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Spontaneous reporting has been defined as:
‘An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organization (e.g. WHO, Regional Centre, Poison Control Centre) 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’(ICH 2003).
Spontaneous reporting is by nature a passive approach to pharmacovigilance (PV), relying entirely on the motivation of individuals to report suspected adverse drug reactions (ADRs) to a local or national pharmacovigilance centre. Spontaneous reporting systems (SRS) can be paper based (e.g. the UK ‘Yellow Card’ system) or electronic (online reporting or mobile applications). Single reports from individual patients submitted to pharmacovigilance centres via these systems are known as Individual Case Study Reports (ICSRs). Information from multiple ICSRs is then used to identify potential ‘signals’ – suggestions of casual associations between a medicinal product and a previously unknown reaction. Detection and confirmation of these signals, though various methods, can identify previously unknown adverse or beneficial effects of a medication. An important feature of SRS is that they cover all medicine use within a whole population for an unlimited time period (WHO 2006), encompassing the entire product life cycle of each medicine.
Spontaneous reporting is so much considered the mainstay of ADR reporting that the existence of a national spontaneous reporting system is one of the World Health Organization’s (WHO) five minimum requirements for a functional national PV system (WHO 2010). It is the basis of the WHO Programme for International Drug Monitoring’s (PIDM) reporting system VigiBase (managed by the Uppsala Monitoring Centre, UMC, Sweden), to which member states of the programme submit ICSRs for accurate international analysis (UMC 2019). The UMC, alongside the various Marketing Authorisation Holders (MAHs) and national Regulatory Authorities (RAs), are one of the 3 main players in PV at a global level. Each of these has its own goals and perspectives when conducting PV activities (Schurer 2019).
- The UMC: To successfully integrate PV data from all WHO member countries and to perform statistical analysis and continuous monitoring of the global PV landscape.
- MAHs: To achieve and maintain regulatory compliance, mitigation of financial and market risks, as well as being able to make informed marketing decisions.
- RAs: To protect and promote patient safety within their public health programs and thus alleviate pressure on their health system.
It is important to note that the strength of the global PV system lies in the integration of national and industry PV systems. While the UMC offers substantial support to the WHO member countries, many developing member countries lack the capacity and capability to take full advantage of the services offered (Schurer 2019). Nevertheless, PV systems in Low-Middle Income Countries (LMIC) are based primarily on spontaneous reporting (Isah, Pal et al. 2012). In 2011, 74% of Sub-Saharan African countries had such a system in place (SPS 2011). Given an increase in African membership to the WHO PIDM ever since, this percentage is certain to have grown.
Spontaneous reporting has some intrinsic advantages over more active reporting methods. The wide coverage means rare, serious ADRs not detected during earlier trials or through other pharmacovigilance methodologies may be revealed (WHO 2006). Indeed, spontaneous reporting during the post-marketing phase generates most drug safety data, even more so than clinical trials during drug development (Lester et al., 2013). The 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).
However, SRS are not without their drawbacks. A primary issue is the reliance on individual motivation for reporting, as in practice this results in only a very small percentage (around 5%) of adverse effects being reported (UMC 2019). Implementation of SRS in LMICs can be hampered by other pressing health priorities and specific challenges, such as remote location, poor telecommunications services and low numbers and level of education of health professionals (Sevene 2008). Health workers may also fail to recognise ADRs, be ignorant of reporting requirements, lack reporting forms, feel guilty about adverse effects or fear litigation (Isah, Pal et al. 2012). In addition, not all existing SRS address the full scope of PV; in Sub-Saharan Africa it is reported that only 50 percent of reports are used for quality defects, 43 percent for treatment ineffectiveness and only 37 percent for medication errors (SPS 2011).
PV systems are complex. The large number of different PV systems, the equally large number of stakeholders within such systems, and the significant dimensions along which effectiveness and efficiency could be measured, adds to this complexity. The primary obstacle to standardising and achieving interoperability between such systems globally is the fundamental difference in purpose of each system (Schurer 2019).
To overcome these challenges, robust active reporting systems should also be used to complement spontaneous reporting. In addition, reporting should be encouraged from all sectors of the healthcare system, including patients, doctors, nurses, pharmacists, traditional practitioners and providers of herbal medicine in order to increase reporting and provide more representative data (WHO 2006). Ehealth tools, particularly via smartphones, are increasingly recognised as valuable for reporting in LMICs where broad mobile phone service can be managed more cheaply than Internet communication, and in more rural areas alternative methods of report communication have been trialled (Sevene 2008, Berrewaerts, Delbecque et al. 2016).
The electronic transmission of ICSRs is outlined in the newly developed ICH E2B(R3) standard, developed to expedite exchange of safety information between systems subjected to various national and international regulations. Interoperability is of vital importance when it comes to avoiding difficulties in reconciling ICSRs on a global level. Adoption and implementation of these standards will be key (Schurer 2019).
Ensuring SRS are utilised and operate to their full potential is challenging, above all in LMICs. Further collaborative research is needed in order to highlight barriers to their implementation to reflect upon and identify potential methodological improvements
References
Berrewaerts, J., L. Delbecque, P. Orban and M. Desseilles (2016). "Patient Participation and the Use of Ehealth Tools for Pharmacoviligance." Front Pharmacol 7: 90.
ICH (2003). Post-approval safety data management: definitions and standards for expedited reporting E2D. European Union International Conference on Harmonisation.
Isah, A. O., S. N. Pal, S. Olsson, A. Dodoo and R. S. Bencheikh (2012). "Specific features of medicines safety and pharmacovigilance in Africa." Ther Adv Drug Saf 3(1): 25-34.
Lester, J., Neyarapally, G.A., Lipowski, E., Graham, C.F., Hall, M. & Dal Pan, G. (2013). "Evaluation of FDA safety-related drug label changes in 2010." Pharmacoepidemiology and Drug Safety, 22, 302-305.
Margraff, F. and D. Bertram (2014). "Adverse drug reaction reporting by patients: an overview of fifty countries." Drug Saf 37(6): 409-419.
Schurer, M.J. (2019). "Towards the interoperability of spontaneous reporting systems in pharmacovigilance: A maturity model approach with a sociotechnical system focus", PhD thesis (still in progress), Dept. of Industrial Engineering, Stellenbosch University.
Sevene, E. M., A.; Mehta, U.; Machai, M.; Dodoo, A.; Vilardell, D.; Patel, S.; Barnes, K.; Carné, X. (2008). "Spontaneous Adverse Drug Reaction Reporting in Rural Districs of Mozambique." Drug Saf 31(10): 867-876.
SPS (2011). Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance. Arlington, VA: Management Sciences for Health, Submitted to the US Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program.
UMC. (2019). "https://www.who-umc.org/." Retrieved 14/02/2019.
WHO (2006). The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool, World Health Organisation.
WHO (2010). Minimum Requirements for a functional Pharmacovigilance System, World Health Organisation.
Useful Links
Uppsala Monitoring Centre:
• Home
• Spontaneous Reporting
• Vigibase
• Vigiflow
• Joining the PIDM
WHO
• The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool
• Minimum Requirements for a functional Pharmacovigilance System
• Methods to study medicine safety problems - Presentation
• Pharmacovigilance Toolkit
Strengthening Pharmaceutical Systems (SPS) Program
• Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance
TGHN
• Global Pharmacovigilance
- Glossary of Drug Safety Terms
- The patient's ‘voice’ in pharmacovigilance – Article