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Pharmaceutical Services Negotiating Committee

Rural Issues

The following information refers to the NHS (Pharmaceutical Services) Regulations 2005.  The NHS (Pharmaceutical Services) Regulations 2012 have revoked these (other than for some pending applications). 

The 2012 Regulations make very little change to the rural provisions.

The 2012 Regulations and guidance can be seen on the control of entry pages.

This web page will be updated shortly.


PharmacyPHARMACEUTICAL SERVICES IN RURAL AREAS

Rurality, controlled localities and the provision of pharmaceutical services by doctors

A meeting was held on 15 October 2010 at which representatives from DH, PSNC, the GPC, the DDA, NHS Employers and NHS PCC discussed the history of rurality, controlled localities and the provision of pharmaceutical services by doctors. A document has subsequently been prepared by the Advisory Group on the NHS (Pharmaceutical Services) Regulations and NHS PCC. It explains the background to the provisions within the 2005 (and previous) regulations which permit doctors to provide pharmaceutical services to eligible patients and the background to controlled localities. A copy of the Clothier report, referred to in the document,can be found here.

 


Guidance for LMCs and LPCs by the GPC/DDA/PSNC


The NHS (Pharmaceutical Services) Regulations 2005, which came into effect on 1st April 2005, replace the 1992 regulations. The sections of these regulations which related to the provision of pharmaceutical services in controlled localities (areas which have been determined as rural in character by the PCT) have changed significantly as a result of an agreement between the Pharmaceutical Services Negotiating Committee (PSNC), the General Practitioners Committee of the British Medical Association (GPC) and the Dispensing Doctors Association (DDA). This guidance sets out the nature of these changes and the background to them for LMCs and LPCs.


Background

NHS legislation provides that in certain rural areas classified as controlled localities general practitioners (GPs) may apply to dispense NHS prescriptions. Permission is granted to GPs providing there is no "prejudice" to the existing medical or pharmaceutical services. Prejudice is defined as: being unable to comply with the medical or pharmaceutical terms of service. The provisions to allow GPs to dispense were introduced to provide patients access to dispensing services in rural communities not having reasonable access to a community pharmacy.


Pharmacy applications in rural areas are also required to satisfy the prejudice test and, unlike GP dispensing applications, are subject to the additional control of entry or "necessary or expedient" test.

Two loopholes in the provisions had been the source of some tension between community pharmacists and dispensing GPs in rural areas: where an application could or has resulted in significant numbers of prescriptions being transferred from a pharmacy to a dispensing doctor (or vice versa). Such situations often resulted in disturbance to patients and a sometimes unwelcome and forcible change to the way in which they receive pharmaceutical services.

The medical and pharmacy representative bodies believe that the 2005 regulations will improve access to rural patients to pharmaceutical services, remove the points of tension to encourage a better service to patients and tidy up certain administrative procedures in the 1992 regulations.


Principles of the Regulations


The over-riding principle is to improve access to and quality of pharmaceutical services for patients in rural areas. The proposals encourage the setting up of pharmaceutical services in rural areas, whilst retaining the existing choice of rural patients to receive medicines from their GPs.

The main principles of the regulations are the result of the agreement between the PSNC/GPC/DDA and are set out below. They take into account the government's commitment to introduce more competition and choice to the regulatory system as a whole.

The important changes are set out below with reference to the relevant paragraph(s) in the regulations.


Registration of Dispensing Doctor Premises (Regulation 68)

 

PCTs have to keep a list of dispensing doctors (regulation 68(1)) and a list of premises from which those doctors are authorised to dispense (regulation 68(2)). It is a requirement that every existing dispensing practice registered their premises with the PCT by April 30th 2005. Under the terms of the agreement all existing dispensing practices maintain the same dispensing rights as they did under the terms of the 1992 Regulations.

Regulation 67(4) required the PCT to notify dispensing doctors of the requirement to register premises and be able to extend the registration response time for good cause (for example, a dispensing doctor being ill or on holiday when the regulations come into force). All existing dispensing premises should have been approved if the PCT was satisfied that a doctor's premises was routinely used for dispensing medicines prior to the new regulations coming into force, or outline consent had been granted after 31st March 2004.

The PCT must have sent the LPC and LMC copies of the premises applications and they had the right to make written representations but neither of these committees had the right of appeal concerning the determinations.



Appeals Controlled Localities (Areas Designated as Rural) (Regulation 31)


The right of appeal against a rurality decision made by a PCT has been extended to dispensing doctors and pharmacy contractors affected by the decision (previously only the relevant LPCs and LMCs could appeal). As in the 1992 Regulations, rurality can be challenged at any time by the PCT, LMC or LPC. Once re-determined, as in the 1992 regulations, no further determination can occur for 5 years unless there has been a substantial change of circumstances in the area. The guidance to the regulations provides information on the factors that are relevant in determining the rurality of an area.


Reserved Locations (Regulation 35)

A new concept of reserved location was introduced by the 2005 regulations. Under the provisions a PCT shall determine whether premises from which an applicant wishes to provide pharmaceutical services (or general location where the specific address is not given) are in a reserved location.

A reserved location is an area within a controlled locality where the total of all patient lists for the area within a radius of 1.6km (1 mile) of the proposed premises or location is fewer than 2750. The effect of determining a reserved location is that the pharmacy application is not required to satisfy the prejudice test (but the necessary or expedient test still applies) in order to be entered onto the pharmaceutical list. However a reserved location pharmacy is not afforded the so called ‘one mile rule' and patients both within one mile of the pharmacy and beyond have the right to choose whether to have their medicines dispensed at a pharmacy or GP surgery. Should the population reach or exceed 2750 the pharmacy if already open can apply to the PCT for a re-determination of reserved location status. If this status is removed then, subject to the prejudice test, the normal one mile rule would apply (i.e. the doctors lose dispensing rights within a mile of the pharmacy).


New Applications to Dispense by Doctors (Regulations 18, 34 & 61)


New applications to dispense by GPs are not be permitted or considered if there is a pharmacy within 1.6km of the premises from which the practice wishes to start dispensing.

Existing dispensing rights are unaffected.

The provisions requiring the registration of GP dispensing premises also provide a related power to PCTs to inspect those premises. A similar provision applies to pharmacy premises.


Additional Premises and Relocation of Premises (Regulation 65)


If existing dispensing practices apply to relocate premises, or open additional premises, then premises approval will only be given if the premises are more than 1.6km from any pharmacy. Approval will not take effect until one year after the application to prevent manipulative moves by dispensing doctors by allowing time for a pharmacy to relocate in such circumstance.


Minor Relocations (Regulation 65)
 

Both pharmacies and dispensing practices are able to relocate their premises under the minor relocation provisions, and if the distance is less than 500m by the most practicable route by foot, the application should normally be granted by the PCT.

In the case of greater distances, a dispensing practice application will be granted if the application would not result in a significant change in the arrangements for the provision of pharmaceutical services or dispensing services in any part of a controlled locality.

Further applications for minor relocation may be considered by the PCT only after 12 months has elapsed since the pharmacy or dispensing practice commenced providing services from the new premises.


Practice Amalgamations (Regulation 66)

The amalgamation of a dispensing practice with a non-dispensing practice will trigger a new application for outline consent to dispense, and application for premises approval. If outline consent or premises approval is not granted then the practices involved can reconsider their amalgamation with no detriment to patient dispensing services provided the amalgamation does not take place. If the amalgamation goes ahead despite a failed application to dispense for the enlarged "new practice" then residual dispensing rights will apply to the existing dispensing patients and residual premises approval will be given to the existing dispensing premises only.

In the case of amalgamations where each practice is a dispensing practice and where there is no change of dispensing premises there will be no requirement to apply for outline consent or for premises approval.


Transitional Provisions (Regulation 73)

Applications made on or before 31st March 2005 were determined under the 1992 Regulations.


More Information

The NHS (Pharmaceutical Services) Regulations 2005 can be accessed on the OPSI website, using links through the Regulations section of the PSNC website:

The NHS (Pharmaceutical Services) Regulations 2005

The Department of Health has published comprehensive guidance on the new regulations, on which the GPC/DDA/PSNC were consulted and this can be found on the Department of Health's website, which is also available through the Control of Entry section of the PSNC website:

Control of Entry section, including Department of Health guidance (PDF Format)


DOWNLOADS: Some documents are available in PDF format, you will require Adobe Acrobat Reader 5.0 or later for viewing which can be downloaded from the Adobe Website

DOWNLOADS: Some documents are available in ‘Microsoft Word’ format. If you do not have Microsoft Word, you can read these forms by downloading the free 'Word Viewer'. This program can be downloaded at the Microsoft website