Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

Abstract

Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States

“…In this study, the percentage of changes made in both countries within 30 days was low at 7.5% and some of the safety label changes had a time lag over 2 years. Pharmacovigilance is a field in which communication is very crucial, and the exchange of information is expected to be done in a timely manner 20 . Nowadays there is a recognized need for competent and rapid communication between national drug regulatory centers as well as to other countries 21 .…”

Pharmacovigilance: reporting requirements throughout a product’s lifecycle

“…For example, postmarketing reporting by HCPs may lack sufficient information to adjudicate AE causality or relationship to drug, creating uncertainty over whether the reported event could be considered drug related. 21 , 27 In unsolicited AE reporting, causality is assumed, not assessed, 64 , 65 and follow-up reports are not required unless new information arises, 65 making it challenging to determine causality if the information provided is incomplete or confounded. 2 When AEs are reported, the lack of standardized definitions used for postmarketing reporting by HCPs 36 and unverified information in these reports 27 may contribute to inaccuracies within the reports.…”

Safety of medicines and vaccines – building next generation capability

“…These still need to be processed and evaluated, according to the strict regulations in place, with a risk of taking the focus away from ICSRs with pharmacovigilance utility that is with the most likely to further understanding of the risk-benefit balance. • Reporting regulations are evolving and extending around the world [92][93][94], but a harmonised approach is not always seen, leading to increased workload. One might reasonably ask whether there is always a compelling link between changes to safety regulation and the accompanying efforts need to assure compliance [95] and their capability to further patient safety.…”