Member Feedback Requested on Proposed Sterile Compounding Regulations

June 30, 2014 BJ Bartleson, RN, MS, NEA-BC

The California State Board of Pharmacy has produced a new draft of proposed regulations for pharmacies that compound or compound sterile preparations. The changes will be considered by the board for release for a 45-day comment period during its July 30 meeting. Many of the proposed regulations affect facility and equipment standards for sterile compounding such as ventilation, negative pressure and ante rooms. It is especially important for small, rural and critical access hospitals to review the proposed regulations. In the interest of developing the best regulations, the Board of Pharmacy has granted CHA an opportunity to submit feedback on physical plant modifications by July 9.
CHA Medication Safety Committee leaders — and others who worked together to compose extensive comments to the board’s original language in January — are analyzing the new regulations and drafting comments. In addition, CHA will host an all-member call on July 8 for interested hospitals to gather information and participate in discussion of the Board of Pharmacy changes, as well as CHA’s comments and proposal.
CHA encourages all members to compare the proposed physical and plant structural changes to current compounding facility and equipment standards and submit comments to CHA on the attached proposed worksheet and/or participate in the July 8 call:
Tuesday, July 8
4 p.m. – 5 p.m.
(800) 882-3610, Passcode 5968133#
Attached are CHA’s Jan. 10 comment letter, the Board of Pharmacy proposed language and a worksheet for submitting comments. 

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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.