MPJE Compounding and Patient Counseling Questions and Answers

Question 1

Under the federal Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which of the following statements is accurate regarding the patient counseling requirement for a new Medicaid prescription?

Accepted Answer

The offer to counsel must be made, but the patient or their caregiver has the right to refuse it.

Answer

OBRA '90 requires that a pharmacist (or their agent, depending on state law) make an 'offer to counsel' for Medicaid beneficiaries on new prescriptions. It does not mandate that the patient must accept the counseling; the patient or their caregiver retains the right to refuse. While written information is a useful supplement, it does not replace the requirement for a verbal offer.

Question 2

Which of the following is a primary distinction between a 503A compounding pharmacy and a 503B outsourcing facility under the Federal Food, Drug, and Cosmetic Act?

Accepted Answer

503A pharmacies must compound based on a valid patient-specific prescription and are not required to follow full Current Good Manufacturing Practices (cGMP).

Answer

A key difference is the prescription requirement. 503A facilities, or traditional compounding pharmacies, must compound for an identified individual patient based on a valid prescription. They are exempt from cGMP requirements, though they must follow USP standards. In contrast, 503B outsourcing facilities can compound in bulk without patient-specific prescriptions, but they must register with the FDA and follow cGMP.

Question 3

When preparing a compounded batch of 'Magic Mouthwash' for the first time, a pharmacist creates a detailed 'recipe' document that includes the ingredients, quantities, mixing instructions, and quality control procedures. Which of the following best describes this document?

Accepted Answer

Master Formulation Record

Answer

The Master Formulation Record is the official 'recipe' or set of instructions for a specific compounded preparation. It contains all the necessary information to create a uniform product. The Compounding Record, in contrast, is the documentation of a specific compounding event, detailing the lot numbers and quantities used for a particular patient or batch.

Question 4

A pharmacist is counseling a patient on a new prescription for warfarin. According to the principles established by OBRA '90, which of the following points of information is the pharmacist expected to cover during the counseling session?

Accepted Answer

Common severe side effects or adverse effects.

Answer

OBRA '90 suggests several topics for counseling to ensure safe and effective medication use. These include the name of the drug, dosage, route of administration, and critically, information on common severe side effects, adverse effects, or interactions, and what action to take if they occur. Financial details, inventory levels, and patent information are not part of the required counseling points for patient safety.

Question 5

A pharmacy technician, under the supervision of a pharmacist, is preparing a non-hazardous, non-sterile topical cream. The technician is wearing a clean lab coat and gloves. According to USP <795> guidelines, which of the following is also a common requirement for personal protective equipment (PPE) to prevent contamination of the preparation?

Accepted Answer

A face mask.

Answer

USP <795> requires appropriate PPE to prevent contamination of the compounded non-sterile preparation (CNSP). In addition to a clean lab coat and gloves, a face mask is typically required to prevent respiratory droplets from contaminating the preparation. Chemotherapy gowns and respirators are for handling hazardous drugs (USP <800>), and sterile gloves are required for sterile compounding (USP <797>).

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Compounding and Patient Counseling Questions and Answers