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Document Reference Code: MM/008/16

This document is only valid on the day of printing

Title: Controlled Drugs Standard Operating Procedures

Purpose: To promote the safe, secure and effective use of CDs, and to
comply with national guidance and legislation.

Applicable to: CFT employees who are involved with the management of
controlled drugs (CD) or CD stationery.

Document Author: Helen Woods and Helen Lobb

Freedom of Information: This document can be released

Ratified by and Date: Helen Woods – Chief Pharmacist

8 November 2016

Review Date: May 2019


6 months prior to the expiry date

Expiry Date: November 2019


3 years after ratification unless there are any changes in legislation
or changes in clinical practice

Document library Clinical: Medication Management


location:

Related legislation and  Medicines Act 1968


national guidance:  Misuse of Drugs Act 1971 and its associated Regulations
 Misuse of Drugs (Safe Custody) regulations 1973
 Safe and Secure Handling of Drugs 2004 (revision of Duthie
Report 1988)
 Controlled Drugs ( Supervision of management and Use)
Regulations 2006
 Health Act 2006
 Safer Management of Controlled Drugs; a guide to good practice
in secondary care (England) DoH Sept 2007
 Safer Management of Controlled drugs : Guidance on Standard
Operating Procedures for Controlled Drugs DoH Jan 2007
 Standards for medicines management NMC 2008
 NPSA rapid response report “ Reducing dosage errors with
opioid medicines”
 NPSA rapid response report “ Reducing risk of overdose with
midazolam injection with adults” 2008

Associated Trust Policies  Medication Matters - Guidelines on Prescribing, Administering,


and Documents: Ordering and Storing Medicines, Adult Services
 Rapid Tranquillisation - Guidelines on the use of medication to

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manage acutely disturbed or violent behaviour in Mental Health


Patients
 Whistleblowing Policy

Equality Impact The Equality Impact Assessment Form was completed in February
Assessment: 2013.

Training Requirements: Staff involved with CDs must be familiar with the Trust‟s Controlled
Drugs Policy and CD SOPs, and must be updated when SOPs are
revised or new systems introduced. All Staff are responsible for
maintaining their competence in managing CDs.

Monitoring Arrangements:  Quarterly audit of controlled drugs will detect presence of nurse
handover and presence of SOP‟s on ward. CD audit results
shared with nurse in charge at the time & then tabled quarterly at
the clinical cabinets
 Pharmacy will complete quarterly audit. Ward managers
responsible for monitoring.
 Audit proforma
 Frequency of monitoring/audit is quarterly, on a rolling basis etc.
 Clinical cabinets will review results and the accountable officer is
responsible for ensuring governance.

Implementation: New SOP‟s have been sent to Inpatient Service Line lead and
CC&D service line lead for distribution and implementation. Also
sent to Community, children‟s and LD service line leads for
implementation.

Version Control

Version Date Reviewed Changes By Whom


August 2013 CD SOP 1 updated
CD SOP 15 and 16 added
March 2014 CD SOP 12 updated
CD SOP 17 and 18 added
September 2014 CD SOPs Special Schools added
Change of AO details
Frequency of nurse handover
September 2015 CD SOP 6 removed
October 2015 CD SOP 9 and CD SOP 16 updated
November 2015 CD SOP 19 and CD SOP 20 added
September 2016 CD SOP 12 updated Helen Woods
November 2016 CD SOP 9 updated Helen Woods
This document Replaces:
MM/008/16 – Controlled Drugs Standard Operating Procedures

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Contents

1. Definition ............................................................................................................................. 6
2. Scope.................................................................................................................................. 6
3. Aim ..................................................................................................................................... 6
4. Responsibilities ................................................................................................................... 6
5. Monitoring and Audit ........................................................................................................... 7
6. Review ................................................................................................................................ 7
7. Training Requirements ........................................................................................................ 7
8. Local or National Guidelines or Alerts ................................................................................. 7
9. Legislation and National Guidance ...................................................................................... 7
10. Standard Operating Procedures (SOPs) ............................................................................. 8
SOP CD 1 – Ordering Controlled Drugs (CDs) for Inpatient and Clinical Areas from Pharmacy ..... 9
SOP CD 2 – Receipt of Controlled Drugs (CDs) from Pharmacy .................................................. 12
SOP CD 3 – Storage and Security of Controlled Drugs (CDs) ...................................................... 14
SOP CD 4 – Record Keeping ....................................................................................................... 16
SOP CD 5 – Emergency or Out of Hours Supplies of CDs ........................................................... 18
SOP CD 7 – Administering Controlled Drugs (CDs) to an Inpatient .............................................. 20
SOP CD 8 – Managing Patients‟ own CDs (including TTOs) on the Ward .................................... 22
SOP CD 9 – Disposal of CDs on wards / clinical areas ................................................................. 23
SOP CD 10 – Prescribing Controlled Drugs .................................................................................. 28
SOP CD 11 – Controlled Drugs Stationery ................................................................................... 30
SOP CD 12 – CD Stock Checks and Incident Reporting ............................................................... 32
SOP CD 13 – Discrepancy between Clinical Area Controlled Drug Balance and Recorded Total in
Controlled Drug Register .............................................................................................................. 37
SOP CD 14 – Controlled Drug Incidents ....................................................................................... 39
SOP CD 15 – Obtaining a controlled drug for a discharge or leave prescription ........................... 41
SOP CD 16 – Raising a concern about CD practices of the controlled drug Accountable Officer .. 42
SOP CD 17 – Liquid controlled drug checking by a pharmacist on a ward (overage adjustment) . 43
SOP CD 18 – Courier Transport of Controlled Drugs .................................................................... 44
CD SOP 19 – Removal of patient‟s own CDs in a patient‟s home ................................................. 48
Appendix 1 – Patient‟s Own Medicines Removal Consent Form ................................................... 50
CD SOP 20 – Collection of CDs from a community pharmacy, transportation and delivery to
patient 51
Standard Operating Procedures for Controlled Drugs in Special Schools ..................................... 52

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CD SOP 1 – Receipt of Controlled Drugs ..................................................................................... 53


CD SOP 2 – Storage of Controlled Drugs ..................................................................................... 55
CD SOP 3 – Record Keeping ....................................................................................................... 57
CD SOP 4 – Administration of a Controlled Drug .......................................................................... 59
CD SOP 5 – Removal and Disposal of a Controlled Drug ............................................................. 62
CD SOP 6 – CD Balance check by the School Nurse / Authorised CD Competent Teaching staff 64
CD SOP 7 – Controlled Drug Stationery ....................................................................................... 66
CD SOP 8 – Controlled Drug Incident Reporting .......................................................................... 67
Frequently asked Questions … and some answers! ..................................................................... 68
Equality Impact Assessment Proforma Initial Screening ............................................................... 71

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1. Definition

Controlled Drugs (CDs) are those defined by the current Misuse of Drugs Regulations 2001, which
classify CDs into 5 schedules according to the level of control required.

2. Scope

This policy applies to all Cornwall Partnership NHS Foundation Trust (CFT) employees who are
involved with controlled drugs (CDs) or CD stationery.

3. Aim

To promote the safe, secure and effective use of CDs and to comply with national guidance and
legislation on CDs.

4. Responsibilities

The Trust‟s Accountable Officer (AO) is Helen Woods, Chief Pharmacist, who can be contacted on
01208 834265 or via email (Helen.woods7@nhs.net) or Bodmin switchboard 01208 251300.

The Accountable Officer is responsible for the safe and effective use of CDs within the Trust. This
includes ensuring safe systems of working with CDs, monitoring and auditing those systems,
investigating and reporting any incidents or concerns involving CDs and ensuring adequate
training for all staff involved with CDs.

The trust AO reports quarterly to the PCT AO, and collaborates with the Local Intelligence Network
(LIN) to share information about potential CD offences and potential or actual systems failures.

The registered nurse in charge of a ward has overall responsibility for the safe and appropriate use
of CDs and CD stationery on that ward.

Prescribers are responsible for ensuring that their CD prescriptions comply with the necessary
legal requirements. A pharmacist is not allowed by law to dispense a CD unless all the information
required by law is given on the prescription. [See current BNF].

All CFT staff involved with CDs are responsible for maintaining their competence in managing
CDs, and for following the processes in this policy and the Standard Operating Procedures
(SOPs), relevant to their area of work. Staff should highlight any areas of concern or difficulties in
following the policy or SOPs.

Pharmacy staff are responsible for promoting the safe and legal handling of CDs within CFT, and
for a quarterly ward audit.

All staff must report any near-miss or incident involving a CD in accordance with the Trust‟s
Medicines Incidents and Near-Misses Policy, and must also report it to the AO promptly.

Any CD discrepancies must be investigated immediately and reported to the senior nurse on duty
at the time, then to pharmacist and AO.

Anyone who has a concern about the use of CDs within the Trust should inform their line manager
then AO.

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5. Monitoring and Audit

The use and management of CDs will be monitored by:

 regular checks by ward staff, as daily shift handover stock check by ward nurses
 regular checks by pharmacist and/or pharmacy technician
 ePACT analysis of prescribing
 incident/near-miss reporting system
 Medicines Safety Group and Medicines Management Forum.

6. Review

This CD policy and / or SOPs will be reviewed every 3 years and / or following a change in
national or local guidance or legislation, or following analysis of a local incident or near-miss.

7. Training Requirements

Staff involved with CDs must be familiar with the Trust‟s Controlled Drugs Policy and Controlled
Drug SOPs, and must be updated when SOPs are revised or new systems introduced.

All staff are responsible for maintaining their competence in managing CDs.

8. Local or National Guidelines or Alerts

Staff will be informed of new guidelines and safety alerts as these are developed. New information
and advice will then be included with this policy for completeness.

9. Legislation and National Guidance

The Trust‟s CD policy and SOPs are based on the following documents:

 Medicines Act 1968


 Misuse of Drugs Act 1971 and its associated Regulations
 Misuse of Drugs (Safe Custody) regulations 1973
 Safe and Secure Handling of Drugs 2004 (revision of Duthie Report 1988)
 Controlled Drugs (Supervision of Management and Use) Regulations 2006
 Health Act 2006
 Safer Management of Controlled Drugs; a guide to good practice in secondary care
(England) DoH Sept 2007
 Safer Management of Controlled drugs : Guidance on Standard Operating Procedures
for Controlled Drugs DoH Jan 2007
 Standards for Medicines Management NMC 2008
 NPSA rapid response report “Reducing dosage errors with opioid medicines” 2008
 NPSA rapid response report “ Reducing risk of overdose with midazolam injection with
adults” 2008
 NPSA rapid response report “ Reducing harm from omitted and delayed medicines in
hospital” 2010

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10. Standard Operating Procedures (SOPs)

SOPs are managed stationery, and the only the current edition must be used.
This CD policy and SOPs are available on-line in the Medicines Management section of the
Documents Library on the Trust intranet, and as a paper copy in the clinical room on each ward.

The purpose of the CD SOPs is to:

 clarify and strengthen governance arrangements for managing CDs


 define accountability and responsibility
 ensure that CDs are handling in accordance with current legislation and national
guidance
 support staff with clear consistent information which can be used in training and
evaluation.

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 1 – Ordering Controlled Drugs (CDs) for Inpatient and


Clinical Areas from Pharmacy

Purpose To ensure that CD orders comply with the legal requirements of the
Misuse of Drugs Act and with policies of Cornwall Partnership Foundation
Trust (CFT) and Pharmacy Royal Cornwall Hospitals Trust (RCHT).

Scope Applies to all registered ward nurses authorised to order CDs and doctors
employed by CFT

Responsibilities Ward Manager and Registered Nurse in charge of the ward

Procedure:

The registered nurse in charge of the wards is responsible for ordering Controlled Drugs (CDs) for
use on the ward. The registered nurse in charge can delegate the task of preparing a requisition
to another registered nurse but the legal responsibility remains with the registered nurse in charge.

The ward manager authorises nurses for that ward to order CDs. The ward manager must
maintain a current list of the names and signatures so authorised, with a copy in Pharmacy RCHT.

The ward manager is responsible for updating the list of authorised signatories and for notifying
Pharmacy RCHT of any changes.

Only registered nurses who are authorised to do so can order CDs for that ward.

In line with existing legislation, a doctor must countersign each CD order.

The purpose of the doctor‟s signature is to:

 Witness the nurse‟s signature for that ward


 Verify that the CDs so ordered are required for a patient on that ward who is currently
prescribed that medicine, or for a patient due to be admitted to that ward and who is
prescribed that medicine.
 The doctor is not responsible for the appropriate management of CDs on the ward; that
responsibility remains with the registered nurse in charge of the ward.

Orders for CDs must be written in the Controlled Drug Requisition book, which must be locked in
the drugs cupboard and only accessible to registered nurses.

1. Take the CD requisition book / CD Order book from the CD cupboard.

2. Ensure the carbon paper is the right way up and between the top white copy and the
bottom pink copy.

3. Complete a separate requisition for each controlled drug required.

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4. Complete the requisition with the following details:

 Name of hospital
 Ward / department
 Drug details
o Name
o Form
o Strength
o Ampoule size, if more than one available
 Total quantity required
 Signature and printed name of registered nurse
 Date
 Signature and printed name of a doctor.

5. If an error is made in the CD requisition book / CD Order book the error must be put in
brackets and then initialled by the signatory. The correct entry should be clearly indicated.
NEVER cross out in a CD requisition book. Gross errors may lead to the
cancellation of the page concerned via two diagonal lines scored across the page,
with ‘CANCELLED’ clearly written between the lines. The original (white top copy)
and cancelled pages must be retained in the book for removal and retention by
pharmacy staff.

6. To ensure the orders are fulfilled for the next transport run, the white top copy of the CD
requisition must be detached from the CD requisition book and faxed to Pharmacy RCHT.

7. Put the white top copy of the CD requisition back into the CD requisition book and place
the book in the small green pharmacy CD order bag. Ensure the bag is clearly addressed
to Pharmacy RCHT, sealed with a security tag and send to Pharmacy RCHT as soon as
possible.

8. The controlled drugs ordered via a requisition will not be supplied until Pharmacy
has received the original requisition.

9. The CD requisition book must be locked in the CD cupboard when not in use.

10. If the CD requisition book is lost, it must be reported immediately to the ward/departmental
manager and pharmacist. An incident report must be completed.

11. Completed CD requisition books must be kept safely on the ward for a period of 2 years
from the date of the last entry.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 22 August 2013

Approved by: Date:


CFT Executive Nurse Sharon Linter 23 August 2013

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

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Review date: 3 years or sooner if there is a change in law or policy

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 2 – Receipt of Controlled Drugs (CDs) from Pharmacy

Purpose To ensure that CDs are handled safely and in accordance with the Misuse
of Drugs Act and policies of Cornwall Partnership NHS Foundation Trust
(CFT) and Pharmacy Royal Cornwall Hospitals Trust (RCHT).

Scope Applies to all registered ward nurses and health care assistants authorised
by the ward manager to act as a witness.

Responsibilities Ward Manager and Registered Nurse in charge of the ward

Controlled Drugs are supplied by Pharmacy RCHT in a locked pharmacy ward box or a tamper-
evident sealed pharmacy bag, and transported via hospital courier.

In an emergency, and if no hospital transport is available, the situation must be discussed with the
mental health pharmacist or on-call out-of-hours pharmacist.

If necessary the controlled drug(s) can be collected by an agreed identified member of staff from
that ward. [See CD SOP 5 “Emergency or OOH Supplies of CDs”]

Pharmacy deliveries must be taken to the clinical room as soon as they are received on the ward,
and opened by a registered nurse. Any items with special storage requirements (e.g. CDs or fridge
items) must be immediately unpacked, checked and stored appropriately.

A registered nurse must immediately check:

 that the correct items have been delivered, by checking the CDs received against the
CD ward order,
 that the items received are the correct drug, strength, form and quantity,
 that complete packs are sealed (not tampered with), and are in date.

The “Fax Back” form accompanying the CD delivery must be signed, dated and faxed back to
Pharmacy immediately, to confirm safe receipt of the CDs on the ward.

Any discrepancies must be reported to Pharmacy and the ward manager immediately.

The pink copy of the order in the CD order book must then be signed and dated by the nurse
receiving the CDs, on the “Received by” line.

The receipt must then be recorded in the CD Register. Each drug, form and strength is recorded
on a separate page, with the pages in use listed at the front of the CD Register. The amount
received, date, CD order number and stock balance must be entered on the appropriate page by
the registered nurse and witnessed by a second registered nurse or an approved witness.

When new stock is to be added to existing stock, the new stock balance must be counted and
recorded. New supplies of sealed packs do not need to be opened when the stock is checked.

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A new page must be started for each new bottle of oral liquid CD received so that the final balance
in each bottle can be checked and confirmed.
The CDs must then be locked in the CD cupboard.

Receipt of CD TTOs

CDs from Pharmacy as part of the patient‟s TTOs must be checked against the discharge or leave
prescription when received on the ward. Any discrepancy must be reported to Pharmacy
immediately.

Unless the patient is being discharged immediately, the CD receipt must be witnessed and
recorded in the back of the CD Register in the Patient‟s Own section or in a separate Patient‟s
Own CD Drugs register. The controlled drug must be stored in the CD cupboard with a note to
remind staff on TTO bag. When the patient is being discharged, a registered nurse and approved
witness must again check the TTO and the quantity supplied against the discharge prescription
and the CD Register. They must then sign the TTO out of the CD Register as “Patient being
discharged”, the remaining stock balance will be Nil and the remaining lines on page must be
scored out.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by: Date:


Professional Head of Nursing Cathy Clegg 14 September 2011

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 3 – Storage and Security of Controlled Drugs (CDs)

Purpose To ensure that CDs are secure and that procedures comply with the
Misuse of Drugs Act and Cornwall Partnership NHS Foundation Trust
(CFT) policies

Scope Applies to all registered ward nurses and Pharmacy staff

Responsibilities Ward Manager and Registered Nurse in charge of the ward

Procedure

The nurse in charge of the ward is responsible for the security of CDs on that ward, and for the
security of the keys to the CD cupboard and for restricting their access. Key holding can be
delegated to another registered nurse, who must then keep the keys on his / her person.

The ward Controlled Drugs cupboard must be kept locked at all times when not in use, and the
keys accessible to registered nurses only.

Pharmacists or pharmacy technicians authorised by CFT may have access to the keys when
checking CD stocks.

If the keys cannot be located, there must be an immediate search and all staff contacted. The Duty
Nurse Manager must be informed. If the keys are not promptly recovered, the pharmacist and the
Trust Accountable Officer must be informed.

All CDs must be locked in the CD cupboard when not in use, including TTO supplies.

The CD cupboard should be used for storing CDs only.

When not in use, Controlled Drug Order books and Registers must be stored in a locked drugs
cupboard, whose keys are accessible to registered nurses only.

The ward manager is responsible for ensuring that CD stocks are checked weekly and recorded.
Pharmacy staff are responsible for checking ward CD stocks every 3 months.

Additional information

CDs must be stored in accordance with the Misuse of Drugs (Safe Custody0 Regulations 1973.)
The CD cupboard should comply with British Standard BS2881.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

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Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 4 – Record Keeping

Purpose To ensure that recording of CDs complies with the Misuse of Drugs Act
and Cornwall Partnership NHS Foundation Trust (CFT) policies and
guidelines

Scope Applies to all staff involved with CD record keeping

Responsibilities Ward Manager and Registered Nurse in charge of the ward

Procedure

All CDs on the ward must be recorded in the CD Register, which is accessible only to registered
nurses and pharmacy staff so authorised by the ward manager.

All entries in the CD Register must be signed by a registered nurse and a witness.

The witness should be a second registered nurse, or if a second registered nurse is not available,
the witness can be another suitably qualified healthcare professional (doctor, pharmacist), a 3 rd
year nursing student or an authorised healthcare assistant who has been approved as competent
by the ward manager, and who has signed to confirm that they have read and understood relevant
CD SOPs.

Entries must be made on the correctly titled page, which shows the drug name, strength and form
of the drug. Each drug, strength and form which is held on the ward should be recorded on a
separate page, with a running balance.

Pages currently in use should be listed at the front of the CD Register.

Entries must be in chronological order and written in indelible pen. If a mistake is made in an
entry, the mistake should be bracketed but without obscuring the original entry. The mistake and
the correct entry should be signed and dated by the person making those entries and by a witness.

When a page is full, details must be transferred to the next available new page. Update the index
at the front of the CD Register by writing a new entry with the new page number.

Record the number of the new page at the bottom of the finished page, with “Records transferred
to page ...” On the new page, fill in the correct details of the drug, strength and form, together with
“Records transferred from page ...”

Check the stock balance with a witness and record it on the new page.

For liquid medicines only (e.g. methadone), start a new page for each new supply received, in
order to simplify accounting and the destruction of any overage left in the old bottle. Continue to
use the old bottle until no further doses can be administered from that bottle. Measure the amount
remaining in the old bottle, and contact the pharmacist or pharmacy technician to have it returned

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to Pharmacy for safe disposal by the ward pharmacist. Don‟t destroy old CDs on the ward; don‟t
return them to Pharmacy in the ward box.
[See CD SOP 9 “Removal/disposal of CDs”]

Patients‟ own CDs and TTOs must be recorded on a separate page at the back of the CD register,
or in a separate Patient‟s Own CD register and not added to records of ward stocks supplied from
Pharmacy RCHT.
[See CD SOP 8 “Managing Patients‟ own CDs on the ward”]

The registered nurse in charge of the ward is responsible for ensuring that the CD Register is kept
up-to-date and in good order.

Completed CD Order books and Registers must be stored securely for at least 2 years from the
date of the last entry and then destroyed as confidential waste.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 5 – Emergency or Out of Hours Supplies of CDs

Purpose To ensure that CDs are managed safely and in accordance with Misuse
of Drugs Act and Cornwall Partnership NHS Foundation Trust (CFT)
policies

Scope Applies to all staff involved with CDs

Responsibilities Ward Manager and Registered Nurse in charge of the ward

Obtaining CDs from Pharmacy in an emergency or Out of Hours

See CDSOP1 for routine ordering of CDs from Pharmacy.

For patients already on the ward who are prescribed CDs, staff must be able to keep an adequate,
but not excessive stock of CDs for that patient, and to send the CD Order book to Pharmacy in the
ward pharmacy box.

If necessary, the CD order can be faxed to Pharmacy and the Pharmacy Order book top white
copy immediately sent to Pharmacy on the next courier.

If a patient has his / her own supply of a CD, and if it has been approved as suitable for his / her
use on the ward under the PODs assessment, that supply should be used first. If a patient does
not have his/her own supply on the ward, the ward must obtain a supply from Pharmacy RCHT as
soon as possible.

Controlled drugs stocks must not be transferred from one ward‟s CD Register to another ward‟s.

Controlled drugs must not be transferred from one ward or hospital to another.

If there will be a significant delay in obtaining a CD from Pharmacy, and delaying the prescribed
dose would cause the patient distress, a dose can be administered from another ward‟s stock,
while awaiting the supply from Pharmacy. A registered nurse must take the prescription card to
the ward which holds the prescribed CD. Two registered nurses then take the necessary drug and
dose from the CD cupboard, administer and witness the administration to the patient, sign the
prescription chart and make a full entry in the CD Register of the ward holding that CD.

In an emergency, or for a CD supply for a new prescription needed out-of-hours, discuss the
situation with the ward pharmacist, a pharmacist at RCHT if the Pharmacy department is open, or
if necessary with the on-call pharmacist via Treliske switchboard.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

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Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 7 – Administering Controlled Drugs (CDs) to an Inpatient

Purpose To ensure that CDs are used safely and that procedures comply with the
requirements of the Misuse of Drugs Act and Cornwall Partnership NHS
Foundation Trust (CFT) policies and guidelines.

Scope Applies to all staff involved in administering CDs

Responsibilities Registered Nurse or Doctor administering the CD

Procedure

Controlled drugs (CDs) may only be administered by a registered nurse or doctor.

The administration must be witnessed by a second registered nurse, or if there is no other


registered nurse then by another healthcare professional (e.g. pharmacist) or an authorised
healthcare assistant who has been approved as competent by the ward manager, and who has
signed to confirm that they have read and understood relevant CD SOPs.

The person administering the CD and the witness must both check the prescription , the selection
of the correct drug, dose and form, the preparation of the dose to be administered, the identity of
the correct patient, the administration of the dose to the correct patient, and the safe disposal of
any part dose or unused dose.

The doctor or registered nurses intending to administer the dose must first check that it is safe for
that patient to receive that dose, by confirming recent previous doses and tolerance [See NPSA

Rapid Response Report 2008 “Reducing dosage errors with opioid medicines”]
The administration must be fully recorded on the correct page in the CD Register and on the
patient medication card and signed by nurse and witness immediately after the dose has been
administered.

The entry in the CD Register must show the date, time, patient name, quantity administered,
balance in stock and the signatures of the person administering the dose and the witness. The
ward stock must be counted and checked against the recorded stock balance (sealed containers
do not need to be opened when checking stock). Any discrepancy in the stock balance must be
investigated immediately.

If a dose is prepared but not administered, or if only part of a dose is used, it must be disposed of
immediately in the yellow-lidded sharps bin on the ward, and the destruction recorded in the CD
Register by both staff involved in the administration.

Patches must be turned in on themselves to prevent release of the drug.

CDs must not be “nurse dispensed” from ward stock for leave or discharge.

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Additional information

Oral syringes or glass conical measure must be used to measure oral liquid CD medicines (e.g.
methadone) as accurately as possible; these are more accurate than medicine pots.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

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Document Reference Code: MM/008/16

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 8 – Managing Patients’ own CDs (including TTOs) on the


Ward

Purpose To ensure that CDs are used safely and that procedures comply with the
requirements of the Misuse of Drugs Act and Cornwall Partnership NHS
Foundation Trust (CFT) policies and guidelines.

Scope Applies to all staff involved in handling patient‟s own drugs

Responsibilities Registered Nurses

Procedure

Patients‟ Own Drugs (PODs) which are CDs must be assessed in the same way as other PODs
for their suitability for use on the ward, under the PODS assessment procedure. Provided they are
suitable and the patient agrees, they can be used for that patient‟s continued treatment; they must
not be used for any other patient.

As for other CDs, Controlled Drug PODs or Controlled Drug TTOs must be stored in the CD
cupboard, not on the medicines trolley.

Patients‟ Own drugs and TTO‟s must be recorded at the back of the CD Register or in a separate
Patient‟s Own CD register if used frequently. A separate page must be used for each item, with
the page clearly headed with the name of the drug, strength, form and the patient‟s name.

Full details of each administration must be recorded, as for ward stock supplies.

If the patient goes on leave or is discharged before his / her own supply has been used up, this
can be used for that period of leave or discharge provided the dose and directions have not
changed during admission, i.e. provided the medicine is still correctly labelled. The medicine must
then be signed out of the CD Register as “Patient being discharged” and witnessed, the balance
recorded as Nil and the remaining lines scored out.

It is good practice to return to the patient only those medicines which the patient is still prescribed.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

Page 22 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS

TITLE SOP CD 9 – Disposal of CDs on wards / clinical areas

Purpose To ensure that the disposal of CDs complies with the Misuse of Drugs Act,
national guidelines and CFT policies.

Scope Applies to all staff involved in handling CDs

Responsibilities Registered Nurses, pharmacy staff

Any individual dose or part dose which is prepared but not administered must be destroyed in the
yellow lidded sharps bin by a registered nurse, and witnessed by a second registered nurse or if
necessary by another approved witness, with a full entry in the CD Register. Patches must be
folded in on themselves to prevent release of the drug.

CDs must not be returned to Pharmacy via the pharmacy ward box or pharmacy bag.

Any expired CDs or CDs earmarked for destruction must be clearly labelled as such and
separated from current stock in the CD cupboard. They must still be locked in the CD cupboard
and included in the running balance for that particular item.

Empty bottles of CD liquids must be disposed of in yellow lidded sharps bin.

Disposal of Controlled Drugs by an authorised Person.

Ward Stock CDs

Destruction of Ward stock CDs are to be witnessed by an independent person authorised by the
Trust (usually a Senior Non-Clinical Manager/director).

This person can be contacted via the Pharmacy team to arrange for them to attend the ward /
clinical area and witness the destruction of the Controlled Drugs.

Patient‟s own CDs

The Accountable Officer for controlled drugs, will authorise the following groups of staff to witness
the destruction of Patients Own Controlled Drugs:

 Pharmacists and Technicians employed by CFT.


 Community Hospital Matrons at their own hospitals. Matrons must not be personally
involved in medicines administration.
 Pharmacists employed under a service level agreement (SLA) from the provider
pharmacy who provide a clinical service to designated community hospitals.
 The independent witness authorised to witness the destruction of Ward Stock CDs can
also witness the destruction of Patient own CDs.

Requesting a visit to destroy Controlled Drugs.

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The following needs to be in place before a visit to destroy Controlled Drugs can be undertaken.

1. The ward manager or senior nurse on duty will complete a Controlled Drug Destruction
Schedule (see attached) of all Controlled Drugs to be destroyed on the ward/clinical
area. This will list the Name, form, strength and quantity of the Controlled Drugs to be
destroyed. Send the part completed form via e-mail to
cpn-tr.CFTmedicinesqueries@nhs.net
2. The Pharmacy team will then arrange for one of the authorised personnel to attend the
ward/clinical area to witness the destruction (Pharmacy team or independent witness).
3. The Authorised Person will need to ensure that the unit has a suitable size DOOP
container to dispose of the Controlled Drugs. Two sizes of container are available,
250ml and 1litre containers. Further supplies of these containers may be obtained via
the Pharmacy team.
4. The Authorised Person will also need to check that the unit has a Yellow lidded sharps
bin large enough to dispose of the DOOP container and any empty liquid bottles
emptied at the time.

Process for the destruction of Ward Stock Controlled Drugs

1. Ward stock must be destroyed with a Registered Nurse working on that unit.
2. The Registered Nurse and Authorised Witness will together count the stock to be
destroyed, the stock remaining in the cupboard and record in the Ward/clinical area
Controlled Drug Register the following information:
 Date
 Quantity of Controlled Drug being destroyed
 “destroyed on ward”
 Registered Nurse‟s signature
 Authorised Person‟s signature and designation
 The new running balance (total quantity remaining in the CD cupboard)
3. Remove all packaging and place in the DOOP container (following the method of
destruction below). On completion add water to the container as directed, replace the
lid and shake well. The contents of the kit should form a gel and solidify in a couple of
minutes of adding liquid.
4. Place the sealed DOOP container in a yellow lidded sharps bin together with any empty
liquid medicine bottles. A new DOOP kit must be used on each occasion. The sharps
bin should be sealed and sent for destruction.
5. Any discrepancies must be investigated and reported on the CFT incident reporting
system.
6. The Authorised Witness and Registered Nurse will sign off each item on the destruction
schedule (see attached) as the item is destroyed, adding the date of destruction. Email
the completed form to cpn-tr.CFTmedicinesqueries@nhs.net

The reason must be documented for any discrepancies between the quantity destroyed and the
original quantity for destruction on the Controlled Drug destruction schedule. If an error is made in
counting, figures must not be altered, but rewritten alongside with a clear line through the error.

Process for the destruction of Patient’s own Controlled Drugs

1. If the patient has died, all medicines including Controlled Drugs should be kept for 7
days to ensure they are not required by the Coroner.

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2. The Registered Nurse and Authorised Witness will together count the patient‟s own
Controlled Drugs and record in the Patient‟s Own Controlled Drug Register the
following information:
 Date
 Quantity of Controlled Drug being destroyed
 “destroyed on ward”
 Authorised person‟s signature and designation
 Registered Nurse‟s signature
 The amount remaining (balance). This would usually be NIL.
3. Follow the instructions for disposal above (3-6)
4. Ensure that any patient identifiable information is destroyed by either shredding or
placing in a confidential waste bin.

Controlled Drugs must be added to the DOOP container as follows:

 If necessary wear gloves when disposing of medicines.


 Face masks may be necessary for the disposal of powders.
 Absorbent gauze cloth may be needed to absorb liquid from a spray applicator.
 All solid dose forms must be added first.
 Large volumes of liquid MUST NOT be added to the DOOP container until the end of
the process.
 If necessary use more than one DOOP container to destroy medicines.
 Ensure there is enough space left in the DOOP container to add water as this ensures
that the gel will solidify properly.
 Refer to the manufacturer‟s specific instructions on the Controlled Drug Destruction Kit
to ensure the capacity of the container is not exceeded.

Dosage Form Method of Destruction


Solid Dosage Forms Remove all capsules and tablets from packaging and place in
e.g. Capsules and Tablets container.
Patches Remove the backing and fold the patch over on itself. Place in
container.
Lozenges Remove from packaging and cut lozenge head off stem. Place
head in container.
Suppositories Remove from packaging and place in bin.
Ampoules containing Break open ampoule and place whole ampoule in bin.
powder
Vials containing powder or Powders – using a needle and syringe add water to the vial,
liquids dissolve the contents and redraw up the liquid into the syringe. Add
to DOOP container.
Liquids – draw up the contents of the vial into a syringe. Add liquid
to DOOP container. Empty vials can be disposed of separately in a
yellow lidded sharps bin.
Ampoules containing liquids Break open the ampoule and add the whole ampoule to the
container.
Liquids Pour the contents of the bottle into the container. Do not exceed the
recommended volume. Water must be added to the container as
instructed to solidify / congeal gel properly. Place empty bottles in
sharps bin.
Aerosol formulations Expel into an absorbent gauze cloth and place in container. Put

Page 25 of 75
Document Reference Code: MM/008/16

empty aerosol container into sharps bin.

Prepared by: Pharmacy Team

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Page 26 of 75
Document Reference Code: MM/008/16

Controlled Drug Destruction Schedule

Hospital:

Ward / Unit name:

Date:

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
Page No. Drug Name Form Strength Quantity to Ward Patient ID Quantity Date Ward Staff Witness
destroy Stock Initials / NHS no. destroyed Signature Signature
Y/N

Step 1: Complete columns 1 to 6 of form for all CDs to be destroyed. Email to cpn-tr.CFTmedicinesqueries@nhs.net

Step 2: Have CD destruction witnessed by authorised CD destruction witness. Sign and date all items destroyed

Step 3: email signed form to e-mail address above

Page 27 of 75
Document Reference Code: MM/008/16

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 10 – Prescribing Controlled Drugs

Purpose To ensure that the prescribing of CDs is safe and legal, complying with the
Misuse of Drugs Act, national guidance and trust policies.

Scope Applies to all prescribers who prescribe CDs

Responsibilities Individual prescribers

All prescribers must be aware of the risks of opiates and the importance of confirming the person‟s
recent opiate history, i.e. doses last prescribed and whether these have been taken regularly.

Prescribers must document that confirmation, and check that the dose, the medicine and the
frequency are all suitable for the individual patient.
[See NPSA rapid response report 2008 “Reducing dosage errors with opioid medicines”].

This is also important for medicines reconciliation on admission to hospital or whenever a patient‟s
care is transferred.
[See NICE/NPSA Patient safety Guidance 1, 2007 “Technical patient safety solutions for
medicines reconciliation on admission of adults to hospitals”]

Prescribers are responsible for maintaining their knowledge and competence in the safe
management and prescribing of CDs.

Inpatient prescribing

If a patient is admitted and is already prescribed a CD, the prescriber must confirm the dose,
medicine, form and frequency with the previous prescriber, and must confirm with the patient that
he/she has been taking that medicine as prescribed.

The initial inpatient prescription and any subsequent changes to the prescription must be fully
documented on RIO, with the reasons for that change.

As for other medicines, a CD inpatient prescription must be clear, unambiguous, and show all
necessary information. The drug name must be printed clearly in block capitals, with the date,
dose, frequency, total maximum dose in 24 hours if the medicine is to be given as required, and
the prescriber‟s signature.

Discharge or Outpatient prescribing

All leave, discharge or outpatient prescriptions for CDs must be written in accordance with the
requirements of the Misuse of Drugs Regulations, as outlined in the current BNF. The prescription
must be dated, indelible and signed by the prescriber with his/her usual signature in his / her own
handwriting.

Good practice would be to prescribe no more than 30 days supply for outpatients.

Page 28 of 75
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Prescriptions for Schedule 2 or Schedule 3 CDs (except temazepam) must show:

 Patient‟s full name, address, and age where appropriate


 Name and form of the medicine
 Strength of the medicine, where appropriate
 Dose, frequency and instructions
 Total quantity or total number of dose units to be dispensed, written in both words and
figures.

Pharmacists may not dispense CD prescriptions which are not correctly written.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy.

Page 29 of 75
Document Reference Code: MM/008/16

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 11 – Controlled Drugs Stationery

Purpose To ensure that CD stationery is secure and is used appropriately, in


accordance with the Misuse of Drugs Act and national and Trust
guidance and policies.

Scope Applies to all CFT staff who handle CD stationery

Responsibilities Individual prescribers, and Registered Nurses in charge of a ward

Procedure

Ward CD order books and CD registers, inpatient prescription cards, leave and discharge
prescriptions and all FP10 prescription forms are controlled stationery. They must therefore be
stored securely and access restricted.

Only one CD order book must be in use.

Any unused CD stationery must be returned to Pharmacy RCHT.

Ward CD order books and CD registers must be ordered from pharmacy RCHT on a CD
requisition by a registered nurse authorised to do so.

They must be kept locked in the drugs cupboard when not in use.

When full, they must be sealed and stored securely for 2 years after the date of the last entry, then
destroyed as confidential waste.

When a new CD register is started, the records from the old register must be transferred by a
registered nurse and witness, in this case a second registered nurse or an authorised pharmacist
or pharmacy technician. Each stock balance must be checked against the stock in the CD
cupboard.

Loss of any CD stationery which could be used to order CDs must be reported immediately to the
registered nurse in charge of the ward, pharmacist and AO.

FP10 prescription forms

All prescribers are responsible for the security and appropriate use of any FP10 prescription forms
to which they have access.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 20 September 2011

Approved by : Date:
Professional Head of Nursing Cathy Clegg 14 September 2011

Page 30 of 75
Document Reference Code: MM/008/16

Prepared by: Linda Hennell (Pharmacist) and Medicines Management Forum

Agreed by: Risk Management Strategy Group CFT

Review date: 3 years or sooner if there is a change in law or policy

Page 31 of 75
Document Reference Code: MM/008/16

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS / UNITS

TITLE SOP CD 12 – CD Stock Checks and Incident Reporting

Purpose To provide a standard procedure to be followed when handing over


controlled drugs.

Scope Applies to all registered nurses within Cornwall Partnership NHS


Foundation Trust (CFT).

Responsibilities Ward Manager, Matron and Registered Nurse in charge of ward

Procedure

1. In Mental Health Controlled drug handover must be performed at the change of each
nursing staff shift and must be undertaken by one registered nurse from the old shift and
the new shift.

2. In ACS Controlled drug handover must be performed once a day and must be performed
by two registered nurses or one registered nurse and one HCA (see below) who has
completed the competency assessment

3. To perform controlled drug handover you will need:

 Keys to the controlled drug cupboard


 Controlled drug record book
 Nursing controlled drug handover book / form if used (see end).

4. Every controlled drug preparation within the CD cupboard must then be counted by both
members of staff. This quantity must then be checked with the stock balance on the
nursing handover book/form or in the register.

5. The nursing handover book or controlled drug record book must be completed for each
controlled drug preparation. This must include:

 Date
 Time of handover
 In Mental Health: Signature of nurse from old shift, Signature of nurse from new
shift
 In ACS: Signature of registered nurse 1, Signature of registered nurse 2 or HCA
described below
 Quantity

For liquid controlled drugs the volume of the stock must be visually checked, at handover, as
correct and not accurately measured. Repeated measuring of the balance at handover will result in
an incorrect balance due to loss in the measure.

6. If the figure is correct, the nursing handover book or controlled drug register must be
signed and dated by both nurses (HCA). If the figure is incorrect, the controlled drug

Page 32 of 75
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record book should be consulted to confirm if doses have been given during the current
shift.

7. Bottles of liquid controlled drugs are often supplied by the manufacturer with a greater
quantity of medication than that identified on the bottle i.e. „overage‟. This will often result in
the amount of liquid controlled drug held as stock exceeding the amount recorded in the
CD register. When this occurs contact the pharmacy team on 01208 834265 Mental
Health or 01209 318057 ACS and a pharmacist will attend the ward to carry out an
overage adjustment as described in SOP 17. This is a normal occurrence and should not
be recorded as an incident.

8. If any discrepancies are found, refer to CDSOP13 discrepancies in stock.

9. When handover is completed, the controlled drugs and controlled drug stationery must be
locked back inside the CD cupboard. Ensure that the keys to the CD cupboard are handed
over to the registered nurse from the new shift.

HCAs may only be used as a witness for checking controlled drugs or other medicines when there
is no other trained member of staff on duty on the unit. The HCA must be trained and assessed as
competent to check the balance and have read an understood this SOP.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 19 September 2016

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee

Review date: 3 years, or sooner if there is a change in law or policy

Page 33 of 75
Document reference code: MM/008/15

Controlled Drugs – Daily Stock Check Record

Daily Stock Check Log for the month of 20 Clinical Area

Stock checks must be carried out. Stock checks must include both ward stock drugs and patient‟s own controlled drugs. It is the Ward Manager‟s
responsibility to ensure that checks are done and that this log is completed. Any errors found must be reported to the Ward Manager, CPFT Pharmacy Team
and reported on Safeguard Incident Reporting System.

Time Nurse 1 Signature Nurse 1 Print Name Nurse 2 or HCA Nurse 2 or HCA Stocks checked Discrepancies Safeguard Incident
signature Print Name and correct found System completed
and Pharmacy
notified.
st
1 ___:___
nd
2 ___:___
rd
3 ___:___
th
4 ___:___
th
5 ___:___
th
6 ___:___
th
7 ___:___
th
8 ___:___
th
9 ___:___
th
10 ___:___
Page 34 of 75
Document reference code: MM/008/15

th
11 ___:___
th
12 ___:___
th
13 ___:___
th
14 ___:___
th
15 ___:___
th
16 ___:___
th
17 ___:___
th
18 ___:___
th
19 ___:___
th
20 ___:___
st
21 ___:___
nd
22 ___:___
rd
23 ___:___
th
24 ___:___
th
25 ___:___
th
26 ___:___
Page 35 of 75
Document reference code: MM/008/15

th
27 ___:___
th
28 ___:___
th
29 ___:___
th
30 ___:___
st
31 ___:___

Page 36 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS and


Community Teams

TITLE SOP CD 13 – Discrepancy between Clinical Area Controlled Drug


Balance and Recorded Total in Controlled Drug Register

Purpose To provide a standard procedure to be followed when a discrepancy is


found between the recorded controlled drug balance in the controlled drug
register and the physical stock present on the ward / team.

Scope Applies to all registered nurses, medical doctors and CFT Pharmacy staff.

Responsibilities Ward / Team Manager and Registered Nurse in charge of ward / Team,
Chief Pharmacist, Accountable Officer, Medical Director

The stock balance of all CDs entered into the controlled drug record book must be checked and
reconciled with the actual amount of controlled drugs in the cupboard. If it is not found to be
identical the discrepancy must be investigated and resolved. A Safeguard entry must be
completed. It is important to remember that a discrepancy could indicate misuse.

All stocks held and record keeping will be audited by the CFT Pharmacy once every quarter and
the results fed back to the ward/team manager and service line lead.

Procedure:

1. Stock balances of controlled drugs must be checked at every shift handover between ward
staff (see CD SOP 12).

2. If a discrepancy is found, then the following steps must be completed:

 Double check all controlled drug stocks to ensure that a counting error has not been
made.
 Double check all entries made in the controlled drug register to ensure that a simple
arithmetic error has not been made.
 If the amount in stock is higher than the balance recorded, check the requisition book to
ensure all drugs received have been documented in the register and check each page
of the register to confirm that there are not two entries for the same day.
 If the amount in stock is lower than that recorded, check prescriptions all controlled
drugs which have been administered have been entered in the controlled drug register.

3. Omissions from the controlled drug register which have been successfully traced back, i.e.
stocks received or dose administered, must be clearly entered into the record book with a
brief explanation. The entry must be witnessed and co-signed by another member of
professional staff, i.e. a second registered nurse, a pharmacist or a medical doctor.

4. Errors found in controlled drug record book entries must be amended in the following way:

 Draw brackets ( ) around the incorrect entry and annotate with a star *
DO NOT CROSS OUT AN INCORRECT ENTRY
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Document reference code: MM/008/15

 If the error is mathematical, the correct information must be recorded by the side of the
original error. If there is no space by the incorrect entry it is feasible to write on a new
line. A * note can be made at the bottom of the page or the register stating „entry
written in error‟.

5. When no errors or omissions are detected and the discrepancy cannot be resolved, follow
CD SOP 14: Controlled Drug Incidents, and ensure the Chief Pharmacist (AO) is informed
immediately.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 22 April 2013

Approved by: Date:


CFT Executive Nurse Sharon Linter 22 April 2013

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Forum and appropriate Clinical Cabinets 13/2/13

Review date: 3 years or sooner if there is a change in law or policy

Page 38 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS and


Community Teams

TITLE SOP CD 14 – Controlled Drug Incidents

Purpose To provide a standard procedure for the management of incidents


involving controlled drugs in CFT

Scope Applies to all CFT staff who may be involved with controlled drug incidents
and the CFT Accountable Officer.

Responsibilities As for Scope

Procedure:

1. ALL incidents involving controlled drugs must be recorded via the Safeguard incident
reporting system on the Intranet and the Trust‟s Accountable Officer and Chief Pharmacist
must be informed immediately.

2. A Controlled Drug incident is defined as:

 Balance in the controlled drug register does not correspond with the amount of
controlled drugs in the cupboard which, following investigation, no errors or omissions
are detected to explain the discrepancy.
 EPACT analysis or review of prescriptions shows unusual prescribing habits or trends.
 High usage of controlled drugs which cannot be explained by ward staff or prescribers
(missing items). Information from ADIOS.
 Non-adherence to SOPs within CFT.
 Non-adherence to SOPs within SLA provider pharmacy.
 Failure to provide secure storage or transport issues.
 Loss of controlled stationery.
 Large amounts of unidentified substances on the person of a patient or on CFT
property.

This list is not exhaustive.

3. All incidents involving medication must be reported in the usual manner via the Safeguard
incident reporting system. If a staff member is unsure as to whether the Accountable
Officer (AO) should be informed immediately, the CFT pharmacy department must be
contacted for advice.

4. The AO is responsible for reviewing the information provided about the incident and for
initiating a SUI where appropriate.

5. The AO is responsible for then ensuring all actions required after an investigation are
implemented and monitored accordingly.

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6. The AO is responsible for providing the appropriate controlled drug network (CDLIN) with a
quarterly report of such incidents and the actions taken to prevent recurrence.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 22 April 2013

Approved by: Date:


CFT Executive Nurse Sharon Linter 22 April 2013

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Forum and appropriate Clinical Cabinets on 13/2/13

Review date: 3 years or sooner if there is a change in law or policy

Page 40 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 15 – Obtaining a controlled drug for a discharge or leave


prescription

Purpose To provide a standard procedure to be followed when ordering controlled


drugs which have been prescribed on discharge or leave prescriptions.

Scope Applies to all CFT registered ward nurses authorised to order CDs.

Responsibilities Ward Manager and Registered Nurse in charge of the ward.

NB: When faxing confidential patient information all staff must adhere to Trust policies for
information governance.

Procedure:

1. When a discharge or leave prescription for a controlled drug is written it must be faxed to
Pharmacy at RCHT along with a copy of the ward inpatient treatment chart.

2. The original discharge or leave prescription for a controlled drug must be photocopied and
placed with the ward inpatient treatment card. It must be clearly indicated that this is a
copy and the date and time it was faxed to Pharmacy at RCHT must be recorded on it.

3. The original discharge or leave prescription for a controlled drug must then be placed in the
small green pharmacy CD order bag. Ensure the bag is clearly addressed to Pharmacy
RCHT, sealed with a security tag and sent to Pharmacy RCHT as soon as possible.

NB: The dispensed controlled drugs cannot be released from the Pharmacy at RCHT until
the original copy of the discharge or leave card has been received. It is unlawful for a
pharmacist to supply a controlled drug without a prescription which has been written in
indelible ink and has the handwritten signature of the prescriber.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 22 August 2013

Approved by: Date:


CFT Executive Nurse Sharon Linter 23 August 2013

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 41 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 16 – Raising a concern about CD practices of the


controlled drug Accountable Officer

Purpose To provide a standard procedure to be followed when raising a concern


about the CD practices of the controlled drug Accountable Officer, as
recommended by the CD Regulations 2013.

Scope Applies to all CFT Staff

Responsibilities As for Scope

Procedure:

1. Concerns about the CD practices of the controlled drug Accountable Officer can be raised
with:

 The Medical Director or any other member of the Executive Team


 Via the Whistleblowing Policy
 Via the Cornwall and Devon Accountable Officer:
Sue Mulvenna on 0113 825 3568
or via sue.mulvenna@nhs.net
or via accountableofficerdcios@nhs.net

Approved by: Date:


CFT Medical Director Ellen Wilkinson 5 October 2015

Approved by: Date:


CFT Executive Nurse Sharon Linter 16 October 2015

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 42 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS on WARDS

TITLE SOP CD 17 – Liquid controlled drug checking by a pharmacist on a


ward (overage adjustment)

Purpose To provide a standard procedure to be followed when checking the


quantity of liquid controlled drugs on the wards. (Bottles of liquid
controlled drugs often have a greater quantity of medication than identified
on the bottle i.e. „overage‟, and therefore adjustment of the recorded
quantity is often necessary).

Scope Applies to all registered pharmacists providing clinical services to areas


where liquid controlled drugs are used, in the presence of the registered
nurse in charge.

Responsibilities As per Scope.

Procedure:

1. Count the number of complete unopened bottles of liquid controlled drug.

2. Measure the volume of opened liquid controlled drug using a glass conical measure(s). If
the amount in the bottle is too small to measure the pharmacist can destroy the amount
with a witness using CD SOP 9.

3. Enter the date and time of checking on the correct page in the Controlled Drug Record
book. Include wording such as „stock checked by pharmacist and balance confirmed or
adjusted for overage‟ and record the actual total amount of liquid controlled drug. The
pharmacist and the second witness (registered nurse in charge) must both sign the entry.

4. Where discrepancies are found, i.e. the quantity measured is less than the figure recorded
in the Controlled Drug Record book; an investigation must be launched immediately to
discover the reason for the discrepancy. The Chief Pharmacist must be notified
immediately. An incident report must be completed.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 19 March 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 19 March 2014

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy.

Page 43 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS

TITLE SOP CD 18 – Courier Transport of Controlled Drugs

Purpose Controlled drugs are drugs specified by the Home Office as requiring extra
legislation and control. They tend to be drugs that could be open to abuse
or at risk of misappropriation.
This SOP provides a standard procedure to be followed by RHCT
Pharmacists, the Courier Service, reception staff, porters and nursing staff
as recommended by the CD Regulations 2013.

Scope Applies to all Pharmacy Staff at Royal Cornwall Hospitals, Treliske, all
Courier Staff, currently hosted by CFT, and all reception staff and CFT
nurses

Responsibilities As per Scope

 Controlled drugs should always be stored securely


 Transport of controlled drugs should be subject to a robust audit trail.

Procedure:

RCHT Pharmacy:

1. RCHT Pharmacy staff will fill orders for controlled drugs accurately and in a timely manner.

2. RCHT Pharmacy staff will package controlled drugs in a transport pouch with an
individually numbered tamper evident seal.

3. A member of RCHT pharmacy staff will complete the delivery duplicate book each day.
One page per delivery route, 1 line per numbered delivery bag.

4. RCHT Pharmacy staff will put the controlled drug pouches in the designated place in the
courier store along with the duplicate delivery book.

5. The RCHT pharmacy Controlled Drugs Assistant will collect the duplicate delivery book at
approximately 9am each morning and ensure that all controlled drugs have left the store.

Couriers:

1. Courier staff will check the delivery book to ensure they have all the necessary controlled
drug parcels for their route.

2. Courier staff will check the numbered tags and sign the delivery book to say that they have
collected the correct numbered bag for delivery and that at the time of that collection it was
sealed. Courier staff are not responsible for the contents of the bag just that the bag
remains secure and sealed in transit and gets delivered to the correct location. Courier
staff will take the duplicate copy of the delivery note with them on their delivery. The
delivery book will remain in the courier store.

Page 44 of 75
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3. Courier staff will take the sealed bag and delivery note to each location. They will get a
signature from a member of staff wearing an appropriate Trust ID badge. Controlled drug
bags must be handed to an individual and not be left in a courier store.

Sample of the delivery book layout:

Delivery Location Bag Placed in courier store by Collected for transport by Received by
number
Hospital Ward Signature Name Date Name Signature Date Name Signature Date Location
& time & time & time

4. Controlled drugs bags must not be left unsupervised. If the van is left it must be locked.

5. The completed delivery forms will be returned to the courier store RCHT at the end of the
transport run and placed in the designated tray.

6. Number tagged packages must be returned to RCHT Pharmacy if a signature cannot be


obtained.

Problems or Queries:

In the event of any problems whilst delivering controlled drugs RCHT courier should ring 01872
253445 immediately. There is an on-call pharmacist available via switchboard 24/7 should any
problems arise outside of RCHT pharmacy opening hours.

Delivery to Bodmin and Longreach Hospitals – CFT Staff:

1. The Courier Service will deliver the sealed bags to a specific agreed location at each
hospital, see below.

Site location Usual delivery point Usual point of contact

Bodmin Mews Entrance, Post Room Duty Porter or Post Room Assistant

Longreach Main Reception Duty Porter or Post Room Assistant.


Nursing staff or admin staff.

2. A member of CFT staff wearing appropriate photo ID must be available to receive the
package from the Courier Service.

3. CFT staff will check the number of packages and the number on the seal on the package.

4. All packages must be sealed and intact on delivery.

5. Once delivery is confirmed as correct the CFT staff member must sign the courier delivery
note and take responsibility for the sealed packages.

Page 45 of 75
Document reference code: MM/008/15

6. The courier will not leave numbered tag packages without a signature. Therefore if they
are unable to find a member of staff to sign for the delivery in a timely manner they will
return the package to RCHT Pharmacy.

Onward delivery of numbered tag packages:

1. At Bodmin or Longreach Hospitals, where the courier delivers to a reception area or post
room, it is the responsibility of the person signing the courier delivery note to either deliver
the parcel to a member of the nursing staff on the ward or contact the ward to request
collection.

2. To complete the audit trail to the ward, registered ward staff collecting or receiving the
numbered tag package must sign to accept final delivery of the package. (See Appendix
1).

Ward Staff:

1. Follow SOP CD 2 – receipt of controlled drugs, to complete the process.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 19 March 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 19 March 2014

Prepared by Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy.

Page 46 of 75
Document reference code: MM/008/15

RECORDED RECEIPT AND DELIVERY OF MEDICATION WITH TAG NUMBER

Signature on Receipt from Courier Signature on Delivery to Ward

Tag Date Time Ward Porter’s Porter’s Nurse’s Nurse’s Time Date
Number Name Signature Name Signature

RETURN COMPLETED FORM TO PHARMACY AT BELLINGHAM HOUSE

Page 47 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS

TITLE CD SOP 19 – Removal of patient’s own CDs in a patient’s home

Purpose To provide a standard procedure for the return of controlled drugs to a


community pharmacy

Scope All registered nurses working in patients‟ homes

Responsibilities Registered Nurses, Community Pharmacy Staff

CDs prescribed for an individual patient are the property of that patient and are not the
responsibility of the registered nurse caring for the patient. When a patient‟s own CDs are no
longer required the patient or carer must be advised to take the CDs to a community pharmacy for
disposal. If the patient or carer is unable to dispose of the CDs themselves the registered nurse
may dispose of the drugs following the procedure below:

1. Identify patient‟s own CDs which are no longer needed

 No longer current treatment


 Patient has died (see Point 9)

2. All unused CDs should be returned to a community pharmacy for destruction.

3. The patient / carer should be asked to sign a Patient’s Own Medicines Removal
Consent Form (Appendix 1).

4. Record all medication and amounts to be removed on to the form and obtain the
patient‟s/carer‟s signature.

5. If the patient/carer refuses to allow the destruction of the CD the registered nurse must
advise the patient to take the medication to a community pharmacy. The patient/carer,
where possible, must then sign the patient‟s own medicines removal form to confirm their
refusal.

6. If the patient/carer is unable to give consent the registered nurse can complete the form on
the patient/carer‟s behalf if, following a risk assessment, it is felt to be appropriate to
remove the medicines.

7. The registered nurse can then remove the CDs and take them straight to a community
pharmacy. The registered nurse must inform the receiving pharmacist that the item is a
CD and ask them to sign the medicines removal form to confirm they have received the
drugs from the nurse.

8. The form must then be uploaded onto RiO.

9. In the event of any death relatives/carers must be advised to keep all medication belonging
to the individual for two weeks following the death, in case they are required by the
Coroner. After this period, all medication, including CDs, should be returned to the

Page 48 of 75
Document reference code: MM/008/15

community pharmacy as soon as possible. Record on RiO that this advice has been given.
If following a risk assessment, it is felt to be safer, the medication can be held in the bases
CD cupboard for this two week period as long as the items are booked into the CD register.
After the two week period has elapsed the items can be booked out of the register and
taken to a community pharmacist for disposal as in point 7

Approved by : Date:
CFT Medical Director Ellen Wilkinson 16 November 2015

Prepared by: Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Operational Assurance Groups

Review date: 3 years or sooner if there is a change in law or policy

Page 49 of 75
Document reference code: MM/008/15

Appendix 1 – Patient’s Own Medicines Removal Consent Form

( ) I give my consent for CFT to remove medicines


Patient / Carer Name Patient / Carer Signature Date

( ) The patient is unable to give informed consent, e.g. patient does not have capacity, is deceased
or has been discharged. (Details to be documented in RiO).
Staff Name & Designation Staff Signature Date

List medicines removed (include strength, formulation, quantities and reason) continue overleaf if
necessary
1. 2.

3. 4.

Return of Patient’s own medicines: Patient confirmation of receipt of above medicines


Patient / Carer Name Patient / Carer Signature Date

( ) I do not want my medicines to be destroyed. I understand I must check with my doctor (GP)
before using them again. I have had the risks explained to me.
Patient / Carer Name Patient / Carer Signature Date

Staff Name & Designation Staff Signature Date

Details (if necessary)

I confirm receipt of the above medications for destruction


Pharmacist (PRINT Pharmacist Signature Date Community
NAME) Pharmacy Stamp

UPLOAD A COPY OF FORM ON TO RiO

Page 50 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS

TITLE CD SOP 20 – Collection of CDs from a community pharmacy,


transportation and delivery to patient

Purpose To provide a standard procedure for the collection of controlled drugs from
a community pharmacy

Scope All registered nurses

Responsibilities All registered nurses

Nurses, doctors, healthcare professionals, carers and patient representatives are allowed to
collect CDs for a patient.

Most community pharmacists can arrange delivery of medication but staff, if required to collect
them, need to:

1. Sign the back of the prescription.

2. Show proof of identity; for example Trust ID badge and professional registration
number. It is a requirement for the pharmacist to establish in what capacity you are
collecting the medication.

3. Provide name and work address.

All medication must be transported out of sight in the locked boot of the car. Medicines must not
be left in vehicles overnight.

After delivery to the patient, make an entry in RiO detailing the person receiving the CDs and proof
of ID seen, drug name, formulation, strength and quantity. If the person is not home the CDs must
be returned to the community pharmacy or stored in the Team base CD cupboard with a
witnessed entry made in the CD register.

DO NOT post medication through letter boxes or leave with neighbours.

Approved by : Date:
CFT Medical Director Ellen Wilkinson 16 November 2015

Prepared by: Helen Woods (Chief Pharmacist)

Agreed by: Medicines Management Committee and appropriate Operational Assurance Groups

Review date: 3 years or sooner if there is a change in law or policy

Page 51 of 75
Document reference code: MM/008/15

Standard Operating Procedures for Controlled Drugs in Special Schools

Page 52 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 1 – Receipt of Controlled Drugs

Purpose To provide a standard procedure to ensure that CDs are secure and that
procedures comply with the Misuse of Drugs Act and Cornwall Partnership
NHS Foundation Trust (CFT) Policies

Scope Applies to all registered special school nurses and competency assessed
teaching staff

Responsibilities Special School Nurse, Head Teacher, competency assessed teaching staff

Procedure:

 If CDs are to be administered in school, parents/carers must provide a separate,


labelled supply to be kept in school which must be in its original container.
 On receipt of the controlled drug the special school nurse (or if the nurse is unavailable
a CD competency assessed member of school staff) must immediately check:

1. That the correct item has been received, by checking drug, form and strength of the CD
against the child / young person‟s medication card.

2. The quantity received.

3. That complete packs are sealed (not tampered with), and are in date.

 The receipt must then be recorded in the CD Register. A separate page must be used
for each item, with the page clearly headed with the name of the drug, strength, form
and the patient‟s name, with the pages in use listed at the front of the CD Register. The
amount received, date and stock balance must be entered on the appropriate page by
the special school nurse and witnessed by a competency assessed member of school
staff (or if the nurse is unavailable two members of competency assessed school staff).
 The controlled drug must be locked in the CD cupboard immediately.
 The receipt of respite Oramorph and buccal midazolam which is being held in school
between respite and home should be recorded on the respite medication log but not
recorded in the school CD register.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Date:


CFT Chief Pharmacist / Helen Woods 2 October 2014
Accountable Officer

Page 53 of 75
Document reference code: MM/008/15

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 54 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 2 – Storage of Controlled Drugs

Purpose To provide a standard procedure to ensure that CDs are secure and that
procedures comply with the Misuse of Drugs Act and Cornwall Partnership
NHS Foundation Trust (CFT) Policies

Scope Applies to special school nurses, competency assessed teaching staff,


Pharmacy staff

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 The Nurse in the special school is responsible for the security of the CDs (Controlled
Drugs) in school and for the security of the keys to the CD cupboard and for restricting
their access.
 CD keys should be kept in a wall-mounted key cabinet when not in use. The special
school nurse has overall responsibility for the CD keys and ensuring that access to the
key cabinet and code is restricted to CD competent school staff only. The code to the
key cabinet should be changed on a quarterly basis or more regularly if appropriate.
 The Controlled Drugs cupboard must be kept locked at all times when not in use and
the keys stored in the locked, wall-mounted key cabinet.
 CFT Pharmacy staff authorised by CFT may have access to the keys when checking
CDs.
 If the keys cannot be located, there must be an immediate search. The Paediatric
Consultant Nurse must be informed. If the keys are not promptly recovered, the school
nurse, Head Teacher, The Lead Pharmacist for Children‟s Services and the CFT Trust
Accountable Officer must be informed.
 All CDs for use within school must be locked in the CD cupboard when not in use.
Respite supply of Oramorph 10mg/5ml and buccal midazolam that is being held in
school between respite and home should be stored in the locked respite medication
cupboard. It is not to be administered in school and it should not be stored in the school
CD cupboard.
 The CD cupboard should be used for storing CDs only.
 When not in use, Controlled Drugs Registers must be stored in a locked drugs
cupboard, whose keys are accessible to the school nurse and CD competent school
staff only.

Additional Information

CDs must be stored in accordance with the Misuse of Drugs (Safe Custody Regulations 1973)
The CD cupboard should comply with British Standard BS2881

Page 55 of 75
Document reference code: MM/008/15

Approved by: Date:


CFT Medical Director Ellen Wilkinson 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Date:


CFT Chief Pharmacist / Helen Woods 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 56 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 3 – Record Keeping

Purpose To provide a standard procedure to ensure that recording of CDs complies


with the Misuse of Drugs Act and Cornwall Partnership NHS Foundation
Trust (CFT) Policies
Scope Applies to all CFT and school staff involved with CD record keeping

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 All CDs to be administered in the special school must be recorded in the CD Register,
which is accessible only to registered nurses, CD competent school staff and pharmacy
staff so authorised.
 All entries in the CD Register must be signed by the school nurse and a member of CD
competent school staff. If the school nurse is not available then two members of CD
competent school staff may sign the CD register.
 Entries must be made on the correctly titled page, which shows the drug name,
strength and form of the drug and child‟s name, with a running balance.
 Pages currently in use should be listed at the front of the CD Register.
 Entries must be in chronological order and written in indelible pen. If a mistake is made
in an entry, the mistake should be bracketed but without obscuring the original entry.
The mistake and the correct entry should be signed and dated by the person making
those entries and by a witness.
 When a page is full, details must be transferred to the next available new page. Update
the index at the front of the CD Register by writing a new entry with the new page
number.
 Record the number of the new page at the bottom of the finished page, with “Records
transferred to page” On the new page, fill in the correct details of the drug, strength and
form and child‟s name, together with “Records transferred from page ...”
 Check the balance and record it on the new page.
 For liquid medicines start a new page for each new supply received, in order to simplify
accounting and the destruction of any overage left in the old bottle. Continue to use the
old bottle until no further doses can be administered from that bottle.
 The special school nurse is responsible for ensuring that the CD Register is kept up-to-
date and in good order.
 The special school nurse is responsible for maintaining a list of signatures of registered
nurses and school staff who have been approved as CD competent by the special
school nurse, and who have signed to confirm that they have read and understood
relevant CD SOPs.
 Completed CD Order books and Registers must be stored securely for at least 2 years
from the date of the last entry and then destroyed as confidential waste.

Page 57 of 75
Document reference code: MM/008/15

Approved by: Ellen Wilkinson Date:


CFT Medical Director 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Date:


CFT Chief Pharmacist / Helen Woods 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 58 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 4 – Administration of a Controlled Drug

Purpose To provide a standard procedure to ensure that CDs are used safely and
that procedures comply with the Misuse of Drugs Act and Cornwall
Partnership NHS Foundation Trust (CFT) Policies

Scope Applies to all CFT and school staff involved with administration of
controlled drugs

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 Controlled drugs (CDs) may only be administered by the school nurse or CD competent
school staff as authorised by the school nurse.
 Both the school nurse and CD competent school staff must witness:
o the removal of the controlled drug(s) from the CD cupboard
o the preparation of the controlled drug(s) to be administered
o confirmation of the identity of the patient
o the controlled drug being administered to the patient
o the destruction of any surplus drug (e.g. part of a tablet not required – according to
Special Schools CD SOP 5.)
 Where liquid controlled drugs have been administered, a small amount of potable water
should be drawn up into the medicine oral syringe (or poured into the medicine tot) and
the patient should be offered the opportunity to swallow the contents.
 A record must be made in the CD Register when a controlled drug is administered to a
patient at the time of administration. The following details should be recorded in the
relevant section of the CD record book:
o Date when dose administered
o Name of patient
o Quantity administered
o Form (name, formulation and strength) in which administered
o Name/signature of nurse / authorised person who administered the dose
o Name/signature of witness (where there is a second person witnessing
administration)
o Balance in stock
o The medication card / patient record must also be signed to indicate that a dose
has been administered
o If part of a tablet is administered to the patient, the school nurse or CD competent
school staff member should record the amount given and the amount wasted, e.g. if
the patient is prescribed 5mg methylphenidate and only a 10mg preparation is
available, the record should show „5mg given and 5mg wasted‟. This should be
witnessed by a second CD competent school staff member who should also sign
the record.

Page 59 of 75
Document reference code: MM/008/15

 The practitioner intending to administer the dose must first check that it is safe for that
patient to receive that dose, by confirming recent previous doses and tolerance [See
NPSA Rapid Response Report 2008 “Reducing dosage errors with opioid medicines”]
see flow chart in appendix 1.
 The administration must be fully recorded on the correct page in the CD Register and
on the child‟s medication card and signed by the school nurse and a member of CD
competent school staff (or when school nurse is not available, two members of CD
competent school staff) immediately after the dose has been administered.
 The CD must be counted (tablets) or visually checked (liquids) and checked against the
recorded balance (sealed containers do not need to be opened when checking stock).
Any discrepancy in the stock balance must be investigated immediately.

Additional information

Oral syringes or glass conical measure must be used to measure oral liquid CD medicines as
accurately as possible; these are more accurate than medicine pots.

Approved by: Ellen Wilkinson Date:


CFT Medical Director 30 September 2014

Approved by: Sharon Linter Date:


CFT Executive Nurse 30 September 2014

Approved by: Helen Woods Date:


CFT Chief Pharmacist / 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 60 of 75
Document reference code: MM/008/15

Page 61 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 5 – Removal and Disposal of a Controlled Drug

Purpose To provide a standard procedure to ensure that the removal & disposal of
CDs complies with the Misuse of Drugs Act and Cornwall Partnership
NHS Foundation Trust (CFT) policies.

Scope Applies to all CFT and school staff involved with the handling of controlled
drugs

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 Any individual dose or part dose which is prepared but not administered must be
destroyed in the yellow lidded sharps bin by the special school nurse / CD competent
school staff, and witnessed by a second CD competent staff member, with a full entry in
the CD Register.
 Used CD patches must be folded in on themselves to prevent release of the drug.
 CDs must not be destroyed on school premises by the special school nurse or school
staff.
 Expired or no longer prescribed CDs should be returned to the parent/carer at the
earliest possible convenience. The drug should be placed in a clearly marked bag and
handed to the parents / carer or secured in the child‟s medicine container used for
transport, with instructions that the drugs should be returned to the community
pharmacy for destruction.
 When CDs are returned to parents/carers for destruction by community pharmacy, a full
entry must be made in the CD register, signed by the school nurse and a member of
CD competent school staff stating that the drug is expired/no longer required; the
quantity and date when given to parent/carer and confirmation that ID has been
checked for the individual.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Date:


CFT Chief Pharmacist / Helen Woods 2 October 2014
Accountable Officer

Page 62 of 75
Document reference code: MM/008/15

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 63 of 75
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STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 6 – CD Balance check by the School Nurse / Authorised CD


Competent Teaching staff

Purpose To provide a standard procedure to ensure that CDs are secure and that
procedures comply with the Misuse of Drugs Act and Cornwall Partnership
NHS Foundation Trust (CFT) policies.

Scope Special school nurse, CFT Pharmacy staff, competency assessed


teaching staff

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 The registered nurse is responsible for ensuring that all CDs for administration in
school are balance checked and recorded at the end of each working day.
The stock check must be recorded in the CD Register and signed and dated by the
special school nurse and competency assessed school staff, (or if the registered nurse
is not available, two competency assessed members of school staff) as a separate
entry on the appropriate page of the CD Register:

”Stock checked and found correct by …... Witness …... “with signatures, and the date.

 Every 3 months, a pharmacist and/or a pharmacy technician who are authorised by


CFT to do so, will undertake a CD audit. Pharmacy staff will report any discrepancies or
concerns to the special school nurse and the Controlled Drugs Accountable Officer
(CDAO) for CFT. The findings of the quarterly CD audits will be presented to Medicines
Management Committee and the Children‟s Clinical Cabinet.
 Any discrepancies should be investigated immediately and reported to the special
school nurse in accordance with Special School CD SOP 8
 The Lead Pharmacist for Children‟s Services and Accountable Officer should be
informed promptly of any concerns, discrepancies, incidents or near-misses involving
CDs.

Approved by: Ellen Wilkinson Date:


CFT Medical Director 30 September 2014

Approved by: Sharon Linter Date:


CFT Executive Nurse 30 September 2014

Approved by: Helen Woods Date:


CFT Chief Pharmacist / 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Page 64 of 75
Document reference code: MM/008/15

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 65 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 7 – Controlled Drug Stationery

Purpose To provide a standard procedure to ensure that CD stationery is secure and


used appropriately in accordance with the Misuse of Drugs Act and Cornwall
Partnership NHS Foundation Trust (CFT) policies

Scope All CFT staff and competency assessed teaching staff who handle CD
stationery

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 CD registers are controlled stationery. They must therefore be stored securely and
access restricted.
 Any unused CD stationery must be returned to Pharmacy RCHT.
 CD registers must be ordered from pharmacy RCHT via the Children‟s Services
Pharmacist.
 They must be kept locked in the drugs cupboard when not in use.
 When full, they must be sealed and stored securely for 2 years after the date of the last
entry, then destroyed as confidential waste.
 When a new CD register is started, the records from the old register must be
transferred by the special school nurse. Each stock balance must be checked against
the stock in the CD cupboard by the school nurse and CD competent school staff.
 Loss of any CD stationery must be reported immediately to the Paediatric Nurse
Consultant, head teacher, school nurse and children‟s services pharmacist who will
inform the Controlled Drugs Accountable Officer (CDAO) for CFT.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Helen Woods Date:


CFT Chief Pharmacist / 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

Page 66 of 75
Document reference code: MM/008/15

STANDARD OPERATING PROCEDURE for CONTROLLED DRUGS in SPECIAL SCHOOLS

TITLE CD SOP 8 – Controlled Drug Incident Reporting

Purpose To provide a standard procedure to ensure that CDs are secure and
procedures comply with the Misuse of Drugs Act and Cornwall Partnership
NHS Foundation Trust (CFT) policies.

Scope All CFT staff and competency assessed teaching staff who handle CDs

Responsibilities Special school nurse, head teacher, competency assessed teaching staff

Procedure:

 The balance must be checked and recorded each time a dose of a CD is administered.

Discrepancies or incidents or near-misses or concerns around CDs

 Any discrepancies should be investigated immediately and reported to the school


nurse, Head Teacher, Paediatric Nurse Consultant and Lead Pharmacist for Children‟s
Services.
 The Pharmacist will then alert the Controlled Drugs Accountable Officer (CDAO) for
CFT.
 Any medicines incidents or near-misses must be reported promptly by the school nurse
on CFT incident reporting system, Safeguard, in accordance with the Trust policy.
Reports involving CDs will be reviewed by the CDAO as well as the Medicines
Management Committee.

Approved by: Date:


CFT Medical Director Ellen Wilkinson 30 September 2014

Approved by: Date:


CFT Executive Nurse Sharon Linter 30 September 2014

Approved by: Date:


CFT Chief Pharmacist / Helen Woods 2 October 2014
Accountable Officer

Prepared by Beth Hodgson (Lead Pharmacist for Children‟s Services)

Agreed by: Medicines Management Committee and appropriate Clinical Cabinets

Review date: 3 years or sooner if there is a change in law or policy

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Frequently asked Questions … and some answers!

(Ask your pharmacist for further information or advice)

Q – How do I know if a drug is a Controlled Drug?

A – Controlled Drugs supplied from Pharmacy to the ward as ward stock, temporary stock or as a
named patient supply for inpatient use will say “Controlled Drug” on the bottom of the label.
Controlled drugs dispensed as TTOs with directions for use will not say “Controlled Drug” on the
label, but still need to be treated as CDs while they are on the ward.

Controlled drugs dispensed in the community and brought in from home by patients (Patients‟ Own
Drugs) will not say “Controlled Drug” on the label, but still need to be handled as CDs on the ward.

To check if a particular medicine is a controlled drug, you can:-

 Check with Pharmacy


 Check in BNF – look up the particular brand name or approved name of
the drug in question. The entry is headed by the drug name (black bold print), then the
manufacturer (brackets), then CD in a little box if the drug is a CD.

The majority of CDs we use are opioids, i.e. morphine-type drugs.

These include: - buprenorphine, dexamphetamine, diamorphine, fentanyl, methadone,


methylphenidate, morphine, oxycodone, pethidine, “Subutex”.

Other CDs are not opioids, e.g. dexamphetamine, methylphenidate (“Ritalin”), midazolam.

Q – What about Morphine Sulphate Oral solution?

A – Cornwall Partnership NHS Foundation Trust chooses to treat Oramorph 10mg in 5ml as a
Controlled Drug because it contains morphine, even though it is a weaker strength of morphine
and as such is not legally subject to the full controls of the Misuse of Drugs Regulations. We
consider this to be a safe and consistent approach to morphine.
(This is why Pharmacy RCHT might say it‟s not a Controlled Drug – we‟re both right!)

Q – What about temazepam and midazolam?

A – Temazepam and midazolam are different from other benzos as their use is controlled under
Schedule 3 of the Misuse of Drugs Regulations; other benzos such as diazepam are Schedule 4.
Cornwall Partnership NHS Foundation Trust requires both drugs to be stored in the CD cupboard
and each administration to be recorded in the CD Register, just as for full CDs. Both temazepam
and midazolam are internationally recognised as being particularly subject to misuse.

Q – What about patches?


Opioid patches (fentanyl, buprenorphine) should only be used when oral route is not possible, as it
is much easier to adjust the dose of oral medication.

A – They should only be used in people who already have some tolerance to opioids.

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Patches must be applied to the skin in accordance with the manufacturer‟s instructions. The length
of time each patch lasts should be double-checked, as the treatment times vary between different
drugs, and between different brands.

All patches deliver a drug slowly through the skin so there is a delay before the drug becomes
effective on starting a patch, and a delay in clearing the drug from the body on removing the patch.
It is good practice to record where the patch has been placed on the body and to check and record
daily that the patch is still in position. Use the form “Application/Replacement of Medicated
Transdermal Patches”.

It is important to remove old patches before a new patch is applied.

Q – How do I dispose of a used fentanyl or buprenorphine patch?

A – Medication may remain in the patch after it is removed from the skin.

After removal, patches should be folded firmly in half, adhesive side inwards so that the adhesive
side is not exposed, then immediately disposed of safely in the yellow-lidded sharps bin.

Q – Where should CD TTOs be recorded in the register?

A – Any CD that has been supplied on a discharge or leave prescription to take home should be
recorded in the Patient‟s Own section of the CD register or in the separate Patient‟s Own CD
register as it is must not be used as stock for another patient .

Q – When can old CD order books and CD registers be destroyed?

A – 2 years from last entry, until that time order books and registers must be sealed and stored in
a safe place on the ward. CD order books and registers must be destroyed with confidential waste.

Q – How do I know when a liquid oral controlled drug has expired?

A – On opening a new bottle, check the manufacturer‟s instructions on the bottle and calculate the
expiry date then write „Do Not Use After and date‟ on the label. If an oral liquid has expired inform
ward pharmacist, so that it can be removed as soon as possible.

Q – What must I do if the balance in the register at the end of a bottle of oral liquid does not
tally with the liquid left in the bottle?

A – Measure the volume left in the bottle, record in CD register and informs ward manager and
ward pharmacist as soon as possible.

CD oral liquids should always be measured very carefully using the appropriate equipment (oral
syringe or glass conical measure for larger volumes).

For this reason the CD SOPs stipulate that a new page in the register should be started for each
new bottle.

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Q – Who can act as a witness?

A – A registered nurse, or if there is no other registered nurse then another healthcare


professional (e.g. pharmacist) or an authorised healthcare assistant who has been approved as
competent by the ward manager and who has signed to confirm that they have read and
understood relevant CD SOPs.

Relevant CD SOPs for Healthcare assistants are

CD SOP 2 Receipt of Controlled drugs


CD SOP 4 Record Keeping
CD SOP 6 Stock Checks
CD SOP 7 Administration of Controlled Drugs
CD SOP 9 Removal / Disposal of Controlled Drugs

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Equality Impact Assessment Proforma Initial Screening

Name of Procedural document to be assessed: Controlled Drugs Standard Operating Procedures

Section: Clinical: Medication Management

Officer responsible for the assessment: Helen Woods, Chief Pharmacist & Controlled Drug Accountable officer

Date of Assessment: February 2013 Is this a new or existing procedural document? E

1. Briefly describe the aims, objectives and To promote the safe, secure and effective use of CDs and to comply with national guidance
purpose of the procedural document. and legislation.
2. Are there any associated objectives of the Safe, secure and effective use of CDs, complying with national guidance and legislation on
procedural document? Please explain. CDs.

3. Who is intended to benefit from this Service Users, Trust Staff, General Public
procedural document, and in what way?
4. What outcomes are wanted from this Safe, secure and effective use of CDs.
procedural document?
5. What factors/forces could contribute/detract
from the outcomes?
6. Who are the main stakeholders in relation Helen Woods, Ellen Wilkinson, Sharon Linter
to the procedural document?
7. Who implements the procedural document, Helen Woods
and who is responsible for the procedural
document?
8. Are there concerns that the procedural Y N Please explain
document could have a differential impact
on RACIAL groups?
What existing evidence (either presumed or

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otherwise) do you have for this?


9. Are there concerns that the procedural Y N
document could have a differential impact
due to GENDER
What existing evidence (either presumed or
otherwise) do you have for this?
10. Are there concerns that the policy could Y N
have a differential impact due to
DISABILITY?
What existing evidence (either presumed or
otherwise) do you have for this?
11. Are there concerns that the policy could Y N
have a differential impact due to SEXUAL
ORIENTATION?
What existing evidence (either presumed or
otherwise) do you have for this?
12. Are there concerns that the procedural Y N
document could have a differential impact
due to their AGE?
What existing evidence (either presumed or
otherwise) do you have for this?
13. Are there concerns that the procedural Y N
document could have a differential impact
due to their RELIGIOUS BELIEF?
What existing evidence (either presumed or
otherwise) do you have for this?
14. Are there concerns that the procedural Y N
document could have a differential impact
due to their MARRIAGE OR CIVIL
PARTNERSHIP STATUS? (This MUST be
considered for employment policies).
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What existing evidence (either presumed or


otherwise) do you have for this?
15. Are there concerns that the procedural Y N
document could have a differential impact
due to GENDER REASSIGNMENT OR
TRANSGENDER ISSUES?
What existing evidence (either presumed or
otherwise) do you have for this?
16. Are there concerns that the procedural Y N
document could have a differential impact
due to PREGNANCY OR MATERNITY?
What existing evidence (either presumed or
otherwise) do you have for this?
17. How have the Core Human Rights Values
of: These have been considered and the SOPs are consistent with Human Rights legislation.

 Fairness;
 Respect;
 Equality;
 Dignity;
 Autonomy

Been considered in the formulation of this


procedural document/strategy

If they haven‟t please reconsider the document


and amend to incorporate these values.

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18. Which of the Human Rights Articles does The right: Y N


this document impact?
 To life;
 Not to be tortured or treated in an inhuman or degrading way;
 To be free from slavery or forced labour;
 To liberty and security;
 To a fair trial;
 To no punishment without law;
 To respect for home and family life, home and correspondence;
 To freedom of thought, conscience and religion;
 To freedom of expression;
 To freedom of assembly and association;
 To marry and found a family;
 Not to be discriminated against in relation to the enjoyment of any of
the rights contained in the European Convention;
 To peaceful enjoyment of possessions and education;
 To free elections
What existing evidence (either presumed or
otherwise) do you have for this?
How will you ensure that those responsible for
implementing the Procedural document are
aware of the Human Rights implications and
equipped to deal with them?
19. Could the differential impact identified in 8 – Y N Please explain
13 amounts to there being the potential for
adverse impact in this procedural document?
20. Can this adverse impact be justified on the Y N Please explain for each equality heading (questions 8 –13) on a separate
grounds of promoting equality of opportunity piece of paper.
for one group? Or any other reason?
If Yes, describe why, and then proceed to a full
EIA.

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21. Should the procedural document proceed to Y N


a full equality impact assessment?
If No, are there any minor further amendments
that should take place?
22. If a need for minor amendments is Y N
identified, what date were these completed
and what actions were undertaken

Signed (completing officer) Helen Woods Date February 2013


Signed (Service Lead) Date

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