Plurality of provision and patient choice

Plurality of provision and patient choice

The treatment centre programme has supported the drive to reduce waiting lists. However, there is a longer-term aim to have a more integrated model for patients to move between the NHS and the independent sector as part of the ‘choice’ agenda. There is a right for patients to make choices about their NHS care and to have information to support these choices, as defined in the NHS constitution.

The Independent Sector Extended Choice Network (IS ECN) and Independent Sector Free Choice Network (IS FCN) are frameworks for independent sector providers, who demonstrate that they meet NHS standards and costs, to offer ‘choice’ and reduce waiting times to NHS patients. As part of the membership requirements for IS ECN and IS FCN the independent sector location must be registered with the CQC for the activities to be delivered. In addition the independent sector providers are required to demonstrate compliance with certain NHS standards, for example the NHS Litigation Authority (NHSLA) Risk Management Standards. The NHSLA standard for managing risks associated with medicines requires processes to be in place to monitor accurate, safe and effective prescribing, administration and self-administration, and the disposal of medicines. This requirement is similar to that required by the CQC and therefore NHS and independent sector organisations can use similar evidence to demonstrate compliance.

Formed in 2005, the NHS Partners Network is an alliance of independent (commercial and not-for-profit) healthcare providers involved in all aspects of NHS care. Its aim is to increase integration of independent healthcare in order to continue to improve patient choice and value for money for patients and taxpayers. In June 2007 NHS Partners Network was incorporated into the NHS Confederation. NHS organisations are supported, through networks, briefings and publications, by the NHS Confederation, which seeks to ensure we have a national health system that delivers first-class services and improved health for all.

Regulation of the acute independent sector from homes to acute services

Until 2002 the Registered Homes Act 1984 provided the legislative frame-work for independent hospitals (as well as independent care homes, nursing homes and mental nursing homes). Part II of the Act covered a wide spectrum of activities under the definition of ‘nursing homes’, including nursing homes through to clinics, acute hospitals and psychiatric hospitals. NHS hospitals were exempt from the 1984 Act.

The Care Standards Act 2000 provided for the establishment of the National Care Standards Commission in England. (There were and remain differences in the way other home countries deal with these issues.) The Secretary of State was given powers to make relevant regulations and to issue national minimum standards applicable to all the relevant services. The registration authorities and providers were required to demonstrate compliance with regulation and national minimum standards through a process of self-assessment and inspection.

The 2000 Act also defined the meaning of an ‘independent hospital’, previously not well defined. An independent hospital is ‘any establishment which has, as its main purpose, the provision of psychiatric or medical treatment for illness (including palliative care) or mental disorder (including detention under the Mental Health Act 1983) or which provides one or more of the specific “listed services” (for example hyperbaric oxygen therapy)’ and which is not a health service hospital.

This definition of an independent hospital also includes private and vountary hospitals previously not regulated, for example those run by bodies established under Royal Charter or by special Act of Parliament. Furthermore the 2000 Act defined the meaning of an ‘independent clinic’ as ‘an establishment (other than a hospital) where medical practitioners provide services’ thereby bringing private primary care services into the regulatory framework for the first time. Registration under the Care Standards Act 2000 continued in the independent sector until 30 September 2010; NHS services were excluded from the 2000 Act.

In April 2002 The Private and Voluntary Health Care (England) Regulations 2001 came into force and set out the regulations by which the independent sector in England would be monitored. Organisations falling within the regulations were required to appoint a registered manager for each establishment and provide the names and date of appointment to the Com-mission. The fitness of the registered manager is defined within the 2001 regulations and later a formal process of ‘fit person’ interviews was introduced.

The registered manager/person is required to define the ‘statement of purpose’ for the establishment and can then only provide services in accordance with that statement. In addition the registered manager/person is responsible for ensuring that services meet the needs of the individual service users and are in accordance with research evidence and other good practice. For medicines management the quality of service provision regulation 15 (5) states that:

The registered person shall make suitable arrangements for the ordering, recording, handling, safe keeping, safe administration and disposal of medicines used in or for the purposes of the establishment, or for the purposes of the agency.

From 1 April 2010 the Care Quality Commission (Registration) Regulations 2009 came into force and provide for the registration of per-sons carrying on a regulated activity. On 1 October 2010 the regulations came into force for adult social care and independent healthcare providers. All health and adult social care providers (whether NHS or independent sector) who provide regulated activities will be required by law to be registered with the CQC. For the first time acute care has been brought under the same definition, namely acute services, and includes:

·        acute NHS hospitals

·        acute independent hospitals

·        NHS community hospitals

·        ISTCs

·        cosmetic surgery clinics.

The Health and Social Care Act 2008 also provides regulations that include the quality and safety of the service provision, for example, the management of medicines. Regulation 13 states:

The registered person must protect service users against the risks associated with the unsafe use and management of medicines, by means of the making of appropriate arrangements for the obtaining, recording, handling, using, safe keeping, dispensing, safe administration and disposal of medicines used for the purposes of the regulated activity.

The CQC will also monitor providers against a set of outcomes defined within the Essential Standards of Quality and Safety. The management of medicines outcome 9 states that:

·           People who use services: will have their medicines at the times they need them,and in a safe way. Wherever possible will have information about the medicine being prescribed made available to them or others acting on their behalf.

This is because providers who comply with the regulations will:

·           handle medicines safely, securely and appropriately

·           ensure that medicines are prescribed and given by people safely

·           follow published guidance about how to use medicines safely.

The outcome is associated with a series of prompts that support providers in how to demonstrate compliance with the outcome.

Although the regulatory framework has become aligned across the acute NHS and independent sector providers, there has been an area of medicines management practice in the independent sector that has fallen outside both CQC and General Pharmaceutical Council regulation, namely injectable cosmetic treatments. However, from 2010 the provision of injectable cosmetic treatments, including dermal fillers and botulinum toxin, will be controlled for the first time under a shared regulation scheme operated by the Independent Healthcare Advisory Service and monitored by Caspe Healthcare Knowledge Systems. The registration, certification and inspection scheme has been developed by the injectable cosmetics industry to promote compliance with medicines management and training standards to improve the safety of patients.

Medicines management delivering consistency of outcome to all service users

Medicines are the most common treatment intervention and the majority of care pathways in hospitals involve medicines. The independent sector and NHS treatment pathways for patients have become more integrated as the ‘plurality of provision’ objective continues to become embedded in healthcare delivery models and regulation by the CQC becomes consistent across all acute hospital provision.

The way pharmacy services are provided has changed and the models of provision are increasingly varied, for example community pharmacy providing the service, NHS acute provision to independent sector, as well as independent sector acute provision to the NHS. There is also a potential for mixed provision across individual service lines; for example, a service may comprise ward pharmacy and medicines information from NHS acute provider, outpatient dispensing from community pharmacy and stock supplies direct by wholesaler.

These changes in service delivery options to a more ‘virtual’ pharmacy platform require improved communication channels, service level agreements and KPIs. These avoid assumptions being made by any party. The important point is that the outcomes of essential standards are met by all providers and ‘people who use services will have their medicines at the times they need them, in a safe way with the relevant information’. This is the objective of the Medicines in Commissioning Toolkit, that is, to ‘get medicine use right’, and is intended to support both commissioners and providers of medicine-related services. The toolkit covers various areas and these are identified in Text box 2.1.

Box 2.1 Medicines in Commissioning Toolkit

Assess needs and provision review

There must be clarity of strategic position, definitions and delivery outcomes between commissioners and providers. Information and data requirements must be clearly defined and assumptions used within a sector avoided, for example quality measurement and criteria may differ between National Health Service and independent sector.

Deciding priorities and investments

The position on priorities must be explicit, for example with reference to any economic requirements to adhere to National Institute for Health and Clinical Excellence guidance that may not be an existing requirement in the independent sector.

Patient safety and governance

Commissioners should ensure policy and procedure documents are based on relevant standards for the service being delivered.

Legal aspects

Commissioning pharmacy or medicines management for acute services from community pharmacy providers will require explicit reference to acute standards since community practice will be regulated and monitored under the standards of the General Pharmaceutical Council rather than the Care Quality Commission.

Service delivery

Service delivery requirements must be explicitly defined within agreements and monitored.

Staff training and competency

The standards and rules of the General Pharmaceutical Council, as well as the compulsory registration of pharmacy technicians, will help to reduce ambiguity in the roles and competency of registered pharmacy personnel delivering service across different sectors.

However, there may be other personnel issues to consider, for example the presence and level of Criminal Records Bureau checks and safeguarding training that may be required in certain establishments where services are delivered, particularly those involving children and vulnerable adults.

Patient experience

The experience of the patient should be able to be compared across sectors. Local service delivery models need to ensure that patient experiences metrics are fully defined and monitored.

Funding aspects

The toolkit provides many examples of funding issues to be considered, including the provision of FP10 prescriptions for NHS patients being treated in the independent sector. Primary and secondary NHS care providers have greater clarity of the responsibilities for medicine supply, including shared-care protocols. The acute independent sector supplies the majority of medicines in accordance with the medical insurance company contracts for NHS patients arrangements would need to be explicit in contracts, including management of shared care.

With respect to governance arrangements, these will become more aligned between independent sector and NHS. However, policy and procedure development has been based on difference standards, namely the National Minimum Standards in the independent sector and the Standards for Better Health in the NHS. Commissioners should ensure this is addressed.

An area that continues to differ between the acute providers in the NHS and independent sector is in relation to consultant staff. In the NHS they are employed whereas in the independent sector the majority of consultants operate privately under a licensing system called practising privileges. This is a robust framework used across the independent sector; however, the indemnity arrangements for any prescribing as part of local contracts would need to be clarified explicitly.

The patient safety agenda is a key focus for all pharmacy and medicines management providers. It is important to note that there are differences in how National Patient Safety Agency (NPSA) and other alerts are disseminated and managed. For example, community providers may not receive direct communications whereas many acute independent sector providers are part of the NHS Central Alerting System. At the time of writing only NHS pro-viders have access to the feedback process that demonstrates compliance with NPSA alerts. Therefore a mechanism for reporting compliance to NPSA and other medication safety alerts may need to be incorporated into service level agreements and KPIs.

Regarding legal issues, when the service delivery model is dependent on the use of patient group directions the differences in the NHS and independent sector must be understood, for example requirement for CQC registration and sign-off by the registered manager in the independent sector.

Historically, there have been issues in monitoring service delivery between the independent sector and the NHS. In July 2007 the Healthcare Commission published a review of the quality of care in independent sector treatment centres and made a number of recommendations, including improving the quality of data, the need for common data sets and improving the partnership relationship between independent sector treatment centres and the NHS. Whilst many of the recommendations have been addressed in central contracting processes, commissioners and providers of local service delivery models need to ensure any differences are fully defined and monitored.

Patient experience

The experience of the patient should be able to be compared accurately across sectors; however, this was not found in the Healthcare Commission’s review of quality of care in independent sector treatment centres. Local service delivery models need to ensure that patient experience metrics are fully defined and monitored.

In conclusion, the safe and effective use of medicines delivered by pharmacy services should be of a consistent standard irrespective of the provider and whether that provider is NHS or independent sector. This is the principle behind the management of medicines requirements in the Essential Standards of Quality and Safety.