Pharmacy law, regulations and references Flashcards
Which group is responsible for approving prescription and OTC medications?
Food and Drug Administration (FDA)
Which group enforces laws and regulations for controlled medications?
Drug Enforcement Administration (DEA)
Which group sets standards for drug manufacturing practices?
FDA
Which group monitors labeling of over-the-counter medications.
FDA
What is PPPA?
Poison Prevention Packaging Act
Which of the following does not require child-resistant packaging?
A. Aviane 0.1mg/0.02mg
B. Nitroglycerin
C. Albuterol
D. Only B and C
E. All of the above
E
NDC: 76329-3316-01
Which number group contains the product code?
A. 01
B. 3316
C. 76329
D. 76329-3316-01
B
NDC: 0338-049-41
Which number group contains the manufacturer code?
A. 049
B. 41
C. 0338
D. 0338-049-41
C
Which law affects the drugs purity, strength, and safety before selling?
Food, Drug, and Cosmetic Act of 1938
Which law prohibits misbranding and prohibits adulteration of medications?
Pure Food and Drug Act of 1906
Which law defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals?
A. Durham-Humphrey Amendment
B. Kefauver-Harris Drug Amendment
C.. Hatch-Waxman Act
D. FDA
A. Durham-Humphrey Amendment
Prescription drugs are also called ___________.
A. Illicit drugs
B. Legend drugs
C. OTC
D. Locked medications
B. Legend drugs
Which act created two classes of medications; prescription (legend drugs) and over-the-counter (OTC)?
A. Pure Food and Drug Act of 1906
B. The Food, Drug, and Cosmetic Act of 1938
C. The Prescription Drug and OTC Act of 1957
d. The Durham-Humphrey Amendment of 1951
D. The Durham-Humphrey Amendment of 1951
Which law limits the retail sale of over-the-counter medications that contain pseudoephedrine?
A. Project BioShield Act
B. Anabolic Steroid Control Act
C. DEA
D. Combat Methamphetamine Epidemic Act
D. Combat Methamphetamine Epidemic Act
Customer wants to purchase Pseudoephedrine, what is the maximum limit for the sale of OTC psuedoephedrine per day?
3.6 gms
Customer wants to purchase Sudafed, what is the maximum limit for sale at of OTC psuedoephedrine per 30 days?
9 gms
Mr. Salinas is purchasing Zyrtec-D (cetirizine/pseudoephedrine) through his mail-order pharmacy for his seasonal allergies.
What is the maximum he can get every 30 days?
A. 3.6 gms
B. 9 gms
C. 7.5 gms
D. 30 mgs
C. 7.5 gms
The iPLEDGE Program is used for patients taking _________.
A. Isotretinoin
B. Fentanyl
C. Clozapine
D. contraceptive medications
A. Isotretinoin
What are the requirements for the iPLEDGE Program?
- Prescribers must register themselves and patient before they writing a prescription
- Patient both male and female must register
- Monthly pregnancy tests
- Use 2 separate forms of birth control if not continuously abstinent
Sally Jenkins gives the pharmacy her prescription of Isotretinoin. What must the pharmacy do before they can fill the prescription?
A. The pharmacy must get authorization from the provider before they can dispense the medication
B. The pharmacy fills the prescription becuase the prescription is on the appropriate iPLEDGE form
C. The pharmacy must log onto the iPLEDGE website or call and get a risk management authorization number
D. Call the director of pharmacy to get authorization
C. The pharmacy must log onto the iPLEDGE website or call and get a risk management authorization number
Sally Jenkins prescription states the following:
Isotretnoin 20mg
Take 2 capsules BID
Qty to dispense: 240 capsules
Refills: 2
What changes, if any, are needed?
iPledge requirements;
30 days supply only
no refills
What is the “do not dispense to patient after” date on the Isotretnoin prescription for female patients of child bearing age?
Prescription must be filled within 7 days after pregnancy test date annotated on the iPledge prescription.
What is the “do not dispense to patient after” date on the Isotretnoin prescription for male patients or female patients that are not of child bearing age?
Prescription must be filled within 30 days after pregnancy test date annotated on the iPledge prescription.
A medication guide must be given to the patient when dispensing Isotretnoin. True or False
True
Protected Health Information (PHI)
A. Any health information that identifies the patient or could be used to identify the patient
B. Laws protecting the privacy and confidentiality of patient health and medical information
C. Regulations that oversee HIPPA
D. Law that protects providers and healthcare workers
A. Any health information that identifies the patient or could be used to identify the patient
Health Insurance Portability and Accountability Act (HIPPA)
A. Any health information that identifies the patient or could be used to identify the patient
B. Laws protecting the privacy and confidentiality of patient health and medical information
C. Regulations that oversee insurance companies
D. Law that protects providers and healthcare workers
B. Laws protecting the privacy and confidentiality of patient health and medical information
What is REMS
Risk evaluation and mitigation strategy is a strategy employed to manage known or potentially serious patient risks that may be experienced with a particular drug or biological agent.
Which medication is part of REMS?
A. Clozaril
B. Accutane (Isotretnoin)
C. Nasal Fentanyl
D. All of the above
D. All of the above
What administration plays an active role in initiating drug recall process?
A. FDA
B. CDC
C. DEA
D. PPI
A. FDA
What is the most serious drug recall?
A. Class IV
B. Class III
C. Class II
D. Class I
D. Class I
The FDA sends out a drug recall for a labeling issue that violated FDA product labeling. What drug recall class would be most appropriate?
A. Class IV
B. Class III
C. Class II
D. Class I
B. Class III
What does OBRA 90 require?
A. That pharmacists make the offer to counsel
B. That the offer to counsel be made in writing
C. That there be a minimum of two pharmacists on duty at all times so that one is available to do counseling
D. That someone provide counseling, but that person can be a pharmacist or a technician- whoever is free at the time
A. That pharmacists make the offer to counsel
Methylphenidate, used by ADHD patients, may
A. be refilled 5 times in 6 months
B. be refilled 6 times in 5 months
C. Be refilled for up to a year
D. Can not be refilled
D. Can not be refilled. Methylphenidate (Ritalin) is a schedule II medication
Schedule III-IV medications can be refilled____
A. be refilled 5 times in 6 months
B. be refilled unlimited times in a 6 month period
C. No refills allowed
D. at the discretion of the pharmacist
A. be refilled 5 times in 6 months
Which of the following is a schedule II medication?
A. Hydrocodone-Acetaminophen
B. Codeine-Acetaminophen
D. Lorazepam
E. Pregabalin
A. Hydrocodone-Acetaminophen
Brand name: Lortab, Vicodin
What classification has no accepted medication use, has a high potential for abuse and not available by prescription?
A. Schedule X (CX)
B. Schedule II (CII)
C. Schedule 1 (C1)
D. Schedule IV (CIV)
C. Schedule I (C1) example: heroin
What law requires manufacturers to prove that their drugs are effective prior to marketing?
Kefauver-Harris Drug Amendment
What guidelines is the standard for pharmaceutical compounding-nonsterile preparations?
USP <795>
What guidelines is the standard for the proper preparation, storage, and transport of sterile medications?
USP<797>
What guidelines is the standard for the proper preparation, storage, and transport of hazardous sterile medications?
USP <800>
What is MSDS?
Material Safety Data Sheets
Specifies hazards of the chemicals or drugs used at the workplace, guidelines for their safe use, recommendations to treat or clean up an exposure.
Which publication is used for approved drug products with therapeutic equivalence (generic substitution)?
Orange book
What is TJC?
The Joint commission, regulatory and accrediting agency that make site visits to evaluate standards compliance.
How often does the Joint Commission survey a facility?
A. Every year
B. Every 2 years
C. Every 3 years
D. Every odd year
C. Every 3 years
How many years does federal law require the pharmacy to keep controlled-substance records?
2 years
What is true for a controlled substance prescription to be valid?
A. Only a licensed prescriber can write for a controlled substance
B. Providers must have a DEA number
C. Provider must hand-write all controlled substance prescriptions
D. Both A and B
E. All of the above
D. Both A and B
Only a licensed prescriber can write for a controlled substance
Providers must have a DEA number
How long is a C III-IV prescription good for?
6 months from the day it was written
If a prescription for Alprazolam was written on 6/22/23, what date will the prescription expire?
12/22/23
What is DAW
Dispense as written
When a patient requests brand name only, what code is used when entering a prescription?
A. DAW 1
B. DAW 2
C. DNS 1
D. DNS 2
B. DAW 2
What are the 4 things that a generic drug must have, according to the FDA, to be a “Pharmaceutical Equivalence” to a brand name drug?
Generic drugs must have the same active ingredients, strength, dosage form and route of administration as the brand name drug.
Is Hydrocortisone 1% cream pharmaceutically equivalent to Hydrocortisone 1% ointment?
No, dosage form is different. Cream and ointments are not the same
Generic substitution is when a brand-name medication is given in place of a generic. True or False
False. Generic substitution is when a generic brand medication is given in place of a name-brand.
Therapeutic Equivalence is
A. Both pharmaceutical equivalent and Bioequivalent
B. Bioequivalent
C. Both Bioequivalent and Route of administration
D. Bothe Strength and dosage form are the same
A. Both pharmaceutical equivalent and Bioequivalent
The Orange book show you the _________ equivalence of a drug.
Therapeutic
In the Orange book what letter denotes that the product is therapeutically equivalent.
The first letter will be an “A”
You are trying to find a therapeutically equivalent medication for Zocor 20mg. You look in the Orange book and notice that the list of equivalent medications has a letter “A” or “B” preceding the equivalents. Which letter denotes that the drug is not therapeutically equivalent?
“B” - denotes that products are Not therapeutic equivalents
Which committee develops and maintains the hospital formulary?
Pharmacy and Therapeutics (P&T) Committee
What DEA form is used for ordering Schedule II medications?
DEA Form 222
What electronic system is used for ordering Schedule II medications?
Controlled Substances Ordering System (CSOS)
Which Medicare plan is responsible for prescription drug coverage?
Part D
Which DEA from would you use to report theft or loss of controlled substances?
DEA Form 106
Federal law requires the pharmacy to keep controlled substance records for how many years?
Federal law requires records for controlled substances be held for 2 years
Before a new drug is approved, the drug manufacturer must submit a new drug application to what governing body?
FDA
Which Amendment requires the label “Caution: Federal law prohibits dispensing without and prescription” or “Rx only”?
Durham-Humphrey Amendment
Which federal law protects the privacy and confidentiality of patient health and medical information?
Health Insurance Portability and Accountability Act (HIPPA)
What is PHI?
Protected health information, any health information that identifies the patient.
The drug company identified that vials of Ketorlac had tiny unidentified particles in their product. Which FDA recall would be most appropriate?
A. Class I
B. Class II
C. Class III
Class II because, it could pose a slight threat to the patient but not life threatening.
_________have/has the regulatory authority to license pharmacies.
A. DEA
B State Departments of Commerce
C. State Boards of Pharmacy
D. FDA
C. State Boards of Pharmacy
Registration or licensure of pharmacy technicians is the responsibility of ____.
A. Pharmacy Certification Board
B. National Boards of Pharmacy
C. State Boards of Pharmacy
D. Drug Enforcement Administration
C. State Boards of Pharmacy
