Ghana FDA puts in stringent checks to rid market of fake drugs
Drugs retail outlets have been cautioned to be wary of purchasing medical products from unregistered sources.
The public has also been advised to patronize genuine medical products by taking time to look at the packages, appearances, and colours of medicines and other products when purchasing these items to enable them use only safe products.
Getting to know the batch numbers of drugs printed on drug labels is also important since it provides manufacturing information about a drug and details of production, so it can easily be traced to its source.
These are some simple ways in which the public can support the Food and Drugs Authority (FDA) to rid the market of substandard and fake drugs.
Mr. Vigil Prah Eshun, Head of Drug Market Surveillance Department of the FDA, speaking to ghanabusinessnews.com in Accra advised the public to also check for the production and expiry dates of products to ensure that they are fit for purpose and safe.
He was responding to questions on what the FDA is doing to ensure that fake and substandard antimalarial drugs and related products such as rapid diagnostic test kits are weeded out of the Ghanaian market.
He said in 2018, due to their surveillance work, the FDA was able to track and recall some substandard antimalarials, branded as Coartem.
In this particular case, he explained that the Coartem was traced to a retail drug outlet, which had purchased the drugs from a wholesale outlet.
He said some of the ways substandard and fake drugs get into the market is when peddlers slip in unregistered drugs while sometimes packing these products and moving them into a vehicle from a wholesale to a retail point of delivery.
The FDA has improved on its capacity and structures to ensure that it gets a proper handle on dealing with unwholesome products and protecting the public.
The FDA has, for the past few years, relocated from its small offices at the ministries in Accra to a bigger office complex as its headquarters, located at Shiashie, close to Legon.
At the lobby of this office, where visitors are received and seated at the reception is a screen constantly putting out messages and educative information on safety and other related issues on drugs, food and other products. Some of the messages actually warn the public about dangerous items that have identified and made their way into the market.
The FDA has also opened more border posts across the country to filter out unwanted products coming in from outside. It has also established various interventions directed at regulating the system.
According to Mr. Prah Eshun, the task of the FDA is to ensure that all drugs, medical devices and other products regulated by the Authority meet standard requirements and that consumers who patronize all products including antimalarials and are not exposed to harmful products.
Global concerns
The need to strengthen regulatory bodies to deal with fake and substandard drugs such as antimalarials has become a global issue.
Fake medical products do not only pose a serious threat to the population but additionally, have implications for the global call on stakeholders to push for universal health coverage.
In July this year, the World Health Organisation (WHO) in a write up which focused on why strong regulatory systems are needed to reach universal health coverage, noted that in recent months, regulators across many countries have recalled dozens of medicines to treat high blood pressure because they were found to contain potentially cancer-causing impurities.
It had added that a “little less recently, in 2014, in the Ituri district of the Democratic Republic of the Congo, several people, 60% of them children, became sick after taking a medicine believed to reduce shivering and fevers from malaria.”
“It turned out the medicine contained haloperidol, an antipsychotic substance used to treat schizophrenia. Investigators found that the tablets people had been taking contained 13mg of the drug, about 20 times the maximum recommended dose for a child. By the time the source of the problem was identified, 930 people had been hospitalized and 11 had died,” it explained.
According to the WHO, health gains can only be achieved if, globally, regionally and nationally, health products do what they are meant to do, which is to prevent illness and improve people’s health and they can only do that if sound regulatory systems are in place.
It noted that current regulatory capacity and enforcement are insufficient in most developing countries.
The WHO estimates that only 3 out of 10 regulatory authorities globally function according to acceptable standards.
It added that the manufacturing of health products has become increasingly globalized, with products and the materials that go into them crossing several borders before reaching patients, requiring even greater global vigilance.
The global agency added that providing oversight of “health products throughout their lifecycle – from laboratory to health facility – is the linchpin of effective prevention, diagnosis and treatment and an essential part of WHO’s drive towards universal health coverage.”
A WHO article released during the launch of the WHO’s five-year plan on “Delivering Quality-assured Medical Products for All 2019–2023”, said despite global progress, serious problems with quality and safety persist, particularly in lower-and middle-income countries.
Adding that these problems threaten the health of people every day and waste resources.
According to the WHO, the quality and safety of medicines, vaccines and other products are compromised when manufacturers, whether by accident or intent, produce substandard products, when the supply chain allows unsafe medical products through, and when systems (usually due to lack of resources) are too slow to respond to adverse events.
In a related development, some news outlets including SciDev.Net, a leading science and technology news outlet, carried reports on a study conducted in the Democratic Republic of Congo and Uganda showing that fake and poor-quality antimalarials accounted for up to 43 per cent of annual economic cost of malaria in children under-five years in sub-Saharan Africa.
The study in the Democratic Republic of Congo, which was published in the American Journal of Tropical Medicine and Hygiene in January this year, had estimated that substandard (poor-quality)] and falsified antimalarials are responsible for US$20.9 million (35 per cent) of $59.6 million in malaria costs in the Kinshasa Province and $130 million (43 per cent) of $301 million in malaria costs in the Katanga region annually.
In Uganda, the researchers estimated that substandard and fake antimalarials accounted for $31 million, or eight per cent cost of the annual burden of malaria among children under-five years who sought care. This finding was published in the Malaria Journal also in January, this year.
Tightening local controls
Substandard and fake drugs, especially antimalarials can destroy the gains made in controlling malaria, globally. Apart from impacting on the management and control of the disease and it can contribute to the spread of resistance and the rise of morbidity and mortality cases. For countries such as Ghana, this can be bad news.
New data from the World Malaria Report 2018 shows that progress in the global malaria response has levelled off and, in some countries, the disease is on the rise.
WHO sources have stated that approximately 70 per cent of the world’s malaria burden is now concentrated in just 11 countries – 10 of them in sub-Saharan Africa (Burkina Faso, Cameroon, Democratic Republic of the Congo, Ghana, Mali, Mozambique, Niger, Nigeria, Uganda and United Republic of Tanzania) and India. These high-burden nations are home to an estimated 151 million cases of malaria and 275 000 deaths.
“In 2017, all of the 10 highest burden African countries reported increases in malaria cases over the previous year, ranging from an estimated 131 000 more cases in Cameroon to 1.3 million additional cases in Nigeria. Only India marked progress in reducing its disease burden, registering a 24 per cent decrease compared to 2016,” the WHO said.
According to the global body, to get the response to dealing with malaria back on track, its Director-General has called for an aggressive new approach that would jumpstart progress against malaria under a “high burden to high impact” country-led approach that would be supported by WHO, the RBM Partnership to End Malaria and other partners.
The WHO High burden to high impact programme is a targeted malaria response which is contained in a document detailing some principles which should, among others, be country-owned and country-led, characterized by packages of malaria interventions which is optimally delivered through appropriate channels and a strong foundation on primary health care.
The global body is calling for a coordinated national malaria response complemented by other sectors, such as environment, education and agriculture.
It added that aligning partners behind this country-led approach would ensure that scarce resources are used as efficiently as possible.
The high burden to high impact programme is therefore expected to demand high-level political leadership, country ownership and commitment from a broad coalition of stakeholders.
It is gratifying therefore that the FDA in Ghana is on the war path and working with other agencies to protect the public from some of these substandard and fake products including antimalarials.
Mr. Prah Eshun said the FDA is part of an interagency committee made up of representatives from various sectors such as the police, the legal profession, Bureau of National Investigations, Customs, Narcotics Board, Pharmacy Council and the Ghana Health Service to ensure that products, drugs, medical devices and foods on the Ghanaian market are meeting the standard requirements put in place by law.
According to him, apart ensuring that all products are registered by the FDA, samples and documents covering drugs and other products are, by law, to be made available to the FDA.
Products have to be registered before they arrive in the country and are taken through evaluation and laboratory test.
Mr. Prah Eshun said when products arrive at the ports, FDA officers at the entry points conduct a physical examination of the products including re-testing before allowing them into the market as part of the surveillance processes.
He added that continuous monitoring and surveillance is also done by officers across the country and sometimes these officers move into the markets and other outlets through undercover means or openly, depending on the situation.
Samples of products and drugs are then picked and subjected to laboratory tests just to track the presence of unwanted and dangerous products that may have slipped into the market.
He said all their offices are empowered to go into town to pick up samples and conduct initial test by an equipment they carry along to town, they can then do a follow up confirmatory test at the laboratory for further evaluation.
He explained that the FDA has a legal department which works with the police to prosecute offenders when it becomes necessary.
Additionally, he explained that the Authority has a safety monitoring department working with doctors, nurses and pharmacists who fill out forms and collect data on adverse drugs reactions among clients they serve, and this provides a reporting system on adverse drug situations.
The system helps the health personnel to gather information when they observe that a particular drug is not working as expected. This is then reported to the FDA for action.
All these actions are helping the Authority to carry out its surveillance work to weed out fake and substandard drugs.
He explained that one other way the FDA works is to also scrutinize the addresses of foreign drug manufacturers outside the country and keep records on these companies, so that the Authority can easily track what and where drugs are coming in from.
Mr. Prah Eshun said the FDA also does some travelling by visiting some manufacturing sites outside the country to ensure that these sites have standard drug manufacturing practices in place.
By Eunice Menka
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