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Promoting the interests of Dispensing Doctors
and the excellence of doctor dispensing for the
benefit of patients
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Chapter 2 Commissioning for quality

• Market entry to be based on a more robust
  Pharmaceutical Needs Assessment (PNA)
• Training for PCTs in commissioning (Autumn 2008)
• A more objective test than the current,
  necessary or expedient

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Chapter 2 Commissioning for quality

• Market entry to be based on a more robust
  Pharmaceutical Needs Assessment (PNA)
• Training for PCTs in commissioning (Autumn 2008)
• A more objective test than the current,
  necessary or expedient

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Factors to be considered by PCTs looking at
pharmacy applications

• Level of access
• Choice and diversity of providers or services
• Innovation in service delivery
• Availability of services to Specific
  populations Specific health conditions
• Longer-term impact of approval

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Exemptions

• 100 hour and Large shopping centre exemptions
  should disappear
• Internet and wholly mail-order exemption to stay
• PCTs to be able to commission less than full
  range of essential services from a given provider
  to meet a particular need

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Q1Do you agree the current market entry system
should be changed to one based on pharmaceutical
needs assessments (PNAs)?

• No. Because PCTs are not yet sufficiently
  experienced to carry out this duty without
  significant risk of legal action.
  Pharmaceutical needs should not be equated with
  the provision of a pharmacist.

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Q2What safeguards may be appropriate to ensure
transparent, fair and unbiased consideration of
applications?

• A set of national minimum standards patient
  choice should be paramount

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Q3Do you agree that specific additional factors,
as identified in this Chapter, should also be
introduced to help PCTs determine applications?
Q4Should decisions be appealable and, if so, to
whom?

• DDA View
• Patient choice should be paramount in all
  cases. There will be problems as different PCTs
  will make different decisions in identical cases,
  further adding to the postcode lottery in health
  service provision
• Yes, appeals should be made to the NHS litigation
  authority

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• Q5If introduced, do you agree such an approach
  should be piloted and evaluated before
  introduction? DDA View Yes, to allow new
  models to develop e.g. internet pharmacy and to
  facilitate joint working. -Results of any pilot
  must be published and be the main driver for
  change and should include patients views
• Q6Do you agree exceptions to this new system may
  be necessary and, if so, what might these
  exceptions be?
• DDA View This is common sense

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Quality

• Proposed new PCT powers to
• Take action against contractors for inadequate
  quality of service
• Proposed regulatory standards on Premises
  Qualifications of staff Training programmes
  Minimum service delivery standards

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Q7 Do you think we should introduce explicit
criteria of quality to govern market exit?

• Yes It is the only way to get a consistent
  application of the regulations across all parts
  of the NHS

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Q8 Do you consider existing legislative powers
under fitness to practise are adequate or not?

• Yes for individual practitioners
• No for contracts

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Q9 Do you agree that PCTs should have the
ability to issue remedial action notices with the
consequence of de-listing if issues are not
addressed satisfactorily within a set timescale
or to withhold payments for contractors who do
not perform to accepted quality and standards?

• Yes to de-listing however needs to be a process
  to go through.
• No to removing payments retrospectively

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Q10 If introduced, do you agree there should be
an independent appeals mechanism?

• Yes. There will be errors and there needs to be a
  way to correct them.

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Q11 Are there other factors the Department needs
to consider?

• How this will remain fair to all.

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Chapter 3 100 Hour pharmacies Supplementary
lists

• Proposes changes to the current arrangements for
  pharmacies opening at least 100 hours per week.
• Proposes supplementary lists for individual
  pharmacists and discusses compliance with the
  Safeguarding Vulnerable Groups Act 2006

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The options (100 hour)

• A distance restriction on new 100 hours per week
  pharmacies of 1.6 km or 2 km.(DH preferred
  option with option 4)
• Impose a requirement to justify the need
• Allow the exemption to continue but use Local
  Pharmaceutical Services (LPS) contract terms.
• Strengthen the requirements for specific services
  a 100 hours per week pharmacy provides. (used
  either alone or in conjunction with the other
  options)

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DDA View

• 100 hour pharmacies Option 4 onlyIllogical to
  have a distance criterion. E.g. either side of
  river

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100 hour pharmacies

• Q12 Do you agree we should we introduce direct
  LPS contracting arrangements for pharmacies
  wishing to open 100 hours per week? NO
• Q13 Do you agree safeguards are needed and, if
  so, what might these comprise (for example these
  could be expressed in terms of services, prices,
  standards, quality)? Same as other pharmacies
• Q14 Is it sensible that such pharmacies are
  required to provide a minimum specified level of
  service such as minor ailment schemes or services
  out of hours as identified or is this best left
  to local decisions and negotiations? Same as
  other pharmacies

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Supplementary Lists

• Q15 Do you agree the introduction of
  supplementary lists for individual pharmacists
  which would cover both employed and self-employed
  pharmacists? Yes
• Q16 Without a supplementary list, how might
  the new NCAS pharmacy service operate for locums?
  Need lists
• Q17 Should this framework extend to pharmacy
  technicians? No madness

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Q18 Do you agree that, in addition to
pharmacists, other people working in community
pharmacy such as pharmacy technicians and others
who provide advice, assistance, guidance and/or
medical treatment need to be ISA-registered?

• No. However if it is to be introduced needs to be
  inclusive and cover both those working in doctors
  dispensaries as well as pharmacy.

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Q19 How might self-employed pharmacists best be
brought within the remit of ISA registration? For
example, would it be appropriate to require this
as part of a self-employed pharmacists inclusion
on a PCT supplementary list?

• Supplementary list appears to be only way forward

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Chapter 4Dispensing by Doctors
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The problem

• Current regulatory arrangements can lead to
  anomalies
• Costs Dispensing doctors more expensive.

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Cross-subsidy

• The sustainability of some primary medical
  services (care from a GP). Some dispensing
  doctors have expressed concern that without their
  dispensing income they would be unable to
  maintain full medical services. The Department
  does not consider that funding arrangements for
  medical services are such as to usually require a
  further cross-subsidy from dispensing income.

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Department View

• It is important to stress that the Department has
  no preferred option at this stage nor has it come
  to a view as to whether any reform of these
  particular arrangements is necessary. However,
  the Department considers there are a number of
  related implications to be considered as part of
  this consultation for
• the treatment of branch surgeries
• maintaining services and
• how any move to new arrangements, if a decision
  were taken on any particular option for reform,
  might be achieved.

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Options on dispensing doctors

• No change.
• PCTs to determine the rural localities where GP
  dispensing is appropriate on the basis of their
  PNA.(1.6Km rule goes, controlled locality stays)
  
• Change distance criterion toThe distance
  between the dispensing surgery and the nearest
  community pharmacy. (Such a distance could be
  put at less than the current 1.6 km, for example,
  at 500 m or at 1000 m.)
• A variation of Option 3. It would mean that a GP
  would not dispense where there is a pharmacy
  within 500 m or 1000 m of the GP practice and a
  second pharmacy within 1500 m.

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Q20 Is the Department right in believing that
there are inequities and anomalies within the
current procedures under which patients can
obtain their medicines and appliances directly
from their surgery rather than from a community
pharmacist?

• DDA view Yes, but removing the option most
  patients prefer, cannot be the right way forward.
  The question incorrectly assumes dispensing
  patients currently have no choice. It is
  non-dispensing patients who have no choice this
  is the underlying anomaly

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Q 21 Have you any personal experience of any
such inequities and anomalies? If so, please
briefly set them out.

• DDA View
• The majority of patients asked would like to be
  able to choose to have their medicines dispensed
  at their surgery.

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Q22 Do you believe that having a local choice
between two or more local dispensers when having
a prescription dispensed is important to you?
Could you quantify how important this is for you
on a scale of 1-5 where 1 is exceptionally
important and 5 is of no importance?

• DDA View
• Genuine choice is to be welcomed
• Artificial limitation of choice is to be
  deplored

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Q23 Is it right for the Department to publish a
national set of rules setting out when a doctor
can provide dispensing services or should the
local NHS, for example your PCT, consulting with
others, have more say?

• DDA view
• National rules should allow patients free choice
  as to where and by whom their prescriptions are
  dispensed.
• Local NHS should have a say, but only if they
  reflect patients wishes.

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Q24Do you agree that the four options set out in
this consultation document relating to dispensing
by GPs are appropriate options for consideration?
Are there others that should be considered?

• A further possible option would be to consider
  the benefits of pharmacist placement (not
  necessarily a pharmacy) in every surgery making
  the pharmacist part of the primary health care
  team.
• The any willing provider option could be given
  consideration.

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Q25If you have a preference between Options 1-4,
please indicate which is your preferred option
and why.

• DDA view
• Option 1 is the only acceptable way forward

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Q26If there were to be change, what issues do
you believe the Department should take into
account when implementing any new system?

1. Patients views and choices should be paramount
2. Regard must be taken of the long term effect on
   medical and pharmaceutical services
3. Joint working between pharmacists and doctors
   must be encouraged destabilisation loss of
   professional co-operation
4. Compensation for loss of business and
   redundancies must be made available.
5. insert job loss survey
6. Rural aspects of GMS funding will need
   renegotiation to ensure maintenance of patient
   services
7. Disproportionate effect on older and disabled
   patients

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Q27Are there other factors to take into account
for example, how well do these options or your
preferred option link to the proposals below for
a common regulatory route for all applications?

• As there are so few new applications for doctor
  dispensing and the current regulations preclude
  many more, it seems unnecessarily complicated to
  change to current application process.
• Option one allows incremental change to take
  place and maintains stability in rural health
  provision

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Q28 common regulatory route for all
applications Do you agree

• Question
• the proposal to align the regulatory route for
  dispensing doctor applications with those of
  pharmacies and appliance contractors?
• dispensing by doctors should, as now, apply to
  those patients who live in designated rural
  areas?
• the approval of doctors dispensing premises
  should continue?

• DDA view
• Agreed as fair
• As a general rule, yes.
• Yes

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Q28 and Q29 A common regulatory route for all
applicationsDo you agree

• Question
• Q28the serious difficulty rule should be
  retained to enable a PCT to authorise dispensing
  for any patient who has serious difficulty
  getting to a pharmacy?
• Q29Are there other factors which need to be
  taken into consideration?

• DDA View
• Yes, it is essential that the procedure is
  there, although patients rarely need it
• Patient choice must be paramount.

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Q30Do you believe that it would be beneficial
for patients and consumers if dispensing doctors
were able to sell general sale list (GSL)
medicines to their patients where there is no
convenient alternative?

• DDA View
• Permitting dispensing practices to supply any GSL
  products to their patients rather than being
  limited, as at present, to supplying products
  blacklisted by the NHS is a logical change but it
  will in fact be a very small market.

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Q31Do you believe that it would be beneficial
for patients and consumers if dispensing doctors
were able to sell pharmacy (P) medicines to their
patients where there is no convenient alternative?

• DDA View
• The sale of (P) medicines only benefits patients
  if
• They would otherwise pay a prescription charge,
  and
• the drugs cost less than that charge
• NOTE Dispensing doctors can only supply
  medicines to their patients, not ,as in a
  pharmacy, to members of the public we do not
  see a need for that to change

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Q32 How might the term convenient alternative
best be defined? For example, should a distance
limit of, say 500 m, be set, or should this be
left to local determination?

• DDA View
• Any fixed distance criterion will create
  confusion if a pharmacy or surgery relocates, as
  far as GSL is concerned. How can one justify a
  garage next door to a pharmacy selling GSL but
  not the surgery on the other side?
• (P) Medicines are different we suggest the right
  might be restricted to dispensing surgery
  premises which are themselves situated in a
  controlled locality

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Q33 If dispensing doctors were to sell P
medicines, do you agree there should be safety
provisions regarding such supply - for example,
similar or equivalent to those that govern the
sale and supply of P medicines through
pharmacies?

• DDA View
• Yes, when medicines are provided otherwise than
  by prescription or NHS supply, the safety
  provisions should be equivalent to those
  governing the sale or supply through pharmacies

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Q34 Are there any risks not identified here in
permitting a dispensing practice to make a profit
from selling medicines to their patients?

• DDA View
• Dispensing doctors will in fact make far less
  profit from the sale of P or GSL items than
  they would if they were to provide them through
  the usual NHS route.
• Thus we see no risk.

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The options appliance contractors

• Replace the existing regulatory structure with a
  national scheme where applications are made to a
  central registering body
• Introduce a new exemption to the current market
  entry arrangements using the existing regulatory
  structure. (Preferred Option)
• Remove market entry arrangements for appliance
  contractors and adopt an any willing provider
  approach.
• A lead PCT or a regional NHS body to handle
  applications on behalf of all PCTs in their area
  using the existing regulatory test.

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Q35 Should we introduce a specific exemption for
applications from dispensing appliance
contractors?

• Yes

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Q36 What specific requirements might be set out
in the regulations such as the types, standards
and the quality of services to be provided?

• This is for guidance and not regulation

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Q37 What safeguards might be appropriate to
ensure the NHS has a reasonable and proportionate
control over any increases in costs through new
dispensing appliance contractor premises?

• Need to review the way that appliances are
  ordered, an NHS body should employ a specialist
  nurse to supervise rather than the appliance
  contractor

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Q38 Do the potential benefits of relaxed entry
restrictions outweigh the potential costs as
identified in the Impact Assessment?

• Yes, market forces should keep costs down.

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Q39 Do you agree the Department should assess in
2009 whether regulation is needed to govern those
who assist in the provision of appliances only?
Q40 Are there alternative approaches which
might be considered?

• Yes
• Guidance and the use of independent appliance
  nurses.

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Q41 If a risk were to be established, do you
agree the provisions of sections 149 and 150 of
the NHS Act should be extended to include those
who assist appliance contractors in the provision
of services?

• Yes only if risk is established

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Q42 Should self-employed appliance contractors
be required to register with the Independent
Safeguarding Authority and, if so, how ?
Q43 Should such requirements be subject to
specific limitations - for example, applying only
to contractors who fit appliances or who do so in
patients homes?

• If needed should be on the PCT supplementary
  list.
• The limitations should be a reflection of what
  happens with everyone else.

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Chapter 6 - other legislative reforms

• Necessary and expedient (?already changed)
• Permitting inducements that encourage healthy
  living e.g. item of fruit or exercise DVD-DDA
  View We feel that no inducement of any kind
  should be offered. E.g.. Loyalty points
• No inducement to be offered to other NHS
  providers
• No hidden arrangements between pharmacies and
  other providers
• Minor changes to LPS

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CHAPTER 6 Other changes to the legislation

• Q44 Do you agree the amendments proposed? No
  incentives of any sort are inappropriate.
• Q45 At this stage, no significant impact has
  been identified from these proposals. However, if
  you think these amendments would have a
  significant impact for PCTs or for business,
  please say what this is and how best any such
  impact might be managed.
• Q46 Are there other amendments you wish to
  propose that the Department should consider? If
  so, please say how they would clarify or improve
  the working of the regulatory system. No

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Q47 Do you agree that the proposed changes to
LPS legislation are needed? Yes

• Q48 Are there other changes to the LPS
  legislation which the Department should consider?
  NO
• Q49 No significant impact has been identified in
  respect of these proposals. If you believe they
  would have such an impact, please explain what
  this might be and how it might best be managed.

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How serious is the problem the proposals seek to
address in relation to smaller firms?

• Nearly all dispensing practices would be classed
  as small businesses. The effect of Options 3 or 4
  (and possibly 2) would be devastating. 5000
  redundancies are predicted. Reduction in patient
  services is inevitable

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What should I do?

• Respond to the consultation using the proforma
• Copy your response to your MP with a personal
  covering letter explaining how it will affect his
  constituents
• Ask your patients to respond to DH and copy to MP

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Responses

• Responses should be sent no later than
• Thursday 20th November 2008 to
  PWPCONS_at_dh.gsi.gov.uk. Alternatively, copies
  can be sent by post to
• Gillian Farnfield
• Department of Health
• Medicines Pharmacy and Industry Group
• Area 453D, Skipton House
• 80 London Road
• London
• SE1 6LH

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Responses

• A template for sending responses to this
  consultation and the associated Impact
  Assessments and other documents accompanying the
  consultation are available from
• http//www.dh.gov.uk/en/Consultations/Liveconsulta
  tions/DH_087324

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National Listening events

• Have taken place

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Party conferences

• Attended all 3
• Spoken to a large number of MPs
• Supportive of the no change option

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PWP DDA discussions with

• DOH
• GPC
• RCGP
• PSNC
• Politicians of all parties
• RPSGB

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Pay

• On going joint discussions with the DOH, NHS
  employers and the GPC around the enumeration for
  dispensing

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Pressures

• Increasing price of generics
• Fuel surcharges
• Decrease in discounts
• PPRS

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Part IX of drug tariff

• Meet with the DOH
• Allow use of appliance contractors
• Discussion around fees

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ETP

• No real change

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What else has the DDA done this year ?

• Dispensers register
• Flu Pandemic planning
• Website
• Members questions
• Discussions with industry

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Promoting the interests of Dispensing Doctors
and the excellence of doctor dispensing for the
benefit of patients