Preparation is critical to high-risk sterile compounding; High-risk compounding should be a last resort to address drug shortages, said ASHP

July 01, 2014

 

 

Every year, FDA reports shortages of hundreds of drugs, the majority of which are sterile injectables. Currently, there are 251 drugs in shortage, 199 of which are sterile injectables, according to the American Society of Health-System Pharmacists (ASHP). These numbers are similar to those of the last 5 years, according to FDA.
In the face of drug shortages, health-system pharmacists often must perform high-risk sterile compounding, but this should be an emergency last resort, said Angela Yaniv, PharmD, Assistant Director of Pharmacy at Cleveland Clinic, at last year’s ASHP Midyear Clinical Meeting and Exhibition in Orlando, FL. Before undertaking high-risk compounding, pharmacists should ensure there is no other way to acquire the drugs. Once the procedure is deemed indispensable, pharmacists should evaluate the feasibility of the high-risk compounding procedure and take measures to ensure the products are well prepared.

Weigh your options

When a drug is in short supply, health-system pharmacists should consider the following before taking on high-risk compounding: (1) expected duration of shortage; (2) the health system’s current supply of the drug and potential for inventory management during the shortage; (3) possible alternative manufacturers or sizes available for aliquoting; (4) possible therapeutic substitutions for the drug and the need for Pharmacy and Therapeutics Committee approval; and (5) outsourcing compounding.