patient-centered label (PCL) instruction 文献调研

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总结和概述 1、pictureRX http://www.ajmc.com/publications/issue/2014/2014-vol20-n12/improving-medication-understanding-among-latinos-through-illustrated-medication-lists 患者教育 患者empowerment

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参考文献列表 以“patient-centered label (PCL) instruction”为关键词在google学术里检索到相关文献 参考文献： 1、 Literacy and Misunderstanding Prescription Drug Labels FREE 2、What’s in a label? An exploratory study of patient-centered drug instructions 3、Improving Patient Understanding of Prescription Drug Label Instructions 4、To err is human: Patient misinterpretations of prescription drug label instructions 5、Effect of Standardized, Patient-Centered Label Instructions to Improve Comprehension of Prescription Drug Use

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第一组 Take-Wait-stop: A Patient-Centered Strategy for Writing PRN Medication Instructions []() []()

解决的问题 a) taking more than two pills at one time,一次吃太多片 (b) exceeding the maximum daily dose, and 每天吃太多 (c) waiting fewer than 4 hours between doses. 每顿隔的时间不够 Development of a Patient-Centered Bilingual Prescription Drug Label Abstract Research shows that prescription drug labels are often difficult for patients to understand, which contributes to medication errors and nonadherence. In this study, the authors developed and qualitatively evaluated an evidence-based bilingual prescription container label designed to improve understanding. The authors developed several prototypes in English only or in English and Spanish. The labels included an image of the drug, an icon to show its purpose, and plain-language instructions presented in a 4-time-of-day table. In 5 focus groups and interviews that included 57 participants, patients and pharmacists critically reviewed the designs and compared them with traditional medication labels and reformatted labels without illustrations. Patients strongly preferred labels that grouped patient-relevant content, highlighted key information, and included drug indication icons. They also preferred having the 4-time-of-day table and plain-language text instructions as opposed to either one alone. Patients preferred having pertinent warnings on the main label instead of auxiliary labels. Pharmacists and Latino patients valued having Spanish and English instructions on the label, so both parties could understand the content. The final label design adheres to the latest national- and state-level recommendations for label format and incorporates additional improvements on the basis of patient and pharmacist input. This design may serve as a prototype for improving prescription drug labeling.

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Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use.

Abstract Objective

To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared to typical instructions. Methods

500 adult patients recruited from two academic and two community primary care clinics in Chicago, IL and Shreveport, LA were assigned to receive: 1) standard prescription instructions written as times per day (once, twice three times per day) [usual care], 2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) [PCL], or 3) PCL instructions with a graphic aid to visually depict dose and timing of the medication [PCL + Graphic]. The outcome was correct interpretation of label instructions. Results

Instructions with the PCL format were more likely to be correctly interpreted compared to standard instructions (Adjusted Relative Risk (RR) 1.33, 95% Confidence Interval (CI) 1.25 – 1.41). Inclusion of the graphic aid (PCL + Graphic) decreased rates of correct interpretation compared to PCL instructions alone (RR 0.93, 95% CI 0.89 - 0.97). Lower literate patients were better able to interpret PCL instructions (low literacy: RR 1.39, 95% CI 1.14 – 1.68; p=0.001). Conclusion

The PCL approach could improve patients' understanding and use of their medication regimen.

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What's in a label? An exploratory study of patient-centered drug instructions.

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Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications. OTC药品 cough and cold 治儿童感冒和咳嗽 Abstract STUDY OBJECTIVE:

The use of nonprescription cough and cold medicines is widespread, but their use has been sporadically associated with severe toxicity and death. We evaluate the role of these medications in pediatric fatalities and identified factors that contributed to the death. METHODS:

Fatalities that involved a child younger than 12 years and mentioned a cough and cold ingredient were obtained from 5 sources. An independent panel of 8 experts (pediatrics, pediatric critical care, pediatric toxicology, clinical toxicology, forensic toxicology, forensic pathology) used explicit definitions to assess the causal relationship between medication ingestion and death. Contributing factors were identified. RESULTS:

Of 189 cases included, 118 were judged possibly, likely, or definitely related to a cough and cold ingredient. Of these 118 cases, 103 involved a nonprescription drug, whereas 15 cases involved a prescription medication alone. Of 103 cases associated with nonprescription drugs, the evidence indicated that 88 involved an overdosage. A dosage could not be assessed in the remaining 15 cases. Several contributing factors were identified: age younger than 2 years, use of the medication for sedation, use in a daycare setting, use of 2 medicines with the same ingredient, failure to use a measuring device, product misidentification, and use of a nonprescription product intended for adult use. All cases that occurred in a daycare setting involved a child younger than 2 years. CONCLUSION:

In our sample, pediatric fatalities caused by nonprescription cough and cold medications were uncommon, involved overdose, and primarily affected children younger than 2 years. The intent of caregivers appears to be therapeutic to relieve symptoms in some cases and nontherapeutic to induce sedation or to facilitate child maltreatment in other cases.

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Standardizing Medication Labels: Confusing Patients Less - Workshop Summary

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Medication misuse, nonadherence, and clinical outcomes among liver transplant recipients Medication nonadherence after liver transplantation (LT) is associated with adverse clinical outcomes such as graft rejection and graft loss. Few studies have examined nonadherence and its impact on clinical outcomes in LT. The study objectives were (1) to evaluate medication understanding (with treatment knowledge and demonstrated regimen use scores) and medication adherence or nonadherence to entire regimens among LT recipients and (2) to examine associations of these exposures with clinical outcomes. We conducted a 2-site study of 105 recipients between 2011 and 2012 at 2 transplant centers in Chicago, IL and Atlanta, GA. Data were collected via detailed, in-person interviews and medical record reviews. Study participants were middle-aged and predominantly male; 15% of the sample had limited literacy. On average, patients were taking 11 medications [standard deviation (SD) = 4], and 39% had undergone a medication change within the last month. The average scores for the entire medication regimen were 86% (SD = 22%) for treatment knowledge and 78% (SD = 22%) for demonstrated regimen use. The mean score for self-reported nonadherence to the entire regimen was 14% (SD = 20%), whereas 32% of the patients were nonadherent according to tacrolimus levels. In multivariate analyses, lower income, less time since transplantation, a higher number of medications, and limited literacy were inversely associated with treatment knowledge scores (all P < 0.05), whereas limited literacy was associated with nonadherence according to tacrolimus levels (P < 0.05). In multivariate models, higher scores for treatment knowledge [incidence rate ratio (IRR) = 0.85, 95% confidence interval (CI) = 0.74-0.97] and demonstrated regimen use (IRR = 0.87, 95% confidence interval = 0.77-0.98) were independently associated with 15% and 13% reductions in the number of posttransplant rehospitalizations, respectively. Inadequate treatment knowledge and improper regimen use may be significant determinants of unintentional nonadherence among LT recipients and are associated with adverse clinical outcomes. Liver Transpl 21:22-28, 2015. © 2014 AASLD.

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PictureRx: Illustrated Medication Instructions for Patients with Limited Health Literacy Abstract Objectives

To describe (1) the role of illustrated medication instructions in pharmacy practice, (2) the evidence for their use, and (3) our experience with their implementation. Practice description

PictureRx is applicable to all pharmacy practice settings. Practice innovation

PictureRx enables pharmacists to rapidly produce evidence-based, illustrated medication instructions that are well-understood by patients of all health literacy levels. Results

PictureRx has been studied in a number of settings. The tool was successfully deployed at a busy, outpatient pharmacy; in a medical clinic for the underserved; and pilot-tested among elderly, community dwelling Medicare recipients. In each of these settings, PictureRx was received favorably by patients, pharmacists, and other health care providers. It improved patients’ satisfaction with the pharmacy and knowledge about their medications. Ongoing research is assessing whether PictureRx enhances medication management among Latinos. Conclusion

PictureRx helps pharmacists address challenges related to low health literacy and can be implemented into a broad range of practices environments. Ongoing research will delineate the extent to which PictureRx reduces health disparities.

PictureRx这家公司的产品怎么山寨

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Perceptions of prescription warning labels within an underserved population ABSTRACT * Objective : To understand how underserved populations attend to prescription warning label (PWL) instructions, examine the importance of PWL instructions to participants and describe the challenges associated with interpreting the information on PWLs. Methods : Adults from an underserved population (racial and ethnic minorities, individuals with low income, older adults) who had a history of prescription medication use and were able to understand English took part in semi- structured interviews. Participants were presented with eight different prescription bottles with an attached PWL. Participants were asked, “If this prescription was yours, what information would you need to know about the medicine?” The number of participants who attended to the warning labels was noted. Other questions assessed the importance of PWLs, the challenges with understanding PWLs, and ways a pharmacist could help participant understanding of the PWL. Results : There were 103 participants. The mean age was 50.25 years (SD=18.05). Majority attended to the PWL. Participants not currently taking medications and who had limited health literacy were likely to overlook the warning labels. Majority rated the warning instructions to be extremely important (n=86, 83.5 %), wanted the pharmacist to help them understand PWLs by counseling them on the information on the label (n=63, 61.2%), and thought the graphics made the label information easy to understand. Conclusions : PWLs are an important method of communicating medication inform ation, as long as they are easily comprehensible to patients. In addition to placing PWLs on prescrip tion bottles, health care providers need to counsel underserved populations on medication warnings, especially individuals with limited health literacy who are not currently using a prescription medication

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Getting to Better Prescription Drug Information

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Improving prescription auxiliary labels to increase patient understanding

Abstract

Objectives To develop new, easy-to-understand prescription auxiliary labels, assess patient understanding of both new and existing labels, and compare the effectiveness of existing labels with the newly developed ones.

Design Cross-sectional study.

Setting Semistructured interviews.

Participants Convenience sample of adults from minority populations who were currently taking or had previously taken a prescription medication and could understand English.

Intervention Easy-to-understand prescription auxiliary labels were developed. Both these newly created labels and existing labels were shown to participants. Participants’ health literacy levels and understanding of the information provided on the labels were determined. The reading difficulty of the auxiliary labels was determined using a Lexile Score.

Main outcome measures Interpretation and understanding of prescription auxiliary labels.

Results The study included 120 participants with a mean age of 40 years (SD = 14). All existing prescription auxiliary labels yielded less than 50% “excellent” interpretations except for those indicating “Take with food” and “Do not chew or crush.” The newly designed labels were better understood compared with existing labels. Some existing labels yielded Lexile scores above the sixth-grade reading level. There was an association between higher levels of education (χ2 = 20.86, P = 0.02) or higher REALM-R (Rapid Estimate of Adult Literacy in Medicine, Revised) scores (χ2 = 26.79, P = 0.02) and better interpretation of auxiliary labels.

Conclusion Simpler auxiliary labels with improved patient comprehension can be developed. Auxiliary label understanding and interpretation is low for commonly used labels. Pharmacies should consider using existing manufacturer auxiliary labels that meet the criteria for patients with low literacy.

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Rethinking Adherence: A Health Literacy–Informed Model of Medication Self-Management Medication adherence has received a great deal of attention over the past several decades; however, its definition and measurement remain elusive. The authors propose a new definition of medication self-management that is guided by evidence from the field of health literacy. Specifically, a new conceptual model is introduced that deconstructs the tasks associated with taking prescription drugs; including the knowledge, skills and behaviors necessary for patients to correctly take medications and sustain use over time in ambulatory care. This model is then used to review and criticize current adherence measures as well as to offer guidance to future interventions promoting medication self-management, especially among patients with low literacy skills. Taking prescribed medicine has long been recognized as one of the most essential self-care activities performed by patients to promote their health. Medication nonadherence is estimated to cost the U.S. health care system more than $100 billion annually and is linked to more than 125,000 deaths each year (Bosworth et al., 2011; Ernst & Grizzle, 2001). As prescription drug use in the United States continues to rise, the salience of promoting safe, appropriate medication use will only become even more important from a public health perspective (Gu, Dillon, & Burt, 2010). Gaining a concrete understanding of patient roles and responsibilities in outpatient settings is necessary to develop and implement comprehensive strategies to support these behaviors. Although medication adherence has received an unprecedented amount of attention over the past several decades, its definition and measurement continue to remain elusive (Andrade, Kahler, Frech, & Chan, 2006; Cramer et al., 2008; Farmer, 1999; Haynes et al., 2005; Osterberg & Blaschke, 2005). Debates over the correct terminology to use to describe related behaviors are common (Cramer et al., 2008; Steiner & Earnest, 2000). Consequently, its measurement is often challenging, cumbersome, and costly (Farmer, 1999). As a result, adherence is typically operationalized as a limited set of behaviors, such as filling a prescription or taking doses of a medication. This emphasis has, over time, simplified the way we think of medication use and has directed attention away from the diverse series of steps a patient must take to self-manage medications in ambulatory care (Osterberg & Blaschke, 2005). Simplistic conceptualizations of medication use have become even more problematic as patients are increasingly being prescribed multiple medications (Gu et al., 2010). To take these multidrug regimens safely and appropriately, patients must engage in a number of behaviors that vary in complexity and require an even greater knowledge and skill set (Wolf, Curtis, et al., 2011). Herein, we propose a new definition of medication use that is guided by relatively recent yet extensive evidence that has emerged from the field of health literacy. Specifically, we introduce a new conceptual model that deconstructs the tasks associated with taking prescription drugs, including the knowledge, skills and behaviors necessary for patients to correctly take medications and to sustain proper use over time in ambulatory care. The field of health literacy in its entirety has made invaluable contributions to this particular topic of research inquiry and to the broader mission of understanding the cognitive and psychosocial demands that are placed on patients as a result of performing requisite health behaviors.

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Evaluation of Language Concordant, Patient-Centered Drug Label Instructions ABSTRACT BACKGROUND

Despite federal laws requiring language access in healthcare settings, most US pharmacies are unable to provide prescription (Rx) medication instructions to limited English proficient (LEP) patients in their native language. OBJECTIVE

To evaluate the efficacy of health literacy-informed, multilingual Rx instructions (the ConcordantRx instructions) to improve Rx understanding, regimen dosing and regimen consolidation in comparison to standard, language-concordant Rx instructions. DESIGN

Randomized, experimental evaluation. PARTICIPANTS

Two hundred and two LEP adults speaking five non-English languages (Chinese, Korean, Russian, Spanish, Vietnamese), recruited from nine clinics and community organizations in San Francisco and Chicago. INTERVENTION

Subjects were randomized to review Rx bottles with either ConcordantRx or standard instructions. MAIN MEASURES

Proper demonstration of common prescription label instructions for single and multi-drug medication regimens. Regimen consolidation was assessed by determining how many times per day subjects would take medicine for a multi-drug regimen. KEY RESULTS

Subjects receiving the ConcordantRx instructions demonstrated significantly greater Rx understanding, regimen dosing and regimen consolidation in comparison to those receiving standard instructions (incidence rate ratio [IRR]: 1.25, 95 % confidence interval [CI]: 1.06-1.48; P = 0.007 for Rx understanding, IRR: 1.19, 95 % CI: 1.03–1.39; P = 0.02 for regimen dosing and IRR: 0.76, 95 % CI: 0.64–0.90; P = 0.001 for regimen consolidation). In most cases, instruction type was the sole, independent predictor of outcomes in multivariate models controlling for relevant covariates. CONCLUSIONS

There is a need for standardized, multilingual Rx instructions that can be implemented in pharmacy practices to promote safe medication use among LEP patients. The ConcordantRx instructions represent an important step towards achieving this goal.

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Helping Patients Simplify and Safely Use Complex Prescription Regimens

Background There is considerable variability in the manner in which prescriptions are written by physicians and transcribed by pharmacists, resulting in patient misunderstanding of label instructions. A universal medication schedule was recently proposed for standardizing prescribing practices to 4 daily time intervals, thereby helping patients simplify and safely use complex prescription regimens. We investigated whether patients consolidate their medications or whether there is evidence of unnecessary regimen complexity that would support standardization.

Methods Structured interviews were conducted with 464 adults (age range, 55-74 years) who were receiving care either at an academic general medicine practice or at 1 of 3 federally qualified health centers in Chicago, Illinois. Participants were given a hypothetical, 7-drug medication regimen and asked to demonstrate how and when they would take all of the medications in a 24-hour period. The regimen could be consolidated into 4 dosing episodes per day. The primary outcome was the number of times per day that individuals would take medication. Root causes for patients complicating the regimen (>4 times a day) were examined.

Results Participants on average identified 6 times (SD, 1.8 times; range, 3-14 times) in 24 hours to take the 7 drugs. One-third of the participants (29.3%) dosed their medications 7 or more times per day, while only 14.9% organized the regimen into 4 or fewer times a day. In multivariable analysis, low literacy was an independent predictor of more times per day for dosing the regimen (β = 0.67; 95% confidence interval, 0.12-1.22; P = .02). Instructions for 2 of the drugs were identical, yet 31.0% of the participants did not take these medications at the same time. Another set of drugs had similar instructions, with the primary exception of 1 drug having the added instruction to take “with food and water.” Half of the participants (49.5%) took these medications at different times. When the medications had variable expressions of the same dose frequency (eg, “every 12 hours” vs “twice daily”), 79.0% of the participants did not consolidate the medications.

Conclusions Many patients, especially those with limited literacy, do not consolidate prescription regimens in the most efficient manner, which could impede adherence. Standardized instructions proposed with the universal medication schedule and other task-centered strategies could potentially help patients routinely organize and take medication regimens.

Patients frequently misunderstand common instructions and warnings that accompany prescription drugs, resulting in unintentional misuse and potentially adverse drug events.1- 6 This should not be surprising, as prescription labels may provide seemingly simple but often unclear directions that are confusing to most patients. In the United States, physician prescriptions and pharmacy labeling typically include vague information detailing recommended medication schedules described either in hourly intervals (eg, every 4-6 hours) or times per day (eg, twice daily). Davis et al1 found that nearly half of patients misinterpreted common instructions when attempting to dose a single prescription medication.

Yet the problem may be more serious than these findings suggest, as patients are increasingly managing multiple prescriptions and over-the-counter medications. According to the Medical Expenditure Panel Survey, the average adult in the United States fills 9 prescriptions annually,7 while adults older than 65 years fill on average 20 prescriptions a year. Greater regimen complexity, based on multiple medications and/or multiple daily doses per drug, may lead to poorer adherence, which in turn will lead to worse health outcomes.8- 12 From a health system perspective, the known variability and poor quality in the manner in which prescription instructions are written by physicians and translated by pharmacies impede an individual's ability to organize and properly dose multiple medications.13,14

The Institute of Medicine, in its 2008 report Standardizing Medication Labels, recognized the need for setting standards within prescribing and dispensing practices to promote safe and accurate medication use for patients.6 Because approximately 90% of prescriptions are taken 4 or fewer times a day,12 a universal medication schedule (UMS) was proposed in the Institute of Medicine report specifying 4 standard times (morning, noon, evening, and bedtime) for the prescribing and dispensing of medication.14 The UMS would describe when to take a drug in the same manner on all prescription labels, removing the current variability often found in the manner in which prescriptions are written by physicians and transcribed by pharmacists.13- 15 All prescriptions would instruct patients to take their medications using these specified times, and label instructions would subsequently be described in a single standardized fashion. This standardization was viewed with both promise and controversy by the pharmacological and medical communities. While it might help patients organize and group increasingly complex medication regimens for daily use, it was concluded that further evidence would be needed to support the need for the UMS. In the present study, we sought to fill the gap of existing literature and to investigate whether patients complicate multiple prescription regimens by taking medications more than 4 times a day. Specifically, we evaluated the accuracy and variability in the way patients implemented a typical 7-drug regimen.

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Interventions for Individuals with Low Health Literacy: A Systematic Review

对于不识字的人群，考虑语音的方式

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Literacy and Misunderstanding Prescription Drug Labels FREE

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What’s in a label? An exploratory study of patient-centered drug instructions Abstract Objective To assess the efficacy of patient-centered label (PCL) instructions on the knowledge and comprehension of prescription drug use compared to standard instructions. Methods A total of 94 participants recruited from an outpatient clinic in Ireland were each randomly assigned to receive: (1) standard prescription instructions written as times per day (usual care), (2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) or with mealtime anchors (both PCL), or (3) PCL instructions with a graphic aid to visually depict dose and timing of the medication (PCL + Graphic). The outcome was correct interpretation of the instructions. Results PCL instructions were more likely to be correctly interpreted than the standard instructions [adjusted relative risk (RR) 1.08, 95% confidence interval (CI) 0.98–1.18]. The inclusion of the graphic aid (PCL + Graphic) decreased the rates of correct interpretation compared to PCL instructions alone (RR 0.98, 95% CI 0.91–1.05). There was a significant interaction between instruction type and health literacy (p = 0.01). Those with limited health literacy were more likely to correctly interpret the PCL labels (91%) than the standard labels (66%), and those with adequate health literacy performed equally well. Conclusion The PCL approach may improve patients’ understanding and use of their medication regimen.