ExCPT Pharmacy Law and Regulations Questions and Answers

Question 1

A pharmacy discovers a significant loss of a Schedule II controlled substance. According to federal law, which DEA form must be completed and submitted to report this loss?

Accepted Answer

DEA Form 106

Answer

DEA Form 106 is the official form required by the Drug Enforcement Administration (DEA) for registrants to report the theft or significant loss of any controlled substances. DEA Form 222 is for ordering Schedule I and II substances, DEA Form 41 is for the destruction of controlled substances, and DEA Form 224 is the application for new registration.

Question 2

A patient brings in a new prescription for oxycodone, a Schedule II controlled substance. Which of the following is true regarding the refilling of this prescription according to federal law?

Accepted Answer

It requires a new prescription for each fill.

Answer

Federal law strictly prohibits the refilling of Schedule II controlled substance prescriptions. A new, valid prescription is required each time the medication is dispensed. Prescriptions for Schedule III and IV substances may be refilled up to 5 times within 6 months if authorized by the prescriber.

Question 3

Under the Poison Prevention Packaging Act of 1970 (PPPA), which of the following oral prescription medications is generally exempt from child-resistant packaging requirements?

Accepted Answer

Sublingual nitroglycerin tablets

Answer

The Poison Prevention Packaging Act (PPPA) allows for several exemptions to child-resistant packaging. Sublingual nitroglycerin is exempt because it is used in emergency situations for conditions like angina, where quick access is critical. Most other oral prescription drugs, including common antibiotics, high-strength NSAIDs, and iron supplements, require child-resistant packaging unless the patient or prescriber requests otherwise.

Question 4

A pharmaceutical company issues a recall for a batch of blood pressure medication because it may cause temporary or medically reversible adverse health consequences. According to the FDA, what is the classification for this type of recall?

Accepted Answer

Class II

Answer

The FDA classifies recalls into three categories. A Class II recall is issued when the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. A Class I recall is for situations where there is a reasonable probability of serious adverse health consequences or death. A Class III recall is for products that are unlikely to cause any adverse health consequences.

Question 5

A patient's daughter calls the pharmacy asking for a list of her mother's current medications. The mother is a long-time patient at the pharmacy. To comply with the Health Insurance Portability and Accountability Act (HIPAA), what is the most appropriate action for the pharmacy technician?

Accepted Answer

Deny the request unless the patient has provided prior written authorization to release information to the daughter.

Answer

HIPAA's Privacy Rule protects a patient's Protected Health Information (PHI), which includes their medication list. PHI cannot be disclosed to family members without the patient's explicit authorization, typically through a signed consent form on file at the pharmacy. Simply verifying a date of birth is not sufficient, and while having the patient call is an option, the core HIPAA principle is the requirement of documented authorization.

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ExCPT Pharmacy Law and Regulations Questions and Answers