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, Kiev E-mail
vigilance_at_pharma-center.kiev.ua www.pharma-center.
kiev.ua
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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)
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Regulatory bodies
Ministry of Health
GMP Department
Pharmacological Center (1992)
Inspection of Medicines Quality Control
Pharmacovigilance Department (1996)
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Comparison of the Responsibility for drug safety
issues in Ukraine and EC
Ukraine
EC
Regulatory authorities
MP manufacturer
Physician
Regulatory authorities
MP manufacturer
Health professional
Law of Ukraine On Medicinal Products
(1996) Directive 2001/83/E?
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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)
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Ukrainian Pharmacovigilance Center

• 68 member in WHO Drug Monitoring Programme (June
  2002)
• Personal (n5)
• Data collection
• Database (n1510 (1996-2002)
• CIOMS forms
• Regional centers (n14)

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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

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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

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ADR spontaneous reports in Ukraine (1996-2002)
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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
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Type of ADE
Type A adverse effects (drug actions common,
dose-, time-relationship, reproducible) Type B
adverse effects (patient reactions
immunoallergic, rare, unexpected)
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Age distribution of patients with ADE
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Duration in occurrence of ADR
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Route of drugs administration that caused ADR
Fatal (Death)
All
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ATC Drugs Categories
Type of Adverse Drug Reaction
Domestic drugs caused 52 of all ADR reporting
cases ( plt0,05)
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Drugs Categories associated with ADR (according
to ATC)
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Type of Adverse Drug Reaction (according to WHO
ADR)
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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 physicians commitment and motivation

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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

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A Good Medication HistoryAVOID 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.ht
  m