Resources for Your Practice: Information on Drug Shortages by Margo Karriker, PharmD, FSVHP
Editor's note: The author, Margo Karriker, is the veterinary pharmacist at the UC Veterinary Medical Center - San Diego, a specialized program of the School of Veterinary Medicine co-located with the Veterinary Specialty Hospital of San Diego. She wrote this article for the October 2011 edition of "Connected," a newsletter for veterinarians published by the hospital; the article is reprinted by permission.
Recently, we have been faced with drug shortages, backorders and recalls in an unprecedented volume. A lack of single-source products is common in the marketplace, forcing us to make clinical decisions without all of our tools available. The concerns of drug shortages have also gained national attention with reports on CBS’s Early Show and the Wall Street Journal in August. The American Society of Health System Pharmacists (ASHP), an association that tracks drug shortages with the University of Utah Drug Information service, states that the number of drug shortages in the U.S. has tripled since 2006.
Currently, there are 175 human-label drugs in short supply according to the ASHP Drug Shortage Resource Center. No reporting database exists for veterinary-label drugs, however, it is estimated that a similar number of small-animal products are in short supply. Anesthetic and antineoplastic products have been particularly impacted this year. With drugs like dexmedetomidine, propofol, doxorubicin, cytarabine, and l-asparaginase in short supply during the last 12 months, the challenge to source the treatment of choice for a particular patient can be substantial.
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While many reasons are cited, the more common drug supply issues are: manufacturing issues, raw/bulk material unavailability, recalls, unexpected shifts in clinical demands, formulation changes, and natural disasters.
On August 24, 2011, the Food, Drug and Law Institute published a report titled, “Can the United States Ensure an Adequate Supply of Critical Medications?” Among their many recommendations, the authors suggested that Congress should: expand FDA authority to require notification from manufacturers about supply interruptions and allow FDA to require manufacturers to develop continuity of supply plans. Further, they recommend that FDA should: encourage notification when there is a single-source product in the market and work to explore incentives that encourage manufacturers to enter the market and stay in the market when they supply vulnerable drugs.
So, how should you manage drug supply issues at your hospital? ASHP has published a guidance document that describes how to manage your own drug inventory prior to and during a short supply situation. A phased process is outlined in “Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems.”
Phase 1: Identification and Assessment
You or your purchasing agent identify that a potential shortage is pending. After verifying the shortage, both an operational and a therapeutic assessment should be performed. Operationally, you: validate the details of the shortage, determine how long stock on hand will last, determine what alternative sources are, estimate the impact on your hospital, and determine the supply of therapeutic alternatives. With a therapeutic assessment, you should: identify which patients will be impacted and identify the utility of therapeutic alternatives, including options if there is no reasonable alternative.
Phase 2: Preparation
First, therapeutic alternatives should be analyzed (cost, ease of use, clinical impact, availability). Often the primary alternative is quickly impacted by the shortage. Next, staff should be communicated the plan for the shortage, including how to utilize and access an alternative product. A plan for how to prioritize patients should be made. During this phase, keep in mind relationships with other hospitals and veterinarians. In some cases, a single supply may be shared among hospitals and patients may be referred to a specialty center with adequate stock on hand. ASHP recommends against stockpiling, as this practice often hinders the overall supply chain. When single hospitals hoard product, supply is diverted from other hospitals and patients. Stockpiles can cause artificial shortages and drain supplies, as well as lead to costly inventory burdens.
Phase 3: Contingency
In this phase, you should establish internal policies about when to use an alternative source, like a compounding pharmacy or importation. In cases where no alternative is readily available, these resources can be utilized on a short-term basis. Remember that compounding regulation varies from traditional drug regulation and this factor should be considered when weighing the utility of alternatives. Different risk-benefit ratios may exist when using any alternative products. Client communication about these issues is essential. Remember, alternatives may rise dramatically in price during a commercial product shortage. Be sure to estimate how this may impact patient care.
It is unlikely that the current drug shortage issues will resolve any time soon. The best options for all of us is to be prepared for short supply issues, communicate with our staff and colleagues about pending shortages, and take the necessary steps to keep our patients’ best interests in mind.
Resources for Your Practice: Information on Drug Shortages
About the UC Veterinary Medical Center - San Diego Pharmacy Services
Clinical Pharmacy Service personnel provide quality medications, teach future pharmacists and veterinarians, and conduct pertinent clinical research. The service is one part of the team of veterinary professionals of the UC Veterinary Medical Center - San Diego that provides the best veterinary care possible for clients living in Southern California who have need of specialized veterinary care for their pets.
Clinic phone number: (858) 875-7505