For everyone concerned with the issues of pharmacovigilance | UPPSALA REPORTS | April 2015
UR 69
WHO Collaborating Centres | Access to data
Signal detection | Substandard medicines | China dictionary DIRECTOR’S MESSAGE
Some time ago I watched a fascinating film, a patient’s own words – be it on a web forum, or called Stories we tell. In addition to being submitted on a case report form. cinematographically innovative, it told a very moving story about a woman – the film director – One of the problems with our current reporting discovering a major family secret, through gentle, systems is that the structured data forms used but persistent interviews with relatives and friends (particularly paper forms) do not lend themselves of the family. Bit by bit, as the interviewees opened well to capturing a complete clinical picture (who up and started talking about the past and what can fit a complete clinical history in a space that is they had observed, a picture emerged of what just about enough for a ‘twitter’?). If, on the other had happened during those months many years hand, we employ tools that allow easy capture of ago when her mother was away from home, and a narrative description of the course of events, we gradually the truth was unravelled about who her are in a much better position to determine the biological father really is. likelihood of causative drug effect in each individual case, which means that we can avoid unjustifiable Marie Lindquist For me, this film is a vivid illustration of how little scare and unnecessary patient suffering due to false Director we often know about people around us, even those signals. Uppsala Monitoring nearest and dearest to us; and how important it is to Centre cover all angles and go beyond what is immediately It must be a top priority to encourage and facilitate apparent in order to get a complete picture, and collection of good quality case data! Reducing time understanding, of complex events. and effort spent on re-entry of already existing data will help. As we heard in the recent conference in We need stories, and good story-telling, in Edinburgh on the UK Yellow Card Scheme 50th pharmacovigilance, too. And I’m not talking about anniversary, some electronic health record (EHR) stories like in fairy-tales or film dramas now, but systems today allow automatic extraction of the clinical case history: the narrative account of patient and medication data to generate an ADR a sequence of events. I believe there is a good level report, which can then be completed with relevant of agreement that pharmacovigilance is about details and submitted electronically. I wish all EHR providing the best available knowledge so that systems had this facility! It was also encouraging patients and health professionals can make wise to hear about an initiative in the Netherlands therapeutic decisions in their use of medicines. to concentrate data entry on relevant clinical Good quality data is a fundamental building information by implementing context-sensitive block in this process. To verify and quantify on-line data entry forms, with follow-up questions overall population effects of adverse medicines generated automatically based on the information reactions, we no doubt need statistical evidence entered. from epidemiological studies, and other sources of data. But, to truly learn about the real life effects of The key is to maximise the use of IT technology – medication on the individual level, including how where it will help us! – and concentrate our minds it affects patients’ well-being and quality of life, we on the critical assessment needed to make sense of also need to make sure that we hear, and listen to, all the information and turn it into the knowledge their stories. that will bring us closer to the ultimate goal of good therapeutic decision making – and safer patients. The gathering of good clinical data starts with the patient; and with the willingness to share information. Only if we believe that our story will make a difference will we go through the effort of making it known. This applies to the dialogue between the patient and their health professional; to the decision by a health professional to report a suspected adverse reaction; and to a story told in
2 UR69 April 2015 www.who-umc.org DIRECTOR’S MESSAGE contents
FEATURES 5 Anniversaries in Edinburgh and London 7 Opening the global database 8-9 Agile signal detection 10 Drug Dictionary in China and the US Anniversary time Two major agencies have just marked 11-13 important anniversaries WHO Collaborating Centres for Safety 16-17 5 After the Ebola crisis in Liberia
REGULARS 2 Global collaboration Director’s Message An in-depth look at the WHO network for collaboration in patient and medicines 4 safety WHO Programme news 6, 14-15, 17, 20 11-13 News from Around the World 18-19 UMC Research 21 Publications 22 Education and training News from Bredgränd Reports from high-level training activity 23 Courses and conferences 17
Publications We review several recent publications to add to the pharmacovigilance bookshelf 21-22
Uppsala Reports 4969 wwww.who-umc.orgww.who-umc.org 3 WHO Programme news
Bangladesh joins WHO Programme Md. Akter Hossain In the field of drug safety, Bangladesh executive order from DGDA to all local has just joined other countries in the pharmaceutical manufacturing world. Pharmacovigilance is now one companies and pharmaceutical importers of the important functions of the to monitor the ADRs of their products Directorate General of Drug INDIA through their own channels and to Administration (DGDA), which is the report to the national centre. We have Bangladesh regulatory authority. a plan to phase in pharmacovigilance activities across the entire country. Early struggles In Bangladesh, pharmacovigilance BANGLADESH Into the Programme started in 1999, but became dormant n Rajshahi It was our pleasure to be informed in due to a lack of legislation, motivation, December 2014 that WHO had th inadequate knowledge and attitude, JDhaka accepted Bangladesh as the 120 as well as a lack of coordination and member of the WHO Programme for communication between stakeholders, INDIA International Drug Monitoring. We resulting in many ADRs not being have established links to the Uppsala properly reported. Monitoring Centre, Sweden and wish to have cooperation and assistance from n Chittagong A fresh start other stakeholders, in order to maintain In January 2013, the United States a good relationship with WHO-UMC. Agency for International Development (USAID) ‘Systems for Improved Access Md. Akter Hossain is the Assistant to Pharmaceuticals and Services’ BURMA Director, Directorate General of Drug programme (implemented by Administration and Focal Point, National Management Sciences for Health) Pharmacovigilance Center, Bangladesh. provided support to DGDA to revive the programme. For this purpose, a monitoring cell, known as Adverse Drug Hospitals and companies Reaction Monitoring (ADRM) was established As a result, the ADRM cell and ADRAC have Afghanistan and designated as the National Drug become fully functional, with meetings taking The Regulation of Medicines and other Health Monitoring Centre by the Ministry of Health place at regular intervals. At present, 30 public Technologies department at WHO has arranged & Family Welfare, Bangladesh. An Adverse and private teaching hospitals in Dhaka city for Afghanistan to become an Associate Drug Reaction Advisory Committee (ADRAC) have been selected as sentinel sites for Member of the WHO Programme, following has also been formed to evaluate, analyze pharmacovigilance activities. More recently, receipt of information from the Director of the and make recommendations on adverse drug we have extended the programme to two General Directorate of Pharmaceutical Affairs events. divisional teaching hospitals (Chittagong and in Kabul about the development of a national Rajshahi Division). We have also circulated an system for reporting of adverse reactions. 2015 Programme meeting Geoffrey Bowring The early preparations for the the WHO Country Office, and 2015 meeting of the WHO the meeting venue in New Programme for International Delhi will be confirmed soon. Drug Monitoring, from 3-6 November in India, continue. Getting to the meeting should be straightforward for national Official invitations from WHO centre representatives. Indira Headquarters, together with a Gandhi International Airport provisional agenda for the three is about 15 kilometres from days, are planned to be sent out the metropolis with good to heads of national pharmaco- links to the centre. One of the vigilance centres towards the busiest airports in the world it end of April. has direct connections from many countries, using the The hosts, the Indian Pharmaco- Terminal 3, opened in 2010. poeia Commission are in regular discussions with WHO HQ and Indian Pharmacopoeia Commission (IPC)
4 UR69 April 2015 www.who-umc.org WHO Programme news NEWS FROM AROUND THE HEWORLDaDER
Anniversaries – and challenges ahead Marie Lindquist developments and scientific innovation in medical devices, and defective and The future is yellow medical technology in healthcare. counterfeit medicines. Four major strategic The UK Medicines and Healthcare Products themes have been identified: Regulatory Agency (MHRA) celebrated 50 Following the keynote speech by Dr Aileen n Improving patient safety through years of the UK Yellow Card scheme with a Keel, Acting Chief Medical Officer of systematic and cultural change Scotland, the Chairman of MHRA, Professor scientific conference on 20 March at the n Embedding Yellow Card into the Royal College of Physicians in Edinburgh. Sir Michael Rawlins, introduced the roadmap for the future, which takes into account the healthcare system The conference looked at how the Yellow widening scope of pharmacovigilance, n Making the best scientific use of Card scheme is evolving, and discussed extended to include incident reporting for Yellow Card data n Sustainability into the future through collaboration.
Along with these themes, there were panel discussions, presentations on scientific developments, parallel workshops, and a lively debate in classic British style (for and against the motion that “health professionals’ role in Yellow Card reporting will diminish in the era of electronic media?”).
In his concluding remarks, Dr Ian Hudson, Chief Executive of MHRA, thanked all contributors who had travelled from around the UK and joined guests from other parts of the world, and said that this conference will have a very positive and tangible impact, in that many of the ideas and comments raised by the participants will be incorporated into the finalisation of the roadmap for the future of the Yellow Card scheme.
Dr Aileen Keel in Edinburgh
opportunities for the future, with a focus on EMA aims high how EMA will contribute to improved public In March several hundred people gathered in health by being the enabler of public access the impressive glass-ceilinged East to innovative medicines therapy. Wintergarden building, a few hundred metres walk from the new EMA offices in London, to celebrate that 20 years have passed since the European Medicines Agency was created.
The purpose of the anniversary conference, entitled ‘Science, Medicines, Health: Patients at the heart of future innovation’, was to serve as a forum for stakeholder dialogue to discuss how EMA should best continue to deliver its mission to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health.
After the introductory congratulatory remarks by distinguished speakers, the ensuing presentations and a panel discussion EMA Chief Medical Officer Hans Georg Eichler and the audience in London touched on a range of challenges and
Uppsala Reports 69 www.who-umc.org 5 News
UMC at the FDA Antonio Mastroianni In January 2015, Antonio Mastroianni, Anki ultimately wisdom, via analysis and understanding UMC, the WHO Programme and US-FDA as a Hagström, and Helena Sköld braved a major of adverse reactions within VigiBase. leader in international pharmacovigilance, to snow storm in Washington DC (4 centimetres around 50 senior staff at the Center for Drug of snow!) to visit the Center for Drug Evaluation Improving the quality of FDA ICSRs improves Evaluation and Research (CDER). This was and Research within the United States Food the overall vigiGrade completeness score of much appreciated, as the staff at CDER and Drug Administration (US-FDA). Not only is VigiBase, which has a large impact on the learned how their actions impact on other the US-FDA the largest contributor of ICSRs value of this data for analysis purposes (both countries in the WHO Programme, and the (Individual Case Safety Reports) to VigiBase® internally at UMC and externally for all responsibility of the FDA to explain their (the WHO global ICSR database), it is also a key countries in the WHO Programme for regulatory decisions to other members of the UMC partner in several scientific initiatives, International Drug Monitoring). WHO Programme. They also heard how effective communication around regulatory decisions have an impact in other countries.
The staff were very pleased to learn about the outreach efforts by FDA and to see the positive impacts on capacity building throughout the WHO Programme. The audience showed particular interest in VigiLyze, which was rewarding for us, since it is a tool of great value for all national centres, from the developing to the advanced. Multiple impacts After lunch Gerald and Dr. David Martin, Division Director, Office of Biostatistics and Epidemiology (CBER), met with UMC to discuss collaboration efforts, teaching and training opportunities, and to hear about the research priorities of the UMC for the coming Suranjan De, Gerald Dal Pan, Anki Hagström, Helena Sköld and Antonio Mastroianni. year. and senior staff from the FDA regularly teach US-FDA implemented their new ICSR Overall it was a very productive visit and at UMC training events and at the WHO reporting system FAERs in 2012, and since feelings were positive due to the National Centres meeting. then UMC has advised FDA on what ICH E2B achievements seen in 2014 regarding data fields should be included to provide more quality. FDA staff saw the importance of Impact of US quality information in their reports and how to their participation in UMC/WHO events, as Dr. Gerald Dal Pan, Director of the Office of improve their vigiGrade completeness score. FDA decisions impact on other countries in Surveillance and Epidemiology (OSE) and By end of 2014 FDA confirmed that four out unexpected ways. In addition, FDA staff Suranjan De, Division Director (OSE) hosted of six recommendations from UMC would be reaffirmed their understanding that ill the UMC and were eager to understand how implemented in the first half of 2015. effects on public health in one country can recent changes to the US-FDA data feed sent have potential to impact US shores and the to UMC will impact the overall analytical Interaction with FDA staff FDA can protect the US population by value of VigiBase data. UMC is always striving In addition to these important discussions continuing to work closely with UMC and to improve VigiBase data and to better convert around data quality improvement, Antonio member countries of the WHO Programme. this data to information, knowledge and and Anki made a presentation about the
Suggestions for further advances included the Recommendations for São Tomé and Principe Lusophone missions incorporation of pharmacovigilance policy included ensuring that the draft National Hilda Ampadu into associated pharmaceutical legislation, Strategic Plan for the Pharmaceutical research in pharmacovigilance using local Department with emphasis on pharmaco- Alex Dodoo and Hilda Ampadu of the WHO population data, and providing leadership and vigilance is approved, designating the Collaborating Centre in Accra, Ghana visited human resources for the development of Pharmaceutical Department as the National two Portuguese-speaking African countries pharmacovigilance in Portuguese-speaking Pharmacovigilance Centre and applying for in the Atlantic in late February. African countries, with workshops in Portuguese. membership of the WHO Programme, as well as applying for start-up funds to key global Cape Verde has made major progress since it The Republic of São Tomé and Principe is donors. Getting healthcare workers on the became a Full Member of the WHO not yet a Programme member, but the team two islands to participate in pharmaco- Programme for International Drug Monitoring met Ministry of Health Pharmaceutical vigilance is a major aim. in 2012. Head of the national regulatory Department and WHO Country Office officials. agency is Carla Djamila Monteiro Reis. There is a keen awareness of the need to re- start previous medicines safety work. 6 UR69 April 2015 www.who-umc.org News Global data access
A big step in patient safety: WHO opens its global database Paula Alvarado VigiAccess™ is here What can we find in VigiAccess? point towards a more empowered attitude and behaviour in relation to medicines. The VigiAccess™ was launched with the aim of VigiBase has over 10 million reports and it is information is organised with a focus on improving patient safety, increasing the biggest dataset on side effects in the clear visual components and patients can transparency and encouraging the reporting world, and the only one with such a global easily find what they are looking for. of adverse reactions to medicinal products. coverage. Nevertheless, this number is not as In an event organised at the Press Club in big as it seems. Spontaneous reporting is “The user interface for VigiAccess has Geneva, WHO and Uppsala Monitoring Centre influenced by many factors and only a small intentionally been kept simple in order to let (UMC) presented VigiAccess on April 17th. percentage of the occurring adverse drug the data play the main part and to avoid reactions are being notified. confusion”, said Helena VigiAccess is a new web-based Sköld, UMC Product Manager application that will allow responsible for VigiAccess. anyone to access information “We have used responsive on reported cases of adverse techniques in the events related to over 150,000 development in order to medicines and vaccines. More make it accessible from than ten million cases from tablets and phones as well”. over 120 countries are held in VigiBase®, the WHO database As part of an effort to of suspected adverse reaction broaden the knowledge of reports which is maintained by pharmacovigilance among the UMC. patients, UMC has launched ‘Take & Tell’ online campaign “VigiAccess is a global public (www.takeandtell.org). ‘Take good,” said Marie-Paule & Tell’ has a very simple Kieny, WHO Assistant message on the importance Director-General for Health of monitoring our experience Systems and Innovation. “By when taking medicines and promoting open access and encourages patients to talk transparency, we hope that to their doctors. It is a small we will also promote drug change in our behaviour with awareness and save lives.” www.vigiaccess.org a big impact in our health. Introducing VigiAccess “VigiAccess is not the answer to all patient Benefit and risk VigiAccess (www.vigiaccess.org) allows us to safety issues.” said UMC Chief Medical Knowledge plus information in one place is a search VigiBase and retrieve statistical data Officer, Pia Caduff-Janosa MD, “but it good combination, but it is very important to on medicines’ and vaccines’ side effects - certainly points us in the right direction; one emphasize that the reports in VigiBase result suspected adverse reactions - reported to of sharing information, promoting knowledge from suspicions of a relationship between a the WHO Programme for International Drug and encouraging patients to be more in drug and a reaction, no causal relationship Monitoring. VigiAccess offers us an charge of their own well-being”. having been proven. The balance between opportunity to understand better how our benefit and risk of a medicine is not the bodies interact with medicines and enables us “We encourage patients to talk to their same for all patients and individual decisions to learn more about possible side effects. The doctors if they experience a side effect, not to must be taken. more we know about suspected adverse drug discontinue their medicine, or to change their reactions and the more information we share, doses. We need to have more dialogue the more we can contribute to a global between patients and healthcare UMC encourages patients to seek the advice culture of patient safety and well being. professionals”, Caduff-Janosa added. of their health care provider if experiencing an unexpected side effect. Medication should A spontaneous reporting system provides very Also, these reports refer to a suspected not be discontinued, or doses changed, unless important information on potential risks and causal relationship between a drug and a advised by the health care provider. helps to identify groups of patients or situations reaction, without this relationship being in which particular attention or special proven. There might be other reasons for a In order to guarantee that neither patients, monitoring might be needed. The information patient to develop the condition reported. nor health care professionals reporting or gathered from a spontaneous reporting treating institutions can be identified we system is unique as it covers all populations Tell me about pharmacovigilance have chosen not to make national data treated as long as a medicine is available on VigiAccess is a tool you may use if you want available as a small number of reports in a the market. It is also very cost effective. to see if the side effect you are experiencing country might lead to a breach of privacy. has been previously reported. It is a starting
Uppsala Reports 69 www.who-umc.org 7 Signals
Agile signal detection – 2014, a year of change
Tomas Bergvall and Lovisa Sandberg Signal detection is a core scientific activity involves literature review and analysis of the The goal in sight directly related to the WHO Programme’s case series in VigiBase, in order to assess In line with the agile process, each sprint has mission of discovering and communicating which combinations merit in-depth a pre-set goal, i.e. a certain number of potential medicine safety issues. Up until assessment – typically performed by a review potential signals to be identified. There are 2013 the UMC signal detection process panel of international experts. many reasons for this decision. First, a clear followed stable and standardized goal is one of the main features procedures, largely established in of the agile process and brings the early 2000s. The routine the group together with the aim screening of VigiBase® data relied of achieving it. Second, we believe on disproportionality analysis and that aiming to find a pre-defined long-established triages. number of potential signals raises the quality of the signals, in As described in UR65, the former contrast to going through a set signal analysis team, responsible number of combinations as in the for the routine signal detection, previous approach. The approach and the research department, has shifted focus from quantity to responsible for the methodological quality and allows more time to research, merged and formed a be spent on combinations that new Research section in 2014. The are likely to become signals. Third, reorganization paved the way for a we have limited resources to take revision of the routine signal on large quantities of potential detection process, both in terms of signals, as all of them require screening methodologies and the further in-depth analysis of the work process. A UMC scrum team working literature and the individual cases. Novel analytical methodologies A sprint is limited in time, i.e. between one Limiting the number of potential signals may The main aim of bringing the two teams to two weeks, and is conducted two or three sound harsh but in reality it would be together was to shorten the lead time between times per year. The whole UMC Research impossible to handle a large number of development of novel analytical methods and section is engaged and gathers four to five potential signals after each sprint. The sprint their introduction to practice. The first novel people in each project room, distributing is closed either when the goal is reached or method to be implemented in the routine competences across the groups. Each when the time for the sprint is up. signal detection was vigiRank1 (see UR67 p12- morning all participants meet to very briefly 13). The algorithm ranks drug-adverse drug recount, one by one, what was done the Review and improve reaction (ADR) combinations according to previous day, what is planned for the coming A major aspect of the agile methodology is the strength of evidence of being a signal. day and if any obstacles have been to continuously improve the process. To Disproportionate reporting is one component encountered. The meeting is kept to 15 support that, a retrospective meeting is held of vigiRank but it also accounts for the quality minutes. with the sprint team, to gather experiences and content of the reports. vigiRank, together and reflections on how the sprint was with a set of selection criteria, is currently the Multi-disciplinary approach performed; what we want to keep as is, what basis for identifying and prioritizing which The purpose of engaging the whole research we want to stop doing, and what would we associations to focus on. The selection section, i.e. research engineers, statisticians, like to start doing. In the meeting each criteria are flexible and can be adjusted ad pharmacists, nurses and medics, is to reduce person is encouraged to give their view of hoc, and enable us to focus on specific the distance between method development the sprint. The main purpose of this medicine safety areas of interest. and routine signal detection. Bringing these retrospective is to identify improvements for different competences together opens up for how to conduct future sprints. Agile process knowledge sharing between staff and The merger of the two teams brought integrates method research as a natural part The agile way of working has also been different competences together and opened of the routine process. adopted in the planning and preparation a window of opportunity for changes also in process for a new sprint. After the medical the signal detection work process. A The interdisciplinary work has made it focus area and dates for the next sprint have completely new way of working, inspired by possible to raise questions with the medical been defined, the preparation work starts. agile methods like scrum (see box on page 9 experts in close connection with the drug- Depending on the scope of the sprint, this for explanation) was integrated in several ADR assessment. Previously, potential signals work starts four to eight weeks before a parts of the process. were suggested by a pharmacist and later sprint. A dedicated team of about five confirmed or refuted by a medical expert, persons is responsible for the preparation. In line with methodologies like scrum, the often resulting in the pharmacist having to routine screening of drug-ADR combinations answer further questions and hence a need The team collects the experiences from the last in VigiBase is now performed in so called for re-opening the investigation, which is sprint together with adjustments needed for ‘sprints’. The aim of a sprint is to identify not as time efficient. the defined focus area and any new ideas for potential signals from the list of drug-ADR improvements, and compiles a list of combinations based on vigiRank. The process
8 UR69 April 2015 www.who-umc.org Signals Signals
requirements. The requirements are prioritized, with an estimation of time needed, in order to make sure we focus on what we think will Scrum offer the most benefit. Using this list of Scrum is an iterative and agile framework, used most often in software development requirements, the weeks preceding the sprint projects, to manage a team-based work environment. Some details are described below are used to make adjustments to the drug- but for in-depth information please see https://www.scrumalliance.org/ ADR combinations list criteria, to comply with 1. Add new ideas to the product requirements and prioritize them according to the specific focus area. The user interface used business value and estimated resource requirements. in the sprint work is also adjusted accordingly. 2. Select the requirements that provide the highest business value and lowest A signal review guideline, serving as the resource requirement and plan them in detail. basis for a common view on the work 3. The heart of scrum is the sprints which usually take about two weeks and are process, is updated for each sprint and all where the actual work happens. Progress is measured every day to enable the research staff are informed about the team to quickly adjust to any problems. changes made for the sprint. 4. A retrospective meeting is held after each sprint to gather thoughts about how to improve team work and processes. The work starts again at step 1. A kick-off meeting is held a few days before the sprint starts, in order to gather the staff, provide a unified message, and give in-depth was kept as close as possible to previous signal In general, the experiences from this new way information about the specific focus area. detection triages to be able to evaluate the of working have been very satisfying and we new process, including the implementation of believe this is a concept we will continue A trio of sprints vigiRank. The two other signal detection sprints with and develop further in coming years. Up to March 2015 three sprints have been have been on the paediatric population and on 1. Caster O, Juhlin K, Watson S, Norén GN. Improved performed in this new format. The first sprint vaccines. The experiences from these will be Statistical Signal Detection in Pharmacovigilance by focused on serious reactions to new drugs and published in a future issue of Uppsala Reports. Combining Multiple Strength-of Evidence Aspects in vigiRank. Drug Safety, 2014. 37(8):617-628. Save the date for Let’s talk PV! 3rd November 2015 Join a team of international experts during the UMC pre-meeting day preceding the 2015 WHO National Centres meeting in New Delhi, India. Let’s talk PV! offers a day on interactive learning, dialogue and discussion of leading themes in pharmacovigilance.
n Latest scientific developments in the field of signal detection n Impact communication: how do we tell the pharmacovigilance story? n Pharmacovigilance in focus – how do we develop it in challenging scenarios? n Sustainability of pharmacovigilance data management
Let’s talk PV! faculty consists of speakers from national pharmacovigilance centres, regulators, academia and UMC. Take this opportunity to learn, share and network with pharmacovigilance colleagues and experts from all over the globe.
Let’s talk PV! is open to all member countries of the WHO Programme for International Drug Monitoring. At the heart of things The International Society of Pharmacovigilance Topics concerning pharmacovigilance gathers from 27th to 30th October 2015 in education, drug safety in special populations, Prague, at the heart of the European continent. the role of pharmacists in patient safety and direct patient reporting will be featured. Czechoslovakia was one of the pioneer countries in There will be a discussion about new the development of spontaneous reporting systems methodologies in pharmacovigilance, and that joined the WHO Programme in 1968. Hosted ‘hot topics’ around the ‘Cube’. by the Charles University in Prague in the Czech Republic, and the Czech Pharmaceutical For more details visit the conference website Society, the 15th Annual Meeting of ISoP http://www.isop2015prague.org/ where you promises serious science in a historic setting. can register online.
The call for abstracts is open until 1 June Secretariat: [email protected]. 2015, and ‘Early bird’ registration rates apply before 31 July. Cubism in Prague Uppsala Reports 69 www.who-umc.org 9 news
The code to China Madeleine Krig China, which is expected to soon become the in WHO DDE. The Chinese dictionary also world’s third-largest prescription drug market, converts medicinal product names found in has an extensive domestic product mix that WHO DDE into Chinese characters if the entry includes synthetic chemicals and drugs, in WHO DDE also exists in WHO DDC. biopharmaceuticals, herbal remedies and locally-prepared traditional medicines. Benefits to users International pharmaceutical companies and More and more companies, both international CROs (contract, or clinical research and domestic, are realizing the value of being organizations) seeking to locate their product able to code Chinese character drug development and clinical trials in China face a information, especially for Traditional Chinese dilemma: how to deal with the thousands of Medicines. By using WHO DDC to improve concomitant medicines being taken by patients data management they are increasing their whose product names they do not recognize understanding of the impact that medicines and which they cannot code in the WHO Drug taken by Chinese patients can have in clinical Dictionary Enhanced™ (WHO DDE). studies and within pharmacovigilance.
A coding solution Unlocking the code For more information about WHO Drug Since December 2013, the Uppsala Monitoring WHO DDC translates Chinese character medicinal Dictionary China please contact sales@ Centre (UMC) has had a new product product names into the WHO DDE coding system umc-products.com available, the WHO Drug Dictionary China™ used worldwide by commercial organizations (WHO DDC). By converting Chinese character as well as national regulatory bodies. This medicinal product names into the unique simple conversion gives non-Chinese speakers WHO DD in US WHO DDE global coding system, WHO DDC access to the up-to-date medicinal product Malin Jakobsson solves this problem and can reveal information information and analytical tools contained The US Food & Drug Administration vital to pharmaceutical development projects. within WHO DDE for drugs used in China, (FDA) has submitted a recommendation, including Traditional Chinese Medicines. ‘Electronic Study Data Submission; Data Search results – achieved in just a few seconds Broad information Standards; Recommending the Use of – give international companies access to a broad the World Health Organization Drug array of up-to-date information and analytical WHO DDC thus helps international companies Dictionary’ in the official US Federal tools needed to progress and understand drug collect and analyze information about drugs Register (published daily with proposed development projects in this huge marketplace. likely to appear as concomitant medication in rules and public notices of federal clinical trials being carried out in China. This Simplified coding for Chinese decisions.) The FDA is encouraging the information includes trade names, the names use of WHO Drug Dictionaries variables market of the active ingredients, a hierarchical in investigational study data provided in The main function of the WHO Drug Dictionary classification of the intended therapeutic use, regulatory submissions to the Center for China (WHO DDC), as with UMC’s WHO Drug and the chemical classification. Drug Evaluation and Research and the Dictionary Enhanced (WHO DDE), is to help Center for Biologics Evaluation and CROs and pharmaceutical companies identify, Comparing Chinese medicinal product data Research. code and analyze concomitant medication with that from other countries follows exactly that appears in clinical trials. the same structure and methodology as found WHO Drug Dictionaries is used to code and analyse the impact of concomitant medications used by subjects during clinical trials and contains unique codes 有备无患 for identifying drug names, active ingredients and drug classes. WHO DDs A Chinese translation of the UMC’s crisis will be listed in the FDA Data Standards management guide ‘Expecting the Worst’ Catalog (see http://www.fda.gov/ was published in January. This was through a forindustry/datastandards/ collaboration between the UMC and staff at studydatastandards/default.htm
10 UR69 April 2015 www.who-umc.org news WHO Programme
WHO Collaborating Centres for Safety and Vigilance Noha Iessa and Shanthi Pal, Medicines Safety, Safety & Vigilance, WHO The World Health Organization (WHO) is the criteria, for example, high scientific and United Nation’s specialist agency for health. technical standing. A work plan and terms of Centres that support Amongst a range of health issues, it covers reference are jointly agreed, planned and WHO/SAV safety and vigilance of medicinal products implemented to ensure activities are designed via the WHO Programme for International to support WHO strategies and operational WHO Collaborating Centre for Drug Monitoring, which was set up in 1968 plans. These activities may not necessarily be International Drug Monitoring following the thalidomide tragedy. The 16.36 the institute’s standard activities. (The Uppsala Monitoring Centre) resolution from the 16th World Health Assembly (1963) called for “a systematic WHO SAV works with four Collaborating Centres collection of information on serious adverse to advance pharmacovigilance in countries. drug reactions during the development and These are, in the order of establishment, the particularly after medicines have been made WHO Collaborating Centre for: International available for public use”. WHO pharmaco- Drug Monitoring, Uppsala, Sweden; vigilance activities are coordinated by the Advocacy and Training in Pharmacovigilance, Safety and Vigilance (SAV) team which Accra, Ghana; Pharmacovigilance, Rabat, forms a sub-unit of the Essential Medicines Morocco, and Pharmacovigilance in and Health Products Department at WHO Education and Patient Reporting, Lareb, the Headquarters in Geneva. Netherlands. The four are responsible for research and scientific development, capacity Marie Lindquist, Director of the Uppsala building and technical support to countries. A Monitoring Centre fifth Collaborating Centre, the WHO CC for Drug Statistics Methodology, located in the The Uppsala Monitoring Centre (UMC) was Norwegian Institute of Public Health in Oslo, the first WHO Collaborating Centre to be Norway, supports WHO/SAV by developing established for pharmacovigilance when, in and training countries in the use of the 1978, the scientific and technical Anatomical, Therapeutic and Chemical responsibility of the WHO Programme for Classification system for medicinal products International Drug Monitoring was and their Defined Daily Doses (ATC/DDD). transferred to Sweden. The Centre is an independent, self-funded, non-profit WHO and the WHO Programme organisation. The WHO overall vision is that health is a fundamental human right, and everyone has The UMC holds and maintains the largest Charlotte Williams, Shanthi Pal, Leticia the right to the highest possible level of global database of individual case safety Megias-Lastra, Noha Iessa, Gauri Deoras & health. The primary role of WHO is to direct reports (ICSRs), known as VigiBase®, on Daisuke Tanaka - Safety & Vigilance Team and co-ordinate international health. In behalf of WHO and its Member States. alliance to the overall roles, the WHO aims Scientific principles are applied to data from Collaborators supporting WHO to define norms and standards of pharmaco- VigiBase for the identification, interpretation vigilance internationally, provide leadership In advancing its global health priorities and and communication of important drug and strategic guidance to pharmacovigilance strategies, WHO works with a network of safety signals and signal strengthening. centres, monitor trends and articulate policy more than 700 Collaborating Centres (WHO Leadership in scientific development and options. Figure 1 below illustrates the CCs) that support implementation of methodological research is evident through application of WHO roles to PV through mandated work. Academic, scientific and the formation and exploration of data activities run by WHO/SAV and its government institutions can be designated as mining techniques and on-going research Collaborating Centres. WHO CCs provided they meet a number of for early detection of signals. Figure 1
Roles of WHO Application to pharmacovigilance
Provide leadership on matters critical to health * Lead strategic development in pharmacovigilance * Advocate and integrate pharmacovigilance as a standard of care, provide the platform and framework for its implementation Shape the health research agenda * Develop and promote PV policies, new approaches and methodological developments in pharmacovigilance * Convene regular meetings of the Member States and other stakeholders, to support information exchange, networking and knowledge sharing in PV Define norms and standards for health * Convene expert committees and working groups to develop and adapt norms, guidelines and standards for best practices in pharmacovigilance * Provide a standard international system for the classification of medicinal products and drug utilization research Articulate policy options for health * Communicate safety signals on a global scale, to influence regulatory decisions and policies on pharmacovigilance * Drive the integration of pharmacovigilance in public health programmes. Provide technical support and build capacity * Establish and co-ordinate a network of experts and Collaborating Centres to provide technical support in pharmacovigilance * Contribute to building and strengthening PV capacity and infrastructure to achieve international standards Monitor health trends * Develop indices and metrics to monitor PV systems and practice * Guide countries in the monitoring and evaluation of PV systems and practices against standard indices and benchmarks
Uppsala Reports 69 www.who-umc.org 11 WHO Programme
The UMC provides technical support and WHO Collaborating Centre guidance to national centres in pharmaco- for Advocacy and Training in vigilance practice. They facilitate information Pharmacovigilance exchange between national centres through portals such as Vigimed, an online web-based The Centre for Tropical Clinical Pharmacology and platform. In addition the UMC develops and Therapeutics, University of Ghana Medical School supports countries with reporting and data management tools such as VigiFlow, a web- based system that integrates international standards to record and manage ICSRs at many Rachida Soulaymani, Director of the Rabat centre national centres. Furthermore the UMC conducts training sessions and publishes scientific articles, Mediterranean, francophone and Arabic books, newsletters and periodicals in pharmaco- countries. They facilitate regional and national vigilance and risk communication. training courses in this geographical area and also support normative functions to promote WHO Collaborating Centre for patient safety. Their annual training course covers Drug Statistics and Methodology Alex Dodoo, Director of the Accra centre topics such as VigiFlow, causality assessments, The Norwegian Institute of Public Health pharmaco-vigilance of herbal medicines, patient The Centre in Accra was designated as a WHO safety, vaccines, and medication errors. Collaborating Centre in 2009. The Accra Centre focuses on providing pharmacovigilance The Rabat Centre is also involved in projects training in African countries, building capacity, aimed at integrating patient safety reporting promoting advocacy and strengthening systems across different types of health reporting. facilities; and pharmacovigilance in public health programmes such as multi-drug resistant As part of the training function, the Accra TB treatment programmes. The Rabat Centre Centre has organised fellowship and internship supports WHO in developing appropriate guidelines, tools and methods to detect and Hanne Strøm, Director of the Oslo centre programmes, attracting fellows from several African countries. They also run courses for minimize medication errors through pharmaco- This Centre forms part of the pharmaco- regulators, such as ‘Data management training vigilance. The Centre also surveys and evaluates epidemiology department at the Norwegian for clinical and regulatory affairs’. performance and development of pharmaco- Institute of Public Health in Oslo. The Centre vigilance systems in Africa. was established in 1982, and is funded by the Activities to support countries and promote Norwegian government. It is responsible for communication and advocacy of pharmaco- WHO Collaborating Centre for developing and maintaining the ATC/DDD vigilance include: hosting annual workshops, Pharmacovigilance in Education classification system for medicines. The ATC/ visiting countries to assess national centres, and Patient Reporting DDD classification ensures organizedand developing high-level training material The Netherlands Pharmacovigilance Centre Lareb standardisation and harmonization of drug and risk management plans. utilization statistics across a range of users and disciplines, such as manufacturers, academics The Centre develops, hosts and maintains a and national pharmacovigilance centres. To pharmacovigilance Toolkit. The Toolkit is a ensure that the system is representative of collection of resources and information needed current practices, it is also responsible for for the practice of pharmacovigilance. It aims keeping classifications up to date. to ensure that practitioners have easy access to information on processes and activities from In 1992, the decision to globalize the ATC/DDD a trusted source. The Toolkit provides links to classification led to the formation of the WHO publications, handbooks, e-learning courses, International Working Group for Drug Statistics and guidelines. There are specific tool-kits for Methodology. This group contains 12 experts pharmacovigilance in HIV, malaria and Agnes Kant, Director of Lareb nominated by WHO and drawn from the WHO immunization programmes. The Accra Centre Expert Advisory Panels for Drug Evaluation and works with the WHO/SAV to provide support The Lareb Centre in the Netherlands is a for Drug Policies and Management. The Working for countries conducting cohort event specialised national centre which focuses on the Group meets twice a year to revise and make monitoring (CEM) and other active surveillance process and scientific evaluation of patient decisions on ATC classifications or DDD studies of new medicines and vaccines. spontaneous reporting. In 2013, it was assignments. WHO Collaborating Centre for designated the WHO Collaborating Centre for Pharmacovigilance in Education and Patient The Norwegian WHOCC also functions to Pharmacovigilance Reporting. Its role is to assist WHO in training stimulate and influence the practical use of ATC Centre Anti poison et de Pharmacovigilance du member countries on how to handle patient systems by interacting with users. They provide Maroc reports. It holds workshops and hosts visitors at technical support, training courses and lectures In 2011, Centre Anti poison et de Pharmaco- the Centre to share their experiences of patient to member countries using the ATC/DDD codes vigilance du Maroc, in Rabat, Morocco, became reporting. Support is provided to countries with within their pharmaco-vigilance systems. They a WHO Collaborating Centre. With the global patient reporting by providing information and also publish guidelines of ATC classification expansion of pharmacovigilance and growing feedback. The Lareb Collaborating Centre and DDD assignment. number of member countries, the Rabat centre training on practical aspects of collecting assists WHO by building capacity in the eastern information about adverse drug reactions and on patient reporting. 12 UR69 April 2015 www.who-umc.org WHO Programme WHO Programme
The Centre conducts research on the contribution Table 1 describes the terms of reference and activities The WHO Programme has existed for nearly 50 of patient reports to pharmacovigilance. The of the five Collaborating Centres. We provide an years, but has grown slowly, especially in research is conducted in collaboration with the overview of the establishment of these Centres, resource limited settings (RLS) because of University of Groningen and has several their roles and contributions to WHO programmes. insufficient engagement of all stakeholders, the publications in the pipeline. Further to the work perception in many RLS that pharmacovigilance involving patient reports, the Centre promotes Going forward is a luxury; lack of strategy to support its growth pharmacovigilance education in academia by While WHO/SAV and the UMC are mandated to in non-Anglophone countries; and inadequate developing and maintaining a curriculum for develop and implement pharmacovigilance, the developments to address the growing needs of medical, pharmacy and paramedical students. A other WHO CCs that support SAV do this as an low- and middle-income countries (LMIC) with project collecting information on the content of additional task, on top of their ‘day-jobs’, and their special disease demographics. WHO’s pharmacovigilance core curricula is in process without compromising their national strategy to establish additional Collaborating and the Lareb Centre will organize workshops responsibilities. This is a remarkable distinction Centres closer to the point of care in LMICs, for Member Countries within the WHO and underlines the commitment and nature of with a focus on public health programmes and Programme for International Drug Monitoring to engagement of the individuals within these local language needs is paying off. discuss the curriculum. WHO CCs. Their support to WHO and the global patient community is invaluable. Growth Table 1 The WHO Programme has been growing steadily in membership and in scope of work these last Name, institution date Place Terms of reference 15 years, especially in those regions with weak of designation, website infrastructure but a high burden of diseases. The WHO Collaborating Centre for Sweden Lead scientific development in the WHO Programme for International WHO CC in Ghana has been instrumental in International Drug Monitoring (Uppsala) Drug Monitoring particularly regarding: integrating pharmacovigilance in malaria and • Identification and explanation of important safety signals related to I January 1978 • medicinal products. immunization programmes in sub Saharan http://www.who-umc.org • Develop best practices in pharmacovigilance. Africa and will continue to support WHO in • Improve the visibility and status of pharmacovigilance globally. developing relevant methods for monitoring in Provide useful, high-quality and cost-effective pharmacovigilance products and services to member countries of the WHO Programme for HIV, TB and other priority programmes. The International Drug Monitoring (PIDM) for local applicability building on Morocco centre has helped bring pharmaco- international standards. vigilance to francophone and Arabic language Contribute to capacity building in WHO PIDM member countries in establishing and supporting sustainable, high quality pharmacovigilance countries; the Centre also supports WHO in systems and evaluating their performance. expanding the scope of pharmacovigilance, to detect and prevent medication errors and the WHO Collaborating Centre for Norway To classify drugs according to the ATC system. Drug Statistics Methodology (Oslo) To establish DDDs for drugs which have been assigned an ATC code. harmonization of reporting systems across To review and revise as necessary the ATC classification system and DDDs. I November 1982 health facilities. Lareb, the latest to join the fleet To stimulate and influence the practical use of the ATC system by http://www.whocc.no cooperating with researchers in the drug utilization field. of WHO CCs is especially important in bringing To organize training courses in the ATC/DDD methodology and to lecture patients to the network and integrating in such courses and seminars organized by others. pharmacovigilance in mainstream curricula. To provide technical support to countries in setting up their national medicines classification systems and build capacity in the use of medicines consumption information. Shared responsibilities Going forward, WHO will continue to exploit WHO Collaborating Centre for Ghana Training in pharmacovigilance in African countries for building and Advocacy and Training in (Accra) strengthening spontaneous adverse drug reaction reporting systems. the WHO CC model and will join hands with Advocacy for pharmacovigilance across Africa either alone or in Pharmacovigilance other groups and initiatives to support global collaboration with WHO 1 October 2009 Promoting the integration of pharmacovigilance into public health pharmacovigilance. For example, WHO/SAV http://who-pvafrica.org/ programmes. will work with the Pan American Health Technical support to national pharmacovigilance centres. Organization and the Pan American Network Support in communication and crisis management to national pharmacovigilance centres. for Drug Regulatory Harmonization to support Acquisition (from WHO, UMC) and distribution of needed literature and Latin American countries; it will work with technical tools to national pharmacovigilance centres and governments regional centres of regulatory excellence in by hosting and maintaining a Toolkit. Research in pharmacovigilance including cohort event monitoring of Ghana and in Zimbabwe, to provide a regulatory specified medicines. framework for LMICs; with the Asia-Pacific Assisting countries to develop and maintain pregnancy registers. Economic Cooperation forum and ASEAN WHO Collaborating Centre for Morocco To conduct and facilitate regional and national pharmacovigilance (Association of Southeast Asian Nations) Pharmacovigilance (Rabat) training courses for Francophone, Eastern Mediterranean and Arabic networks in Asia and Pacific regions; with countries. 1 November 2011 To support the WHO normative functions related to pharmacovigilance professional organizations such as ISoP, to www.sante.gov.ma and promote patient safety. influence global best practices, to name a few. www.capm.ma To assist WHO in pharmacovigilance assessments and in the provision of technical support to Member States in pharmacovigilance and patient safety. Global pharmacovigilance is a shared responsibility of many stakeholders: it requires WHO Collaborating Centre for The Netherlands To work with WHO in the development and maintenance of a core the commitment and engagement of health Pharmacovigilance in Education (‘s-Hertogenbosch) pharmacovigilance curriculum to be part of the university curriculum for pharmacy, medical and paramedical professions. professionals, regulators, patients and civil and Patient Reporting To assist WHO in the promotion of the pharmacovigilance core society, academics and researchers, inter- 1 May 2013 curriculum. government agencies and their Member States, www.lareb.nl To assist WHO and the member countries of the WHO International Drug Monitoring Programme in the development of patient reporting systems. global health initiatives, donors, industry. To work with WHO in providing training to member countries of the WHO Working through WHO CCs and other partners, International Drug Monitoring Programme in handling patient reports. To contribute to research in pharmacovigilance, to identify and we are enlisting a global participation in investigate the value of additional data sources such as reports submitted pharmacovigilance, one stakeholder at a time. by patients.
Uppsala Reports 69 www.who-umc.org 13 NEWS FROM AROUND THE WORLD
Medication use in pregnancy BylineKristina Star and Lovisa Sandberg The EUROmediCAT consortium and the research project financed by the European interesting since this was the first time Poznan´ University of Medical Sciences in Union’s 7th Framework Programme and runs broad exploratory analysis was conducted Poland organized a European conference on between 2011 and 2015. The initiative aims on this type of data. The conference ‘Safety of Medication use in Pregnancy’ on to build a European system to evaluate the concluded with a discussion on the 2-4 February 2015. The EUROmediCAT is a risk for congenital anomalies in relation to recommendations for reproductive medication use in pregnancy. The pharmacovigilance in Europe. EUROmediCAT database, used for the research in this project, is based on the Highlighting the issue EUROCAT central congenital anomaly Several publications have been and will be database with information on medication visible in the scientific literature based on use during the first trimester of pregnancy. the EUROmediCAT initiative, which will benefit pharmacovigilance work in the New findings reproductive area. The conference was very Research findings and final results from the well attended and the Polish hosts did a project were presented at the conference in great job to promote the importance of the February: the central database and software subject. We hope that the researchers will development; prescription data linkage; receive funding to continue this important internet use and risk management; safety work to protect pregnant women from and utilization of antiepileptics, antidiabetics, teratogenic drugs. antidepressants and antiasthmatics in pregnancy and signal detection in the Further information can be found on the Safer medicine use in pregnancy in Poznan´ EUROmediCAT registry. The findings in the following sites: http://euromedicat.eu/ and signal detection session were particularly http://www.eurocat-network.eu/. A rich palate in Mysore Rebecca Chandler The International Society of Pharmaco- The meeting opened with a ceremonial lamp The second day featured presentations of a vigilance (ISoP) and the Uppsala Monitoring lighting by YK Gupta from the All Indian more ‘bread and butter’ flavour: signal Centre (UMC) agreed in 2014 to collaborate Institute of Medical Sciences (AIIMS) New detection basics, causality assessment, in training efforts to increase education and Delhi, B Suresh, G Parthasarathi, both from disproportionality statistics. There was also to harmonise safety reporting requirements the JSS University in Mysore; with Andrew a much-appreciated, interactive and ‘hands- and systems in Asia. The 2nd International Bate (representing ISoP) and Marie Lindquist on’ session introducing VigiLyze by Anders ISoP/UMC training course, ‘Risk Management (UMC). Viklund. through Fostering Good Pharmacovigilance Practice in Emerging Markets’ was held The first day included lectures describing the Day 3 focused on risk management, with between January 12 – 14, 2015 in Mysore, current status of pharmacovigilance in India/ presentations on the EU Risk Management India. Asia from the perspectives of industry, Plan, methods of risk minimization, and academia, and regulators. Other highlights studies to measure the effectiveness of risk Expert guidance on offer were a session on the history and importance minimization activities. Ralph Edwards and The course focus was to provide a multi- of pharmacovigilance by YK Gupta and a talk Marie Lindquist explored considerations in coloured guide and expert perspectives on on counterfeiting and quality defects by risk / benefit assessment and the importance the essentials of pharmacovigilance, former Deputy Drug Controller in India, Dr D of risk communication with an entertaining including safety data management, signal Roy. tag-team session. detection/causality assessment, and risk management/risk minimization. Speakers Scents and colours were an international group: members of the The city of Mysore provided a feast for all ISoP Executive Committee, UMC staff, the senses: the brilliance of the illuminated pharmacovigilance leaders in India, Mysore Palace and the colour of the harvest representing government, academia and festival Makar Sankranti; the smells of industry. sandalwood incense and warm curries; the constant beep-beeps of the tuktuks and The 50 participants, predominantly from the explosions of night-time/early morning JSS College of Pharmacy, but also working at fireworks; and of course the incredible, industry and regulatory agencies, came mouth watering buffets of curries, naan, mainly from India, but some travelled from chapati, and fresh papaya and pineapple. Singapore and Thailand. Sensorial brilliance in Mysore
14 UR69 April 2015 www.who-umc.org NEWS FROM AROUND THE WORLD NEWS FROM AROUND THE WORLD
Much activity in Chile Juan Roldán Saelzer There was a lot for Elki Sollenbring to observe and get involved in when we welcomed her to Chile in early March. The National Pharmacovigilance Centre of Chile (CNFv) within the Instituto de Salud Pública (ISP) was the centre of her busy stay. As the regular UMC contact person with the CNFv team we had plenty to discuss with her about technical management issues and guidelines of the WHO Programme, an essential aspect of the daily work at the Centre. Hospital visit The opportunity to visit two hospitals in Santiago (one paediatric, the other for adult patients), gave Elki a chance to discuss issues with the Clinical Pharmacist in charge of their pharmacovigilance activities and with other professionals. A significant number of ICSRs (Individual Case Safety José Luis Castro (PAHO), Elki Sollenbring (UMC), Adiela Saldaña (ISP), Deok-Ryun Kim (IVI), David Mena Reports) are generated there and managed (ISP), Juan Roldán (ISP) in Santiago via the new on-line notification system developed by the CNFv. Data transmission tool allowed us to gain advice on essential The following day a workshop involving technical elements of the proposal submitted Vaccines experts from the International Vaccine by IVI and PAHO. All this will be taken into A meeting of the ‘Proyecto Multicolaboración Institute (IVI), the Pan American Health account during the next stages of the Multi-país’ on vaccines safety on 4-5 March Organization (PAHO) and the CNFv team development of the tool and help determine in Santiago was attended by experts from examined the development of a tool to its final characteristics, including the data eight countries in the region. The project permit data transmission of ICSRs from Chile structure used in the current CNFv ICSR concerns building signal detection capacity to VigiBase, with the emphasis on vaccines. database. in the field of vaccine safety. Again Elki’s presence at these meetings Symposium in West Bengal Sten Olsson A two-day symposium on medicine safety Several lectures were devoted to the need and pharmacovigilance was organized at the and challenges of introducing pharmaco- School of Tropical Medicine, Kolkata, West vigilance in public health programmes (PHP), Bengal, India, on 2–3 March 2015. The main particularly those against tuberculosis and organizer was Santanu K. Tripathi, Professor HIV/AIDS. of Clinical and Experimental Pharmacology. Sten Olsson from UMC, representing the WHO Programme, talked about WHO norms Arab meeting report and standards in pharmacovigilance and the An article describing the first Arab/EMR methods recommended by WHO to PV meeting in Rabat last year has complement spontaneous reporting in PHP. appeared in the journal Drugs – Real Sessions were devoted to the progress of the World Outcomes. It includes reports from Pharmacovigilance Programme of India and the working groups and examples of how to use VigiFlow for data management. harmonised Arab pharmacovigilance An engaging talk was given on the promising terms. The link is: http://link.springer.com/ future of stem cell therapy and its potential article/10.1007/s40801-015-0015-8 risks. Young researchers also competed in orally presenting adverse reaction case Bilal Bham. The First Eastern reports in the most enlightening and Mediterranean Region/Arab Countries engaging manner. Meeting of Pharmacovigilance. Drugs - Real World Outcomes (2015) 2:111–115. DOI 10.1007/s40801-015-0015-8. S. K. Tripathi, Kolkata
Uppsala Reports 69 www.who-umc.org 15 NEWS FROM AROUND THE WORLD
Ebola Crisis in Liberia: a pharmacovigilante reflects
Hasipha C. Tarpeh Background indicate that some deaths were due to treatment and later discharged because they unauthorized, self-designed treatment. were tested negative after the supportive Ebola is a deadly haemorrhagic disease with treatment. Many survivors are children an incubation period of 21 days and signs whose parents lost their lives to the EVD. and symptoms similar to diseases such as The outbreak of the EVD also affected cholera, malaria and typhoid. Despite several pharmacovigilance activities when the attempts since its discovery in 1976, to date expert committee ceased, as there were no there is no scientific evidence of a cure for cases to be verified in any manner and form. the Ebola Virus disease (EVD). Lessons learned The EVD broke out in Liberia in March 2014 The greatest lesson learned as a result of the when an individual infected with the virus Ebola epidemic is that Liberia has a very travelled from Guinea to Liberia. The weak health system; a system with no outbreak paralyzed the health system in capacity to contain the EVD or similar Liberia, and major health institutions and disease. This is in terms of manpower, activities, including the pharmacovigilance infrastructure, equipment and logistics. programmes in the schools, hospitals and Most health facilities have very poor the regulatory authority, came to a stand- laboratory facilities and there are few United Nations military personnel seen still. The crisis greatly affected pharmaco- specialists – for example the lack of clinical immediately after washing his hands to enter vigilance activities due to the nationwide pharmacists. Most health practitioners, a pharmacy store in Monrovia – closure of the health facilities. especially physicians, are only general 6 year-old boy holds certificate stating that practitioners. This weakness was blamed by he is now Ebola-free. The period between July and November 2014 Health Minister Dr. Walter Gwenegale on The construction of ETUs around the country witnessed the shutdown of several businesses in inadequate budgetary allotment. The health helped solve the lack of secure bed space the country, departure of investors and loss of system needs to be improved and which initially led to rejection of patients jobs. The government declared a state of strengthened to be able to contain future and many deaths. Monrovia city and its emergency, ordered the closure of schools and outbreaks of diseases. There needs to be a environs has six ETUs, and at least one is to entertainment centres, and quarantine clearly defined treatment protocol for the be constructed in each of the other 14 measures. Restrictions were imposed on social EVD management. counties; nine already have been. activities aimed at breaking the transmission and stabilizing the disease, such as a restriction One positive outcome is the display of Ebola Donations from all walks of life in cash and in the number of persons riding vehicles (rather awareness messages on private residential kind created a good atmosphere and a than the usual practice of passengers sitting on buildings, public buildings, vehicles, bus- balance to effectively fight the disease. each other’s laps). All these measures, though stops, etc. As a result of persistent and These came from the international difficult to enforce 100%, brought some level continuous public awareness activities, the community as well as local groups, banks, of sanity in the struggle to fight the disease. state of denial no longer exists. Public awareness of safety issues is of course vital individuals and the like. The international Challenges in pharmacovigilance too. response saw the USA playing a leading role in providing financial support and manpower, Some of the major problems which impacted followed by the Economic Community of safety monitoring: West African States, the African Union, 1. A total collapse of the health system other friendly governments and groups. due to the outbreak of the EVD presenting as a strange disease in the Current disease trends country. Many health workers died from July 2014 witnessed hundreds of daily lack of experience in its management. deaths at the Ebola Treatment Units (ETU), 2. Deaths of health workers due to the street corners, in communities, churches, lack of protective equipment, and mosques, etc. The entire country became the abrupt closure of major hospitals terrified between July and November 2014, reporting adverse drug reactions (ADR). with over 3,000 persons losing their lives to Ebola awareness messages on a bus stop on Ebola in Liberia. 3. The circulation of fake and substandard street leading to Monrovia from the airport. medicines due to the slowdown of As a result of the experience in the fight regulatory activities. Another success was the establishment of an against the disease, Liberia has seen the 4. To date only a few health facilities Incident Management System headed by need to share success stories with the other are returning to full operation. Focal Assistant Minister of Health, Tolbert countries to the extent of sending some persons for spontaneous reporting of Neyenswah (a public health specialist). health workers to Sierra Leone. Unless ADRs in hospitals are yet to return to neighbouring countries are free of Ebola, work, posing a question about training On-going coordination Liberia risks experiencing cases again, as our new people for reporting. Currently, there are close to 1,000 survivors borders with our sister countries are very porous. 5. More than 3,000 persons, including many who were admitted into Ebola Treatment health workers died; unconfirmed reports Units (ETU), tested positive, given supportive
16 UR69 April 2015 www.who-umc.org NEWS FROM AROUND THE WORLD NEWS FROM AROUND THE HEWORLDaDER
Asia Pacific Training Anki Hagström The First Asia Pacific Pharmacovigilance within a culture are the most important vigilance. “I strongly recommend people to Training Course was arranged in Mysore, India ‘take home’ messages for me.” attend this training as once-in-a-life-time from 16-28 February 2015. This two-week opportunity.” training programme was organized by JSS Practical sessions University Mysore and Uppsala Monitoring The course provides solid practical foundations Open environment Centre in collaboration, with the objective of on the principles of drug safety and covers Training is built around lectures, workshops sharing knowledge and skills in topics essential to effective capacity building and hands-on exercises, in an open and pharmacovigilance to healthcare professionals in the field. Sessions included pharmaco- interactive environment. There is plenty of and regulators across the Asia Pacific region. vigilance best practices, signal detection, opportunity for participants to interact with reporting culture, pharmacovigilance in drug JSS staff, UMC staff, faculty experts and Advocacy development, benefit/harm assessment and fellow course participants. Social activities Countries in this part of the world face pharmacovigilance tools, communications comprised an official course dinner and increasing awareness of adverse drug and risk management. sightseeing tours. reactions among health care professionals and the public, “I really enjoyed the multicultural placing demands on effective class, fruitful workshops, and communication to reach a amazing advice. It has been a large and diverse audience. pleasure to attend the course, Another challenge is to which made us feel so empowered” establish sustainable safety enthused Mark Tyan A Lirasan surveillance systems, which (Regulation Officer, FDA, requires purposeful advocacy Philippines). towards ministers of health and other stakeholders to Sixteen participants from eight secure funding and resources countries participated, and the for pharmacovigilance The joint training course students and teachers success of the training was activities. Training is closely confirmed both by faculty and related to equipping pharmacovigilance Dr. Shanthi Pal from the WHO Safety and course participants. At the end of the course experts in addressing those challenges and Vigilance Group, UMC, JSS University and Chuon Vibol (Pharmacovigilance Technical to building capacity for patient safety in pharmacovigilance experts from universities, Officer, Department of Drugs and Food, relation to the use of medicines. UMC and academic institutions and pharmaceutical Cambodia) told us that “Upon completion of JSS University offered the Asia Pacific industry across the region contributed to the this training and my return, I have strong training course to meet pharmacovigilance training. confidence that I will be able to get involved training needs and to help support the more actively in developing and also advancement of pharmacovigilance in the Chaitanya Kulkomi (Drug Safety Associate, enhancing pharmacovigilance activities, and region. Lupin Ltd, India) commented that the in particular aspects in the health care programme had “an excellent adapted system in Cambodia.” Barbara Muller (Medicine Safety Unit curriculum which touches base with almost Pharmacist, Vanuatu) explained that all the aspects of global pharmacovigilance The establishment of this joint training course pharmacovigilance is known as “problems practices”, finding the speakers very shows UMC’s and JSS University’s dedication with medicines” in Vanuatu and the training professional with in-depth knowledge of to contribute to the advancement of in Mysore certainly covered many of those different subjects. He was also “amazed to pharmacovigilance. The challenges and problems. “The designing of a relevant and see that the passion and enthusiasm in the training needs in the Asia Pacific region apply simple-to-use ADR reporting form, the trainers and speakers about pharmaco- to many other countries and participants training in why, how and when to use it, and vigilance”, and felt that one would be able to from other regions are welcome to apply for the importance of how to communicate develop a similar passion for pharmaco- the next course, on 18-29 January 2016.
Conclusion ahead if the human resource challenge is Hasipha C. Tarpeh, B.Sc. B.Pharm. R.Ph. MPAL, adequately addressed. MPH, MILM A return to full healthcare services is a major challenge to government and all stakeholders. Clearly the EVD has had a major impact on Lecturer, University of Liberia and Cuttington President of Liberia Madam Ellen Johnson our work in pharmacovigilance but the crisis University Graduate School; Chief Registrar, Sirleaf commented “The restoration of health has shown that reliable funding, a good Liberia Medicines & Health Products services depends on the economic recovery of infrastructure and committed individuals are Regulatory Authority the country”. Restoration of the health system as essential in combating a major public therefore, is a concern for all residents and health crisis as in routine safety monitoring donors alike. The government of Liberia with to protect the public. The other lessons the support of partners has the challenge of relate to the merits of crisis planning and human resource development. Liberia will decisive action at the early signs of a crisis. experience a great deal of sanity in the years
Uppsala Reports 69 www.who-umc.org 17 Research news
Finding substandard medicines in VigiBase® Kristina Juhlin & Maria Andér The Uppsala Monitoring Centre in and selected pilot country sites to perform too long, and would need to be decreased to collaboration with the National Centres in the assessments on the suspected clusters of approximately 30 days to enable a Malaysia, Singapore, South Africa, South substandard medical products. meaningful follow-on investigation. Korea, the UK and the USA have just published Increased awareness, and hence increased the results of a pilot study on the potential to The participating countries were Malaysia, reporting of adverse events related to identify substandard medical products in Peru, Singapore, South Africa, South Korea, substandard medical products, is also VigiBase®. The study is published as open UK and US, which were chosen based on needed, especially in regions where access in Drug Safety. prevalence of highlighted clusters and with substandard medical products are known to respect to having a good geographical spread. be a significant problem and where pharmaco- Background vigilance systems are still maturing. Substandard medicines, whether the result The algorithm for identifying substandard of intentional manipulation or of lack of medical products highlights clusters of Prerequisites for effective compliance with good manufacturing and reports based on a higher than expected distribution practice (GMP/GDP), pose a prevalence of MedDRA terms indicative of routine use of algorithm significant potential threat to patient safety. lack of effect or directly suggesting product 1) Reporting of lack of effect and The effects of substandard products can be quality issues. To capture local occurrences quality issues established within severe; patients can suffer adverse reaction of substandard products, clusters are defined the country to additives and substitute products or a lack as ‘reports on a product with the indicator 2) Time efficient reporting process of therapeutic effect leading to worsening of terms from a single country and year’. to VigiBase guaranteed - from the disease and possible death. Substandard products made with the main intent to Empirical evaluation occurrence of AE to ICSR available mislead or deceive patients for financial From the clusters of suspected substandard in VigiBase gain, also lead to loss of money, productivity, products identified by the algorithm, 147 3) Reporting occurs on product name and confidence in health systems worldwide. were randomly selected by the UMC for level evaluation by the participating national Identifying substandard 4) NCs need necessary capacity to centres. Out of these, 8 clusters were perform investigations and follow-up medicinal products classified as ‘confirmed’ and 12 as ‘potential’ In 2011, the Uppsala Monitoring Centre substandard medicines. 57 of the clusters (UMC) developed an algorithm to identify were classified as ‘indecisive’, which reflects However, the interviews confirmed an reporting patterns suggestive of substandard the difficulty of evaluating suspected interest in a routine use of the algorithm medicines in the WHO global ICSR database, substandard products retrospectively when among five of the seven countries. Provided VigiBase™. The initial research was performed additional information from the primary that prerequisites are met, there may be a within the Monitoring Medicines collaboration, reporter as well as samples may no longer be potential benefit of putting the algorithm and included a limited evaluation of a possible to obtain. into routine use for resource limited restricted set of highlighted clusters. In order countries or for countries where limited to thoroughly evaluate the effectiveness of Potential for future use monitoring for substandard medical products the algorithm the assessment of potential The UMC also investigated the status of is done today, to help highlight suspected clusters should be done as near as possible prerequisites for effective routine use of the cases and to guide initial investigations. to the original sources of information, as algorithm through interviews with specialists assessment often requires that additional at the pilot country sites. The responses Next steps details are gathered from the original show that these prerequisites are not Since effective investigation and follow-up reporter. Therefore, this pilot study was set fulfilled today. Most importantly, the current of potential cases of substandard medicines up as a collaborative project between UMC lead times in the reporting to VigiBase are is not possible with the current reporting lead times, it is not yet the time to introduce the algorithm into routine use. UMC is recommending that actions are taken by UMC, WHO and countries with an interest in routine use of the algorithm to improve current pharmacovigilance processes, to move towards fulfilling the prerequisites for better detection of substandard medical products.
Article available in Drug Safety online: http://link.springer.com/article/10.1007/ s40264-015-0271-2
This study has been conducted with financial support from the FDA in the United States.
18 UR69 April 2015 www.who-umc.org Research news Research news
Medical record data as reference source in signal work Kristina Star The paper ‘Longitudinal medical records as a Accessing THIN during signal detection in in identifying drug-adverse reaction complement to routine drug safety signal VigiBase provided a useful clinical context combinations that were most likely to be analysis’ was recently published online for the drug-adverse reaction combinations associated with the underlying or ahead of print by Pharmacoepidemiology under review. However, the paucity of data concomitant disease. and Drug Safety. The UMC authors explored in THIN for many of these combinations, the feasibility of using longitudinal meant that only a small number of potential This study has added one more piece to the electronic medical records as a source of signals from VigiBase could be evaluated in puzzle of knowing how to best use electronic reference in the early phases of signal the electronic medical records. Data was medical records in the context of signal detection and analysis of individual case particularly sparse for newly marketed drugs detection and analysis. The full list of authors safety reports in VigiBase®. The original idea reported with serious reactions as defined by is Kristina Star, Sarah Watson, Lovisa for this study was suggested by Dr Marie the WHO Adverse Reaction Terminology Sandberg, Jeanette Johansson and I Ralph Lindquist. (WHO-ART) critical terms. Edwards.
We used The Health Improvement Network Another challenge was matching medical The paper is published open access via the (THIN) database of electronic medical event terms recorded using the ‘Read’ code following link: http://onlinelibrary.wiley. records from UK general practice, on which a terminology in THIN with adverse reactions com/doi/10.1002/pds.3739/epdf previously published temporal pattern coded using WHO-ART in VigiBase. The main discovery method with a self-controlled value of using THIN data in this study was Reference 1 design, vigiTrace, had been applied. vigiTrace the opportunity to view drug-event patterns 1. Norén GN, Hopstadius J, Bate A, Star K, Edwards IR. on THIN was used as a source of reference in vigiTrace displayed in the chronographs, Temporal pattern discovery in longitudinal electronic during manual review of 458 drug-adverse i.e. a specific medical event displayed patient records. Data Min Knowl Discov 2010; reaction combinations generated from monthly three years before and after a 20:361–387. VigiBase during the third quarter of 2011. specific prescription. This particularly helped
ADRs for cardiometabolic drugs from Sub-Saharan Africa Kristina Star This was a collaborative study between same group of drugs from the rest of the The authors are Derbew Fikadu Berhe, researchers in the Netherlands, Ethiopia, world constituted the primary comparator. Kristina Juhlin, Kristina Star, Kidanemariam South Africa and Sweden (UMC). Peter GM G Michael Beyene, Mukesh Dheda, Flora M Mol, Assistant Professor at the Department In SSA, 9% of the reports concerned Haaijer-Ruskamp, Katja Taxis and Peter GM of Clinical Pharmacology, University Medical cardiometabolic drugs compared with 18% Mol. Center Groningen, Netherlands, and his PhD in the rest of the world. In the SSA subset of student Derbew Fikadu Berhe from Ethiopia reports on cardiometabolic drugs, 79% were Reference initiated the investigation on adverse drug from South Africa, and 81% had been 1. Juhlin, K., Star, K., Norén, G. N. (2013). Pinpointing reaction (ADR) reports with cardiometabolic received after 2007. Drugs acting on the key features of case series in pharmacovigilance - a drugs from Sub-Saharan Africa (SSA). Since renin-angiotensin system were reported novel method. Drug Safety, 36(9), 912–913 (conference abstract). the majority of the reports in the study disproportionately more frequently in SSA originated from South Africa, and (36%) than in the rest of the world (14%). clarifications to questions on these reports Lip swelling, cough, angioedema, face were needed during our analysis, Mukesh oedema, swollen tongue and throat irritation Dheda also got involved in the writing up of were more frequently reported in SSA, most the study. likely reflecting the known ADRs of ACE- inhibitors. This finding is in line with prior The burden of cardiometabolic disease is knowledge that ACE-inhibitors seem to be increasing rapidly in SSA. Berhe and his co- less tolerated in the black population. authors aimed to identify key features in ADR reports on cardiometabolic drugs from This is probably the first study to focus on SSA. Individual case safety reports entered in ADR reports with cardiometabolic drugs VigiBase® from 1992 to 2013 were included across countries in SSA. The findings in the study. Key features were identified emphasize the importance of continuing using vigiPoint, which is a logarithmic-odds pharmacovigilance efforts in this part of the ratio-based method used to compare world in order to increase our understanding covariate values (e.g., age, gender, reporter, of the benefits and risks of medicines in the drugs and adverse reactions) in a selected population of SSA. The paper is published subset of reports of interest with one or online ahead of print and the abstract is several comparators.1 In this analysis, reports available at: http://www.ncbi.nlm.nih.gov/ with cardiometabolic drugs from SSA were pubmed/25704305 the subset of interest and reports with the Uppsala Reports 69 www.who-umc.org 19 Antibacterial resistance
Antimicrobial resistance: UMC joins global initiative Antonio Mastroianni On June 2 and 3, decision-makers, opinion if it is not addressed in a global and sciences community with hands-on leaders and experts from politics, industry, coordinated fashion. A growing burden of international experience in many of today’s academia and civil society at the Uppsala antimicrobial resistance will increase the most important healthcare issues. Uppsala Health Summit will discuss how research mortality among frail groups such as patients has a strong science base with two leading results and innovations can tackle a major health with pre-existing conditions and vulnerable academic institutions, Uppsala University challenge (www.uppsalahealthsummit.se). populations in unsanitary environments and the Swedish University of Agricultural The Summit will provide a critical opportunity lacking access to regular medical services. Sciences, internationally competitive to discuss consequences of actions and non- As a result, routine medical interventions research in several fields, and clinical actions for people, animals and the planet in may again become interventions of high risk. research at Uppsala University Hospital. The relation to antibiotic resistance, one of the One problem. Different perspectives. research infrastructure, including platforms great global health threats that needs urgent for large-scale biomedical research, coordinated action on a global scale. Dialogue biobanks, patient registries and resources for Importantly, this will be one of the first The 2015 Uppsala Health Summit will rely on advanced computational science, open up major international venues following the frank and open dialogue on how the current many new possibilities to improve healthcare World Health Assembly in May 2015, where state of knowledge and innovations can lead worldwide. WHO is expected to present a formal global to action on global, national and local levels, action plan against antimicrobial resistance, to reduce the threat from antibiotic In addition, Uppsala is home to two to be coordinated by WHO. resistance. It will cover: regulatory authorities, the Medical Products n measures for rational use of antibiotics Agency and the National Veterinary Institute, UMC is supporting the Summit because this for human and veterinarian purposes and a wide network of international issue is not only a key component in effective organizations, such as ReACT and Uppsala pharmacovigilance, but also in patient n environmental issues Monitoring Centre - the WHO Collaborating safety. We see antimicrobial resistance as n business models for innovation and Centre for International Drug Monitoring. part of the broad scope of pharmacovigilance, release of new antibiotics This ecosystem contributes to the overall which also includes medication errors, bad n prevention of infections. ability to put research results into practice quality drugs, etc. to improve health and health outcomes. The Uppsala Health Summit series was Burden ahead started by local, regional and national 2014 WHO report, ‘Antimicrobial Resistance As underlined in the WHO 2014 report, governmental and academic institutions to – Global Surveillance’ ‘Antimicrobial Resistance – Global create a natural meeting point in Sweden to www.who.int/drugresistance/documents/ Surveillance’, anti-microbial resistance will tackle pressing health-related issues facing surveillancereport/en/ result in ordinary infections becoming lethal the world. Sweden has a thriving life Be part of the Summit The Uppsala Health Summit (June 2-3 of antimicrobial resistance will increase is expected that WHO will outline a global 2015) aims to bring together decision- the mortality among frail groups as action plan against antimicrobial makers, opinion leaders and experts to patients suffering from other diseases, and resistance, to be coordinated by the WHO. discuss consequences of actions and of even simple surgical interventions will non-actions for people, animals and the once again become interventions of high Uppsala Health Summit is a by invitation planet in relation to antibiotic resistance, risk. During the World Health Assembly it only event, that can host only up to 200 which is one of the great threats persons. If you have yet not to health globally, a threat that received an invitation, but have a needs urgent coordinated action distinct role forming the future on a global scale. Antibiotic healthcare sector, as decision resistance is a key component of maker, opinion leader or expert pharmacovigilance and the from private sector, academia, irrational use of these medicines public sector or civil society, The and lack of awareness by those Organizing Committee is happy to that abuse them have the potential add you to their list of invitees. of cataclysmic consequences for Please contact the entire world. [email protected].
The WHO underlines in its 2014 More information about the Uppsala report “Antimicrobial Resistance Health Summit can be found at – Global Surveillance”, that if not http://www.uppsalahealthsummit. dealt with, ordinary infections se/antibiotics-antibiotic- that we today consider treatable resistance-2-3-june-2015/ Uppsala congress centre, the Summit venue will kill again. The growing burden
20 UR69 April 2015 www.who-umc.org Antibacterial resistance Publications
Medicines for Women Geraldine Hill This comprehensive new 627-page supports targeted, short-term use of MHT unregulated drug market with widespread publication* brings together in one volume specifically for the treatment of menopausal over-the-counter availability make women many issues that relate to the use of symptoms, and emphasizes the need for in developing countries particularly medicines by women. While much has been women to be fully informed of the risks and vulnerable to the potential harms of written separately on the various topics benefits associated with this treatment. medicines, as is discussed in Chapter 17. The covered in the book, this valuable resource Chapter 12 addresses the use of final two chapters address risk sharpens the focus on women and their bisphosphonates for the prevention of communication and emphasise that specific needs in relation to medicines. It fractures in osteoporotic women: it describes information on the risks and benefits of examines the intricacies of prescribing to the pharmacology and mechanism of action medicines must be communicated in a way women: from the distinctive pharmaco- of this group of drugs and discusses the that is relevant and understandable, and kinetics of medicines in women to the socio- efficacy and safety of each of the currently that personal, social and cultural factors will cultural understandings that form the available drugs in this class. The final chapter influence how that information is processed context in which medicines are used by in Part II provides an overview of the use of by women. women. A key message in this book is that ‘a The book comprises three parts. Part I, holistic approach that values women Prescribing Medicines for Women: and considers their socio-cultural General Principles and Consideration of environment is important when Special Sub-populations, starts with a prescribing medicines and in all stages brief history of the use of medicines in of medicines regulation and monitoring’. gynaecology and notes how the history of Women are not a minority group, but contraception has been closely linked to there are important differences between the socio-cultural and economic position men and women that influence the of women over time. The personal efficacy and safety of medicines that account by Elizabeth Claire Hooper of her should be considered specifically during experiences with diethylstilboestrol (DES) drug development, prescribing and and the poster promoting DES to pregnant monitoring. There is still room to improve mothers are powerful reminders of how the evidence and communication of the the health needs of women have been benefits and potential harms to women exploited by the commercial interests of for all medicines, not only those pharmaceutical companies, with little developed specifically for women. thought to the safety or efficacy of these products. Topics covered in Part I include This book will be of interest to clinicians, the peculiarities of drug pharmacokinetics nurses and pharmacists (and students of in women and how they affect drug safety herbal and complimentary medicines for these professions) who provide health care to and efficacy, special considerations when women’s health and notes that while these women. It will also be important reading for prescribing to adolescent women, and remedies now form the basis of a multi- regulators, pharmacovigilance colleagues, the medication use in pregnancy. billion dollar industry, there is a lack of pharmaceutical industry and others with an evidence for the efficacy and safety of many interest in women’s health. The text is Part II, Specific Medicinal Products for of these products, and they remain largely accessible to a wide audience, with easily Women: Benefits and Risks, deals with unregulated. understood language and clear take-home medicines used either exclusively or messages for each chapter. predominantly by women. It includes Part III, International Perspectives on * Editor chapters on the risks and benefits of oral Medicines for Women and Risk Mira Harrison-Woolrych contraceptives, with a separate chapter Communication starts with a chapter on dedicated to the risk of venous prescribing for women in the primary care Authors thromboembolism, emergency contraception setting, which notes that information on Sue Bagshaw, Emily Banks, Julie Craik, Brian and contraceptive devices. The development dosing, efficacy and safety of medicines is Edwards, Emmanuel Fadiran, Yifat Gadot, of the two HPV vaccines is discussed in often not available specifically for women, Wayne Gillett, Bruce Hugman, Katarina Ilic, Chapter 9 and concludes that their safety yet women are more likely to be prescribed Susan Jick, David Jones, Nighat Khan, Gideon and efficacy are well established; the medicines. The chapter on medicines Koren, Gail Mahady, Dee Mangin, Louise challenge now is to ensure that the vaccine regulation goes on to highlight the need for Melvin, Janet Nooney, June Raine, Stuart is accessible to all girls in the target age- strong evidence to support a positive Ralston, Sam Rowlands, Margaret Stanley, group (9-14 years). Chapter 10 discusses benefit:risk evaluation for medicines such as Veronika Valdova, Sheila Wicks and Lei Zhang medicines used in the treatment of Chronic contraceptives that are used by healthy Pelvic Pain (CPP) and emphasizes the need to women. Chapter 16 provides a fascinating Published take a holistic approach to managing the discussion on political and religious Adis, 28 January 2015 pain, noting that the evidence for effective perspectives regarding the risks and benefits 627 pages; 38 illustrations, 25 in colour. treatments is lacking. A chapter on of women’s medicines. Weak health systems, Printed book: Hardcover or a printed eBook. Menopausal Hormone Therapy (MHT) lack of access to qualified health workers, As an eBook it can be purchased from summarises the current evidence that poor quality medicines and a largely springer.com/shop
Uppsala Reports 69 www.who-umc.org 21 news COURSES & CONFERENCES
a new career in software development. He Ingrid Johansson and Yvonne Thomson. has been working in that field for more than Anneli Lennartsson, who joined the UMC as Staff news 15 years, both in industry and in government Team Support and P.A. back in September Jonas Avelin, born in Hallstahammar and organizations. His previous employer was 1999, has now taken well-earned retirement. raised in Västerås in central Sweden, moved the Swedish National Food Agency. We wish them all the best in the future. to Uppsala at the age of 20. After his PhD in mathematics, he worked as a university Jonas joined PDQ-IT (Production, Development After two years working in our research lecturer for a couple of years before starting and Quality – IT) at the beginning of this year, team in Uppsala, Geraldine Hill moved back and is currently working on development of to New Zealand in December. However, she the next generation VigiLyze system. will fortunately not be lost to the WHO Programme and will be working directly with “During the fall of 2014, I visited UMC a WHO Headquarters providing expertise in couple of times and was very glad when pharmacovigilance in public health Jonas Ahlkvist offered me a position in IT. My programmes and supporting countries impression so far is that everyone is really running CEM studies. We look forward to friendly, and also passionate about their collaborating with Gendie in her new role, jobs. The competence is high, and I consider thank her for all the work done and the good myself privileged to work here”. time we had together at UMC and wish her and her family all the best back in their Departures home town Dunedin. Over the last few months we have said farewell to Ulrika Rydberg, Ola Strandberg,
The book also has a chapter entitled ‘The Humane Cardiovascular drugs Dimensions of Effective Communication’ by Cardiovascular drugs and the risk of systemic Books received Bruce Hugman, and a chapter from Sudan autoimmune diseases – Pharmaco- Pharmacoinformatics on the work of the national pharmaco- epidemiological and experimental approaches. Pharmacoinformatics and Drug Discovery vigilance centre. Individual chapters may be Technologies: Theories and Applications purchased separately from the IGI website. This is a book based on the thesis by Hilda de Jong. It covers: We did not mention the publication in 2012 of a book which may be interest to some UR readers. n Signal detection for statin-associated This 440-page book from IGI Global (ISBN 13: autoimmune disorders in spontaneous 9781466603097) is mainly concerned with reporting systems maximizing the benefits from the use of n Cardiovascular drug use and the information systems and technologies for incidence of autoimmune diseases in the provision of decision support tools electronic health records necessary for improved drug management, n Statin use and autoimmunity use, and administration practices. n Causal relationship, statin use and It includes a chapter on pharmacovigilance autoimmune diseases. (by Jimmy Jose, University of Nizwa, Oman) which focuses on the application of Among the distinguished co-authors may be pharmacoinformatics in the practice of noted H.G.M. Bert Leufkens, Ronald H.B. pharmacovigilance and covers experiences Meyboom and Frank de Vries, and the book in industry, regulatory, and hospital settings. can be read on-line at the digital archive of Maastricht University.
The event is nation-wide and this year over 4.2 Spinning to give million SEK was raised – a new record! UMC’s participants were (in order of hope appearance): Helena Sköld, Anna Mattsson (pictured), Madeleine Krig, Jenny Adamsson, th Saturday 28 of March saw the annual Malin Zaar, Camilla Westerberg, Cecylia Swedish event Spin of Hope – an event where Wojcik, Damon Wallin Fahimi, Jessica Avasol, companies or private teams can sponsor a Emma Rofors and Thomas Vidinghoff. spinning cycle for 12 consecutive hours to raise money for cancer research in children. UMC sponsored one cycle and 11 participants from UMC staff kept the cycle running throughout the day.
22 UR69 April 2015 www.who-umc.org news COURSES & CONFERENCES
dates title place ORGANISER/CONTACT 18 May 2015 A practical guide to writing risk management plans London, UK Management Forum Ltd Tel: +44 (0)1483 730008 E-mail: [email protected] www.management-forum.co.uk
18-29 May 2015 17th International Pharmacovigilance Training Uppsala, Sweden Uppsala Monitoring Centre Course www.who-umc.org
20-21 May 2015 Global Regulatory Pharmacovigilance Environment Hammersmith, Drug Safety Research Unit London, UK Tel: +44 (0)23 8040 8621 www.dsru.org/trainingcourses E-mail: [email protected]
1-12 June 2015 9ème Cours Francophone de Pharmacovigilance Rabat, Morocco Centre Anti Poison et de Pharmacovigilance du Maroc www.capm.ma/
1-19 June 2015 The WHO Collaborating Centre Vaccine Accra, Ghana WHO Collaborating Centre for Advocacy & Training in Pharmacovigilance Fellowship Pharmacovigilance Tel: +233 302 268 746 / +233 289 014 000 E-mail: [email protected] www.who-pvafrica.org
9-11 June 2015 Signal Detection Conference London, UK Drug Safety Research Unit (See above for contact details)
10-11 June 2015 Medical Approach in Diagnosis and Management Paris, France DIA Europe of ADRs www.diahome.org/en-GB/Meetings-and-Training/
14-18 June 2015 DIA 2015 : 51st Annual Meeting Washington, DC, DIA USA www.diahome.org/Home/Flagship-Meetings/DIA-Annual- Meeting.aspx
24-26 June 2015 Medical Aspects of Adverse Drug Reactions Southampton, UK Drug Safety Research Unit (See above for contact details)
27-30 June 2015 12th Congress of the European Association for Clinical Madrid, Spain EACPT Pharmacology and Therapeutics (EACPT 2015) http://www.eacpt2015.org/
22-26 August 2015 31st Annual Conference ICPE Boston MA, USA International Society for Pharmacoepidemiology (ISPE) www.pharmacoepi.org
9-10 September 2015 Back to Basics in Pharmacovigilance Fareham, UK Drug Safety Research Unit (See above for contact details)
14 September-9 October 2015 The WHO Collaborating Centre Pharmacovigilance Accra, Ghana WHO Collaborating Centre for Advocacy & Training in Fellowship Pharmacovigilance (See above for contact details)
30 September-1 October 2015 Pharmacovigilance Planning and Risk Management Fareham, UK Drug Safety Research Unit (See above for contact details)
13-14 October 2015 9th Annual QPPV Forum London, UK DIA Europe (See above for contact details)
14-15 October 2015 Case Narrative Writing for Reporting Adverse Fareham, UK Drug Safety Research Unit Events (See above for contact details)
21-22 October 2015 Risk Benefit Assessment in Pharmacovigilance Fareham, UK Drug Safety Research Unit (See above for contact details)
27-30 October 2015 ISoP 2015 Annual Meeting Prague, Czech Republic International Society of Pharmacovigilance E-mail: [email protected] www.isop2015prague.org/
3-4 November 2015 Benefit/Risk Management Paris, France DIA Europe (See above for contact details)
5-6 November 2015 Signal Management in Pharmacovigilance Paris, France DIA Europe (See above for contact details)
24 November 2015 4th Nordic Pharmacovigilance Conference Stockholm, Sweden Läkemedelsakademin www.lakemedelsakademin.se/templates/kurs/kurstillfalle. aspx?kId=6101&id=6102
25-27 November 2015 2nd African Society of Pharmacovigilance (ASoP) Accra, Ghana ASOP 2015 conference ‘Pharmacovigilance In Africa : New www.asop2015.com Methods, New Opportunities, New Challenges’
Uppsala Reports 69 www.who-umc.org 23 For everyone concerned with the issues of pharmacovigilance | UPPSALA REPORTS | UR69
The Uppsala Monitoring Centre (UMC) is a not-for-profit foundation and an independent centre of scientific excellence in the area of pharmacovigilance and patient safety. We provide essential research, reference, data resources and know-how for national pharmacovigilance centres, regulatory agencies, health professionals, researchers and the pharmaceutical industry round the world.
Many of our services and products have been developed as a result of our responsibility - as a World Health Organization Collaborating Centre - for managing the WHO pharmacovigilance network of over 120 countries and the WHO global individual case safety report database, VigiBase®. A core function is the screening and analysis of data with the aim of detecting potential issues of public health importance in relation to the use and safety of medicines. Other services include technical and scientific support to WHO and its member countries, and provision of tools, such as VigiLyze™ and VigiFlow®, for data entry, management, retrieval and analysis.
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