Experience of Belarus in introducing enhanced pharmacovigilance for linezolid in treatment of M/XDR-TB

Transcription

1 Experience of Belarus in introducing enhanced pharmacovigilance for linezolid in treatment of M/XDR-TB Alena Skrahina, NPT Svetlana Setkina, NPhC Minsk, Belarus 17 th Wolfheze Workshop May, 2015

2 Objectives and rationale M/XDR-TB in Belarus M/XDR-TB treatment outcomes 4.3% 9.9% % 32.7% Cured Completed Died 24.6% Failed Lost to follow up Not evaluated 41.5% % 9.8%

3 System components background characteristics NTP National PV system Hierarchical structure and subordination National TB register Clinical and laboratory basis National TB policy based on WHO recommendations National TB guidelines National PV Center (NPVC) Legislation in PV sphere Spontaneous reporting system (5,4 per ) CEM for HIV, 2012 CEM for HIV-M/XDR TB, 2013

4 PV for TB drugs GOALS PV system implementation in NTP Improving of effectiveness and safety in TB and M/XDR-TB OBJECTIVES reporting and professional skills of HCP Early warning of problems related to TB drugs TB management and monitoring improvement unfavorable consequences Encouraging the safe, rational & more effective use of TB drugs Assessment benefit, harm, effectiveness and risk of TB drugs Promote understanding, education, training and communication

5 S TRENGTHS Capacities of NTP & NPVC Support from the MoH & local health authorities SWOT-analysis W EAKNESSES Weak cooperation between NTP & NPVC Poor ADR reporting culture Low motivation of HCP Shortage in human & financial recourses O PPORTUNITIES National TB-register System for detecting, reporting, analysis of ADR Capacities for risk minimization measures Implemented TB patients cohort analysis Implemented CEM T HREATS Negative reaction of HCPs (additional duties & workload)

6 Collaborative TB-PV working group. Order MoH, June 2014 Intensive training program for HCP in NTP Components CEM of Lnz-treated TB patients CEM of BDQ-treated TB patients

7 Intensive training program for NTP HCPs Materials Deliverables National guidelines for: ADR detecting, verification & reporting TB, MDR-TB management Training modules for: ADR detection and reporting CEM TB drugs safety monitoring TB, M/XDR-TB management Knowledge and skills on safety monitoring & ADR reporting awareness & motivation Professional skills for CEM

8 Milestones CEM of TB patients on Lnz April-June 2014 preparatory phase Introductory training (with WHO experts) July 2014 pilot phase August 2014 implementation in all sentinel sites (7) Monitoring visits (quarterly) March 2015 intermediate training December 2015 planned enrollment 341 M/XDR -TB patients December 2016 CEM completing January 2017 CEM results evaluation final report, recommendations, risk minimization measures

9 Patients Inclusion criteria Exclusion criteria M/XDR-TB (DST) Indications for Lnz age years Known hypersensitivity to Lzd MAO inhibitors, Serotonin re-uptake inhibitors, tricyclic antidepressants, 5- HT1 antagonists, buspiron Uncontrolled arterial hypertension Pheochromocytoma Hyperthyroidism, thyrotoxicosis Malignancy

10 Enrollment form Patient ID Patient data Monitoring site/hcp data Microbiological and laboratory data (hematological, hepatological, renal, pancreatic, metabolic, immunological parameters) Pre-conditions: Co-morbidity/ Risk factor/ Profile-modifying factors Drugs, traditional medicines, additives before admission Clinical events before admission

11 Treatment monitoring form Patient ID Patient data Monitoring site/hcp data New clinical events Laboratory data (hematological, hepatological, renal, pancreatic, metabolic, immunological, electrolyte, parameters) Anti- TB treatment Concomitant medication, traditional medicines etc. DST Outcomes Audiogramm, ECG, ophthalmologist, neurologist examination, X-ray

12 Design and data 1 m 2 m 3 m 4 m 5 m 6 m 12 m 15 m 18 m 21, 24 m Vigibase National database of ADR Analysis Report Recommendations Data analysis and database input

13 Identification of suspected drug. Causality assessment Methodology of causality assessment (WHO-UMC) Temporal relationship. Dechllange/rechallenge results Pharmacological, toxicological, immunological plausibility Clinical plausibility Role of the other factors. Risk factors Concomitant medications Co-morbidity Anamnesis for ADR Other individual factors (abusing, misuse, psychoemotional, social etc.)

14 PV always at work 1. TRAINING 2. CREATION OF COHORT & IT SYSTEM 6. FEEDBACK 4. SUPERVISION 3. DATA ENTRY 5. ANALYSIS

15 Lzd project current status 70 M/XDR- TB patients 192 ADEs 62(88%) patients one to several ADRs Major ADRs Blood & lymphatic system Hepatobiliary system Renal and urinary system Gastrointestinal system Nervous system & psychiatric Metabolism & nutrition Ear & labyrinth

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