Should the USP Appeal Process Delay Pharmacy’s Responsibility to Patients?
Before we answer this question, let’s step back and look at the basics. Compounding, or the mixing of medications, has been a staple upon which the profession of pharmacy was founded. The definitions of pharmacy are “the art, practice, or profession of preparing, preserving, compounding, and dispensing medical drugs” and “a place where medicines are compounded or dispensed.”[i]
The practice of compounding encompasses a wide variety of preparations for patients, broadly classified into non-sterile and sterile preparations. These classifications are further subclassified into non-hazardous drugs, hazardous drugs, and radiopharmaceuticals, defining characteristics of these preparations where special handling is required. The United States has relied on the USP to provide standards for medications since 1820. Without these standards the public is at risk of, as described in Samuel Hopkins Adams ‘The Great American Fraud: The Patent Medicine Evil’ describing medications of the early 1900s as ‘Drugs that make victims.’ The pharmacy profession has an obligation to the public to strive for excellence with the preparations that are selected, prepared and dispensed. Without standards, we wane back to pre-1900 practices.
We must remember that USP’s mission is to “promote the public health by developing and disseminating quality standards and information for medicines, healthcare delivery, and related products and practices.”2 And we shouldn’t forget that the USP standards and resources are developed through voluntary efforts of expert representatives in pharmacy, medicine, academia, government, the pharmaceutical industry, health plans, and consumer organizations as well as other healthcare professions.2 When it comes to the development and maintenance of quality standards, USP believes public input is critical to ensuring our standards have the intended effects of advancing quality and reducing patient risk. This is why USP has a robust standard setting process and allows for appeals from the public to address critical standards which prompted the September 23, 2019, appeal and delay of USP <795> (2019) and USP <797> (2019) proposed revised standards and the newly developed USP <825> (2019) chapter.
Since the revised USP <795> and USP <797> are now postponed pending appeal there is no immediate impact on current compounding compliance efforts and sites should ensure that they are in full compliance with the existing versions of USP <795> (2014) and USP <797> (2008). Central to the appeals is the Beyond Use Dates (BUDs) and applicability of the standards for veterinary practices and oversight of radiopharmaceuticals. Details to the appeals are listed:
- Beyond Use Dates in proposed updates for <795>, <797>, and newly proposed <825>
- The removal of the “technologies, techniques, materials, and procedures other than those described …” provision from <797>
- Applicability of <795> and <797> to veterinary practices
- Specific to <825>, compounding from sterile substances
- The applicability of <825> within radiopharmaceutical regulatory context
Since the primary element of the USP <795> and USP <797> appeals impact the BUDs, sites should continue to work to enhance all other elements of their programs to meet the new chapter requirements since it is unlikely that anything outside of the current appeal will change
Extracts from 2019 USP chapters clearly trumpet the focus pharmacy must appreciate with each product we provide to patients:
USP <795> (2019) Pharmaceutical Compounding – Non-sterile Preparations
“The requirements in this chapter must be followed to minimize harm, including death, to human and animal patients…”
USP <797> (2019) Pharmaceutical Compounding -Sterile Preparations
“This chapter describes the minimum standards to be followed when preparing compounded sterile human and animal drugs [compounded sterile preparations (CSPs)]”
USP <800> (2019) Hazardous Drugs- Handling in Healthcare Settings
“This chapter describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.”
USP <825> (2019) Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging
“This chapter is intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities (e.g., the practice of pharmacy and the practice of medicine).”
To summarize, USP has provided these standards to minimize harm, including death, to human and animal patients by providing uniform minimum standards for the preparation, compounding, dispensing and repackaging of products to promote patient safety, worker safety and environmental protection. Beyond the ‘minimum’ standards exists best practices. The following summarizes best practices sites must consider beyond the standards. However, compliance with all the standards should be the primary focus.
Top 10 Best Practices and Beyond Checklist (because USP chapters are a baseline):
- Designate an individual(s) who are responsible and accountable for the performance and operation of the facility and personnel for the preparation of medications. The designated person(s) must be identified in a Standard Operating Procedures and designated with a specific job description;
- Create formal compounding spaces and remove all excess clutter to create an environment that promotes the professional practice of pharmacy;
- Implement garb that minimizes exposure of the compounding environments and products to the #1 contaminate, the human;
- Enhance cleaning programs based on the science of cleaning and the chemical process of cleaning solutions, rather than checking off a ‘task’;
- Conducting frequent (daily) non-viable and viable surface and air testing to ensure EVERY product compounded is compounded in the appropriate environment;
- Treat all drugs as hazardous for personnel who handle them, since the continuous occupational exposure to these ‘chemicals’ has not been fully elucidated;
- Always use FDA approved premade products;
- Implement and maximize the ability of (IV) Workflow systems to enhance the safety of ALL compounded products;
- Automate the critical steps of compounding;
- Immediately stop dangerous practices known to cause patient harm, syringe pull-back method, compounding of FDA approved premade products, unsanitary conditions in compounding areas.
So, to answer the question posed in the title, no! Pharmacy as a profession ‘must’ continuously strive for excellence for the products provided to patients. There is no other profession that has been gifted the professional obligation of compounding medications safely for patients and the public.
Let Visante not only help you meet USP standards, let us help you achieve best practices for your patients. Contact us today to learn more.
[i] Merriam Webster’s Collegiate Dictionary. 10th ed. Springfield: Merriam-Webster, Inc.; 1993. Pharmacy; p. 871.