Medicine SafetyDrug Shortages

While the number of drug shortages has declined substantially in recent years, any drug shortage places substantial burdens on health care providers who may have to ration medicines or identify alternative treatments. The issue of drug shortages demands attention and collaboration from all stakeholders involved in providing life-saving medicines to patients. This includes the biopharmaceutical companies producing brand-name medications, as well as generic drug and biosimilar manufacturers, wholesalers, distributors, pharmacies and health care providers.

Biopharmaceutical companies work proactively to prevent and mitigate this issue by coordinating with the U.S. Food and Drug Administration (FDA) and other stakeholders to address the root causes of drug shortages.

For health care providers and patients, the FDA provides up-to-date information on medicines that have been reported in short supply or that have been discontinued. Patients should discuss with their health care provider potential alternative treatments if any of their medications are in shortage.

Why Drug Shortages Occur

The factors that contribute to drug shortages are complex and multidimensional. Drug shortages can occur for a variety of reasons and at a variety of points throughout the drug supply chain. These may include: Shifts in clinical practices; wholesaler and pharmacy inventory practices; raw material shortages; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers; natural disasters; and manufacturing issues. For example, a manufacturer may experience an unforeseen breakdown in manufacturing equipment that disrupts production.

According to the FDA, quality and manufacturing issues are the major reason for shortages. A large number of shortages has been for generic sterile injectable medicines. The small number of manufacturers and limited production capacity for generic sterile injectables, combined with long lead times and the complexity of the manufacturing process for injectable medicines, results in these drugs being vulnerable to shortage, according to the FDA.

Preventing & Mitigating Shortages

PhRMA member companies are deeply concerned about patients’ well-being and are committed to maintaining good manufacturing practices, as well as working closely with the FDA, supply chain partners, health care providers, and patients to prevent and mitigate drug shortages of brand-name prescription medicines.

Our members make significant investments in processes that ensure proper supply of brand medicines and alert the FDA of any anticipated shortages. To address shortages, the FDA works with biopharmaceutical companies to address the underlying causes of shortages and to enhance the availability of prescription medicines.

The FDA may also engage with other biopharmaceutical companies to determine whether they may have the capacity to help address the shortage. If other manufacturers can ramp up production and are willing to do so, the FDA can and does expedite review of new production lines to help resolve shortages of medically necessary drugs.

In addition, when a shortage occurs, and a biopharmaceutical manufacturer has inventory that is close to expiry or already expired, the FDA can work with the manufacturer to review and approve an extended expiration date if the manufacturer has data to support potential extension of the expiration date for that inventory.

Reporting Shortages

Manufacturers of life-saving medicines or those intended to prevent or treat a debilitating disease, are required to notify the FDA six months in advance, or as soon as practicable, of a permanent discontinuance or interruption in manufacture of the drug that is likely to lead to a meaningful disruption in supply in the U.S. For other medications, manufacturers are encouraged to notify the FDA of any anticipated disruption in supply. The FDA provides annual reports to Congress on actions taken to prevent and mitigate drug shortages.

The biopharmaceutical industry is committed to providing early notification of potential shortages and working with the FDA and other stakeholders to maintain treatment options and prevent a shortage.

 

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