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100 Member Countries | the ABC of E2B

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100 Member Countries | the ABC of E2B For everyone concerned with the issues of pharmacovigilance | UPPSALA REPORTS | October 2010 UR 51 100 member countries | the ABC of E2B Vaccine updates | Travelling in Europe | Introducing RACS DIRECTOR’S MESSAGE A year has now passed since I took up the post as memorable landmark I take the opportunity to Director of the UMC. Looking back, it has been express my sincere appreciation of Sten Olsson for a good year for me and the UMC team of now his tireless enthusiastic efforts over many years to nearly 70 people in our offices here in Uppsala. We expand the global network. Thank you, Sten! have worked hard and tackled many challenges; there have been many developments, small as We have known for a long time that the need for well as more substantial, that the dedicated UMC pharmacovigilance education and training is team have managed on top of the large bulk of enormous, and that currently there are not anywhere work maintaining and developing our baseline near the resources available to meet those needs, services. Unavoidably there have been a few particularly in developing and emerging countries. disappointments, but we have also been able to This notion has been further strengthened by recent deliver what we all hope are really useful services surveys done by UMC-A, clearly indicating that and products, and realize new opportunities. training and education is a top priority in Africa. UMC-A has also responded to this challenge by Very soon it is time to pack our bags and set off to creating a web-based ‘Pharmacovigilance Toolkit’ a real pharmacovigilance hot-spot – Accra, Ghana with support from the Global Fund and other Marie Lindquist – for one of the highlights of the year, the annual Global Health Initiatives. The first version of this Director meeting of national pharmacovigilance centres, should be available by the year’s end. the Uppsala Monitoring followed by the 2010 International Society of Centre Pharmacovigilance meeting. When in Ghana, I shall As my ambition is to develop the UMC into an be very happy to present our recent achievements, organization that has what it takes to respond to so I won’t go into details here, but I would like to future expectations and challenges, development mention a few things that give an indication of how of our capacity to deliver training and education the UMC in the past year has responded to needs is very high on my agenda. The aim is not for expressed by the pharmacovigilance community. the UMC to solve all the world’s problems in this area – at least not immediately! – but to develop The roll out of PaniFlow, the web-based tool for education materials that can be used by member pandemic flu vaccine safety monitoring, is an countries, and together with WHO and other example of a successful new venture – which we partners deliver training programmes according to undertook with very short notice. Fortunately, a ‘train-the-trainers’ approach. A UMC Education the pandemic did not develop as feared, but the and Training section dedicated to the development important thing was that we were able to provide of our efforts in this area is now being implemented a tool which could be used by those who otherwise in our Pharmacovigilance Services department, would have had no realistic means of reporting and to complement the existing two teams: Reporting, recording vaccine adverse events. Analysis and Country Support (RACS) and the team responsible for product management of our I am also delighted about the successful pharmacovigilance tools (including VigiSearch, establishment of UMC-A in Accra, Ghana, as the VigiFlow and CemFlow). I am also recruiting first stage of our global outreach programme to a manager for the department. If you know of have a major presence outside Sweden. Under the someone who would be interested in taking on this leadership of Alex Dodoo we now have what will be important job, please let me know. a hub of an African network of professionals who can help and support one another in developing The RACS team is introduced in this issue – pharmacovigilance on the African continent, take there will be more information about our other an active part in the WHO Drug Monitoring pharmacovigilance teams in coming numbers of Programme and contribute to fulfilling the vision of Uppsala Reports. safe use of medicines for patients all over the world. I am looking forward to meeting meet many old One reason for celebration is that the WHO and new colleagues and friends in Ghana, and to Drug Monitoring Programme has reached the learn about your expectations for the years to come! impressive membership of 100 (actually, we have just reached 101) fully participating national pharmacovigilance centres. This issue of Uppsala Reports has a feature celebrating this achievement of the Programme. In connection with this 2 UR51 October 2010 www.who-umc.org CONTENTS FEATURES theUPPSALA MONITORING 6-7 CENTRE Reporting statistics - the last six months 10-11 Education and the web - new initiatives 12-13 The WHO Programme Introducing the UMC’s Reporting, Analysis and Country Support team Our global network of pharmacovigilance centres passes an important landmark. 14-15 Vaccines - what’s been happening in the monitoring of vaccines 4 16-17 The ABC of E2B Supporting development The consultants for pharmacovigilance in Africa meet in Togo. 9 REGULARS 2 Director’s Message 4-5 WHO Programme news: 100 countries; news about PANDRH Reporting, Analysis and Country Support 8-9, 18-19 News from Around the World The team at the centre of the UMC’s 12-13 activities presents itself. 20 Publications 21-22 News from Bredgränd 23 Courses and conferences National centre visits Reports on meetings to support national centres in Europe and other recent conferences. 19 Uppsala Reports 4951 www.who-umc.org 3 WHO PROGRAMME NEWS Now 100 full members of the WHO Programme Sten Olsson The WHO Programme for International Drug Monitoring recently welcomed its 100th member country. With the accession of Slovenia, there are now 100 countries which are full members in the WHO Programme, all with a commitment to working together and sharing information to optimize the safe use of medical drugs and vaccines for the benefit of patients around the world. Expanding Programme The WHO Programme, founded in 1968, initially consisted of western European and north American countries, with New Zealand Member countries cumulative and Australia. The driving forces behind the creation of the Programme and the activities during the first years were recently described in an article by Jan Venulet and Margaretha 1 Helling-Borda . Over the last 40 years, the Year Programme has gradually expanded to include countries in all corners of the globe. Growth in membership of the WHO Programme for International Drug Monitoring, 1968-2010. Recent progress The last decade has seen a significant encourage healthcare professionals, increase in the number of member countries. pharmaceutical companies and the public to Earlier this year Zambia, Kenya and DR record and report adverse effects and other Congo were admitted to the WHO medicine-related problems. These individual Programme, following successful submission case safety reports (ICSRs) are assessed of adverse reaction reports from their locally and may lead to action within the national pharmacovigilance centres to the country. Members of the WHO Programme Uppsala Monitoring Centre. Since the agree to share their ICSRs collected admission of Slovenia, just as we go to press, nationally with all other members and in Côte d’Ivoire has become our 101st member, turn have access to all reports collected in and Burundi has applied for associate other member countries. In technical terms membership – more good news. We hope to sharing means that ICSRs are submitted to introduce the two newest member countries the Uppsala Monitoring Centre in the E2B more fully in UR52. format (see page 16-17). For many countries this is most easily achieved via the case WHO Programme principles management system VigiFlow. The basis for the WHO Programme for International Drug Monitoring is that all Challenges in the future member countries have systems which Clearly there are challenges to the WHO Programme and the way in which it functions and we will return to those in the next Uppsala Reports. For the moment we celebrate the new milestone and thank all countries for their support and work to make the WHO Programme what it is today – a truly global partnership of covering all continents, working closely with WHO Headquarters to support patient safety around the world. 1 Jan Venulet, Margaretha Helling-Borda. WHO’s International Drug Monitoring – The Formative Years 1968–1974 Drug Safety 2010; 33((7): e1–e23 Flags in Geneva - the WHO Programme is a truly international network. 4 UR51 October 2010 www.who-umc.org REPORT FROM AMERICA PAHO/WHO perspectives José Luis Castro Pharmacovigilance, from the regulatory Figure. 1. Mission and Objectives of the Focal points perspective, is a function that allows Pharmacovigilance working group of PANDRH. The group has also decided to support the knowing, evaluating, preventing and making development of the network of focal points decisions and plans in relation with problems Mission for pharmacovigilance in the Americas that is generated by the use of medicines. Its To develop and strengthen pharmacovigilance expected to be in place by September 2011. importance lies not only in globally through activities and proposals of This network will allow countries to share addressing new serious adverse medicines harmonized regulatory actions that promote news, knowledge, resources and even criteria. reactions but in monitoring unwanted the safe and rational use of medicines as a The experience of Caribbean countries with population events related to medicines necessary component of Public Health the VigiCarib network (initiated with support utilization in the context of the health policies in the Region of the Americas.
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