Medicines and Health Technologies News
Using a virtual platform promoted by PAHO/WHO, they are monitoring quality and generating alerts when faced with irregular situations or supply problems
Drug regulatory agencies and ministries of health in the Americas are collaborating to strengthen drug safety and management in the Region, by exchanging information on irregularities in the manufacture of drugs and biologicals, as well as potential supply problems, in just one of the initiatives launched with support from the Pan American Health Organization / World Health Organization (PAHO/WHO).
With this objective in mind, the countries are now using a virtual tool called the Regional Platform on Access and Innovation for Health Technologies (PRAIS in Spanish), which PAHO/WHO launched last May and which already has more than 800 users—among them, the regulatory authorities of the United States, Canada, and Argentina.
The objectives of this platform are to improve transparency, information flow, and cooperation among the different sectors involved in medical products and technologies in the countries of the Americas.
“This tool is part of a series of activities that will make it possible for our Region to strengthen its surveillance of the quality and safety of the medicines consumed, as well as to help us fill information gaps among the sectors involved in drug management,” explained James Fitzgerald, Senior Advisor on Essential Medicines and Biologicals at PAHO/WHO. “The Organization is working with drug regulatory authorities and other stakeholders to find ways to better coordinate joint surveillance efforts in the Region,” he added.
PRAIS can be used by regional health authorities; national drug regulatory authorities; and departments of science, technology, and innovation in the countries—as well as by scientists, researchers, and research institutions in general. Other users include representatives from the pharmaceutical industry and members of civil society, nongovernmental organizations, and foundations working in the areas of medicines and health technologies.
For more information about this press note, please click here.
Washington, D.C., April 8 2013 (PAHO/WHO) — Countries in the Americas can save money and improve their access to medicines for hypertension, diabetes, cardiovascular diseases, and cancer through the Revolving Fund for Strategic Public Health Supplies of the Pan American Health Organization/World Health Organization (PAHO/WHO), known as the PAHO Strategic Fund.
“The objective is to help countries increase their access to medicines and assure these are of high quality and available at competitive prices, to help them deal with the chronic disease epidemic in the Americas,” said James Fitzgerald, PAHO/WHO senior advisor on medicines and health technologies.
Noncommunicable diseases (NCDs) are the leading cause of death in the Western Hemisphere. More than 200 million people in the Americas suffer from a noncommunicable disease, and many suffer from more than one, making NCD prevention, treatment, and care a major challenge for the region’s countries.
As of April 2013, the list of products available through the Strategic Fund includes 16 essential medicines for hypertension, diabetes, cardiovascular diseases, and cancer.
The expanded list of medicines is part of the implementation of the 2012-2025 Strategy to Prevent and Control Noncommunicable Diseases, approved in 2012 by PAHO/WHO Member States. The strategy seeks to reduce premature mortality from four main NCDs by at least 25% by 2025, as well as to reduce morbidity, risk factors, and their associated costs.
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The Pan American Health Organization (PAHO) together with Health Canada are pleased to announced the VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH), which will be held in Ottawa, Canada from September 5th-7th, 2013 with the theme “Sixteen years promoting Good Regulatory Practices in the Region of the Americas”. This Conference is coordinated by PAHO, with the collaboration and financial support of the Regulatory Authority of Canada (Health Canada).
Among the key issues to be discussed at this conference is the PANDRH Strategic Development Plan 2014-2020, which aim to:
• Promote efficient governance of the network, active participation and cooperation of National Regulatory Authorities (NRAs);
• Establish priorities for regulatory harmonization and support their dissemination, adoption and implementation;
• Promote strengthening of Good Regulatory Practices; and
• Promote exchanges of experiences and lessons learned between NRAs of the Americas and NRAs of other regions.
Importantly, the reception is open from posters to be presented at the conference; more information can be found by clicking here.
The VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH) is held every two or three years. Its mission “to promote drug regulatory harmonization for all aspects of quality, safety, and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas”.
The first CPANDRH was held in 1997 in Washington, D.C., and is considered to have been the first step in the creation of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Since then, a total of six conferences have taken place; three in the United States of America (1997, 1999 and 2002) in the Dominican Republic (2005), in Argentina (2008), and most recently in Brazil (2011).
Valuable technical documents and guidelines related to drug regulation in the region of the Americas and information from previous CPANDRH are available at: www.paho.org/pandrh.
Subsequently after the VII CPANDRH, from September 9th -13th, Health Canada will be hosting the V Annual Health Products and Food Branch (HPFB) International Regulatory Forum, as part of their international regulatory cooperation and capacity building programs. This Forum provides an overview of Canadian regulatory processes for multiple human health products, including biological products, pharmaceuticals and medical devices, throughout the pre- and post-market life cycle.
The HPFB has been held annually since 2009 and is open to all regulatory agencies only, from around the world, to exchange regulatory experience and expertise in different discussion areas, through panels, plenary sessions and cases studies. Please note that the Forum is exclusive to regulators only.
There is no registration fee for NRA representatives who wish to participate in either of these two events. However, all expenses related to hotel, travel and transportation as well as visa formalities are the responsibility of the concerned parties, who are required to notify their interest in participating by completing the registration forms and sending them to the main contacts listed below.
Delta Ottawa City Centre - http://www.deltaottawacitycentre.com
101 Lyon Street Ottawa, ON, K1R579, Canadá. Tel.: +1-866-599-6674
On February 26, 2013, Ms. Margareta Skold, PAHO/WHO Representative in Jamaica made an official presentation of the publication “Pharmaceutical Situation in Jamaica: WHO Level II Assessment – Health Facilities and Household Survey” to the Minister of Health, the Honorable Dr. Fenton Ferguson.
Following the official presentation, Mrs. Princess Thomas Osbourne, Director of the Standards and Regulations Division in the Jamaica Ministry of Health and Ms. Marilyn Entwistle, PAHO Health Systems and Services Advisor in the PAHO/WHO Jamaica office, made a detailed Power point presentation on the findings and recommendations of the assessment.
The assessment of the pharmaceutical situation was undertaken in Jamaica from July 2009 to May 2010, with technical and financial support from PAHO/WHO through the EU/WHO ACP Project “Partnership on Pharmaceutical Policies” and the Centre for Pharmaceutical Policies of the Oswaldo Cruz Foundation in Brazil, PAHO/WHO Collaborating Centre on Pharmaceutical Policies. Mrs. Cynthia Lewis Graham from the Ministry of Health was the principal investigator for this assessment.
Overall access indicators showed that key essential medicines were largely available in public health facilities (93.3%), warehouses that supply the public health system (100%) and private pharmacies (93.3%) and 76.7% of the prescribed medicines were dispensed or administered to patients at public health facility dispensaries. One recommendation was the development and official adoption of a national pharmaceutical policy to address the main challenges and constraints identified in the surveys. The report can be accessed at:
Using a standardized methodology developed by the WHO, the study had two components: health facilities and households survey.
• In the first approach, data related to the pharmaceutical policy outcome was collected from public healthcare facilities, public and private pharmacies and public warehouse that supply public facilities.
• In the second, data came from a survey conducted at household level.
The Honourable Dr. Ferguson indicated that he was pleased to receive the publication “in consonance with Ministry of Health’s mandate of ensuring the provision of quality health services and promoting healthy lifestyles and environmental practices as well as the efforts of the Ministry to promote universal health coverage providing Jamaican citizens medicines of ensured quality, safety and promoting their rational use. The gaps identified are an important resource for the development of the National Pharmaceutical Policy and to continue improving the quality of care across the country.”
Additionally, Ms. Margareta Skold stated that “PAHO/WHO’s essential mission is to strengthen national and local health systems and improve the health of the peoples of the Americas, in collaboration with Ministries of Health, other government and international agencies, nongovernmental organizations, universities, social security agencies, community groups, and many others. PAHO/WHO seeks to strengthen the health sector capacity in countries to advance their priority programs through intersectoral action, promoting an integral approach to health problems.
PAHO/WHO is pleased to support the Ministry of Health in the collection, analysis and use of the data. A comprehensive assessment of the pharmaceutical sector helps to determine what the gaps are in order to design effective interventions and allows evaluation of the impact of interventions over time and are crucial for informing pharmaceutical policies and advocacy work. We look forward to continue technical cooperation with the Ministry as it proceeds to consider implementation of recommendations from the report.”
Areas of Work Project of Medicines and Health Technologies
Regional Office for the Americas of the World Health Organization