Important information about cancer drug benefits, and related uncertainties, is frequently omitted from official prescription drug information sources for clinicians and patients in Europe, finds an analysis published by The BMJ today.
Despite the commitment of medicines regulators to shared decision making and person centred care, the researchers say better information on the benefits and potential harms of medicines are needed to help inform treatment decisions, especially for patients with time limiting conditions such as advanced cancer.
To receive and participate in medical care, patients need high quality information about treatments, tests, and services, including information about the benefits of and risks from prescription drugs. Previous studies have looked at how information on drug risks and adverse effects is communicated to patients, but research on communication of drug benefits is limited.
To address this, researchers set out to assess the extent to which information about cancer drug benefits, and related uncertainties, is communicated to patients and doctors in regulated prescription drug information sources in Europe.
They reviewed official written and electronic information for clinicians (through a summary of product characteristics), patients (information leaflets) and the public (public summaries) for 29 new cancer drugs approved by the European Medicines Agency (EMA) during 2017-2019.
They then compared the information on drug benefits reported in these sources with the information available in regulatory assessment documents (known as European public assessment reports or EPARs), which contain everything required for drug approval.
They found that both patient and public facing information sources were often lacking in relevance. For example, information on drug benefits was not reported in any patient leaflets, while other – potentially less relevant information for patients (eg. how a drug works in the body) – was consistently included.
They also found instances where the reporting of a study design and study findings was inconsistent with the information reported in EPARs and potentially misleading.
Important gaps and uncertainties in the evidence base were also rarely reported, particularly those that might be relevant and useful for patients, such as whether a drug extended survival or improved quality of life.
Finally, scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public.
The researchers acknowledge that their review may not have captured all information about each trial or drug benefits and uncertainties that might be relevant and useful for patients. What’s more, they included only new cancer drugs and it’s not clear whether these findings extend to other disease areas.
Nevertheless, this was a comprehensive review of documents which they say “identified important shortcomings in the communication of information on drug benefits and related uncertainties in regulated sources.”
The findings “highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians,” they conclude.
The takeaway message from this study is that information about drugs is rarely communicated well—and particularly not communicated well to patients, say BMJ editors in a linked editorial.
It also raises questions about whether this knowledge gap is interfering with shared decision making and whether new ways to present information such as visual representation of data on benefits and harms - used for covid-19 vaccines - could be applied to other types of medicines.
“The trust between patients and healthcare providers remains pivotal in ensuring that patients are fully informed about benefits and harms of drugs,” they write. “But regulatory agencies should pay closer attention to important gaps in information for patients, and further research should aim to determine more precisely where these gaps occur and to work with patients to fill them.”
[Ends]
Journal
The BMJ
Method of Research
Observational study
Subject of Research
People
Article Title
Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe
Article Publication Date
29-Mar-2023
COI Statement
All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/coi_disclosure.pdf and declare: This study was partly funded by Health Action International and the EU Commission’s Consumers, Health, Agriculture and Food Executive Agency (CHAFEA). CD reports membership of Health Action International (HAI), serving as HAI’s representative on the European Medicines Agency (EMA) Patient and Consumer Working Party (PCWP) and receiving reimbursement from EMA for attendance at PCWP meetings; AKW reports grants from the American Cancer Society outside the submitted work, and payment or honorariums from the University of Hong Kong; BM reports membership of HAI, L’Association Mieux Prescrire, and the Scientific and Education Committee of the Therapeutics Initiative (University of British Columbia), and reports serving as an expert witness for Health Canada during a legal case involving marketing of an unapproved drug product in Canada; JL reports grants from the non-profit organisation HAI to undertake data collection and analysis for the submitted work; HN reports grants from the Health Foundation, the National Institute for Health and Care Research, and UK Research and Innovation outside the submitted work, and consulting fees from the World Health Organization and Pharmaceutical Group of the European Union; HN also reports being an adviser to the Analysis section of The BMJ; the other authors declare no support from any organization for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.