Better together: Caribbean unites to tackle poor-quality medicines

KINGSTON, Jamaica — Sydonna Tugwell, a laboratory technologist at the Medicines Quality Control and Surveillance Department of the Caribbean Public Health Agency, or CARPHA, arrives for work each day at an inconspicuous building in Kingston’s Hope Gardens. Outside, the botanical surroundings are filled with birdsong and the city’s traffic is down to a dull hum. Perhaps surprisingly, it is in this tranquil setting that Tugwell and seven other colleagues are playing a crucial role in transforming the region’s health care system.

It is the team’s responsibility — at the request of Caribbean National Medicines Regulatory Authorities — to test medicines circulating in the 26 CARPHA member states to confirm their quality and ensure that those being dispensed by doctors and pharmacists perform as expected. To assist them in this important work, the CARPHA MQCSD lab boasts an array of high-tech machines with all manner of spindles, scales, and screens that enable staff to test medicine quality by doing things like imitating the acidity of the human stomach to see how long it takes a tablet to dissolve: If it dissolves too quickly, it may not be effective; too slowly, and it may pass through a person’s body without being absorbed at all.

As Tugwell measures out substances, fills a graduated cylinder with solution, and writes down her findings, she says that the team conducts multiple tests on an array of products every month. One product might have multiple ingredients, with each sourced from various manufacturing plants, often from different countries, before the medication is assembled and distributed from yet another country.

“We perform a series of chemical and physiochemical tests such as identification tests, dissolution tests, related compound tests, and a uniformity of content test,” Tugwell said.

According to the World Health Organization, 1 in 10 medical products on the market in lower-income countries are substandard or falsified. The prevalence of these products tends to be higher in countries where regulation is inadequate and technical capacity to enforce quality standards is limited.

“[Prior to 2017], the state of regulatory systems in the non-Latin Caribbean region was showing that on indicators of basic regulatory capacity, the Caribbean was achieving 39% while the other subregions in the Americas were all at 90% or above,” said Charles Preston, adviser of regulatory system strengthening for medicines and other health technologies at the Pan American Health Organization. The data was gathered using PAHO and WHO assessment tools to evaluate the state of regulatory system capacity.

Substandard medicines are unlikely to treat patients effectively and — if there is an insufficient active ingredient — can lead to prolonged illness and even antimicrobial resistance. The lack of strong regulatory systems that ensure rigorous oversight could be responsible.

But with such small populations, there often are not enough people to staff an operation, Preston said. The U.S. Food and Drug Administration, for example, has 15,000 employees, while a state like Montserrat has a population of only 5,000 people.

“What are they supposed to do? How are they supposed to cover all of the regulatory functions that WHO recommends with only so few people?” Preston asked.

According to CARPHA staff, roughly a quarter of CARPHA member states have market authorization procedures. Others rely instead on procurement programs to supply the public sector and, in some cases, have no regulation of the private sector.

Preston said the small populations — and thus small volumes of sale — in the Caribbean can provide little incentive for pharmaceutical companies to offer their medicines or to comply with additional regulatory requirements. Lower-quality products have been found in the Caribbean market, and as there is limited regulation compared with the United States or European Union, the dangers are evident, he added.

“Companies can send different-tiered versions of the same products to different parts of the world,” Preston said. “I don't think the global community is aware of the risks to quality if you don't have strong regulatory systems in place.”

If “the bigger the better” is an incentive for pharmaceutical companies to supply lifesaving medicines to a population, one solution is to create a common market.

CRS successes so far

Still in its infancy and yet to realize its full potential, the CRS is already seeing success. Out of the 120 drug marketing authorization applications that Extavour and her team have reviewed since its inception, roughly 65 medicines have been recommended, such as treatments for HIV and noncommunicable diseases. These have come from more than 20 different applicants, including multinational generic and innovative companies.

Access to standardized quality-assured medicines, reduction in cost across the region, reduced workload for national regulatory staff and public confidence in medical products — whether they are sold in Jamaica, Trinidad and Tobago, or Guyana — are the systems’ greatest potential benefits, explained Osbourne.

But the CRS still has some way to go, Extavour said. Eventually, the team wants to expand its scope to look at inspections of regional manufacturers and medical devices and to roll out training sessions for in-country staff — beyond those USP have already provided in Jamaica — on the tenets of medicine registration.

“Companies who see the potential of entering the Caribbean through the CRS will continue to increase if more countries take on the recommended products, including regulatory authorities and national procurers,” Preston said, adding that countries should think about how they can best make use of their limited resources. “This goes beyond public health. If done correctly, the CRS creates a better business climate where regulators are more efficient, transparent, and accountable, and that will attract more trade and investment in the region.”

While other places, such as Africa, are in various stages of implementing regional systems for regulation of medicines, this is the first cluster of small states to put the idea into practice. CRS is a collective response toward health system strengthening that others can look to replicate, Cairatti said. There are 42 countries with small populations considered “small states” among the member states in the World Bank system, and many struggle with the same issues of regulation. The Pacific Islands, for example, recently took the first steps toward a regional approach to medicines regulation and are looking to the Caribbean for insights.

As a starting point, Extavour said countries must continue to develop trust in CARPHA’s systems and collaborate by sharing information about the quality and safety of medicines. “Leverage your strengths. Make use of what's available internationally and within the region you're in … See the information sharing as an opportunity to grow rather than competition, because that could be one of the limitations,” she said.

“There's protection in large numbers. As we grow, we strengthen each other, then we also protect the weaker among us.”