Sterile Compounding: The Standards, Regulations and Best Practices
Even though sterile compounding has been a crucial element in quality healthcare and delivery, there have been ongoing challenges with regards to the industry’s ability to standardize the basic processes. Sterile compounding pharmacies have been trying to keep up with the changes especially when it comes to compliance. Most of the states are adopting the use of USP Chapter 789 which seeks to improve the safety and outlook of the patient and the technician. The industry standards have been gaining momentum ever since 2004. One of the challenges has been the state-level implementation thus compliance and oversight has been inconsistent ever since. There have been high-profile sterile compound mishaps in the last couple of years. The most recent one happened in 2012 and resulted in 64 deaths because of a fungal meningitis outbreak. These mishaps have altered the way state and federal regulators view compounding practices. The expectations and compliance have been expanded at both the federal and state level. We are likely to see more of such trends in the coming years. At present, 27 states have adopted USP 797 standards and there is enforcement to some degree. In the past, the oversight was usually handled by the state government but the federal government has started being involved. This was made possible with the introduction of the Drug Quality and Security Act. The FDA conducted more than 148 inspections of compounding pharmacies between 2012 and 2014. During the inspection, it was found out that there was a safety concern in 9 out of 10 facilities that they inspected.
Regulatory Developments In Compounding
Pharmacies need to stay up to date with the compounding regulations, especially at the state level. They should also be knowing what is happening in the industry in general so that improve the processes and safety in place when doing the compounding. The introduction of USP 797 was an important moment as it marked the start of formalizing a standardized safety process for sterile compounding. With a comprehensive guide, all the concerns in sterile preparation are addressed. USP 797 is very specific when it comes to documentation of the competences, quality of metric processes, sample protocols and environmental testing. The Introduction of USP 800 IN 2014 is very categorical in the strategies of protecting the employees and the environment they work in. This is because more than 80 million health workers are always at risk because of the hazardous conditions in which they work. When handling both sterile and non-sterile compounding, the focus should be on:
Only close system drug-transfer should be implemented when administering dangerous drugs or during the compounding process.
Sterile Compounding Facility Design
Any drugs deemed hazardous should be stored in negative pressure. The compounding should only be carried out and completed in safety cabinets that are biologically certified.
Cleaning and Disinfection
The cleaning and disinfection should be done with an oxidizer, sterile alcohol, or with a germicidal detergent.
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