MPJE Compounding and Patient Counseling Questions and Answers — 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?
- Counseling is only required if the patient explicitly asks for it.
- The offer to counsel must be made, but the patient or their caregiver has the right to refuse it. (Correct answer)
- A pharmacy technician may provide the full counseling session if the pharmacist is unavailable.
- The law mandates that written information, like a patient leaflet, is a sufficient substitute for a verbal offer to counsel.
Correct answer: The offer to counsel must be made, but the patient or their caregiver has the right to refuse it.
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?
- 503B facilities can compound sterile products, while 503A pharmacies are restricted to non-sterile compounding only.
- 503A pharmacies must compound based on a valid patient-specific prescription and are not required to follow full Current Good Manufacturing Practices (cGMP). (Correct answer)
- 503A pharmacies are prohibited from performing any anticipatory compounding.
- 503B facilities are licensed only by state boards of pharmacy, whereas 503A pharmacies must register with the FDA.
Correct answer: 503A pharmacies must compound based on a valid patient-specific prescription and are not required to follow full Current Good Manufacturing Practices (cGMP).
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?
- Standard Operating Procedure (SOP)
- Master Formulation Record (Correct answer)
- Compounding Record
- Safety Data Sheet (SDS)
Correct answer: Master Formulation Record
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?
- The manufacturer's wholesale acquisition cost.
- The pharmacy's current inventory level of the medication.
- Common severe side effects or adverse effects. (Correct answer)
- The date the drug's patent is set to expire.
Correct answer: Common severe side effects or adverse effects.
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?
- A disposable chemotherapy gown.
- A full-face respirator.
- Sterile gloves.
- A face mask. (Correct answer)
Correct answer: A face mask.
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>).
Question 6: Under federal law, a traditional 503A pharmacy may compound a drug product in limited quantities before the receipt of a prescription for an individual patient. This practice is known as:
- Anticipatory compounding (Correct answer)
- Outsourcing
- cGMP manufacturing
- Office-use compounding
Correct answer: Anticipatory compounding
Section 503A of the FD&C Act permits a pharmacy to compound in limited quantities before receiving a patient-specific prescription, provided it is based on a history of receiving valid prescriptions for that specific compounded product. This practice is known as anticipatory compounding. Office-use compounding (compounding for prescribers to have as stock) is generally not permitted for 503A pharmacies under federal law and is the domain of 503B outsourcing facilities.
MPJE Compounding and Patient Counseling Questions and Answers
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?