Do patients see, read and retain the new mandatory medicines information leaflets?
The Pharmaceutical Journal Vol 264 No7083p268-270
February 12, 2000 Original Papers
Do patients see, read and retain the new mandatory medicines information leaflets?
By D. K. Raynor, PhD, MRPharmS, and P. Knapp, PhD, RGN
AIMS To assess how many medicines are supplied with information leaflets for patients, subsequent to this becoming mandatory on January 1, 1999, and to determine how many patients see, read and retain the leaflets.
DESIGN A structured telephone interview of patients, 4?7 days after receiving their prescription.
SUBJECTS AND SETTING 215 patients collecting prescriptions from 3 community pharmacies, with telephone follow-up at home, in March and April 1999.
OUTCOME MEASURES Number of medicines with an available leaflet and patient self-report of behaviour.
RESULTS Of the 428 medicines supplied to the 215 patients, there was no leaflet available for 139 medicines (32%). Of the 161 patients who received at least one medicine with a leaflet, 44 (27%) were using the item for the first time. The leaflet was noticed by 134 patients (83%) and had been kept by 120 (74%). At least some of the leaflet was read by 64 patients (40%), and 34 (21%) said they had read it all. Of the 64 patients reading some or all the leaflet, 7 (11%) reported taking action as a result, including two who had returned to see their GP and one to their pharmacist.
CONCLUSION Three months after the introduction of mandatory comprehensive medicine information leaflets supplied as package inserts, significant numbers of medicines remained without a leaflet. There is a limited evidence-base associated with this major change in information provision to patients and this study confirms that delivery as a package insert does not guarantee that all patients will be aware of the leaflet and that only a minority will read at least some of it. Further work is required to determine the contribution of the method of delivery to this low level of usage.
Since January 1, 1999, across the European Union, all medicines should be supplied with a comprehensive information leaflet for patients, under EC Directive 92/27.1
The provision of leaflets as package inserts by manufacturers in order to comply with this law is a major change in practice with significant consequences for patients and professionals.2 There are also significant resource implications, but the evidence associated with comprehensive leaflets supplied as package inserts is thin. Most previous research in the United Kingdom relates to less detailed leaflets handed to the patient.3
The most detailed research was conducted by Professor C. F. George's team in Southampton.4 It was based on two-sided A5 leaflets which contained brief information on one side and more detailed information on the reverse. The work showed that the leaflets resulted in some increase in knowledge and satisfaction, but no effect on medication adherence in chronic therapy. The new leaflets (which are mandatory unless all the information can be included on the pack) should contain all the information contained in the product's data sheet (or summary of product characteristics) written in a form understandable to the patient. The resulting leaflet is considerably longer than the Southampton leaflets.3
In the light of the limited research in the UK on the outcomes associated with leaflets delivered as package inserts, our study aimed to answer some of the unanswered questions about this initiative:
lHow many medicines are, in practice, supplied with information leaflets?
- How many patients see, read and retain the leaflets?
- What reasons do patients give for not reading the leaflets?
- Are patients who are using the medicine for the first time more likely to use the leaflet?
- Do patients change their behaviour as a result of reading the leaflet?
The study was a telephone survey, the first cohort of which has been reported previously.5 Patients were recruited as they collected their prescriptions from three Leeds community pharmacies in March and April, 1999. Inclusion criteria were that patients:
- Were aged 16 or over
- Were collecting their own medicine
- Had sufficient use of English for interview
- Were available for telephone interview the following week
A researcher asked patients to participate in "a study of the information given to patients collecting their medicines". The protocol was approved by the local research ethics committee and written consent was obtained from each patient. The researcher phoned the patient four to seven days later to ask questions about each medicine. Patients not contacted after five telephone attempts were recorded as lost to follow-up. The pharmacists provided details of the medicines dispensed for each patient, and whether a manufacturer's leaflet was available for supply.
We analysed data on all prescribed items in respect of whether a leaflet was supplied. We analysed at the patient level the data relating to the patient's response to a leaflet, and sampled randomly if a patient was dispensed more than one item with a leaflet. We approached 281 consecutive adult patients collecting their own medicines, of whom 215 (76 per cent) were recruited. Recruited patients were aged 18?85 years (median 58) and 64 per cent were female. Reasons for non-recruitment were: refused (33), no telephone (12), away following week (11), unable to use the telephone (6), too ill (2), and insufficient English (2). We used logistic regression to analyse the data, generating odds ratios (OR), with 95 per cent confidence intervals (CIs).
The 215 patients were dispensed a total of 428 items (median 1, range 1?10). For 139 items (32 per cent), there was no manufacturer's leaflet available for the pharmacist to supply with the medicine. Telephone follow-up was possible on 196 patients (90 per cent). One hundred and sixty-one received at least one medicine with a leaflet; of these 44 (27 per cent) were using the item for the first time. The leaflet was said to have been noticed by 134 patients (83 per cent) and kept by 120 (74 per cent). At least some of the leaflet was reported to have been read by 64 patients (40 per cent) and 34 (21 per cent) said they had read it all. Patients who had received a leaflet but had not read it were asked why (see Table 1).
Patients taking the medicine for the first time were no more likely to notice the leaflet than those who had received the medicine before (39/44 v 95/115). However, patients with new prescriptions were more likely to read at least part of the leaflet (32/43 v 32/115, OR=7.5 [95 per cent CIs 3.4, 16.9], P <0.001); see Table 2. Among patients who read at least part of the leaflet, those taking the medicine for the first time were no more likely to read all the leaflet (16/32 v 18/32; OR=0.78 [0.29, 2.1] P=0.62) or to keep it (31/42 v 89/113; OR=0.76 [0.33, 1.7] P=0.51).
Those who had read at least part of the leaflet were asked if they had done anything as a result of what they had read. Seven of the 64 patients (11 per cent) who had read some or all the leaflet reported taking such action (see Table 3). The changed behaviour reported by three patients related to inhaler technique, dose-taking time and breast feeding, respectively. Those taking the medicine for the first time were more likely to do something as a result (5/32 v 2/32) but the difference was not statistically significant (OR=2.8, P=0.24).
This is the first study of medicine information leaflets for patients since the change in European law requiring comprehensive leaflets in all medicines packs. The results show that three to four months after this law was implemented, a third of dispensed medicines were still without an available leaflet. Manufacturers had planned to comply with the requirements through the Patient Pack Initiative, a joint approach between key stakeholders to move to patient packs of one month supply, each containing a leaflet.6 However, a change in the approach of the Department of Health in 1998 delayed implementation. Apart from the legal implications, this situation presents problems for professionals, as they do not know which medicines are being supplied with a leaflet and which are not. This makes it difficult to dovetail verbal and written information provision, which is thought to maximise effectiveness.7The new leaflets were promoted as a means of increasing patients' knowledge and adherence to medication. However, there is little evidence of an effect on adherence with similar standard written information.3 Any effect on knowledge and adherence depends on the leaflets being noticed and read. In this study, almost a fifth of patients did not notice the leaflet, which presumably remained inside the pack. There are few data on the proportion of patients who are aware of leaflets supplied as inserts. A small Norwegian study,8 similarly based on telephone interview, found that 48 per cent of patients had not found or could not remember having seen a leaflet in the package. The level of awareness was higher among patients on short course therapy than those on long term treatment. This supports our findings that supply as package inserts, promoted as a means of ensuring delivery of the information, does not guarantee that the patient is made aware of the leaflet's presence. This is in addition to the significant proportion of the medicine-taking population who are blind or partially sighted and hence are also not aware of (or cannot take advantage of) the leaflets.9
The proportion of patients reading the leaflets is disappointing, but to be expected. There is little in the literature about the extent of reading of package insert leaflets. Ley10 summarised a series of American studies from the 1970s which found that, overall, 72 per cent of patients read the package inserts and that they were kept by about half the patients. The high proportion of patients reading the leaflet in these studies may relate to patients being more aware of the nature of the research which may have encouraged reading of the leaflets. A Belgian study11 of patients given a package insert leaflet with a non-steroidal anti-inflammatory drug for an acute condition found that, after one week, 32 per cent of patients said they read the leaflet "thoroughly" and 42 per cent "superficially". A further study from the same research group found that two-thirds of patients treated with anti-hypertensives had read the package insert.12
In his extensive review of the literature, Ley concluded that around three-quarters of patients will read leaflets about their medication,10 although the studies reviewed included those with leaflets as inserts and those where the leaflets were handed to the patient. Wright has suggested that more patients will read leaflets if they are handed to them personally, as patients will perceive the leaflet as having more personal relevance.13 Multi-folded leaflets on thin paper which contain large amounts of information, in small type and inserted in the pack may not invest the importance in the leaflet that professionals assume. This lack of investment of importance and relevance is compounded by the way that every month the patient gets the same leaflet. Sixty-eight per cent of those who did not read it said it was because they had read it in the past. This is a potential problem, as warnings and precautions can change and memories are short.
The figure that only 21 per cent had read all the leaflet needs to be interpreted in context. These are long and quite complex leaflets, and an expectation that most patients will read them all on receipt may be unreasonable. However, despite the low level of reading, most patients (74 per cent) said they had kept the leaflet. This is encouraging, as one of the functions of such a leaflet is to be an information resource, available to patients at any time after supply. Again there are few studies for comparison; an early US study found that 45?57 per cent said they had kept the leaflet (quoted by Ley10) and a UK study of oral contraceptive package inserts found that two-thirds of patients did not throw the medicines information leaflet away.14 However, follow-up in the current study was only seven days after supply, and long-term retention cannot be assumed. In addition, keeping the leaflet may not have been a conscious or active decision, as some patients who had "kept" the leaflet may have simply left it inside the box. Nevertheless, it would be available for reference if the need arose.
The numbers of patients who took specific action as a result of reading the leaflet, although small, represents a significant impact on the health service if the results are generalisable. In particular, the two patients who said they had returned to see their GP represent just over 1 per cent (out of the 161 who received a leaflet), and this figure, applied generally, would mean a significant increase in GP workload. This compares with a figure of 12 per cent of hospitalised elderly patients who said they had previously asked for advice from their doctor or pharmacist as a result of reading a leaflet.15 Three patients said they had changed their behaviour as a result of reading the leaflet, which shows that such leaflets have the potential to influence behaviour. These analyses are based on small numbers of patients and should be treated with caution. However, it suggests that, although only a minority of patients read some of the leaflet (and a smaller minority read it all), some patients make important changes to their medicine-taking behaviour, and others make contact with a health professional, as a result. This merits further investigation. In the US and Australia, in-pharmacy computer-generated leaflets are the chosen method of delivery.16 In contrast to package inserts, these can be personalised, supplied only when required, instantly updated and handed personally to the patient. However, the most potent characteristic is probably that of individualisation. A key problem with the mandatory leaflets is their length, and individualisation allows tailoring of the information for the individual patient. Irrelevant information can be omitted (eg, pregnancy information for male patients) and only age-specific dose and precautions information included. Thus the leaflet is shorter and appears more relevant to the individual patient. Only electronically generated information can provide this sophistication, and it is already available and in use in the US.17 The increasing use of the internet will widen this availability.
Drawbacks associated with the method used in this study include the fact that many of the patients most dependent on medicines do not collect them in person from the pharmacy and so were excluded by the recruitment method. However, such patients have distinct information needs, as they will rarely receive verbal information from the pharmacist (or be able to ask questions of him or her). The situation for this group of patients needs investigating separately. Another issue is that the data depend on accurate reporting by the patient. However, we suspect that patients would be more likely to over-report their use of leaflets to a researcher. In this context, the 21 per cent of patients who reported reading all the leaflet may be an overestimate.
Given the amount of patient information available generally, the amount of associated research is small.18
Patients need good information to be active participants in their care19 and the provision of comprehensive medicines information leaflets as package inserts is now a major plank in this provision in Europe. However, the evidence base for outcomes associated with such leaflets is patchy: there was little existing evidence that the chosen method would achieve its aims. This sits uneasily in the current climate in the National Health Service of evidence-based medicine.
The data in this study suggest that most patients do not gain full benefit from leaflets supplied through the delivery method chosen in Europe. Key issues relate to the lack of awareness of the leaflets, a low perception of their importance and the inability of professionals to incorporate them easily into the wider information-giving process. Further work is needed to determine how much of this is due to the method of delivery. New guidance from the European Commission requires manufacturers to undertake some form of user testing on their leaflets.20 This will be a wasted effort if the method of delivery is inappropriate and results in most patients not reading the leaflet. As information technology advances, leaflet inserts may become an irrelevant legal "back-stop", overtaken by electronically generated and individualised leaflets.
ACKNOWLEDGMENT We thank the patients and pharmacists who agreed to take part in the study.
Dr Raynor is head of the division ofacademic pharmacy practice and Dr Knappis lecturer in medicines information for patientsat the University of Leeds school of healthcare studies. Correspondence to Dr Raynor at the Division of Pharmacy Practice, University of Leeds, 10 Clarendon Road, Leeds LS2 9NN(e-mail D.K.Raynor@leeds.ac.uk)
Citation: The Pharmaceutical Journal URI: 20000495
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