Addressing concerns over rise in poor quality medicines
• 75% substandard oxytosin samples present in Nigeria, contributes to increased maternal mortality
• PQM programme will increase supply of quality-assured drugs, curb market failures, says Anyakora
The global health challenges caused by poor quality medicines and approaches to achieving quality-assured medicines in low-and middle-income countries (LMICs) like Nigeria has remained a huge burden.
According to the World Health Organization (WHO), roughly one-third of the world’s population lacks access to even the most basic essential medicines — a figure that climbs to nearly half the population in the poorest parts of Asia and Africa.
The WHO estimates that 10 per cent of medicines in LMICs are either fake or substandard, and a new study published in the JAMA Network Open journal suggests that this number may even be close to 19 per cent in sub-Saharan Africa.
This, according to experts is as a result of unavailability of essential and generic medicines, lack of access to treatment due to cost, as people may be inclined to procure medicines from informal sources, such as markets, which typically contain medicine of unknown origins that could often be falsified and substandard, and may be less effective, toxic, or even lethal.
In addressing these issues by ensuring steady supply of affordable, quality-assured medicines in communities across Nigeria, the Head of Party, United States Pharmacopeia (USP) in Nigeria, Dr. Chimezie Anyakora, explains the importance and focus of the Promoting Quality of Medicines (PQM) program in the country – from working closely with pharmaceutical manufacturers, to correcting for market failures and addressing supply chain issues.
About the PQM programme in Nigeria
He said: “The PQM programme is funded by the U.S. Agency for International Development (USAID) and implemented by the USP, a nearly 200 year-old American nongovernmental organisation whose mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
“In Nigeria and many lower- and middle-income countries throughout the world, the PQM programme is working to prevent a major health challenge—preventing poor-quality medicines from reaching patients. In the context of the worldwide and regional statistics, by the World Health Organisation, Nigeria is one of the PQM programme’s focus countries. Thus, PQM supports the country with expertise from both its headquarters in the U.S. and a local office in Lagos. This intense level of assistance has been going on for the past five years.
“One of our main objectives is to ensure the sustainability of our activities when the program ends in September 2019. This will come through a combination of country ownership and collaboration with future programmes like PQM.
“The PQM programme works with governments to strengthen regulatory systems and with manufacturers to increase the supply of quality-assured medicines. Like in any programme funded by USAID, PQM considers the in-country organisations it supports to be partners and seeks to meet those organisations’ goals.
“On the regulatory side, our partner in Nigeria is the National Agency for Food and Drug Administration and Control (NAFDAC). Regulators like NAFDAC are essential in ensuring the quality of medicines in the country because they are in charge of approving new medicines for the national market and monitoring the quality of medicines in circulation. PQM is particularly working to ensure that NAFDAC’s product testing laboratories gain accreditation from the International Organisation for Standardisation (ISO), which means their facilities and the tests they conduct meet international standards. In other words, the results of any test they conduct will be recognised and accepted worldwide.”
On the issue of High maternal mortality and the rising cases of cesarean sections, how does this link up with the issue of assumed substandard oxytocin circulating in Nigeria and what is PQM doing about it?
Anyakora said: “Oxytocin is a life-saving medicine, which also means administering substandard or fake oxytocin to a patient can result in death. It is used to induce contractions during labour and prevent post-partum haemorrhage. In remote areas where safe caesarean sections are not possible to perform, oxytocin’s utilisation for inducing contractions is all the more important.
“The important thing to know about oxytocin is that it should be stored in refrigerated conditions or its potency degrades. In other words, even if a dose of oxytocin is manufactured to standard, it may be of dangerous poor quality when it reaches a patient because the cold chain wasn’t respected during transport and storage.
He noted: “Two years ago we worked with NAFDAC to conduct a survey to determine the quality of oxytocin being used in Nigeria. The results were alarming—75 percent of the samples we tested were substandard. When we then did a second study to learn about doctors and nurses’ experiences, we learned that the proliferation of poor-quality oxytocin resulted in health professionals administering as many as five doses in a day to a patient in the hopes of effectively treating mothers in need. In effect, poor-quality oxytocin is affecting the confidence that patients and health workers alike have in the health system.
“To follow up these studies, we supported NAFDAC in sensitising stakeholders to the risk of poor-quality oxytocin and the origins of this risk. One result was that most companies that had been approved to sell the medicine in Nigeria withdrew from the market because they could not maintain cold chain storage.
Emphasizing on measures to take when existing sources of oxytocin are dwindling and the cold chain weak, Anyakora added: “PQM worked to identify and support local manufacturers to produce quality-assured oxytocin. One of such manufacturer is already doing so and others are expected to join in the near future. Because they are producing the product here in Nigeria, NAFDAC’s ability to regulate them has improved and, most importantly, the length of the cold chain is significantly reduced because long-distance transport is eliminated.
“PQM is also now working with the Ministry of Health on a study in seven states— Akwa Ibom, Ondo, Bauchi, Kano, Sokoto, Enugu and Lagos to determine the cost of cold chain and validity of the local cold chain.”
On the continuous rise in fake and substandard drugs in Nigeria
He said: “Finding and eliminating the sources of fake or falsified drugs is extremely important. And, it’s not easy. Increasingly complex global supply chains, along with sophisticated criminal networks, make the problem more challenging. Counterfeiters create almost indistinguishable copies of legitimate medicines that may have little or no therapeutic value, or may contain harmful substances. WHO also claims offshore foreign companies and bank accounts are used to facilitate the sale of falsified medicines.
“But, in the PQM programme’s patient-focused model, we don’t really distinguish between a medicine that has been willfully falsified and one that is substandard, either due to poor manufacturing or degradation along the supply chain. That is, we want to prevent all forms of poor-quality medicine from reaching patients. We thus ask ourselves mainly how we can strengthen regulation in Nigeria to better ensure that only quality-assured medicines come to market and we also ask ourselves what role pharmaceutical companies that follow good manufacturing practise can play.’
The concept of WHO pre-qualification as a recipe to also tackling substandard and fake product
He explained: “WHO pre-qualification of medicines is a program set up to help low- and middle-income countries, without very stringent regulatory authorities, have access to international tenders and supply of medicines globally. So any company that has WHO PQ will have access to international tenders and supply its medicines to different countries. Most donors require WHO PQ, stringent regulatory authority approval or in some cases expertise review panel recommendation for procurement.
“It is important to recognise that WHO pre-qualification doesn’t solve all problems related to medicines quality. It is specific to medicines that prevent or treat high-burden diseases. As of September 2018, the WHO’s list of prequalified medicines and finished pharmaceutical products included 532 commodities for treating Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), tuberculosis, malaria, neglected tropical diseases, influenza, and for reproductive health.”
The efforts of the USP in helping Nigerian pharmaceutical industry upgrade in terms of general manufacturing practice and getting WHO pre-qualification
Anyakora said” Nigerian manufacturing sector has made significant progress. Admittedly, we are not yet at the point of competing with foreign pharmaceutical companies for the international market, but we can say that three PQM-supported local companies are likely to get WHO prequalification next year and we see this as the beginning of a trend.
“The capacity building that PQM provides is funded by USAID. But, pharmaceutical companies receiving support have to be willing to make their own investment to upgrade their facilities and systems. This is where Nigeria offers a particular advantage. We are Africa’s largest country in terms of population. The investment that companies make to serve that population is a good one and can lead Nigerian manufacturers into becoming leaders for the entire continent when they attain international accreditation.
“But, again, the PQM programme is looking at the question of manufacturing from a patient-centred point of view. We highlight economics as an incentive to enroll manufacturers with the potential to produce quality-assured essential medicines, but view this as one piece of holistic approach to expanding patients’ access to safe medicines. Medicines are meant to treat people and shouldn’t make them sicker; and certainly shouldn’t kill them”
Relationship between USP and NAFDAC in trying to make these things work in Nigeria
He said: “NAFDAC and the PQM programme are partners. One of the most important changes we’ve accompanied NAFDAC in achieving is the introduction of post-marketing surveillance. This means that NAFDAC isn’t only deciding whether a product meets the necessary quality standards to be offered on the Nigerian market, but it now also monitors the quality of products in circulation. This is an important capacity for removing medicines that have lost potency along the supply chain like the oxytocin we discussed before and falsified medicines that are of such great concern.
“The PQM programme developes and promotes a risk-based approach to post-marketing surveillance through which efforts are focused on the medicines, locations, and drug samples that present the greatest health risks, thereby optimising human and financial resources while still protecting the public”
The issue of biovaccine lab with NAFDAC
He said: “Trends are changing. More medicines are coming in the form of biological. The PQM programme and NAFDAC have set a target for this year to ensure that NAFDAC laboratories meet international standards for testing biologicals and vaccines. Again, you can’t regulate what you can’t test.
“It is also our priority to have a Nigerian company produce vaccines. The federal government and May & Baker Nigeria PLC have signed a memorandum of understanding for such. The PQM programme is supporting this stepwise activity because it contributes yet another piece to disease reduction.”
Bringing in the programme into the universities in terms of their curriculum.
Anyakora noted: “I think it’s possible for Nigeria to become Africa’s pharmaceutical industry leader in the next five years. But, a well-trained workforce is necessary to make that happen. If India is one of the world’s most active pharmaceutical producers today, it’s certainly not by chance. They looked first at human resources and built from there. We have intelligent and talented people here in Nigeria. It pains me to see our country spending so much money on outside expertise when capacity can be built from within.
“With this in mind, we work with the Pharmacists Council of Nigeria (PCN) so that university-level curriculum can mobilise those who will lead Nigeria’s pharmaceutical sector in the future. We have begun with a pilot curriculum at Nnamdi Azikiwe University, Awka and will add new schools soon. We train faculty and provide them with necessary materials. We also teach students and bring them to pharmaceutical manufacturing facilities for field-based learning experience.”
But is that related to the Pharm D programme?
He explained: “The new Pharm D program has taken into consideration the aspect of building a workforce to support the impending growth in the pharmaceutical sector in Nigeria and to support continent as the source of pharmaceutical expertise for the region. I am happy that the Pharmacists Council of Nigeria made sure that the Pharm D program is focused on ensuring our needs as country are met. We need to have medicine security and the new program will address this.”
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