12-Beijing III challenges.pptVIP

Current Challenges in Pharmacovigilance Sten Olsson WHO Collaborating Centre for International Drug Monitoring Uppsala, Sweden Content Global coverage Pharmacovigilance in Public Health Programmes Direct patient reporting Involvement of health care providers New methods Monitoring of traditional medicines Need for training Better communications Patient safety Global coverage Public Health Programmes Crucial and critical Well established Technically performed Good financial support Pharmacovigilance Seen as a luxury discipline Not fully established No spontaneous reporting culture, no PV competence Poor support Direct Patient Reporting Direct patient reporting today Australia Canada Denmark France (pilot) The Netherlands Sweden United Kingdom USA Patient reporting Issues + imperative for self medication + new aspects of drug-related problems + major increase in reporting + better reporting of older medicines duplicate reports less reliable - more noice? resource demanding influencing physician – patient relationship? Pharmacovigilance in ICH Countries Strong focus on regulatory requirements/actions Serious, unlabelled reactions to new drugs Pharmacovigilance planning and risk management Major problems in health-care neglected Industry stewardship has major role Expedited reporting, PSURs Standardized format for exchange of case information E2b and MedDRA Immediate needs Better documentation of burden of drug related problems in non-ICH countries Greater involvement/concern from health care providing organizations and health insurance companies Carry the costs of ADRs Attention on commonly used drugs with ADRs, not only new drugs Prevention has major public health impact Potential of new methods Statistical methods to identify disproportionality in occurrance of event (data mining) Relevant for big databases e.g Chinese Identification of patterns in reporting Apply to longitudinal data bases of patient records Closer to real life Verify and quanti