HISTORY
Doctors and pharmacists have argued over who should dispense for patients in rural areas since the advent of the NHS. In 1975 the two professions agreed a voluntary standstill on changes in dispensing arrangements while they engaged in discussions. Following these discussions a number of actions occurred:
1977 ‘Report of the National Joint Committee of the medical and pharma- ceutical professions on the dispensing of NHS prescriptions in rural areas’ – commonly known as the ‘Clothier Report’.
1983 The Rural Dispensing Committee (RDC) was to determine applica- tions for dispensing in rural areas and to determine the ‘rurality’ of an area.
1990 RDC abolished and decisions made by Family Health Service Authorities (FHSAs) (now Primary Care Trusts (PCTs)).
2001 The professions reach agreement on further reform.
2004 Advisory Group on Reform of the NHS Pharmaceutical Services (PS) Regulations 1992 propose introduction of more competition and choice.
2005 Proposals implemented in NHS (PS) Regulations 2005.
2012 The new Regulations basically repeat the provisions of the 2005 Regulations.
THE CURRENT RULES
The NHS Act 1977 made it clear that doctors would only be allowed to dis- pense drugs in exceptional circumstances and that the prime suppliers of medi- cines would be pharmacists.
The provisions to allow general practitioners (GPs) to dispense were intro- duced to provide access to dispensing services for patients in rural communi- ties who do not have reasonable access to a community pharmacy.
The legislation provides that in certain rural areas classified as controlled localities the GPs may apply to dispense NHS prescriptions.
Permission is granted to GPs providing there is no ‘prejudice’ to the exist- ing medical or PS. Prejudice is defined as being unable to comply with the medical or pharmaceutical terms of service (TOS).
They may then dispense to patients who are residents in the controlled locality and living at a distance of more than 1.6 km from an NHS pharmacy.
Distance selling pharmacies are excluded. The pharmacy itself does not have to be in the controlled locality.
According to the Dispensing Doctors Association, there are 1300 dis- pensing practices in the UK, with around 6500 doctors, supplying 4 million patients.
Pharmacy applications in rural areas are also required to satisfy the preju- dice test and are subject to the additional control of entry test based on the relevant pharmaceutical needs assessment (PNA).
Serious Difficulty
An additional exception was made for patients who would otherwise have extreme difficulty in getting to a pharmacy. GPs may be directed to dispense for such patients. (Lord Justice Schieman in R v. North Staffs HA, ex parte Worthington 1996)
This occurs where a patient satisfies the Board that they would have seri- ous difficulty in obtaining any necessary drugs or appliances from a pharmacy because of the distance or because of an inadequacy of means of communica- tion (usually referred to as the ‘serious difficulty test’). The patient may be resident anywhere in the country.
Current Legislation
The current legislation is mainly in Parts 7 and 8 of the NHS (P & LPS) Regulations 2013. Chapter 14 of the Department of Health (DH) Guidance deals with applications from pharmacists in rural areas.
Controlled Locality
The current rural dispensing rules apply to areas termed ‘controlled localities’.
A controlled locality is an area which has been determined to be ‘rural in char- acter’. PCTs were required to delineate the boundaries of the controlled areas on a map. Where a previous determination of rurality has been made under earlier regulations, then that area continues as a controlled locality.
Regulation 36(1) of the 2013 Regulations states:
Any area that was, or was part of, a controlled locality for the purposes of the 2005 Regulations immediately before these Regulations come into force continues to be, or to be part of, a controlled locality for the purposes of these Regulations (unless or until it is determined that the area is no longer, or no longer part of, a controlled locality).
The Board may at any time determine whether an area is rural. The Board must determine rurality if requested in writing by the Local Pharmaceutical Committees (LPC) or Local Medical Committee (LMC). (Regulation 31(3))
What Makes an Area ‘Rural in Character’?
The DH issued guidance in the document ‘Regulations under the Health Act 2009: Market entry by means of PNAs. Information for Primary Care Trusts Chapter 14 Provision of pharmaceutical services in controlled localities’:
A controlled locality must be rural in character (Regulation 36(2)). There is, however, no prescribed way to define what is rural in character. Each case must be judged on individual circumstances and will depend on a variety of factors.
A rural area is normally characterised by a limited range of local services. There are a range of factors (as they pertain at the time of the determination) that might be considered by PCTs in determining whether an area is rural and these have been clarified over the years. They include, for example:
● environmental – the balance between different types of land use;
● employment patterns (bearing in mind that those who live in rural areas may not work there);
● the size of the community and distance between settlements;
● the overall population density;
● transportation – the availability or otherwise of public transport and the frequency of such provision including access to services such as shopping facilities; and
● the provision of other facilities, such as recreational and entertainment facilities.
In 2004 following a review in 2002 of the urban and rural area definitions used by government, the Department for Environment, Food and Rural Affairs (DEFRA) Rural Strategy described a definition of rurality which is available to download from the website:1
Areas which have not been classed as ‘controlled’ are not necessarily urban.
According to the guidance document:
PCTs should be aware of misconceptions about rurality. The fact that an area is not classified as controlled or that a decision is taken to remove such a classification, does not necessarily mean that it is urban.
The ‘Five-Year Rule’
Regulation 36(3) states that where a PCT has decided whether or not an area is rural, the question may not generally be considered again in the next 5 years.
The exception is where the Board is satisfied that there has been a ‘substantial change of circumstances’ in relation to the area, or to a part of it, since the matter was last determined.
Meaning of ‘Substantial Change’
No definition is given in the Regulations.
Appeals
Dispensing doctors and pharmacy contractors affected by the decision may appeal against a rurality decision, as may be relevant to the LMCs and LPCs.
Applications by Pharmacists to Dispense in Rural Areas
Pharmacists wishing to open in rural areas face a number of barriers and a complex application process.
There are five separate issues to be considered when a routine application is made for a pharmacy in an area that may be rural in character:
(1) whether the proposed premises are within a controlled locality
(2) whether or not the application needs to be refused on the basis of the
‘five-year rule’ as a preliminary matter
(3) whether or not the application relates to a reserved location (4) the ‘prejudice’ test
(5) PNA tests.
Applications are made in a similar manner to those relating to non- controlled areas. They are subject to special procedures set down in Regulations. The Regulations lay down a timetable and indicate which other persons or bodies should be consulted before a decision is taken.
Stage 1 – Refusals Because of Preliminary Matters
The Board must first of all determine whether the application would be dis- missed under Regulation 40.
This stage applies to all routine applications where the applicant is seeking the listing of pharmacy premises which are in a controlled locality and which are:
(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or (b) from an NHS pharmacist:
(i) to relocate to different pharmacy premises in the area, or
(ii) to open additional pharmacy premises within the area, from which to provide PS.
The application must be refused if the premises are at a location which is:
(a) in an area in relation to which outline consent has been granted under either the 2005 or 2013 Regulations within the 5-year period; or
(b) within 1.6 km of the location of proposed pharmacy premises, in respect of which:
(i) a routine application under these Regulations, or
(ii) an application to which Regulation 22(1) or (3) of the 2005 Regulations (relevant procedures for applications) applied, was
refused within the 5-year period. Distance selling premises are ignored for this decision.
The 5-Year Period
(i) starts on the date on which the proceedings relating to the grant of outline consent reached their final outcome, and
(ii) ends on the date on which the application is made.
Change of Circumstances
If the Board is satisfied that since the date on which the 5-year period started, there has been a ‘substantial and relevant change of circumstances affecting the controlled locality’ it may consider the application.
Stage 2 – Refusals Because Premises in a Reserved Location
The Board must determine whether to grant the application would be dis- missed under Regulation 41.
Reserved Locations
The 2005 Contract Regulations introduced a new concept of ‘reserved loca- tion’. A reserved location is an area within a controlled locality where the total of all patient lists for the area within a radius of 1.6 km (1 mile) of the pro- posed premises or location is fewer than 2750.
If a pharmacy opens in a reserved location, people living within a radius of 1.6 km may choose whether to use the doctor dispensing or pharmacy dispens- ing, or both.
The pharmacy does not have the usual 1.6 km radius where patients auto- matically cease to receive dispensing from the GP.
According to Regulation 41(3) of the 2013 Regulations the area within a 1.6 km radius of a relevant location is a ‘reserved location’ if:
(a) the number of individuals residing in that area who are on a patient list (which may be an aggregate number of patients on more than one patient list) is less than 2750; and
(b) the Board is not satisfied that if PS were provided at the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2750 or more.
The Board may not grant an application if a previous one relating to the same premises was refused, in the 5-year period, for the reasons relating to prejudice in:
Regulation 44(3) of the 2013 Regulations, or Regulation 18ZA(2) of the 2005 Regulations.
Change of Circumstances
If the Board is satisfied that since the date on which the 5-year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality it may consider the application.
Second and Subsequent Determinations of Reserved Location The Board may make second and subsequent determinations of reserved loca- tion status under Regulation 42.
Stage 3 – the ‘Prejudice Test’
A routine application for a contract in a controlled locality that is not also a reserved location is subject to the ‘prejudice’ test.
Regulation 44(3) states:
The Board must refuse the application if granting it would, in its opinion, prejudice the proper provision of relevant NHS services in the area or in a neighbouring area.
‘Relevant NHS services’ means PS, LPS and primary medical services.
What Is Meant by ‘Proper Provision’
Proper provision means provision of the service to the standard which the con- tractor is obliged to provide in order to comply with the TOS.
What Is Meant by ‘Prejudice’?
The services will be prejudiced if the contractor would be unable to comply with the TOS. A reduction in the standard of service will not, in itself, consti- tute prejudice to the proper provision. This interpretation has been approved by the Secretary of State in a number of decisions and it is also given in the Guidance document.
Location
At this stage an application is not required to give the exact address of the pro- posed pharmacy, but the location must be given sufficiently clearly for the test to be applied. In practice that seems to mean that it must be possible to look at the population within a 1.6 km radius of the proposed site, so as to determine how they are affected.
Appeals
The applicant or a person given notice of the determination who is mentioned in the regulations may appeal to the Secretary of State within 30 days of the decision. The appeal must include a concise and reasoned statement of the grounds of appeal.
The ‘Serious Difficulty’ Rule Regulation 48 states:
Where a patient satisfies the Board that he would have serious difficulty in obtaining any necessary drugs or appliances from a pharmacy by reason of distance or inadequacy of means of communication he may at any time request in writing the doctor on whose list he is included to provide him with pharmaceutical service.
This provision applies to any patient, including any resident in urban areas.
In considering whether the patient has a serious difficulty, the PCT is expected to consider:
● personal circumstances of the patient
● local arrangements for medical and PS
● transport
● any collection and delivery services
● availability of telephones
● any other relevant factors.
There is no appeal procedure from a decision of the Board that the patient does not have any serious difficulty.
Temporary Residents
Doctors who provide PS to at least some of the patients on their list may also dispense to any temporary residents which they accept. (Regulation 49)
APPLICATIONS BY DOCTORS
Existing dispensing practices were required to register their premises with the PCT by 30 April 2005. (Regulation 68(2) of 2005 Regulations)
Additionally the Board must prepare and publish a dispensing doctor list.
The dispensing doctor list includes:
● the premises where the doctor has premises approval;
● whether the premises approval is granted, temporary or residual;
● the date on which premises approval took effect or where it has not taken effect, the date when it was finally granted;
● the area where the doctor has outline consent and premises approval;
● premises, identified separately, where the doctor has outstanding applica- tions for premises approval. (Regulation 68(4) of 2012 Regulations) The Board must refuse an application under Regulation 51(1) (but not under regulations 54, 55 or 58) for premises approval if the premises in respect of which approval is sought are within a radius of 1.6 km of pharmacy prem- ises that are not distance selling premises.
Regulations 54, 55 and 58 apply to relocations and temporary arrangements.
Outline Consent
Otherwise doctors may apply for ‘outline consent’ to dispense for those of their patients who live more than 1 mile from a pharmacy. The same test is used – whether to grant the application would prejudice the proper provision of GMS or PS. (Regulation 51)
The application must specify the area for which the grant of ‘outline con- sent’ is sought. The application must be in writing, but no particular form is specified.
The effect of a grant is that the doctor may then dispense to any of his or her patients residing in the specified area, who request him or her to dispense, and who live more than 1.6 km of radius from an NHS pharmacy.
Relocations
A dispensing doctor who is providing PS from listed dispensing premises, and who wishes to relocate may apply in writing and that application must be granted if:
● the new location is not significantly less accessible for the existing patient groups;
● the change would not result in a significant change to the existing arrange- ments for the provision of PS;
● the change would not cause significant detriment to proper planning in respect of the provision of PS in its area.
Appeal Procedure
Appeals may be made within 30 days to the Secretary of State.
Self-Assessment Questions 1. What is a controlled locality?
Answer: A controlled locality is an area which has been determined to be
‘rural in character’. The former PCTs were required to delineate the bound- aries of the controlled areas on a map. Where a previous determination of rurality has been made under those earlier regulations then that area contin- ues as a controlled locality.
2. What is a reserved location?
Answer: ‘Reserved location’ is a concept introduced by the 2005 Contract Regulations. A reserved location is an area within a controlled locality where the total of all patient lists for the area within a radius of 1.6 km (1 mile) of the proposed premises or location is fewer than 2750. If a pharmacy opens in a reserved location, people living within a radius of 1.6 km may choose
ADDITIONAL RESOURCE
1. http://www.defra.gov.uk/statistics/rural/what...rural/rural-urban-definition/
whether to use the doctor dispensing or pharmacy dispensing, or both. The pharmacy does not have the usual 1.6 km radius where patients automatically cease to receive dispensing from the GP.
3. What is meant by ‘prejudice’?
Answer: The services will be prejudiced if the contractor would be unable to comply with the TOS. A simple reduction in the standard of service will not, in itself, constitute prejudice to the proper provision.
Pharmacy Law and Practice. DOI: 85
© 2013 Elsevier BV. All rights reserved.2013
http://dx.doi.org/10.1016/B978-0-12-394289-0.00007-2