Can supervision relaxation undermine patient safety in community pharmacy?

In the light of the introduction of the responsible pharmacist Regulations and ongoing consultation on potential changes to supervision, Pharmacy Research UK (PRUK) commissioned researchers at the Manchester Pharmacy School to investigate supervision in community pharmacy.

The full report and an executive summary can be found at PRUK’s website: www.pharmacyresearchuk.org.

Why is supervision such a hot topic?

The effective and safe dispensing of medicines remains a core function of community pharmacy but pharmacists are increasingly becoming more clinical and patient-centred professionals. Appropriate advice is given alongside the sale and supply of medicines, and increasing levels of medicines and public health services are provided to support patients’ medicines and lifestyle choices and behaviours.

It is a requirement under the Medicines Act 1968 that all sales and supply of medicines are supervised by a pharmacist. This supervision currently also requires the physical presence of a pharmacist on the premises. However, it may be that certain pharmacy activities could safely be performed even when a pharmacist is not physically present, thus enabling him or her to use the two-hour absence allowed under the responsible pharmacist Regulations to provide clinical services away from the premises. Whether and how this absence is used in practice may also depend on who is working in the pharmacy, because many pharmacies operate with just one pharmacist with a team of support staff.

The subject of supervision has created much debate, with many pharmacists particularly concerned about the effect a change to the requirement for physical presence may have on patient safety. However, what has been lacking is evidence on current arrangements for supervision and views on how this could change, and on perceived risk associated with various pharmacy activities being performed by support staff during a pharmacist’s absence.

Supervision explored

We undertook a study to investigate these issues (see Figure 1).  We began by making a number of informal observations in five different community pharmacies to make sure that our approach was grounded in current and real-life pharmacy practice. We then invited pharmacists and pharmacy support staff to one of four nominal group discussions (stage 1). We also undertook one-to-one telephone interviews with six superintendent pharmacists.

Figure 1: A diagrammatic representation of the study stages and processes Click here for a larger version of the image

Based on stage 1 findings, we designed a questionnaire that included a list of 22 pharmacy activities, both medicines- and service-related, and asked respondents to think about each of these activities being performed by a member of pharmacy support staff during a pharmacist’s absence. We then asked respondents to rank how they perceived the level of risk to patient safety, and also whether it would be safe for suitably trained and competent support staff to perform these activities.

Although this study focused specifically on supervision in community pharmacy, we also involved hospital colleagues in both stages. We thought that some areas of skill mix and role delegation may be further developed in hospital pharmacy, with pharmacy technicians commonly in charge of dispensaries, and that practice and experience could usefully be shared across sectors. This study did not define, or differentiate between, pharmacy support staff, ie, it did not assume support staff were registered pharmacy technicians.

Findings

A number of mostly more technical and transactional activities were seen as “safe” to be performed by support staff by all respondent groups, such as selling general sale list medicines, taking in prescriptions, assembly and labelling. Respondents were also agreed on the provision of healthy living advice and signposting to other services as being safe activities. There was general agreement between how respondents rated the risk to patient safety of support staff performing various pharmacy activities and whether they believed support staff could perform them safely.

Pharmacy activities which respondents definitely thought could not be safely performed during a pharmacist’s absence either concerned Controlled Drugs, or were ones that would involve clinical input or advice. All respondent groups (pharmacists and pharmacy technicians in both community and hospital pharmacy) agreed that these activities were “unsafe”.

However, there were a number of activities where respondents were less agreed and, interestingly, community pharmacists appeared to be the most cautious respondents.   Pharmacy technician respondents in both community and hospital were, on the other hand, more willing to perform these “borderline” activities, with hospital pharmacists more closely aligned with pharmacy technicians.

So why were community pharmacists the most cautious group, seemingly most reluctant to delegate pharmacy activities to support staff during their absence? Both further items and open questions included in the questionnaire, as well as data captured during the nominal group discussions,¹ provided valuable insights.

Community pharmacists commonly believed that their presence was critical to safe pharmacy operation, which provided them with opportunity for intervention, necessary or otherwise, in the interests of patient safety. Besides a reluctance to relinquish control, community pharmacists voiced concerns about the importance of knowing the team and trusting support staff, their competencies and their ability to recognise their own limitations. Here are the views of two community pharmacists:

“I’m very conscious that I’ve worked in certain pharmacies where, as a locum, I haven’t had the confidence that the staff would be able to do that.”



“I absolutely agree. That’s why I’m saying, within a situation where you’re working with a team you know, it is absolutely fine. I’m lucky at the moment, that I’m working with a team that I know, but I have worked in stores where I haven’t, in the last few years.  And you think, “Hmm, I don’t know what their level of training is.”

Hospital pharmacists, who had more experience of working away from the dispensary, were more open to certain activities being performed during their absence, particularly if they remained contactable. One said:


“I think it comes down to having that good relationship … with your support staff and knowing their limitations and them knowing what you’re willing to accept them to do within their role.”

Taking professional responsibility was a central theme that was raised by participants in all nominal groups and was further explored in the survey. Pharmacists thought that support staff should be accountable for their own decisions and actions, although views among support staff varied. Some
were unsure about taking responsibility; others (particularly in hospital) embraced this in the context of pharmacy technicians now being registered and regulated professionals.

The six superintendents interviewed were generally supportive of a need to reform supervision requirements to enable greater flexibility and allow pharmacists to offer more clinical, patient-focused activities. All recognised community pharmacy’s strength as the accessibility of the pharmacist for patients, while being supportive of using the skills and competencies of trained support staff effectively.

So what?

This article only provides a brief overview of some of our key findings, with more available in the executive summary and the full report at the PRUK website. Through this study we have been able to identify a list of 22 community pharmacy activities and explored which ones are viewed, by pharmacists and pharmacy technicians, as being able to be safely performed by trained and competent support staff. Some such activities would need to be considered together, for many are part of multistage processes, such as dispensing, and all would need to be safely performed
by support staff to enable a pharmacist’s absence.

Trust was seen as important and established in a stable team, where members of staff would feel more secure and confident in assigning a wider range of activities to their support staff, thus enhancing the practicality of maintaining the operation of the pharmacy in the absence of the pharmacist. Best practice to enable pharmacist absence may thus require a pharmacist working with a familiar and well trained team, where all individual members of support staff are clear about their competencies, limitations and responsibilities.

This study made the availability of trained and competent support staff a premise for its investigation. However, with concerns raised over support staff competence, and the need for clarification of professional responsibility and accountability identified, these issues will require further exploration. This study will, however, go some way to informing the Department of Health-led “Rebalancing of medicines legislation and pharmacy regulation” programme, which is likely to look at supervision some time in 2014–15.


Acknowledgement This article is based on independent research commissioned by Pharmacy Research UK (PRUK). The views expressed in this article are those of the authors and not necessarily those of the PRUK. The authors thank the pharmacists and pharmacy support staff who participated in this study.