CAOP - Competency Assessment of Overseas Pharmacist Extemporaneous Compounding Questions and Answers — Questions and Answers
Question 1: A pharmacist is required to compound a preservative-free aqueous oral mixture for a paediatric patient. According to the Australian Pharmaceutical Formulary (APF) guidelines, what is the maximum recommended beyond-use date (BUD) for this preparation when stored in a refrigerator?
- 24 hours
- 7 days
- 14 days (Correct answer)
- 30 days
Correct answer: 14 days
The Australian Pharmaceutical Formulary (APF) provides default expiry dates for compounded preparations. For non-preserved (preservative-free) aqueous formulations, the BUD is not more than 14 days when stored at controlled cold temperatures (refrigerated) to minimise the risk of microbial growth.
Question 2: When creating a compounding record or worksheet for a non-sterile preparation, which of the following details is NOT considered a mandatory component according to Australian professional standards?
- The name of the pharmacist who performed the final check
- The patient's reported allergy status (Correct answer)
- The batch number and expiry date of each ingredient
- The assigned beyond-use date (BUD) of the final product
Correct answer: The patient's reported allergy status
A compounding record's primary purpose is to ensure traceability, quality, and reproducibility of the formulation. It must include details of the ingredients (batch numbers, expiry), the personnel involved in preparation and checking, the method used, and the assigned BUD. While checking for patient allergies is a critical clinical step before compounding, the allergy status itself is part of the patient's clinical file, not a required field on the technical compounding worksheet.
Question 3: A doctor writes a prescription for a specific strength of a cream that is commercially available. The prescription includes a note stating, 'Please compound in a different base as patient has a known allergy to an excipient in the commercial product.' What is the most appropriate action for the pharmacist?
- Refuse to compound the cream because a commercial product exists.
- Contact the TGA to get special access approval before compounding.
- Inform the doctor that compounding is only for unavailable medicines.
- Compound the cream as requested due to the documented clinical need. (Correct answer)
Correct answer: Compound the cream as requested due to the documented clinical need.
Pharmacy Board of Australia guidelines state that a medicine should not be compounded if a suitable commercial product is available. However, an important exception is when a commercial medicine is unsuitable for a specific patient, for example, due to an allergy to an excipient. The prescriber's note provides the necessary clinical justification to proceed with compounding.
Question 4: Which of the following best describes the initial step in the compounding technique of geometric dilution?
- Combining all ingredients at once and triturating until uniform.
- Mixing the ingredient present in the smallest quantity with an approximately equal amount of the diluent. (Correct answer)
- Mixing the ingredient present in the largest quantity with half of the other ingredients.
- Melting the base completely before adding any of the active ingredients.
Correct answer: Mixing the ingredient present in the smallest quantity with an approximately equal amount of the diluent.
Geometric dilution is a method used to ensure that small quantities of potent substances are mixed evenly with a larger quantity of a diluent. The process always begins by mixing the ingredient with the smallest volume with an approximately equal volume of the diluent, followed by successive additions of diluent to the mixture.
Question 5: According to the Pharmacy Board of Australia's guidelines, which of the following is a key labelling requirement for an extemporaneously compounded medicine?
- The Australian Register of Therapeutic Goods (ARTG) number.
- A statement identifying the product as a compounded medicine. (Correct answer)
- The manufacturer's details for each raw ingredient.
- A complete list of all excipients used in the formulation.
Correct answer: A statement identifying the product as a compounded medicine.
Compounded medicines are exempt from TGA registration and therefore do not have an ARTG number. A critical labelling requirement is to clearly inform the patient and other health professionals that the product has been extemporaneously prepared and has not been evaluated by the TGA. Wording such as 'This is a compounded medicine' or similar is required.
Question 6: A pharmacist is checking a compounded paediatric suspension and observes that small particles of the active ingredient have not fully dissolved, settling quickly at the bottom. What is the most significant safety concern associated with dispensing this product?
- The taste of the medication will be unpleasant for the child.
- The beyond-use date will need to be shortened significantly.
- The mixture will be difficult for the parent to pour accurately.
- There is a high risk of inaccurate dosing and potential toxicity. (Correct answer)
Correct answer: There is a high risk of inaccurate dosing and potential toxicity.
The presence of undissolved active ingredient in a suspension that should be uniform indicates a failure in the formulation, leading to a non-homogenous mixture. This means that each dose administered could contain a widely variable amount of the drug, creating a significant risk of under-dosing (therapeutic failure) or over-dosing (toxicity), which is especially dangerous in paediatric patients.
CAOP - Competency Assessment of Overseas Pharmacist Extemporaneous Compounding Questions and Answers
A pharmacist is required to compound a preservative-free aqueous oral mixture for a paediatric patient.
According to the Australian Pharmaceutical Formulary (APF) guidelines, what is the maximum recommended beyond-use date (BUD) for this preparation when stored in a refrigerator?
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