Blog – Page 69 – PRAIS 2.0

PANDRH Network: Ongoing Project of the PARF Network coordinated by CECMED and FIFARMA

Murilo Freitas - 11:28, 3 de July de 2018923

The May 2018 issue of the digital journal of the Medicines Information Association (DIA), entitled DIA Global Forum, aimed at offering global and regional expertise on the discovery, development, regulation, surveillance and commercialization of products for the health, presents an article on the Certificate of Pharmaceutical Product (CPP)Project written by the focal points of the project, D.S Celeste Sánchez in CECMED and Dr. Jaime Oliveira in FIFARMA, named “CPP Requirements for Medicines Registration in the Region of the Americas. A PANDRH CPP Project “. Access to the full text of this work is here.

We hope you enjoy reading the article and join the CPP Project Community in the PRAIS Platform of PAHO where you can find additional information about the Project.

Source: http://www.cecmed.cu/content/en-curso-proyecto-de-la-red-parf-coordinado-por-cecmed-y-fifarma

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Paraguay: Guarantee in the provision of medicines thanks to a large public investment

Murilo Freitas - 12:37, 29 de June de 20181,065

[Original text in Spanish]

The optimization of scarce financial resources, coupled with reengineering to prioritize strategic expenditures, has been the basis for achieving sustainability in public health services, as well as in the realization of key investments, as was the one made for the provision of medicines and medical supplies for Public Health services.

G. 2,895,126 million is the amount invested in supplies and medicines for supply to the 18 health regions, 23 hospitals, 14 programs, and 7 other institutions (outside the MSPyBS network).

For more information go to https://www.mspbs.gov.py/portal/15245/garantia-en-la-provision-de-medicamentos-gracias-a-una-gran-inversion-publica.html

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Dominican Republic: DIGEMAPS participates in the XII Meeting of the Ibero-American Network of Drug Authorities

Murilo Freitas - 12:14, 29 de June de 20182,535

Santo Domingo.-The Ministry of Health, through the Directorate General of Medicines, Food and Health Products (DIGEMAPS), participates in the XII Meeting of the Ibero-American Network of Medicines Authorities (EAMI Network) held in Lisbon and where The modern systems of regulation of medicines and health products in the region are discussed..

In the meeting that takes place from June 26 to 29 of this year, joint actions are also defined to generate knowledge through the exchange of experiences, technical, legislative and organizational information that guarantees to users, from the perspective of service public, access to medicines and medical devices, ensuring the quality, efficacy, safety, correct identification and information of them.

For more information in Spanish go to http://msp.gob.do/MS-participa-en-el-XII-Encuentro-de-la-Red-Iberoamericana-de-Autoridades-de-Medicamentos

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FDA Drug Topics: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS) – June 26, 2018

Murilo Freitas - 12:03, 29 de June de 2018713

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, June 26, 2018, at 1:00PM (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS). This webinar introduced health care professionals to web resources about Risk Evaluation and Mitigation Strategies (REMS), including a REMS resource portal and the REMS@FDA website, and focused on what type of information is available, where, and how to navigate these resources.

View Presentation: https://collaboration.fda.gov/p2gmf8ine1f/

Presentation Slides: Web Resources Available (REMS) (PDF – 2.09MB)

Activity Outline and Continuing Education Information: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS) (PDF – 321KB)

Source: https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm607741.htm

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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

Murilo Freitas - 11:56, 29 de June de 20181,391

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).

It is THC (and not CBD) that is the primary psychoactive component of marijuana.

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For more information go to https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

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Information for laboratories on medicines quality control analysis for INVIMA

Murilo Freitas - 11:48, 29 de June de 2018746

The National Institute for Medicines and Food Surveillance (INVIMA) informs laboratories of quality control of medicines in the country, that the process of authorization of laboratories for various products and methodologies is underway.

Access the link for more information: https://www.invima.gov.co/informaci%C3%B3n-para-los-laboratorios-que-quieran-realizar-an%C3%A1lisis-de-medicamentos-para-el-invima.html

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Health Canada reminds Canadians of the limitations of fentanyl test strips being used to check street drugs before consumption

Murilo Freitas - 11:35, 29 de June de 20181,233

Posting date: June 22, 2018

OTTAWA – With the growing availability of fentanyl test strips on store shelves and online, Health Canada would like to remind Canadians of the potential limitations when using fentanyl test strips to detect fentanyl or other deadly substances in street drugs before consuming them.

No fentanyl test strips are specifically designed to check street drugs before consumption. Some strips are designed to detect fentanyl and some analogs (similar chemicals, such as carfentanil) in an individual’s urine sample to determine whether they have taken the drug. Others are designed to detect fentanyl and some analogs in substances that are, for example, seized by law enforcement. Therefore, it is important that people who are using fentanyl test strips to check street drugs before consuming them understand the limitations and use the necessary precautions.

Health Canada is reminding Canadians that to help prevent a fatal overdose, it is important to treat all street drugs as though they are potentially contaminated with unknown deadly substances.

(…)

For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67106a-eng.php

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Anvisa maintains status in the European Union for pharmaceutical supplies

Murilo Freitas - 11:28, 29 de June de 2018827

During the period, Anvisa and the National Health Surveillance System (SNVS) were submitted to the European Union’s audit whose main objective was “to evaluate the regulatory framework applicable to API for human use / 2014-2018 period.”

During the two weeks, the European Community auditing team, Anvisa representatives and local health surveillance visited manufacturers of IFAs in the states of São Paulo, Piauí and Minas Gerais.

Source: ANVISA

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ANMAT will host a meeting to conclude the development of the regulatory systems assessment tool

Murilo Freitas - 11:13, 29 de June de 2018893

[Original text in Spanish]

ANMAT, one of the eight authorities recognized as a regional reference in medicines of PAHO / WHO in the Americas, will host a meeting on the development of a regulatory systems assessment tool.

The meeting will take place from July 23 to 25 in Buenos Aires, Argentina, and will have the participation of global regulators representatives. Among the objectives of the meeting are:

Improve the global assessment system for regulatory systems (GBT) according to the recommendations of the public consultation and feedback process of the representatives of the National Regulatory Authorities (ARNs) that have provided advice to WHO and PAHO.
Provide recommendations to the editor of the tool.
Support the development / definition of quantitative indicators to be included in the tool.
Discuss the training requirements and competencies of the evaluators.

Source: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf

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Dominican Republic: Ministry of Health publish new basic List of Essential Medicines 2018

Murilo Freitas - 10:28, 20 de June de 20182,139

[Original Text in Spanish]

SANTO DOMINGO.-The Dominican Government through the Ministry of Health guarantees access to essential medicines with the implementation of the 7th version of the Basic List of Essential Drugs, with 797 selected drugs. This selection was made based on scientific evidence and through the use of a systematized methodology that considered the national epidemiological profile, the different levels of care, clinical therapeutic guidelines and care protocols, thereby complying with the General Law of Health 42-01.

Compared to the version of 2015, the Basic List of Essential Medicines 2018, has 35 additional drugs, in the following categories: psychoactive drugs, cardiovascular, analgesics, antibiotics, antiepileptic drugs, contraceptives, tuberculosis treatments and HIV medicines for hepatitis B and C.

More information on the link http://www.msp.gob.do/MS-oficializa-Cuadro-Basico-de-Medicamentos-Esenciales-2018