The pharmacy regulator must take a role in ensuring minimum staffing levels if it is serious about patient safety

Staffing levels in pharmacy are inextricably linked to patient safety and care. The General Pharmaceutical Council’s (GPhC) role is to protect patients and the public, and it should have a role in ensuring staffing levels meet or exceed defined mandatory minimums. This would not only benefit patients, but pharmacists and pharmacy staff too, through improved working conditions.

Contractors could rely on staffing minimums in funding negotiations with the government. I am aware of the political dynamics, but above the politics, two things hold true: the responsibility of our profession and that of the GPhC to protect patients.

Link to patient safety

There is a logical link between staffing levels and patient safety. Any human motion — such as a step in a safety process — takes a certain amount of time to complete. Methods–time measurement involves observing human motions and, as part of an international effort ongoing since 1948, average times for human motions have been determined^[1]
. There are standard times that apply to any motion, from ticking a box or picking up a pen from 20cm away, to walking a step or speaking a word. These times can be used to determine precisely how long a particular process will take, or how much time could be added or saved by the addition or removal of certain steps of a process. The concept leads to an important question, with profound implications for patient safety and liability: how can any expectation be placed on a person to follow a step in a safety procedure, unless the corresponding amount of staffing time is provided to allow the person to do so?

I considered this link to patient safety from another perspective when I worked as a clinical governance pharmacist and professional standards manager at Boots between 2011 and 2015. Some pharmacists may recall that in January 2018, Boots told the UK public — via the BBC, in an online news report, and in an Inside Out special investigation ‘Boots: Pharmacists under Pressure?’— that it had commissioned academic research that showed pharmacies with higher levels of dispensing staff were associated with higher error rates^[2]
. The research followed an internal investigation in 2012 into the pharmacies with the highest error rates. 

I am not aware of any link between an academic institute and the author of the report; the author was not a pharmacist and had a background in statistics. The report repeatedly emphasised that the results needed further investigation and interpretation by staff with sufficient insight and experience to explain the associations. The author’s conclusions appear to be based on the assumption that all dispensing errors were reported and were framed on that basis — referring to ‘error rates’ instead of ‘reported error rates’.

When the General Pharmaceutical Council inspects pharmacies, how does it consistently assess whether there are enough staff, unless it already has a defined minimum staffing level?

In June 2014, I conducted an analysis across 838 Boots pharmacies by comparing staffing data (the number of pharmacy staff hours actually employed as a percentage of the hours allocated by the company model) with reported incident rates (the number of reported pharmacy incidents — ‘dispensing errors’ — as a percentage of the prescription items supplied). I concluded that the rate of reporting of dispensing errors increased as staffing levels increased, in progressively smaller steps, until it reached somewhere between 120–140% of the staffing levels ordinarily provided by the company. Somewhere above 120–140%, the reported error rate started to decrease. The data were not perfect and I would have appreciated a peer review of the statistical analysis and method. I sent it for consideration by the Boots superintendent and his deputy, but I did not receive a response.

Boots is a member of the ‘Community Pharmacy Patient Safety Group’, whose logo includes the words ‘be open’ and ‘share’^[3]
. In the interests of patient safety, perhaps Boots should publish the full report and my analysis for peer review.

The current approach

Standard 2.1 of the GPhC’s ‘Standards for registered pharmacies’ — which it uses during pharmacy inspections — says there should be “enough staff, suitably qualified and skilled, for the safe and effective provision of the pharmacy services provided”^[4]
.

But when the GPhC inspects pharmacies, how does it consistently assess whether there are enough staff, unless it already has a defined minimum staffing level? I gained some insight into the GPhC’s approach to staffing in 2015. A senior official at the GPhC told me that it could not take any action in relation to my concerns about understaffing unless I could prove there was not a Responsible Pharmacist on duty. I do not think the public should have to settle for that approach.

The GPhC also employs what are known as ‘strategic relationship managers’ (SRMs). Each of the large multiples has an assigned SRM who meets with the company three times per year and assesses them against the pharmacy standards at a corporate level^[5]
. Very little information is provided by the GPhC about this in the public domain; as far as I can tell, there is no information about it on the GPhC’s website. How does it assess staffing levels during those meetings and how does that affect the inspection outcome at an individual pharmacy?

The General Pharmaceutical Council’s guidance seems to be worded so vaguely that it is difficult to see how anyone could be held to account against it

In June 2018, the GPhC issued staffing levels guidance in its ‘Guidance to ensure a safe and effective pharmacy team’^[6]
, but it is a naked emperor. Guidance is, by definition, optional and advisory. Unlike the GPhC’s standards, it cannot be enforced. Even if the guidance was enforceable, it seems to be worded so vaguely that it is difficult to see how anyone could be held to account against it. I fear that some may try to give the impression that it provides the requisite controls, but I doubt they would do so with a straight face.

In at least 667 pharmacy inspections since November 2013, the GPhC has had, in its own words, “major concerns about patient safety … that require immediate improvement”, where the pharmacy is “likely to present an unacceptable risk of harm to patients and the public. This means the risk is likely to occur and/or will have moderate to high impact”^[5]
. However, since its inception in 2010, the GPhC has issued 4,111 sanctions against individual registrants, but it has never issued any sanctions against pharmacy owners or superintendents for a breach of pharmacy premises standards^[7]
. There is no reason that I can see to suppose the GPhC would treat risks related to staffing levels any differently. Over the past few years, I have seen pharmacy inspection reports in which members of staff have directly raised concerns to inspectors about inadequate staffing levels, but the pharmacy has been graded ‘satisfactory’ against that principle of the inspection. I am not convinced the GPhC is recording or identifying such concerns as whistleblowing, despite the regulator’s recently published report on the matter.

How staffing standards could be set

Some broad principles could apply across many pharmacies, which take account of different variables, just as the staffing models that are used by the multiples across thousands of pharmacies do. During the development of the Pharmacists’ Defence Association’s Safer Pharmacies Charter, we considered these principles; for example, there must be enough staff to ensure physical safety and allow pharmacists to meet legal, regulatory and contractual obligations, meet the expectations placed upon them, take their statutory and contractual rest breaks and avoid imposed self-checking^[8]
.

The pharmacist’s professional judgement and autonomy should be respected — there may be a requirement for higher staffing levels depending on the circumstances

At the same time, the pharmacist’s professional judgement and autonomy should be respected — there may be a requirement for higher staffing levels depending on the circumstances (to accommodate increased service demand, for example).

Other, more granular principles could be defined; for example, in relation to pharmacy services, the backfill during a staff member’s absence, the level of training/qualifications of pharmacy staff and time for training, communications and management.

In addition, as a profession we could (where underpinned by academic research) develop and agree some numerical minimum staffing standards that apply in certain situations. Consideration should also be given to staffing standards beyond registered pharmacies; for example, on hospital wards.

Agreeing and setting minimum staffing standards would demonstrate a serious approach to patient safety from our profession and would be a hallmark of pharmacy’s professionalism. Above all, I believe we owe it to patients to do so.