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Constructing an evaluation framework for primary pharmacovigilance systems in developing countries: a case study from

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Summary

A new evaluation framework for primary pharmacovigilance systems in China was developed. This system enhances medication safety and can be adapted for similar regions with developing pharmacovigilance infrastructure.

Keywords:
analytic hierarchy process (AHP)delphi methoddeveloping countryevaluation indicator frameworkpharmacovigilance system

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Health Systems Evaluation
  • Public Health Policy

Background:

  • Primary pharmacovigilance systems are crucial for medication safety.
  • Developing countries often face challenges in implementing robust pharmacovigilance.
  • A context-specific evaluation framework is needed for China and similar regions.

Purpose of the Study:

  • To develop an evaluation framework for primary pharmacovigilance systems tailored to the Chinese context.
  • To adapt existing guidelines (WHO) to national policies and resource constraints.
  • To support consistent pharmacovigilance practices and enhance medication safety.

Main Methods:

  • Utilized semi-structured interviews, literature reviews, and group discussions to establish preliminary indicators.
  • Employed the Delphi Method for indicator screening based on inclusion principles.
  • Applied the Analytic Hierarchy Process (AHP) to determine indicator weights.

Main Results:

  • Achieved 100% response rates in both rounds of the Delphi method.
  • Demonstrated high reliability (coefficients 0.87-0.88) and significant consensus (Kendall's W, P < 0.001).
  • Established a final system with 3 first-level, 9 second-level, and 35 third-level indicators.

Conclusions:

  • Developed a practical, context-sensitive evaluation framework for Chinese primary pharmacovigilance systems.
  • The framework serves as a feasible assessment tool for system improvement and resource allocation.
  • Offers a valuable reference for regions with similar pharmacovigilance system maturity or developmental stages.