The many ills of a little pill

The withdrawal of a substandard thyroxin tablet, commonly used in Sri Lanka, brings up questions of quality control, informing the public and the quality of the substitute drug
By Kumudini Hettiarachchi, Pic by M.A. Pushpa Kumara

A quality failure, a drug is withdrawn from the state and private sectors but doctors are concerned not only whether there has been adequate “transparency” in letting people know about the issue but also whether the efficacy of the substitute is any better.

In the eye of the storm is the small, white thyroxin pill which many people like Kamala, a young woman, who has been grappling with hypothyroidism for many years has to take daily. On no account can she stop it, not only for her own health but also due to the fact that she is newly-married and may become pregnant.

However, for the past two weeks she and her husband have been rushing from one pharmacy to another in search of thyroxin with speculation and rumours doing the rounds that the low-cost thyroxin which has been prescribed by most doctors is substandard.

What has gone wrong with thyroxin, in a country where the prevalence of goitre problems is around 5% of the population?

“We have had quality issues with a particular thyroxin tablet that we have been prescribing in the state hospitals,” confirmed Consultant Physician and Endocrinologist Dr. Noel Somasundaram of the National Hospital in Colombo, when contacted by The Sunday Times.

Although for two years they have been experiencing doubts about its efficacy, with the drug working for some patients and not working for others, their suspicions had aggravated in January when they witnessed major problems, he said, explaining that they first discussed the matter with the Drug and Therapeutics Committee and with the National Drug Quality Assurance Laboratory (NDQAL). Subsequently, they sent a letter to the Director-General of Health Services.

The Sunday Times learns that physicians, both in the state and private sectors, across the country have been having issues with the thyroxin freely available in the market with several voicing concern on the impact it would have on pregnant women and also their unborn babies. (See box for the devastating effects on the foetus.) Echoing the view of many others, Dr. Somasundaram said that they have seen expectant mothers who have uncontrolled hypothyroidism giving birth to babies also with uncontrolled hypothyroidism. What would be the mental health of these children when they grow up?

In recent times, National Hospital doctors realized that the tests to check the adequacy of levels of the thyroid-stimulating hormone (TSH) in the blood of patients were not showing positive results. However, when the same type of drug but from a different manufacturer was prescribed, the levels improved, said another senior Consultant Physician of the National Hospital. Obviously, it was due to something being wrong with the earlier medication, he said. A normalizing TSH would indicate to doctors that the drug dosage is adequate.

“When we heard about the efficacy issues with regard to thyroxin being dispensed at the state hospitals, the matter was referred to the Drug Evaluation Sub-Committee and the drug was tested at the NDQAL which found a quality failure,” said a high-level official of the Health Ministry, explaining that it was followed up with all state hospitals being informed to return the stocks.

The state hospitals’ requirement of thyroxin per month is around 1.5 million tablets, which is met by a well-known pharmaceutical company which has been doing so for the past 18 years, The Sunday Times understands. The company imports the raw material and manufactures the tablets in Sri Lanka, and supplies the requirements of the state sector, on a tender basis, through orders placed by the Medical Supplies Division and procured by the State Pharmaceutical Corporation.

“Of course, the stock withdrawal resulted in a shortage and although there are two more varieties of thyroxin tablets imported from India and Britain, mainly for the private sector, the stocks are much smaller,” the official said. Attempts to purchase more stocks from those two companies and also from other sources failed. However, the company whose tablets were withdrawn and blacklisted or registration cancelled for this drug, reacted promptly and stopped their raw material import from China and sought out raw material from Germany.

The official added that now the drugs made from the German raw material have been tested and found to be of the quality required. “The NDQAL checked it and found no quality issues while samples have also been sent abroad for testing,” the source said, adding that pending the report from abroad, the pharmaceutical company has been allowed to manufacture thyroxin for the state. The company has also done independent testing of the drug with the new raw material.

The thyroxin tablets imported from India (each costing around Rs. 3) and Britain (each costing around Rs. 4) meet the requirement only of a small number of patients even in the private sector, The Sunday Times learns, while once again it is the local tabets (costing about 30 cents) that comprise about 90% of that market as well.

So what happens in the private sector?

As soon as a drug needs to be withdrawn, the Medical Technology and Supplies Division (the drug regulatory authority) issues a notice through the media while also informing its drugs inspectors to spread the word to the pharmacies to return the stocks.Then the drugs inspectors would check whether such blacklisted stocks are still on the shelves and seize any stocks left, it is learnt.

Meanwhile, the pharmaceutical company which manufactures the thyroxin locally assured that all measures had been taken through its distribution network to recall the stocks in question. “We have acted with responsibility. Even though efficacy could be affected due to many reasons such as place of storage etc, we have withdrawn the stocks, changed our supplier of raw materials and gone through the stringent procedure of the Medical Technology and Supplies Division to get registration for the new drug which we are manufacturing with raw material from elsewhere,” said a company official who declined to be identified, adding that such issues with regard to thyroxin were experienced not only in Sri Lanka but in countries across the world.

Another important area the doctors insisted that the authorities should focus on was “bio-availability” not only of thyroxin but of any drug. “Bio-availability is the amount of ‘active drug’ in any medication, especially in tablet form that is absorbed by the human body,” explained another physician questioning whether the NDQAL had tested even the new thyroxin for this. These concerns were reiterated by many doctors who said that checking whether the weight is right, the packing is good etc, were not the only tests that should be carried out with the most important being bio-availability.

They have requested that testing be performed by giving the drug to patients and checking whether the TSH levels in the patients have been normalized. The largest society of endocrinologists, the Endocrine Society based in America had highlighted this issue in June 2008 by publishing a position paper titled ‘Bioequivalence of Sodium Levothyroxine’. It had argued that merely checking the thyroxin quantity is not good enough as its effects on the body need verification by the authorities. It had also quoted instances where serious adverse events occurred due to the switch of thyroxin products from one to another (due to a difference in efficacy).

While doctors were perturbed over bio-availability and bioequivalence, they also claimed that people got to know about the thyroxin withdrawal by word of mouth as transparency on the part of the authorities was questionable. The Sunday Times was unable to get verification from the Medical Technology and Supplies Division whether it had in fact placed advertisements in the media to inform not only pharmacies but also the patient who may have stocked up two-three months of tablets.

Have the authorities conveniently ignored that all-important patient-victim in this thyroxin crisis? The need to keep them informed whether the right measures have been taken to prevent a drug disaster and what they should do in case they have purchased extra stocks is the duty of the government. Otherwise, it may very well lead to a health crisis in Sri Lanka.

What is Hypothyroidism?

Hypothyroidism is when the thyroid gland is under-active and does not make enough of the thyroxin hormone which is essential to keep the body’s function or metabolism working at the correct pace. Many cells and tissues need thyroxin to keep them working right and not slowing down.

Lack of thyroxin would cause symptoms such as tiredness, weight gain, constipation, aches, feeling cold, dry skin, brittle and coarse hair, fluid retention, mental slowing and depression.

If hypothyroidism is untreated, the possible complications could be: increased risk of developing heart disease and if a person is pregnant an increased risk of abortion, pre-eclampsia, anaemia, premature labour, low birth weight babies, stillbirth and serious bleeding after delivery.

As the foetus is fully dependent on the mother for his/her thyroxin requirements, doctors say, it is essential for the mother to take the recommended dosage. If the foetus does not get the required thyroxin particularly during the first 10 weeks of life, the baby could have permanent brain damage, doctors say.

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