Strategies for Navigating Complex Pharmacovigilance Reporting Requirements: A Focus on Uganda's Unique Challenges

A critical process in the pharmacovigilance (PV) system of a Marketing Authorization Holder (MAH) is the submission of Individual Case Safety Reports (ICSRs) to Health Authorities (HAs). The process provides core metrics used to measure the PV system's performance.

Multinational MAHs with a centralised PV system, however, face tremendous challenges in complying with varying reporting formats and timelines for different categories of ICSRs. The categories include in-country or foreign cases, expected or unexpected cases, and severe or non-severe cases.?

Their timelines vary accordingly and with different markets, and aligning these with internal processes is a PV nuisance. An internal process such as submitting cases originating from literature surveillance often takes longer than the submission timeframes set by HAs for such reports. With third party outsourcing, receiving and processing these cases may take time before the MAH can forward a final report to the HA. For cases that require submission within 24 to 48 hours by the HA, this is usually an unattainable feat.?

Uganda is one such market that distresses MAHs? with its complex reporting requirements, which deviate considerably from international and regional guidelines. ICH E2D Post-Approval Safety Data Management: Definitions And Standards For Expedited Reporting and EAC Harmonized Compendium on Safety and Vigilance of Medical Products and Health Technologies guide timeframes for reporting Adverse Drug Reactions (ADRs).?

Besides never fully adapting to any of the above, Uganda’s guidelines also notably don’t? define ‘day zero’ and ‘become aware,’ which means MAH rely on the global definition. According to ICH, the regulatory reporting time clock is considered to start on the date when any MAH personnel first receive a case report that fulfills the minimum criteria and expedited reporting criteria. This isn’t always the case with Uganda’s system in practice.

The table below illustrates how Uganda’s reporting requirements differ from the regional and ICH guidelines. Take for example, foreign serious and unexpected adverse events are required to be submitted within 15 calendar days while in the regional guideline, such cases are reported as per regular timelines within the PSUR.?

As a PV manager, how, then, do you navigate the complex and grey requirements for ICSR submission in countries such as Uganda:

1. Automation of submission. Uganda requires serious and unexpected cases outside Uganda to be submitted within 15 calendar days. MAHs can receive hundreds or even thousands of these cases in a month, and manual submission can be daunting. Safety databases set to automate submission to HAs can improve efficiency and compliance.?
2. Internal procedures and statements of work with external providers, such as in-literature surveillance, should include unique provisions to ensure compliance with cases that have to be submitted in less than 48 hours.
3. Initial notification. For serious and unexpected cases in Uganda that should be submitted within 24-48 hours, notify the HA even when you don’t have all the supporting documents. This can happen for cases originating from literature sources. There may be delay in obtaining the full-text article that is supposed to be submitted in tandem with the ICSR so you work with what you have as you acquire all that you need.?
4. Advocacy for harmonisation. Write to the HAs on the challenges in meeting the requirements and the need for more clarity in current guidelines. While the requirements won’t be changed immediately, advocacy from MAHs could ensure the necessary changes whenever the guidelines are updated.?

In conclusion, Uganda’s ICSR reporting requirement is unique and complex and differs significantly from that of other countries. MAHs’ PV systems should cater to these differences and? comply with the country’s regulations.

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Assessing the Impact of EAC Harmonized Compendium on Pharmacovigilance Regulations: Progress, Challenges, and Future Outlook