Clinicians and cancer patients need better information on the benefits – and potential harms – of medicines, experts say today.
Analysis by a team led by Dr Courtney Davis, of the Department of Global Health and Social Medicine, King’s College, London, UK, said important information about cancer drugs is often missing from official prescription drug information sources.
Writing in The BMJ, they say patients need high quality information about treatments, tests, and services, including information about the benefits of and risks from prescription drugs to be able to participate in their medical care.
Although there have been studies on how information on drug risks and adverse effects is communicated to patients, there is limited evidence about the communication of drug benefits.
The team reviewed official written and electronic information for clinicians, through a summary of product characteristics, as well as information leaflets for patients and public summaries for members of the public, for 29 new cancer drugs approved by the European Medicines Agency (EMA) between 2017 and 2019.
They went on to compare the information on drug benefits reported in these sources with the European public assessment reports (EPARs), which contain everything required for drug approval.
They found both patient and public facing information sources were often lacking in relevance: information on drug benefits was not reported in any patient leaflets, while other, potentially less relevant information for patients, such as how a drug works in the body, was consistently included.
They also found instances where the reporting of a study design and study findings were inconsistent with the EPARs information and were 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.
They also found 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.
They conclude 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”.
Davis C, Wagner AK, Salcher-Konrad M et al. Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe. BMJ 30 March 2023; doi: 10.1136/bmj-2022-073711
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