Pharmacovigilance in real life   may 12
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Pharmacovigilance in real life may 12

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    Pharmacovigilance in real life   may 12 Pharmacovigilance in real life may 12 Presentation Transcript

    • Pharmacovigilance in Real Life An Industry PerspectiveBarry ArnoldEU Qualified Person for PharmacovigilanceAstraZeneca
    • Content of presentation• Why undertake pharmacovigilance?• Pharmacovigilance processes• Impact of new EU legislation PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Why UndertakePharmacovigilance?
    • Historical Milestones ……. 50 years agoPV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Milestones 1961 Thalidomide: phocomelia 1962 High dose isoprenaline: asthma deaths 1970 High dose oestrogen oral contraceptives: thromboembolic disease 1971 Diethylstilboestrol: vaginal carcinoma in daughters 1974 Pertussis vaccine: encephalopathy 1975 Practolol: oculomucocutaneous syndrome 1979 Triazolam (Halcion): psychiatric symptoms 1982 Benoxaprofen (Opren): hepatotoxicity & photosensitivity in elderly patients 1993 Fialuridine: hepatotoxicity 1993 Sorivudine: fatal neutropenia (interaction with 5FU) 1996 3rd generation oral contraceptives: venous thromboembolism 1997 Troglitazone (Rezulin): hepatoxicity PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Milestones cont‟d 1998 Seldane (terfenadine) Posicor (mibefradil) Duract (bromphenac) „Fen-phen‟ (fenfluramine/phentermine) 1999 Hismanal (astemizole) Raxar (grepafloxacin 2000 Prepulsid (cisapride) Lotronex (alosetron) 2001 Baycol (cerivastatin) 2004 Vioxx (rofecoxib) 2005 Tysabri (natalizumab) Bextra (valdecoxib) 2007 Avandia (rosiglitazone)2008/09 Selective Serotonin Reuptake Inhibitors2008/12 Proton Pump Inhibitors 2012 Implementation of new EU legislation PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Why undertake pharmacovigilance?• To quickly identify, evaluate and communicate potential risks to patients - Optimise prescribing information & patient information - Comply with regulations, and satisfy regulators - Reduce the risk of product liability PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • “Show me a drug without side- effects and I shall show you a drug that does not work” DunlopPV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • The Pharmacovigilance Process
    • What is Pharmacovigilance?• The science & activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problems (WHO).• The ongoing process by which we conduct a systematic evaluation of safety data in order to anticipate, identify, respond to and communicate about safety issues throughout the life-cycle of pharmaceutical products (Anon). PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Pharmacovigilance has no boundariesPV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • AstraZeneca Patient Safety Executive Director Global Development Chief Medical Officer VP, Clinical Development QPPV VP, Patient Safety Epidemiology Processes & Standards Team Safety Science USA UK SwedenTata Consulting Services Safety Surveillance Support PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Role of AstraZeneca Patient Safety• Provide integrated strategic safety expertise to clinical development programmes• Conduct active pharmacovigilance with rapid identification and analysis of safety signals; define the safety profile of AZ products and drive patient risk management• Deliver high quality product safety information throughout the product life cycle• Ensure regulatory compliance PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • EU Qualified Person for Pharmacovigilance• QPPV responsible for: - Collection and collation of all suspected ADRs; to be accessible at least at one point within the EU - Preparation of expedited and periodic safety reports, and reports on post-authorisation safety studies - Ongoing pharmacovigilance evaluation - Responding to requests for information from regulatory authorities - Provision of additional information upon request from Competent Authorities relevant to evaluation of benefit- risk - Notifying changes to benefit-risk profile - QC/QA of the pharmacovigilance system PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Pharmacovigilance Process Healthcare Professional Consumer Lawyer Regulatory Authority Literature Regulatory SafetySpontaneous Reports Reports Updates Reports Database Data Review Data In Output Action Entry & EvaluationStudy & PMS Data Follow-up Data Response to Signal Regulatory Enquiry Generation Reports PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • AstraZeneca Case Handling Process Queries Queries Reporter/ Data Entry Site AZ staff Investigator JASPER MC/CRO Marketing Companies Regulatory Authorities PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Expedited ADR Reports• Clinical development products - 7 days: fatal/life-threatening unexpected ADRs - 15 days: other serious unexpected ADRs• Marketed products - 15 days: serious ADRs• All products: other important safety information to be submitted without delay• AZ generates reports for all serious ADRs submitted individually (selected by computer algorithm) PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • PSURs• Provided to EU regulatory authorities: - 6 monthly for first 2 years after marketing - Annually for subsequent 2 years - Thereafter at 3 yearly intervals• Presentation, analysis and evaluation of new or changing safety data received during period of PSUR• Reassure all relevant regulatory authorities that: - Safety surveillance activities are appropriate - Core Data Sheet (with any proposed amendments) accurately reflects the benefit-risk profile of the product and its safe use in clinical practice PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Safety Surveillance• Proactive detection of safety signals - Optimises protection of patients - Meets regulatory expectations• Safety signals arise from numerous sources e.g. individual case reports, published literature, clinical studies, regulatory authorities, etc• Manual review supported by automated quantitative signal detection (disproportionality analyses) of in- house and external safety databases• Cross-functional peer review process for signal evaluation PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Risk Management Plans• Risk Management Plan: A plan identifying the risks associated with a medicinal product, methods to further clarify the safety profile of a product, and ways to minimise risk to individual patients in clinical use  Safety Specification  Pharmacovigilance Plans  Risk Minimisation Activities• Each RMP should be unique for the product under consideration PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Risk management A risk that is recognised, quantified and publicised is a risk accepted A lesser risk, as a surprise can kill a drug Anon PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Risk Management Plans Could these products have avoided withdrawal if they had effective risk management plans at launch? • Alosetron • Sibutramine • Cisapride • Soruvidine • Cerivastatin • Terfenadine • Felbamate • Troglitazone • Sertindole PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Impact of EUPharmacovigilance Legislation
    • Rationale for new legislationIn light of experience and following an assessmentmade of the EU pharmacovigilance system……madeby the Commission, it has become clear that newmeasures are necessary to improve how the EU rulesoperate on the pharmacovigilance of medicinalproducts.Today’s proposals seek to change the existing EUlegislation on pharmacovigilance (…). They aim atstrengthening and rationalizing the EUpharmacovigilance system, with the overall objectivesof better protecting public health, ensuring properfunctioning of the internal market and simplifying thecurrent procedures.PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • EU Pharmacovigilance Legislation• Objectives  Strengthen & rationalise EU pharmacovigilance system  Greater transparency• Published in Official Journal of EU (31 December 2010)  Regulation (EU) 1235/2010, amending Regulation (EC) 726/2004  Directive 2010/84/EU, amending Directive 2001/83/EC  New provisions will apply from July 2012/January 2013/2015• Further details to be provided during 2012  European Commission ‘Implementing Regulation’  European Medicines Agency guidelines (Good Vigilance Practice & Post-Authorisation Efficacy Studies) PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Implementing Regulation1. Pharmacovigilance system master file2. Quality system for performance of PV activities3. Monitoring of data in EudraVigilance4. Use of terminology5. Transmission of suspected adverse reactions6. Risk management plans7. Periodic safety update reports8. Post-authorisation safety studies9. Final provisionsAnnexes I-III PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Good Vigilance Practice Guideline• Principles to be applicable to MAH PV systems globally• To apply across all member states  Any deviation from the guideline to be fully justified• 15 modules + 5 annexes: will be several hundred pages long!• Draft guidelines being issued in ‘waves’ for public consultation - Wave I – February 2012; 8 weeks consultation period - Wave II – to be determined PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Principles for Good Vigilance Practice• Higher management to lead implementation of the quality system and motivation for all staff in relation to quality objectives• All persons within the organisation to be involved in and support the pharmacovigilance system on the basis of task ownership and responsibility; all persons should engage in continuous quality improvement• Resources and tasks to be organised to support proactive, risk-proportionate, continuous and integrated conduct of pharmacovigilance• All available evidence on benefit-risk of medicinal products should be sought; all relevant aspects, which could impact on benefit-risk and the use of a product, should be considered for decision-making PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Summary of the Pharmacovigilance System• Each MAA to include the following information: - Proof that the applicant has the services of a QPPV - Member State where the QPPV resides & works - Contact details for the QPPV - Statement signed by the applicant to the effect that the applicant has the necessary means to fulfill its pharmacovigilance responsibilities - Location of the pharmacovigilance system master file• Amendment to this information will require a ‘variation’ PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Supervisory authority• The ‘supervisory authority’ for pharmacovigilance will be the competent authority of the Member State in which the MAH pharmacovigilance system master file is located• Responsible for verifying on behalf of the Community that the MAH meets pharmacovigilance requirements i.e. through PV inspections PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • European Medicines Web-Portal• EMA to establish European medicines web-portal increase transparency of pharmacovigilance issues• Public access to:  List of CHMP, CMDh & PRAC members  PRAC meeting agendas & minutes  List of products subject to ‘additional monitoring’  List of locations of MAH master files & contact information for pharmacovigilance enquiries  PSUR reference dates, frequency of submission, and PSUR assessment reports (conclusions)  Summaries of RMPs  PASS protocols & abstracts of results  Information on ‘urgent’ EU procedures PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Impact on workload• Increased workload associated with the following: - Quality system - PV System Master File - Data management - Signal management - ICSR reporting - Assessment of off-label use - Risk management plans - Effectiveness of risk minimisation - Post-authorisation studies• Periodic reports: depends what type of product the company markets• Increased transparency: difficult to predict PV in real life | May 2012 Global Medicines Development | Chief Medical Office
    • Future Expectations• Changes to regulatory requirements - EU legislation: Strengthening, transparency and rationalisation of pharmacovigilance requirements - Clinical Trials Directive: strengthen or rationalise?• Increased involvement of patients in pharmacovigilance - Direct notification of AEs - Public access to safety data and reports• Utilisation of electronic healthcare records for ‘real-time’ pharmacovigilance?• Development of methods for risk minimisation, and assessment of their effectiveness?• Increased litigation & media attention to drug safety? PV in real life | May 2012 Global Medicines Development | Chief Medical Office