ArticleDrug safety2008
Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK.
Article in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Readability of medicinal package leaflets: a systematic review.Revista de saude publica · 2015Pooled it
- Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.Health expectations : an international journal of public participation in health care and health policy · 2016Trial
- Communicating the risk of side effects to patients: an evaluation of UK regulatory recommendations.Drug safety · 2009Trial
- Assessment of patients' attitudes and actions toward Patient Information Leaflets in Jordan: A cross-sectional study.Farmaceuticos comunitarios · 2026Article
- Multicentre quality improvement initiative to improve patient education and safety in the prescription of Sodium-Glucose transporter 2 inhibitors.BMJ open quality · 2025Article
- Article
- The Challenges for EU User Testing Policies for Patient Information Leaflets.International journal of environmental research and public health · 2024Article
- Knowledge, Attitude, and Practice Regarding Pharmacovigilance and Barriers to Reporting Adverse Drug Reactions Among the General Population in Saudi Arabia.Risk management and healthcare policy · 2024Article
- 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
- Public awareness regarding the manufacturer provided information about medicine usage, safety, and adverse drug reactions in Balochistan, Pakistan.Frontiers in pharmacology · 2023Article
- Replacing vaccine paper package inserts: a multi-country questionnaire study on the acceptability of an electronic replacement in different target groups.BMC public health · 2022Article
- Effective communication regarding risk of fracture for individuals at risk of fragility fracture: a scoping review.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022Article
- Communicative and Discursive Perspectives on the Medication Experience.Pharmacy (Basel, Switzerland) · 2021Article
- Public Awareness about Medicine Information, Safety, and Adverse Drug Reaction (ADR) Reporting in Dammam, Saudi Arabia.Pharmacy (Basel, Switzerland) · 2020Article
- Evaluation of the community pharmacists' performance in the screening of non-steroidal anti-inflmmatory drugs risks in Saudi Arabia.Saudi medical journal · 2020Article
- Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine.BMC public health · 2017Article
- Readability and Suitability of COPD Consumer Information.Canadian respiratory journal · 2017Article
- Exploring consumer opinions on the presentation of side-effects information in Australian Consumer Medicine Information leaflets.Health expectations : an international journal of public participation in health care and health policy · 2016Article
- Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey.Drug safety · 2015Article
- Patient information leaflets: informing or frightening? A focus group study exploring patients' emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices.BMC family practice · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOne of the most important categories of information that patients want to know about the drug they are taking is the likelihood or probability of adverse effects. All patients should receive such information in the patient information leaflet that is supplied with all drugs. Anecdotal evidence suggests that most leaflets give little indication of the likelihood of adverse effects. The UK Medicines and Healthcare products Regulatory Agency (MHRA) suggests using a combination of words and numbers to convey this information. However, an EU guideline suggests using five verbal descriptors on a scale from common to rare, the use of which has been shown to lead to gross overestimation of the risk of adverse effects.
methodsWe assessed the leaflets supplied with the 50 most frequently prescribed drugs in England, to determine the extent to which the likelihood of adverse effects was described, and whether it met the requirements of the EU guidance and/or best practice. We examined both the method used to describe the likelihood of adverse effects, and the format of this information in the leaflet.
resultsTwenty of the 50 leaflets (40%) gave no indication of the likelihood of adverse effects occurring. Six (12%) used the recommended EU terms and a further 20 (40%) used a wide range of other verbal descriptors. Only four leaflets (8%) provided any form of numerical indication of risk. Over half (52%) presented long lists of adverse effects in paragraphs of continuous text.
conclusionsPatient need is not being met in terms of the provision of usable information about the likelihood of adverse effects. Most patients receive no information, whereas some are given verbal descriptors, both of which lead to overestimation of the risk. Very few of the patient information leaflets assessed used currently described best practice, i.e. to present verbal descriptions alongside numerical information in the form of natural frequencies, e.g. 'rare (affects less than 1 in 1000 people)'.
Indexed as
Identifiers
18366241What OpenQuestion holds
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.