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Meeting Highlights
2003 © Ashley Publications Ltd ISSN 1474-0338 195
Ashley Publicationswww.ashley-pub.com
1. Background
2. Current situation
3. Issues
4. The future
5. Conclusion and expert opinion
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Electronic Reporting for Clinical Drug Safety and Pharmacovigilance29 – 30 October 2002, Amsterdam, The Netherlands
Renald HennigChiron Vaccines, PO Box 1630, 35006 Marburg, Germany
The 31 January 2003 deadline for electronic reporting to the EuropeanAgency for the Evaluation of Medicinal Products has helped to focus industryand regulator attention alike. This conference provided a wide perspectiveon background and scope, recent successes, and possible future develop-ments by specialists from regulators, pharmaceutical industries, software ven-dors and more. Organised by IIR Conferences Ltd, attendees had theopportunity to gain an overview of all major aspects of electronic reportingof individual case safety reports, to broaden their knowledge, and to net-work with individuals concerned by these issues.
Keywords: electronic reporting, electronic submission, EudraVigilance, Individual Case SafetyReport (ICSR)
Expert Opin. Drug Saf. (2003) 2(2):195-197
1. Background
E Juarros (former Chair of the Telematics Committee and the EudraNet WorkingGroup, Brussels, Belgium) pointed out that electronic reporting started as early asNovember 1994, when the ICH (International Conference on Harmonisation) E2Adefined the standards for expedited reporting, particularly since ICH E2B definedthe data elements for the electronic transmission of Individual Case Safety Reports(ICSRs) (Version 4.0, September 1997). Message specification was published by theICH in April 1999. Electronic reporting of suspected adverse drug reactions requiresa defined medical terminology, which was achieved by MedDRA (Medical Diction-ary for Regulatory Activities). After the establishment of the EudraVigilance data-base, electronic transmission of ICSRs in the EC (European Community) started on1 December 2001. The deadline for the end of the implementation phase by regula-tors and pharmaceutical companies was originally envisioned to be31 January 2003. However, this deadline is not a legal requirement, but rather anattempt to focus the attention of all stakeholders involved, as D Schwartz (Manag-ing Director of Cyclon Commerce Europe, Winchfield, UK) pointed out.
2. Current situation
At the time of the conference, only a handful of companies, and even fewer regula-tors, could successfully transmit safety reports electronically. D Konrad (BoehringerIngelheim, Ingelheim, Germany) and P Schulz (Bayer Vital, Cologne, Germany)shared experiences from the perspective of the pharmaceutical company. Systemevaluation for available database options started as early as 1996 for BoehringerIngelheim, and the electronic reporting project started in July 2002. As ofOctober 2002, fully E2B-compliant software was in operation. A number of issues,such as additional fields in the company database, field length or conversion prob-lems, remain. Bayer Vital is already reporting electronically to the European Agencyfor the Evaluation of Medicinal Products (EMEA), the US FDA, and the BfArM(Bundesinstitut für Arzneimittel und Medizinprodukte). Schulz pointed out major
Electronic Reporting for Clinical Drug Safety and Pharmacovigilance
196 Expert Opin. Drug Saf. (2003) 2(2)
differences between US and EU (European Union) reporting,two of the issues being the number of regulatory authoritieswithin the EU, and the rapid implementation of electronicreporting in the EU as compared to the gradual transitionwithin in the US. The third, and as yet unresolved, issue is thequestion of labelling of adverse events, which tend to differbetween different national registrations – hence inducing dif-ferent reporting requirements.
A Schneider (Swissmedic, Bern, Switzerland), and R Car-mona and A Gomes (Portuguese Regulator INFARMED,Lisboa, Portugal) presented the regulators’ view point.Whereas Swissmedic, receiving an estimated 2500 ICSRs in2002, reports electronically to the WHO (World HealthOrganization) database in Uppsala, Sweden, Portugal was thefirst and only EU country to report electronically toEudraVigilance (October 2002). In addition to the minimalinformation required to define a case, the E2B/M2 standarddefines additional information such as the sender’s uniquesafety report identifier, the initial day of receipt, the world-wide unique case identification number and the identity ofthe sender themselves. Extended markup language (XML) isused for transmission.
3. Issues
G Ladds (former Head of Global Pharmacovigilance for ShirePharmaceuticals, Andover, UK) pointed out that when chairingthe first day, the emphasis so far has been placed on transmit-ting postmarketing cases only. Will this include safety reportsfrom postauthorisation safety studies or intensified monitoring?
A Fowkes (AstraZeneca, London, UK) pointed out thatthere may be issues with field lengths in database-to-data-base transmission, as well as with correct formatting of timeintervals, dates, and also in mapping code lists. There arealso fields in the E2B/M2 format that may not have directmatches in the companies’ databases. Whereas the EUrequires low level terms (LLTs) for all MedDRA-codedfields, the FDA prefers preferred terms (PTs).
S Ottosen and R Glahn (Genmab, Copenhagen, Denmark)mentioned that the EMEA has enabled webpage entry andupload, which may be feasible for companies with small casenumbers to be processed. However, this would require dou-ble-case entry (company and EMEA webpage) with associatederror susceptibility. The question of security levels and dataprotection is still not completely solved.
C Cannizzaro (Galt Associates, Sterling, USA) presenteddifferent electronic submission strategies. A significantnumber of companies have not yet migrated to the MedDRA-coding system, which is a prerequisite for electronic reporting.
For small- or medium-sized companies, the investment in afully E2B-compliant software system may simply be unfeasi-ble. A number of larger companies have actually found thevendors’ software implementations unsatisfactory. The timerequired to develop and maintain such an application –whether home-grown or vendor-supplied – also needs to betaken into consideration. As for the time being, ICSRs cannotbe sent electronically if they have an attachment, e.g., a pdffile of a hospital discharge report.
4. The future
All speakers were in agreement that the wave of electronicreporting of ICSRs, although growing slowly, is going to belarge and inevitable. Companies, regulators, software vendorsand other concerned stakeholders will eventually solve theoutstanding issues. Solutions have been found, and will con-tinue to be found, for smaller companies.
P Marquez (PharmaMar, Madrid, Spain) who presented onclinical safety, reminded attendees that there is a whole worldof other issues that will keep all involved busy after completeimplementation of ICSR electronic reporting. One of these iselectronic submission of and in clinical trials. First steps havealso been initiated by the ICH to prepare for electronicreporting of periodic safety update reports (PSURs).
5. Conclusion and expert opinion
Electronic reporting of ICSRs has arrived, and will continueto grow. Increasingly so, this will also be true for informationon clinical trials as well as for PSURs. This conference hasmade clear that all concerned stakeholders are in the sameposition. Pilot projects are created and implemented withclose cooperation between regulators and pharmaceuticalcompanies. Software vendors adapt their programs to theneeds of companies and regulations. The need to worktogether closely emphasises the importance of human beings.Electronic submission is not about technical issues, as impor-tant as they may seem; it is about people.
One question still remains to be answered, however. It wasnot answered in the conference, nor in the many discussionsthat took place before and after. This question, put simply, is‘So what?’.
Will patients be any safer as a result of electronic gatheringof large amounts of data, which in reality already exist? Whohas the necessary expertise and will actually take the time tocarry out sensible and effective analysis of the data? Is thefuture system more effective than the system currently in place?
We will see. Or maybe we will never know.
Hennig
Expert Opin. Drug Saf. (2003) 2(2) 197
Websites1. http://www.arisglobal.com
Pharmacovigilance software vendor.
2. http://www.cyclonecommerce.comGateway provider for electronic reporting.
3. http://www.emea.eu.intEMEA webpage.
4. http://www.eudravigilance.orgEudraVigilance webpage.
5. http://www.fda.gov/cder/aerssubFDA webpage on adverse event reporting.
6. http://www.fda.gov/cder/m2FDA webpage on electronic reporting (M2).
7. http://www.Galt-Assoc.comPharmacovigilance software vendor.
8. http://www.ich.orgHomepage of the International Conference on Harmonisation.
9. http://www.ifpma.org/ich1.htmlLink to ICH 1 via IFPMA (International Federation of Pharmaceutical Manufacturers Associations) website.
10. http://www.ifpma.org/ich5e.htmlLink to ICH 5 via IFPMA website.
11. http://www.iir-lifesciences.comWebpage of IIR Conferences Ltd.
12. http://www.meddramsso.comHomepage of MedDRA maintenance organisation.
13. http://www.relsys-inc.comPharmacovigilance software vendor.
AffiliationRenald Hennig, M.D., MBAChiron Vaccines, PO Box 1630,35006 Marburg, GermanyTel: +49 6421 39 2025; Fax: +49 6421 39 3662;E-mail: [email protected]
