DOCSLIB.ORG

Spontaneous Reports of Vasculitis As an Adverse Event Following

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Spontaneous Reports of Vasculitis As an Adverse Event Following Vaccine 34 (2016) 6634–6640 Contents lists available at ScienceDirect Vaccine j ournal homepage: www.elsevier.com/locate/vaccine Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases a,∗ a a a Patrizia Felicetti , Francesco Trotta , Caterina Bonetto , Carmela Santuccio , b c,d e f Yolanda Brauchli Pernus , David Burgner , Rebecca Chandler , Giampiero Girolomoni , g h i j k Robert D.M. Hadden , Sonali Kochhar , Merita Kucuku , Giuseppe Monaco , Seza Ozen , l m n o p Barbara Pahud , Linny Phuong , Novilia Sjafri Bachtiar , Amina Teeba , Karina Top , q r s t Frederick Varricchio , Robert P. Wise , Giovanna Zanoni , Sasaˇ Zivkovicˇ , u,b 1 Jan Bonhoeffer , for the Brighton Collaboration Vasculitis Working Group a Italian Medicines Agency, Rome, Italy b Brighton Collaboration Foundation, Basel, Switzerland c Monash Children’s Hospital-Clayton, Melbourne, Australia d Murdoch Children’s Research Institute (MCRI) - Department of Paediatrics, Melbourne University, Australia e Uppsala Monitoring Centre, Uppsala, Sweden f University of Verona, Department of Medicine, Section of Dermatology and Venereology, Verona, Italy g King’s College Hospital, London, UK h USAID, Deliver Project, JSIPL, New Delhi, India i Department of Vaccines Control, National Agency for Medicine & Medical Devices, Tirana, Albania j Centre for Pharmacovigilance, The Lombardy Region, Milan, Italy k Hacettepe University, Department of Pediatric Rheumatology, Ankara, Turkey l Children’s Mercy Hospital, Kansas City, MO, USA m Monash Children’s and Royal Children’s Hospitals, Melbourne, Australia n Bio Farma Vaccine Institute, Bandung, West Java, Indonesia o Centre National Anti Poison et de Pharmacovigilance, Rabat, Morocco p Department of Pediatrics, Dalhousie University, Halifax, NS, Canada q Independent Consultant Vaccinologist, Wakefield, RI, USA r MedImmune/AstraZeneca, Gaithersburg, MD, USA s Immunology Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy t University of Pittsburgh Medical Center and Neurology service, MSL, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA u University of Basel Children’s Hospital, Basel, Switzerland a r t i c l e i n f o a b s t r a c t Article history: Background: Vasculitides have been reported as adverse events following immunization (AEFI) following Received 3 September 2015 various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems. Accepted 10 September 2015 Methods: All spontaneous reports of vasculitis following immunization between January 2003 and June Available online 21 September 2015 2014 were retrieved from Eudravigilance (EV), the Vaccine Adverse Event Reporting System (VAERS), and ® VigiBase . A Standard MedDRA Query (SMQ) for vasculitis was used and vaccine types were categorized Keywords: using the Anatomical Therapeutic Chemical classification system. We performed a descriptive analysis Vasculitis by source, sex, age, country, time to onset, vaccine, and type of vasculitis. Vaccines ® Immunization Results: We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase . Vasculi- tis was predominantly reported in children aged 1–17 years, and less frequently in the elderly (>65 Adverse event following immunization (AEFI) years). The generic term “vasculitis” was the most frequently reported AEFI in this category across the Spontaneous reporting three databases (range 21.9% to 27.5% of all reported vasculitis for vaccines). For the more specific Eudravigilance terms, Henoch–Schoenlein Purpura (HSP) was most frequently reported, (19.1% on average), followed VigiBase® by Kawasaki disease (KD) (16.1% on average) and polymyalgia rheumatica (PMR) (9.2% on average). Less VAERS frequently reported subtypes were cutaneous vasculitis (CuV), vasculitis of the central nervous system Pharmacovigilance ∗ Corresponding author. E-mail address: [email protected] (P. Felicetti). 1 See Appendix A for additional members of the Working Group. http://dx.doi.org/10.1016/j.vaccine.2015.09.027 0264-410X/Published by Elsevier Ltd. P. Felicetti et al. / Vaccine 34 (2016) 6634–6640 6635 (CNS-V), and Behcet’s syndrome (BS). HSP, PMR and CuV were more frequently reported with influenza vaccines: on average in 29.3% for HSP reports, 61.5% for PMR reports and in 39.2% for CuV reports. KD was reported with pneumococcal vaccines in 32.0% of KD reports and with rotavirus vaccines in more than 20% of KD reports. BS was most frequently reported after hepatitis and HPV vaccines and CNS-V after HPV vaccines. Conclusion: Similar reporting patterns of vasculitides were observed in different databases. Implemen- tation of standardized case definitions for specific vasculitides could improve overall data quality and comparability of reports. Published by Elsevier Ltd. 1. Introduction In this paper, we present the methods and findings of vasculitides reported as AEFI to three large spontaneous reporting systems. Vasculitides are a heterogeneous group of disorders character- ized by inflammation of blood vessels leading to tissue or end-organ 2. Methods injury [1]. The tissues and organs involved, the etiology, the type of vessels affected, and consequently, the clinical manifestations All reports of vasculitis following vaccine(s) administration and prognosis can be very different [2]. Vasculitides affect both spontaneously reported to Eudravigilance (EV), the Vaccine ® adults and children but often with varying epidemiology and clini- Adverse Event Reporting System (VAERS), and VigiBase , between cal features [3]. Some vasculitis subtypes, such as Kawasaki disease January 2003 and June 2014 were retrieved [18–21]. (KD), occur almost exclusively in children, whereas others (e.g., All adverse events are coded according to the standardized temporal arteritis) occur almost exclusively in adults. Moreover, medical terminology developed by the International Conference other vasculitides, such as polyarteritis and granulomatosis with of Harmonization (MedDRA dictionary) [22]. The vaccine types are polyangiitis (formerly known as Wegener’s granulomatosis), have categorized using the Anatomical Therapeutic Chemical (ATC) clas- different aetiological, clinical, and prognostic characteristics in chil- sification system (for classification details, please see Table S1) [23]. dren compared to adults and the elderly [4]. The databases were searched using the terminology of MedDRA Vasculitides have been reported as adverse events following Dictionary version 17.0. The adverse events were expressed accord- immunization (AEFIs) with several types of vaccines and according ing to the Preferred term (PT), and the data were retrieved through to some vaccine summaries of product characteristics, they are con- the Standard MedDRA Query (SMQ) Vasculitis (code 20000174) sidered expected adverse reactions [5]. Vasculitides may be serious [24,25]. The SMQ vasculitis was available as “narrow” and “broad” and require early diagnosis in order to start appropriate treatment. searches. We employed the more specific narrow approach (i.e., to The etiology may be difficult to establish as the same type of vas- identify events highly likely to have a condition of interest). This culitis can have different causes, and the same agent can induce search method was applied consistently across the three databases different types of vasculitis [6]. (see Annex 1 in the supplementary information for the list of PT An important criterion guiding the causality assessment of each included in the SMQ narrow). single event is the temporal relationship between the vaccine and The following variables were available from the retrieved ICSRs: the event, which for drug and vaccine induced vasculitis is deemed age, sex, vaccine type (grouped according to the Anatomic Thera- to be in the range of one to six weeks [7,8]. Heterogeneity in clinical peutic Classification, i.e. ATC code), type of vasculitis (i.e. PT), AEFI features, epidemiology, and lack of internationally accepted clinical onset and outcome. The criteria adopted to select vasculitis sub- diagnostic criteria for each subtype make data comparison across types for in-depth analysis were based on frequency and severity different studies challenging. of each subtype. All analyses were performed separately on data Several attempts have been made to propose definitions and from each of the three databases to allow for comparison. A single classifications of vasculitis. The two main proposals were the event may include more than one PT (related to vasculitis) and/or classification criteria of the American College of Rheumatology more than one vaccine. Thus, the number of adverse events could in 1990 and the criteria used since 1994 by a panel of experts differ from the number of distinct ICSRs. Similarly, this data struc- at the Chapel Hill Consensus Conference to standardize the ture implied that an adverse event reported with more than one definitions of subtypes of vasculitis [9–11]. However, both are vaccine was counted once for each. primarily classification systems with limited diagnostic criteria The events of vasculitis were analyzed as available in the for each subtype. Additional tools incorporating new knowl- databases without further adjudication; no exclusion criteria were edge of diagnostic testing and pathogenesis of the disease were adopted. Causality assessments were beyond the scope of this work. included in the European Medicines Agency algorithm for classifi-
Load more

Recommended publications
  • 1 Conclusions and Recommendations from the Thirteenth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACS
    Conclusions and Recommendations from the Thirteenth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) Geneva, Switzerland 21 - 22 June 2016 The WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) has been constituted to provide advice on pharmacovigilance (PV) policy and issues related to the safety and effectiveness of medicinal products. The conclusions and recommendations from the Tenth meeting of ACSoMP are presented below. Pharmacovigilance (PV) Priorities for World Health Organization (WHO): - Increasing access to essential, quality, safe and affordable medical products is a leadership priority for WHO. The ongoing WHO-reform process is to ensure that the organization is more effective, efficient, responsive, objective, transparent and accountable to its partners and stakeholders. The scope of the Safety and Vigilance (SAV) team within WHO includes: advocacy for safety and vigilance activities, establishing and consolidating partnerships for implementing and advancing the safety and safe use of medical products, strengthening infrastructure, active surveillance and training in pharmacovigilance (PV), and supporting the use of effective tools and systems for monitoring medical products of significant public health importance. - The 2016-2017 priorities for SAV/Medicines Safety are to focus on a few countries, to build capacity and support them through the full cycle of PV activities, from collecting PV data and information, to making regulatory decisions and therapeutic choices based on the collected information. The strategy would be to assess and to improve the quantitative and qualitative aspects of PV activities and outcomes in these countries. The long-term objective is to build comprehensive, sustainable, results-driven PV systems that improve our knowledge, power our decisions and promote the safe use of medicines.
    [Show full text]
  • Medicinal Products and Medical Devices in Clinical Trials Conduct and Disclosure
    Medicinal products and medical devices in clinical trials condduct and disclosure – and ndever the twain shall meet! Raquel Billiones 1 and Kathy B. Thomas 2 Despite some fundamental differences, 1 Takeda Pharmaceuticals, Zurich, Abstract similarities and overlaps in the requirements Switzerland “Medicinal products and medical devices are and details between the CTR and MDR are 2 Medical & Scientific Writing & Publication different species…they live in parallel evident. There is also a clear aim for the Services, Meersburg, Germany universes” according to a medical device electronic databases, as described in the two expert. But is it really so? This article regulations, to be interoperable. This high - challenges that notion by comparing the level comparison of the CTR and MDR Correspondence to: Clinical Trial Regulation EU No. 536/2014 shows that while the requirements of the two Raquel Billiones (CTR) and the EU Medical Device regulations have been aligned and are very [email protected] Regulation 2017/745 (MDR) in the context similar, their impact on the respective of clinical studies and public disclosure. industries is quite different. Two parallel universes years, we already switch between these universes pharmaceutical industry. The major changes “WARNING : Medicinal products and medical and firmly believe that linking these two is not were the centralised clinical trial application, the devices are different species. They live in parallel only feasible but also profitable, as other increased disclosure requirements, and the universes. They may appear similar (“medicinal colleagues can also attest. 2 Nevertheless, the setting up of a new EU portal and database (to products”), but they are not.
    [Show full text]
  • Reporting Adverse Drug Reactions a Guide for Healthcare Professionals
    BMA Board of Science Reporting adverse drug reactions A guide for healthcare professionals May 2006 improving health BMA Board of Science Reporting adverse drug reactions A guide for healthcare professionals May 2006 Reporting adverse drug reactions: A guide for healthcare professionals i BMA Board of Science Editorial board A publication from BMA Science & Education department and the BMA Board of Science Chair, Board of Science Professor Sir Charles George Director of Professional Activities Professor Vivienne Nathanson Head of Science & Education Dr Caroline Seddon Project manager Nicky Jayesinghe Research and writing Gemma Jackson Editorial secretariat EeMun Chen Nicola Fookes Darshna Gohil Emily Hoy Acknowledgements The association is very grateful for the help provided by the BMA committees and many outside experts and organisations. We would particularly like to thank: • Professor Munir Pirmohamed, Professor of Clinical Pharmacology and Director of CSM Mersey. • Dr June Raine, Director of the MHRA Post Licensing Division. • Professor Alison Blenkinsopp, Professor of the Practice of Pharmacy and member of the Committee on Safety of Medicines Patient Reporting of Adverse Drug Reactions Working Group. • Dr Patricia Wilkie, lay member of the Committee on Safety of Medicines and Chair of the Committee on Safety of Medicines Patient Reporting of Adverse Drug Reactions Working Group. • Ms Barbara Wood, Chair, BMA patient liaison group and member of the Committee on Safety of Medicines Patient Reporting of Adverse Drug Reactions Working Group. British Library Cataloguing-in-Publication Data. A catalogue record for this book is available from the British Library. ISBN: 1 905545 07 X Cover photograph: Getty Images © British Medical Association 2006 all rights reserved.
    [Show full text]
  • Sharing Pharmacovigilance Data in the WHO Programme for International Drug Monitoring Reporting Fact Sheet
    Inspire. Engage. Transform. Sharing pharmacovigilance data in the WHO Programme for International Drug Monitoring Reporting fact sheet The appointed National Centre (NC) for Pharmaco- VigiFlow vigilance (PV) in each member country is responsible for For member countries lacking an E2B compatible database sharing their Individual Case Safety Reports (ICSRs) with for ICSR management, UMC has developed VigiFlow, a other members of the WHO Programme for International web-based ICSR management system. Copies of the Drug Monitoring by sending the ICSRs to Uppsala domestic data can easily be shared with the WHO Monitoring Centre (UMC) for inclusion in VigiBase, the Programme by an automated service to VigiBase. WHO global ICSRs database. What information to share Transmission options All adverse events occurring in a post-marketing situation NCs can send ICSRs to UMC either as e-mail attachments and qualifying for your national ICSR database should be (preferably as encrypted files), via Eudralink from where shared with the other members of the WHO Programme, 1 UMC can then download them (for countries in EEA), or on both serious and non-serious cases. VigiBase is mainly a a CD by regular mail. UMC also provides an API (Application database for spontaneous ICSRs on registered medicinal Programming Interface) for countries that wish to fully products. However, UMC also accepts cases from clinical automate the transmission process using server-to-server trials and literature; the type of report should be specified communication. in the ICSR. ICSRs on medication errors, counterfeit/substandard Frequency of transmissions medicines and therapeutic failure should also be submitted. Member countries are expected to share their PV data on a regular basis; preferably more often than once a month, and ICSRs on ordinary allopathic medicines, traditional at the very least every quarter, to keep VigiBase as up-to-date medicines (herbals), as well as biological medicines, as possible.
    [Show full text]
  • Evolving National Pharmacovigilance Systems in Africa
    EVOLVING NATIONAL PHARMACOVIGILANCE SYSTEMS IN AFRICA Haggar Hilda Ampadu ISBN: 978-94-6182-927-6 Copyright © 2018 H. H. Ampadu. All rights reserved. Cover layout and printing: Off Page, Amsterdam EVOLVING NATIONAL PHARMACOVIGILANCE SYSTEMS IN AFRICA ONTWIKKELENDE NATIONALE FARMACOVIGILANTIE SYSTEMEN IN AFRIKA (met een samenvatting in het Nederlands) Proefschrift ter verkrijging van de graad van doctor aan de Universiteit Utrecht op gezag van de rector magnificus, prof.dr. H.R.B.M. Kummeling, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op woensdag 9 januari 2019 des middags te 4.15 uur door Haggar Hilda Ampadu geboren op 7 januari 1977 te Accra, Ghana Promotoren: Prof. Dr. H.G.M. Leufkens Prof. Dr. A.N.O. Dodoo Copromotoren: Dr. J. Hoekman Dr. H. Gardarsdottir TABLE OF CONTENTS Chapter 1 General introduction 7 Chapter 2 The role and position of national pharmacovigilance centres 29 2.1 Adverse drug reaction reporting in Africa and a comparison of 31 individual case safety report characteristics between Africa and the rest of the world: Analyses of spontaneous reports in VigiBase® 2.2 Organizational capacities of national pharmacovigilance centres in 51 Africa: assessment of resource elements associated with successful and unsuccessful pharmacovigilance experiences Chapter 3 Participation and awareness of reporters and evaluators 89 3.1 The contribution of Ghanaian patients to the reporting of 91 adverse drug reactions: a quantitative and qualitative study 3.2 Evidence based pharmacovigilance for medicines
    [Show full text]
  • Eudravigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection
    Drug Saf https://doi.org/10.1007/s40264-018-0647-1 SPECIAL ARTICLE EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection 1 1 1 2 Rodrigo Postigo • Sabine Brosch • Jim Slattery • Anja van Haren • 3 1 1 1 Jean-Michel Dogne´ • Xavier Kurz • Gianmario Candore • Francois Domergue • Peter Arlett1 Ó The Author(s) 2018. This article is an open access publication Abstract The analysis of safety data from spontaneous European Union regulatory network. Driven by the full reporting systems has a proven value for the detection and implementation of the 2010 pharmacovigilance legislation, analysis of the risks of medicines following their placement EudraVigilance has undergone further enhancements on the market and use in medical practice. EudraVigilance together with a major revision of its access policy, taking is the pharmacovigilance database to manage the collection into account the use of the new individual case safety and analysis of suspected adverse reactions to medicines report standard developed by the International Council for authorised in the European Economic Area. EudraVigi- Harmonization of Technical Requirements for Pharma- lance first operated in December 2001, with access to the ceuticals for Human Use and the International Organiza- database being governed by the EudraVigilance access tion for Standardization. The aim of the broadened access policy. We performed a literature search including data up is to facilitate more effective safety monitoring of autho- to December 2016 to demonstrate how the data from rised medicines, to make more data available for research EudraVigilance has been used in scientific publications. and to provide better access to information on suspected We describe the results, including by type of publication, adverse reactions for healthcare professionals and patients.
    [Show full text]
  • European Medicines Agency Policy on Access to Eudravigilance Data for Medicinal Products for Human Use (Eudravigilance Access Policy)
    23 August 2019 EMA/759287/2009 Revision 4* Inspections, Human Medicines Pharmacovigilance & Committees Division European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use (EudraVigilance Access Policy) Start of public consultation 4 August 2014 End of public consultation 15 September 2014 Final draft agreed by Project Team 1 “Collection of key information September 2015 on medicines” of the EMA/Member States governance structure for the implementation of the pharmacovigilance legislation Final draft submitted to the EudraVigilance Expert Working Group for 23 September 2015 information Final draft agreed by Pharmacovigilance Risk Assessment Committee 5-8 October 2015 (PRAC) Final draft agreed by Project Co-ordination Group of the 12 October 2015 EMA/Member States governance structure for the implementation of the pharmacovigilance legislation Final draft agreed by the European Risk Management Facilitation 12 October 2015 Group (ERMS-FG) Final draft agreed by the Committee for Human Medicinal Products 19-21 October 2015 (CHMP) and the Co-ordination group for Mutual recognition and Decentralised procedures – human( CMD-h) Final draft submitted to IT Directors for information 22 October 2015 Final draft submitted to Heads of Medicines Agencies Human (HMA- 21-23 October 2015 h) for information Revision 2 adopted by the EMA Management Board 16-17 December 2015 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019.
    [Show full text]
  • Implemented Data Mining and Signal Management Systems On
    170 Current Drug Safety, 2012, 7, 170-175 Implemented Data Mining and Signal Management Systems on Spontaneous Reporting Systems’ Databases and their Availability to the Scientific Community - A Systematic Review Luís Miguel de Almeida Vieira Lima*,1, Nuno Gonçalo Sales Craveiro Nunes2,3,8, Pedro Gonçalo Pires da Silva Dias4,5,6,7 and Francisco Jorge Batel Marques2,8 1University of Coimbra, Coimbra, Portugal 2AIBILI – Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal 3Health Sciences Department, University of Aveiro, Aveiro, Portugal 4Beira Interior University, Covilhã, Portugal 5Polytechnic Institute of Leiria, Leiria, Portugal 6Center of Investigation in Human Motricity, Leiria, Portugal 7Research Center in Sports, Health Sciences and Human Development, Vila Real, Portugal 8School of Pharmacy, University of Coimbra, Coimbra, Portugal Abstract: Adverse drug reactions’ spontaneous reporting systems are an important element in worldwide pharmacovigilance, gathering potentially useful information for post-marketing drug safety surveillance. Data mining and signal management systems, providing the capability of reading and interpreting these systems’ raw data (data that has not been subjected to processing or any other manipulation), improve its analysis process. In order for this analysis to be possible, both data mining and signal management systems and raw data should be available to researchers and the scientific community. The purpose of this work was to provide an overview of the spontaneous reporting systems databases reported in literature as having implemented a data mining and signal management system and the implementation itself, evidencing their availability to researchers. A systematic review was carried out, concluding that they are freely provided to researchers within institutions responsible for maintaining the spontaneous reporting systems, but not to most researchers within the scientific community.
    [Show full text]
  • Experiences with Adverse Drug Reaction Reporting by Patients an 11-Country Survey
    Drug Saf 2012; 35 (1): 45-60 ORIGINAL RESEARCH ARTICLE 0114-5916/12/0001-0045/$49.95/0 ª 2012 Adis Data Information BV. All rights reserved. Experiences with Adverse Drug Reaction Reporting by Patients An 11-Country Survey Florence van Hunsel,1,2 Linda Ha¨rmark,1,2 Shanthi Pal,3 Sten Olsson4 and Kees van Grootheest1,2 1 Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, the Netherlands 2 University of Groningen, Department of Pharmacy, Pharmacotherapy and Pharmaceutical Care, Groningen, the Netherlands 3 Quality Assurance and Safety of Medicines, World Health Organization, Geneva, Switzerland 4 World Health Organization Collaborating Centre for International Drug Monitoring, Uppsala, Sweden Abstract Background: Patients are important stakeholders in pharmacovigilance; how- ever, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted. Objective: This study aims to review the methods of patient reporting of adverse drug reactions (ADRs) in 11 countries worldwide and to compare different aspects of their experiences. Methods: A survey based on telephone interviews, e-mail discussions and field visits of existing practices in consumer and patient reporting of ADRs was performed in the second half of 2010. Results: The start dates of the patient reporting schemes vary from 1964 (Australia) to 2010 (Norway). The number of patient reports per country varies widely. Most countries would ideally spend more resources on making the public aware of the possibility that patients can report ADRs. Most countries have three different ways for patients to report ADRs – a paper form, an electronic form on a website or by telephone.
    [Show full text]
  • Transparency of Authorities: Opportunities and Restrictions
    Transparency of authorities: opportunities and restrictions Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs“ der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von Dr. Nadine Corvey aus Hanau Bonn 2010 Betreuer und 1. Referent: Prof. Burkhard Sträter Zweite Referentin: Dr. Christine Haas Transparency of authorities ─ opportunities and restrictions Table of Contents List of Abbreviations....................................................................................................................2 1. Introduction ...................................................................................................................3 2. Legislative framework leading to increased transparency........................................4 2.1. European Union ..............................................................................................................4 2.2. National Provisions .........................................................................................................9 3. Transparency within the European Medicines Regulatory System ........................12 3.1. Implementation of transparency by the European Medicines Agency (EMEA) .............12 3.1.1 Transparency in the EMEA daily business ....................................................................12 3.1.2 Direct interaction with stakeholders...............................................................................25 3.1.3 Cooperation within the
    [Show full text]
  • Paediatric Safety Signals Identified in Vigibase: Methods and Results from Uppsala Monitoring Centre
    Received: 19 May 2018 Revised: 1 October 2018 Accepted: 10 December 2018 DOI: 10.1002/pds.4734 ORIGINAL REPORT Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre Kristina Star1,2 | Lovisa Sandberg1 | Tomas Bergvall1 | Imti Choonara3 | Pia Caduff‐Janosa1 | I. Ralph Edwards1 1 Research Section, Uppsala Monitoring Centre, Uppsala, Sweden Abstract 2 Department of Public Health and Caring Purpose: The purpose of this study is to uncover previously unrecognised risks of Sciences, Uppsala University, Uppsala, medicines in paediatric pharmacovigilance reports and thereby advance a safer use Sweden 3 Division of Medical Sciences and Graduate of medicines in paediatrics. Entry Medicine, University of Nottingham, Methods: Individual case safety reports (ICSRs) with ages less than 18 years were Derby, UK retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, Correspondence K. Star, Research Section, Uppsala Monitoring in September 2014. The reports were grouped according to the following age spans: 0 to Centre, Uppsala, Sweden. 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years. vigiRank, a data‐driven Email: kristina.star@who‐umc.org predictive model for emerging safety signals, was used to prioritise the list of drug events by age groups. The list was manually assessed, and potential signals were identified to undergo in‐depth assessment to determine whether a signal should be communicated. Results: A total of 472 drug‐event pairs by paediatric age groups were the subject of an initial manual assessment. Twenty‐seven drug events from the two older age groups were classified as potential signals.
    [Show full text]
  • Adverse Drug Reactions in Norway: a Systematic Review
    Review Adverse Drug Reactions in Norway: A Systematic Review Mojtaba Vaismoradi 1,*, Patricia A. Logan 2, Sue Jordan 3 and Hege Sletvold 1 1 Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway 2 Faculty of Science, Charles Sturt University, Bathurst, NSW 2795, Australia 3 College of Human and Health Sciences, Swansea University, Swansea SA2 8PP, UK * Correspondence: [email protected]; Tel.: +47‐75‐517813 Received: 28 June 2019; Accepted: 22 July 2019; Published: 25 July 2019 Abstract: Prescription medicines aim to relieve patients’ suffering but they can be associated with adverse side effects or adverse drug reactions (ADRs). ADRs are an important cause of hospital admissions and a financial burden on healthcare systems across the globe. There is little integrative and collective knowledge on ADR reporting and monitoring in the Norwegian healthcare system. Accordingly, this systematic review aims to investigate the current trends in ADR reporting, monitoring, and handling in the Norwegian healthcare system and describe related interventions. Appropriate keywords, with regard to ADRs in both English and Norwegian languages, were used to retrieve articles published from 2010 to 2019. Six articles met the inclusion criteria. The findings offer a comprehensive picture of ADR reporting and monitoring in the Norwegian healthcare system. Psychotropic medicines were most commonly implicated by patients, while professionals most commonly reported ADRs associated with anticoagulants. The current ADR systems were compiled with the involvement of both patients and healthcare providers to record all types of drugs and ADRs of various severities, and aimed at improving ADR tracking. However, there is a need to improve current initiatives in terms of feedback and quality, and more studies are needed to explore how ADR profiles, and the associated vigilance, can improve the safety of medicines management in Norway.
    [Show full text]