How COVID-19 fuels spike in fake drugs
Recent reports indicate that the ongoing Coronavirus disease (COVID-19) has led to scarcity and rise in prices of essential medicines, sanitisers, Personal Protective Equipment (PPEs) and medical products. Unconfirmed reports suggest that the situation has led to more people patronising counterfeit and fake or substandard medicines – both to prevent and treat COVID-19.
The situation has raised lots of questions: What are the possible sources of fake and substandard drugs at times like this? What are the implications on efforts to contain COVID-19? What are the best ways to address the situation?
A consultant clinical pharmacist, public health specialist/health educator and National Chairman, Association of Hospital and Administrative Pharmacists in Nigeria (AHAPN), Dr. Kingsley Chiedu Amibor, said the COVID-19 pandemic no doubt has completely disrupted the medicines supply chain and brought with it huge challenges in ensuring medicines security in Nigeria. Amibor said for Nigeria, being an import dependent country for active pharmaceutical ingredients (APIs) and finished products from China and India to some extent, prices of drugs have skyrocketed as a result of lockdown placed by several countries at the outbreak of COVID-19, as well as restrictions on export of finished products and APIs by countries listed above as well as others. He said the result is drug scarcity as well as higher prices of essential and non-essential medicines in the country as supply struggles to catch up with demand.
Amibor said the consequences of these developments have seen further pressure being mounted on the economy, as pharmaceutical manufacturers have to source for foreign exchange (forex) to bring in scarce medicines into the country. The pharmacist said in an attempt to fill the lacuna created by exorbitant and scarce products, drug merchants operating in open markets have seized the opportunity by supplying fake, falsified or substandard medicines to fill the gap. He said there was a time it was reported that over 60 per cent of drugs circulating in Nigeria were fake: but thanks to the doggedness of the National Agency for Food, Drug Administration and Control (NAFDAC), that value was drastically reduced.
“Now, the COVID-19 pandemic is gradually returning us to the dark days of falsified medicines. The other day, the Federal Ministry of Health sounded an alert on the existence of fake hand sanitizers circulating in the Federal Capital Territory. That is exactly part of what I am talking about,” Amibor said.
On possible sources of fake and substandard drugs at times like this, the pharmacist said: “Charlatans, drug merchants, unscrupulous patent medicine dealers, drug hawkers, open drug markets are all sources of falsified and substandard medicines in Nigeria. There is indiscriminate hawking of medicines in public places and the open markets, motor parks, buses and along the streets and these largely constitute sources of fake and substandard medicines in Nigeria. All these groups mentioned are capitalizing on the challenges of medicines unavailability and high cost to revisit falsification of drugs in Nigeria.”
On the implications on efforts to contain COVID-19, Amibor said the indiscriminate hawking of drugs in public places and the open markets, motor parks, buses and along the streets has become a common feature in most cities and rural areas and definitely constitutes a threat to control efforts for COVID-19. For one, the pharmacist said patients prescribed medications for control of COVID-19 such as Hydroxychloroquine and Azithromycin, who feel the prices in pharmacies are beyond their reach, may end up purchasing the falsified or substandard medicines from the open drug markets or unlicensed patent medicines vendors who they feel might sell cheaper, oblivious of the fact that they could be fake or substandard.
“And of course, when that happens, you can be sure that such patients’ conditions may get worse and they may end up developing respiratory and other complications with possibility of death. Yet some Nigerians who are managing their COVID-19 at home by self-medication may patronise the quacks because of their cheap prices without suspecting they could be purchasing falsified or substandard medicines. All these have negative implications for the control efforts of COVID-19 since morbidity and mortality from the infection will continue unabated. Nigeria has lost millions of naira to the activities of these drug merchants, since the outbreak of COVID-19,” Amibor said.
On recommendations to address the situation, Amibor said the challenges posed by drug hawkers and fakers are enormous. He said one major challenge pharmacists are encountering in exercising absolute control over drug distribution in Nigeria is the fall out of absence of drug distribution guidelines, which has meant that anybody can access any medicine from any shop in Nigeria without prescription.
The pharmacist said patent medicine shops stock medicines beyond their scope, while some are even said to administer injections behind their curtains. He said they are enabled to perpetuate all these because the laws guiding sale of medicines in Nigeria are either obsolete or are not being implemented because of impediments on the path of regulatory agencies. The AHAPN boss said they are having a jamboree selling all kinds of substandard products, making merchandise of ignorant clients and feasting on the absence of proper regulatory framework for drug distribution in Nigeria.
Amibor said the Pharmaceutical Society of Nigeria (PSN) is collaborating with the government regulatory agencies, Pharmacists Council of Nigeria (PCN) and NAFDAC to ensure strict regulation of medicines sale in Nigeria. He said PSN, the umbrella of all pharmacists in Nigeria, has been championing advocacy for sanitisation of the chaotic drug distribution system in Nigeria for some time now. He said PSN in collaboration with the PCN the government regulatory agency in charge of pharmacy practice in Nigeria, came up with a set of guidelines known as National Drug Distribution Guidelines (NDDG), designed to sanitise and bring order to medicines distribution, using the concept of Coordinated Wholesale Centres (CWC).
Amibor said a major component of the guidelines is to build mega drug distribution centers, under the control and supervision of pharmacists, to replace the open drug markets. He said the guidelines were presented to the Federal Ministry of Health over three years ago; unfortunately since then, not much action has been taken.
Amibor said the takeoff date of the implementation of the NDDG has been shifted severally, meanwhile medicines falsification is gradually returning. Implementation of the guidelines will lead to better control and regulation of medicines distribution and sales in Nigeria. He said what is needed now is for the relevant authorities to summon the political will to implement the guidelines in Nigeria.
Secondly, he said PCN in 2018, came up with a Bill known as the Pharmacy Council Bill of 2018, which among other objectives targeted sanitizing the chaotic drug distribution system in addition to reviewing obsolete pharmacy laws. He said the Bill was passed by the immediate past National Assembly, but was not signed into law before the winding up of the last legislative assembly. Amibor said right now, the Bill has been represented to the current National Assembly and it is hoped that it will be passed and signed into law early enough. He said that Bill contains enough provisions to deal with the chaotic drug distribution in Nigeria and pharmacists are pleading with government to sign the Bill into law early enough to bring order to medicines distribution and for better regulation of pharmacy practice.
Thirdly, Amibor said there is need to empower the regulatory agencies, PCN and NAFDAC by recruiting additional personnel and making resources, including vehicles available to enable them embark on routine inspection activities regularly. Additionally, he said there may be need to set up a Task Force on Falsified and Substandard Medicines as we had in Nigeria several years ago. “The PCN has what they call Pharmaceutical Inspectors Committee, charged with inspecting premises where medicines are sold. A major challenge they encounter is that after a raid, seizure of unwholesome medicines and closure of such premises, the next thing you see is that after some days, those premises are back again to business. These are some of the challenges the government will need to look into,” he said.
Amibor added: “Finally, only recently, the government through the Central Bank rolled out an intervention Fund for the healthcare and pharmaceutical sectors of the country. Not all importers or manufacturers who applied for the funds have accessed it yet. This is an appeal therefore for relevant bodies to fast track access by all intended drug manufacturers and importers so they can bring in the much-needed essential medicines, which will in turn force prices of medicines down, discourage faking as well as rejuvenate the medicines supply chain in Nigeria.”
A virologist/vaccinologist and Chief Executive Officer (CEO) of Innovative Biotech, Keffi, Nasarawa State, and Innovative Biotech, United States of America (USA), Dr. Simon Agwale, told The Guardian: “It is well known that underground markets that sell drugs tend to flourish in times of crisis, and the COVID-19 pandemic is no exception. Some of the possible sources include, but not limited to importation, Internet websites that look like ordinary e-commerce websites, dedicated group-chats and channels on encrypted instant messaging services like WhatsApp and ICQ. This according to experts will create a parallel pandemic of substandard and falsified products which could led to serious sides effects and toxicities.”
Agwale said: “My recommendation as always is to promote local manufacturing of our health products because it is easier for regulatory authorities to monitor factories locally than to regulate imported products.”
Former President, PSN and Chief Executive Officer (CEO) of TOGMED Ventures, Olumide Akintayo, told The Guardian: “I cannot confirm there is rise in fake and substandard drugs because as experimental scientists, we are compelled to rely strictly on empirical data at all times. It is very important to stress at any rate that some of the factors, which drive circulation of fake, counterfeit and substandard drugs are scarcity or exorbitant prices of genuine stock. If any of the core drugs for treatment is scarce, you can be sure that merchants of death will explore the lacuna to lubricate their machines of destruction. This is same if prices skyrocket because they fill a gap that suits the pocket of the uniformed and the poor.”
Akintayo the sources of fake, adulterated, counterfeit, falsified and substandard drugs remain the same. The consultant pharmacist said if over 70 per cent of all drug needs are imported from India and China, then it is logical to believe a commensurate but gargantuan quantum of the fakes and substandard items are also from the destination countries where the country sources imported lines. “Similarly, the local sources of fake drugs will remain alive. A seeming reluctance to allow the full weight of the law to come against the structures of violators in the Drug Distribution sector ordinarily incentivises the merchants of death who specialize in faking,” he said.
Akintayo said if the faking postulation or is it hypothesis is found to be true, then of course it out-rightly jeopardises the goal of drug therapy as an integral part of the management of COVID-19. He said the obvious fall-out would include depending on exposure, patient vulnerability in terms of underlying clinical disease status morbidity, mortality/fatality, therapeutic failure, drug resistance and much more to sound very modest.
The consultant pharmacist said Nigeria is basically sick because the country has continued to fail in the quest to build systems and institutions based on invincible structures.
Akintayo said the Federal Ministry of Health (FMoH) in the last five or so years has been led by substantive Debtor-Ministers who appear to be experts in failure with due respect to the last three successive ministers in particular. He said policy somersaults are commonplace in the health sector because the FMoH has gradually become a cemetery of progressive ideas.
How can the situation be addressed? Akintayo said: “With respect to the specific subject matter which is how to tackle the distribution of fake, sub-standard and counterfeit medicines, you will recollect that the Federal Government (FG) through the FMoH had adopted a National Drug Distribution Guidelines (NDDG) policy as far back as 2014. Pharmaceutical stakeholders sought and got an approval to replace the unlawful Open Drug Markets (ODM), which have been proven to be the sources of fake drugs with a Coordinated Wholesale Centres (CWC) as a compromise position since 2015. On the basis of this, a deadline was declared for the sealing of ODM in Nigeria.
“Thrice in his inglorious era, the immediate past Health Minister shifted the deadline to dislodge the ODMs. The incumbent who recently declared that all the operatives at the FMOH are Doctors is certainly not aware of endeavours of this nature because he has a wrong mentality and mindset.
“In Lagos, I am aware that some of the operatives in the ODM at Idumota had started the journey to a Lagos CWC since 2016, but the lukewarmness of the Health Minister who should champion this agenda appears to have jeopardized the CWC initiative in Nigeria.
“The regulatory agencies which should also anchor this endeavour especially the PCN is also in avoidable distress of a crises imposed deliberately through wrongful and probably unlawful appointments thus reducing any chance to prevail anytime soon in our ailing Drug Distribution Channels.
If the truth must be told, only a total restructuring of the dysfunctional and malfunctioning FMoH can save Nigeria from the tragedy of fake drug circulation.”