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.
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.