Medicine SafetyDrug Shortages & Supply Chain Info

Millions of prescriptions are processed every year in the U.S. Keeping track of these legal medications is a challenging task and it’s vital that we continue to improve the security of the nation’s pharmaceutical supply and ensure patient access to medicines is not impacted by shortages.

Drug Shortages

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, as well as wholesalers, distributors, pharmacies and health care providers.

Shortages affect less than 1 percent of all drugs on the market, and most shortages involve generic medicines, with the Food and Drug Administration (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.

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 website 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.

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; and 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. 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.

Preventing Drug 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 health care 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.

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.

Supply Chain Information

PhRMA supported The Drug Quality and Security Act (DQSA), that was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

This system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will: 

  • enable verification of the legitimacy of the drug product identifier down to the package level;
  • enhance detection and notification of illegitimate products in the drug supply chain; and
  • facilitate more efficient recalls of drug products.

PhRMA is working with the other participants in the supply chain including wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) to develop this new system.