ArticleDrug safety2015
Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey.
Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe.BMJ (Clinical research ed.) · 2023Article
- Evaluation of Medication Package Inserts in Ethiopia.Journal of environmental and public health · 2022Article
- What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?BMC complementary and alternative medicine · 2019Article
- People's Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England.Drug safety · 2017Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPatients' perceptions of side effect risks are important influences on their medicine-taking behaviour. A previous survey of Patient Information Leaflets (PILs) showed considerable variation in the terms used to communicate risks.
objectiveOur objective was to assess the methods used to describe risk of side effects in recent PILs and to compare them with PILs sampled in 2006.
methodWe sampled PILs for the 50 most frequently dispensed medicines in England and Wales in 2012 and PILs for the 50 most recently licensed medicines. We assessed the use of risk frequency terms or numbers, and the use of the risk format recommended by the European Medicines Agency (EMA).
resultsA majority (76 %) of PILs for the most frequently dispensed medicines included a risk frequency descriptor, with 66 % using the recommended format. No difference was seen between PILs for branded and generic medicines. All 50 PILs for the most recently licensed medicines used the EU recommended risk format. PILs from the 2012 sample were much more likely than those from the 2006 sample to include risk descriptors and to use a consistent approach.
conclusionThe increased use and consistency of risk descriptors in PILs should benefit patients, particularly those using multiple medicines produced by different market authorisation holders. A need remains for further research evaluating the risk format recommended by the EMA. There is also a need for research evaluating spoken information and other sources of printed risk information about medicines that is available to patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.