Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible

'Risk Management Plan Educational Materials' (RMP EMs) are additional risk minimization measures (aRMMs) intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient. While the healthcare sector is embracing various digital tools and platforms for educational and/or awareness building purposes, paper-based materials have remained the mainstay approach for implementation of aRMMs by pharmaceutical companies. Novartis in Singapore conducted a pilot on the feasibility of distributing electronic copies of RMP EMs (e-RMP). Post-pilot, e-RMP was officially implemented in Novartis Singapore. A year following the launch of e-RMP, a survey was performed with healthcare professionals (HCPs) to understand end-users' experience. The survey responses revealed a general preference by both HCPs and patients towards e-RMP. Digital methods of delivering educational aRMMs offer great benefits over traditional paper-based programs. e-RMP significantly reduces the time needed for updated RMP EMs to reach HCPs and their patients/caregivers. This is important to ensure that HCPs and patients/caregivers are made aware of any updates in key safety messages of the products in a timely manner to ultimately ensure patient safety. The successful transition to digital solutions requires purposeful collaborations between key stakeholders of the healthcare ecosystem including regulatory authorities, pharmaceutical companies, HCPs, patients and caregivers. This article aims to provide insights on the digitalization journey of e-RMP, a case study in Singapore, outlining the value but also some of the challenges faced during this transformation.

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Publication Details

Journal
Therapeutic Innovation & Regulatory Science
Published
2024-11-25
DOI
https://doi.org/10.1007/s43441-024-00717-3
Citations
2
Primary Topic
Technology and Data Analysis
Type
article
Field-Weighted Citation Impact
1.56
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article

Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible

Beatriz Fernandes, A. Ng, Ayn Nova Celo
2 citations
Therapeutic Innovation & Regulatory Science
Technology and Data Analysis
1.56
article

Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible

Beatriz Fernandes, A. Ng, Ayn Nova Celo
article en
2 citations

Abstract

'Risk Management Plan Educational Materials' (RMP EMs) are additional risk minimization measures (aRMMs) intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient. While the healthcare sector is embracing various digital tools and platforms for educational and/or awareness building purposes, paper-based materials have remained the mainstay approach for implementation of aRMMs by pharmaceutical companies. Novartis in Singapore conducted a pilot on the feasibility of distributing electronic copies of RMP EMs (e-RMP). Post-pilot, e-RMP was officially implemented in Novartis Singapore. A year following the launch of e-RMP, a survey was performed with healthcare professionals (HCPs) to understand end-users' experience. The survey responses revealed a general preference by both HCPs and patients towards e-RMP. Digital methods of delivering educational aRMMs offer great benefits over traditional paper-based programs. e-RMP significantly reduces the time needed for updated RMP EMs to reach HCPs and their patients/caregivers. This is important to ensure that HCPs and patients/caregivers are made aware of any updates in key safety messages of the products in a timely manner to ultimately ensure patient safety. The successful transition to digital solutions requires purposeful collaborations between key stakeholders of the healthcare ecosystem including regulatory authorities, pharmaceutical companies, HCPs, patients and caregivers. This article aims to provide insights on the digitalization journey of e-RMP, a case study in Singapore, outlining the value but also some of the challenges faced during this transformation.

Therapeutic Innovation & Regulatory ScienceVol. 59(1)
Novartis (India) (IN), Novartis (Singapore) (SG)
Partnerships for the goals
Openalex Percentile: Top 12%
Technology and Data Analysis
1.56
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Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible — Beatriz Fernandes, A. Ng, et al. · Therapeutic Innovation & Regulatory Science (2024) | TGRS Research Map | TGRS