Can your patient read this? The need to move to patient-centered medication product labels and patient information leaflets

Medication product package labels (MPPLs) and patient information leaflets (PILs) are sometimes the last source of information for patients before they take their medications. They provide a setting in which patients can immediately inform themselves about the medication they are taking or reread any content provided by physicians or pharmacists, as needed. Despite the growing number of people who are at risk of vision impairement, some pharmaceutical companies print MPPLs and PILs in fonts that patients cannot read. Problems arising from MPPLs and PILs have been identified as remarkable sources of medication errors and fatalities. As a result, the purpose of this article is to emphasize the need for patient-centered MPPLs and PILs to protect public health.     

Regulatory agencies' recommendations for medicine information leaflets: Are they in line with research findings?

The design of medicine information leaflets can determine whether a leaflet will be read or discarded by patients. It may also influence patients' ability to understand the information about their medicines within the leaflet. Researchers compared regulatory agencies' recommendations for medicine information leaflet design from New Zealand, the United Kingdom, the European Union, and the United States against recommended good design principles to determine the appropriateness, comprehensiveness, and consistency of their recommendations. Recommendations for medicine information leaflets varied between the regulatory agencies. There were some inconsistencies between the recommendations and some gaps were identified. There was little regulatory guidance given to creators of medicine information leaflets in New Zealand compared to other countries, and this could lead to manufacturer-produced information leaflets of a poorer quality. Up-to-date and enforceable guidance for creators of medicine information leaflets should be provided in all countries to ensure they are of an appropriate standard.     

Knowledge of and attitudes to medicines in the Southampton community.

A 1 in 200 sample of the Southampton electorate was sent a postal questionnaire in January, 1984. Of the 740 adults surveyed, 443 (59.9%) returned completed questionnaires. One hundred and eighty-eight (42.4%) of those replying had been prescribed a medicine within the previous month. Two hundred and seventy-five respondents (62%) felt that not enough was explained about medicines by doctors or pharmacists. Consistent with this, was the fact that 37% were unaware of safe methods of disposal of leftover medicines. In addition, 112 of 154 (72.7%) people currently taking a prescribed medicine knew of no side-effects which could result from this. Eighty-three per cent of respondents thought an information leaflet would be helpful. Of nine items which previous authors had suggested should be included, seven were thought to be important by more than 75% of those replying. Although 54% of people wanted detailed information, 43% stated a preference for short, summarized points. We conclude that most patients need to have more information about prescribed medicines and they would welcome written leaflets. However, further work is necessary to determine the best format for such leaflets.     

General medical practitioners' attitudes towards the use of patient medication records

A survey was conducted to ascertain general medical practitioners' (GPs') attitudes to community pharmacists' use of patient medication records (PMRs) and to assess whether GPs envisage a role for family health service authorities (FHSAs) in maintaining records of patients' data. The survey questionnaire was sent by post to all 1,257 GPs in contract with Avon and Devon FHSAs. A total of 811 questionnaires was returned, an overall response rate of 64.5 per cent. A majority (59 per cent) of GPs considered that community pharmacists should keep patient medication records and there was strong support for pharmacists holding PMRs for the elderly and confused, and also for patients with diabetes, asthma, epilepsy, and those patients who had experienced major adverse drug reactions or allergies. Some GPs, however, remained unconvinced of the usefulness of a pharmacy PMR. Seventy four per cent of respondents considered that patients should keep their own medication records. In contrast, only 4 per cent were in agreement with patient medication data being stored by FHSAs. The community pharmacist's role in maintaining PMRs received less support from doctors in dispensing practices than from their non-dispensing counterparts. Some 80 per cent of respondents were in favour of pharmacists providing PMR system-generated patient information leaflets with dispensed medicines. Most GPs considered that such leaflets had a positive effect on patient compliance. Recently registered GPs were found to be more supportive than their older colleagues of community pharmacists recording patients' clinical conditions and providing information leaflets.     

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.     

Patient information: community pharmacy needs and perspectives

Providing complete and understandable information to patients about medicines is considered an integral component of high-quality medical and pharmaceutical care. With such information, not only can the level of general health increase, but costs associated with noncompliance, including polypharmacy and hospitalization, can decrease. Although patient information leaflets (PILs) have been available since the 1970s, their use is more relevant today because of the counseling requirements of the Omnibus Budget Reconciliation Act of 1990. A national survey of community pharmacists was conducted to determine their attitudes toward this patient education strategy. Results demonstrate that pharmacists believe PILs benefit patients, but that PILs need revision in terms of readability, understandability, and standardization.     

Someone like me? Inhaler‐users' views of the models who demonstrate inhaler technique

Patient information leaflets are mandatory, but highly standardised A sample of mainly white English‐speaking inhaler‐users aged 12 to 87 was asked for their views on the white male models used in a widely used patient information leaflet (n = 48) and a multimedia touch‐screen program (n = 57) Of 75 people expressing an opinion, a third (25) said the choice of model mattered to them, and 13 (17 per cent) thought it might matter to some people There were differences between the two methods in terms of engaging information; there was an association between interest in the information and global change in inhaler technique Multimedia enables users to personalise the way information is presented; this could increase acceptability and make information more effective     

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.     

How useful are medication patient information leaflets to older adults? A content,readability and layout analysis

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.     

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

Background 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. Results 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. Conclusion 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.