PTCB Final Exam Study Guide
What is the 1938 Federal Food, Drug and Cosmetic Act?(Ans- Misbranding and mislabeling
What is the 1951 Durham-Humphrey Amendment?(Ans- Distinction between legend drugs and otc drugs
What is the 1970 Poison Prevention Packaging Act?(Ans- Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging
What is the 1983 Orphan Drug Act?(Ans- Encourages companies to develop drugs for rare diseases by providing research assistance, grants and cost incentives
What is 1990 Omnibus Budget Reconciliation Act (OBRA)?(Ans- Pharmacist must offer to counsel a patient
What is the 1996 Health Insurance Portability and Accountability Act
(HIPAA)?
(Ans- To protect patients health information
What is the maximum amount for pseudoephedrine to be sold ?(Ans- 3.6 g in a day
- g per 30 days retail
7.5 g per 30 days by mail order
How is pseudoephedrine stored ?(Ans- Behind the counter and locked in a cabinet
Pseudoephedrine documentation is kept in ? And if used what identification must be provided?(Ans- Kept in a log book and must provide: 1 / 3
Records of all information must be kept for at least 2 years.Drug name Drug strength Drug amount Date/time of sale Customer's name Customer's address Customer's signature
Define what the FDA does ?(Ans- enforce the guidelines for manufacturers to Ensures all medications are pure, safe and effective.
What does the DEA enforce?(Ans- Controlled Substances Act investigates and prosecutes violators of controlled substance laws.
How many refills are permitted on class 2 substances ?(Ans- Zero need a new prescription every time
Class III-V can be refilled how many times ?(Ans- Maximum of times or within 6 months from the original
Class 5 can be refilled how many times?(Ans- As often as prescribed
Scheduled 3-5 can be refilled how many times ?(Ans- One time basis
What scheduled drug must be locked away or refrigerated?(Ans- Schedule 2
What is the name of the program on which patients can return unused controlled substances?(Ans- Take back program 2 / 3
Define form 106 (Ans- Report of theft
Define form 41 (Ans- Destruction due to damage
Define form 222 (Ans- Order scheduled 2 drugs
What is a boxed warning?(Ans- Type of warning on medications that carry high risks
What does the Occupational Safety and Health Administration (OSHA) do?(Ans- Ensures a safe workplace for employees
What does the Joint Commission do?(Ans- sets standards for accrediting health care facilities tans surveying every 3 years
Common drugs for bipolar disorder ?(Ans- Lithium Rispirdal Zyprexa Geodon
the suffix -pril indicates what drug class?(Ans- ACE inhibitors
The suffix -faxine and -etine indicates what drug class ?(Ans- Serotonin norepinephrine reuptake inhibitors
The suffix -TRIPTYLINE indicates the drug is (Ans- Tricyclic Anti-depressants
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