Inappropriate dosage instructions in package inserts

Fuchs, Joerg; Hippius, Marion

doi:10.1016/j.pec.2007.03.009

Cited by 52 publications

(50 citation statements)

References 14 publications

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“…In this context, healthcare professionals are responsible for assuring the transmission of information fundamental to the adequate use of medicines, despite what materials might exist, in particular dosage instructions, side effects and strategies for patients' adherence [25][26][27].…”

Section: Questionnaire Part B: B) Participants' Suggestions To Improvmentioning

confidence: 99%

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Pires

Cavaco

2014

Eur J Clin Pharmacol

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2 AbstractPurpose To explore and compare the opinions of physicians, pharmacists and potential users on the readability of a package insert of an over-the-counter medicine.Methods Exploratory study based on the administration of a semi-open questionnaire. This instrument was developed according to the readability guideline of the European Medicine Agency (EMA) and used to evaluate participants' accessibility to, and comprehensibility of, the package insert for diclofenac 12.5 mg tablets. Sixty-three participants were recruited from the Lisbon region and enrolled in three groups: 21 physicians (Dg), 22 pharmacists (Pg) and 20 potential consumers (PCg).Results Almost all (85%) of the PCg participants were educated above the 9 th grade, although the majority of them (95%) referred at least one package insert interpretation issue, mainly related to the comprehension of technical terms. Amongst other differences between groups, the Pg participants obtained a significantly less score regarding the opinion on the layout of the titles. Furthermore, the Pg and Dg participants proposed technical enhancements, such as the use of a table to explain the posology, precautions in case of renal failure, or the recommendation to take the tablets with meals.Conclusions Differences in the way of using the diclofenac tablets are expected, considering the comprehension dissimilarities between health professionals and potential consumers. The package insert of diclofenac 12.5 mg could be enhanced. Regarding the readability assessment of this package insert, the method proposed in the EMA guideline might not be as effective as expected. Future research is advisable.

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Section: Questionnaire Part B: B) Participants' Suggestions To Improvmentioning

confidence: 99%

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Pires

Cavaco

2014

Eur J Clin Pharmacol

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“…13,19 Other suggestions for improvement have included quantifying doses in terms of tablets or volume in standard measures, avoiding foreign words, using short and precise information only, and avoiding nonquantifiable statements. 11,47 Cultural differences should also be considered, as it is known that different cultures may interpret pictograms and symbols differently. 27 Although challenging, the goal is to provide information that is comprehensible to people of different cultures, ages, levels of education, and types of employment whenever possible.…”

Section: Suggestions For Improvement Of Wmimentioning

confidence: 99%

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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“…Despite repeated attempts to sensitize the authorities regarding inadequacy of information of presently available PI at both national and international level, there is still a lot of deficiencies in the presently available regulations for designing the PI, especially in a developing country like India. [13][14][15][16][17] Therefore, the present study was carried out to further emphasize these differences in the presently available PIs by measuring the completeness (availability of key information) of PIs in India according to a set of standard criteria and grade them according to the scores obtained.…”

Section: Introductionmentioning

confidence: 99%

Analysis of completeness of drug package inserts available in India

S¹,

Revankar²,

Vedavathi³

et al. 2017

Natl J Physiol Pharm Pharmacol

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Background: Information about the drug used can be obtained from various sources of drug information. One of the easily available sources of drug information is package insert (PI). The PI is the primary source of drug information. The PI or leaflet is the leaflet containing information about the medicinal product which accompanies the medicinal product. A good PI contains the approved, essential, and accurate information and it contains information in a language that is not promotional, false, or misleading. It is evidence based and periodically updated. However, not all PIs conform to all the above standards. Hence, the present study was undertaken to evaluate the appropriateness of presently available drug PIs. Aims and Objectives: The aim of this study is to evaluate the completeness of the presently available PIs and grade them. Materials and Methods: The present study was cross-sectional, observational, prospective study. 55 PIs were collected from various pharmacies in request. Out of them, 5 were found to be duplicated and were rejected. Remaining 50 PIs were analyzed based on criteria laid under the Drugs and Cosmetics Rules 1945 under section 6.2 and 6.3 of schedule D. Results: Among the 50 PIs, 35 (70%) were of Indian companies and 15 (30%) were of multinational companies. Furthermore, 31 (62%) were parenteral preparations, 15 (30%) were oral formulations, and 04 (8%) were topical preparations. PIs were inadequate as to retail price of drug (0%), references (14%), effect on ability to drive machines(26%), updated information, and provision of full information on request (38%). 52% of PIs were A category, 48% of PIs were B category, and none of PIs were C category. Conclusions: The present study shows that there is still paucity of information and requirement of standardization of the presently available PIs, especially with regard to the size and shape of PIs, font size, references, effect on ability to drive machines, updated information, and provision of full information on request. Furthermore, PIs should be made mandatory with all medications.

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Inappropriate dosage instructions in package inserts

Cited by 52 publications

References 14 publications

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Patients’ attention to and understanding of adverse drug reaction warnings

Analysis of completeness of drug package inserts available in India

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Inappropriate dosage instructions in package inserts

Cited by 52 publications

References 14 publications

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

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

Analysis of completeness of drug package inserts available in India

Contact Info

Product

Resources

About

Patients’ attention to and understanding of adverse drug reaction warnings