WHO Statement on DTG – Geneva, 18 May 2018
http://www.who.int/medicines/publications/drugalerts/Statement_on_DTG_18May_2018final.pdf?ua=1
The Federal Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, reported that so far in this federal administration, COFEPRIS has secured 10.1 million irregular medical devices and seized more than 335 tons of irregular drugs.
More information by the link: https://www.gob.mx/cofepris/articulos/10-1-millones-de-dispositivos-medicos-irregulares-asegurados-cofepris-157511?idiom=es
May 17, 2018
The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm
The National Administration of Medicines, Food and Medical Technology calls for a scholarship for the granting of a scholarship under the “Research Scholarship in Regulatory Science” approved by Disposition ANMAT 10451/17, on “Obtaining and preclinical evaluation of pharmaceutical nanovehicles for application in the treatment of Chagas disease “.
For more information go to http://www.anmat.gov.ar/comunicados/Llamado_a_Concurso_Beca_5-18.pdf
A new MedWatch Safety Alert: Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement – Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy intended for: Oncology, Pharmacy, Risk Manager was just added to the FDA MedWatch Webpage.You can read the complete MedWatch Safety Alert that includes recommendations at: https://go.usa.gov/xQPtf
Source: World health statistics 2018: monitoring health for the SDGs, sustainable development goals. Geneva: World Health Organization; 2018. CC BY-NC-SA 3.0 IGO.
ISBN: 978-92-4-156558-5
Published online: May 2018
The World Health Statistics series is WHO’s annual snapshot of the state of the world’s health. This 2018 edition contains the latest available data for 36 health-related Sustainable Development Goal (SDG) indicators. It also links to the three SDG-aligned strategic priorities of the WHO’s 13th General Programme of Work: achieving universal health coverage, addressing health emergencies and promoting healthier populations.
The latest data show that:
:: Less than half the people in the world today get all of the essential health services they need.
:: In 2010, almost 100 million people were pushed into extreme poverty because they had to pay for health services out of their own pockets.
:: 13 million people die every year before the age of 70 from cardiovascular disease, chronic respiratory disease, diabetes and cancer – most in low and middle-income countries.
:: Every day in 2016, 15 000 children died before reaching their fifth birthday.
:: 303 000 women died due to complications of pregnancy or childbirth in 2015. Almost all of these deaths occurred in low- and middle-income countries (99%). Reducing maternal mortality crucially depends upon ensuring that women have access to quality care before, during and after childbirth.
For details and additional information / Más información y material adicional click here.
Full report / Informe completo click here.
The Brazilian Health Surveillance Agency (Anvisa) certified for the first time in Good Manufacturing Practices (GMP) two Colombian pharmaceutical laboratories without a visit, which is based exclusively on inspection reports of the National Institute of Food and Drug Surveillance (Invima).
The certified laboratories are: Procaps S.A (Barranquilla) and Eurofarma Colombia S.A.S. (Bogotá).
This important achievement is based through the level of recognition that Invima gained by being a National Regulatory Authority of Regional of Reference (NRAr) level VI by the Pan American Health Organization (PAHO), indicating that the agency has uniform and transparent methodologies for the fulfillment of its functions of control, efficacy, safety and quality of medicines. Likewise, ANVISA is also recognized as one of the eight NRAr.
05-16-2018 Update
In addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication below, FDA has also approved new patient Medication Guides for all GBCAs.
Health care professionals and patients can access the patient Medication Guides according to the GBCA drug name* on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.
All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.†
*The brand names of the GBCAs can be found in Table 1 below.
†For more information on distribution of Medication Guides, see the Guidance Document, the Drug Info Rounds Video, or the Code of Federal Regulations at 21 CFR 208.26.
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For more information go to https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
[5-14-2018] The Food and Drug Administration is advising consumers not to purchase or use Best Candy, a product promoted as an energy booster on various websites and possibly in some retail stores. This product was identified during an examination of imported goods.
FDA laboratory analysis confirmed that Best Candy contains nortadalafil. Nortadalafil is structurally similar to tadalafil, the active ingredient in Cialis, an FDA-approved prescription drug for erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients should report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
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For more information go to: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm607663.htm
En el próximo viernes, 18 de mayo, as las 11hs (ETS), será realizada la 22da edición del programa de Webinars de RedETSA, el próximo viernes, 18 de mayo, a las 11hs (EST).
El Dr. Carlos Eduardo Pinzón-Flórez, Subdirector de Evaluación de Tecnología en Salud del Instituto de Evaluación Tecnológica en Salud (IETS), Colombia, dará una presentación sobre “Incorporación del valor social y la perspectiva de pacientes y ciudadanos en el desarrollo de la ETS”.
El link de WebEx que utilizaremos es el siguiente: https://goo.gl/238dg9
El presente Webinar está dirigido a todos interesados en el tema “Evaluación de Tecnología en Salud (ETS)”.
A continuación está disponible una tabla con el horario correspondiente a cada país.
Contamos con su presencia.
Equipo RedETSA y HSS/MT
Horario Webinar – viernes 18 de mayo:
| Argentina | 12 hs |
| Brasil (Brasilia) | 12 hs |
| Bolivia | 11 hs |
| Canadá | 11 hs |
| Chile | 12 hs |
| Colombia | 10 hs |
| Costa Rica | 9 hs |
| Cuba | 11 hs |
| Ecuador | 10 hs |
| El Salvador | 9 hs |
| Honduras | 9 hs |
| México | 10 hs |
| Panamá | 10 hs |
| Paraguay | 11 hs |
| Perú | 10 hs |
| Uruguay | 12 hs |
Red de Evaluación de Tecnologías en Salud de las Américas – RedETSA
