Author : Joyce Crawford
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Book Synopsis Drug Manufacturer Masquerade by : Joyce Crawford
Download or read book Drug Manufacturer Masquerade written by Joyce Crawford and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compounding pharmacies mix, combine, or alter drugs that are not otherwise available in the commercial market. This paper discusses the development of the compounding industry, and the various state and federal oversight authorities surrounding it. These entities are a necessary part of the healthcare delivery system, especially in hospitals and clinics where compounded drugs are needed in greater volume and cannot be produced on-site. Recently, however, the compounding industry has grown rapidly, and the industry controls that preserve safety and quality controls are no longer sufficient. In order for the industry to remain a viable option for safe medication to healthcare providers, changes need to be made to ensure the quality of the products. This objective could be made from within the industry through management or technology; however, this paper discusses how federal and state regulatory agencies can better ensure that no matter what the source, the public is supplied only with safe medication. As discussed later, it became apparent that regulatory responsibility over this industry between state and federal agencies was not clear. A thorough investigation by Congress has determined that lack of definition and clarification of Federal oversight created confusion and agency liability exposure in the compounding manufacturer industry. The most recent and extreme case occurred in late 2012, when an outbreak of fungal meningitis was caused by contaminated vials of methylprednisolone acetate, produced by the New England Compounding Center in Framingham, Massachusetts. The contaminated solution was injected into patient' joints and spine to treat pain, but instead caused 751 infections and 64 deaths. In light of this horrific tragedy, the state and federal agencies, along with Congress, have investigated and discussed how to prevent this from happening again. The result of this investigation was the exposure of a gap in regulatory authority between the state boards of pharmacy that license pharmacies within their state, and the FDA which oversees the mass production and distribution of drugs nationally. This gap allowed facilities to operate under a state license, and hide behind state authority, even when there was evidence that they were operating more like a manufacturer. To close this gap, ensure compliance with safety controls, and prevent another outbreak of adverse events, Congress has enacted legislation, the Drug Quality and Security Act, to clarify jurisdictional definition, and require specific registration and reporting from compounding manufacturers. This paper discusses the strengths and weaknesses of the Drug Quality and Security Act, and what issues remain.
