ExCPT Pharmacy Law and Regulations Questions and Answers — 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?
- DEA Form 222
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 224
Correct answer: DEA Form 106
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?
- It can be refilled up to 5 times in 6 months.
- It can be refilled as authorized by the prescriber for up to one year.
- It requires a new prescription for each fill. (Correct answer)
- It can be refilled once within 30 days.
Correct answer: It requires a new prescription for each fill.
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?
- Amoxicillin oral suspension
- Sublingual nitroglycerin tablets (Correct answer)
- Ibuprofen 800mg tablets
- Ferrous sulfate tablets
Correct answer: Sublingual nitroglycerin tablets
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?
- Class A
- Class III
- Class I
- Class II (Correct answer)
Correct answer: Class II
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?
- Provide the list, as she is an immediate family member.
- Deny the request unless the patient has provided prior written authorization to release information to the daughter. (Correct answer)
- Ask the daughter to verify her mother's date of birth before providing the list.
- Tell the daughter to have her mother call the pharmacy directly.
Correct answer: Deny the request unless the patient has provided prior written authorization to release information to the daughter.
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.
Question 6: Which government agency is primarily responsible for licensing pharmacists, registering pharmacy technicians, and disciplining licensees for misconduct within a specific state?
- Food and Drug Administration (FDA)
- Drug Enforcement Administration (DEA)
- State Board of Pharmacy (Correct answer)
- The Joint Commission
Correct answer: State Board of Pharmacy
The State Board of Pharmacy is the regulatory body responsible for establishing and enforcing pharmacy laws and regulations at the state level. This includes licensing pharmacists and pharmacies, registering technicians, and taking disciplinary action against those who violate the state's Pharmacy Practice Act. The FDA regulates drug manufacturing and approval, while the DEA enforces controlled substance laws.
ExCPT Pharmacy Law and Regulations Questions and Answers
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?