very authorized medicine has potential benefits and potential risks; its benefits must outweigh its risks for it to be licensed and remain in the market. We can improve the balance between benefit and risk by minimizing the risks, especially those that are serious and may substantially impact patient safety. Risk mitigation can be substantially improved by engaging patients in co-creating educational materials on the medicines they use.

According to the World Health Organization: “Patient and family engagement is a pivotal strategy to advance safety in healthcare. As users of healthcare systems, with first-hand experience of the entire patient journey, the perspectives of patients, families, and caregivers are invaluable in improving patient safety. The impact of meaningful patient engagement is remarkable, with studies showing a potential reduction in the burden of harm by up to 15%, saving countless lives and billions of dollars each year.”

With regard to safer use of medicines, CIOMS WG XI published: “Excluding patients and expected medicine users from the development and use of medicines beyond the role of passive recipient fails to respect them as persons. Such exclusion can reduce benefit and increase harm; this goes against the principles of beneficence and nonmaleficence.”

As part of Good Vigilance Practices, Marketing Authorization Holders (MAH) are required to continuously evaluate the risk-benefit profile of their medicines and propose how to mitigate the risks and ensure the safety of patients taking the medicine. Patient-centricity is a principle that all stakeholders in the healthcare system, including pharmaceutical manufacturers, must follow to truly meet unmet needs. However, applying this principle to post-market pharmacovigilance and patient safety sometimes misses transforming it into action by creating change that can positively impact safer uses of medicines through listening to patients or through consulting or co-creating solutions with patients.

Measures to ensure patient safety and minimize their risk can be relatively routine (e.g., changes to labeling, targeted follow-up to enhance the quality of data collected from spontaneous sources). If the risks require more than the usual risk minimization measures, Additional Risk Minimization Measures (ARMM) can be implemented through communication and educational initiatives by providing information to raise awareness or understanding about a specific risk and promoting attitudes or actions to minimize it as part of their Risk Minimization Strategy. These materials are usually printed or digitally distributed under the assumption that the person receiving that information is able to properly read and comprehend it.

However, as part of the ARMM strategy supporting a new ophthalmologic product, the local pharmacovigilance operation of a multinational pharmaceutical company deemed it necessary to develop and distribute educational material to patients with reduced sight or other visual impairment due to macular degeneration. Considering the diverse educational and health literacy levels of the target patient population, they decided to validate these educational materials with a local ophthalmology Patient Council as part of its ARMM. This validation was accomplished in two rounds: One to review the first version of educational materials the company prepared, and the second to present the adapted material to patients after incorporating feedback received in the first round.

First Consultation: Review Educational Materials

In the first Patient Council, the company presented the concept of safety education materials; items such as health literacy, clarity of images, layout, distribution form, and digital and/or print formats were discussed, and patients provided their feedback.

The session was attended by five patients and separated into three blocks of questions. The first block focused on discussion around the content, proper language, and how the guide (material) could be presented to patients so that they can understand the information. The second block discussed the graphic presentation, with consideration of the patients’ visual restrictions to access the information. The third block addressed how to distribute these materials so that they reach patients effectively.

Examples of contributions made by the Patient Council include:

• Content understanding: Need to adapt the explanatory content, such as replacing some words (e.g., replace “implant” with “put”) to increase comprehension, and provide more detailed explanations about issues such as symptoms and details of the procedure.
• Graphic presentation: Patients viewed both the printed and the digital formats as highly relevant, as long as they presented standardized and managed (updated) information; increased the number of illustrations and included descriptions (captions); and applied large fonts (size 14 and above) and non-fluorescent colors.
• Method of distribution: Coordinate distribution with the doctors or healthcare professionals responsible for communicating this material for greater “humanization” and awareness.

Based on this feedback and local legislative or other requirements (e.g., Good Pharmacovigilance Practices, compliance requirements for pharmaceutical company promotional activities, etc.), adaptations were made to promote better health literacy and accessibility to the materials, including image descriptions and other visual accessibility options.

Second Consultation: Review Adapted Educational Materials

The local ophthalmology Patient Council met again with the same five patients from the first round to evaluate the updates incorporated into the educational material. The council unanimously recognized improvements in these materials based on the changes made. They made additional suggestions so that the guide could be even more informative and accessible to patients.

At the end of the process, they expressed their satisfaction in response to these four questions:

1. How does the solution help you better understand the target disease?
   The materials help patients to be better informed and safer.
2. Did the solution help you (the patient) engage with your doctor about your treatment?
   100% of patients responded yes and found the materials useful for engaging with their doctor.
3. Would you recommend this solution (educational material) to a friend or colleague?
   100% of patients would recommend the material to friends or colleagues.
4. On a scale from 1 to 5, how do you rate your overall satisfaction with this solution?
   Their overall satisfaction was 4 out of 5 because they would like to see versions in Braille and in sign language.

Conclusion

As patient-centricity becomes more prevalent in pharmaceutical industry discussions around the globe, the science of pharmacovigilance is simultaneously evolving to improve how it engages with the patients being treated by these pharmaceutical solutions. This case study provides insights on how to promote inclusion and put patients at the center of discussions about solutions aimed for their use. Co-creation of risk communication solutions, part of the regulatory requirement for mitigation measures, more effectively ensures that these communications reach their full potential in their target audience.

Another conclusion is that patient safety cannot be achieved by working in silos. External and internal integration and partnerships (with different organizations, and across different departments) are essential to get the “view from outside” (customer) perspective.

Finally, we would all be wise to bring our own lived experience with diversity and inclusion into practice and to follow the familiar patient advocate refrain: “Nothing about me, without me.”