The sudden hospitalization of dozens of children in Paraguay for severe breathing problems in 2013 led to an alarming discovery: an entire shipment of poor-quality medicine for treating colds was contaminated with levomethorphan, an extremely potent and potentially lethal opioid. World Health Organization (WHO) global surveillance that began that same year revealed that the active pharmaceutical ingredient had originated in India and had already caused 50 deaths in Pakistan in 2012.
Such stories are still not rare. The WHO issued a report last November revealing that roughly one in ten medical products sold in low- and middle-income countries is of poor quality. Michael (Mick) Deats, team leader for the WHO’s surveillance efforts, shares his views from the front line of the fight against poor-quality medicines. The struggle involves the global health and medical community, including businesses and regulators along the fast-growing supply chain, and the patients they serve. The force is bolstered by USP, an organization that sets international standards for quality medicine.
How much medicine might be falsified or substandard?
Many believed the problem was restricted to branded, expensive products from major pharmaceutical companies, but that’s definitely not the case. Generics and branded, expensive and less-expensive, are all affected by this issue. If there’s a market, if there’s unmet demand for medicines, somebody will step into the vacuum.
So this problem is being overlooked in wealthy countries?
That’s absolutely right. It’s a global issue and everyone’s affected. High-income, middle-income and low-income countries are vulnerable in different ways. In high-income countries, we often see falsified medicines penetrating online pharmacies and informal supply chains. In low- and middle-income countries, problems result from weak systems and technical capacity, porous borders, governance issues, and access difficulties. We get reports every day. A recent report from Europe related to a cancer medicine.
Tell us how WHO surveillance began and how it’s working in Africa, Asia and in emergencies around the globe.
It began in West Africa, which was a hotspot. [42 per cent of bad medicine reports came from Sub-Saharan Africa.] It was launched in Nigeria in 2013 and incrementally rolled out, with workshops in Africa and SE Asia. Now we’ve got 600 regulators trained in 141 countries (including 18 West African countries) to increase their surveillance and their stakeholder engagement with national health ministries and regulators, so they’re being informed of problems. We encourage them to search the WHO database and report their cases. When countries do need assistance, we will provide it, usually by facilitating complex laboratory testing. In severe emergencies we’ll send people to help them deal with the case. USP will be working with us again in West Africa in April, and I look forward to that.
How do you manage risk along the medicine’s journey to the patient and ensure drug quality and safety?
It’s impossible to be able to look at everything if you’ve got 10,000 drug outlets in a major city, and a regulatory agency that may have 30 people. And if you’ve got 20,000 medicines registered in your country, you’re not going to be sampling all of those. You need information as to what products are most at risk, which regions and geographic locations are most at risk, and what part of the supply chain is most at risk, and then focus your resources. If you’re not looking after the last mile to the patient, that’s where bad stuff is going to get into the chain.
We’ve been working hand in hand with USP [recently officially recognized by the WHO as a standard-setter and trusted expert on quality medicines], which has proved to be a good collaborative alliance to prevent harm, safeguard health advances and reduce costs.
How do you take on corruption, limit the black market and encourage reliable reporting?
If a country wants to tackle this issue, there’s got to be political will from the top. You’ve also got to create an environment where there’s clear water between the regulator and the regulated. When regulators are transparent, it’s very clear what action they will take when certain things happen, and that any sanctions are used proportionally if they are required.
In some countries, medicines are as good as money. You can put steps in place to secure the supply chain and make sure you haven’t got expired medicines hanging around, which will surely be taken and distributed on the market. Corruption is incredibly tough to deal with. Healthcare professionals report the most serious cases, and their information is the most reliable. But they also report the fewest cases. You hear, ‘I’m scared,’ or ‘I want to keep my job’. We need to deal with that.
The WHO’s report highlights lax legal penalties, including a case where selling fake antimalarials in sub-Saharan Africa resulted only in fines and suspended sentences. Would stronger penalties help?
Having a nice piece of legislation on the books is all very well, but you’ve got to have a criminal justice system capable of dealing with that case. If you’re taking an antimalarial that’s made of potato starch, it’s not going to poison you, but neither is it going to treat your malaria. The courts are used for cases where you can see damage to an individual. We’re now seeing a lot of awareness training among prosecutors, barristers, lawyers, judges, police, and Customs officers to demonstrate that this is doing severe damage and needs to be prioritized.
What is the WHO’s vision for achieving more rapid and accurate monitoring?
The more we encourage transparency and openness, then the better picture we’ve got. Too often, it’s only after a long time and a bad outcome from a patient that a healthcare worker will request examination of the medicine, and realize that there’s no active ingredient in it. We need to accelerate that process through education and awareness, simpler reporting systems, smartphone applications for healthcare workers, and try to remove some of the barriers.
How can international standards strengthen the forces resisting bad medicine?
Medicines, especially some of the molecules, are subject to degradation and may have left the manufacturing site meeting the standards. Unfortunately, by the time it reaches the country in which it’s going to be dispensed, it’s degraded. It is critical that we have those pharmacopeial standards in place so we can test and be sure.
Clear, precise, and accurate standards across the board are welcomed by regulatory agencies. When a country is struggling with an issue, and they can pick up a recognized international standard, it can help them get out of trouble. It’s a lifeline if you’ve got good standards.
To learn more about the need for quality standards in medicines, visit The Science of Quality.