Introduction

Adverse drug reaction (ADR or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. Adverse drug reactions can be considered a form of toxicity; however, toxicity is most commonly applied to effects of over ingestion (accidental or intentional) or to elevated blood levels or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). Definition  All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.  The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least reasonable possibility ICH E2A.

Why ADR Reporting

 ADRs are among the leading cause of death in many countries (WHO, 2008).

 Account for 5% of all hospital admission in India.

Who can report ADR

 Healthcare professionals are urged to report suspected ADRs directly to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme using the electronic form.

 Patients and their care taker can also report suspected ADRs to the MHRA. Reports can be submitted directly to the MHRA through the Yellow Card Scheme using the electronic form.

What Should be Reported?

 Serious, unexpected ADRs.

 Serious, unexpected AE related to trial procedures and which could modify the conduct of the clinical trial.

 Other events and/or safety issues as per applicable local regulatory rules.

Suspected Adverse Reaction ( Same as ADR )

 Any adverse event for which there is a reasonable possibility that the drug caused the adverse event.

 For the purposes of Investigational New Drug (IND) safety reporting, reasonable possibility means there is evidence to suggest a causal relationship between the drug and the adverse event US FDA(CFR), Section 21, Part 312.32.

Expectedness

 Unexpected adverse drug reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure for an unapproved investigational medicinal product).

Rechallenge

 Information about whether an adverse event reappeared or disappeared, fully or partially, upon reintroduction of the product at a reduced dose or reintroduction if temporarily discontinued.

Dechallenge

 The withdrawal of a drug from a patient; the point at which the continuity, reduction, or disappearance of adverse effects may be observed WHO Information about whether an adverse event disappeared, fully or partially, upon reduction in dose or discontinuation of a study product.

Reporting Time Frame

 Fatal or life-threatening unexpected ADRs – as soon as possible but no later than 7 calendar days after first knowledge by the sponsor, followed by a complete report within 8 additional calendar days (this report must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar medicinal products).  All other serious, unexpected ADRs – as soon as possible but no later than 15calendar days after first knowledge by the sponsor.  Shorter timeframes may apply.

Reporting Timelines

EU

Adverse (drug) reaction that is both serious and unexpected, whether foreign or domestic

 Serious suspected adverse reactions that occur in the EU and third countries

 Non-serious suspected

Timeline

 Serious: 15 days

 Non-serious: 90 days

FDA

Adverse (drug) reaction that is both serious and unexpected, whether foreign or domestic Timelines

 15 calendar days

Global reporting forms CIOMS I form

 Globally accepted suspect drug adverse reaction report form developed by the Council for International Organizations of Medical Sciences (CIOMS).

Submission to FDA

• MedWatch/3500A

To report serious unexpected suspected adverse reactions associated with drugs, devices, and biologics.

CHEARS

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Adverse Drug Reaction Reporting

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