CD legislation changes put forward by Home Office
Amendments to the prescribing and auditing of Controlled Drugs, following
recommendations from the Shipman Inquiry, are put forward in the Home
Office’s consultation on changes to CD legislation, which opened
last week (PDF 370K).
The Government proposes allowing pharmacists to amend prescriptions for
CDs when there is a technical error but the intention of the prescriber
is clear. The Department of Health is working with the Royal Pharmaceutical
Society to define the types of error that would count as “technical
errors”, but these are likely to include errors such as impossible
dates and disagreements between the amount ordered and the quoted dose.
This is one of a series of amendments to the Misuse of Drugs Regulations
2001, under the Misuse of Drugs Act 1971, being proposed.
The changes will apply to England, Scotland and Wales and begin the programme
of action the Government set out in its response to the Fourth Report
of the Shipman Inquiry (PJ, 24 July 2004, p103, and PJ, 18/25 December,
2004, p874).
Lynsey Balmer, head of professional ethics at the Society, said: “There
are a number of areas in the consultation which will affect pharmacists.
For instance, the consultation outlines proposals to reduce the timescale
within which prescriptions for Controlled Drugs can be dispensed from
91 days to 28 days, to standardise private prescription forms for CDs,
to record prescriber and dispenser details on CD registers and to enable
pharmacists to amend technical errors on prescriptions. In the long term
there is a proposal that the schedules of CDs could be simplified, which
the Society will advise on.”
Changes to the audit trail
Suggested improvements to the audit trail for CDs include the
use of standard forms for requisitions of CDs, which would be sent
to the Prescription Pricing Authority, and the amendment of regulations
for CD registers so that it is clear that CD registers may include
a running balance of stock. Once electronic CD registers are in
common use, the Government intends to make such running balances
mandatory. |
The consultation puts forward a number
of changes to the audit trail (see Panel). It also proposes making it
possible to link information
relating to all prescribing by a single prescriber and all prescriptions
for a single patient, by having a unique identification number for each
prescriber and including patients’ NHS numbers on CD prescriptions.
A requirement to ask for some personal identification for anyone collecting
CDs is also proposed, although pharmacists would have discretion to supply
to patients or their representatives where no ID is presented.
The Society is preparing a formal response to the consultation, but Ms
Balmer said it supports the proposals for measures to strengthen safeguards.
“However,” she added, “strengthened controls must be
balanced with the need to ensure that patients can access the CDs necessary
for
their clinical care.”
The consultation closes on 21 October. Responses can be submited by e-mail
to regulationchangepostshipman@homeoffice
gso.gov.uk or sent to Chris Edwards, Drugs Legislation and Enforcement
Unit, Home Office, Floor 6, Peel Building, 2 Marsham Street, London SW1P
4GF.
A number of the proposals in the consultation also relate to legislation
set out in the Medicines Act 1968. This is the responsibility of the
Medicines and Healthcare products Regulatory Agency, which will separately
consult on these proposals. |
The
Pharmaceutical Journal
Acrobat
Reader