Are you ready for Priority Two?

August 7, 2019

What you need to know to comply with the non-sterile compounding standards.

The deadline for pharmacies to comply with the first two priorities of the Standards for Pharmacy Compounding of Non-sterile Preparations is fast approaching. Pharmacies who compound—or plan to compound—non-sterile preparations, no matter the frequency, must comply with Priority One and Priority Two by January 1, 2020.

In this article, we’ll focus on what you need to know to comply with Priority Two: Compounding and cleaning, personnel training, and quality assurance.

Policies and procedures

As indicated in ACP’s Getting Started document, begin by reviewing your pharmacy’s policies and procedures. Section 5.3 of the Guidance Document for Pharmacy Compounding of Non-sterile Preparations provides a comprehensive list of policies and procedures that your pharmacy should consider. It’s also important to identify any gaps that you documented from Priority One.

“Many pharmacies have procedures that aren’t in written form,” said Mark Munchua, ACP Pharmacy Practice Consultant. “Pharmacy teams should be looking for gaps of what’s documented and what isn’t, and identifying any outdated policies that may exist. Perhaps what is documented no longer applies in your pharmacy. I often talk about it in the context of when you get a new staff member. Documented and up-to-date policies and procedures are useful in their training.”

Cleaning

It’s also critical to assess the skills required by cleaning personnel in your pharmacy. Do they have the knowledge and skills required for properly clean a non-sterile compounding area?

“Even though cleaning personnel are not involved in compounding, they are entering the compounding area,” said Mark. “Everything that is required of them is to ensure the safety and quality of your end product. If they are entering the compounding area and performing cleaning activities, it’s important they know about things like cleaning and decontaminating equipment, which specific equipment to use and how to use it, which cleaning agents to use or not, and which areas require cleaning and why. They also must document this on a cleaning schedule. If the cleaning isn’t done correctly, there’s an increased chance of cross contamination in the compounding area.”

Cleaning personnel also must be familiar with the pharmacy’s policies and procedures before entering the compounding area, including what personal protective equipment may be required, hygiene, and the pharmacy’s emergency procedures in case of accidental exposure or a spill.

Skills assessment

Another key element of Priority Two is to complete the skills assessment checklist available on the non-sterile compounding page on the ACP website.

“Having good policies and procedures is one thing; the actual implementation is another,” said Mark. “We want to ensure that all compounders have and maintain the necessary skills to compound safely and prepare quality products. If you complete the checklist, it will help identify training gaps you may have with your staff. I make the analogy of baking a cake. You might have a great recipe, but that doesn’t necessarily mean the cake will be any good when it comes out of the oven. You need to have skills and follow the recipe to a “T” for it to turn out.”

Quality assurance

Priority Two also requires having a good quality assurance program. The program must include the following:

  • verification and maintenance of equipment,
  • environmental control of facilities and primary engineering control,
  • environmental monitoring of chemical contamination for hazardous products, and
  • quality assurance of compounded non-sterile preparations (protocol, compliance with prescription, and documentation).

“It’s important to monitor all these components,” said Mark. “A deficiency in any one area could compromise the safety and integrity of your final product.”

Proper hygiene is crucial for non-sterile compounding. It’s an element of Priority Two that shouldn’t be taken lightly. Mark recommends having written procedures and posting them near the compounding area to ensure all staff comply consistently. When it comes to hygiene, little things make a big difference.

“It’s important compounding personnel remember that what they’re doing in their workplace practices are complementary to ensuring a safe and quality product, in addition to the verification and maintenance of the equipment,” said Mark. “For example, the hood is an important piece of equipment, but it’s not a magic box. A lot of what you’re doing with your cleaning procedures and your compounding technique will affect the quality of the end product.”

Finally, Mark says that by complying with Priority Two, pharmacy teams will be in a much better position to comply with Priority Three: Facilities and equipment.

“Understanding all of the components that fit together is important to compounding a safe product, and will help to identify gaps requiring renovation which may not be adequately addressed through policies and procedures.”

The deadline for Priority Three is July 1, 2020.

For all the resources mentioned in this article, and more, visit the non-sterile compounding page on the ACP website.

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