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Controlled Drugs Template

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					Template for Dental Practice Standard Operating Procedure for Controlled Drugs
                                                                                                Responsible
                                                                                                Person
Objective      To ensure the ordering, recording, storage and destruction of Schedule 2
               and Schedule 3 CDs conforms to current legislation and that systems are in
               place within the surgery to facilitate this.
Scope          To be applied to the handling of all Schedule 2 and Schedule 3 CDs at XXX
               Surgery/Practice.
Specialist     A Home Office license is required for the supply of diamorphine, dipipanone      Responsibility of
Prescribing    and cocaine to addicts for drug dependence.                                      prescriber
Ordering       Forms and Stationery
               The ordering of CDs by a qualified prescriber is on a prescription (an FP10D     Name of
               – NHS prescription or FP10PCD-NC -personalised or FP10PCD-SS –non                member of staff
               personalised – private prescriptions) or via a requisition written on a          responsible for
               designated form. Registration for six figure private prescriber code is via      ordering CD‟s
               PPSA and forms are available from Coitbury House, Winchester.
               Prescriptions for Prescription Only Medicines can only be written for
               individual patients; CDs required for stock must be ordered on a requisition.
               Requisitions for stock
               The requisition does not have to be in the recipient‟s handwriting but must
               be signed by them.
               Prescriptions
               Only items listed in the Dental Prescribing Formulary can be prescribed on
               Form FP10 (D). Dentists working in secondary care issuing FP10
               Prescriptions may prescribe any drug or medical device that would normally
               be allowed on an FP10 Prescription.
               Computer generated prescriptions will be logged automatically in the
               patients clinical record. If a hand written prescription is generated then a     Responsibility of
               manual log must be made on the patient‟s notes by the prescriber within 24
                                                                                                Prescribers to
               hours of the prescription being written.
                                                                                                document hand
               All prescriptions for CDs must include: Name and address of prescriber,          written script
               name and address of patient, name, form, strength and dose of drug, total
               quantity in words and figures, signature of prescriber, date prescription
               written, prescriber identifier (six figure NHS code or in case of private
               prescriptions six figure private prescriber code). The prescription can be
               computer generated, but must be signed by the prescriber. Health
               professionals must put their name and prescriber identifier on the
               prescription. Prescriptions for Schedule 2, 3 and 4 CDs only remain valid for
               28 days.
               It is recommended that a signature is obtained when CD prescriptions are
               collected, if possible and appropriate.
               Where a prescription is written by a dentist following the administration of a
               CD to a patient from an emergency bag or stock, the dentist should endorse
               the prescription form with the word „administered‟ and then date it. This aims
               to avoid unauthorised individuals attempting to reuse such prescriptions to
               obtain CDs illegally. Information should also be entered into the patient‟s
               record as soon as practicable. The prescription should be forwarded to PPD
               to enable full monitoring and audit.
               Prescriptions issued by a dentist must contain the words „for dental             Names of
               treatment only‟.                                                                 Prescribers
                                                                                                authorised to
               Authority
                                                                                                order CD‟s
               The practice must maintain a list of Prescribers authorised to order CD‟s

                                                                                                Name of
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                       Date of Issue: 10 April 2008    Review Date: May 2009
          Purchase/Supply                                                                  member of staff
          The prescription/requisition will be delivered to / by the local pharmacy and    responsible for
          collected / received by the prescriber placing the order.                        collection of
          If a CD ordered on a requisition note is not collected by the prescriber then    CDs
          the person sent to collect may only be supplied with the CD if he/she
          produces to the supplier a statement in writing given by the prescriber to the
          effect that the messenger is empowered to receive the drug on his/her
          behalf.
Receipt   Receipt of Order
          On receipt of an order, confirmation that the correct items and quantity have
          been sent must be made against the ordering record book/ the ordering
          computerised spreadsheet (*delete as appropriate) and a note of receipt
          made. The expiry date of the CD‟s must also be checked on receipt.
          Original sealed packs do not need to be opened. All invoices need to be
          retained for a minimum of two years.
          The member of staff must ensure that the CD‟s are recorded appropriately
          and stored securely or received promptly by the ordering prescriber.
Receipt   CD Register (Practice or Emergency Bag)
          Recording of CD‟s either receipt or supply must be made immediately or as
          soon as possible within a 24 hour period
          Schedule 2 CDs must be entered in a register.
          This must be a bound book or folder, thereby ensuring pages cannot be
          removed. There must be a separate section/page for each drug and a               Name of staff
          separate section/page for each presentation; however with effect from 1          member
          February 2008, entries made in respect of each Schedule 2 drug obtained          responsible for
          and supplied may be made on the same page or on separate pages in the            recording CD‟s
          register.
          The entries must be in chronological order
          The entries must be indelible                                                    Name of staff
          Any errors or corrections must not be crossed out, amendments must be            member of
          made as footnotes or marginal notes                                              responsible for
          Corrections must be dated and initialled                                         maintaining
          Each prescriber who carries CD‟s is responsible for maintaining his/her own      register
          register
          All registers must be kept safe for at least 2 years from the date of the last   Names of staff
          entry                                                                            authorised to
          Practice and bag registers must be available for inspection by the „AO‟ for      supply CD‟s
          the PCT or police                                                                from the
          Recording of receipt in CD Register (Practice or Emergency Bag)                  Practice CD
          Date of receipt                                                                  cupboard and
          Name and address of supplier                                                     make entry in
          Amount obtained                                                                  CD register
          Form obtained
          Running balance (Currently good practice)
          Signature
          Recording of supply in CD Register (Practice or Emergency Bag)
          Date supplied;
          Name/Address of person or firm supplied;
          Details of authority to possess – prescriber or licence holder‟s details;
          Quantity supplied;
          Person collecting Schedule 2 controlled drug (patient/ patient‟s rep /
          healthcare professional) and if healthcare professional, name and address;
          Was proof of identity requested of patient/ patient‟s rep (Yes/No);
          Was proof of identity of person collecting provided (Yes/No).
          Records are not legally required in the case of a drug supplied to a GP,
          dentist or pharmacist for the purpose of destruction but it is recommended
          that a separate record book is maintained.
          The regulations permit use of computerised CD Registers but entries must
          be attributable and capable of being audited. Full details of the requirements
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                  Date of Issue: 10 April 2008    Review Date: May 2009
                 for computerised CDRs are available from the following link:
                 www.opsi.gov.uk/si/si2005/20052864.htm
Storage          Storage of CD’s in a Practice                                                    Names of staff
                 All Schedule 2 and Schedule 3 require secure storage. The storage unit is        authorised to
                 required to be double locked (i.e. a locked cupboard within a locked             have access to
                 cupboard or a locked cupboard in a locked room). Access to these drugs is        CD cupboard
                 only available to those who are prescribers or those who administer the
                 drugs. No other personnel must be given access to the storage facility, apart
                 from authorised inspections.
                 Storage in Emergency bag
                 An emergency bag is a locked bag, box or case for home visits, etc., which       Dentists are
                 should be kept locked at all times unless in immediate use. A combination        responsible for
                 lock is considered better than a key lock. Legal precedent holds that such a     CDs in their
                 bag is a suitable container for storing CDs but a locked car is not. The bag     possession
                 should not remain in an unattended vehicle.
                 It is good practice for the contents of each emergency bag to be checked
                 monthly, to verify the CD Register against physical stock and to date check
                 the contents. These checks should be undertaken by two persons, where
                 possible.
                 Emergency bags should be stored securely within the practice premises
                 when not in use. The location will be determined through a risk assessment.
                 CDs held in the emergency bag must be kept to a minimum, based on an
                 assessment of previous use.
Administration   Administration of CD’s; Practice and Emergency Bags
                 Each time a drug is used the following must be recorded in the CD register       Dentists are
                 by the person administering the medication                                       responsible for
                 Date / Receiving patient‟s name and address / Quantity used / Authority to       maintaining their
                 supply/administer / Form supplied / Time of administration / Signature           own CD register
                 Maintenance of a Running balance column is good practice.
                 Disposal / recording arrangements for any unused portion
                 Small amounts of CDs, for example, the surplus when a dose smaller than
                 the total quantity in an ampoule or vial is drawn up or when a dose is drawn
                 up but not used, should be rendered irretrievable by placing in a sharps bin.
                 The whole syringe, vial or ampoule should be placed in the sharps bin.
                 When the bin is sent for destruction it should be labelled “contains mixed
                 pharmaceutical waste and sharps – for incineration”. The CD Register must
                 show the amount administered and the amount destroyed locally, to account
                 for the total contents of the ampoule or vial. These actions should be
                 witnessed and signed into the register.
                 Larger amounts of liquid and any amount of solid CD waste should be
                 returned to a pharmacy (by preference), GP, dentist or veterinarian for
                 destruction.
Destruction      Destruction of Stock CDs
                 CDs which are stock and have expired need to be destroyed in the
                 presence of an authorised person. A small number of PCT staff are
                 authorised by the PCT „AO‟ to carry out this role for the practice (as long as
                 they are not involved in the work of the practice).
                                                                                                  Name and
                 „Stock‟ CDs awaiting destruction must be clearly marked “For Destruction         contact details
                 Only – Stock” and stored in the CD cabinet / safe, separated from in-use         of staff
                 stock.                                                                           authorised to
                 A record of the destruction must be made in the corresponding section of         witness
                 the CD register and the following must be noted:                                 destruction of
                 Date                                                                             CDs
                 Name, quantity and form destroyed
                 Authority of person to carry out destruction
                 Signature of person destroying and witness
                 The CDs must be denatured in a resin pot as directed in the instructions.

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                         Date of Issue: 10 April 2008    Review Date: May 2009
For more detailed instructions please see below. The CD denature pots are
available through the waste company which collects the practice out of date
drugs. Once the denaturing process is complete, the pot can be placed in
the ordinary waste drug bin for collection later.
Protective clothing must be worn during the destruction process: Gloves and
plastic apron are a minimum requirement.
Broken ampoules are included within the definition of “sharps” but complete
ampoules, bottles, vials, etc, are not.
Yellow-lidded sharps receptacles should be used (undischarged / partially
discharged medicinal waste requiring disposal by incineration). Sharps
boxes should be collected when three-quarters full and must never exceed        Name of
the permissible marked mass. If seldom used, the sharps box should be           member of staff
collected after a maximum of three months regardless of the filled capacity.    and partner
When the bin is sent for destruction it should be labelled “contains mixed      authorised to
pharmaceutical waste and sharps – for incineration”.                            destroy patients
Aerosol formulations                                                            own CDs
Aerosol formulations should be expelled under water in a small container (to
prevent droplets of drug entering the air). As a further precaution, it would
be advisable for a facemask to be worn by staff undertaking the activity and
to ensure that the area where the destruction takes place is well ventilated.
The resulting solution can then be disposed of in accordance with the
guidance on destruction of liquid formulations, as below. The aerosol
container should be disposed of by appropriate means.
Liquid dose formulations
A CD liquid can be poured from its container and added to the normal CD
denaturing kit where it will mix with the contents, thus rendering it
irretrievable. The container should be rinsed into the denaturing kit to
remove final traces of the CD. The kit may then be added to an appropriate
waste medicine disposal bin or sharps bin, supplied by the waste contractor.
The container should be disposed of by appropriate means.
Parenteral formulations
Liquid ampoules should be opened and as much of the content as possible
emptied into the CD denaturing kit, as outlined above. It may be necessary
to use a syringe and needle for this purpose – the syringe should be flushed
through into the denaturing kit on completion and the needle must be placed
in a sharps box.
Ampoules containing the CD in a powder form can be opened, water added
to dissolve the powder and the resultant mixture poured into the CD
denaturing kit.
The ampoule should be crushed and the glass placed into the CD
denaturing kit. The kit may then be added to an appropriate waste medicine
disposal bin or sharps bin, supplied by the waste contractor.
Patches
The active ingredient in the patches can be rendered irretrievable by
removing the backing and folding the patch over on itself and then placing it
in a CD denaturing kit. The kit may then be added to an appropriate waste
medicine disposal bin or sharps bin, supplied by the waste contractor.
Solid dose formulations
Instructions provided by the CD destruction kit manufacturer should be
obeyed. In addition to this, the following process should be followed:
Tablets and capsules can be removed from their outer packaging, removed
from blister packaging and placed in a CD denaturing kit. Gloves must be
worn if a person is removing tablets / capsules from blister packs. Best
practice would be to grind* or crush* the solid dose formulation before
adding to the CD denaturing kit to ensure that whole tablets or capsules are
not readily recoverable. The kit may then be added to an appropriate waste
medicine disposal bin or sharps bin, supplied by the waste contractor. The
outer packaging and blister packaging should be disposed of by appropriate
means.

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        Date of Issue: 10 April 2008    Review Date: May 2009
                *If grinding or crushing of tablets or capsules takes place, steps must be
                taken to ensure that particles of CD dust are not released into the air or that
                this is minimised. The use of a small amount of water whilst grinding or
                crushing may assist. It may also be necessary for the person involved in the
                grinding or crushing to wear a suitable face mask for protection and ensure
                that the area is well ventilated.
                Destruction of Patients Own CDs
                It is recommended that the practice does not accept patients own drugs for
                destruction but ask patients to take them to their local Community Pharmacy
                for destruction. However, if this cannot be arranged then the following
                should take place.
                A separate bound record book should be used to audit the destruction of
                prescribed CDs which have been returned by a patient or their
                representative. This book should be used in the form of a continuous list
                and should record the following information:
                date of return
                each item returned including drug name, form, strength and quantity
                the name of the patient they were prescribed to
                the signatures of the accepting member of staff and the patient or patient's
                representative (not staff)
                Any unused space must be crossed through
                „Patient returned‟ CDs awaiting destruction must be clearly marked “For
                Destruction Only – Patient Returned” and stored in the CD cabinet / safe,
                separated from in-use stock.
                At a suitable time, a practice partner plus a designated member of staff
                must destroy the returned items; with both signing next to the entry to state
                that the drugs have been destroyed. However, it is recommended that an
                authorised person is used, even though the law does not require one.
Training        Any newly named „Responsible Person‟ should receive training to enable            Clinical
                them to carry out their role appropriately.                                       Governance
                                                                                                  lead
Reporting an    All CD incidents should be reported in the first instance to the practice         Clinical
incident        Clinical Governance Lead who should ensure that an Adverse Event Report           Governance
                / Significant Event documentation is filled out and sent to the PCT.              lead
                The AO should be informed of the incident.
PCT             Matthew Thomas, Accountable Officer, Raebarn House, Hulbert Road,
Accountable     Waterlooville, Hampshire PO7 7GP
Officer         023 9224 8814 matthew.thomas@ports.nhs.uk
Procedure for   Where a review is indicated all personnel named on the document should            Involve all
review          be involved in the process or be available to comment on the review               personnel in
                process.                                                                          practice
                When completed the reviewed document should be distributed to all
                members of staff.
Review date     One year from implementation date, unless there is a change in legislation
                or personnel.
Written by      (Matthew Thomas)


All staff should sign a form to acknowledge that they have read and understood the Dental
Practice Standard Operating Procedure for Controlled Drugs




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                        Date of Issue: 10 April 2008    Review Date: May 2009

				
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