Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Abstract

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

“…Reports from patients are a well‐established source of information in drug safety 3. Despite patient participation gaining more and more attention worldwide, this does not necessarily mean that countries have fully embraced patient reporting 4, 5. More experience and sharing of information between countries is needed to fully understand its value.…”

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR

“…For example, the users of the UK’s Yellow Card app can select MedDRA terms from a drop-down list to describe their ADR, ensuring that the reaction data are already coded when they are submitted to the MHRA. For the patient version, the MHRA is currently exploring ways to make this feature easier for patients to use with a patient-friendly MedDRA list that contains descriptions of medical concepts in layman’s terms [ 17 , 18 ]. Additionally, distinct questions could be presented to different types of users who may be more likely to be able to provide certain details; for example, a patient may be able to report that a medical product was purchased from an Internet pharmacy, whereas that patient’s HCP may not have that level of knowledge If different versions of a mobile app are needed to best meet the differing needs of multiple target groups, it is recommended that a single app prototype is developed with as many standard features as possible.…”

‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework

“…These approaches usefully illuminate existing engagement activities in pharmacovigilance and risk minimisation, which are often beset by limitations in the impact of, and compliance with, safe use and risk minimisation advice, alongside underreporting of ADRs. Interrelated challenges of motivation, legitimacy [1,16,[48][49][50] and accuracy of risk management-related processes [9,11,17,18,20] are central here.…”

“…This has been argued for the European case [10], the USA [1] and more internationally via CIOMS [8]. In practice, pharmacovigilance is composed of structured processes, including aggregating adverse drug reaction (ADR) case reports [1,[11][12][13][14][15], reviewing pharmacoepidemiological and other study data, identifying and assessing new risks and making decisions [11,[16][17][18][19][20][21] on risk management strategies [22] and their implementation in healthcare [23][24][25][26]. While engagement is increasingly pursued in practice [27,28] and receives global attention [8], empirical research [16,29] into pharmacovigilance engagement remains in its infancy [7].…”