FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

The US FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA.

Additional information: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use and https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

The National Regulatory Authority in Mexico (COFEPRIS) has published on its website its actions to deal with the health emergency derived from COVID-19; among them: measures in relation to clinical trials, technical guidelines for clinical trials protocols related to the therapeutic use of convalescent plasma, regulatory flexibility in import and export processes for all health supplies, and provisions for the acquisition and manufacture of ventilators.

COFEPRIS’ actions to attend to the COVID-19 emergency are available at: https://www.gob.mx/cofepris/acciones-y-programas/acciones-sobre-covid-19?state=published

PAHO publication:

In the event that the available resources (such as ventilators or ICU beds) are not sufficient to meet all the needs of the population in the COVID-19 pandemic, we must proceed ethically. Since we cannot do everything that we should do, what is the most ethical path of action? Responsible action calls for health authorities to establish criteria for the priority-setting decisions that may be necessary.

This brief ethics guidance provides four basic recommendations to guide these decisions. It is available at: https://www.paho.org/en/documents/ethics-guidance-use-scarce-resources-delivery-critical-health-care-during-covid-19

WHO also has a publication on Ethics and COVID-19: resource allocation and priority-setting. Additional information is available at: https://prais.paho.org/en/who-ethics-and-covid-19-resource-allocation-and-priority-setting/

WHO publication:

Ethics and COVID-19: resource allocation and priority-setting

Governments, international agencies and health systems have an obligation to ensure, to the best of their ability, adequate provision of health care for all. However, this may not be possible during a pandemic, when health resources are likely to be limited. Setting priorities and rationing resources in this context means making tragic choices, but these tragic choices can be ethically justified. This is why we have ethics. This document answers a number of questions about the ethics of setting priorities for the allocation of resources during times of scarcity, and provides a high-level ethical framework that can be used to guide decision-making.

It is available at: https://www.who.int/who-documents-detail/ethics-and-covid-19-resource-allocation-and-priority-setting

WHO has issued a Medical Product Alert on 31 March 2020 regarding falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19

Additional information: https://www.who.int/news-room/detail/31-03-2020-medical-product-alert-n-3-2020

New PAHO publication:

This document provides a template of standard operating procedures for ethics review in emergency situation, along with guidance for committees to adapt them to their contexts and adopt them. It is available at: https://www.paho.org/en/documents/template-and-operational-guidance-ethics-review-and-oversight-covid-19-related-research.

This publication supplements PAHO’s 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.

Both publications will be presented at a virtual seminar in English on Tuesday April the 21st at noon (Washington D.C. time). To participate go to: https://paho.webex.com/paho/onstage/g.php?MTID=eede4995e137569b2aa66bbb1d4ffccd9.

The website with updated information on INVIMA’s action on COVID-19 as well as supply of medicines and medical devices in Colombia is available at  https://www.invima.gov.co/coronavirus-covid-19

Actions [Spanish]: 

• Virtual inspections for the certification of the good practices  (NEW)
• Virtual inspections for certification of good manufacturing practices of cosmetics related to COVID-19 (NEW)
• Requirements for the evaluation of efficacy, safety and performance of nationally manufactured prototype mechanical fans during the COVID-19 emergency 
• Updated list of IVDs for COVID-19 detection 

Health Alert [in Spanish]:

The safety reports and health alerts issued by INVIMA are available through the following link: https://app.invima.gov.co/alertas/alertas-sanitarias-general

Resolutions [in Spanish]:

• Requisitos para la importación y fabricación de productos cruciales en el contexto del Covid – 19 
• requisitos para la fabricación de antisépticos y desinfectantes 
• Medidas administrativas transitorias en el marco de la emergencia sanitaria

This guidance aims to provide general consideration to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during COVID-19 pandemic.

The document is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

Virtual seminar:

Strategies and operational guidelines  for the ethics review and oversight of COVID-19-related research

In a publication available at:https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research we provide guidance and strategies to streamline the ethics review and oversight of COVID-19-related research with human subjects.

We invite you to participate in a virtual seminar to discuss this publication and an upcoming one with a template of standard operating procedures for ethics review in emergency situations. In preparation for the seminar, we invite you to send your questions about these topics to bioethics@paho.org.

The virtual seminar in English will take place on Tuesday April the 21st at noon (Washington D.C. time). To participate go to: https://paho.webex.com/paho/onstage/g.php?MTID=eede4995e137569b2aa66bbb1d4ffccd9.

In its web page, the National Regulatory Authority of Argentina (ANMAT) keeps information, recommendations of the Ministry of Health and actions on COVID-19 prevention:  https://www.argentina.gob.ar/salud/coronavirus-COVID-19

Further information is available in its original language (Spanish):

Enlaces de interés

Lista actualizada de los reactivos de uso in vitro para detección de COVID-19 

Plan Estratégico para regular el uso de plasma de pacientes recuperados de COVID-19 con fines terapéuticos 

Mecanismo simplificado para empresas que importen o fabriquen productos médicos críticos relacionados a la pandemia por COVID-19,

Mecanismo de emergencia para el registro de productos médicos críticos de clase I y II relacionados a la pandemia por COVID-19.

Aplicación de autoevaluación de síntomas de COVID-19 está disponible para que el usuário descargue la aplicación en su mobile

Estudios de farmacología clínica

Medidas y recomendaciones con el objeto de preservar las actividades de los estudios de farmacología clínica (EFC) protegiendo la seguridad y bienestar de los participantes del estudio.

Información específica:

• La ANMAT establece criterios y procedimientos extraordinarios para el registro en el contexto de la emergencia sanitaria por COVID-19 de productos desinfectantes categorizados como domisanitarios.
• Instructivo para la solicitud de autorización de productos para diagnóstico in vitro no registrados
• Se exceptúa temporalmente de la intervención de ANMAT el ingreso al país en calidad de importación de barbijos, tapa bocas y guantes de examinación, en el marco de la Emergencia Sanitaria en relación al COVID-19
• ANMAT aclara a la comunidad que hasta el momento no existe evidencia científica que indique una influencia en la transmisión y evolución de la enfermedad por coronavirus (Covid-19) de las terapias basadas en medicamentos antihipertensivos *(inhibidores de la ECA y sartanes).

Información Normativa:

•  ventiladores (respiradores)
•  barbijos 
• aguas lavandinas 
• alcohol en gel