Reporting Pharmacovigillance Data
Session 11: Reporting Pharmacovigillance Data
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
35 minutes Presentation
2 Ways of Reporting pharmacovigillance Data
Buzzing
3 25 minutes Presentation Expedited Reporting Requirements
45 minutes Presentation Necessary Information in pharmacovigillance
4
Brainstorming Reports
5 05 minutes Presentation Key Points
6 05 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: Ways of Reporting Pharmacovigilance Data (35 minutes)
Activity: Buzzing (10 minutes)
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
The following are ways of reporting pharmacovigillance data
o Spontaneous reports are termed spontaneous as they take place during the clinician's
normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion
that the drug may be implicated in the causality of the event.
o Spontaneous reporting system relies on vigilant physicians and other healthcare
professionals who not only generate a suspicion of an ADR, but also report it.
o It is an important source of regulatory actions such as taking a drug off the market or a
label change due to safety problems.
o Spontaneous reporting is the core data-generating system of international
pharmacovigillance, relying on healthcare professionals to identify and report any
adverse events
o One of the major weaknesses of spontaneous reporting is that of under-reporting.
o Spontaneous reports are a crucial element in the worldwide enterprise of
pharmacovigillance and form the core of the World Health Organization Database
o Also known as SAE (serious adverse event) reporting from clinical trials, safety
information from clinical studies is used to establish a drug's safety profile in humans
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and is a key component that drug regulatory authorities consider in the decision-making
as to whether to grant or deny market authorization (market approval) for a drug.
o SAE reporting occurs as a result of study patients (subjects) who experience serious
adverse events during the conducting of clinical trials. (Non-serious adverse events are
also captured separately.)
o SAE information, which may also include relevant information from the patient's
medical background, are reviewed and assessed for causality by the study investigator.
This information is forwarded to a sponsoring entity (typically a pharmaceutical
company) that is responsible for the reporting of this information, as appropriate, to drug
regulatory authorities.
o This refers to ICSRs (individual case safety reports) that involve a serious and unlisted
event (an event not described in the drug's labelling) that is considered related to the use
of the drug.
o Spontaneous reports are typically considered to have a positive causality, whereas a
clinical trial case will typically be assessed for causality by the clinical trial investigator
and or the license holder.
o Periodic Safety Update Reports (PSURs) are important pharmacovigillance documents.
o They provide an opportunity for Marketing Authorization Holders (MAHs) to review
the safety profile of their products and ensure that the Summary of Product
Characteristics (SPC) and Package Leaflets are up to date.
o They also provide a valuable source of pharmacovigillance data.
o MAHs should submit PSURs to regulatory outhority example TFDA.
o Information on the product (i.e. brand name, dosage form, strength,
manufacturer and country of origin),
o The scope of drug safety data and the surveillance period,
o Collection of adverse drug reaction (ADR) information (i.e. local serious ADRs,
local non-serious ADRs, foreign serious ADRs, foreign non-serious ADRs, case
reports published on international or local literatures including academic
conferences).
o A simplified reporting form (Annex 5 of TFDA) should be used by patients to report
information on suspected adverse drug reactions.
o Patients should be encouraged to report adverse events and seek medical attention
through their health care providers.
o Further information on the report can be sought from the health care provider for
serious
and/or unknown reaction reported directly from patients.
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STEP 3: Expedited reporting requirements(25 minutes)
reporting form (Annex 1of TFDA).
days from receipt of the minimum information required for an adverse reaction report by a
health care provider or personnel of the manufacturer.
the manufacturer is aware should be reported to the TFDA on an expedited basis.
case, the reporting time is considered to begin again for submission of the follow-up
report.
for expedited reporting upon receipt of follow-up information that indicates the case
STEP 4: Necessary information in Pharmacovigillance Reports (45 minutes)
Activity: Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
should be completed: patient information, description of the event, medicine information,
and notified information.
o Information on the suspect medicine: generic or patent name, dosage, route of
administration, treatment start and end dates, indications for use, expiration date, lot
number, and manufacturer;
o Data from the patient on his/her disease: health status before starting the medication,
co-morbidities, relevant family history of disease;
o Concomitant medicines. All other medicines taken by the patient (including self-
medication): names, dosage, route of administration, start and end dates;
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o Information on the notifying professional. The name and address of the notifier should
be considered confidential and used only to verify or complete the data or follow-up on
the case.
o Risk factors (for example, altered kidney function, exposure prior to taking the suspect
medicine, known allergies, use of recreational medicines);
o Documentation on the diagnosis of the event, including the procedures used to obtain the
diagnosis;
o The clinical course of the patient and outcome (hospitalization or death). Patient
outcome might not be available when the report is sent. In such cases there will be a
follow-up.
o Laboratory findings (including blood levels) corresponding to the start of treatment, the
medication period, and subsequent therapies.
o Information on the response after the medication is suspended, and re-exposure.
o Any other relevant information (e.g., additional details related to the event or
information on benefits received by the patient, if important for assessing the event).
STEP 5: Key Points (5 minutes)
expedited reporting,periodic safety reporting and clinical trial reporting.
the medicine suspected and description of the nature of adverse event
STEP 6: Evaluation (5 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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