Saint Vincent and the Grenadines (SVG) has recently became Full Member of the WHO Programme for International Drug Monitoring (PIDM).  SVG joins three other CARICOM states as full members: Barbados, Jamaica and Suriname. The Programme was established in 1968, and consists of a group of more than 150 countries that work nationally and collaborate internationally to monitor any harm caused by medicines, to reduce the risks to patients and to establish worldwide pharmacovigilance standards and systems.

The Uppsala Monitoring Centre (UMC) has been responsible for the technical and operational aspects of the programme since 1978, and from October 2017, the Caribbean Regulatory System (CRS) of the Caribbean Public Health Agency (CARPHA) VigiCarib program began sharing reports from SVG with the UMC, which has contributed to achievement of full membership. As of April 2020, 99 case reports of suspected adverse drug reactions have been reported to the UMC via the CRS from the SVG Pharmacovigilance and Drug Information Centre, and SVG has become a leader in reporting in CARICOM.

CARICOM States with membership in the WHO PIDM

Full Members: Barbados, Jamaica, Saint Vincent and the Grenadines, Suriname

Associate Members: Antigua and Barbuda, Belize, British Virgin Islands, Dominica, Haiti, Grenada, Guyana, Saint Kitts and Nevis, Saint Lucia

Further information at https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/who-programme-members/ and https://carpha.org/What-We-Do/CRS/VigiCarib

In a prior publication PAHO has stressed the moral obligation to do research about COVID-19 as quickly as possible to produce the evidence that is needed to respond to the pandemic.

This new publication provides guidance and strategies to streamline the ethics review and oversight of COVID-19-related research with human subjects. It is available at: https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research.

In an upcoming publication a template of standard operating procedures for ethics review in emergency situation, which committees can adapt to their contexts and adopt will be given.

The National Regulatory Agency in Chile (Instituto de Salud Pública) has made available online the COVID-19 action plan:  https://www.minsal.cl/nuevo-coronavirus-2019-ncov/informe-tecnico/

The Center for Drug Evaluation and Research (CDER) launch a webpage with activities and information related to COVID-19: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs

Serology tests for COVID-19  

The FDA issued an  note about the importance of serology tests for  COVID-19 as well as the situation about firms falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19

Reference links for fraudulent COVID-19 products:

• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits
• https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
• https://www.cbp.gov/newsroom/local-media-release/cbp-officers-o-hare-seize-prohibited-medical-test-kits
• https://www.flickr.com/photos/fdaphotos/albums/72157713334402986
• https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products

Update of the Emergency Use Authorizations for diagnostic tests: 

• https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

R&D

• https://www.fda.gov/medical-devices/database-reference-grade-microbial-sequences-fda-argos/fda-argos-sars-cov-2-reference-grade-sequence-data

• The Brazilian National Regulatory Authority, Anvisa, is carrying out several regulatory and informative actions to address the international public health emergency related to SARS-CoV-2 (a new type of coronavirus), which causes COVID-19. All related information is gathered on the link: http://portal.anvisa.gov.br/coronavirus
• The list of specific regulations and guidance is regularly updated and available at http://portal.anvisa.gov.br/coronavirus/regulamentos

• The FDA has made available in its webpage the Fraudulent Coronavirus Disease 2019 (COVID-19) Products
• The FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile to be distributed and used for certain hospitalized patients with COVID-19
• FDA expedites review of diagnostic tests to combat COVID-19
• FDA update on EUA for diagnostic tests
• 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic

The United States Pharmacopeia (USP) has made available some resources and information related to COVID-19 to the public:

• Free Access to USP-NF Standards Critical to the Development of Vaccines and Antivirals
• Free Technical Assistance for Developers of COVID-19 Antiviral Drugs and Vaccines
• Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic
• USP Response to Shortages of Garb and PPE for Sterile Compounding During COVID-19 Pandemic
• USP Reference Standards Supply Chain Information
• All On-Demand Education at a 75% Discount Through May 31, 2020: use the promotion code USPEDU75OFF upon check-out to receive discount

We invite you to participate in this virtual seminar to present and discuss PAHO’s ethics guidance for COVID-19 research available at: https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic.

To participate follow this link: https://paho.webex.com/paho/onstage/g.php?MTID=eb1e5b00997fab7e37c834c5d35d9ad3f

Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

We are waiting for you.

PANDRH Secretariat

Go to this Safety Alert at MedWatch 

Pan American Journal of Public Health: Recently published articles / NEW info on COVID-19 for authors and readers

Clinical trials of drug repositioning for COVID-19 treatment 

Sandro Rosa and Wilson Santos

Brief communication l Published March 20 2020 l https://doi.org/10.26633/RP