Why Drug Shortages Happen—and What to Do
Patient access to medicines is vital for the health of patients and the economy. The issue of drug shortages demands attention and collaboration from everyone involved in providing life-saving medicines. This includes both the pharmaceutical companies producing brand-name medications and generic drug manufacturers (whose products accounted for 88 percent of prescriptions filled in 2013), as well as wholesalers, distributors, pharmacies and healthcare providers.
Shortages affect less than 1 percent of all drugs on the market, and most shortages involve generic medicines, with the FDA specifically calling attention to growing shortages among “older, sterile injectable drugs”. However, any shortage of medicines can deeply impact patients. Biopharmaceutical companies have worked to prevent drug shortages in advance, and will continue to work closely with the FDA to prevent manufacturing disruptions.
When your medication is in short supply
As a patient, it’s important to know the right steps to take if you are experiencing or anticipating a drug shortage. Patients concerned that their medicine may be in short supply have several options available, including visiting the FDA’s Current Drug Shortages page to see if the drug has been reported in short supply. You should also talk to your doctor about other medications that might be an effective substitute.
Watch this video to learn more drug shortage do’s and don’ts.
Why drug shortages happen
The factors that contribute to drug shortages are complex and multidimensional. They can occur for a variety of reasons found throughout the supply chain, including:
- shifts in clinical practices
- wholesaler and pharmacy inventory practices
- raw material shortages
- changes in hospital and pharmacy contractual relationships with suppliers and wholesalers
- adherence to distribution protocols mandated by the FDA
- individual company decisions to discontinue specific medicines
- natural disasters
- manufacturing challenges
When a shortage is expected
In the instance a shortage is anticipated, an innovator or generic manufacturer is encouraged to notify the FDA in order to address, avert, and mitigate the problem. In the event that the only version of a medically necessary drug is going to be discontinued, the manufacturer is required to inform the FDA six months in advance.
Pharmaceutical manufacturers have stepped up the voluntary reporting of anticipated events that could lead to drug shortages. According to the FDA, in 2011, this early notification helped prevent over 195 shortages. The biopharmaceutical industry will continue to work with FDA and other stakeholders to improve upon existing reporting requirements. Addressing anticipated occurrences of a drug shortage early in the process helps both healthcare providers and manufacturers identify treatment alternatives more efficiently, and we will continue to work with FDA to improve upon existing reporting requirements.
PhRMA’s commitment to preventing shortages
PhRMA member companies are deeply concerned about patients’ well-being and are committed to maintaining good manufacturing practices, as well as working closely and collaboratively with the FDA, supply chain partners, and healthcare providers and their patients when unexpected–and rare–shortages of brand-name medicines occur. Our members make significant investments in processes that ensure proper supply of branded medications, and work diligently to alert the FDA of any anticipated shortage. Once notified, the FDA can work with other firms that make similar products to ramp up production and fill any gaps in the domestic supply. When unexpected shortages occur, PhRMA’s member companies work closely with the FDA, supply chain partners, and providers.
The problem of price gouging
When a drug shortage happens or one is anticipated, a “gray market” may spring up, with the potential for price gouging. The practice of price gouging by secondary wholesalers, which largely comprise the “gray market” is unacceptable and presents serious concerns for patient safety, as it cannot be assured that the products have been handled in a way that maintains their integrity. The manufacturer of a drug has no influence or control over the prices charged by a secondary wholesaler to a hospital or pharmacy.