Question

question 51

a pharmacy technician should identify that which of the following federal laws requires pharmacies to offer counseling to medicaid patients receiving new prescription medications?

• the durham-humphrey amendment
• the kefauver-harris amendment
• the omnibus budget reconciliation act of 1990 (obra 90)
• the food, drug, and cosmetic act

Explanation:

Identify the core legal requirement

Using the OBRA-90 Regulations and Patient Counseling Requirements knowledge points

$$ \text{OBRA '90} \implies \text{Mandatory offer to counsel Medicaid patients} $$

Evaluate the alternative options

Using the Durham-Humphrey Amendment and Kefauver-Harris Amendment knowledge points

• Durham-Humphrey Amendment (1951): Established the distinction between prescription (Rx) and over-the-counter (OTC) drugs.
• Kefauver-Harris Amendment (1962): Required drug manufacturers to prove both safety and efficacy before marketing.
• Food, Drug, and Cosmetic Act (1938): Gave the FDA authority to oversee safety of food, drugs, and cosmetics.

Answer:

• The Durham-Humphrey Amendment
• The Kefauver-Harris Amendment
• The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Correct answer)
• The Food, Drug, and Cosmetic Act