Controlled Drugs Newsletter
Kent and Medway Area Team
Welcome
Welcome to the first edition of
the NHS England Kent and
Medway Area Team Controlled
Drugs Newsletter. This
newsletter has been produced
to ensure that the Area Team,
CCGs, Police and other
regulatory bodies share good
practice guidance and incidents
involving CDs with healthcare
professionals in all sectors
across Kent and Medway. The
Area Team has a responsibility
to monitor the management
and use of CDs following the
recommendations from the
Shipman Inquiry. The
recommendations were
enforced in the Controlled
Drug (Supervision of
Management and Use) Act
2013.
Sally Allum, Director of
Nursing, is the Controlled Drug
Accountable Officer (CDAO) for
the Kent and Medway Area
Team. This role is supported
by Jane Hodges, Selena Steed
and Kay Scott from South East
CSU.
We welcome all feedback and
suggestions for this
newsletter.
Tel: 01227 791256
Email: [email protected]
October 2014
Edition 1
Supervised Consumption Enhanced Service Reminder
Supervised consumption is not a task that can be delegated. It has to be
undertaken by the Pharmacist.
All missed doses are significant and should be reported to the prescriber if
a pattern emerges. If three doses are missed, the prescriber has to be
contacted before a dose can be dispensed as the patient may have lost
tolerance.
It is good practice to state which Pharmacy the prescription is being
expected at by noting this in the top left hand box. If you are presented
with a prescription bearing the name of another Pharmacy for a controlled
drug please ensure you contact the prescriber before dispensing.
Please ensure that patients take a drink after methadone or buprenorphine
consumption, around 200ml is recommended
Reducing Dosing Errors with Opioid Medication
We urge all practices to re-read the 2008 National Patient Safety - Reducing
Dosing Errors with Opioid Medicines.
http://www.nrls.npsa.nhs.uk/alerts/?entryid45=59888
Investigation of these incidents has highlighted that SOPs are not being
followed and pharmacists are self-checking. Please ensure that labelling
and assembling is kept separate from the final check.
Waste exemption: T28 sort and denature controlled drugs
for disposal
It is necessary to apply for a T28 exemption from the environment agency
in order to be able to sort and denature Controlled Drugs for disposal.
Previously the exemption was automatic for community pharmacies.
This exemption allows pharmacies and other similar places to comply with
the requirements of the Misuse of Drugs Regulations 2001 by denaturing
controlled drugs (making them unsuitable for consumption). This includes:
 GP practices, including dispensing practices, if they hold Controlled
Drugs
 prison pharmacies
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
Legislation
The Controlled Drugs
(Supervision of Management
and Use) Regulations 2013
The Controlled Drugs (Supervision
of Management and Use)
Regulations 2013 came into
effect in England on the 1st April
2013. These Regulations set out
the requirements for certain
NHS bodies and independent
health care bodies to appoint an
accountable officer and describe
the duties and responsibilities of
accountable officers to improve
the safe management and use of
CDs. The regulations also require
bodies to co-operate with each
other, including with regard to
sharing information, concerns
about use and management of
controlled drugs and set out
arrangements relating to powers
of entry and inspection.
Misuse of Drugs Regulations 2001
The use of CDs in medicine is
permitted by the Misuse of Drugs
Regulations (MDR). The current
version of the Regulations made
under the Misuse of Drugs Act
1971 are the Misuse of Drugs
Regulations 2001
(2001Regulations) which came
into operation in February 2002.




prison healthcare, if they do not return unwanted Controlled Drugs
to the pharmacy service;
dental practices
hospitals and hospices
care homes with nursing; and
Veterinary surgeries.
The exemption allows the holder to:


store or treat up to 1 cubic meter of waste at any one time
store waste for up to six months
More information can be found on the Guidance page on
https://www.gov.uk/waste-exemption-t28-sort-and-denature-controlleddrugs-for-disposal. Further information and the link to apply for an
exemption, section 2, see https://www.gov.uk/environmental-permit-howto-apply/overview
FAQ
Q. Is there a requisition form for ordering a stock of CDs?
A. Following regulatory changes that apply to requisitions used for supply of
schedule 1, 2, and 3 CDs that came into effect on 1st January 2008, a
standard requisition form FP10 CDF was developed. For prescribers with a
PIN, these can be obtained from:
http://www.nhsbsa.nhs.uk/Documents/PrescriptionServices/FP34PCD.pdf
Learning from Incidents - Concentrated Controlled Drug
Liquid
Misuse of Drugs Act 1971
The Misuse of Drugs Act controls
the export, import, supply and
possession of dangerous or
otherwise harmful drugs. In effect
the Act largely renders unlawful all
activities for drugs controlled
under the Act except provided for
under the regulations made under
the Act. Drugs controlled under the
Misuse of Drugs Act 1971 are
divided into three classes A, B and
C for the purposes of establishing
the maximum penalties which
can be imposed.
There have been a few of incidents where patients have received a different
strength of a Controlled Drug liquid and have been under or over dosed.
On one occasion a patient was given oxycodone 10mg/ml in the hospice but
when it was requested from the GP, oxycodone 5mg/5ml was prescribed.
The product which was on repeat was prescribed because the hospice
discharge document was not acted upon. The patient was under dosed and
had to return to the hospice for stabilisation.
In another incident the patient was given oxycodone 5mg/5ml in the
hospice, at a dose of 20mg (20ml). She had some concentrated 10mg/ml at
home and took 20ml of that when she returned home. She also had to
return to the hospice for monitoring. A third incident involved a patient
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being given oxycodone 10mg/ml without being told that they had been
changed to the stronger product.
Quick Tips
The following basic tips will assist
providers in identifying misuse
and diversion:
Always record lost/stolen
prescriptions using the
appropriate “read code” so that
trends can be quickly identified
by running a report on that
code.
Please communicate with the patient and colleagues and do act upon
communication received.
Home Office Controlled Drug Domestic Supply Licenses
A common theme of discussion at the CD networks across the region has
been the Home Office’s advice about the requirement for a CD Domestic
Supply Licence.
The requirement to hold a CD supply licence is linked to the need for a
wholesale dealers licence. If a Pharmacy requires a MHRA Wholesale
Dealers licence for their activities then they will be required to obtain a
Don’t be afraid to phone 999 if
Home Office Controlled Drug Domestic Licence if their wholesaling
patients become aggressive
when trying to obtain medication activities include any controlled drugs (schedules 2 to 5). Therefore
without the Home Office Licence any supply to an organisation via
which the GP has refused. Local
requisition for stock would constitute an illegal transaction.
police will support you!
Following CQC recommendations
With effect from 14 August 2012, Section 10 (7) of the Medicines Act 1968
always sign the CD register so you has been repealed. This was the exemption that allowed pharmacists to
know who made each entry
wholesale deal medicines without a wholesale dealer’s licence, where that
dealing constitutes no more than an inconsiderable part of that business.
Make sure overage from liquid
We advise all pharmacies to review whether any of their normal business
preparations is recorded in the
transactions involve supply of stock to another organisation and to
CD register by adding it like you
investigate the need for a wholesale dealers licence for their premises.
would add a receipt from a
wholesaler
MHRA has previously given guidance that in situations where there is a
Always include the invoice
number when completing the CD
register supplier details. This
helps investigate discrepancies
specific patient need, a pharmacy needing to obtain small quantities of a
medicine from another pharmacy may do so without the need for the
supplying pharmacy to hold a WDA(H). This is subject to the supply meeting
all of the following criteria:
 it takes place on an occasional basis
 the quantity of medicines supplied is small and the intention is to meet
the needs of an individual patient
 the supply is made on a not for profit basis.
We advise you to contact the MHRA and Home Office to be certain what
licences or exemptions should be in place for your premises. You can
contact the Home Office and MHRA using the following:
MHRA: [email protected] or 020 3080 6844
Home Office: [email protected]
Removal of Temazepam Prescribing Exemptions
The ACMD has recommended that the exemptions applicable to the
prescribing of temazepam in the public sector should be removed to bring
temazepam in line with all other schedule 3 drugs.
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Useful Websites
Home Office
https://www.gov.uk/
government/organisation
s/home-office
Department of Health
https://www.gov.uk/
government/organisations/
department-of-health
General Pharmaceutical Council
The ACMD advice is available at:
www.gov.uk/government/publications/temazepan-advice.
Ministers are considering the ACMD’s advice.
Prescription Security
Aide memoirs on prescription security aimed at prescribers, practice
managers and NHS England area teams have been published, these one
page documents highlight and summarise the key points for managing the
security of prescription forms.
The documents can be found on the Medicine Security webpage on the NHS
Protect website at: http://www.nhsbsa.nhs.uk/4430.aspx
www.pharmacyregulation.org
Care Quality Commission
http://www.cqc.org.uk/
National Prescribing Centre
(Legacy site)
FAQ
www.npc.nhs.uk
NICE Medicines and Prescribing
www.nice.org.uk/mpc/Medicine
sPrescribingAlerts.jsp
Q. Do I need an authorised witness when destroying
patient returned CDs?
A. No, patient returned CDs can be destroyed without an
authorised witness. It is advised that a witness is still
present but this can be another member of staff at the
practice/pharmacy. A record should be kept of the
following details: date received, date de stro y ed and
signatures of the person destroying and the person
witnessing the destruction. Standardised patient
returned registers are available from a number of CD
Stationery providers.
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