Document name:
Controlled Drug Policy
Section 14 Medicines Code
Portfolio
Document type:
Medicines Management
Policy
Standard Operating procedures for
the Management of Controlled drugs
within SWYPFT
All clinical staff
Staff group to whom it applies:
Distribution:
Hard copy to all in-patient areas.
Intranet
How to access:
Intranet
Issue date:
October 2012
Version 4
Next review:
September 2014
Approved by:
Drug and Therapeutics Sub
Committee
Executive Management Team
Lynn Haygarth
on behalf of the Drug and
Therapeutics Committee
Medical Director
Director of Nursing
Developed by:
Director leads:
Contact for advice:
Ward Pharmacist
Med.information @swyt.nhs.uk
lynn.haygarth@swyt.nhs.uk
1
IN D E X
SECTION A - Controlled Drug Policy
1
General….............................................................................................................
2
Responsibility and Ratification…..........................................................................
3
Review…..............................................................................................................
4
Contributions….....................................................................................................
5
Classification of Controlled Drugs (CDs)…...........................................................
6
Controlled Drugs Requiring Safe Custody Schedule 2 & 3…...............................
7
Other CDs coming under Schedules 4 & 5 requiring weekly monitoring..............
8
Legal Requirements for Controlled Drug Prescriptions........................................
10
Controlled Drug Prescription Form.......................................................................
SECTION B – Standard Operating Procedures
SOP 1 Ordering, receipt of pharmacy stock of controlled drugs ...................................
SOP 2 Receiving, validating, dispensing, labelling and checking prescriptions for
controlled drugs in the pharmacy..........................................................................
SOP 3 Checking stock of controlled drugs in pharmacy..................................................
SOP 4 Distribution of controlled drugs – Ward and Pharmacy Staff................................
SOP 5 Ordering and receipt of CD‘s on wards.................................................................
Flowchart for ordering and receipt of CDs on wards............................................
Authorised signature form.....................................................................................
Deviation from Medicine Code..............................................................................
SOP 6
SOP 7
SOP 8
SOP 9
SOP 10
SOP 11
SOP 12
SOP 13
SOP 14
SOP 15
SOP 16
SOP 17
4
5
7
7
8
10
11
12
14
17
21
26
28
30
31
32
34
Obtaining temazepam tablets for an in patient, out of hours, at Fieldhead Hospital
35
Local procedure for possession/storage of the controlled drugs cupboard keys
36
Administration to service users on wards............................................................. 37
Flowchart for administration of CD’s to in-patients............................................... 38
Recording of patient’s own CD’s on wards........................................................... 39
Flow chart for patient bringing in own CDs…………………………………………. 40
Flow chart of death of a patient on a ward …………………………………………. 41
Checking stock of controlled drugs on wards....................................................... 42
Flowchart for handling discrepancies on wards and departments........................ 44
Storage of controlled drugs................................................................................... 45
Flowchart for the receipt and storage of CD’s on wards....................................... 46
Return, disposal, destruction of unwanted CD’s................................................... 47
Flowchart for the return/disposal of unwanted CD’s on the wards....................... 50
Control of stationery.............................................................................................. 55
Returning controlled drugs to pharmacy when a ward closes
57
Compliance Aids with controlled drugs................................................................ 59
Procedure for dealing with suspected illicit substances handed in by or found
on a service user on an in-patient unit................................................................. 60
Destruction of controlled drugs in pharmacy........................................................ 63
Security and transportation of CD’s...................................................................... 65
Controlled drug delivery log.................................................................................. 66
Controlled drug weekly satellite transport log....................................................... 67
Archiving controlled drug documentation.............................................................. 68
Appendix 1
Appendix 2
Appendix 3
Equality Impact Assessment Tool........................................................... 69
Checklist for the Review and Approval of Procedural Document............. 70
Version Control Sheet………………………………………………………. 71
2
Abbreviations and terms used in this document
AO
CD
D&T
EMT
GPhC
RSP
SOP
Accountable officer
Controlled drug
Drug and Therapeutics Committee
Executive Management Team
General Pharmaceutical Council
Royal Pharmaceutical Society
Standard Operating Procedure
Ward Manager
Nurse in charge
Authorised nurse signatory
Nurse responsible for the ward
Nurse responsible for the ward on that day/shift
Nurse who is permanently working on the ward who has
completed pre-ceptorship and induction
3
SECTION A - CONTROLLED DRUG POLICY
1
GENERAL
The procedures contained within this document are to ensure all activity concerned with
controlled drugs (CDs) is in accordance with the law and promotes the safe and effective use
of these items within the Trust.
Controlled Drugs are subject to numerous pieces of legislation including:
Misuse of Drugs Act 1971

Misuse of Drugs Regulations 2001

Medicines Act 1968 (and regulations)

Misuse of Drugs (Safe Custody) Regulations 1973

Health Act 2006

Controlled Drugs (Supervision of Management and Use) Regulations 2006
The Health Act 2006 required all healthcare organisations to appoint an Accountable Officer
and also requires Standard Operating Procedures (SOPs) to be available for the use and
management of controlled drugs.
SOPs are needed:

To improve governance of controlled drugs within the Trust;

To provide clarity and consistency for all staff handling CDs;

To define accountability and responsibilities, and clarify where responsibility can be
delegated;

To ensure practices are in line with the regulatory frameworks;

As a training tool for new and existing staff.
The Misuse of Drugs Act 1971 controls “dangerous or otherwise harmful drugs” which are
designated “Controlled Drugs”. The primary purpose of the Act is to prevent the misuse of
‘controlled drugs’. It does that by imposing a total prohibition on the possession, supply,
manufacture, import or export of controlled drugs, except as allowed by regulations or by
licence from the Secretary of State. Recommendations made by the RPSGB as a result of the
fourth Shipman report are included in this document: ‘Changes in the Management of
controlled drugs affecting pharmacists in England, Scotland and Wales – Version 2 June 2006’
Therefore, the use of controlled drugs within the Trust is permitted by the Misuse of Drugs
Regulations 2001 and other regulations dealing with the safe custody of controlled drugs and
the notification of and supply of drugs to treat and manage addiction. One of the most
important roles of pharmacy is to prevent the misuse of these drugs within the Trust, by
patients, staff or visitors.
4
2
RESPONSIBILITY AND RATIFICATION
The Accountable Officer for SWYPFT is the Chief Pharmacist and is responsible for the safe
use and management of CDs within the Trust.
The designated ward managers are responsible for ensuring that controlled drugs are
managed in line with the SOPs in their department.
The Principal Pharmacist, Wakefield and Forensic based at Fieldhead is responsible for
ensuring the Controlled Drugs are managed safely in line with SOPs in Fieldhead Pharmacy.
The Lead Pharmacist in Barnsley is responsible for ensuring Controlled Drugs are managed
safely in the BDU.
The Principal Pharmacist for Calderdale and Kirklees is responsible for ensuring Controlled
Drugs are managed safely in the BDUs.
This policy has been submitted to the Director of Nursing, the Drug and Therapeutics Sub
Committee and the Executive Management team for approval.
Individual responsibilities relating to this document.
Any member of staff should report any concerns relating to controlled drugs to the ward
manager/ team leader or if preferred directly to the accountable officer or in her absence the
deputy.
Accountable Officer (AO)
To complete a performance report that ensures the relevant checks have been carried out,
noting any deficits and detailing incidents that have occurred.
This will also list any remedial action that has been taken.
Director of Nursing
To ensure the SOPs are fit for purpose and advise of any updates required as a result of
legislation affecting nurses.
Business Development Units (BDUs)
The General Managers in the BDUs are required to ensure that the AO has an up to date
signatory list of all ward managers. Changes to ward managers must be immediately
informed to the AO.
The BDUs are responsible for ensuring the SOPs are implemented in the appropriate areas
together with the Principal or Lead Pharmacist.
WARD ACTIVITIES
Ward Pharmacist
Each ward pharmacist is responsible for ensuring a 3 monthly check of CDs is carried out by a
pharmacist or designated senior pharmacy technician on their allocated wards. This includes a
check of the most up to date authorised nurse signatory list for that unit.
The secretary to the AO must be informed every three months that the checks have been
carried out.
The ward pharmacist must ensure the AO is informed of any discrepancies
The ward pharmacist is responsible for destruction of patients’ own CDs unfit for use.
Ward pharmacy technician
Carries out weekly tablet count of drugs liable to misuse.
5
Authorised pharmacy technician
This is a pharmacy technician who has been approved to carry out CD ward stock checks and
support removal of unwanted stock from the ward to return to pharmacy.
To carry out a weekly ward stock of CDs in current use and to ensure the ward orders the CD
stocks required
The authorised technician must ensure the ward pharmacist and dispensary manager for their
location is immediately informed of any discrepancies.
Immediately inform the ward or dispensary pharmacist of any discrepancies.
S/he is not able to destroy CDs on the ward.
Ward Manager
To ensure the AO has their signature and to ensure the CD policy is being followed on their
ward.
To ensure the ward staff are clear about their responsibilities relating to CDs within the ward
and Trust.
To ensure the authorised nurse signatory list is kept up to date.
To ensure a random check of the CDs requiring safe custody (held in the CD cabinet) is
carried out every month on the ward.
To inform the AO of any discrepancies.
To inform the AO if they are leaving the ward.
Nurse in charge of the ward for the shift
To ensure the safety of the CD cupboard keys by ensuring they are only issued to the
authorised nurse signatories and identified pharmacy staff.
To carry out daily ward stock check of Controlled Drugs. For items in regular use this check
can be carried out during the administration process. A check of all stock levels should be
carried out independently of administration once a week.
Authorised nurse signatories
To hold the CD keys and ensure the safety of the CD cabinet.
To order, receive, and administer CDs in line with the approved SOPs.
Witness destruction of CDs unsuitable for use in line with the destruction policy.
Carry out weekly tablet count of drugs liable to misuse together with the pharmacy team.
Qualified nurses undergoing pre-ceptorship
To check the administration of CDs to service users in line with the SOPs.
To administer CDs under the supervision of the authorised signatory whilst undergoing
medicines with respect training.
Qualified nurses working as “Bank” on the ward
To check the administration of CDs to service users in line with the SOPs.
Other regular staff on the ward
To act as messengers to collect the CDs from pharmacy.
To check the administration of CDs if a deviation from the medicines code order is in place in
individual circumstances— for example if no second registered nurse is available.
6
DISPENSARY ACTIVITIES at Fieldhead Pharmacy
Designated Pharmacist responsible for CDs
To ensure a three monthly check of CDs is carried out and the AO informed. To respond to
any issues relating to CDs in the dispensary in line with the SOP.
Responsible Pharmacists in charge for the shift
To clinically check, dispense or accuracy check and complete the CD register in line with the
SOPs. To respond to any queries and advise the designated pharmacist or AO of any
discrepancies before leaving.
Authorised Pharmacy technicians
To carry out delegated activities relating to CDs in the pharmacy under the responsibility of the
designated pharmacist.
Qualified Pharmacy technicians
To order, receive, dispense, accuracy check and make entries in the CD register in line with
SOPs.
Pre-Registration Pharmacists and Pharmacy technicians
Under supervision and only when allocated to do so by the line manager/student supervisor,
To order, receive, dispense, accuracy check and make entries in the CD register in line with
SOPs.
Locum Staff
When induction complete. To order, receive, dispense, accuracy check and make entries in
the CD register in line with SOPs.
3
REVIEW
All SOPs should be reviewed routinely every two years.
Incidents reported via Datix may require SOPs to be amended prior to a routine review.
Changes in legislation will require an immediate review of SOPs affected by the changes.
4
CONTRIBUTIONS
The following staff have contributed to the production of the SOPs:
Lynn Haygarth
Accountable Officer and Chief Pharmacist
Paul Hardy
Principal Pharmacist, Wakefield and Forensic
Martine Wilkinson Senior Clinical Pharmacist Wakefield
Mandy Spencer
Ward manager
Sarah Hudson
Lead Pharmacist, Barnsley
7
5
CLASSIFICATION OF CONTROLLED DRUGS (CDs)
Schedule 1 (Controlled Drug Licence)
This schedule includes the hallucinogenic drugs (e.g. LSD and cannabis). A licence from the
Home Office is required for production, possession or supply; such licences are limited to
research and other special purposes. It would be unusual for the Trust to be conducting
research involving the drugs in this schedule. Any such research would need to be approved
by the Drug and Therapeutics Sub Committee and the Research and Development Approvals
Group. Once approved, a licence must be obtained before possession. The licence would be
held by the Chief Pharmacist and a copy would be kept in the relevant dispensaries involved.
The only other reason for possession of schedule one drugs is where these substances are
taken into possession for either destruction, or to hand over to the police.
Please note that Sativex spray has been given an exemption by the home office and
should be treated like a Schedule 2 drug if prescribed within our services
See: Illicit substances.- Practical Guidance and Management in the document store
Schedule 2 (Controlled Drug)
This schedule includes the opiates (e.g. diamorphine, oxycodone morphine, methadone)
major stimulants (e.g. amfetamines) and quinalbarbital. They may be supplied by a pharmacist
to a patient on the authority of a prescription in the required form. They may be supplied by a
pharmacist to a nurse in charge of a ward/unit on the authority of a requisition in the required
form. Full storage, register and destruction requirements apply.
Schedule 3 (Controlled Drug – No Register)
This schedule includes a small number of drugs which are either not so likely to be misused as
those in Schedule 2 or not so harmful if they are misused (e.g. phenobarbital, temazepam,
buprenorphine and flunitrazepam). Different regulations apply regarding registers but this is
very confusing for the wards and departments.
The Trust has decided to enforce the controls applying to Schedule 2 drugs to also apply to
Schedule 3 drugs therefore a register is required for these within the Trust.
Schedule 4 (Part 1 – CDs Benzodiazepines & Part II – CDs Anabolic)
This schedule contains most of the anabolic and androgenic steroids, growth hormones and
the benzodiazepines. As there is not a restriction on the possession, record of supply, or safe
custody requirements of these substances, when in the form of a medicinal product, these
drugs are not regarded as “controlled drugs” under this Trust policy. However as these drugs
are subject to misuse weekly reconciliation stock checks must take place both within the
pharmacy and on the wards.
Schedule 4 part 1 controlled drugs must be denatured before being placed into waste
containers.
Schedule 5
This schedule contains preparations of certain controlled drugs, such as codeine, pholcodine,
cocaine, morphine, which are exempt from full control when present in medicinal products of
low strength.
8
I
Schedule
Schedule 1 (CD Lic)
Schedule 2 (CD POM)
Schedule 3 (CD No
Register)
Schedule 4 Part I (CD
Benz)
Schedule 4 Part II (CD
Anab)
Schedule 5 (CD Inv)
Examples
Hallucinogenic drugs (e.g.
LSD), ecstasy-type
substances, cannabis
Opiates (e.g.
diamorphine), major
stimulants (e.g.
amfetamine), secobarbital
Minor stimulants (e.g.
benzfetamine), other drugs
not thought so likely to be
misused as those in
schedule 2 (e.g.
temazepam,
buprenorphine,
phenobarbital)
Most of the
benzodiazepines,
ketamine
Most of the androgenic
and anabolic steroids,
clenbuterol and growth
hormones (5 polypeptide
hormones)
Includes preparations of
certain controlled drugs
such as codeine,
pholcodine, cocaine and
morphine at a sufficiently
low strength to be exempt
from full control
Comments
Production, possession and
supply of drugs in this schedule
is limited to research and other
special purposes and a licence
from the Home Office is required
for lawful possession. Safe
custody regulations apply.
Safe custody applies to all
schedule drugs except
secobarbital.
Safe custody applies to
temazepam, buprenorphine and
flunitrazepam. At SWYPFT
these drugs are treated as
schedule 2 drugs in terms of
ordering, register and
destruction.
Safe custody does not apply.
These must be denatured before
adding to waste
Safe custody does not apply.
These must be denatured before
adding to waste
Safe custody does not normally
apply.
However it does apply in
SWYPFT to Oromoph.
9
6
CONTROLLED DRUGS REQUIRING SAFE CUSTODY SCHEDULE 2 & 3
List of drugs to be stored in the CD cupboard and recorded in the CD register when safe
custody requirements apply in the trust..
All drugs noted as CD2/CD3 CD4partI
in the BNF
See list of commonly used preparations below: This list is not exhaustive.






















Temazepam tablets and liquids
Buprenorphine tablets – Temgesic®, Subutex®
Buprenorphine patches - Butrans®, Transtec®
Barbiturates
o Amylobarbital (formerly amylobarbitone)
o Butobarbital (formerly butobarbitone)
o Phenobarbital (formerly phenobarbitone)
o Secobarbital (formerly quinalbarbitone)
Dexamfetamine tablets and liquid - Dexedrine®
Diamorphine tablets and injection
Dipipanone with cyclizine - Diconal®
Fentanyl patches - Durogesic DTrans®
Fentanyl buccal tablets, sublingual tablets, lozenges.
Methadone mixture, tablets, injection
Methylphenidate tablets/capsules - Ritalin®, Concerta®, Equasym®, Medikinet®
Midazolam injection
Midazolam buccal oral solution
Morphine sulphate oral solution – Oramorph®
Morphine sulphate MR tablets / capsules - MST/ Zomorph®
Morphine sulphate tablets - Sevredol®
Morphine sulphate injections
Oxycodone M/R tablets - Oxycontin®
Oxycodone capsules - Oxynorm®
Oxycodone liquid, injections
Pethidine tablets and injection
Targinact tablets
This list is not exhaustive.
10
DRUGS LIABLE TO MISUSE AND CDs COMING UNDER SCHEDULES 4 & 5 REQUIRING WEEKLY MONITORING
NAME
FORM
STRENGTH
CHLORDIAZEPOXIDE
CAPSULES
5mg
CHLORDIAZEPOXIDE
CAPSULES
10mg
CODEINE PHOSPHATE
TABLETS
15mg
CODEINE PHOSPHATE
TABLETS
30mg
DIAZEPAM
TABLETS
2mg
DIAZEPAM
TABLETS
5mg
DIAZEPAM
TABLETS
10mg
DIAZEPAM
LIQUID
5mg/5ml
LORAZEPAM
TABLETS
1mg
LORAZEPAM
INJECTION
1mg/4ml
NITRAZEPAM
TABLETS
5mg
ZOLPIDEM
TABLETS
5mg
ZOLPIDEM
TABLETS
10mg
ZOPICLONE
TABLETS
3.75mg
ZOPICLONE
TABLETS
7.5mg
STOCK
LEVEL
DATE
DATE
DATE
DATE
TOTAL
ORDERED
IN STOCK
TOTAL
ORDERED
IN STOCK
TOTAL
ORDERED
IN STOCK
TOTAL
ORDERED
IN STOCK
TOTAL
ORDERED
IN STOCK
WARD / UNIT ……………………………………………………………….
DATE
Others
Sign & print
Pharmacy technician
Stock checked and signed by
Authorised Nurse
11
7
OTHER DRUGS LIABLE TO MISUSE AND CDs COMING UNDER SCHEDULES 4 &
5 REQUIRING WEEKLY MONITORING
List of drugs that are subject to misuse where stock levels require to be monitored weekly to
prevent misuse and mis-appropriation.
These do not require to be stored in the CD cupboard or administered as per the full CD
regulations but do require weekly checking of stocks to ensure the levels are reconciled. This
is carried out by the ward pharmacy technician and an authorised nurse signatory (ideally the
medicines champion for the ward).
Commonly used preparations below:
Chlordiazepoxide capsules
Clonazepam tablets
Codeine tablets and liquid
Dihydrocodeine tablets
Diazepam tablets
Lorazepam 1mg tablets (no more than 2 boxes (56 tablets) to be stored at any one time)
Lorazepam injection
Loprazolam tablets
Lormetazepam tablets
Nitrazepam tablets
Oxazepam tablets and capsules
Zolpidem tablets
Zopiclone tablets
This list is not exhaustive.
8
LEGAL REQUIREMENTS FOR CONTROLLED DRUG PRESCRIPTIONS
It is unlawful for a prescriber to issue a prescription, which does not comply with the
requirements of the Misuse of Drugs Act. It is unlawful for a pharmacist to dispense such a
prescription.
8.1
Inpatient prescription charts
The written requirements for controlled drugs on these charts are the same as all other
medicines:

Drug name, strength, form

Route

Dose

Frequency (if prn, minimal interval for administration must be specified, e.g. every 6
hours)

Signed and dated
12
8.2
Prescriptions required for outpatients, for patients under the crisis resolution
services, for leaves and for discharges
No more than 30 days supply.
These prescriptions must be written in accordance with the requirements of the Misuse of
Drugs Act and subsequent Regulations.
Prescriptions for schedule 2 & 3 drugs [except temazepam] (an outpatient CD prescription or
is not required for temazepam except in Barnsley) must be in indelible ink and contain, in the
prescribers own handwriting, the following details:

Name and address of patient

Drug form and strength

Dose and frequency (‘as directed’ is not acceptable)

Total quantity in words and figures

Signature of prescriber

Date
The prescription must bear the work address of the prescriber and be signed and dated by the
prescriber.
Controlled drugs should be prescribed on the Trust official stationery or on FP10 prescriptions
written for CDs to be supplied from community pharmacy.
SWYPFT Controlled Drug Prescription.
These are classed as controlled stationery and as such are covered by a full audit trail.
Each prescription is individually numbered and this number will be indicated in the CD register
in the dispensing pharmacy.
These should be ordered from Pharmacy at Fieldhead or from your locality pharmacist in
Barnsley, Dewsbury and Calderdale.
In Barnsley an out patient prescription can be used.
Controlled Stationery should NOT be photocopied. If controlled stationery cannot be found
13
please contact your locality pharmacist.
CONTROLLED DRUG PRESCRIPTION FORM
9
(For discharge / out–patient use)
The clear sections of this prescription must be written in the Doctor’s own handwriting.
All sections must be completed
The information requested is a legal requirement. For further information on the prescription requirements for
controlled drugs please refer to “Controlled Drugs and Drug Dependence” in the “Guidance on Prescribing”
section of the current BNF.
Consultant
Ward / OP
Hospital No.
Full name and address of patient (Do not use “patient sticker”)
Date of birth
NAME, FORM & STRENGTH
OF PREPARATION
Name of preparation
(Dose form must be stated)
Form of preparation
Please ensure preparation
being prescribed exists in the
strength being prescribed
Strength of preparation
DOSE (If PRN the time interval must be stated)
Total quantity to be supplied
(i.e. the total number of tablets, ampoules, or mls
of liquid to be supplied)
This must be supplied in both words and figures,
no more than 30 days supply
Total quantity to be supplied
Words
Figures
Signature of prescriber
Date
Name of prescriber (please print)
Pharmacy Only
Clinical
Check by
Collected by (tick by
appropriate option)
Dispensed
by
If H/C professional –
name and address (e.g.
of ward or unit)
Checked
by
Date
Proof of identity
Handed out
Requested Y/N
By
Provided Y/N
Date
Patient
Patient’s rep
H/C professional
Signature of person
collecting…………………..
14
SECTION B
STANDARD OPERATING PROCEDURES
OBJECTIVES
To ensure all transactions involving controlled drugs in Clinical Areas/Departments within the
Trust are made according to current legislation, professional guidelines and SWYPFT
Medicine Code
SCOPE
Applies to Pharmacy and all Wards within the Trust
RESPONSIBILITY and APPLICABILITY
The Accountable Officer is responsible for the safe use and management of controlled drugs
within the Trust.
The Ward Manager is responsible for controlled drug activity within his/her Ward
The Nurse in charge of the ward is responsible for controlled drug activity during his/her period
of duty.
Authorised Nurses Signatories are responsible for their CD register entries of controlled drugs
in Wards.
Medical Staff are responsible for signing CD registers in the event that they performed the
administration
A second responsible person is responsible for acting as a witness to CD register entries
This is normally a second registered nurse.
In patients own homes where CDs are being administered by a community nurse a second
checker is not required.
Pharmacy staff are responsible for the safe storage, dispensing and receipt of controlled drugs
in pharmacy.
For community patients it is their responsibility of the patient or their family to return CDs to the
Community Pharmacy
15
16
STANDARD OPERATING PROCEDURE 1
Ordering, receipt and storage of Pharmacy (Fieldhead) Stock of Controlled
Drugs
1.1
Ordering of CDs from Pinderfields General Hospital (PGH)
To order a Controlled Drug a qualified pharmacist or qualified pharmacy technician needs to
call 01924 541359 to speak to a member of staff in the pharmacy stores at Pinderfields
Hospital. State the drug name and the quantity required.
Stock levels should be kept to a minimum that are compatible with demand and
replenishment. Minimum stock levels displayed inside CD cabinet.
BUT
The following situations will need a signed order to obtain the CD from PGH dispensary:
Order for a CD which may be delayed as a minimum order quantity needs to be met before
PGH can order, in this instance the order needs referring back to Fieldhead Pharmacy so a
signed order can be generated.

Order for an urgent CD needs a signed order generating.
1.2






Receipt
Once a Controlled Drug order for Fieldhead has been received at Pinderfields pharmacy
store, the stores staff will notify Fieldhead Dispensary by telephone.
Fieldhead dispensary will notify the porters at the Fieldhead site. The porters will make a
collection from the Pinderfields store at some point in the same day.
On collection of a sealed bag containing Controlled Drugs and delivery note from
Pinderfields Pharmacy, Fieldhead porters will sign to acknowledge receipt of Controlled
Drugs for delivery to Fieldhead pharmacy.
A qualified pharmacist /qualified technician will open the bag and check the contents
against the delivery note. If there are any discrepancies, refer to a pharmacist for advice.
The pharmacist / technician will sign the porter’s form to acknowledge receipt from the
Fieldhead porter, and return a copy to him/her and a copy needs to be filed in the
designated storage box in the Controlled Drugs room.
The Controlled Drugs need to be entered into the Controlled Drugs Register. Controlled
Drugs waiting to be entered into the register must be stored in a secure area.
A register must be kept of all receipts of schedule 2 and 3 Controlled Drugs. Controlled Drugs
must be entered into the register on the same working day that they are received. The register
entry may be made by a pharmacist or qualified technician. Qualified pharmacists/qualified
technicians may make entries without a witness. All other staff, e.g. during training, must have
their entry countersigned by a qualified pharmacist/qualified technician.
17
The register entry must include the following details: Date of receipt
 Order number
 Name and address of supplier
 Amount received
 Form in which received
The balance must be checked and initialled as correct by the person making the entry. A three
way check should be carried out, JAC/ Controlled Drugs Register/ stock in the Controlled
Drugs Cupboard.




1.3
The pharmacist / technician needs to sign the delivery note and fax it to the Pinderfields
pharmacy store (fax number 01924 541361), to verify safe receipt of the items.
The delivery note needs to be filed at the top position in the CD Invoices box file which is
kept in the CD room. Delivery notes (invoices) for schedule 3 drugs must be retained by
Pharmacy for two years.
The stock must be put away into the appropriate section of the Controlled Drug cabinet.
The Controlled Drug cabinet must be kept locked when not in use.
Storage
Controlled Drugs must be stored in a cabinet which meets the British standard for complying
with the safe storage of medicines. This must be held in a secure room or department and
kept locked at all times if it is unattended. Access to the keys is restricted to the pharmacist in
charge of the dispensary and can be issued to appropriate pharmacy staff so that they can
carry out their dispensary duties.
18
Date
Pinderfields General Hospital
Aberford Road
Wakefield
West Yorkshire
WF1 4DG
Pharmacy Department
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
West Yorkshire
WF1 3SP
Tel: 01924 327067
Fax: 01924 327076
Signed order for a controlled drug
Please supply the following controlled drug to Fieldhead Pharmacy
Department for dispensing purposes.
Name
Formulation
Strength
Quantity in words
Quantity in figures
Signature of pharmacist
Name of pharmacist
Chair: Joyce Catterick OBE
Chief Executive: Steven Michael
19
TRANSPORT OF CONTROLLED DRUGS BETWEEN
PINDERFIELDS AND FIELDHEAD PHARMACY
DATE/TIME ………………………………………………………………..
This is to acknowledge that the portering staff have collected a sealed
pouch from Pinderfields Hospital pharmacy containing ward controlled
drugs for delivery to Fieldhead Hospital pharmacy.
SIGNED …………………………………………………………………….
This is to acknowledge that the portering staff have delivered a sealed
pouch containing ward controlled drugs to Fieldhead Hospital
pharmacy.
SIGNED …………………………………………………………………….
20
STANDARD OPERATING PROCEDURE 2
Receiving, Validating, Dispensing, Labelling and Checking Prescriptions
for Controlled Drugs in Fieldhead Pharmacy
The Misuse of Drugs Act requires certain prescribing and record keeping legislation to be
followed. These are adhered to within this procedure.
The components of this procedure are:1.
2.
3.
4.
5.
2
Validating the prescription/requisition
Completing the Register
Dispensing the item
Accuracy checking
Delivery
Validating the prescription/requisition
Prior to dispensing, a clinical check should be carried out by a pharmacist to identify if the
request is for an item held on stock.
If it is for a new item or new patient, the pharmacist must have authorised the prescription by
means of a clinical check and a patient profile should be available with details of the dose and
administration.
If this is not available it must be clinically checked prior to dispensing. If it is an outside unit
then a fax of the prescription and administration chart should be sent to pharmacy and
clinically checked by a pharmacist before dispensing.
2.1
Ward requisitions
These must be received in pharmacy in the ward CD order book.
The requisition must be written by an authorised signatory and state:

Hospital or full authorised name of outside unit

Ward/Department

Drug name, form and strength

Quantity required

Signature and name of nurse
o – this must be printed and be identifiable on the ward authorised signatory list

Date

The second (pink) copy must be identical to the top (white) copy.
They must be validated by checking the signature of the person writing the requisition against
the list kept in the pharmacy department. They will be validated by the person DISPENSING
the item. If the requisition does not comply with the above, it should be returned to the ward to
be altered before dispensing.
21
2.2
Prescriptions
Use approved Controlled Drug Prescriptions. These must be used for all types of dispensing
that will be taken off-site, e.g., prescriptions for patients of the crisis resolution teams,
medicines required for leave, discharge and out-patient prescriptions. These are individually
numbered and treated as controlled stationery and should state:

Prescriber’s address.

Patient’s name and address.

Name, form, strength of drug.

Dose (maximum dose and daily dose if prescribed ‘when required’ e.g. ‘One or two up to
six times a day when required’ is acceptable but ‘when required’ is not).

Total quantity of each individual product to be dispensed in words and figures (like writing
a cheque); the total quantity in milligrams is not acceptable.
These must be validated by the pharmacist performing the clinical check.
2.3
Signatures
Ward Requisitions
These must be signed by a nurse who is an authorised signatory. The pharmacy will have a
list of authorised signatories for ward controlled drug order books, controlled drug checks and
signature checks. The list should be checked and updated at each three-monthly ward
controlled drug check. This is the responsibility of the ward pharmacist.
New signatures must be authorised by the Ward/Unit Manager and the list updated and
retained in pharmacy. Only authorised staff working regularly on the ward (not ‘bank or
agency’ staff) are able to order controlled drugs.
Prescribing by Doctors
The list of doctors’ signatures is held by the pharmacy office and a copy of all new doctors’
signatures is sent to the relevant pharmacist. This will be the lead pharmacist for each locality.
The prescription should be validated by the pharmacist performing the clinical check. If there
is any doubt about the validity of the signature, the prescriber should be contacted in order to
verify their authority to prescribe.
If a prescription does not comply with the above, it should always be returned to the prescriber
to be altered before dispensing. In exceptional circumstances, where the intentions of the
prescriber are clear to the pharmacist, the prescription may be dispensed (eg a provision
permitted following the Shipman enquires.
2.4
Completing the register
The register must be completed under the authority of a registered pharmacist. It is the view
of SWYPFT pharmacy department that this task may be undertaken by:

Any registered pharmacist under their own authority.

Any technician under the authority of any registered pharmacist.

Pharmacy assistant/student technician/pre-reg pharmacist who is being trained by any
competent member of pharmacy staff.
Each drug form and strength is given a different page in the register. An index is kept in the
register. The register entry must be made in black ink.
22
If a mistake is made it must be clearly bracketed and annotated as an error and a new entry is
then made, stating date, balance checked and correct, signed by the member of staff. Under
no circumstances may crossings out, alternations or tippex be used.
The Register entry must include:

Person collecting schedule 2 and 3 CD (patient/patients representative/healthcare
professional), and if a healthcare professional collecting their name and address.

Was proof of identify requested of patient/patients representatives (yes/no).

Was proof of identify of person collecting provided (yes/no)

Date of transaction.

Name and address of person supplied.

Licence or authority of person supplied.

Amount supplied.

Form in which supplied (but not necessary in each individual entry; see above).

The identification number on the CD prescription.
COLUMN IN
REGISTER
“Date of transaction”
WARD
REQUISITION
Date dispensed
Name and address from
who received. Also
write requisition
number in this box
“Name of person
Name of nurse
supplied”
“Address of person
Ward/dept name
supplied”
and hospital name
“Authority of person
supplied to be in
possession”
“Amount received”
“Amount supplied”
“Balance”
Status of
professional, e.g.
RMN, RGN
PRESCRIPTION
Date dispensed
INTERDISPENSARY
TRANSFER
Date supplied
Name of patient
Name of pharmacist
Patient’s home
address or address
on discharge
Name of prescribing
doctor
Dispensary name and
hospital name
MRPharmS
Leave blank or put a small line
Write in quantity supplied
Write in total balance remaining. Check balance, tick and initial as
correct.
A rolling stock check must be carried out after each transaction.
23
2.5
Fieldhead Pharmacy Dispensing of Controlled Drugs
This should be carried out by a Registered Pharmacist, Technician or by a Pre-Registration
Pharmacist or technician under supervision.
2.6
Ward Stocks
Each carton, syringe or bottle must be labelled individually. Do not label outer wrappers that
are likely to be discarded.
The label must state:








2.7
Drug name, form and strength
Quantity
“Store in controlled drug cupboard and enter each dose in a controlled drug register”
Department dispensed to
Date of issue
Expiry date if dispensed from bulk
Keep out of reach of children
Address of pharmacy
Out-patients/Self Medication/Discharge Prescriptions/Crisis/Leave Medication
These will be labelled in accordance with SWYPFT Labelling Procedure. In addition Self
medication/crisis/leave medication/discharge medication will be put in a dispensing bag and
prominently labelled:
“STORE IN A CONTROLLED DRUG CUPBOARD”
for ward staff information prior to the patient leaving the hospital.
2.8
Dispensing the item in Fieldhead pharmacy
Ward Stock
Method












Check that all copies of the order are identical to each other.
Produce the label. –
o
All items will be labelled in accordance with the SWYPFT Pharmacy Labelling
Procedure.
Always use earliest expiry date stock, including split packs. Different batch numbers may
be merged if of the same appearance.
Check you have picked the correct drug and strength.
Select appropriate container and lid.
Dispense required quantity. If dispensing from bulk liquids, powders etc annotate the bulk
quantity remaining.
Place label on pack carefully, so as not to obscure important information.
Check and sign the labels
Add expiry date label if information not already on pack.
Add Patient Information Leaflets.
Sign the order.
Complete entry in the register
24



2.9
Place with signed order for checking.
Carry out a 3 way check that level remaining in cupboard equals register and pharmacy
computer system. Tick and initial balance.
NB – Liquids and other bulk stocks often include an overage. This should be measured
and entered in the register as an overage. This amendment to the register level must be
witnessed and signed by a second member of pharmacy staff. The pharmacy computer
system level should also be amended if applicable during the three monthly stock check.
Accuracy checking
Accuracy checking must be carried out in accordance with SWYPFT Accuracy Checking
Policy, i.e., the person performing the accuracy check must have successfully completed their
training and proven their competency during the simulation exercise.
The accuracy checker MUST check that all copies of the prescription or requisition for the
controlled drug are the same, i.e. the second (pink) copy of the ward requisition must match
the top (white) copy; all copies of the discharge prescription must state the same details. It is
particularly important to check the quantity and strength ordered.
The entry in the CD register must be checked by the accuracy checker.
The item must be placed in the designated secure area to await collection or delivery.
25
STANDARD OPERATING PROCEDURE 3
Checking Stock of Controlled Drugs in Fieldhead Pharmacy
The register level, the actual drug level and the pharmacy computer should always tally. If
one or more of these levels does not tally, this discrepancy must be investigated and resolved.
It is important to remember that a discrepancy may indicate misuse.
Stock checking must include a review of security and a reconciliation of balances.
All reconciliation of balances will be documented on the next line of the relevant page of the
controlled drugs register, using the following format:
Date
Balance checked and correct
Signature
Balance
Tick and initial
A record must be made of all stock checks and retained for two years, as part of the register
and as rolling stock sheets.
It is the responsibility of the designated pharmacist at Fieldhead Pharmacy to ensure that
pharmacy controlled drug stocks are checked at least once every three months. The stock
check for temazepam should be carried out weekly. This task may be carried out by a
pharmacist, or a trained Pharmacy Technician.
.The check must include:




.
A reconciliation of levels including the pharmacy computer system.
Removal of time-expired or poor quality stock; to be booked out of the register and
pharmacy system and booked into the controlled drug waste register for destruction.
A rolling stock take should also be performed at the same time.
Signing the register as in 4 above.
The Police Inspection Officers may call upon the dispensary at random to inspect the
registers.
3
Controlled Drug Discrepancies in the dispensary
Where a discrepancy is found between the register/actual balance and the pharmacy system,
the following must be carefully checked:


All transactions in the register have been entered onto the pharmacy computer
All transactions on the computer are correct according to the register
If the error or omission is traced, contact a Senior Pharmacist who will witness the amendment
as it is done.
26
Where a discrepancy is found between the register and the actual balance, the following must
be carefully checked:




All orders received have been entered into the correct page of the register.
All supplies made have been entered into the register.
All returns from wards have been entered into the register.
Items have not been accidentally put into the wrong place in the cupboard.
If the error or omission is traced, contact the Senior Pharmacist and if necessary the
Ward/Unit Manager, who will witness the amendment as it is done.
If the cause of the discrepancy (i.e. the transaction error) cannot be found, contact the
Medicines Management Pharmacist who will then check that the checks above have been
correctly carried out.
All unresolved discrepancies must be reported to the Accountable Officer for CDs currently the
Chief Pharmacist.
If no error is found, the accountable officer will decide, in conjunction with local managers,
what action needs to be taken. This may include a decision to notify the police or other
outside agencies. If the discrepancy is on a ward, the Ward Manager and Service Manager
must also be informed. An incident form must be completed.
27
STANDARD OPERATING PROCEDURE 4
Distribution of Controlled Drugs - Ward and Pharmacy Staff
4.1
Signatures
At each point where a controlled drug moves from the authorised possession of one person to
another, a signature for receipt should be obtained by the person handing over the drug. A
record will be maintained in pharmacy of all controlled drugs distributed, showing the following
details:




Date
Name, form, strength and quantity of drug
Name and signature of person taking possession
Destination
This information will be recorded on the pharmacy copy of the order.
4.2
Distribution
The following methods of distribution may be used:






Collection by ward staff from Fieldhead pharmacy or Lloyds in Barnsley.
o In Barnsley, for Lloyds, where a taxi is used a staff member must accompany the
CD.
Collection by the patient or their representative from pharmacy OR ward.
Collection by external customer or their representative.
Collection by pharmacy staff.
Delivery by pharmacy staff.
Trust delivery service.
Lloyds pharmacy delivery service (Barnsley).
4.3
Ensuring Security of Delivery
Trust Delivery Service (including porters, drivers, security):




Check valid ID badge.
Ensure destination is known.
Ensure person making delivery is aware of safe storage and security and the
importance of handing over item and obtaining a signature for delivery.
Obtain signature.
Commercial Delivery:



Check valid ID.
Ensure destination is known.
Ensure person collecting parcel is aware of the importance of delivery directly to
destination and of not leaving the item at a general delivery point.
Patients or their representatives:
28


Check name.
Ask for address and check against the one on the prescription record name and
address of representative and if possible proof of identity to be provided.
The pharmacist must ascertain the role of anyone collecting a Schedule 2 or 3 Controlled
Drug. It must be ascertained whether the person is the patient, the patient’s representative or
a healthcare professional acting within their professional capacity as such. If a healthcare
professional is collecting, their name and address must be obtained and if they are not known
by the pharmacist, ID must be requested.
29
STANDARD OPERATING PROCEDURE 5
Ordering and Receipt of CD’s on wards
5.1

















The responsibility for ordering, receipt and storage of CDs is that of the ward manager
and nurses who are authorised signatories on the ward.
CDs can only be ordered from the supplying pharmacy by submitting a requisition from
the official CDs Requisition Book signed by an authorised nurse signatory. In Barnsley
these need to be signed by a doctor.
All CDs must be delivered to wards or departments in a tamper evident package.
Where appropriate a porter or messenger may deliver CDs in a tamper evident package.
The porter or messenger must sign a Drugs Delivery Record Sheet.
A trained member of staff must receive the package and sign the Drugs Delivery Record
Sheet.
The trained member of staff signs for receipt of a tamper evident pharmacy container.
If the CDs are to be collected by a trained member of staff the appropriate part of the
CDs Requisition Book must be signed and the medicines transported back to the ward in
a sealed package.
An authorised signatory must check the contents of the package containing CDs against
the requisition.
o Any discrepancy must be reported to the pharmacy immediately.
o If correct, the authorised signatory must sign the requisition.
The authorised signatory must enter the new stock into the CDs register on the
appropriate page, witnessed by another qualified nurse, a pharmacist or an authorised
Employee who must verify the stock level and sign the register.
o The balance should be adjusted to take account of the new stock received and the
existing stock. The balance should be doubled checked.
Each drug and each strength of the same drug must be entered on a separate page of
the CD register
o The number of the page should be indicated in the Index of the CD register
o If it is a new item or strength then a new page should be identified
o The name and strength of the drug should be written in the index and in block
capitals at the top of the page identified.
o When the page is complete a new page should be identified. At the bottom of the
complete page it should say go to Page XX. The index should also be updated. The
name and strength of the drug should be written in the index and in block capitals at
the top of the page identified.
The medicines must then be immediately locked away.
Where sealed packs of CDs are supplied with tamper evident seals, there is no
requirement to open these packs for stock checking purposes.
CDs must be stored in a locked medicines cupboard, approved by pharmacy and
reserved for the sole storage of CDs.
Access must be limited to nurses who are Trust authorised signatories, qualified nurses
regularly working on the ward, Pharmacists or Authorised Pharmacy Technicians.
Registers and Requisition Books for CDs are controlled stationery and obtainable only
from the pharmacy.
Requisition books should be locked away.
Orders and records must be in permanent ink and must be retained for seven years.
30
5.2
Flowchart for ordering and receipt of CD’s on wards
Registered Nurse orders the CD by completing an entry
in the CD requisition book for the ward/team.
Book signed by a doctor in Barnsley.
Book sent to pharmacy
Pharmacy staff check the nurse is authorised to order
CD’s by checking his/her details in the ‘register of
authorised staff signatures for CDs’.
Authorisation confirmed
Dispense the CD and complete the
necessary CD paperwork components
Return the CD requisition book and the
dispensed CD to the requisitioning
ward/department in the sealed
pharmacy bag
Authorisation not confirmed
Contact the requisitioning staff nurse
and inform them that CD cannot be
dispensed without written confirmation
of an authorised signature
Staff nurse
completes the
necessary
paperwork for
authorisation if
appropriate
OR
Another
authorised
registered nurse
goes to
pharmacy and
writes a new
requisition for
the CD and
original is
crossed ‘not
dispensed’
Dispense the CD and complete the
necessary CD paperwork components.
Receipt at ward /department.
A registered nurse must receive the pharmacy
bag containing the CD and must sign for
receipt of it. (Sign the requisition slip in the CD
order book.
Return the CD requisition book and the
dispensed CD to the requisitioning
ward/department in the sealed
pharmacy bag.
31
Authorised signature form
Staff authorised to sign for and order medicines and controlled drugs
(All registered nurses)
Ward…………………………………………………………………………………..........…
Staff signing this form agree to have read and understood their responsibilities in the
medicines code and the CD manual
Signature
Name
Countersigned and dated by
manager
Revalidated at 3
monthly CD check by
manager, to be initialled
and dated.
Received in Pharmacy by:
Name………………………………………………….Date…………………………..
Signature……………………………………………………………………………….
32
Authorised signature form
Pharmacy Staff authorised to stock check and manage controlled drugs on wards and
departments
Pharmacy team based at ……………………………………………..........……………………..
Staff signing this form agree to have read and understood their responsibilities in the
CD manual.
Name
Signature
Pharmacy Manager’s
signature
Date
Received on ward/department by:
Name………………………………………………….Date…………………………..
Signature……………………………………………………………………………….
33
5.4
Deviation from Medicines Code
Local procedure for administration of Controlled Drugs
Ward
……………………………………………………………………….
Locality
North Kirklees
South Kirklees
Wakefield
Calderdale
Forensic
Barnsley
(Please circle)
The Medicines Code states that “the administration of all controlled drugs must be witnessed
by a second practitioner”. Practitioner is a term used to describe a qualified nurse.
In the above named circumstances it has been agreed that the witness may be another
member of permanent (ie not bank/agency staff)…………………... (Ward name) staff to. This
may be a healthcare support worker. The deviation acknowledges that at all times only one
qualified nurse practitioner may be on night duty. All other requirements of the Medicines
Code must be followed.
Unit manager
Signed
................................................................................................................................
Date
................................................................................................................................
Unit pharmacist
Signed
................................................................................................................................
Date
................................................................................................................................
34
5.5
Procedure for obtaining temazepam tablets for an in patients at Fieldhead Hospital when
the Fieldhead Hospital pharmacy is closed.
If an in patient at requires temazepam tablets out of hours, the on call pharmacist can ask the
nurse in charge on Chantry Ward to write the supply in their CD order book (a box containing
6 X 10mg tablets). The nurse in charge on Chantry Ward will write that the supply has been
transferred to the requesting ward and will also sign the transfer note. The nurse in charge on
the receiving ward will sign the transfer note to confirm that the ward has received the supply.
If it is an off site in-patient unit then the unit manager would be required to arrange transport.
35
Deviation from Medicines Code
Local procedure for possession/storage of the controlled drugs cupboard keys:
Name of Service…Crisis and Home Based Treatment Teams
Locality
North Kirklees
South Kirklees
Wakefield
Calderdale
Barnsley
(Please circle)
The Medicines Code states that “the keys for the CD cupboard are held for the duration of the
shift by the nurse in charge of the shift and only given to nurse authorised signatories for
administration of medicines or designated pharmacy staff for the checking of medicines”
It has been agreed that in certain community based teams it is not practicable for the
designated nurse in charge to personally be in possession of the controlled drugs key. The
designated nurse in charge of a shift is usually required to leave the base unit to conduct
home visits etc. The key may have to change hands many times over a shift, thus risking
inadvertent misplacement. In this situation the controlled drugs key is to be stored in the
medicines key code safe together with the other medicines keys. All other requirements of
the Medicines Code must be followed.
Unit manager
Signed
..............................................................................................................
Date
.............................................................................................................
Unit pharmacist
Signed
................................................................................................................
Date
................................................................................................................
Chief Pharmacist / Accountable Officer
Signed…………………………………………………………………………………
Date……………………………………………………………………………………
36
STANDARD OPERATING PROCEDURE 6
6A Administration to service users on wards
6.1 (a)
normal
local
The administration of all CDs must be witnessed by a second practitioner. In
circumstances this will be by a second qualified nurse. In certain circumstance a
policy for deviation from this may be approved as in 5.4.
6.2 (a) An entry must be made in the ward or department CDs register, including:
o Date and time of administration.
o Name of service user.
o Dose administered.
o Full signature of both practitioners.
o Remaining stock balance must be checked.
o Any medicine prepared and not used, or only partly used, must be destroyed in the
presence of a second practitioner. An entry must be made in the CD register and
signed by both practitioners.
6.3(a) If a mistake is made in the CD register it should bracketed in such a way that the
original entry is still clearly legible. This should be signed ,dated and witnessed by a
second registered nurse or other registered professional. The witness may be a
healthcare support worker if a deviation from the medicines code is in place.. The
witness should also sign the correction.
6.4(a) Any discrepancies must be brought to the notice of the ward manager as soon as
possible and to the responsible pharmacist on the next working day and reported
immediately on Datix.
6 B Administration to service users in their own homes
6.1 (b)
There is no need for the CD administration to be checked by a second nurse,
however in this situation the administering nurse should be extra vigilant.
6.2 (b)
The administration of the Controlled Drug should be recorded on the patient’s
Controlled Drug Medication administration record.
The remaining stock balance should be checked
6.3 (b)
Any discrepancies must be brought to the attention of the patient, their carer and
where this cannot be resolved this must be reported on DATIX as soon as
possible.
37
6.5(a) Flowchart for administration of CDs to in-patients 6A
Patient requires administration of a CD as per their prescription
Single nurse administration does not apply here. Registered nurse along with a
second registered nurse as checker must process the prescription. (In certain
circumstances a deviation form may be completed .5.4)
Remove the appropriate CD as per prescription from the CD cupboard
Check the following particulars of the selected CD against the prescription:
 Name of the drug
 Strength required
 Formulation required (tabs/caps/liquid/injection)
 Quantity of drug requested
 Expiry date of the drug
Once happy that the correct drug has been selected measure out using an
appropriate measuring apparatus/count out the quantity of drug required
Second nurse should check that the correct drug and quantity has been selected
at this point
First nurse will enter the particulars of the drug to be administered in the CD
record book as follows:
 Date and time of administration
 Name of client to be administered to
 Quantity to be administered
 Signature of the administering registered nurse
 Signature of the checking nurse
 Running balance
Registered nurse will check the ‘running balance figure’ with the quantity of the
CD remaining in the cupboard
NB This procedure can be followed either in the clinic room or at the patient’s bedside
Balance in cupboard and
record book CORRECT
Registered nurse initial the
running balance figure as being
correct
Balance in cupboard and
record book INCORRECT
Follow the procedure for handling
CD discrepancies after the CD
has been administered
Administer the measured out CD to the named patient – checking their identity
before administration and the prescription against the CD selected one last time
Annotate the prescription that the drug has been administered
Return the stock CD box/bottle to the CD cupboard. Lock the cupboard.
38
STANDARD OPERATING PROCEDURE 7
Recording of Patient’s own CD’s on wards
(At MVH, NRU (Barnsley) this is a separate book.)
If a patient brings in his/her own supply of Controlled Drugs they must be entered separately in
the ward CD register on a separate page. This is allocated towards the back of the CD
register. If they are to be administered to the patient then records as in 6 above must be made
or in a separate book in Mount Vernon and NRU
Clearly identify that the drug on the page is patients own.
Identify if the medicines is suitable for use.
If they are deemed suitable for use, see flow chart below,
On the death of a patient on the ward (this applies to patients own drugs and not ward
stock)










Patients’ own Controlled Drugs must never be returned to a relative or carer and must
be kept on the ward in quarantine in the Controlled Drugs Cupboard for two weeks in
case they are requested by the coroner.
The CDs must be booked out of the CD register and an entry made stating “Patient
deceased”.
The CDs, together with other PODs must be placed in a sealable bag with the patient’s
name on it.
A list of these medicines, along with their quantities, must be entered both on RiO and
in the ward diary and the entry dated and the date after which they can be destroyed.
This should be witnessed and signed by two nurses, or a nurse and a member of the
pharmacy team. The bag should then be sealed and the two people involved in
witnessing the sealing should sign across the seal along with the date. The bag should
then be stored in the CD cupboard.
CDs will have been booked out of the CD register; they do not need checking when the
weekly CD check is done.
If the Coroner asks for the medicines they can be released to his or her approved
representative. The wording “Handed over to the Coroner” along with the date handed
over should be written against original entry in the ward diary and on RiO and this
should be signed by the coroner’s representative removing them and by a nurse who
must witness the removal. The name of the coroner’s representative must also be
documented on RiO.
If after two weeks the Coroner has not asked for the medicines, inform pharmacy who
will arrange for the return to pharmacy in the sealed bag. The wording “Returned to
pharmacy” along with the date returned, should be written against original entry in the
ward diary, on RiO and in the CD register and this should be signed by the member of
the pharmacy team removing them and by a nurse who must witness the removal.
If the relatives or carer insist on collecting the medicines after the two weeks, advice
should be sought from the Chief Pharmacist or Deputy Chief Pharmacist.
In Barnsley CDs must not be returned to pharmacy. An authorised witness
should be asked to attend the ward to destroy the CDs..
39
Patient brings in own CDs.

Registered nurse checks the suitability of them for continued use
whilst on the ward (see Medicines code Section 13).
The following to be checked:
 Good appearance and quality
 Accuracy of drug and label
 Be in their original dispensed container
Expiry date, or if no expiry date is available, dispensed within last
six months
Continue to use and record details in the
patient’s own section of the CD record
book or the patient’s own register. Store
in CD cupboard. Action should be
checked by a second qualified nurse or
pharmacist/authorised pharmacy
technician.
Page heading should include:

Name

Strength

Form of CD

Patient’s name

Ward


Not suitable for use.
Contact designated pharmacist to
remove from ward for disposal.
Record details in record book
under patient’s own meds and
store in CD cupboard. Action
should be checked by a second
qualified nurse.
Return of patient’s own controlled drugs to the patient
Patient’s own controlled drugs may be returned to the patient upon
discharge if appropriate
Return to patient
Document in patient’s own section of
the ward controlled drug register or the
patient’s own register.
Unfit for return to the patient or
not appropriate
Must be destroyed with the
patient’s consent
Item must be destroyed by a
registered pharmacist witnessed by
a registered nurse
Document in CD register under
patient’s own section
40
Flowchart on the death of a patient on a ward
*Do not return CDs to a relative or carer*
Patient’s own CDs and medicines to be put in a
sealed bag with patient’s name on it and
quarantined in the CD cupboard for two weeks
Entry to be made in the CD register stating “Patient deceased”
Enter in ward diary, in patient’s notes in the diary
and on RiO  name of medicines,  quantity of
each medicine,  date of the entry,  state the
date after which the medicines can be destroyed.
Require to be kept for 2 weeks in case the Coroner
requests them.
Entry to be witnessed and signed by two nurses or
a nurse and a member of the pharmacy team.
The witnesses need to sign across the seal of the
bag and add the date.
If requested by coroner
CDs and medicines can be released to
the coroner’s approved representative
Enter the following in the ward diary on
RiO and the ward CD register against
original entry
 handed over to coroner,
 time and date handed over.
Entry in ward diary and CD register to be
signed by representative removing the
medicines and nurse authorising
removal.
If after 2 weeks and the coroner has NOT
requested the medicines, inform pharmacy to
arrange for a pharmacist to denature the CD’s
and dispose of the other medicines as per Trust
waste procedure.
Enter the following in the ward diary on RiO and
the ward CD register against original entry
 medicines wasted / denatured on the ward,
 date and time.
Entry in ward diary and the CD register to be
signed by the pharmacist and the nurse
authorising the denaturing/wasting of
CDs/medicines
41
STANDARD OPERATING PROCEDURE 8
Checking Stock of Controlled Drugs on Wards
8.1
Nursing responsibilities













8.2
Controlled drug stock should be checked on a daily basis by the nurse in charge.. For
items in regular use this check can be carried out during the administration process. A
check of all stock levels should be carried out independently of administration once a
week.
There is no need to open packs with intact tamper evident seals for stock checking
purposes. Where possible there should also be verification of entries in the register
against entries made on individual prescriptions.
The nurse in charge must be an authorised nurse signatory for the ward.
A record indicating this check has been carried out must be kept in a separate record
book/sheet or in the CD register and must confirm the stock is correct. The record must
be dated and signed by both practitioners.
The ward manager must ensure that these checks are carried out.
The ward manager must undertake a random check of all CD cupboards at least once a
month and record it in the ward register.
It is good practice that stock balances of individual preparations be checked after every
administration. An exception to this are liquid medicines where stock balances can only
be checked when the bottle is empty.
Any discrepancy must be reported to the nurse in charge who must inform the ward
pharmacist or AO.
The need for more frequent checks will be decided by the ward manager in liaison with
the AO
A pharmacist or authorised pharmacy technician must check the CDs balance a
minimum of every three months and when overall responsibility for the medicines
change e.g. change of appointment of the ward manager. Where possible there should
also be verification of entries in the register against entries made on individual in-patient
prescriptions.
In the event of a discrepancy between the stock balance and register for CDs the nurse
in charge must immediately and thoroughly investigate the loss together with the ward
pharmacist.
A missing entry must be sought but, after an unsuccessful investigation, the
discrepancy must be reported immediately to the senior manager responsible for the
ward or department and the AO who can then consider whether or not the police should
be notified.
An incident report must be completed
Pharmacy responsibilities
All stocks of Controlled Drugs outside pharmacy will be checked by a pharmacist or authorised
pharmacy technician at least every 3 months and at other times when requested by the
Ward/Department Manager or at the discretion of the Chief Pharmacist. Security and quality
of record keeping will be reviewed at each stock check. The list of authorised signatures for
ordering will be updated. A system will be in place to draw Ward Manager’s and Ward
Pharmacist’s attention to exceptional usage of a particular Controlled Drug.
(NB: The procedure of the acute trust must be followed at Calderdale Royal Hospital and the
Dewsbury District Hospital)
42
8.3
Equipment required
a) Signature list of Nursing Staff authorised to order Controlled Drugs for a
Ward/Department.
NB – This must be checked for accuracy at each ward CD check and be in date.
8.4
Quality and quantity check on the Ward/Department
Arrange with the Ward/Department Manager a suitable time to carry out the check. The check
must be carried out in conjunction with the Ward Manager/nurse in charge.
Review the quantities and range of Controlled Drugs on the ward with the Ward
Manager/nurse in charge.
Start at page 1 of the ward controlled drug register and gradually work through the book. At
each page check the quality of record keeping – look for crossings out, deletions and other
anomalies that may indicate incorrect record keeping. At the bottom of each page ensure
stock balances are correctly transferred to a new page.
At each current stock entry check the following:

The controlled drug has not reached its expiry date and appears to be in good
condition.
The balance in the register matched the number in stock.
The container is appropriate.


If the controlled drug is correct make an entry in the register in BLACK ink in the following
style:
Date
1/1/2005
8.5
Quantity in words ‘checked
and correct’
Twelve ampoules checked and
correct
Signature
F Bloggs
Quantity in figures in the
balance column and circled
(12)
Security
Check the security arrangement for the storage and ordering of Controlled Drugs.
Take to the ward a photocopy of the authorised signature list. Give the Ward Manager the
copy of the authorised signatures and ask for it to be updated and then sent to the pharmacy
for filing (where it will replace the original).
Review the report of Controlled Drug supplies and highlight any unusual trends to the Ward
Manager.
8.6
Discrepancies
The pharmacist must inform the Ward Manager and the AO of any discrepancies and
complete a Datix Report.
43
8.7
Flowchart for Handling Discrepancies on wards and departments
Running balance discrepancy noted by registered nurse
Notify appointed practitioner in charge of the discrepancy
Both practitioners to thoroughly investigate all previous
entries and checks made with specific prescriptions if
necessary
Discrepancy identified
Inform the designated pharmacist of the
discrepancy
Designated pharmacist together with
one of the designated practitioners
involved will adjust the balance stating
an explanation of the discrepancy in
the record book entry with the
adjusted running balance. Both the
designated practitioner and
pharmacist to sign against the entry.
Discrepancy not identified
Inform the designated pharmacist and
the senior manager responsible for the
ward / department to further investigate
the discrepancy
Discrepancy
identified
Discrepancy not
identified
Balance
adjusted by the
designated
pharmacist and
explanation
stated in the
record book.
Both the
designated
pharmacist and
appointed
practitioner in
charge to sign
the entry.
Contact the
Trust
Accountable
Officer to further
investigate the
discrepancy.
The
Accountable
Officer will
decide if the
police need to
be informed
44
STANDARD OPERATING PROCEDURE 9
Storage of Controlled Drugs
9.1
The Misuse of Drugs (Safe Custody) Regulations 1973 cover the safe custody of
controlled drugs in certain premises. The Regulations also set down certain standards
for safes and cabinets used to store controlled drugs.
9.2
All CDs must be stored in a locked cupboard which can only be opened by a person
who can lawfully be in possession, such as pharmacist or a Ward/Unit Manager, and an
authorised nurse signatory.
The keys for the CD cupboard must be stored on a key ring that is able to be separated
from the rest of the keys for the clinic room and from the other medicines keys. The
keys for the CD cupboard are required to be held for the duration of the shift by the
nurse in charge of the shift and only given to nurse authorised signatories for
administration of medicines or designated pharmacy staff for the checking of medicines.
Pharmacy staff must ensure the keys are returned to the nurse in charge of the ward or
an authorised nurse signatory.
9.3
In the Trust, the following standards apply to the storage of controlled drugs:





Cupboards must be kept locked when not in use
The lock must not be common to any other lock in the hospital
Keys must only be available to authorised members of staff
The cupboard must be dedicated to the storage of controlled drugs. No other
medicines or items may be stored in the controlled drug cupboard. (except
where a deceased patients drugs must be stored
Controlled drugs must be locked away when not in use.
In addition, the following standards relating to the actual cupboard should be met:
Ward Cupboards must conform to BS2881 or be otherwise approved by the Pharmacy
Department.
Pharmacy cupboards should comply with the advice given by the Police Crime
Prevention division i.e.:

Able to withstand attack for 15 minutes after the departmental alarm has been
triggered.

Not located on an external wall.

Ideally the contents should not be visible to patients or visitors when the
cupboard is open.
9.4
There are no storage requirements for the storage of CDs in patients’ own homes.
However nursing visiting should provide advice on safe and appropriate storage of
controlled drugs.
45
9.5
Flowchart for the receipt and storage of CDs on wards
Receipt of CDs into ward/department
The registered nurse receiving the pharmacy bag containing the CD must
immediately put away the CD safely.



Check the CD received against the requisition. Checking for:
Correct drug, strength, formulation, quantity
An in-date expiry date
Any discrepancies must be reported to pharmacy immediately
Place the CD in the cupboard
Enter the details of the received CD into the ward CD record book. To include:
 Date and time received.
 Received from pharmacy – requisition serial number
 Quantity received.
 Signature of receiving nurse and signature of checking nurse (registered
if available otherwise an authorised health care worker).
 Running balance.
 Check the running balance figure with the quantity in the CD cupboard.
Balance in cupboard and
record book CORRECT
Balance in cupboard and
record book INCORRECT
Follow the procedure
for handling CD
discrepancies
Lock CD cupboard. Safely file away CD
record book and requisition book in the
appropriate place in the clinic room
(usually inside the CD cupboard).
Lock the clinic room on exit and return
the CD cupboard keys to the authorised
member of staff (nurse in charge of the
ward)
46
STANDARD OPERATING PROCEDURE 10
Return/Disposal/Destruction of unwanted CDs
Destruction of Controlled Drugs at ward level
10.1
Patients own Controlled drugs
These can be destroyed using an approved denaturing kit by the ward pharmacist together
with either the ward manager or an authorised nurse signatory.
Consent should be given by the patient prior to destruction of the CDs.
An entry must be made in the patient’s own section on the relevant page stating that the CD
has been destroyed.
Both the authorised nurse and the pharmacist must sign the book to say the CD has been
destroyed including the date the time and any medicines left on the ward.
The denaturing kit is now classed as “waste medicines” and can be disposed of in line with the
Trust policy for disposal of medicines.
10.2
Ward stock
10.2.1
Units that are supplied by Fieldhead Pharmacy
On the ward
When there is stock that is no longer required on the ward this should be returned to
pharmacy. This should be done together by an authorised nurse signatory and the
ward pharmacist/authorised pharmacy technician.
Make an entry in the ward controlled drugs register stating that the CD has been
returned to pharmacy.
Make an entry the ward CD order book stating the name, form, strength and quantity of
drug being returned to pharmacy.
These should be signed by both the authorised nurse signatory and the ward
pharmacist/authorised pharmacy technician.
The book should then be returned with the CDs to pharmacy. The appropriate section
of the page in the book should then be signed by the member of pharmacy receiving
the CDs. The medication and ward CD order book must be transported to pharmacy in
a sealed tamper evident container. If it is an outside unit appropriate transport
arrangements MUST be made.
Excess stock should be returned to pharmacy as soon as possible and NOT left on the
ward to incur daily stock checks. See section 1.10
47
In the pharmacy at Fieldhead
Stock returned to pharmacy must be entered into the pharmacy register that working
day. This entry MUST be witnessed by another pharmacist or a qualified pharmacy
technician.
10.2.2
Wards and departments in Barnsley and any other areas where ward stock
cannot be returned to the supplying pharmacy.
The CDs should be destroyed using the denaturing kit in the presence of an authorised
witness together with the ward manager or the nurse in charge of the ward. The nurse
is required to be an authorised nurse signatory.
Make an entry in the ward controlled drugs register stating that the CD has been
destroyed.
The de-naturing kit is now classed as “waste medicines” and can be disposed of in line
with the Trust policy for disposal of medicines.
The Controlled drug destruction record should be completed.
10.2.3 In patients’ homes. CDs should be returned to the community pharmacy by
the patient’s own family or carers. SWYPFT staff should only return CDs for patients in
exceptional circumstances and this should be recorded in the notes. Under no
circumstances should any waste medicines be returned to hospital sites from patients’
homes.
48
Date :
10.2.3 Controlled Drugs Destruction Record
Location :
Stock /
Patient
Return
Authorised
Designation)
Details (drug description, quantity destroyed & patient initials [if
applicable])
Witness
(Name
&
Second Witness ( Name & Designation)
Comments (if required): (please continue overleaf or separate sheet if necessary)
Lynn Haygarth Accountable Officer, South West Yorkshire Partnership NHS Trust. D
49
10.3
Flowchart for the return/disposal of unwanted CD’s on the ward
(this does not apply in Barnsley)
CD is no longer required, or
CD has expired (out of date)
Authorised nurse signatory to contact the ward pharmacist to remove the CD
from the ward / department
Ward pharmacist will remove the unwanted CD from the CD cupboard in the
presence of an authorised nurse signatory
Ward pharmacist will make an entry in the CD record book to include:
Date and time of the removal
Reason for removal of the CD
Enter the appropriate stock balance – checking against the stock in the
CD cupboard and indicating if it is correct by initialing the balance figure
 The authorised nurse signatory will countersign the entry as a witness



A copy will be made in the CD order book stating medicines returned to
pharmacy. The book will accompany the medication in the temper evident
package. The pharmacist will return the unwanted CD to the pharmacy.

Fieldhead Pharmacy
It is the pharmacist’s responsibility to ensure the following occurs:
 Drugs are returned on the pharmacy computer system
 Drugs will be entered into the register and placed in the correct location
within the controlled drugs cupboard.
 If the drugs are deemed unsuitable for recycling, they will be entered directly
into the pharmacy destruction register. They will not be returned onto the
pharmacy computer system.
This process must be witnessed by another pharmacist or qualified
pharmacy technician.
 CDs to be denatured must be stored in a designated area of the CD
cupboard separate from other stock CDs.
Patient’s own medication can be entered into the destruction register under
patients own medication section and can be denatured by a pharmacist
50
Form 2
Record of Drugs Requiring Denaturing in Fieldhead Pharmacy
All CDs and drugs liable to misuse denatured by pharmacy (pharmacy stock / patient’s own returns etc.) must be recorded on this form.
Records must be kept on the ward/area for a minimum of 2 years
Date
Drug Name
Strength
Quantity
Reason for denaturing
Denatured by
Witnessed by
51
10.4
Ward Disposal/Destruction of Prepared/Partly-Used or CDs not
administered
Any dose of a CD that is prepared but not administered, including partly used syringes used in
syringe driver pumps shall be destroyed on the ward or department. The destruction of the CD
must be in the presence of a second registered nurse. The appropriate entry should be made
in the CD register, which includes the signatures of the 2 practitioners involved in the
destruction.
In the community the nurse should place any unwanted or unusable partly used drugs in the
sharps bin with the other paraphernalia.
Dose of a CD that is prepared and not administered for whatever reason (e.g.
contaminated, fell on floor, broken capsule)
Destroy on the ward/department by the registered nurse using a denaturing kit
(obtained from pharmacy) or in the sharps bin.





An entry made in the CD record book to include:
Date and time of destruction
Reason for destruction
Signatures of both practitioners
Running balance
One designated practitioner to initial the balance if the stock and record
book balances are correct
52
10.5
Destruction of CDs
Type of
drug
Where
Person who
must destroy
drug
Person who
must witness
destruction
Pharmacist
Authorised
nurse
signatory
Where
register
entry
must be
made
Ward CD
register
Notes
Patient’s
own unsuitable
for use
On the
ward
Patient’s
own –
unsuitable
for use
handed in
directly to
Pharmacy
by patient
Ward stock
– unfit for
use
The
Pharmacy
to which
they have
been
handed in
Pharmacist
Pharmacist
Authorised
pharmacy
technician
Pharmacy
Destruction
Register
Return to
pharmacy
or
Pharmacist
Pharmacist
Authorised
pharmacy
technician
Ward
controlled
drug
register
On the
ward
Trust
authorised
witness
Authorised
nurse
signatory
On the
ward –
Authorised
nurse
signatory
Registered
nurse,
pharmacist, or
doctor
Ward
controlled
drug
register
Ward register
must state
name of patient
and details of
dose/wastage
e.g. 5mg
given/5mg
wasted.
Authorised
nurse
signatory
Registered
nurse, doctor,
or pharmacist
Ward
controlled
drug
register
Register must
state name of
patient and
reason for nonadministration.
Person who
Where
Wastage
from part
doses
drawn up on
ward for
individual
patient, e.g.
when giving
5mg dose
from 10mg
ampoule.
Dose drawn
up on ward
for
individual
patient but
not given
Type of
Or
Trust
authorised
witness.
or
In a
denaturing
kit or in the
sharps bin
On the
ward –
In a
denaturing
kit or in the
sharps bin
Where
Person who
Patient’s own
drugs may be
kept on the
ward for
destruction after
the patient has
been
discharged. The
patient should
consent to the
destruction.
The patient
must consent to
the destruction.
The
destruction
Register must
be kept for 7
years
Notes
53
drug
must destroy
drug
must witness
destruction
register
entry
must be
made
Ward CD
register
(separate
section or
separate
register for
suspected
illicit
substance)
Suspected
illicit drug or
substance.
Ward
Pharmacist or
Police Officer
Authorised
nurse
signatory
Suspected
illicit
substance/d
rug taken
away by
police
CDs in
patient’s
home when
patient has
died
N/A
Police officer
Authorised
nurse
signatory
Ward
register
Return to
community
pharmacy
preferably
by family
member or
carer.
N/A
N/A
N/A
No patient name
required
Possession is
illegal unless for
the purpose of
destruction or
handing to the
police; such
disposal must
be timely. These
substances
must never
under any
circumstances
be handed back
to the patient.
See Pg 17-18
Record required
in ward CD
register of drug
being removed
by police
Record required
on a CD
administration
card in patient’s
own home.
NB when a sharps bin contains Pharmaceuitcal waste it should be labelled
“Contains mixed Pharmaceutical waste and sharps for incineration”
54
STANDARD OPERATING PROCEDURE 11
Control of Stationery
11.1
All stationery stored on the ward, which is used to order controlled drugs, must be kept
in a locked cupboard or drawer.
11.2
All stationery stored in pharmacy which is used to order controlled drugs must be kept
in a secure area which is locked when there is no one present.
11.3
A written order must be received for supply of stationery.
11.3.1 Stationery may be ordered from pharmacy using the ward-controlled drug
requisition book.
11.3.2 Stationery includes:

FP10 Prescriptions

Controlled drug order books

Controlled drug ward register

CD prescriptions (these must not be photocopied, they are numbered).

Lloyds out patient prescriptions
Stationery may be ordered by Ward Manager or an authorised nurse signatory or by Ward
Pharmacy staff. In the case of a new ward opening, stationery will be authorised by the Ward
Pharmacist/Pharmacy Manager.
11.4
A record must be kept for the supply of stationery.
11.4.1 The record of supply will include the following details:

Date

Ward/Department

Name of person ordering the stationery

Type of stationery issued

Quantity

Signature of pharmacy staff making the supply

The attached Proforma may be used.
11.4.2 Any unused stationery returned to pharmacy will be recorded as a return
in the supply record; giving the details above.
11.5
Loss or theft of any controlled stationery which may be used to order drugs must be
reported immediately to the ward pharmacist or the AO.
11.6
Transfer of balances to a new ward register may be carried out on the ward by ward
staff.
11.7
Completed ward requisition books and registers must be retained for two years from
the date of the last entry. CD registers to be kept for seven years if records of
destruction of CDs on ward are in the register. These should be retained on the ward.
If the ward closes, they should be retained by the relevant nursing management.
55
11.8
CONTROLLED DRUGS STATIONERY
Record of Issue from Pharmacy
DATE
WARD/DEPT
NAME OF
TYPE OF
PERSON
STATIONERY
ORDERING
ISSUED
STATIONERY
QUANTITY
(serial
number if
appropriate)
SIGNATURE
OF
PHARMACY
STAFF
56
STANDARD OPERATING PROCEDURE 12
12A Returning Controlled Drugs to Pharmacy when a Ward Closes
(Not applicable in Barnsley )
When a ward closes for a short period (less than 3 months), Controlled Drugs must be
returned to Pharmacy. This is for security reasons.
12.1
The Controlled Drugs must be removed from the Ward cupboard in the presence of a
registered nurse and a second person who will act as a witness; this may be another
registered nurse or a pharmacist who is going to return the Controlled Drugs to the
pharmacy department for safe storage.
12.2
Each drug will be signed out of the appropriate section of the ward register by the
nurse. The witness will countersign the entry. The entry will state that the drugs have
been temporarily taken to Pharmacy for safe storage.
12.3
The Controlled Drugs will be sealed into a container, for example, a tamper evident
container. The seal will be signed by both persons. The container will clearly state:



Date
Name of both persons
Ward area
12.4
The container will be taken to pharmacy and placed for safe storage into the pharmacy
Controlled Drug cabinet.
12.5
When the Ward re-opens the sealed container will be returned to the Ward. Once on
the Ward, the container will be opened by a registered nurse, witnessed by a second
nurse or a Pharmacist. An entry in all of the appropriate sections of the register will be
made, stating that the drugs have been returned to the Ward; this entry will be signed
by the nurse and the witness.
12.6
The contents of sealed containers that are being stored in pharmacy WILL NOT BE
ENTERED INTO THE PHARMACY STOCK REGISTER.
12.7
Controlled Drugs that are being transported between wards and pharmacy must be
carried in a safe and secure tamper evident container.
When a ward closes permanently all Controlled Drugs must be removed from the
Ward.
12.8
If the drugs are fit for re-use, they must be returned to pharmacy and the returns policy
followed.
12.9
If the drugs are not fit for use, they must be destroyed following the destruction of
controlled drugs policy.
12.10 The ward register and other controlled stationery will be retained by the
57
appropriate nursing manager. They will not be stored in Pharmacy.
STANDARD OPERATING PROCEDURE 12 B
12 B When a Ward closes in Barnsley
When a ward closes in Barnsley for a short period (less than 3 months) CDs must be placed in
a tamper evident bag and transferred to a neighbouring ward.
12.1
The Controlled Drugs must be removed from the Ward cupboard in the presence of a
registered nurse and a second person who will act as a witness; this may be another
registered nurse or a pharmacist who is going to return the Controlled Drugs to the
pharmacy department for safe storage.
12.2
Each drug will be signed out of the appropriate section of the ward register by the
nurse. The witness will countersign the entry. The entry will state that the drugs have
been temporarily taken to Pharmacy for safe storage.
12.3
The Controlled Drugs will be sealed into a container, for example, a tamper evident
container. The seal will be signed by both persons. The container will clearly state:



Date
Name of both persons
Ward area
12.4
The container will be taken to pharmacy and placed for safe storage into the pharmacy
Controlled Drug cabinet.
12.5
When the Ward re-opens the sealed container will be returned to the Ward. Once on
the Ward, the container will be opened by a registered nurse, witnessed by a second
nurse or a Pharmacist. An entry in all of the appropriate sections of the register will be
made, stating that the drugs have been returned to the Ward; this entry will be signed
by the nurse and the witness.
12.6
The contents of sealed containers that are being stored in pharmacy WILL NOT BE
ENTERED INTO THE PHARMACY STOCK REGISTER.
12.7
Controlled Drugs that are being transported between wards and pharmacy must be
carried in a safe and secure tamper evident container.
When a ward closes permanently all CDs must be destroyed.
58
STANDARD OPERATING PROCEDURE 13
Compliance Aids with Controlled Drugs
13.1
Prescriptions requesting compliance aids may include requests for controlled drugs.
Controlled drugs may be dispensed into compliance aids IF THE COMPLIANCE AID
PROCEDURE IS FOLLOWED unless:-

The patient is being discharged to a Nursing Home

The patient is using the compliance aid in hospital under the Trust’s SelfMedication guidelines. Such drugs would require entry into the register so this would
not be practical.

The drug is unsuitable for dispensing into a compliance aid, e.g.. Hygroscopic
medicines. See SWYPFT compliance aid policy for full details.
13.2
Where a controlled drug is dispensed into a compliance aid, it must be labelled in
accordance with SWYPFT Labelling Procedure.
In addition, if the compliance aid is prescribed for self-medication or discharge, the box and
bag must be labelled “Store in a controlled drug cupboard” for the information of the Ward
staff.
59
STANDARD OPERATING PROCEDURE 14
Procedure for dealing with suspected illicit substances handed in by or
found on a service user on an in-patient unit
Philosophy
Service users with mental health problems co-morbid with substance misuse form a
substantial and significant proportion of in-patients. The principle underlying this procedure is
to engage the service user in treatment and harm reduction rather than into the criminal justice
system.
Illicit substances handed in by/found on a service user will be disposed of in accordance with
Trust policy.
Procedure
If a substance handed in by/found on a patient is thought to be a suspected illicit substance it
should be dealt with on the ward by two members of staff as follows:

Wear disposal gloves

Retain the substance – exceptions are syringes which must be disposed of in the sharps
bin immediately

Place item in a self sealing bag labelled with the following details
i. Found by:
ii. Found in possession of:
iii. Ward:
iv. Date ……… Time…..….

Inform the nurse in charge of the ward

Nurse in charge to complete Suspected Illicit Drug Confiscation Form
For small quantities
_
_
_

Place substance in controlled drug cupboard
In the Controlled Drugs register designate a page for suspected illicit substances
and enter the details as in 3 above.
Inform the ward pharmacist within 24 hours or on the next working day in the
case of weekends and bank holidays.
Inform bleep holder who will inform the police if necessary. (e.g. large quantities/class A
drugs).
For larger quantities
60
_
_
_
Seal in a designated container and hand to West or SouthYorkshire Police for
storage or disposal
Police and Bleep holder to sign confiscation form.
The police will take possession of suspected illicit substance.

Balance between treatment and pursuit of criminal prosecution should be clear in the care
plan. It may be necessary to convene a CPA meeting to determine course of action.

Inform RMO at the earliest opportunity.

Copies of the confiscation form will be handed to the police (where informed) or Ward
Pharmacist, the Unit Manager and the ward will retain a copy.

Complete Health and Safety incident/SUI form
Destruction

Small quantities of suspected illicit substances should be destroyed or disposed of
by the ward pharmacist together with the nurse in charge of the ward. This will be
carried out using the approved controlled drug denaturing kit.

The destruction must be recorded and signed by the ward pharmacist and the nurse
in charge of the ward, witnessed and countersigned using the controlled drug
register and the confiscation form.

The Ward Manager and Modern Matron or Senior Manager (on call manager if
necessary) must be informed immediately (that working day).
61
14.1
SUSPECTED ILLICIT DRUG CONFISCATION FORM
Date:
Time Found:
Name of Patient or Visitor:
Patient’s Hospital Number:
Ward / Department:
Details of suspected illicit substance and circumstances surrounding incident:
Signature of Staff Member (1)…………………………………. Print Name:
Signature of Staff Member (2)…………………………………..Print Name:
Details of disposal:
Signature of pharmacist destroying the substance
Witnessed by
(Senior Nurse on duty)
To be completed by Bleep Holder
Date and time police contacted (If applicable):
Handed to police by (signature / print name):
Receiving police officer (signature / print name):
Copy: (please circle) Ward /team/ CSM / Chief Pharmacist /Audit
62
STANDARD OPERATING PROCEDURE 15
Destruction of Controlled Drugs in Pharmacy
15.1
General Principles
Controlled drugs must be destroyed in accordance with the requirements of the Misuse of
Drugs Regulations 1985.
This policy is based upon the guidelines laid down in the South West Yorkshire Partnership
NHS Foundation Trust Medicines Code. It is intended to provide a timely method of
destroying controlled drugs that are unfit for use.
Controlled drugs may only be destroyed in the presence of a witness authorised by the
accountable officer e.g. RPSGB inspectors, police chemist liaison officers and Home Office
inspectors, executive officers of the Trust and officers reporting to executive officers.
Destruction must occur in such a way that the drug is denatured or dissipated so that it is
incapable of being retrieved, reconstituted or used.
Destruction must occur in a timely fashion, so that excessive quantities are not stored awaiting
destruction.
All destruction must be documented in the appropriate section of the register (see below). It
must be witnessed by a second authorised person. Both persons must sign the register.
A separate register of drugs awaiting destruction will be kept in pharmacy for all drugs that
must be destroyed within the pharmacy. These drugs will be stored separately from pharmacy
stock controlled drugs.
A separate section of the destruction register should be maintained for suspected illicit
substances.
Pharmacy stock controlled drugs for destruction must be booked out of the pharmacy
computer system to the relevant cost centre.
If a controlled drug is spilled in pharmacy. It must be booked out on the pharmacy computer
system to the Pharmacy waste cost centre and booked out of the register. The register must
be countersigned by a second member of pharmacy staff. At least one witness must be a
Pharmacist.
15.2
Method of Destruction
Wherever possible the out of date controlled drugs will be disposed of using the approved
controlled drug denaturing kit. This will then be disposed of as pharmaceutical waste.
Patches will be destroyed by removing the backing and folding the patch over upon itself. The
patch will then be disposed of using the approved denaturing kit.
63
Ampoules should be opened, the liquid transferred to a denaturing kit and the ampoule itself
be put in a sharps bin. An ampoule that contains powder can have water added to it to
dissolve the power and the resulting mixture transferred to a denaturing kit.
Following the Shipman report it has been deemed appropriate for a the Accountable officer to
nominate senior officers of the Trust who do not take part in the day to day activity of use of
CDs to destroy controlled drugs.
The following are nominated to destroy CDS
Sue Barton
Sarah Hudson
Chris Bontoft
Anne Hoyle
Simon Plummer
Sean McDaid
Deputy Director of Business Development
Lead Pharmacist Barnsley
Service Manager Kirklees
Head of nutrition and dietetics
Clinical Lead Learning Disabilities
Nurse Consultant AWA Wakefield
An appointment must be made by the pharmacist in charge of Fieldhead Pharmacy with the
relevant person to when there is a need to destroy Controlled drugs.
In Fieldhead Pharmacy all entries should be checked and enough denaturing kits available to
ensure safe and effective destruction of the controlled drugs. A minimum of five minutes per
item should be allocated
An authorised witness form will be completed and signed by the AO.
This and the approved Trust ID should be taken when requested to destroy Controlled drugs.
When there is a requirement to destroy Controlled drugs on a ward or unit by the authorised
witness the ward or unit manager should make an appointment with the authorised witness
An audit trail of destroyed Controlled drugs must be available using the approved Controlled
drugs destruction record (see SOP 10).
64
STANDARD OPERATING PROCEDURE 16
Security and Transportation of CDs
In principle CDs should be transported in a sealed secure container which will be
accompanied by the appropriate requisition book and delivery paperwork for signing for receipt
of the container by the requesting ward/department.
If there is any breach of security in transportation this should be notified to the accountable
designated practitioner requesting the CD to be transported and the designated pharmacist so
that the situation can be investigated thoroughly. If necessary the Trust’s Accountable Officer
may become involved.
16.1
Transportation within Fieldhead site:See Standard Operating Procedure 5 (Ordering and Receipt of CD on wards)


Medicines must be transported within hospitals by members of staff.
Medicines must not be left unattended at any time during transport.
16.2
Transport to satellite units with trust approved transport:-











The driver signs the appropriate section of the CD order sheet to confirm collection of
the bag at FHH pharmacy.
The delivery point column of the CD delivery log (see 16.3) is completed by a member
of the pharmacy staff and the medication and CD order book is then put into a sealed
tamper evident bag, the CD delivery log must be handed to the driver. 1 sheet per
pouch.
A log of the delivery must be kept at Pharmacy for audit purposes. (see 16.4)
The medication and CD order book are delivered to the satellite unit/ ward.
Delivery vans should be externally distinguishable from other Health Service vans.
DELIVERY VANS SHOULD NOT CARRY ANY UNAUTHORISED PASSENGERS.
Delivery vans must be locked when unoccupied.
Where pouches do not arrive directly to the ward base the second column must be
completed for a change of carrier, the second signature is also a confirmation the seal
is still in tact, where a number of the seal is recorded this must be checked at all
locations where a transfer occurs.
On transfer to ward staff the transfer 2 column is completed and the log faxed back to
the pharmacy.
The member of the ward staff will need to provide ID.
On entering the CD’s into the ward register the nurse will then break the seal and check
the contents of the bag and sign the appropriate section of the CD order sheet.
16.3 Community Nursing Staff
 Community Nursing Staff should not transport controlled drugs in their cars unless
there is an urgent clinical need.
 Where this is the case this should be documented appropriately.
65
16.3 Controlled Drug Delivery Log
from Pharmacy department: - Fieldhead
Date ___________ Time__________
Delivery point
Drivers name ______________ Signature__________________
Complete on collection Transfer 1
from Pharmacy
Complete on transfer to second vehicle / security
Fieldhead
desk
Number of
Is the bag Received by
Received by
Is the
Red
sealed?
print name
Signature
Bag still
Controlled
(ID must be
sealed?
Drug
seen)
Pouches
Transfer 2
To be Completed by ward staff
Name of person
collecting from
ward
(ID must be
checked)
Signature of
person collecting
from ward
Where 2nd carrier or interim holder is not used complete only transfer 2 column
On completion immediately fax sheet to Fieldhead Pharmacy on 01924327076.
Return original copies to Fieldhead Hospital Pharmacy in the next available pharmacy pouch
All sheets must be returned to pharmacy Fieldhead hospital for audit purposes
Completed sheets to be kept for 2 years
66
16.4
Date
Time
Controlled Drug weekly satellite transport log
Delivery point
Driver
Fax received
Original
received
Comments
Week commencing ___________
Completed sheets to be kept for 2 years
67
STANDARD OPERATING PROCEDURE 17
Archiving controlled drug documentation
17.1
Stationery that has been used in conjunction with controlled drugs must be retained in
accordance with the Misuse of Drugs Act.
17.2
The standards given in the Pharmacy Services Guidelines for Archiving document must
be followed. A copy should be found in each dispensary in the Operational Services
Core Procedure file.
17.3
The time periods for archiving controlled drug documentation is as follows:-
Requisitions
Registers
Extemporaneous worksheets
Aseptic worksheets (adult)
Aseptic Worksheets (paed)
External orders and delivery notes
Prescriptions (inpatients)
Prescriptions (outpatients)
Clinical trials
CD destruction
17.4
2 years
7 years
13 years
13 years
26 years
2 years
2 years
2 years
15 years
7 years
Ward registers and controlled drug requisition books are to be archived by the ward or
Nursing Management. They will not be stored in Pharmacy.
68
Appendix 1 - Equality Impact Assessment Tool
To be completed and attached to any policy document when submitted to the Executive Management Team for
consideration and approval.
Yes/No
1.
Comments
Does the policy/guidance affect one group
less or more favourably than another on the
basis of:
 Race
 Ethnic origins
travellers)
No
(including
gypsies
and
No
 Nationality
No
 Gender
No
 Culture
No
 Religion or belief
No
 Sexual orientation including lesbian, gay
and bisexual people
No
 Age
No
 Disability - learning disabilities, physical
disability, sensory impairment and mental
health problems
No
2.
Is there any evidence that some groups are
affected differently?
No
3.
If you have identified potential
discrimination, are any exceptions valid,
legal and/or justifiable?
No
4.
Is the impact of the policy/guidance likely to
be negative?
No
5.
If so can the impact be avoided?
N/A
6.
What alternatives are there to achieving the
policy/guidance without the impact?
N/A
7.
Can we reduce the impact by taking
different action?
N/A
If you have identified a potential discriminatory impact of this policy, please refer it to the Director of Corporate
Development or Head of Involvement and Inclusion together with any suggestions as to the action required to
avoid/reduce this impact.
For advice in respect of answering the above questions, please contact the Director of Corporate Development or
Head of Involvement and Inclusion.
69
Appendix 2 - Checklist for the Review and Approval of Procedural Document
To be completed and attached to any policy document when submitted to EMT for consideration and approval
Title of document being reviewed:
1.
2.
4.
5.
6.
7.
Comments
Title
Is the title clear and unambiguous?
Yes
Is it clear whether the document is a guideline,
policy, protocol or standard?
Yes
Policy
Rationale
Are reasons for development of the document
stated?
3.
Yes/No/
Unsure
Yes
Development Process
Is the method described in brief?
Yes
Are people involved in the development
identified?
Yes
Do you feel a reasonable attempt has been
made to ensure relevant expertise has been
used?
Yes
Is there evidence of consultation with
stakeholders and users?
N/A
Content
Is the objective of the document clear?
Yes
Is the target population clear and
unambiguous?
Yes
Are the intended outcomes described?
Yes
Are the statements clear and unambiguous?
Yes
Evidence Base
Is the type of evidence to support the
document identified explicitly?
Yes
Are key references cited?
Yes
Are the references cited in full?
Yes
Are supporting documents referenced?
Yes
Approval
Does the document identify which
committee/group will approve it?
Yes
If appropriate have the joint Human
Resources/staff side committee (or equivalent)
approved the document?
NA
Dissemination and Implementation
Is there an outline/plan to identify how this will
be done?
Yes
Does the plan include the necessary
training/support to ensure compliance?
Yes
70
Title of document being reviewed:
8.
9.
10.
11.
Yes/No/
Unsure
Comments
Document Control
Does the document identify where it will be
held?
Yes
Have archiving arrangements for superseded
documents been addressed?
Yes
Process to Monitor Compliance and
Effectiveness
Are there measurable standards or KPIs to
support the monitoring of compliance with and
effectiveness of the document?
Yes
Is there a plan to review or audit compliance
with the document?
Yes
Review Date
Is the review date identified?
Yes
Is the frequency of review identified? If so is it
acceptable?
Yes
Version 3
Overall Responsibility for the Document
Is it clear who will be responsible
implementation and review of the document?
Appendix 3 -
Yes
Version Control Sheet
This sheet should provide a history of previous versions of the policy and changes made
Version
Date
Author
Status
Comment / changes
1
2
Feb 2010
Lynn Haygarth
3
Oct 2011
Lynn Haygarth
Information
on
management
of
medicines after death.
Introduction of BDU responsibility.
Information on compliance with the
recently introduced information on
destruction of controlled drugs.
Strengthening of the ward qualified
nursing responsibilities of controlled
drugs on each shift change.
Included Barnsley locality where
possible.
Indicated where the pharmacy policies
relate specifically to Fieldhead
pharmacy.
71