In an ideal world, there would be a system for warning providers in advance of impending drug product shortages; this would give them ample opportunity to proactively address and manage all aspects and implications of the shortage. In lieu of this ideal, pharmacists, when confronted with the unavailability of a drug product, want information on which to base decisions about meeting patient needs for the product. Segments of the supply chain, especially manufacturers and distributors, have been inconsistent in providing information and assistance to health systems. The difficulty in obtaining information is exacerbated by the many players, complexities, and uncertainties in the supply chain.

The pharmacy department must take a leadership role in managing shortages by developing and implementing appropriate strategies and processes for optimizing the safe and effective use of therapeutic alternatives. Health systems should develop a contingency planning strategy to prepare for the possibility of a prolonged drug product shortage.¹⁹ Although it often is not possible to predict when shortages will occur, the process for dealing with them can be defined in advance. The health system should identify a point person to implement and monitor this process and establish an organizational approach to decision-making and communication. The institution should determine committee structures and responsibilities for decision-making during each phase of the process (e.g., pharmacy and therapeutics committee, medical executive committee).

Planning can be divided into three phases: identification and assessment, preparation, and contingency. Assessment requires a critical evaluation of the current situation and the potential effect of the shortage on the health system. An effective evaluation examines the reason for the shortage and estimates an end date; both internal and external supply availabilities are assessed.

The preparation phase consists of all activities that can be performed before the actual effects of the shortage are felt. Depending on the health system’s inventory, when a back order or other notice is received, there is often lead-time before actual stock depletion. All patients whose treatment depends on the unavailable drug product and alternative therapies should be identified. Since many drug products have limited therapeutic alternatives, outages can have significant patient care and cost consequences. Health systems need to gauge the effect of those consequences on their institutions. Preparation should also include the development of methods for implementation and communication.

The contingency phase involves operations and circumstances for which preparation is limited because of incomplete information, financial constraints, or circumstances beyond the health system’s control. For example, biological products are available only in increments and at a very high cost when no therapeutic alternatives are readily available or when shortages are longer than anticipated. Since direct control over availability is not possible, health systems must prepare for a product’s unavailability.

Identification and Assessment Phase. The purchasing agent is often the person who identifies a shortage and may be the person responsible for managing drug product shortages. This person must be cognizant of aberrant fluctuations in the health system’s supply chain that may indicate a potential shortage (e.g., partial orders filled, one strength difficult to obtain, most manufacturers have no more stock). If the purchasing agent is not a pharmacist, he or she must work with a designated pharmacist.

When a shortage is identified, the point person or his or her designee should conduct an assessment to evaluate its potential effect. A threat analysis using the shortage’s expected duration and an assessment of the current inventory and usage patterns can be used to determine the potential consequences of the shortage.

Details and duration of shortage. Pharmacists can contact product manufacturers, distributors, FDA, CDC, and other sources to determine the reason for the shortage and its expected duration. This information may already be available on the ASHP Drug Shortage Resource Center Web site (www.ashp.org/shortages). If not, visitors to the site can report a shortage online. Predictions of when the product will be available help determine the health system’s ability to endure the shortage and guide its short- and long-term management strategies.

Although the end result is the same, the time to impact and the duration of effect vary according to the reason for the shortage and where in the supply chain problems occur—from raw materials to manufacturer, manufacturer to wholesaler, or wholesaler to health system. A lack of raw materials may affect several manufacturers of the finished drug product. A manufacturer’s problems may affect only its product. Effects on distributors are dependent on their inventory levels.

Inventory on hand. Once a shortage is confirmed, the pharmacy should count the inventory on hand and estimate the time period it will cover. Available inventory includes all supplies of the drug product within the health system, including the pharmacies, inpatient units, ambulatory care clinics, automated medication storage and distribution devices, floor stock, resuscitation carts, and prepared trays.

Based on available quantities and historical usage, the pharmacy should estimate how long the health system can endure a shortage. Usage history can be obtained from procurement and issue records held by distributors, the purchasing department, and the pharmacy department. Billing and automated medication storage and dispensing device records can assist in determining actual usage within the system.

Inventory counts of all alternative drug products should be converted into common measurement units to augment estimates of use. Both current use rates and reduced rates after conservation measures are implemented should be included when assessing how long the available inventory of the shortage drug product and possible alternative products will last.

Threat to patient care and costs. A threat analysis evaluates all factors relevant to the shortage (e.g., duration, current inventory, medical necessity, alternative sources or therapies) to determine the shortage’s potential effect on patient care and costs. Shortages affect safe medication practices throughout the medication distribution and administration process within a health system. When considering alternative dosage forms or therapies, pharmacists must consider changes in their procedures for look-alike and sound-alike medications, bar coding, distribution paths, and the effect on automation, contract compliance, and final product preparation.²⁰ The extent to which a health system will be affected by a given shortage depends on the health system’s scope and level of services and its service population.

Preparation Phase. Once an imminent shortage is confirmed, the health system should take steps to prepare for known and potential problems in maintaining patient care and controlling costs.

Therapeutic alternatives. The first step in the preparation phase is to identify therapeutic alternatives to the unavailable drug product. A formal process for identifying and approving therapeutic alternatives for the health system should be established. The health system should make decisions about alternative agents in collaboration with medical, nursing, and pharmacy representatives and obtain approval of the appropriate medical committees. Therapeutic alternatives should be inventoried to ensure adequate supplies to meet new demand. In many cases, supplies of the best alternative agent may be affected by the current shortage.

Communication and patient safety. Information about the drug product shortage, alternative therapies, temporary therapeutic guidelines, and implementation

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