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President Tabaré Vázquez of Uruguay is a co-chair of The WHO Independent Global High-level Commission on noncommunicable diseases

16 February 2018 | Geneva – WHO is announcing today a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.

The WHO Independent Global High-level Commission on NCDs is co-chaired by President Tabaré Vázquez of Uruguay; President Maithripala Sirisena of Sri Lanka; President Sauli Niinistö of Finland; Veronika Skvortsova, Minister of Healthcare of the Russian Federation; and Sania Nishtar, former Federal Minister of Pakistan.

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The new Commission was established by WHO Director-General Dr Tedros Adhanom Ghebreyesus and runs until October 2019. It will provide actionable recommendations to contribute to the Third United Nations General Assembly High-level Meeting on NCDs scheduled for the second half of 2018. This will include the submission of its first report to Dr Tedros in early June.

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For more information go to http://www.who.int/mediacentre/news/releases/2018/world-leaders-ncds/en/

 
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TECENTRIQ (atezolizumab) – Risk of Myocarditis

Audiences

Healthcare professionals including oncologists, uro-oncologists, urologists, oncology nurses, oncology pharmacists, emergency room staff, and other healthcare professionals providing care to cancer patients, including those working in hospitals, cancer centers, oncology clinics, and pharmacies.

Key messages

  • Severe cases of myocarditis have been reported in patients being treated with TECENTRIQ (atezolizumab) in clinical trials.
  • Healthcare professionals are advised to:
    • monitor patients receiving TECENTRIQ for signs and symptoms of myocarditis.
    • withhold TECENTRIQ therapy in patients with Grade 2 myocarditis.
    • permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis.
    • administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis.
  • The Canadian Product Monograph has been updated to include this new safety information.

For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/65990a-eng.php

Posting date: February 14, 2018

 
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Mexico promotes opportunities for expansion and access to the pharmaceutical and medical device market

As part of the strategy to strengthen links at a global level, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) participated in the work of India Pharma 2018, where it presented the regulatory advances reported by Mexico to expedite the population’s access to medicines and supplies for quality, safety and efficacy.

For more information go to https://www.gob.mx/cofepris/articulos/fortalece-la-cofepris-vinculos-internacionales-147624?idiom=es

 
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MEDICC Review interview Director of CECMED, Cuba

Science at the Service of Public Health: Rafael Pérez Cristiá MD PhD Center for State Control of Medicines and Medical Devices.

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Cuba’s nascent biotechnology sector began making scientific breakthroughs in the 1980s, including the isolation of human leukocyte interferon alpha (1981) and the development of the world’s first safe, effective meningitis BC vaccine (1989). With positive results in hand and a growing R&D pipeline, the island nation established a national regulatory authority (NRA) to implement and oversee best practices for all pharmaceuticals and medical devices, domestically produced and imported, used in the country’s universal health system. Founded in 1989, Cuba’s Center for State Control of Medicines and Medical Devices (CECMED) is the entity charged with regulating all phases of scientific innovation for health, from clinical trial design to postmarketing surveillance.

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For more information go to: http://www.cecmed.cu/content/entrevista-de-medicc-review-director-del-cecmed-science-service-public-health-rafael-perez

 
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ANMAT DETECTS COUNTERFEIT LOTS OF VARIOUS MEDICINES

Argentina, February 7, 2018 [Source in Spanish]

The ANMAT, National Regulatory Authority of Argentina, informs the population that the existence of counterfeit lots of the following medicinal specialties has been detected:

  • ISENTRESS Raltegravir 400 mg, for 60 coated tablets. Lot ARG0324 / L026309 vto. ABR / 2018.
  • PERUGE Pertuzumab 420 mg / 14 ml, for 1 concentrated vial for solution for infusion. Lot H0109918 vto. 10/2019.
  • VIRORREBER 600 Efavirenz 600 mg, for 30 coated tablets. Lot MEG35IK4 Vto. 02/19.

The warning arises as a result of having carried out a series of inspections in different cities of the country, during which units of the items detailed in sample were withdrawn. After the relevant verification were made to the respective marketing authorization holders, it could be verified that they are illegitimate.

Because of the above, and taking into account that the other units in question could have a valid expiration date and could be found in the market, the population is warned to refrain from consuming them and, if they have any of them in their possession, contact the “ANMAT Responde” Program (toll free: 0-800-333-1234; mail: respuesta@anmat.gov.ar).

Source in Spanish: http://www.anmat.gov.ar/comunicados/Isentress-Perjeta-Virorreber%2006-02-18.pdf

 

 
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Dominican Republic: Vice-president, Minister of Health walk through new construction Hemocentro

Santo Domingo.- The Vice-President of the Republic, Margarita Cedeño de Fernández and the Minister of Health, Altagracia Guzmán Marcelino, made a tour on Monday to verify the progress made in the construction work of the new Hemocentro. They made the tour accompanied by other personalities.

More information through the link http://www.msp.gob.do/Vice-presidenta-Ministra-de-Salud-recorren-construccion-nuevo-Hemocentro

 
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Webinar: Use of REDCap for the improvement of health care processes (in Spanish)

The Unit of Medicines and Health Technologies of PAHO / WHO is pleased to invite you to:

Webinar: Use of REDCap for the improvement of health care processes (in Spanish)

Friday, February 16, 2018, 10:00 a.m. of Washington DC, United States

REDCap is a web software created by Paul Harris and colleagues at Vanderbilt University and designed for data management in Translational Research. With more than 10 years of development it offers a large number of features that make it attractive for researchers (multi-projects, security, surveys, randomization, branches, blind, automatic emails, access groups, user profiles, among many others). All this has led REDCap to be adopted by more than 2700 institutions, reaching almost 700,000 users in 117 countries, and has been cited in more than 4700 publications. Although the initial intention was to develop a software for Research, the use of this tool for management and operation is being increasingly validated worldwide. This presentation aims to convey the success stories of the use of REDCap for both clinical and administrative management of health care.

Cristóbal Carvajal is a surgeon, graduated from “Universidad del Desarrollo”, Santiago Chile. 5 years ago, she works in the Biomedical Informatics Department at “Clínica Alemana de Santiago”, and since 2015 she is in charge of the Clinical Data Unit. The development of its activity has been based on innovation and creative solution of problems through the use of information, so it has specialized in the modeling and data capture in different scenarios. He recently completed a stay at Quality & Improvement at the Children’s Hospital of Philadelphia, USA, which has allowed him to complement his vision of data analysis with quality aspects. Dr. Carvajal is an advanced user of the REDCap software and a pioneer in the use of this tool for purposes other than research, which has allowed him to capture information and optimize various processes in multiple scenarios. He has presented his experience in various congresses in Chile, Argentina and USA. He is an active participant in the REDCap community and a member of the Spanish-speaking group. In addition, from 2013 to the present, he works as a clinician in an Emergency Service of the “Mutual de Seguridad” (which covers accidents at work and occupational diseases).

Diego Macías Saint-Gerons has a degree in pharmacy from the University of Salamanca, a Master’s Degree in Quantitative Methods of Research in Epidemiology from the Autonomous University of Madrid and a PhD in Health Sciences from the Complutense University of Madrid. He is the author of numerous scientific articles on the use of drugs and their effects. He has worked at the University of Valladolid, the Spanish Agency for Medicines and Health Products (AEMPS), and as an expert of the European Medicines Agency (EMA). He is currently working as an international consultant (IPC) in the Medicines and Health Technologies Unit of PAHO / WHO.

Access will be provided through: https://paho.webex.com/paho/onstage/g.php?MTID=e11f25011f597fc2e8ea93b378557adc4

Additionally, it can be accessed by telephone through the United States line: + 1-415-655-0002 by dialing the access code 642 964 895

We hope count with your participation.

HSS / MT

 
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Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas

Author

Lessa, Fernanda

Caccavo, Francisco

Curtis, Stephanie

Ouimet-Rathé, Stéphanie

Lemgruber, Alexandre

Series

Rev Panam Salud Publica;41, dec. 2017

Objective. Health technology assessment (HTA) has been adopted by countries in order to improve allocative efficiency in their health systems. This study aimed to describe and analyze the HTA decision-making process in the Region of the Americas. Methods. A literature review was done to better understand the HTA situation in the Region. Also, in 2014 and 2015, individuals responsible for conducting HTA in countries of the Americas were identified and received a questionnaire on HTA and the decision-making process. Results. A total of 46 questionnaire responses were obtained, from 30 countries. The respondents were similar in terms of their institutions, main funding sources, and technology types assessed. Of the 46 respondents, 23 (50%) work for their respective ministry of health. Also, 36 (78%) undertake and/or coordinate HTA through coverage and reimbursement/pricing decisions and other HTA-related activities, while 24 (52%) use HTA for emerging technologies. While some countries in the Region have created formal HTA units, there is a weak link between the HTA process and decision-making. Most of the countries with recognized HTA institutions are members of the Health Technology Assessment Network of the Americas (RedETSA). Despite the advances in the Region overall, most countries in Central America and the Caribbean are still at the early stages of implementing HTA to support decision-making. Conclusions. Many countries in the Americas have benefited from the exchange and capacity-building opportunities within RedETSA. However, there are still many challenges to overcome in the Region in terms of the discussion and creation of HTA-related policies.

Source: http://iris.paho.org/xmlui/handle/123456789/34574

 
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Belize: Ministry of Health issues first list of ‘Over the Counter’ Medications for General Use

The Ministry of Health issues the first list of Over the Counter Medications for General Use.

“Note that this is a provisional first list and the Director of Health Services will be reviewing this list continuously while making necessary modifications as we aim to keep the safety of the consumers as our primary principle.”

For more information go to http://health.gov.bz/www/publications/belize-health-information-system-unit/970-ministry-of-health-issues-first-list-of-over-the-counter-medications-for-general-use