Article

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe-08-01-2012
Volume24
Issue 8

The Truth About Drug Shortages

Author(s):

Most of the products affected by growing drug and ingredient shortages are cancer medications, anesthetics used for patients undergoing surgery, emergency medications and intravenous electrolytes.

Most of the products affected by growing drug and ingredient shortages are cancer medications, anesthetics used for patients undergoing surgery, emergency medications and intravenous electrolytes. Sterile injectables, which dominate short-supply lists globally, are prime targets for shortages because of limited production lines and capacity challenges. Everything from manufacturing delays, to increased market demand, to product discontinuation can cause a shortage problem. Unfortunately, it's the patients who need these crucial drugs who are bearing the brunt of the problem.

Angie Drakulich

In the US, FDA is tackling the issue with new guidance. A recently issued draft document, Notification to FDA of Issues That May Result in a Prescription Drug or Biological Product Shortage, is meant to address growing concerns by increasing communication between industry and regulators. The draft guidance clarifies that the "sole manufacturer" (i.e., the only applicant currently supplying the market with the drug product) holds responsibility for reporting such information. The document also calls out certain actions that may lead to a temporary or permanent drug supply problem, such as delays in acquiring active or inactive ingredients, equipment failures and manufacturing shutdowns. Manufacturers will need to notify FDA of these issues if they could lead to disruption in supply. The agency also asks industry to notify it on a voluntary basis when certain problems (e.g., stability concerns, facility transfer) could "reasonably" be expected to lead to a shortage or disruption.

I have high hopes for solving the global drug supply problem. In 2010, for example, 38 shortages were prevented in the US alone because companies notified FDA of potential problems. Meanwhile, in the UK, where parallel trade has led to certain drug shortages, the Medicines and Healthcare products Regulatory Agency has pledged to address shortages and is working to better track which products are in short supply and who is exporting them. As long as companies do their part, these regulatory efforts should pay off. Just as we tell our children, it's always best to tell the truth—even if it hurts a little to do so—because in the end, it's simply the right thing to do.

Angie Drakulich is the editorial director of PharmTech Europe.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content