Expired drugs – both a medical and an economic issue

Is it OK to use expired drugs? The short answer is: yes. But this stand needs to be qualified…

A few weeks ago it was reported that an allegedly expired drug had been administered to a patient in a public hospital, leading to problems. In fact, from time to time there have been similar cases that have received media coverage. How far the use of an expired drug can be harmful is one aspect, the medical one, of the problem. The other aspect is the fact that the drug bill of the public health sector is a major chunk of its budget, so that there is an economic dimension also to the problem.

Among the many factors to be taken into consideration when making estimates of drug needs, past trends are a guide, but projecting future requirements depends not only on the latter but also on change in prescribing practices, the availability of new substitutes or new formulations, besides policies regarding the procurement process which may not be as transparent as is desired. As a result, 100% accurate estimates are not possible, and at any given time there will be stocks of drugs that have expired or are approaching expiry date.

The question therefore arises as to whether it is OK to use expired drugs? The short answer is: yes.

This stand needs to be qualified – which will be done shortly – but this is the conclusion of a report published in the Journal of the American Medical Association (JAMA) in November 2012 which has recently been cited again in a fresh discussion of this issue. It is of course one of perennial relevance and continuing interest to all stakeholders in the treatment or therapeutic chain that includes among others pharmacists, doctors, nurses, patients and their responsible parties.

Before we come to the publication under reference and other sources of authoritative inputs, some comments about the local context are in order, because as mentioned above on a number of occasions there have been reports in the media about expired drugs having been used. While this is naturally a matter of concern, what is not acceptable is that such a hullaballoo and bogey should be raised as to cause undue alarm, confusion and distress to already stressed parents or relatives and, further, that there should be a quasi-trial by the press in every case by people who are ignorant of the nuances and implications of such a highly technical and complex subject. Invariably, there is a blame game and even before a proper investigation is initiated names of staff involved are cited most unfairly, and culprits practically already identified!

It is therefore important to appreciate that the basic consideration about a drug is its efficacy, that is, will it have the desired effect on the condition which it is prescribed for?

The potency of expired drugs

The efficacy depends on the potency of the chemical constituent(s) of the drug, which is of course given in the right dose and frequency. No health professional prescribing, dispensing or administering a drug will resort to an expired one en connaissance de cause. However, in the exceptional case – which all such reported incidents are as a matter of fact – such a mishap may happen inadvertently (this is such a loaded word in our country these days!).

Any side-effect of a drug, about which the doctor is usually aware and takes into consideration when prescribing, is normally associated with consumption of a higher than recommended dose, although it can also occur with even normal doses. So a drug which is of lower potency is not likely to produce an unwanted side-effect. On the other hand, allergy to a drug can take place irrespective of the dose, and cannot be predicted by the prescriber, especially its most severe and potentially fatal form known as anaphylaxis. What is of more importance, from the patient’s point of view, is that this condition is well known to doctors and experienced nurses, and can be immediately diagnosed and effective measures promptly instituted…”


It does not follow that a loss of potency of an expired drug, and that too of a single dose, can lead to death or an unwanted complication, which is the fear that is instilled in the minds of patients and their relatives by irresponsible reporting and by making unnecessary noise about the case. If at all, since the overall effectiveness of the treatment is the result of a course of drugs given in several doses over several days (usually), it should be clear to all people who use their reason – instead of résonne couma tambour as a mature person once told me – that the taking of a single or perhaps even two doses of an expired drug is not likely to have any significant impact on effectiveness of treatment. In any case, once the situation is recognized, the doctor will take the necessary remedial measures.

Moreover, any side-effect of a drug, about which the doctor is usually aware and takes into consideration when prescribing, is normally associated with consumption of a higher than recommended dose, although it can also occur with even normal doses. So a drug which is of lower potency is not likely to produce an unwanted side-effect. On the other hand, allergy to a drug can take place irrespective of the dose, and cannot be predicted by the prescriber, especially its most severe and potentially fatal form known as anaphylaxis. What is of more importance, from the patient’s point of view, is that this condition is well-known to doctors and experienced nurses, and can be immediately diagnosed and effective measures promptly instituted to relieve the patient or save his life.

Panic under such situations cannot be the response of health professionals, who must keep their cool so as to deal with them effectively. It is only uninformed people who over-react unduly and cause more harm than good.

What the authorities say

According to the JAMA report, certain kinds of medication may retain much of their potency for as many as 40 years.

But then why do drugs have an expiry date? The Harvard Health Letter says that an expiry date is a legal requirement that has been imposed by the FDA since 1979. It is meant to be the date until when ‘the manufacturer can still guarantee the full potency and safety of the drug’. However, research shows that 90% of more than 100 types of medication, both over-the-counter and prescription, are fine to use even 15 years after they have supposedly expired.

Furthermore, a report from Medscape claims that expiry dates don’t tell you how long the medication is actually ‘good’ or ‘safe to use’, and in fact, many medical authorities claim that it’s okay to take most drugs well after they’ve supposedly expired.

As regards how long past the date is OK, the JAMA study went well past 15 years, and the findings revealed that most of the active ingredients were still at least 90% effective, which is considered to be the minimum potency acceptable. The only drugs which fell below this threshold were aspirin, phenacetin (a painkiller), and amphetamine (for ADHD and narcolepsy). Aspirin is the only drug that is commonly used locally.

What’s more, a former director of the FDA’s testing program said that ‘expiry dates put on by manufacturers typically have no bearing on whether a drug is usable for longer’, and that these dates were typically used for ‘marketing, rather than scientific, reasons… it’s not profitable for them to have products on a shelf for 10 years. They want turnover’.

However, there are a few notable exceptions, the few drugs that should not be used past their expiry date: insulin, liquid antibiotics, nitroglycerin, and tetracycline.

The economic dimension

In conclusion, the JAMA report provided ‘additional evidence that many prescription pharmaceuticals retain their full potency for decades beyond their manufacturer-ascribed expiry dates’. Given the potential cost-savings, it was suggested that ‘the current practices of drug expiry dating be reconsidered’.

The economic dimension was a major concern, given that ‘Americans currently (2012) spend more than $300 billion annually on prescription medications’, according to the JAMA report which stated that ‘extending drug expiry dates could yield enormous health-care expenditure savings’. 

The plea here is that, as suggested, ‘the current practices of drug expiry dating be reconsidered’ as a matter of policy, because this will surely result in tangible savings. It goes without saying that long-standing problems such as adequate storage space and the ideal conditions of drug storage must be ensured to accompany any reviewed policy in expired drug use, and sensitization campaigns carried out to reassure the public.

At the individual level, to the user it is recommended that ‘if you’re thinking of taking an expired drug, you should first consider what it is and why you need to take it. If it is listed in the notable exceptions list above, or if your life depends on it being 100% effective, then throw it out and get some unexpired medication instead. You should be fine otherwise, but if you have any questions, then make sure to check with your doctor or pharmacist first’.

That is the sensible approach, not raising hell and fury out of total ignorance.

 


* Published in print edition on 13 April 2018

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