Anyone who has worked in primary care will tell you it is busy - NHS Digital's data on appointments in general practice in England show that there are approximately 25 million consultations with GPs every month.
With such high numbers it is inevitable that sometimes things will go wrong. What is more difficult to precisely discern is how often patients experience avoidable harm as a result of clinical care provided by their GP. For example, the Health Foundation in an analysis of published evidence in 20111 found that around 1-2% of consultations featured an adverse event, and also noted that the prescribing error rate was much higher, at around 11%. The report also noted that most adverse events did not cause harm to patients.
An interesting observation in the Health Foundation study was that although there is much academic debate about the exact level of adverse events in primary care, there appears to be consensus on the some of the underlying causes of medical errors. These include human factors (and in particular communication), structural processes such as reporting systems, and clinical factors such as medication errors (see below).
Helping to shine a light on the occurrence of avoidable harm in general practice is Professor Tony Avery. He and his colleagues carried out a retrospective case note review, randomly sampling over 14,000 GP patient records across three regions in England. Their findings were published in 20202.
One of the features of the study was that rather than describing the prevalence rate per consultation, as most other studies have done, the authors reported the incidence of avoidable harm (stated to be 35 to 58 per 100,000 patient years), thus allowing for reliable estimates of the number of cases of avoidable significant harm to patients each year to be made.
What the new study also shows is that when it comes to avoidable harm, clinical factors were the most important. Within the clinical factors group, diagnostic error was the largest proportion (approximately 61% of cases) followed by medication errors (approximately 26% of cases) and delayed referrals (approximately 11% of cases).
These findings resonate with what we have seen in the MDU for many years. For example, Dr Clare Wratten describes the common medication errors seen in claims defended by the MDU, noting the most frequent errors were prescribing for a patient with a known drug allergy, prescribing the wrong drug (where there were similar names), or at the wrong dose.
Diagnostic errors have often featured in MDU articles and the difficulties of diagnosing lung cancer in primary care is analysed by Dr Edward Farnan and Dr Simon Watkin, who highlight just how difficult the diagnosis can be and the importance of having a low threshold for considering that non-specific symptoms could indicate lung cancer. Finally, Dr Kathryn Leask describes the problems seen when there is a delay in referring skin lesions that turn out to be malignant melanomas (and other delays in the diagnostic process).
In the Avery study, of the patient notes sampled, there were over 2,000 new, significant health problems identified and in 97% of these cases there was no evidence of avoidable harm. Although there is no place for complacency in medicine, it is nonetheless reassuring to see evidence that avoidable harm in primary care is a rare occurrence. Therefore, a key question when presenting reports about patient safety is how do you strike a balance between highlighting that the overwhelming majority of clinical care that is provided is safe, yet at the same time recognising that there still needs to be continual improvement?
The dilemma on striking that balance goes beyond simply how facts are presented, although it is important this is done accurately and accessibly. It may be that our continual struggle with blame culture affects the narrative - the long and faltering journey away from a blame culture to a just and learning culture remains one of great challenges facing everyone who is involved in promoting patient safety research and initiatives.
Although there is no place for complacency in medicine, it is nonetheless reassuring to see evidence that avoidable harm in primary care is a rare occurrence.
There is, however, some cause for optimism. In January 2020 the National Patient Safety Syllabus was published. It is an ambitious document, describing a series of key domains that build on each other as an individual works their way through them. Underpinning the domains are four fundamental themes of knowledge and expertise - these are systems expertise, human factors, risk expertise and safety culture.
Rather than a narrow focus on merely what has gone wrong in clinical practice, the syllabus instead pays attention to the systems and behaviours that give rise to error and result in harm. It is also clear that blame has no place in a modern safety culture, and instead promotes the concept that the Just Culture Guide is a lens through which individual failure can be understood in a systemic context.
Second, the Healthcare Safety Investigation Branch demonstrates that there is another way to analyse what has gone wrong, so as to maximise the learning in a way that supports staff (you can find out more here in our interview with HSIB chief investigator Keith Conradi). The HSIB makes clear that it does not apportion blame or liability. Instead, its values are independence, collaboration, trust, respect, compassion and accountability.
In particular, compassion is well illustrated in a recent HSIB report on support for staff. The report highlights the need to provide effective support for staff caught up in patient safety incidents, recognising that high levels of psychological harm will itself impact directly on patient care.
Finally, there is encouragement in learning from trusts that have been successful in developing and committing to a just and learning culture. The best known of these is Mersey Care NHS Foundation Trust, and its web page describing the journey to developing such a culture is worth reading. A perfect illustration of the move away from a blame culture can be seen in Mersey Care's statistics on staff discipline:
"There has since been a significant reduction in disciplinary cases. One of the four clinical divisions saw 64 percent reduction in disciplinary cases between 2016 and 2017. In the period from 2018, 199 investigations and 57 suspensions have been avoided."
If staff feel safe that they will be treated fairly and with respect by their employer, they will be more likely to speak up when things go wrong and set in train the necessary processes to enable learning. That is not to say that there should not be accountability, which this remains an important facet of professionalism - it just means that an individual's culpability will be fair and proportionate.
As we strive for a utopian vision of a just and learning culture, we should of course continue to support evidence-based patient safety initiatives and recognise our part in ensuring that mistakes result in learning and colleagues feel supported. We should also take heart from Prof Avery's paper that despite all the challenges of clinical practice, doctors and their clinical colleagues continue to do a fantastic job, day-in and day-out. With the profession at breaking point during the coronavirus pandemic, it is as timely as ever to be reminded of the good that our clinical colleagues do.
Comment from Professor Tony Avery
Few people outside of primary care recognise the complexity of our clinical work; the scale of serious (multiple) conditions that are handled by general practitioners, and the complicated systems we must navigate to manage patient care. Therefore, it is not surprising that patient safety in primary care receives little attention - and resource - compared with hospital-based care, and that there has been relatively little research on the topic.
Funded by the National Institute for Health Research Policy Research Programme, we have addressed this by completing one of the largest and most detailed studies of the frequency, nature and causes of avoidable harm in primary care. As pointed out in the article above, in many ways the findings are reassuring in that there was no evidence of avoidable harm for 97% of patients presenting with significant health problems.
Nevertheless, extrapolating our findings to the whole of England, there are likely to be over 20,000 cases of avoidable significant harm from primary care each year, equating to three or four cases per year in an average size general practice. Also, the problems we identified are ones that both GPs and patients would almost certainly regard as significant, including late diagnosis of cancer (including major delays in referral), delayed diagnosis of deep vein thrombosis and ischaemic limb, and drug-induced nephrotoxicity (due to lack of effective patient monitoring).
The cases of avoidable significant harm we identified are similar to ones that have been highlighted by the MDU over many years and are typical of those discussed at regular 'learning events' in general practice across the country. In general, they reflect the challenges we face in trying to keep patients safe when dealing with multiple complex problems in short consultations, and where providing continuity of care is becoming increasingly difficult. We highlight some potential solutions in our paper, and many of these involve improvements in the systems we use.
One of my main reflections, however, is that what keeps patients safe is the diligence of GPs in practising high quality medicine (effective history taking, examination, investigation, treatment and follow up), communicating well with patients and colleagues, and the effective use of safety netting. The challenge is that we need to be 'on top of our game' much of the time, not just in consultations but also when doing clinical administrative tasks.