Backing for Shipman proposals on regulating CDs
In its response to the fourth report of the Shipman
Inquiry, the Council is to offer its general support for the report’s 33 recommendations on the regulation of Controlled Drugs in the community, which include tighter controls on the prescribing, dispensing, storage, inspection and destruction of CDs. Among the proposals are new limitations on
prescribing rights, the creation of a CD inspectorate, the introduction
of special CD prescription forms, the redesign of CD registers and
the development of a patient-held drug record card.
The Council also agreed that its response should raise a number of additional
issues for consideration, including prescribing by other health care
professionals, supply by patient group direction, the format of the CD
register, the use of bar coding and radio frequency tagging to provide
an audit trail and the need to review the training of health care professionals.
The Council made most of its decisions, some of which are highlighted
below, on the recommendation of its Shipman Working Group, whose chairman,
Elizabeth Filkin, presented a draft response for consideration at the
October Council
meeting.
In a section on inspection arrangements, the draft response welcomes
the proposed creation of a multidisciplinary CD inspectorate and says
that the Society’s inspectorate should be centrally involved in
its development.
In a section on doctors’ prescribing rights, the draft response
supports a number of proposed limitations. These included medical practitioners
only being able to prescribe or administer CDs for the purposes of “actual
clinical practice”, being prohibited from prescribing for themselves
or their families except in an emergency and being required to report
to the General Medical Council any conviction or caution for a CD offence.
The proposed development of a standardised private prescription form
and the revision of the NHS form for CDs is welcomed in the draft response.
It calls for the adoption of computer-generated CD prescriptions and
electronic transmission of CD prescriptions as soon as secure systems
are in place.
The draft response supports proposals that a CD prescription should bear
the prescriber’s GMC registration number and a patient-specific
identifier number, but suggests that the absence of either should not
invalidate the prescription so long as the pharmacist judges it to be
a purely technical breach.
On a proposal that a CD prescriptions should bear a brief description
of the condition for which the CD has been prescribed, the draft response
suggests that giving pharmacists access to patient care records — also
proposed — would be a more suitable way of allowing them to satisfy
themselves about the appropriateness of the prescribing.
The draft response supports a proposal that supply on a single prescription should
be limited to a 28 days’ supply. It adds that if a prescription calls for
a longer supply it should be treated as a technical breach, with the pharmacist
having discretion to dispense a maximum of 28 days’ supply. The draft also
supports a 28-day limit on the validity of a CD prescription.
The draft supports a proposal that when computer generated prescriptions and
ETP are introduced the computer systems should record the time of prescribing
and time of dispensing.
The draft welcomes a proposal that pharmacists should have discretion to amend
and dispense CD prescriptions that have technical defects without having to return
them to the prescriber. It supports the spirit of a proposal that the CD register
should include details of the persons who collect the prescriptions but points
out that concerns about patient confidentiality may need further consideration.
The response also supports the proposal that persons collecting in Schedule 3
or 4 CDs should sign the back of the prescription form.
Supporting a recommendation for electronic CD registers, the draft response calls
for this proposal to be implemented at the earliest opportunity. It also supports
running balances in pharmacy CD registers and says that the Society will provide
appropriate guidance. Supporting a proposal that CD register entries should include
the prescriber’s name and professional registration number and the name
of the pharmacist making the supply, the draft response suggests that the supplying
pharmacist’s registration number should also be recorded. Also supported
is a proposal that CD records should be kept for at least seven years rather
than the current two years.
Responding to recommendations in a section on CDs in the community, the response
supports a proposal that every supply of an indictable Schedule 2 drug should
be accompanied by a patient drug record card (PDRC), on which the health care
professionals who administer the drug would keep records. It also supports the
idea that on a patient’s death, or when medication is no longer required,
all CDs should become the property of the Crown, but suggests that this should
be extended to cover all prescribed drugs both to help avoid confusion and because
medicines other that CDs may pose a risk if diverted.
Although supporting a proposal for tighter controls on the destruction of CDs,
the draft warns that suggested statutory controls could lead a member of the
public to commit a criminal offence inadvertently. It also says that arrangements
for the removal or destruction of CDs following a patient’s death should
not cause further distress to the bereaved.
Finally, the response supports a proposal that primary care organisations should
implement arrangements for disposing of CDs, but it adds that the Society would
like to see co-ordinated systems and a unified approach.
After the presentation by Mrs Filkin, members of Council went on to make a number
of suggestions for inclusion in the final version of the Society’s response.
Gill Hawksworth, referring to proposals for the disposal of CDs, said that she
was concerned that pharmacists are not included in the loop of people who get
to know when patients have died. Perhaps the primary care organisation should
have the responsibility of informing the dispensing pharmacist.
Hassan Argomandkhah said that some proposals would increase pharmacists’ workload,
and the remuneration system should take that into account. Encouraging people
to return unwanted medicines to the pharmacy raised health and safety issues,
he added.
Linda Stone suggested that limiting the validity of a CD prescription to 28 days
was a potential issue for the chronic patient, stabilised on a CD, who needs
regular prescriptions but does not need to see the GP every month for an assessment.
Special prescription pads for CDs would double the number of pads in circulation
and double the security risk. She added that the report included proposals for
what the pharmacist has to do to order stocks, but there was nothing about the
wholesaler’s responsibility in delivering those stocks. What security would
the wholesaler have that the individual who ordered the stock was entitled to
order it?
Nicola Gray said that there should be clarification about which classes of CD
the various proposals referred to. Many of the proposals would presumably not
apply to Schedule 5 CDs, but only one response specifically separated out Schedule
5.
Alison Ewing said that she had huge concerns if the proposed controls were to
be extended to hospitals. Many would be inappropriate and some would be unenforceable.
The response should emphasise that it related only to the community setting.
Maurice Hickey, commenting on the suggested use of patient-specific identifier
numbers, said that every computer-generated prescription in Scotland bears a “community
health index number” identifying the patient — a 10-character code
based on the patient’s date of birth. The system could easily be adopted
to the other parts of the UK.
On limiting the validity of prescriptions, Mr Hickey suggested that the prescription
should include an expiry date that the prescriber should determine. The norm
might be three months but — certainly for the likes of drug abusers — the
doctor could reduce the validity of the prescription.
Clive Jackson said that one thing that had emerged was problems relating to the
complexity of the scheduling system. Restructuring the scheduling could be recommended
as a general comment.
Concluding the debate, the President said that the comments would be incorporated
and the revised draft would return to the office for him and the Secretary and
Registrar to sign off in consultation with Mrs Filkin. |
The
Pharmaceutical Journal