Development of a Theory-Based Intervention to Enhance Information Exchange during Over-The-Counter Consultations in Community Pharmacy

(1) Background: Community pharmacy personnel help mitigate risks of self-care by consumers who seek over-the-counter (OTC) medicines or treatment of symptoms and/or conditions. Exchange of information facilitates the OTC consultation, but pharmacy personnel often report difficulties in engaging consumers in a dialogue. The aim of this study was to describe the development of a behaviour change intervention to enhance information exchange between pharmacy personnel and consumers during OTC consultations in community pharmacies. (2) Methods: The Behaviour Change Wheel methodological framework was used to link factors that influence consumer engagement with information exchange during OTC consultations with intervention functions to change behaviour. Options generated were rationalized and the final intervention strategy was derived. (3) Results: Education, persuasion, environmental restructuring, and modelling were determined to be potential intervention functions. The intervention incorporated placing situational cues in the form of posters in the community pharmacy modelling information exchange behaviour, persuading through highlighting the benefits of exchanging information and educating about its importance. (4) Conclusions: A systematic, theoretically underpinned approach was applied to develop candidate interventions to promote information exchange in OTC consultations. The feasibility and efficacy of the intervention strategy has since been tested and will be reported elsewhere.


Introduction
Community pharmacy personnel manage over-the-counter (OTC) enquiries every day [1,2], which include requests for named OTC medicines as well as the treatment of symptoms and/or conditions [3,4]. Consumers are becoming increasingly confident in self-managing minor ailments by using information from a variety of sources, such as the internet, to self-diagnose and select medicines they view to be appropriate [5,6]. This is facilitated by the wide range of OTC medicines available from community pharmacies in many countries, which require varying levels of involvement by pharmacy personnel, depending on the legal classification and regulation [7][8][9]. Furthermore, community pharmacies are accessible, often with extended opening hours, and without the need to book an appointment to see a pharmacist [10][11][12][13].
Benefits of consumers in engaging with self-care for minor ailments include convenience, and time and cost savings [6,14]. However, there is a risk that consumers could misdiagnose their condition(s), resulting in delays in initiating appropriate treatment [6,14]. Consumers may also underestimate the risks of OTC medicines, which could result in adverse effects [15][16][17][18][19]. Pharmacy personnel play an important role in mitigating the risks associated with self-care. Community pharmacists are qualified to manage the complexity of OTC enquiries in the community pharmacy setting by engaging with consumers in a consultation [20][21][22]. Gathering information from consumers about the symptom or condition, the person's medical history and medicines, and their treatment goals, assists pharmacists in providing appropriate recommendations [2,23]. Many factors influence information exchange during OTC consultations, including the communication skills of pharmacy personnel, consumer expectation to purchase an OTC medicine without needing to answer questions, privacy, and the legal classification of the medicine [24][25][26][27][28][29][30][31][32][33][34][35][36][37].
Pharmacists and pharmacy personnel often report difficulties in engaging consumers in a dialogue, particularly when the request is for a specific medicine by name [25,27,[38][39][40]. OTC consultations ideally should involve two-way communication "between the pharmacist and the patient in which the pharmacist ascertains the needs of the patient and provides them with information required to effectively use medicines and/or therapeutic devices" [20] (p. 50). This interaction requires clinical knowledge and reasoning, as well as effective communication. There is substantial evidence, however, that the management of the diverse range of OTC enquiries encountered in community pharmacies is sub-optimal, and that this is mainly due to inadequate information gathering and/or advice or information provision by pharmacy personnel [1,[26][27][28][29]31,32,[41][42][43][44][45][46]. While there has been a number of interventions to improve the exchange of information between pharmacy personnel and consumers, with varying levels of success [47], there are also studies which show that pharmacy personnel are not complying with appropriate standards [26,29,[41][42][43]45].
The aim of this study was to describe the development of a behaviour change intervention to enhance information exchange between pharmacy personnel and consumers during OTC enquiries in community pharmacies.

Materials and Methods
This study was the third phase of a larger project with the aim of enhancing the quality management of OTC consultations in community pharmacies ( Figure 1). In the first phase, a systematic literature review identified interventions targeted towards improving communication between consumers and pharmacy personnel during OTC consultations in the community pharmacy setting [47]. Focus group discussions were then conducted to determine pharmacist, non-pharmacist pharmacy personnel and consumer perspectives regarding barriers and facilitators for information exchange during OTC consultations in community pharmacies [39]. The results from the first two phases identified that to enhance information exchange between pharmacy personnel and consumers during OTC enquiries, consumers needed to engage with the process. The methodology described in the Behaviour Change Wheel (BCW) [48] was subsequently used to develop an intervention strategy to target this behaviour.

Underpinning Theory
The BCW is a validated methodological framework developed from the synthesis of 19 behaviour change frameworks to assist researchers to apply the COM-B (Capability Opportunity Motivation-Behaviour) model of behaviour in any setting to develop an intervention strategy. The BCW identifies sources of behaviour in terms of the complex interactions between capability, opportunity and motivation.
The Theoretical Domains Framework (TDF) [49] was also applied in this study. The TDF is a validated derivation of the COM-B which identifies 14 domains that determine behaviour. In Table 1, the TDF domains are linked to source behaviours of COM-B. An analysis using TDF provides a more detailed understanding of determinants of behaviour from which an intervention strategy can be developed. The BCW describes interventions in terms of nine functions: (i) education, (ii) persuasion, (iii) incentivisation, (iv) coercion, (v) training, (vi) restriction, (vii) environmental restructuring, (viii) modelling and (ix) enablement. A function of an intervention is an aspect of the intervention that influences behaviour. The BCW links intervention functions with behaviour change techniques (BCTs), which are the active components that can be used in the intervention strategy [50]. The BCTs are assessed against the APEASE (Affordability, Practicability, Effectiveness and cost effectiveness, Acceptability, Side-effects/safety, Equity) [51] criteria and to enable decisions on intervention content and delivery that are within the scope of the study.
In Phase 3, a 2-stage process was used to develop the intervention. In Stage 1, to fully understand the target behaviour, an independent duplicate (LS, KW) behavioural 'diagnosis' of consumer engagement with information exchange during OTC consultations was conducted, using themes from the focus groups undertaken in Phase 2 [39]. The researchers coded focus group themes to the COM-B model and TDF. The results were discussed with a psychologist experienced in pharmacy practice (L. Smith, see Acknowledgments) until consensus was reached. Independent duplicate (LS, KW) mapping of the key factors that influenced this behaviour to intervention functions and BCTs [48] was conducted (Stage 2). Disagreements were resolved by consensus and involvement of a third researcher, when required (RC). Options for the intervention were generated by the research team (LS, KW, LH, MW, RC) then rationalised (LS, KW) through assessment against the APEASE criteria [51] and discussion. The final intervention strategy was decided by consensus (LS, KW, LH, MW, RC).

Stage 1: Behavioural Analysis
A behavioural diagnosis on the target behaviour, as described in the BCW and resulting COM-B and TDF coded themes from Phase 2 focus group discussions, was conducted ( Table 2).

Belief about consequences
(Acceptance of the truth, reality, or validity regarding outcomes of a behaviour in a given situation) [52] Consumers did not understand the risks of medicine use √ Consumers engage in information exchange if they ask about a symptom but not if they ask for a specific product Education Persuasion Modelling Consumers did not know that being asked questions is for their benefit √ Consumers did not know that their consultation information will be kept confidential √ Consumers do not know that pharmacy personnel are bound by privacy laws

Intentions
(A conscious decision to perform a behaviour or a resolve to act in a certain way) [52] Consumers expected to purchase an OTC product without exchanging information √

Education Persuasion Incentivisation
Coercion Modelling Consumers expected to answer questions if asking about a symptom √ Consumers resisted information exchange if repeatedly requesting the same product √

Reinforcement
(Increasing the probability of a response by arranging a dependent relationship, or contingency, between the response and a given stimulus) [52] Consumers did not feel it necessary to be asked questions (not from focus group but an observation of the research group)

√
If consumers exchange information and have a positive outcome as a result, this will subconsciously encourage information exchange behaviours in future consultations.

Training Incentivisation
Coercion Environmental restructuring

Behavioural diagnosis of the relevant COM-B components
Psychological capability, physical opportunity, reflective and automatic motivation need to change in order for the target behaviour "consumer engaging in information exchange" to occur.

Stage 2: Identify Intervention Options, Content and Implementation Options
Education, persuasion, environmental restructuring, and modelling were determined to be potential intervention functions ( Table 3) that met the APEASE criteria. The BCTs identified to be able to deliver the four intervention functions are listed in Table 3 with examples of BCTs to address identified barriers.

Intervention Strategy
The research team discussed the results of the analysis and developed the intervention. Situational cues, in the form of a poster displayed in a community pharmacy (environmental restructuring), depicting consumers with OTC enquiries engaging in information exchange (modelling), highlighting the benefit of this behaviour (persuasion) and the reasons why it is important (education), were identified as the most appropriate intervention. A second poster depicting a pharmacist and information about the qualifications and role of a pharmacist was developed. An additional situational cue, in the form of a badge, was developed to be worn by pharmacy personnel to identify their position as either pharmacist or pharmacy assistant.

Discussion
This study described the development of an intervention strategy to enhance information exchange during OTC consultations. With the growing trend for self-care and the empowerment of consumers to make health decisions, it is essential that their safety is protected through the expertise available from pharmacists and other pharmacy personnel.
A systematic, theory-based approach was undertaken to fully understand the key components impacting information exchange.
The target of most interventions to date has been pharmacy personnel, with varying degrees of success [47]. Interventions targeting consumers have been neglected [47]. Through the systematic process, the behaviour of interest was identified to be information exchange and the consumer's engagement in information exchange was determined to be the target as there was a scarcity of interventions directed at the consumer.
The scope of this study was to derive an intervention to promote information exchange. The strength of this study lies in using a rigorously developed theory-based methodology for the systematic development of an intervention. The steps involved in the intervention development are described in detail, therefore making it reproducible.

Conclusions
A systematic, theoretically underpinned approach was applied to candidate interventions to promote information exchange in OTC consultations. The feasibility and efficacy of the intervention has since been tested and will be reported elsewhere.