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
THeglobal health challenges caused by poor quality medicines and approaches to achieving quality-assured medicines in lowand 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 or- ganisation 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.
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