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El Salvador and Brazil exchange experiences on pharmacovigilance

[Original text in Spanish]

The National Directorate of Medicines of El Salvador (DNM) and the National Health Surveillance Agency of Brazil (ANVISA) exchange experiences on pharmacovigilance in the framework of the Bilateral Cooperation Program between El Salvador and Brazil 2017-2019.

Both Medicines Regulatory Authorities develop training among their members and the pharmaceutical industry to strengthen health surveillance and regulation. Part of these activities were developed in the facilities of the DNM, on dates of May 7 to 10, 2018.

The training program was attended by Adalton Guimarães Ribeiro, Technical Director of Pharmacovigilance and Fernanda Simioni Gasparotto, Specialist in Health Regulation and Surveillance of ANVISA.

The specialists provided technical knowledge for the sector of the pharmaceutical industry on specific topics such as: Pharmacovigilance Master File, Minimum Standard Operating Procedures for the operation of a Pharmacovigilance system in the Industry, Pharmacovigilance Inspections in the Pharmaceutical Industry, Periodic Safety Updat Report, Risk Management Plan, and Spontaneos Adverse Events Report.

For more information go to http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/261-dnm-y-anvisa

 
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Pan American Journal of Public Health: Thematic number on the health system in Cuba

The National Health Policy in Cuba gives priority to health as a right, an essential component of human well-being and a strategic objective of development.

The country devotes efforts and resources to the development and consolidation of the National Health System (NHS), characterized by the principles of universality, gratuity, accessibility, regionalization and comprehensiveness, with scope to all citizens in the countryside and the city, and also with an internationalist conception.

Primary health care is the strategy and the fundamental axis of the SNS, which is currently immersed in a process of transformation in order to continue advancing towards universal health, improving the health of the population, increasing the quality of services, and make their actions more efficient and sustainable.

(…)

More information in Spanish by the link: http://www.sld.cu/noticia/2018/04/30/revista-panamericana-de-salud-publica-numero-tematico-sobre-el-sistema-de-salud-e 

Pan American Journal of Public Health: https://www.paho.org/journal/ 

 
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El Salvador: Swearing in to Dr. Leonor Morales de Acosta as National Director of Medicines (DNM)

The President of the Republic Salvador Sánchez Cerén, this day, was sworn in to Dr. Leonor Morales de Acosta as National Director of Medicine.

The swearing in took place in the Presidential House Honor Room. It should be noted that Dr. Acosta already served as Director of said autonomous interim from January to date, but with this appointment the President of the Republic makes it official in the position.
The new incumbent served for six years as Executive Director of this same institution, therefore, she has the technical and scientific knowledge, as well as the capacity and leadership to assume with responsibility the leadership of the National Directorate.

With his appointment to the position, the continuity of the projects and institutional objectives outlined is guaranteed, including the Level IV Certification, granted by the Pan American Health Organization. This certification converts the National Directorate of Drugs into a Regional Reference Regulatory Authority.

Dr. Acosta, assumes the commitment to lead this great project of the nation that seeks to continue to guarantee the quality, safety and efficacy of medicines, as well as their rational use and low prices.

Source: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/259-juramentacion

 
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Pharmacopoeias of Mexico and the USA sign memorandum of understanding

COFEPRIS, FEUM and USP strengthen their bilateral cooperation

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the Pharmacopoeia of the United Mexican States (FEUM) and the United States Pharmacopoeia (USP for its acronym in English) today signed a Memorandum of Understanding which will contribute to the development and strengthening of a bilateral cooperation framework through the implementation of projects and activities that have a positive impact on the development of the health sector.

For more information go to https://www.gob.mx/cofepris/articulos/farmacopeas-de-mexico-y-de-eeuu-firman-memorandum-de-entendimiento-155888?idiom=es

 

 
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Primer número del Boletín Técnico del Instituto de Salud Pública de Chile

El Instituto de Salud Pública (ISP) te invita a revisar el primer boletín técnico del Instituto de Salud Pública de Chile (ISP) que tiene como objetivo dar a conocer a la ciudadanía temas de interés vinculados al quehacer del ISP por el enlace http://www.ispch.cl/boletintecnico/ 

Contenido del Boletin No. 01/ Abril 2018:

  • Investigación realizada por profesionales del ISP, apoya incorporación de limite permisible ponderado específico para polvo de harina de trigo
  • Proyecto de apoyo al fortalecimiento de la regulación de dispositivos médicos en Chile con el banco interamericano del desarrollo
  • ISP realizó capacitación en farmacovigilancia a representantes de la industria farmacéutica
  • Laboratorio de Metrología aprobó sistema de gestión de calidad en el sistema interamericano de metrología
  • Autoridades de sanidad del Ejército de Chile y Estados Unidos visitaron las instalaciones del ISP
  • Profesionales del CDC capacitaron a funcionarios del ISP en secuenciamiento de última generación para virus influenza.
 
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PAHO WEBINAR Traditional and Complementary Medicine in Primary Health Care; 40 years after Alma-Ata

The Pan American Health Organization cordially invites you to participate in the webinar “Traditional and Complementary Medicine in Primary Health Care; 40 years after Alma-Ata”, on May 8, 2018. Speakers will examine the role of traditional and complementary medicine in the context of the 40th anniversary of the Alma-Ata Declaration, the PAHO Universal Health Strategy, and the WHO Traditional Medicine Strategy 2014-2023.
The inclusion of traditional medicine is key to addressing ethnic inequities in health in the region, and it is therefore included as a central component of the intercultural approach of PAHO´s Policy of Ethnicity and Health.

DATE: May 8
TIME: 2 – 4 PM (EST)
LIVESTREAM:

AGENDA
Opening remarks: Anna Coates, Chief, Office of Equity, Gender, and Cultural Diversity, PAHO/WHO
Moderator: Ricardo Fabrega, Regional Advisor for Integrated Health Services, Health Services and Access Unit, PAHO/WHO

PANEL

  • The Role of Integrative and Complementary Practices in Primary Health Care in Brazil. Daniel Miele Amado, National Coordinator, Integrative and Complementary Practices in Health, Ministry of Health of Brazil
  • The Importance of Traditional Medicine for the Ethnic Diversity of the Americas. Vivian Camacho, Indigenous rights activist, member of PAHO´s High-Level Commission for the 40th anniversary of Alma-Ata
  • Integrative Health Competencies for Primary Health Care Professionals. Benjamin Kligler, National Director, Integrative Health Coordinating Center, Office of Patient-Centered Care & Cultural Transformation, Veterans Health Administration; Chair, Interprofessional Leadership Team, National Center for Integrative Primary Health Care
  • Virtual Health Library in Traditional, Complementary, and Integrative Medicine for the Americas: information, collaboration, and inclusion to advance towards Universal Health. Veronica Abdala, Manager of Cooperative Information Services and Production of Information Sources, BIREME/PAHO/WHO

Closing remarks: James Fitzgerald, Director, Department of Health Systems and Services, PAHO/WHO

The event is a collaboration of the Health Services and Access Unit, the Office of Equity, Gender, and Cultural Diversity, and BIREME/PAHO/WHO.

 
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CRS facilitates access to WHO recommended cholera vaccine in the Region

On Wednesday, April 25th, the CARPHA/Caribbean Regulatory System (CRS) recommended its first vaccine to CARICOM states for marketing authorization/import permit.

 The product, called Euvichol-Plus, is manufactured by EuBiologics Co., Ltd. of South Korea, and is intended to protect against cholera. It is a new type of cholera vaccine that is easier to deliver in challenging field conditions and is much less costly than previous alternatives.

Although cholera is often dealt with in the context of disasters, including recent outbreaks in the CARICOM state of Haiti, an effective vaccine is an important part of a comprehensive prevention package. This vaccine is prequalified by the World Health Organization (WHO) and meets WHO’s high standards for quality, safety and efficacy.

 The CRS relied on assessment information confidentially shared by WHO, and verified documentation provided by the manufacturer to ensure it was the same product. This case demonstrates the way the CRS is facilitating access to high quality and life-saving medicines in the region.

In the context of limited human resources and financing in the many small states of CARICOM, the CRS is serving as a mechanism to  rely on trusted authorities for their reviews of products regarding safety, quality, and efficacy, and providing a regulatory channel for manufacturers to expeditiously send these same high quality products to the region.

Source: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS

 
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Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall – Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall – Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm606863.htm

 
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Health Canada – Several GlaxoSmithKline Inc. vaccines: Potential Risk of Underdosing

Audiences

Healthcare professionals including family physicians, pediatricians, pharmacists, nurses, nurse practitioners, physicians’ assistants, and those working in travel clinics.

Key messages

  • This information is applicable to the following vaccines: BOOSTRIX, BOOSTRIX-POLIO, ENGERIX-B, HAVRIX, HAVRIX Junior, INFANRIX-IPV, INFANRIX-IPV/HIB, INFANRIX-hexa, TWINRIX and TWINRIX Junior (see section “Products affected*”).
  • Leakages have occurred from ceramic coated tip (CCT) syringes used for several GlaxoSmithKline Inc. vaccines in Canada.  The leakages occurred at the connection of the syringe tip and the needle hub during vaccine preparation or administration at an approximate rate of 3 per 100,000 syringes distributed. The integrity of the syringe and sterility of the contents were not compromised. 
  • Administration of vaccines from leaking syringes can result in a potential risk of underdosing, that may leave patients inadequately protected from disease after vaccination (see section “Information for healthcare professionals”). 
  • Healthcare professionals are advised:
    • not to use the syringe when the leakage occurs during reconstitution of lyophilized vaccines. 
    • when the leakage occurs during vaccine injection and the individual received less than the standard dose, the decision to revaccinate should take into account both the potential benefits and risks associated with administering a repeated dose (see section “Information for healthcare professionals”). 
  • GlaxoSmithKline Inc. has been working with Health Canada to provide information regarding the leaking syringes for vaccines and the corrective actions implemented. The introduction of improved CCT syringes on the Canadian market is anticipated in 2018. However, both improved and affected CCT syringes are expected to be on the market until the end of 2019, the estimated time for using up the potentially affected syringes.

Issue

There have been reports of leakage from CCT syringes used for several GlaxoSmithKline Inc. vaccines during vaccine preparation or administration. Although the leakage does not pose a concern for the vaccine sterility, there is a potential risk of underdosing associated with administration of a vaccine from a leaking syringe that may leave patients inadequately protected from disease after vaccination.

For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66674a-eng.php