Preparing For and Managing Drug Shortages

October 2006 - Vol.3 No. 7
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By Erin R. Fox, PharmD

DRUG SHORTAGES IMPACT PRACTITIONERS IN MULTIPLE WAYS; HOWEVER, the actual definition of a drug shortage is different depending on the perspective of the patient, pharmacist, manufacturer, or wholesaler. From the patient and pharmacist perspective, a drug shortage typically means that a drug is not available for a treatment. The most common shortage is the wholesaler shortage. Pharmacists are experienced in dealing with these usually brief shortages, as they occur almost daily, are typically minor in nature, and are resolved within days. A manufacturer’s shortage on the other hand, can pose a bigger challenge. There are multiple reasons for manufacturer shortages, such as raw material supply problems, increased demand for product, or regulatory action. Despite the differences in definitions of drug shortages, pharmacists are clearly impacted by shortages on a daily basis. However, with proper upfront preparation, pharmacists can minimize the disruption caused by drug shortages to both clinical and automation systems.

In 2001, the number of drug shortages affecting pharmacies across the nation peaked when pharmacists experienced over 100 drug shortages.1 In the face of this unprecedented problem, the American Society of HealthSystem Pharmacists (ASHP) launched a Drug Product Shortages Management Resource Center. Content for this resource is provided by the University Health Care Drug Information Service, through a grant from Novation. The goal of the resource center is to provide accessible drug shortage information to all clinicians. You can access the resource center at www.ashp.org/shortage.

Preparation
Although drug shortages are certainly unpredictable, there are methods for pharmacists to prepare for a potential drug shortage. First, ensure effective communication strategies are in place2. For example, identify the staff members who will be responsible for developing communications regarding drug shortages. Establish a system wherein the purchasing agents alert these staff members as soon as a shortage is suspected. Next, make decisions ahead of time about whether your response to a shortage will include purchasing product only from the manufacturer and/or authorized distributors, or whether you will consider utilizing smaller distributors who are not authorized distributors of record*. Finally, staff should be prepared to provide recommendations for alternative agents, as well as drug information about an alternative agent’s drug interactions or safety profile. Recommendations of alternative agents may be found at the ASHP Drug Shortage Resource Center at www.ashp.org/shortage.

Shortage Management
While the management of a drug shortage will always be institutionand shortage-specific, there are two strategies that all pharmacists can use to effectively manage shortages. The first is to act quickly. Let clinicians know about a shortage as soon as possible. Provide the reason why the shortage is occurring and an estimated date for resolution, if you have this information. Get a communication out as quickly as possible, and continue to update the clinicians as additional information becomes available. At University Health Care Hospitals and Clinics, we use e-mail alerts and an intranet site to notify staff about shortages impacting patient care. The second strategy is to involve stakeholder clinicians — such as the attendings and floor pharmacists in the area where the drug is used most — in establishing the approach to the shortage. Clinician involvement is key, particularly if only a limited amount of drug is available. If the decision is made to reserve a drug for a specific group of patients, clinician involvement will make or break this process. An institution’s pharmacy and therapeutics committee can be an invaluable resource when making decisions about reserving product for a specific population.

Hospitals with a significant amount of automation may find that shortages present additional challenges for pharmacies beyond the clinical impact. Alternative products may differ in size and specifications. This can pose problems for automated dispensing machines and other automated systems that rely on a specific product bar code or tablet size. Therefore, simply purchasing a different brand of a product may cause difficulty within automated storage, distribution, and administration systems. Being aware of your system’s requirements and limitations before a shortage occurs can help prevent problems when alternatives are required.

Erin R. Fox, PharmD, is the drug information specialist at the University Health Care Hospitals and Clinics in Salt Lake City, Utah. She was a clinical pharmacist before starting her current position in 2001. She received her PharmD at the University of Utah and completed a specialized residency in Drug Information at the University of Utah Hospitals and Clinics.

REFERENCES:
1. Fox ER, Tyler LS. Managing drug shortages: Seven years’ experience at one health system. Am J Health Syst Pharm. 2003;60(3):245-53.
2. Fox ER, Tyler LS. One pharmacy’s approach to managing drug shortages. Am J Health Syst Pharm. 2003;60(1):27, 31.

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