The PDA has been a lone voice in calling for changes to the RP regulations ever since they were first proposed; an independent study reported to government and major pharmacy organisations shows PDA’s worse fears to be justified.
Review vindicates PDA position on RP
The PDA’s long-standing position on the Responsible Pharmacist Regulations has been vindicated as part of a review process that was approved by the government following pressure from the PDA. The independent, survey-based report makes the same recommendations that the PDA has been calling for since 2005. It concludes that the Regulations have not improved patient safety or professional autonomy, but have significantly increased pharmacists’ criminal liability, stress and paperwork.
The PDA has been a lone voice in calling for changes to the RP regulations ever since they were first proposed. It called for a delay to their implementation in 2009, supported by a petition of more than 5,000 pharmacists’ signatures. And last year it asked the pharmacy minister to suspend the Regulations. Persistent PDA lobbying finally persuaded the Government to ask the Royal Pharmaceutical Society to commission this survey, in which the views of 8,000 pharmacists were canvassed.
Without support from other pharmacy bodies, the PDA’s ability to affect changes has been hampered to date. But now, armed with these findings, Chairman Mark Koziol believes that the PDA’s calls for change are strengthened.
Regulations fundamentally flawed
“The results of this survey show what can happen when pharmacy bodies’ fail to properly engage with the issue of RP regulations, and because of their lack of support these matters were left to fester,” says Mr Koziol. “The views of thousands of pharmacists have now shown beyond doubt that the Responsible Pharmacist Regulations are fundamentally flawed and that change is long overdue. Rather than try to make a silk purse out of a sow’s ear, we want fundamental changes – we want to look at the basics and consider new models of practice going forward. Common sense says the Department of Health’s consultation on supervision must now be delayed while we sort out these issues. Only then can we realistically develop a supervision regime to support that vision of practice.”
Mr Koziol continues: “The RP Regulations do not support the original intended strategic intent, which was to allow the development of new professional roles. The focus on SOPs would mean the end of professionalism for pharmacists, particularly after a recent employment tribunal effectively ruled that they must take precedence over professional discretion as far as employment law is concerned. And in hospitals pharmacists are being taken away from clinical ward-based duties to act as the Responsible Pharmacist. Another way must be found to drive new roles, while also ensuring the safe supply of medicines.”
“Ultimately, the PDA’s policy on supervision in the community pharmacy setting has always been that it should make the pharmacist more accessible to the public in the pharmacy, not less so.”
Eight key recommendations
The report’s authors made eight key recommendations, which have all been repeatedly forwarded by the PDA over the past few years:
- Clarify the policy intent around absence, defining what can be done and enabling the clinical role of the pharmacist
- Empower the RP to make decisions around how absence is used, as well as to make changes to safety procedures
- Distinguish the balance of responsibilities between RP and superintendent/owner
- Reduce the complexity of SOPs to a minimal standardised framework
- Provide clarity on the role of the technician and liability in relation to dispensing errors
- Address the impact on locums
- Address the poor operational fit with hospitals – consider dis-applying the regulations in hospitals altogether.
- Ensure the regulations are future facing, accommodating changing models of practice.
“We highlighted all these issues over several years since 2005, yet the government and the then regulator, the RPSGB, still ploughed ahead. Widespread refusal to acknowledge the shortcomings has hindered professional development and not been in patients’ best interests. This process has unnecessarily sapped much energy within the profession and we must never indulge in this type of exercise again,” says Mr Koziol.
DH arguments rebuffed
The PDA wrote to the pharmacy minister, in July 2010, asking him to suspend the regulations. In its letter the PDA warned that the impact of the Regulations on individual pharmacists has been, “increased criminal liability, bureaucracy, relationship breakdown with their employers and resultant stress”. It warned that the Regulations were not delivering any tangible benefit to patients, and in certain respects are detrimental to the public interest.
In his response Earl Howe indicated that he genuinely believed that the regulations were delivering “high quality clinical outcomes for patients and a safe medicines supply system”. He acknowledged that the PDA had been “vocal” in its opposition to implementation of the Regulations, but felt reassured about their suitability by the fact that no other pharmacy organisations had ever raised similar concerns.
The independent report now sets the record straight – the report’s authors conclude that: “Seven out of ten pharmacists agreed that the Regulations put the RP in a difficult position by making them legally responsible for people and processes outside their control; qualitatively this was driving behaviours which were felt to undermine patient safety, as well as adding professional stress and workplace tension.” Only 12 per cent thought the Regulations had had a positive impact on patient safety.
More professional empowerment required
Half of all pharmacists felt that they should be more empowered to exercise professional judgement, but in reality they needed to follow SOPs closely. Around half agreed that the Regulations made the use of SOPs more important to protect them from accusations of unprofessional behaviour, and pharmacists are practising defensively as a result.
Only around one in three RPs believe that they have they the authority to make changes to SOPs and staff roles and responsibilities. A quarter of locums never read SOPs and only four in ten do this at all or most of the premises where they are the RP. A quarter of locums had thought about refusing to work as an RP in the last 18 months because of how a pharmacy operates, but then went ahead and worked anyway because they felt a refusal would damage their employability.
Pharmacists under stress
Rest breaks have become shorter and less frequent since the Regulations were implemented, with 22 per cent of locums reporting that the situation had deteriorated. A number of pharmacists reported a ‘degree of demonstrable emotional stress’ as a result of the regulations, mainly in relation to the stipulation of ‘100 per cent responsibility’. This was particularly the case where pharmacists did not feel that they had the authority to support this level of responsibility, namely those working in multiples and supermarkets.
There is a lack of clarity about how the Regulations work in practice and the research revealed a “fundamental tension” within the Regulations between a perception of a broadened definition of legal accountability on the one hand driving RPs to be more present, and the absence provisions on the other. Most pharmacists agreed that the Regulations had made little positive impact, but more than a quarter replied that they had increased their admin burden.
What next?
A stakeholder meeting involving all of the pharmacy organisations is to be held on January 26th, 2012, to discuss what needs to be done next.
Mr Koziol comments: “Already there appear to be a diverging range of views emerging from stakeholder organisations as to what now needs to be done. This ranges from a significant re-working of the Regulations at one extreme, as advocated by the PDA, to the ‘let’s leave things as they are and muddle through’ approach being advocated by others.”
“Members can rest assured that we will be putting our arguments with some enthusiasm at this meeting and we will be sending you information in early January giving a detailed synopsis of the points for discussion. You will receive a detailed briefing on the next stage of the campaign to resolve the issues with the RP regulations early in the New Year.”