Pharmacists, Technicians Can Work to Mitigate Risks of Pharmacy Compounding
A more comprehensive body of regulations is required to achieve consistency and safety for patients.
Due to less rigorous oversight of pharmacy compounding compared with oversight of FDA-approved drugs, some risks may be associated with compounding drugs in the pharmacy environment. As a result, pharmacists and technicians can work to mitigate any potential problems.
Pharmacy compounding involves the preparation of customized medications for individual patients’ needs. It is typically done on a small scale for a single prescription, according to an opinion article published in Drugs in R&D.
Whereas FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations (GMPs), compounded drugs are exempt from this process and testing to assess product quality is inconsistent. Compounded products are not clinically evaluated for safety and efficacy, and do not have standard product labeling or prescription information for patients.
Furthermore, compounding pharmacies are not required to report adverse events to the FDA, unlike manufacturers of FDA-regulated medications. Some pharmacies also conduct larger-scale compounding without individual patient prescriptions or compound drugs that have not been approved for use in the United States.
Without GMPs, compounded drugs are at a greater risk for potential preparation errors, which can be particularly dangerous when compounding is performed on a large scale. FDA reports and state agency investigations have consistently shown that compounded drugs fail to meet specifications at a higher rate than FDA-approved drugs.
Additionally, compounded sterile preparations are at risk of microbial contamination without proper processes. Non-sterile compounding has been known to result in large outbreaks of meningitis and other illnesses, and have resulted in increased scrutiny on compounding procedures, according to the authors.
Despite these concerns, traditional pharmacy compounding is an important way to provide access to medications for individuals with unique medical needs that cannot be met with commercially available products. For example, pharmacists can compound a liquid suspension for a pediatric or geriatric patient with trouble swallowing.
Compounding sterile medications requires specific conditions and practices to prevent microbial contamination, bacterial endotoxins, chemical and physical contaminants, and lower-quality ingredients. USP <797> classifies aseptic manipulation of sterile products or ingredients as low risk, but the sterility assurance level of these products still tends to be significantly lower than pharmaceutical products manufactured under GMPs. USP <797> is enforceable by the FDA, but the authors noted that the agency generally defers pharmacy regulation to the states.
All of these concerns have significant implications for clinical practice, according to the authors. Prescribing compounded drugs should itself be carefully considered, and the reason why the FDA-approved version is not appropriate should be documented. Notably, however, the Principles of Compounding by the Pharmacy Compounding Accreditation Board says that price differences are not enough to justify compounding.
Traditional pharmacy compounding provides an important option for many patients, the authors concluded, but it must be done carefully and safely. They added that a more comprehensive body of regulations governing every aspect of drug manufacturing and testing, and enforced through FDA inspections, is required to achieve consistency and safety for patients.
Gudeman J, Jozwiakowski M, Chollet J, and Randell M. Potential Risks of Pharmacy Compounding. Drugs in R&D 13(1-8) (2013). Accessed September 22, 2022. https://link.springer.com/article/10.1007/s40268-013-0005-9