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168 Cards in this Set
- Front
- Back
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What organization enforces the Federal Controlled Substances Act (CSA)?
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DEA
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What CS class is peyote?
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I
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Ecstasy?
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I
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What CS class has severe physical dependence?
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II
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What can a Rph NOT change on a CII RX?
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Patient name, CS prescribed, Signature
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Initial CS inventory requires what for records?
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Date, time, drug (strength, form, #).
- Recommended: name, address, DEA#, signature |
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Who is allowed to prescribe CS, but is exempt from being registered under the CSA?
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PHS, Bureau of Prison, and military physicians
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What information must be on a CS RX?
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1) Patient name and address
2) Date of issue 3) Drug and quantity 4) Dosage form 5) Directions for use 6) # refills 7) Prescriber name, address, DEA# |
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What can be used to write a CII RX?
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Ink, indelible pencil, typewritten + manual signature from prescriber
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What are the 3 exceptions to a written CII RX?
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1) Fax: home infusion/IV pain, LTCF, hospice
2) Emergency 3) Partial |
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What are the requirements for emergency dispensing of a CII?
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1) RX is immediately written (except for prescriber signature)
2) Qty is limited to treatment during emergency period 3) Rph attempts to verify authenticity 4) Prescriber MUST provide a signed, written RX w/in 72 hours |
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What are the requirements for partial dispensing of a CII?
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1) Full qty is not available
2) Balance MUST be dispensed within 72 hours 3) Qty dispensed is written on front of RX |
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What is the exception for partial filling of CIIs?
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LTCF or "terminally ill" patient (noted on RX), partial fills are allowed for 60 days
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When can a non-narcotic treatment program doctor administer a narcotic?
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1. To relieve acute withdrawl symptoms
2. Not more than 1 days meds x 3 days |
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When can narcotic administration by a non-narcotic treatment program hospital be done?
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If treating for other than addiction
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What medicines require MD's special DEA # that starts with an "x"?
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Suboxone (burprenorphine) and Suboxone (w/naloxone)
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What DEA Form is used for lost or stolen CS?
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Form 106
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What DEA Form is used for CS destruction?
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Form 41
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What are the CO Rules for location of PSE?
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Behind the counter (does not have to be in a locked cabinet like federal law)
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What are the PSE limits?
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1. 3.6 grams/person/day
2. 9 grams/person/30 days |
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What medicines require MD's special DEA # that starts with an "x"?
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Subutex (burprenorphine) and Suboxone (w/naloxone)
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What DEA Form is used for lost or stolen CS?
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Form 106
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What DEA Form is used for CS destruction?
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Form 41
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What are the CO Rules for location of PSE?
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Behind the counter (does not have to be in a locked cabinet like federal law)
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What are the PSE limits?
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1. 3.6 grams/person/day
2. 9 grams/person/30 days |
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What act was prompted by unsanitary practices in food and drug industries and prohibited ADULTERATION and MISBRANDING?
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The Pure Food and Drug Act of 1906
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What act stated that new drugs must be proven to be SAFE (to the FDA). This was prompted by the deaths from sulfanilamide elixir.
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The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
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What 2 things did the Durham-Humphrey Amendment (1951) do?
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1. Established RX and OTC drugs
2. Authorized ORAL prescriptions and refills |
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What 3 things did the Kefauver-Harris Amendment (1962) do? It was prompted by the thalidomide disaster.
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1. Drugs must be proven to be EFFECTIVE
2. Established GMP 3. Required informed consent of research subjects |
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What act said that prescription labels must contain the symbol "RX only?"
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1997 FDA Modernization Act
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What term describes a drug that contains filthy, putrid, or decomposed material or held under unsanitary conditions?
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Adulteration
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What term describes a drug that does not contain necessary labeling?
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Misbranded
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What 6 restrictions did the FDA place on manufacturers' promotion of drugs for off-label use?
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1) Unabridged peer-reviewed articles published in scientific/medical journals not influenced by drug company
2) Approved labeling 3) Comprehensive bibliography 4) Contrary publication 5) Known safety risks 6) Conflict of interest |
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What is a drug or device that contains an unsafe color additive?
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Adulterated
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What is a drug or device whose quality or strength has been reduced by the addition or substitution of other substances?
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Adulterated
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What is a drug or device that fails to have required statements prominently displayed and easily understood?
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Misbranded
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Per FDCA, what are the package insert requirements that the manufacturer/distributor must include (labeling, descriptive matter, advertising) in order for the drug or device to not be misbranded?
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1. Generic name
2. Formula with each ingredient and quantity 3. Information on effectiveness 4. Side effects and CI |
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What 3 agencies are DRUGS recognized by?
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1. US Pharmacopeia
2. Homeopathic Pharm 3. National Formulary |
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What is the definition of a DRUG?
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Articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention if disease in man or other animals
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Non Child-resistant containers are ok for elderly/handicapped if labeled in what way?
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1. Package not child-resistant OR
2. This package for households without young children |
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What are the 4 exceptions for not using a child-resistant container?
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1. SL NTG, isosorbide dinitrate
2. Prescriber request for each patient for each individual RX 3. Patient's specific request (preferably in writing) 4. Topical and other non-oral applications |
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What agency created a commission that is responsible for the Hazardous Substances Act and PPPA?
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Consumer Product Safety Act
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When are Tamper Resistant RX pads not required?
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If RX is electronic, verbal, fax (NOT WRITTEN)
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What 3 traits must a tamper-resistant pad have?
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1) prevent unauthorized copying
2) prevent info erasure/modification 3) prevent use of counterfeit RX forms |
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What 3 organizations enforce the Federal Anti-Tampering Act?
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1. FDA
2. FBI 3. Dept. of Agriculture |
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What is required to receive a dealer's stamp?
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$54 and AFT Form-11
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What requires an annual alcohol tax and license?
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Alcohol for medicinal purpose (including compounding) and/or retail liquor
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What type of alcohol does not require a dealer stamp?
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190-proof ethyl alcohol
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What are the 4 requirements for hospitals regarding tax-free alcohol?
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1. Special AFT permit
2. Only for tx of patients, medicinal, or scientific purposes 3. CANNOT sell to outpatients 4. Must be labeled, stored, and secured to prevent unauthorized access |
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Describe how one would mail a CS
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Inner container: sealed and labeled with pharmacy name and address.
Plain outer container/wrapper - no marking to indicate contents |
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Who is an unlicensed person who performs duties under supervision of a pharmacist?
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Pharmacy technician
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After a license is revoked, how long do you have to wait before reapplying for licensure?
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At least 2 years
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If pharmacy manager terminates employment, how soon much the owner transfer State Board Registration to a new manager?
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14 days
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When does a pharmacy manager need to notify the Board if terminating employment?
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Immediately
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When must a NEW pharmacy manager notify the Board?
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Immediately
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What 3 items must a PDO display?
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1. Board Registration
2. Owner and Manager's names 3. Pharmacist and Intern (original) licenses |
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If a PDO transfers ownership, changes name, or changes location they must do what?
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Apply to Board
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What requirements are there for a PDO to register with SBOP as a compounding PDO?
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1. Accredited
2. Must be owned solely by pharmacist |
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What can a compounding pharmacy do if it is accredited?
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Compound >10% total sales for practitioners or PDO w/ same owner
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Who can a manufacturer or wholesaler sell drugs to?
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1. Wholesaler
2. Hospital 3. PDO 4. Practitioner |
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If a casual sale (<10%) is done, who can a PDO or hospital sell to?
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1. PDO
2. Wholesaler 3. Prescribing practitioner |
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You can NOT compound commercially available drugs except when?
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1. If significantly different OR
2. It is the best medical interest for the patient (dye allergy) ** MUST notify patient |
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A 24 hour drug supply can be given to a registered ER patient by hospital employees IF:
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1) If ordered by practitioner
2) If employee can administer (nurse) or dispense (pharmacist) meds |
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What are 2 things an intern can NOT do?
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1. Supervise
2. Initial interpretation or final RX evaluation (II/FE) |
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A pharmacist can supervise up to 3 techs if 1 of the 3 techs has what?
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1. Certification by National Board
2. Pharmacy tech training degree 3. 500 hours experience at the pharmacy certified by manager |
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What is required on the label for a chart order?
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1. Hospital name
2. Patient name and location 3. Drug and precautionary statements 4. Exp date if needed |
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When MAY a pharmacist substitute a generic drug?
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1. Identical active ingredient
2. Communicated to patient orally and in writing ("generic ok?") 3. RX label and file has both prescribed and substituted drug name 4. Cost to patient is less than prescribed drug |
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When can a pharmacist NOT substitute?
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1. DAW box checked
2. Hand-written or initialed on RX by prescriber 3. ORALLY communicated by prescriber |
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What way of communication is NOT allowed for DAW?
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Fax of signature or initials. No pre-printed DAW signature or form.
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With regards to types of discipline, is a letter of admonition public or private? A confidential letter of concern?
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Admonition is public. Letter of concern is private.
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Who can donate unused non-CS meds for redispensing? (With regards to LTCF)
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Patient of a licensed facility or patient's family
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Where can the donated meds be redispensed?
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To another patient of the SAME facility or medical assistance program. Also can be donated.
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What is considered to be a "licensed" facility for redispensing?
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1. Hospital
2. Hospice 3. LTCF 4. Assisted living |
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What are the SBOP regulations for meds returned for redispensing?
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1. Unopened and sealed
2. Individually packaged 3. Can only be redispensed once 4, Expire >6 months after donation |
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How are cancer med redispensed?
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To patients that meet certain eligibility requirements. Pharmacists cannot charge the receiving patients
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How long should CS records be kept?
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2 years
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What items must the CS record contain?
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1. Name and address of patient
2. Date 3. Kind and Qty |
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What Form is used for a CS loss?
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106
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What Form is used for a CS stolen?
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106
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What must be recorded if a CS is lost, destroyed, or stolen?
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Kind, qty, and date
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How many days do you have to report theft to appropriate law enforcement, Board and DEA?
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30 days
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Specific individual data from the PDMP is available to what 4 groups of people?
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1. Practitioners prescribing a CS to a current patient or monitoring a patient in CS abuse program
2. Pharmacists dispensing CS to a current patient 3. Law enforcement officials with a court order for a specific individual 4. Patient who receives CS |
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What are the exceptions to the disclosure of patient confidentiality?
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1. Patient or patient's authorized representative
2. Practitioner, pharmacist, or intern caring for the patient. 3. Technicians and insurance company as above 4. Recordkeeping pharmact 5. Law enforcement 6. If authorized by law or patient |
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What must be included on each written/oral order?
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1. Dispensing/compounding date
2. Qty dispensed (if not what ordered) 3. II Pharmacists name/initials/# |
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What additional info must be included on each written/oral order for a CS?
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1. Patient address
2. Prescriber address and DEA # |
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What additional info must be included on each written/oral order for LTCF?
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Serial #
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What must be recorded for an order clarification change?
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1. Initials
2. Date 3. Person conveying change |
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What must be included on RX order for substituted drug?
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1. Both drug names AND
NDC# OR distributor |
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How long is refill info kept?
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2 years
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What information is included for refills?
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1. Date
2. Qty (if changed) 3. Person authorizing refill 4. Pharmacist name/initials/# |
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If a patient or patient's agent wants a copy of their prescription, what must be written on the copy? On the original RX?
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"Copy for Reference Only"; Initials, date, and copy indication on original
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What does the transferring pharmacist need to write on the original RX?
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1. "Void"
2. Name of receiving pharmacist/intern 3. Name, address, phone of receiving PDO 4. DEA# if CS |
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What must a receiving pharmacist write on a transferred RX?
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1. "Transfer"
2. Issue date. Dispensing date. 3. Original refills. Refills remaining 4. Date of last fill 5. RX# 6. Name of transferring pharmacist/intern 7. Name, address, phone of transferring PDO 8. DEA# if CS 9. Practitioner's DEA if CS |
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What must be recorded for II AND FE
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Pharmacist's name/initials/#
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When is drug regimen review completed? II or FE?
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II
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When is the medication properly prepared, in a suitable container, with proper label? II or FE?
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FE
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How long are records of II and FE kept?
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2 years from date of any transaction on that RX
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How is documentation of II/FE done?
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1. Written II/FE Notice is signed and dated by manager.
2. Posted next to current Board Registration 3. Kept for 3 years from date last used |
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What does the II/FE Notice contain?
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1. How II/FE is recorded and maintained
2. Statement that all pharmacy personnel can print II/FE records |
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When does a new manager need to sign and date II/FE Notice
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Within 72 hours of starting
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If there is no valid preexisting patient-practitioner relationship, a pharmacist can NOT dispense if the RX is issued in what 3 ways?
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1. Internet-based questionnaire
2. Internet-based consultation 3. Telephone consultation |
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How is a legitimate doctor-patient relationship described?
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1. Patient has medical complaint
2. Medical history taken 3. Physical exam performed 4. Logical connection between complaint, history, exam, and prescribed drug |
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What constitutes a valid RX (for dispensing CS over the Internet)?
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Issued for legitimate medical purpose by practitioner conducting > or = 1 in-person medical evaluation
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What MUST be on an online pharmacy website?
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1. Location
2. Identity and licensure of pharmacy 3. Pharmacists and prescribers 4. States where authorized to practice |
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What is the transfer, distribution, or delivery of RX drugs to non-consumers?
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Casual sale
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What labeling information must be on a chart order?
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1. Hospital name
2. Patient name and location 3. Drug and precautionary statements 4. Expiration date if needed |
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What needs to be listed in the record for return to stocks?
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1. RX #
2. Drug name and strength 3. Qty returned to stock 4. Date of return 5. In centrally filled, the location where filled |
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What 3 people can perform packaging in a PDO?
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Pharmacist, intern, or technician
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When does a pharmacist or intern need to notify the SBOP about an address or employment change?
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30 days
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What does a pharmacist or intern's ID badge need to say?
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"Intern Pharmacist" or "Pharmacist + License #"
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You must pass the NAPLEX and MPJE within how many months of each other?
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24 months
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What are the requirements to reinstate/reactivate a license that has been inactive or expired <24 months?
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1. 24 hours CE (in past 24 months)
2. Application and fee |
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What are the requirements to reinstate/reactivate a license that has been inactive or expired >24 months
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1. 1 hour CE times # months inactive/expired
2. Pass MPJE 3. Application and fee |
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When must a PDO alert the SBOP after transfer of ownership?
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Immediately
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What defines a "transfer of ownership" of a PDO?
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1. Sale of > or = 20% shares or ownership interest
2. Incorporation of an existing PDO |
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When must a PDO apply to SBOP for relocation?
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At least 30 days before
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When a PDO is discontinued, how long does the manager have to relocate RX's to another PDO?
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Within 72 hours
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What does a non-resident PDO need to include in their written notice to the SBOP? And how often do they report it?
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Officers and pharmacists dispensing drugs to CO residents. Reported annually and within 30 days of officer/pharmacist change.
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How long does a new manager have to conduct a CS inventory?
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72 hours
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If the pharmacy is open less than how many hours they have to report to the Board
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32
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What are the minimum pharmacy business hours?
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2 days per week and 4 continuous hours per day
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What must be included in a pharmacy's professional reference library?
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1. CO PPA
2. CO CSA 3. SBOP Rules and Regs 4. DEA CS Rules 5. Fed CSA 6. Sterile/cytotoxic compounding if applicable |
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How much time do you have to submit a written report of a security breach to the SBOP?
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10 days
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What 3 thing is CDTM pursuant to?
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1. Physician diagnosis
2. Physician order 3. Written agreement |
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What is the name of a specific written plan for course of medical treatment? It describes the nature and scope of CDTM for specific conditions or diagnoses.
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Protocol
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What are the 4 requirements for a good protocol?
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1) Clear criteria and specific directions
2) Instructions for responding to acute allergic reactions and ADRs 3) Consistent with EBM 4) Signed and dated by authorizing physician |
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How often is the written agreement reviewed?
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At least annually
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What must a CDTM pharmacist report to the SBOP?
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1. SBOP Notification Form
2. Written agreement with physician or general authorization plan (In-pt/HMO) |
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What must a CDTM pharmacist have on file at his location?
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1. Documentation of successful completion of qualification requirements
2. Access to protocols 3. Scientific literature upon which protocols are derived |
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Besides having an unrestricted pharmacy license, what qualifications must a CDTM pharmacist have? (6)
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1) Accredited pharmacy practice residency in the specialty being practiced
2) ACPE certification program and 40 hours of supervised clinical training 3) 40 hours of CE in clinical practice and 40 hours of supervised clinical training 4) BCPS 5) Grandfather clause (8/1/05). Personal and physician attestation and documentation of employment dates 6) In-pt HMO: 40 hours supervised clinical practice, approved protocols, documented competency |
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How long do CDTM records need to be kept?
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7 years
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What 4 things must the pharmacy manager post for each technician?
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1) Certificate from national board OR 2) diploma from accredited training program OR 3) documentation of 500 hours experience OR 4) documentation that tech does not have any of the prior 3
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With regard to advertising, what can be on an RX label?
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Only the address of the outlet
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If you are in a legal proceeding about a drug or device law how long do you have to notify the Board in writing of your knowledge?
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72 hours
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If you are in a legal proceeding about a drug or device law how long do you have to notify the Board of disposition?
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30 days
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How long do you have to notify the Board of discipline in another State?
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30 days
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Emergency kits can be given to what 3 State licensed or certified facilities?
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1. LTCF
2. Hospices 3. Home health agencies (HHA) |
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What are the e-kit requirements for LTCF and INPATIENT HOSPICES?
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1. Contents determined by medical director
2. 60 drugs. 12 can be CS. 3. < or = 30 doses 4. Oral dosage forms permitted |
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What are the e-kit requirements for OUTPATIENT HHA and HOSPICES?
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1. Contents determined by director of nursing
2. 60 drugs. NO CS. 3. < or = 30 doses 4. NO oral dosage forms |
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When does an e-kit expire?
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Earliest of any drug in the kit or 1 year from sealing
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How often must a pharmacist/designee inspect e-kit contents?
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Annually or within 72 hours of opening
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What 6 things must be IMMEDIATELY available to the Board?
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1. Executed DEA 222 forms
2. CS inventories, dispensing, and receipt 3. RX drug orders 4. RX and CS distribution, loss, surrender, or disposal 5. Pharmacist/intern employee list 6. Manufacturer, distributor, or repackager symbols and codes |
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What 3 things must be available to the Board within 48 HOURS?
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1. UNexecuted DEA 222 forms
2. Receipt records for non-CS 3. Other records |
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What 4 things must a CS inventory record?
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1) Name
2) Strength and dosage form 3) # units or volume 4) Outdated CS |
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What 2 methods satisfy DAILY documentation of C3-5 refills?
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1. FE pharmacist verifies, dates, and signs hard copy OR
2. Pharmacist signs separate file/log book attesting computer refill info has been reviewed and is correct |
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If the computer system fails how many days do you have to restore info into the computer system?
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7 days
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What must be on an RX RECEIPT? (Same info that is on record of distribution/casual sale)
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1. Drug name, strength, and dosage form
2. Qty and date received 3. Generic name and/or NDC 4. Distributor and receiving outlet name and address 5. If CS both DEA #s 6. If C-II: DEA Form 222 |
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What types of receipts can be kept off premises?
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Non-CS receipts
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How many years after completion of the peer health assistance program are records destroyed?
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3 years
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How long must immunization records be kept?
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3 years
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For SBOP inspection, what 4 things do you need with regards to immunizations?
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1) Certificate of completion of CDC approved course and CPR card
2) Copy of MD's immunization authorization 3) Protocol for allergic reactions 4) Written policy for contaminated supplies |
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What 3 documents do you need to provide when giving vaccines?
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1) Epidemiology and Prevention of Vaccine-Preventable Diseases
2) Written, signed patient informed consent 3) Give vaccine information statement (VIS) to each patient |
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What is the max days supply you can provide for a compounded med?
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> or =90 days
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What 2 items must a compounding label contain?
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1. BUD
2. Batch (lot) # |
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What statement must a compounded med for a RX or practitioner have on its label?
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"This product was compounded by the pharmacy"
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When must a new manager sign the Policy and Procedure Manual for non-sterile compounding?
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Within 30 days
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How often must a manager review and sign the Policy and Procedure Manual for non-sterile compounding?
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Annually
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Who must the SBOP notify if your Colorado license is revoked or suspended?
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DEA
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When does a CO pharmacist license expire?
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10/31 of odd years
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When does a CO outlet registration expire?
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10/31 ANNUALLY
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What organization approves our CE?
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ACPE
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What 3 requirements must a APN or RN have to prescribe?
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1. Listed on Board of Nursing APN Registry
2. Written collaborative agreement with CO doc 3. RXN # from Board of Nursing |
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What are DDS or DMD (dentist) requirements?
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Colorado license
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What are OD (optometrist) requirements?
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Colorado license and certified as Therapeutic Optometrist (TPA)
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What are OD limits of prescriptive authority?
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1. Exam - mydraitics, miotics, cycloplegics, anesthetics
2. Tx/Prescribe - antibiotics, anti-inflammatories, antihistamines, analgesics (NO C-IIs) 3. Prescribe - antiglaucoma |
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What are PA (physician assistant) requirements?
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CO Certification by Board of Medical Examiners
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What are PA limits on prescriptive authority?
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1. Within supervising physician's practice area
2. Written RX on supervising physician's RX forms with preprinted name, address, and phone # of supervising MD and PA 3. Own DEA # to prescribe CS |
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What are the requirements for a DPM (podiatrist) or DVM (vet)?
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CO license
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