Incorporating ‘reason for use’ into the prescribing process of medication: a survey on the opinion of patients in Flanders, Belgium

A prescription for medication has a central place in the current practice of health care reflecting the prominence of pharmacotherapy. It is not without complications, however, and the literature is filled with data about overuse, underuse, misuse, and side effects of drug use [1, 2]. The causes of these problems do not come solely from the drugs themselves, but also from how prescriptions are formulated [3] and executed [4]. There clearly can be more to a prescription than just the name and dose of a particular drug although the exact nature of this communication between health care workers has been the subject of contentions debates for decades [5‐7]. Ultimately, however, this communication should benefit the patients as their safety is at stake [8, 9].

Including an indication or a ‘reason for use’ is, with a few exceptions, a missing element in the medication prescribing process [10‐15]. Schiff et al. delineate five aspects that are important to guarantee the safety of medication use and delivery: (i) the right patient, (ii) the correct drug, (iii) the appropriate dose, (iv) the correct time, and (v) the appropriate dosage form. Information about the indication is in their view a sixth essential aspect to guarantee a safe course of medication use and delivery [11]. When the ‘reason for use’ must be included on prescriptions, prescribers have sometimes expressed concern about the greater workload, the confidentiality of the information, the liabilities connected to off-label prescribing, the difficulty of expressing this in an accessible manner in addition to concerns about clinical autonomy [11].

The current research on including ‘the reason for use’ was recently and comprehensively reviewed by Mercer et al. [16] using that specific phrasing and therefore, in this manuscript, the term ‘reason for use’ is utilized unless a direct reference to another study is made. Some data is available about the opinions of physicians and pharmacists regarding this possible extra aspect of the prescription [17‐19]. Pharmacists are undoubtedly the long-time leading enthusiasts as they perceive this extra information a prerequisite for providing better pharmaceutical care. From their point of view, including reason for use could help identify and correct medication errors and could eliminate unnecessary time-consuming contacts with prescribers [20‐23]. In contrast to pharmacists, the opinions of prescribers were more diverse and on average clearly less supportive. Concerns about privacy are expressed and there is some apprehension about the extra effort needed to include a ‘reason for use’ [19, 21]. These dispositions from the literature were also present in our survey in 2019 of pharmacists and physicians in Flanders [24]. In the US, a survey showed that the indication was present in 8% of the prescriptions [15]. Furthermore, in the Netherlands, the uptake of the mandatory inclusion of the indication for a select subgroup of medications was also low at 13% [25].

Patient opinions on the inclusion of a ‘reason for use’ have been much less studied [16], mostly through focus groups or through other qualitative research methodologies [13, 19, 21, 25]. Bearing this in mind, a study of the public opinion on these matters in Flanders, Belgium was initialed through an online survey. At the time of the study there were no regulations or software implementation features mandating of restricting the addition of extra information, such as a ‘reason for use’ to prescriptions but its inclusion in primary care is very rare. It should also be made clear that in Belgium prescriptions are routinely made available to insurance companies for auditing purposes.

A Dutch questionnaire was prepared to investigate the opinion of the general public on including a ‘reason for use’ (the condition) on prescriptions for medication. Its design was an iterative process with the active participation of all authors. The different themes resulting from the qualitative studies in the literature [13, 16, 19, 21, 24, 25] guided the selection of topics in the questionnaire. Interim versions were piloted among a small number of people without a professional medical background. A final version with 37 questions was transformed into an online questionnaire with the QualtricsXM software [26]. An internet-based questionnaire, consisting mainly of 5-point Likert scale questions, labelled with ‘Strongly agree’, ‘Agree’ ‘Neutral’, ‘Disagree’,‘Strongly disagree’, was used to register the opinions of the participants. An English translation of the questions asked can be found in the in supplementary material. These were preceded by a few general demographic questions (see Table 1) and a question about whether the respondents were practicing physicians or pharmacists, or were in training to become one.

The study was approved by Ethical committee of the Antwerp University Hospital (Belgian registration number: B3002020000202), informed consent was obtained from all subjects for study participation. The survey was online for 1 month starting on the 3rd of November 2020.

The survey was distributed in a pragmatic way through social media channels, primarily Facebook, and through a number of websites including patient organizations (i.e. Flemish patient platform (www.​vlaamspatientenp​latform.​be), Diabetes Liga (www.​diabetes.​be)), and insurance organizations (Christian health insurance fund (www.​CM.​be)), the website of Plus Magazine (www.​plusmagazine.​be), Seniorennet (www.​serniorennet.​be) and the Flemish network of pharmacists (www.​VAN.​be).

For the statistical analyses JMP pro 15 was used and a chi-square test was performed. A p-value of < 0.05 was considered significant. All reported p-values were those corrected for multiple comparisons which the Bonferroni-Holm method [27] using IBM SPSS statistics software [28]. Heatmap creation was performed in R using the package pheatmap [29] and illustrates the order and extent of agreement among participants asked to rank a list presented to them in a random order.

This questionnaire-based study was initiated to investigate the opinion of the general public concerning inclusion of ‘the reason for use’ on a medical prescription. Because of a lack of quantitative data on this topic and because of the constraints inherent to the COVID-19 situation, an internet-based questionnaire was used. Even before the COVID-19 crisis, this became the predominant survey methodology [31], although it can introduce a certain amount of bias [31‐34] as those with limited digital skills or those not fluent in Dutch may not be reached [35]. This kind of bias is, to a certain extent, inherent in all questionnaire studies [36]. The COVID-19 situation will undoubtedly have further familiarized numerous people in Flanders to online surveys [37, 38]. In addition an online questionnaire may have reduced the risk of bias linked to the style and additional instructions provided by the in-person interviewer [34]. Independent from its online implementation, the convenience sampling used in our study is another limitation that could have led to underrepresentation of certain groups, limiting the generalizability of the findings. The survey was, by design, kept short in order to maximize fully completed responses. On average, less than 10 minutes were needed, well below the 13 minute limit as has suggested by Fan et al. [39].

Experts have clearly spelled out the advantages and disadvantages of including a ‘reason for use’, [11, 40] but a successful implementation is rare, particularly in primary care [41]. The range of opinions connecting barriers and disadvantages with resistance, hesitancy, or opposition to implementing these changes are well known from qualitative studies [13, 19, 21, 25] and guided the development of the questionnaire with the aim to inform this debate with objective, quantitative data.

The results point toward a large majority of our respondents which are open to the idea of more information transfer from the physician to the pharmacist concerning the condition that led to the prescribing. This opinion is positively related to being prescribed multiple drugs, as this presumably induces more frequent contact with the pharmacist. People who are already convinced that this increases the potential for the pharmacist to intervene on medication errors and those who realize that the pharmacist can already deduce the condition in a sizable number of cases, not surprisingly, also favor this inclusion. The link with a particular pharmacy/pharmacist is important on several levels: (i) people who have high loyalty to a particular pharmacy are more in favor of information transfer; (ii) people object to the further dissemination of this information beyond their habitual pharmacy. This is important considering the actual existence in Belgium of a shared personalized database of dispensed medicines quarriable in all pharmacies [42]. The relative reluctance to having a condition labeled on the medicine package or explicitly printed on the paper prescription, can be seen in the same context: people want this information to selectively reach the pharmacist and not the occasional third person who picks up the medication for them or a visitor spotting the medicine package in the cupboard. There is a certain correspondence to some of the objections expressed by physicians in the use of this information beyond that particular pharmacists/pharmacy. This data may, for example, reach insurance companies and trigger reimbursement issues and there is the obvious fear of legal liability in the context of off-label prescribing.

The questions concerning the mentioning of specific diseases had a predictable gradient of acceptability, but even for STDs a majority of the respondents did not object. This gradient in acceptability could certainly inform a potential practical implementation order and therefore increase patient acceptability, although a selective approach introduced in the Netherlands was not particularly successful [25].

Instead of trying to discourage the main stakeholders, physicians and pharmacists, from participating in the survey, their responses were analyzed separately. The smaller number precludes an in-depth analysis but, not surprisingly, the quantitative trends reflect what the literature [16] and our previous experiences [24] already conveyed us: near universal enthusiasm among pharmacists and a very divide opinion among physicians. Extra information about disease specific doses of methotrexate does not influence these opinions in stark contrast to the general public.

One main conclusion of this study is that information about the advantages on the information transfer of the ‘reason for use’ to the pharmacists must be communicated with the patients to increase acceptability of a potential policy initiative. With the support of the majority of patients other implications for practice are the possible increase in patient safety by preventing dosing errors and improved pharmaceutical care through better patient counselling about medication with multiple uses.

Overall, this data further informs the debate on the information transfer from the prescribing physician to the pharmacists. It is a concept that is supported by a big majority of patients, but this support is conditional on several qualifications. The data also indicates that it is not productive to simplify everything to a binary debate: a simple yes or no to tightly couple the prescription of a particular drug with a particular ‘reason for use’. In the context of increasing digitalization of the prescription process this tight linking may increase resistance among patients because of the fear of further use. The digitalization without tight coupling and information transfer solely to the pharmacy chosen by the patient may on the other hand increase the acceptability and alleviate other privacy objections such as the pickup of medication by a third party. Additional research should extend these findings to other regions and further explore the implementation issues.

The data presented document strong support by patients for the information transfer to their regular pharmacy, in a secure and privacy conscious way, of the ‘reason for use’ linked to a particular prescription. The data also show that patient support for this change in practice can be broadened by providing information about patient-safety benefits and by taking into account the sensitivities around certain conditions.