Suitability and readability of consumer medical information accompanying prescription medication samples

Wallace, Lorraine S.; Keenum, Amy J.; Roskos, Steven E.; Blake, Gregory H.; Colwell, Strant T.; Weiss, Barry D.

doi:10.1016/j.pec.2007.11.017

Cited by 50 publications

(46 citation statements)

References 26 publications

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“…Neste contexto os doentes têm oportunidade de esclarecer as suas dúvi-das e de receber informações consideradas determinantes para a utilização racional e segura dos medicamentos. [29][30][31] Complementarmente, a investigação sobre a adequabilidade da apresentação e da extensão dos FIs, assim como a avaliação do impacto da utilização de FIs mistos nos resultados em saúde, deveria incluir testes de legibilidade específicos para avaliar as variações na resposta entre os doentes ou potenciais utilizadores dos medicamentos dos diferentes países da União Europeia, já que as populações destes países apresentam diferentes níveis educacionais. 26 Embora este não tenha sido o foco principal da presente investigação, verificou-se que alguns FIs estavam indisponíveis na base Infomed, o que eventualmente poderá comprometer o acesso imediato à informação por parte dos utilizadores da base (doentes ou profissionais de saúde), ainda que os profissionais de saúde supostamente consultem preferencialmente o resumo das características do medicamento, que também se encontra publicado nesta base.…”

Section: Considerações Finaisunclassified

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

2015

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Introduction:All medicines for human use are marketed with a package leaflet. Every package leaflet must contain an initial list mentioning all sections of the document in accordance to the European template Quality Review of Documents, being not to extensive, i.e. comprising approximately 1500 words. The so-called mixed leaflets contain information about medicines with more than one strength/ pharmaceutical form, and only exceptionally are authorized. In this context, the objectives of the present study comprised the identification of issues in all package leaflets of Portuguese non-generic medicines: 1. to confirm the presence of an initial list, 2. to quantify the number of mixed leaflets, and 3. to evaluate their length (in number of pages). Material and Methods:Consultation of the leaflets, in a public database (Infomed), according to the classification of the National Prescribing Guide (1 st trimester 2012). The data collected was subject to quality control and statistical analysis. Results: Identification of 2729 package leaflets, representing 3080 medicines. A total of 2042 leaflets were evaluated, with 181 (8.9%) missing the initial list and 351 (17.2%) being mixed. The average number of pages was 6.9 (SD=2.6), the minimum = 2 and the maximum = 26. Discussion: In some cases, readability and comprehension of some Portuguese leaflets might be compromised since: 1) some leaflets did not contain an initial list, 2) were classified as mixed leaflets, and/or 3) were classified as too extensive. Conclusion: Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.

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Section: Considerações Finaisunclassified

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

2015

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“…[10][11][12][13][14] Carrigan et al assessed leaflets from 50 of the most commonly prescribed drugs in the United Kingdom, with half of the leaflets representing generic medications and half representing brand-name medications. 10 Researchers found immense variability in the presentation of information, and 40% of leaflets gave no indication of the likelihood of ADEs occurring.…”

Section: Written Medication Informationmentioning

confidence: 99%

“…No WMI was presented with the drug sample 46.9% of the time. 12 When WMI was included, it was written at a reading level higher than that of the average American adult. 12 The importance of color-coded type has also been evaluated using patient questionnaires.…”

Section: Written Medication Informationmentioning

confidence: 99%

“…2 In addition, extensive printed drug information written at a reading level higher than that of the average reader can also contribute to patient dissatisfaction and inaccurate medication administration. 2,12,17,35 It has been noted that with decreasing levels of education 27,36 and increasing numbers of prescriptions, 36 the percentage of patients reporting lack of comprehension of WMI increases.…”

Section: Health Literacy and Numeracy Of Patientsmentioning

confidence: 99%

“…Appropriate font, large text, appropriate reading level, pictorial aids, and prominence of important warnings are all important for improving patients' perceptions of drug warnings. 12,13,35 In a study by Wolf et al, patients suggested the use of numeric symbols was preferable to the written word whenever possible (ie, "2" vs "two"). 35 Patient leaflet design and layout are key aspects which may make information more appealing and more likely to be read.…”

Section: Suggestions For Improvement Of Wmimentioning

confidence: 99%

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Patients’ attention to and understanding of adverse drug reaction warnings

McNeal¹,

Colbert²,

Cable³

et al. 2010

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Introduction:Medications are critical to the management of patient conditions, and they can have significant effects on the success or failure of medical interventions. Patient perceptions of drug warnings play an important role in medication compliance and ultimately disease management. Several factors may affect patients' understanding of drug warnings and drug labeling, including health literacy and interactions with physicians and pharmacists. Purpose: The purpose of this article is to provide a review of the literature related to patient perceptions of drug warnings and drug labeling. Descriptive articles and studies regarding patient perceptions and knowledge of adverse drug reaction warnings were reviewed. Methods: The following databases were utilized to search the literature related to patient perceptions of drug warnings: PubMed, Academic Search Premiere, CINAHL, Medline, Psych Info, Business Source Complete, Alternative Healthwatch, Health Source (both Nursing/Academic and Consumer additions), JSTOR, and Master File Premiere. For the purpose of this review, any peer-reviewed article was eligible. Exclusionary criteria included: articles published in languages other than English, articles/studies on patient perceptions of vaccines and chemotherapy, and articles related to perceptions of medications administered in the inpatient setting. Forty-six articles were included in the review. Results: Health literacy has been shown to have a major impact on patients' ability to understand potential adverse reactions and instructions on correct dosing of medications. Direct communication with physicians and pharmacists is one of the most important and effective variables in promoting understanding of drug warnings. Appropriateness of written medical information that is informative and timely can improve patients' perceptions of drug warnings and hopefully disease management. Conclusion: As patients increasingly assume more personal responsibility as informed consumers of health care, it is even more important to address patient perceptions of drug warnings considering how this fits in the context of their overall care.

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Characterizing the Relationship Between Free Drug Samples and Prescription Patterns for Acne Vulgaris and Rosacea

2014

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Importance Describing the relationship between the availability of free prescription drug samples and dermatologists’ prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician’s office. Objective To investigate the relationships between free drug samples and dermatologists’ local and national prescribing patterns and between the availability of free drug samples and prescription costs. Design, Setting, and Participants Cross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of a nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of either acne vulgaris or acne rosacea in 2010. Main Outcome Measures National trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples. Results On a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase directly correlates with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs $200 at an academic medical center without samples). Conclusions and relevance The benefits of free samples in dermatology must be weighed against potential negative impacts on prescribing behavior and prescription costs.

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Suitability and readability of consumer medical information accompanying prescription medication samples

Cited by 50 publications

References 26 publications

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

Patients’ attention to and understanding of adverse drug reaction warnings

Characterizing the Relationship Between Free Drug Samples and Prescription Patterns for Acne Vulgaris and Rosacea

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Suitability and readability of consumer medical information accompanying prescription medication samples

Cited by 50 publications

References 26 publications

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

Problemas Identificados nos Folhetos Informativos dos Medicamentos Não Genéricos Portugueses

Patients&rsquo; attention to and understanding of adverse drug reaction warnings

Characterizing the Relationship Between Free Drug Samples and Prescription Patterns for Acne Vulgaris and Rosacea

Contact Info

Product

Resources

About

Patients’ attention to and understanding of adverse drug reaction warnings