Drug Safety 2012; - Uppsala Monitoring Centre

434 Edwards Detailed audit of results of the decisions willbe the main outcome measurement, and notdetails of methodology.2. Project management and quality assurance inPV: Methodology that is proven to be optimalin supporting PV, which must be qualityassured (e.g. data and data management). These functions will be audited in detail toensure that all stakeholders get the same dataand information. This responsibility should be truly internationaland not just within a developed countrynetwork.3. PV health professional guidelines: safety andbenefit-risk assessment and decisions: Collegialguidelines and networks for sharing methodologyand information about developingsafety hypotheses and benefit-risk decisions. The development of the signal hypothesisshould not be proscribed. Any signal (fulfilling the definition) from anystakeholder should be referred to the PRAC,who should make decisions on the next steps,utilizing expert advice as necessary. A sub-committee could be set up to filterincoming work. This would reduce bureaucracy and keepdecision functions separate from any directinfluence on the work of PV professionals. The PRAC should have more patient andhealth professional members. The PRAC would be audited by resultsas in (1) above, and their decisions subject toappeal.Perhaps it is also time to take away the personallegal liability of the QPPV for all that goeswrong in PV!Many will see this proposal as not very differentfrom the GVP, but I think it makes clearerwhere freedom of thought can be separated fromthe quality systems that underpin creativity.Comments on this editorial are welcomed byboth Drug Safety and myself. Documents frommajor drug regulatory agencies can have a greatimpact on the practice and developing scienceof PV. In particular, I would like to hear otherviews than my own about this aspect of GVPguidelines.AcknowledgementsThe author has no conflicts of interest that are directlyrelevant to the content of this editorial.References1. European Medicines Agency. European Medicines Agencyreleases good pharmacovigilance practice modules forpublic consultation [online]. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001451.jsp&mid=WC0b01ac058004d5c1&jsenabled=true [Accessed 2012 Apr 24]2. The European Parliament and the Council of the EuropeanUnion. Directive 2010/84/EU of the European Parliamentand of the Council of 15 December 2010 amending, as regardspharmacovigilance, Directive 2001/83/EC on thecommunity code relating to medicinal products for humanuse [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF [Accessed 2012 May 3]3. The European Parliament and the Council of the EuropeanUnion. Regulation (EU) No 1235/2010 of the EuropeanParliament and of the Council of 15 December 2010amending, as regards pharmacovigilance of medicinalproducts for human use, Regulation (EC) No 726/2004laying down Community procedures for the authorizationand supervision of medicinal products for human and veterinaryuse and establishing a European MedicinesAgency, and Regulation (EC) No 1394/2007 on advancedtherapy medicinal products [online]. Available from URL:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF [Accessed 2012 May 3]4. European Medicines Agency, Heads of Medicines Agencies.Guideline on good pharmacovigilance practices (GVP):module II – pharmacovigilance system master file [online].Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123206.pdf [Accessed 2012 May 4]5. US FDA. Guidance for industry: Good pharmacovigilancepractices and pharmacoepidemiologic assessment [online].Available from URL: http://www.fda.gov/ohrms/DOCKETS/ac/05/briefing/2005-4136b1_02_Good%20Pharmacovigilance%20Practices.pdf [Accessed 2012 May 4]6. Volume 9A of the rules governing medicinal products in theEuropean Union: guidelines on pharmacovigilance formedicinal products for human use [online]. Available fromURL: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf [Accessed 2012 May 4]7. European Medicines Agency. Guidelines on good pharmacovigilancepractices (GVP): introductory cover note to thepublic consultation of the first seven modules [online].Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/02/WC500123145.pdf[Accessed 2012 May 4]8. Edwards IR. An agenda for UK clinical pharmacologypharmacovigilance. Br J Clin Pharmacol. Epub 2012 Feb 239. Goldacre B. Dithering over statins’ side-effects label finallyends [online]. Available from URL: http://www.guardian.co.uk/commentisfree/2009/nov/21/statins-side-effects-bengoldacre[Accessed 2012 Apr 24]Adis ª 2012 Springer International Publishing AG. All rights reserved. Drug Saf 2012; 35 (6)

Good Pharmacovigilance Practice and the Curate’s Egg 43510. Rubin R. How did Vioxx debacle happen? [online]. Availablefrom URL: http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm [Accessed 2012 Apr 24]11. Wilson RM, Michel P, Olsen S, et al. Patient safety in developingcountries: retrospective evaluation of scale andnature of harm to patients in hospital. BMJ 2012; 344: e83212. Pirmohamed M, James S, Meakin S, et al. Adverse drugreactions as cause of admission to hospital: prospectiveanalysis of 18 820 patients. BMJ 2004; 329: 15-913. European Medicines Agency. Good pharmacovigilancepractices [online]. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac05804fcdb1 [Accessed 2012 May 8]14. European Medicines Agency, Heads of Medicines Agencies.Guideline on good pharmacovigilance practices (GVP):module IX – signal management [online]. Available fromURL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123209.pdf [Accessed2012 May 14]15. Montero D, De Lisa R. The PRAC – Pharmacovigilance RiskAssessment Committee [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500108031.pdf [Accessed 2012 Apr 24]Correspondence: Professor I. Ralph Edwards, UppsalaMonitoring Centre, Box 1051, Uppsala SE 751 40, Sweden.E-mail: ralph.edwards@who-umc.orgAdis ª 2012 Springer International Publishing AG. All rights reserved. Drug Saf 2012; 35 (6)