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77 Cards in this Set

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Schedule I Drugs
Methaqualone
Heroin
Mescaline
GHB
LSD
Marijuana
Peyote
Schedule II Drugs
Amobarbital, Cocaine, Fentanyl, Meperidine, Methamphetamine, Morphine, Oxycodone, Pentobarbital, Amphetamines, Diphenoxylate, Hydromorphone, Methadone, Methylphenidate, MS Contin, Oxycontin, Secobarbital
Schedule III Drugs
Anabolic Steroids, Buprenorphine, Fiorinal/Codeine, Hydrocodone, Paregoric, Tylenol/Codeine, Xyrem (GHB) sodium oxybate [must have narcolepsy indication on RX], Codeine/ASA, Buprenorphine/Naloxone, Hycodan, Hydrocodone/Ibuprofen, Tussionex, Amobarbital, Secobarbital, Pentobarbital Suppositories, Dronabinol
Schedule IV Drugs
Alprazolam, Choral Hydrate, Clonazepam, Diazepam, Flurazepam, Oxazepam, Phenobarbital, Sibutramine, Zolpidem, Midazolam, Butorphanol, Chlordiazepoxide, Clorazepate, Ethchlorvynol, Lorazepam, Pentazocine, Propoxyphene Naplsylate/APAP, Temazepam, Halazepam, Mazindol, Triazolam
Schedule V Drugs
Actifed/Codeine, Novahistine Expectorant, Phenergan/Codeine, Robitussin AC, Tussi-Organidin NR, Lomotil, Novahistine DH, Phergan VC/Codeine, Tylenol/Codeine Liquid
Anabolic Steroids
Ethylesternol, Stanozolol, Testosterone Patch, Nandrolone decanoate, Fluoxymesterone
Under Federal Law, what are the time frames regarding emergency dispensing.
Within 7 days, the physician must have delivered (or postmarked) a prescription to the pharmacy with the words "Authorization for emergency dispensing".

In PA, the time frame is 72 hours.

Pharmacist should notify DEA if prescription is not obtained.
What are the exceptions to the 72 hour rule for partial filling of CIIs
Long-term care facilities may dispense partials for up to 60 days.

Also up to 60 days in patients with documented terminal illness in any setting.
Which controlled substances must be counted exactly when taking inventory?
Schedule I, II, and opened bottles of III, IV, and V containing more than 1,000 pills.
Which 222 forms need to contain only certain substances?
Vet substances such as carfentanil, etorphine HCL, and Diprenorphine should be on forms only containing these substances
True or False?
It is very important for the purchaser to record the number of containers received and the date received on copy 3.
True
How long must 222s be kept on file?
2 years from the last use. (keep in mind refills)
Federal Term:
Must enable a recipient to positively verify the signer without direct communication with the signer and subsequently be able to demonstrate the verifaication to the third party.
Authentication
Federal Term:
Must ensure that strong and substantial evidence is available to the recipient of the sender's identity, sufficient to prevent the snder from successfully denying having sent the data.
Nonrepudiation
Federal Term:
Must be able to determine whether the contents of the document have been altered during transmission or after receipt.
Message Integrity
Do individual pharmacists or do pharmacies need to register with the DEA every 3 years.
The pharmacy is responsible
What is the maximum % that a pharmacist can make as a controlled substance in solution, without registering with the DEA as a manufacturer?
20% of complete solution
What is the maximum % of prescriptions a pharmacy can distribute to another pharmacy or physician, without having to register as a distributor?
5% of all prescriptions
Which individuals are exempt from individually registering with the DEA?
A practitioner that is an agent or employee of a hospital or other institution, acting under normal employment or officials of the Armed Services, Public Health Service, and Bureau of Prisons
What would be reason for registration with the DEA to be suspended/revoked?
Materially falsified the application
Conviction of a felony relative to controlled substances
A state license being suspended, revoked, or denied
What is the DEA form 41?
The form used to notify the DEA of intention to destroy controlled substances
Under federal law, how long does the registrant have to notify the DEA of a theft or loss of controlled substances?
Within 1 business day
What form itemizes the losses during a theft or loss of controlled substances?
DEA Form 106
How can a physician obtain controlled substances to dispense at his or her practice?
For CII's, have the provider complete a 222 form

For CIII - CV complete the invoice for both parties
What can the pharmacist NOT change on the controlled substance prescription?
The patient's name, controlled substance prescribed (except generic substitution), or the prescriber's signature
What is the proper method for transferring a controlled substance prescription?
VOID on the face of the script
Name, address, and DEA of the transferee pharmacy
Name of transferee pharmacist
date of transfer
Name of pharmacist transferring
How many times can a controlled substance be transferred between pharmacies?
One-time-only

Except in pharmacies using real-time online systems
What is the proper method for receiving a transferred controlled substance?
TRANSFER on the face of the script
Date of issue of the original script
Original # of refills
Original date of dispensing
# of refills remaining and locations of previous fills
pharmacy name, address, DEA#, and script # from which the script was transferred
Name of pharmacist transferring
pharmacy name, address, DEA#, and script # of orignal location
Under what circumstances can a provider request additional refills on CIII-CV substances?
Total quantity authorized does not exceed five refills or extend beyond 6 months from the date of issue.
The pharmacist initials and records the date, quantity authorized, and number of additional refills authorized on the reverse of the original prescription.
The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling
What can a pharmacist do when a notice of inspection is served?
The pharmacist has the right to refuse the inspection or withdraw consent at any time during the inspection.

Search warrants cannot be refused
Can CII prescriptions be faxed?
Yes, but the original must be obtained before release of prescription. Except for direct parenteral aministration, a hospice patient, or a patient in a longterm care facility
What would the DEA number be for a physician authroized to dispense suboxone?

AB 9787079
XB 9787079
How do you verify the DEA # of a provider?
2nd + 4th + 6th numbers x 2
1st + 3rd + 5th numbers + sum of previous

Last number should = last number in DEA number
What are the limits on the sales of methamphetamine precursors?
Daily sales limits: not to exceed 3.6 g PSE per day per purchaser
30-day Purchase Limits: Individuals are prohibited from purchasing more than 9.0 g PSE per 30 day period
Mail Order Limits: Not to sell more than 7.5 g PSE to a customer per 30-day period
What are the base quantities in methamphetamine precursors?
20.57 mg base in 25 mg Ephedrine HCl
24.65 mg base in 30 mg PSE HCl
23.22 mg base in 30 mg PSE SO4
How does the FD&C Act define a drug?
- articles recognized in the USP, Homeopathic Pharmacopeia of the US, or the NF, or any supplement to them
-articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals
-articles other than food intended to affect the structure or any function of the body
-articles intended for use as a component of a drug but does not include devices or their components, parts, or accessories
Can a dietary supplement be used for diagnosis or cure?
No
What did the Durham Humphrey Amendment change?
It created a statutory distinction between prescription and OTC drugs. ALSO it authorized refills on prescriptions, as well as oral prescriptions.
In addition, it deemed the prescription label as meeting the adequate directions for use requirement.
What did the Kefauver-Harris Amendment change?
This 1962 amendment was triggered by the Thalidomide disaster. It required more careful control of clinical studies and required drugs to be effective along with being safe. It also established Good Manufacturing Practices and increased the inspection authority of the FDA.
What qualifies a drug as being adulterated?
If the drug has been prepared, packed or held under unsanitary conditions where it may have been contaminated with filth or rendered injurious to health.
If the container is composed of a poisonous substance that may leech into the contents
If it contains an unsafe color additive
If the drug is not listed in the official compendium
If it is a drug and any substance has been added to reduce its quality
What qualifies a drug to be misbranded?
If its label or labeling is false or misleading
If the drug is listed in the official compendium but labeled and packed differently
The drug is subject to deterioration and the label does not bear statements
The drug is health-endagering if used in the manner suggested on the label
The drug is subject to PPPA and not packed accordingly
A pharmacist sells the drug without a prescription or refills a prescription without authorization
What are the exceptions to the Tamper Resistant Packaging Requirement?
Dermatologicals
Dentrifices
Insulin
Lozenges
Who enforces the PPPA?
The CPSC (Consumer Product Safety Commission) not the FDA
What OTC products require child resistant packaging?
Aspirin, Iron containing products, APAP, Diphenhydramine, ibuprofen, loperamide, lidocaine, dibucaine, mouthwashes, naproxen, ketoprofen, minoxidil, fluoride, and any drug that was previously prescription status
What are the 3 types of drug recalls?
Class I: possibility that serious adverse health effects or death can occur
Class II: product may cause temporary or medically reversible harm
Class III: product is not likely to cause adverse health effects
What did the Waxman Hatch Amendment change?
This amendment to the FD&C Act, also known as the Drug Price Competition and Patent Term Restoration Act of 1984, allowed the generic manufacturer to only show that the generic is bioavailable and bioequivalent to the innovator drug. Also, the amendment extended the patent life for the time of the FDA approval process.
Look up Plan B laws.
Pretty sure its 17 and older can get without a prescription.
What Non-Physician Prescribers can write for C-II's to C-V's?
CRNP - 72 hour supply of CII's and 30 days of III-V w/out refills
PA - 72 hour supply of CII for initial therapy or a 30-day supply of ongoing therapy (clearly stated for ongoing therapy). Also III-V with refills
Optomotrists - No C-II. III - IV analgesics not beyond 6 weeks.
Midwife - C-IIs for up to 72 hours and III-IV limited to 30 days and refills requiring approval from physician
In PA, conditions of fire, water, or extreme temperature may be grounds for adulteration or misbranding according to the PA Controlled Substance Drug Device and Cosmetic Act. Who should be contacted if these conditions are believed to have altered a product?
The PA Department of Health
What drugs can be substituted with a B-rated drug?
Nothing. Not even other B's.
In PA, if a drug is A-rated, but it has a narrow therapeutic window, can another A-rated drug be substituted for the written substance?
NO. And refills must be filled identically, unless the patient and prescriber provide authorization in advance.
True or False? It is considered grossly unprofessional conduct to not have pocket card available when practicing.
True
What is the punishment for any person whom fails to disclose information to the Board within reasonable time?
A fine not to exceed $1000.
What is the penalty for a person committing an unlawful act?
This person will be guilty of a misdemeanor and shall be senteced to undergo imprisonment for not more than one year or pay a fine of not more than $5,000, or both, and for each subsequent offense, shall be senteced to undergo imprisonment of not more than threee years or to pay a fine of not more than $15,000, or both.
Schedule A Poisons
Arsenic, Cyanides, Mercury, Thallium
Schedule B Poisons
HCl, Nitric Acid, Sulfuric Acid, Acetic Acid, Potassium and Sodium Hydroxide, Chloroform, Ether, Formaldehyde
Sale of Poisons
Buyer must be 16 y/o
Buyer aware of poisonous character and using for legitimate purpose
Schedule A poisons must be recorded
What kind of setting can a pharmacist manage drug therapy?
It must be in written agreement with a licensed physician and in an institutional setting
How many pharmacies can a pharmacy manager serve at a time?
Just 1
How long can a pharmacy operate (without extensions or one-manager rule) without a pharmacy manager?
15 days

Then the extensions and waivers get added to the 15 days
Right now, can interns accept orders over the phone?
No.
Does the pharmacy manager or the pharmacy preceptor sign and date the interns protocol?
The pharmacy manager
As part of the $5,000 worth of non-proprietary drugs and devices, what supplies and equipment are still required under new regulations?
Refrigerator in the prescription area (with a thermometer)
Original prescriptions (or images) must be maintained for 2 years from the date of the most recent filling
What are the required pharmacy dimensions?
Prescription area should be at least 250 square feet
Prescription counter should be at least 10 feet by 2 feet

If more than 2 pharmacists are on duty simultaneously, increase the required length by 5 feet for each additional pharmacist.
What is a synonym for prescription drugs?
Non-proprietary drugs
What drugs are prohibited in the mail?
Reconstituted antibiotics
Drugs generally known to be subject to deterioration due to heat, cold, agitation, etc.
Under OBRA 90, when is PDR prescription counseling required for patients?
PDR is required for retail, outpatient, and personal care home prescriptions. It is not required for inpatients, ER, nursing homes, and drugs dispensed by the provider.
Look up Faxing prescriptions laws.
PA is suposedly identical to Federal
When are pharmacy permits renewed?
Pharmacy permits are renewed every 2 years in odd-numbered years
When are pharmacist licenses renewed?
Pharmacist licenses are renewed every 2 years in even-numbered years
Can e-prescribing be used for CII's?
No
What is a central processing center?
A pharmacy operated under the direction of a pharmacist that processes information related to the practice of pharmacy and that engages solely in centralized prescription processing but from which drugs are not dispensed
What is a central processing center exempt from?
The requriement to maintain an inventory of $5,000 worth of non-proprietary drugs and devices
The minimum size requirements of a pharmacy
The requirement to have a sink used solely for pharmaceutical purposes
What is drug therapy MGMT?
Adjusting a drug regimen
Adjusting drug strength, frequency, of administration or route
Administration of drugs
ordering tests
With drug therapy MGMT, how long does the pharmacist have to notify the physician of a change in therapy?
72 hours
How long must immunization documents be kept on file?
2 years
When notifying the physician of an administered immunization etc, what is the difference between an order and a written protocol?
Both cases need to have the physician informed within 72 hours, but with an order, the pharmacist must also inform the physician of the route of administration.