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Better communication of upcoming shortages is desired
What started as a distant drumbeat now appears to reaching a loud alarm: There are a growing number of shortages in needed drugs, and healthcare professional organizations are trying to raise the level of concern at FDA and elsewhere.
The most comprehensive shortage list is posted on the website of the American Soc. of Health-System Pharmacists (ASHP; Baltimore; ashp.org), and as of late December, listed 140 drugs with shortage status. That society, together with the American Soc. of Anesthesiologists, the Am. Soc. of Clinical Oncology, and the Institute for Safe Medication Practices, held a public meeting in early December on the issue; an action plan for addressing it will eventually be produced. Last September, ISMP published a survey of practitioners conducted over the summer, and says that the large number of responses suggest that the problem “has risen to the level of a national public health crisis.” Of particular concern to ISMP is what happens when a drug is not available: If it can’t quickly be located elsewhere, alternative drugs or dosages are used, and this can in turn lead to medication errors or adverse events. ISMP also notes that the number of shortages has doubled since it opened a resource center in 2004.
Most of the drug shortfalls involve generics; although there are some areas where both a generic and branded product are in distribution, and an upset from either can create a shortage. In addition, there are vaccines and biologics like heparin currently on the list that generally come from branded pharma manufacturers. Healthcare providers would like to get some level of advance warning when shortages are cropping up, rather than to be left to their own response mechanisms.
FDA has an existing Drug Shortage Program, and has coordinated responses from manufacturers to address shortages, but it also notes its limitations in mandating production. (It can, on occasion, allow for the importation of non-US product.) A PhRMA spokesperson notes that while PhRMA has no specific program for drug shortages, it sponsors the RxResponse program (rxresponse.org), which is set up to address emergency shortages due to national disasters or pandemics. (HDMA, GPhA, NACDS and other associations are also involved.)