USP committed to quality assurance of medicines

• There is no magic wand to eliminating fake drugs, foods from circulation, says Anyakora

Dr. Chimezie Anyakora, a Pharmaceutical Chemist by training, is the Chief of Party of the United States Pharmacopeia Convention (USP) in Nigeria. Anyakora has been intensely involved in public health through his research for many years. In this interview with The Guardian, said he has tremendous confidence in the future of Nigeria’s pharmaceutical sector. He said there is no magic wand to eliminate falsified and substandard medicines and foods from circulation world-wide, but strengthening quality assurance systems is part of the prescription for containing them and preventing people from being exposed. The pharmaceutical chemist stressed the importance of including quality assurance in national plans for fighting the emergence of antimicrobial resistance. CHUKWUMA MUANYA writes. Excerpts:

Why is USP in Nigeria? What is your mission in Nigeria?
The mission of the USP is to improve global health through public standards and related programmes that help ensure the quality, safety and benefit of medicines and foods. Through one of these programmes, Promoting the Quality of Medicines (PQM), an initiative funded by the United States Agency for International Development (USAID) and implemented by USP, we collaborate with partners in government and industry to build local capacity in medicines quality assurance.

Assuring the quality of medicines is a global challenge that we must continue to ascertain and overcome collectively. Part of this task starts by building capacity locally. Having an office in Nigeria will enable us to better support our partners’ efforts to build capacity in the regulation and manufacture of medicines and assure the quality, safety, and efficacy of the medicines used in the prevention and management of diseases in Nigeria.

What have been the challenges?
There are many challenges in assuring the quality of medicines. One is the large volume of medicines in Nigeria that need quality testing and evaluation. Given the enormity of this task, Nigeria needs to develop additional technical, infrastructure, and human resources. With Nigeria being a major port of entry of medicines to the region, as well as a recipient of medicines from donor countries, there are a lot of medicines coming into the country and in circulation. We also have local manufacturers producing medicines for distribution to local, regional, and international markets. Thus, it is critical for Nigeria to continue to prioritize interventions and initiatives that strengthen medicines quality assurance systems. The effectiveness of the healthcare delivery system is dependent on it. Although there is an enormous amount of work to do, with collaboration we can expedite the process and see considerable progress.

Would you say you have achieved anything?
Speaking of progress, Nigeria has made great advances in medicines quality assurance recently, and I am very confident that the nation will continue to blaze a trail for other countries to follow that are also battling a proliferation of poor quality medicines. Over the past two years, the impact of our collaborative efforts has become quite notable, particularly in the areas of medicines quality surveillance, monitoring and evaluation, policy, regulation, and local manufacturing of essential medicines. We are especially proud of what our primary partner, the National Agency for Food and Drug Administration and Control (NAFDAC), has accomplished as a result of their intense quality assurance system strengthening initiatives. We are also proud of local drug manufacturer, Drugfield Pharmaceuticals, for stepping up during a crisis, which allowed the Nigerian government to continue to provide supplies of quality-assured chlorhexidine to prevent newborn infections and deaths after withdrawal of an unregistered, imported product that caused blindness.

I believe these efforts have put Nigeria in a better position to assure the quality, safety, and efficacy of their medicines, both now and in the future, but there is still much more work for us to do given fake and substandard medicines are not yet completely eliminated.

Fake and adulterated food and drug products are still big issues in Nigeria. Do you have the magic wand?
There is no magic wand to eliminate falsified and substandard medicines and foods from circulation in countries around the world, but strengthening quality assurance systems is part of the prescription for containing them and preventing people from being exposed. This is a battle for everyone that can be won in part through quality assurance, including the adoption and consistent application of quality standards for medicines and foods.

PQM works closely with the Ministry of Health and members of Nigeria’s pharmaceutical sector to strengthen parts of health systems where medicines quality is most affected. This helps ensure that Nigerians have increased access to quality-assured medicines and reliable protection from substandard and fake products. This work also helps ensure that the health services and programs dependent on quality-assured medicines have a chance at being effective, too.

Strengthening quality assurance systems and implementing sustainable solutions takes time, but the idea is that they will lead to desired health outcomes in Nigeria. So, while there are no magical or immediate solutions, the initiatives currently underway and planned can help significantly improve the quality of medicines and public health in Nigeria.

There is global fear that existing antibiotics have failed and even the anti-malaria drug of choice, Artemisinin Combination Therapy (ACT). Why is that? Is USP/PQM doing anything about this?
Recently, on August 26th, NAFDAC issued a warning to Nigerians about a fake antimalarial medicine, quinine sulphate, that was identified in circulation in Cameroon and the Democratic Republic of Congo. We commend the Agency for its vigilance and efforts to keep substandard, falsified, and unregistered antimalarial from Nigeria’s supply chains and markets, and for its regional coordination and communication.

Antimicrobial resistance compromises the effective prevention and treatment of a range of infections, including malaria; and thus represents a considerable public health threat. Though medicines regulation is the responsibility of individual nations, superbugs do not recognize national boundaries, and allowing poor quality medicines to prevail anywhere threatens the long-term effectiveness of efficacious medicines everywhere. Among the factors contributing to antimicrobial resistance, the role played by substandard medicines—products made by legitimate manufacturers that fall short of meeting established quality standards—is preventable.

USP and PQM are committed to medicines quality assurance, and we stress the importance of including it in national plans for fighting the emergence of antimicrobial resistance. Specifically, this should include continued work to build robust systems for post-marketing product quality surveillance and enforcement, as well as work with manufacturers to diversify sources of quality-assured antibiotics.

PQM is supporting NAFDAC in its efforts to strengthen its post-marketing surveillance function, which we anticipate will considerably reduce the presence of poor quality antimalarial medicines and their attendant implications, which include antimicrobial resistance.

Do you have plans to support Nigeria’s plans to resuscitate its vaccine production?
Ensuring the quality of vaccines is essential; however, PQM does not work on their production directly. We do support several systems strengthening initiatives that will help assure the quality of all medical products in the country, including medicines, vaccines, diagnostic tools, prophylaxes, and other technologies.

What is the relationship with government agencies such as NAFDAC and Nigerian Institute of Pharmaceutical Research and Development (NIPRD) who are supposed to be critical for you to meet your mandate?
PQM’s work is conducted in close partnership with national authorities, including NAFDAC and NIPRD. Our work in Nigeria is primarily to support them. PQM’s focus is on strengthening health systems in Nigeria. We are very grateful for the support of the Honorable Minister of Health through the Food and Drug Administration, and for their partnership and collaboration. We commend the Ministry’s great vision for medicines quality in this country.