By Gatonye Gathura
The presence and use of low quality, fake and substandard medicines may be cause for poor treatment outcomes and even deaths of many patients in Kenya.
Two recent reports show exceptionally high rates adverse drug reactions and side effects among patients on hypertension and cervical cancer medicines.
Medical experts, say the medicines for chronic disease such as cancer, diabetes and hypertension have, due to their high value become a prime target for unscrupulous drug traders.
On Tuesday during the World Anti-Counterfeiting Day the Chairman of the Kenya Association of Pharmaceutical Industry (KAPI) Dr Anastasia Nyalita raised a red flag over increasing imports of illicit medicines into the country.
“We have already petitioned the Pharmacy and Poisons Board on the entry of uninspected medicines into the country and want them to take action.”
“I have ordered the Pharmacy and Poisons Board to move in quickly and remove all poor quality medicines from the market,” says Cabinet Secretary for Health Dr Sicily Kariuki.
The government, the CS said is in the process of revising laws and fines that will make it highly punitive for importers of illicit medicines.
“We are conscious that we have to change our regulatory approach to deal with criminal elements if we have to achieve Universal Health Coverage,” said the CS.
At a meeting with pharmaceutical manufacturers and distributors at the Pharmacy and Poisons Board in Nairobi, the CS said no bad apple will be spared. “There is no short cut in ensuring proper medicines reach the public.”
“We have instructions from the President to destroy any counterfeit product on site and that is what we are doing,” says Chris Kiptoo the Principal Secretary of International Trade.
Two weeks ago a survey by the Kenya Medical Research Institute (KEMRI) found a third of anti-epilepsy drugs in private pharmacies, kiosks and even public facilities to be of poor quality.
“A poor quality anti-epilepsy drug is almost worse than the non-availability of good medicines,” lead author Dr Jeremy Jost, told the Standard.
Most of the substandard products the survey showed to be coming from China and India, with no indication they have been inspected as required.
In August the World Health Organisation (WHO) warned of fake Avastin and Sutent cancer medicines in the region and cautioned they could compromise patient care.
The health body said such drugs may be of poor quality, toxic to patients and may interact dangerously with other medicines used in patient chemotherapy. They may also contain less or no active ingredient hence of no value to the patient.
Around the same period a study at Kenyatta National Hospital led by Amsalu Degu of the University of Nairobi reported high death rates among cervical cancer patients receiving chemotherapy.
More than 93 per cent of the patients had reported drug related problems. While the study did not exclusively link the problems to the quality of drugs experts say the presence of poor medicines could further complicate the treatment of cancer in the country.
“Such deviations will very quickly lead to disastrous outcomes,” says Prof Nicholas Abinya, a cancer specialist and lecturer at the University of Nairobi.
Prof Abinya an advisor to the government and WHO on the list of essential cancer medicines set up the first training programme in medical oncology at the University of Nairobi in 2016.
He says there are too many types of cancer medicines in Kenya coming from all sorts of unverified sources which makes it difficult for doctors to establish what works.
Dr Ayan Ajuoi Magot of the University of Nairobi has also reported similar problems with hypertension patients attending KNH.
A recent study by the World Bank also found high presence of poor quality medicines in private clinics and pharmacies in Nairobi County.
The research conducted by World Bank found that patients in the city are routinely given drugs, including antibiotics and painkillers, which do not meet the required standards.
Medicines include the popular painkiller ibuprofen, the antibiotic amoxicillin, the asthma drug prednisone and the allergy treatment cetirizine. Others are clavulanic acid combinations, salbutamol and zinc tablets.
Seventeen per cent of these samples failed quality tests at Kenya National Quality Control Laboratory.
Low quality medicines were found in both poor and rich neighbourhoods with samples collected from Dagoretti, Kamkunji, Kasarani, Langata, Starehe and Westlands.
The survey is part of Kenya Patient Safety Impact Evaluation Project, a joint initiative of Ministry of Health and the World Bank Group.
Much of the low quality medicines and counterfeits, have been blamed on poor regulatory mechanism that has opened the widow to unfettered access to the Kenyan market mainly by Chinese and Indian pharmaceutical companies.
“India and China have taken over the space of local manufactures offering over 70 per cent of medical imports most of them of unverified quality,” says James Kamau the CEO at the NGO Kenya Treatment Access Movement-KETAM.
“There are more than 1000 manufactures from India and China registered in Kenya, far outstripping local capacity to inspect their competence as required by law,” said Kamau in a letter to the health CS.
PS Kiptoo and the head of the Anti Counterfeit Agency Elema Halake have however said they do not have the capacity to effectively monitor goods entering the country.
CS Kariuki has also asked the pharmaceutical industry to suggest ways of keeping our bad medicines keeping medicines affordable.
One way to do so, suggests importers is for the State to protect parallel importation of medicines.
Parallel importation, is legal in Kenya and allows importers to source medicines from cheaper markers across the world.
Some important terms in medicine trade
Substandard: authorized medical products that fail to meet either their quality standards or specifications, or both.
Unregistered/unlicensed: products that have not undergone evaluation or approval by the board
Falsified: Deliberately/fraudulently misrepresent their identity, composition or source.
Couterfeit/spurious: A product that is deliberately and fraudulently mislabeled with respect to source or identity. They may be of good or bad quality
Parallel imports: Purchase of genuine medicines in one market for resale to another. It is regal in Kenya and makes medicines cheaper.