By: Hamid Razaki, PharmD
Drug shortages seen across pharmacies in the United States continue to be an issue in patient care. A drug product shortage is defined as a supply issue that affects how the pharmacy prepares or dispenses a drug product, or that influences patient care when prescribers must use an alternative agent.1 Drug shortages have steadily risen in frequency over the past decade. In 1996, University of Utah Health Sciences Center (UUHSC) had 3 drug shortages, which quickly jumped to 18 drug shortages by the year 2000. By 2002, UUHSC had 157 shortages.2 Whether in the hospital or community setting, many details need to be addressed once a prescribed medication is not available due to a shortage in supply. Some examples of these pertinent issues include whether the patient or hospital can afford alternative medications, if the alternative is appropriate in managing the disease-state according to guidelines, what adverse patient outcomes are related to the drug shortages, the consequent delay in medical procedures, etc. There are several factors that go into why we have a drug shortage crisis on our hands. A thorough understanding of why drug product shortages occur is essential for their successful management.1
One of the most problematic contributions to drug supply shortages is when the raw and bulk materials are unavailable for drug manufacturers. Issues arise when multiple manufacturers are producing a drug product from which there is only one source of raw material.3 Around 80% of the raw materials used by manufacturers are imported from outside the United States.4 Several issues such as the political disruptions, quality of the materials, and climatic changes have all contributed to unavailability of raw and bulk material.1 Natural disasters such as hurricanes have led to the destruction of raw materials. Also, areas hit by a natural disaster may be in demand for medication themselves. A recent example was in 2005, when Hurricanes Katrina and Rita both caused an increased need for medications and the inability to obtain them1. Shortages can also occur when the FDA halts a manufacturer’s production due to non-compliance with Good-Manufacturing Practices (GMPs).3 Resolution of these issues often takes time due to lengthy inspections, injunctions, or seizure of products.1 When the drug product involved is considered a medically necessary product, the FDA aids the manufacturer in restoring GMPs rapidly.
Voluntary recalls may create shortages, especially when one manufacturer produces majority of a drug product.3 Recalls usually affect specific lots of medications, due to a concern in safety to the public or due to technical issues such as labeling deficiencies. Manufacturers may also decide to reduce production of certain drug products to reallocate resources for other drug products. Discontinuance of a drug product because of insufficient financial return or a high cost to correct manufacturing issues can cause an unanticipated and serious shortage, especially in the instance of a sole-source or medically necessary product.4
Poor inventory practices may also lead to drug shortages. Stockpiling and hoarding medications expected to be out of stock impacts inventory in other pharmacies. Facilities in rural areas face additional inventory challenges due to the distance between them and the distribution centers, along with the difficulty in borrowing items from nearby pharmacies.1 When an unexpected increase in demand for a certain drug product occurs, production may not be adequate to keep up. Reasons for an increase in demand for a drug product include disease outbreaks, and drug products with newly approved indications and new therapeutic guidelines.
While most view drug shortages as something detrimental, others have tried to take advantage of the current drug shortage crisis. “Grey” market vendors have seen the profitability of pharmaceuticals in high demand, and certain vendors selectively purchase excessive quantities of certain drug products. As the available stock diminishes, these vendors then sell the products to consumers at inflated prices.3
Managing drug shortages can be a difficult task in any healthcare setting, but there are resources to aid in its management. Three main resources are currently available for assistance with drug shortages: the manufacturing company supplying the drug in short supply, the Food and Drug Administration website, and the American Society of Health-System Pharmacists.3 You can find information about drug product availability, information on alternative agents, reports of emerging drug shortages, and strategies on how to manage drug shortages.3
Manufacturers are not obligated to inform pharmacies of drug shortages. Along with not having notifications of drug shortages from manufacturers, calling the company for information may be difficult at times. Often manufacturing companies cannot specify how long a drug shortage may last. Although some hospitals might want to be on the safe side and “stockpile” certain medications, this practice is not recommended. “Stockpiling” may lead to the expiration of drugs that could have been used in other hospitals and increases difficulty in getting the drug to patients that need it the most.5
Awareness of drug shortages is imperative for pharmacies throughout the country. At a national level, professional organizations as well as congressional representatives should be aware of the shortage, and actively lobby for action.2 When congressional representatives are aware of drug shortages, help from the government level can be attained. Drug shortages due to lack of raw material or natural disasters can be resolved quicker with help from congressional representatives. Hospital Pharmacy and Therapeutics committees should collaborate with physicians in coming up with strategies to manage current and future drug shortages. Attempting to compound products or purchase them from compounding pharmacies during shortages can be hazardous to patients due to lack of oversight by the FDA. The FDA has no control over the quality and consistency of the preparation process used.2 This point was illustrated by the recent outbreak of fungal meningitis in 2012 was caused by compounded methylprednisolone acetate epidural injections. According to the Center of Disease Control and Prevention (CDC), as of January 14, 2013, 678 people in 19 states had contracted the fungal disease, of which 44 had died.6
Drug shortages are caused by multiple factors, and these shortages have increased over recent years. It’s impractical for pharmacies to avoid all drug shortages, but in the event that shortages do occur, there are increasing strategies and resources that can help facilities manage. Proper planning can help reduce adverse effects in patient care. Collaborative work with pharmacies, physicians, administrators, and manufacturers is imperative for successfully managing these shortages.
- Fox ER, Brit A, James KB, et al. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009; 66:1399-406.
- Tyler LS, Fox ER, Caravati EM. The Challenge of Drug Shortages for Emergency Medicine. Ann Emerg Med. 2002;40:598-602.
- Tyler LS, Mark SM. Understanding & Managing Drug Shortages. ASHP Advantage 6-052A:01-05.
- Hensley S, Wysocki B. Shots in the Dark. As Industry Profits Elsewhere. U.S Lacks Vaccines, Antibiotics. Wall St J. 2005; Nov 8:A1.
- Provisional Observations on Drug Product Shortages: effects, causes, and potential solutions. AM J Health-Syst Pharm. 2002; 59:2173-82.
- “Persons With Meningitis Linked to Epidural Steroid Injections, By State. Centers For Disease Control and Prevention (CDC). Accessed September 23, 2013.