Poor regulation, corruption, scarcity, quacks escalating fake drugs in Nigeria

By Adeze Ojukwu

Fighting fake drugs is tough everywhere. In Nigeria the battle is even tougher.

Systemic deficiencies and endemic corruption, pervading the  public sector, have combined with other negative forces to undermine the war and best practices in the nation’s health system.

With bribery rife among the rank and file in government circles, it takes little or nothing to ship in containers of adulterated medicines into the country.

Sadly the  cartel behind the invincible trade is both vicious and  formidable. The sophistry involved is equally very ingenious and complex.

However the seeming ‘ingenuity’ thrives, essentially due to faultlines and fraudulent activities, allegedly perpetrated by some scrupulous elements in  regulatory agencies.

Licensing of non-pharmacists and  traditional medicine practitioners, who  inundate the market with questionable products, some of which are highly toxic and lethal is very worrisome and disconcerting.

According to stakeholders, virtually every mile in the  entire strata of production, importation and distribution of substandard products, is riddled with high-level sharp practices.

Efforts to flush out these rogues and their enablers, are often ineffective, because these illegal operators deploy various vicious tactics to escape surveillance and arrest.

In some cases, these criminals threaten the lives of officials and whistleblowers, just to short-change gullible end-users.

Indeed sanitizing the pharmaceutical industry has become imperative. The consequences of not doing so is certainly a disservice to the nation and its hapless citizens.

However this operation requires concerted strategies and synergies, among regulatory authorities, health practitioners, stakeholders, media and the public, in order to effectively kick out the evil merchandise.

This was the consensus among pharmacists, medical experts and participants, at a recent summit tagged ‘Intensifying the fight against fake drugs in Nigeria.’

The colloquium featured top pharmaceutical chieftains and prominent personalities, who brainstormed over innovative strategies to accentuate the battle against substandard and adulterated drugs.

The keynote address from the Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Mojisola Adeyeye focussed on deploying  technology, detection and enforcement  in checkmating the menace.

She was represented by Pharm. Joseph Asikpo, Deputy Director and Chairman, NAFDAC Substandard and Falsified Medical Products Taskforce, Hajj. Fatima Abubakar of Drug Evaluation and Research Directorate and Pharm. Adesanya Oluwaseun, the NAFDAC/WHO Focal Person on Substandard and Falsified Medical Products.

Other speakers included former President of Pharmaceutical Society of Nigeria(PSN), Amb. Ahmed Yakasai and Ms. Elizabeth Mattfeld of United Nations Office on Drugs and Crime(UNODC).

The programme was  executed, under the aegis of the Coalition of Development Advocates and Health Journalists(CODAHJ), established for the promotion of social and economic reforms in society.

The advocacy group was initiated by Mrs Adeze Ojukwu, a Fellow of Hubert H Humphrey Fellowship and publisher of Devcomradar.org magazine, in partnership with Dr. Godwin Uwaoma, a public health physician and founder, Association for Peace and Development Initiative (APDI).

The summit was moderated by accomplished broadcaster, Soni Irabor, as well as Managing Director of Evans Baroque Pharmaceutical company, Mr. Onyeka Onyeibor.

The awareness campaign was supported by NAFDAC, Safe Medicines Foundation, Engr Anthony Akpokene, Chief Executive Officer of Polygon Energy Services and FLOMAT Books and Dr. Okon Okon-Umoren, Executive Director, Africa Vision Tract House Society (AVTHS).

Others included Vice President of United States Government Exchanges Alumni Association (USGEAA), Mr. Joseph Iorwuese and Engineer Adegbemi Adekambi of AVTHS as well as Intelligent Youths Against substance Abuse Foundation (IYASAF).

‘The exercise is in line with our commitment towards improved access to basic amenities and health care for all citizens, crucial for the implementation of Sustainable Development Goals(SDGs) in Nigeria.’

According to the World Health Organization(WHO), one in 10 medications sold in Africa are either fake or substandard, with a high prevalence in Nigeria.

The Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, said ‘substandard and falsified medicines particularly affect the most vulnerable communities.’

‘Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die.’

‘Consumption of adulterated products devastates the health of citizens and damages the image of the country and its pharmaceutical manufacturing sub-sector.’

‘It also undermines the excellent work being undertaken by genuine pharmacists and drug manufacturers in Nigeria.’

Several research findings have revealed that some of these products contain little or no active ingredients, thus prolonging illness, complications and emergencies.

‘As a result, people inadvertently, take medicines that are not only deficient but life-threatening conditions, in some instances,’ he noted.

‘The economic losses, associated with this ugly trend are equally huge, as these phony drug manufacturers use spurious tactics to sell their lethal wares to unsuspecting individuals and health systems, causing organ failure, mortalities and morbidities.’

‘Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat,’ he added.

‘In 2018 alone, data from the National Agency for Food and Drug Administration and Control, NAFDAC, revealed that the agency destroyed fake foods and drugs worth N4.7 billion in four exercises in Abuja as well as three states including Ogun, Kaduna and Gombe.’

‘Undoubtedly, the fake drug syndrome, can be tenaciously addressed, through a renewed media and mass sensitization campaign, to boost public awareness about current regulatory policies and enforcement efforts by NAFDAC and allied organizations.’

‘This advocacy is therefore timely and strategically, positioned for policy makers, pharmacists and health experts to continue to address the numerous challenges and enunciate practical steps towards eradicating  unwholesome products.’

‘For effective delivery of   objectives of the summit, the coalition is collaborating with several online and mainstream media organizations to ensure adequate coverage and promotion of the recommendations.’

The sensitization project targets the general public, as well as chemists, dispensaries and health centers, particularly in rural areas.

‘Top health professionals and media arsenals are working, concertedly, with policy makers, regulatory authorities and industry players to promote more public interest about the dangers inherent in  patronizing these substances, through this discourse.’

Find below the incisive views advanced by the accomplished  speakers and participants at the health conclave.

Prof.  Mojisola Adeyeye Director General, NAFDAC

The prevalence of substandard and falsified medical products has been acknowledged as a global threat to humanity.

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.

With Nigeria, being an import-dependent country for Active Pharmaceutical Ingredients(APIs) and finished products, prices of drugs have increase rapidly as a result of the lockdown placed by several countries at the outbreak of COVID-19, as well as restrictions on export of finished products and APIs.

This has led to drug scarcity as well as higher prices of essential and non-essential medicines in the country as supply struggles to catch up with demand.

NAFDAC has adopted several strategies in countering the prevalence of substandard and falsified medicines in Nigeria amongst which includes the frameworks of prevention, detection and response.

In order to prevent the distribution of falsified medicines, NAFDAC has put in place the following strategies such as, increased surveillance on regulated products as well as public alert notices to consumers, retailers, distributors and importers of medical products.

The agency has also increased the capacity of the laboratory to carry out standardization tests on all regulated products.

Furthermore it has developed regulations to address gaps identified around NAFDAC activities as well as initiated more collaborations with stakeholders, for instance in Clean Report of Inspection and Analysis(CRIA).

Major activities include conduct of Risk-Based Post Market Surveillance(RBPMS), capacity building of laboratory analysts and upgrading of her laboratories for efficient detection of falsified medical products.

Other areas of focus include procurement and deployment of field kit/detection technologies such as RxAll Scanner/Additional Truscan  devices, for the detection of   falsified medicines.

The agency has also established traceability techniques and intensified regulatory sanctions.

This is more effective and faster than prosecution, because it involves putting on-hold of production line, suspension or revocation of a license or deregistration of a product.

NAFDAC also utilizes Quality Management Systems(QMS), ISO 9001 certification and WHO global benchmarking and assessment to promote integrity in the sector.

Pharm. Ahmed Yakasai, Fellow Pharmaceutical Society of Nigeria (FPSN) Founder/Chairman of Safe Medicines Foundation(SMF) and former President, PSN

Safe Medicines Foundation which is a public health group totally committed to the safety of all medicines and protecting consumers against substandard and falsified or otherwise unsafe medicines.

Health/Pharmatech Industry is emerging and able to address the fault lines that enable falsified drug distribution and attraction which can be categorized into three areas namely access to genuine medicines at last mile, for example, myMedicines.com, affordability of medicines, as well as the quality of medicines.

I will dwell more on the technology which must be embraced. We need RxALL, which checks drug with Nanoscanner. It is a new technology developed by a Nigerian pharmacist Adebayo  Longe.

The platform, enables real time drug-testing and tracking of drug quality tests using artificial intelligence.

We need it, if we really want to fight against fake drugs in Nigeria.

It helps Federal Drug Agencies(FDAs) and Pharma companies audit medicines using Nanoscanner and phone apps in 20 seconds identifying the drug and its quality level which is a backend cloud-based platform tracking all tests and showing where bad drugs are showing up the percentage quality and what batches are poor quality. It is also good for post marketing surveillance and inspections at ports.

With RXALL technology, reports can be sent directly to the pharmaceutical companies and  FDAs from Stakeholders in the field.

Scans are recorded on the block chain, enabling the tracking of product quality across the supply chain.

I am happy that NAFDAC launched Pharmaceutical Traceability Document and Traceable Desk with implementation of the Technical Working Group with five-year plan ending 2024.

We need more emphasis on post marketing Surveillance as well improve our drugs supply chain and distribution system, hence the need to dust and revisit the idea of distribution of drugs on PharmIT initiated during my tenure as the President of PSN, which is a transparent IT-driven and robust drug distribution network.

Lastly, all hands must be deck to help NAFDAC execute its mandate effectively including the  customs, police, judiciary, pharmacists, doctors, scientists, food technologists and consumers. You cannot have quality of care without access to good medicines.

Ms Elizabeth Mattfeld, Project Coordinator of Prevention, Treatment and Rehabilitation Unit Drug Prevention and Health Branch UNODC.

Lack of access to essential controlled medicines in the regulated market may contribute to falsified medicines.

During the last ten years, increased discussions and debates have centered around the barriers to accessing controlled medicines, and the need for governments to overcome those barriers in order to provide access.

More than 80 percent of the world’s population are still without access to controlled medicines.

Countries should define the roles of the pharmaceutical industry and increase the authority as well as resources and use of the existing electronic import/export systems.

Government needs to define the role of pharmaceutical industry, streamline registration and licensing requirements that result in a lack of availability or access, such as a lengthy process to register pharmacies or a high fee to stock controlled medicines in particular.

Additionally, it should incorporate strategies related to screening and identifying fraudulent controlled medicines in line with the existing national policies.

In summary, increasing access to and availability of controlled medicines that are affordable to the majority of patients requires the integration of actions within the three ‘core areas’ of system integration, education and a supply chain that is responsive to the needs of patients.

A key element of success is embedded in a high level of political commitment from the outset and a willingness to take an integrated and strategic approach with patient health as the focal point.

Efforts should be made to address lack of education and awareness, which are barriers to availability of medicines.

They should address this deficit not only at the level of health care workers, but should include also policy makers, community leaders, faith leaders, emergency or first responders, caregivers, and patients.

We need a flexible drug supply chain, with the rights of  patient at its center, in order to reduce the demand for fake medicines.

As medications become scarce and expensive, with COVID-19 disrupting the supply chain, people turn to non-regulated sources to decrease their suffering and address their health needs.

Countries should adopt a patient-centered approach by improving access to drugs, strengthening the health systems, promoting staff training and  community awareness.

Fostering synergies among regulators, practitioners, media and all stakeholders is crucial for better cohesion and  outcomes.

Therefore we need a strong and controlled supply chain to ensure, for instance that when COVID-19 vaccine will not be falsified.

The target is to ensure health equity, particularly in this difficult period of COVID-19.

People should not settle for substandard medicines, because human right is tied to our health.

The right to health is a human right, especially quality health.

Prof. Olayinka A. Abosede, (rtd) Community Health & Primary Care of the College of Medicine, University of Lagos, a Hubert Humphrey Fellow, from Johns Hopkins University, USA and pioneer Chairman of the Lagos State Primary Health Care Board ( 2009 -2012).

A long term, sustainable solution to reduction of demand for fake drugs requires a functional community-based health care system.

Consumers are forced to buy fake drugs because even basic health services are unaffordable for a high proportion.

If health facilities have appropriate staff, equipment, materials and essential drugs, demand for fake drugs will reduce.

Self medication is very common especially where quality, basic health care services are not readily accessible and affordable.

One of the long term solutions to the menace of the sale and utilization of fake drugs is demand reduction.

This can be achieved when Primary Health Care (PHC) services,at the first point of contact with the health system, are appropriate, have the needed manpower, equipment, materials and essential drugs that are authentic.

Ideally, every ward in Nigeria should have at least one functional PHC facility where the ward Health/Development Committee (WHC/WDC) partners, with the health care providers to ensure quality services. If needed drugs are always available at a community/ward’s health facilities/registered pharmacies at affordable costs, the challenges of fake drug utilization will be drastically reduced.

Professor Lere Baale of Organization Transformation in Business School Netherlands, International Director of World Institute of Action Learning, board member, Forbes Biz Council, Stetson University TLAC, Florida USA and alumnus of Haggai Leadership International.

Falsified medicines  involve various levels of  infringements. Therefore it is not every Cotrimoxazole, that is septrin, unlike what some prescribers think. It is  not every Paracetamol that is Panadol. Not every Piroxicam is Feldene.

Also the economic search for cheaper generics also plays a role in the supply of falsified medicines.

I am very pleased to refer to the United Kingdom(UK)  Medicines and Healthcare products Regulatory Agency (MHRA)  second Anti-Counterfeiting Strategy.

The first was launched in November 2007, as a response to the most serious infiltration of falsified medical products in the UK regulated supply chain which followed a number of previous incidents. On these occasions, the visual appearance of the products concerned convinced dispensers that they were genuine.

It was not until expert analysis of the packaging and chemical analysis of the product were conducted that they were found to be falsified.

These serious incidents provided the trigger for the development of a comprehensive strategy aimed at minimizing this tangible and worrying threat to public health. The first strategy set out a three strand approach drawing together communication with the public and healthcare professionals, collaboration with relevant stakeholders and a range of regulatory activities to mitigate the threat.

As a result of implementing the strategy in 2007, the MHRA has seen a marked reduction in known incidents of falsified medical products which have penetrated the regulated UK supply chain. In 2009 the MHRA recalled one batch of falsified product on one occasion.

In 2008 and 2011 respectively, there were individual incidents of authentic products packed in falsified packaging reaching the UK market which were intercepted at wholesale level before being sold on to pharmacies.

However improved international collaboration has revealed clear evidence that the UK pharmaceutical market is still attractive to counterfeiters. Consignments of falsified high value medical products have been seized en route to the UK and this has shown that those engaged in this activity have employed sophisticated methods of concealment to transport the product across the world. There is no room for complacency.

High value medical products with a high turnover combine with large and complex supply chains to maintain the UK as an attractive and lucrative market for falsified medical products.

Incidents of falsified medical products reaching pharmacies are mercifully rare but access to falsified medical products is more common through unregulated websites.

This strategy also details the measures taken by the MHRA to tackle this complex aspect, bringing together relevant stakeholders and international partners to combine efforts in raising public awareness and carrying out proportionate enforcement activity.

Efforts to combat falsified medical products call for partnership working and extensive international collaboration.

There is clear evidence to show that producers of falsified medical products who have historically targeted their products against the developing world, now also target a broad range of medical products and therapeutic categories across developed markets.

Onyeka Onyeibor, MD Evans Baroque Pharma

The current economic challenges and poor purchasing power of many citizens, create incentives for falsified and unsafe drugs.

The regulatory authorities need adopt a different approach in order to achieve better results.

Some victories have so far been won, but things need to be done differently to stem the fake drug pandemic.

We need to strengthen the management, protocols and  surveillance involved in the entire process.

Adaku Efuribe, UK-based pharmacist, United Nations (UN) SDG advocate and ONE Youth Ambassador.

We do not have enough doctors and pharmacists to serve our over 200 million population.

To encourage community healthcare, we need to utilise the integrated healthcare model by training and engaging more community healthcare workers, nurses and healthcare assistants and residents  in public health projects.

This would ensure, that no one is left out of basic universal health coverage at the grassroots.

An effective way to checkmate proliferation of fake drugs in Nigeria is to close down the open drug markets,  then establish manufacturing hubs, state drug distribution companies and to ensure only licensed pharmacists/pharmacies are fully in charge of drug distribution.

Enforcement remains severely handicapped by weak laws and regulations for tackling counterfeiters.

So we need to ensure that we have the mechanisms in place to enact and enforce laws to checkmate proliferation of fake drugs.

Also a multidisciplinary team approach will enhance effectiveness in the nation’s health sector.

To build an efficient sustainable health system, all healthcare worker salaries should be revised and harmonised so that people can be rewarded as well as gain some fulfilment for the services they offer, the focus should not be relativity or superiority in my opinion.

We must utilise the expertise of medical and healthcare professionals for a sustainable health system that put people first.

The United Nations(UN) recognizes that  the number of pharmacists is important for wellbeing.

The density of pharmacists will now be taken into account in measuring the achievement of the United Nation’s Sustainable Development(SDGs) Goal 3.

To achieve sustainable health systems, we need to reduce inequalities in health serviced, by bridging the gap between the rich and poor.

Public healthcare services should be provided in deprived areas.

Additionally health promotion exercises, will go a long way to ensure healthy lives and wellbeing of the citizens.

In order to achieve this, education and public health campaign strategies should be adopted to foster healthy living lifestyles, exercise, cutting down on alcohol consumption, quitting smoking as well as banning smoking in public places, because it endangers others.

Dr. Godwin  Uwaoma, Public Health Physician and Founder Association for Peace and Development Initiative (APDI)

Fake and adulterated drugs have changed the way they present currently.  NAFDAC has done a lot to control it yet the problems still persist, because of financial benefits to the perpetrators.

A lot of alternative medicine practitioners and traditional healers market products that bear NAFDAC number.  How does NAFDAC ascertain the efficacy of these drugs? What informs the issuing of these numbers?

Distribution of drugs in Nigeria is very suspect.  We see drugs being distributed by people who do not have the requisite qualifications to be so occupied.

The end users are doctors who prescribe to patients. There is a need for doctors and pharmacists to synergize with the ministries of health in the states and at the federal level.

Reorganization of the distribution chain is essential, if we must combat this menace.

We need enlightenment at the retail level, in terms of vigilance to detect fake drugs and in terms of helping with arrest and disabling of the perpetrators.

Government needs to ascertain if we still need patent medicine dealership in Nigeria today?

It also needs to upgrade relevant policies to take care of drugs dispensing in the country.

Soni Irabor, ace broadcaster and advertising practitioner

A lot has unfolded at this webinar. Clearly there is a disconnect among the health professionals.

Also NAFDAC should do more. Government should give you  more money so that you can successfully monitor, investigate and carry out your duties. Stakeholder engagement is inevitable to winning the war against unauthorized  medicines.

Polycarp Mbah, a pharmacist and Missions Director, AVTHS

All over the world, drugs  go through professionals.

In other countries drugs are not classified as ordinary goods.

In Nigeria drugs are treated as goods. Persons who do not have understanding of drugs operate freely in the sector more  than the professionals.

In fact persons who do not have any understanding about drugs are more than the professionals in the drug distribution network.

Quacks are everywhere. Our health ministries have kept quiet endangering our citizens. Health care service is the booming business for any body.

The distribution of drugs in Nigeria is the most chaotic in planet earth.

Quacks cut corners and edge out those trained to do the job, thus endangering the health of our people.

Pharmaceutical Council of Nigeria(PCN) has not done well because licensing quacks is an error.

The earlier that is stopped the better for the country.

There is no synergy among health professionals, which endanger the lives of patients. The practice is equally chaotic, because some profession usurp the roles of others.

Also government should standardize our education.

When we have substandard education how can we produce standard professionals.?

Engineer  Agbotiname Imoize, German Academic Exchange Service (DAAD) Research Scholar at Ruhr University, Germany,  Fulbright scholar and lecturer in Department of Electrical and Electronics Engineering, University of Lagos

It is important to promote robust collaborations and synergies among regulatory agencies and other experts in different fields.

For example, the pharmacists and pharmaceutical professionals need to collaborate with computer scientists and engineers to develop appropriate Machine Learning-based algorithms for easy identification of fake drugs.

A database of the licensed practitioners, especially the product manufacturers and distributors need to be well tracked and highly regulated. The media will also play a key role to inform members of the public about fake drugs and companies or parties promoting fake drugs.

Amb. Sunny Irakpo, Youth advocate and founder, SILEC Initiatives

It is unfortunate that Nigeria has become a destination for  suspicious pharmaceuticals products due to nefarious activities of  unauthorized dealers.

Government should strengthen all regulatory and enforcement policies in order to checkmate these evil  trade, that have sent many nationals to untimely and unnecessary deaths.

Indisputably, the implementation of the diverse and profound recommendations generated at this international summit, will surely contribute significantly towards the eradication of unsafe medications from Nigeria.

.Ojukwu, a journalist, publisher and Fellow of  Hubert Humphrey Fellowship, wrote this treatise, to intensify the  advocacy for the promotion of quality health care delivery and optimal socio-economic services, as well as the implementation of Sustainable Development Goals (SDGs) in society. Kindly send feedback to [email protected]