Recently, the CARPHA/CRS recommended Gilead’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg) film-coated tablet for the treatment of Hepatitis C.

The product is the first combination of its kind, and is listed on the WHO Essential Medicine List. It is also a first line therapy as recommended by WHO. The rationale for such an important status is that Epclusa is curative for all genotypes of Hepatitis C. If not treated, Hepatitis C can lead to negative health outcomes like liver failure and cancer.

This is a significant development for patients in CARICOM because there are estimated to be perhaps 100,000 cases of Hepatitis C in the region, but few authorized treatments. Epclusa, for example, does not have marketing authorization in any CARICOM state. It is also significant for public health. Cures such as this one are critical to strategies to eliminate Hepatitis C in the Americas.

Patients need access to these innovative therapies quickly, and major manufacturers are increasingly using the CRS because of the efficiencies it brings in speeding access to medicines. The CARPHA/CRS pools CARICOM markets together and offers a single portal of entry to the region’s 17 million people with one set of internationally recognized standards, and accelerated and transparent timelines. It is a major improvement over the current status quo in regulation of medicines, where products can take years to receive approval in the different national systems of CARICOM.

The list of recommended products is growing by the month and can be found here.

 For more information go to http://carpha.org/what-we-do/laboratory-services-and-networks/crs

Check out the latest news from PAHO Health Systems and Services Department and get to know our projects and advances toward universal access to health and universal health coverage in the Region of the Americas.

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Prohibition became effective as of January 1, 2019. Measure is the result of the Minamata convention.

The manufacture, importation and commercialization of thermometers and pressure meters that use a column of mercury for health diagnosis is prohibited. The measure also includes a ban on the use of such equipment in health services, which will have to dispose of the solid waste containing mercury, according to the norms defined by Anvisa (Resolution of the Collegiate Board of Directors – RDC 306/2004) and Environmental Bodies (Federal and State ).

The measure was defined by the Resolution of Collegiate Board of Directors – RDC 145/2017, and entered into force on Tuesday (1/1). The prohibition of thermometers and sphygmomanometers, as technically called mercury column pressure meters, is a result of the Minamata Convention. The convention was signed by Brazil and 140 countries in 2013 and aims to eliminate the use of mercury in different products such as batteries, lamps and health equipment, among others.

For more information go to ANVISA

The Caribbean Regulatory System (CRS) recently recommended its first non-communicable disease (NCD) medicines, including amlodipine for high blood pressure and anastrozole for breast cancer. The Caribbean is the worst affected sub-region in the Americas for NCDs, which are a leading cause of premature mortality, making up about half of all deaths of people under 70.

The recommended medicines are some of the most important tools that health providers and patients have to correct dangerous conditions like high blood pressure and cancer. For example, amlodipine is recognized as a critically effective blood pressure lowering medicine and is one of the most highly purchased products in the sub-region. Anastrozole is a key treatment in breast cancer and is listed on the World Health Organization’s (WHO) list of essential medicines.

Commenting on the development Dr. Virginia Asin-Oostburg, Director of Surveillance, Disease Prevention and Control at CARPHA who manages the CRS programme said, “This marks an important new milestone for assuring quality NCD medicines in the region, where we know regulatory capacity can be limited due to small populations and few human resources.“  She further noted that each medicine has to be pre-approved by a strong regulatory authority like the United States Food and Drug Administration or the World Health Organization, and be suitable for the Region, before it can be recommended by the CRS to CARICOM member states.

There are more NCD medicines under review at the CRS, and a goal of the program is to have recommended quality versions of all NCD medicines listed on WHO’s list of essential medicines.

Source: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS

The National Director of Drugs, Dr. Leonor Morales de Acosta presented the report of accountability for the period from June 2017 to May 2018, in which she highlights important achievements.

Dr. de Acosta, highlighted that now El Salvador has a market of quality medicines and fair prices, also reported that the market has been revitalized with the registration of more than 6 thousand new medicines which guarantees the supply and availability of more therapeutic options for patients.

“Another achieved unprecedented for the Central American region has been the regulation of retail prices, El Salvador now has the lowest prices in the region, consequently the population has saved a significant amount of money, in these 6 years saving in the pocket has been about 500 million dollars, “said the head of the DNM.

For more information https://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/291-memoria-de-labores-2018

On December 19, 2018, the CECMED workshop was held to initiate the collection of information on the timely prevalence study of antimicrobial use, within the WHO / PAHO Project “Initiative of the National Regulatory Agencies of medicines for the containment of resistance. antimicrobial in the framework of regional and global plans on the subject “.

Hospital researchers included in this research, specialists from CECMED and from the OPS Cuba Coordination participated in it. The objective of the meeting was to update the participants on the implementation of the project and to instruct the researchers in the proposed methodology for the collection of information.

For more information go to https://www.cecmed.cu/content/constituido-el-grupo-regulador-para-la-contencion-de-la-resistencia-antimicrobiana-en-cuba