Proposed Set of Indicators for
Monitoring and Evaluation of
Pharmacovigilance Activities
Isah, Ambrose Ohumagho (1); Pal, Shanthi (2); Olsson, Sten (3)
1:University of Benin, Benin City, Nigeria (INRUD Nigeria), Nigeria;
2: World Health Organization, Geneva;
3: International Collaborating Centre, Uppsala, Sweden
ICIUM 2011, Antalya Turkey
Proposed Set of Indicators for Monitoring and Evaluation of Pharmacovigilance Activities
Isah, Ambrose Ohumagho (1); Pal, Shanthi (2); Olsson, Sten (3)
ambroseisah@yahoo.com
1: University of Benin, Benin City, Nigeria (INRUD Nigeria), Nigeria; 2: World Health Organization, Geneva;
3: International Collaborating Centre, Uppsala, Sweden
Problem Statement: The thalidomide tragedy triggered global consciousness regarding the safety of medicines. The need to
monitor safety issues regarding the intake of medicines has resulted in the tremendous growth of pharmacovigilance (PV)
structures and activities. However, there are no acceptable standard set of indicators to measure and monitor these
activities. Furthermore, there are no indices for comparison of measures in relation to baseline periods or inter- and intracountry, region, and facility comparisons.
Objectives: To outline a set of indicators for monitoring PV activities
Design: A qualitative study with the identification of a set of candidate indicators.
Setting: The envisaged setting for use will include country, regional, health facilities and public health programmes.
Methods: The set of indicators were identified from several sources— initially from a detailed review of the established
pharmacovigilance process/routine, contributions from pharmacovigilance experts, national pharmacovigilance centres, and
groups including Pharmacovigilance sans Frontiers (PVSF), the World Health Organization (WHO) Advisory Committee on
Safety of Medicinal Products (ACSoMP), WHO-Uppsala Medical Centre, and literature sources.
Results: A total of 64 candidate indicators were identified. The indicators were categorized into structural (19) which assesses the
existence of key PV structures, systems, and mechanisms in the setting; process (26) which assesses the entire mechanisms
and degree of PV activities; and outcome/impact (19) which measures the effects (results and changes) of PV activities
indicators . A set of background information (10) to put into perspective the PV milieu (demographics, economics, health
care system, and pharmaceutical scenario) generating the indicator data was also noted. This will also serve to provide the
denominator for measuring the indicators. A further categorization into Core and Complementary were made. A further
subset for use in public health programmes is also highlighted
Conclusions: The set of indicators provide a useful robust tool to monitor and evaluate PV activities at various levels of the
healthcare system as well as to provide indices for comparison of PV activities at country, regional, and facility levels, and
within public health programmes.
Funding: WHO
ICIUM 2011, Antalya Turkey
Introduction
• The thalidomide tragedy kindled global consciousness
regarding the need to monitor the safety of medicines
• The erection of Pharmacovigilance (PV ) systems from the
initial steps of ADR reporting has resulted in the tremendous
growth of structures and activities.
• There are no acceptable standard set of indicators to measure
and monitor these activities.
• Furthermore, there are no indices for comparison of measures
in relation to baseline periods or inter- and intra-country,
region, and facility comparisons.
ICIUM 2011, Antalya Turkey
Objectives
Broad Objective
• To provide objective measures which will enable the assessment
of the status of Pharmacovigilance, the activities and its impact,
globally at all levels of the healthcare system, with a view to
ensuring patient safety.
Specific Objectives
• To outline a set of indicators for monitoring and evaluating PV
activities
• To provide a tool for measuring changes in the
Pharmacovigilance System as well as the impact of PV
intervention
ICIUM 2011, Antalya Turkey
Methods
The set of candidate indicators were identified and revised from
several sources:
• Initially from a detailed review of the established
pharmacovigilance systems - processes/routines and literature
sources.
• Contributions from Pharmacovigilance Experts affiliated to
the following
– National Pharmacovigilance Centres (+ Survey)
– Pharmacovigilance sans Frontiers (PVSF)
– WHO Advisory Committee on Safety of Medicinal Products
(ACSoMP) – ( + Validation)
– WHO-Uppsala Monitoring Centre
ICIUM 2011, Antalya Turkey
Pharmacovigilance Indicators
Framework
Structural
(19)
Outcome/Impact
(19)
Assesses key PV
structures, systems
and mechanisms
(qualitative)
Process
(26)
Assesses the degree
of PV activities
Measures the effects
(results and changes)
of PV activities
Core (9)
• Core (9)
• Core (9)
• Complementary
• Complementary
Complementary
BACKGROUND INFORMATION (10)
ICIUM 2011, Antalya Turkey
Provides information on PV millieu
Pharmacovigilance Indicators
CORE
Indicators considered
to be highly relevant,
important and useful
in characterizing PV.
They should be stated
in most instances
where comparative
PV indices are
required.
COMPLEMENTARY
Other useful indicators
which serve to further
characterize the
pharmacovigilance
situation in the stated
setting but need not be
used in all instances.
INDICATORS: STRUCTURAL PROCESS OUTCOME/IMPACT
BACKGROUND INFORMATION
ICIU11, Antalya Turkey
Core Structural Indicators
1.
Is there a Pharmacovigilance (PV)Centre/Department/Unit with a standard
accommodation?
YesNo
2. Is there a statutory provision (national policy, legislation) on PV?
YesNo
3. Is there a Drug Regulatory Authority/Agency?
YesNo
4. Is there any financial arrangement (statutory budget) for the PV centre?
YesNo
5. Is the personnel (Full time equivalents) disposition in the PV centre adequate?
YesNo
6. Is there a case management system in place?
YesNo
7. Is there a standard ADR reporting form containing the essential elements in the
setting?
YesNo
8. Percentage of registered manufacturing industries with a functional
Pharmacovigilance unit?
YesNo
9. Is PV incorporated into the curriculum of the various health care professionals?
Doctors Yes No; Dentists Yes No ; PharmacistsYes No;
Nurses Yes No Others(specify______)
ICIUM 2011, AntalyaYes
Turkey No
Core Process Indicators
1. Total number of ADR reports received in the last year?
(also express as no. per 100,000 persons in population)
2. Total number of reports in the national/regional/local database
3. Percentage of total annual reports issued informative feedback
4. Percentage of total reports subjected to causality assessment
in the year
5. Percentage of total annual reports satisfactorily completed and
submitted to the National Centre / committed to UMC.
6. Percentage of medicines that are counterfeit/substandard in the
pharmaceutical market
7. Number of total medication errors reported in the year?
8. What proportion of pharmaceutical industries have a
functional PV system
9. Average number of reports per pharmaceutical industry per year
ICIUM 2011, Antalya Turkey
____ (_)
____
____
____
____
____
____
____
____
Core Outcome/Impact Indicators
1. No. of signals generated in last 5 years
2. Number of medicine -related hospital admissions per 1,000
admissions
3. Number of medicine- related deaths per 100,000 persons
in the population
4. Medicines -related deaths per 1,000 persons admitted into
hospital (annual)
5. Number of regulatory actions taken in the preceding year
consequent on pharmacovigilance activities?
– Label changes (variation)
– Safety warnings
– Drug withdrawals
6. Average cost of treatment of medicines related illness
7. Mean duration of medicines-related hospital stay
8. Average cost incurred for medicines - related hospitalization
9. Average Work/School days lost due to drug related problems
ICIUM 2011, Antalya Turkey
_____
_____
_____
_____
_____
_____
_____
_____
_____
_____
_____
Pharmacovigilance Indicators for Public Health
Programmes
1. Is there a Pharmacovigilance system in place?
2. Is there a standard ADR reporting form containing the
essential elements ADRs in the setting?
3. Total number of Adverse reports in the database
4. Total number of reports per 1000 patients/population
exposed to medicine
5. Total number of lack of efficacy reports in database
6. Total number of substandard/ counterfeit medicine reports in
database
7. Percentage of satisfactorily completed reports submitted to
the National Centre
8. Percentage of reporters issued informative feedback
9. Number of medicine - related hospital admissions
per 1,000 admissions
10. Number of medicine - related deaths per 1,000 persons
admitted into hospital (annual)ICIUM 2011, Antalya Turkey
Yes No
Yes No
______
______
______
______
______
______
______
______
CONCLUSION/IMPLICATIONS
• The set of indicators provide a useful, simple, robust
tool to monitor and evaluate PV activities at various
levels of the healthcare system.
• They also serve as indices for comparison of PV
activities at country, regional, and facility levels, and
within public health programmes.
• The availability of these indicators will enable
monitoring of the impact of policy provisions and
interventions in the pharmacovigilance system
ICIUM 2011, Antalya Turkey