Pharmacovigilance and Spontaneous Reporting

Definition of Spontaneous Reporting

• Spontaneous reporting is an unsolicited communication by a healthcare professional or consumer to a company, regulatory authority, or other organization that describes one or more adverse drug reactions in a patient who was given one or more medicinal products.
• It does not derive from a study or any organized data collection scheme (ICH 2003).

Characteristics of Spontaneous Reporting Systems (SRS)

• Passive approach to pharmacovigilance (PV), relying entirely on the motivation of individuals to report suspected adverse drug reactions (ADRs).
• Can be paper-based (e.g. UK 'Yellow Card' system) or electronic (online reporting or mobile applications).
• Single reports from individual patients submitted to pharmacovigilance centres via SRS are known as Individual Case Study Reports (ICSRs).
• Information from multiple ICSRs is used to identify potential 'signals' – suggestions of casual associations between a medicinal product and a previously unknown reaction.

Importance of Spontaneous Reporting

• Covers all medicine use within a whole population for an unlimited time period (WHO 2006), encompassing the entire product life cycle of each medicine.
• Considered the mainstay of ADR reporting, with the existence of a national spontaneous reporting system being one of the World Health Organization's (WHO) five minimum requirements for a functional national PV system (WHO 2010).
• Basis of the WHO Programme for International Drug Monitoring's (PIDM) reporting system VigiBase, to which member states submit ICSRs for accurate international analysis (UMC 2019).

Global Pharmacovigilance System

• Strength lies in the integration of national and industry PV systems.
• The UMC, alongside MAHs and national RAs, are one of the 3 main players in PV at a global level, each with its own goals and perspectives when conducting PV activities (Schurer 2019).
• Many developing member countries lack the capacity and capability to take full advantage of the services offered by the UMC (Schurer 2019).

Advantages of Spontaneous Reporting

• Wide coverage means rare, serious ADRs not detected during earlier trials or through other pharmacovigilance methodologies may be revealed (WHO 2006).
• Generates most drug safety data, even more so than clinical trials during drug development (Lester et al., 2013).
• Relative ease of operation and low cost, coverage of whole patient populations and lifecycle follow-up of medicines, non-interference with prescribing habits, and potential to allow for follow-up studies make them a practical and inviting approach for LMICs (Isah, Pal et al. 2012).

Learn about spontaneous reporting in pharmacovigilance, its definition, and characteristics. Understand how it differs from organized data collection schemes.