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Jamaica: Ministry of Health delivers Complaint Management System

The Standards and Regulations Division of the Ministry of Health, with support from Health Policy Plus (HP+), has published a Complaint Management System (CMS) Manual and Toolkit that is to inform the delivery of health services to the public.

With the Ministry’s increased focus on patient-centred care, the manual forms part of its ongoing efforts to strengthen its Client Complaint Mechanism (CCM) and overall CMS.

  • The CMS aims to improve the quality of service delivery in the public health sector by, among other things:
  • collecting feedback from internal and external clients;
  • providing a means for failures and/or complaints to be investigated; and
  • providing redress to clients.

This current manual is now aligned with the International Organisation for Standardisation (ISO) 9001, Quality Management Systems – Requirements (2008) and outlines clear processes for accessing, documenting, investigating and resolving customer complaints.

It also includes a monitoring and evaluation framework that ensures complaint data is captured for quality improvement activities and programme and policy development.

For more information go to https://www.moh.gov.jm/health-ministry-delivers-complaint-management-system-manual-toolkit/

 
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Anvisa: Jarbas presents the 2017 Activities Report to Senators

[Original text in Portuguese]

Reduced queues for drug certification and analysis time for rare disease treatments are among the major breakthroughs.

Reduction of the queues for drug certification and the time of analysis for treatments of rare diseases, and increased import of products destined for research are among the main advances of Anvisa in 2017 presented by the CEO Jarbas Barbosa. He attended the Social Affairs Committee (CAS), chaired by Senator Marta Suplicy (MDB-SP), on Wednesday (4) to detail the Agency’s Activities Report 2017.

For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4615665

 
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CRS Reviews Its First Reproductive Health Product

The CARPHA/CRS recently reviewed and recommended to CARICOM Member States its first reproductive health product, Levoplant. The product, made by Shanghai Dahua Pharmaceutical Co., Ltd., was prequalified by the World Health Organization on June 30, 2017, meaning it meets the United Nations standards of safety, efficacy, and quality for all its procurement programs. It has also been approved for country program purchase by the United Nations Population Fund. The CRS verified that the product the manufacturer intends to sell in CARICOM is the same as the prequalified version.

The active ingredient, levonorgestrel, prevents pregnancies by inhibiting or altering ovulation and thickening the cervical mucus. The product provides long term (up to 3 years of use) but reversible contraception, and becomes active when inserted into the upper arm. CARICOM Member States will now have an additional option for quality, affordable hormonal implants if they register this medicine.

More information about the product can be found on the manufacturer’s partner websites, including FHI 360.  Click here.

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

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

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

[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

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

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

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.

(…)

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

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

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