Sunday, July 31, 2011

Help on the way?

The March 30th blog entry, 'The why's of drug shortages', introduced the issue of drug shortages and provided some statistics re how bad the problem has become over the last few years. The issue has been polemicized, with many making arguments based on widely-different views, for example from 'Got Meds? Not Necessarily, Say U.S. Hospitals' ("deeper, more hidden reasons" responsible... implying malfeasance by manufacturers and suppliers) to 'Rx Drug Shortages: Regulation Can Be Deadly' (faulting excessive government regulatory intervention...).

Some of our worthy Senators pop up in the news every time a drug shortage occurs and hits the newspapers, a prime example being Senator Amy Klobuchar (D-Minnesota), see:

Klobuchar asks FDA for solution to chemo drug shortage
Klobuchar seeks to ease medication shortage
Klobuchar Addresses Medication Shortages
Klobuchar Urges FDA to Address Shortage of Shingles Vaccine

... and she has introduced legislation on the subject. S296, the 'Preserving Access to Life-Saving Medications Act'. A number of groups (the American Society of Anesthesiologists, American Society of Clinical Oncology, American Hospital Association, Institute for Safe Medication Practices, and the American Society of Health-System Pharmacists) also wrote a letter in support of S296.

So what does S296 do? It requires pharmaceutical manufacturers to notify the FDA six months in advance of planned interruptions, disruptions, or discontinuations of drug supplies; and as soon as possible following unplanned ones. The HHS Secretary is mandated to develop the reporting mechanisms and develop monetary penalties for reporting failures; as well as to identify which drugs might have shortages, in which case he/she then also needs to work with the manufacturers to "address" the shortages...

A good question to ask might be if this legislation actually addresses any of the multiple reasons that cause drug shortages... This blogger would argue that the answer is 'no'. While frustrating for practitioners to never know in advance what shortages are impending, the mere addition of possible earlier notifications to the current situation will prove of limited utility, and in many cases will exacerbate the problem (since the reflex action of any hospital's Pharmacy purchasing staff will be to 'advance buy' as much of the drug as possible before it goes on back-order!!)

S296 - ‘‘Preserving Access to Life-Saving Medications Act’’
ASA BRief summary: S.296 - Preserving Access to Life-Saving Medications Act

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