The number, range and duration of drug shortages in the US appear to be, at best, maintaining the levels seen in the recent past. It is now becoming essential for institutions to draft formal policies and procedures to manage them. An article by two hospital pharmacists summarises the information available and outlines the steps needed to make the best of the situation [1].
Identify shortages
At present there is no definitive, early warning system to alert pharmacists of an impending drug shortage. This means that in many cases shortages are only discovered when supplies of a particular medication are exhausted and additional supplies cannot be found. Authors, Nilesh Amin and Phu Huynh therefore believe that ‘it is essential to devise a method to preemptively identify drug shortages quickly so that the pharmacy department will be better prepared to methodically handle a shortage in an organised and responsible way.’
There is therefore a need for institutions to be proactive and establish processes for managing drug shortages. These should, according to Amin and Huynh, include ‘identification, assessment and estimate of impact, development and implementation of restrictions or utilisation of alternatives, communication of relevant information to practitioners, monitoring of current supply, and ultimately, ending any necessary restrictions if and when the shortage ends.’
There is currently no requirement for drug manufacturers or wholesalers to report impending drug shortages to FDA, although legislation is now being hammered out by the US House and Senate to try to curb further shortages by requiring manufacturers to notify FDA six months in advance of any potential shortage [2]. Therefore, it is perhaps not surprising that manufacturers rarely, if ever, inform the healthcare community of an impending shortage, however, not being able to acquire product is a telltale sign. Amin and Huynh advise that ‘those drug orders not filled by your wholesaler in a timely manner should be subjected to further investigation in order to figure out why. It is important to determine whether the shortage is isolated to one manufacturer or is affecting multiple manufacturers, as this will affect the decision of finding a substitute product or rationing what remains available.’
Build a plan
The article suggests designating a single pharmacist to act as a gatekeeper for the remaining drug, if a drug has specific criteria that the patient must meet and also requires a pharmacist to assess multiple patient factors. If a drug is widely used in different patient populations and the facility has to place restrictions on this drug, then it would be advisable to have a diverse group of pharmacists to assess the situation and serve as gatekeepers.
After assessing the situation, the gatekeeper(s) should convene a meeting of pharmacy, physician, and nursing managers to discuss the specifics of the shortage and what impact is likely on patient care. The main purpose of such a meeting is to establish approved indications and uses, and determine feasible alternatives should the drug become unavailable.
The article also recommends predicting potential shortages by a pharmacist performing a daily review of the dedicated pages on the websites of American Society of Health-System Pharmacists (ASHP), FDA, and the Centers for Disease Control and Prevention (CDC), among others. The different information available from each site is discussed.
Conclusion
Careful monitoring of available information sources, including looking for trends in your own purchasing and acquisition data, as well as detailed planning and preparation, can prevent drug shortages from turning into crisis situations.
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References
1. Amin NH, Huynh P. Process for Proper Management of Drug Shortages. Pharmacy Purchasing & Products. 2012;9(5):40.
2. GaBI Online - Generics and Biosimilars Initiative. Drug shortages are persisting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-are-persisting
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