Preliminary investigation of patient information leaflets as package inserts

In the United Kingdom, patient information leaflets (PILs) are now supplied with all medicines licensed or re-licensed since January, 1994. This means that, by 1998, all medicines will come with one of these detailed leaflets inside the pack. In a preliminary investigation of the impact of these leaflets, 117 elderly inpatients were questioned on their experience of PILs prior to admission. Ninety-one (78 per cent) said they had received a PIL and 57 (49 per cent) had read one. The main reasons for not reading a leaflet were the perceived difficulty in understanding and being put off by excessive information. Of the patients who had read a leaflet, 23 (40 per cent) reported difficulty in reading the small print and 26 (46 per cent) said they had difficulty understanding the content. Thirteen patients (23 per cent) reported having to seek help with reading a leaflet. Forty-two of those who had read a leaflet rated it as helpful. Eleven patients said they had asked for advice from their doctor or pharmacist as a result of reading a leaflet. Nine patients said the leaflet had caused some anxiety, with two stopping their medicine as a result. The move to universal PILs in patient packs is a major development in the provision of information to patients about medicines. This study suggests that elderly patients have problems relating to understanding the content of PILs and reading the size of print used in these leaflets.     

Medicine information leaflets for non-steroidal anti-inflammatory drugs in Thailand

Background The importance of promoting the use of patient-oriented medicines leaflets is recognized in many countries. Leaflets should include basic information plus specific warnings, and be provided with all medicines, but there is little attempt at enforcement of these requirements in Thailand. Objective To determine content and availability of Thai information leaflets for nonsteroidal anti-inflammatory drugs (NSAIDs). Methods Leaflets for all NSAIDs available for purchase from 34 pharmacies in a large city were evaluated against a checklist and number of leaflets assessed against number of medicine packs available in each pharmacy. Results Of the 76 leaflets for ten different NSAIDs, 67 (88 %) were for locally manufactured products. Only 22 % of 76 leaflets were sufficient in number for distribution with medicines, while only 4 % had patient-oriented leaflets. No leaflet covered all topics in the checklist. Less than half included safety information, such as contraindications (46 %), precautions (47 %), and adverse drug reactions (34 %). Locally-produced leaflets provided less information than those for originator products and no leaflet included all the warnings required by Thai regulations. Conclusion This study illustrates the variable availability and quality of NSAID information leaflets. The lack of accessible essential information about medicines in Thailand requires urgent attention to enable patients to minimise adverse reactions.     

Preparation,validation and user-testing of pictogram-based patient information leaflets for hemodialysis patients

Background: Patient information leaflets are universally-accepted resources to educate the patients/users about their medications, disease and lifestyle modification. Objectives: The objective of the study was to prepare, validate and perform user-testing of pictogram-based patient information leaflets (P-PILs) among hemodialysis (HD) patients. Methods: The P-PILs are prepared by referring to the primary, secondary and tertiary resources. The content and pictograms of the leaflet have been validated by an expert committee consisting of three nephrologists and two academic pharmacists. The Baker Able Leaflet Design has been applied to develop the layout and design of the P-PILs. Results: Quasi-experimental pre- and post-test design without control group was conducted on 81 HD patients for user-testing of P-PILs. The mean Baker Able Leaflet Design assessment score for English version of the leaflet was 28, and 26 for Kannada version. The overall user-testing knowledge assessment mean scores were observed to have significantly improved from 44.25 to 69.62 with p value <0.001. Conclusion: The overall user opinion of content and legibility of the leaflets was good. Pictogram-based patient information leaflets can be considered an effective educational tool for HD patients.     

Electronically produced information leaflets increase patients' understanding of antibiotics

The effects of electronically produced patient information leaflets on the understanding of and compliance with antibiotic medication were studied in 15 pharmacies in Finland. The study subjects (n=500) were randomly divided into two groups, the control group receiving only verbal information and the intervention group receiving both verbal and electronically produced written information. A few days later the participants were interviewed by telephone. In the intervention group the patient's understanding about the proper use and adverse effects of the medication was better than in the control group. Enhanced awareness of possible adverse effects of the medication did not lead the patients in the intervention group to interrupt their antibiotic medication. Electronically produced written material is easy to administer, and it can be an important counselling aid for pharmacists.     

Evaluation of drug information for cardiology patients.

1. Cardiologists and pharmacists at the University Hospital of Wales collaborated to write 20 individual leaflets incorporating guidelines for a range of drugs used in the treatment of cardiology patients. The Plain English Campaign advised on the intelligibility and presentation of the information. 2. One hundred and twenty-five patients from the Regional Cardiology Unit, University Hospital of Wales were randomly allocated to receive usual verbal counselling about their drug treatment with or without an individualised drug information wallet. Two weeks after discharge from hospital patients completed a postal questionnaire to determine their satisfaction with the information about their drug treatment and their understanding of it. Forty-nine questionnaires were returned from the leaflet group and 52 from the control group. 3. The provision of written guidelines resulted in significant improvements in patients' satisfaction with their drug treatment (chi 2 = 33.3, P less than 0.001) and their understanding of it (P less than 0.001, Mann-Whitney test). Overall, patients who received leaflets were more likely to be aware of the potential side effects of their drugs but less likely to be apprehensive about them. Succinct guidelines concerning drug therapy can be assimilated by cardiology patients and provide them with a permanent record for future reference.     

COMPREHENSIBILITY OF THE PACKAGE LEAFLETS OF ALL MEDICINAL PRODUCTS FOR HUMAN USE: A QUESTIONNAIRE SURVEY ABOUT THE USE OF SYMBOLS AND PICTOGRAMS

Directive 92/27EEC establishes that the package leaflet is a document, which must be included in the package of medicinal products for human use in EU countries. This informative leaflet is directed at the users and it must give full and comprehensible information. The Law suggests the use of symbols but it does not give advice about the subjects to be represented. In order to evaluate the attitude of patients towards package leaflets provided with symbols, we planned a survey interviewing 1004 patients in pharmacies. The data suggest that Italian patients usually read the package leaflet but they neither understand it easily nor find the needed information readily. Most respondents (74.3%) considered the use of symbols helpful in finding the needed information. We proposed five symbols for each heading (therapeutic indications, side effects, paediatric use, contraindications, use in pregnancy) and asked to select which symbol could be used. In the case of 'side effects', 'paediatric use', 'use in pregnancy' and 'dose', most of the respondents chose the same symbol. In the case of 'therapeutic indications' and 'contraindications' there was no uniformity in the answers. The choice depends greatly on education, age and employment of respondents.     

Evaluation of website medicines information content,in comparison with official patient information

Objective To evaluate the content and presentation of websites accessed by the public for information about two non‐steroidal anti‐inflammatory drugs, ibuprofen and naproxen. To assess the accuracy and completeness of website content compared with official patient leaflets, and assess the quality of presentation of each site. Setting Medicines are the most frequent intervention in healthcare, and people need appropriate information to use them safely and effectively. There is evidence that the leaflets supplied with medicines do not meet peoples' needs. There are many websites containing medicines information, but it is not known how the content compares with the official information. Method The search words ‘Brufen’ and then ‘Naprosyn’ were used in the Google search engine. We identified the first 10 sites containing information comparable to that in conventional medicines leaflets (more than 100 words and at least three of five categories of information). Each site was scored for presence and accuracy of each point of information included in official leaflets. Each site was also scored for quality of presentation, assessing 10 attributes (scored 1–3). Key findings We found 7 Brufen and 10 Naprosyn sites meeting the inclusion criteria and the mean score for completeness of information was 50% (range 23–79%). Eight inaccuracies were found in 7 out of the 17 sites. Four had significant potential clinical impact (all relating to dose) and four were minor in significance. The overall mean score for website presentation was 77%. Conclusion Compared to official leaflets, information found on websites generally contained about half the total amount of pieces of information. There were a small number of inaccuracies related to dose, which are potentially dangerous. The websites scored well overall for quality of presentation. The two overall highest‐scoring websites were a manufacturer's site and one aimed at health professionals.     

Survey of outpatients’ use and needs of patient medicine information leaflets in Thailand

International Journal of Clinical Pharmacy - Background Patient information leaflets are important sources of medicine information. Regulations of patient information leaflet provision varies among...     

Effectiveness of a printed leaflet for enabling patients to use digoxin side-effect information

The effectiveness of a printed leaflet designed to inform patients about digoxin was evaluated. The printed leaflet alone was compared to the verbal consultation alone and the verbal consultation in addition to the printed leaflet. The study assessed patients' decisions about the appropriate course of action to take if side-effect symptoms occurred. Patients receiving the printed leaflet alone scored higher than patients receiving the verbal consultation; however, they scored lower than patients receiving both the printed leaflet and verbal consultation together. Patients receiving both verbal and printed information scored significantly higher than those receiving verbal consultation only. The findings suggest that printed materials together with verbal consultation are essential for enabling patients to make appropriate decisions with respect to side effects. There is not enough evidence to support the use of printed materials in place of verbal consultation. Health practitioners should use printed materials as an adjunct to verbal information.     

Impact of Vietnamese written and verbal medicine information on Vietnamese-speaking Australians' knowledge and satisfaction

AIMS: To develop three Vietnamese medicine information leaflets and to evaluate their impact in combination with verbal counselling (in Vietnamese) on consumers' medicine knowledge and satisfaction with the written information received. METHODS: Leaflets in Vietnamese were developed for three drug classes: biguanides, calcium channel blockers and HMG-CoA reductase inhibitors. A two-group (comparison and intervention), randomized, repeated measures design was used. The comparison group (n = 51) received routine verbal counselling in English. The intervention group (n = 44) received verbal and written information in Vietnamese. Australian Vietnamese-speaking consumers were recruited. Data on consumer knowledge and satisfaction were collected from both groups at three time points: baseline (prior to receiving leaflets and verbal counselling), at 1-2 weeks (first postintervention) and 8 weeks after receiving the information. RESULTS: All intervention group respondents were satisfied with the information. Mean medicine knowledge and satisfaction scores increased with time in the intervention group, and were significantly higher than in the comparison group (knowledge, F = 18.5, d.f. = 2, P < 0.0001; satisfaction, F = 19.8, d.f. = 2, P < 0.0001). The increases observed in the intervention group's mean knowledge and satisfaction scores at first postintervention were significantly higher compared with baseline for all drug classes. CONCLUSIONS: Delivery of written and verbal medicine information in Vietnamese resulted in an increase in consumers' medicine knowledge and satisfaction with written information. This study highlights the importance of providing information in languages other than English and in consumers' native tongue to aid in the quality use of medicines.     

Consumer study on the use of patient information leaflets

The aim of this study was to get a clear idea of the reading frequency of the patient information leaflet (PIL) and to set up a profile of the reader in specific. Apart from that, we also wanted to evaluate the impact of the internet in the patient's search for information on health and medication. Do patients consult the digital PIL and is the FAGG website known by common people? In order to answer these research questions, a specific inquiry was performed in 800 respondents. Some interesting conclusions can be drawn: only one out of four participants reads the full PIL when purchasing a medicine they never used before. People who always read the PIL are mainly older than 65. However, the largest amount of people who never reads the PIL is also situated in the plus 65 scale. In general, men show little interest in reading the PIL unlike woman, who read clearly more often the PIL. The parts of the PIL most often read by patients are the sections on dosage (section 3) and side effects (section 4). Unfortunately, too little attention is paid to the section 2, which contains the most warnings, such as contra-indications. The most important reason why the PIL is not read is because patients believe they get sufficient information from the doctor and the pharmacist. Another remark is that the internet is used by more than half of the respondents to search for health-related information. There is also a remarkable difference between men and woman, men rarely search for health information or information on medicines on the internet. The number of respondents searching for leaflets on the internet is quite limited. Additionally, the Federal Agency Medicines and Health Products (FAMHP) website is unknown to most internet users. We can conclude that the actual PIL is read too little. In order to make the PIL more appealing and even more patient friendly than it is actually, taking patients' needs into account should be a priority. The digital leaflet should be drawn attention to in order for patients to make more use of the information that is available to them.