Abstract
ObjectivesTo establish how the terms recommended by the European Commission to describe side‐effect risk in patient information leaflets (PILs) influences expectations of side‐effects and to identify factors associated with these side‐effect expectations.DesignA cross‐sectional online survey was carried out by a market research company.SettingData were collected in England between 18th March and 1st April 2016.ParticipantsA total of 1003 adults aged between 18 and 65. Main outcome measures: Self‐reported expectation that the described side‐effects would affect participants if they took the medicine, measured on a likelihood scale from 1 (very unlikely) to 5 (very likely).ResultsParticipants formed high expectations of side‐effects for “very common” and “common” side‐effects, with 51.9% and 45.0% of participants rating these as “very likely” or “likely” to happen to them, respectively. This fell to 8.1% for “uncommon,” 5.8% for “rare” and 4.1% for “very rare.” For each descriptor, higher expectations of side‐effects were more associated with women or being from an ethnic minority, or having less education, a household illness, high perceived sensitivity to medicines or negative beliefs about medicines.DiscussionThe current use of verbal descriptors to communicate side‐effect risk in PILs leads to high side‐effect expectations. These expectations could contribute to nocebo‐induced medication side‐effects experienced by patients. Additional work is required to identify ways to improve the way risk information is conveyed in PILs.
Highlights
Medications may generate adverse reactions, with studies showing that around 6.5% of patient admissions to hospitals are related to an adverse drug reaction (ADR).[1]
Objectives: To establish how the terms recommended by the European Commission to describe side-effect risk in patient information leaflets (PILs) influences expectations of side-effects and to identify factors associated with these side-effect expectations
The current use of verbal descriptors to communicate side-effect risk in PILs leads to high side-effect expectations
Summary
Medications may generate adverse reactions, with studies showing that around 6.5% of patient admissions to hospitals are related to an adverse drug reaction (ADR).[1] ADRs are noxious, unintended responses to medication which occur at normal doses.[2] Medication side-e ffects such as these can significantly reduce patient adherence[3] often leading to reduced therapeutic benefit for the patient |2 mean financial costs for health services as they are a major cause of hospital admissions, and emergency department and outpatient care visits.[4]. Expectations have been found to contribute to the side-effects that patients experience from their medications.[10,11] This is a problem as side-e ffects are an important cause of patient non-adherence.[3,12]
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