Doctor talks about safety of taking expired ARVs with extended shelf lives

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Following an outcry over the government’s decision to distribute antiretroviral drugs that it had prolonged the life of, a doctor weighed in saying the drugs were still safe and effective.

According to Dr Brighton Chireka, the practice of extending the shelf life of drugs is common around the world.

We publish Dr. Chireka’s article in full below,

Setting the record straight by Dr Brighton Chireka

This photo has gone viral and some people are shocked and are calling the government all kinds of names. Some people don’t know it has been going on for about 12 months. In short, there is nothing wrong with doing. It’s just that the media takes advantage of the fact that most of us don’t understand how expiration dates are calculated. It is a good story to sell newspapers, but we have to set the record straight so that we can see the situation objectively.

Drug manufacturers are required by law to place expiration dates on prescription products before they market. The expiration date is the last day on which the manufacturer guarantees the full potency and safety of a drug. Let me clarify that this is not the date on which the product becomes toxic or ineffective. It may be surprising to know that for most drugs it is an arbitrary date, usually 2 or 3 years, that the manufacturer chooses to test for the stability of the drug. In reality, the stability of the drug can be much longer, but no one is testing it.

We know that once the original container is opened, whether by the patient or the healthcare provider who will dispense the drug, the original expiration date on the container can no longer be relied upon. However, studies have shown that the actual shelf life of these drugs can be much longer than the expiry date stated on the packaging.

So, do drugs lose their effectiveness sooner after the expiration date?

The American Medical Association (AMA) concluded in 2001 that the actual shelf life of some products is longer than the expiration date stated on the label. The AMA said the best evidence lies in the Shelf Life Extension Program (SLEP) undertaken by the FDA for the United States Department of Defense. This study found that the drugs were still effective 12 months to 184 months (over 15 years) after the expiration date.

What does this mean for us?
This does not mean that if you have outdated medicines at home, you can use them without seeing a doctor. The study shows that if expired drugs are tested by medical experts and found to be effective, they can be used for a certain period of time.

If the wholesalers have more drugs than they need and some are out of date, it doesn’t make sense to throw them away and leave people untreated. Treatment must continue, so if expired drugs can be used safely, they should be used while the supplies are being sorted. This obviously does not have to be the norm but can be used in shortage situations.

The drugs we are talking about are those that are still in wholesalers where they are kept under strict conditions. We know that the effectiveness of drugs is affected by heat, humidity, light and other storage factors. In view of this, only drugs tested by medical experts should be used.

So what should we do with the message in this picture?

We have to commend the health care professionals for talking openly about the drugs they give people. They could have been lying and just giving people medicine in different packages which is unethical and immoral. Now, to be honest and frank about it, we are “attacking” them. There is nothing wrong with them doing. We must take the drug according to the instructions and carry out regular checks. If we experience any unusual side effects, we urgently need to see our doctors.

Hope this clarifies this problem

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