Compounded drugs, or extemporaneous drugs, refer to those drugs manipulated for individual patients. All medications used to be like that, back in the 1900s. Raw ingredients are gathered following a patient-specific prescription. The Pharmacy Board of Australia doesn’t assess compounding medications. That said, there’s a federal law regulating the compounding pharmacy industry. It ensures that those medications meet high-quality standards. In this article, you’ll read more about this essential type of treatment.
Understanding the Industry
Unlike mass-production drugs, the government can’t analyse all compounded drugs. The Therapeutic Goods Act, from 1989, exempts outsourcing facilities from a few criteria. That’s why it’s difficult to determine whether they’re safe and effective. Some patients report adverse effects or even getting harmed by using not-so-appropriate medication.
Compound pharmacies must follow strict regulations. Those regulations include manipulation of compounds, essential equipment, sterile compounding, and so on. The National Coordinating Committee on Therapeutic Goods (NCCTG) handles this activity in Australia. There are specific guidelines to follow when preparing simple and complex compounds. Those guidelines deal with the use of sterile products, dosage forms, etc. Professionals and laboratories have to abide by those guidelines.
Anyone working in this industry must also hold accredited qualifications. Those pharmacists must have proper training on both simple and complex compounding. The Pharmacy Board of Australia has created the Professional Practice Profile. It determines what competencies a pharmacist must have to work in the field.
The Handbook for Extemporaneous Dispensing
It’s always advisable to choose standardised formulae over too original ones. There’s a long list of tried and tested compounded formulae with assured safety. Those formulae are in the Australian Pharmaceutical Formulary and Handbook. The latest version is the 25th edition which is available from download from their website
The Pharmacy Board of Australia has rigid protocols about compound dispensing. Such protocols aim to ensure a compound medication reaches the basic safety standards. Here are some of the essential rules and protocols.
Risk Assessment Criteria
Pharmacists should follow the risk assessment process for the preparation of extemporaneous preparations. This guideline is in the Australian Pharmaceutical Formulary and Handbook. Those drugs must abide by the quality standards stated by the Therapeutic Goods Act of 1989. It further guarantees their safety and is available on their website.
Keeping Track of the Process
Pharmacists are also required to document the preparation process of a compounded drug. Documentation criteria may vary between states and territories. Still, they’re crucial in recalls or to assure quality standards.
The compounding process should only involve trained professionals. Those professionals include assistants, students, or interns. A pharmacist should supervise those professionals under the Guidelines for Dispensing of Medicines. The Board’s Guidelines also explains the pharmacist’s responsibilities in detail.
In Australia, outsourcing facilities must follow governmental agencies and professional boards’ guidelines. Tight regulations must be in place on this kind of practice to ensure safety. Failing to follow the guidelines can be very dangerous. In 2012, a fungal meningitis outbreak in the US, caused by lab cross-contamination, contaminated 700 patients across 20 states, causing 64 deaths.
Regardless, compound drugs are as safe as any other when regulated and operated by the rules. The Australian healthcare system doesn’t cover all extemporaneous drugs. During the pandemic, compounding facilities are supplying drugs that are in shortage.