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Stay Current on Medication Compounding Standards to Advance Public Health and Patient Safety

HealthStream periodically publishes guest blog posts from our partners, who provide expert learning content and industry leading solutions that strengthen our ability to improve outcomes. This post comes from United States Pharmacopeia (USP).

Compounding Is an Essential Medication Delivery Option

Millions of medications are compounded each year in the United States to meet the unique needs of patients. Compounding is the mixing or alteration of ingredients, in any setting, to create a medication that meets unique, patient-specific medical needs. Compounding is an important treatment option that often provides access to medication 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 are essential for patient safety. 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.

USP Provides Health Care Quality Standards for Compounding

USP is a not-for-profit, science-driven organization that has an established process for convening 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 of the expertise of science and health care practitioners, while providing opportunities for public input for stakeholders throughout the standards’ process.

General 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 by developing General Chapters such as <795>, <797>, and <800>. The first two, <795> and <797>, describe a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations. General Chapter <800> has a goal of helping to protect health care workers from the risks associated with handling of drugs while compounding, preparing, or handling medications.

Public Comment Is Incorporated

Public comment is integral to the standard-setting process. During standard development, public comment mechanisms are designed to obtain input from stakeholders, such as patients, health care practitioners, policymakers, regulators, academicians, and industry representatives, to help ensure that broad perspectives are included in the standard.

Training and Education for Compounding Safety and Compliance

In order to help healthcare workers meet quality and compliance expectations related to USP compounding standards, 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!

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