Pharmacovigilance Resources
- ISoP Women's Medicines Group
- The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- UMC book: Expecting the worst
- Erice Statement 2009
- Pharmacovigilance in Emerging Markets
- Announcements FDA
- MHRA-Targeted Research Programme
- WHO Drug Information
- EMA
- Good Pharmacovigilance Practice Guide
- EudraVigilance
- The Observational Medical Outcomes Partnership
- Declaration of Helsinki
- Erice Manifesto 2006
- London declaration
- BMA report about pharmacovigilance
- Guidelines on ADRs
- EudraLex - Volume 9a (Pharmacovigilance guidelines)
Women's Medicines Group
ISoP Group Taking Issues Forward
Following an interesting and invigorating session on Women's Medicines at the ISoP annual meeting in Istanbul in October 2011, a group of ISoP members have continued to develop the ISoP Women's Medicines Group. The members of this group have a specific interest in medicines used by women, in particular contraceptive products, medicines used in pregnancy and medicines used by post-menopausal women. The purposes of this group are as follows:
Information sharing and networking
Communicating mainly by e-mail, the group intends to share interesting news items, research findings, regulatory actions and other information on women's medicines issues which have been identified worldwide. Sharing views on these may just be for information and interest but may also lead to action (see below).
Collaborative Projects
Some members of the group are involved with interesting projects on women's medicines and would like to invite others around the world to work on these too. One example is that Dr Katarina Ilic from Belgrade is undertaking a study of pharmacists' knowledge of emergency contraception (EC) and is willing to share the questionnaire for use in other countries. This could lead to a multi-centre/country collaborative study of EC. If you would like further information about this topic, please e-mail Dr Katarina Ilic at: katarina.v.ilic@gmail.com
Initiatives regarding Medicines in Pregnancy
Many of us would like to improve the information regarding the safety of medicines used in pregnancy. There is a need to develop pregnancy registers for all medicines and in particular those used in IVF treatments. Other groups including the WHO and ISPE are also working on these issues and the ISoP Women's Medicines Group aims to liaise and work with these other groups.
Advising and Influencing on Women's Medicines issues
There continue to be issues relating to women's medicines on which those of us expert in this area believe we should take some action. Methods might include writing editorials or other articles for international journals; writing letters to guidelines groups or professional bodies like the Family Planning Association.
Membership of the ISoP Women's Medicines Group
Any member of ISoP who has an interest in medicines used by women is very welcome to join our group. Our group includes members from several different continents and like ISoP in general, we are truly international! The group is open to men and women as we believe everyone has a part to play in improving the safety of medicines used by women. Experience in obstetrics and gynaecology, family planning, general practice, research or regulation of women's medicines, or any other aspects of women's health is an advantage, but not essential. The main thing we would like is your interest and your support!
If you would like to join the ISoP Women's Medicines Group please contact Dr Mira Harrison-Woolrych by e-mail at: mira.harrison-woolrych@otago.ac.nz
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
The European Medicines Agency (EMA) would like to inform you that the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group on 3 May 2011.
The document is now available on the following link:
http://www.encepp.eu/standards_and_guidances/documents/ENCePPGuideofMethStandardsinPE.pdf
The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been subject to a public consultation. An overview of comments received and how each was addressed will also be available on the ENCePP website (www.encepp.eu)
This guide is an important tool that reviews and gives direct electronic access to methodological guidance for research in pharmacoepidemiology and pharmacovigilance. It is planned that updates of the electronic document will be performed regularly with a view to maintaining the dynamic nature of the guide.
Pharmacovigilance in Emerging Markets
Dr John McEwen (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
EMA
EU Pharmacovigilance Regulation updates
The pharmacovigilance Regulation (EU) 1235/2010 amending Regulations (EC) 726/2004 and (EC) 1394/2007 was published in the Official Journal of the European Union on 31/Dec/2010
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF
It is not due to come into force until 02/Jul/2012.
The corresponding Pharmacovigilance Directive 2010/84/EU amending Directive 2001/83/EC was published in the same edition of the Official Journal of the European Union
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF
This Directive enters into force on the 20th day following its publication in the Official Journal of the European Union (i.e. Sunday 20/Jan/2011), but Member States have until 21/Jul/2012 to adopt its provisions.
European Medicines Agency Consultation: draft concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
The European Medicines Agency has recently published a draft "Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues".
The current quality guideline (EMEA/CHMP/BWP/49348/2005) was published in 2006, at a time where little experience was available on the registration of biological medicinal product claiming to be similar to another one already marketed. Significant experience has now been gained and it is recognised that the guideline needs refinements taking into account several practical considerations relating to the lifecycle (from development to product discontinuation) of similar biological medicinal products.
The document is available for consultation on the following webpage:
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/02/WC500102285.pdf
Comments related to this concept paper should be provided using this template:
http://www.ema.europa.eu/docs/en_GB/document_library/Templates_and_Form/2009/10/WC500004016.doc.
The completed comments form should be sent to:
bwp.biosimilar.revision@ema.europa.eu.
Please note that the deadline for comments for this concept paper is 31 May 2011.
European Medicines Agency's Press Release: Review of the manufacture of Baxter's peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches
Following our previous communication regarding the presence of endotoxins in peritoneal dialysis (PD) solutions produced by Baxter (Dianeal, Extraneal and Nutrineal), we would like to inform you that the problem has not been solved and that Baxter cannot guarantee the production of endotoxin-free solutions from a production line at its Castlebar plant in Ireland in the short-term. As a consequence, the Agency's Committee for Medicinal Products for Human Use (CHMP), at the request of the European Commission, started a full review of the manufacture of Baxter's dialysis solutions at the affected plant. There is a risk that patients who receive PD solutions that contain endotoxins may develop aseptic peritonitis. However the number of PD bags affected is likely to be very small and the overall risk to patients remains low.
Patients and healthcare professionals should continue to look out for any symptoms that suggest the development of aseptic peritonitis (e.g. cloudy effluent seen in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and possibly fever) and report any cases as soon as possible. Once finalised, the Agency will communicate the outcome of the CHMP's review. Healthcare professionals will be sent updated advice, including information on new supplies from outside the EU as it becomes available. The EU regulatory system is intensively monitoring this issue on a continuous basis.
The complete press release document referring to this matter can be found in the following link:
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/01/WC500101070.pdf.
European Medicines Agency's Road map to 2015
The European Medicines Agency has published its final 'Road map to 2015' today, coinciding with the 16th anniversary of its inauguration. You can find it in the link below:
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf.
The 'Road map to 2015' sets out the Agency's vision in further developing its role as a European public-health agency in the field of medicines and has been drafted in consultation with the Agency's partners and stakeholders to ensure as broad a consensus as possible on the best way forward.
The road map proposes three priority areas for future actions to strengthen the Agency's role in protecting and promoting human and animal health in the European Union:
- Addressing public-health needs by: stimulating medicines development in areas of unmet medical needs, neglected diseases and rare diseases, and for all types of medicines for veterinary use; facilitating new approaches to medicines development; applying a more proactive approach to public-health threats where medicines are implicated.
- Facilitating access to medicines by: addressing the high attrition rate during the medicines-development process; reinforcing the benefit/risk-balance assessment model; continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review.
- Optimising the safe and rational use of medicines by: strengthening the evidence base in the post-authorisation phase to enable better regulatory decision-making; enhancing patient safety by avoiding unnecessary risks to patients as a result of the use of medicines; becoming a reference point for information on medicines evaluated by the Agency; improving the decision-making process by taking due account of patient experience, thus contributing to the rational use of medicines.
In developing its road map, the Agency continues to ensure that its vision is consistent with and complementary to strategic directions provided by the European Commission, the Council of the European Union and the Heads of Medicines Agencies. Detailed information on the implementation of the road map will be provided in the document 'From vision to reality', to be published shortly.
EMA Human Medicines Highlights - February 2011 issue
February 2011 issue (click to open)
This newsletter is addressed to patients, consumers and healthcare professionals' organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency.
The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intended to comprise a full set of the Agency's information.
The newsletter is published at the end of each month and is available upon subscription.
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.ema.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.ema.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.ema.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.ema.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.
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).
London declaration
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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". ------- Note to Editors: For further information, please contact: Mr Mitchell Dvorak Ms Jo Harkness |
BMA report about pharmacovigilance
Report : pdf file
http://www.bma.org/ap.nsf/Content/AdverseDrugReactions