4. EudraVigilance

1. EudraVigilance

1.6. Public Access to EudraVigilance

The adrreport.eu web portal is the gateway to access information from EudraVigilance. This is of specific interest for stakeholder group II, i.e., healthcare professionals and the public.

Since as already mentioned not all data elements can be made available publicly, the following table gives an overview of data elements released for stakeholder group II and from which section of the database.

Table 3: Overview of accessible data elements for stakeholder group II (HCPs, public) and respective EudraVigilance sections and explanatory notes (adapted from EudraVigilance access policy and EudraVigilance User Manual for online access (Version 2.0))

Stakeholder Group II Healthcare Professionals and the Public
Access point: Adrreports.eu portal	Content overview Aggregated data outputs based on predefined queries ICSR line listings (based on core ICSR data elements) ICSR forms (for individual case review)
Section according to ICH E2B(R3) ICSR Implementation Guide	Data element name	Explanation/possible values
C.1 Identification of the Case Safety Report	Type of Report “EudraVigilance Local Report Number”	classification of a report by sender (e.g., spontaneous report) displayed as “EudraVigilance Local Report Number”
C.2.r Primary Source(s) of Information	Reporter’s Country Code Qualification (reporter group)	Country code displayed as EEA or Non-EEA Healthcare Professional (Physician, Pharmacist or Other HCP) Non-Healthcare Professional (Lawyer, Consumer or Other non-HCP)
C.3 Information on Sender of Case Safety Report	Sender Type Sender’s organisation	Displayed as e.g. "EEA Regulator" or “Regional Pharmacovigilance Centre”
C.4.r Literature Reference(s)	Literature Reference(s)
C.5 Study Identification	Study Registration Number Study Name Study Type Where Reaction(s) / Event(s) were Observed
D. Patient Characteristics	Patient Age Group (as per reporter) Sex	Age group (mapped against “Age at Time of Onset of Reaction/Event”, based on the reported patient age or calculated based on difference between “Date of Birth” and “First Reaction Start Date”) Male/female/not specified
E.i Reaction(s)/event(s)	Reaction / Event (MedDRA code^E)
	Results in Death Life Threatening Caused / Prolonged Hospitalisation Disabling / Incapacitating Congenital Anomaly / Birth Defect	Serious
	Other Medically Important Condition (Non-Serious) Suspected Reported Reaction (Preferred Term in MedDRA) (PT) Reaction Group (System Organ Class in MedDRA) (SOC)	Any undesirable effect (suspected adverse reaction) reported by the reporter e.g. Headache, Ear infection e.g. Nervous system disorders
	Duration of reaction / Event (number) Duration of Reaction / Event (unit)
	Outcome of Reaction / Event at the Time of Last Observation	Recovered/resolved Recovering/resolving Not recovered/not resolved Recovered/resolved with sequelae Fatal Unknown Not specified
G.k Drug(s) information	Characterisation of Drug Role Pharmaceutical Product Identifier (PhPID) Medicinal Product Name as Reported by the Primary Source^F Substance / Specified Substance Name^F
G.k.4.r Dosage and Relevant Information	Dose (number) Dose (unit) Number of Units in the Interval Definition of the Time Interval Unit Duration of Drug Administration (number) Duration of Drug Administration (unit) Pharmaceutical Dose Form Term ID Route of Administration Term ID Parent Route of Administration Term ID
G.k.7.r Indication for Use in Case	Indication (MedDRA code) Action(s) Taken with Drug
G.k.9.i Drug-reaction(s) / Event(s) Matrix	Did Reaction Recur on Re-administration? Additional Information on Drug (coded)

Users can search by defined parameters (e.g. product (medicines), active substance, reaction, age group, gender, time period)

There are ‘Download’ and ‘Print’ functions for search results. This might be a summary or individual reports based on defined data elements ensuring compliance with personal data protection legislation. Users are provided with clear guidance on interpretation of the data.

Of the presently 272 data elements per report, for stakeholder group II access will be granted to 53 of the data elements.

It also needs to be recognised that not all data elements of ICSRs are always completed. This means that although access is provided to certain data elements, information may not always be available given the type of the report or the primary source of the information.

Public access to aggregated EudraVigilance data: In November 2017 public access via www.adrreports.eu was further improved by providing additional outputs such as line listings and individual case report forms. By the end of 2019, the website provided information on a total of 3,724 active substances, of which 753 contained in centrally authorised products (CAPs) and 2,971 in nationally authorised products (NAPs).