Last year we saw a large increase in the number of reported complaints relating to the compounding of medicines in pharmacies in NSW. In 2017/2018 there were 42 complaints, which was up from 20 reports in 2016/2017. This also represents a total of 13.5% of the total number of complaints received last year by the Council, specifically relating to compounding activities.
Since 2010, we have received over 40 complaints which involve the non-adherence to legislation or in breach of the Pharmacy Board of Australia Guidelines on Compounding of Medicines. One particular area we identified as a source of confusion was the procurement and assessment of raw materials used for compounding. In response, the Council has produced a Factsheet which is available here.
Around 25% of the complaints received since 2010, relate to the compounding of medicines where a commercial product is available, or the formulation of a compounded product that would not be likely to produce a different therapeutic outcome to a commercial product. Pharmacists are expected to undertake a risk assessment when receiving a request to compound a medicine to assure themselves that the product they are compounding is appropriate for the individual patient, and to consider safety, quality and efficacy. Evidence supporting the decision to compound a medicine where there is no formula available in a reputable reference source should be documented. The pharmacist must also ensure that the patient has been advised if a medicine is compounded under these circumstances.
More recently an increasing number of complaints have highlighted inadequacies in more complex compounding activities, including preparation of medicines containing hormones without a containment hood or use of personal protective equipment; and compounding of eye drops in a non-sterile environment. This has prompted Council to develop a Guidance document relating to more complex compounding activities which is currently open for comment until 12 April 2019. We invite feedback on this document which is available here. Please send your feedback to firstname.lastname@example.org