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Saint Vincent and the Grenadines Achieves Full Membership in the WHO PIDM

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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

 

 
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PAHO: Guidance and strategies to streamline the ethics review and oversight of COVID-19-related research

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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.

 
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FDA: actions related to COVID-19

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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:

Update of the Emergency Use Authorizations for diagnostic tests: 

R&D

 
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ANVISA: actions related to COVID-19

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  • 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
 
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FDA: COVID-19 regulatory update

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USP: resources and information related to COVID-19

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

 

 

 
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PAHO: The imperative to catalyze COVID-19 ethical research – Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

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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

 
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Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders – Do Not Use as Treatment for COVID-19 in Humans

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TOPIC: Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders – Do Not Use as Treatment for COVID-19 in Humans
AUDIENCE: Consumer, Health Professional
ISSUE: The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.
Our primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs.

 

Go to this Safety Alert at MedWatch 

 
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Clinical trials of drug repositioning for COVID-19 treatment

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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