Process for Proper Management of Drug Shortages


May 2012 - Vol. 9 No. 5 - Page #40

This past year, famotidine injection joined over 200 other drugs that went on shortage in 2011. Shortages of this kind are a result of many factors, including disruptions in the acquisition of raw materials, mechanical manufacturing breakdowns, manufacturers’ non-compliance with good manufacturing practices, regulatory changes, business decisions by manufacturers, shifts in demand, and industry consolidation. In many instances, the cause of a shortage is never revealed to health care practitioners. Regardless, the impact of shortages on patient care can be substantial, especially if they necessitate the use of alternative therapies that may prove less safe, less effective, or create a delay in care.  

A growing number of outlets for shortage information and the ever-increasing expedition of receiving such information has had a positive influence, but the challenge for pharmacy departments in handling a shortage such as that of famotidine injection remains: what does the facility do once a shortage is discovered? To address this most critical element of shortages, institutions should be proactive in establishing processes for managing drug shortages that include identification, assessment and estimate of impact, development and implementation of restrictions or utilization of alternatives, communication of relevant information to practitioners, monitoring of current supply, and ultimately, ending any necessary restrictions if and when the shortage ends.

Identifying Shortages and Building a Plan
Unfortunately, at this point in time there is no definitive, early warning system to alert pharmacists of an impending drug shortage. All too often, a shortage is only discovered after a given medication supply is exhausted at an institution and no additional supply can be secured. In order to avoid scrambling to develop a plan to address such an event, it is essential to devise a method to preemptively identify drug shortages quickly so that moving forward, the pharmacy department will be better prepared to methodically handle a shortage in an organized and responsible way. 

While manufacturers will rarely, if ever, inform the health care community of an impending shortage, not being able to acquire product is a telltale sign. Those drug orders not filled by your wholesaler in a timely manner should be subjected to further investigation in order to figure out why. While performing this investigation, 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.

Another method of predicting potential shortages is to perform a daily review of the dedicated pages on the websites of ASHP, the FDA, and the CDC (see Figure 1). These resources can provide a variety of information and draw from various sources. For example, ASHP has collaborated with the Drug Information Service at University of Utah Health Care to help manage its drug shortage website. ASHP’s site remains the most comprehensive, as it provides information on any supply issue affecting a drug, even if the issue is only affecting one manufacturer or a particular dosage strength or size. On the other hand, the FDA’s site focuses on shortages that impact drugs used to prevent or treat life-threatening diseases with no available source or alternative drug therapy, and the CDC’s site focuses on vaccine shortages. Whatever combination of these monitoring methods is employed by the pharmacy department, the key is ensuring these daily reviews and identifications occur. Given the increasing number of shortages that have occurred over the last 18 months, these duties have the potential to require significant pharmacy staff resources.



Assess Shortage Impact
Once a new drug shortage is identified, every effort should be made to assess what the impact of the shortage will be on patient care. First and foremost among this assessment is to make a qualified determination of how long the shortage is expected to last and whether multiple manufacturers are involved. A facility’s response will depend on the severity of these factors and there will be shortage situations that require no action. These situations include if the shortage is projected to be brief, if the same drug product is available from other manufacturers, or if the facility does not use (or uses very little of) the given drug in shortage. However, if the drug shortage is projected to be lengthy and involves multiple manufacturers, then further action will invariably be necessary. Famotidine injection was a classic example of this scenario. Institutions that identified the shortage late inevitably had to place restrictions and/or utilize alternatives such as other injectable H2 blockers or injectable proton pump inhibitors. In most cases, the alternatives were not ideal for a few reasons. For many institutions, such substitutions required a change in administration practices, required additional monitoring due to potential drug-drug interactions, or were simply more costly than famotidine injection. 

The next step is to determine if the drug is still available for acquisition from your wholesaler. Wholesalers often allocate drugs entering shortage if few suppliers remain active in order to prevent hoarding. A facility’s given allocation will typically be based on its monthly ordering volume, so this is a factor that should be considered during contract negotiations. Lastly, determining the current inventory of the shorted drug, in concert with the information already gathered, will help form a robust impact projection for your facility.

Authorize a Gatekeeper
When an established picture of shortage information has been determined, a management and action plan must be applied for moving forward. If a sufficient supply remains available to the facility through your wholesaler—either through your allocation or simply because the wholesaler has an excessive amount—or there is enough of the drug already within the institution to last until the projected end of the shortage, then a basic monitoring of the shortage is likely all that will be required. If supply is tenuous at the wholesaler, the facility, or both, then it is imperative to convene a meeting of pharmacy, physician, and nursing managers to discuss the specifics of the shortage and what its impact is likely to be 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. 

Expeditious communication of designated restrictions and alternatives to pharmacy and clinical staff is essential to ensure a uniform understanding of the situation. The pharmacy department may have to take further action, such as centralizing supply of the remaining drug to the pharmacy, especially if automated dispensing machines are used in the institution. In addition, it is advisable to designate a member of the pharmacy department as a gatekeeper for the remaining drug. Depending on the shortage, this designation can be a single pharmacist or a select group of pharmacists can be named. Using the famotidine injection shortage as an example, if a 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 since this drug is widely used in different patient populations. On the other hand, if a drug has specific criteria that the patient must meet and also requires a pharmacist to assess multiple patient factors, then it would be advisable to have a single pharmacist or a small group of pharmacists assigned to be the designated gatekeeper. 

Working as a gatekeeper for drugs on shortage can be a sensitive issue, so gaining buy-in from all affected parties to the authority and logical benefit of such a designation is key. Creating the criteria of essential need for shortage drugs can and should be a collaborative process, but the ultimate gatekeeper should be given the necessary authority to make decisions moving forward. If a prescriber then requests a dose or doses of the shortage drug for therapeutic use, the gatekeeper will determine if the patient meets the established criteria and dispense the drug accordingly. Regardless of whether significant response action is necessary, monitoring of remaining supply is essential in the event the conditions of the shortage change such that a reevaluation of the response is needed.

Conclusion
Due to the unknown nature of most drug shortages, management plans must be able to adapt, even so far as to become semi-permanent. However, if a shortage is short lived and drug supply becomes fully available again, then the plan enacted for that drug shortage should be terminated. This is not as simple as saying the shortage is over, as the drug must be taken off restriction and pre-shortage operations must be reinstituted in a clear and open manner. A large part of such a resolution is clear communication of appropriate actions to pharmacy and other health care staff.

Given that drug shortages appear to be, at best, maintaining the levels seen in the recent past, it is essential for institutions to draft formal policies and procedures to manage them. While establishing a concrete forecasting tool for drug shortages is currently untenable, careful monitoring of available information sources, including watching 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.


Nilesh H. Amin, PharmD, is a clinical pharmacy specialist at Yale-New Haven Hospital in New Haven, Connecticut. He received his PharmD from the University of Utah and his professional interests include infectious diseases and pharmacy informatics.

Phu Huynh, PharmD, BCPS, is a drug information specialist at Yale-New Haven Hospital. He received his PharmD from the University of Maryland School of Pharmacy. Phu completed a drug information residency also at Yale-New Haven Hospital and focuses the bulk of his professional attention to this area of pharmacy practice.

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