In January 2012, at least 100 people died after receiving substandard medication while being treated at Lahore’s Punjab Institute of Cardiology. Unfortunately, this is not an isolated case. In 2008, more than half of antibiotics sampled in Egypt, Jordan, Lebanon and Saudi Arabia were found to be substandard. Similarly, poor-quality antimalarial medication is estimated to have cost the lives of 122,350 children under 5 years old in 39 sub-Saharan countries in 2013 alone. Falsified and substandard medicines have become a threat to public health, and risk undermining many of the gains of the last 20 years.
Governments — such as the United States, Nigeria, Myanmar and Liberia — and donors are responding to this threat by working in partnership with others to develop national capacity and ensure falsified and substandard medicines are removed from the supply chain.
Though no reliable figures exist on the actual scale of the problem, Interpol suggests that falsified medical products, which include medicines and medical devices and equipment, could account for as much as 30 percent of the market in some countries in Asia, Africa and Latin America. Anti-infectives such as antimalarial medicines and antibiotics are particularly prone to falsification, given the weak regulatory and enforcement mechanisms in countries where these diseases are present. For example, a study carried out by the World Health Organization in 2008 found that 64 percent of antimalarial drugs in circulation in Nigeria at the time were either falsified or substandard. This poses a serious risk to public health and a real challenge to both donor organizations and host countries trying to address these diseases.
“Diseases have no borders, and effective, quality products have no borders; they treat people everywhere and prevent disease from spreading anywhere. If quality medicines are available we have the possibility of treatment, and if there is treatment, we are all safer.”— Dr. Bikila Bayissa, deputy director-general of food and medicines quality assessment at Ethiopia’s Food, Medicine, and Health Care Administration and Control Authority
Falsified medicines are not the only sources of poor-quality pharmaceuticals, according to Dr. Paul Nkansah, who is deputy technical director of the Promoting the Quality of Medicines, or PQM, program, funded by the U.S. Agency for International Development and implemented by USP. “A large number of medicines circulating in the market are substandard due to poor manufacturing or deterioration in the supply chain during transportation, distribution and storage.”
The hidden challenges of good intentions
During the first decade of the new millennium, attention was focused on ensuring people in developing countries had access to affordable medicine. Issues such as intellectual property rights in relation to generic medication occupied a great deal of international attention, especially in light of the ratification of the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights in 2001. Far less attention was paid to quality. As a result, billions of dollars in aid, channelled through initiatives such as UNITAID, the U.S. President’s Emergency Plan for Aids Relief, and The Global Fund to Fight Aids, Tuberculosis and Malaria to purchase and distribute medicines may have been compromised.
The situation in Nigeria is similar to that of many other low- and middle-income countries, according to Dr. Chimezie Anyakora, the PQM program’s chief of party in Nigeria.
“In the early 2000s donors wanted to get medicines into Nigeria as quickly as possible to address health needs, but the health system was in a mess,” said Anyakora. “Poor storage and distribution processes meant that when medicines did get to where they were needed, they were degraded and substandard.”
What are falsified and substandard medicines?
The European Medicines Agency defines falsified medicines as “fake medicines that pass themselves off as real, authorized medicines.” Many of these medicines contain poor-quality ingredients, the wrong ingredients or the wrong dosage. These are different from substandard medicines, which the World Health Organization defines as “out of specification” products: “These are authorized medical products that fail to meet either their quality standards or their specifications, or both.”
Access to medication that is quality assured has recently been recognized as a public health priority. Governments committed to this in the Sustainable Development Goals, in ensuring everyone has “access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” In some of the poorest and most vulnerable countries, however, this commitment is being undermined by strained health systems unable to test and detect falsified and substandard pharmaceutical products. This poses a serious risk to both patients and to public health.
Poor-quality medicines can result in treatment failures and, in some cases, contribute to drug-resistance, which can make patients worse or kill them. According to Nkansah, “all global strategies for the control, elimination and eradication of AIDS, tuberculosis, malaria and neglected tropical diseases, as well as other communicable diseases rely on sustainable access to affordable, quality-assured medicines.”
Many low- and middle-income countries, Nkansah added, often have “weak or no medicines regulations and testing capacity, and this lack of regulatory oversight provides fertile ground for falsified and substandard medicines.”
Identifying the problem as a means of addressing it
If countries are unable to test pharmaceutical products, they cannot differentiate between quality and substandard medicines or uphold international standards. This undermines any subsequent regulatory, policy or law enforcement efforts to address both falsified and substandard medication in the supply chain. It also reduces the incentive for the private sector to invest in costlier processes and facilities that conform with international production, storage and handling standards, if they are then being undercut by manufacturers with less rigid standards producing and selling cheaper products.
The PQM program is addressing this challenge by taking a holistic approach to the problem. The program collaborates with countries to build capacity of medicines regulatory authorities, strengthen testing capability of national quality control laboratories and provide technical assistance to manufacturers that supply local and international markets to ensure sustainable production of quality-assured essential medicines. PQM assists countries in setting up medicines quality assurance systems that make it easier for authorities to identify and remove poor-quality medicines from the market.
In Myanmar, as in many other developing countries, authorities have struggled to detect and remove falsified and substandard medication from the supply chain. To address this, the PQM program worked with technical experts across Myanmar’s ministry of health to tighten regulation and develop laboratory capacity to test pharmaceuticals and grant licenses to products. The program focuses not only on technical expertise in testing, but also on management systems, effective auditing and the development of policies and guidelines for the proper management and use of documentation. Four years after the launch of the program, Myanmar’s Nay Pyi Taw laboratory now has international accreditation and is able to accurately and reliably test, validate and license medicines.
Dr. Khin Chit, director of the department of food and drug administration within Myanmar’s ministry of health, said that the ministry was very grateful for the international input. This support has allowed the country to become a regional leader in the testing and licensing of medication allowing them to offer these services to neighboring countries for a fee and generate revenue.
“We now face the challenge of maintaining this standard and accreditation,” she said. “Unless we are able to ensure the standard and quality of health products, faith in our health system will remain compromised.”
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These sentiments are echoed by Dr. Bikila Bayissa, deputy director-general of food and medicines quality assessment of Ethiopia’s Food, Medicine and Health Care Administration and Control Authority, known as FMHACA. The PQM program in Ethiopia supported the national quality control laboratory in gaining its international accreditation in 2011, which allowed it to effectively test medicines and other health products such as condoms — critical in a country with 769,600 people living with HIV and an estimated annual rate of new infections of around 15,000 cases. Improved laboratory testing capacity of both medicines and medical devices has allowed FMHACA to identify and take regulatory actions on poor-quality products.
In 2016 alone, for example, the authorities were able to identify and prevent the distribution of 69 million condoms following testing that identified defective products, potentially preventing countless infections. This comprehensive approach of working with regulators, laboratories and the private sector increases public confidence in both regulators and local manufacturers.
“In the long term, our ambition is to become self sustainable,” said Bayissa. “We hope to establish our own equipment maintenance and calibration team and provide services to others in the region.”
Identifying and removing falsified and substandard medicines from the pharmaceutical supply chain requires strong regulation that is both widely understood and effectively enforced. In Myanmar, Khin Chit acknowledges the country’s regulation of medicines is “weak.”
“We need to upgrade our drug regulation systems and develop standards for pharmacies in particular,” she said. “But this is proving a challenge, especially in Myanmar’s 17 border-free trade zones that have very weak regulation and through which many medicines arrive into the country.”
The private sector as partners in eliminating falsified medicines
Effective national policies, medicine regulation and enforcement play an important role in ensuring poor-quality medicines do not enter the market and that appropriate enforcement of violations are carried out.
“We’ve seen lots of good work in this area, but more needs to be done,” said Nkansah, adding that there needs to be continued advocacy for investment in strong post-marketing surveillance, reporting and enforcement. “This is the most effective use of limited regulatory resources and will ensure poor-quality medicines in circulation are quickly identified and removed from the market, protecting patients and serving as a deterrent to would-be rogue actors.”
Combatting the spread of falsified and substandard medicines is a complex challenge, and cannot be addressed by the public sector alone — regulation and testing need to be accompanied by a reliable supply of affordable, quality-assured medicines. The private sector, both pharmacies and pharmaceutical companies, have a critical role to play to ensure the supply and distribution of quality medicines and the removal of falsified and substandard products from the market. The PQM program is addressing this by bringing the private sector and regulators together in joint trainings on pharmaceutical standards and regulations. This helps establish common expectations between the private sector and regulators and increases collaboration to remove falsified and substandard products.
But businesses are not always driven by public health concerns alone, said Anyakora, who stressed that they “need to see higher returns on investment.”
He added that authorities need to tackle the issue from both the supply and the demand side and create incentives within the market for quality medicines. Governments must recognize that the circulation of falsified and substandard medicine is also a market response to a context where a lack of regulation, access to medical facilities and public information create a large market for cheaper products. Only by working with the private sector to address these market incentives will governments be able to drive up standards.
“If businesses could be rewarded for producing quality pharmaceuticals — for example through procurement contracts from donors and others — there would be a far greater incentive to improve standards across the board,” said Anyakora. “We can promote public health better if we incentivize the private sector.”
How can the international community tackle the threat of falsified medicines? Have your say by leaving a comment below.
This article is the fourth and final article in a series on global health challenges caused by poor-quality medicines and approaches to achieving quality-assured medicines in low- and middle- income countries. For more information, visit www.usp-pqm.org or attend the Medicine Quality and Public Health Conference, organized by the Centre for Tropical Medicine and Global Health in Oxford, UK, from 23-28 September.