The NHS Regulations (Pharmaceutical Services) 2005

from Dr Malcolm Ward, Chairman of the Dispensing Doctors' Association

18 March 2005

The new regulations not only deal with the rural aspects that we have been working towards for so long, but also revisions to the Control of Entry rules in the wake of the OFT Report and of course the new Pharmacy Contract. In this article my main concern is to outline the principal changes to the rural regulations and how they will impact upon dispensing practices. However the relaxation of the Control of Entry Rules could have some impact on dispensing services and so I will make brief reference to them.

Control of Entry

The new regulations provide that the Control of Entry regulation 12 (Necessary or Desirable clause) will not apply in the following scenarios subject to criteria stipulated in regulations 13 -16.

• Large shopping centres >15,000sq.m.
• Pharmacies open > 100hrs a week
• Applications from consortia: new one-stop centres
• Wholly mail order or Internet based pharmacy services

It seems likely that these exemptions will not greatly affect rural areas although it is possible that some out of town shopping centres may do so. Applications under exemption criteria in a controlled locality are subject to the prejudice test in Regulation 18. Distance selling chemists cannot bypass the rural regulations because the persons receiving pharmaceutical services cannot receive them at the premises referred to in the application or the exemption criteria will not be fulfilled.

Registration of dispensing doctor premises:

Not only will the PCT have to keep a list of dispensing doctors, but also a list of premises from which those doctors are authorised to dispense. In order for the changes to take place, it is essential that every existing dispensing practice registers their premises with the PCT by April 30th. 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. It was agreed that the PCT must notify dispensing doctors of the requirement to register premises and be able to extend the registration response time for good cause (e.g. a dispensing doctor being ill or on holiday when the regulations come into force). All existing dispensing premises should be approved but the PCT can refuse to give premises approval if it has good evidence that a doctor's premises was not routinely used for dispensing medicines prior to the new regulations coming into force. The PCT must send the LPC and LMC copies of the premises applications and have the right to make written representations and both these committees have the right of Appeal re the determinations. Register your premises on 1.4.05 to be sure of meeting the dead line.

The 1992 Pharmaceutical Services Regulation "loopholes"(Reg.18)

It was agreed that the key principle elements of the 1992 Regulations should be enshrined in the new regulations with regard to Necessary or Desirable and Prejudice tests and that the loopholes re the prejudice test in the 1992 Regulations should be closed. These were a) the so called Barham loophole whereby a dispensing doctor could apply to open a pharmacy and escape the prejudice test if the proposed pharmacy premises were at the same premises as used for dispensing and b) the loophole whereby a pharmacy applicant could escape the prejudice test if the pharmacist already held a pharmacy contract.

Appeals: Controlled Localities (areas designated as rural - Reg.31)

The right of appeal has been extended to dispensing doctors and chemists (previously just LPCs and LMCs). As in the 1992 Regulations rurality can be challenged at any time by the PCT or LPC. Once re-determined as in the 1992 regulations no further determination can occur for 5 years. The LMC and dispensing doctors may supply evidence as to the rural nature of the area at such times.

Notification of Applications

The notification of pharmacy applications and for outline consent in controlled localities has been widened to include patients and patient forums that the PCT considers would have an interest in the provision of Pharmaceutical Services in the neighbourhood.

Reserved locations (Regulation 35)

If the total population living within a radius of 1.6Km (1mile) of a new pharmacy in a controlled area is less than 2750, then although the pharmacy may open, dispensing patients will be able to continue to receive dispensing services from their doctor (i.e. the 1 mile patient rule does not apply). This is a very significant improvement to the 1992 Regulations as it will drastically reduce the number of speculative pharmacy applications that have caused so much instability for dispensing practices and their rural communities in the past. Once the population reaches 2750 a pharmacy if already open can request a re-determination re reserved location status and if removed then subject to the prejudice test the dispensing pharmacy would gain the 1 mile/1.6km protection (i.e. the doctors lose dispensing rights within a mile of the pharmacy). A new pharmacy application at a point where the applicant thinks that 2750 has been reached would request a re-determination re reserved location status and if successful reserved location status would be removed and the applicant should then be subject to the prejudice test.

New Applications to dispense by doctors (Regulations 18, 61)

Will not be permitted if there is a pharmacy within 1.6Km of the premises from which the practice wishes to start dispensing. NOTE: This only applies to new applications. Existing so called market town dispensing practices will retain their dispensing rights.

Inspection (paragraph 10 of terms of service for doctors Schedule 2)

All premises from which dispensing by doctors takes place will be open to inspection by the PCT to ensure terms of service are being complied with.

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 mile/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)

A minor relocation can only be considered for a pharmacy if there has not been a relocation in the previous 12 months. A similar provision will allow dispensing practices to relocate without formally re applying for outline consent to dispense or for premises re-registration approval provided it is considered to be a minor relocation with no adverse affects on existing Pharmaceutical Services. The Association is not entirely happy with last minute changes to the drafting of this aspect of regulation 65 and we will be seeking an amendment to it. This is important for practices that outgrow their premises or where premises become condemned.

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. It is strongly advised that when practices are considering amalgamation that the dispensing applications be made and be determined before the amalgamation takes place. This allows practices to withdraw without affecting existing dispensing rights in the event of the dispensing approval being turned down.

Transitional provisions (Regulation 73)

This provides that applications by pharmacists or doctors that have been made but not determined prior to 1.4.05 that they should be determined under the provisions of the 1992 regulations. Due to a drafting error this provision for dispensing doctors was omitted but fortunately the DDA picked this up and the omission was rectified in the final drafting.

Regulation 19 of 1992 Regulations and personal administration

The important provision that allows all GPs to dispense personally administered items (and be appropriately reimbursed/remunerated) does not appear in the new Ph S. regulations. The DDA raised the issue but it was deemed unnecessary to have a provision in these regulations as there is adequate provision in the NHS GMS Regulations 2004 (regulation 52).

These new regulations are both complex and voluminous. No doubt there will be some who will be intent on finding loopholes to exploit. The consultation period was very short and although the Association was able to raise some important drafting issues that have been rectified we are still unhappy about 1 or 2 details. The key advantage over the infamous problems with the 1992 Regulations amendments is that this time we have an agreement to amend the 2005 Regulations in the event of problems arising that are contrary to the principles agreed between the PSNC, GPC and the DDA. The Association firmly believes that these Regulations should bring more stability in the provision of Pharmaceutical Services in rural areas. This should enable dispensing practices to feel more secure in developing the highly valued services they provide for rural patients. This would not have happened were it not for the cooperation and the constructive relationships that have evolved between the DDA, the GPC and the PSNC and the huge amount of effort put in over the past 8 years.