Pharmacovigillance Methods
Session 9: Pharmacovigillance Methods
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
2 05 minutes Presentation Definition of PharmacovigilanceMethods
45 minutes Presentation
3 Small group Pharmacovigillance Methods
discussion
4 20 minutes Presentation Explanations on Pharmacovigillance Methods
25 minutes Presentation Comparing the Reporting Methods of
5
Buzzing Pharmacovigillance
6 10 minutes Presentation Key Points
7 10 minutes Presentation Evaluation
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SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Definition of Pharmacovigillance Methods (5 minutes)
surveillance of adverse events or any other drug related problem. It can be either active
surveillance or passive surveillance
STEP 3: Pharmacovigillance Methods (45 minutes)
Activity: Small Group Discussion (20 minutes)
DIVIDE students into small manageable groups
ASK students to discuss on the following questions
ALLOW students to discuss for 15 minutes
ALLOW few groups to present and the rest to add points not mentioned
CLARIFY and SUMMARIZE by using the contents below
o Spontaneous reporting
o Intensified ADR reporting
o Targeted reporting
o Cohort Event Monitoring
o Electronic health record(EHR) mining
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o Passive surveillance methods include; Spontaneous reports, Case series, Stimulated
reporting
o Active surveillance methods include; Sentinel sites, Medicine event monitoring, Cross-
sectional study (survey) ,Case-control study
Refer students to Handout9.1: pharmacovigillance methods
STEP 4:Explanations on PharmacovigillanceMethods(20 minutes)
o A system to monitor the safety of all medicines on the market
o Voluntary submission of ICSRs by health professionals, pharmaceutical
manufacturers and patients to the nationalpharmacovigillance centre
o Requires two initial steps:
A reporter
Suspects that an undesirable medical event may have been caused by exposure to a
medicine
o Reports the suspicion to the national pharmacovigillance centre
o Reports may include;
Serious ADRs
Severe ADRs
New drug
Unknown (unlabelled reactions)
ADRs in vulnerable groups (children, pregnant women, elderly
o Advantages of this method
Most commonly used method
Easiest method to establish
least labour intensive
relatively inexpensive
o Disadvantages of this method
Inherent under‐reporting
Captures only suspected ADRs
Possibility ofReporting bias
o To enhance ADR reporting of specific medicines in early post‐marketing phase
o Extension of Spontaneous Reporting Programme
o Medicines under additional monitoring include, medicines contain new active substance,
biologicalmedicines that require additional studies e.g. more data on long term use or on
rare side effects in clinical trials
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o intensified ADR Reporting within a defined cohort
o it target specific medicines, population, ADR, and clinics
o To gather more information on the safety profile of a new chemical entity in early post‐
marketing phase
o Observational cohort study design
o Patients enrolled into cohort and actively followed‐up during treatment to record all
adverse events (not just suspected ADRs)Characterise known reactions
o Detect signals of unrecognised reactions
o Identify interactions with other medicines
o Detect inefficacy of medicine
o Assess safety in pregnancy and lactation
o Make use of existing health records to supplement pharmacovigillance activities
o Potentially rich source of ADR data
o Mining of the THIN data base is currently being evaluated
recommended for all products focused pharmacovigillance is better out under specified
conditions when safety issues or potential safety issues need to be addressed .Active studies
are undertaken when data is needed quickly
STEP 5: Comparing the Reporting Methods (25 minutes)
Activity: Buzzing (10minutes)
ASK students to pair up and buzz on the following question
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
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METHOD MEDICINES POPULATION REPORTS
Spontaneous Reporting All medicines life, All exposure All ADRs
cycle of products individuals but
denominator
unknown
Intensified ADR Reporting Specific medicines All exposure All ADRs
individuals but
denominator
unknown
Targeted Reporting Specific medicines Defined cohort Specific ADRS
All ADRs
Cohort Event Monitoring Specific medicines Defined cohort All events
Electronic health record All medicines Defined cohort All events
mining
STEP 6: Key Points (10 minutes)
Reporting, Targeted Reporting and Cohort Event Monitoring
surveillance
STEP 7: Evaluation (10 minutes)
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References
Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of
pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).
The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the
Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349
WHO Operational package for assessing, monitoring and evaluating country pharmaceutical
situations. (2015, November 20). Retrieved from
https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/
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Handout 9.1: : Pharmacovigillance methods
communication by a healthcare professional or consumer to a company, regulatory authority
or other organization (e.g. the World Health Organization, a regional centre, a poison
control centre) that describes one or more adverse reactions in a patient who was given one
or more medicinal products and that does not derive from a
study or any organized data collection scheme
o Stimulated reporting can occur in certain situations, such as after a direct healthcare
professional communication, a publication in the press or questioning of healthcare
professionals by company representatives, and adverse reaction reports arising from
these situations are considered spontaneous reports
o Reporting can also be stimulated by invitation from patients‘ or consumers‘
organizations to their members
Japan, is also considered stimulated reporting.
o Passive Surveillance
o Stimulated Reporting
o Active Surveillance
o Comparative Observational Studies
o Targeted Clinical Investigations
o Descriptive Studies
o Mostly for new products for early post authorization (e.g., black triangle schemes)
EPPV in Japan
o Stimulation after notification of certain risks, not managed by the MAH
o MAH planned stimulation also possible to gather more information on certain safety
issues Handled as spontaneous reports
o Seeks to ascertain completely the number of adverse events via a continuous reorganized
process.
o Examples described include:
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o Sentinel Sites
o Drug Event Monitoring
o Registries
o Cross-Sectional Study (Survey)
o Case-Control Study
o Cohort Study
o Use of databases
o pharmacokinetic and pharmacodinamicstudies
o Genetic testing
o Interaction studies (drug-drug, drug-food)
o In special populations
o Large simplified trial
o Natural History of Disease
o Drug Utilization Study
o Seeks to ascertain more completely the number of adverse events in a given
a particular medicinal product through a risk management system. Patients who fill a
prescription for this product may be asked to complete a brief survey form and give
permission for later contact
o Active surveillance gives more comprehensive data on individual adverse event
reports than passive reporting system
o Automatic detection of abnormal laboratory values from computerized laboratory
reports in certain clinical settings may also provide an efficient active surveillance
system
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