Health literacy is vital for health, be it living healthy, disease prevention or to achieve the best possible results from medical care.
- Received FDA approval of our sixth health literate patient label
- New clinical trials now include teach-back and cultural competence as part of their investigator training
We are dedicated to helping patients understand their medical condition or disease, the reasons they are being treated, and the appropriate use of their medications and other treatments
Health literacy is linked to individuals’ literacy levels and entails people’s knowledge, motivation and competence to access, understand, appraise and apply health information in order to make judgments and take actions in everyday life concerning health care, disease prevention and health promotion, to maintain or improve quality of life.
Health literacy challenges can affect people of all ages, races, incomes and educational levels. Some population groups in the U.S. are more vulnerable to low health literacy. They include the elderly, people with less than a high school education, people living in poverty, racial and ethnic minorities and people with limited English proficiency.
External trends driving recognition of health literacy as critical include data transparency, patient advocacy, misinformation (including vaccine hesitancy), and social determinants of health. Some policy makers are also beginning to make the link between health literacy and health outcomes, in particular in Europe, and we anticipate this trend will increase.
As a company, we are committed to improving health literacy as part of our mission to save and improve lives. We are dedicated to helping patients understand their medical condition or disease, the reasons they are being treated, and the appropriate use of their medications and other treatments.
This collaborative and enterprise-wide effort is led by the by the company’s Global Population Health team within the Social Business Innovation organization.
Because of the special needs of cancer patients, we have also started to focus on cancer literacy at meetings and through research, recommending cancer literacy be an integral part of National Cancer Control Plans and Europe’s Beating Cancer Plan of the European Commission.
Our internal efforts focus on improving internal awareness and the systematic adoption of health literacy.
Our company has set goals/targets across the company to advance our health literacy efforts, including departments standardizing health literacy reviews for patient materials, health literacy training for 90 percent of the U.S. pharmacovigilance group, and 85 percent or better comprehension of the patient information for new molecules by people of all health literacy levels.
We have an external health literacy agency review a variety of patient-facing and internal communications materials, including website and digital marketing content; clinical trial materials; videos; consumer surveys, and internal policy guidance documents.
Global external efforts are driven by a strong commitment to scientific excellence in health literacy. For example, throughout 2018 and 2019, we co-chaired a working group of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT) focused on health literacy in clinical research. The group produced publicly available tools, resources and case studies to aid patient advocates, pharmaceutical companies and academic researchers in applying health literacy best practices during all phases of clinical research. The intent of this work was to empower participants to be fully informed and engaged during clinical trials.
In 2019, the FDA approved our sixth health literate patient label which was developed with iterative patient input. There are two more health literate labels currently in development, including one vaccine label.
We also advocate for health literacy in discussions with regulators, directly and through engagement in Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) patient-focused work groups. FDA draft guidance documents on Patient-Focused Drug Development include health literacy references. Because of our company’s engagement in health literacy, we have seen increased awareness and adoption in PhRMA and BIO.
We are working across six continents to advance awareness and impact of addressing health literacy. This includes publications with scientific leaders and patient advocates; conference presentations; national and international working group participation; and engagement with policy makers.
Company-wide we have a focus on training and impact. Over 1,000 people have participated in health literacy training in the last several years, including people living or working in the United States, Australia, China, the United Kingdom, India and Kenya.
We focus on training our global workforce in health literacy, engaging employees in small-group experiential training sessions that are tailored to specific departments. We also created four e-learning modules to expand our global reach and impact, including two modules relevant to employees who create content for patients and specific modules for our pharmacovigilance and commercial teams.
There are many examples of health literacy in action across our company’s product lifecycle, including our early clinical trials, informed consent, diversity in trials, patient labeling, instructions for use, packaging and patient education. Beginning in 2019, new clinical trials included teach-back and cultural competence as part of their investigator training. Early in 2020, our commercial organization launched a process to integrate health literacy reviews more consistently across all therapeutic areas.
We understand improving health literacy takes a multifaceted effort focused on public policy, engaging diverse stakeholders and new ways of communicating. We are calling upon government agencies, health care providers, patient advocacy groups and health care companies to work together to increase patient understanding of health care, health promotion and prevention, and shared treatment plans.
Our company collaborates with various partners to help share best practices and drive health literacy. Some of these external efforts include numerous presentations and keynote talks at workshops and meetings (often with patient advocates), plans to publish papers related to health literacy, and membership on several Committees.
We partner with health literacy experts at Emory University and Northwestern University Feinberg School of Medicine to integrate their expertise and feedback from people across a range of health literacy levels into the development of patient labeling for new molecules.
We also work with Health Literacy Media to conduct reviews of materials for patients and recently began to engage on materials for policy makers, who have reacted positively to simpler communications as a foundation for discussions.