Push up medical expenses and put pressure on finance Can you put a scalpel on "drug expiration date" problem?

There is an expiration date for drugs as well as expiration dates that are a measure of disposal in foods, and expired drugs are discarded. However, if there is no medicinal effect on expired medicine, it is an open secret that it is not so limited, and in order to halt the rise in medical expenses that put pressure on the national finances, "to extend drug expiration date We are asked about the pros and cons of measures to "do".

The Myth of Drug Expiration Dates - ProPublica
https://www.propublica.org/article/the-myth-of-drug-expiration-dates

Lee Cantrell who runs the California Poison Control System came across a case where a medicine that was originally supposed to be returned or discarded at a pharmacy was mistakenly stored. The old one was manufactured in 1969, and it was only chemicals that were over 30 years since the expiration date.


In the USA, each drug has an expiration date, and sales of medicines that have expired are forbidden. Therefore, drug pharmacies that have expired are sent back to the pharmaceutical manufacturer for disposal, so it seems that there is rare opportunity to touch chemicals for more than 30 years since the expiration date. Prior to that valuable medicine, Mr. Cantrell wrote, "To what extent are the efficacy of expired medicines declining? Is it really a useless thing?" Dr. Roy Gellona of the University of California, San Francisco I asked for analysis.

Dr. Gellona from the Philippines seems to have been more interested in analytical results thanks to a number of examples that have been prescribed medicines that have expired in the home country and have given efficacy. As a result of testing on 14 kinds of compounds such as antihistamines and analgesics, we found that 12 kinds of compounds are as efficacious as when producing medicine.

When Mr. Cantrell and Dr. Gellona published this finding as an article and announced it on Archives of Internal Medicine in 2012, there was an echo as expected. Citrell said that some people say "it is an irresponsible announcement", Mr. Cantrell said, "Even if there is an opinion that we should review the method of setting the expiration date of medicine, we will never recommend the use of expired drugs It is said that it was chased by the explanation that it is. In addition, Mr. Cantrell thinks that the term "effective" deadline of medicine itself is misleading and inappropriate in itself. It is because it does not mean that the effectiveness of the drug will be shortened as soon as it expires.


A nonprofit group that is researching the cause of the fact that the American medical system is the world's highest, high costProPublicaI think that the big cause is "waste". This waste includes not only thorough use of generic medicine but also disposal problems of medicine. An expert estimates the loss due to the disposal of medicine to about 765 billion dollars (about 86 trillion yen) annually, equivalent to a quarter of medical expenditure across the country. If medicines that are medicinal and have no safety problems are discarded due to "expiration date", there is huge waste in reducing medical expenses.

Although the expiration date of many medicines is set to 2 to 3 years, the discussion that this expiration date is too strict should be reconsidered has been a long time ago. However, there is no incentive to conduct research on the useful life of a medicine, as a pharmaceutical company has a structure that leads to the sales of new medicines if the medicine is disposed of at an expiration date because it expires. The pharmaceutical manufacturer insists that "patient safety is the top priority," and is resisting the revision of the expiration date.


However, the case that the expiration date of the medicine is prolonged is not centered on government agencies. For example, in 1986 the US Air Force asked the FDA to extend the expiration date of certain medications in order to compress the exchanging costs of medicines stockpiling, resulting in drugInventory extension programHas been approved. Air Force stockpile drugs are patch tested every year, it is checked whether safety can be verified and the expiration date can be extended, and in 2006the study(PDF file), 122 kinds of medicines have been lengthened by the extension program, and it is clear that two-thirds of the medicines examined for efficacy and safety have passed. According to the paper published in the Journal of Pharmaceutical Sciences, we also know that the expiration date has been extended by more than 4 years on average.

Mr. Mark Yoon, a pharmacist who helped manage the extension program from 2006 to 2009, said, "The program has achieved a measurable return on investment." According to officials of the Department of Defense, the expense required for examination etc. to execute the extension program of 2016 is 3.1 million dollars (about 350 million yen), it is actually avoided by the "expiration" due to "expired" The cost of replacing medicines that became unnecessary was 2.1 billion dollars (about 240 billion yen). In other words, it is a very excellent project that you can reduce the cost of $ 677 with a one dollar investment.


According to ProPublica, there are cases where the pharmaceutical manufacturers themselves rarely offer extension of the expiration date of their products. Pfizer, a pharmaceutical manufacturer, was approved in June 2017 for the extension of the expiration date of drugs such as atropine, dextrose, epinephrine. This is due to insufficient inventory of the manufacturer, but Dr. David Berkowitz of Newton-Wellesley Hospital highly appreciates Pfizer's application for extending the term of validity. At the same time, we are complaining about the necessity of confirming whether there is any medicine being discarded despite being still effective and safe.