There is a growing concern among healthcare providers about the increasing number of drug shortages. As of the beginning of the year almost 140 drugs are currently listed in a shortage status. Most of the drug shortages currently involve generic drugs; although there are some areas where both a brand and generic product are in shortage.
Drug shortages can be a costly burden for health plans, compromise patient care and increase the risk of medication errors. The FDA defines a drug shortage as when the total available supply of all versions of an approved product does not meet the current demand, and an alternative manufacturer is not able to meet the current and projected demands. Some common explanations for drug shortages include manufacturing difficulties or natural disasters which affect production, reductions in the supply of raw materials, voluntary recalls, manufacturer business decisions, FDA enforcement actions to ensure public safety, and artificial shortages due to stockpiling. Oftentimes generic medications are available from multiple manufacturers and if the profit margin is too low on a particular medication, a manufacturer is not likely to take up production line time to cure the shortage if a better product margin is available elsewhere. A drug shortage can have a domino effect leading to a shortage of another medication used to treat the same condition because of the increased demand for the alternate medication. Additionally, there has been a dramatic increase in drug recalls in the last few years. These include prescription and over the counter medications.
There is currently a senate bill to address the increase in drug shortages. If S.296 is enacted, manufacturers would be required to advise the FDA when any discontinuance, interruption, or other action is likely to decrease the supply of a drug to a level below the current demand. Currently manufacturers are not required to alert the FDA to potential shortages or explain the delays. Also with this legislation if there is an impending shortage of a drug, the FDA should have the authority to establish an expedited process to approve substitute treatments or the importation of safe, clinically- equivalent drugs from outside the United States.
Unfortunately, there is unlikely to be an improvement in the number of drug shortages with the increased amount of generic drugs hitting the market.
There are two websites which are dedicated to keeping the public up to date on drug shortages: www.fda.gov/cder/drug/shortages and www.ashp.org/shortage.