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Preventing Risks Involved with Compounding Medication

April 1, 2021
April 1, 2021

HealthStream regularly features guest blog posts from partners whose expert learning content strengthens the ability of healthcare providers to improve outcomes. This post comes from United States Pharmacopeia (USP) and follows up their previously published post, Stay Current on Medication Compounding Standards to Advance Public Health and Patient Safety.

Compounding Can Be Necessary for Medication Delivery

To ensure medication is delivered effectively to patients, millions of doses are compounded each year in the United States. Compounding involves the mixing or alteration of ingredients, in any setting, to match patient-specific medical needs. Compounded medication often works for patients who may not be able to use commercially available formulations as a result of dosing requirements, allergies, or rare diseases. Compounded medications can be sterile or nonsterile.

Compounding Comes with Inherent Risks

Understanding the risks inherent in sterile and nonsterile compounding and incorporating established standards into daily practice is essential for patient safety. Here are a few of the risks involved with this treatment option:

  • Compounded drugs made without the guidance of standards may be subpotent, superpotent, or contaminated, exposing patients to significant risk of adverse events or even death.
  • Compounded sterile preparations are potentially most hazardous to patients because they are more likely to be administered into sterile body spaces, such as the central nervous or vascular system, eyes, or joints.
  • The introduction of contaminated compounded medications to sterile body spaces that were previously microbe-free can lead to infection, serious injury, or even death.
  • Incorrect ingredients or incorrect quantities of ingredients can result in medicine that is not therapeutically effective or is even toxic to the patient.
  • More than 12 billion doses of hazardous drugs are handled by U.S. healthcare workers each year; yet less than 10% of these drugs are labeled as hazardous.

USP Provides Health Care Quality Standards for Compounding

USP is a not-for-profit, science-driven organization that convenes independent experts in the development and maintenance of health care quality standards. The process is public health-focused, leveraging current science and technology, and draws on the expertise of science and healthcare practitioners, while providing opportunities for public input for stakeholders throughout the standards’ process.

USP Chapters <795>, <797>, and <800>

To help reduce risks, such as contamination, infection, or incorrect dosing in all health care settings, USP develops standards for preparing compounded drugs. These General Chapters are:

USP <795> Pharmaceutical Compounding—Nonsterile Preparations

Provides standards for compounding quality nonsterile medicine. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls, and training. General Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations.

USP <797> Pharmaceutical Compounding—Sterile Preparations

Provides standards for compounding quality sterile medication. The objective of this chapter is to describe conditions and practices to prevent harm to patients, including death that could result from microbial contamination, excessive bacterial endotoxins, and variability in the intended strength of correct ingredients, unintended chemical and physical contaminants, or ingredients of inappropriate quality.

USP <800> Hazardous Drugs—Handling in Healthcare Settings

The goal of these standards is to help protect healthcare workers from the risks associated with hazardous drugs. USP General Chapter <800> contains sections related to types of exposure; personnel and facility responsibilities for handling hazardous drugs; appropriate use of personal protective equipment; and deactivation/decontamination, cleaning, and disinfection.

Training and Education for Compounding Safety and Compliance

In order to help healthcare professionals meet quality and compliance expectations related to compounding and safe handling of hazardous drugs, HCCS, A HealthStream Company, is collaborating with USP to release the Compounding and Safe Handling of Hazardous Drugs Library. It consists of two offerings, a Pharmacy Library and a Healthcare Staff Library. Both libraries focus on how to effectively understand USP’s internationally recognized quality standards. The standards help ensure the quality and safety of compounded medicines and safety of healthcare workers as it pertains to handling hazardous drugs. The Pharmacy and Healthcare Staff libraries consist of six courses each, based on the particular standard and applicable role. All USP standards are found in the Compounding Compendium electronic product (PDF) in both libraries.

Learn more about the USP institution Solution here.

For more information on USP Standards on Compounding and Safe Handling of Hazardous Drugs, please register for our upcoming webinar, USP Standards: Compounding and Safe Handling of Hazardous Drugs.

Click here to register!