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26 BUSINESS THROUGH INNOVATION COMPOUNDING WTHY STERILE COMPOUNDING IS NOT FOR EVERYONE he compounding of sterile Atropine eye drops concern preparations is a high-risk Atropine eye drops are available as a activity that potentially poses registered product at a concentration of significant risks for both the one per cent (atropine 1 per cent). patient and the compounder, whom it However, low dose atropine eye requires to strictly adhere to all relevant legislation, guidelines and professional practice standards. Significant costs are also involved, including the setting up of a dedicated sterile lab, completion of sterile compounding training and regular ongoing validation, both of the facility and the compounder. Guidance Under the Pharmacy Board of Australia Guidelines on Compounding of Medicines, pharmacists have the option to comply with the principles and procedures outlined in one of three sets of practice standards: • PIC/S Guide to Good Practices for the Preparation on Medicinal Products in Healthcare Establishments (PE010). • PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009). • USP-NF <797>: Pharmaceutical Compounding – Sterile Preparations. In practical terms, the first two options most likely represent small- batch manufacturers, whereas the third option is the most likely choice for pharmacists compounding in a community pharmacy setting. These guidance documents are the very first port of call. All are available as free downloads online, so if you’re not motivated enough to access these independently, then sterile compounding is definitely not for you! What needs to be sterile All pharmacists should be able to recognise those items that must be supplied to the patient as a sterile product. Dosage forms that must be sterile include (but are not limited to) products administered by injection or infusion, those intended for ophthalmic use (eye drops, eye lotions and eye ointments), and those intended for irrigation use, or for optic use after surgery. They also include items for use as implants or intended for intra-urethral use, as are sometimes requested for treatment of erectile dysfunction. The requirement for sterility applies to human and animal prescriptions received at the pharmacy. A common misconception is that veterinary eye preparations, for example, are not required to be sterile. This is false, irrespective of whether the vet says it doesn’t matter. Pharmacists must adhere to recognised practice standards at all times. Sterile cleanrooms and processes A significant financial outlay is involved in setting up a sterile compounding lab, with ongoing validation of the facility and equipment adding to the spend. Ongoing cleaning validation, microbial testing, pest control and electricity costs can add up, too, so it’s critical that any pharmacist considering setting up a sterile facility must be completely aware of yearly operating costs. I often hear pharmacists comment that much of the cost of a compounded product is taken up ‘just opening the door to the sterile room’. Another factor to consider is that compounds must be prepared on an individual-patient basis, unlike registered products that can be made in batches. Furthermore, the compounded products generally have a much shorter beyond-use-by date, based on risk categories, stability and sterility validation. All these factors may become a barrier to patient acceptance over the long term, particularly for ongoing therapies. If this is the case, the patient should be referred back to the prescriber to discuss the matter. Taking a short cut, and providing a product labelled ‘non -sterile eye ointment’, for example, is not an option. drops (atropine 0.01 per cent) are recognised as an effective treatment strategy to slow myopia in children and young adults. Atropine 0.01 per cent must be compounded as there is currently no TGA registered product. The cost of compounded atropine eye drops may be significantly greater that that expected of a commercial product, but pharmacists are strongly reminded that they must not dilute eye drops in a non-sterile facility. Pharmacists not only put their patients’ safety at risk, by potentially providing a contaminated product that could lead to a severe eye infection, but also their own pharmacy registration, which may be called into question if a complaint is made. Pharmacists should refer patients to a compounder whose facility meets one of the standards discussed earlier. Sterile compounding is a high-risk activity that requires constant vigilance by the pharmacist. It’s not a practice for everyone, and certainly not the risk averse. If you think this is an area of practice you might be interested in, make sure your due diligence is extensive, and ask lots of questions, so your homework is not only about your professional obligations but the ongoing costs involved. Patient safety is paramount and if you take short cuts, then it’s likely to cause long-term harm. Please consider whether you’re suited to this type of practice. For any inquiries, please contact me directly. By Marina Holt. Education and Training Manager PCCA Australia Marina Holt BPharm Dip Quality Auditing Cert IV TAE is the Education and Training Manager at PCCA Australia. Her main role is to give training on all aspects of compounding pharmacy to registered pharmacists and students, and to increase awareness of health professionals on the benefits compounded medications may have for their patients. Inquiries: marina@pccarx.com.au RETAIL PHARMACY • JUN 2021