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Development of Pharmacovigilance system in Ukraine: first results

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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 : Ukraine.

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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 :



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)


Regulatory bodies

Ministry of Health

GMP Department

Pharmacological Center (1992)

Inspection of Medicines Quality Control

Pharmacovigilance Department (1996)


Comparison of the Responsibility for drug safety issues in Ukraine and EC



Regulatory authorities

MP manufacturer


Regulatory authorities

Health professional

MP manufacturer

* Law of Ukraine “ On Medicinal Products” (1996)

** Directive 2001/83/EС


Factors for Adverse Drug Events



Quality (counterfeit and substandard MP)

MP Properties(pharmacodynamic, interactions, prescription)

MP Properties(pharmacodynamic, interactions, prescription)

Quality (counterfeit and substandard MP)


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)
main responsibilities
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

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

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


Health care settings

Data collection, statistic form


Case report of ADE of MP, primary medical documentation


Type of ADE

Type A adverse effects (drug actions: common, dose-, time-relationship, reproducible)

Type B adverse effects (patient reactions: immunoallergic, rare, unexpected)




ATC Drugs Categories

Type of Adverse Drug Reaction

Domestic drugs caused 52% of all ADR reporting cases (* p<0,05)

reasons for low reporting rate
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
possible measures to be taken to improve reporting
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

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)