The many challenges of tackling substandard and falsified medicines

BERLIN — It was only two years ago that World Health Organization member states agreed on a definition of substandard and falsified medicines. The scale of the distribution of those products — which range from drugs that fail to meet quality standards to medical products that deliberately misrepresent what they are — is only beginning to emerge, although WHO puts the rate at 1 out of every 10 medicines in lower-income countries.

That didn't stop experts at the World Health Summit, which launched in Berlin on Sunday, from using the meeting to discuss some of the legislative and technological approaches to stopping their procurement and distribution.

Though much is still not known, the implications of not acting are clear. False and substandard medications kill patients outright or hinder their recovery. Peter Beyer, senior WHO adviser, said 116,000 deaths in sub-Saharan Africa have been attributed to using substandard or falsified antimalarials.

Substandard medicines can contribute to antimicrobial resistance by allowing the survival of some pathogens that have mutated enough to withstand a low dose of the medicine. And they lead patients to lose faith in a health system that wastes taxpayer money on drugs that don’t cure them.

"This is public money; patient money spent on drugs that don't work," Beyer said. "This is a really, really huge problem."

One of the major challenges is that there are so many entry points for falsified or substandard medicines, from a process of procuring drugs from international or domestic suppliers to porous distribution pipelines that give access to criminal syndicates manufacturing their own contraband medication. Then, there are the distributors in rural settings who are hard to regulate, but essential to communities that have little other access to health coverage. That leaves underfunded and understaffed regulators scrambling to try to plug all these gaps.

"The solutions are here and there, but they're not really everywhere," said Shushan Tedla, a pharmacist with action medeor, a Europe-based medical aid organization.

Much of the responsibility falls on domestic regulatory agencies. In the global south, they frequently lack the authority or capacity to investigate and enforce regulations, even where they exist. Many countries still need to pass legislation identifying and criminalizing the distribution of falsified and substandard medicines.

There are also a variety of proven interventions that countries could borrow from to ensure that safe and effective medications reach patients. Tanzania, Tedla said, has had success with accredited drug dispensing outlets.

The government built a national network of ADDOs, where the dispensing staff were trained and procedures put in place to verify the quality of medicines. It was particularly useful in rural areas, where patients often turn directly to pharmacists for medical care in the absence of health clinics. This way, they were at least guaranteed quality products, she said.

But even though these programs have been in place in Tanzania since 2003, Tedla told Devex that only Ghana has shown an interest in adopting something similar.

That might be, in part, because of a lack of awareness or a lack of start-up funding — something that might be resolved by regional collaborations that allow governments to pool the limited funds they have for monitoring drug safety.

Even this strategy has proven difficult, though, said Mirfin Mpundu, executive director of the Ecumenical Pharmaceutical Network, who spoke on a WHS panel. "For countries to work together is a difficult thing," he said. "Interests are different. Who gets the taxes, who charges the registration fee. It's complicated."

In the absence of domestic and regional activity, global observers have turned to other stakeholders who have an interest in improving the situation. That includes the pharmaceutical companies that lose money from the sale of falsified and substandard medicines, and also see patient belief in their products decline with every purchase of a fake drug.

They are working with researchers to spur technological advances that will make it easier to confirm that a medicine is what it says it is. Some use chromatography to separate and test mixtures while others rely on spectroscopy, training lasers on the chemical preparation to match it against a spectrum of all authentic commercial products.

The success of these interventions depends on having a functioning health system, staffed with people who can be trained to use the instruments. It also depends on being able to afford the technology, which is still expensive to buy and maintain.

There was some discussion of applying a European intervention that assigns a unique identifier to each package of medicine that can then be scanned at various points along the distribution route. But Lutz Heide, a professor of pharmaceutical biology at the University of Tübingen in Germany, said that the affordability of this intervention in a low-income context was still decades away.

While there are many access points to address substandard or falsified medicines, that underscores just how many entry points there are for introducing the products into the system too.

Fixing the situation, said Cyntia Genolet, head of health systems and Africa policy for the International Federation of Pharmaceutical Manufacturers & Associations, "requires a lot of different expertise. You have so many elements that need to be put in place to fight falsified medicines. But we are talking about making sure that people access safe, quality medicines, so you have to do this work."

The first critical step is making sure that people are even aware of the problem, putting pressure on politicians to address it. They can also be educated to look for rudimentary signs, such as misspellings on packaging — a small step until more comprehensive systems come into place.