PHARMACY UPDATE TRAINING COURSE

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PHARMACY UPDATE TRAINING COURSE
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• NHS Act 1977 (as amended)
• The NHS (Pharmaceutical Services) Regulations
  2005 S.I. 2005 No. 614 as amended by S.I.
  2005/1015, 2005/1105, 2005/3315, 2005/3491,
  2006/552, 2006/913, 2006/1501, 2006/3373

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• Guidance Information for Primary Care Trusts
  (Control of Entry) recently amended.

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PCTS PHARMACEUTICAL NEEDS ASSESSMENT
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The Application Form

• No longer a prescribed form
• Annex D and Para 3.6 to the Guidance
• Power to set a date for applications each month
• Power to invite applications Para 3.19

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CHECKING THE APPLICATION

• status of applicant see Para 3.23
• reject if
• not pharmacist or
• a partnership which does not consist wholly of
  pharmacists or
• a company which does not comply with S71 of
  Medicines Act 1968

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FULL APPLICATIONS
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PROCESSING A FULL APPLICATIONconsultations
Reg. 23 and Para 3.92

• LPC, LMC, Patients Forum, any person on the
  pharmaceutical list who might be significantly
  affected, LPS providers
• neighbouring PCTs within 2 kilometres of the
  premises
• any other patient, consumer or community groups.

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TIME LIMITS

• response to be within 45 days from date
  notification sent or such longer period as the
  PCT may allow.
• gives right to be notified of decision
• gives right of appealN.B. Check date
  neighbouring PCT sent out consultation letter.

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Considering the Applications

• Hearing applications together
• Should there be an oral hearing see reg. 24
• Confidential information
• Fitness to practice and information provided

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The Principles of Natural Justice and The
Human Rights Act 1998
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THE DECISION...
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WHAT CAN BE TAKEN INTO ACCOUNT?

• Pharmaceutical services and LPS in the
  neighbourhood - Reg 12(2)(a)
• Reasonable choice for recipients of services and
  persons Reg 12(2)(b) see revised guidance para
  3.71 onwards
• Any relevant information - Reg 12(2)(c)
• Any information received as part of the
  consultation procedure Reg 12(2)(d)
• Other proposed services Reg 12(3)

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REGULATION 12(1)

• an application...shall be granted ...only...if
  it is satisfied that it is necessary or desirable
  to grant the application in order to secure, in
  the neighbourhood in which the premises from
  which the applicant intends to provide the
  services are located, the adequate provision by
  persons included in a pharmaceutical list, of the
  services, or some of the services specified in
  the application.

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THE NEIGHBOURHOOD
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THE NEIGHBOURHOOD

• the Cooper and Anglin case (1991)
• the Bangor decision (1994)
• ex p. Suri and Gompels (1994 and 1995)
• Cribbs Causeway (1996)
• ex p. Shah and Tescos (1997)

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Is it necessary or desirable to secure adequate
services...?

• What information is needed
• How to determine adequacy
• See guidance at para 3.90 and Annex A

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to whom...?

• residents?
• workers? in the neighbourhood
• shoppers?

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and when...?

• ex p. Boots (1992) (Trowbridge)
• Cribbs Causeway
• Gemini Park
• look at planning situation
• economy in the area
• the situation on the ground.

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IDENTICAL AND OVERLAPPING APPLICATIONS

• where only one pharmacy is needed
• premises
• access
• services to be provided
• hours
• choice/competition
• time of application

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THE DECISION

• Has to be in writing
• Has to give reasons
• How to draft
• www.nhsla.com.FHSAU/pharmacy

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Exempt applications Regs 13 to 16 and Guidance
at Para.4.1 onwards

• Pharmacies in large retail areas
• Pharmacies which intend to open for more than 100
  hours a week
• Consortia wishing to establish a new One Stop
  Primary Care Centre
• Wholly mail order or internet based pharmacy
  services

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PROBLEMS WITH EXEMPT APPLICATIONS

• LPS in neighbourhood
• Design of the premises
• PNA requirements

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HOURS

• Paras 22 25 of Schedule 1 T of S
• 40 hours unless consent of PCT or Sec of State.
• Power to direct.
• No longer normal hours

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MINOR RELOCATIONS
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R EG 6(1)where the applicant intends to change
within the neighbourhood the premises from which
he provides pharmaceutical services, being the
same services as he intends to provide from the
new premises, and the PCT is satisfied that the
change is a minor relocation and ...the provision
of pharmaceutical services will not be
interrupted (except for such period as the PCT
may for good cause allow) the PCT shall grant
the application
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IS THE MOVE WITHIN THE NEIGHBOURHOOD?

• see ex p. Suri and Gompels.

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IS IT A SHORT DISTANCE?ARE THERE ANY BARRIERS?

• see ex p. Suri and Gompels which affirmed the
  Cumbria decision

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Will the same services be provided?Will there
be any interruption?Note restrictions on further
applications
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EXEMPTION FROM TEST

• Moves which satisfy the test but are less than
  500m.
• See Reg. 6(3) and
• Para 3.37 to 3.40

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Minor Relocations between PCTs

• Application dealt with under Reg 7.
• Paras 3.41 onwards and Flow chart
• NB Receiving PCT checks any fitness to practise
  issues

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MAJOR RELOCATIONS
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MAJOR RELOCATION

• application made under Reg 5(b)(ii)
• same test as in Reg 12
• ex p. Tesco and Sharma (1997)

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TIME FOR OPENING

• Reg. 39(2) full/minor relocation grants 6
  months one or more extensions of 3 months
• Reg. 40(1) preliminary consent 6 months BUT no
  power to extend.

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THE APPEAL
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• Para 3.162 onwards for who has the right of
  appeal in what circumstances
• the Committee can determine to hear appeals
  together even where the PCT has not exercised its
  discretion under Reg. 24(7)
• the Committee has a discretion as to whether it
  holds an oral hearing

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The oral hearing

• it is by way of a complete rehearing - ex.p.
  Dixon Lane Chemists Ltd (1993)
• composition of the panel
• practicalities - timing, legal representation,
  who may speak, the information required, the
  documentation.

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The decision is that of the Pharmacy Committee,
but if the Committee is to overrule an oral
hearing panel, it must give good reasons.

• Ex.p. Dr Lowe (1999)

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APPLICATIONS IN CONTROLLED LOCALITIES
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RURALITY

• Regulation 31 and Para 5.8 onwards - it is
  for the PCT to determine whether an area is
  rural in character.

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GUIDANCE

• What makes an area rural - see Paras 5.12
  onwards
• a visit is vital

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POINTS TO NOTE

• THE PCT HAS TO DETERMINE PRECISELY THE
  BOUNDARIES OF ANY AREA OR PART OF AN AREA WHICH
  IT DETERMINES TO BE RURAL IN CHARACTER Reg 31(7)
• THE FIVE YEAR RULE Reg 31(11)

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APPLICATIONS BY PHARMACISTS

• Check previous decisions - Reg 34
• Consultations under Reg. 33.
• Should the area be a reserved location?
• If not, is there prejudice? Reg. 18
• Multiply by average scripts to give idea of
  scripts/money lost
• How will that affect doctors income?
• Gradualisation?

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RESERVED LOCATIONS

• PCT shall determine whether the premises are in a
  reserved location
• Number on all patient lists within 1.6kms is less
  that 2750 or other factors. See para 5.45
• Do not go through the prejudice test.
• Do go through N or D test.
• If change and pop. rises then Prejudice test.
• BUT prejudice does apply to 4 exemptions

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When can doctors dispense?

• See Reg. 60
• A patient has serious difficulty, OR
• lives in a controlled area more than 1.6kms from
  pharmacy OR
• lives in a controlled area within 1.6kms and is a
  reserved location
• AND doctor has outline consent to dispense plus
  premises approval
• BUT see which patients are eligible

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OUTLINE CONSENT TO DISPENSE BY DOCTORS

• Check previous decisions under Reg 34
• Reg. 62 and para 6.1 guidance.
• Who must be consulted? Reg. 33
• Reserved location determination prior to 19.1.07
• SHALL refuse if there would be prejudice to the
  proper provision of PMS, dispensing services, LPS
  or pharmaceutical services Reg. 18

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HOW TO CALCULATE

• Burden is on party alleging prejudice
• What do the parties say?
• Problems with confidentiality
• Target income/target numbers

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Premises Approval

• Transitional provisions relating to premises for
  doctor dispensing. Para 6.41 onwards.
• Right of appeal

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Applications in respect of existing outline
consents

• Wish to change existing premises
• Minor relocation
• Move where pharmacy catches up
• Amalgamations
• Guidance Paras. 6.23 to 6.40 and
• Regs. 65 and 66

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PHARMACY UPDATE TRAINING COURSE