Communication on drug safety-related matters to patients: is it even more significant in this digital era?

José, Jimmy

doi:10.1177/2042098620915057

Cited by 4 publications

(1 citation statement)

References 25 publications

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“…Inclusion of a PPL based on the Summary of Product Characteristic in the medicine packaging is a legal requirement for all medicines, including vaccines [15][16][17]. Although the PPL should not be the sole way to inform the patient [18,19], and despite some improvement and the existence of guidelines [13], several problems remain [20][21][22][23][24][25]. There is evidence that the current leaflets for vaccines can be improved [26,27].…”

Section: Introductionmentioning

confidence: 99%

Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups

et al. 2022

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Background In the European Union it is mandatory to include paper package leaflets (PPL) with all medicines, including vaccines, to inform the recipient. However, it is difficult to meet the necessity for localized PPLs in each of the 24 official European languages. Replacing PPLs with electronic versions offers many advantages including redistribution across nations, reduced storage space, accessibility by the visually impaired, easily updated information or the addition of video content. We wanted to assess the attitudes of patients (vaccine recipients or their parents) to the potential of replacing PPL with electronic versions. Methods We surveyed vaccinees or their parents in four European countries—Belgium, Italy, Bulgaria and France—for their actual use of vaccine PPLs and their opinions about switching to an electronic package leaflet. Our survey was conducted online because of the COVID-19 pandemic and resulted in 2518 responses to a questionnaire targeted at three specific groups with particular information needs: parents of young children, pregnant women and the elderly (≥ 60 years). Results Our main findings are that currently vaccine PPLs are rarely used and frequently unavailable for the vaccinee. Across the four countries surveyed 55–82% of vaccinees would accept an electronic version, as did 64% when there was an option to request a printout of the leaflet. Conclusions We found that switching to electronic versions of vaccine PPLs is an acceptable alternative for the public, potentially increasing the quality and amount of information reaching vaccinees while eliminating some barriers to redistribution of vaccines between countries.

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Section: Introductionmentioning

confidence: 99%

Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups

et al. 2022

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Introduction to Drug Safety and Pharmacovigilance

Jose,

Cox,

Bate

2024

Principles and Practice of Pharmacovigilance and Drug Safety

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When, Why and How to Re-challenge Clozapine in Schizophrenia Following Myocarditis

Qubad,

Dupont,

Hahn

et al. 2024

CNS Drugs

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Clozapine-induced myocarditis (CIM) is among the most important adverse events limiting the use of clozapine as the most effective treatment for schizophrenia. CIM necessitates the immediate termination of clozapine, often resulting in its permanent discontinuation with considerable detrimental effects on patients’ psychopathology and long-term outcome. Consequently, a clozapine re-challenge after CIM is increasingly regarded as a viable alternative, with published reports indicating a success rate of approximately 60%. However, published cases of re-challenges after CIM remain limited. Here, we provide a narrative review of the current state of research regarding the epidemiology, pathophysiology, risk factors, diagnosis and clinical management of CIM as well as a synthesis of current recommendations for re-challenging patients after CIM. This includes a step-by-step guide for this crucial procedure based on the current evidence regarding the pathophysiology and risk factors for CIM. Slow dose titration regimes and addressing risk factors including concomitant valproate and olanzapine are crucial both to prevent CIM and to ensure a safe and successful re-challenge. Furthermore, we discuss the utility of C-reactive protein, troponin, N-terminal-pro hormone and brain natriuretic peptide, therapeutic drug-monitoring and cardiac magnetic resonance imaging for CIM screening and diagnosis as well as for post-CIM re-challenges.

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Communication on drug safety-related matters to patients: is it even more significant in this digital era?

Cited by 4 publications

References 25 publications

Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups

Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups

Introduction to Drug Safety and Pharmacovigilance

When, Why and How to Re-challenge Clozapine in Schizophrenia Following Myocarditis

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