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From Signal Detection to Safety Assessment and Selection

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From Signal Detection to Safety Assessment and Selection 3/13/2017 HEALTH CANADA’S PHARMACOVIGILANCE ACTIVITIES FOR MARKETED PHARMACEUTICAL PRODUCTS: FROM SIGNAL DETECTION TO SAFETY ASSESSMENTS AND SELECTION OF RISK MITIGATION STRATEGY Nadiya Jirova M.Sc. Marketed Pharmaceuticals and Medical Devices Bureau Marketed Health Products Directorate Health Canada CAPRA meeting, January 2017 Outline Overview of Pharmacovigilance at MHPD Signal Detection • Signal Detection Working Groups • Prioritization of safety issues Signal assessment • Work process • Sources of data • Considerations • Options • Recommendations • Examples of Signal Assessments Summary Safety Reviews http://www.hc-sc.gc.ca/ewh-semt/pubs/occup-travail/balancing_six-equilibre_six/index-eng.phpQuestions 2 1 3/13/2017 MPMDB within Health Canada Health Canada Health Products Branches and Food Branch Directorates Marketed Health Products Directorate Marketed Pharmaceuticals Bureaux and Medical Devices Bureau 3 Lifecycle Approach to Product Vigilance MPMDB activities span the lifecycle of a Health Product in Canada 4 2 3/13/2017 MPMDB Activities within MHPD Medication PSUR Policy InfoWatch Complementary Advertising Incidents Review Development Activities Signal Signal Risk RMP Review Detection Assessment Minimization review Activities AE Risk Comms Risk Comms Risk Comms Risk Comms Basic Reg. collection Pharmac. Biologics NHPs Med. Dev. Activities 5 Pharmacovigilance at MHPD Signal detection working groups • Safety literature • Canada Vigilance database • Foreign agency actions • Info submitted by MAH • TPD Bureau requests Other Emerging safety issues Possible outcomes/ risk mitigation strategies: Signal detection and labelling, risk Assessment Prioritization communication, publication to raise awareness and stimulate reporting, etc. Do we need to investigate it further? Is it a signal? (validation step) • Possible causal relationship • Previously unknown or incompletely documented • Generate sufficient suspicion of an association • Warrant further investigation 6 3 3/13/2017 SIGNAL DETECTION ACTIVITIES AT MPMDB 7 WHO Definition of a Safety Signal “Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information” 8 4 3/13/2017 Characteristics of a Signal • A working hypothesis • May point to unknown (or new aspects of a known) adverse reaction associations for: • Old or new drugs • Drug-drug interactions • General or restricted group populations • Not a proof of causal relationship and require further evaluation • May or may not lead to regulatory action 9 Overview of Pharmacovigilance Activities Note: RMPs “changed the game” Sources Signal Risk management somewhat identification Scanning: Other regulatory actions: •Media Market withdrawal, •Medical and scientific labelling change, RMPs literature Risk Management Int. Regulatory Agencies: Signal Detection •Databases Strategy •Warnings/Advisories •Pharmacovigilance Forums Manufacturer: •Phase IV studies •PSURs Risk communication •Registries Prioritization •RMPs and related activities •Public Advisory Health Canada: •Health Professional Communication •CanadaVigilance & Public Communication •WHO •Notice to Hospitals Evaluation •Pre-market safety •Product Information Update information •Media •InfoWatch --------------------- Signal evaluation Drug Safety & •MedEffect/MedEffet Effectiveness Network •It’s Your Health MONITORING 11 5 3/13/2017 Signal Detection Working Groups (SD-WG) • Four working groups at MPMDB based on signal sources: • Safety Literature Scanning Working Group • Signal Identification from Foreign Agencies Working Group • Market Authorization Holder Submitted Information Working Group • Pharmaceutical Program Signal Detection Working Group • Each group consists of a blend of scientific evaluators and medical officers. 12 Literature scanning at MPMDB . About 8500+ medical journals are weekly being scanned by Health Canada library . About 949 literature / media article screened by evaluators annually . If related to an active ingredient combined to a medical device, then it is assigned to the appropriate group according to the issue at stake (e.g., testosterone pump) . 85% of items dismissed without further group discussion (predominantly due to sufficient labelling) . Remaining items are brought for discussion (i.e., 6 articles per meeting, most items are dismissed due to insufficient evidence to support a signal or methodological issues ) 13 6 3/13/2017 Signal IdentificationSignal Identification from fromForeign Foreign Agencies Agencies WG Communications issued by the following are systematically screened: • WHO (World Health Organization) • FDA (Food and Drug Administration), USA • EMA (European Medicines Agency) • ANSM (Agence nationale de sécurité du médicament et des produits de santé), France • MHRA (Medicines and Healthcare products Regulatory Agency), U.K. • TGA (Therapeutic Goods Administration), Australia • Medsafe (Medicines and Medical Devices Safety Authority), New Zealand • SwissMedic (Swiss Agency for Therapeutic Goods) • PMDA (Pharmaceutical and Medical Devices Agency), Japan 14 International Collaboration in Signal Detection Bilateral arrangements with foreign regulators: • United States, Europe, Singapore, Switzerland, Australia, New Zealand, etc. (ad-hoc regulatory information sharing) SignalEngaged Assessments in multilateral 130 initiatives:days Serious• Heads Adverse of Agency Reactions International 15 days Pharmacovigilance Work sharing Group (Canada, Australia, Singapore, Switzerland) • Teleconference (Canada, United States, Australia, New Zealand) for signal detection • World Health Organization (WHO) Uppsala Collaborating Centre: adverse drug reaction monitoring Participates in networks of interest: • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, Pharmacoepidemiological Research on Outcomes of Therapeutics, and U.S. FDA MedSUN Sentinel Initiative 15 7 3/13/2017 Market Authorization Holder Submitted Information • Signal detection based on review of safety information submitted by the MAH • Preliminary screening of data to determine if in depth review is warranted • Identification of important updates to CCDS Scope of Activities • MAH (submitted directly to MHPD) e.g. ‘ad hoc’ information (e.g. study results, PSURs, position statements …) solicited Periodic Safety Update Reports (PSURs) (e.g. follow-up to an RMP or other review) and solicited study reports and any other information requested by MPMDB • MAH (forwarded to MHPD internally) e.g. information from TPD (unsolicited RMPs submitted with SNDS) or from another signal detection working group Number of PSURL1 completed per year FY 2011‐2012 FY 2012‐2013 FY 2013‐2014 FY 2014‐2015 FY 2015‐2016 # of PSUR L1 completed 75 164 167 149 133 16 Pharmaceutical Program Signal Detection WG • Sources of information: • ad hoc safety information and recommendations provided by pre-Marketing review bureaux. Safety information may originate from a Notifiable Change (NC) submission, a New Drug Submission (NDS) or a Supplemental New Drug Submission (SNDS). • Safety information originating from other stakeholders e.g. Drug Safety and Effectiveness Network (DSEN) or Canadian Network for Observational Drug Effect Studies (CNODES) • Safety information originating from the Canadian Agency for Drugs and Technologies in Health (CADTH). • Additional activities: screening of NCs and SNDs submissions for potential risk communication issuance including InfoWatch updates. 17 8 3/13/2017 Considerations during signal detection Corroboration from other sources? Publications on same issue, actions from other regulatory agencies, Canadian or international cases in Pharmacovigilance databases, class effect, etc. Potential impact on clinical practice Anticipated change in prescribing behaviour (e.g., increased frequency or severity of AE, potential for risk management, shift in benefit-risk profile, etc.) Public health related issue? Involvement of vulnerable populations, wide use of health product, etc. Canadian context and experience? How the practice described in the article relates to the Canadiansituation (e.g., health risk applicable in Canada, domestic case reports, etc.) Identify issues that are relevant to Canadians 18 Detection and Triage of Signals Other – Media, Pre-Marketing International **Literature MAH Submitted, Academia, Review Bureaux / Regulatory (Environmental) PSURs, etc Conferences, Office of Clinical Agencies Scanning DSEN etc Trials Signal Identification/Coordination Drug / Med Dev Signal Identification Canada Combo Products WorkingCoordination Group Vigilance Signal Prioritization Meeting 19 9 3/13/2017 SIGNAL PRIORITISATION Weekly meetings of the management team 1-3 potential signals /meeting 20 Considerations during signal prioritization New AE ( unknown) Unlabelled AE Clinical characteristics of AE (e.g. lab. results, rare or low natural frequency) New Health Product (HP) (2 years or less) Public Health aspect (e.g. Amount of HP use, number of adverse event cases ) Vulnerable populations involved Risk perception by media / by the general population: Potential Shift in the benefit/risk ratio Preventability by regulatory or risk management intervention Strength of the association between the AE and the HP ( e.g. biological plausibility / inherent toxicity. compatible temporal relationship) 21 10 3/13/2017 Signal Prioritization
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