Wall Street Journal Best Seller Dr. M's Seven-X Plan for Digestive Health
Current practice
Pharmaceutical companies are required to post the time period during which the drug shall be not just safe but also effective. The consumer determines it based on the expiration date noted on the drug.
What happens to the medication beyond the date? Does the drug which is deemed safe and effective one day, suddenly become ineffective the next day, just because of the date printed on the label.
Before you read on, be advised that this post is merely informational and not meant as advice to use expired drugs!
Is this really true?
Data suggests that, assuming the medications are stored properly, they continue to remain potent well beyond their expiration date.
Is It Leaky Gut or Leaky Gut Syndrome?
Studies and speculation
Pharmaceutical companies as well as governments stockpile critical medicals for use in times of emergencies. People have long suspected that the expiration date may many a times be arbitrarily minimal duration tested by the pharmaceutical company, and the actual stability of the drug could be much longer.
Studies on this issue seem to corroborate this speculation. The best supporting data comes from the government’s own Shelf-Life Extension Program (SLEP) was started in 1986.
SLEP (from FDA site)
“Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored.
Is It Leaky Gut or Leaky Gut Syndrome?
SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel can be extended after select products undergo periodic stability testing conducted by FDA…
Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. "
Results from SLEP
As part of studies, the FDA examined several stored medicines for stability rather than throw away billions of dollars to trash. Almost 90% of the 122 pharmaceutical agents studied qualified for extension of expiration date.
While company labelled shelf life of most medications varies from 1-5 years, an average of 5.5 years of extension was granted by SLEP program. In some cases, extensions were as high as 20 years.
The Cantrell Study
Dr. Cantrell and colleagues from the California Poison Control System, San Diego Division, University of California San Francisco School of Pharmacy, San Diego, and co-investigators examined 8 expired medication formulations constituting 15 different active components that were found unopened for 40 years in a retail pharmacy.
86% of the formulations contained at least 90% of the amount of drug in the label. This level also corresponds to the minimally acceptable level for use. Three of the formulations actually contained 10% of drug more than what was stated on the label.
There was variation in lots as well. For example, one medication phenacetin was present in excess of 90% in formulation from one lot and less than 90% for another.
Is It Leaky Gut or Leaky Gut Syndrome?
Shelf life extensions
While shelf life extensions do occur in government stockpiles as a result of continued studies, the utilization of this data does not extend to local supplies, hospitals, retail pharmacies and patients themselves.
Regulations just do not allow the use of “expired” medicines, they also prohibit their donation to poor countries who can ill-afford such medications.
Implications of extending expiration/expiry date of medications
Most formulations may be eligible for significant extensions of shelf life resulting in:
- Reducing shortage of critical and expensive drugs
- Billions of dollars in savings to the health care system.
- Improvement in environment by reducing contamination caused by disposal of “expired drugs’: Blair and colleagues from the University of Wisconsin-Milwaukee, Milwaukee, WI found 32 medications and personal care products in Lake Michigan. In addition, they found 30 such products in the sediment, some being seen as far as 3.2 km away from shore. Even though the environmental impact of such medicinal and personal care products has been deemed to be insignificant because of high rate of dilution, the high levels of such substances found in the large water systems pose a high health risk for the population.
Dr. Minocha’s comments
- For most medicines, the major concern is loss of efficacy and not the development of toxic compounds.
- The pharmaceutical companies should be asked to update and extend as appropriate, the expiration of their pharmaceutical products on a regular basis for the larger good of the society.
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Wall Street Journal Best Seller Dr. M's Seven-X Plan for Digestive Health
