SOP for Pharmacovigilance

OBJECTIVE

• This SOP provides guidance to the pharmacovigilance department on good practices and assessment of observational data regarding drugs, Specifically, this document provides guidance on

1. safety signal identification,
2. assessment and safety signal interpretation, and
3. Pharmacovigilance plan development. (i.e. collecting health) .

• Background: An integrated pharmacovigilance system shall include the collection, collation, assessment and analyses on information on adverse drug reaction cases, research of risk factors, and risk assessment, prevention and management, etc. The collection of adverse drug reaction cases is the most important and basic task.

SCOPE

This SOP is to be used by the Pharmacovigilance (PV) department which includes the QPPV and Head QPPV and any personnel which may be included in the team at a later date, to maintain a standard process of reporting to ensure compliance with the MOH regulations and decrease risk s of failure to report or inadequate reporting which may lead to legal obligations.

RESPONSIBILITY

QPPV: To prepare the Pharmacovigilance SOP

Executive QPPV: To review the Pharmacovigilance SOP

Head QPPV: To ensure the correctness of the document and approval.

• Establishing and maintaining/managing the Pharmacovigilance system
• Adverse drug reactions/medication errors
• Drug quality/Risk Management Plans
• Health care professional and consumers
• Periodic Safety Update Reports (PSURs)
• Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products.
• Ensure the marketing authorization is maintained and reflects the latest information.
• Conducting continuous pharmacovigilance evaluation.
• Respond to any request from the MOH.
• Provide the MOH any other information relevant to the evaluation of the benefits and risks of a medicine product.
• Acting as a contact point for the MOH on a 24 hour basis.
• Follow-up of reports for missing information and for info1mation on the progress and outcome of the case(s)
• Detection of duplicate reports
• Expedited reporting
• Meet legal obligations (Time frame) for reporting of suspected adverse reactions
• Meet legal obligations regarding the preparation and the submission of Periodic Safety Update Reports (PSURs)
• Preparation for inspections and audits.

ACCOUNTABILITY

Head of Quality Assurance Department

PROCEDURE

Prerequisities

• Criteria for Serious adverse event
• Death
• Life Threatening
• Results in permanent disability
• Congenital anomaly/birth defect
• Requires inpatient hospitalization or prolongation of existing hospitalization;
• Required intervention to prevent permanent impairment/damage (important medical condition includes pregnancy).

Definition of SUSAR

• Suspected unexpected serious adverse reactions (SUSARs) are serious adverse events judged to be related to therapy.
• A SUSAR is to be reported to the regulatory authority by using the CIOMS form. The adverse reaction must be unexpected. This means not foreseen in the Summary of Product Characteristics (SPC) in the case of an authorized medicinal product.

Causality

• The relationship between the drug and the occurrence of each adverse event will be assessed and categorized (as detailed below).
• Clinical judgement will be used to determine the relationship between the adverse reaction and drug. Alternative causes such as natural history of underlying diseases, concomitant therapy, other risk factors etc will be considered.
• Not Related: Temporal relationship of the onset of the event, relative to administration of the drug, is not reasonable or another cause can by itself explain the occurrence of the event.
• Unlikely: Temporal relationship of the onset of the event , relative to the administration of the product, is likely to have another cause which can by itself explain the occurrence of the event.
• Possibly related: Temporal relationship of the onset of the event, relative to administration of of the product, is reasonable but the event could have been due to another equally cause.
• Probably related: Temporal relationship of the onset of the event, relative to administration of of the product, and is reasonable and the event is more likely explained by the product than any other cause.
• Definitely related: Temporal relationship of the onset of the event, relative to administration of of the product, and is reasonable and there is no any other cause to explain the event or any a re-challenge (if feasible) is positive.
• Where an event is assessed as possibly, probably or definitely related the event is an adverse reaction and is only reported if there is a change in severity.

Establishing and maintaining PV system

Steps to be follow ed upon acquiring information of a serious adverse event (SAE) using the companies SAE form. These steps do not apply for serious adverse event reporting during clinical trials. During clinical trials any SAE regardless of the causality should be reported to the MOH (IRB) and REC within 24 hours if death.

Good case reports must include the following elements

• Description of adverse event and disease experience, including time from onset of signs and symptoms.
• Suspected and concomitant product therapy details (e.g dose, batch number, schedule, dates and duration), including over the counter medications, dietary supplements and recently discontinued medications.
• Patient characteristics including demographic information (e.g ages sex, and race), baseline medical condition prior to product therapy , co-morbid conditions, use of concomitant medications, relevant family history of disease and presence of other risk factors.
• Documentation of the diagnosis of events including methods used to make the diagnosis.
• Clinical course of the event and patient outcomes (e.g hospitalization or death)
• Relevant therapeutic measures and laboratory data at baseline, during therapy and subsequent to therapy including blood levels as appropriate.
• Information to dechallenge or rechallenge.
• Any other relevant information (e.g other details relating to the event or information on benefits received by the patient if important to the assessment of the event).

Expedited Reporting (Spontaneous Reporting)

• In expedited reporting (spontaneous reporting) a minimum amount of information is required to fulfill good reporting practice;
• Identifiable patient's information, identifiable reporter's information, a suspected reaction and suspect drug(s).
• Risk management and Pharmacovigilance plan: using safety data collected and reported assessed signals and risk factors and follow risk management and pharmacovigilance plan.
• Assign SAE number in the following format: SAE/YY/ZZ 

where, 

SAE stands for Serious Adverse Event; 

YY stands for the last 2 digits of the year and 

ZZ stands for serial number starting from 01 

for example SAE/24/01 is the first serious adverse event in the year 2024.

ANNEXURES
Annexure 1: Flow chart for adverse events

ABBREVIATIONS

SOP: Standard Operating Procedure

No.: Numbers

MOH: Ministry of Health

IRB: Independent review board

REC: Research ethics committee

PV: Pharmacovigilance

SAE: Serious adverse event

PI: Principle investigator in clinical trials

CAPA: Central administration for pharmaceutical affairs

QPPV: Qualified Person Responsible For Pharmacovigilance

SUSAR: Serious Unexpected Serious Adverse Reaction

PSUR: Periodic Safety Update Report

REVISION HISTORY

Nil