Health Canada warns about the risks of using fraudulent and unauthorized N95 respirators, as they may not protect consumers against COVID-19:.https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72707a-eng.php
Likewise, the actions on COVID-19 from Health Canada are available at: https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html
In anticipation of increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available by publishing product-specific guidances (PSGs) to support generic drug development for these drugs.
Additional information: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidances-chloroquine-phosphate-and-hydroxychloroquine-sulfate
The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
Additional information: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-second-emergency-use-authorization-decontaminate-n95
PAHO/WHO keeps an online page dedicated to share reliable and up to date information on COVID-19: Click here to access it
Additionally, technical documents can be accessed here
News and Public Information
News release
PAHO warns of potential blood shortages during the COVID-19 pandemic
Countries in the Americas should ensure continuity of donations and safety for donors
Washington, DC, April 10 2020 (PAHO/WHO) – The Pan American Health Organization (PAHO) today warned that countries in the Americas face potential shortages of blood for transfusions due to a significant reduction in voluntary blood donations during this time of the COVID-19 pandemic.
According to the latest available data, in 2017 more than 10.5 million units of blood were collected, through 1,800 blood donation centers in 37 countries and territories of the Americas. Given the current pandemic, health services are now running the risk of shortages in availability.
“We are concerned that blood bank reserves are being depleted, as this puts at risk the lives of many people who need transfusions,” said PAHO Director Carissa F. Etienne. People with cancer and leukemia, people needing transplant services, and women who suffer postpartum hemorrhage are among those who arrive at hospitals every day requiring transfusions. In addition, emergency services require continuous availability of blood to respond to trauma cases arising from road traffic accidents and other injuries..
Dr. Etienne called on governments to maintain adequate blood supplies even as they work to reduce the spread of COVID-19. This means ensuring that voluntary blood donors can continue to safely donate blood, platelets and plasma. “The need for blood is becoming critical,” said Dr. Etienne. “Health services must coordinate with donors to make appointments for blood donation, either within a health facility, or through mobile collection systems and health services.”
The risk of transmission of the new coronavirus through transfusion of blood and components is likely minimal. Respiratory viruses have never been reported to be transmitted through blood or blood components, and to date there have been no reports of COVID-19 infection in blood recipients.
“Stopping donations is not an acceptable action at this time. We must find ways to ensure that blood donations continue uninterrupted and are safe for both the donor and the recipient,” said Dr. Etienne.
She called on hospitals and blood banks to take precautionary measures to minimize any risk and prevent COVID-19 infection. This includes maintaining physical distancing and implementing adequate biosecurity practices to protect their personnel and donors.
Dr. Etienne urged countries to implement appointment systems, extend donor hours, use mobile collection systems, monitor emergency blood supplies, and reschedule elective surgeries.
She also called for ensuring the availability of critical supplies for blood collection, including personal protective equipment for health personnel, and urged health officials to inform the public about who can donate in the context of the pandemic and what measures they should take to ensure safe donation.
Who can donate blood during COVID-19?
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Links:
Maintaining a safe and adequate blood supply during the pandemic outbreak of COVID-19
https://www.who.int/publications-detail/maintaining-a-safe-and-adequate-blood-supply-during-the-pandemic-outbreak-of-coronavirus-disease-(covid-19)
Information on COVID-19
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.
PAHO has launched the MedList, an annotated medicine and device lists portal that provides evidence summaries based on a context and question about a medicine clinical use.
Here you can find scientific and technological information related to COVID-19 on medicines and other health technologies, explore the international database of grade guidelines, explore WHO prequalified vaccines tool, and access BRISA, the database for technology assessment reports.
The National Regulatory Agency in Chile (Instituto de Salud Pública, ISP) has made available online the COVID-19 action plan, that inlcudes the updated list of IVDs, pharmacovigilance, health alerts besides news and information on COVID-19.
Additional information:
The latest information on FDA actions related to COVID-19 are available at: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#new
At-a-glance: FDA COVID-19 response summary
Medical Devices:
FDA posted a new webpage with frequent questions and answers on importing medical devices during the COVID-19 pandemic
Drug Shortages: FDA updates its webpage on COVID-19 drug shortages responses
Hand Sanitizers containing methanol: List of recalled hand-sanitizers that contain undeclared methanol as ingredient
Emergency Use Authorizations (EUA):
Product-Specific Guidance:
Abbreviated New Drug Applications (ANDA): Albuterol sulfate inhalation solution 0.021% and 0.042%
Guidelines:
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:
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Coronavirus Treatment Acceleration Program (CTAC)
Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)
FDA encourages recovered patients to donate plasma for development of blood-related therapies
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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
