Advertisement

Blog Viewer

Protecting Patients and the Future of Pharmacy Compounding: An ASHP Advocacy Update

By Kasey Thompson posted 04-01-2013 13:51

  
Nearly six months after the initial reports of meningitis caused by contaminated methylprednisolone acetate compounded by the New England Compounding Center (NECC), ASHP continues to work diligently to devise solutions that will protect patients from preventable harm by ensuring that compounding outsourcers are appropriately regulated and inspected.

In the aftermath of the NECC incident, policy makers moved quickly to investigate the issue and explore avenues to close regulatory gaps in the oversight of compounding outsourcers. I represented ASHP at one of the earliest hearings on the issue held by the Senate Committee on Health, Education, Labor and Pensions. ASHP staff are actively engaged with Congress and officials at the Food and Drug Administration (FDA) on the issue. A particular area of focus for us is to distinguish patient-care driven hospital and health-system based IV admixture services from commercial sterile compounding outsourcing.

ASHP believes that hospitals and health systems should be exempt from potential new laws and regulations that would clarify FDA’s authority to regulate and inspect large scale commercial compounding manufacturers. Sterile IV admixture preparation in hospitals and health systems is patient specific or is done in reasonable anticipation of patient need. And hospitals and health systems are not preparing these products for commercial sale. The medications are compounded for use with their own patients. Hospitals and health systems are also accredited by quality improvement organizations such as The Joint Commission, regulated by state health departments or boards of pharmacy and have strong internal controls through pharmacy and therapeutics committees, formularies, quality and risk management committees, infection control committees, and adhere to USP Chapter 797 standards and other applicable standards.

The Society believes that pharmacy compounding that is done in response to a prescription or medication order for an individual patient where a prescriber-patient- pharmacist relationship exists should be solely regulated by state boards of pharmacy.

We feel strongly that Congress must clarify and provide FDA with the authority it needs to regulate large scale commercial compounding manufacturers that are compounding sterile preparations without a prescription or medication order solely for anticipatory use.

As ASHP CEO Paul Abramowitz noted in a column in ASHP InterSections, compounding and pharmacy are inextricably linked, so this is an issue for which we have a great deal of passion. We are committed to protecting the safety of our patients and guaranteeing the future of a practice that is at the core of our profession.

#Compounding #Congress #FDA #sterileproducts #PatientSafety #Quality #Advocacy
0 comments
1846 views

Permalink