The Department of Health’s view
Views on why pharmacists should prescribe, what training
they should receive, how supplementary prescribing will work in practice
and what
legal responsibilites prescribing brings were all presented at the seventh
annual Hospital Pharmacist conference held in London on 30 October. Gareth
Jones and
Rachel Graham (on the staff of Hospital Pharmacist) report
Gul Root: don’t make clinical management plans bureaucratic - let’s keep them simple |
The Department of Health’s vision of supplementary
prescribing was set out by Gul Root, principal pharmaceutical officer
at the DoH. Mrs Root took delegates through the principles of supplementary
prescribing, paying special attention to issues of practical importance
to pharmacists, patients and the NHS and setting out potential new developments.
One key principle is that supplementary prescribing must be of benefit
to patients and the local NHS. Because of this, it is vital that any
pharmacist who undertakes the training has a prescribing role waiting
for them to perform when they complete the course, Mrs Root stressed.
This is one area in which supplementary training for pharmacists can
learn from the experiences of nurse prescribing - many nurses have qualified
as prescribers but have not taken on prescribing roles on completion
of their training. This is unsatisfactory for them, and is not cost-effective,
Mrs Root pointed out.
Another key principle is that supplementary prescribing is a voluntary
partnership between the supplementary prescriber, the independent prescriber
and the patient. Patients’ agreement with the clinical management
plan and with the fact that the pharmacist will be prescribing for them
must be sought. A signed consent is not necessary, but the agreement
of the patient should be recorded on the clinical management plan and
patient record. Without this agreement, supplementary prescribing cannot
proceed. The supplementary prescriber must also be happy with what they
are being asked to prescribe – it will be they who have to take
clinical responsibility for their prescribing.
Patient safety is another of the key principles of supplementary prescribing.
Mrs Root urged supplementary prescribers to act only within their own
competencies, knowing when to refer to the independent prescriber and
being aware of their own limitations. It would be helpful for pharmacists
who become supplementary prescribers to review their insurance cover,
she said.
Effective communication between the independent and supplementary prescriber
is paramount to ensure patient safety, Mrs Root added. Supplementary
prescribers should ideally record their prescribing and monitoring contemporaneously
in the shared patient records. In some circumstances (for example, weekends
and bank holidays) where this may not be possible, they should be recorded
within 24 to 48 hours. Where possible, prescribing and dispensing functions
should be separated, Mrs Root added. She noted, however, that there may
be exceptional circumstances where the same pharmacist would need to
prescribe and dispense medicines and, following discussions with pharmacy
organisations, it was agreed that within the context of supplementary
prescribing, this could happen provided robust clinical governance and
audit arrangements were in place to ensure patient safety.
From a practical point of view, one of the key messages is that clinical
management plans should be kept simple. According to Mrs Root, it is
important to remember that clinical management plans are for individuals
and not for groups of patients. So they should not be prescriptive documents.
Two templates are available from the DoH website, but these
are there to help the NHS and are not mandatory. The only requirements
are those set out in the POM order amendment (for example, patients’ name,
illness, reference to medicines or class of medicines to be prescribed,
the arrangements that have been made for the notification of adverse
drug reactions and the circumstances in which the supplementary prescriber
should refer back to the independent prescriber). Clinical management
plans should gener-ally be reviewed not less than annually, she said.
Mrs Root went on to say that clinical management plans can contain either
specific or general instructions. For example, when managing hypertension,
they might state that drug “x” should be used if a patient’s
blood pressure increases above a certain level. Alternatively, they might
just state that the condition should be managed according to British
Hypertension Society guidelines, or the hospital protocol (ie, national
or local evidence-based guidelines). The level of delegation will depend
on the relationship between the independent prescriber and the supplementary
prescriber and the skills and expertise of the supplementary prescriber,
she said. There is no need for clinical management plans to repeat information
contained in such guidelines or in patient records shared by both prescribers. “Please
don’t make them too bureaucratic” Mrs Root urged, especially
since medical practitioners could be dissuaded from supplementary prescribing
if developing a clinical management plan is an arduous task. “Let’s
try and make it simple for everybody”.
Regarding the education and training of pharmacist prescribers, Mrs Root
stressed that some face-to-face learning is seen by the DoH as an important
part of the course, particularly for learning about the physical examination
of patients and the different models of consultation. However, it is
also recognised that open learning for some aspects would be helpful.
The DoH has commissioned a review of the minimum number of hours that
need to be spent on face-to-face learning, Mrs Root said.
Recommended reading for pharmacy managers and for those thinking of training
as supplementary prescribers includes the competence framework developed
by the National Prescribing Centre, the clinical governance framework
(for both organisations and individual supplementary prescribers) developed
by the Royal Pharmaceutical Society and the supplementary prescribing
section of the DoH website, she added.
Mrs Root also discussed the removal of the restrictions that prevent
pharmacists prescribing controlled drugs and unlicensed medicines. For
controlled drugs, she explained that the Home Office is currently preparing
instructions for its lawyers to draft regulations extending the scope
of supplementary prescribing to include controlled drugs. This follows
on from an agreement with the Advisory Council on the Misuse of Drugs
that the proposal can go ahead, and from public consultations by the
Home Office, where no major objections were raised. Home Office regulations
should be in place by early 2004. Mrs Root pointed out that the ability
to prescribe controlled drugs are particularly important in oncology
and palliative care, where supplementary prescribing would be of limited
application without them.
For unlicensed medicines, the Medicines and Healthcare products Regulatory
Agency (MHRA) is currently preparing a consultation letter extending
the scope of supplementary prescribing to include specials and unlicensed
medicines.The aim is for this consultation to
be issued by the end of the year. Currently, supplementary prescribers
can prescribe only unlicensed medicines used in clinical trials. Mrs
Root pointed out that pharmacists can currently prescribe “black
triangle” and “off label” drugs, but urged pharmacists
to make sure that they were happy to accept clinical responsibility for
prescribing them. She suggested that if there was a body of opinion (for
example, references in paediatric formularies) supporting their decision
to use these agents, that would be helpful.
There are also likely to be developments relating to inpatient charts,
Mrs Root continued. These are needed because of uncertainty about whether
supplying medicines against instructions written by non-medical prescribers
on inpatient charts complies with Article 15 of the POM Order. The DoH
and the MHRA have taken the opportunity to clarify the situation beyond
doubt. The changes proposed would ensure the legitimacy of current practice.
Supplying medicines against inpatient charts written by medical prescribers
is specifically covered by Article 12 of the POM order, but Article 12
has not yet been amended to cover non-medical prescribers. Consultation
on the proposal to extend Article 12 is under way, however, and a decision
from ministers is expected imminently, with changes to Article 12 expected
in early 2004, Mrs Root said. [Ministers have since agreed
to the proposal - see p468]. In the meantime, “the DoH and MHRA would not wish
to inhibit current safe practices”, Mrs Root said.
Moves towards independent prescribing were also discussed by Mrs Root.
She told delegates that discussions with professions, patient organisations
and the NHS to
develop a framework for independent prescribing by pharmacists will begin
in early 2004. She will also be talking to pharmacists informally to
see how to take independent prescribing forward. “Watch this space”,
she concluded.
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