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1
Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
2
Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
Scope
This Standard Operating Procedure (SOP) applies to witnesses authorised by the
AO for NHS Rotherham and members of the Medicines Management Team
(MMT). It relates to the destruction of out-of-date or unwanted Schedule 1 and 2 CD
stock.
In this procedure stock refers to CDs that have not been issued/dispensed to a
patient. Once medication has been issued/dispensed to a patient, generally known
as Patient Returns the requirements for witnessed destruction do not apply.
It explains how CDs should be destroyed in the presence of authorised witnesses
and how any discrepancies/problems found during the destruction process should be
processed.
This SOP is to be used in conjunction with NHS Rotherham Medicines Policy.
Please note all schedule 3 controlled drugs can be denatured and disposed of
as clinical waste and do not need to be recorded in the register or disposed of
by an authorised witness.
ON RECEIPT OF REQUEST
On receipt of the request the following information must be collected on the
Controlled Drugs Destruction data base found at
U:\CD LIN\CD Destruction Requests\Controlled Drugs Destruction Database.mdb
Date of request
Date appointment request actioned
Name and address of premises
Type of premises (e.g. GP, Pharmacy)
Contact telephone number
The premises will be sent (by e-mail or post/ fax if an e-mail address is not available)
a copy of the Controlled Drug Destruction Witness Record (Appendix A) to complete
if they do not already have access to one. This will need to be returned to the
Medicines Management Team before any appointment with an Authorised Witness
can be confirmed, as time required for the appointment will need to be approximated.
The Medicines Management Officer (or their deputy in their absence) arranges an
appointment with an Authorised Witness. The appointment is to be made within 4
weeks from the date the request is made. Further details are then to be added to the
CD Destruction Database.
Time and date of appointment
Name & Title of Authorised Witness
Name and Title of the Nominated Person from the Premises
If the appointment cannot be made in the designated timescale then the reasons for
this are to be added to the database.
Authorised Witnesses will undertake the supervision of destructions on an equal rota
basis.
The Authorised Witness shall not be a relation or have a personal relationship with
the nominated person who will be destroying the CDs. If they do then another
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
authorised witness will attend the destruction or a different person at the premises
must be nominated.
Authorised Witnesses must not witness the destruction of CDs for a GP Practice or
NHS Rotherham clinical provider premises to whom they are providing Prescribing
Support or where they work at the time of destruction.
Authorised Witnesses must not act in that capacity within any Community Pharmacy
premises in which they are currently also providing services as a Pharmacist or a
Pharmacy Technician (employed or locum).
Any medical practitioner must not witness destruction in their own practice.
Confirmation is to be obtained from premises that:
The nominated person who will be destroying the CDs during the
appointment will have sufficient time to undertake the process and not be
required for other duties
The nominated person is permanent member of staff (e.g. not a locum). This
person does not have to be a pharmacist or the person responsible at the
premises
The premises have sufficient denaturing kits and the appropriate equipment
to undertake the process with regards to relevant health and safety/ COSHH
regulations
The premises have a T28 certificate -Sorting and denaturing of controlled
drugs for disposal
The premises have a Standard Operating Procedure (SOP) for the
Destruction of Controlled Drugs.
The completed form will be saved by date and name of organisation under
U:\CD LIN\CD Destruction Requests\Destruction Records
PRE-VISIT
The Authorised Witness will assemble
A printed copy of the submitted CD Destruction Witness Record, U:\CD LIN\CD
Destruction Requests\Destruction Records
A spare CD denaturing kit and labels for applying to used kits
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
The Authorised Witness will need to confirm any directions and/or contact details
before committing to the visit and ensure they have their NHS Rotherham ID badge
and authorisation letter (Appendix B).
2. The Visit
PREPERATION
On arrival at the premises the Authorised Witness will identify themselves, using
their NHS Rotherham ID badge (if they are not already known to staff) and letter of
authorisation and ask for the nominated staff member who is to destroy the CDs.
The Authorised Witness will request to see a copy of the pharmacies T28 certificate Sorting and denaturing of controlled drugs for disposal and a copy of their Standard
Operating Procedure (SOP) for the Destruction of Controlled Drugs. If either of these
documents are not available then the destruction cannot take place.
All parts of the process must take place in the presence of the Authorised Witness.
CDs must be destroyed using a CD/Drug denaturing kit designed for that purpose.
No other method of destruction may be used. The kits include instructions for use;
these must be followed to ensure effectiveness.
The CDs quarantined for destruction are to be removed from the CD
cupboard
Verify the quantity of drug and strength to be destroyed with the CD
destruction form previously prepared
Any extra items can be added to the destruction list at the discretion of the
Authorised Witness. If needed, a further visit can be arranged.
Check the drug is out-of-date or otherwise unwanted and has not been
dispensed/issued to a patient
Ensure that the instructions on the denaturing kit are followed
CONTROLLED DRUGS REGISTER
Before any CDs are destroyed, the relevant pages of the CD register must be
verified by the Authorised Witness. The entry in Controlled Drug Register must
contain the following information
Name, strength and form of the product (If drug details are on the top of the
page in the register then only the quantity needs to be filled in for each entry)
Date and quantity destroyed
Reason for destruction, e.g. Out of date, unwanted, discontinued stock
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
Tablets/Capsules
Tablets and capsules are to be removed from their outer packaging, removed
from blister packaging and placed in the kit. NB. Some kits require the tablets
to be crushed and capsules opened
Patches
Lozenges
Lozenges must be removed from their packaging and placed in the kit. If there is
any excess uncontaminated packaging (e.g. the plastic stick which the lozenge is
attached to) then is to be cut off
Ampoules
Liquid and powder ampoules should be opened using an ampoule breaker and as
much of the content as possible emptied into the kit. The ampoule must be rinsed
with water into the denaturing kit to remove the final traces of the CD. The empty
ampoule should then be disposed of in the glass or sharps bin. Gloves must be
worn at all times to help protect the member of staff
Aerosol
formulations
Liquid
Add directly to the denaturing kit. The container should be rinsed into the kit to
remove final traces of the CD.
Once all the CDs have been added to the denaturing kit, the following instructions
are to be followed:
Replace the lid on the kit and shake powder around to ensure that the powder
has encased the contents
Open container, fill to line with water, replace lid securely and shake
vigorously in accordance with the kit manufacturers directions
The kits are then labelled using those provided by NHS Rotherham (figure1)
to show when the kit was used, so that it can be completely disposed of after
the denaturing process is complete. The label is to be completed by the
Authorised Witness
Request that the kit is locked away in a CD cabinet / secure medical cupboard
for 24 hours to ensure that the full denaturing process occurs. After this the kit
is then safe to dispose of via a normal pharmaceutical waste bin. All premises
(including GP and Dental practices) must have arrangements in place to
dispose of pharmaceutical waste.
Figure 1
Mixed Waste Controlled Drugs
Please remove from CD cupboard
after ..../..../.....
and place in pharmaceutical waste bin
3. Post-Visit
The completed Controlled Drug Destruction Witness Record sheet must be returned
to the Medicines Management Officer, NHS Rotherham (or their deputy in their
absence) on behalf of the Accountable Officer on the day of the destruction or the
next working day if that is not practical.
The form is to scanned and filed under
U:\CD LIN\CD Destruction Requests\Destruction Records
Replacing the form submitted during the request process.
The form itself is then kept on file in the Medicines Management Team Office in the
folder marked Controlled Drugs Local Intelligence Network.
4. Discrepancies
Discrepancies that are not traced and corrected (e.g. a mathematical error within the
CDR) at the time of the destruction must be recorded in the CDR and on the CD
Destruction Witness record.
The presence of discrepancies does not necessarily prevent the destruction of CDs
from taking place. The Authorised Witness must consider the risks (if any) of not
allowing the destruction the CDs during the visit, recording what has not, been
destroyed and include any relevant information.
It is not the function of the Authorised Witness to investigate untraced discrepancies
at the time of destruction. The Authorised Witness must make a detailed note of the
discrepancy on the CD Destruction Witness Record and advise the premises to
undertake a full investigation and inform NHS Rotherham Accountable Officer, or
their deputy of their finds via an Incident Alert Form with-in one week of the visit.
It is the responsibility of NHS Rotherham Senior Pharmaceutical & Prescribing
Advisor (Non-medical Contractors, Mental Health & Governance) to ensure that a full
investigation into the discrepancy takes place.
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
5. Validation
TRAINING
NHS Rotherham will agree and ensure appropriate training for all Authorised
Witnesses. Once training is competed the Authorised Witness will be issued with an
authorisation letter (Appendix B), which will be valid for 12 months.
Training will include:
Reading this SOP
Witnessing a visit
Completing a supervised visit
NHS Rotherham will provide updates and where necessary additional training for all
Authorised Witnesses as and when the need arises.
AUDIT
NHS Rotherham Senior Pharmaceutical & Prescribing Advisor (Non-medical
Contractors, Mental Health & Governance) will ensure an annual audit of staff
adherence to this SOP is undertaken.
DEVELOPMENT
Previous Standard Operating Procedure ref CD09/001
Reviewed by: NHS Rotherham Medicines Management Team April 2011
Lead Author: Joanna Hallatt Community Pharmacy Development Pharmacist
Ratified by: NHS Rotherham Medicines Management Committee (19 May 2011)
Review Date: 31 March 2013
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
6. Declarations
All named Authorised Witnesses, NHS Rotherham Accountable Officer and
members of the Medicines Management must sign the declaration below to confirm
that they have read, understood and will abide by the Destruction of Controlled
Drugs Standard Operating Procedures.
Name
Title
Signature
Date
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
Appendix A
Controlled Drug Destruction Witness Record
This document must be retained by the NHS Rotherham Accountable Officer for a
minimum of 11 years
Date :
Location :
Quantity
Destroyed
Strength
Form
(e.g. tablet)
Expiration
date
Reason for
Destruction
(e.g. OOD)
T28 Certificate
Pharmacy Specific SOP in place:
Authorised Witness (Name & Designation)
Nominated Premises Person ( Name & Designation)
Date:
Date:
Comments (if required): (please continue overleaf or separate sheet if necessary)
Please return to: Medicines Management Officer, Oak House, , Moorhead Way, Bramley, Rotherham, S66 1YY
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
Appendix B
Template letter for Authorisation for Named Persons to Witnesses the
Destruction of Controlled Drugs
Name
Designation
(Hereinafter called the authorised person), until (valid date twelve months) or any
prior revocation of this authority , to supervise the destruction of Controlled Drugs
held in community pharmacies on the pharmaceutical list of NHS Rotherham and
any healthcare premises where controlled drugs are stored which are under the
jurisdiction of NHS Rotherham . The authorised person will follow the Standard
Operating Procedure for the Destruction of Controlled Drugs (Ref 002)
When this authority expires on (valid date twelve months), or if at any time before
that date the authorised person ceases to carry on their current professional role, or
if the Accountable Officer for NHS revokes this authority, then the authorised person
must return this authority to the Accountable Officer at NHS Rotherham for
annulment
Stuart Lakin
Head of Medicines Management and NHS Rotherham Accountable Officer
Date:
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
Appendix C
General Information
CD REGISTERS (CDRS)
The format and requirements for CD registers are specified in Regulations 19, 20
and Schedule 6 of the Misuse of Drugs Regulations 2001 as amended. Schedule 6
of the regulations was deleted on 1st February 2008.
From the 1st February 2008 it is no longer a legal requirement to maintain a CDR in
a prescribed format. The regulations will specify only the headings/field to be used in
the CDR.
The CDR may set out entries to be made in the case of obtaining and entries to be
made in cases of supply on the same or separate pages. Two separate pages will
no longer be required. This supports the increased use of electronic registers and
maintenance of running balances.
Be bound (not loose-leaved) or a computerised system which is in
accordance with best practice guidance
Separate pages (in paper) or sections for each strength and form of an
individual drug will be required
page, together with the name of drug to which the entries on the page of the
CDR relate
In the case of electronic registers, they must be capable of printing or
displaying the name, form and strength of the drug in such a way that the
details appear at the top of each display or printout.
Have the entries in chronological order and made on the day of the
transaction or the next day
Have the entries made on consecutive lines (no blank lines).
computerised form in which every such entry is attributable and capable of
being audited and is in accordance with best practice guidance endorsed by
the Secretary of State under section 2 of the NHS Act 1977
Not have cancellations, obliterations or alterations; corrections must be made
by a signed and dated entry in the margin or at the bottom of the page
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
to contain addition information so that any trends and possible causes can be
identified.
An Authorised Witness will not visit the premises to supervise the disposal of
a Spoilt CD
The premises MUST contact the Medicines Management Team Office by telephone
(01709 302631) on the day the CD is spoilt, or the next working day if the incident
occurs when NHS Rotherham Officers are closed.
The following must be undertaken by the premises in which the stock is held for all
formations:
Ensure the medication is witnessed by a second party before any attempt to
destroy/ clean- up the CD is made
Quantify the amount of CD spoilt with as much accuracy as possible. For
example number of tablets, vials effected or the volume of any liquids (as
much of the liquid as possible must be measured)
Extreme care is to be taken where broken glass is involved. Staff must wear
gloves. No attempt to separate small pieces of glass from the CD are to be
made
An entry is to be added to the CDR that includes
Name, strength and form of the product (If drug details are on the top
of the page in the register then only the quantity needs to be filled in for
the entry).
Date and quantity disposed of (if this is an approximation for a liquid
this also is to be noted)
Reason for disposal without an Authorised Witness, e.g. damaged
stock
Signature, name (printed) and professional registration no (if
applicable) of both the person undertaking the disposal and the second
witness
The running balance is to be amended to show the amount that has
been disposed of
The CD including any small pieces of glass is to be placed in a denaturing kit
Replace the lid on denaturing kit and shake powder around to ensure that the
powder has encased the contents.
Open container, fill to line with water, replace lid securely and shake
vigorously in accordance with the kit manufacturers directions
The kits should be marked to show when it was used, so that it can be
completely disposed of after the denaturing process is complete
The kit shall be locked away in the CD cabinet for 24 hours to ensure that the
full denaturing process occurs, after this the kit is then safe to dispose of in
normal pharmaceutical waste bin. If pharmaceutical waste disposal is not
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012
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Document Reference Number CD11/002
This document is operational from 09 May 2012
This document expires on 31 March 2012