Every 2 years
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What is the maximum time period one may forego renewing their pharmacist license without making it unrenewable?
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3 years
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What is the maximum amount of time a pharmacy may leave the pharmacy and leave other non-pharmacists in the pharmacy?
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No more than 30 minutes for meal or other breaks
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What is the period of time Rx records must be produced from an off-site storage facility when requested?
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48 hours
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What is the period of time a PIC must do an investigation and report once a medication error is discovered?
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Within 48 hours of discovery of error
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What is the maximum amount that may be charged as an administrative fee in addition to the cost of an Emergency Contraceptive agent?
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$10
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What is the maximum amount that may be charged as an administrative fee in addition to the cost of OTC Plan B?
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No fee allowed
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What is the notice requirement by the board and response to notice by licensee upon pharmacy closure?
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After notice licensee must respond within 10 days
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Upon closure of a pharmacy, how long does a pharmacy have to complete a transfer of drugs and consequently provide notice to the board that the transfer has been completed?
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Within 10 days of the closure, and must be done in writing
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What is the definition of a pharmacy being "closed down"?
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Pharmacy no longer engaged in activity it was licensed for, or not operating at least one day per week in 120 day period
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What form must a pharmacy use if controlled substance is lost due to theft?
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DEA form 106 filled out online
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Can a pharmacist fill an out-of-state Schedule II controlled substance for an out-of-state resident that is not written on a security prescription form?
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Yes, as long as a the security prescription form is not required by the other state's laws
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