As per ICH-GCP E6 Guidelines Adverse Event is “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). “

OR

As per ICH-GCP E2A “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”

An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

If it occurs due to unsuitable or incorrect dosage or procedure then this is called medical error and not a complication.

Adverse events data recording is applied for all licensed medicines, over the counter drugs, herbal supplements and unlicensed medicines found in cosmetic treatments. Physicians, pharmacists and nurse even patient can be report the adverse event to authorities or pharma concerned person.

adverse-event

Classification

In drugs, adverse events defined as: “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”

In clinical trials, a difference is made between adverse events and serious adverse events. Trials data helps in outcome result of particular drug and labeling of the medication to provide valid information for both patient and the physicians.

If adverse event move to serious side then it termed as “life-threatening”, in which the patient was at risk of death at the time of event and we can say “Serious Adverse Events”.

See Also: Serious Adverse Events (SAE)

Adverse Event Reporting systems

Adverse events is categories in serious zone that’s why many countries make a law for adverse event reporting and it is mandatory for each and every drug, medical device and medical related instruments which is taken by patients. In clinical trials, Investigator is responsible to report these events in clinical study report. Many countries have a specific name and format of adverse events reporting form and process.

United Kingdom: In United Kingdom, it is Yellow Card Scheme and it is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) to collect information on adverse events to medicines.

Australia: In Australia, adverse event is administrated by the combination of two committees, Adverse Drug Reactions Advisory Committee (ADRAC) and a subcommittee of the Australian Drug Evaluation Committee (ADEC). ADRAC publishes the Australian Adverse Drug Reaction Bulletin in every two months.

New Zealand: In New Zealand, all the adverse events related issue handle and managed by Centre for Adverse Reactions Monitoring (CARM).  Currently CARM have over 80,000 reports stored in their database and on the basis of these reports they serve to support clinical trials.

Canada: In Canada, it is administrated by Health Products and Food Branch (HPFB) of Health Canada. Marketed Health Products Directorate (MHPD) also works with HPFB and other international organizations to facilitate the sharing of information.