A systemic failure on drug inspection

By DANN OKOTH

Kenya's porous borders, lack of personnel to man the borders, poor pay and utter apathy by Pharmacy and Poisons Board (PPB) employees could be allowing fake and substandard drugs into the country.

PPB admits that the only recognised and manned borders are the Mombasa port, Jomo Kenyatta International Airport (JKIA), Namanga, Busia and Malaba border points.

"However there are panya routes, which are not manned. Consignments arriving by air are also tricky to monitor because unscrupulous individuals land with cargo in the dead of the night and quickly clear the same using all means, including bribing airport police," says PPB deputy registrar Fred Siyoi.

Lazy inspectors

Lazy inspectors complicate the picture as they simply refuse to thoroughly inspect incoming drugs cargo. This is more common at the port of Mombasa.

Poor pay exacerbates corruption by PPB officials, reveals the drugs inspector, adding: "For someone like me earning a meagre Sh30,000 and I’m supposed to stand guard over goods worth billions of shillings week in week out, the temptation to accept a bribe is real," he says.

"Sometimes I have up to seven or eight containers to clear and the officers are required to strip the containers down to the last item," says a clearing and forwarding agent at the Coast who identified himself only as Moha and who clears cargo for leading drugs suppliers in the country.

"The task is odious and the officers are only too willing to find a shortcut. Once in a while, I part with a few bucks to line their pockets because after all they make my work easier," he says.

The greatest danger is that these drugs find their way into the market while they have not been verified by PPB, says Charles Lenjo, a pharmacist in Nairobi.

"There is also the risk that products that are not registered in the country can easily find their way into the drugs system through this route," he adds. A case in point is an incident last year when fake anti retroviral drugs were discovered in the country. HIV/ Aids patients were already using the drugs, which had to be recalled after the discovery.

Quality problems

Medicins Sans Frontieres (MSF) mission in Kenya detected quality problems with antiretroviral medicines (ARV) used by people with HIV and Aids after its nurses reported irregularities on the appearance of the product such as friability and discolouration of the tablets.

The falsified antiretroviral medicine (Zidolam-N) found in Kenya were actually expired medicines that had been deliberately re-labelled to alter the expiry data and re-introduced into the medication supply.

Mr Richard Veerman, (MSF) head of mission in Kenya says it is critical that all countries protect patients by increasing vigilance for falsified medicines while at the same time maximising access to affordable generic medicines, thus prioritising the patients’ health and wellbeing.

Veerman says: "While we were surprised to find falsified medicines in the supply chain, being watchful for such events is important for all providers of medicines. We have learned that a system can be vulnerable to the malicious will of a few individuals and we are reminded that proper surveillance systems need to be maintained and improved. This includes strengthening the PPB, streamlining and simplifying the medication supply chain and distribution."

Veerman insist committed and concerned personnel at the field level are critical to the process of pharmaco vigilance in the country.

He says after their nurses identified the problem with the medicines, MSF immediately informed the appropriate Kenyan authorities and the World Health Organisation (WHO), and then rapidly obtained sufficient quantities of replacement medicine and began to call back patients for exchange of their medicines.

In all MSF followed up nearly 3,000 of the HIV patients who received ARVs from falsified batches and provided them with replacement drugs. These patients were also offered an evaluation to ensure their good health.

Official investigation

At this point, says Veerman, an official investigation has been launched and is on-going. "We are happy to fully cooperate with the authorities. We have not been informed of any outcomes from this investigation. Our major focus is on our patients’ health and wellbeing and on ensuring that MSF medicines meet high safety and quality standards," he says.

But the experiences in the past year has left the medical fraternity reeling and the PPB with egg in the face especially after it emerged the board could be abetting corruption or even participating in it as the country’s drugs import system falters with possible damning consequences for millions of Kenyans who depend on the board for access to safe medicine.