CCA & AIMp Response To 'Pharmacy In England: Building On Strengths, Delivering The Future: Proposals For Legislative Change', UK
In order to respond effectively to this consultation, the CCA & AIMp have sought to understand the assumptions that underpin Pharmacy in England: building on strengths, delivering the future: proposals for legislative change, which we see as critical to analysing these proposals. To this end, we have scrutinised the impact assessments carefully.
In general, we feel there is a lack of detail surrounding the establishment of PNAs and supplementary lists. This makes it difficult to assess whether the cost/benefit assessments made are accurate. That said, we do have a number of specific concerns. These are outlined below:
Supplementary lists
Based on published NPSA data on error rates in community pharmacy, we believe the error rates cited for community pharmacy in the evaluation of supplementary lists are extremely high. Given that the benefits of supplementary lists are calculated against a reduction in errors from an elevated baseline, we believe that the impact assessment consequently overestimates improvements in clinical standards expected from supplementary lists.
Furthermore, we believe that the majority of errors predicted to be prevented are of minor clinical significance. The impact assessment provides little evidence on how supplementary lists will reduce more clinically significant errors. To more accurately assess the impact of supplementary lists on clinical standards, we would like to see the evidence that shows that supplementary lists will impact on significant clinical events as well.
We also believe that the cost of supplementary lists for our members will be significantly higher than those estimated in the impact assessment.
As a result, on balance, we believe that the costs of their introduction as outlined in this paper are disproportionate to the benefits.
Pharmaceutical Needs Assessments
We believe that there are aspects of the impact assessment for PNAs that are also fundamentally flawed. For instance, it is unclear if the cost of £98,000 for PNAs is per PCT or a total across England. We believe that the initial cost of developing robust PNAs is likely to be much higher if the job is done well. Furthermore, we see no calculation within the impact assessment for the cost of ongoing maintenance of the PNA; a process, which is critical to its effectiveness over time.
Worryingly, there are also no provider costs attributed to the development of PNAs in the current calculations. If this indicates that the Department of Health (DH) does not envisage providers being involved in PNA development process, then we would be extremely concerned. If contractor involvement is anticipated or expected, then the costs to pharmacy must be recognised in the impact assessment.
Link with the contractual framework
For CCA & AIMp members, the key issue in this consultation is the proposed regulatory changes concerning the arrangements for granting NHS dispensing contracts. Across our members, there are different perspectives on the fundamental principle of limitation of entry to the pharmacy market, but whatever their individual views, the system for determining market entry is of fundamental importance to all.
From our challenging discussions and wide-ranging debate on this issue, we have concluded that it almost impossible to reconcile fully the wants and needs of both schools of thought within CCA & AIMp, but there are many issues around these proposals upon which we do agree. This response focuses on those.
Our members all agree that market entry regulations are a fundamental part of the economic and business model for community pharmacy, and there is an inextricable link between the proposed regulatory changes to market entry and redesign of the pharmacy contract.
As the future shape of remuneration within the contract is currently unknown, it makes it very difficult to know what impact these regulatory changes will have on access to pharmacy services in the longer term. This makes it difficult for our members to respond comprehensively to these proposals.
The CCA & AIMp recognise that changes in remuneration are unlikely to happen in the near future; and certainly not within the time frame anticipated for the finalisation and implementation of the regulations included in this consultation. But the inextricable link between these two issues cannot be ignored. We want to be involved with the development of joined up policy thinking around potential future models of remuneration so that these can be scoped into and inform legislative changes, which need long term future proofing now.
Given the importance we place on the need for a joined up approach, this response is couched with the caveat that there is a pressing need to address the fundamental issue of redesigning the pharmacy contract to ensure the right incentives are in place to drive quality, innovation and investment in pharmacy service development.
The CCA & AIMp are fully supportive of individual member companies submitting their own responses to this important consultation to explain their individual positions on this issue more forcefully. We believe that the issue of market entry should be robustly debated so that the full range of stakeholder perspectives can be heard and inform robust policy development.
Market entry based on Pharmaceutical Needs Assessment (PNA)
If the agreed way forward for managing market entry is through PNAs, this is acceptable to CCA & AIMp members, and they will work with it, notwithstanding a number of caveats:
1. That pharmacy contracts must be of sufficient duration to create incentives for ongoing investment in service development and delivery;
2. That development of the new PNA process is robust and includes a fully evaluated pilot programme;
3. That implementation of the PNA process is systematic and consistent across PCTs;
4. That PCT commissioners meet a set of competencies in pharmacy service commissioning, aligned with world class commissioning requirements, that demonstrate their competence to use the new system prior to their being granted new freedoms to implement a PNA based process;
5. That a fundamental review of the current pharmacy contract happens as soon as possible.
Definition of a PNA
PNAs were originally a tool designed to ensure cost effective planning of the service offered across a network of pharmacies; not necessarily to determine the need for new pharmacies.
We believe that the current definition and practice of undertaking PNAs is wholly inadequate to meet the functions of a PNA set out in this consultation. To constructively contribute to the debate, the CCA & AIMp have sought to define what we would see as a robust PNA process. The use of this new process must be introduced over time and PCT commissioning freedoms aligned with proven competence in pharmacy commissioning.
Our definition for a PNA is:
"The PNA sets out the health and well being needs of the local population that can be met through community pharmacy network, leading to more effective service provision that contributes to improved health and well being and reduced health inequalities."
Good PNAs:
- Are broad and cover a range of primary care services that could be provided in community pharmacy, including those traditionally based in other NHS settings.
- Are focused on NHS commissioned pharmacy based services.
- Take a population based approach. They outline the current and anticipated future (foreseeable) pharmacy service and pharmaceutical need, matched against current and potential providers, thereby highlighting any "gap" between need and provision. They are a tool for identifying groups whose needs are not being met.
- Have a time frame of 3-5 years. They are reviewed in light of major local service reconfiguration, and, at bare minimum annually. They are fundamentally refreshed every three years in line with local area agreement reviews.
- Are enabling rather than restrictive. They are living plans that continually evolve. PNAs are fair to incumbent and new providers alike.
- Define a locality transparently and consistently;
- Are readily available on the PCT website, as are proceedings for contract applications.
- Use a common, systematic approach, underpinned by partnership working, public engagement and an understanding of the evidence base, backed with a focus on outcomes.
- Have planning processes embedded with other local needs assessment and commissioning processes, including: local area agreements, joint strategic needs assessment, local area agreements, workforce planning strategies, strategies to support specific groups e.g. carers, children, older people, sustainable community and regeneration strategies and PBC, PCT and LA commissioning strategies.
- Mirror joint strategic needs assessment processes (JSNA). DH provides a core data set for PCTs to use when conducting PNAs. This is then supplemented with local data. The core dataset for JSNAs may be just as relevant to PNAs.
- Recognise the limitations of data reliability and availability and attach risk to PNA assessments where there is uncertainty.
- Has effective data collection and management systems in place to ensure PNA data sets are regularly updated.
- Are developed through an inclusive process. Stakeholders, including: patients and the public, pharmacy providers, GMS/PMS providers, commissioners and public health leads at both PCT and local authority are all key partners in the PNA process. Their views on key elements such as choice, diversity of provider, accessibility and the range of services that can be provided from pharmacies are included in the PNA.
- Use a process that engages, but also challenges providers to look beyond prescription volume to consider quality and the range of services they could usefully and realistically provide to their communities.
- Are accompanied by sustained service commissioning intentions; and backed with commitment to fund services recognised priorities to meet the needs of the local population.
In addition, we believe a good PNA is more likely to be achieved where:
- Responsibility for the development and implementation of an integrated PNA is at a senior level (Director of Commissioning).
- Commissioners recognise the imperative for all providers to provide a commercially viable service over the long term. In terms of pharmacy applications, for instance, the long term impact of granting (or refusing) a contract application should be considered in its broadest sense.
- Pharmacy commissioning and provider development is co-ordinated and championed within the PCT by a designated person. These pharmacy roles are a key part of relevant individuals' job description and key performance indicators.
- The new PNA process and its implementation is independently scrutinised and monitored to ensure consistency of approach across PCTs. The SHA has an important role in monitoring the use of PNAs within commissioning. To scrutinise the quality of PNAs, the CCA & AIMp is proposing the establishment of a national, independent assessor, akin to MONITOR to scrutinise PNA implementation across PCTs.
Development and piloting of a template PNA
PCT representatives at Listening Events strongly advocated the development of a template PNA to ensure a systematic approach at local level. The CCA & AIMp also support this approach, but the complexity of this process and success of creating a robust template cannot be underestimated.
As important as agreeing the definition and principles of a robust PNA that underpin any template PNA, is consideration of measures of effective implementation within a PCT; and identification of outcome measures that will demonstrate individual PNA processes are maximising value for money for the NHS and improvements in health and well being for the local population.
The CCA & AIMp do not believe that PCTs (independently or through NHS Employers) can develop the new PNA model or template in isolation. We believe that this is a task that requires broad engagement and partnership working from the outset at national level with pharmacy contractors and their representative bodies, including the CCA & AIMp. We understand that work on a template PNA has begun. We are not engaged in this process currently, but would want to be engaged fully moving forward.
Furthermore, we would expect DH to make a significant investment in commissioning a robust programme of research, conducted by a multidisciplinary academic team from public health, pharmacy, health economics and business to review the strengths and weaknesses of current PNAs and, in partnership with a broad range of stakeholders - including the CCA & AIMp - scope out a new template, best practice implementation toolkit and develop a core data set.
This new PNA process should then be piloted rigorously in real life practice and on paper across a representative range of localities; to allow testing against current processes for validity and predictability.
Tests of PCT commissioning competence
The White Paper recognises that PNAs are currently variable in quality and that significant resource needs to be allocated at PCT level to improve their effectiveness as integrated planning tools. Contractors' experience of PNAs is that they are too often:
- Conducted in a vacuum from other PCT planning process, and not joined up;
- Limited in scope, concentrating on the delivery of basic services and not recognising the potential for pharmacy to deliver additional services;
- Fixed at one point in time, rather than reflecting the dynamic nature of the healthcare environment and populations;
- Unable to recognise the existence of discrete local markets within the total PCT boundaries;
- Supported by poor quality data that is infrequently updated;
- Inconsistent in terms of scope and quality across PCTs.
Any new PNA process is a business critical issue for our members. They will not accept a system that delivers anything less than a systematic, transparent, robust and predictable process conducted by PCTs who have demonstrated their commissioning competence. Until these two essential caveats are met, the CCA & AIMp could not endorse any new system.
We believe that the principles of world class commissioning (WCC) (1) should apply to the PNA process, pharmacy service commissioning and procurement. We want to see a framework created that tests that PCTs are meeting relevant WCC sub competencies and will prove PCT competence to deliver the new system. The CCA & AIMp are keen to input into the development of this set of pharmacy specific WCC competencies.
Implementing PNAs
The CCA & AIMp want to see PNAs undertaken in a systematic way.
A process that seeks to identify the current and future health and well being needs of the population in term of existing pharmacy services and future pharmacy service planning and embed it within the wider context of PCT and local authority (LA) commissioning plans, the JSNA and other local planning processes is a highly complex one.
PNA development requires complex partnership working with a range of stakeholders, including pharmacy service providers, with the PCT playing a key facilitation role. There is a need for careful relationship management to ensure ongoing positive engagement between all stakeholders and the PCT.
This clearly requires greater PCT management resource and higher level management input than PNAs and pharmacy commissioning have enjoyed until now.
In addition, we believe that national guidance on conducting PNAs, similar to guidance on JSNAs (2), should be issued, and that a core PNA data set that can be supplemented with local data should be developed to support PCTs with this process.
Appeal against PNA processes
To manage appeals against PCT PNA planning processes we propose the creation of an independent national body, akin to Monitor, whose role is the scrutiny and alignment of PNA processes. This body should have a range of experts on its panel, including: consumers, patients, contractors, commissioners, local councillors and public health experts.
Application process and decision making criteria
- All applications should be judged against a robust PNA and a set of clearly defined, transparent criteria. All 'additional factors' to be considered should feature in the PNA and therefore become criteria against which consideration of any decision on a new contract application is judged.
- PCT decision making processes and the reasons for decisions must be transparent; - The rationale for granting or rejecting an application, together with the names of the panel and any declaration of personal interest must be published in the public domain;
- There should be consistency of approach across PCTs in their decision making so that given the same set of very similar circumstances in two PCTs, the outcome of an application should be predictable;
- Under the new system, LPCs should continue to be involved in and empowered to make local representations on proposals to grant contracts for pharmaceutical services;
- An appeal process is still needed. But with a robust PNA and transparent criteria for awarding contracts, we believe that the number of appeals should be low. However, it is always possible for there to be differences of view on whether criteria set have been applied or whether the PNA has been conducted systematically, so the need for scrutiny by local contractors remains.
- Over time, as the new system beds down, we believe the focus of the appeal process will increasingly shift towards the PNA itself, rather than individual contract applications. However, by fully engaging with local providers during the development of the PNA and keeping the PNA updated, such appeals should be kept to a minimum.
Market entry arrangements for 100 hour pharmacies
There is no consensus view on this issue amongst our members.
PCT performer lists
We believe that the DH and PCTs are confusing poor service provision with poorly performing pharmacists. There is a need for clear delineation between a PCT's role in contract performance management, over which they rightly exercise significant control; and pharmacist performance, which is a matter for employers and the regulator.
The CCA & AIMp believe that PCTs already have adequate powers to tackle poor professional performance without recourse to additional powers or performer lists. All pharmacists declare their fitness to practice to the regulator. If the PCT has a complaint about the professional conduct of an individual pharmacist, this should be referred directly to the regulator whose role it is to deal with professional standards and performance against those standards. It is not the role of the PCT to be the arbiter of professional standards.
Performance management of contracts
It is our belief that the most effective way to improve performance is through incentives in the contract for quality improvement, rather than penalties for poor performance. We see little discussion of this in this consultation, and believe that this should be looked at more closely moving forward.
Currently, all pharmacy owners, directors and superintendent pharmacists of a body corporate have to make a fitness to practice declaration for pharmacy services to the PCT have to make a fitness to practice declaration for the pharmacy services they provide to the PCT.
The PCT has the duty to performance manage contracts for pharmacy services. It has significant power to deal with poor performance - up to and including suspension of the contract. For local enhanced services, service level agreements (SLA) can contain explicit terms for performance and remedies that can be put in place in the case of poor performance. World Class Commissioning competencies are already focused on improving quality through contract management, and these should apply equally across the whole primary care playing field. If a PCT has a complaint against a pharmacy or pharmacist for non-compliance with contract terms, then the PCT can use its existing powers to remedy the situation, up to and including termination of the contract.
To enable objective and transparent decisions to be made about whether a pharmacy is performing adequately, we believe that PCTs should create much clearer criteria and parameters for effective pharmacy contract monitoring and quality improvement. We would propose the development of a national template SLA for enhanced primary care (including pharmacy) services, and national guidance on how to handle breaches as part of PCT's support and development framework for world class commissioning status.
The PCT human resource currently allocated to the management of pharmaceutical services is very modest indeed, when compared, for instance, to the resources allocated to managing general medical services. Given this and high mobility of the pharmacy workforce across PCTs, the positive experience of harmonising pharmacy accreditation through the North West SHA's Harmonisation of Accreditation Group, we believe that DH must now take a more pragmatic view of national accreditation and other common pharmacy contract management processes across PCTs. All stakeholders agree that it would reap significant benefits for commissioners and contractors alike. We clearly want to see more process harmonisation in the future.
Moving forward, alongside competency frameworks and accreditation processes for locally commissioned services, we would find it very helpful if PCTs set core performance criteria at national level for all pharmacy services in the contractual framework. In the context of performance management, amongst other benefits, this would enable benchmarking between PCTs. As we have done consistently, the CCA & AIMp would advocate a nationally led approach to performance management of all pharmacy services.
Once a problem with service quality is identified, PCTs also need a clear process for assessing performance; determining remedial action; informing the pharmacy; and assessing the effectiveness of remedial action taken. Any remedial action notice issued should be sent to both the poorly performing pharmacy, and the owner of the business to ensure that action recommended can be followed up by line managers.
Remedial notices, while part of the fitness to practice regulations, should not require notification to the home PCT. Only formal non-remedial notice based action should require such notification. Remedial notices should be taken forward through a stepwise approach e.g. 2 months to complete an audit, 1 week to review SOPs as a result of a serious error.
In the event of the PCT wishing to revoke a contract, a clear and transparent process is required for terminating the contract and reallocating the contract if that is deemed appropriate within the context of the PNA. The process for revocation of a contract should be clear and consistent, requiring verbal warning, followed by written warning and a period to allow appropriate remedial action to be taken. The process must include the right to appeal against any decision taken.
In the event of such action, the contractor must not be subject, as a result of the process, to deliberate or consequential financial penalties that may make the business non-viable. Payments must continue during the appeals process, and in the event of an appeal being successful the contractor, must be awarded any lost remuneration.
Supplementary lists
The CCA and AIMp recognise that as the result of the Shipman Enquiry, there is an imperative for the NHS to assure itself that all health professionals are safe to work with the public and vulnerable people. The NHS solution is to introduce supplementary lists held at PCT level.
We also recognise the need for pharmacists to prove that they are safe to work with NHS patients and vulnerable people. However, we believe that in the context of the highly mobile pharmacy workforce in community pharmacy, supplementary lists will not prove an efficient or effective system for our profession.
They may, in fact, inadvertently lead to reduced access to pharmacy services for patients.
Furthermore, we believe that the supplementary list is a blunt instrument in the monitoring clinical competence, and no substitute for an effective regulator. We think it is unreasonable to expect a PCT to assess clinical competence and rule on whether a pharmacist is fit to practice as this highly specialised role is the regulator's raison d'etre. That said, PCTs must have a way of assuring themselves that pharmacists have no criminal records and can work with vulnerable groups.
By creating an annotated master list held by the regulator, with open access for all NHS and community pharmacy employers, we believe that our sector will deliver the NHS with a speedier and more responsive system to ensure that those who need to check (PCTs and employers) can assure themselves that on any given day, the pharmacists providing NHS services are approved to do so
Because of the highly mobile nature of the pharmacy workforce across geographies and sectors and the high number of locum pharmacists working in the community, this system will not only be a more cost effective way of achieving the aims of supplementary lists, but it will also be safer and more comprehensive. For instance, under current proposals to regulate access to vulnerable people, free lance locums; area managers (who sometimes provide cover in pharmacies), and owner pharmacists are missed out. Our proposed system would ensure their inclusion.
Unless such a system is adopted for pharmacy, we believe there will be significant restrictions on workforce mobility that will jeopardise access to pharmacy services for the public. Having discussed this issue at the White Paper Listening Events, our members are clear that DH still does not understand fully the operational implications of these proposals.
For example, we understand that DH is proposing that there can be no cross-border 'working for Welsh and Scottish pharmacists working in England. This would mean that Welsh or Scottish pharmacists not registered on a PCT list in England would not be allowed to work in England.
Amongst our members, it is common for a pharmacist who normally working in Wales to be asked to work in England in an emergency (perhaps when a pharmacist is sick). Under these proposals he or she would be unable to do so. This would then mean that with no pharmacist in the pharmacy, patients would not be able to access pharmaceutical services. It would also place the contractor in breach of their terms of service and liable to action from the PCT- despite a professionally-registered pharmacist being available to work. This is clearly not in the patients' best interests.
We urge the DH to listen to our members very real concerns on this issue. Rather than blindly following the precedent set in other professions whose workforce is far less mobile than community pharmacy's, we want to work with DH and the regulator to design a process for pharmacy that delivers the same safeguards as supplementary lists, but is tailored to working practices in our sector.
Dispensing by Doctors
The CCA and AIMp start from the premise that every patient deserves access to a full pharmacy service. We see issues related to dispensing doctors as a side issue to this White Paper because our members' priority is expanding the range of pharmacy based services for patients. We believe that the high profile campaigning undertaken by dispensing doctors has been unhelpful insofar as it has distracted policy makers from their intended focus within this White Paper; pharmacy service development.
We believe that dispensing doctor services are justified only in exceptional circumstances; where a full pharmacy service is not viable. These instances are few but they do exist. This means that abolishing doctor dispensing completely is not a viable option.
We think dispensing by doctors should be limited to the small number of places where a dispensing doctor service is the only viable option. This would lead, over time, to more stringent rules being applied - especially in market towns - so that current anomalies are reduced. In the interim period, the current arrangements should remain.
Most importantly, the dispensing doctor service, as with all NHS services, must represent value for money. The Government has signalled to pharmacy owners that our business model must change and that dispensing can no longer subsidise clinical pharmacy services. The same rules should apply to dispensing doctors. They should be fairly rewarded for the medical services they provide. Doctor dispensing services should not subsidise general medical services. We believe such a shift would remove perverse incentives from the doctor dispensing system, and would enable PCTs to commission medical and dispensing services more fairly and effectively.
Sale of GSL medicines from dispensing premises
The CCA & AIMp believe that in the absence of a convenient pharmacy or other retail outlet selling GSL medicines (distance limit at least 5km) and in the interests of public health and access to medicines, it might be difficult to argue against proposals to allow dispensing doctors to sell GSL medicines.
Dispensing doctors can prescribe (and therefore supply) any medicine to their dispensing patients. Given the safeguards established within the Medicines Act governing the classification of medicines, we strongly oppose allowing dispensing doctors to sell Pharmacy medicines.
In addition, the CCA & AIMp believes that these rights should be limited to those dispensing doctors providing an essential medicines supply service and that the same regulatory framework should apply to the sale of GSL medicines from dispensing practices as applies within pharmacy, and that patients should enjoy the same quality of care and be protected by similar safeguards. The detail of what this looks like in the context of a dispensing practice requires further scoping work.
Other changes to legislation
LPS
PCTs are commissioning organisations. We do not believe that there are any circumstances when PCTs should act as provider organisations - including provision of LPS. They must use their commissioning and contracting powers to ensure adequate pharmaceutical service provision in a sustainable business model.
Changes and charges opening hours
We cannot support PCTs charging contractors for changing opening hours.
We would like to see the notice period for changes in opening hours reduced to 6 weeks.
Sunday trading restrictions mean that many of our supermarket members must close their stores on Easter Sunday. Currently many PCTs appear to be unaware of this, and assume in their out of hours planning that these stores will be open. This leads to poor provision of service on Easter Sunday. We would ask that the DH ensures that PCTs are aware of Sunday trading restriction, and class Easter Sunday as a bank holiday within pharmacy rotas moving forward.
References
1. Department of Health. (2007) World Class Commissioning Competencies http://www.dh.gov.uk/worldclasscommissioning
2. Department of Health. (2007) Guidance on Joint Strategic Needs Assessments. http://www.dh.gov.uk
Source
Georgina Craig
Head of Communications and Partnership Development
The Company Chemists' Association
http://www.thecca.org.uk
CCA & AIMp rãspuns la "farmacie în Anglia: sprijinindu-se pe punctele forte, Livrarea de viitor: Propuneri legislative Change", Marea Britanie - CCA & AIMp Response To 'Pharmacy In England: Building On Strengths, Delivering The Future: Proposals For Legislative Change', UK - articole medicale engleza - startsanatate