Safety incidents on the rise
Patient safety incidents in pharmacy are on the rise, up by almost a third for the first quarter of 2019 compared with the final quarter of 2018, according to the latest NPA Medication Safety Officer’s report. The NPA has previously noted that ‘work and environment’ factors are a major contributor to safety incidents, linked to “workload, distractions and time pressures due to staff shortages”.
Fitness-to-practise concerns raised with the GPhC are also at record levels. Is there a link with staff shortages? Research by Pharmacy Magazine earlier this year revealed that 13 per cent of contractors had made staff members redundant due to the funding cuts. Surely this must add to workplace pressures and risk compromising patient safety? Is it a concern to the GPhC?
Rudkin says data from inspection visits, for example, does not indicate there is a causal or obvious link between staff numbers and safety incidents. Indeed, the number of pharmacies – 26 – failing to meet Standard 2.1 (“there are enough staff, suitably skilled and qualified, for the safe and effective provision of the pharmacy services provided”) actually fell in the last quarter of 2018 compared to the previous four quarters.
However, it is a complicated area to analyse and he is wary of putting two numbers together and “drawing a hasty conclusion”, especially when the absolute numbers of pharmacies concerned are still quite small and many other factors are at play.
One of the reasons behind the GPhC’s rising fitness-to-practise caseload may lie in the increasing complexity of modern practice and more patients and members of the public using pharmacy services, he says.
“We are constantly trying to understand what the data is telling us and are investing to improve our capacity in dealing with fitness-to-practise issues but also to analyse the data and ultimately draw insight from it. But it is very complicated,” he admits.
The regulator has written to pharmacy bodies to ask how they are implementing its 2018 guidance on ensuring safe and effective pharmacy teams and to describe the challenges relating to staffing levels. It will continue to monitor the situation closely and in February held a meeting with key stakeholders to identify further actions that can be taken to help ensure safe working in pharmacies.
Focus on individuals?
The GPhC has been criticised in the past for focusing on individual registrants in fitness-to-practise cases and rarely on employers and the external circumstances contributing to errors, for example.
A freedom of information request by the Pharmacists’ Defence Association in 2017 found that the regulator had issued over 3,500 sanctions since 2010 against individual registrants but had never brought a fitness-to-practise case for failing to comply with the standards for registered pharmacies.
To what extent does the GPhC consider human, environmental factors and context (e.g. staffing levels and employment practices) when considering errors in fitness-to-practise cases?
“We look at all the circumstances surrounding an error including all mitigating and aggravating factors,” says Rudkin. “For instance, was the individual open and honest when something went wrong and took steps to put it right or did they conceal the error?”
Through robust investigation processes, we arrive at a fair and proportionate outcome based on the facts of the case, he adds, while the investigation can also take account of the context in which the issue arose.
“We encourage a just culture through our professional standards. Our standards for pharmacy professionals make it clear that people must speak up when they have concerns or when things go wrong. Under principle 2 of our standards for registered pharmacies, owners are required to ensure that there is a culture of openness, honesty and learning.”
Perhaps with the notorious Bawa-Garba case in mind, where a junior doctor was convicted of manslaughter for the death of a six-year-old boy and struck off the medical register – there were concerns at the time that the doctor’s reflections in her learning portfolio were used against her in court – Rudkin recognises that the possibility of disciplinary action can deter people from reporting errors. (The Bawa-Garba striking off was later overturned by the Court of Appeal.)
“It is important to emphasise that single dispensing errors would not in our view constitute a fitness-to-practise concern, unless there were aggravating factors.”
He says pharmacists may wish to look at the GPhC’s suite of good decision-making guidance. These help to provide transparency about the processes it uses and “gives people confidence that decisions we take are consistent, fair and proportionate”.