Alarm over poor quality epilepsy medicines on sale in pharmacies

More than a third of epilepsy medicines in Kenya are of poor quality, a survey in three African countries has revealed.

The study shows that most of the poor quality medicines are imported from China and India

The study by the Kenya Medical Research Institute (Kemri) and the University of Limoges, France, analysed the quality of epilepsy drugs in Kenya, Madagascar and Gabon.

The report published last week in the journal Epilepsia found some 32 per cent of anti-epilepsy tablets in the three countries to be of poor quality.

In Kenya, 37 per cent of the medicines were of low quality and 34 per cent in Madagascar and 26 per cent in Gabon.

The study, which covered Kilifi and Mombasa, involved researchers from Oxford University, UK, and Paris Descartes University, France.

The researchers collected 3,782 tablets and capsules from public, private and informal pharmaceutical outlets such as shops, kiosks and streets from the three countries and shipped them to France for testing.

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The medicines were tested for uniformity, dissolution, disintegration, friability, chemical stability, impurities, content, packaging and patient information.

Epilepsy drugs in public facilities in Kenya were more likely to be of low quality than those in the private sector.

“A poor quality anti-epilepsy drug is almost worse than the non-availability of good medicines,” says Dr Jeremy Jost, the lead author.

Dr Jost explained that long-term exposure to poor-quality epilepsy drugs may result in lack of confidence in formal medicines, pushing patients to alternative and unproven treatments.

The researchers found anti-epilepsy drugs manufactured in Africa to be of much better quality than those from China and India.

Ninety per cent of the good quality anti-epilepsy drugs were those manufactured in Kenya, Senegal and Madagascar, much higher than those from Europe.

Compromised quality

Good quality drugs imported from the European Union represented about 65 per cent, 38 per cent from India and 23 per cent from China.

“These results support the local production of anti-epilepsy medicines and dispels locally held beliefs that drugs manufactured in Europe are necessarily of higher quality,” says the new study.

The study tested a wide range of anti-epilepsy drugs including carbamazepine, phenytoin, sodium valproate, phenobarbital and diazepam, all which failed tests at different levels.

But even where drugs were of good quality, poor storage and distribution practices compromised quality.

This was especially aggravated by lack of temperature and humidity controls in most of the drug distribution points.

This, study co-author Dr Symon Kariuki of Kemri says, is likely to lead to drug deterioration especially in an environment like Mombasa with high humidity and temperatures.

It was also observed that in Kenya, retailers are likely to unpack the medicines and sell in small units.

The practice of unpacking, the experts say, is likely to expose the products to further deterioration.

The researchers also observed poor packaging standards especially in Kenya.

“All the samples collected from Kenya were sold without secondary packaging while 22 per cent were without any packaging,” says Dr Kariuki.

The Kenya National Guidelines for the Management of Epilepsy 2016 describes epilepsy as a chronic brain disorder characterised by repetitive unprovoked seizures more than two times 24 hours apart in a year.

It is estimated that the disease affects more than 70 million people worldwide. In Kenya, it is estimated that around 800,000 to one million people are living with epilepsy.

Of this, only about 10 per cent are on treatment.

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