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Summary
The ABPI supports in principle the proposals to extend prescribing rights as set out in
the Review of Prescribing, Supply and Administration of Medicines (Crown Report), but is
concerned to ensure that certain safeguards are put in place in order to assure patient
safety.
The review embodies recommendations that could potentially provide efficiencies for the
NHS, arising through better use of the expertise and capabilities of health care
professionals and optimisation of patient care through easier access, improved compliance
and other benefits. One obvious example of a helpful change would be for community
pharmacists to be allowed to alter prescribed quantities of medicines – within
reasonable limits to allow the dispensing of complete patient packs through the range of
available packages.
However, industry has a number of concerns that changes to existing systems could
create
hazards and increase costs if introduced without careful evaluation. These concerns
fall under the following headings:
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Safety |
Industry accepts that it is appropriate to review existing arrangements but current
systems have stood the test of time and, broadly speaking, work to protect the interests
of the patient. Any arrangements that introduce the potential for misunderstanding and
confusion between health care professionals when considering prescribing decisions must be
avoided.
Industry has concerns that patient safety may be compromised if non-medical
practitioners are unaware of multiple pathology and co-morbidity. Comprehensive access to
medical records is not yet possible and a lack of awareness of other prescribed or self
administered therapies, and possible side effects, could compromise safety.
Currently prescribers have responsibilities to report adverse drug reaction (ADRs) to
the Medicines Control Agency. This is an extremely important safety feature which must not
be lost, or weakened, if new prescribing rights are granted.
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Probity |
Some recommendations, if introduced, could lead to generic or therapeutic substitution
by dependent prescribers, notably pharmacists. Prescribing practice should be determined
by good clinical management, but community pharmacy is practiced in a fiercely competitive
commercial environment. There is the risk that conflicts of interest could arise. Nothing
in the proposals should divert the original intention to treat the patient with the
therapy that has been determined by the doctor in consultation with the patient, and with
a full knowledge of the patients history.
If there are links for the transfer of information between a practice and a pharmacy
this will result in directing patients to certain pharmacies and therefore issues of
probity again could arise.
There should be no pecuniary interest on the part of dependant prescribers in changing
the original prescribing decision.
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Training |
There will be a considerable, and ongoing, requirement for education and training for
all professionals involved in these processes and industry has an excellent track record
in the provision of such training for medical staff. There are considerable opportunities
for closer working between NHS professionals and the industry. Industry wish to be assured
that all groups enabled by the recommendations will receive appropriate training and that
such training will be regular, timely and subject to review by an appropriate third party
agency.
Any guidelines on training should be drawn up with potential sponsors i.e. industry.
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Legal Responsibilities |
Where new arrangements for the prescribing and supply of prescription medicines
are proposed then absolute clarity of responsibilities and liabilities is necessary.
Responsibility for prescribing should rest with the professional responsible for the
clinical care of the patient, unless agreed otherwise by the individual professionals
concerned.
As the major provider of information on medicines to both patients and health care
professionals industry will be concerned to ensure that full information on medicines is
made available to all prescribers.
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Costs/Benefits |
Clear objectives and performance management systems are required in order to
evaluate the impact of any changes. There is the potential to increase both the workload
and legal liability of health care professionals without producing real benefits to
patients and their carers.
If dependent prescribers were allowed to prescribe current ‘P’ or
‘GSL’ medicines this would mean a large number of exempt patients would receive
these treatments free of charge. This could lead to an increased financial burden on the
NHS.
Dependent prescribers will need to have access to equipment (e.g. blood pressure
monitors) and will have to provide appropriate clinical environments and have suitable
counselling areas. They are likely to require remuneration to at least cover their time
and costs and this will lead to an added financial burden to the NHS in the short term.
New "prescribers" will have new liabilities and will have to cover the increased
cost of personal medical insurance.
There is a significant cost implication for the NHS in training the appropriate groups,
validation and the maintenance of registers of those qualified to prescribe as dependant
prescribers.
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Communications |
Industry understands and appreciates the requirements to formalise existing ad
hoc arrangements that exist in hospital and clinic environments. It is particularly
difficult, however, to envisage changes taking place in existing community pharmacy
environments without significant changes to both practice and information technology.
Until these changes are in place it is difficult to comment further, but it is easier to
envisage good practice emerging in discrete areas of patient care e.g. asthma clinics,
where health care professionals work together closely, than it is in environments where
independent practitioners work on remote sites.
Sharing information on patient records between independent and dependent prescribers is
not yet possible in an electronic format. As this capability develops major issues of
patient confidentiality will arise.
Conclusion
The review embodies recommendations that could provide potential efficiencies for the
NHS, arising through better use of the expertise and capabilities of health care
professionals and optimisation of patient care through easier access, improved compliance.
These changes could also potentially result, in the longer term, in savings of hospital
resources if patients can be safely managed in primary care settings. There are, though,
significant issues to be addressed before the pharmaceutical industry would support the
widespread extension of prescribing rights to health care professionals. These are chiefly
concerned with safety, legal responsibilities and probity.
Specific comments on individual recommendations are attached (Appendix 1)
Appendix 1
Recommendation 1
The legal authority in the United Kingdom to prescribe, including authorising NHS
expenditure should be extended beyond currently authorised prescribers.
Para 6.6 (iii) The need for the responsibility and accountability for clinical care
to be clear and unambiguous.
The recommendations could potentially provide efficiencies for the NHS arising through
better use of professional capabilities of health professionals and the optimisation of
patient care through easier access, improved compliance etc. These changes could also
potentially result in the longer term in savings of hospital resources if patients can be
safely managed in primary care settings.
As new arrangements for the prescribing and supply of prescription medicines are
proposed then absolute clarification of responsibilities is required. All systems must
have patient safety as the first priority. There is the potential to increase both the
workload and legal liability of health care professionals without demonstrating real
benefits to patients and their carers. Clear objectives and performance management systems
are required in order to evaluate the impact of any changes.
However, industry recommends that all newly authorised prescribers should be included
in the adverse reaction reporting (yellow card) scheme).
Industry is concerned that some recommendations, if introduced, could lead to generic
or therapeutic substitution by dependent prescribers, notably Pharmacists. Prescribing
practice should be determined by good clinical management, but community pharmacy is
practised in a fiercely competitive commercial environment. There is considerable risk for
conflict of interest to arise. Nothing in the proposals should divert the original
intention to treat the patient with the therapy that has been determined by the doctor in
consultation with the patient.
Recommendation 2
Legal authority for new professional groups to prescribe or to authorise NHS
expenditure should normally be limited to medicines in specific therapeutic areas related
to the particular competence and expertise of the group and may include prescription only
medicines within those areas.
Para 6.10 Prescribers will however be expected to be familiar with the
implications of multiple pathology and co-morbidity.
Industry has concerns that patient safety may be compromised if practitioners are
unaware of multiple pathology and co-morbidity. Comprehensive access to medical records is
not yet possible and a lack of awareness of other prescribed or self administered
therapies, and possible side effects, could compromise safety.
Possible areas where the creation of dependent prescribers could benefit the NHS would
include cardiovascular, respiratory, community psychiatry, migraine, diabetic and
gastrointestinal therapeutic areas. In all of these areas dose titration to optimal doses
and/or change of dosage form could greatly benefit patient care.
If dependent prescribers were allowed to prescribe current ‘P’ or
‘GSL’ medicines this would mean a large number of exempt patients would receive
these treatments free of charge. This could lead to an increased financial burden on the
NHS.
Industry is concerned that some recommendations, if introduced, could lead to generic
or therapeutic substitution by dependent prescribers, notably Pharmacists. Prescribing
practice should be determined by good clinical management, but community pharmacy is
practised in a fiercely competitive commercial environment. There is considerable risk for
conflict of interest to arise. Nothing in the proposals should divert the original
intention to treat the patient with the therapy that has been determined by the doctor in
consultation with the patient.
Recommendation 3
Two types of prescriber should be recognised:
- the independent prescriber who is responsible for the assessment of patients with
undiagnosed conditions and for decisions about the clinical management required, including
prescribing. At present, doctors, dentists and certain nurses in respect of a limited list
of medicines are legally authorised prescribers who fulfil the requirements for
independent prescribers and this should continue. Certain other health professionals may
also become newly legally authorised independent prescribers, subject to the process
described below.
- the dependent prescriber who is responsible for the continuing care of patients
who have been clinically assessed by an independent prescriber. This continuing care may
include prescribing, which will usually be informed by clinical guidelines and will be
consistent with individual treatment plans; or continuing established treatments by
issuing repeat prescriptions, with the authority to adjust the dose or dosage form
according to the patients’ needs. There should be provision for regular clinical
review by the assessing clinician.
These definitions seem broadly appropriate however, they do lead to many issues
concerning legal liability for the new independent and dependent prescribers.
Many classes of therapy can be considered e.g. there is a case for dependent prescriber
status for Multiple Sclerosis (MS) specialist nurses, particularly in clinics where they
work along side neurologists. MS nurses are screening patients to assess whether they
would be suitable for treatment with beta interferons before the patient sees the
neurologist. Once a clinical assessment has been made, the neurologist would then pass the
patient back to the nurse who would administer and monitor the treatment. There may also
be a case for MS nurses to prescribe certain symptomatic treatments independently.
In addition, dependent prescribers will need to have access to equipment (e.g. blood
pressure monitors) and will have to work in an appropriate environment and provide
suitable counselling areas. They are likely to require remuneration to at least cover
their time and costs and this will lead to an added financial burden to the NHS in the
short term. This does, however, have the potential to be off-set by longer term savings
e.g. less hospitalisations etc.
As the major provider of information on medicines to both patients and health care
professionals industry will be concerned to ensure that information is made available to
all prescribers.
Pharmaceutical companies will need to review the current advice given to prescribers
about their products to ensure that they meet the needs of new prescribers.
New "prescribers" will have new liabilities and will have to cover the
increased cost of personal medical insurance.
Recommendation 4
There should be adequate arrangements for sharing information between independent and
dependent prescribers. In particular,
- both clinicians should have access to a complete medication record, and
- both clinicians should have access to relevant parts of the patient’s medical
record.
Sharing information on patient records between independent and dependent prescribers is
not yet possible in an electronic format. As this capability develops this will bring
about major issues of patient confidentiality. In addition there are numerous and, as yet,
unresolved issues with IT capability which allow transfer of records for drug treatment
and comprehensive medical records. Patients will retain the right to self medicate and
this has implications for health care professionals as they change treatments.
If there are links for the transfer of information between a practice and a pharmacy
this will lead to the issue of directing patients to certain pharmacies and therefore
issues of probity will arise.
Issues of safety and liability are of great concern to the industry and clear
procedures for monitoring the performance of dependant prescribers to protocols are
required.
Recommendation 5
Changes to patterns of clinical care using new models for the prescribing, supply and
administration of medicines should be introduced only after full consultation with patient
interests, and should wherever possible increase patient choice.
Individual patients and patient groups should be fully consulted on all proposals. It
is important, however, that any process put in place does not delay implementation of
agreed proposals.
The interim report of the Crown Committee recommended the use of group protocols in
clearly defined situations for the supply and administration of certain medicines, thus
formalising a procedure that already exists in many practices. Under a group protocol
appropriately trained medical professionals, such as a nurse or pharmacist, would be able
to prescribe specified products for specific indications, provided the patient satisfied
previously agreed criteria and the specific procedures set out in the protocol were
followed.
Recommendation 6
A UK-wide advisory body, provisionally entitled the "New Prescribers Advisory
Committee", should be established under Section 4 of the Medicines Act to assess
submissions from professional organisations seeking powers for suitably trained members to
become independent or dependent prescribers.
There is a role for the NPAC if it is limited to deciding which groups can and cannot
prescribe. However, it this is broadened to consider the cost implications of proposed
changes there is possible duplication with NICE, and it should not be the role of the NPAC
to assess the cost effectiveness, nor availability of medicines.
Recommendation 7
Proposals for new professional groups to be considered as potential prescribers will be
expected to come from nationally recognised organisations. They should confirm that the
group is formally recognised by the appropriate regulatory body and that that body has
seen and is content with the proposed arrangements for training in prescribing and for
registration.
As industry holds the most comprehensive data on products it should be involved in
providing information for new prescribers. This already happens for current prescribers
within the Code of Practice regulations and is an invaluable resource for the NHS.
There is a cost implication for the NHS in training the appropriate groups, validations
and holding registers.
Proposals for new professional groups to be considered as potential prescribers will
come from nationally recognised organisations. Confirmation that the group is formally
recognised by the appropriate professional regulatory body is necessary. The professional
body must have approved any proposal and be assured of the proposed arrangements for
training in prescribing and for registration prior to rights being granted.
All decisions taken by the NPAC should be subject to an appeal procedure and should be
reviewed annually.
Recommendation 10
Newly authorised groups of prescribers should not normally be allowed to prescribe
medicines in the following categories:
- controlled drugs (drugs subject to the Misuse of Drugs Act 1971);
- unlicensed drugs, or drugs used outside their licensed indications;
- "black triangle" drugs;
- drugs over which there is continuing professional concern, e.g. drugs used to treat
children and young people with mental health problems;
- drugs which on public health grounds should be subject to particular safeguards, for
instance antibacterial antibiotics.
Any black triangle drugs, which have successfully passed through the National Institute
of Clinical Excellence review process, should be removed from the exclusion criteria.
There is considerable room for detailed debate on the criteria by which different
therapeutic categories and different patient groups could be included/excluded from such
provisions. One detailed comment is the consideration as to whether the restriction on CNS
drugs (above) should be widened to all age groups, given the side effect profile of some
CNS drugs and the suicide risk of untreated CNS disease. Industry would urge caution and
would welcome the opportunity to make detailed comment on any proposals for
inclusion/exclusion on other therapeutic categories.
Recommendation 11
Initial prescribing and supply of medicines should normally remain separate functions
in order to protect patient safety and provide other safeguards. Where a prescription
cannot be furnished, the current arrangements for the emergency sale or supply of
medicines should apply.
Para 6.59 The team recognises that some professional groups which currently have the
authority to sell or supply certain medicines in the course of treatment may apply for new
powers to prescribe those medicines. We recommend that professional organisations, in
putting forward proposals for extensions to prescribing, should consider whether these
proposals could put their members in the position of both prescribing and supplied POM
medicines to the same patient and if so what safeguards are required to maintain patient
safety and ensure probity.
Recommendation 12
Where exceptionally it is in the interests of patients for the same professional to be
responsible for prescription and supply of medicines, this should be subject to clinical
audit and probity checks.
Recommendation 13
Professional organisations, in putting forward proposals for extensions to prescribing,
should consider whether this could result in members prescribing and supplying POMs to the
same patient, and if so what safeguards are required to maintain patient safety and ensure
probity. The NPAC, in assessing any proposals from professional groups which could result
in members prescribing and supplying POMs to the same patient, should consider the
adequacy of the safeguards proposed.
Para 6.19In particular, it is of vital importance that both clinicians have
access to a
complete medication record, and that the dependent prescriber has access to a summary
of the patient’s medical record.
Comments on recommendations 11,12 and 13
The model used for dispensing doctors could, in broad outline, be suitable. Pharmacists
could be allowed to prescribe and dispense (or sell) medicines and probity is an issue.
Many community pharmacists practice in a fiercely competitive retail environment.
Safeguards would need to be in place in the form of guidelines for audit and compliance
with prescribing protocols.
Recommendation 17
Repeatable prescriptions should be available on the NHS.
Recommendation 18
Limits should be introduced for the number of times a repeatable prescription can be
dispensed and the duration of its validity. These restrictions should apply across all
sectors, and not be limited to NHS practice.
Comments on recommendations 17 and 18
Industry supports the use of repeatable prescriptions as a way of reducing the burden
on GPs and as an aid for the pharmacist to monitor patient compliance when patients return
to collect supplies. There is a potential role for pharmacists to proactively contact
patients who do not return. Improved compliance will facilitate improved patient care.
Conversely there is a risk that if effective communications are not in place then the
doctor will become less aware of changes to therapy that may be necessary, with adverse
affects on the quality of care provided to the patient.
Recommendation 19
Where particular extensions to prescribing authority could involve significant cost to
the NHS, or where the balance of cost and benefit appears to be uncertain, there should be
a thorough evaluation of the likely costs and benefits to the NHS before general adoption
is encouraged. This should not be allowed to result in unnecessary delays in improving
care.
This should not form part of the remit for the NPAC. It could lead to duplication with
NICE and will increase the requirements for data etc from the pharmaceutical industry.
This will increase costs to the health care system and result in delays in the provision
of the best possible treatment for patients.
Recommendation 20
The Government should take general powers in primary legislation, enabling ministers,
through regulations, to designate new categories of dependent and independent prescribers
for the purpose of the Medicines Act, to authorise them to prescribe medicines for
reimbursement by the NHS, and to limit or specify the medicines or classes of medicines
which they may prescribe.
Industry would seek assurances that that any decisions made by Government, under powers
taken under the Medicines Act, should be made on the basis of safety and efficacy only. To
take cost, or any other factor, into consideration under the Act would seriously damage
the credibility of the Act and the work of the Medicines Control Agency.
Recommendation 22
The professional regulatory bodies should draw up clear guidelines on the circumstances
in which commercial support or sponsorship for training programmes related to prescribing
could be acceptable. Training programmes should not be used to promote particular
products.
Para 8.12 Training programmes, whether part of initial training or of continuing
professional development, should not be used to promote particular products. We
recommend that the regulatory bodies should draw up clear guidelines on the
acceptance of any commercial support or sponsorship for such training
programmes.
As industry holds the most comprehensive data on products it should be involved in
providing information for the new prescribers. This already happens for current
prescribers within the Code of Practice regulations and is an invaluable resource for the
NHS.
The current Medicines Act provision under the Advertising Regulations are statutory
controls that already cover the distinction between educational sponsorship and promotion.
This currently works well and should be sufficient. The industry has an extremely good
track record in the provision of education and training to doctors.
There is a cost implication for the NHS in training the appropriate groups, validations
and holding registers.
Recommendation 23
Professional organisations considering applying for extended prescribing authority
should, in conjunction with the appropriate professional regulatory organisations, ensure
that adequate arrangements would be established for
- accrediting training programmes for prescribing;
- maintaining a register of individuals who have acquired and are maintaining competency
as prescribers;
- reviewing the results of clinical audit programmes and ensuring that any general lessons
are fed back into the content of training;
- keeping the content of the prescribing formulary under review and submitting any
proposals for change to the Medicines Control Agency.
Para 8.13( iii) ensuring that the content of professional training programmes takes
account of changing needs, and that any such changes are appropriately monitored.
The key issues around this recommendation include how will it be funded, organised and
audited? Failure to have properly funded and auditable systems in place from the outset
may lead to a diminution of standards over time, to the detriment of patient care.
Registers of individual practitioners that have acquired competency to prescribe should
be open to public perusal.
Recommendation 25
The new arrangements should be subject to evaluation and monitoring, for which
appropriate resources should be made available.
Industry is entirely in agreement with this and seeks clarification as to who will be
responsible for this, how it will be monitored and who will meet the costs for this.
Professional bodies that become responsible for these activities will be liable if
incidents arise, thereby increasing workload and costs to these organisations.
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