Know the current standards.
IF YOU PREPARE medications to meet unique patient needs, stop and ensure you are up to speed on United States Pharmacopeia (USP) standards to help ensure patients receive quality medications that are free of contaminants.
In the United States, millions of medications are compounded (prepared) each year to meet the unique needs of individual patients. Compounding provides access to medication for patients who may not be able to use commercially available formulations because of dosing requirements, allergies, rare diseases, or other health conditions.
Compounded medications can be sterile or nonsterile. Understanding the risks inherent in each and incorporating established standards into daily clinical practice are essential to patient safety. Although compounding is essential to meeting specific patient healthcare needs, 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 more hazardous to patients because they’re more likely to be administered into sterile body spaces such as the central nervous or vascular system, eyes, or joints. These spaces are typically microbe free, and the introduction of contaminants can lead to infection, serious injury, or even death. In addition, incorrect ingredients or incorrect quantities of ingredients can result in medicine that is not therapeutically effective or is toxic to the patient.
To help reduce patient risks, USP provides standards, such as USP General Chapters <795>, <797>, and <800>, for preparing quality compounded medications. (See At a glance: USP compounding chapters.)
USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.
Staying up-to-date is an important aspect of public health advancement, so USP is revising the compounding chapters to better align the standards with changes and advances in science and clinical practice and to help ensure quality compounded preparations. The chapters are anticipated to be official in December 2019.
Shawn Becker is senior director and Loredana I. Jinga is director of Healthcare Quality & Safety at USP.