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Pharmacovigilance in Emerging Markets

Dr John McEwen (ISoP EC member / University of Canberra , Australia ) wrote an article on Pharmacovigilance in Emerging Markets for the Singapore based electronic publication "PharmAsia".

Announcements FDA

There are several automatic email subscriptions that will provide you information from FDA to consumers, healthcare professionals and industry. Here are links to several email subscription services located on www.FDA.gov , that ISoP membership can subscribe to :

Health Professional Updates http://www.fda.gov/ForHealthProfessionals/default.htm  scroll to the bottom for links to:

•  MedWatch E-list - Timely, actionable new safety information on all human medical products used in day-to-day patient care, including prescription and over-the-counter drugs, biologicals and vaccines, medical devices, dietary supplements and cosmetics.

•  Health Professional updates  - Recent announcements, medical product approvals, opportunities to comment on proposed rules, upcoming public meetings, and other information of interest to health professionals

Consumer Updates- http://www.fda.gov/ForConsumers/default.htm . Timely and easy-to-read articles covering all FDA activities and regulated products.

Industry updates http://www.fda.gov/Safety/Recalls/default.htm  - Recalls, Market Withdrawals, & Safety Alerts

MHRA - Targeted Research Programme

Official launch of the Targeted Research Programme held on 6 November 2009, London

WHO Drug Information (Volume 22, Number 4, 2008)

Index contains Pharmacovigilance Focus which summarises the 2008 Annual ISoP Meeting in Buenos Aires
http://www.who.int/medicines/publications/druginformation/issues/DrugInfo08vol22_4/en/index.html

EMEA

The European Medicines Agency has published the first in its series of weekly pandemic influenza pharmacovigilance update reports. The document is available on the following web page: http://www.emea.europa.eu/pdfs/influenza/78468109en.pdf

The European Medicines Agency (EMEA) has published final HCP WG Recommendations and Proposals for Action. The document is available here:
http://www.emea.europa.eu/pdfs/human/hcpwg/18503608enfin.pdf

The aim of this document is to provide recommendations and proposals for action in the following priority areas:

  • Information on medicines
  • Pharmacovigilance
  • Involvement of healthcare professionals’ organisations in the work of the EMEA’s scientific committees.

For further information about the HCP WG (EMEA/CHMP Working Group with Healthcare Professionals’ Organisations) and the elaboration of this document, please refer to the following web page:
http://www.emea.europa.eu/htms/human/healthcareprof/healthcareprof.htm

Good Pharmacovigilance Practice Guide

Book description & purchasing: Pharmaceutical Press (official publisher).
Also available at Amazon.

EudraVigilance Expert Working Group's (EV-EWG's) Important Medical Event Terms list

The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day to day pharmacovigilance activities of stakeholders in the EU. The IME list is intended for guidance purposes only.

(http://eudravigilance.emea.europa.eu/human/textforIME.asp)

In order for the EMEA to obtain feedback from interested parties, the IME list is available for a pilot testing period of 12 months.

The Observational Medical Outcomes Partnership

The Observational Medical Outcomes Partnership (OMOP) is a public-private partnership designed to protect human health by improving the monitoring of drugs for safety and effectiveness. The partnership will conduct a two-year initiative to research methods that are feasible and useful to analyze existing healthcare databases to identify and evaluate safety issues of drugs already on the market. OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration (FDA), and other federal agencies. It is funded and managed through the Foundation for the National Institutes of Health.
OMOP plans to use its website as a primary tool to engage with the broader research community throughout the initiative. The research team will post research proposals for public review and comment, facilitate discussion forums around specific methodological issues of observational analyses, and share learnings from all research conducted. We will also use the site to post job openings and requests for application for specific research tasks to allow interested parties to get involved themselves. If you are interested in reviewing OMOP proposals and participating in forum discussions, simply create a new account and log in and you will have access to all the posted documents. You will also be able to register for RSS feeds to let you know when material has been updated.

OMOP website

Erice Statement 2009

Erice Statement 2009: Communication, Medicines and Patient Safety
Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://www3.interscience.wiley.com/authorresources/onlineopen.html

Erice Manifesto 2006

In June 2006, in Erice (Sicily) a group of twenty-seven experts in pharmacovigilance discussed and debated the global reform of the safety of medicines for patients (The Erice Manifesto is published in Drug Safety journal).

Special Article : The Erice Manifesto

London declaration

PATIENT AND CONSUMER ORGANIZATIONS WELCOME OUTCOMES OF WORLD HEALTH ORGANIZATION FIRST PATIENTS FOR PATIENT SAFETY WORKSHOP

London, United Kingdom, 8 February 2006 - Today, patient and consumer organizations joined together to welcome the publication of the London Declaration from Patients for Patient Safety following the World Health Organization's (WHO) first Patients for Patient Safety workshop last year. The International Alliance of Patients' Organizations (IAPO) and Consumers Advancing Patient Safety (CAPS) commended the WHO on incorporating the patients' voice in a meaningful way into the WHO World Alliance for Patient Safety and congratulated Patients for Patient Safety on its achievements to date. Patients for Patient Safety is one of six action areas of the WHO World Alliance for Patient Safety.

"Patients must be at the centre of our quest to improve patient safety" said Sir Liam Donaldson, Chair of the World Alliance for Patient Safety. "When things go wrong, they and their families suffer from any harm caused. Patients for Patient Safety is designed to ensure that patients and their families are a central part of international efforts to improve patient safety through this WHO Alliance".

The groundbreaking Patients for Patient Safety workshop was held in London, 27-30 November 2005 running in parallel to the EU Summit on Patient Safety, organized by the UK Government in its role of Presidency of the EU during 2005. Following a competitive application process, 24 patient and consumer advocates - patient safety champions - were selected together representing 21 countries across developed, transitional and developing countries, providing a truly global voice.

The key outcome of the workshop was the publication of the London Declaration through which the patient safety champions expressed their vision for safer health care systems worldwide and highlighted concrete areas where patients and consumers - and the organizations that represent them - can work in partnership with health providers to make a significant contribution to the improvement of patient safety.

"We learned from the 24 thoughtful patient safety champions that challenges in delivering safe, compassionate health care cut across all geographic, ethnic and socio-economic boundaries", said Susan E. Sheridan, MIM, MBA, CAPS Co-Founder and President and Lead of Patients for Patient Safety. "The London Declaration will be the soul of the work of the World Alliance".

IAPO and CAPS congratulated the workshop participants for their incredible focus and skill in defining and developing the role of patients and consumers in the WHO's World Alliance for Patient Safety. In addition to the concrete outcomes, the workshop was also an important signal of highlighted the importance of the patient voice in health policy-making.

IAPO and CAPS have announced their support for the London Declaration with its commitment to harness the expertise, knowledge and motivation of consumers and patients to work through partnerships to improve patient safety for all patients. IAPO Chair, Albert van der Zeijden, commented, "This Declaration demonstrates the strong commitment of consumers and patients, and the organizations that represent them, to contribute their knowledge and expertise to improve patient safety in a structured and effective way".

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Note to Editors:
1. CAPS is a consumer-led non-profit organization formed to be a collective voice for individuals, families and healers who wish to prevent harm in healthcare encounters through partnership and collaboration. CAPS envisions a partnership between consumers and providers to create global healthcare systems that are safe, compassionate and just. Susan E. Sheridan, MIM, MBA, CAPS Co-founder and President, also leads Patients for Patient Safety, the consumer action area of the WHO World Alliance.
2. IAPO is the only global alliance representing patients of all nationalities across all disease areas and promoting patient-centred healthcare worldwide. Our members are patients' organizations working at the local, national, regional and international levels to represent and support patients, their families and carers. A patient is a person with any chronic disease, illness, syndrome, impairment or disability. IAPO was founded in 1999 by forty patients' organizations from around the world.
3. Patients for Patient Safety is one of the six action areas of the World Alliance for Patient Safety and is designed to ensure that the perspective of patients and families, consumers and citizens - whichever term resonates best - in both developed and developing countries is a central reference point in shaping the important work of the Alliance.
4. The patient champions selected were from 21 countries: Argentina; Australia; Canada; China; Egypt; Fiji; Germany; India; Italy; Mexico; The Netherlands; Nigeria; Pakistan; Poland; Sudan; Uganda; Ukraine; United Kingdom; United States of America; Yemen and Zambia.
5. The London Declaration is available online here.
6. For a full copy of this press release, please click here.

For further information, please contact:

Mr Mitchell Dvorak
Executive Director
Consumers Advancing Patient Safety (CAPS)
Tel: (312) 274-1301
Fax: (312) 274-9696
Email: mdvorak@patientsafety.org
Website: www.patientsafety.org

Ms Jo Harkness
Policy & External Affairs Director
International Alliance of Patients' Organizations (IAPO)
Tel: +44 20 7721 7597
Fax: +44 20 7721 7596
Email: policy@patientsorganizations.org
Website: www.patientsorganizations.org .

BMA report about pharmacovigilance

Report : pdf file
http://www.bma.org/ap.nsf/Content/AdverseDrugReactions

 
 
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