Blog: DSRU Global Pharmacovigilance Observatory – An Introduction

Samantha Lane and Saad Shakir

03 February 2021

There are a number of broad similarities between national medicines regulators across the world, however there are also important differences in how each agency operates. A long-standing important issue is why different national regulatory authorities can reach different decisions. One factor is that countries can have different health systems and different regulatory schools. While some differences in the decisions about marketing authorisations can be understood because of the complexity of healthcare systems, societal differences, and marketing plans by pharmaceutical companies, it can be more difficult to justify many, if not most, major pharmacovigilance decisions.

One high-profile example is the removal of rosiglitazone from market in Europe, while the drug remained available in the United States (US). The product was on the market for around ten years in both territories, and multiple studies including tens of thousands of exposed patients had been conducted, however questions remained about its cardiovascular safety. The European Medicines Agency (EMA) recommended the suspension of rosiglitazone-containing medicines throughout Europe in 2010 (European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim | European Medicines Agency (europa.eu)). The Food and Drug Administration (FDA) launched a review at the same time, however it was deemed that there was no increased risk in cardiovascular events compared with alternative Type 2 Diabetes Mellitus medicines also available in the US; therefore the product remained on the market with some prescribing and dispensing restrictions (FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines | FDA).

Regulatory authorities around the world handle spontaneous reports of suspected adverse drug reactions differently. Differences include methods for signal detection and communication. For example, for vaccines and medicines for COVID-19 some plan to publish regular summaries of reports they receive, while other agencies are not disseminating this information.

The DSRU Global Pharmacovigilance Observatory brings together outputs from several regulatory authorities into one place. This is important for improving the understanding of adverse drug reactions; bringing reports into one document increases the numbers, allowing for higher accuracy and more advanced analyses where appropriate. Many of the analyses will be "living" which will be updated when new relevant information becomes available. The DSRU Global Pharmacovigilance Observatory will fill a knowledge gap which has been needed for many years.