Over the counter medicines may be a lifesaver, especially when health insurance does not cover drugs, but they can come at a painful cost.
Several mystery shoppers—researchers hired to pose as customers— recently uncovered the dangers patients sometimes face.
The drugmakers lobby, the Kenya Association of Pharmaceutical Industry (KAPI), sponsored the mystery shoppers, who found that 17 per cent of medicines they bought were of poor quality or were falsified.
“Seventeen per cent of products that were analysed from samples collected through mystery shopping exercises did not meet the standards as per the monograph specifications,” said Juma Mwashuruti, the associate director, anti-falsified medicines Africa, at Novartis Sub-Saharan Africa. The exercise was conducted in 2017 but no other study has shown any improvement.
Juma spoke on World Anti-Counterfeit Day, marked globally on June 4. The event was organised by KAPI.
He said such counterfeit medicines pose grave risks to patients' health.
“This highlights the urgent need for action to curb the manufacture, distribution, sale and use of counterfeit medicines in the country,” he said.
The World Health Organisation says falsified medical products may contain no active ingredient, the wrong active ingredient, or the wrong amount of the correct active ingredient.
“They are also found to commonly contain corn starch, potato starch or chalk.”
Many are produced in poor and unhygienic conditions by unqualified personnel, contain unknown impurities, and are sometimes contaminated with bacteria, WHO said.
WHO said substandard and falsified medical products are also difficult to detect.
“They are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction. However, they often will fail to properly treat the disease or condition for which they were intended, and can lead to serious health consequences including death,” WHO said in a statement.
KAPI issued a statement calling on regulatory agencies, including the Anti-Counterfeit Authority and the Competition Authority of Kenya, to take decisive action in promoting standardisation and uniformity of requirements for the importation, distribution and sale of medicines.
“KAPI also urges these agencies to uphold and enforce safeguards for intellectual property rights, preventing unauthorised dealers from trading in medicines without explicit authority from IP rights holders,” the statement said.
Dr Onesmus Saidimu, the regulatory officer in charge of product safety at the Pharmacy and Poisons Board, the medicines regulator, said the levels of falsified medicines in Kenya is low, but did not give figures.
He said the falsified medicines range from expensive products for cancer to inexpensive products for treatment of pain.
"Anti-malarials and antibiotics are among the most commonly falsified products," he said.
He said the board conducts regular post-market surveillance to weed out counterfeit products.
“Some falsified medical are almost virtually identical to genuine product and are difficult to detect. However many can be identified by examining packaging condition, spelling mistakes or grammatical errors,” he said.
He also advised pharmacists and consumers to check manufacture and expiry dates and ensuring details in outer packaging match those in the inner packaging. “Ensure the medicine looks correct, not discoloured, degraded or has no unusual smell,” he said.
In January, PPB signed a deal with the Anti-Counterfeit Authority to work together in combating the problem of counterfeit medicines in the country.
The Memorandum of Understanding signed between the two aimed to strengthen the regulation and enforcement of health product and technology owners' rights.
The focus will be on preventing the circulation of counterfeit health products within Kenya.
Key components of the agreement include the exchange of information, joint investigations, collaboration in training programmes, research, sharing of expertise, technical exchanges and outreach activities.
“Working committees will be established to implement the MoU, focusing on detailed planning and the execution of cooperative activities, defining the scope of action,” the statement said.