Harmonising global sharing of patient safety data

The “Simplified E2B Guide for Primary Reporters” aims to overcome some of the barriers that health authorities may face in submitting adverse drug reaction reports to the global database VigiBase.

One might think that under-reporting from health authorities, i.e. national centres (NCs), to VigiBase, the WHO global individual case safety reports (ICSRs) database, is due to a lack of willingness to share patient safety data globally. It is quite the opposite. NCs are striving to add their national safety data to VigiBase, to boost the value of global pharmacovigilance data. The challenges for NCs are how to easily and efficiently collect national patient safety data, and ultimately how to allow for an easy and efficient sharing of that data. Electronic data captured from sources that utilise existing standards might be a solution. Standards are however often perceived to be complex – as we will see they don’t have to be.

In most countries, paper-based reporting is still the core method for reporting suspected adverse drug reactions (ADRs) to medicines. However, more sophisticated and electronically developed reporting solutions (e.g. mobile apps and online reporting) are rapidly evolving. No matter how sophisticated the collection process is, if it is not harmonised with global standards available for pharmacovigilance information, failure to share data globally is still the harsh reality.

The document “Simplified E2B Guide for Primary Reporters” can help any electronic reporting solution to create and transfer safety data in a harmonised way, using the international ICH E2B standard.

“The [guide] is a very comprehensive and focused document on the main concepts of E2B R2,” Stéphanie Bodin-Pärssinen said after reviewing the document. Bodin-Pärssinen, director of the QPPV office at UCB Biopharma SPRL. Quality Assurance and one of the partners in the WEB-RADR project, continued: “The xml structure, code lists, formats et cetera are illustrated through graphical representations and very valuable examples.”

“This constitutes a fantastic introduction to the ICH E2B R2 standard for IT personal or vendors unfamiliar with pharmacovigilance safety reporting and also for pharmacovigilance staff willing to know more about the technical aspects of the ICSR transmission,” she said.

Most NCs are already capable of handling ICSRs according to these standards, either through a vendor, or home-built systems, or through the widely adopted VigiFlow system. The NCs’ needs are different and international standards can be utilised in several different ways. There is no one-size-fits-all solution in place, and standards can be introduced step by step, starting with simple primary reporting scenarios and continuing all the way to full fledged data-exchange workflows with pharma industry.

Taking into account the international dimension of ADR reporting and the need to achieve harmonisation and high quality between all parties involved, ICSRs should be submitted electronically as structured data with the use of controlled vocabularies. In respect of the content and format of electronic ICSRs, all involved parties are encouraged to adhere to internationally agreed ICH-guidelines and standards. To interpret and implement these comprehensive guidelines/standards is however complex and time consuming. The aim of the guide is to make the essential parts of those complex standards reachable for everyone; thereby facilitating international data exchange.

This blog post was also published in Uppsala Reports, issue 74.