subject: Running Out Of Drugs? [print this page] The contributions of pharmaceuticals to society are obvious; they have improved our quality of life, treatment satisfaction, and have extended our lifespan. Until recently, our perceptions of a never-ending supply of lifesaving drugs have remained unchallenged. However, in the past five years, drug shortages have emerged as a serious threat - especially for children, the elderly, and individuals with rare diseases.
In the scheme of things, drug shortages are increasing. Currently, about 11% of all the FDA approved and marketed drugs, vaccines, and other biologics had a documented shortage (1). Injectable products; such as vaccines, are most likely to be in short supply followed by certain oral medications.
Defining a drug shortage is not easy. The Federal Food & Drug Administration (FDA) views drug shortages as a situation in which the total supply of all clinically interchangeable versions of a FDA-regulated drug is inadequate to meet the current or projected demand at the user level.
While drug shortages occur for multiple reasons, repercussions for providers and patients are certain. Some patients may be switched to a medication that is more expensive or less effective, while access to medications for others may be completely jeopardized. During a shortage, additional labor costs are incurred as health care providers use their resources to track inventory, send out notices, and reconnect with patients once the supply is replenished; providing that replenishment is an option.
Drug shortages arising from the supply-side are more difficult to anticipate and control; they are also more complex. Reasons cited for shortages include delayed manufacturing, increased demand, and unplanned removal of drugs from the market. In some situations, shortages are attributed to an active pharmaceutical ingredient (API) that is not available because of asymmetry in the market place. For example, if demand for a drug is limited to certain individuals, the quantity of that drug produced by a manufacturer will also be limited (i.e., low-volume drug); thus, only a few manufacturers may produce the drug. Sometimes, only one manufacturer is producing the drug.
Consequently, any drugs in this situation are at a greater risk for a shortage. Given the dynamics of supply and demand, price increases would be expected during the shortage.
Pharmaceutical companies also compete with entities that are deft at buying the rights to market drug products. With the marketing rights, these entities have considerable leverage with respect to drug access and production.
As a consumer, it is possible to avert some drug shortages. First, discuss drug use with physicians, nurses, and pharmacists - especially if the drug is targeted for a rare disease or has special instructions for handling or storage. Second, if possible, have access to the drug through more than one source (e.g., pharmacy, hospital, or clinic). Third, contact company representatives to obtain more information about a drug, allay concerns about drug availability, identify other suppliers, and to discuss alternatives if a drug shortage is imminent. Fourth, use the automated refill system offered by most pharmacies to ensure drug availability when needed. Fifth, request the health plan to reduce copayments for alternative, non-formulary, drugs that have to be used when the preferred drug product is not available because of a shortage. Sixth, if the drug is produced by only one manufacturer, be sure to keep at least a 90-day supply of the medication. Finally, if the drug is received through a mail-order pharmacy, always have a backup prescription to obtain the drug at a local pharmacy in case of an emergency.
Another issue is the realization that countries besides the US, European Union, and Japan are playing a greater role in drug development. Thus, a concerted effort is needed to manage resources to accommodate the global demand for unique raw materials and special ingredients used to manufacture drugs. Second, definitions used to describe a drug shortage need to be standardized to help manufacturers improve response time, which will prevent bottlenecks, alleviate medication stockpiling, and support competitive pricing strategies. Finally, these efforts will facilitate a rapid response by wholesalers to ensure that the drug supply is commensurate with demand. When it comes to our global drug supply, running on empty is not an option.
