14 Oct 2018
The prime objective of the pharmacovigilance indicators is to measure the existence and performance of major pharmacovigilance activities. They provide information about attainment of pharmacovigilance goals. Pharmacovigilance indicators are tools to identify strength, weakness, opportunity and threat to pharmacovigilance system.
Characteristics of ideal pharmacovigilance indicators:
The characteristics of ideal pharmacovigilance indicators are:
- Simple to understand
- Easy to measure and interpret
- Specific and sensitive to any pharmacovigilance facility
Classification of pharmacovigilance indicators:
The pharmacovigilance indicators are classified based on their importance or how essential they are to a functional pharmacovigilance system. The most fundamental indicators are classified as Core, and others as Complementary.
The core indicators are needed to address pharmacovigilance issues which are highly important. They should not only provide information to enable determination of the status of pharmacovigilance setting but also allow for comparison with other settings. For the proper characterization of pharmacovigilance system, such indicators are needed and are highly relevant and important.
The complementary indicators need not be used in all instances however they are relevant and should be determined when necessary to provide additional information in the sphere of pharmacovigilance.
The pharmacovigilance indicators are also further classified in to three sub-categories:
- Structural Indicators
- Process Indicators
- Outcome or Impact Indicators
The structural indicators measure the existence of key pharmacovigilance structures, systems and mechanisms in place to carry out the various activities. The availability of basic infrastructure is required to enable pharmacovigilance operations. These indicators assess the elements that give visibility to pharmacovigilance. They also assess the existence of a policy and regulatory framework which enable pharmacovigilance to operate. The data for these indicators are essentially qualitative.
The process indicators assess the extent of pharmacovigilance activities. They focus on the constellation of activities which describe the mechanism of pharmacovigilance – the collection, collation, analysis and evaluation of ADR reports. These are measures that assess directly or indirectly the extent to which the system is operating. The data for these indicators are essentially quantitative.
Outcome or impact indicators
The outcome or impact indicators measure the effects (results and changes) of pharmacovigilance activities. They measure the extent of realization of the pharmacovigilance objectives which, in essence, constitute ensuring patient safety. The data for these indicators are essentially quantitative.
WHO has developed pharmacovigilance indicators for the assessment of pharmacovigilance systems. Apart from core and complementary indicators, additionally a set of indicators are developed by WHO to address public health programmes. There are 27 core pharmacovigilance indicators: 10 structural, 9 process and 8 outcome or impact indicators. There are 36 complementary indicators: 11 structural, 13 process and 12 outcome or impact.
The Indicator-Based Pharmacovigilance Assessment Tool (IPAT):
Manual for conducting assessments in developing countries is developed by the U.S. Agency for International Development (USAID)-funded Strengthening pharmaceutical systems (SPS) program 2009. This tool is useful for evaluating the current state of collection, analysis, and interpretation of data on the safety aspects of medicine regulation as well as to ensure safe use of medicines at public health programs, health facilities, and the health care worker and consumer levels.
IPAT has 43 indicators—26 core and 17 supplementary—that address five pharmacovigilance and medicine safety system components:
(a) Policy, law, and regulation (4 indicators)
(b) Systems, structures, and stakeholder coordination (15 indicators)
(c) Signal generation and data management (6 indicators)
(d) Risk assessment and evaluation (8 indicators)
(e) Risk management and communication (10 indicators)
- WHO PHARMACOVIGILANCE INDICATORS: A PRACTICAL MANUAL FOR THE ASSESSMENT OF PHARMACOVIGILANCE SYSTEMS, 2015 (http://www.who.int/medicines/areas/quality_safety/safety_efficacy/EMP_PV_Indicators_web_ready_v2.pdf)
- Strengthening Pharmaceutical Systems (SPS) Program. 2009. Indicator-Based Pharmacovigilance Assessment Tool: Manual for Conducting Assessments in Developing Countries. Submitted to the U.S. Agency for International Development by the SPS Program. Arlington, VA: Management Sciences for Health. (http://apps.who.int/medicinedocs/documents/s21303en/s21303en.pdf)