Over the counter medicines and the need for immediate action: a further evaluation of European Commission recommended wordings for communicating risk

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Abstract

A study examined people’s interpretation of European Commission (EC) recommended verbal descriptors for risk of medicine side effects, and actions to take if they do occur. Members of the general public were presented with a fictitious (but realistic) scenario about suffering from a stiff neck, visiting the local pharmacy and purchasing an over the counter (OTC) medicine (Ibruprofen). The medicine came with an information leaflet which included information about the medicine’s side effects, their risk of occurrence, and recommended actions to take if adverse effects are experienced. Probability of occurrence was presented numerically (6%) or verbally, using the recommended EC descriptor (common). Results showed that, in line with findings of our earlier work with prescribed medicines, participants significantly overestimated side effect risk. Furthermore, the differences in interpretation were reflected in their judgements of satisfaction, side effect severity, risk to health, and intention to take the medicine. Finally, we observed no significant difference between people’s interpretation of the recommended action descriptors (‘immediately’ and ‘as soon as possible’).

Introduction

The promotion of consumer involvement in their healthcare is currently a core principal of the UK National Health Service [1]. One way this is being achieved is through an increase in the number of medicines that can be purchased ‘over the counter’ (OTC), rather than prescribed by a doctor. Over the counter medicines are becoming an increasingly important part of treatment in the NHS and across the developed world. In 2000, sales of OTC medicines in the UK amounted to £1.6 billion. Such sales are equal to one-third of the NHS drugs bill [2]. In addition to their potential benefits for patient choice, OTC medicines are seen by governments as an effective method for shifting a greater proportion of the costs of healthcare to the consumer.

Given that people are being encouraged to be more active in their healthcare and to select and purchase their own medicines, they must have access to clear information about these medicines so that they choose and use them effectively. A particular concern with OTC medicines is that many consumers assume that the drugs are completely safe, otherwise they would not be so readily available [3]. In addition, people may be less likely to comply with the manufacturers’ instructions when storing and taking the medicines than when using prescribed medication, assuming that this will not have any adverse effect on their health outcome. Such unwarranted assumptions reinforce the need for OTC drugs to be accompanied by comprehensive information leaflets that are read and understood by consumers.

In line with this, the Medicines Control Agency uses ‘information provision’ as one of its key criteria in assessing applications for drugs to be transferred from prescription to OTC status. Similarly, the European Commission (EC) Directive covering consumer medicines information [4] does not differentiate between prescription and OTC drugs; both are required to be accompanied by a comprehensive patient information leaflet (PIL), meeting identical criteria (including a list of all recognised side effects). Unfortunately, several studies by our own research group (e.g. [5], [6]), as well as by others (e.g. [7], [8]), have shown that people often do not interpret side effects information in the way intended by the manufacturers. In a recent series of studies, for example, we examined how people interpret a set of five verbal probability labels, ranging from ‘very common’ (>10%) and ‘common’ (1–10%) to ‘very rare’ (<0.01%), proposed for use in an EC Guideline [9]. We found that both members of the general public [10], [11] and patients visiting a cardiac clinic [6] consistently overestimated the risk of side effects, when presented with the recommended descriptors, and that this in turn affected their perception of risk to health and their likelihood of taking the medicine in question.

It is important that consumers are not just given information about side effects and their likelihood, but also about what to do if they do occur. Accordingly, in addition to advocating the use of particular verbal labels for describing the risk of side effects occurring, the EC Guideline recommends that, in such a situation, if the consumer needs to seek medical help urgently, the term ‘immediately’ should be used. In contrast, if the situation is less urgent, then the appropriate term is ‘as soon as possible’. Unfortunately, as with the advocated verbal probability descriptors, the recommendation was not based on empirical evidence. Indeed, we can find no empirical studies that have looked at how people interpret such ‘action’ instructions.

The purpose of the present study is therefore two-fold. First, given that our previous studies have all involved prescribed medicines (either actual or hypothetical), we thought it was important to extend our work to look at people’s interpretation of risk in relation to OTC medicines. Secondly, given that there has been no published work to date examining how people interpret the EC recommended ‘action’ labels if a side effect does occur, we decided to add a second phase to our existing method to address this omission. In majority of our earlier studies, members of the general public have been presented with hypothetical (but realistic) scenarios about visiting their GP, being diagnosed as suffering from a throat or ear infection, and being prescribed a (hypothetical) short course antibiotic. The drug was said to be associated with a number of adverse side effects, and information about their likelihood of occurrence, was presented either numerically or verbally (using one of the EC recommended descriptors). Participants were asked to assess the presented information on various dimensions, which included their estimating the probability of their experiencing one or more of the side effects, and rating their perceived risk to health and likelihood of taking the medication. In the present study, we adapted the above scenario so that it described a relatively common situation involving the purchase of a relatively common OTC medicine, Ibruprofen [12]. After reading the scenario, participants were asked to rate the information on similar dimensions to those used in our earlier studies. They were then introduced to a (new) second phase of the study in which they were told that, should a particular rare (and severe) side effect occur, they should seek medical help either ‘immediately’ or ‘as soon as possible’ (the two terms recommended in the EU Guideline), depending on the particular experimental condition to which they had been allocated. They then had to select the action that they would take.

Following our earlier studies, we predicted that participants who received the EC verbal descriptor would estimate the probability of side effects occurring to be significantly higher than those given the numerical descriptor. They would also perceive risk to health to be significantly higher and rate intention to take the medicine significantly lower. In terms of interpreting the action labels, if the EC recommendations are well-founded then participants given the term ‘immediately’ should be more likely to select actions which involve seeking help urgently (e.g. calling 999 or going to a hospital casualty department) than those given the term ‘as soon as possible’.

Section snippets

Participants

Participants were 188 volunteers from the general public, aged between 18 and 70 years. There were 78 males and 110 females. They came from a range of educational backgrounds (from having no formal qualifications to having higher degrees), and worked in a range of occupations (e.g. shop, clerical and office workers, managerial staff, teachers, students, as well some retired and unemployed). The majority of the participants were residents in the Reading area. They were recruited by a single

Phase 1: subjective ratings and probability estimates

Table 1 shows mean (and standard deviation) ratings for satisfaction, side effect severity, likelihood of experiencing side effects, perceived risk to health, and intention to take the medicine, together with mean probability estimates, as a function of mode of presentation (numerical/verbal). It also lists associated F values and significance levels. It can be seen that those who received the verbal descriptor were significantly less satisfied with the information provided, and rated the side

Discussion and conclusion

In line with the findings from our earlier work with prescribed medicines [5], the present study has shown that consumers significantly overestimate the risk of side effects occurring when interpreting the verbal descriptor ‘common’. In fact, only one participant produced a probability estimate that was within the range assigned to the term ‘common’ in the EC guideline (i.e. 1–10%). Furthermore, participants who received the verbal descriptor were significantly less satisfied with the

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