2022-09-20 10:06:04
The Professional Standards Authority (PSA), which oversees all the statutory UK healthcare regulators, has just published a report entitled Safer Care for All https://www.professionalstandards.org.uk/safer-care-for-all
The report concludes that there are structural gaps in healthcare regulation. A key recommendation in the report is that each UK nation should have a Health and Social Care Safety Commissioner UK. The commissioners should sit above all other health and care organisations, spanning public as well as private provision. They would also be independent of Governments.
What follows is a summary of issues raised by the report that may have specific application to pharmacy, together with some of the PSA’s recommendations.
Patient safety incidents and workplace cultures
“The big push towards learning and just workplace cultures is vital in achieving safety aims, and allowing professionals to practise without fear of being unfairly punished if things go wrong.”
“Regulators should do more, both individually and collectively, to clarify and explain their approach to cases where a professional has been involved in a patient or service user safety incident.”
“Health professionals and social workers are not robots, and by virtue of the high-risk work they do, can make mistakes that lead to permanent injury and even death. These mistakes are more likely to happen when professionals are under pressure, and working in challenging conditions. It is the role of professional regulation neither to punish for past wrongdoing nor to divorce professional failings from the context in which they occurred.”
Discrimination in fitness to practice proceedings, and racism
“Staff…face inequalities and discrimination…within the regulatory process, which can lead on to patient safety issues. Regulators and registers are alive to these issues but are still to resolve the disproportionate representation of groups with protected characteristics throughout the regulatory process…
We recommend that:
- Regulators…work collaboratively to improve the diversity of fitness to practise panels, other decision-makers and senior leadership to ensure they reflect the diversity of the community more closely
- Regulators…gain a better understanding of the demographic profile of complainants and reduce barriers to raising complaints for particular groups…
- Regulators…review how their fitness to practise processes and guidance address allegations of racist and discriminatory behaviour…
In overseeing the regulators and scrutinising their final fitness to practise decisions we have observed a variable approach to how they deal with racist behaviour, both within their sanctions guidance and in practice…sometimes panels are uncertain about what kind of sanction to impose. It is also important to note that cases ending up within the fitness to practise process are likely to represent the more obvious cases of racist behaviour, as opposed to more subtle or insidious behaviours and micro-aggressions that can also be very damaging. Regulators and registers should review how their fitness to practise processes, including their indicative sanctions guidance and other fitness to practise guidance, address allegations of racist and discriminatory behaviour. Guidance should be clear that racism and other discrimination are a serious breach and may result in removal from the register.”
High street healthcare/private healthcare
The PSA acknowledges that the GPhC has modern processes (unlike some other healthcare regulators) but it seems to view high street healthcare and private healthcare as sinister, giving rise to specific risks. Although doctors, dentists and other types of healthcare professionals are mentioned, pharmacies and optometrists seem to be singled out for the risks they pose to the public. Some passages from the report are quoted below.
“…it is becoming more common for local pharmacies, surgeries and dentists to be owned by large corporate bodies”
“We are seeing large corporate chains accused of ‘hard sell’ tactics, and other questionable practices, that seem to prioritise profit over the best interests of both patients and registrants. However, the regulation of ‘high street’ providers of healthcare is complex and piecemeal, and may not be fit for purpose”
“technology is transforming both how we deliver care, and the techniques and services on offer. Remote and virtual consultations have become widespread in sectors such as primary care and counselling and people can now access a whole range of healthcare online, including pharmaceutical, optical and dental service”
“Evidence suggests that online healthcare businesses are underperforming against their ‘physical’ competitors in terms of quality of care and sometimes engage in risky practices.
“the overall system of business regulation is fragmented and confusing.”
“The GPhC’s inspection and enforcement powers are unique among the healthcare professional regulators. They give it significant scope to influence a number of areas including governance, risk management and safe staffing. However, there are also potential shortcomings in the GPhC’s model. The Pharmacists Defence Association (PDA) says that ‘treatment of pharmacy owners is in stark contrast with [GPhC’s] treatment of individual registrants’ and believes that ‘the regulator should achieve a fair and balanced regulation regime that is equally demanding upon both pharmacists and the employers’. The PDA believe that the GPhC is better equipped to use its powers against individual pharmacists than against pharmacy owners, and that as a result it is much more likely to take action against individual pharmacists than owners.”
“There is a “relative power imbalance between the regulator and some large corporations. Not only are regulators outstripped financially by large businesses, there is also the question of how feasible it would be, in practice, for regulators to impose the most serious sanction of erasure on a large chain. Boots for example has over 2,200 UK stores, Lloyds Pharmacy over 1,500…These businesses play an integral role in the delivery of healthcare in the community. Were regulators to take the most extreme action of removing these businesses from the register it would leave a large number of people – in the short term at least – without a healthcare provider they can rely on. These businesses may, in effect, come close to being too big to fail.”
“private businesses, whether as small independent providers, or as part of large multinational chains…use techniques designed to optimise profits, such as sales targets and employee incentives, or managing costs by keeping staffing levels to a minimum.”
“Both pharmacies and opticians have been criticised for engaging in a range of practices that go against the best interest of patients.”
“In the pharmacy sector, large chains such as Boots have been accused of failing to maintain safe levels of staffing as a deliberate tactic to increase profit margins and of setting inappropriate sales targets. Questions about unethical practice in the sector were brought into sharp focus during the Covid-19 pandemic when some pharmacies were found to be charging hugely inflated prices for essential products including hand sanitiser, face masks and paracetamol. This prompted the GPhC and the Competition and Markets Authority (CMA) to issue a joint letter warning pharmacies against ‘unfair business practices.”
“Similarly, the PDA 2021 Safer Pharmacies Survey found that 46% of respondents stated that patient safety was placed above ‘commercial or other operational considerations’ only half the time or less. Putting undue pressure on health professionals to meet commercial targets is likely to create a conflict between the demands of the employer and patient interests. While it should be clear that complying with professional standards must be the priority, it may be challenging for individual registrants to make this case, particularly where targets are set at a distance by a large corporation, and store managers may not be registrants and therefore not subject to the same professional standards.”
“However, the inherent tension between profit and patient best interest should be monitored. Regulators will need to consider whether they need to be more interventionist in their approach where it is in the best interests of the public”.
Online pharmacy
In relation to online pharmacy, the PSA sees significant risks that it considers are not adequately regulated. Below are some quotations. Please note that although the PSA cites a prosecution by the Care Quality Commission (CQC) of Pharmacorp Ltd, Pharmacorp was not prosecuted specifically in relation to pharmacy services: it was prosecuted because doctors were prescribing for patients who used Pharmacorp’s website (medicinedirect.co.uk) but the company had failed to register with the CQC. The link cited by the PSA no longer works, but members who are interested can view further details here https://www.cqc.org.uk/news/releases/cqc-take-action-against-online-doctor%E2%80%99s-service-providing-unregistered-services
Below are two passages from the PSA report:
“Issues include allowing customers to effectively ‘shop’ for particular medicines, poor identity checking processes, and prescribing high risk medications through an online form. The GPhC has stated that of the online pharmacies it has taken action against, the majority were working with online prescribing services that were ‘prescribing medicines which are liable to abuse, misuse and overuse to people, on the basis of an online questionnaire’ and added that this ‘puts patients at risk of serious harm or death.’ In the recent case of Pharmacorp, an online pharmacy prosecuted by the CQC, the company was found to be posting prescription medication to patients based on an online questionnaire, with prescriptions issued by doctors based in Romania. The CQC stated that the service carried a ‘real risk of misdiagnosis’ and ‘exposed patients to a significant risk of harm’.”
“Boots, which has been trialling online consultations since 2020, has recently announced a new training programme on digital healthcare for all its pharmacists, and Amazon has registered its pharmacy operation. The Governments should use the regulatory reform programme to ensure that regulators have the agility to address the challenges brought about by new technologies.”
Of the GPhC and some other regulators, the PSA says: “regulators are sometimes reluctant or unable to intervene (for example in matters relating to commercial practices) even where there is a legitimate case for doing so. This is partially due to the risk of challenge if there is no specific duty to act.”
Further recommendations
“We recommend the development of reliable mechanisms for anticipating changes in service provision that open up public protection gaps across the sector, and identifying ways to address them…
We recommend that
- Regulators tackle business practices that fail to put patients first, risk undermining confidence in the professions, or fail to allow registrants to exercise their professional judgement. A cross-sector review should be conducted of the effectiveness of arrangements to address financial conflicts of interest among healthcare professionals.
- Governments, regulators and registers review how they will determine the lines of accountability for new technologies used in health and care.
- Governments use the current healthcare professional regulation reform programme to:
- Review the adequacy and effectiveness of the powers of regulators with a role in regulating businesses
- Consider whether there is a case for extending business regulation powers to all regulators whose registrants work in ‘high street’ practices
- Ensure regulators have the agility to address the challenges brought about by new approaches to funding and delivering care, including the introduction of new technologies.