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PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA. WORKING TOGETHER TODAY TO MAKE SOUTH AFRICA SAFE TOMORROW!!!. CURRENT SITUATION…. 1987 Established National Adverse Events Monitoring Centre (Cape Town)

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PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

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  1. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA WORKING TOGETHER TODAY TO MAKE SOUTH AFRICA SAFE TOMORROW!!! PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  2. CURRENT SITUATION… • 1987 Established National Adverse Events Monitoring Centre (Cape Town) • Spontaneous Reporting of all drugs registered in South Africa (receive reports from Industry and HCP) • Collaborating Centre of WHO Monitoring Centre in Uppsala PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  3. CURRENT SITUATION… • Pharmacovigilance committee within the MCC established 2002: performs a regulatory function in Pharmacovigilance, makes recommendations to MCC in terms of availability of medicines and related substances; advises on ‘Dear Healthcare Professional’ safety letters and Medicines Safety Alerts (Drug Alerts), Urgent Safety Update Notifications (Package inserts and communications by Industry), international signals, alerts and warnings. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  4. CURRENT SITUATION… • ADR Reporting Guidelines and Form (accessible from website www.mccza.com) • Industry required to report actively. Internal pharmacovigilance systems ‘should’ be in place. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  5. CURRENT SITUATION… • Many years experience of spontaneous reporting and associated signal detection PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  6. CURRENT SITUATION… • Comprehensive Plan approved by Cabinet November 2003 – included Pharmacovigilance! • April 2004, launched ARV Program • Current infrastructure insufficient to support needs of program • Task of Pharmacovigilance for ART must be comprehensive enough to support program. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  7. PHARMACOVIGILANCE NEEDS: Pharmacovigilance in HIV and AIDS Program • Create awareness and consciousness of safety issues in ART among HCP and Public Who, How, By When? • Identify new ADE/ADR specific to ART How? • Monitor known ADR’s – develop therapeutic guidelines enhance therapeutic success in South African setting Who? How? • Counteract myths Who? How? PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  8. RESPONSE TO PHARMACOVIGILANCE NEEDS • Continue spontaneous reporting to NADEMC Who? How? • MEDUNSA Pharmacovigilance Centre - coordinating focus surveillance –Adult ART, drug interactions (CAM, ATM, foods) Who? How? • Bloemfontein Centre – Paed ART + Pregnancy Registry Who? How? • Data Mining (?) automated databases Who? How? PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  9. SYSTEM STRATERGIES: SIGNAL GENERATION HYPOTHESIS TESTING COMMUNICATION PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  10. SIGNAL DETECTION: Passive Surveillance • Spontaneous reporting – NADEMC • Evaluation of data PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  11. SIGNAL DETECTION: Active Surveillance • Cohorts * Prescription Event Monitoring (ARV naïve patients) – detect new signals, guide investigation of all significant events * Intensive Drug Safety Monitoring (Investigate Extent, Frequency and Severity of known events) * Registries PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  12. SIGNAL DETECTION: • Automated databases – data mining of data bases How? PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  13. HYPOTHESIS TESTING • Create Expert Panel to determine which signals warrant investigation • To confirm signal – design focussed studies at sentinel sites • Selection criteria for sites – well functioning – create a nucleus of sites – form a base group – used in the future to recruit rural sites to develop network. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  14. HYPOTHESIS TESTING • Qualitative issues – insight into “experiences” of ART ADRs PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  15. COMMUNICATION AND RISK MANAGEMENT • To HCP  Patients and Treatment Buddies Who? How? • Reporting to Regulatory Authority  responsible public awareness Who? How? • Media strategy Who? How? • Creation of toll free 24 hour help line for patients and HCP Who? How? PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  16. TRAINING PRIORITES • Priorities include: • Education on pharmacovigilance • Promote reporting • Understand therapies • Train the trainers to  educate the patient  empower the patient PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  17. TRAINING STRATEGY • Audit current training structures in the provinces. Who? How? • Incorporate Pharmacovigilance training into these established training for HIV Who? How? • Evaluate existing gaps in Pharmacovigilance Who? How? • Develop training manuals relevant to gaps and audiences Who? How? PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  18. TRAINING CONTENT • ART And ADR’S • Signs and Symptoms • Management • Use booklet already developed from NADEMC to address issues of Why, How, When and To Whom to report. PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

  19. PHARMACOVIGILANCE CENTRE • CULMINATE INTO … • Forum for Communication and Training • Focussed surveillance fuelling research initiatives • Panel of experts to inform policy and therapeutic guideline • Patients aware and conscious of ADRs and understand that they are part of risk aspect of effectiveness-risk continuum PHARMACOVIGILANCE PLAN FOR SOUTH AFRICA

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