WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems

Abstract

Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed.

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

“…The unsolicited or spontaneous reporting of such ADRs is the cornerstone of data generation in post-marketing drug safety and surveillance. However, research suggests that spontaneous reporting is not a sufficiently comprehensive method of generating the data needed to make quantitative conclusions about the safety of medicines in the long term ( [9], [10], [11]). …”

“…The primary benefit of CEM is realised when it is used to observe the effects of a new medicine in the early stages of post-marketing authorisation [10]. Although all PV activities are centrally focused on patient safety, CEM focuses on a specific medication for the time before and during the control period.…”

“…Targeted spontaneous reporting (TSR) is a methodology similar to spontaneous reporting, but involving well-defined patient groups where healthcare professionals (HCPs) are on the lookout for specific ADRs [10]. TSR is an active method of surveillance in a well-defined population group, whereas spontaneous reporting is a passive method of surveillance used within an undefined population [13].…”

Are patients ready to take part in the Pharmacovigilance system? a portuguese preliminary study concerning adr reporting

“…(12,15) Spontaneous reporting is generally used for signal detection purposes and in publications about ADR. …”

“…(15) In fact, spontaneous reporting of ADRs is the most common method used in Pharmacovigilance, and remains one of the most effective methods to detect new, unusual and serious drug reactions; (17) spontaneous reporting has been the primary postmarketing safety evidences source, that contribute to the early identification and evaluation of the drug safety issues, that could result in different regulatory actions such as product withdrawal, continued monitoring, product labelling changes or new medication guide-related communication, among others. (18) The monitoring of adverse drug reactions through pharmacovigilance is vital to patient safety.…”