Impact of findings on practice

  • Significant improvement in the quality of service delivery in the management of requests involving non-prescription medicines.

  • Provision for the large scale implementation of commonly accepted and recognised standards and protocols for the management of requests involving non-prescription medicines in community pharmacy.

Introduction

In Australia, the classification of medicines provides for two categories of non-prescription medicines that can only be purchased from a pharmacy, pharmacy medicines and pharmacist only medicines. This is a different system from the USA, for example, in which prescription-only or general sale are the only two categories of medicines. Classifying non-prescription medicines in this way is not unique to Australia. However, Pharmacist only and pharmacy medicines categories also exist in countries such as New Zealand and Canada, while in the UK and France, there is a pharmacy only category [1]. The purpose of these categories is to allow consumers to have reasonable access to effective medicines without a medical prescription. The underlying assumption of the regulation that restricts sales of these medicines to pharmacies is that pharmacists will monitor sales and intervene where necessary to ensure people use medicines safely, appropriately and effectively.

In Australia, the Industry Commission into the Pharmaceutical Industry (the industry includes manufacturers, wholesalers and community pharmacies) recommended that the current scheduling for pharmacy and pharmacist only medicines should only be retained, “pending further research into the role of the pharmacist counselling in ensuring improved health outcomes, and the monitoring of the extent of such counselling” [2].

A more recent inquiry recommended that for “over-the-counter medicines” (pharmacy only and pharmacist only), “consumers must have adequate information and understanding to enable them to select and use the most appropriate medicines for their condition and to use it safely and effectively, taking into account their health status” [3]. This same inquiry “accepted that some pharmacists do provide good service to consumers who obtain pharmacy and pharmacist only medicines from them, but that the standard is not generally high, nor do all pharmacists always provide proper care” [4]. Indeed, studies conducted in Australian and other countries support this assertion. These few studies indicate that standards of practice in relation to non-prescription medicines vary a great deal in community pharmacy. Whilst some pharmacies do provide quality services and advice, others do not [5–7].

The legal requirements in relation to pharmacy only and pharmacist only medicines and criticisms of the performance of community pharmacists in relation to the monitoring of these products has led to the development of comprehensive national standards of practice in relation to these products[8]. This represented a significant development in the area of standards for community pharmacy. Guidelines produced by the International Pharmaceutical Federation for standards of practice focus on the supply and use of prescription medicines [9], and while many countries have professional practice standards, few address the provision of non-prescription products, let alone have a separate set of standards dealing with these medicines [10].

Following consultation with key industry and consumer groups and selected community pharmacists, standards of practice were developed including protocols for the sales of pharmacy and pharmacist only medicines (Tables 1, 2) [8]. The Standards defined and described what professional activities are required in the provision of pharmacist only and pharmacy medicines at a consistent and measurable level of practice. These were in the areas of Resource Management; Professional Practice; Pharmacy Design and Environment; and Rights and Needs of Customers [8]. The Standards were followed by criteria, which are clearly defined process guides describing how each standard is achieved in practice. They described key components of the standard and specified the appropriate level of performance required by expressing what a competent professional would do in terms of observable “outputs”. Each criterion was followed by a number of indicators that assisted in deciding the degree to which an individual criterion had been met. The development of the Standards of Practice has been reported elsewhere [8].

Table 1 Standards of practice for pharmacy and pharmacist only medicines
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Table 2 Protocols for the sales of pharmacy and pharmacist only products
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Initial testing process of the Standards demonstrated a significant improvement in the quality of service delivered by community pharmacies in the management of non-prescription medicines and led to a recommendation for the development and execution of a national implementation strategy [8].

Aim of the study

Following this recommendation, the current study aimed at implementing a quality improvement package in relation to the Standards in each State and Territory of Australia.

Method

Research design

Within-subjects (repeated measures) design was employed. Randomly selected pharmacies were coached on the implementation of the Standards of Practice for the Provision of Non-Prescription Medicines. Pre and post measurements of the level of adherence to the Standards were taken.

Sample size

The study was conducted from January 2000 to December 2002. Out of a total of approximately 5,000 pharmacies in Australia at the time, 2,706 pharmacies were selected by the local registering authority to take part in the study (Table 3). The randomisation procedure was not controlled by the researchers but conducted by the registering authorities. Researchers contacted the registering authorities and requested that they provide a random sample of 50% of their community pharmacies. The sample size, determined by budgetary constraints was composed of approximately 50% of the total number of pharmacies in Australia. The randomisation procedure was used in every state and territory of Australia with the exception of pharmacies from the state of South Australia where the registering authority decided that they wished all pharmacies to participate in the program (389) and provided additional funding.

Table 3 Number of pharmacies visited at least once per location (State)
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Recruitment

The selected pharmacies were firstly contacted by their local registering authority via a letter outlining the pharmacy’s role, a description of the Quality Improvement (QI) cycle and a copy of the individual Standards of Practice. The letter also made the proprietor aware that a pharmacy educator from the project would be visiting the pharmacy within the following 2 weeks for the first of a series of three visits (Fig. 1).

Fig. 1
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Educator visit protocol

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Measures

Compliance with the standards was assessed via an auditing process. Educators went through the individual Standards of Practice and assessed whether or not they had been met. Practice behaviour, was monitored via pseudo-patron visits, also known as simulated patient visits. That is, confederates of the researchers were trained to go to the pharmacies in the study and enact particular scenarios. A trained educator provided feedback and coaching to the pharmacist immediately after the pseudo-patron visit. This training method had been previously shown to be effective in shaping practice behaviour of community pharmacists and their staff in relation to the provision of non-prescription medicines [5, 11–15]. The pseudo-patron method was critical in assessing standards of practice related to customer care and advice and resources management (Table 1). However, although the results pertaining to customer care and advice and resources management are reported, the current study will focus on the auditing process as results from pseudo-patron visits have been reported in detail elsewhere [16].

Visit process

At each visit point, assistance with the requirement of the Standards was an integral part of the educator’s role. During the first visit, the pharmacy educator explained the project, answered questions and also conducted an assessment of the level of compliance with the Standards. At each visit point, assessment involved the measurement of all practice indicators (Table 4) with the exception of criteria 1.1.3, 2.1.1, 2.1.2, and 2.1.3 which relied on pseudo-patron visits for assessment.

Table 4 Example of one standard with accompanying criteria and indicators
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A follow-up letter from the project was sent to the participating pharmacies after each visit point. The letter related to the assessment of the individual Standards of Practice highlighting the standards that had been met and providing suggestions and motivation to pursue the standards that had not yet been met. Twenty-one pharmacy educators were employed for the visit process.

Data analysis

Frequency distributions were used to compare compliance with the standards overtime and chi square analysis of proportions was used to test for significance.

Results

Pharmacy educators emailed data to the authors who for reliability and validity reviewed available paper data for accuracy of data entry. All 2,706 pharmacies in the study received the first educator visit, 2,534 pharmacies received the second educator visit and 2,371 pharmacies received the third and last educator visit. The most common reasons for attrition were pharmacy withdrawal from the study due to unforseen circumstances (e.g. pharmacy closure, sale), educators’ omission to collect data, and educators’ contradiction of study protocol and introduction of potential bias by delivering the second audit visit prior to the pseudo-patient visit.

Compliance with the standards

At each visit point, educators assessed the individual Standards of Practice (Table 1). This was accomplished by determining whether or not individual criteria had been met. The proportion of criteria met (compliance rates) was calculated for each of the three visits (Table 5).

Table 5 Compliance rates for Visits 1, 2, and 3
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Figure 2, below, shows the national adherence to the Standards of Practice at Visit 1. At this point, the lowest levels of adherence were to documentation process (44%) and to Customer Care and Advice (46%).

Fig. 2
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National adherence to standards of practice at Visit 1

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Figure 3 shows compliance to Standards at Visit 2. At this visit, more than 80% of pharmacies had met most criteria. The lowest levels of compliance were to criteria 1.1.1, 2.1.1, 2.1.3 and 2.2.2, which required written operating procedure for specific tasks.

Fig. 3
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National adherence to the standards of practice at Visit 2

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Figure 4 shows compliance to Standards at Visit 3. At this visit, compliance to most criteria had significantly improved compared to Visits 1 and 2. Consistent with previous visits, criteria related to documentation had the lowest levels of compliance.

Fig. 4
figure 4

National adherence to standards of practice at Visit 3

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Discussion

The current study represented the first attempt in Australia, and perhaps globally, to implement standards of practice specific for non-prescription medicines, at a large scale. The implementation strategies seemed to have been well accepted by participants and results indicate pharmacies across the country were better equipped to provide higher quality service to consumers of non-prescription medicines.

Results showed that the methodology had been effective in sensitising community pharmacists and staff to the importance of pharmacist counselling in the non-prescription area. However, it should be noted that the results presented in this paper might not represent true behavioural measurement of pharmacy performance, but indicators. Pharmacists and staff were aware of the impending pseudo-patron visits, which could have made performance reactive.

It is also noted that across the auditing visits the lowest level of compliance was observed for criteria related to documentation process. It seems reasonable to suggest that a belief that the keeping of consumer records constitutes extra professional duty and lack of mechanisms for recording patient details may at least partially explain these results. It is true that the successful implementation of sustainable behaviours in community pharmacy requires that pharmacies develop mechanisms to allow them to integrate documentation procedures into routine professional practice.

As one would expect, criteria related to behaviours where pharmacists already had in their repertoire which were also mandatory by legislation—such as storage of pharmacist only medicines in secure area, location of pharmacy medicines in a professional area—presented the highest levels of compliance throughout the study.

Also, it is noted that criteria related to pharmacist only medicines and those related to pharmacy medicines improved in parallel between Visit 1 and 3 but failed to reach significant different scores. A limitation of the study lies in the fact that researchers did not record who provided advice and care (criteria 2.1.3), consequently data obtained from pharmacists could not be compared to those obtained by pharmacy staff. It is not known whether or not scores obtained by pharmacists were higher than those obtained by other staff members. Further research is needed to assess appropriateness of advice and care in relation to who in the pharmacy team delivers the care.

Finally, attrition was spread proportionately across Australian states and territories with a total rate of 11.8% (318 pharmacies). Therefore, generalisation from the sample to the population of Australian pharmacies can be made with a high degree of confidence.

Conclusion

Community pharmacists across Australia responded favourably to the large-scale implementation of standards of practice for the provision of pharmacy and pharmacist only medicines. Professional practice in relation to the handling of these medicines improved considerably as measured by the auditing procedure. The good acceptability of large-scale implementation of these standards of practice in Australia indicates that such an approach could be taken beyond Australia. It should also be noted that the current study did not include a cost-benefit analysis. Such an analysis has been conducted in a separate study and reported elsewhere [1].