I would like to open up this topic for discussion. I recently read an article entitled, “Pharmacy Professionals Believe CMS Rules Contribute to Drug Shortages.” This article, authored by Jamie Oh, states:

“Almost all surveyed pharmacy professionals believe outdated federal mandates requiring adherence to drug labels and expiration dates contribute to the national drug shortage, according to an American Medical News report.”

The Institute for Safe Medication Practices (ISMP) surveyed 715 hospital-based pharmacists and pharmacy managers where 96 percent of respondents consider a CMS mandate to follow FDA-approved drug labels and expiration dates a contributor to the drug shortages. According to the report, respondents believe that some drugs may have a longer shelf life – demonstrated through medical research.

The article cited the example of neuromuscular blocker drug succinylcholine that is labeled as “stable” for 14 days at room temperature. However, research reveals the drug may be stable for 30 days at room temperature, and its shelf life extends as room temperature drops. More than 1/3 of respondents claim that adhering to FDA labeling often results in wasted drugs, while another 43 percent believe that following labels always results in wasted drugs.

I posted this same discussion on LinkedIn a few weeks back, and I received mixed responses on the topic. A pain relief specialist from the UK stated:

 “Drugs are wasted most of the time as they not only do not produce the cure, but also cause so many misunderstood or so called side-effects. … We may consider drug shortages are because of the economic downturn and the drug companies’ instructions from shareholders to cut back to pave the way for dividends.”

A Florida MD added:

“I know for a fact that many of the expired drugs end up in Latin America when missions are organized to go there by some US medical schools.”

I have performed numerous stability tests with compounded sterile pharmaceuticals to investigate use dates, and I have found many drugs to be within USP specifications well beyond the labeled use date. I am simply stating that I have performed critical analyses regarding this topic and found several labeled expiration dates to be premature; by no means am I saying that beyond-date drugs should be used for patients.

Do I believe that outdated federal mandates contribute to the drug shortage crisis? I don’t know. I have done a lot research into the drug shortages, and most signs point to delays in new and existing manufacturing facility applications, plant shutdowns due to quality assurance issues and outdated manufacturing technologies, and stringent government price controls for generic drugs. Are there other contributing factors, such as the economic downturn and shareholder cutbacks? Possibly, but my research has not confirmed this.

Patient safety is at the forefront of all medical professionals’ minds. Therefore, we would never provide patients with drugs that could be harmful or life-threatening. But if science has proven that drugs are stable beyond current federal mandates, and if we trust utilizing expired drugs for patients of countries lacking proper medical regulation as suggested by the Florida MD, then should we consider the possibility of extending certain drug use dates if there is sound research supporting such a move? If this could decrease drug waste and somewhat alleviate shortage problems, might it be a win-win?

I would be interested in hearing your comments on both use dating and the drug shortage dilemma. Please write to questions@hartleymedical.com. Or make a comment in the comment box provided below. Thanks!

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Source: http://www.beckershospitalreview.com/quality/pharmacy-professionals-believe-cms-rules-contribute-to-drug-shortages.html…