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.     

Over‐the‐counter ibuprofen: how and why is it used?

Objectives — To pilot an over‐the‐counter (OTC) medicine pharmacovigilance project, using ibuprofen as a model. Method — All users of any tablet or capsule form of ibuprofen (excluding compound products) purchased from 61 participating community pharmacies, aged ≥18 years and able to give informed consent, were eligible to join the study. A postal questionnaire one week after the index purchase monitored the follow‐up rate, drug usage, past medical history, concurrent medication, symptoms and health service utilisation. Setting — Primary care: community pharmacies in Grampian, Scotland. Key findings — A total of 443/544 (81 per cent) questionnaires were completed. The recommended daily dose of OTC ibuprofen (1,200mg) was exceeded by 35 customers (8 per cent) on at least one day and the recommended maximum daily dose that can be prescribed by a physician (2,400mg) was exceeded on five occasions. During the seven days after the index purchase, ibuprofen was used by 15 customers (4 per cent) with an active or past history of peptic ulcer, and 30 (7 per cent) with an active or past history of asthma. Thirty‐eight per cent had purchased ibuprofen for a chronic condition and 32 per cent were still taking it at the end of the initial seven‐day period. Twenty‐eight of 412 customers (7 per cent) sought advice during the seven‐day period about at least one symptom: 13 consulted their general practitioner, 12 consulted a pharmacist, two consulted both their GP and a pharmacist, and one consulted a hospital doctor. Some of these consultations (23/28, 82 per cent) might have related to an adverse reaction to ibuprofen: 11 customers (3 per cent) consulted about lower abdominal symptoms, nine about gastric symptoms and three about wheeziness. Conclusions — This pilot study identifies instances of contraindicated and excessive use of OTC ibuprofen, indicating a need for pharmacovigilance studies of OTC medicines; it also demonstrates the feasibility of a major study.     

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.     

Patient recall of medication information

One hundred and nine patients were randomly assigned to the study groups. All questions were administered by the same pharmacist as outlined on a standard questionnaire. Tetracycline was selected as the study drug. All patients were given a pre-test and post-test in order to assess the degree of learning which took place during their pharmacy visit. Patient data were tabulated and analyzed statistically. The mean level of recall prior to pharmacist intervention was 26.6 percent. The highest level of recall obtained was 89.2 percent which occurred in patients who received both verbal and written medication instructions from the pharmacist. Through the use of verbal and/or written instructions, the pharmacist was able to reinforce the medication instructions of the physician and had a significant impact on the level of patient knowledge.     

Health promotion by community pharmacists: consumers' views

As part of the evaluation of the Barnet family health services authority high street health scheme (HSHS), 592 consumers were interviewed in six pharmacies. The objectives were to investigate whether the consumers came to the pharmacies for advice on general health matters, saw pharmacists as a reliable source of advice about staying healthy, read health promotion leaflets and had heard of HSHS. The general medical practitioner's (GP's) surgery was felt to be the most convenient place to get advice about staying healthy, and the GP the best person from whom to get it. The pharmacist was rated second in each case, above the media, although only 90 (15 per cent) of respondents had ever asked the pharmacist for general health advice. Only 237 (40 per cent) thought that it was the “usual” job of the pharmacist to give advice about general health, 112 (19 per cent) thought that it was not, and 243 (41 per cent) did not know. Those who had taken away leaflets to read (178, 30 per cent) were significantly more likely to be frequent visitors to the pharmacy, to have chronic illnesses, to think the media was the most convenient place to get advice, to have previously asked the pharmacist for advice about staying healthy and to think it was usual job of the pharmacist to give advice about staying healthy. Only 65 (11 per cent) had heard of the HSHS. Many consumers do not currently perceive that there is a role for community pharmacists in health promotion, and the profession needs to think again about some of the presumptions that have been made in the past.     

Medicines counter assistants: roles and responsibilities in the sale of deregulated medicines

The work reported here aimed to quantify the involvement of medicines counter assistants (MCAs) in the United Kingdom in the sale of deregulated medicines and to provide insights into their role and experiences in this process. Non-participant observation for five days in each of 10 community pharmacies was used in conjunction with interviews and focus groups with MCAs working in these pharmacies. It was found that MCAs dealt with 84 per cent of the deregulated medicines requested, without the formal involvement of a pharmacist. MCAs dealt with 96 per cent of requests for aciclovir, and 100 per cent of requests for cetirizine, Canesten Combi, famotidine, hydrocortisone cream and topical ibuprofen without the intervention of a pharmacist. MCAs viewed themselves as front-line health care workers carrying out an important role in consumer care. However, in instances where difficulties were encountered during an MCA-consumer interaction, MCAs knew and appreciated that they had the backup of a pharmacist to whom to refer. MCAs identified a number of dilemmas which impinged on their ability to ask questions and provide advice to consumers requesting deregulated medicines. Given these findings, the current role, workload and experiences of MCAs merit more attention than has hitherto been accorded in pharmacy practice and health services research.     

Counterprescribing for ophthalmic conditions: a survey of community pharmacists

All 123 community pharmacies in the Southampton area were telephoned and the pharmacist invited to answer questions on the management of patients with ophthalmic conditions. Of those approached, 95 per cent (n=117) agreed to participate. The mean number of patients seeking advice on eye conditions was 14 per pharmacist per week. All but one pharmacist stated that they discussed the condition with the patient, and 97 per cent (n=114) examined the eye. Fifty-one per cent (n=60) did not feel qualified to touch the eye or lids while the remainder were prepared on occasion to carry out a contact examination. Only 6 per cent (n=7) had a pen-torch to aid examination. The most commonly counterprescribed products were Brolene drops and ointment, Otrivine-Antistin drops and artificial tear preparations. Sixty per cent (n=70) of pharmacists had no information available on the diagnosis and treatment of eye conditions and 88 per cent (n=103) said they would welcome more information. Ninety-six per cent (n = 112) routinely advised the patient to consult their general practitioner if the condition failed to resolve, the remainder advising attendance at the casualty department of the eye hospital. The study shows that community pharmacists are regularly consulted by patients with ocular pathology. Locally produced guidelines and education could lead to improved patient care.     

The benefits of providing benefit information in a patient information leaflet

Objective To examine the effects of providing two different types of written information about medicine benefits in a patient information leaflet (PIL). Setting Participants were 358 adult volunteers from the general population recruited from a London railway station and central Reading. Method The study used a controlled empirical methodology in which people were given a hypothetical, but realistic, scenario about visiting their doctor and being prescribed medication. They then read an information leaflet about the medicine that contained neither, one, or both benefit statements, and finally completed a number of Likert rating scales. Outcome measures included perceived satisfaction and helpfulness of the information, effectiveness and appropriateness of the medicine, benefit and risk to health, and intention to comply. Key findings Both types of benefit information led to significantly higher ratings on all of the measures taken. Conclusions Provision of a relatively short ‘benefit’ statement can significantly improve people's judgements and intention to take a medicine. The findings are important and timely as the European Union is currently considering reviewing their regulations to allow for the inclusion of limited non‐promotional benefit information in PILs.