Pneumonia generic drugs from Nairobi pharmacies fail quality test

By Gatonye Gathura

More than a dozen pneumonia generic drugs from Nairobi pharmacies have failed to meet internationally accepted benchmarks at the National Quality Control Laboratory.

Generics are supposed to have the same quality as brand name drugs, but recent test of 16 types from retail pharmacies in Nairobi County failed to meet equivalence tests.

Of 16 generics tested at the National Quality Control Laboratory (NQCL) only four had met the acceptable criteria for similarity with the brand product Klacid.

The drugs derived from the compound clarithromycin are used in the treatment of pneumonia, the lead killer disease in Kenya taking 21,000 lives last year.

Clarithromycin is also used to treat various skin infections, chlamydia, tonsils, sore throat and stomach ulcers when in combination.

The report published last Wednesday in the journal Scientia Pharmaceutica by scientists at NQCL and the University of Nairobi suggests generic medicines in the local market do not meet international benchmarks.

“We only picked on clarithromycin because it is normally an unstable compound and wanted to know how the market is dealing with the challenge,” lead author Rebecca O. Manani told the Standard on Saturday.

The study team now wants extensive studies carried out to establish the quality of generics in the county and specifically whether they are of the same standards with the brand products they claim to mimic.

This study, explained Manani implies the quality parameters set for various generics sold in the local market may not be stringent enough to match international benchmarks.

“The regulator should look into this and possibly adopt more stringent benchmarks that will ensure generics are equivalent to the originator brands.”

This was the third report in about a month where crucial medical inputs in Kenya have failed to meet required performance standards.

On 24th March, findings published by the National AIDS and STIs Control Programme and others, and reported in this newspaper showed almost all dominant HIV testing kits are returning deceptively high rates of wrong diagnoses.

On 20th April a report published by the World Health Organization (WHO), Johns Hopkins Bloomberg School of Public Health and Population Services International showed accessories being used in testing for malaria in the private sector are substandard.

The WHO report showed accessories being used in the rapid diagnostic kits in Kenyan and several other counties are of poor quality.

Responding to complaints over the performance of malaria testing kits in the private health sector in Kenya, Madagascar, Nigeria, Tanzania and Uganda, WHO had set up a project to investigate and remedy the matter between 2013 and last year.

In Kenya the project coordinated by the US NGO Population Services International found crucial inputs for malaria testing kits in private health facilities and pharmacies to be of poor standards

“In Kenya, quality assurance team visits identified test kits with no blood transfer devices, dry alcohol swabs, and stained packaging indicating buffer vial leakage,” says the report published in Malaria Journal.

WHO says use of such defective inputs could mean patient are being wrongly diagnosed and treated or not treated for the killer disease.

The report blames poor market surveillance by regulatory authorities and wants a more stringent system put in place to safeguard the lives of patients.

Last week we shared the pneumonia drugs failure study with the Pharmacy and Poisons Board but are yet to respond to our requests.

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