Medicine Label Research Articles

User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines.

User testing evaluates written medicine information (WMI) usability by examining participants' ability to find and understand information. It can also be an effective method to determine how consumers say they will act on information on an over-the-counter (OTC) label. To examine consumers' proposed behaviors regarding dosage and storage as a measure of a medicine label's usability and consumers' functional health literacy. User testing of 5 diclofenac OTC labels (by 50 subjects; 10 per label) measured consumers' ability to find and understand key points of information using a 13-item questionnaire. Consumers were required to elaborate on their behavior in regard to 2 additional questions: 1) when they would take diclofenac if they had constant back pain from 8 am (dosage-related) and; 2) where they would store it in their home (storage-related). Responses were transcribed verbatim, and coded by 2 pharmacists. Appropriate dosing for constant back pain was reported by 29 consumers. However, dosing intervals shorter than the specified 8h were often reported (n=19), due to adjusting intervals to accommodate up to themaximum of 8 tablets in 24h, desire for pain relief, and/or pragmatic dosing (e.g. around bedtime). Only29 consumers stated completely appropriate storage location examples (e.g. medicine cabinet). Consumers may act inappropriately on OTC label information about dosage and/or storage, which could potentially adversely impact medication use. User testing can contribute to the development of high quality WMI and help identify where label wordings are inappropriate for the health literacy levels of consumers.

Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.

Regulatory agencies are increasing the pharmacogenomic information in their official drug labeling. However, despite the importance of regulatory harmonization, this implementation may not be running in parallel among major agencies. Comparing labeling of medicines approved by different agencies may identify gaps to solve. Our study compared the cytochrome P450 pharmacogenetic information included in the United States (US) Food and Drug Administration (FDA) drug labels and European Union (EU) Summaries of Product Characteristics (SmPCs). US labels presented significantly more specific pharmacogenetic subheadings (51 vs 26%), more prevalence and pharmacokinetic data for each metabolic phenotype (59 vs 25% and 82 vs 48%, respectively) and more applicable information about dose modifications required (25 vs 5%). Approximately 75% of the US labels evaluated scored higher on the overall quality than the analogous EU SmPCs, and this difference was not associated with the time since the EU SmPCs' last review. To enhance harmonization, regulatory agencies should simultaneously introduce the pharmacogenetic information in their drug labeling.

Evaluation of an Australian health literacy training program for socially disadvantaged adults attending basic education classes: study protocol for a cluster randomised controlled trial.

BackgroundPeople with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes.Methods/designThis is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education colleges across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content).The primary outcome is functional health literacy skills – knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, more advanced health literacy skills; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention. A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program to better understand implementation issues and to strengthen the potential for scaling up the program.DiscussionOutcomes will provide evidence regarding real-world implementation of a health literacy training program with health worker involvement in an Australian adult education setting. The evaluation trial will provide insight into translating and scaling up health literacy education for vulnerable populations with low literacy.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000213448.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3034-9) contains supplementary material, which is available to authorized users.

Health Literacy and Moderate to Vigorous Physical Activity During Aging, 2004-2013.

Health literacy (the ability to read and understand health information) may help to support sustained participation in moderate to vigorous physical activity (MVPA) during aging; this relationship has never been examined longitudinally. This study aimed to investigate the relationship between health literacy and participation in weekly MVPA over an 8-year period among older adults. Data were from interviews with 4,345 adults aged 52-79 years in the English Longitudinal Study of Ageing from 2004/2005 to 2012/2013, analyzed in 2015. Health literacy was assessed in 2004/2005 as reading comprehension of a medicine label, defined as "low" (≤2/4 items correct); "medium" (3/4); and "high" (4/4). The outcome was maintaining weekly MVPA at all of five time points from 2004/2005 to 2012/2013. A population-weighted logistic regression model was adjusted for sociodemographic, physical health, and cognitive (memory and verbal fluency) covariates. Overall, 72% (3,128/4,345) of the sample had high health literacy; 18% (797/4,345) had medium health literacy; and 10% (420/4,345) had low health literacy. Of those with high health literacy, 59% (1,840/3,128) consistently reported weekly participation in MVPA, compared with 33% (138/420) of those with low health literacy (AOR=1.37, 95% CI=1.04, 1.80). Better memory was weakly positively associated with long-term MVPA (AOR=1.03, 95% CI=1.00, 1.05, per point increase out of 24), as was better verbal fluency (AOR=1.05, 95% CI=1.01, 1.09, per point increase out of 9). High health literacy and good cognitive function are independently associated with participation in weekly MVPA over an 8-year period during aging.

Testing of Candidate Icons to Identify Acetaminophen-Containing Medicines.

Adding icons on labels of acetaminophen-containing medicines could help users identify the active ingredient and avoid concomitant use of multiple medicines containing acetaminophen. We evaluated five icons for communication effectiveness. Adults (n = 300) were randomized to view a prescription container label or over-the-counter labels with either one or two icons. Participants saw two icon candidates, and reported their interpretation; experts judged whether these reflected critical confusions that might cause harm. Participants rated how effectively each icon communicated key messages. Icons based on abbreviations of “acetaminophen” (“Ac”, “Ace”, “Acm”) were rated less confusing and more effective in communicating the active ingredient than icons based on “APAP” or an abstract symbol. Icons did not result in critical confusion when seen on a readable medicine label. Icon implementation on prescription labels was more effective at communicating the warning against concomitant use than implementation on over-the-counter (OTC) labels. Adding an icon to a second location on OTC labels did not consistently enhance this communication, but reduced rated effectiveness of acetaminophen ingredient communication among participants with limited health literacy. The abbreviation-based icons seem most suitable for labeling acetaminophen-containing medications to enable users to identify acetaminophen-containing products.

의약품 표시와 관련 규정에 대한 소비자의 인식

의약품 표시와 관련 규정에 대한 소비자의 인식

English

Self-care with over-the-counter (OTC) medicines have evolved from the “dark ages” of patent medicine manufacture and sale to a modem era of new drug development involving prescription-to-OTC switch. This evolution is largely due to the OTC review, which placed science at the cornerstone of safety, effectiveness, and labelling of non-prescription medicines. As selfcare with OTC drugs has evolved, the switching of drugs from prescription to non-prescription status has produced important benefits, creating more self-reliant consumers through novel self-care therapeutics, significant cost savings to the health care system, expanded markets for companies, enhanced science for regulatory decisions, a more consumer friendly label for all OTC agents, and a more consistent and predictable drug approval process. OTC drugs also known as Non-Prescription drugs are those medications which can be obtained without a Registered Medical Practitioner (RMP) and can be easily purchased in pharmacies, grocery stores, and convenience stores. According to American College of Preventive Medicine, they define OTC as “Drugs (Prescription and OTC drugs) are substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease”. The present study has been designed to investigate the benefits & risks, various classes and status of OTC medications in India.

The Ethics Around Drug Labels and Generic Medicines.

The labels of off-patent medicines can be obsolete and even misleading when compared to the contemporary, evidence-based use of the medicine. Apart from serious adverse drug reactions that can lead to rapid changes to the label, regulatory agencies can only review and approve proposed changes to the label submitted by the sponsor of the medicine. There are many reasons why a sponsor may not wish or have incentive to submit proposed changes, particularly once a medicine is off-patent. The problem of misleading and potentially dangerous medicines labels post-patent expiry needs to be addressed. Consideration is needed of the roles of the label at patent expiry, how well that role is fulfilled and the possible alternatives. Our preference is for a ‘partnership’ approach to support production and maintenance of up to date, and relevant information for generic medicines that is pragmatically situated within the context of other sources of high quality information and advice. Reform is clearly needed but progress will be dependent on convincing stake-holders of that need and will require much lateral and innovative thought from all stakeholders best facilitated by an ‘honest broker’ such as the DIA. The importance of drug labels A medicine is more than a pill, solution for injection or a topical product. It includes at least as significantly, the medicines information that optimizes the chance for safe and effective therapy in individual patients. This information is contained within the product ‘label’, ‘approved product information’ [PI] or ‘summary of product characteristics’ [SPC]— henceforth referred to as the ‘label’. The label, which is the Regulatory agency’s officially approved information document, accompanies each registered medicine. Despite these expectations, for reasons that will be discussed below, it is unavoidable that the longer a drug has been available on the market the more the official information in the label is likely to be obsolete, less relevant or even misleading. Furthermore, information for the patient, for example the corresponding patient information that is derived from the ‘label’, may also be inconsistent with the contemporary use of the medicine or the indication/s for which the medicine is being prescribed. Labels or consumer information that are not up-to-date and consistent with contemporary, evidence-based practice can, therefore, lead to stress and uncertainty for clinicians or patients who want to make use of this information.

Cognitive Function and Health Literacy Decline in a Cohort of Aging English Adults.

BACKGROUNDLow health literacy is common among aging patients and is a risk factor for morbidity and mortality. We aimed to describe health literacy decline during aging and to investigate the roles of cognitive function and decline in determining health literacy decline.METHODSData were from 5,256 non-cognitively impaired adults aged ≥ 52 years in the English Longitudinal Study of Ageing. Health literacy was assessed using a four-item reading comprehension assessment of a fictitious medicine label, and cognitive function was assessed in a battery administered in-person at baseline (2004–2005) and at follow-up (2010–2011).RESULTSOverall, 19.6 % (1,032/5,256) of participants declined in health literacy score over the follow-up. Among adults aged ≥ 80 years at baseline, this proportion was 38.2 % (102/267), compared to 14.8 % (78/526) among adults aged 52–54 years (OR = 3.21; 95 % CI: 2.26–4.57). Other sociodemographic predictors of health literacy decline were: male sex (OR = 1.20; 95 % CI: 1.04–1.38), non-white ethnicity (OR = 2.42; 95 % CI: 1.51–3.89), low educational attainment (OR = 1.58; 95 % CI: 1.29–1.95 for no qualifications vs. degree education), and low occupational class (OR = 1.67; 95 % CI: 1.39–2.01 for routine vs. managerial occupations). Higher baseline cognitive function scores protected against health literacy decline, while cognitive decline (yes vs. no) predicted decline in health literacy score (OR = 1.59; 95 % CI: 1.35–1.87 for memory decline and OR = 1.56; 95 % CI: 1.32–1.85 for executive function decline).CONCLUSIONSHealth literacy decline appeared to increase with age, and was associated with even subtle cognitive decline in older non-impaired adults. Striking social inequalities were evident, whereby men and those from minority and deprived backgrounds were particularly vulnerable to literacy decline. Health practitioners must be able to recognize limited health literacy to ensure that clinical demands match the literacy skills of diverse patients.Electronic supplementary materialThe online version of this article (doi:10.1007/s11606-015-3206-9) contains supplementary material, which is available to authorized users.

Internet use, social engagement and health literacy decline during ageing in a longitudinal cohort of older English adults

BackgroundHealth literacy skills tend to decline during ageing, which is often attributed to age-related cognitive decline. Whether health literacy skills may be influenced by technological and social factors during ageing...

Do people regard generic drugs as good as original brand-named drugs, and are there age or gender differences?

Much of the migrant workforce in Qatar is of low literacy level and does not understand Arabic or English, presenting a significant challenge to health care professionals. Medicine labels are typically in Arabic and English and are therefore poorly understood by these migrant workers.To develop pictograms illustrating selected medicine label instructions and to evaluate comprehension of the pictograms or conventional text supported with verbal instructions in foreign workers with low literacy skills.A range of common labeling instructions were identified and pictograms depicting these were developed using visual concepts and ideas from the literature. The process involved a consultative approach with input from the researchers, a local graphic artist, and members of the target population. The final set was evaluated for comprehension in participants who were randomized to one of three study groups: text plus verbal instructions, pictogram-only label, and pictogram with verbal instructions. One-way ANOVA and Chi-square tests were used to assess differences between group variables. Statistical significance was set at P ≤ 0.05.Of 23 label instructions screened, 11 were selected for the study. A total of 123 participants took part in this study. Pictogram plus verbal instructions group achieved better results in interpreting the majority of the label instructions (P ≤ 0.05). The best interpreted pictograms with verbal instructions included: “Take two tablets three times a day,” “Take one tablet in the morning and one tablet at night,” and “Instill one drop in the eye.” The worst interpreted pictograms with verbal instructions were: “Do not take with dairy products” and “Do not use by mouth.” Some pictograms were difficult to interpret even when accompanied with verbal instructions, suggesting the need to thoroughly pilot them among users prior to implementation.Medication labels consisting of simple pictorials supported by verbal instructions were better comprehended by individuals with low literacy skills than labels with written plus verbal instructions in a language that the individual did not understand. Further, pictogram-only labels were the least comprehended types of medicine labels among the participants.

Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review.

Over-the-counter medicines must be supplied with appropriate, user-friendly medicine information to satisfactorily support consumer self-management and safe use. Product labels and written medicine information leaflets are highly accessible over-the-counter medicine information sources for consumers. Factors such as comprehensibility and design underpin the usefulness of over-the-counter labels and leaflets and should be further examined to better inform future optimisation strategies. Aim of the review To undertake an in-depth exploration of studies that have evaluated design and/or comprehensibility of over-the-counter labels and written medicine information leaflets Methods Database searches were performed using Medline, Embase, International Pharmaceutical Abstracts and PubMed. Studies exploring over-the-counter medicine label and/or leaflet comprehensibility and/or design were identified. Additional author and reference list searches were performed to identify studies which met the inclusion criteria and key terms. A total of 35 studies were included in the review, which explored OTC medicine information design and/or comprehensibility via researcher evaluation alone (n = 8) or with consumers (n = 27). Researcher-determined over-the-counter written medicine information leaflet readability (n = 4) has highlighted suboptimal readability, with few studies evaluating over-the-counter leaflet performance using the gold standard method of 'user testing' with consumers (n = 2). Variable over-the-counter label comprehensibility was identified in consumer studies, ranging from satisfactory understanding to considerable misunderstanding. The review findings indicate that consumer outcomes were influenced by information design, where implementation of good design principles generally improved over-the-counter label and leaflet performance. Significant diversity existed in study design aspects such as sampling frames, sample sizes and tools used to evaluate over-the-counter medicine information, which hindered the ability to adequately compare various study aspects and findings. A wide spectrum of consumer understanding of over-the-counter medicine labels is evident in the literature, with limited studies examining over-the-counter written medicine information leaflet comprehensibility with consumers. The application of good information design principles in over-the-counter labels and leaflets contribute to improved performance. Well-designed consumer studies are needed to ascertain and optimise over-the-counter label and leaflet performance.

Quality use of an unlicensed medicine and off label use of a medicine

This paper gives an overview of the concept and process of quality use of unlicensed medicines and off label use of medicines, with special attention on the professional roles and responsibilities of prescribers and pharmacists. It also focuses on the policy requirements, sets of guidelines, recommendations, best practices, and other aspects addressed under this topic that represent the state of update knowledge. As a complex and specific issue, the use of an unlicensed medicine and off label prescribed medicine in different health care levels is of particular importance for the healthcare settings in the Republic of Macedonia since, the existing regulatory structure requires adoption and development of a comprehensive strategy relating to this topic in the near future with an aim of encouraging and supporting the development and maintenance of a sound health system with high standards of medication-use policies.

Labelling for cosmetic products and medical devices: rules, regulations and requirements

In the author's last article, she wrote about the new 2013 EU regulations for cosmetic products which changed to the new Cosmetic Products Regulation 1223/2009 in July 2013 ( Bowes, 2013 ). This paper will expand further on cosmetic product regulations by reviewing the legal labelling requirements for the cosmetics and ‘cosmeceuticals’ stocked by medical aesthetic practitioners, as well as their responsibilities as stockists selling directly to consumers. As it is equally important to understand the labelling requirements for medical devices such as dermal fillers, which are used frequently in aesthetic practice, the author will also explore these in the second half of the article. It is important to note that the labelling of prescription-only medicines, such as botulinum toxin, is outwith the scope of this article.

Development and evaluation of pictograms on medication labels for patients with limited literacy skills in a culturally diverse multiethnic population

Much of the migrant workforce in Qatar is of low literacy level and does not understand Arabic or English, presenting a significant challenge to health care professionals. Medicine labels are typically in Arabic and English and are therefore poorly understood by these migrant workers. To develop pictograms illustrating selected medicine label instructions and to evaluate comprehension of the pictograms or conventional text supported with verbal instructions in foreign workers with low literacy skills. A range of common labeling instructions were identified and pictograms depicting these were developed using visual concepts and ideas from the literature. The process involved a consultative approach with input from the researchers, a local graphic artist, and members of the target population. The final set was evaluated for comprehension in participants who were randomized to one of three study groups: text plus verbal instructions, pictogram-only label, and pictogram with verbal instructions. One-way ANOVA and Chi-square tests were used to assess differences between group variables. Statistical significance was set at P≤0.05. Of 23 label instructions screened, 11 were selected for the study. A total of 123 participants took part in this study. Pictogram plus verbal instructions group achieved better results in interpreting the majority of the label instructions (P≤0.05). The best interpreted pictograms with verbal instructions included: "Take two tablets three times a day," "Take one tablet in the morning and one tablet at night," and "Instill one drop in the eye." The worst interpreted pictograms with verbal instructions were: "Do not take with dairy products" and "Do not use by mouth." Some pictograms were difficult to interpret even when accompanied with verbal instructions, suggesting the need to thoroughly pilot them among users prior to implementation. Medication labels consisting of simple pictorials supported by verbal instructions were better comprehended by individuals with low literacy skills than labels with written plus verbal instructions in a language that the individual did not understand. Further, pictogram-only labels were the least comprehended types of medicine labels among the participants.

P112 Morphine and other opioid painkillers for moderate to severe pain: a NICE guidance compliant patient information leaflet

The Medicines Management Group (a multidisciplinary team comprising of medical, nursing and pharmacy representation) at an independent hospice has developed a patient information leaflet (PIL) on strong opioids. This decision...

Activation cross-section measurement of deuteron induced reactions on cerium for biomedical applications and for development of reaction theory

In the frame of a systematic study of deuteron induced nuclear reactions on lanthanides we have measured the excitation functions on natural cerium for production of 142,139,138m,137Pr, 143,141,139,137m,137,135Ce and 140La up to 50MeV deuteron energy using the activation method with stacked-foil irradiation technique and high-resolution γ-ray spectrometry. The cross-sections of the investigated reactions were calculated using the modified pre-compound model codes ALICE-IPPE-D and EMPIRE-II-D. A comparison was made also with the data retrieved from the TENDL-2012 library, based on the latest version of the TALYS code system. The measured cross-section data are important for further improvement of nuclear reaction models and for practical applications in nuclear medicine and other labeling and activation studies.

Survey of feasibility of a peelable and point-of-use labelling system

ObjectivesThis article describes a collaborative survey undertaken along with clinical practitioners in the UK and in Canada, in the fall of 2008. Its purpose was to identify the risks associated...

Patient knowledge of medicines dispensed from Ghanaian community pharmacies

One vital requirement for patient adherence to medicines is good patient knowledge of the medicines dispensed and this will invariably be linked to good labelling and counselling. The aim of this study was to evaluate the quality of labelling of medicines and determine patient knowledge of the administration of medicines dispensed from a community pharmacy in Ghana. From 6th to 29th January, 2010, dispensed prescriptions of 280 clients were purposely sampled to evaluate the quality of labelling. These clients were also interviewed about their knowledge of the last medicine received immediately after dispensing. A scoring system was employed by awarding a point for each attribute written on the package and each attribute stated by the patient. The dispensing attributes noted were name, dosage, frequency, duration, quantity and route of administration. Of the 280 patients interviewed, 157 (56%) were males. Thirty one (11%) had no education and 99(35%) were secondary school graduates. Antimalarials comprised 17.9% and analgesics, 15.4% of medicines dispensed. The name, quantity, dosage, frequency, duration of therapy and route of administration were written on the label in 98%, 99%, 55%, 54%, 6% and 2% respectively of the dispensed medicines. The mean labelling score was 3.096 (SD=1.05) out of 6. The corresponding patient knowledge values were 63%, 80%, 80%, 75%, 57% and 86%. The mean knowledge score was 4.375 (SD; 1.38) out of 6. The chi square test p-value for the effect of demographic characteristics (sex, educational background, location) on patient knowledge of medicines dispensed were p=0.454; p=0.000, and p=0.138 respectively. Patient knowledge of the administration of dispensed medicines was rated good; and this largely corresponded with the quality of labelling, except that the duration of therapy and route of administration was not frequently written and so labelling was rated just above average.

Health literacy among consumers in community pharmacy: perceptions of pharmacy staff

Low health literacy has important consequences for health status, medication adherence and use of health services. There is little insight from the perspective of pharmacy staff into how they identify the information needs of consumers and particularly the signals and risk factors of limited health literacy that they encounter in their day-to-day communication with consumers. To investigate factors impacting on consumer health literacy, from the perspective of pharmacy staff. The research comprised semi-structured interviews conducted in a convenience sample of pharmacies in the south-east region of Queensland, Australia. Eleven pharmacists and nine pharmacy assistants agreed to participate. Interviews were audio-recorded and transcribed verbatim. Initial coding of the anonymized transcripts was performed using NVivo(®). Codes were analysed into overarching themes and subthemes, which were then re-named and refined through consensus discussion. Three overarching themes were identified from the coding process: complexity of the health system, clarity of information, and dialogue among consumers and health-care professionals. Two of the themes were system related, namely the health system and pharmacy labels; the health literacy issues included lack of clarity, complexity and misunderstanding. The third theme was related to communication. Complexity of the health system, clarity of information and dialogue among consumers and health-care professionals were identified as factors associated with consumers' health literacy. We call for increased engagement between pharmacy staff and consumers with improved focus on areas of potential confusion, such as medicine labels and navigation of the health system, aiming to minimize negative consequences of limited health literacy and optimize patient health outcomes.