June 26, 2019
New non-sterile compounding standards are designed to improve safety, both for pharmacy teams and patients.
ACP’s new Standards for Pharmacy Compounding of Non-sterile Preparations were created to ensure the safety of patients and the safety of pharmacy personnel involved in non-sterile compounding. No matter what you might be compounding, there are risks involved, and the standards are intended to help you identify and mitigate these risks, particularly when it comes to long-term exposure to potentially harmful materials.
Improving safety in the compounding area begins with a training and skills assessment of the pharmacy team.
“There certainly are competencies and skills related to safety that all personnel should be aware of and need to practise,” said Tim Fluet, Pharmacy Practice Consultant with ACP. “Whether it’s dealing with a potential spill, making sure their equipment is running well, and having the skills to properly use personal protective equipment, those are all important ways to minimize risks and certainly areas that pharmacists and pharmacy technicians should be competent in.”
Another key contributor to improving safety for both pharmacy team members and patients is having documented policies and procedures in place to mitigate risk.
“It’s about having a formalized, consistent process in the pharmacy,” said Tim. “The compounding supervisor must make sure those policies and procedures are current and complete and that personnel can access them. Risk assessments talk about things like exposure risks, the personal protective equipment that’s required for a specific compound, and special competencies and training that may be required. Compounding personnel need to know what risks they’re putting themselves into and how they can minimize the harmful effects.”
Ensuring facilities and equipment are clean and in good working order also contributes to safety. If either is compromised, there is a risk of contamination of the product being compounded and/or exposure possibilities for pharmacy team members.
“A good example is your ventilation system or powder containment hood,” said Tim. “If it’s not performing its role and not working as it’s supposed to, then you’re potentially exposing yourself to the active pharmaceutical ingredients (APIs) you’re compounding.”
Even if your pharmacy does not work with hazardous materials when compounding, it is also important to have an eyewash station and other emergency equipment available.
“Safety data sheets for APIs outline the possible risks and recommendations or requirements to keep personnel safe,” said Tim. “An eyewash station and other emergency equipment are often recommended. If you’re compounding infrequently or in small volumes, you could still expose your eyes or other sensitive areas to some of the APIs. Even if they’re not considered hazardous materials, they could still be harmful.”
One of the most important contributing factors to team member and patient safety is the requirement that non-sterile compounding be conducted in a separate area from the rest of the pharmacy.
“If an area is used for multiple purposes, it compromises the state of control,” said Tim. “You would then run a higher risk of contamination, not only microbial but cross-contamination with other products. Another factor is workflow. If you have lots of traffic, you’re generating a lot of dust and there’s more likely to be an error. One of the risk factors that we look for in our risk assessment is uninterrupted workflow. That contributes to safety and a quality product as well.”
When you add it all together, non-sterile compounding comes with risks to both patients and pharmacy team members. Complying with the standards is essential. Critically analyzing all potential risk factors through your risk assessment process is the best way for you and your compounding personnel to stay informed.
“It may seem like a lot, but it’s really in your best interest to minimize risk,” said Tim. “It’s not worth it to cut corners or put you or your staff into a situation where they may have some health consequences.”For more information on the standards and guidance, including additional resources such as Getting Started, Compounding Essentials, and FAQs, please visit the non-sterile compounding page on the ACP website.