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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 

 
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FDA: Advancing the Science of Nanotechnology in Drug Development

Xiaoming Xu, Ph.D., Senior Staff Fellow, Office of Testing and Research, Office of Pharmaceutical Quality, CDER

The use of nanotechnology in products regulated by the FDA has been ongoing for several decades and has included foods, cosmetics, medical devices and drugs. Within the purview of FDA’s Center for Drug Evaluation and Research (CDER), there is great diversity in drug products containing nanomaterials.

There has been a steady increase in the number of approved drug products containing nanomaterials, including investigational new drugs, new drug applications, and abbreviated new drug applications (commonly known as generics). More than 60 applications have been approved since the early 1970s, and interest continues to rise.

Drug products containing nanomaterials are unique in several ways because they may take on different chemical, physical, or biological properties compared to other types of drugs. In some instances, this may impact the quality, safety, or efficacy of the product. For example, drug products containing nanomaterials may follow a different pathway in the body compared to a small molecule drug. After a drug product formulated as a nanomaterial enters the bloodstream, it could interact with specialized immune cells called macrophages, which engulf and transport a drug to the location for which it has been programmed, such as where bacteria, fungi, or viruses reside. These areas are typically difficult to reach for a small molecule.

In another example, a drug formulated as a nanomaterial may have a special “coating” that prevents it from interacting with immune cells so that the drug can circulate in the bloodstream for prolonged periods of time until it reaches tumor tissues. The ability to target areas of the body and bypass others can significantly reduce the risk of side effects, such as toxicity to nontarget organs, and potentially increase the effectiveness of the treatment. For these reasons, nanomaterials are most frequently used in the treatment of cancer or infections. Formulations like liposomes, nanocrystals and nano-emulsions are among the most common types of drug products containing nanomaterials being approved.

(…)

For more information go to https://www.fda.gov/Drugs/NewsEvents/ucm605837.htm

 
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Paraguay: Consultores de OPS supervisan manejo de la Tuberculosis en la Red de Barrio Obrero con estrategia de monitoreo y farmacovigilancia de la Tuberculosis Drogorresistente.

Consultores de la Organización Panamericana de la Salud-OPS/OMS, en compañía de referentes del Programa Nacional de Control de la Tuberculosis del Ministerio de Salud, realizaron una visita de monitoreo para la verificación del “Manejo Clínico y Programático de Tuberculosis Drogorresistente”, en la Red de Barrio Obrero.

En este sentido, se hicieron presentes en la sede del Hospital General Barrio Obrero donde fueron recibidos por autoridades y responsables del Programa de TB, para luego trasladarse hasta otros establecimientos componentes  de la Red de Barrio Obrero. Como los servicios de San Alfonso, Centro de Salud N° 8 y la Unidad de la penitenciaría de Tacumbú.

Durante el recorrido verificaron expedientes clínicos de pacientes afectados por Tuberculosis Drogorresistente, y monitorearon la organización de los laboratorios que procesan las muestras para el diagnóstico de TB, como también los avances en la implementación de fármaco-vigilancia activa, para supervisar y evaluar la respuesta de los tratamientos.

Los resultados del monitoreo serán presentados al Ministro de Salud, confirmaron los visitantes.

Fuente:  https://www.mspbs.gov.py/portal/14739/consultores-de-ops-supervisan-manejo-de-la-tuberculosis-en-la-red-de-barrio-obrero.html

 
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El Salvador: DNM participa en encuentro Regional de Autoridades Regulatorias

La Directora Nacional de Medicamentos, Dra. Leonor Morales de Acosta participó en la reunión de la Red Centroamericana de Autoridades Reguladoras de Medicamentos y Otras Tecnologías.

La reunión se desarrolló en República Dominicana, los días 23 y 24 de abril. En dicho encuentro participaron las Autoridades Regulatorias de Centroamérica y República Dominicana y se abordaron temas como la Integración Regional de la Salud y la Validación de la Estrategia de Medicamentos para Centroamérica y República Dominicana.

Además, se discutieron las brechas regulatorias en los países de la región y se hicieron los planteamientos de las líneas de trabajo integrado, estas líneas de trabajo no solo fortalecerán las acciones regulatorias de las autoridades participantes, sino que también la creación de una propuesta de herramienta regional para combatir la falsificación de medicamentos.

http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/258-autoridades-regulatorias