Sources of ICSR: Unsolicited Sources

Unsolicited Sources:

Spontaneous Reports: A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme. Stimulated reporting may occur in certain situations, such as a notification by a "Dear Healthcare Professional" letter, a publication in the press, or questioning of healthcare professionals by company representatives. These reports should be considered spontaneous.

Consumer reports:Consumer adverse reaction reports should be handled as spontaneous reports irrespective of any subsequent "medical confirmation", a process required by some authorities for reportability. Even if reports received from consumers do not qualify for regulatory reporting, the cases should be retained. Emphasis should be placed on the quality of the report and not on its source.

Literature:The Marketing Authorisation Holder (MAH) is expected to regularly screen the worldwide scientific literature, by accessing widely used systematic literature reviews or reference databases. Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, might qualify for expedited reporting. A regulatory reporting form with relevant medical information should be provided for each identifiable patient. The publication reference(s) should be given as the report source; additionally a copy of the article might be requested by the local regulatory authority to accompany the report. All company offices are encouraged to be aware of publications in their local journals and to bring them to the attention of the company safety department as appropriate. The regulatory reporting time clock starts once it is determined that the case meets minimum criteria for reportability. MAHs should search the literature according to local regulation or at least once a month. If the product source, brand, or trade name is not specified, the MAH should assume that it was its product, although reports should indicate that the specific brand was not identified.

Internet:MAHs are not expected to screen external websites for ADR information. However, if an MAH becomes aware of an adverse reaction on a website that it does not manage, the MAH should review the adverse reaction and determine whether it should be reported. Unsolicited cases from the Internet should be handled as spontaneous reports. MAHs should regularly screen their websites for potential ADR case reports. MAHs and regulators should consider utilising their websites to facilitate ADR data collection, e.g. by providing ADR forms for direct reporting or by providing appropriate contact details for direct communication. For the determination of reportability the same criteria should be applied as for cases provided via other ways.

Other Sources:If MAHs become aware of a case report from non-medical sources, it should be handled as a spontaneous report.

Source: ICH Guidelines 

Terminologies: Vigimed,Vigiflow,Vigibase and Vigisearch.

Vigibase: The name for the WHO International ADR Database

Vigiflow: is a sophisticated case report management system created by the UMC, complying with GxP requirements.

Vigisearch : is a custom search offered by the UMC to third –party inquirers for which several types of standard presentation are available.

Vigimed: E-mail conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring.

Source: www.who-umc.org/graphics/15338.pdf

Causality assessment

The evaluation of the likelihood that a medicine was the causative agent of an observed adverse reaction.
Causality assessment is usually made according established algorithms.

Methods of causality assessment:

• WHO assessment scale
• Naranjo’s scale
• European ABO system
• Karch and Lasagna’s scale
• Kramer scale
• Bayesian network
• Yale Algorithm
• Spanish Imputation System

WHO Causality categories:

1. Certain
2. Probable
3. Possible
4. Unlikely
5. Conditional/Unclassified
6. Unassessable/Unclassifiable.

Reference: WHO

Adverse Event Types

Adverse Events are categorized in to 4 different types based on the following criteria:

• Intensity: Based on intensity it is again categorized in to Mild ,Moderate, Severe.

• Seriousness: Based on its seriousness it is again categorized in to Non Serious and Serious.

• Expectedness: Based on its seriousness it is again categorized in to Expected and Unexpected.

• Causality: Based on the causality assessment  it is again categorized in to Related and Un-related.

Glossary of Important Terms in Pharmacovigilance

PharmacovigilanceWHO, 2002 :The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Adverse reactionWHO, (1972):'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'.

Adverse event: Unintended effect occurring at normal dose related to the pharmacological properties.

Serious adverse event or reaction: Any untoward medical occurrence that at any dose;
Results in death; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent of significant disability or incapacity.

Unexpected adverse reaction: Not consistent with applicable product information or characteristics of drug.

Signal: Reported information on possible causal relationship between an adverse event and drug Previously unknown or incompletely documented; More than one report is needed.