Changes to the Controlled Drug Register
Changes concerning the format of the Controlled Drug Register (CDR) and the headings/titles of columns used to capture the mandatory fields of information will come into force on 1 February 2008. These changes will apply to England, Scotland and Wales.
Records must be kept by pharmacists of all Schedule 1 and 2 Controlled
Drugs received or supplied.
Format of CDR and information legally required to be
recorded From 1 February
2008 the fixed format of the CDR will be removed from legislation. It will
no longer be a legal requirement to maintain a CDR as described in Schedule
6 of the Misuse of Drugs Regulations 2001, as amended.
Instead of the current prescribed format, the Regulations will require
that certain headings must appear in the CDR and certain fields of information
must be completed.
In the CDR, (or separate part of the register used for each class of drug),
a separate page must be used for each strength and form of that drug.
Entries made in respect of drugs obtained and drugs supplied may be made
on the same page or on separate pages in the register.
For Controlled Drugs obtained and supplied, the following must be specified
in the CDR at the head of each page:
• The class of the drug
• The strength of the drug
• The form of the drug
Guidance states that the name of the drug must also appear at the head
of each page.
For Controlled Drugs obtained, the following headings must be used and
the following information must be recorded in the CDR:
• Date supply received
• Name and address from whom received
• Quantity received
For Controlled Drugs supplied, the following headings must be used and
the following information must be recorded in the CDR:
• Date supplied
• Name / Address of person or firm supplied
• Details of authority to possess — prescriber or licence holder’s
details
• Quantity supplied
• Person collecting Schedule 2 Controlled Drug (patient/patient’s
representative/healthcare professional) and, if healthcare professional,
name and address
• Was proof of identity requested of patient/patient’s representative?
(Yes/No)
• Was proof of identity of person collecting provided? (Yes/No)
In the case of a healthcare professional, proof of identity should be
their professional registration number.
These particulars are the minimum fields of information that must be recorded
in the CDR. The regulations do not prevent additional related information
being recorded.
Additional related information that may be recorded
in the CDR Additional
related information that will help guarantee the integrity and accuracy
of the audit trail may be recorded in the CDR.
The following are examples of information that may be recorded in the CDR.
This additional information
is not legally required from 1 February 2008:
• Running balances
• Private prescriber identification number (six digit private doctor
code or the NHS prescriber code)
• Professional registration number of the prescriber
• The name and professional registration number of the healthcare professional
supplying the Controlled Drug (the pharmacist supervising the supply
of the Controlled Drug to the patient, or the patient’s representative,
would be the person whose details should be entered in the CDR, in this
case)
Once electronic CDRs are in common use, and subject to a change in the
legislation being approved, the Government will make it compulsory to record
the prescriber’s identification, the supplying healthcare professional’s
identification and for the CDR to contain a running balance.
Electronic CDRs As an alternative to a bound book, pharmacists may elect
to keep their CDR electronically.
Electronic CDRs must be capable of printing or displaying the name, form
and strength of the drug in such a way that the details appear at the top
of each display or printout to comply with the new requirements.
Electronic CDRs must comply with best practice guidance, which can be found
in the current edition of the Medicines, Ethics and Practice (MEP) guide.
Other legal requirements in relation to CDRs The other legal requirements
for CDRs still remain in force and must still be complied with. These can
be found in the current edition of “Medicines, ethics and practice — a
guide for pharmacists and pharmacy technicians”. |
The
Pharmaceutical Journal