New IACP tool helps evaluate pharmacies for compounded medication services

October 20, 2011

The IACP has developed an assessment questionnaire to help hospitals, practitioners, and non-compounding pharmacies identify and evaluate compounding pharmacies.

With hospital medication shortages increasing throughout the North American healthcare system, the International Academy of Compounding Pharmacists (IACP) has developed an assessment questionnaire to help hospitals, practitioners, and non-compounding pharmacies identify and evaluate compounding pharmacies, as they seek alternative sources for medications that currently are in short supply.

IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQ) provides a comprehensive checklist of what to look for in a compounding pharmacy practice. It is based on United States Pharmacopeia (USP) standards, which compounding pharmacists are obligated to follow according to state board of pharmacy regulations or standards of practice. Collaboration between licensed compounding pharmacists and their colleagues in hospitals and institutions is a longstanding response to back-orders and shortages.

The CPAQ includes evaluation points in the following areas: regulatory compliance, licensing/permits, internal controls and quality assurance, testing and verification, and site visits.

“Drug shortages have been an ongoing problem for healthcare facilities, and the number of drug products that are unavailable due to manufacturer back orders and discontinuation is on the rise,” said Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, compounding pharmacy operations coordinator, Indiana University Health. “These facilities are often trying to find substitutions for the drug products or alternative treatments, and there is often a delay in the patients’ treatment. Compounding pharmacies may be able to prepare these medications using bulk active pharmaceutical ingredients. However, it may be difficult for the healthcare pharmacy administrators to know if the compounding pharmacy can provide quality compounded medications to meet their facilities’ needs, because they are unfamiliar with the USP standards for compounding sterile and non-sterile preparations. The IACP has developed a checklist of standards and criteria to assist the administrators in finding a suitable compounding pharmacy to meet these needs.”

“IACP leadership recently participated in FDA’s conference on prescription drug shortages,” said Scott Karolchyk, RPh, FIACP, IACP president-elect. “While there were many good intentions expressed during the conference, there were no real solutions for now. Each day, pharmacists and physicians are grappling with making sure our patients get the medicines they need. What was clearly overlooked was how compounding pharmacists are providing solutions today as they work with U.S. hospitals, surgery centers, and practitioners to make those medicines available.”