Expired drugs prescribed to patients by MoH

The effect could be anything from reduced effectiveness to poisoning

A case of expired drugs given for a child in Thimphu with a rare heart condition has brought to fore the controversial practice of government hospitals and pharmacies in supplying expired medicines to patients.

It has also attracted the ire of the autonomous Drug Regulatory Authority (DRA) who’s Act says that no pharmacy weather government or private can supply expired drugs without it’s testing and approval.

Sonam (name changed), a mother of a three year old child with a heart problem was given a syrup called Digoxin for 14 days for her son, so that it can help in a more regular beating of his heart. To her shock when she checked the label of the drug (see picture) she found that the drug would expire the very next day of starting the treatment course for her son. This would mean that her son would be consuming an expired drug for 13 days.

The mother was prescribed Digoxin on 5th October 2012 but the expiry date was on 6th October 2012.

However, this is one of the many cases as government pharmacies do supply expired drugs to patients as DRA itself found recently.

The DRA’s Officiating Chief Regulatory Officer Nawang Dema said, “We were notified at one point of time and found that intentionally a drug one week after the expiry date was found to have been used.”

“They have their own professional interpretation but we said that the law would not allow it, and in such cases if anything happens to that patient, they are liable,” added Nawang.

As per international medical journals expired drugs pose a health risk in three ways. One is that in most cases it loses its potency failing to combat the illness effectively, secondly the danger is that in some infective cases where drugs like antibiotics are needed the weakened drugs strengthen the bacteria and finally in some cases the compounds of the expired drugs degrade to become toxic.

The medical literature says that expired medicines is dangerous especially for heart patients who as they rely on exact dosage requirements. Medicines like eye and ear drops lose their sterility over time and can cause infection in the eyes.

 

MoH explains

Health Ministry’s Director General of Department of Public Health, Dr. Ugen Dophu said, “Expired medicines are not just given to patients and incase they are given then these expired medicines would be already tested by us.”

He said, “For the expired medicines we do the test in Delhi to test its effectiveness. Once it is found to be effective and we get certificates then, we distribute that certificate to all health facilities.”

“Those expired medicine which can be used for another three or six months might have been given to them”, he said. “Without testing we don’t give such medicines and sometimes we cannot dispose some expired medicines the since some are very expensive to buy and are important.”

He said that cheap drugs are disposed instantly.

A Medical specialist in the Hospital who did not want to be named said that expired medicines can be taken for few more months after expiry.

Dr. Ugen Dophu said, “Actually it is said that medicines works for three months after the expiry date but we test such drugs and then only so we use them.”

When asked about the danger of taking such medicines especially for a child who is a heart patient, he said, “He might have taken the medicines that we have already tested and confirmed. If not they won’t give the medicines, they would be more careful when it comes to such cases.”

However, he agreed that from the date of expiry, normally the effectiveness of the medicines will disappear.

“There is no danger other than that since there is no effectiveness,” he said.

Dr. Ugen Dophu, clarified that the general policy is that no expired drugs are given to patients, and if any are given then it has been tested. “Without testing, we don’t know whether it is working or not and later it could be of danger to the patients,” he said.

 

DRA says rules have been violated

However, officials from the DRA do not agree with the Director General’s assessment. Officials from DRA say that these are old rules, before DRA came into existence.

“They are not allowed use expired drugs and it has to be out of the shelf,” said Drug Controller Sonam Dorji.

“Whether it is expensive or not, they have to consult us and testing is our work,” he said.

DRA’s stand is that any pharmacy or hospital on their own cannot extend expiry dates and cannot dispense any expired medicines to patients as this is in contravention to the DRA Act.

Nawang Dema said that as per the country’s regulation, “No expired drugs can be allowed to be dispensed”. She, however, said that there are instances of checking expired drugs.

She also said that there is a possibility of patients storing drugs and not using them leading to expiry date drugs.

The Drug Controller also said that patients also have a practice of hoarding drugs, especially heart patients, diabetic patients, and ones who have to take medicines on a daily basis.

“We cannot say it is a wrong for patients to hoard medicines because sometimes health facilities and pharmacies run out of stock and so patients keep it for safety,” said Sonam Dorji.

Nawang Dema said that normally during inspections, drugs that are expiring first have to be kept in the front so that they can dispense it out.

“Sometimes they intentionally give expired drugs due to it being out of stock”, she added.

DRA officials told the paper that they would always entertain patients with such complaints since it is their duty to investigate and confirm it. “If such expired drugs are dispensed then liabilities can be imposed on them because we stand for consumers,” said DRA official.

Sonam Dorji said, “the Ministry of Health as a government institution has huge stocks of the same medicine in all 28 hospitals and 175 Basic Health Units. If some of the medicines are about to expire there is a means to come to us and tell us that such amount of medicines are going to be expired and that there is need for extension after the testing.”

He said if this was done then DRA would put it to the Drug Technical Advisory (DTA) committee for the test. “Some medicines because of their chemical nature may be still potent and can be used for another three months or six months but for some it cannot be used at all,” added Sonam.

Under section 28.1of the DRA’s Act states “from such date as notified by the Board, no exposed medicine shall be sold or distributed through the pharmacy”.

It further states in case anyone contravenes section 28, they shall be liable for a fine equivalent to the national daily wages of three months to one year or imprisonment which may extend from six months to 3 years or both.

As per the gravity of the offence determined by the Board for conviction, the establishment may be liable for closure. He shall also be liable to compensate the damage caused by the violation.

The mandates of DRA include quality, safety and efficacy in order to safeguard the consumers.

 

MoH procurement scam

The quality and expiry issue of drugs have cropped up in the past in relation to a MoH procurement scam where drugs and medical equipment of dubious quality and exaggerated quantities were purchased to benefit suppliers.

As per rules, the minimum shelf-life of drugs that are purchased has to be for two years. However, A Royal Audit Authority report in 2010 found that in a test check of 306 types of drugs it showed that 112 drugs had less than the minimum required shelf life of two years. In some cases the shelf life was only eight months. This meant that Nu 18.64mn worth of drugs was purchased which were below the minimum shelf life. For example, 200 vials of Multivitamin IV had already expired by 72 days due to a low shelf life.

The report says that acceptance of drugs with a low shelf life may lead to increased loss due to expiry of drugs. “The possibility of collusion between suppliers and the officials of the DVED management in enforcing the clause relating to the minimum shelf life of drugs cannot be ruled out,” says the report.

The report also found that 13 different drugs procured by the health ministry and distributed through the hospitals in the country in 2008-2009, had failed safety tests.

Overall the report on drug procurement by the health ministry has found numerous instances of ‘unhealthy practices’ and lapses worth Nu 127mn.

 

 

 

 

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18 comments

  1. This is a nice job done by the bhutanese. DRA, must do something or else.. it is dangerous..

  2. tashi for your kind info dr ugyen is director general of department of medical services and not public health,

  3. The story is like this.Medicines which are are expensive and not easily available are stored for VIPs and please note that it is at the expense of public/govt. money.So,when general public are asked to buy these medicines,for VIPs they do not have to.And when these medicines are about to expire,they are sorted out and distributed for general public use.So,both way the losers are the general public.Till the medicines are separately lept for VIPs these things will continue.Very Simple!!!

  4. How can an expired drugs be used? Its dangerous and whats the guarantee of the tests.. I think first Doctors kids must be given then to the patients..are the doctors sure abt its usage after its expiry? Bhutanese hospitals are fast becoming like pvt. Indian hospitals now..we can’t fully trusts our MoH now…BE CAREFUL PEOPLE NEXT TIME U R IN THE HOSPITAL…IT CUD BE U OR ME?

    • I thought drugs are given at pharmacy counters.. Are doctors themselves handing over the drugs these days. It’s strange and unique well it’s a GNH country could be possible.
      If it’s the pharmacy counters who is giving away drugs then how come doctors come into picture. Well, it’s more strange the people are blaming doctors for expiry drugs, when it is procurement section who procure it. I think people should do some research before writing something in a forum like this one.

    • MoH scam which did surface about two years back has brought no results as to who are the real culprits except that Dr. Gado had pretended to be owning some responsibility. In the absence of such a thorough investigation revealed and the culprits are brought to justice, such lapses are bound to be in practice. And in between we would have victimised ouselves as consumers of the outdated medicines causing premature deaths rather than curing from various deseases. ACC is still in their deep sleep and do not know when they are timed to wake up.

    • dear messi….. the neurons in your brain must be as messi as your name is….  maybe you been seeing a quack or a tshampa thus far for all your illness ( only they do the multitasking of diagnosing, investigating, despensing & treatment procedures by a single hand) ,,

      doctors only advice the drugs, pharmacists dispense, the management keeps things in place ,,,,,  the procurement division etc…  

    • why are doctors blamed all the time in Bhutan? You should be little empathetic when you make such allegations against these group of noble people…..First know the fact well about something that you are gonna utter, it was an absolute nonesense…. how does a doctor come into picture when the expired drug was dispensed from the pharmacy……? Next time I expect you to be sensible Mr. Mssi.

  5. messi,
    Kindly spare the doctor here. He is not involved in this case as he do not dispense the medicine.

  6. If this is true, it is completely unacceptable and some heads need to roll.

  7. Doctors are not the ones giving drugs to the patients……expiry of drugs needs to be checked by the pharmacy, and the pharmacy should only accept drugs with longer duration of shelf life. Plz guys, don always blame doctors for everything related to MoH.

  8. And the one who is writing the report in the public media needs to know lil bit in depth before he/she writes the story.

  9. Every drug has a shelf life and hence an expiry date on it. It’s there for a purpose right? Having expiry drugs in store says one thing- the fault in procurement calculation or distribution. 

    One batch of drugs may be tested and may past the test to be use for an extended period but what guarantee is there the other drugs in the same batch were stored and transported in the same manner. 

    Let’s not play around with OTHER PEOPLES’ lives. MoH already has a reputation for that so as citizens we are happy DRA is playing it’s role effectively. DRA please keep up the good work

  10. here are my 2 cents:
    1. med that have expired should never be used, whatever explanation they give.
    2. doctors r not directly dipensing the drugs, they only prescribe the meds n its dosage..dispensing is done by pharmacy, purchase n procurement by DVED and regulation by DRA. so stop blaming the docs.
    3.ppl cannot expect ‘quality’ healthcare when u directly dont pay for it, i accept a part of ur salary is ‘taken away’ for healthcare service, but it is a mere trifle to pay for ‘ quality’ u expect.
    4. i too have heard that best meds r ‘ reserved’ for the VIPs, and cheap meds given to the common person..isn’t it time we become ‘democratic’ in our action n stop bowing infront of any Tom, dick and harry claiming to be a VIP, in a functioning democracy the masses rule, not few rich n famous.

  11. One thing about Bhutan is that we are small and we know each other. So even small problems surface out. It may be true that that an expired medicine would have been given by mistake. But we should not generalize and conclude that such cases are common. There is risk of selling expired medicines from a pvt. pharmacy for financial benefits but in a govt. hospital, since medicines are free there is no reason why expired medicines should be given. It must have happened by mistake. Expiry date on the medicine is to meet the regulatory requirements and does not necessarily mean that the medicines are not at all effective.

    Visit the following sites:
    http://www.doctorsolve.com/blog/2010/01/drugs-past-their-expiration-date-are-they-safe-to-use.html
    http://askdrgottmd.com/is-expired-medication-safe/

    • why highlight scam part as ACC is doing enough on that

      ofcourse actions are delayed… it is expected to come soon with stingent action unlike gyalpozhing land scam case

  12. than wat is the use of mentioning expiry date…if it cn be reuse……..expiry means expired like death means to death……

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