Off-label drug use report

Damages of Off-Label Drug Use

Target Audience: high school students(aged 15-18) and

middle-aged adults(aged 45-55)

Part I: Campaign Plan

1. Research Information

Off-label drug use or using medications beyond their approved indications, is a complex yet crucial aspect of modern medicine. This practice is particularly common in treating rare diseases, where limited patient populations make large-scale trials unfeasible.  In Analysis of Off-Label Drug Use in Rheumatoid Arthritis (Xu Qianyu, 2023), based on the hospital's statistical data on off-label drug use for rheumatoid arthritis from July 2021 to June 2022, the proportion of off-label prescriptions in outpatient rheumatoid arthritis cases reached 64.121%, with all involved medications being off-label. This finding strongly demonstrates the widespread prevalence of off-label drug use.

Off-label drug use can drive medical innovation, offering patients access to potentially life-saving treatments. For instance, thalidomide, initially developed as a sedative, became a key therapy for multiple myeloma. However, off-label use also raises ethical and safety concerns, since efficacy and risks are often unclear. In fact, doctors prescribing off-label treatments may face legal liability, especially if adverse effects occur. Moreover, from a financial perspective, off-label drug use imposes a significant burden on patients, mostly due to the fact that national health insurance programs and commercial insurances do not cover the expense of off-label prescriptions. The lack of reimbursement forces patients to bear the full cost of treatment, making the lifesaving treatment inaccessible for many, particularly those with rare diseases who often rely on OLDU due to the lack of approved alternatives. Therefore, financial strain can be devastating, especially for long-term or high-cost therapies.

Addressing these issues requires policy reforms, including clearer regulatory pathways for off-label drug use approval, expanded insurance coverage for well-supported off-label uses, and stronger legal protections for doctors acting in good faith.

2. Target Audience Analysis

Our primary target audience consists of high school students, as they represent a crucial demographic for raising awareness and fostering future advocacy for off-label drug use issues. By engaging young individuals early on, we aim to cultivate a generation that is knowledgeable about healthcare policies and empathetic toward patients facing medical and financial hardships. To effectively engage students, who typically know little about off-label drug use, in taking in information of off-label drug use, the content should be fun and interactive. Also, activities should allow students to deliver their own opinions.

In addition to engaging high school students, we also aim to improve the current situation by raising awareness among middle-aged individuals(typically 45 years old). Middle-aged individuals are at a higher risk of developing chronic illnesses that may eventually require off-label drug treatments. Activities targeting middle-aged individuals need to be more serious, easy to understand, and authoritative, while also including real-life cases for their reference. Therefore, we organize lectures and invite experts to join us in explaining how to prevent the burdens caused by off-label drug use for patients and clarifying that doctors prescribe off-label drugs not for profit.

3. Campaign Design

a) Campaign goal and plan

Goal: According to research information, the ultimate solution to the issue of off-label drug use is policy-level changes. Therefore, our ultimate goal is to promote the implementation of policies that improve the regulation of off-label drug use. .

1. Increasing public awareness of off-label drug use through social media.

2. Providing a detailed explanation of the financial burden that off-label drug use imposes on patients.

3. Informing the public on how to avoid the additional financial burden caused by off-label drug use.

At the same time, we’ve also noticed the legal risks that doctors face when dealing with off-label drug use. We hope to organize initiatives to safeguard doctors' rights to practice medicine under current regulations.

1. Educating the public on the legal implications of off-label drug use.

2. Promoting regional policies that regulate off-label drug use.

Plan:

1. Publishing articles on social media to introduce concepts related to off-label drug use.

2. Organizing a lecture on the harms of off-label drug use and ways to avoid them, based on cases collected through social media.

3. Conducting surveys to gather information from patients about their medication usage.

4. Drafting a proposal based on the collected information and submitting it to policymakers.

b) Marketing strategy

We actively utilized popular events, such as the School Club Culture Festival, to attract more students in order to promote the public’ awareness. Moreover, Students who actively participated in lectures and completed surveys were rewarded with snacks as incentives. Additionally, we incorporated interactive elements to spark interest, such as allowing students concerned about off-label drug use to visit Anzhen Hospital, where they engaged in discussions with doctors and rare disease patients suffering from aorto-arteritis regarding the challenges of off-label medication.

c) Campaign format and content

Knowledge Quiz – Conduct an quiz to test and reinforce participants' understanding of off-label drug use, encouraging active engagement and learning

Lecture and Expert Discussion – Host a seminar with medical professionals to explain off-label prescriptions, misconceptions, their significance in rare disease treatment.

Hospital Visit and Patient Interviews – Engage with doctors and patients at Anzhen Hospital to understand real-world challenges of off-label drug use, including financial burdens and treatment accessibility.

Proposal Writing – Drafting proposals based on knowledge and insights from patient interviews, aiming to advocate for policy improvements and raise awareness.

d) Campaign Materials

Feedback tools:

· Review: Inviting participants to provide feedback on our lecture.

· Survey: Distributing surveys to rare disease patients before and after the lecture to assess their understanding of off-label drug use.

· Proposal: Collaboratively drafting and writing a proposal to support policy implementation.

Part II:Activities Conducted

Activity I: Introducing off-label drug use through offline quizzes and article on Wechat

Activity time: Sep 5, 2024-Sep 11, 2024

Activity content:

1. raise awareness about off-label drug use at Club Culture Festival: using a quiz on off-label use knowledge.

2. Popularize the concept and cases of off-label use on the club's official WeChat account.

Photos:

Audience Number: 120+ (We prepared 120 quizzes, distributed all of them, and collected the students' responses.)

1681 (reading)

Feedback Results from the audience:

As of March 13, our official account, with the joint efforts of four students, has completed the selection and editing of articles, achieving a total of 1,681 reads, 365 likes and 18 comments from patients, doctors and students.

Activity II: Holding an online lecture on legal issues related to off-label use.

Activity time: February 1, 2025

Activity content:

Lecturing through PPT:

Definition of Off-Label Drug UseEvaluation of Off-Label Drug UseCauses of Off-Label Drug UseBenefits of Off-Label Drug UseOff-Label Drug Use Is Not OvermedicationReal-World Cases of Off-Label Drug Use

Check for understanding: pre and post lecture questionnaires

Photos:

Photos:

Audience Number: 25

Feedback Results from the audience:

Survey on people's awareness of         Survey on people's awareness of

off-label drug use before the lecture:     off-label drug use after the lecture: over 90%

 Over 80% of respondents had never     respondents understand at least the basic

 heard of it.                         Definition of off-label drug use or more.

Sample responses from a parent:

“Attending a lecture on off-label drug use broadened my knowledge and deepened my understanding of its medical significance. I learned that when no specific treatment exists, doctors may explore off-label medications, offering new hope to patients. This spirit of medical innovation inspired me, highlighting the importance of courage and continuous exploration. This lecture made me realize the value of an exploratory mindset. Whether in academics or daily life, we should seek new solutions and push beyond our limits.”

Activity III: interviewing at Anzhen Hospital and collaboratively complete a proposal.

Activity time: March 8, 2025

Activity content:

l Conducting interviews with cardiology patients at Anzhen Hospital:interviewing about their medication situation, usual healthcare benefits, etc.

l Conducting interviews with doctors in the cardiology department at Anzhen Hospital: asking about patients' medication situations, current prescribing practices, and thoughts on the doctor-patient relationship.

l Based on information from the internet, actual cases, and survey interviews, we created promotional posters and a proposal, and plan to submit them to the district people's congress representatives.

Photos:

Audience Number: 6

Feedback Results from the audience:

“During this event, we visited Anzhen Hospital, interviewed aorto-arteritis patients, and learned about the financial burdens caused by off-label drug use. Patients struggle with high costs due to lack of insurance coverage, despite doctors widely prescribing drugs like methotrexate for treatment.

This experience deepened my understanding of off-label drug challenges, highlighting both patient hardships and doctors’ dilemmas within policy constraints. It also made me reflect on the complexities of the healthcare system beyond just treating diseases.

Hearing the voices of marginalized patients firsthand was eye-opening, reinforcing my respect for dedicated medical professionals. This meaningful event broadened my perspective and strengthened my awareness of medical equity issues. After interviewing patients, I successfully incorporated their experiences into a well-structured proposal, which gave me a strong sense of accomplishment. I look forward to seeing this proposal make a real impact and help improve their situation.”

References                                                                                                                                                                                                 

某疗养院老年患者超说明书用药情况调查与研究-论文-万方医学网. (2016). Wanfangdata.com.cn.https://med.wanfangdata.com.cn/Paper/Detail?id=DegreePaper_Y3035995&dbid=WF_XW

徐倩瑜. (2025). 药物期刊_药物资讯杂志_药物资讯_汉斯出版社. Hanspub.org. https://www.hanspub.org/journal/PI.html