The Truth About Drug Shortages - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

The Truth About Drug Shortages


Pharmaceutical Technology Europe
Volume 24, Issue 8


Angie Drakulich
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.

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 The draft guidance clarifies that the "sole manufacturer" (i.e., the only applicant currently supplying the market with the drug product) holds responsibility for reporting such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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology Europe,
Click here