International Society Of Pharmacovigilance Research Articles

An Overview of Pharmacovigilance and Adverse Drug Reaction Monitoring of Drugs and Vaccines during the COVID-19 Pandemic

Once a drug is approved in phase III of clinical trials, pharmacovigilance (PV) becomes very important for the surveillance of drug, vaccine or medical devices. PV constitutes part of the phase IV approval, which involves a study for collecting, detecting, and monitoring adverse events in any population that the drug is used. The adverse events that are reported must be assessed to ascertain the causal effects and prevent or avoid unanticipated side effects on the population. With the advent of the coronavirus disease 2019 (COVID-19) pandemic, vaccination has been the motor for the management of the pandemic, and through intensive health sensitization, more people are vaccinated in a short period leading to greater challenges to the PV taskforce and the PV operating centrers. Global partnerships including the international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and a multitude of others are working in synergy towards putting in place a continuous collaboration work package with many sensitization, education, capacity building, and research initiatives. This is within the framework of identifying the safety and efficacy of vaccines in order to provide solutions to emerging challenging ethical questions.
 Through PV, signal detection is in progress for the identification of adverse events. The unanticipated emergence and negative impact of COVID-19, caused by the severe acute respiratory syndrome virus 2 (SARS-CoV-2) has significantly compelled global pharmacists and drug actors to collectively play an important role in the management of COVID-19. This has to be done within the framework of therapeutic strategies and guaranteed safety, efficacy and quality of new and old xenobiotics. In the current treatment COVID-19 has created health-related challenges and a shift in paradigm in drug discovery and development of new chemical entities (NCE), for vaccine or drug repurposing for different levels of treatment interventions. The accelerated interest in dynamic research and innovation have led to different approaches of treatment and this has come with potential side effects, which has led to the call for post marketing surveillance and monitory. PV is therefore a key component for phase IV study for the drugs and vaccines approved for global use. This paper gives an insight into the global PV monitoring and surveillance of new chemical entities (drugs and vaccines) and new technologies targeting the management of COVID-19.

Covid-19 vaccines pharmacovigilance-a rapid review

The rapid process of research and development and lack of follow-up time post-vaccination aroused greater public concern about the safety profile of COVID-19 vaccine candidates. Pharmacovigilance is critical for gathering, recognising, and monitoring adverse events, which is the primary goal. The reported adverse events should be evaluated to determine the causal relationship and avoid unnecessary consequences on the recipient. Many people are getting vaccines in a short period of time, putting a strain on pharmacovigilance facilities. The International Society of Pharmacovigilance (ISOP), the French National Agency for Medicines and Health Products Safety (ANSM), and many others worked together and took many initiatives to determine the safety and efficacy of vaccines, as well as to provide answers to the questions that were raised. Signals were discovered and several adverse occurrences were identified thanks to pharmacovigilance. BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzervria, Sputnik V, and Convidicea pharmacovigilance is discussed. There were 12,249 ADRs reported with BioNTech/Pfizer-mRNA, 577 ADRs with Moderna-mRNA vaccine, 447 ADRs with Covishield, 653 ADRs with Johnson and Johnson, and 743 ADRs with Vaxzervria. As a result of these immunizations, Immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, fatalities, and a variety of other potentially lethal reactions have all been linked to these immunizations. However, the recorded incidents were minor in comparison to the patients' safety. The Uppsala monitoring centre kept track of all of these events. Uppsala monitoring centre, an initiative of WHO to detect various ADR relating to medications and preventing serious causalities associating with it have a greater role in minimizing the serious cases occurs with medicine dysfunction.

Safety surveillance and challenges in accelerated COVID-19 vaccine development.

The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have had limited impact, and people, businesses, and economies have suffered. The disease has disproportionally impacted elderly and individuals with certain pre-existing conditions and has highlighted health and social inequities in some racial and ethnic minority groups. The majority of those who contract the disease recover completely, but some experience long-lasting complications. Vaccines have the potential to end the pandemic, and through the intense collaboration of scientists in government and private sectors, more than 200 COVID-19 candidate vaccines have been or are being developed, using known platforms and previous experiences with severe acute respiratory syndrome (SARS), at unprecedented speed. The expectations for vaccine safety and quality in the setting of accelerated development are the same as during non-emergency times; however, challenges inherent with the circumstances of the pandemic situation provide opportunities to improve clinical trial conduct and strengthen pharmacovigilance systems. We have reviewed and analyzed existing PV guidelines and recommendations throughout the lifecycle of vaccine development with a focus on developing a global/worldwide effort for post-marketing vaccine safety surveillance.Plain Language Summary The Important Role of Pharmacovigilance in Accelerated COVID-19 Vaccine Development This is an extensive review that intends to address important aspects of COVID-19 vaccines’ accelerated development and safety surveillance. It is focused on regulatory requirements for long-term safety monitoring, practical applications, and current global efforts in developing robust pharmacovigilance systems for post-authorization surveillance.Notably, different perspectives of authors from industry, academic institutions, and contract research organizations involved in drug safety were incorporated to reflect on various regulatory requirements and new developments in vaccine safety. All co-authors are current members of International Society of Pharmacovigilance (ISoP).

A review on vaccine pharmacovigilance during covid-19

Pharmacovigilance is important for collecting, detecting, monitoring adverse events which is the main objective. The adverse events reported should be assessed in order to know the casual relationship and avoid unnecessary effects on the recipient. Many people are vaccinating in a short period, so it is becoming much burden to the pharmacovigilance centers. The international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and many others were in continuous collaboration and taking many initiatives to identify the safety and efficacy of vaccines and to provide answers to the raised questions respectively. Through pharmacovigilance, signals were detected, and many adverse events were identified. Pharmacovigilance of BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzevria, Sputnik V, Convidecia are addressed. With BioNTech/Pfizer-m-RNA 12,249 ADRs, with Moderna-mRNA vaccine 577 ADRs, with Covishield 447 ADRs, with Johnson and Johnson 653 ADRs, with Vaxzevria 743 ADRs were reported. These vaccines resulted in immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, deaths, and many other reactions which may be fatal. But the events reported were less compared to the safety of the patients. All these events were maintained by the Uppsala monitoring center.

The role and strategy of ISoP in global pharmacovigilance.

Applying the WHO definition of pharmacovigilance, the International Society of Pharmacovigilance, (ISoP) is concerned with all aspects of medicine safety. The safety of patients exposed to medicines depends on a wide variety of factors, where the understanding of each factor is associated with its own professional competence and skillset. For pharmacovigilance systems to work efficiently, a broad understanding of the necessary contribution of each of the different scientific competence areas and professional skills is required. ISoP is an independent, not-for-profit international professional organization, concerned with the best interest of patients exposed to pharmaceutical interventions in all healthcare systems in the world. ISoP offers an open platform for professionals from around the world with different expertise and skillsets, to network and exchange information and knowledge in a friendly environment. The society wishes to become a stronger global voice, speaking up in favour of patient safety and to be at the frontline of the global patient safety movement.

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.

This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from both pharmacological and organizational science, which addresses human factors and transparency, to enhance organizational learning and continuous improvement. As happens with investigations in other sectors of society, such as the chemical and aviation sector, this systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change. As we will discuss further on, approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design.

Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping.

The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS. The Newcastle-Ottawa Scale and appropriate guidelines from the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) were used to assess the quality of included studies. After screening 832 articles, 58 were selected (of which 14 were found by checking the reference lists of reviews): 30 case reports and case series, 24 longitudinal studies and four randomized controlled trials. Seven longitudinal studies had good (at least 7 out of 9) quality scores, whereas case reports/case series presented several limitations. Half of included articles focused on immunomodulatory drugs (etanercept, infliximab and adalimumab), especially in case reports/series, suggesting an association with MS occurrence. Contraceptives and antibacterials were investigated in some population-based studies, without definite results. A heterogeneous pharmacological profile of identified classes emerged. Low strength of evidence and conflicting results highlighted the difficulties in addressing the possible contribution of drugs in MS occurrence. Methodological advances are needed, especially to control the confounding role of underlying disease for specific drug classes.

Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization(WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products

Event Abstract Back to Event A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products Brian Edwards1*, Bernard Bégaud2, Esther Daemen3, Ioannis Dokas4, Jonathan Fishbein5, Howard Greenberg6, Alan Hochberg7, Herve Le Louet8, Jytte Lyndvig9, Nataliya Mogles10, Kathyryn Owen11, Christine Prendergast12, Martin Rejzek13, Sofia Trantza14, David Webb15, Mathew Whalen16 and Simon Whiteley17 1 ACRES, Product Safety Culture Initiative, UK 2 Universite de Bordeaux, Pharmacology, France 3 Trium Clinical Consulting NV, Clinical Research, Belgium 4 Democirtus University of Thrace, Systems Engimeering, Greece 5 PRA Health Sciences, Medical Services, United States 6 Thomas Jefferson University, Clinical Pharmacology, United States 7 F. Hoffman-La Roche Ltd, Drug Safety, Switzerland 8 Publique Hôpitaux de Paris, Pharmacovigilance, France 9 Danish Medicines Agency (retired), CEO (retired), Denmark 10 University of Bath, Computer Sciences, UK 11 Owen Clinical Consulting Ltd, Consultant, UK 12 Quintiles IMS, Pharmacovigilance, Ireland 13 Zurich University of Applied Sciences, Switzerland 14 National Medicines Agency (EOF);, Pharmacovigilance, Greece 15 University of Edinburgh, Clinical Pharmacology, UK 16 Alliance for Clinical Research Excellence and Safety (Acres), United States 17 Whiteley Aerospace Safety Engineering & Management Ltd; , UK Purpose: We believe that repetition of potentially preventable and adverse outcomes during clinical research through not identifying and acting upon all systematic vulnerabilities is a situation that needs urgent change and that time for action is now. Methods: A joint assessment has been performed by individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety and the International Society of Pharmacovigilance. Results: By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur starting with first-into-human trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organisational science which addresses human factors and transparency to enhance organisational learning and continuous improvement (1, 2). Conclusions: This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. Approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency leading to better systems design and enhanced trust in clinical research.

Prevention and Pharmacovigilance

The last annual International Society of Pharmacovigilance (ISoP) meeting, held in Istanbul from 26–28 October 2011, was a well organized and run occasion with a potpourri of topics that must have provided something for everybody. They certainly allowed me many opportunities for thought after the meeting. I find it is often the way that, during and after a meeting, perhaps while walking around beautiful and interesting cities like Istanbul, I subconsciously connect lecture contents in a way that was probably not meant, and might not even be logical. I would like to meander through the streets of Istanbul with you and share some loosely connected thoughts, which were interrupted by sightseeing and chatting to friends. There were four papers that particularly caught my attention because, not only were they each masterly presentations of their topic, but also they caused me to reflect (yet again) on the purpose of pharmacovigilance. These were: Dr Mary Mease on ‘Measuring REMS effectiveness: time for a program overhaul’ (abstract OP03 Drug Safety); Professor Joerg Hasford on ‘Ethics in clinical research and pharmacovigilance’; Professors Robin Ferner and Jeffrey Aronson who did a double act called ‘Better than cure’; Professor Valerie Beral on ‘Long-term effects of medicines commonly used in women’. I very much hope that each of these presentations will be available on the ISoP website (available to members). 2. Risk Management Plans

Off-Label Pharmacovigilance

This edition of Drug Safety contains the abstracts for the annual International Society of Pharmacovigilance (ISoP) meeting being held in Istanbul, Turkey, 26–28 October 2011. Browsing the agenda for the meeting indicates that a session will be devoted to off-label use of drugs. This interesting topic has not been pursued much in pharmacovigilance, but it should be in the core of what we do. In a recent editorial in Nature Medicine, the risk of off-label use was exemplified by haemostatic agent recombinant factor VIIa (rFVIIa; also known as eptacog alfa) [NovoSeven , Novo-Nordisk]. They referred to a postmarketing review of 35 studies showing increased risk of arterial thromboembolic events in patients with various clinical conditions, but not in healthy volunteers, treated with NovoSeven through off-label use as well as some other studies. Another review of rFVIIa concludes by saying ‘‘... The outcomes (effectiveness and safety) of all off-label uses should be systematically evaluated and reported. Adequate data to assess cost effectiveness for eptacog alfa does not exist for most off-label indications.’’ The Nature Medicine review also points to an increase in off-label use of drugs in other therapeutic areas. The US FDA has recently added a ‘black-box’ warning to NovoSeven ’s label of serious thrombotic adverse events linked to off-label use. These postmarketing findings have clear safety implications and the first, and obvious, message is that safety in conditions other than haemophilia could only have been signalled if the indication for using the drug was known. Individual case harm reports (ICHRs) often do not mention indication for use; moreover, during investigation of healthcare databases, I have found that it is not always clear what the indication for the use of a drug really is, and sometimes the labelled indication ismentionedwhen it does not seem correct for the clinical setting. If we are to find early signals of this sort we must redouble our efforts to get full and accurate information both in ICHRs and also recorded in healthcare databases. Proven data quality is arguably a more pressing issue than ‘underreporting’. The circumstances of off-label use of drugs certainly must be fully documented for there to be a chance of considering benefit or effectiveness to risk balance for the individuals treated. Some years agoKees vanGrootheest andmyself pointed out some approaches to tackle off-label prescribing. In summary these were as follows: 1. Education: Clinicians need to know about the comparative merits of the effectiveness and risk of drugs, as well as how they work pharmacologically and toxicologically, and what interactions they have with each other. 2. Frequently, physicians do not consult the Summary of Product Characteristics (SPC) for verification, leaving aside whether they have taken notice of the contents of the official SPC in the first place. We recommended that the accessibility of SPCs should be enhanced for doctors and pharmacists, drawing attention specifically to any changes. There needs to be a single body of information that covers every drug. 3. Communication and understanding: There is much to be done in this area both in terms of follow-up and understanding of health professionals’ behaviour and how to empower best practice. The dispensing pharmacist can play an important role in the implementation of warnings and contraindications. 4. Professional freedom: It goes without saying that doctors who issue off-label prescriptions EDITORIAL Drug Saf 2011; 34 (10): 795-797 0114-5916/11/0010-0795/$49.95/0

What do Stakeholders Think about Pharmacovigilance?

Sylvie Fainzang, a medical anthropologist, has written on ‘‘Discourse on Safe Drug Use: Symbolic Logics and Ethical Aspects’’ in this edition of Drug Safety. To many, this article will seem very different in structure, method and content compared with usual Drug Safety material. The article is based on a presentationmade at the 2009 International Society of Pharmacovigilance (ISoP) meeting and it caused controversy. In discussions with colleagues following the presentation, some found it interesting and thought provoking, others thought it was ‘unscientific’. Although anthropology has used some of the broadly positivist thinking that we use in medical science, there is in social anthropology much use of ethnography. Ethnography uses techniques such as direct observation, individual and group interviews, and others that resemble focus group analysis conducted by interviewing, directly or by questionnaire, a number of selected people on a particular matter of interest. The result of this is a reasoned analysis of the interviewees’ responses and the investigator’s interpretation of them, and the validity of this approach is argued within Dr Fainzang’s article. The aim is to develop a hypothesis about how humans behave, and how their beliefs shape their behaviour. Understanding the logic of these beliefs within their own social context can illuminate some behaviour that might otherwise be derided as noncompliant or irrational. In this instance, Fainzang looks at patient behaviours around drug use, and some factors that influence them; the interaction between doctors and patients in discussing drug risks; and the pharmaceutical industry’s stance over selfmedication and risks. Fainzang opens by arguing that patients are an active part of the pharmacovigilance team, not only passive recipients, whether or not the professionals on the team accept them as such; theymake choices based on their own perceptions of drug safety, which may result in them refusing to buy or to take drugs they regard as too risky. Fainzang argues that patients’ views about safety are inextricably related to their background knowledge and beliefs. Their perceptions are real to them and influence how they behave andwhat they say, and in turn this influences clinical trials and case reports. The focus of Fainzang’s patient study explores the influence of religious-cultural origins on attitudes to drug therapy and outcomes. Her study group is small and the assessments are qualitative, so this information in pharmacovigilance terms represents a fascinating signal that can open the door to further similar studies or to alternative approaches. To pick one example, she points out the prime importance of memory to Jewish individuals and the fear they expressed that psychotropic drugs might impair memory. This realization might result in comparative studies of drug use and individual case harm reports (ICHRs). Fainzang’s commentary on the discourse between doctors and patients and her reflections on aspects of the discourse between the industry and the public are based on information we may already know. Indeed, her assertion that some doctors adumbrate or prevaricate around adverse reactions to drugs is well recognized. More important are her comments around the effects of such practices. These demonstrate and perpetuate a mutual lack of trust between the two EDITORIAL Drug Saf 2010; 33 (8): 619-621 0114-5916/10/0008-0619/$49.95/0

WHOʼs International Drug Monitoring – The Formative Years, 1968–1975

In early 2009, Jan Venulet (JV), gratefully agreed to the suggestion by the President of the International Society of Pharmacovigilance (ISoP) to write ‘a chapter or two’ on the earlier periods of pharmacovigilance. The purpose of ISoP’s project, to which several others will also contribute, is ‘to collect the memories of the beginning of pharmacovigilance with the objective to put it on the website for future generations’. The second author, Margaretha HellingBorda (MHB), invited by JV to collaborate on this walk down memory lane of the WHO’s International Drug Monitoring, was also part of the early and formative years, 1968–1975. Our starting point for refreshing our memories was JV’s own library and numbered references from which we selected relevant publications from the 1960s and 1970s and unpublishedWHO documents. Among the latter, one in particular has been a major reference source (seemingly the only existing copy) entitled ‘‘Pilot Research Project for International Drug Monitoring – Assignment Report, 9 January 1968–10 March 1970 by Dr Jan Venulet, Senior Project Officer’’. Apart from the above, together with World Health Assembly (WHA) Resolutions (Appendix 1), our other primary reference sources in writing this paper have been: Presentation at the 25th Anniversary of the World Health Organization’s Programme for International Monitoring by Jan Venulet. In: Proceedings of the XXVIIth CIOMS (Council for International Organizations of Medical Sciences) Conference in Geneva (organized jointly by CIOMS and WHO), 14–15 September 1993. ‘‘Experience with the World Health Organization: International Monitoring of Adverse Reactions to Drugs’’, WHO, Geneva, by Margaretha Helling. In: Tognoni and Vander Kleijn, editors. Clinical Pharmacy and Clinical Pharmacology. Gouveia. Chapter 9, 141–151, 1976. For a further list of references and selected bibliography, see Appendix 2. The following is a brief summary of the history, development, activities, outputs, results and reflections of the formative years, 1968–1975, of the WHO International Drug Monitoring.

Guidelines for Submitting Adverse Event Reports for Publication

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies’ web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

Guidelines for submitting adverse event reports for publication

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Guidelines for Submitting Adverse Event Reports for Publication

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Risk management plans ??? one year on from the EMEA guidelines

In November 2005, the European Medicines Agency, the EMEA, published its guidelines on risk management plans (RMPs). Just under a year later, in order to aid consistency of the format and content of such plans, the EMEA released a template for companies to use when submitting what have become known as 'EU-RMPs'. It was therefore timely that the topic of one of this year's pre-conference training sessions at the 6th Annual Meeting of the International Society of Pharmacovigilance [Liege, Belgium; October 2006] was RMPs.1,2

International Society of Pharmacovigilance (ISOP)

The Quality Assurance JournalVolume 9, Issue 4 p. 312-313 ProfileFree Access International Society of Pharmacovigilance (ISOP) G. Velo, G. Velo Administration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKSearch for more papers by this authorS. Spence, Corresponding Author S. Spence administration@isoponline.org Administration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKAdministration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKSearch for more papers by this author G. Velo, G. Velo Administration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKSearch for more papers by this authorS. Spence, Corresponding Author S. Spence administration@isoponline.org Administration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKAdministration, International Society of Pharmacovigilance, P.O. Box 32974, London SW19 8YG, UKSearch for more papers by this author First published: 06 December 2005 https://doi.org/10.1002/qaj.349AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume9, Issue4December 2005Pages 312-313 RelatedInformation