Document Type: Protocol 3 5 July 2022 NHS Foundation Trust

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTVersion 3 (June 2019) Page 1 of 23

CONTENTS

1. SUMMARY

2. LEGISLATION AND GOVERNANCE ARRANGEMENTS2.1 General2.2 Accountability and Responsibility2.3 The Controlled Drug (CD) Accountable Officer2.4 Standard Operating Procedures

3. SUPPLY AND ADMINISTRATION OF CONTROLLED DRUGS (CDs)3.1 Patient Group Directions3.2 Midwives Exemptions3.3 Administration3.4 Self-administration of CDs

4. PRESCRIBING4.1 Inpatients4.2 Discharge Prescriptions4.3 Outpatients4.4 Supplementary Prescribers4.5 Non-Medical Independent Prescribers

5. MANAGEMENT OF CDs IN WARDS AND DEPARTMENTS5.1 Accountability and Responsibility5.2 Controlled Drug Stocks5.3 Requisitioning of Controlled Drugs5.4 CD Top-up Schemes5.5 Transport and Receipt of CDs5.6 Storage of CDs5.7 Key-holding and Access to CDs5.8 Record-keeping5.9 CD Record Books5.10 Records of Receipts5.11 Controlled Drug Stock Checks5.12 Archiving of Controlled Drug Records5.13 Returning CDs to the Pharmacy5.14 Disposal of CDs in Wards and Departments5.15 Controlled Stationery5.16 Just in case bags

Document Type: ProtocolReferenceNumber : 1763

VersionNumber: 3

NextReview Date: 5 July 2022

Title: Controlled Drugs, Medicines Policy for Torbay and South DevonNHS Foundation Trust

Document Author: Governance Pharmacist & Medication Safety Officer

Applicability: As defined in document


6. MANAGEMENT OF CDs – GENERAL PROCESSES AND SPECIFICCIRCUMSTANCES

6.1 CD Stationery6.2 Transfer of CDs within the Hospital6.3 Transfers from Ward to Ward or Theatre to Ward6.4 Management of CDs that are the Patient’s Property6.5 CD Discharge Medicines (TTOs)6.6 Out-of-hours Supply6.7 Ward Closure and Transfer of Wards6.8 Controlled Drugs for Midwives6.9 Discrepancies and Diversion6.10 Illicit Substances6.11 Receipt of CDs by Outpatients or Patients Discharged from Hospital

7. DRUGS OF DIVERSION

8. MANAGEMENT OF CDs IN COMMUNITY NURSING SERVICES8.1 Storage of CDs8.2 Record Keeping8.3 Controlled Drug Stock Checks8.4 Administration8.5 Disposal of CDs8.6 Just in case bags8.7 Discrepancies and Diversion

9. STAFF TRAINING FOR MANAGEMENT OF CDS

Appendix 1 – Controlled Drugs SchedulesAppendix 2 – Role of the CD Accountable OfficerAppendix 3 – Common Drugs of DiversionAppendix 4 – Recommendations for Controlled Drugs Cupboard / Cabinets


1. Summary

The purpose of this policy is to promote the safe and effective use of controlled drugs (CDs)in Torbay and South Devon NHS Foundation Trust (TSDFT), and incorporates thestrengthened governance arrangements and legislative changes resulting from theGovernment’s response to reports of the Shipman Inquiry (Safer Management of ControlledDrugs) on behalf of the Department of Health.

It sets out systems for procuring, storing, supplying, transporting, prescribing, administering,recording, and disposing safely of CDs, with the aim of developing strong governancearrangements that fit with the current legal framework.

2. Legislation and governance arrangements

2.1 General

The management of CDs is governed by the Misuse of Drugs Act (1971) and it’s associatedRegulations (in England, Wales and Scotland). Additional statutory measures for themanagement of CDs are laid down in the Health Act (2006) and its associated Regulations.

The Misuse of Drug Regulations (MDR) classifies the drugs in five schedules according to thedifferent levels of control required (see below). While Schedule 1 CDs are subject to thehighest level of control, drugs in this group have virtually no therapeutic uses and aretherefore not considered as part of this policy except in the case of illegal possession orhandling of illicit substances.

Drugs in Schedule 4 (includes benzodiazepines and anabolic steroids) and Schedule 5(includes low dose opioids) are subject to a much lower level of control in law. While themajority of these drugs are not classified as CDs in the Trust, some products in Schedule 5(those containing only codeine, or only dihydrocodeine, and morphine sulphate solution 10mgin 5ml (e.g. Oramorph®)) have been subject to additional controls from 1 January 2012. Whileprescription requirements and recording in a CD Register do not apply, supply will only bemade against an authorised requisition, and safe custody is required. This group of productsis referred to as ‘CDs in Schedule 5’ in this Policy.

The remaining drugs (i.e. those in Schedules 2 and 3) are together classified as CDs and aremanaged in a consistent way in the Trust. The only exemptions to this are:

· midazolam, which was re-classified as Schedule 3 on 1 January 2008, but for whichthe requirements for record keeping and safe custody do not apply, and

· tramadol, which was re-classified as Schedule 3 on 10 June 2014. While records donot need to be kept for this drug, it has been agreed that safe custody requirements doapply, and all tramadol products must therefore be stored in the CD cupboard.

See Table 1 for a summary of requirements, and Appendix 1 for a summary of Schedulesallocated to specific drugs.

It should also be noted that, because of the risks associated with use, concentrated solutionsof potassium for injection are also subject to the same levels of control as Schedule 2 CDs.


2.2 Accountability and Responsibility

At local level, the Trust is accountable, through the CD Accountable Officer (see below), forensuring the safe management of CDs, and for the monitoring of all aspects of the use andmanagement of CDs by all healthcare professionals. This should be done through normalgovernance arrangements such as analysing baseline data and clinical governance visits (forexample by clinical governance leads).

Where one organisation provides services to another, responsibility for governancearrangements must be specified in the service level agreement, with reporting to the CDAccountable Officer for the organisation that is receiving the service. (Once the CDs havebeen received responsibility for them passes to the receiving organisation).

2.3 The CD Accountable Officer

The CD Accountable Officer is responsible for all aspects of the safe and securemanagement of CDs in the organisation, including ensuring that safe systems are in place forthe management and use of CDs, monitoring and auditing the management of systems andinvestigation of concerns and incidents related to CDs.

The regulatory requirements for CD Accountable Officers are set out in full in the ControlledDrugs (Supervision and Management of Use) Regulations 2006. In discharging hisresponsibilities, a CD Accountable Officer must have regard to best practice in relation to themanagement and use of controlled drugs. Please see Appendix 2 for more about the CDAccountable Officer role.

2.4 Standard Operating Procedures

Each of the activities that relate to CDs must be described in a standard operating procedure(SOP) that must be kept up-to-date and reflect current legal and good practice requirements.All staff who are involved in the prescribing, supplying, administering or disposing of CDsneed to be familiar with the SOPs, which must be formally approved by the CD AccountableOfficer.


Table 1. Summary of Requirements that Apply to Controlled Drugs

Schedule(refers toschedules ofthe Misuse ofDrugsRegulations)

Schedule 2Includes –Ketamine,Opioids (e.g.diamorphine),amphetaminesand remifentanil

Schedule 3Includes minorstimulants,temazepam,buprenorphineandbarbiturates

Schedule 3Midazolam,gabapentinandpregabalin

Schedule 3Tramadolonly

Schedule 5Productscontaining onlycodeine; onlydihydrocodeine;and morphinesulphatesolution 10mg in5ml

Schedule 4Sativex®(cannabinoidoromucosalmouth spray)

TrustDesignation

CD CD CD CD CD CD

Safe Custody(storage in CDCupboard)

Yes Yes No Yes Yes No

Prescriptionrequirementsapply(outpatient anddischarge)

Yes Yes Yes Yes No No

Requisitionsnecessary forsupply andreturn ofstocks?

Yes Yes Yes Yes Yes Yes

Records to bekept in CDregister

Yes Yes No No No Yes

Pharmacistmust ascertainthe identity ofthe personcollecting CD

Yes Yes Yes Yes No No

Prescriptionvalid for

28 days 28 days 28 days 28 days 6 months 28 days

Maximumduration thatshould beprescribed

30 days 30 days 30 days 30 days 30 days 30 days

3. Supply and Administration of CDs

There are a number of mechanisms for the supply and administration of CDs. They can be:· prescribed by a doctor or nurse/pharmacist independent prescriber· supplied and administered by a midwife· supplied and administered under Patient Group Directions

However, certain restrictions apply to each of these routes of supply.


3.1 Patient Group Directions

Named nurses, and other specified health professionals can supply and administer certainCDs under PGDs in limited circumstances:

· registered nurses in Accident and Emergency and Coronary Care Units in hospitalscan supply or administer diamorphine for the treatment of cardiac pain

· all Schedule 4 or 5 CDs can be supplied or administered in accordance with a PGD,except for the anabolic steroids in Schedule 4, and injectable formulations for thepurpose of treating a person who is addicted to a drug.

Although midazolam was rescheduled to Schedule 3 from 1 January 2008, it can continue tobe used under a PGD. In addition, ketamine is available for use under PGDs for theimmediate treatment of sick or injured persons.

3.2 Midwives Exemptions

Registered midwives may lawfully administer parenterally, a number of specified CDs in thecourse of their professional practice. These are diamorphine; morphine; and pethidinehydrochloride; local Trust procedures apply.

3.3 Administration

The administration of CDs must comply with general policies and procedures for theadministration of medicines. Nurses and midwives must follow Nursing and Midwifery Councilstandards and guidance.

All schedule 2 CDs, the schedule 3 CDs temazepam, buprenorphine & barbiturates and theschedule 4 Sativex® must be administered by 2 people. All other schedule 3 CDs and thosein schedules 4 & 5 do not need 2 person administration.

Two Person Administration

Two people must be involved in the administration of CDs, and both must be present duringthe whole of the administration procedure. At least one of these people must be a registerednurse, midwife, doctor or ODP, and both must witness:

· the preparation of the CDs to be administered.· the CD being administered to the patient.· the destruction of any surplus drug (e.g. part of an ampoule infusion not required).

A record must be made in the ward or department CD Record Book when a CD is removedfrom the CD cupboard, and the following details must be recorded for CDs administered:

· date and time when dose administered· name of patient· quantity administered· form (name, formulation and strength) in which administered· name and signature of nurse or authorised person who administered the dose· remaining balance of stock, checked on return to the cupboard· name and signature of witness


If part of a vial or other container e.g. epidural infusion bag is administered to the patient, theregistered nurse, midwife or registered health professional must record the amount given andthe amount wasted. This must be witnessed by a second registered nurse midwife orregistered health professional who must also sign the record.

If a second registered nurse midwife or registered health professional is not available, thetransaction can be witnessed by another registered practitioner (e.g. doctor, pharmacist,pharmacy technician) or by an appropriately trained healthcare assistant. Larger volumes thatare wasted may be returned to the Pharmacy for disposal.

Individual doses of CDs that have been prepared but not administered must be destroyed bya registered nurse, midwife or registered health professional on the ward or department in thepresence of a witness. The reason must be documented in the CD Record Book.

3.4 Self-administration of CDs

Patients must not have responsibility for self-administration of CDs in wards and departments.

4. Prescribing

4.1 Inpatients

For hospital inpatients, initiation of treatment with CDs should normally be through a patient-specific direction written by the prescriber on the official ‘Drug Prescription and AdministrationRecord’ chart in line with local procedures. The written requirements for CDs on these chartsare the same as for other medicines.

4.2 Discharge Prescriptions (does not apply to CDs in Schedule 5)

Prescriptions for CDs for patients who are going home (discharge medicines) should bewritten on the approved TTA prescription forms for dispensing by the Pharmacy. Theseprescriptions must conform to all requirements of the Misuse of Drugs Regulations for a CDprescription.

Medical doctors who have not achieved full registration with the GMC are permitted toprescribe CDs on these prescription forms as a TTA for inpatients.

Prescriptions must contain the following details, written so as to be indelible, i.e. written byhand, typed or computer-generated:

· the patient’s full name, address, hospital number and, where appropriate, age· the name and form of the drug, even if only one form exists· the strength of the preparation, where appropriate· the dose to be taken· the total quantity of the preparation, or the number of dose units, to be supplied, in both

words and figures.

The prescription must be signed by the prescriber with his / her usual signature, in his ownhandwriting (this must be handwritten) and dated by him/her (the date does not have to behandwritten)


If the prescription is prepared by someone other than the prescriber, then that person should,ideally, be a registered healthcare professional.

Up to a maximum of 30 days’ supply should be prescribed, as a matter of good practice.Where the prescriber believes that it is in the clinical interest of the patient to prescribe formore than 30 days and would not pose an unacceptable threat to patient safety, theprescriber must make a note of the reasons in the patient’s notes.

The use of pre-printed sticky labels on prescriptions is not recommended. However, if theyare used, they must be tamper-evident, and the prescriber should also sign the sticky label orat least start their signature on the sticky label.

Community hospitals may occasionally use FP10 prescriptions for dispensing in communitypharmacies. These must conform to all requirements of the Misuse of Drugs Regulations for aCD prescription.

4.3 Outpatients

Prescriptions for CDs for outpatients must be written in accordance with the requirements ofthe Misuse of Drugs Regulations. The prescription document may either be an approvedoutpatient prescription form for the outpatient pharmacy to dispense, or a hospital FP10 for acommunity pharmacy to dispense. Prescription requirements are as for discharged patients.

4.4 Supplementary Prescribers

Regulations were amended in 2005 to permit a supplementary prescriber, when acting underand in accordance with the terms of an agreed individual clinical management plan (CMP) toprescribe and administer and / or supply or direct any person to administer any CD exceptdiamorphine, cocaine and dipipanone for the treatment of addiction, provided that the CD isincluded in the CMP.

If the patient takes his prescription to a community pharmacy for dispensing, then theappropriate prescription form must be used (FP10SS).

4.5 Non-Medical Independent Prescribers

Changes to the Misuse of Drugs Regulations 2001 relating to nurse and pharmacistindependent prescribing of controlled drugs came into force in April 2012. Nurse IndependentPrescribers and Pharmacist Independent Prescribers can now prescribe any CD listed inSchedules 2 to 5 for any medical condition within their competence, except diamorphine,cocaine and dipipanone for the treatment of addiction.

They are able to requisition controlled drugs and are authorised to possess, supply, offer tosupply, administer and to prescribe. Persons acting in accordance with the directions of aNurse or Pharmacist Independent Prescriber are authorised to administer any schedule 2 to 5drugs they prescribe.

Physiotherapist and chiropodist independent prescribers have authority to prescribe a limitedrange of controlled drugs: both professions are also authorised to administer the specificdrugs they are able to prescribe, but are not authorised to possess, stock or supply thesedrugs.


5. Management of CDs in Wards and Departments

5.1 Accountability and Responsibility

The registered nurse, midwife or Operating Department Practitioner (ODP) in charge of award or department is responsible for the safe and appropriate management of CDs in thatarea. While control of access (i.e. key-holding) to the CD cupboard can be delegated toanother, such as a registered nurse or ODP, responsibility remains with the registered nurse,midwife or ODP in charge.

5.2 Controlled Drug stocks

There must be a list of the CDs to be held in each ward or department as stock items. Thecontents of the list should reflect current patterns of usage of CDs in the ward or departmentand should be agreed between the pharmacist or pharmacy technician responsible for stockcontrol of medicines on the ward, and the registered nurse, midwife or ODP in charge. Itmust be subject to regular review.

5.3 Requisitioning of Controlled Drugs

The registered nurse, midwife or ODP in charge of a ward, department, operating theatre ortheatre suite is responsible for the requisitioning of CDs for use in that area, but may delegatethe task of preparing a requisition to another, such as a registered nurse or ODP. Ordersmust be written in the Ward Controlled Drugs Order Book, and must be signed by anauthorised signatory. A copy of the signature of each authorised signatory must be availablein the pharmacy department for validation.

Requisitions must contain the following:· name of hospital· ward / department· drug name, form, strength, ampoule size if more than one available· total quantity· signature and printed name of registered nurse· date· signature of person issuing the item from the pharmacy.

5.4 CD Top-up schemes

Replenishment of CD stocks on wards and departments may be carried out by suitably-trained pharmacy technicians as part of a pharmacy-led CD top-up scheme. However,responsibility for CDs in a ward or department remains with the registered nurse, midwife orODP in charge. The technician is responsible for checking the stock balances in the wardControlled Drug Record Book against the levels in the agreed stock list and preparing the CDrequisition forms in order to replenish the stock. These requisition forms must be signed bythe registered nurse, midwife or ODP in charge.

5.5 Transport and Receipt of CDs

CDs may be transported by a pharmacist or by an authorised messenger, and will becontained in an Envopak with a numbered tamper-proof seal. This person accepting the CDs


for transit must sign for receipt on a two-part Transport Form.

When CDs are delivered to a ward or department they must be handed personally to aregistered nurse, who will sign the white copy of the Transport Form. On no account shouldthey be left unattended at any time. It is good practice that the receiving person is not be thesame person who ordered the controlled drugs.

As soon as possible after delivery the registered nurse, midwife or ODP in charge, togetherwith either a second member of ward staff or pharmacy staff must:

· ensure the supply matches the order. If this is correct then the duplicate sheet (pinkcopy) in the Controlled Drug Requisition Book must be signed in the “Received by”section. Any tamper-evident seals on packs should be left intact when they arereceived from Pharmacy. Any discrepancies must be reported to the PharmacyDepartment immediately, who will investigate according to their local procedure

· check the existing stock of the item in the CD cupboard· enter details of the receipt in the Controlled Drugs Record Book, update the running

balance and check that the balance tallies with quantity that is physically present.· lock the supply in the CD cupboard immediately

5.6 Storage of CDs

Ward CD cupboards are required, under the Misuse of Drugs (Safe Custody) Regulations1973, to conform to BS2881 and include specific additional features or be otherwise approvedby the Pharmacy Department, see Appendix 4. Additional safeguards must be considered aspart of a risk assessment for areas where there are large amounts of drugs in stock at a giventime, and / or there is not a 24-hour staff presence, or easy control of access.

CDs must be stored in a locked receptacle of adequate size which is dedicated to theirstorage and which can only be opened by a person who can lawfully be in possession, suchas a pharmacist or the registered nurse, midwife or ODP in charge, or a person working undertheir authority.

When CD discharge medicines (TTOs) are sent to the ward several hours before the patientleaves, the medicines may be stored in the CD cupboard. These medicines must besegregated from the ward CD stock.

General measures for storage of CDs include:· cupboards must be kept locked when not in use· the lock must not be common to any other lock in the hospital· keys must only be available to authorised members of staff and at any time the key-

holder should be readily identifiable· there must be arrangements for keeping the keys secure. This is particularly

important for areas that may not be operational at all times, such as day surgery unitsand other departments.

5.7 Key-holding and Access to CDs

Responsibility for CD Keys

The registered nurse, midwife or ODP in charge is responsible for the CD keys. While key-holding may be delegated to other suitably-trained, registered healthcare professionals, the


legal responsibility rests with the registered nurse, midwife or ODP in charge.

The CD cupboard keys must not leave the ward or department, and must be returned to thenurse, midwife or ODP in charge immediately after use by another registered member of staff.Keys may be stored in a separate locked cupboard accessible only to suitably-trained,registered healthcare professionals, if a department / ward has a completed MedicinesSecurity Risk Assessment.

Missing CD Keys

If the CD keys cannot be found then urgent efforts must be made to retrieve the keys asspeedily as possible e.g. by contacting nursing, midwifery or ODP staff who have gone offduty.

A procedure should be in place to ensure that the senior registered nurse, midwife or matronor the duty nurse or midwife manager is informed as soon as possible and the ward / on-callpharmacist as soon as appropriate. The procedure should specify the arrangements forpreserving the security of CD stocks and for ensuring that patient care is not impeded e.g. byissuing a spare key.

If the keys cannot be found then the CD Accountable Officer must be informed. Dependingon the circumstances, it may also be appropriate to contact the police.

5.8 Record-keeping (does not apply to midazolam, tramadol or CDs in Schedule 5)

Each ward or department that hold stocks of CDs must keep a record of CDs received andadministered in a CD Record Book. The registered nurse, midwife or ODP in charge isresponsible for keeping the CD Record book up to date and in good order.

5.9 CD Record Books

The CD Record Book must be bound (not loose-leaf) with sequentially numbered pages and itmust have separate pages for each drug and each strength, so that a running balance can bekept. Entries must be made in chronological order, in ink or be otherwise indelible. It must bekept securely at all times.

All entries must be signed by a registered nurse, midwife or ODP and must be witnessed by asecond person, preferably a registered nurse, midwife or ODP. If a second registered nurse,midwife or ODP is not available, then the transaction can be witnessed by another registeredpractitioner (e.g. doctor, pharmacist, pharmacy technician) or by an appropriately trainedhealthcare assistant.

5.10 Records of Receipts

A record must be kept of all CDs that are received or administered.

For CDs received, the following details must be recorded on the appropriate page in the CDRecord Book:

· date of entry· serial number of requisition


· quantity received· form (name, formulation and strength) in which received· name and signature of nurse or authorised person making entry· name and signature of witness· balance in stock

5.11 Controlled Drug Stock Checks

Ward Checks

The registered nurse, midwife or ODP in charge is responsible for ensuring that the stockbalance of all CDs entered in the CD Record Book is checked and reconciled with theamounts in the cupboard as frequently as possible - ideally at every shift change, but as aminimum once every day.

Two members of staff, one of which must be a registered nurse or midwife or registeredhealth professional, must perform this check, which involves checking of balance in the CDRecord Book against the contents of the CD cupboard (not the reverse), to ensure allbalances are checked. Wherever possible, the second person involved in the process willalso be a registered healthcare professional.

Stock balances of liquid medicines should generally be checked by visual inspection.However, the balance must be confirmed to be correct on completion of a bottle, and anaccurate measurement will be undertaken at the 3-month check with Pharmacy.

It is not necessary to open packs with intact tamper-evident seals for stock checkingpurposes.

A record indicating that this reconciliation check has been carried out and confirming thestock is correct must be made on the relevant page of the CD Record Book, and be signed bythe registered nurse, midwife or ODP, and the witness.

Pharmacy Checks

All stocks of CDs held in wards and departments must be checked by a pharmacist orpharmacy technician at least every three months, and at other times when requested by theward or department manager. The checks must cover the following:

· Check that the levels of drugs in stock tally with the balances recorded in the CDRecord Book.

· Check a sample of CD requisition copies to ensure that they have been enteredcorrectly in the CD Record Book

· Review of the security and quality of record keeping· Checking and updating (if required) of the list of authorised signatories for CD

requisitions· Check for exceptional usage of CDs· Check of the physical security arrangement for the storage of CDs, CD stationery and

the key-holding policy.

The procedure may also include a check of patients’ own CDs held on the ward at the time. Arecord of the stock check must be made clearly in ink in the CD Record Book. The entry must


be signed and dated. A Ward CD Inspection Report Form must be used to record all aspectsof the CD stock-check procedure for audit purposes.

Discrepancies

If a discrepancy is found it must be investigated without delay following the standardoperating procedure.

5.12 Archiving of Controlled Drug Records

Arrangements will be made to store all CD records, including documents designed to trackand / or monitor CD usage, for a minimum period of two years. When complete, all registersand CD Record Books must be sent to Pharmacy, where they will be kept for a period of atleast two years from the date when the last entry was made.

5.13 Returning CDs to the Pharmacy

Torbay Hospital

Unused CD stock from wards or departments may be returned to the Pharmacy. ThePharmacy Department should carry out a risk assessment of CDs returned to pharmacy toensure they are fit for re-use. Any CD that is no longer needed on the ward must be returnedto Pharmacy as soon as is practicable.

CDs that are time-expired or otherwise unfit for use (e.g. opened liquids) must also bereturned to the pharmacy for safe destruction and onward disposal.

Records of CDs Returned (also applies to CDs in Schedules 3 and the specific products inSchedule 5)

The ward or department must keep a record of drugs returned to Pharmacy. This must be inthe form of a returns note completed in the CD Requisition Book, so that both the Pharmacyand the ward have a record of the transaction. This must include:

· date· name, form, strength and quantity of drug being returned· reason for return· name and signature of the registered nurse, midwife or ODP returning the drugs· name and signature of pharmacist or technician receiving the drugs

The top copy will be taken from the book and transported with the drugs to the pharmacy.

In addition, an entry must be made on the relevant page of the ward CD Record Book,showing:

· date· reason for return· names and signatures of the registered nurse, midwife or ODP responsible and of the

pharmacist or pharmacy technician· quantity removed· name, form and strength of drug· balance remaining


The drugs must be securely transferred to the pharmacy in a sealed Envopak.

Community Hospitals

CDs must not be returned from community hospitals unless there are exceptionalcircumstances.

5.14 Disposal of CDs in Wards and Departments

Torbay Hospital

In the interests of safety and containment of environmental pollution, CDs should whereverpracticable be returned to the pharmacy for safe denaturing and disposal.

Only small amounts of CDs should be disposed of on wards, for example, the surplus when adose smaller than the total quantity in an ampoule or vial is drawn up or when a dose is drawnup but not used. However, in some areas larger volumes of CDs (e.g. above 20ml containedin part-used PCA syringes) require disposal, and these can be denatured by discharging intoadsorbent contained in blue-lidded Pharma waste containers or into a suitably-sizeddenaturing kit that is approved by Pharmacy. The supply and collection of these containers isco-ordinated by Pharmacy, who can also receive material for destruction in specific cases.

All such disposal must be documented in the appropriate section of the CD Record Book, andbe witnessed by a second competent professional such as a registered nurse, midwife, ODP,pharmacist or pharmacy technician. Both persons must sign the CD record book.

Stocks of CDs no longer required must never be disposed of in wards and departments, butmust always be returned to Pharmacy according to the relevant procedure.

Community Hospitals

CDs that are time-expired or otherwise unfit for use (e.g. opened liquids) and unused CDstock must be destroyed on the ward/department by the Matron/Ward Manager in thepresence of an authorised witness, as soon as is practicable in accordance with the standardoperating procedure. Until they can be destroyed these CDs must be clearly segregated fromthe other CDs in the CD cupboard. CD disposal must be into a suitably-sized denaturing kitthat is approved by Pharmacy.

The CD Accountable Officer will authorise the named witnesses.

Patient’s own CDs are and remain the property of the patient. If the patient wishes, themedicines may be returned home via an identified adult. Responsibility for security is given tothat adult. If the medicines are not appropriate for use, then the patient and/or patient’srepresentative should be advised and they must be asked for their consent to have themdisposed of on the ward. Patient’s own CDs must be destroyed on the ward/department bythe Matron/Ward Manager in the presence of an authorised witness, as soon as is practicablein accordance with the standard operating procedure.

Small amounts of CDs such as the surplus when a dose smaller than the total quantity in anampoule or vial is drawn up or when a dose is drawn up but not used should be disposed of


on the wards. Larger volumes of CDs (e.g. above 20ml contained in part-used syringe drivers)require disposal, and these can be denatured by discharging into a suitably-sized denaturingkit that is approved by Pharmacy. Used denaturing kits can be placed in to blue Pharmawaste containers.

All such disposal must be documented in the appropriate section of the CD Record Book, andbe witnessed by a second competent professional such as a registered nurse, midwife, ODP,pharmacist or pharmacy technician. Both persons must sign the CD record book.

5.15 Controlled Stationery

In common with all controlled stationery that could be used to obtain medicines fraudulently,there is a requirement in all areas to ensure the security of all prescription forms, charts andother documents used to record details of CDs.

A documented risk assessment should be undertaken in all areas where controlled stationeryis used, and a procedure implemented to ensure appropriate levels of security of all storagefacilities, clarification of responsibilities and the establishment of audit trails.

See section 6.1

5.16 Just in Case Bags

Prescribing, supply and administration of anticipatory medicines in Just in Case Bags (JICB)must comply with the JICB standard operating procedure.

6. Management of CDs – General Processes and Specific Circumstances

6.1 CD Stationery

All stationery which is used to order, return or distribute controlled drugs must be storedsecurely, and access to it restricted. These measures are important to guard againstunauthorised use of the stationery to obtain CDs for inappropriate purposes.

CD stationery includes:· Controlled Drug Requisition Books· Controlled Drug Record Books· other CD documents such as CD returns notes, Pharmacy distribution documents

Secure Storage of CD Stationery

CD stationery held in wards, theatres or departments must be kept in a locked cupboard ordrawer.Stocks of CD stationery held in Pharmacy Departments must be kept in a secure area that islocked when there is no one present.

Supply

CD stationery must be issued from the pharmacy against a written requisition signed by apractitioner authorised to requisition CDs. A record must be made of the supply, to include:


· date· ward/department· name of person ordering the stationery· type of stationery issued· quantity· the serial numbers of the stationery· signature of the member of pharmacy staff making the supply· signature of member of staff receiving the stationery.

All stationery issued will bear the name of the requesting ward / department. Any unusedstationery returned to Pharmacy will be recorded as a return, with the details above, in thesupply record.

Loss or Theft

Loss or theft of any controlled stationery which may be used to order CDs must be reportedimmediately to the Chief Pharmacist and CD Accountable Officer and an incident formcompleted.

Use of CD Stationery

Only one CD Requisition Book per ward or department should normally be in use.

When a new CD Record Book is started, the balance of CDs in stock must be written into thenew book promptly by ward staff. This transfer must be witnessed by a registered nurse,midwife or operating department practitioner or authorised member of staff e.g. pharmacist orpharmacy technician.

Completed CD Requisition Books and CD Record Books must be returned to Pharmacy forretention for a minimum of two years from the date of the last entry.

6.2 Transfer of CDs within the Hospital

CDs must be transferred or conveyed in Envopaks with numbered tamper-evident seals. Aprocedure should be in place to ensure all transfers are fully auditable and explicit as to whohas custody of the controlled drugs at any point in time. CDs may not be transported inpneumatic tubes.

At each point where a CD moves from the authorised possession of one person to another, asignature for receipt must be obtained by the person handing over the drug, and the personreceiving it.

Messengers

The person who conveys the CD acts as a messenger, that is to say he / she carries a sealedtamper-proof container and is responsible for delivering the intact container. The personacting as the messenger must:

· ensure the destination is known· be aware of safe storage and security, the importance of handing over the item to an

authorised person and obtaining a signature for delivery on the delivery document.· have a valid identification badge


CDs for an individual ward or department may be collected from the pharmacy by a nurse,who may not be registered, if he or she has been authorised by the relevant ward manager todo so. The nurse must carry identification and sign and print their name on the relevantsection of the Transport Sheet. The Pharmacy department must either have a specimensignature of the nurse, authorised by the ward manager, on file, or confirm the name andidentity of the nurse with the relevant ward manager prior to handing over the CD.

Where, very exceptionally, a commercial courier or taxi driver is responsible for conveying aCD he / she must be asked to show their valid company ID, as they would for any othermedicine. Taxi drivers or commercial couriers must not be made aware that CDs are beingtransported as this may increase the potential for diversion or may discourage taxi driversfrom carrying CDs. Where possible, the taxi registration number must also be recorded.

6.3 Transfers from Ward to Ward or Theatre to Ward

Local procedures must define safe, secure and auditable methods to transfer CDs from wardto ward when a patient moves. The three situations in which this is most likely to arise arewhen a patient is receiving a CD by means of syringe pump (PCA pump), infusion or when apatient has his/her own CDs.

6.4 Management of CDs that are the Patient’s Property

A local procedure must be in place for the management of patients’ own CDs that are thepatient’s property. This procedure will include the use of a dedicated CD Record Book that isused to document all receipts, administration of medicines on the ward, and othertransactions.

Use of a Patient’s own CDs on the Ward

It may be appropriate to use a patient’s own CDs (i.e. CDs brought into the hospital by thepatient on admission) whilst they are in hospital, for example, if the medicine is temporarilyunavailable on the ward. On such occasions the drugs must be checked for suitabilityaccording to the local procedure for patients own drugs (PODs) to ensure that they are fit forpurpose.

If patients’ own CDs are not required for use then one of the following procedures must befollowed and all actions must be recorded:

· if the patient or the patient’s agent agrees, the medicines may be sent to the pharmacyfor safe destruction.

· if the patient wishes, the medicines may be returned home via an identified adult.Responsibility for security is given to that adult. If the medicines are not appropriate foruse, then the patient and/or patient’s agent should be advised and they should beencouraged to send them to the pharmacy for safe destruction.

Patients’ own CDs that are not used on the ward or department must only be storedtemporarily whilst they are awaiting collection and removal. They must be placed in the CDcupboard, but must be clearly marked and kept separate from ward stock.


6.5 CD Discharge Medicines (TTOs)

When CD discharge medicines (TTOs) are sent to the ward some time before the patientleaves, the medicines may be stored in the CD cupboard. These medicines must besegregated from the ward CD stock and clearly marked and must remain in a sealed bag. CDTTOs are subject to the same procedures as all other CDs in respect of collection andtransfer. When delivered to the ward, receipt and issue to the patient or their carer must bedocumented in the Patients’ Own CDs Record Book.

6.6 Out-of-hours Supply

There should be a local procedure for the supply of CDs out-of-hours. A ward sister (or theregistered nurse, midwife or ODP in charge) can only supply CDs to a patient on that ward,theatre or department in accordance with the written instructions of an authorised prescriber,and every effort must be made to ensure that adequate stock levels are maintained to meetlikely needs.

However, if required urgently, a single dose may be given to a patient on one ward from thestock of another ward. The dose must be signed out of the CD Record Book of the supplyingward. The record must note that the named patient is from a different ward.

6.7 Ward Closure and Transfer of Wards

There must be a local procedure for the management of CDs during ward closures, and whenwards transfer. The procedure must ensure the security of the CDs and must be auditable.

When such changes occur, the list of authorised signatories for the ward that is kept in thepharmacy must be reviewed and annotated so that pharmacy staff are aware that the ward istemporarily closed. The list will be reviewed when the ward reopens, or when the change iscomplete, to ensure that signatures are valid and up to date.

Temporary Ward Closure

Stocks of CDs must be written out of the Ward CD Record Book by a registered nurse,midwife or ODP and pharmacist or pharmacy technician, and the entry must state that thedrugs have been removed because of the ward closure. The CDs must be placed in tamper-evident containers and transferred to the Pharmacy Department for safe storage.

CD cupboards must be checked to ensure that they are securely locked and the keys handedto the appropriate Nurse-in-Charge or Matron. When the ward is re-opened CD stocks will bereturned from the Pharmacy department and the nurse and pharmacist, or pharmacytechnician, must make the appropriate entries in the CD Record Book.

Long Term Closure

All medicines must be returned to the pharmacy department. Stocks of CDs must be writtenout of the Ward CD Record Book according to the normal procedure.

Transfer of wards

When a ward moves to another location, a decision must be made as to whether its CDs and


CD Record Books may be transferred or, where swapping of wards occurs, left on the ward.This will depend upon the appropriateness of the stock list, the periods for which wardpremises will be unoccupied and the security of the drugs during this time.

6.8 Controlled Drugs for Midwives

Registered midwives may supply and administer, on their own initiative, any of thesubstances that are specified in medicines legislation under midwives exemptions, provided itis in the course of their professional practice. They may do so without the need for aprescription or patient-specific direction (PSD) from a medical practitioner. (See protocol 0427Medicines Management in Maternity Services).The only controlled drugs on the midwives exemption list are diamorphine, morphine andpethidine. Midwives continue to have authority to possess any unused CDs and to supplythem to a person who may lawfully have possession e.g. a pharmacist, for destruction.

6.9 Discrepancies and Diversion

The balances in the CD Record Book must always tally with the amounts of CDs in thecupboard. If they do not, the discrepancy must be reported, investigated and resolved. Theremust be a procedure for dealing with discrepancies and this must specify the arrangementsfor reporting and investigation.

If the error or omission is traced, the registered nurse, midwife or ODP in charge must makean entry in the CD Record Book, clearly stating the reason for the entry and the correctedbalance. This entry must be witnessed by a second nurse, midwife, ODP, pharmacist,pharmacy technician or doctor. Both persons will sign the CD Record Book.

If no errors or omissions are detected then the discrepancy must be reported to the Directorof Pharmacy and the CD Accountable Officer without delay, and an incident form completedin line with the procedure for reporting incidents.Where theft or fraud is suspected then the Local Counter Fraud Specialist must be contacted.

6.10 Illicit Substances

Practitioners may be asked to deal with substances removed from patients on admission,which may include Schedule 1 CDs e.g. cannabis. As a license is required to possessSchedule 1 CDs, the person cannot take possession of the product other than in the followingcases:

· for the purpose of destruction· for the purpose of handing over to a police officer

Reference must be made to the Trust procedure relating to Handling of Illicit Substances /Illegal Possession of Drugs.

6.11 Receipt of CDs by Outpatients or Patients Discharged from Hospital

Patients or their representatives must be asked to provide evidence of identity when collectingCDs and the Pharmacy will establish whether the person collecting the medicine is thepatient, their representative or a healthcare professional acting in their professional capacity.Where the person is the patient or their representative, the Pharmacy Department must

https://icon.torbayandsouthdevon.nhs.uk/corp_doc_mgmt/Clinical%20Effectiveness/G0427.pdf

https://icon.torbayandsouthdevon.nhs.uk/corp_doc_mgmt/Clinical%20Effectiveness/G0427.pdf


request evidence of that person’s identity, and may refuse to supply the medicine if they arenot satisfied as to the identity of the person

It must be ensured that patients have access to medicines they need and have beenprescribed for them, and the requirement placed on the Pharmacy Department allowsdiscretion not to ask patients or patient representatives for proof of identity if, for example,they have concerns that to do so may compromise patient confidentiality or deter patientsfrom having their medicines dispensed.The Pharmacy Department must record the following for all CDs supplied on prescription:

· whether the person who collected the drug was the patient, the patient’s representativeor a health care professional acting on behalf of the patient

· if the person who collected the drug was a health care professional acting on behalf ofthe patient, that person’s name and address

· if the person who collected the drug was the patient or their representative, whetherevidence of identity was requested (as a matter of good practice a note as to why thedispenser did not ask may be included but this is not mandatory).

· whether evidence of identity was provided by the person collecting the drug.

7. Drugs of Diversion

Drugs of diversion are a group of medicines that are not classified as controlled drugsaccording to the Misuse of Drugs Act (1971), but are never the less open to abuse. SeeAppendix 3 for a list of the most common drugs of diversion. The registered nurse, midwife orODP in charge of the ward, department, operating theatre or theatre suite must be aware ofthe use of any drugs of diversion within their area. Any concerns about the use of the drugs ofdiversion must be raised with the pharmacy department. Usage of drugs of diversion will bemonitored by the pharmacy department who will liaise with areas where issues are identified.

8. Management of CDs in Community Nursing Services

In the community setting, the collection of CDs dispensed for a named patient is theresponsibility of the patient or carer. In exceptional circumstances, a TSDFT employee maycollect a CD from the pharmacy or dispensing practice, where they will be asked to sign asthe patient’s representative and prove identity by the pharmacist or dispensing practice. AnyCDs collected must be kept secure and out of sight within their vehicle and taken directly tothe patient’s home or inpatient setting.

In the community, prescribed medicines remain the property of the patient they are prescribedfor at all times.

8.1 Storage of CDs

After risk assessment and with prior agreement of the client, controlled drugs may be storedafter receipt in the patient’s home in a suitable locked storage container if this is consideredappropriate to reduce risk.

Patients own CDs remain the property of the patient. However, there should be a riskassessment undertaken if there are any concerns about storage / safeguarding. Alternativesecure storage may be required. However a record of consent will be required.


8.2 Record-keeping

Use approved Trust documentation for recording, receipt, stock balance and administration,any stock adjustments and disposal.

Principles of recording are the same as on a ward setting except a competent witness isrequired only when available.

A signed record of any drug administration (including CDs), must be maintained inaccordance with clinical record keeping policy, to include the name, form and strength ofmedicine, dose given, the date, time, route of administration, site of injection if appropriateand any dilution or calculations made. The names of the persons administering andwitnessing the drug must also be recorded. Where the CD is witnessed by another member ofstaff, they must also sign the documentation.

8.3 Controlled Drug Stock Checks

In the community setting all schedule 2 and 3 controlled drugs must be recorded on theCommunity Medication Stock Record and running stock balances maintained. The pharmacylabel must be checked to ensure that stocks are being kept for the intended client. Tamper-evident seals should be left intact until contents are first used.

The stock balance of all schedule 2 and 3 CDs used to support syringe driver care must bechecked and reconciled on each visit.

The stock balance of Schedule 2 and 3 medicines supplied in respect of Just in Case /Anticipatory Prescribing will be in accordance with the relevant Trust Standard OperatingProcedure.

A full stock balance check and reconciliation of the physical stock against the runningbalances for each drug record in the controlled drugs record documentation must beundertaken by a registered practitioner. This must be entered in the CD recorddocumentation for each CD at each visit and countersigned by a competent witness ifavailable (see below for liquids). The stock balance check counter signatures must beentered on each page corresponding to each CD stocked.NB: The exception to this rule is that when the registrant is involved with administration ofcontrolled drug transdermal patches, stock reconciliation must be made on the day whenpatches are changed

It is not necessary to open packs with intact tamper-evident seals for stock checkingpurposes.

All CDs associated with a specified community nurse episode of care (including discontinuedCDs) must have a full stock balance, chart and reconciliation at each visit.

Discontinued CDs must be disposed of as soon as possible.


8.4 Administration

The administration of CDs must comply with general policies and procedures for theadministration of medicines. Nurses and midwives must follow Nursing and Midwifery Councilstandards and guidance. Witnessing of administration by a competent witness must takeplace wherever possible but it is recognised that this is not always possible in a communitysetting.

In the community registered and non-registered staff have a supportive, educational andmonitoring role in patient self-administration. However, some medication will need to beadministered by appropriately trained staff.

Staff administering a controlled drug must have access to the authorisation to administer i.e.the signed Prescription and Medication Administration Record for the patient.

In specialist care units, the authority to administer will be documented and signed on theapproved form. The authorisation form must be complete and up to date (written withinprevious 4 weeks).

Where equipment is required to administer a controlled drug, staff must be familiar with andcompetent to use this equipment e.g. Syringe Driver.

Registered practitioners delegating the administration of a medicinal product must ensure thatteam members have the appropriate competence to undertake the procedure and therelevant information to enable the task to be performed safely.

Where other services are involved in the administration of a controlled drug in a patient's ownhome environment, it is best practice to advise them that there may be a stock balance sheetin the home for them to complete.

8.5 Disposal of CDs

Patient’s own CDs are and remain the property of that patient. Staff working in the communitymust not themselves routinely remove unwanted or expired medicines, including CDs from apatient’s home or possession, either during care of or after the death of a patient. The patient,their representative or family member should be advised to return unwanted or expiredmedicines to the local community pharmacy for safe disposal.

In the case of an unexpected / sudden or suspicious death, all medicines, including controlleddrugs, relating to the care of that patient must be regarded as evidence and must not beremoved or destroyed without instruction from the Coroner (See Standard OperatingProcedure for the Management of Unexpected/Sudden or Suspicious Death of a patient).

In the case of a death which has been confirmed as expected, and has not been referred to aCoroner, a nurse may remove Controlled Drugs from the patient’s home with the consent ofthe patient’s representative.

If a community nurse considers it appropriate to remove excessive drugs for the benefit orprotection of the patient, and with the consent of the patient or patient’s representative, thenurse must complete the relevant form (see local procedure) which must be countersigned by


the patient or patient’s representative before removing the drugs to the nearest communitypharmacy for destruction.

In exceptional circumstances, and for non-Coroner cases, residual parenteral CDs (in asyringe driver or giving set) must be denatured on the premises. A risk assessment must beundertaken. The medication will be denatured (e.g. using absorbent paper) and placed in ayellow sharps bin with yellow lid for safe disposal together with the empty syringe or givingset. When the bin is sent for destruction it must be labelled “contains mixed pharmaceuticalwaste and sharps – for incineration”. The destruction will be witnessed by a competentwitness (which may include a family member where this is appropriate, and will not causeadditional distress). In such circumstances it is advisable to obtain written consent for thedestruction of medication. Actions taken must be documented.

8.6 Just in Case Bags

Prescribing, supply and administration of anticipatory medicines in Just in Case Bags (JICB)must comply with the JICB standard operating procedure.

8.7 Discrepancies and Diversion

If a discrepancy is found between the requisition for CDs ordered and CDs received thesupplying pharmacy must be contacted as soon as possible to investigate the discrepancy.

If a discrepancy is found between recorded stock and physical stock, check back through theentries for that drug and ensure that there has not been a numerical error in the record. Thismust be carried out as a priority as soon as a discrepancy is identified.

If the discrepancy is resolved, a note must be made in the CD record book correcting thediscrepancy in the balance and witnessed. Do not cross out or alter any entries, but make anote in the margin or new line or as a footnote in the controlled drugs record book.

If the source of the discrepancy cannot be identified the Matron, Senior Nurse, Line Manageror Cluster / Zone Manager or the senior manager on call must be informed.

The Director of Pharmacy and the CD Accountable Officer must be informed without delay,and an incident form completed in line with the policy and procedure for reporting incidents.

9. Staff Training for Management of CDs

Staff should receive appropriate training on local standard operating procedures for controlleddrugs as part of induction and when they first become involved in prescribing, supplying,administering or disposing of controlled drugs and then regularly thereafter. This training willbe facilitated by the provision of an information pack containing all local procedures relating toCDs. This pack should also be readily available on each ward and department for reference.

Staff should be informed and, if necessary receive additional training when SOPs are revisedor amended and when new CD products or systems are introduced.

Appendix 1 – Controlled Drugs ScheduleAppendix 2 – Role of the CD Accountable OfficerAppendix 3 – Common Drugs of DiversionAppendix 4 - Recommendations for Controlled Drugs cupboards / cabinets

Collated by Clinical Effectiveness Controlled Drugs SchedulesVersion 3 (June 2019) Page 1 of 1

Appendix 1Controlled Drugs Schedules

DRUG SCHEDULE DRUG SCHEDULEAlfentanil 2 Ketamine 2Alprazolam 4 Pt1 Loprazolam 4 Pt 1Amphetamine 2 Lorazepam 4 Pt 1Amobarbital (Amylobarbitone) 3 Lormetazepam 4 Pt 1Bromazepam 4 Pt 1 Meprobamate 3Buprenorphine 3 Methadone 2Butobarbital (Butobarbitone) 3 Methylphenidate 2Cannabinol derivatives (exceptdronabinol or its derivatives) 1 Midazolam 3Cannabis and cannabis resin 1 Morphine 2/5Chlordiazepoxide 4 Pt 1 Nabilone 2Chorionic gonadotrophin (HCG) 4 Pt 2 Nandrolone 4 Pt 2Clobazam 4 Pt 1 Nitrazepam 4 Pt 1Clonazepam 4 Pt 1 Oxazepam 4 Pt 1Cocaine 2 Oxycodone 2Codeine 2/5 Oxymetholone 4 Pt 2Codeine Linctus 5 Pentazocine 3Co-Proxamol 2/5 Pethidine 2

Cyclobarbital (Cyclobarbitone) 3Phenyl barbital(Phenobarbitone) 3

Dexamphetamine Sulphate 2 Pholcodine 2/5Dextromoramide 2 Physeptone 2

Dextropropoxyphene 2/5Quinalbarbital(Quinalbarbitone) 2

Diamorphine 2 Sativex® 4 Pt 1

Diazepam 4 Pt 1Secobarbital(Secobarbitone) 3

Diethylpropion 3 Somatropin 4 Pt 2Dihydrocodeine 2/5 Stanozolol 4 Pt 2Diphenoxylate 2/5 Tapentadol 2Dipipanone 2 Temazepam 3Fentanyl 2 Testosterone 4 Pt 2Flunitrazepam 3 Tramadol 3Fluoxymesterone 4 Pt 2 Zopiclone 4 Pt 1Flurazepam 4 Pt 1Hydromorphone 2

Note: Schedule 5 includes preparations of certain controlled drugs, such as codeineand morphine, which are exempt from full control when present in medicinal productsof low strength. A drug can therefore be classified in more than one Schedule.For a more comprehensive list seehttps://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation.

https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation



Collated by Clinical Effectiveness Role of Controlled Drugs Accountable OfficerVersion 3 (June 2019) Page 1 of 3

Appendix 2

ROLE OF THE CONTROLLED DRUG ACCOUNTABLE OFFICER

1. Background

Controlled drugs are an essential part of modern clinical care. They are medicines used totreat a wide variety of conditions.

Controlled drugs are however subject to special legislative controls because there is potentialfor them to be abused and/or diverted causing possible harm. In response to the case of DrHarold Shipman, the Government introduced strengthened measures to ensure controlleddrugs are managed safely. These governance arrangements are designed in a way thatsupports professionals and encourages good practice in the use of controlled drugs.

Under the Health Act 2006 and Regulations 3 and 4 of the Controlled Drug Regulations,Primary Care Organisations (PCOs), Acute Trusts, and other ‘designated bodies’ have astatutory duty to nominate a specific lead – a CD Accountable Officer – to be responsible for arange of measures relating to the monitoring of the safe use and management of controlleddrugs in their organisation.

2. Appointment of CD Accountable Officer

As part of the Government’s response to the Shipman Inquiry, the Health Act 2006 requiresNHS and Foundation Trusts to appoint to the role of the ‘CD Accountable Officer’ to monitorthe use of controlled drugs within their organisation, and to take appropriate action wherenecessary. This may be a stand-alone or additional role.

The CD Accountable Officer will therefore have a statutory duty to oversee the managementand use of controlled drugs within the organisation. Such Officers will need to possess, or beable to access, skills and expertise in data analysis, investigative skills, networking, andadministrative support.

The CD Accountable Officer must be a “fit, proper, and suitably experienced person” whodoes not routinely prescribe, supply, administer, or dispose of controlled drugs as part of hisor her duties. They should have credibility with all healthcare and social care professionalsand be of sufficient seniority to be able to take action regardless of how a concern is raised.The CD Accountable Officer must be an Executive Director or report directly to an ExecutiveDirector.

3. Role of the CD Accountable Officer

NHS and Foundation Trusts, through their CD Accountable Officer, are required to ensurearrangements are in place for monitoring the routine use and management of controlled drugsby all healthcare professionals who they employ, or with whom they have a contract. Thisshould include analysis of baseline data, clinical audit, identification of triggers for concernand clinical governance visits. Where one organization provides services to another, thecommissioner of the service has responsibility for ensuring that appropriate systems are inplace and are specified in the contract.


The CD Accountable Officer has a statutory responsibility to ensure that:

· appropriate action is taken for the purposes of protecting patients or members of thepublic in cases where concerns in relation to the management of controlled drugs by aperson or area appear to be well founded.

· ensuring that individuals involved in the prescribing, supplying, administering, ordisposing of controlled drugs receive training to carry out their responsibilities.

· robust systems are in place to enable concerns about controlled drugs to be raised, to logthese concerns, and initiate investigative actions.

A legal duty of collaboration has been included in the Health Act 2006. This places astatutory responsibility on the CD Accountable Officer and NHS/Foundation Trust to shareinformation and intelligence relating to controlled drug use in the health and social caresector. Local organizations are required to cooperate with other healthcare organizations,police, and relevant inspectorates (Healthcare Commission, Royal Pharmaceutical Society).CD Accountable Officers within PCOs have been deemed responsible for establishing andcoordinating the intelligence networks.

4. Arrangements in Torbay and South Devon NHS Foundation Trust

The CD Accountable Officer must:· report directly to the Medical Director· be a fit, proper and suitably experienced person· not routinely prescribe, supply, administer, or dispose of controlled drugs· have credibility with all healthcare and social care professionals· have sufficient seniority to be able to take action regardless of how a concern is raised· have regard for best practice in relation to the management and use of controlled drugs

Responsibilities include:· securing the safe management and use of controlled drugs.· establishing and ensuring appropriate arrangements to comply with the Misuse of drugs

legislation.· ensuring adequate and up to date standard operating procedures are in place in relation

to the management and use of controlled drugs.· ensuring adequate destruction and disposal arrangements for controlled drugs.· ensuring monitoring and auditing of the management and use of controlled drugs.· ensuring relevant individuals receive appropriate training· maintaining a record of concerns regarding relevant individuals· assessing and investigating concerns· taking appropriate actions if there are found to be concerns· establishing arrangements for sharing information and co-ordinating local Intelligence

networks

Support for the Accountable Officer:· The Controlled Drugs (Supervision of Management and Use) Regulations 20064 make it

clear that the NHS Trust should provide the “CD Accountable Officer" with funds andresources to enable them to carry out their role.

· In Torbay and South Devon NHS Foundation Trust the nominated CD AccountableOfficer will have support from :

· The Medical Director· The Chief Nurse· The Governance and Patient Safety Leads


· The Medicines Management Committee· Senior Pharmacists· The Controlled Drugs Governance Committee· Clinical Directors, Matrons and SDU Managers across the Trust

Framework for discharging responsibilities:· The overarching role of the CD Accountable Officer is to ensure that adequate and

satisfactory mechanisms exist for the safe management and use of controlled drugs· The Pharmacy Department has a central role in ensuring safe management and use of

controlled drugs, and in supporting the CD Accountable Officer in his role· The Controlled Drugs Governance Committee acts as the platform in helping the CD

Accountable Officer in his role.

The Controlled Drugs Governance Committee should therefore:

· ensure that Controlled Drugs are used safely within the organisation in line with thelatest legislation

· provide written reports to the Trust’s Medicines Management Committee.

· ensure that practice within the Trust in relation to controlled drugs is compliant withcurrent legislation, Department of Health Guidance and professional standards

· ensure appropriate audits of compliance with national and local policies andprocedures relating to controlled drugs are undertaken on a regular basis.

· continually review and update the Trust’s Medicines Policy to ensure it complies withcurrent controlled drugs legislation and regulations

· develop, review and authorise standard operating procedures which are relevant to theuse of controlled drugs within the Trust

· review any reported incidents involving controlled drugs

· monitor compliance with Trust Policy and procedures through local reviews and audits

· ensure that the Trust meets the necessary Care Quality Commission, NHSLA andother related requirements for controlled drugs

· support the activities of the CD Accountable Officer in ensuring the Trust is compliantwith current legislation

· advise the Trust on any training requirements necessary to meet the requiredstandards

The Deputy CD Accountable Officer should:· assist the CD Accountable Officer in their role as above· communicate effectively with the CD Accountable Officer· take over the responsibilities of the CD Accountable Officer in their absence· represent the Trust when required, on behalf of the CD Accountable Officer

Collated by Clinical Effectiveness Common Drugs of DiversionVersion 3 (June 2019) Page 1 of 1

Appendix 3

Common Drugs of Diversion

ChlordiazepoxideClobazamClonazepamCodeine (including linctus & combination products)CyclizineDiazepamDihydrocodeine (including combination products)GabapentinLoprazolamLorazepamLormetazepamMisoprostolNefopamNitrazepamOxazepamPholcodeinePregabalinProcyclidineSildenafilTadalfilTestosteroneVardenafilZolpidemZopiclone

Collated by Clinical Effectiveness Recommendations for Controlled Drugs Cupboards/CabinetsVersion 3 (June 2019) Page 1 of 2

Appendix 4

Recommendations for Controlled Drugs cupboards / cabinets

Introduction: Controlled drugs (CDs) must be stored in such a way to meet legally definedcriteria which are laid out in Regulations, which describe the specifications for the safecustody of controlled drugs, including controlled drugs cupboards / cabinets requirements.A number of factors must be considered when choosing a controlled drugs cupboard /cabinet, to ensure that the cupboard / cabinet (referred to as ‘cupboard’ herein) is fit forpurpose and meets the safe custody requirements:

1. The cupboard in which controlled drugs are stored must conform to the British Standardreference BS2881 and comply with the requirements of The Misuse of Drugs (Safe Custody)Regulations 1973:

· When purchasing a cupboard for controlled drugs storage, ensure that the productdescription and specification made by the manufacturer / supplier includes a statementsaying that the cupboard meets the Misuse of Drugs (Safe Custody) Regulations 1973.

· This is a minimum security standard and may not be sufficient for areas where there isnot a 24-hour staff presence, or easy control of access. In this case the advice ofsecurity specialists or crime prevention officers should be sought.

· The CD cupboards should be approved by the pharmacy department.

2. Positioning of the cupboard within the unit:· Wherever possible, cabinets should be fixed to an internal wall constructed of brick,

concrete blocks or reinforced concrete. Installation should be by means of four M10wall fixing expanding bolts (rag bolts).

· Where possible fit the cabinet up to a corner with the lock side closest to a wall whichwill make it more difficult to forcibly lever open the door.

· The position of the cupboard within the room must be risk assessed, taking intoconsideration that controlled drugs may be a target for theft according to the followingcriteria:

o The position of the cupboard in relation to external windowso Whether the cupboard is located within a room that is accessible by patients /

the publico Whether the cupboard is located within a locked room that is not accessed by

patients / the public· The position of the cupboard must be such that the medicines stored therein are kept

stored according to the requirements of the TSDFT Medicines Policy and associatedStanding Operating Procedures.

3. Capacity of the cupboard:The capacity size of the cupboard must be sufficient to:· Store controlled drugs ward stock· Store record books for controlled drugs· Store requisition/order books· Store patient’s own controlled drugs separately· Allow segregation of high dose ampoules of morphine and diamorphine,

NPSA/2006/12· Other controlled stationery according to local need (e.g. FP10 pads)

Collated by Clinical Effectiveness Recommendations for Controlled Drugs Cupboards/CabinetsVersion 3 (June 2019) Page 2 of 2

4. General considerations for the cupboard:· It is not necessary for the cupboard to have a light indicating when the cupboard is

open, although some cupboards have this feature.· Nothing on the outside of the cupboard should draw attention to the fact that controlled

drugs are stored within.· No other items should be stored in the cupboard.· The CD cupboard must be situated within a locked room and the CD cupboard must be

locked at all times.· Store used controlled drug denaturing kits, which can be ordered when needed.

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTDocument Control Information

Version 3 (June 2019) Page 1 of 2

Document Control Information

This is a controlled document and should not be altered in any way without the express permissionof the author or their representative.

Please note this document is only valid from the date approved below, and checks should be madethat it is the most up to date version available.

If printed, this document is only valid for the day of printing.

This guidance has been registered with the Trust. The interpretation and application of guidancewill remain the responsibility of the individual clinician. If in doubt contact a senior colleague orexpert. Caution is advised when using clinical guidance after the review date, or outside of theTrust.

Have you identified any issues on the Rapid (E)quality ImpactAssessment. If so please detail on Rapid (E)QIA form. Yes ☐

Please select Yes No

Ref No: 1763

Document title: Controlled Drugs, Medicines Policy for Wards and Departmentsat Torbay Hospital

Purpose of document:

The purpose of this policy is to promote the safe and effectiveuse of controlled drugs (CDs) in Torbay and South Devon NHSFoundation Trust (TSDFT), and incorporates the strengthenedgovernance arrangements and legislative changes resulting fromthe Government’s response to reports of the Shipman Inquiry(Safer Management of Controlled Drugs) on behalf of theDepartment of Health.

It sets out systems for procuring, storing, supplying, transporting,prescribing, administering, recording, and disposing safely ofCDs, with the aim of developing strong governancearrangements that fit with the current legal framework

Date of issue: 5 July 2019 Next review date: 5 July 2022Version: 3 Last review date:Author: Governance Pharmacist and Medication Safety OfficerDirectorate: Organisation WideEquality Impact: The guidance contained in this document is intended to be

inclusive for all patients within the clinical group specified,regardless of age, disability, gender, gender identity, sexualorientation, race and ethnicity & religion or belief

Committee(s)approving thedocument:

Care and Clinical Policies Group MeetingMedicines Management Committee

Date approved: 18 April 2019Links or overlaps withother policies:

0427 - Medicines management in Maternity Services

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTDocument Control Information


Does this document have implications regarding the Care Act?If yes please state: ☐ ☐

Does this document have training implications?If yes please state: ☐ ☒

Does this document have financial implications?If yes please state: ☐ ☒

Is this document a direct replacement for another?If yes please state which documents are being replaced: ☒ ☐

Document Amendment History

DateVersion

no.Amendment

summary Ratified by:1 February 2016 1 New Chief Nurse

Medical DirectorClinical Director of Pharmacy

10 March 2017 2 Revised Clinical Director of PharmacyCare and Clinical Policies Group

5 July 2019 3 Revised Care and Clinical Policies GroupMedicines Management Committee

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTThe Mental Capacity Act 2005


The Mental Capacity Act 2005

The Mental Capacity Act provides a statutory framework for people who lack capacity tomake decisions for themselves, or who have capacity and want to make preparations for atime when they lack capacity in the future. It sets out who can take decisions, in whichsituations, and how they should go about this. It covers a wide range of decision makingfrom health and welfare decisions to finance and property decisions

Enshrined in the Mental Capacity Act is the principle that people must be assumed to havecapacity unless it is established that they do not. This is an important aspect of law that allhealth and social care practitioners must implement when proposing to undertake any act inconnection with care and treatment that requires consent. In circumstances where there isan element of doubt about a person’s ability to make a decision due to ‘an impairment of ordisturbance in the functioning of the mind or brain’ the practitioner must implement theMental Capacity Act.

The legal framework provided by the Mental Capacity Act 2005 is supported by a Code ofPractice, which provides guidance and information about how the Act works in practice. TheCode of Practice has statutory force which means that health and social care practitionershave a legal duty to have regard to it when working with or caring for adults who may lackcapacity to make decisions for themselves.

All Trust workers can access the Code of Practice, Mental Capacity Act 2005 Policy, MentalCapacity Act 2005 Practice Guidance, information booklets and all assessment, checklistsand Independent Mental Capacity Advocate referral forms on iCare

http://icare/Operations/mental_capacity_act/Pages/default.aspx

Infection Control

All staff will have access to Infection Control Policies and comply with the standards withinthem in the work place. All staff will attend Infection Control Training annually as part oftheir mandatory training programme.

“The Act is intended to assist and support people who maylack capacity and to discourage anyone who is involved incaring for someone who lacks capacity from being overlyrestrictive or controlling. It aims to balance an individual’sright to make decisions for themselves with their right to beprotected from harm if they lack the capacity to makedecisions to protect themselves”. (3)

http://icare/Operations/mental_capacity_act/Pages/default.aspx

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTQuality Impact Assessment


Quality Impact Assessment (QIA)

Please selectWho may be affected by thisdocument? Patient / Service Users ☒ Visitors / Relatives ☐

General Public ☐Voluntary / Community

Groups ☐

Trade Unions ☐ GPs ☐

NHS Organisations ☐ Police ☐

Councils ☐ Carers ☐

Staff ☒Other Statutory

Agencies ☐

Others (please state):

Does this document require a service redesign, or substantial amendments to an existingprocess? ☐

If you answer yes to this question, please complete a full Quality Impact Assessment.

Are there concerns that thedocument could adverselyimpact on people andaspects of the Trust underone of the nine strands ofdiversity?

Age ☐ Disability ☐

Gender re-assignment☐

Marriage and CivilPartnership ☐

Pregnancy and maternity ☐Race, including

nationality and ethnicity ☐

Religion or Belief ☐ Sex ☐

Sexual orientation ☐

If you answer yes to any of these strands, please complete a full Quality Impact Assessment.If applicable, what actionhas been taken to mitigateany concerns?

Who have you consultedwith in the creation of thisdocument?

Note - It may not be sufficientto just speak to other health &social care professionals.

Patients / Service Users ☐ Visitors / Relatives ☐

General Public ☐Voluntary / Community

Groups ☐

Trade Unions ☐ GPs ☐

NHS Organisations ☐ Police ☐

Councils ☐ Carers ☐

Staff ☒Other Statutory

Agencies ☐

Details (please state):

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTRapid (E)quality Impact Assessment


Rapid (E)quality Impact Assessment (EqIA) (for use when writing policies)

Please contact the Equalities team for guidance:For South Devon & Torbay CCG, please call 01803 652476 or email [email protected]

Policy Title (and number) Version and DatePolicy AuthorAn (e)quality impact assessment is a process designed to ensure that policies do not discriminate or disadvantage peoplewhilst advancing equality. Consider the nature and extent of the impact, not the number of people affected.Who may be affected by this document?Patients/ Service Users ☐ Staff ☐ Other, please state… ☐

Could the policy treat people from protected groups less favourably than the general population?PLEASE NOTE: Any ‘Yes’ answers may trigger a full EIA and must be referred to the equality leads belowAge Yes ☐ No☐ Gender Reassignment Yes ☐ No☐ Sexual Orientation Yes ☐ No☐Race Yes ☐ No☐ Disability Yes ☐ No☐ Religion/Belief (non) Yes ☐ No☐Gender Yes ☐ No☐ Pregnancy/Maternity Yes ☐ No☐ Marriage/ Civil Partnership Yes ☐ No☐Is it likely that the policy could affect particular ‘Inclusion Health’ groups less favourably than the generalpopulation? (substance misuse; teenage mums; carers1; travellers2; homeless3; convictions; social isolation4;refugees)

Yes ☐ No☐

Please provide details for each protected group where you have indicated ‘Yes’.

VISION AND VALUES: Policies must aim to remove unintentional barriers and promote inclusionIs inclusive language5 used throughout? Yes ☐ No☐ NA ☐

Are the services outlined in the policy fully accessible6? Yes ☐ No☐ NA ☐

Does the policy encourage individualised and person-centred care? Yes ☐ No☐ NA ☐

Could there be an adverse impact on an individual’s independence or autonomy7? Yes ☐ No☐ NA ☐

EXTERNAL FACTORSIs the policy a result of national legislation which cannot be modified in any way? Yes ☐ No☐What is the reason for writing this policy? (Is it a result in a change of legislation/ national research?)

Who was consulted when drafting this policy?Patients/ Service Users ☐ Trade Unions ☐ Protected Groups (including Trust Equality Groups) ☐

Staff ☐ General Public ☐ Other, please state… ☐

What were the recommendations/suggestions?

Does this document require a service redesign or substantial amendments to an existing process? PLEASENOTE: ‘Yes’ may trigger a full EIA, please refer to the equality leads below

Yes ☐ No☐

ACTION PLAN: Please list all actions identified to address any impactsAction Person responsible Completion date

AUTHORISATION:By signing below, I confirm that the named person responsible above is aware of the actions assigned to themName of person completing the form SignatureValidated by (line manager) Signature

mailto:[email protected]

Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTRapid (E)quality Impact Assessment


For Torbay and South Devon NHS Trusts, please call 01803 656676 or email [email protected] form should be published with the policy and a signed copy sent to your relevant organisation

Consider any additional needs of carers/ parents/ advocates etc, in addition to the service user2 Travelers may not be registered with a GP - consider how they may access/ be aware of services available to them3 Consider any provisions for those with no fixed abode, particularly relating to impact on discharge4 Consider how someone will be aware of (or access) a service if socially or geographically isolated5 Language must be relevant and appropriate, for example referring to partners, not husbands or wives6 Consider both physical access to services and how information/ communication in available in an accessible format7 Example: a telephone-based service may discriminate against people who are d/Deaf. Whilst someone may be able to act on theirbehalf, this does not promote independence or autonomy


Collated by Clinical Effectiveness Controlled Drugs, Medicines Policy for TSDFTClinical and Non-Clinical Policies – Data Protection


Clinical and Non-Clinical Policies – Data Protection

Torbay and South Devon NHS Foundation Trust (TSDFT) has a commitment to ensure thatall policies and procedures developed act in accordance with all relevant data protectionregulations and guidance. This policy has been designed with the EU General DataProtection Regulation (GDPR) and Data Protection Act 2018 (DPA 18) in mind, andtherefore provides the reader with assurance of effective information governance practice.

The UK data protection regime intends to strengthen and unify data protection for allpersons; consequently, the rights of individuals have changed. It is assured that theserights have been considered throughout the development of this policy. Furthermore, dataprotection legislation requires that the Trust is open and transparent with its personalidentifiable processing activities and this has a considerable effect on the way TSDFTholds, uses, and shares personal identifiable data.

Does this policy impact on how personal data is used, stored, shared or processed in yourdepartment? Yes ☐ No ☐

If yes has been ticked above it is assured that you must complete a data mapping exerciseand possibly a Data Protection Impact Assessment (DPIA). You can find more informationon our GDPR page on ICON (intranet)

For more information:· Contact the Data Access and Disclosure Office on [email protected],· See TSDFT’s Data Protection & Access Policy,· Visit our Data Protection site on the public internet.

https://icon.torbayandsouthdevon.nhs.uk/areas/gdpr/Pages/default.aspx


https://icon.torbayandsouthdevon.nhs.uk/areas/information-governance/Policies/TSDFT%20Policy%20Data%20Protection%20and%20Access.pdf

https://www.torbayandsouthdevon.nhs.uk/about-us/data-protection/

Documents

Document Type: Protocol 3 5 July 2022 NHS Foundation Trust