Monday, January 6, 2014

Compounding series shows good, bad of industry

The Ocala Star-Banner deserves credit for devoting the resources and space to the subject of pharmacy compounding. It is a topic very much on the minds of local readers due to the tragic deaths of several residents from the meningitis outbreak relating to the New England Compounding Center (NECC) as well as earlier adverse events involving a local compounding pharmacy.
We are grateful that the paper called our organization and our board members for comment and perspective. We offer the following comments in response to the series and the related editorial.
Consistency is key. States must adopt uniform standards that will ensure patient safety, and chief among those is USP 797, the standard for sterile compounding. USP 797, and USP 795 for nonsterile compounding, keep patients safe and should be recognized as the standard by every state in the union.
Our organization long has fought for greater consistency in state standards. Those standards need to be applied not only to compounding pharmacies but to all other settings in which customized medications are prepared, including hospitals, physician offices and surgical centers.
Regulations only work when enforced. The best regulations will not keep patients safe. They must be enforced through unannounced inspections. Case in point: Massachusetts. The Bay State had some of the best regulations in the land, yet NECC still allegedly committed gross errors that led to patient deaths and illness.
The state, while having clear and firm regulations, did not adequately enforce them because it did not devote the necessary resources to inspections.

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