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Dec 12

The Hidden Iceberg – The Problem with Safety Reporting

In most cases, a drug’s full harmful side-effects are only discovered within the post-marketing stage – once the drug has already gone to market. This is often due to the number and diversity of test subjects, within the clinical trial phase, being an inaccurate and inadequate representation of the general public – resulting in the clinical trial’s consequential reduced detection capacity for side-effects and a potential increased risk of harm for patients.

As a result, this places an increased significance on the importance of reporting adverse drug reactions (ADRs) and adverse events (AEs), by both health care professionals (HCPs) and by patients. However, the under-reporting of ADRs and AEs remains a major global concern for both patients and those within the pharmaceutical industry – with an approximated 1/10 of total serious adverse drug reactions (SADRs) being officially reported to the appropriate authority (Timmerman, 2015). Meaning that, if we are missing ADRs and only picking up 10% of all reactions, then for very rare reactions – that are classified as occurring in 1/10,000 patients – we need exposure to 100,000 patients, to pick up the one adverse reaction.

In a report from the Institute for Safe Medicines Practices, a non-profit prescription drug watchdog group outlined that adverse events are extremely under-reported – finding that only 1% of an approximate 276,000 serious adverse experiences were officially reported to the Food and Drug Administration (FDA) in 2017 (Silverman, 2019). This is correlated in the volume of submissions to the National Agency for Food and Drug Administration and Control (NAFDAC) between 2004-2016, with only 20.6% of nationally distributed ADR forms resulting in the submission of individual case safety reports (ICSRs) (Avong et al, 2018). Altogether, outlining the severity of the issue that is chronic under-reporting.

Furthermore, within a study conducted by a Canadian research group, which aimed to address the existing opinions of Health Care Professional (HCPs) with regards to barriers against formal ADR documentation, it was found that there are indeed multiple reasons for why there is an evident under-reporting of ADRs and AEs. These range from patients being unaware of how to properly access said forms, to HCPs and other front-line industry professionals believing the forms and associated reporting process is not suited to working practice, due to the lack of transparency and convenience in locating, completing and submitting the appropriate forms – altogether deterring reporters from providing valuable safety data to the Pharma Industry and Regulators.

Moreover, within their findings, it was proposed that the key barrier to the reporting of ADRs and AEs by HCP’s was the time constraints associated with their profession, with reporting to external authorities seen as a duplication of workload; thus, resulting in a general lack of motivation for routine reporting, due to existing processes being overly labour intensive. (Hohl et al, 2018).

As a result, in addition to there being an evident need for improving the education of HCPs in the importance of reporting ADRs (Hussain,2019), there is an ever-growing belief that accessibility to proper reporting be given more to the patient; with awareness campaigns created on how they can better complete this process directly. This is reaffirmed within a research project of 820 consumers of medicine, where 96.1% felt that direct reporting by the consumer would significantly improve the ADR documentation process, with 93.7% also stating that they’d be happy to utilise a consumer reporting programme in the future (Patel et al, 2019).

It is therefore the responsibility of pharmacovigilance providers to help raise awareness for this global issue; looking towards improving processes, to ease the reporting procedure for front-line staff, by making general ADR documentation simpler and less time consuming. In addition to investing in innovative solutions that takes sole reporting responsibility away from the HCP and more towards the patient – perhaps even towards an automated nature, easing the process for all stakeholders.

CEO Comment

The above article highlights what has been known by pharmacovigilance departments for years. Under-reporting; delayed reporting; lack of follow up due to time constraints; lack of understanding of what needs completing and ease of locating the forms and submitting them have all contributed to the paucity of essential reports that help Pharma understand the risks associated with their products better, earlier and to take action to mitigate against such risks.

Pharsafer believes the capability to improve all of these things is there and, in 2020, we look forward to exploring fresh approaches to target and resolve these issues.


Avong, Y. (2018). Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study. Available at: (Accessed 6th Dec. 2019).

Hohl, C. et al. (2018). Why Clinicians Don’t Report Adverse Drug Events: Qualitative StudyJMIR Public Health and Surveillance.  Volume 4. Issue: 1.

Hussain, R. et al. (2019) Evaluation of an Educational Intervention on Physicians’ Knowledge About Adverse Drug Reaction Reporting System. Journal of Public Health.

Patel, J. et al (2019). Knowledge, Attitude and Practice Among Consumers About Adverse Drug Reaction ReportingInternational Journal of Basic & Clinical Pharmacology. Volume 8. Issue: 8.

Silverman, E. (2019). What Side Effects? Problems with Medicines may be Vastly Under-Reported to the FDA. Available at: (Accessed 6th Dec. 2019).

Timmerman, L. (2015). Failing To Report Severe Drug Side Effects: A National Embarrassment. Available at: (Accessed 6th Dec. 2019).

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