With the U.S. Pharmacopeial Convention’s (USP’s) General Chapter <797> set for release in the public this summer and USP <800> due in 2019, safe compounding, both sterile and non-sterile, fills the minds of pharmacists. There are some concerns in regard to perennial problems. However, Patricia Kienle, Rph, MPA, the director of accreditation and medication at Cardinal Health Innovative Delivery Solutions, and a member of the USP Compounding Expert Committee, shared 10 tactics to help pharmacists get up to speed. Kienle found during her speech these issues were due to the concerns “from the FDA, the Joint Commission or state boards of pharmacy during their site evaluations.” Here are some of her building blocks:
Make Sure the Pharmacy Staff Knows the USP Standards
A good rule of thumb is to subscribe to the USP Compounding Compendium, Any major compounding practitioners will be able to access all compounding-related General Chapters and monographs from the United States Pharmacopeia and the National Formulary (USP-NF), the official compendia for drugs marketed in the United States. With 40 general chapters and over 170 compounding monographs, it is the type of guide that practitioners can use to their advantage. It’s in PDF format, and is updated regularly with each new release of the USP-NF edition and supplement.
Know the State Regulations
Like any subject matter, it’s important to become familiar with the territory. In this case, you want to know the state regulations and what accreditation organizations want to see during inspections due to expecting different and possibly stricter expectations. An example of this is, “For example, many states expect pharmacists to be compliant with USP Chapter <800> in advance of the Dec. 1, 2019 official date.” In addition to this, 11 recently released Joint Commission FAQs offer background on sterile compound including the following: urgent sterile compounding to closed-system transfer devices, personal cleansing, testing data and low-risk compounding, and harmful medication permissible practices.
Review Updates of FDA Compounding Guidance Documents
It’s important not only to become familiar with the basics, but keep tabs on it due to the FDA updates and releases on guidance documents pertaining to 503A pharmacies and 503B outsourcing facilities. This is a good way to help you monitor the quality of different products bought. Additionally, you’ll see what regulatory practices are up to date.
Review Proposition on Revision to USP Chapter <795>
This is a document available to the public. Ms. Kienle states that, “Every hospital performs nonsterile compounding.” She suggests that a containment ventilator enclosure (CVE) be used when weighing powders. Very few facilities have this as a part of their nonsterile compounding devices, but Kienle would include this in the design.
Review Second Public Comment Edition of USP Chapter <797>
The main idea is awareness, because all compounding pharmacies have to take a look at this document, because it affects anyone that does sterile compounding. It’ll have changes in the new document due to all of the valuable input from practitioners who viewed the first public comment version back in September 2015.
Assess the Risk for Hazardous Drugs
This includes anything you handle from variables like specific dosages and formulations.
Be Well Aware of USP Chapters <797> and <800> Requirements on Decontamination and Cleaning of Sterile Compounding Areas
Make it vital to create a detailed protocol on for decontaminating, cleaning, and disinfecting. Be sure to include the order in how you did the tasks, the steps used in decontamination, and even the cleaning solutions.
Documenting Your Environmental Monitoring Process
There’s a certain standard you must take in order to get everything up to speed. Start by documenting your air and space sampling procedures, how often you monitor things, and the way you interpret and resolve problems. Make sure you file everything after addressing issues, because different state boards of pharmacy and accreditation organizations are evaluating the processes. You want to make sure patients are getting the best standard possible.
Find Out What’s in Your Certification Reports
Even though these may seem like rocket science, it’s important that you go through it all so that you’re aware of any discrepancies in the certification process. This way, you’ll be able to address anything that doesn’t meet certification requirements. It’s important that you not only identify the issues with noncompliance, but take care of them in advance to keep things certified.
Go to the Critical Point Site and Complete the Annual Survey and Gap Analysis for USP Chapters <797> and <800>
Kienle recommends people visit Critical Point to not only see what areas they aren’t compliant, and to gives a good “baseline sense of where they are compared to the other survey respondents.”