Pharmaceutical Needs Assessment
Pharmaceutical Needs Assessment
|Pharmacy Regulations 2013|
From 1987 when applications for inclusion in an NHS pharmaceutical list where dealt with under the ‘necessary or desirable’ test until 2005, pharmacy applications were assessed on the adequacy of pharmaceutical services in the neighbourhood. In 2005, four exemptions were introduced which avoided the assessment of the adequacy of pharmaceutical services:
- pharmacies in large out of town retail developments;
- pharmacies undertaking to open for a minimum of 100 hours per week;
- pharmacies in ‘new’ one stop primary care centres; and
- mail order or internet pharmacies.
Simultaneously, competition and choices was introduced into the adequacy test.
Two years later, Anne Galbraith was appointed to conduct a review into whether the new arrangements reflected wider changes in commissioning and contributed to the aims of the White Paper – Our Health, our care, our say.
One aspect of that review suggested that pharmaceutical needs assessments (PNA) prepared by Primary Care Trusts had an important place in identifying where pharmacies are needed, and that putting the PCT in the position of developing the PNA would shift the balance so that the NHS could decide what it needs and where, and applicants would be able to see these PNAs and submit applications where pharmacies are needed.
The Health Act 2009 introduced the statutory framework, requiring PCTs to prepare and publish a PNA, the first ones to be published by 1 February 2011. A revision to the control of entry test also included in the Health Act 2009 would in future see the PNA as the basis for determining applications for new pharmacies (the ‘market entry test’).
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Pharmaceutical Needs Assessments (PNAs)
The content of PNAs is set out in Schedule 1 to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. The PNA must contain:
- A statement of the pharmaceutical services provided that are necessary to meet needs in the area;
- A statement of the pharmaceutical services that have been identified by the HWB that are needed in the area, and are not provided (gaps in provision);
- A statement of the other services which are provided, which are not needed, but which have secured improvements or better access to pharmaceutical services in the area;
- A statement of the services that the HWB has identified as not being provided, but which would, if they were to be provided, secure improvements or better access to pharmaceutical services in the area;
- A statement of other NHS services provided by a local authority, the NHS Commissioning Board (NHS England), a Clinical Commissioning Group (CCG) or an NHS Trust, which affect the needs for pharmaceutical services;
- An explanation of how the assessment has been carried out (including how the consultation was carried out); and
- A map of providers of pharmaceutical services.
The PNAs published by PCTs prior to 1 April 2013 remain in force until they are replaced by a PNA published by the HWB. Health and Wellbeing Boards have until 1 April 2015 to publish their own PNAs, unless there is a more urgent need to update the PNA. Because the PNA development goes through an extensive engagement and formal consultation process, a PNA is likely to take in excess of 6 months to prepare, and as many PCTs found, the process can take up to a year or even more.
In the meantime, if there are changes in provision of services, which would have an impact on a market entry determination, the HWB may instead of revising the PNA, publish a supplementary statement setting out the changes in provision.
Market Entry and PNAs
In her report, Anne Galbraith commented that PNAs must have national comparability in breadth and depth. To inform the regulations that would eventually be laid to require every PCT to develop and publish a PNA, the Department of Health and Social Care formed an Advisory Group on the NHS (Pharmaceutical Services) Regulations. This group included representatives from NHS Employers, patient representative organisations, the General Practitioner’s Committee of the BMA, and PSNC. The three representatives from PSNC were Sue Sharpe (Chief Executive), Gary Warner (Independent Regional Representative for the South Central Region and Chair of the PSNC Service Development Sub-Committee) and Steve Lutener (Head of Regulation at PSNC).
The Advisory Group met 26 times, to discuss the structure of the PNAs, and the legislative provisions that should apply to the development of the PNA, including requirements for consultation. As the draft regulations took shape, a ‘guidance’ sub-group was formed to develop the accompanying guidance to assist PCTs when they develop their PNAs.
The initial meetings of the Advisory Group developed the regulations which obliged PCTs to develop and publish a PNA, and once those draft regulations had been completed, commenced work on regulations that would replace the ‘necessary or desirable’ control of entry test, with a ‘market entry’ test in which applications are to be assessed against the needs or improvements or better access identified in the PNA. Again a sub-group developed parallel guidance for PCTs on those draft regulations.
In due course the regulations were laid, and the first PNAs were required to be published by all PCTs by 1 February 2011. The regulations implementing the PNA based test were laid in July 2012 and came into force on 1 September 2012.
During the course of amending the primary legislation to reform the structures of the NHS (The Health and Social Care Act 2012), it was recognised that a PNA prepared by a local authority Health and Wellbeing Board, against which NHS England would assess applications, must not inappropriately create an obligation on NHS England to grant all applications dependent on the wishes of the HWB (because NHS England would be responsible for funding the pharmacy). The Health and Social Care Act 2012 therefore amended the market entry test. The Department of Health and Social Care recalled the Advisory Group, and new regulations were prepared which came into force on 1 April 2013.
The role of LPCs in PNA development
Many local authorities will have had limited involvement in the commissioning of services from pharmacies. LPCs, on the other hand, represent the pharmacy contractors in their area, and will know what services are provided, the aspirations and willingness of existing pharmacy contractors to provide additional services, and they will be able to help the Health and Wellbeing Boards to engage with pharmacy contractors.
The development of the PNA is an iterative process, which will take into account the Joint Strategic Needs Assessment and the Joint Health and Wellbeing Strategy – and which will also take into account the information about current and future provision of services.
The support of LPCs was invaluable to PCTs when they carried out their assessments in 2010 / 2011, and in many cases, the LPC supported the use of PNA questionnaires to obtain up to date information on current provision, and willingness to provide further services from community pharmacies. LPCs are likely to be even more involved as Health and Wellbeing Boards develop their own PNAs, as they can provide much of the background information about the provision of pharmaceutical services, that may be unfamiliar to the HWB.
PSNC has produced a questionnaire for use by LPCs to gather information on the services offered by their contractors and inform discussions on PNA development with HWBs. This form is not mandatory, and can be downloaded from “Related resources” below.
As the PNA is a crucial part of the market entry system, and to support robust commissioning decisions, it is important that HWBs prepare PNAs to national comparable standards. The Department of Health and Social Care has published guidance to Health and Wellbeing Boards.
As LPCs have experienced the development of PNAs during 2010/11 and the legislative requirements have not changed, their engagement by the HWBs will help ensure a robust PNA.
Q. What services must be included in the PNA?
A. “Pharmaceutical services” which can only be commissioned by NHS England must be included in the PNA. These include directed services provided by those on the pharmaceutical list (pharmacy contractors), provision by local pharmaceutical services under an LPS scheme (LPS pharmacies) and dispensing by dispensing doctors.
‘Other NHS services’ can only be included in the PNA if they ‘affect’ the need for pharmaceutical services (which may be of a specified type) in the area or of if they ‘affect’ whether further provision of pharmaceutical services would secure improvements or better access. Otherwise, other NHS services should not be included in the PNA.
Pharmaceutical needs assessments: a guide for local authorities (January 2013)
This guidance document for local authorities was jointly developed by PSNC, the Royal Pharmaceutical Society and Pharmacy Voice.