Fed Flashcards
What does the Federal Anti-Drug Abuse Act of 1988 include?
- It is prohibited for employees to have unlawful possessions of controlled substances in the work place.
- Any employee who has been convicted of criminal possession of drugs must inform their employer of their conviction within 5 days.
- Employers have the right to take appropriate action in order the keep the work place free of drugs.
Why was HIPAA enacted?
- To control the dissemination of patient information.
- To only disseminate patient information upon authorization of the patient
- To keep personal identifiable health information protected when transmitted or maintained by electronic or other medias.
Who is responsible for the Medicaid and Medicare programs?
Centers for Medicare & Medicaid Services (CMS)
Who issues licenses for pharmacies?
State Board of Pharmacy
Can a drug product be exempt from demonstrating therapeutic equivalence?
Yes, but only under the grandfather clause.
Do prescription labels need to have an NDC number on them?
No this is not mandatory. The same goes for package labels and individual dosage units.
When does a unit dose package that is prepared from a bulk container or a commercial drug product expire?
25% of the remaining time between the date of repackaging and the manufacturer’s expiration date, but in no case can the dating applied to the repackaged unit exceed six months.
What should the supplier do if a DEA 222 Form cannot be filled?
Return copies 1 & 2 to the purchaser and state the reason for not filling.
DEA implements a new single-sheet format for DEA Form 222. This rule includes a “sunset date” of October 30, 2021—the date after which use of the triplicate forms will not be allowed.
If a DEA Form 222 cannot be filled for any reason, the supplier must return the original DEA Form 222 to the purchaser with a statement explaining the reason the order could not be filled. For electronic orders, if the order cannot be filled, the supplier must notify the purchaser and provide a statement as to the reason; if the order is refused, a statement that the order is not accepted is sufficient.
Who does the Americans with Disabilities Act (ADA) of 1990 apply to?
- All companies employing 15 or more people.
- All companies receiving or not receiving federal financial assistance.
- Replaced the word “handicapped” with “disabled”.
What is the USP/NF?
United States Pharmacopoeia/National Formulary (USP/NF). This serves as a reference and revisions are published bimonthly in The Pharmacopoeia Forum (PF)
What is tamper-evident?
Packaging designed to prevent foreign materials from getting into the final product.
What should you know in regards to take home medication for a patient in a comprehensive treatment program?
- All medication must be labeled with the name, address and phone number of the treatment center.
- All medication must be packaged in child-resistant containers.
- Narcotics should only be given to a patient if there has reasonable judgment by the program physician regarding the patient being responsible in handling narcotic drugs.
In an emergency situation, what should the pharmacist know in regards to dispensing a Schedule II medication upon receiving oral authorization from a prescribing practitioner?
- The prescription must immediately be reduced to writing by the pharmacist and must contain all required information, with exception of the prescribers signature.
- If the pharmacist does not know the prescriber, he/she must make all reasonable efforts to contact them to determine that the oral order is legit.
- If the prescriber fails to deliver a written prescription within seven days after authorizing the emergency oral prescription, the pharmacist needs to notify the nearest DEA office to report this.
How do clinical human trials work?
- There are 3 phases before the final approval of a drug by the FDA
- There is one phase after the drugs has been marketed.
- A drug must complete each phase successfully before progressing to the next phase.
What is VIPPS?
The Verified Internet Pharmacy Practice Sites. Established in 1999 for the public concern of the safety of pharmacy practices on the Internet. A coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups provided their expertise in developing the criteria which VIPPS accredited Pharmacies follow.
What is a requirement if an Internet pharmacy wants to be VIPPS accredited?
To be VIPPS accredited, a pharmacy must comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals. In addition, pharmacies displaying the VIPPS seal have demonstrated to NABP compliance with VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists.
How would you label a drug container that does not display the legend “Rx only”?
Misbranded
What are orphan drugs?
Drugs used to treat diseases that relatively affect very few people.
What form would a pharmacy need to purchase 95% Ethanol for routine compounding?
Form ATF-11
What drug titles are used when writing a prescription for a drug product for dispensing?
Trade name & brand name
Where would you treat a patient requiring rehabilitation or a lower level of medical care needed for a hospital?
Skilled Nursing Facility (SNF)
What are the classifications of controlled substance schedules based on?
The drugs potential for abuse and dependence
Does a prescriber need a prescription to administer or dispense a Schedule III, IV, or V controlled substance to a consumer in the course of their professional practice?
No
Can a pharmacist dispense drug samples given to them from pharmaceutical companies?
No. A physician is allowed to give them to their patients, but a pharmacist should not give out samples to their customers.
What did the Pure Food and Drug Act of 1906 regulate?
Prevents the manufacture, sale, or transportation of adulterated or misbranded or poisonous or
deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.
What do licensed private practitioners and community pharmacists do in a medication unit of a narcotic treatment program?
A medication unit is a facility established as part of a narcotic treatment program. In a medication unit,
private practitioners and community pharmacist are permitted to administer and dispense
Can pharmacies sharing a real-time online database transfer Schedule III, IV, or V prescriptions for refills?
Yes, refill prescriptions, up to the maximum limit by law, can be transferred given the following criteria:
- The transfer must be communicated directly between 2 licensed pharmacists.
- The transferring pharmacist must:
- Add information to the electronic prescription record that the prescription has been transferred.
- Add to the electronic prescription record; the name, address and DEA number of the pharmacy and the name of the pharmacist receiving the prescription.
- Record the date and the name of the pharmacist transferring the information.
- Provide the receiving pharmacist the following information in addition to the original electronic prescription data:
- Date of original dispensing
- Number of refills remaining and the dates and locations of previous refills
- The transferring pharmacy’s name, address, DEA #, and Rx # for each dispensing
- Name of the pharmacist transferring the prescription
- The name, address, DEA # and Rx # from the pharmacy that originally filled the prescription if different
- The receiving pharmacist must create an electronic record for the prescription that includes the
receiving pharmacist’s name and all of the information transferred with the prescription (listed above).
-The original and transferred prescriptions must be maintained for a period of 2 years from the last refill.
What forms need to be filed simultaneously, with both the FDA and the state authority, when trying to obtain approval for a
narcotic treatment program?
- Form FDA-2632: This is an application for approval to use narcotic drugs in a treatment program and it is
to be signed by the program director, in duplicate. - Form FDA-2633: This is a medical responsibility statement for use of narcotic drugs in a treatment
program and it is to be signed by each licensed physician authorized to administer or dispense narcotic
drugs, in duplicate.
What group of patients should generally NOT be give LAAM in treatment of narcotic dependence?
Pregnant women & people under the age of 18. Levacetylmethadol (LAAM) is a synthetic opioid similar in structure to methadone. It is indicated as a second-line treatment for the treatment and management of
opioid dependence if patients fail to respond to drugs like methadone or buprenorphine.
What is a Type S drug?
Type S drug indicates that it is similar to other drugs on the market.
Who is responsible for designating non proprietary assigned to pharmaceuticals marketed in the U.S.?
United States Adopted Name (USAN)
What conditions must be met with an Automated Data Processing System?
An Automated Data Processing System is a computer used for storage and retrieval of refill information
for prescription orders for Schedule III, IV, or V controlled substances. It must provide online retrieval of original prescription order information for all prescriptions currently authorized for refilling. It also must provide online retrieval of the current refill history for prescription orders authorized for refill in the past
six months.
If you make an error on a DEA Form 222, can you correct it and put your initials next to it?
No, corrections cannot be made on a DEA Form 222 A new DEA Form 222 must replace it.
Can Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness be
maintained in a computerized system?
Yes, given the computerized system is capable of the following:
- Output data of the original prescription
- Immediate updating of the prescription record each time a partial filling of the prescription is done.
How would a physician prescribe a Schedule II medication for one of their hospital patients?
By sending in a written or faxed medication order. (A prescription is an order for medication which is
dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for
immediate administration to the ultimate user).
How are cosmetic products intended for use in body cavities, such as mouthwashes and vaginal creams, packaged?
In tamper-resistant packaging
When can pharmacies compound drugs extemporaneously?
- When the drug products compounded are not compounded versions of FDA approved drug products.
- if the ingredients included in the compounded dosage form meet official standards of the USP/NF
- If the pharmacy does not actively solicit business for specific drug products by advertising or by
otherwise promoting their compounding capabilities. However, they may advertise to both the public
and health professionals that it specializes in prescription compounding. - The quantity prepared is reasonable for filling either existing prescriptions or those anticipated based
upon prescribing habits or prescribers and prescriptions already on file. - The dosage forms prepared are not being compounded, provided or sold to other pharmacies or third-
parties such as physician’s offices. - The pharmacy does not attempt to compound a drug product that is on the list of products that have
been withdrawn or removed from the market because they were unsafe or ineffective.
Who is in charge of regulating advertising and/or labeling of cosmetics?
The Federal Trade Commission (FTC) regulates all forms of advertising. The FDA regulates the content
and form of food labeling, cosmetic labels, dietary supplement labels and drug labels. Labels are simply
special form of advertising, so both FTC and FDA regulate them in one way or another.
What did the Durham-Humphrey Amendment of 1951 make it mandatory for manufacturer’s to provide?
The Durham-Humphrey Amendment of 1951 defined two categories for medications, legend (rx) and OTC.
It required medications that should be used only under the supervision of a health practitioner to carry the
statement “Caution: Federal law prohibits dispensing without a prescription”.
It also mandated that there must be “adequate directions for use”, on the manufacturer’s label for the
class of drugs which do not require medical supervision to be used safely (OTC’s).
Who do you report adverse effects of controlled substances and medical devices to?
MedWatch is the FDAs reporting system for adverse events, founded in 1993. An adverse event is any
undesirable experience associated with the use of a medical product. The MedWatch system collects
reports of adverse reactions and quality problems, primarily with drugs and medical devices.
What drug schedule does Phenobarbital fall into?
Schedule IV
What did the FDCA of 1938 address?
The Federal Food, Drug and Cosmetic Act (FDCA) is a set of laws passed by Congress in 1938 giving
authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and
cosmetics. The proof of fraud intent was no longer required to stop false claims or misbranding for
drug products. Authority was granted for factory inspections and warnings of habit-forming drugs were
required on all drug product labeling.
What determines OTC status on drugs?
- Drugs that are safe for use without the supervision of a physician
- Drugs that meet suitable conditions for self-diagnosis
- Drugs that have adequate written directions for self use
How many days can a narcotic drug be administered for a short term detoxification from narcotic drugs?
The narcotic drug can be administered daily, under close supervision, for no longer than 30 days. Dosages
should be tapered down over this period of time.
Can a pharmacist dispensing solid oral medications use their discretion as to the beyond use dating for the product?
Yes, as long as it doesn’t exceed the expiration date stated on the manufacturer’s label.
How would the FDA classify a unit dose drug product that does not have an expiration date on the label?
Misbranded
What are some of the major objectives of a drug formulary?
- Reducing Inventory
- To allow therapeutic substitution
Can manufacturers of OTC products designate one size of a product as a non-compliant container?
Yes, provided that the product contains a conspicuous warning label that states:
- This package is for households without young children or package not child resistant
What did the Kefauver-Harris Amendment of 1962 declare?
It declared that all new drugs marketed in the U.S. had to be shown to be safe and effective. This not only
applied to new drugs, it also applied to products that were approved between the years of 1938 and 1962.
What type of drugs fall into Pregnancy Category D?
- Drugs in which there has been positive evidence of risk to the human fetus, mainly based upon adverse
reaction data from either investigational or marketing experiences. - Drugs that should be administered in pregnant women ONLY if the potential benefits of the drug are
greater than the potential risk.
What is the maximum volume of Ipecac Syrup that can be sold without a prescription?
30 mL
