Some healthcare providers turned to compounding pharmacies to solve drug shortages when closures at big manufacturers made some drugs hard to come by. Now that compounders have run into new regulatory issues, providers are again looking for new ways to come up with what they need.
State officials in Massachusetts, home of the large-scale compounder at the heart of a national meningitis outbreak, are trying a program there to ease the problems that are particularly acute for rural hospitals. According to The Boston Globe, the state is setting aside a rule that prevented hospitals from sharing drugs. Under the new regulation, the state health commissioner can permit long-term agreements for certain hospitals, such as rural or smaller facilities that don't have as many resources for finding the drugs they require, the newspaper reports.
When injectable steroids produced at New England Compounding Center (NECC) in Framingham, MA, were tied to a meningitis outbreak that has sickened more than 700 and led to 46 deaths, it turned into a national scandal. It has raised questions about whether the FDA needs to be actively regulating large-scale compounders. NECC closed down and filed for bankruptcy protection and a sister company, Ameridose, voluntarily ceased operations while the FDA and others examined its operations. That has exacerbated shortages of certain drugs that the compounders had started making on a larger scale when other producers ran into their own supply issues.
Read more: New rule helps small hospitals struggling with shortages - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-rule-helps-small-hospitals-struggling-shortages/2013-02-19#ixzz2LNOV3oFg
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