Amendments to the Misuse of Drugs Regulations: guidance
for pharmacists
A number of amendments to the Misuse of Drugs Regulations 2001 come
into force next week. This guidance for pharmacists has been prepared
by the Royal Pharmaceutical Society's Practice and Quality Improvement
Directorate
The following amendments to the Misuse of Drugs Regulation
2001 come
into force on Monday 14 November. The changes will apply to England,
Wales and Scotland. The Northern Ireland Department of Health and Social
Services will consider similar changes.
Controlled Drug prescriptions
The requirement that Controlled Drug prescriptions (except prescriptions
for Schedule 4 or 5 CDs, or temazepam) should be written in the prescriber’s
own handwriting has been removed. Prescriptions must still be written
so as to be indelible and other prescription requirements (eg, to express
the total quantity in both words and figures and state the form of
the preparation) still apply, but only the signature now needs to be
handwritten by the person authorising the prescription. All other details
on CD prescriptions, including the date, can be computer generated.
This change also permits the use of stamps and allows other people
to write the body of the prescription and means that prescribers no
longer need to have a handwriting exemption. Controlled Drug
registers
The definition of a Controlled Drug register has been amended
to include
a computerised system which complies with specified best practice guidance.
This means that it is now permissible to maintain a computerised CD
register provided that certain requirements are met. The Regulations
require that every computerised entry must be attributable and capable
of being audited. The computerised register must be accessible from
the premises to which it relates and persons authorised by the Secretary
of State (eg, the Society’s inspectors) are able to request that
a copy of the register, in its computerised or other specified form,
be sent to them.
Pharmacists are advised that CD registers may only be held in a computerised
form if safeguards are incorporated into the software to ensure all of
the following:
· The author of each entry is identifiable
· Entries cannot be altered at a later date
· A log of all data entered is kept and can be recalled for audit purposes
Access control systems should be in place to minimise the risk of unauthorised
or unnecessary access to the data and adequate backups must be made.
Pharmacists are also advised that arrangements must be made so that inspectors
can examine computerised records during a visit with minimum disruption
to the dispensing process.
Computerised CD registers should not be maintained unless you can be
satisfied that the above requirements (and any future guidance that may
be issued) can be adhered to.
Preservation of records
Registers, requisitions, orders and private prescriptions for Controlled
Drugs must be preserved for two years. The regulations have been
amended to allow the information contained in these records to be preserved
in the original paper form, or as a copy on computer. As with computerised
CD registers, pharmacists need to ensure that, where copies of requisitions,
orders and private prescriptions are held on computer, safeguards
are
in place to ensure the data cannot be altered at a later date, that
all data can be recalled for audit purposes, that adequate backups
are made and that systems are in place to minimise the risk of unauthorised
access to the data. Extended formulary nurse prescribing
Amendments have been made to the Regulations to extend the range
of Controlled Drugs that extended formulary nurse prescribers can
prescribe, supply
or administer. Extended formulary nurse prescribers will be able
to prescribe, administer or supply the following CDs, solely for
the medical
conditions indicated: · Diamorphine, diazepam, lorazepam, midazolam, morphine or oxycodone
for use in palliative care
· Buprenorphine or fentanyl for transdermal use in palliative care
· Diamorphine or morphine for pain relief in respect of suspected myocardial
infarction or for relief of acute or severe pain after trauma, including
in either case post-operative pain relief
· Chlordiazepoxide hydrochloride or diazepam for treatment of initial
or acute alcohol withdrawal symptoms
· Codeine phosphate, dihydrocodeine tartrate or co-phenotrope (no restrictions
on medical conditions)
Extended formulary nurse prescribers will not be authorised to prescribe,
administer or supply these drugs for these conditions until corresponding
changes have been made to Medicines Act legislation. Pharmacists will
be advised of the corresponding changes in due course.
Ascorbic acid
Ascorbic acid has been added to the list of drug paraphernalia that
specified persons (including pharmacists) can supply to illicit drug
users for
the purpose of administering or preparing controlled drugs. Cocaine preparations
Preparations containing not more than 0.1 per cent cocaine are no longer
exempt from prohibitions on import, export and possession. |
The
Pharmaceutical Journal