Professor Vladimir K' Lepakhin

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• Professor Vladimir K. Lepakhin
• Senior Clinical Adviser
• Essential Drugs and Medicines Policy, WHO

The International Society of Pharmacovigilance
Conference, Amsterdam, October
2002 Pharmacovigilance in Newly Independent
States of Eastern Europe
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• ? In response to requests of 8 NIS countries (a
  total population of 275 million) the WHO
  Headquarters EDM/QSM started in 2000 the new
  project Implementation and Development of
  Pharmacovigilance in Newly Independent States of
  Eastern Europe.

WHO Project
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• ? To reduce drug morbidity and
• mortality by implementing contemporary systems
  of
• pharmacovigilance that ensure access to
  safe drugs and rational use of drugs.

Objectives
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• The targets, indicators, expected outcomes and
  work plan for the project were elaborated in
  collaboration with responsible representatives of
  Drug Authorities of all eight countries.
• ? Development of national legislation/regulation
  for drug monitoring in participating countries
• ? Establishment or strengthening of National
  and Regional ADR Monitoring Centres in 8
  selected NIS countries.

Targets
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• ? Putting into practice system of drug safety
  information for medical and
• pharmaceutical professionals.
• ? Developing ADR reporting culture in health
  care of participating countries
• ? Participating in the WHO Programme for
  International Drug Monitoring

Targets contd.
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• ? Education and training specialists on
  pharmacovigilance in participating countries
• ? Involve NIS in international drug
  information exchange

Targets contd.
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• ? Preliminary investigations and evaluation
  of the statues of the issue of drug safety
  monitoring in participating states have revealed
  that the situation with regard to adverse drug
  reactions study and evaluation vary dramatically
  between these countries.

Actions taken
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• ? Recommendations for necessary
  legislation/regulation on PhV have been worked
  out and proposed to
• all participating countries

Actions taken
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• ? Recommendations for setting up and the
  development of national systems of
  pharmacovigilance were given to each
  state- member of the Project.
• For example, it was recommended to the
  Russian Federation, Kazakhstan and
  Ukraine- states with large populations and big
  territories, to establish the regional system
  of pharmacovigilance with the National Centre
  and a number of Regional Centres on Drug
• Monitoring.

Actions taken
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• ? WHO Guidelines for setting up and running a
  Pharmacovigilance Centre were adopted for NIS,
  translated into Russian and provided to the
  responsible officers in Drug Authorities of all 8
  countries.

Actions taken
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• ? Educational and training materials were
  prepared and 4 training seminars (using train
  the trainers principle) were conducted for
  representatives of 9 countries. All participants
  received relevant documentation for their
  practical activities.

Actions taken
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• ? National pharmacovigilance systems were
  established in all 8 countries by special
  legislations and/or regulations.
• ? Special departments on drug monitoring were
  organized in Drug Authorities of 6 participating
  countries.
• ? Functions of National ADR centres were
  delegated to these departments or to
  Pharmacological Committees.

Results
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• ? A number of Regional ADR Centres were set up
  in Russia (30) Kazakhstan (15) and Ukraine (25).
• ? Staff of National Regional ADR centres
  have received educational materials, guidelines
  and training for the organization and running of
  a Pharmacovigilance Centre.
• ? Armenia and Russia started to publish special
  Bulletins on Drug Safety. Other countries
  include information on Drug Safety in their Drug
  Bulletins.

Results
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• ? More than 200 educational and informational
  seminars and meetings on pharmacovigilance were
  organized for health care providers. The
  principles, demands and methods of
  pharmacovigilance were explained to more than
  7000 medical doctors and pharmacists.
• ? Reporting of ADR started and National Data
  Bases for ADR were set up in all 8 countries.

Results
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• ? Additionally to Russia, Armenia, Belarus,
  Moldova and Ukraine joined the WHO Programme on
  International Drug Monitoring. Kazakhstan,
  Kirgizstan and Uzbekistan are going to join the
  Programme at the beginning of 2003.
• ? Pharmacovigilance was included in curricula
  for students studying medicine and pharmacy
• ? Participating countries agreed on establishing
  NIS network on pharmacovigilance

Results
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• ? The legal basis for implementation of
  pharmacovigilance systems is established in 8
  NIS countries
• ? The functioning of PhV systems has been
  started successfully in
• participating states

Conclusions
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• ? Health care providers began to receive much
  more independent information on drug safety (in
  understandable language) and started to
  participate in postmarketing surveillance
• ? There is a great need in further developing
  and strengthening pharmacovigilance systems in
  participating countries as well as create and
  develop a reporting culture in these states

Conclusions
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• ? WHO can and must continue to collaborate with
  countries in the region for implementation,
  developing and harmonization of all aspects of
  pharmacovigilance

Conclusions