he value of Risk Management Plan Educational Materials (RMP EMs) depends on real-time access to the latest approved version. If paper-based materials are lost, delayed, or outdated after a safety update, users may not have current advice on monitoring, precautions, or actions to take. Electronic access can reduce delays linked to printing and physical distribution and can help keep safety information available beyond the clinic visit.

Thailand has made RMP EMs available on the Thai Food and Drug Administration (Thai FDA) website, providing an additional digital access channel alongside traditional paper-based distribution through Quick Response (QR) codes.

This shift represents more than a change in format. The important question is not only what changed, but why it matters: A digital route can help healthcare professionals (HCPs), patients, caregivers, and regulators access current safety information more quickly and consistently when risk-minimization messages are updated.

Electronic RMP EMs give patients and caregivers continued access to approved risk-minimization information beyond the clinic visit, allowing key risks, precautions, monitoring advice, and actions to be revisited when needed to support safe medicine use. Hosting the materials on regulatory websites together with e-labeling further enhances the value by creating a centralized and trusted pathway. Hosting the materials on regulatory websites together with e-labeling further enhances their value by creating a centralized and trusted pathway to access.

Why Is Paper Alone Not Enough?

RMPs outline how a company will identify, characterize, and minimize risk of a medicinal product throughout its lifecycle. EMs are additional risk-minimization tools used to communicate practical safety information to HCPs, patients, and caregivers, including prescriber guides, patient or caregiver guides, checklists, patient cards, and key safety actions. Electronic access to RMP EMs helps keep safety information readily available to users.

Regulatory context also matters. European Medicines Agency (EMA) Guidance on Good Pharmacovigilance Practices (GVP) describes RMPs and risk-minimization measures, and its addendum on effectiveness evaluation emphasizes assessing whether risk-minimization activities work in practice. In Thailand, approved electronic RMP EMs can be hyperlinked to the official Thai FDA drug information portal, providing a centralized public route for product prescribing information.

Benefits to HCPs, Patients, and Caregivers

Thailand provides a particularly relevant setting for this alternative accessible model because HCPs and the general public increasingly rely on digital channels for accessing healthcare information, while regulators continue to expand the availability of online medicine information resources. This makes QR-code-enabled access to approved safety materials both practical and aligned with the broader direction of medicine information access in Thailand.

Thailand’s story is important because this alternative accessible model creates practical benefits for three groups.

• For patients and caregivers, digital approaches provide easier access to current, approved RMP EMs containing key safety information. The RMP EMs continue to be available after the clinic visit, reducing reliance on misplaced or outdated documents and supporting consistent discussions with HCPs on key risks, monitoring, precautions, and safe use. Patients and caregivers can revisit the materials whenever needed.
• For HCPs, centralized national platform and QR-code access can simplify accessing and retrieving current prescribing information and RMP EMs during consultations or follow-up discussions, reducing reliance on possibly outdated stored paper copies.
• For regulators, centralized hosting on the Thai FDA platform can support consistent public access to the latest approved versions of risk-minimization materials from a trusted regulatory source, while creating a more sustainable update pathway when safety information changes.

At the same time, electronic-first should not mean electronic-only. Patient and caregiver needs vary, and some users may still prefer or require printed materials. The Thailand model, which combines Thai FDA-hosted electronic access with targeted paper support for patients who wish to receive paper, can modernize safety communication while preserving inclusivity.

What Thailand Implemented

in January 2025, in response to an informal suggestion from the Thai FDA, the Thailand-based subsidiary of a multinational pharmaceutical and biotechnology corporation introduced digital distribution of RMP EMs for four medicinal products. Once approved by the Thai FDA, the EMs were uploaded by the company and published on the Thai FDA website together with e-labeling which refers to the Thai FDA-approved product information made available electronically, including prescribing information (PI), patient information leaflets, and other approved product information where applicable. QR codes and HCP notification letters supported access, while HCPs could direct patients or caregivers to the same materials during clinical visits.

This model is designed to be nonpromotional: The materials are intended to support safe and appropriate use of medicines, not to promote products or make product claims. The operational goal was to align safety communications across letters, QR codes, and the Thai FDA website so that updated risk-minimization information remains current and easier to locate.

Survey Results

Following the implementation of digital distribution for RMP EMs, this subsidiary conducted a voluntary, quantitative, cross-sectional survey among HCPs prescribing the four medicinal products included in the initiative. Invitations were sent to 310 HCPs; 112 responded to the survey, a response rate of 36.1%. Data were collected from July 2025 to March 2026 using a Microsoft Forms questionnaire accessed by QR code. The survey explored HCP preferences for electronic versus traditional paper-based formats for both HCPs and patient/caregiver materials, HCPs’ views on patients’ preference for the format of patient/caregiver materials, and the HCPs’ expected future use of electronic formats.

Figure 1. HCP responses on preferred format for RMP EMs.

• HCPs demonstrated a clear preference for electronic RMP EMs when the materials were intended for their own use. More than two-thirds of respondents (70.5%) accessed materials through QR code-linked electronic format, compared with 8.9% who preferred paper-based materials, while 20.5% reported no specific preference.
• Preferences for patient/caregiver materials were more evenly distributed, with 49.5% favoring electronic format, 27.9% preferring paper-based materials, and 22.5% indicating no specific preference.
• When asked to consider the preferences of patients or caregivers themselves, respondents perceived a near-even split between electronic materials (39.3%) and paper-based (37.5%) formats, with 23.2% indicating no specific preference.

Survey responses also showed strong perceived usefulness. Nearly all respondents agreed that electronic formats made risk-management information easier, more convenient, and faster to access, with 68.8% (n=77) strongly agreeing and 30.4% (n=34) moderately agreeing. Most respondents also expected to use electronic materials more often than paper materials in future practice (67.6% strongly agreed, n=75; 30.6% moderately agreed, n=34).

Digitalization Changing More Than Delivery Format

The findings are consistent with those of a previously published Singapore case study that demonstrated positive acceptance of electronic RMP EMs and improved dissemination timeliness following digital implementation. Thailand advances this approach by adopting a health authority-hosted model, with approved RMP EMs accessible through the Thai FDA website together with e-labeling. This creates a centralized, trusted, up-to-date source of risk-minimization information for HCPs, patients, and caregivers.

Thailand’s experience suggests that digitalization of RMP EMs is more than a change in delivery format: It offers an opportunity to strengthen the accessibility, sustainability, and consistency of safety communication. Future efforts should focus on optimizing user-friendly access through the Thai FDA website, maintaining clear communication of updates, preserving alternative access options for users who require them, and continuing to evaluate whether digital access translates into greater awareness and utilization of key safety information in routine clinical practice. Ultimately, the goal is not simply to reduce reliance on paper-based materials but to ensure reliable, real-time access to key safety messages to ensure patient safety.

Supplemental Resources

• EMA Guideline on Good Pharmacovigilance Practices Module XVI, Risk Minimisation Measures
• EMA Guideline on Good Pharmacovigilance Practices Module V, Risk Management Systems
• EMA GVP Module XVI Addendum II, Methods for Evaluating Effectiveness of Risk Minimisation Measures
• Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible