April 2009 - Uppsala Monitoring Centre

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HIV/AIDSPharmacovigilance for ARVs pilot projectImproving patient safety, patient care and treatment outcomes forpeople living with HIV/AIDS treatmentDr Micheline Diepart, Medical Officer, Department of HIV/AIDS, WHOReaders may recall the WHO/UNAIDS ‘3 by 5’ initiative, launched in2003 to provide antiretroviral medicines for 3 million people sufferingfrom AIDS by 2005. This target was only reached by end of 2007, butthis was seen as a major success, considering the challenges andthat most of the people on treatment are from resource-limitedcountries. This initiative has not yet been matched by the same effortto improve pharmacovigilance for antiretroviral medicines (ARVs) inlow- and middle-income settings.The background to monitoringToday, close to 4 million people worldwide have access to antiretroviralmedicines, and the new target is ‘Universal access to treatment forall’. The effectiveness of treatment programmes, particularly inresource-limited countries, risks being compromised by problemsrelated to toxicity, intolerance and drug–drug interactions. Adverseevents linked to antiretroviral medicines used in AIDS infection,whether acute or chronic, mild or severe are relatively common,affecting both individual patients and public health. They not onlyreduce the treatment efficacy with increased morbidity and mortality,but also become a public health issue, as treatment programmeeffectiveness may be reduced through increased risk of emergenceof secondary drug resistance. In spite of this, they remain onlyintermittently identified and scarcely systematically reported in lowandmiddle-income settings. New adverse events and toxicities areidentified, and antiretroviral therapy became a chronic infectiousdisease, life-long treatment, with built-in toxicities. The availabilityof numerous new drugs and drug combinations makes it critical tosystematically monitor adverse events linked to antiretroviralmedicines.The need for dataAntiretroviral medicines and other drug interactions are receivingincreasing attention too. For instance, many patients receiving ARTin low- and middle-income countries are also being treated fortuberculosis (TB) or malaria. Increasingly questions are raisedconcerning the acute and cumulative toxic effects, and impact onARV efficacy resulting from drug regimes that combine treatmentfor HIV and TB. Limited data have been collected on co-administrationof ARVs and second-line anti-TB treatment, and on artemisinincombination therapies for malaria. The influence of co-morbidity(especially hepatitis) and metabolic conditions on drug toxicity anddrug–drug interactions also needs to be better understood.Different setting, different approachMoreover, what we know of adverse events and toxicities inantiretroviral drugs is provided by pharmacovigilance and cohortevent monitoring data from developed countries. These data do notnecessarily apply to the low- and middle-income settings, where themetabolic, nutritional, genetic background may differ. In thesesettings, through a public health approach, treatments are based onstandard population-based HIVDR monitoring and surveillance,focusing on increased adherence, with a limited number ofprequalified medicines, generic products and simple recommendationsfor when to start, substitute or switch medicines due to toxicity.WHO strategyThe WHO Department of Essential Medicines and PharmaceuticalPolicies has published a document on pharmacovigilance for ARVsand organized country training in different parts of the world butthere is a need for more effort in pharmacovigilance. A joint project,initiated by the HIV and EMP Departments, funded by the Bill andMelinda Gates Foundation will develop in four directions. Firstly,harmonizing norms and definitions, tools and methodologies forimproving pharmacovigilance for ARVs as a preliminary step towardsbetter management of available information. The UMC is fully andactively involved in the development of these tools and morespecifically in developing CemFlow, an online tool for recordingadverse events observed in a cohort of patients treated with one ormore medicines. Secondly, a few countries have been selected andwill be supported to field test and implement the tools developed.The objective is to propose a model that could later be adapted andadopted in other countries, if possible integrating active and passivesurveillance methods, with training included. Thirdly, to meet theimmediate needs for critical information on adverse events andtoxicities in resource-limited settings and to better inform WHO andnational guidelines, policies and strategies, key studies will beundertaken, based on a research agenda for the three years of theproject. A project advisory group has been established and Dr MarieLindquist, UMC, has accepted to be part of it. This Advisory Groupwill, over the lifespan of the project, help WHO define, plan andguide the project’s scientific agenda, and more specifically, thetargeted studies. A first meeting in March has defined the first year’sresearch agenda. While focusing on low-income settings, it wasagreed that the project will include and refer to the very significantexisting and potential work undertaken by international cohortcollaborators to rapidly bring some response to urgent questionsregarding patient safety. Research protocols will be offered forcompetitive bidding.Collaboration in prospectThe project team will ensure the appropriate co-ordination of theproject activities and accurate reporting of data analysis and promotea wide sharing and dissemination of tools developed and datacollected. This project attracts much interest within WHO and frompartners, implementers in countries, researchers, academicians. Asfor most activities linked to pharmacovigilance, the expectation isthat it will further strengthen the collaboration between the WHO,the project partners, and the UMC.12 UR45 April 2009 www.who-umc.org
NEWS FROM AROUND THE WORLDUganda training assignmentSten Olsson and Helena WilmarSet-upPharmacovigilance in Uganda began in 2004 with the establishmentof the National Pharmacovigilance Centre (NPC) at the NationalDrug Authority (NDA). In June 2007 the NPC became a full memberof the WHO Programme for International Drug Monitoring, and sincethen Regional Centres (RCs) have been created within seven referralhospitals. Around 300 individual case safety reports (ICSRs) havebeen received through spontaneous reporting since the start of theprogramme (VigiFlow TM software is used).The practical VigiFlow training in KampalaActivitiesA training course took place in February with UMC participation,opened by Mr Apollo Muheirwe, NDA Chief Executive Officer. Thecourse members were 32 professionals from the seven regionalcentres. As well as lectures, working groups discussed causalityassessment and its application to case scenarios, and practicalsessions took place on VigiSearch TM and VigiFlow. After the course,on 20 February, the NPC was formally inaugurated with speeches byDirector General of the Ministry of Health, and the Chairman and theChief Executive Officer of the NDA, recorded by the media.MasakaOn 23 February 2009 Sten Olsson was taken by Helen Ndagije andAngela Bonabana of the NPC to the referral hospital in Masaka (oneof the Regional Centres), 2½ hours by road south of the capitalKampala. Discussions focused on the wish of the hospital to developfurther its pharmacovigilance activities, and the value the hospitalmanagement attach to quality of care. A visit was made to the HIV/AIDS clinic. While acknowledging the importance of thepharmacovigilance activity, the clinician in charge found it difficult tofind time to report adverse reactions to ARV treatment (the clinic seesaround 250 patients per day). At the health service of the District ofMasaka, the responsible officer for the healthcare system wassupportive of the pharmacovigilance system and wished to set anambitious fixed monthly target of ICSRs coming from his district.ConclusionsAs a result of the course and site visits the UMC and NDC staff haveassessed the current challenges to effective pharmacovigilance inUganda. In spite of being relatively young, the Ugandapharmacovigilance programme has a good degree of institutionaland structural stability and contains many of the key elements forachieving efficient monitoring of patient safety issues. Althoughinfrastructure, resources and time for clinicians are – as in manycountries – a key problem, there are certain steps that could be takento build on the excellent foundations which Ugandan staff havemade. These include legislation, better communications and furthereffort to involve public health programmes and professional medicaland pharmaceutical councils.Dr Sam Zaramba (Director General of the Ministry of Health), Dr FrankMwesigye (Chairman, NDA) and Mr Apollo Muhairwe (Chief ExecutiveOfficer, NDA) at the launch of the national centre.Back row: Mrs Helen Byomire Ndagije (Head of NPC), Mr Babiiha Julius,Christine Naluswata, Ms Huldah Nassali, Mr Sten OlssonFront row: Ms Angela Bonabana, Mrs Helena Wilmar, Ms VictoriaNambasa Bukenya and Dr Jeanne MuhindoWith further support on many levels the Ugandan system could movetowards reliable outcomes in terms of drug safety signals and supportfor decision-making for the benefit of patient safety at all levels ofthe Uganda healthcare system.Uppsala Reports 45 www.who-umc.org 13
Page 2 and 3: DIRECTOR’S MESSAGENo one method c
Page 7 and 8: At a glance CemFlowCemFlow is a web
Page 10: GENETIC PREDICTION OF ADRSEUDRAGENE
Page 16 and 17: DRUG SAFETY AND THE MEDIAMore educa
Page 18 and 19: NEWS FROM AROUND THE WORLDAdvising
Page 20 and 21: PUBLICATIONSDrugs and BugsAnna Cel
Page 22 and 23: NEWS FROM BREDGRäNDWelcome to Sara
Page 24: the Uppsala TeamDirectorRalph Edwar

April 2009 - Uppsala Monitoring Centre

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