Yes, it is unethical.

Drugs are meant for patients and gradually and significantly lose their pharmacological activity (and constituent stability) following expiration. Thus, expired drugs are no longer able to serve initial intended purpose -amelioration of the distress of the sick. Since healthcare professionals (or anyone acting in that capacity in a given situational context) have the moral obligation to foster the medical good of the patient, it is therefore unethical and unprofessional to give expired drugs that will not foster the medical good of patients, whether or not these patients come from emerging economies

Yes, I think it is unethical as it also consumed local resources to distribute the expired drugs. However, there may be a middle ground if the sponsor is willing to donate shortly before the first expiry and most drugs could extends the expiry date after proper procedure. This may safe a lot of wastage and be able to help those in need.

The simple anSwer is, it is not unethical if they will be used responsibly by those wh know what the are doing and the benefits outweight the risks. I del with a like issue when I became aware of a TB outbreak on Bouganville shortly after the te yer blockade of that country during its war if independence. They had no functioning X-ray machine to screen for it on the main south island. I knew of a 'retired' portable machine that had been discontinued only becaus it was heavy and had no motor to move it making it a risk to the backs of staff. The company were happy to donate it and after a service to prepare it for the tropics, obtaining supplies of disposables, and with the. help of a trucking magnate, Lindsay Fox and the Australian armed forces it made its way to an amphibious landing Bouganville. It might have caused back problems there, but it Is also likely to have played a major role in contributing to the health of the islanders. I have also been involved in shipping surplus mdical materials and pharmaceuticals to East Timor. They went to places that were without antibiotics and many other medications. If used knowledgeably medications that are are only just out of date are likely to be of much greater benefi than no medications. Superseded equipment is better than no equipment. Ideally, developed countries would supply aid at such level that countries had at least basic levels of healthcare, but that is not so and it makes sense to make use of discarded materials where tht can be done safely. I remember we did have to check what we sent. Sening diet and weight loss medications to East Timor would not have served any useful purpose.

It is unethical if done without careful considerations. As was said earlier, there are changes to the medication effectiveness over time. sometimes less potent and sometimes more. The drugs would have to be handled by experts in pharmacollogy and prescribed by a physician based on the new pharmacological information - and only if the drugs can be used to treat illness and lessen suffering of the ill. Sending expired over-the-counter medications would also be unethical as they can be harmful when not regulated with the same precautions as I list above. Generally, the practice of donating expired drugs, while some think it is a kindness, often actually is a lack of respect for the people in those economies as we do not take the same care in providing and prescribing.

I just would like to learn the justification behind the idea of "it is ethical". What is the motive/dynamic behind the question? Why should we leave the status quo (it is unethical). Is the argument simply based on "better than nothing" thought, or is there something else? Then it would be easier to analyse the argument I believe.

It is nonsense to suggest that drugs lose their effficacy as though that happened immediately on expiration of the due date. Those who suggest that it is unethical to make intelligent use iof drugs that are still effective in the absence of nothing else are simply benefitting Big Phrma.

In a developing country and able to access recently expired drugs from developing countries, this may be all there is when there is no money to pay developing world prices.

Thank you all for taking the time to reply. Murat, thanks for asking an important question, namely why was the question framed in the way it was. It is quite difficult to get the answer you are seeking if you prompt for it by framing the question in the wrong manner.

There is an assumption that expiry refers to the pharmacological properties of the drugs involved. It does not, except wet antibiotics and tetracycline in particular. Taking old tetracycline can give rise to di Gigliamos syndrome, whatever that is. (40 years since I heard of it).

The expiry date of a drug is a stock control date and it is not dependant on the rate of decay of pharmacological effectiveness. If it was one would need to know the storage conditions (temperature, humidity, light exposure etc.) If drugs are perishable then they should carry a "use by date". I have used, in the tropics, a drug that was 5 years beyond its shelf life. It was equally effective as a fresh dose despite a stated requirement to keep it in a fridge (which did not exist). There is a very interesting article found here that sheds some light on this matter.http://www.health.harvard.edu/fhg/updates/update1103a.shtml

The reason I chose the word ethical as apposed to effective is precisely because of the uncomfortable feeling one has when you are abroad and forced to do something which you probably could not do in the comfort of your regular workplace. There is a danger of mixing "ethical" and "effective".

I personally do not object to using or being given stock control expired drugs. The real issue therefore is: is it unethical to destroy these drugs rather than take them to places where they can be used when, in their absence, there is no alternative or the funds could be used to buy different medical items. In essence developed economies waste so much useable material that wasting some more hardly pricks our conscience. It is unlikely that manufacturers will do it because it is not to their advantage but would it not be "greener" or humanitarian to insist that the name be changed to "stock control date" rather than "expiry date"?

Drugs whose pharmacological properties do change with time should be identified by an appropriate "use by date" the same as food products.

If you do use drugs beyond their "expiry date" does anybody believe there are specific consent issues?

hi Flavio

I am not sure which questions you think are unethical to ask. please can you enlighten me?

Looking into the origens of the expiry date idea it seems that the ecpiry date was originally defined ad the tme taken for a stored drug to lose 10% of its effectiveness. this assumed ideal storage condotions. If this is the csse then would it not be equally unethical to use drugs that are not stored in idesl conditions? In either case the user will not know the percentage of effevtive drug remaining. The significance of percentage drug remaining is only really important when a drug is administered without a defined endpoint to the response. For example an intravenous anaesthetic is administeted until the patient is anaesthetised rather than on a mg/kg basis.

Hello Flavio, thank you for your reply. I am not sure which question you believe is unethical to ask. Please can you enlighten me? The original defenition of "expiry date" defined this point as the time it took to reduce the effective dose by 10%. Thus drugs that have just expired remain 90%effective. This assumed ideal storage conditions. Is it therefore no more or less unethical to administer a drug that you know has not been stored in ideal conditions, or that you do not know how they were stored at all? Does the same argument apply if you administer a drug that you titrate against a clinical end point? anaesthetics for example?

Thank you Dhastagir. Very informative science. Without wishing to cause offence to anyone but does a donation of an expired drug from an affluant country to a poor country as apposed to poor community to por comunity affect the way anyone regards the ethics? I realise this may be sensitive but it is important to determine if this relationship is formative in creating individuals views.

I appreciate what you are saying and agree that double standards are are not always acceptable. Not always is carefully chosen. Please indulge me with some temporary use of imagination if only because it enables me to try to make a point. If for example you were unfortunate enough to be shipwrecked and have been cast into the water. There are lifebelts being thrown into the sea from a rescue boat. There are enough for nine people and you are the tenth. Instead of a tenth lifebelt you see a life belt that has been broken so only half remains. What is your decision? Use it or ignore it?

As an answer to your question regarding expired drugs and my own children, now that we understand the significance of an expiry date I believe I would use the drug if it was necessary in the first place. (With the exceptions highlighted above - liquid antibiotics etc) Maybe I would use a bigger dose depending on how far past the expiry date we found ourselves to be.

There is no question about using "expired' drugs. The standards set for expiry is to concern about the safety on human being. Hence it is unethical in thinking about the expired drugs to use it... for any means. But poor countries have this practice as many of the drugs are expired and often the labels are simply changed and sold

Hi, guys!

Double standards are not always unethical. All-or-nothing statements like that are easy to refute, because they require only one counter example. If we limit the degree of autonomy granted to a five-year-old child, we are not acting immorally when our motive for doing so is in the best interest of the child. If we granted an eighteen-year-old the same limited kind of autonomy we grant to the five-year-old, how is that justified? Moral decisions require us to examine the individuals and individual details of any given example. If all relevant ethical conditions are equal, then, yes, it would be difficult, if not impossible, to justify a double standard in our decision making process.

When you know that the date of expiry of a medicine is already over, then it is harmful for everyone. Such a medicine is a medicine no longer. What right does one have to 'donate' such medicines to someone who is poor! In fact, can that be called 'donation'?

I fail to understand the philosophy behind such 'donations'.

When I traveled to Cuba with a delegation of the New York Bar Association in 2005, we were encouraged to bring any pharmaceutical products (prescription or over-the-counter medications) we had on hand or were willing to purchase with us. We even took old eye glasses to donate. We left everything with the Pharmacy in the Jewish Center where professional pharmacists would determine whether the medications were safe to dispense to the populace. In short, where the would-be recipients of the drugs are desperate for medicines and the drugs are not given to them directly, but to professionals who can make a learned decision about the relevance of the "expiry date," I think it is OK to donate the drugs. This is especially true if the drugs are from the U.S. where companies err on the side of caution in establishing an expiry date because the U.S. population is so litigious. (I have attached a picture of the Youth Choir singing in front of the Jewish Center in Havana,) Gwen

Indeed, the question should actually have been: 'Is it ethical to......?' instead of: 'Is it unethical to......?'

First you donate something that you yourself would not consume, and then you claim that it is a donation! This is an insult to humanity. Of course it is unethical to donate poison in the name of donating medicine.

I could not have imagined that people from the rich countries 'donate' medicine after the expiry date is over to people of poor countries. Only after I have come across this question, I came to know this fact.

The world is a peculiar place, really!

@ Dhastagir Sheriff : very nice information, I appreciate!

There is a famous quote in urdu, "tumhara khoon khoon, hamara khoon pani."

Translated it reads, "your blood is blood while ours is merely water"

No need to elaborate

It is unethical and is outrageous to give expired drugs. There is a reason the expiry date is suggested based on danger to the human being. All human beings are alike. Any civilized person should be ashamed of such a behavior.

Dear Eric and Contributors,

As a previous professor of pharmacy and pharmaceutical sciences, I would like to ADD one additional perspective to the comments already submitted and that is simply that for the vast majority of pharmaceutical preparations they: (1) do NOT cease to be effective on the "expiration date"; and (2) do NOT become toxic on the "expiration date".

The "expiration date" has to do primarily with the concept of pharmaceutical "shelf-life" (i.e., how long a product will remain optimally safe and effective). Obviously, the shelf-life, in turn, is dependent upon a number of variable such as the chemicals found in the preparation (and their respective physical chemical properties), the adjuncts (i.e., formulation products), the storage conditions (e.g., in a refrigerator, in the direct sunlight in the desert). In addition, most major pharmaceutical manufacturers "over-pack" each dose (depending upon specific drug and its "therapeutic index", this can be up to 10% more than the stated amount) in order to maintain the desired therapeutic effect of the drug for a longer period of time (in terms of "shelf-life").

The process of determining if a particular "outdated" medication is safe to use or not is admittedly complicated and requires specialized knowledge, but it is simply INACCURATE to state that all outdated drugs are ineffective and/or unsafe.

I trust that this will add a little more "light" to the conversation.

Sincerely,

Lou

PS Recognizing the gist of what I have presented, the US military has for decades bought large quantities of "outdated" medications, retested them, provided NEW (revised) expiration dates, and distributed them to their military personnel in hospitals, clinics, etc.

I live in affluent Australia, and I do take expired medications and I'm reassured by Pagliaro's note above (thank you). I would expect that the expiry date is about POSSIBLE lower efficacy. Furthermore, if the expiry date is 1st April 2014, then 2nd April 2014 does not see this drug become either toxic or ineffective.

The matter of ethics ... now that's a different question.

It is unethical that drugs are priced out of the range of people in developing countries.

It is obviously unethical.

Dear colleagues think we agree that its totally unethical to do this

Dear Eric:

Donating drugs that have passed their expiry date to emerging economies is both an unethical issue and is against human rights.

If price is the issue, there are other ways to think of to reduce prices of drugs to such economies.

Regards,

ZAF

Its not at all ethical, every human being no matter where they live or they are of emerging economies they have the right of well being, their safety is equally important, so pls do not donate the expired medications..

It's all about perception. Giving expired items to some groups while giving non-expired ones to others show that there is an unequal treatment of the groups, no matter whether the drug is still efficacious. People in the developing countries won't like this one bit. The WHO is bound to pass such guideline because they are a world body. Besides, if the drug may still be good after the expiry date, normal users still don't know how long after that when it turns bad. So even though it's a matter of perception, it is still a serious ethical issue.

I am convinced coming from the so called developing economies myself that it is wrong to donate 'about to expire' or expired drugs. It raises more questions than answers.

The quality, safety and efficacy of such medicines is in question already. The storage conditions during transit and further handling plus the ex-stock status means that we cannot give any further assurance. Should there be a pharmaco-vigilance incident would we do a recall, who would be responsible or answerable? Obviously the manufacturer will not take responsibility. Does the manufacturer still have the mandate of a post marketing surveillance in this case? What standards would we embrace in order to export the expired drugs? Supposing the donation is not even worth it, maybe its even counterfeit.

Most HAART programs are donor funded in Africa. This itself lends itself to certain give and take, course skewed towards the giver who does lots of less than ethical research on the poor citizens that would otherwise be a cause of litigation in the donor countries.

Stavudine, one of the oldest ARVs has several side effects including serious peripheral-neuropathy. This drug is nolonger used wherever its manufactured (for export only) due to these side effects, but we have stocks lasting more than a year, we are told to finish the stock, yet the patients are being subjected to these toxic effects daily.

What would you feel as a clinician prescribing something that you obviously know is expired, probably stored in less than favourable conditions? Does the patient have the right to this information? What considerations do we need to make in case of a legal issue arising out of its use? Ethically, do we still have the duty of care?

Having said that it is not careless to say that with poverty incorporated as is obvious in the case of developing economies, that we will continue to not only receive expired medicines, outdated technology but worse accept some that are not given in good faith but as a dumping ground.

The reality which I will only share covertly (if you allow) is that even whatever expires in our hands is not just disposed out rightly, it is almost like a system issue that 'some things don't expire! ' for others 'you give them like 3 months', its not unusual to find someone say that 'some things are only known to expire when they change colour'.

Saying NO to donations(expired or not) then is a fluid position that one in these side of the divide can never hold strongly whether or not WHO says so.

I feel instead of trying to arrive at an answer democratically (by voting), in this particular instance, a scientific approach should be followed which will obviously be beyond dispute. It must be understood and specified why a (particular) medicine expires and what is meant by this expiry viz., what is going to happen to different constituents of a particular medicine that makes them (the constituents) ineffective -- this term' 'ineffective' [which might comprise a combination of parameters such as , one or more or all of the constituents getting 'diminishingly effect'ive' eventually becoming 'zero effective' ; 'spoiled'; 'harmful'; 'pathogenic'; 'deadly' , 'fatal' etc.] must also be ascertained and specified for each individual drug before its release. If it comes to that, instead of a simple Expiry Date, a usage schedule indicating respective dates with assured % effectiveness (such as 100, 75, 50, 25, 0% and thereafter the negative effects, if any) must be established and specified individually on each drug (since the constituents of different drugs, singly or in combination, might behave differently). The answer to the present question will then probably be computerized.

After all a patient, in general, is a layman w.r.t. medical science and relies fully on Physician's expertise, integrity and advice believing that all aspects of threats have duly been taken care of by the specialists' chain facilitating the medical prescription to him/her. This burdens the experts with added responsibility.

@ Simon. I agree that it is wrong to donate 'about to expire' or expired drugs.

Thanks, Eric.

I live and work in the contry that is "normal" by now  (by the European standards), but I remember the period after the martial law was imposed in 1981, and we  became really, I mean really poor. I was a  young doctor at that time, We were getting a lot of gifts from abroad at that time, medication close to the expiry date (or expired) included. We we using common sense if the drug's shelf-life was 24 months, and the medication was just ne month past its' expiry date, the package looked good, with no visible damages, we woud use is, especially that there was nothing to replace it. And it saved lives.

There arre "emerging economies" and "emerging economies". Sending antibiotics, which will be "expired" shortly to the areas where a war is going on, and the drug will be used immediately, saves lives. I would not call it a double standard. It is good to remember that many people still make their lives for 1$ per day,

Best regards,

Bogumila

What is really unethical is that we have countries that can be described as 'developing' in the first place.  In many cases they would already have developed if they had not been invaded, colonised and exploited by those that have the nerve to call themselves developed.  The development is of course technological not moral.  My country became enormously wealthy because of exploiting others.  It now has a duty to provide them with medicines fit for purpose. 

Too often "developing" is a polite word for "poor", or "extremely poor". I worked in very poopr countries several times, always for a short period of time, and I remember how its felt to have nothing more that indipensable drugs and equipment. You must forget all "disposables". You do not dispose of anything. You clean it, you sterilise it the best you can, and you reuse untill it falls apart. You start early in the morning, when the temperature in the operating room is 25 deg C, because it will raise about 1 deg/hour, so in the afternoon it will exceede 37 dedrees. Not only you sweat, but your anaesthetic starts to boil in the vaporised, so the only way to judge the depth of anaesthesia is by clinical signs. And an anaesthetic overdose may be lethal, so you try to do your jor as fast as you can.

Does it mean that we must not operate on the uninsured children with cleft lip or cleft palate? Can you imagine what they would look like at the age of 10? I hope you cannot,  Believe me, they look like monsters, but they are mentally normal, so they sufer even more.

On the other hand, would you blame an employer for not having paid health insurance for 14 children of his employee?

Compassion requires living by the local standards. I am afraid we must humbly accept that we cannot provide everything to everybody.

Dear Bogumila

The only reason we cannot provide decent medical treatment, clean water and food to every person on the planet is because if we did it rich people would have to accept a reduction in their fortunes.  The reason children have to live with cleft lips and other hideous treatable medical conditions is because wealth is more valued than humanity in our societies.  

I am not being a hopeless idealist here, it is simple economics.  Super rich people are super rich because they have the wealth that could be spent treating the worlds problems.   

The defense in most cases is based upon the fact that the drugs being donated are still effective even beyond their declared expiry date. This, in turn, admits the reluctance to donating the actually '"EXPIRED" drugs to anyone.  In effect, everyone is agreeing that the drugs must be put to use only as long as they remain effective and  not beyond that. The task now remaining is just to ascertain precisely the effective life of a drug (implying that the printed expiry dates are not correct) . Once this effective life of the drug is over, whether within or beyond the printed expiry date, nobody will advocate donating a really "EXPIRED" drug to any segment of the mankind. If the drugs are effective even after their printed expiry dates, it means they are not expired yet and the question, under reference,  does not relate to those drugs.  Apprehensions raised are related to the drugs which are actually expired.

Based on respect for the Ethic of Reciprocity and the principles of Justice and equal rights, the answer lies in the question: " Is it unethical to donate drugs that have passed their expiry date to poor people"

Donating expired drugs is not a donation; it is throwing away drug wastes. However, the discussion is open if pharmaceutical companies print a  different "efficacy shelf life for each ingredient including preservatives" on the label.

So, it is not only unethical; it is illegal in most jurisdictions.

The evidence provided in these answers has shown that medicines remain effective after expiry and that using them, provided one knows what one is doing, is effective treatment and not a greater risk.  So the question is, might I do something that will be of benefit?  The harsh reality is that if this is the best that can be offered with the available resources, then it is obviously a good thing to do.   Imposing developing country expiry dates on the situation and thus denying people effective treatment would be a great wrong.   It serves only the interests of Big Pharma  which  would see this use as a  lost commercial opportunity.  Anyone who has worked in developing countries knows the agony of seeing people suffering from treatable or preventable conditions for lack of resources.  One of my African students is fretting over his father who has an infected finger back home in Uganda and it may be amputated because he has no access to antibiotics.  If I could supply the father with a recently expired antibiotic in time then I would do it very gladly and with a clear conscience

@Nicholas.

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Uganda is a good example, the kingdom of Buganda in the late nineteenth century was a powerful Kingdom of East Africa in the late nineteenth century and early twentieth century was invaded and fragmented by the United Kingdom.

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The invasion occurred only after Italian pious missionaries introduced by Eritrea in 1887 cattle plague (rinderpest) decimating approximately 95% of all cattle in Africa (as they say: Hell is full of good meanings, but heaven is full of good works).

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In the name of bringing civilization to Africa Britain invaded the Kingdom of Buganda dividing and fragmenting an order that existed for more than five centuries (even with all the social disorder caused by famine the British had to fight five against Africans).

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It was so edifying entry of Europeans until the religious wars of Catholics and Protestants were transferred to Uganda (1892).

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In summary, Uganda is not a poor country, Uganda has been transformed in a poor country by several European interventions until 1961 in its domestic politics.

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The mexicans as a joke that says that "one of the problems Mexico is being far from God and too close to the United States". I would say that Africa has the same problem, "being far from God and too close to Europe". So the problem is not solved Africa sending there expired medications, but when Africa achieve it upon himself to his fate.

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What is wrong in donating good quality medicines to poor countries if the people are really sympathetic? While sending the expired medicines to already suffering, helpless poorest of poors, just imagine treating your own family members the same way so as to save a little money even at the cost of their lives!!! How did this mean idea occur to someone's distorted mind? Extreme rich section of the society, capable of affording this much of charity very comfortably/effortlessly, has not vanished yet - rather growing day by day.

Some of the comments are really sarcastic. A comment should not be just for the sake of commenting. If a medicine is still workable, it is not expired yet and the method of determining and declaring the date of expiry is erroneous needing necessary amendments. Once a medicine expires really, it must not be administered upon anybody whomsoever. A person consuming a medicine after the printed expiry date is a real great.

This is not just about donating drugs that still work and saving lives.  Drug dumping causes a great deal of trouble in many countries as the following article shows:

http://www.tanserve.co.tz/Documentary/index_files/medicine.htm

This is about disposing of largely unsaleable products into an unregulated market where large amounts of out of date drugs do cause real health and social problems.  

Antibiotic abuse is common in many African countries where 'donated' (dumped) out of date antibiotics are distributed willy nilly and people are induced to take them to 'prevent' diseases.  These drugs are often re-sold and are therefore not a free donation to the end user.

What is particularly shocking and callous is the tax benefit that some drug companies who do this can obtain.  

We should perhaps be less inclined to sell weapons to these countries while 'donating' out of date drugs.  If our super economies were not designed in a way that handicap and obstruct the 'emerging economies' we talk of here there may be a day in the future where they make the drugs themselves and distribute them in an efficient and fair way.  

That will not of course suit our giant pharmaceutical companies who benefit greatly from 'donating' (dumping) what is effectively a waste product on countries that we patronisingly refer to as 'emerging'.   

So effectively the exercise turns out to be a hidden business, in the disguise of a charity, yielding  manifold benefits to the donor:

• An honored status of a donor
• Relief from a dumping menace and allied legal complications
• Saving on dumping cost
• Tax exemption
• Blessings from even the dieing patients/survivors/families of survivors and even the dead(s)/Govt.s receiving donated medicines
• Other hidden benefits better known to donors

All said and done, just imagine about those (and their families) who would otherwise have survived even without these medicines but succumb to the expired medicines.

Poors are not dumping yards! Follow dumping norms. Please donate brand new medicines and be a proud donor. 

Read the following link (out of umpteens) on "Guidelines for Safe Disposal of Unwanted Pharmaceuticals":

http://www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf

May a fair sense prevail!

In a context where human dignity is regarded as being dependent on economic status, people deemed to belong to a lower rung of dignity may be given expired drugs.

However, if the inherent worth of people shape their dignity qua persons then such a course of action will be deemed unethical.