Objective To study and analyze the current situation of patient medication guide in foreign countries,aiming to provide references for the preparation of patient medication guide in China. Methods The current situation of patient medication guide by consulting literatures was mastered.In addition,the design concept of patient medication guide in foreign countries was summarized,the existing problems were analyzed,and the need for improvement was discussed. Results America,Australia,European countries and some Asian countries have developed a mature patient medication guide system under the supervision of the government departments.Patient medication information overseas takes patients' health literacy into consideration.It employs the concept of information design,focuses on risks and adverse reactions of drugs,and tells patients how to communicate with doctors and pharmacists.At the same time,it has some problems such as improper content and presentation,excessive emphasis on medication risk,not satisfying drug information demand of patients,as well as a lack of medication information for special groups such as the elderly. Conclusion The design,management and practice of patient medication guide in foreign countries set a good example for us.
Key words:
Drug package insert
;
Medication information,patient
;
Medicine information,consumer
;
Rational drug use
患者用药说明书在国外有多种表现形式,如在欧盟国家和新加坡称为患者信息活页(patient information leaflets,PILs),澳大利亚称为消费者用药信息(consumer medicine information,CMI)。在美国,患者用药说明书有多种表现形式。针对非处方药的有药物信息标签(drug facts label);而处方药根据可能引起安全性问题的程度,分别制定患者药品说明书、用药指导(medication guides,MedGuides)、CMI、患者信息单(patient information sheet,PIS)。除美国的CMI是由学术组织或个人编写,其内容和形式不需官方审核批准外,患者用药说明书大多是由药品制造商编写,并经官方部门批准才能发布[3]。
BAKER SJ.Who can read consumer product information?[J].Aust J Hosp Pharm,1997,27(2):126-131.
Aim: To assess the readability of a sample of Consumer Product Information (CPI) leaflets for Australian pharmaceutical products. Method: 30 CPIs were randomly selected from a total of 83 supplied from the Australian Pharmaceutical Manufacturers Association (90%) and the remainder from a community pharmacy. The CPIs were scanned as a computer file or typed into WordPerfect 6.1 and analysed for readability using the Flesch Reading Ease (FRE) formula. CPIs were also assessed for good design features using a newly created measure — the Baker Able Leaflet Design (BALD). Results: The mean FRE score was 51 (SD, 6.8; range 37—60) so the sampled CPIs could be understood by 40% or less of the population. The mean BALD score was 17 (SD, 3.6; range 10– 22) out of a maximum of 32. This compared favourably to a few overseas leaflets but not to some non-CPIs produced in Australia and there were many features that could be easily remedied to make CPIs easier to use. Conclusion: CPIs are pitched at a level beyond the comprehension of most of the population. People who have English as their second language would have even more difficulty. Aust J Hosp Pharm 1997; 27: 126–31.
KOO MM,KRASSI,ASLANIP.Patient characteristics influencing evaluation of written medicine information:lessons for patient education[J].Ann Pharmacother,2005,39(9):1434-1440.
ABSTRACT Written medicine information (WMI) is considered an important component of patient education. Despite the wealth of information on many aspects of WMI, there is a paucity of studies examining how patient characteristics influence use and evaluation of WMI. To investigate the influence of patient characteristics on the evaluation and intended future use of consumer medicine information (CMI), a form of WMI. A questionnaire was administered to patients from 3 rheumatology/pain clinics in teaching hospitals and 40 community pharmacies. The questionnaire examined patients' perceptions of CMI (comprehension, perceived usefulness, design rating) and likelihood of using CMI in the future. Information on patient characteristics (demographic data, health literacy level) was also collected. Multiple regression analysis was used to examine associations between patient characteristics and their evaluation and intended future use of CMI. A total of 479 patients participated. Comprehension of CMI was associated with speaking primarily English at home, having attained secondary education or higher, and having adequate health literacy levels. Perceived usefulness of CMI was influenced by age and number of medications. Design rating was influenced by type of CMI, patient age, gender, and highest level of education. Intended future use was affected by health literacy level. In addition to individual patient characteristics, overall comprehension and perceived usefulness of CMI also influenced its intended future use. Patient characteristics were found to influence evaluation and intended future use of CMI. These findings should be taken into consideration in future research, development of WMI, and education of patients in everyday practice.
WOLF MS,DAVIS TC,SHRANK WH,et al.A critical review of FDA-approved Medication Guides[J].Patient Educ Couns,2006,62(3):316-322.
Reading level of text in Medication Guides should be reduced, summaries or “highlights” provided, and the scope of information limited to increase the likelihood of use among individuals with limited literacy. Consumers should be involved in their development.
WINTERSTEIN AG,LINDENS,LEE AE,et al.Evalua-tion of consumer medication information dispensed in retail pharmacies[J].Arch Intern Med,2010,170(15):1317-1324.
United States retail pharmacies are key sources of written consumer medication information (CMI) through leaflets dispensed with prescription drugs. The content and format of this CMI are unregulated. Public Law 104-180 stipulates that by 2006, 95% of prescriptions be accompanied by "useful" CMI. Professional shoppers filled prescriptions for lisinopril and metformin in a national sample of 365 pharmacies. Dispensed CMI was evaluated according to explicit criteria (77 for lisinopril and 78 for metformin) adapted from Food and Drug Administration guidelines. Six percent of pharmacies did not provide any written CMI. A mean (SD) of 60.2% (20.7%) and 57.7% (20.1%) of the criteria for useful CMI were met for lisinopril and metformin prescriptions, respectively. Shortcomings concerned especially "directions about use" with means of 53.4% (95% confidence interval [CI], 51.4%-56.5%) and 45.6% (43.7%-47.6%), and "comprehensibility/legibility," with means of 43.8% (42.6%-44.9%) and 42.6% (41.1%-43.7%) for lisinopril and metformin, respectively. The CMI leaflets ranged from 33 to 2482 words, with more than 1000-word differences among those meeting higher than 80% of the content criteria, suggesting large variations in conciseness. Chain pharmacies had better adherence to content criteria than did independent stores, with mean differences of 22.1% (95% CI, 15.8%-28.4%) for lisinopril and 21.1% (95% CI, 14.9%-27.3%) for metformin. Although distribution through pharmacies seems effective, the content, format, reading level, and excessive length of CMI are disconcerting. Private sector initiatives to provide useful CMI have failed. Research is needed on effective information selection and presentation in terms of effects on comprehension, retention, and appropriate patient actions to derive optimal drug benefit.
HERBER OR,GIESV,SCHWAPPACHD,et al.Patient information leaflets:informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices[J].BMC Family Practice,2014,15(1):1-8.
Abstract BACKGROUND: With increasing life expectancy the number of people affected by multimorbidity rises. Knowledge of factors associated with health-related quality of life in multimorbid people is scarce. We aimed to identify the factors that are associated with self-rated health (SRH) in aged multimorbid primary care patients. METHODS: Cross-sectional study with 3,189 multimorbid primary care patients aged from 65 to 85 years recruited in 158 general practices in 8 study centers in Germany. Information about morbidity, risk factors, resources, functional status and socio-economic data were collected in face-to-face interviews. Factors associated with SRH were identified by multivariable regression analyses. RESULTS: Depression, somatization, pain, limitations of instrumental activities (iADL), age, distress and Body Mass Index (BMI) were inversely related with SRH. Higher levels of physical activity, income and self-efficacy expectation had a positive association with SRH. The only chronic diseases remaining in the final model were Parkinson's disease and neuropathies. The final model accounted for 35% variance of SRH. Separate analyses for men and women detected some similarities; however, gender specific variation existed for several factors. CONCLUSION: In multimorbid patients symptoms and consequences of diseases such as pain and activity limitations, as well as depression, seem to be far stronger associated with SRH than the diseases themselves. High income and self-efficacy expectation are independently associated with better SRH and high BMI and age with low SRH.
KNAPPP,RAYNOR DK,BERRY DC.Comparison of two methods of presenting risk information to patients about the side effects of medicines[J].Qual Saf Health Care,2004,13(3):176-180.
Abstract OBJECTIVE: To determine whether the use of verbal descriptors suggested by the European Union (EU) such as "common" (1-10% frequency) and "rare" (0.01-0.1%) effectively conveys the level of risk of side effects to people taking a medicine. DESIGN: Randomised controlled study with unconcealed allocation. PARTICIPANTS: 120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction. SETTING: Cardiac rehabilitation clinics at two hospitals in Leeds, UK. INTERVENTION: A written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, "common" or 2.5%; for pancreatitis, "rare" or 0.04%). MAIN OUTCOME MEASURE: The estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine. RESULTS: The mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors. CONCLUSIONS: Patients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine.
SATOT.What is a medication guide suits patients' needs?[J].Yakugaku Zasshi,2015,135(2):297-306.
In order for a patient to read a medication guide and develop appropriate behavior regarding use of the medication, the guide should suit patients' needs. In medical care, the primary needs of patients are preventing/curing disease and/or relieving symptoms. Certainly, patients would like knowledge about what can be expected after taking a medication. However, current "Drug Guides for Patients" are based on drug labeling, which is essentially a medically sophisticated instruction manual for medical professionals who have existing knowledge about the medical treatment of the disease. Thus, there seems to be a gap in patients' needs and the contents of existing drug guides. Consequently, this disconnect may be part of the reason Drug Guides for Patients have been underused. If a patient treatment guide, which gives an overview of the disease and possible treatment strategies, is provided in conjunction with a drug guide, this combination may be useful for satisfying patients' needs. In addition, patients generally prefer detailed drug information. Consistently, surveys have revealed that many patients would like to get more information about prescribed medicine than what is frequently provided in medical practice. Furthermore, one survey reported that detailed information about possible side effects resulted in improved compliance. The need to provide patients with drug information can be considered from three points of view: patients' rights, best decision-making by the patient, and minimizing risks. Although in daily practice doctors and pharmacists may have some difficulty providing detailed medication information that includes all possible risks, more effective ways to communicate this information to patients have been suggested.
RAYNOR DK,BLENKINSOPPA,KNAPPP,et al.A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines[J].Health Technol Assess,2007,11(5):1-160.
To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes.Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations).Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands.Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome.The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.
LIUF,ABDUL-HUSSAINS,MAHBOOBS,et al.How useful are medication patient information leaflets to older adults?[J].Int J Clin Pharm,2014,36(4):827-834.
Abstract BACKGROUND: Patient information leaflets (PILs) are the most important information source for older patients to effectively manage their drug therapy. OBJECTIVE: The objective of this study is to evaluate the appropriateness of current available PILs for use by older adults. METHODS: The content of the PILs were assessed by checking the availability of information relevant to older patients including pharmacokinetics, safety and dose instructions. The layout of the PILs was evaluated using criteria derived from the relevant regulatory guidelines on the design of PILs. The Gunning Fog Index was used to determine the readability of the PILs to older adults. RESULTS: Total of 48 PILs were analysed involving 25 drug substances for the treatment of cardiovascular disease and type 2 diabetes. One out of the 48 PILs contained information on pharmacokinetic changes in older patients and only 15 % of the PILs specified the age of the older person. Thirty-one percent of the PILs provided nonspecific warnings to the older population, while only 15 % included specific side effects that could occur in the older generation. Text font sizes of the PILs were generally too small for older adults to read, with only 9 % of the PILs used type size 12 or over. The readability of 63 % of the PILs had a score above 12, which is considered difficult for older people to understand. CONCLUSION: Currently available medication PILs are inappropriate for use by older adults to manage their medications effectively, which could adversely affect patient safety and adherence to drug therapy.
... 患者用药说明书在国外有多种表现形式,如在欧盟国家和新加坡称为患者信息活页(patient information leaflets,PILs),澳大利亚称为消费者用药信息(consumer medicine information,CMI).在美国,患者用药说明书有多种表现形式.针对非处方药的有药物信息标签(drug facts label);而处方药根据可能引起安全性问题的程度,分别制定患者药品说明书、用药指导(medication guides,MedGuides)、CMI、患者信息单(patient information sheet,PIS).除美国的CMI是由学术组织或个人编写,其内容和形式不需官方审核批准外,患者用药说明书大多是由药品制造商编写,并经官方部门批准才能发布[3]. ...
Patient characteristics influencing evaluation of written medicine information:lessons for patient education
Patient information leaflets:informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices
A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines
, 方松, 符旭东
