What is the quality of drug safety information for patients: <scp>A</scp>n analysis of <scp>REMS</scp> educational materials

Chan, Hilda Wai-Han; Russell, Andrea M.; Smith, Meredith Y.

doi:10.1002/pds.4614

Cited by 18 publications

(14 citation statements)

References 35 publications

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“…Fact sheets, handbooks/brochures/booklets are more dispersed across readability indices potentially highlighting the variability in the consideration applied to these materials in terms of their accessibility to low health literacy population. Compared to print chronic kidney disease materials and drug safety information for patients, both of which averaged a ninth‐grade reading level, presently identified deprescribing patient education materials were much more difficult to read with at least an average 10th‐grade reading level. However, due to the limitation of readability indices which consider a limited set of parameters and are not always indicative of ease of comprehension, readability indices form only a fraction of the picture so should be interpreted cautiously, particularly given that different readability measures can provide very different results …”

Section: Discussionmentioning

confidence: 99%

Availability and readability of patient education materials for deprescribing: An environmental scan

Fajardo

Weir

Bonner

et al. 2019

Brit J Clinical Pharma

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Aims To identify and evaluate content and readability of freely available online deprescribing patient education materials (PEMs). Methods Systematic review of PEMs using MEDLINE, Embase, CINAHL, PsycINFO and The Cochrane Library of Systematic Reviews from inception to 25 September 2017 to identify PEMs. Additionally, deprescribing researchers and health professionals were surveyed to identify additional materials. Known repositories of materials were searched followed by a systematic Google search (22–28 January 2018). Materials were evaluated using an approach informed by the Patient Education Material Assessment Tool and the International Patient Decision Aids Standards Inventory. Readability of text‐based materials was assessed using the US‐based Gunning–Fog Index and Flesch–Kincaid Grade level. Results Forty‐eight PEMs were identified. PEMs addressing deprescribing of medications for symptom control (81%) were most common. Preventative medications were rarely addressed and material (39%) focused on older people. Only 37% of PEMs provided information about both potential benefits (e.g. reducing risk of side effects) and harms (e.g. withdrawal symptoms, increased risk of disease) of deprescribing, while 40% focussed on benefits only. Readability indices indicated an average minimum reading level of Grade 12. Option Grids and Decision Aids (mean reading level below Grade 10) were most suitable for people with average literacy levels. Conclusions Over 1/3 of deprescribing PEMs present potential benefits and harms of deprescribing indicating most of the freely available materials are not balanced. Most PEMs are pitched above average reading levels making them inaccessible for low health literacy populations.

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Section: Discussionmentioning

confidence: 99%

Availability and readability of patient education materials for deprescribing: An environmental scan

Fajardo

Weir

Bonner

et al. 2019

Brit J Clinical Pharma

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“…Our study has provided a broad overview of patient attitudes to medicine safety information. Much of the research in this field to date has had a single research area focus, for example consumer use of the package insert, [ 7,9,14 ] consumer attitudes towards pharmacist‐delivered health services and health information [ 1 ] or the public perception of the pharmaceutical industry. [ 15 ]…”

Section: Discussionmentioning

confidence: 99%

“…Package information leaflets may not provide information on medication side effects at an appropriately accessible level. [ 9,22–25 ] Indeed, we may require a tailored approach to information dissemination that takes into account the nature of the side effect, its likelihood and the patient demographics. [ 14,16,25–27 ]…”

Section: Discussionmentioning

confidence: 99%

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Patient literacy and awareness of medicine safety

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Butcher

Banh

2020

International Journal of Pharmacy Practice

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Objective To assess public understanding of medicine safety, approach to risks and preferences in accessing safety information. Methods Qualitative data were obtained from an online survey (n = 1079) covering four major themes around side effects and risks of medicines: willingness to accept side effects of medications, information seeking, sufficiency of information and understanding pharmacovigilance process. Comparisons were made for age, gender and social/financial status. Key findings Most respondents acknowledged medications were associated with side effects. If side effects were experienced, most (73%) would seek advice from their doctor or pharmacist. Four in 10 respondents felt doctors and pharmacists do not provide sufficient information about medications, even though many (47%) relied on their doctor to provide this. Although 51% felt that pharmaceutical companies were already providing enough information to patients, 95% responded that extra effort could still be made. Two‐thirds of the respondents felt it was the companies’ responsibility to educate doctors and pharmacists so they could pass the information on, even though younger respondents preferred direct communication to patients compared to older respondents (<24 years, 36% versus >65 years, 10%; P < 0.001). Men were more willing to accept risks, while women were more likely to seek information about their medicines. Understanding of the role of pharmaceutical companies and government in maintaining the safety of medicines was generally poor. Conclusions There is an ongoing need for consumer education regarding medicine safety. Doctors and pharmacists remain the more trusted source of information. Pharmaceutical companies play an important role in ensuring such information is both accessible and accurate.

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“…Educational theory suggests that presenting congruent information in multiple formats can help to increase comprehension. 25 Some studies suggest that pictures can enhance patients' understanding of the effect of medication treatment 53 and self-management recommendations. 54 In our study, we found that patients preferred to use pictures showing clinical manifestations to judge whether they had the same symptoms, and patients, especially those with low health literacy, preferred to obtain important knowledge through cartoon stories.…”

Section: Discussionmentioning

confidence: 99%

Readability in printed education materials for Chinese patients with systemic lupus erythematosus: a mixed-method design

et al. 2020

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ObjectivesTo assess the readability of printed education materials (PEMs) for patients with systemic lupus erythematosus (SLE) and to explore the perceptions of patients with SLE with different health literacy regarding the readability of PEMs.DesignA mixed-methods study, including a cross-sectional survey and semistructured interviews.SettingThe SLE PEMs were collected from 13 hospitals in China. The interviews were conducted in the Department of Rheumatology of a hospital in Hefei, China.ParticipantsIn the cross-sectional survey, convenience sampling was used to select the Chinese SLE PEMs, with 20 PEMs included. In the qualitative study, the patients with SLE were divided into two groups based on their health literacy. Then, purposive sampling was used to select participants in each group, with 18 patients recruited.Outcome measuresThe readability of PEMs was assessed by the language analysis technology and the Chinese version of the Suitability Assessment of Materials (SAM-C) instrument.ResultsFor text factors of readability, the mean Chinese language difficulty coefficient was 67.09±8.03, which indicates that the text of PEMs was difficult to read. For non-text factors, the mean SAM-C score was 45.62±9.51. Eight PEMs were rated not suitable, 12 were adequate and none were superior. In the interviews, eight categories were identified: information source, content, actionability, plain language, pictures, tables, numbers and layout. Patients with different health literacy had discrepant views on the detail of basic information, the necessity of question list, the location of functional pictures and the application of mathematical symbols.ConclusionsThe readability of Chinese SLE PEMs does not perform well, and it is necessary to reduce the difficulty of words, shorten the length of sentences and improve the picture design and actionability. To develop PEMs tailored to patients’ level of health literacy, patients’ unique view of readability should be integrated into the design of PEMs.

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What is the quality of drug safety information for patients: An analysis of REMS educational materials

Cited by 18 publications

References 35 publications

Availability and readability of patient education materials for deprescribing: An environmental scan

Availability and readability of patient education materials for deprescribing: An environmental scan

Patient literacy and awareness of medicine safety

Readability in printed education materials for Chinese patients with systemic lupus erythematosus: a mixed-method design

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