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Development of Pharmacovigilance system in Ukraine: first results

Development of Pharmacovigilance system in Ukraine: first results. Dr. Marina Sharayeva, MD, PhD Head of Pharmacovigilance Department, State Pharmacological Center, Ministry of Health of Ukraine, Kie v E-mail : vigilance@pharma-center.kiev.ua www.pharma-center.kiev.ua. Ukraine.

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Development of Pharmacovigilance system in Ukraine: first results

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  1. Development of Pharmacovigilance system in Ukraine: first results Dr. Marina Sharayeva, MD, PhD Head of Pharmacovigilance Department, State Pharmacological Center, Ministry of Health of Ukraine, Kiev E-mail : vigilance@pharma-center.kiev.ua www.pharma-center.kiev.ua

  2. Ukraine Population: 49,3 millions Territory: 603700 square km Regions: 25 Hospitals: 3049 Universities: 19 Physicians: 203006 Pharmacists: 42645 Health care budget spending: 2,8% of GDP (2000)

  3. Regulatory bodies Ministry of Health GMP Department Pharmacological Center (1992) Inspection of Medicines Quality Control Pharmacovigilance Department (1996)

  4. Comparison of the Responsibility for drug safety issues in Ukraine and EC Ukraine* EC** Regulatory authorities MP manufacturer Physician Regulatory authorities Health professional MP manufacturer * Law of Ukraine “ On Medicinal Products” (1996) ** Directive 2001/83/EС

  5. Factors for Adverse Drug Events Ukraine EC Quality (counterfeit and substandard MP) MP Properties(pharmacodynamic, interactions, prescription) MP Properties(pharmacodynamic, interactions, prescription) Quality (counterfeit and substandard MP)

  6. Ukrainian Pharmacovigilance Center • 68 member in WHO Drug Monitoring Programme (June 2002) • Personal (n=5) • Data collection • Database (n=1510 (1996-2002) • CIOMS forms • Regional centers (n=14)

  7. Main Responsibilities: • Collecting, analyzing case reports on ADRs/ADEs • Regulatory affairs/decisions • Alerting health professionals, manufacturers and public in case of risk • Safety monitoring in regions • Promotion of educational and training course • Exchange of data

  8. Regulatory decisions (due to drug safety information) • Prohibited - Cimetidine • Restriction in prescription: • Theophylline (aminophylline) • Gentamicin • Metamizole sodium • Nitrofurantoin • Blood formation and electrolytic fluids • Kava products

  9. ADR spontaneous reports in Ukraine (1996-2002)

  10. Pyramid of ADR reporting Ministry of Health orders State Pharmacology CenterRegulatory Agency Regional Health State Administration Data analysis, statistic form Regional Pharmacovigilance Department Serious ADE (additionally) Health care settings Data collection, statistic form Physician Case report of ADE of MP, primary medical documentation

  11. Type of ADE Type A adverse effects (drug actions: common, dose-, time-relationship, reproducible) Type B adverse effects (patient reactions: immunoallergic, rare, unexpected)

  12. Age distribution of patients with ADE

  13. Duration in occurrence of ADR

  14. Route of drugs administration that caused ADR Fatal (Death) All

  15. * * ATC Drugs Categories Type of Adverse Drug Reaction Domestic drugs caused 52% of all ADR reporting cases (* p<0,05)

  16. Drugs Categories associated with ADR (according to ATC)

  17. Type of Adverse Drug Reaction(according to WHO ADR)

  18. Reasons for low reporting rate: • no commitment with the manufacturers • absence of clinical pharmacists • low reporting culture (less than 1% of population and physicians) • quality of reports (10% underestimated) • lack of available and reliable ADE information • network and technical problems • absence of physician’s commitment and motivation

  19. Possible Measures to be Taken to Improve Reporting • Legislative/ Administrative efforts (initiation of ADR statistical reports) • Education efforts (student, graduate, postgraduate, training courses) • Encouragement of health professionals (journals, pharmacists involvement) • Regional pharmacovigilance – information centers • Methodological needs • Needs of International Communication and Training

  20. A Good Medication History:AVOID Mistake • Allergies? • Vitamins and herbs? • Old drugs and OTS? … as well as current • Interactions? • Dependence? • Mendel: family Hx of benefits or problems with any drugs? • (From Preventable ADR: a Focus on Drug interactions) • www.arizonacert.org/educ/padr/index_files/frame.htm

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