Latin America Roundup: Panama adopts international pharmacovigilance standards

Panama is implementing internationally standardized reporting codes for pharmacovigilance, following the lead of several other Latin American and Caribbean countries.

Argentina, Mexico, Brazil, Colombia, Ecuador, Uruguay and Peru have all adopted the WHODrug Global and MedDRA (Medical Dictionary for Regulatory Activities) dictionaries.

MedDRA, which standardizes terms used to code licensed drugs and medical events,
allows health authorities and companies to exchange and analyze safety reports related to licensed products and more readily classify adverse event data from clinical trials. WHODrug Global, maintained by the World Health Organization’s Uppsala Monitoring Centre, creates standard codes for drugs and active ingredients used in clinical trials and post-marketing surveillance.

The systems allow faster, more straightforward communication among regulatory agencies and regulated entities.

Officials with Panama’s National Directorate of Pharmacy and Drugs (DFND) announced the adoption of international standards and explained how its pharmacovigilance system will be updated to incorporate them at a meeting on 11 April. The change, Panamanian officials said, will “strengthen national and regional pharmacovigilance activities, parallel to the expansion of the regulations in force in Panama.”

Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS), which adopted WHODrug and MedDRA in 2018, is updating their use in a new electronic pharmacovigilance reporting system. In a statement dated 24 April, the agency detailed the time frame in which companies are expected to align their products and licensing documents with the updated terms.

DFND statement (Spanish), COFEPRIS statement (Spanish)

Colombia’s INVIMA gets new director of medicines

Colombia’s National Food and Drug Surveillance Institute (INVIMA) has resumed high-level staffing after a long period without firm leadership, naming Sandra Montoya Escobar as its new technical director of medicines and biological products.

Escobar is a pharmaceutical chemist who has the support of the country’s two major academic associations of pharmacists. At her confirmation ceremony, INVIMA director Francisco Rossi said Escobar “will be decisive in optimizing the institutional capacities” of the agency.

The appointment marks Rossi’s first significant hire since assuming the agency's directorship this year, following a string of acting directors.

Rossi highlighted the importance of building relationships with the Colombian pharmaceutical sector, particularly with the technical directors of manufacturing labs. These professionals “assume important responsibilities in public health,” INVIMA said in a 23 April statement. Escobar is expected to help deepen INVIMA’s dialogue with them.

Rossi has long championed efforts toward self-sufficiency for medicines in Colombia, which includes promoting public production of certain products and increasing supplies of locally produced medicines. Under current leadership, INVIMA seeks to transition from its traditional technical role into an entity that can generate “new relevant knowledge in making national decisions in health,” the agency said in a statement.

INVIMA statement (Spanish)

Dominican Republic expands list of essential medications

Another 74 products have been added to the Dominican Republic’s list of essential medicines, bringing the total number to 871, the news outlet El Caribe has reported. The number of active pharmaceutical ingredients deemed essential also increased, from 465 in 2018 to 506 this year.

The essential medicines list, updated eight times since its inception two decades ago, describes medicines that must be in stock and accessible to all citizens through the public health system. The list takes into consideration the country’s current disease and demographic profiles, environmental factors, and drug costs.

Leandro Villanueva, director of the Dominican Republic’s Directorate General of Medicines, Food and Health Products (DIGEMAPS), said the update is part of a comprehensive strategy to meet the objectives of a national pharmaceutical policy. “Beyond the expansion of the [list], we actively seek to improve procurement, supply, financing through social security, prescription, donation management, health education and education to professionals in the sector,” he said.

The agency did not specify which medications or active pharmaceutical ingredients had been added; however, in February, while the update was in progress, the government published a statement saying that the number of mental health treatments would increase.

News story in Elcaribe.com (Spanish)

COFEPRIS presents to PAHO on controlled substances tracking

COFEPRIS officials traveled to Washington, DC, to present to the Pan American Health Organization on the impact of its digital platform on controlled substances and chemical precursors, according to a 23 April news release.

The system, called SISUS, was designed to monitor and track narcotic drugs, psychotropics, and chemical precursors from their arrival in Mexico through their formulation and packaging to their final destinations. Since its implementation last year, the platform has simplified administrative procedures and provided a key tool for coordinating surveillance with authorities in other countries, according to COFEPRIS. It also helps transparency by avoiding contact with corrupt public servants.

The statement did not provide specific figures about the program’s impact.

COFEPRIS statement (Spanish)

Researchers call for a Latin American CDC

Echoing recent calls for a multinational Latin American medicines agency, a group of public health researchers led by Patricia J. Garcia of the Universidad Peruana Cayetano Heredia in Lima has called for the creation of a Latin American Centers for Disease Control and Prevention modeled after the US agency.

In an editorial published on 25 April in The Lancet, Dr. Garcia and her colleagues wrote that “scarce collaboration between Latin American countries during the COVID-19 pandemic” had hindered the effective use of regional resources, resulting in “missed opportunities for coordinated negotiation and procurement of diagnostic tests, medications, ventilators, vaccines, and other medical supplies.”

The researchers noted that because the Pan American Health Organization “exclusively engages governments on a one-to-one basis,” it “restricts the scope of horizontal cooperation (South-to-South) between two or more countries in the region. This limitation underscores the absence of a platform through which Latin American countries can collaborate to prevent and control disease outbreaks.” The researchers wrote that recent severe dengue outbreaks across Central and South America underscore the need for collaborative, scientifically sound international surveillance and prevention efforts.

Over the past four years, the US CDC has sought to increase its presence in Latin America, opening new offices in Panama, Brazil and Argentina and existing hubs in Guatemala and Jamaica.

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Latin America Roundup: Panama adopts international pharmacovigilance standards

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