Post -Marketing

Drug Safety Surveillance

Introduction

• Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period– Post-marketing surveillance has traditionally been carried out by

systematic manual review of spontaneous reports of adverse drug reactions

• Good Vigilance Practice (GVP) establishes standards for post-marketing safety management related to the collection, evaluation, and assessment of proper use information and to the implementation of measures for safety assurance

Types of Post-Marketing Surveillance

1) Spontaneous/voluntary reporting of cases– National (FDA MedWatch)– Local or Regional (Joint Commission Requirement)– Scientific literature publications

2) Post-marketing studies (voluntary or required) – Observational studies (including automated healthcare databases)– Randomized clinical trials

3) Active surveillance– Drug‐Induced Liver Injury Network (DILIN)– Sentinel initiative

Routine Post-marketing Pharmacovigilance

Post-marketing Pharmacovigilance

Periodic Safety Update Report

Datamining

FDA Adverse Event

Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS)

• FAERS contains adverse drug reaction reports FDA has received from manufacturers as required by regulation

• Single or multiple Individual Case Safety Reports (ICSRs) comprises of FAERS

• The MedWatch site provides information about voluntary and mandatory reporting of FAERS

Individual Case Safety Reports (ICSRs)

Description of adverse event

Suspected and concomitant product therapy details (e.g.,

dose, dates of therapy)

Patient characteristics (e.g., age, sex), baseline medical condition, co-

morbid condition, family history, other risk factors

Documentation of the diagnosis

Clinical course and outcomes

Relevant therapeutic measures and laboratory

data

Dechallenge and rechallenge information

Reporter contact information

Any other relevant information

A Good Quality ICSRs should contain following information for an adequate assessment of safety signals

Limitations of FDA Adverse Event Reporting System (FAERS) Events with high background rates Worsening of pre‐existing disease Issue is beyond the name of the drug Comparative incidence ratesComparing drugs in the same classDisease is reflected in the adverse event Looking for drug interactionsReporting biases

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