The value of direct patient reporting in pharmacovigilance

Abstract

Nurses, pharmacists, doctors and patients each hold a piece of the puzzle and only by placing the pieces together will we be able to see the big picture at last. Everyone-patients includedneeds to be invited to the big round table of medicine safety 1. Of the 59 approved new molecular entities in 2018, 48 include a table summarizing whether

Health Literacy: The Common Denominator of Healthcare Progress

“…Pharmacovigilance has not been a large experimental ground for patient participation; on the one hand, this is because it has always been perceived as an area where only healthcare professionals have the right competence to deal with adverse events and the associated risks, and on the other hand, because patients have not historically been encouraged to play an active role in this issue. With an increasing number of drugs being approved on shorter trials that involve fewer patients, obtaining timely and accurate reports of adverse events and side effects after approval from all members of the post-marketing ecosystem is more important than ever [ 19 ].…”

Patient Associations as key players in pharmacovigilance: results of an Italian survey from the Patient Safety Council

“…From their side, Regulatory Authorities are increasingly planning to involve patients and PAs in their activities (17). Despite its fast evolution in the last years (18), pharmacovigilance (PV), has not been fully included in this evolving scenario in Italy. Indeed, we are currently in the era of Pharmacovigilance 2.0, a revolutionary change made possible by digitalization.…”

“…An increasing number of drugs are being approved after short trials involving few patients; therefore, accurate reports of AEs and side effects following approval are becoming imperative. Real-world evidence obtained by patients is gaining paramount importance in regulatory evaluations (18). Independent and subjective patient reporting is crucial, as physicians often underestimate or dismiss specific side effects like fatigue and overestimate others.…”

Adverse drug reaction reporting for more than a decade: The need for pharmacovigilance policy implementation in Turkey

“…Active patient participation in PV activities is beneficial for a higher ADR reporting rate. 11 , 12 New policies and implementations are needed – such as in Europe – to compel and encourage all stakeholders (including patients) in the healthcare system to report suspected ADRs in Turkey. 6 As such, a direct patient reporting system should be implemented to actively participate in ADR reporting.…”

“…All HCPs at hospitals – including physicians, pharmacists, nurses, and other paramedical personnel – might inform and educate patients about the opportunity to self-report side effects when they begin treatment as well as the necessary action in the case of any experienced ADRs. 12 The hospital's PV centre can make a significant contribution to the spread of accurate information about the necessity of direct reporting in PV to patients visiting the hospital.…”