Question

question 57

a pharmacy technician should recognize that which of the following medications requires a medication guide to be dispensed with every prescription under fda regulations?

• lisinopril
• isotretinoin (accutane)
• metformin
• omeprazole

Explanation:

Identify the regulatory requirement

Using the Medication Guides knowledge point
FDA regulations require a Medication Guide (MedGuide) to be issued with specific medications that pose a significant public health concern, to help patients avoid serious adverse effects.

Evaluate the drug options

Using the Isotretinoin Regulations knowledge point

• Lisinopril: An ACE inhibitor; does not require a Medication Guide under standard FDA regulations.
• Isotretinoin (Accutane): A highly teratogenic drug regulated under the iPLEDGE REMS program; it strictly requires a Medication Guide with every dispensing due to severe risks of birth defects.
• Metformin: A biguanide for diabetes; does not require a Medication Guide.
• Omeprazole: A proton pump inhibitor; does not require a Medication Guide.

Answer:

• Lisinopril
• Isotretinoin (Accutane) (Correct answer)
• Metformin
• Omeprazole