How accurate is pharmacy compounding? When a medicine is made up by hand for one person, it is fair to ask whether the dose will be right every time. In Australia, compounding is not left to chance. Pharmacists who compound medicines are expected to follow guidelines set by the Pharmacy Board of Australia, use ingredients that meet recognised standards, and check and record each step. Many pharmacists also draw on the training and quality programs of compounding networks such as PCCA. Here is what those standards cover, and what you can ask before you have a medicine made up at a compounding pharmacy.
Compounding Standards in Australia
The Pharmacy Board of Australia’s Guidelines on compounding of medicines set out what pharmacists must do when they make up a medicine. Under these guidelines:
- only pharmacists who are competent to compound should do it, and more complex work, such as sterile medicines, calls for specific skills and ongoing professional development
- compounding should take place in premises that are suitably designed, equipped and maintained for the type of work done
- formulas should come from reputable references, such as the Australian Pharmaceutical Formulary and Handbook
- where needed, the pharmacist works with the prescriber to agree that a formulation suits the patient
The guidelines also point pharmacists to recognised quality standards, including the United States Pharmacopeia chapters on non-sterile and sterile compounding (USP 795 and USP 797).
Compounding Quality Control
Quality control is about making each medicine the same way, every time, so that it works as the prescriber intended. The Board’s guidelines describe several checks along the way:
- Ingredients – before an ingredient is used, the pharmacist must have evidence that it meets recognised pharmacopoeia standards and is safe to use.
- Written procedures – pharmacies that compound are expected to have standard operating procedures that all relevant staff follow.
- Self-assessment and audit – pharmacists should review their compounding practice against the standards. For complex medicines, samples may be sent to an accredited laboratory for testing.
- Expiry dates – each compounded medicine is given an expiry date based on recognised guidance, so it stays suitable for the length of the treatment.
- Records – the preparation of each medicine is documented, and the label carries a unique code that links the medicine to those records.
The label itself tells you a lot. It should list the active ingredients and their strengths, the date the medicine was made, its expiry date, storage details and directions for use, along with a note that it has been compounded by the pharmacist. You are also entitled to know what is in your medicine. The guidelines say a compounded medicine should not have “secret” ingredients.
What PCCA Is
PCCA is a membership network for compounding pharmacies. It supplies compounding ingredients, equipment, formulas and training to licensed pharmacies, and it publishes its own quality program, The PCCA Standard.
PCCA says it assesses the makers of the active ingredients it supplies against more than 40 factors, covering their facilities, equipment, processes and staff. It also says each batch of ingredient it receives goes through more than 20 checks, tests and verifications, including a test that confirms the ingredient is what its label says. Ingredients from a supplier that tests this way can add another layer of compounding quality control before a medicine is made.
Questions to Ask Your Pharmacist
If you would like to know more about how a compounded medicine will be made, it is reasonable to ask:
- Which reference does the formula come from?
- Where do the ingredients come from, and how are they checked?
- How long will the medicine keep, and how should I store it?
- Has the pharmacist talked with my prescriber about the formulation?
A compounding pharmacist should be happy to answer these questions. For more on what to look for, read our guide to choosing a compounding pharmacy. If you would like to talk about a compounded medicine, call our pharmacists on (02) 4296 5548.