When you are a bit under the weather and the doctor prescribes medication, you take it diligently and wait for the effects to kick in and make you better.
It doesn’t occur to you that maybe what you have swallowed is more like a placebo (no efficacy) or a poison (not safe) – a counterfeit masquerading as a potent drug.
Extensive investigations by the HealthyNation show that you might need to be more cautious before you pop that hypertension pill or swallow that paracetamol syrup you desperately need.
Last December, the Ministry of Health announced that a common anti-malarial) Duo-Cotecxin) had been flagged for recall from the Kenyan market, for failing laboratory quality tests.
Samples of the antimalarial drug, purchased by the HealthyNation from a popular pharmacy in Nairobi’s central business district, failed assay tests by the Drug Analysis and Research Unit (DARU) at the University of Nairobi – one of three such accredited facilities in the country.
“The sample of Duo-Cotecxin tablets submitted was found not to comply with the specification for assay of dihydroartemisinin tablets,” DARU said in its drugs analysis.
This means that the drugs, whose packaging lists its manufacturer as Chinese company Zhejiang Holley Nanhu Pharmaceutical Company, are substandard or outright knockoffs.
The sampled drugs (batch number 160621) are set to expire in May, making it highly plausible that the pills are still circulating in the market, posing a grave health risk to patients who are innocently consuming them.
Health Cabinet Secretary Dr Cleopa Mailu said that the fact that the batch was still within its expiry date, meant it could be “readily consumed”, necessitating its speedy removal from the market.
However, since the medication is manufactured abroad, the minister said his officers would “use the batch number to “trace and withdraw” the drugs and then “take the matter up with the manufacturer.”
Another round of tests, on other common drugs, conducted with funding assistance from the Code for Africa impactAFRICA Fund, arrived at similarly grim conclusions.
The studies revealed that 66.7 per cent of the medicines sampled complied with quality criteria for safety. Although the majority of samples complied with the required standards, according to Dr Kennedy Abuga, the head of DARU, none of them had the exact content claimed on the packaging.
“For instance, a submitted sample of Neurobion Forte, a Vitamin B Complex manufactured by Merck Limited, was found to comply with the US Pharmacopeia (a safety standard reference) specifications for identification, weight uniformity and assay of vitamin B Complex tablets. “Two tablets, however, deviated from average weight.”
ANTIMALARIALS WORST CULPRIT
While these findings may come as a shock to many, it falls well within the results of recent analysis done by the World Health Organisation (WHO).
A report the UN health body released last November showed that one in every 10 medical products circulating in low- and middle-income countries such as Kenya is substandard or falsified.
The study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products collected over 48,000 samples of drugs from across the world – mainly Africa with 3,500 of them coming from Kenya. Antimalarial products were the most highly recorded as substandard and falsified, meaning they make consumers sicker rather than cure them.
This same report also placed Kenya among 88 countries where 42 per cent of the world’s fake medicines are dumped. The WHO lead on substandard and falsified medicines, Michael Deats, noted that while none of the drugs sampled have caused any recorded adverse reactions or caused recorded deaths, the samples contained no active pharmaceutical ingredient.
Fake medicines not only make patients sicker, whether through not curing them or giving them new illnesses, or creating drug-resistance, but they also bleed state health budgets which are often inadequate as it is.
While Dr Mailu may implement his intention to recall the defective Duo-Cotecxin from the local market, past cases on the enforcement of such directives leave a lot to be desired.
In our analysis, for instance, the laboratory skipped tests on 14.8 per cent of the total sampled Nulide tablets – a fever and pain medication – since the drug was banned globally nine years ago.
Use of the drug was forbidden for exposing patients to fatal liver damage. The drug has never been approved for use in countries like the US, the UK, Canada, Australia New Zealand and Japan due to safety concerns.
NOT ABOUT THE BOARD
However, despite this ban, this potentially lethal medication, also referred to as Nise or Nimesulide is still available for purchase in Kenyan pharmacies through briefcase suppliers, posing grave danger to unsuspecting consumers.
When put to task about the availability of this banned drug, the Director of Medical Services Dr Jackson Kioko, said in an earlier interview that he had asked the Pharmacy and Poisons Board’s (PPB) crime unit to investigate the matter. PPB is the industry regulator in charge of medicine control and regulation.
Dr Kioko said that they were working with the Directorate of Criminal Investigation, and were committed to apprehending the culprits and getting the drugs off the market.
“Cracking down on drugs which were banned in 2006 or 2009 is doable,” said Dr Kioko, who is also the PPB chairman, adding that the problem of fake and counterfeit medication in the country is under control.
“It is not about the Board, it is not about the Ministry but it is about all of us together to make sure that these things (fake drugs) finding their way into the market illegally are stamped out.”
According to Dr Abuga, four factors determine the efficacy of a drug – quality, safety, effectiveness and good manufacturing process. The totality of these dynamics determine whether a drug serves its purpose or not. Laboratories, such as DARU, only deal with the quality of drugs; for instance, do the constituent ingredients match the standard requirements?
Although the majority of samples complied with the required standards none of them had the exact content as claimed on the package labels.
Dr Pius Wanjala, the deputy director at the National Quality Control Laboratory, noted that while it is impossible for results to match their marketed ingredients to the gramme, results should fall within an internationally-accepted range. “It is impractical to have the tests read the exact numbers declared on the label. However, if it falls outside a range it becomes substandard,” he said.
Falsified medicines are those that contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient, according to the WHO’s definition.
Most of the time, these medications contain corn starch, potato starch or chalk, but sometimes pass lab tests, thereby making it to your pharmacist or hospital.
The fact that these drugs are manufactured in unhygienic conditions by unqualified personnel oblivious of protocol, means that more often than not, they contain unknown impurities including pathogens that may not be seen even in laboratory analyses.
“Substandard and falsified medical products are by their very nature difficult to detect,” explained Dr Wanjala. “Lab tests may not detect adulteration yet it can be very dangerous if the manufacturing process is not adhered to,” he added.
Mr Deats, who is in charge of vigilance against falsified medical products at the WHO, said that Kenya only reported a handful of substandard and falsified medicines to the Global Surveillance and Monitoring System database thus hindering the fight against the deep-rooted vice.
He added that governance issues related to substandard and falsified medical products in Kenya are similar to the issues faced by all other countries. Both the private and public sectors need to be accountable and use transparent systems. A key tool in fighting substandard and falsified medical products is a functioning and appropriate legal framework.
“More cases of substandard medicines could be underreported,” Deats noted. “It is important to harness political will and ensure cooperation from all relevant stakeholders – from civil society, to public and private procurement actors. Efficient, effective and responsive reporting systems should be in place for public and industry reporting of suspected substandard and falsified medical products.”
Mr Deats advised patients and procurers to ensure they obtain their medical products from reputable sources. They must not hesitate to carefully examine the products and report any unusual features such as, for example, spelling mistakes on the label, poor packaging, expiry and manufacturing dates, and unusual appearance of the product.
An example is a resident of Nairobi’s Eastlands, who noticed a variance in batch numbers on Augmentin – prescription antibiotic – he bought from a neighbourhood chemist. The batch number on the blister pack (726320) was different from the one on the packaging (716975).
Surprisingly, the chemist had the Pharmacy and Poison’s Board poster of authenticity, yet the patient was able to buy the prescription-only Augmentin without a doctor’s note. “I swallowed the first dose without side effects, but I still felt sick. I had a terrible flu, a pounding headache, tonsillitis and joint pains,” he told HealthyNation.
“I realised the batch numbers were different after I had already swallowed the drugs. After reaching out to GSK, the manufacturers of Augmentin, they told me they checked the batch and confirmed ‘it was not fake but a mix-up of packaging’.” That experience, according to Mr Deats, is a counterfeit alert and it could be lethal to a consumer.
Reporting for this story was supported by Code for Africa’s impactAFRICA fund and the Bill and Melinda Gates Foundation.