Health  

How to curb ‘fake’ food, drug products in Nigeria by PQM

Anyakora

Anyakora

• USAID-funded PQM provides technical support to NAFDAC, drug industries on quality assurance, security of medicines supply chain
• Plans to make Nigeria major pharmaceutical hub for Africa *Why generator fumes are linked to rising cases of cancer, sudden death 

Dr. Chimezie Anyakora is the Chief of Party for the United States Agency for International Development (USAID) funded programme, Promoting the Quality of Medicines program (PQM), which is implemented by the United States Pharmacopeia (USP) through a cooperative agreement with USAID.

With the USAID support, PQM is working to strengthen health systems in 35 countries across the world. Anyakora in an interview with The Guardian said the PQM programme is providing technical assistance and support to the National Agency for Food Drug Administration and Control (NAFDAC), the Federal Ministry of Health (FMoH), pharmaceutical manufacturers and other parties to improve access to quality medicines and protect the supply chain from poor quality products, contributing to improved health outcomes for the Nigerian population.

Anyakora who was a lecturer on pharmaceutical chemistry at the University of Lagos, said USP, which was founded in 1820, develops quality standards for medicines, foods and dietary supplements for ingredients and products marketed in the United States and that their standards for identity, strength, potency and purity are enforceable by the U.S. Food and Drug Administration (FDA) and are used in more than 140 countries in the world.

The pharmaceutical chemist said one of the many ways to fight fake and substandard drugs is to help increase the supply of good and quality assured medicines locally.

He said the PQM programme is interacting with faculties of Pharmacy and departments of Chemistry in Nigerian Universities to see how to contribute to a more up-to-date curriculum in their training. Anyakora also explained why having an electric generating set predisposes one to higher chances of cancer, heart attack, strokes and sudden death. CHUKWUMA MUANYA writes. Excerpts: 

HOW is PQM fighting the problem of fake drugs? PQM is very much interested in the public health of the Nigerian people and in the fight against fake drugs. One of the many ways to fight fake and substandard drugs is to help increase the supply of good and quality assured medicines locally.

USAID has invested heavily in this over the past years and the PQM program is one of such investment. With USAID support, PQM has helped many local manufacturers in Nigeria to attain international Good Manufacturing Practice (GMP) standards.

Currently, a number of Nigerian companies can participate in international tenders put out by United Nations Agencies. A number of these companies are receiving technical assistance from PQM.

USP, through the PQM Program and other initiatives – including USP’s Center for Pharmaceutical Advancement and Training (CePAT) in Accra and the Network of Official Medicines Control Laboratories (NOMCoL) – supports developing countries by promoting quality assurance for medicines.

The USP/PQM Program provides technical assistance and support to NAFDAC in many aspects of their regulatory functions especially in the area of quality control laboratories.

Right now, NAFDAC has a lab that can produce analytical data that are acceptable anywhere in the world and that have positive implications for the Nigeria pharmaceutical industry and in the fight against substandard or fake drugs.

PQM also supports NAFDAC and the Federal Ministry of Health in the area of quality assurance and security of medicines supply chain.

It seems this PQM programme you have just described has great benefits, what is the programme’s overarching vision for Nigeria? PQM’s mandate is to sustainably strengthen health systems in developing countries by building capacity in the regulation and manufacture of medicines, ensuring the availability of quality medicines needed for positive and lasting health outcomes.

Basically, PQM focuses on four basic areas: capacity building and strengthening of quality assurance systems; helping to increase the supply of quality assured medicines; combating counterfeit and substandard medicines and providing technical leadership and advocacy in the medicine quality assurance space.

The programme will have a local office in Lagos, which will be officially opened in 2016. That will allow PQM to work even more closely with our partners in Nigeria in their pathway to become a strong country in Africa when it comes to providing quality medicines and preventing counterfeit and substandard products.

What services do you offer to the general public? We contribute our quota by helping make sure that the medicines consumed by the public are of good quality.

We achieve this by partnering with NAFDAC in various ways and making our expertise and global experience are available to NAFDAC.

We do this also by working with local manufacturers to raise the quality standards for their products. Ultimately, going beyond Nigeria, medicines produced here will have a reputation for good quality in the region and improve the economy of the country.

The goal is to also have experienced quality assurance professionals, who can be available to play a role in improving public health. What have been the challenges and achievements? We have a peculiar kind of challenge.

We are overwhelmed by the demand for what we do. It is clear that Nigeria wants to be a big player in the pharmaceutical sector, from improving manufacturing quality standards to building capacity for pharmaceutical regulation and regulatory science.

It is exciting to have a program that is in great demand and contributing to improved health outcomes in Nigeria. The government of Nigeria and NAFDAC have invested heavily in improving its medicines quality assurance systems and by working together with PQM, they are committed to improve Nigeria’s capacity to manufacture good quality medicines and safeguard the supply chain from falsified, substandard and unapproved products.

With NAFDAC’s commitment and PQM support, some Nigerian manufacturers are now able to produce pharmaceuticals that meet the World Health Organisation (WHO’s) international standards.

The quality of these medicines is comparable to what you can find in countries with strong regulatory systems. With USAID’s support, we want to see an increase the number of those manufacturers, particularly those that can produce priority essential medicines.

Manufacturers who are not in the race for quality will naturally be taken off the game in a couple of years. Improving the quality of medicines from Nigeria’s pharmaceutical manufacturers positions Nigeria to becoming a major pharmaceutical hub for the region, thus contributing to foreign exchange earnings for the country as well as increases employment opportunities in the pharmaceutical sector.

Who are your key partners and targets populations? We work primarily with NAFDAC, policy makers, manufacturers, the medicine supply chain managers, the Federal Ministry of Health and its disease programmes in Nigeria, and the health professional associations.

Of course there are several other international agencies doing some great public health work in Nigeria and we also collaborate with them on areas with common interest. Our work directly contributes to improved health outcomes.

Every Nigerian, even the person living in the remotest part of the country is part of our target population. Improving the quality of medicines in the country impacts everyone.

Are you part of the global anti-counterfeiting crusade by the WHO through the Substandard, Spurious, Falsely-Labeled, Falsified, and Counterfeit (SSFFC)? USP is a globally recognized science-based standard setting organization that is a key contributor to international discussions on product quality around the world.

Nigerian researchers have also demonstrated that constant exposure to gasoline power generator could induce some biochemical changes, which may be toxic to exposed individuals and may lead to adverse health conditions such as cancer.

USP collaborates with the WHO Member States Mechanism on Substandard, Spurious, Falsely-Labeled, Falsified, and Counterfeit (SSFFC) medical products, the International Criminal Police Organization or INTERPOL- an intergovernmental organization facilitating international police cooperation- and other global initiatives that are focused on the prevention, detection and response to the public health challenges of SSFFC medical products.

We also raise awareness and share information and experience on SSFFC across the world. How do you intend to sustain the good work you are doing? USP began the formal process of establishing a local office in Nigeria, but PQM has been supporting Nigeria since 2012, when we started to work to strengthen the country’s capacity to assure the quality of antimalarial medicines.

In 2013, PQM activities extended to include manufacturers that produce maternal, newborn and child health priority commodities for the United Nations.

With our future local office and regular contacts with NAFDAC, we will be able to do more for the country and help support NAFDAC and other agencies and organizations that have the ability to contribute to improving pharmaceutical quality in Nigeria.

PQM provides technical support from a systems strengthening approach, and we are confident based on the improvements we have seen that NAFDAC can sustain the improvements and continue to serve the Nigerian people well.

To further ensure sustainability of our interventions, PQM programme is exploring ways to strengthen collaboration with academic institutions to contribute to the training of quality assurance personnel for the country.

We will be interacting with faculties of Pharmacy and Departments of Chemistry in Nigerian Universities to see how to contribute to a more up-to-date curriculum in their training.

Some of your published works have established that generator fumes are linked to rising cases of cancer and sudden death in the country.

How is that? Yes having an electric generating set predisposes one to higher chances of cancer, heart attack, strokes and sudden death. In one of our studies published in Biomarkers in Cancer we concluded: “The data available from this study shows that generator fumes contribute significantly to the atmospheric level of Polynuclear Aromatic Hydrocarbons (PAHs) and that the level is dependent on the distance from the point of generation.

PAHs are a major component of fuel generator fumes. Carcinogenicity of these compounds has long been established. “This suggests significant risk of cancer to the population in an environment where the use of generator is commonplace. Considering the lipophilicity of PAHs, small concentrations can accumulate over a long period of time.”

Lipophilicity refers to the ability of a chemical compound to dissolve in fats, oils, lipids, and non-polar solvents such as hexane or toluene.

The study titled “1-Hydroxypyrene Levels in Blood samples of Rats After exposure to Generator Fumes” was carried out by researchers from the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos and Department of Biochemistry, Faculty of Basic Medical Science, College of Medicine, University of Lagos.

The researchers include: Clinton Ifegwu, Miriam Igwo-ezikpe, Chimezie Anyakora, Akinniyi Osuntoki, Kafayat A. Oseni and eragbae O. Alao.

Nigerian researchers have also demonstrated that constant exposure to gasoline power generator could induce some biochemical changes, which may be toxic to exposed individuals and may lead to adverse health conditions such as cancer.

The study also published in Biomarkers in Cancer is titled “Exposure to gasoline power generator exhaust fume negatively affected hematological, liver and kidney function parameters in female albino rats.”

The University of Lagos researchers from the Departments of Biochemistry, Pharmaceutical Chemistry and Pharmacology include: Miriam Igwo-Ezikpe; Olufunsho Awodele; Chimezie Anyakora; Clinton Ifegwu; Bukola Owolabi; and Ayodele Oyewale.

The study investigated hematological, liver, kidney, hormonal and histopathological changes in female albino rats exposed to gasoline power generator exhaust fume at varied distance of 100, 200 and 300 meter respectively after 42 days.

The study showed that there was significant increase in packed cell volume, white blood cells, lymphocytes, neutrophiles, monocytes and platelets in the exposed animals compared to control unexposed rats.

Liver and kidney function parameters were also significantly increased whereas there were no significant difference in follicle stimulating hormone, prolactin, progesterone and estradiol amongst the animals, however, luteinizing hormone was increased in 300 meter exposed rats.

Histopathological investigation showed degenerated organs in the exposed animals compared to control. Generally, the observed variations in the parameters were proportional to the distance from source of exposure.



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