Controlled Drugs Standard Operating Procedure · This Standard Operating Procedure (SOP) relates to...

Controlled Drugs Standard Operating Procedure FINAL 4.0 January 2019

Pharmacy and Medicines Management

Controlled Drugs SOP v4 0 Jan 2019 -APPROVED DTC

Document Control

Title

Controlled Drugs Standard Operating Procedure

Author

Author’s job title Governance Pharmacist

Directorate Planned Care – SOP applies Trustwide

Department Pharmacy / Medicines Management

Version Date

Issued Status Comment / Changes / Approval

1.1 June 2016

Draft Initial version for consultation – developed from Controlled Drugs Standard Operating Procedure version 1.0a November 2015.

1.2 July 2016

Draft Discussed at Drug and Therapeutics Committee 21/06/16.

1.3 July 2016

Draft Comments added into version 0.1, following initial consultation, including clarification of the role of the second checker / signatory (in discussion with Head of Quality Improvement).

1.4 Sept 2016

Draft Amended version, following comments from Stakeholder consultation, commenced 25-08-16 until 07-09-16. (Comments from Professional Lead for Community Nursing and Chief Pharmacist). Points added to support compliance with NICE NG46 – safe use and management of controlled drugs.

2.0 Sept 2016

Final Approved by Trust Drug and Therapeutics Committee on 15th September 2016 (version control numbering updated).

2.1 Nov 2017

Draft Minor amendment made to wording – page 8 secondary bullet point 9 of 10, for approval by DTC 18-01-2018. Trust logo updated.

3.0 Jan 2018 Final Approved by DTC – for publication on Trust website

3.1 Jan 2019 Draft Minor amendments made to SOP, in preparation for the introduction of Nursing Associates in January 2019. Provision made for use of mobile technology in exceptional circumstances to obtain second check.

3.2 Jan 2019 Draft Information relating to second checking procedure with mobile technology moved from Policy to SOP.

4.0 Jan 2019 Final Approved by Trust Drug and Therapeutics Committee 17th January 2019.

Main Contact Governance Pharmacist North Devon District Hospital Unit 1 Exeter International Office Park Clyst Honiton, Exeter EX5 2HL

Tel: Direct Dial – Tel: Internal – Email:

Lead Director Deputy Medical Director

Document Class Standard Operating Procedure

Target Audience All staff managing controlled drugs (CDs)




Distribution List Senior Clinical Managers Professional Leads Corporate Governance Lead Quality Improvement Lead Trust Chief Pharmacist / Accountable Officer for Controlled Drugs

Distribution Method Trust’s internal website

Superseded Documents Controlled Drugs SOP FINAL version 3.0 January 2018

Issue Date January 2018

Review Date January 2021

Review Cycle Three years

Consulted with the following stakeholders

Trust Deputy Medical Director

Trust Chief Pharmacist / Accountable Officer for Controlled Drugs

Trust Director of Nursing and Deputy Director of Nursing

Trust Drugs and Therapeutics Committee

Trust Medicines Governance Group

Trust Professional Nursing Leads

Trust Non-Medical Prescribing Lead

Contact responsible for implementation and monitoring compliance: Pharmacy / Medicines Management Team

Education/ training will be provided by: Pharmacy / Medicines Management Team

Approval and Review Process

Trust Drug and Therapeutics Committee

Local Archive Reference Document linked below: Local Path Pharmacy / Policies and Procedures Filename Controlled Drugs SOP v4.0 Jan 2019 -APPROVED DTC

Policy categories for Trust’s internal website (Bob) Pharmacy, Policies and Procedures

Tags for Trust’s internal website (Bob) Controlled Drugs CDs




CONTENTS

Document Control........................................................................................................................ 1

1. Background .......................................................................................................................... 4

2. Purpose ................................................................................................................................ 4

3. Scope ................................................................................................................................... 4

4. Location ............................................................................................................................... 5

5. Equipment............................................................................................................................ 5

6. Procedure............................................................................................................................. 6

7. References ......................................................................................................................... 21

8. Associated Documentation ................................................................................................. 22




1. Background

1.1. Building on the monitoring and inspection arrangements for controlled drugs introduced by the Health Act 2006 and Regulations, the Health and Social Care Act 2012 and Controlled Drugs (Supervision of Management and Use) Regulations 2013 have subsequently introduced a number of requirements for organisations to meet, in relation to the use and management of controlled drugs.

1.2. The Northern Devon Healthcare Trust Medicines Policy and Controlled Drugs Policy provide an overarching framework for the safe prescribing, handling, supply, storage, administration and disposal of medicines, including controlled drugs within the Trust, to meet the current legal requirements.

2. Purpose

2.1. The Standard Operating Procedure (SOP) has been written to:

Provide standards and procedures for the safe management and use of controlled drugs, particularly in relation to Schedule 2 and Schedule 3 controlled drugs (Ref Appendix 1), within Northern Devon Healthcare Trust.

Be used in conjunction with Professional Codes of Conduct and Standards including the statutory and advisory publications listed in the references.

Be used in conjunction with the Trust Controlled Drugs Policy, which includes key definitions and terms used in this Standard Operating Procedure.

Be used in conjunction with the Trust Medicines Policy and associated Standard Operating Procedures.

Be used in conjunction with local and national sources of clinical information to ensure the safe and effective use and appropriate clinical monitoring of patients who have been prescribed controlled drugs.

3. Scope

3.1. This Standard Operating Procedure (SOP) relates to the all registered staff employed by and working within Northern Devon Healthcare Trust who are involved in the safe and secure handling of controlled drugs within the acute, community hospital or other setting, including the community;

3.2. All registered staff employed by and working within Northern Devon Healthcare NHS Trust who prescribe, administer, supply and manage controlled drugs must work within their Professional Codes of Conduct and Standards, organisational policies and procedures, which includes this Standard Operating Procedure and the Trust Controlled Drugs Policy.

https://www.northdevonhealth.nhs.uk/2018/09/medicines-policy/

http://ndht.ndevon.swest.nhs.uk/controlled-drugs-policy/








3.3. Staff employed by and working within Northern Devon Healthcare NHS Trust, who are involved in supporting patients with their medicines in the community, and are trained and follow to the Trust Medicines Policy for Skilled Non Registered Community Staff as part of their role.

3.4. For the purposes of this Standard Operating Procedure, in line with NMC Standards for Medicines Management, the second checker / signatory will be another registered healthcare professional or student professional able to demonstrate competency in practice, following the appropriate Standard Operating Procedure/s.

3.5. In the exceptional circumstances, mobile technology may be used to facilitate the second check, provided that electronic evidence of the of the second check (photographs and confirmation messages or emails) is retained until the CD register is signed by the second checker as soon as possible thereafter, and within 24 hours. Verbal orders are not permitted for controlled drugs, so any use of mobile technology must replicate the process for a second check. This second check must be recorded in the CD register in real time; the CD register must be annotated by the first practitioner / signatory to record the second check to include:

Details of the second checker: Name, job title, professional registration number;

How the second check was obtained: Mobile technology used - photograph seen and confirmation obtained (text message or email).

4. Location

4.1. This Standard Operating Procedure must be implemented in all clinical areas where controlled drugs are located and administered by Trust staff.

4.2. Staff undertaking this procedure must be able to demonstrate continued competence as per the organisational policy on assessing and maintaining competence.

5. Equipment

Controlled drugs cupboard (Trust sites) Oral syringes for the measurement and administration of oral controlled drug

liquids Controlled drugs destruction kit, and any other protective safety items (e.g.

gloves) required for denaturing and disposal.

http://ndht.ndevon.swest.nhs.uk/medicines-policy-for-skilled-not-registered-snr-community-staff/





6. Procedure

6.1. Prescribing of controlled drugs (to be followed with reference to the Trust Controlled Drugs Policy and Medicines Policy)

Prescribing of controlled drugs must only be undertaken by prescribers, according to their professional competence, expertise and in accordance with prescribing status as identified within their professional registration, legislation and the Northern Devon Healthcare Trust Medicines and Controlled Drugs Policies, using approved Trust stationery.

Verbal orders are not permitted for controlled drugs.

For opioid naïve patients, when an opioid medicine is prescribed for the first time, the prescriber must ensure that they are familiar with the usual starting dose of the medicine prescribed; that the appropriate starting dose is prescribed, in line with to local Joint Formulary prescribing recommendations, the BNF or Summary of Product Characteristics (SPC), available at: www.medicines.org.uk.

The prescriber must ensure that an accurate medication history has been taken prior to prescribing controlled drug, to confirm any recent opioid dose, formulation, frequency of administration and any other analgesic medicines prescribed for the patient (“Medicines reconciliation”). This may be done for example through discussion with the patient or their representative (although not in the case of treatment for addiction), the prescriber or through medication records. This must include checking whether the patient is currently prescribed or wearing any analgesic / opioid patches.

The prescriber must ensure that where a dose increase is intended, that the calculated dose is safe for the patient (e.g. for oral morphine or oxycodone in adult patients, not normally more than 50% higher than the previous dose); if the dose is to be increased by more than 50% from the prescription that this is checked to ensure that this is safe and intentional*. Reasons for not following prescribing guidance must be clearly documented in the patient’s care record. If further advice is required, see Appendix 2 for local expert contact details.

If controlled drug medication is reviewed and changed, the prescriber is accountable for checking and ensuring that any calculation of opiate dose equivalence is correct and documented in the patient s record. Refer to the Joint Formulary guide to equivalent doses for opioid drugs for further dosing information.

* While dose increments should be in line with the above recommendations, it is recognised that in palliative care higher than normal doses may be required. Recommendations are not designed to restrict clinical use of opioid medicines, but to ensure they are used in a way that is as safe as possible for patients (National Patient Safety Agency Rapid Response Report: Reducing Dosing Errors with Opioid Medicines. NPSA/2008/RRR05).




https://www.medicinescomplete.com/mc/bnf/current/

http://www.medicines.org.uk/

http://northeast.devonformularyguidance.nhs.uk/documents/Formulary-documents/Palliative-care/NE-Guide-equivalent-doses-opioids-inc-bup-POST-FIG.pdf





When prescribing controlled drugs:

Clearly document the indication and regimen for the controlled drug in the person’s care record;

Check the patient’s current clinical needs and, if appropriate, adjust the dose until a good balance is achieved between benefits and harms;

Ensure that the patient is given the opportunity to be involved in making decisions about their medication;

Discuss the arrangements for reviewing and monitoring treatment with the patient and / or their carer;

Be prepared to discuss the prescribing decision with other health professionals if further information is requested about the prescription.

When prescribing ‘when required’ controlled drugs:

Document clear instructions for when and how to take or use the drug in the person’s care record

Include dosage instructions on the authority to administer /prescription (with the maximum daily amount or frequency of doses) so that this can be included on the label when dispensed

Ask about and take into account any existing supplies the person has of ‘when required’ controlled drugs.

NB: When prescribing liquid formulations (oral or injectable) - always state a dose in milligrams (mg) or micrograms, not millilitres (ml). Legal requirements for the prescribing of Schedule 2 and Schedule 3 controlled drugs apply to any discharge, outpatient and FP10 prescription, including hospital FP10HNCs and are set out in Appendix 3.

Alterations to prescriptions for controlled drugs should be avoided, but if any are made, they must be clear and unambiguous.

When prescribing for discharge, outpatients and on FP10 prescriptions, only prescribe enough controlled drug to meet the person’s clinical needs for no more than 30 days. If, under exceptional circumstances, a larger quantity is prescribed, the reasons for this should be documented in the person’s care record.

6.2. Administration of controlled drugs (to be followed with reference to the Trust Controlled Drugs Policy, Medicines Policy, Injectable Medicines Policy and all Standard Operating Procedures associated with these Trust Policies, together with Professional Codes of Conduct and Standards) 6.2.1 Prior to the administration of a controlled drug – all settings:

The registered practitioner must have a clinical and pharmaceutical knowledge of the medication they are administering, including the usual starting dose, frequency of administration, standard dosing increments, symptoms of overdose and common side effects.




http://ndht.ndevon.swest.nhs.uk/injectable-medicines-policy-prescribing-preparing-and-administering-injectable-medicines-policy/




The registered practitioner must have access to the Prescription and Medication Administration Record for the patient at the time of administration; they must check that the controlled drug is due to be administered within the time regime established within the Prescription and Medication Administration Record and that any previous administrations reconcile with all documented records of administration.

The registered practitioner must ensure that the medication to be administered meets the clinical needs of the patient and that the patient is ready to receive the medication.

The registered practitioner must check the patient identity and that the patient has no allergies, hypersensitivities or intolerance to the prescribed controlled drug medication. If an allergy, hypersensitivity or intolerance to the prescribed CD is identified, this must be referred back to the prescriber for review prior to administration.

If administering the controlled drug via the injectable route, the Trust Injectable Medicines Policy and associated Standard Operating Procedures must be followed; the injectable medication must have been risk assessed, with action taken to mitigate any identified risks, in discussion with the Pharmacy / Medicines Management Team.

Where equipment is required to administer a controlled drug, staff administering must be familiar with and competent to use the required equipment (e.g. oral syringes for liquid CDs; syringe driver for injectable CDs), together with any relevant Trust Policies and Procedures.

6.2.2 Administration in acute, community hospital and specialist service settings:

As a general principle, patients should be asked whether they wish to self-administer their own medication, which may include Controlled Drugs, following the Trust Self-Administration of Medication for Adults Standard Operating Procedure.

In addition to the following the Administration of Medicines Standing Operating Procedure, the registered practitioner administering a controlled drug will:

Work with a second checker / signatory who will challenge any step of the checking / witnessing process if procedures are not followed and / or the records do not tally at any point.

Have the up to date Prescription and Medication Administration Record and the ward Controlled Drug Record Book available.

Check that any previous administrations reconcile with all records of administration both on the Prescription and Medication Administration Record and the Ward Controlled Drug Record book.

Continues on next page



http://ndht.ndevon.swest.nhs.uk/self-administration-of-medication-standard-operating-procedure/


http://ndht.ndevon.swest.nhs.uk/administration-of-medicines-in-community-hospitals-standard-operating-procedure/

http://ndht.ndevon.swest.nhs.uk/administration-of-medicines-in-community-hospitals-standard-operating-procedure/




The registered practitioner, working with the second checker / signatory, will then:

o Select and remove the controlled drug (CD) from the CD cupboard;

o Check the name and strength of the selected CD against the Prescription and Medication Administration Record and the Ward Controlled Drugs Record Book, the latter to reconcile the stock balance.

o Check the expiry date of the CD medication.

o Document any dose calculations made in the patient’s clinical records.

o If administering a solid dose form, remove the correct quantity of the controlled drug, ready for administration;

o If administering an oral liquid formulation, measure and check the correct volume, using an oral syringe (to minimise the risk of wrong route administration);

o If preparing / administering an injectable formulation, follow the Injectable Medicines Policy and Standard Operating Procedures;

o Ensure that a record is made in the Ward Controlled Drugs Record Book which includes the running stock balance, which is checked and reconciled with the physical amount of stock left;

o The registered practitioner will administer the CD in the presence of the second checker / signatory, who will both sign the controlled drugs record book when the controlled drug is removed from the CD cupboard; The registered practitioner is accountable for completing the administration record on the Prescription and Medication Administration Record, which must be counter-signed by the second checker / signatory” at the time of administration.

o The registrant and second checker / signatory will witness, record and dispose of any excess / wasted controlled drugs – see Section 6.11 (Destruction and disposal of controlled drugs).

If the patient declines or is unable to take the CD after it has been prepared, the dose must destroyed (see Section 6.11) and be discarded in accordance with the Northern Devon Healthcare Trust Waste Management Policy and Waste Management Manual, witnessed by the second checker / signatory.

All medication omissions, including any omissions of controlled drugs, must be documented in the patient record, following the Trust Omitted and Delayed Medicines Standard Operating Procedure.



http://ndht.ndevon.swest.nhs.uk/omitted-and-delayed-medicines-standard-operating-procedure/





6.2.3 Administration process in a community setting:

Medicines in the community/home setting are the property of the person for whom they are prescribed and dispensed. Registered and non-registered staff have a supportive, educational and monitoring role in patient self-administration. However, some medication will require administration by appropriately trained staff*:

Staff must ensure that they have access to the completed, valid Authority to Administer / Prescription and Medication Administration Record for Community Use from which to administer in the home/community environment.

Staff must ensure that the medication is available within the home/community environment.

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

A signed record of any drug administration (including CDs), must be maintained in accordance with Trust Clinical Record Keeping Policy, to include the name, form and strength of medicine, dose given, the date, time, route of administration, site of injection if appropriate and any dilution or calculations made. The name of the person administering the drug must also be recorded.

See Section 6.7 for record keeping procedures in the community setting.

* Skilled non-registered staff employed by Northern Devon Healthcare NHS Trust may be involved in supporting service users with their medication in the community, following the Trust Medicines Policy for Skilled Non-Registered Staff.

6.4. Additional safety points to consider – all settings:

When prescribing liquid formulations (oral or injectable) - always check and ensure that the dose is stated in milligrams (mg) or micrograms, and not millilitres (ml);

If a dose is prescribed in millilitres (ml), seek clarification of the required dose in milligrams (mg) or micrograms;

Refer to the Joint Formulary guide to equivalent doses for opioid drugs for further dosing information;

For Transdermal Patches, a Trust ‘Transdermal Patch Application Record’ (TPAR) should be completed as a record of application, to form part of the patient’s documentation. NB: The TPAR is used alongside the Prescription and Medication Administration Record (PMAR) as a record of site application and removal, not administration.

http://ndht.ndevon.swest.nhs.uk/clinical-record-keeping-policy/



http://ndht.ndevon.swest.nhs.uk/wp/wp-content/uploads/2011/10/FINAL-Transdermal-Patch-Application-Record-v2.0.pdf




6.5. Access to controlled drugs cupboards / cabinets - acute, community hospital and specialist service settings:

There must be two sets of keys for each CD cupboard / cabinet. The ward CD keys must be stored separately from the duplicate set, which must be stored in a secure location on the premises; authorised staff must be aware of this location.

The registered practitioner in charge of the ward or unit is responsible for the CD key, which must be held by this person or delegated registered practitioner at all times and they must know their whereabouts at all times.

The CD key may be given to another registered member of staff for a specific task, but must be returned to the registered practitioner in charge immediately after use.

CD keys must not be handed to non-registered staff: Where medicines keys are required to be handed to authorised non -registered staff for specific agreed duties, CD key must be kept separate and held by the registered practitioner.

On occasions, for the purpose of stock checking or audit, the CD key may be handed to an authorised registered member of the pharmacy team, i.e. pharmacist, pharmacy technician.

If the CD key cannot be located, urgent action must be taken to identify whether the key have been taken away in error by a member of staff, and action taken retrieve the key as quickly as possible, e.g. by contacting the registrant who have just gone off duty.

If the CD key/s cannot be found this must be reported immediately to the Duty Site Manager and/or Clinical Matron. If these staff are not available, then the loss must be reported to the on-call manager as soon as possible. The Local Security Management Specialist must also be informed promptly of the loss.

If the CD key/s are identified as missing, the registered practitioner in charge must ensure that the controlled drugs are secure and that medication is available for patients in a timely manner.

Any incidents involving suspected or actual loss of CD keys must be reported on the Trust Incident Reporting System (Datix), which will alert other relevant individuals, including the Chief Pharmacist, who is the Trust Accountable Officer for Controlled Drugs (CDAO).

6.6. Ordering and supply of department, ward or unit stock controlled drugs (CDs)

6.5.1 When ordering controlled drugs:

Stock levels must be assessed against the ward / unit suggested stock level prior to ordering to ensure excess stock is not held.

Controlled drugs not included on the ward stock list must only be ordered for named patients, when required for that specific patient. CDs ordered for named patients are classed as ward stock CDs for the purposes of this SOP (not patient’s own).

Orders for CDs must be made in the designated CD requisition book for the department, ward or unit, with each item being ordered on separate and successive pages.

CD requisition books are controlled stationery and as such must be stored securely when not in use. It is best practice to ensure that one order / requisition book is available for ordering at all times. This can be facilitated by having two CD requisition books.




Orders (requisitions) for all controlled drugs covered by this Policy must be made using the controlled drugs order book and must comply with legal requirements and must include the following:

Name of the hospital

Name of the department, ward or unit

Drug name, form and strength

Total quantity in words and figures

Signature and printed name of the registered professional*

Date

* CD requisitions must be signed by an authorised registered practitioner working on the receiving department, ward or unit. It is the responsibility of the supplying Trust pharmacy to obtain, monitor and check the signatures of authorised registered practitioners against specimen signatures provided.

The following may also be required:

The container (e.g. ampoule, vial) where required for clarification when more than one presentation is available

A counter signature (see next section below) The CD requisition book must be taken / sent to the supplying Trust Pharmacy.

6.5.2 Departments, wards or units ordering controlled drugs from another organisation:

Departments, wards or units ordering controlled drugs from another organisation or Trust via a supply Service Level Agreement (e.g. Northern Devon Trust departments, wards or units ordering controlled drugs from the Royal Devon and Exeter NHS Foundation Trust Pharmacy department) must have CD requisitions counter-signed by a Doctor or Dentist employed or engaged in work at the ordering site. This is a legal requirement.

Refer to Appendix 4 in this SOP and the Trust Controlled Drugs Policy Section 5.5 for further information.

When a department, ward or unit orders controlled drugs from a separate supplying organisation, the authorisation form for the ordering of CDs (Appendix 5), or supplying Trust Pharmacy equivalent, must be completed by each member of staff employed or contracted by the Trust who will be signing or countersigning CD requisitions. The authorisation form/s must be completed, signed and sent to the supplying Trust Pharmacy, prior to that individual signing the CD order book. The counter-signature of the doctor or dentist must be distinct and attributable to that individual.

The registered practitioner in charge of the department, ward or unit must keep a copy and collate the completed authorisation form/s (Appendix 5), which will be kept available for audit or inspection, as specimen signatures, and the originals sent to the supplying Trust Pharmacy, as described above. NB: The specimen signatures must be stored separately and away from the CD order book.

Each department, ward or unit must agree a controlled drug stock list with the Pharmacy / Medicines Management Team, which will include suggested stock levels. The controlled drug stock list must be kept up to date to reflect prescribing patterns / requirements of that ward or unit. This may be useful as a reference for any prescriber requested to counter sign a CD requisition order.





6.5.3 Collection of Controlled Drugs (CDs) in the community:

Staff working in the community should not routinely become involved in the delivery or custody of prescribed medicines and only in exceptional circumstances should community staff transport CDs, where patients or their carers / representatives are unable to collect them, provided the nurse is conveying the CD to a patient for whom the drug has been prescribed and dispensed (for example from a pharmacy to the patient’s home). The registered practitioner will be asked to sign and prove their identity to the community pharmacist. Any CDs must be kept secure and out of sight within their vehicle and taken directly to the patient’s home.

6.7. Receipt of department, ward or unit stock Controlled Drugs (CDs)

On receipt of Controlled Drugs from the supplying Trust Pharmacy, the package or ward pharmacy box must be signed for on delivery and stored securely until the order can be checked and entered into the controlled drugs record book for that department / ward / unit.

The controlled drugs received must be checked against the requisition to ensure that the supply received tallies with the order.

On recording the receipt in the controlled drugs record book, the running balance must be updated, and checked against the physical stock, to ensure they are the same. The entry will be signed by a registered practitioner and second checker / signatory.

If stock is received which is unfit for use, it must be signed for as received in the usual way and entered into the controlled drugs record book, including the running balance and reason why the stock is not fit for use. The supplying Trust pharmacy will be contacted to inform them of the unfit stock received and arrangements for replacement of stock made. The unfit stock will be clearly marked and stored separately from the in-date controlled drugs ward stock / patient’s own CDs and further advice sought from the supplying Trust Pharmacy regarding the appropriate action to take. This will be reported as an incident in accordance with Trust Incident Reporting and Management Policy.

6.8. Record Keeping Procedures

Department, ward / unit Controlled Drugs record books:

Department, ward / unit controlled drugs record books must be ordered from the supplying Trust Pharmacy, by completing a requisition within the controlled drugs order book. It is useful to note that the “notes for completion” in the front of the ward controlled record and ordering books may be outdated – ward staff should check the information with their ward pharmacist / pharmacy technician if unsure.

Department, ward or unit controlled drugs record books are controlled stationery and as such must be stored securely when not in use. Controlled drugs record books must be stored within the locked medicines cupboard, controlled drugs cupboard or be kept securely in the locked treatment room, where the CD cupboard is located.

Each area storing controlled drugs must keep separate controlled drugs record books for ward stock and patient’s own controlled drugs.

Each individual CD record will include a running balance (total) of the CDs held by the department, ward / unit.

http://ndht.ndevon.swest.nhs.uk/incident-reporting-and-management-policy/




For ward stock, a separate page must be used for each individual medicine, formulation and strength; the heading on the page will indicate the name of the medicine, the form and the strength. For clarity, this may include the brand name in addition to the name of the medicine (e.g. Fentanyl 12 micrograms per hour patches; “Matrifen”).

Each entry in the CD record book will include the following:

Date and time of the transaction

Transaction details (e.g. “receipt”, “destruction” or the patient details)

Quantity of the controlled drug received, destroyed or to be administered

Signature of the registered practitioner

Signature of the second checker / signatory

Record of the new running balance calculated (checked and reconciled with the actual quantity remaining)

For patient’s own controlled drugs, see Section 6.12

Entries must be in chronological sequence, made on the day of the transaction.

All entries must be signed by a registered practitioner and second checker / signatory.

Incorrect entries must NOT be crossed through or correction fluid used: Entries in the controlled drugs record book must not have any cancellations, obliteration or alteration. Corrections must be made as a timed, dated and signed separate entry on a new line, in the margin or as a footnote at the bottom of the page. The entry must be signed by the

registered practitioner and second checker / signatory.

Ward controlled drugs record and requisition books must be kept in their original form for two years from the last date of entry.

Any discrepancies identified in the controlled drugs record book must be dealt with according to Section 6.13 of this Standard Operating Procedure “Dealing with Discrepancies”.

Controlled Drug record keeping in community settings:

If Trust staff are required to administer controlled drugs (CDs) in other provider settings such as care homes then the controlled drugs procedures for that provider must be followed for CD record keeping (i.e. the Controlled Drugs Register (CDR) / record book for that care home / provider is completed and signed as a record of the administration, detailing the patient / resident’s name, the dose and time administered, together with the running balance).

6.9. Storage of Ward Controlled Drugs (CDs)

The requirements for safe and secure storage of controlled drugs are described in the Trust Controlled Drugs Policy. Refer to this Policy for further information.

The storage of controlled drugs are subject to the Misuse of Drugs (Safe Custody) Regulations 1973, meaning that any cabinets used to store controlled drugs must confirm to these requirements, which are described in the Trust Controlled Drugs Policy.






6.10. Controlled Drugs (CDs) Ward Stock and Balance Checking Procedures

Routine ward stock and balance checks must not be undertaken by members of the Pharmacy / Medicines Management Team, who must remain independent of the routine / weekly stock and balance checks.

A full stock balance check and reconciliation of the physical stock against the running balances for each drug record in the controlled drugs record books (ward stock and patient’s own CDs) must be undertaken by a registered practitioner, entered in the CD

record book, and checked and countersigned by a second checker / signatory for each CD on a weekly basis, including a visual check of oral liquids (see below). More frequent checks may be agreed in specific, local circumstances.

A visual check of oral liquids will also be undertaken on a weekly basis. If a discrepancy of more than 20% is suspected on the basis of the visual check, this discrepancy must be investigated and further advice and guidance must be sought from the Pharmacy or Medicines Management Team.

The Pharmacy / Medicines Management Team will complete a CD balance check and reconciliation every three months, by checking and reconciling the CD record and order books against the issue record from the supplying Trust pharmacy. This check must be arranged and carried out with a second registered practitioner, who will counter sign the records checked.

If non-stock CDs and/or excess ward stock are identified, arrangements will be made for this to be returned to the supplying Trust pharmacy, or to be disposed of, following the procedures in Section 6.10.

If any discrepancies are identified as part of the stock and balance check, follow the dealing with discrepancies Section 6.13.

6.11. Return of Ward Stock Controlled Drugs (CDs)

The department, ward / unit pharmacist or pharmacy technician are authorised to take CDs back to the supplying Trust Pharmacy. The following procedure must be followed to return controlled drugs to the supplying Trust Pharmacy:

Controlled drugs must not be returned to the supplying Trust Pharmacy in the pharmacy box or by any means other than via the department, ward / unit pharmacist or pharmacy technician.

When ward stock controlled drugs are no longer required (e.g. non-stock CDs ordered for a specific, named patient), the registered practitioner in charge must inform the department, ward / unit pharmacist or pharmacy technician that excess ward stock CDs need to be removed. The department, ward / unit pharmacist or pharmacy technician will make the necessary arrangements with the supplying Trust Pharmacy for the excess stock to be returned according to the supplying Trust Pharmacy agreement.

Ward stock CDs that are no longer required must be clearly annotated in the as such in the ward controlled drugs record book (e.g. no longer required; awaiting collection by the ward pharmacist or pharmacy technician).

When returning ward stock CDs to the supplying Trust Pharmacy, a record of the returned stock will be will be made in the ward CD order book, with the page clearly annotated to identify the return.




An entry detailing the return must also be made in the ward controlled drugs record book, including the running stock balance, which will be reconciled with any physical stock remaining. The entry will be made by the registered practitioner and will be countersigned by the pharmacist or pharmacy technician returning the stock to the supplying Trust Pharmacy.

If it is not possible to return the excess ward stock CDs to the supplying Trust Pharmacy, the ward pharmacist or pharmacy technician will make the appropriate arrangements for the controlled drug/s to be denatured and destroyed on site, by an appropriate person. See Section 6.11 below:

6.12. Destruction and Disposal of Controlled Drugs (CDs)

The destruction and disposal of Controlled Drugs (CDs) must not be undertaken following the unexpected/sudden or suspicious death of a patient.

In coroners’ cases, any medicines (including controlled drugs), syringes and syringe drivers must be handed to the police. Where syringe drivers are used two registered practitioners must give written confirmation of the unused amounts of drug in the syringe, the amount used, the rate of administration and the timing of the last dose if intermittent. It is essential that the data is recorded and the drugs kept for analysis if it is thought to be necessary.

Destruction or disposal of stock Controlled Drugs in Trust departments, wards or units:

Ward stock controlled drugs that are no longer required must, wherever possible, be returned to the supplying Trust pharmacy, following Section 6.10.

Where it is not possible to return ward stock controlled drugs to the supplying Trust Pharmacy, controlled drugs may be denatured and destroyed on the ward in the following circumstances:

Ward stock Schedule 2 CDs can only be denatured and destroyed in the presence of a specific ‘Authorised Witness’, following the Authorised Witness Destruction of Controlled Drugs Standard Operating Procedure (See Appendix 1). This situation does not currently occur or therefore apply in Northern Devon Healthcare NHS Trust.

Ward Stock Schedule 3 CDs and Patient’s own CDs may be denatured, destroyed and witnessed by a pharmacist or pharmacy technician and second registered practitioner (See Appendices 1 and 7). This situation does not currently occur or therefore apply in Northern Devon Healthcare NHS Trust.

Patient’s own CDs are the property of that individual and can only be destroyed providing that the patient or carer’s consent has been obtained and documented, by completing the Patient’s Own Controlled Drugs Consent Form (Appendix 6). Refer to Section 6.12 (Patient’s own controlled drugs) for information about denaturing and destruction.

Permission to dispose of medicines brought to the Trust mortuary with a deceased patient should be obtained from the patient’s family / carer without causing additional distress. The deceased patient’s medicines will then be labelled by mortuary staff, using pre-printed labels supplied by pharmacy - ‘Medication to be returned to pharmacy for destruction – may include controlled drugs’. Any controlled drugs will then be identified by pharmacy staff, who will record and retain the deceased patient’s own CDs for denaturing and safe disposal.




Departments, wards or units must ensure that any CDs awaiting destruction (including out of date CDs) are clearly labelled as such and are stored separately in the CD cupboard, to ensure that they are not used in error.

If a part vial needs to be administered to a patient, the registered professional and second checker / signatory will record the amount administered and the amount wasted in the controlled drugs record book. e.g. if the patient is prescribed 2.5mg diamorphine and a 5mg vial is used, the record will state “2.5mg administered and 2.5mg wasted”; the remainder must be rendered irretrievable before disposal. Appendix 7 provides further information on the denaturing and disposal of small quantities (less than 10mls) if liquid controlled drugs.

Small amounts of individual CD doses which have been prepared but not administered must be recorded in the controlled drugs record book stating the reason for the dose omission. The individual dose can be denatured and destroyed on the ward by a registered practitioner and witnessed by a second checker / signatory; Appendix 7 provides further information.

Larger volumes of CDs (e.g. parenteral doses; epidural bags or Patient-Controlled Analgesia syringes) which have been prepared but not or only part administered must be destroyed by a registered practitioner and witnessed by a second checker / signatory; Partial doses administered must be clearly documented in the patients clinical record; The volume not administered must be rendered irretrievable by emptying into an appropriately sized CD destruction kit, and must be recorded in the department, ward or unit controlled drugs record book.

Any stock that is damaged or broken on the ward (e.g. vials or ampoules) must be recorded in the department, ward or unit controlled drugs record book, including the running balance; the entry will be counter-signed by a second checker / signatory, and the incident reported on the Trust incident reporting system. The incident report reference number must be also reported alongside the entry in the CD record book.

The unfit stock must be clearly labelled and stored separately from the in-date controlled drugs ward stock / patient’s own CDs until returned to pharmacy or destroyed, following the procedures described above. Further advice may be sought from the ward pharmacist, pharmacy or medicines management team regarding any other required actions.

Destruction of Controlled Drugs (CDs) in the community setting:

In the community setting, controlled drugs will have been prescribed and dispensed for a specific patient and as such, must be treated as patient’s own controlled drugs - See Section 6.12 below:




6.12. Patient’s Own Controlled Drugs (CDs)

Patient’s own controlled drugs are defined as any controlled drug that has been prescribed and dispensed for a specific patient, and is therefore classed as and remains the personal property of that patient.

Patient’s Own Controlled Drugs in departments, wards or units:

Patients own CDs are the property of the patient and must therefore never be considered as ward stock and must not be administered to any other patient. On admission, or when any patient’s own controlled drugs are brought into the hospital / ward / unit, a Patient’s own controlled drugs consent form – the “Patient’s Own Controlled Drugs Consent Form ” (Appendix 6) must be completed, which will be signed by the patient or carer as a record of consent for destruction, if required. The completed form will be kept in the patient’s clinical record.

Unless a patient is self-administering their medication, any controlled drugs belonging to the patient must be stored within the controlled drugs cupboard, be clearly labelled and be in a clearly identifiable, separate area for patient’s own controlled drugs.

For patient’s own controlled drugs, each individual medicine, formulation, strength and quantity will be recorded in a separate ward patient’s own controlled drugs record book (if a specific patient’s own controlled drugs record book is not available, a controlled drugs record book may be used for this purpose).

To reduce medicines waste, a patient’s own controlled drug may be administered to that patient until a stock supply has been ordered and received by the ward or unit, providing the patient’s own CD is confirmed as the correct drug, be in date and within the original named dispensed container.

If a patient’s own CD is administered to that patient, an entry must be made by the registered practitioner in the patient’s own controlled drugs record book as soon as possible after administration. The entry will include recording the running balance, which will be checked and reconciled against the physical stock remaining and will be countersigned by a second checker / signatory.

Patient’s Own Controlled Drugs on discharge:

If the patient still requires their controlled drug/s, these will be returned to the patient or carer at the point of discharge. An entry will be made in the patient’s own controlled drugs record book by the registered practitioner returning the medication to the patient. This will be witnessed and countersigned by a second checker / signatory. The “Patients’ Own Controlled Drugs Consent Form” (Appendix 6) will also be completed and signed as indicated and be filed in the patient’s clinical record.

Patient’s Own Controlled Drugs no longer required: If a patient’s own controlled drugs are no longer required by the patient, these may be denatured and disposed of on the ward, providing that the patient has given their documented consent as described in Section 6.11 and Appendix 6, following the destruction and disposal process described in Section 6.11 and Appendix 7; this must include a pharmacist or pharmacy technician.




If patient consent cannot be obtained (e.g. due to lack of capacity, or is deceased) and the medication cannot be returned to the patient / next of kin / family for safe disposal to the patient’s community pharmacy / dispensing practice, the controlled drugs may be destroyed after 7 days (providing that the death is not unexpected/sudden or suspicious/Coroner’s case), with the agreement of the registered practitioner in charge, following the destruction and disposal process described above.

Destruction of Controlled Drugs (CDs) - patient’s own CDs in the Community Setting:

Patients own CDs are and remain the property of that person. Staff working in the community should not routinely remove unwanted or expired medicines, including CDs from a patient’s home or possession, either during their care or after the death of a patient. The patient, their representative or family member should be advised to return unwanted or expired medicines to the local community pharmacy or dispensing practice for safe disposal, unless directed otherwise by the Coroner, or it is deemed not appropriate to do so (e.g. where there may be a risk of misuse).

In exceptional circumstances, and for non-Coroner cases, where a risk assessment has been undertaken the medication will be denatured and the destruction witnessed by a competent witness (which may include a family member where it is appropriate to do so, and this will not cause additional distress). In such circumstances it is advisable to obtain written consent for the destruction of medication. All actions taken must be documented, and a signature obtained from the witness (where, if a family member, carer or other non-registrant will not cause additional distress).

When a proportion of a controlled drug (CD) remains on renewing a syringe driver or giving set, the residual CD must be denatured on the premises and be recorded in the patients’ clinical records.

6.13. Dealing with Discrepancies

If a discrepancy is found between the requisition for controlled drugs ordered and controlled drugs received, the supplying Trust Pharmacy should be contacted as soon as possible to investigate the discrepancy. If unresolved, the discrepancy must be reported in accordance with Trust Incident Reporting and Management Policy.

If a discrepancy is found between the stock balance in the controlled drugs record book and the physical stock held, the controlled drugs record book entries must be checked, by checking back through the entries and calculations for that drug and ensuring that there has not been a book-keeping or numerical error in the record book.

If a book-keeping or numerical error is identified and the discrepancy is resolved, the ward controlled drugs record book must be corrected as follows to resolve the discrepancy:

o Incorrect entries must NOT be crossed through or correction fluid used.

o Errors must be marked as ‘entered in error’ and be signed, timed and dated by the registered practitioner and second checker / signatory.

o The corrected entry will be made as a separate new line, which will also be timed, dated and signed by the registered practitioner and second checker / signatory.

If the source of the discrepancy cannot be identified the Divisional Senior Nurse, Line Manager or Duty Site Manager on call must be informed as soon as possible and the incident / discrepancy be reported in accordance with the Trust Incident Reporting and Management Policy, which will ensure that the Trust Chief Pharmacist (who is the Trust Accountable Officer for Controlled Drugs, CDAO) and Local Security Management Specialist are informed.







6.14. Information for Patients – drugs and driving – the law

In March 2015 the Government introduced a new drug driving law in England and Wales, covering the following prescription medicines:

amphetamine, eg dexamphetamine or selegiline clonazepam

diazepam

flunitrazepam

lorazepam

methadone

morphine or opiate and opioid-based drugs, eg codeine, tramadol or fentanyl

oxazepam

temazepam

Staff must be aware of the medicines listed on the previous page and must inform patients if any of the medicines listed above are commenced prior to discharge. Patients should be informed that it is illegal in England and Wales to drive with legal drugs in your body if it impairs their driving. Patients should be advised to speak to their doctor if they have been prescribed any of the above medicines and are concerned that their driving may be impaired.

Information, leaflets and advice can be obtained from the Gov.UK website (Drug driving law – Information for Healthcare Professionals). The North Devon pharmacy department may also be able to supply leaflets.

6.15. Information and advice to people taking or carers administering controlled drugs

Document and give information to the patient taking the controlled drug or their carer administering it, including:

What the controlled drug has been prescribed for;

How long the person is expected to use the medication;

When supplying more than one formulation (for example immediate-release and sustained-release formulations) of a controlled drug, discuss the differences between the formulations with the person, and their family members or carers if appropriate, and check that they understand what the different formulations are for and when to take them.

How the medication may affect the person’s ability to drive (see Section 6.14 above);

That it is to be used only by the person it is prescribed for;

For newly prescribed medication, how long it will take to work.

Inform people who are starting controlled drugs that, following discharge, they or their representative may need to show identification when they collect the controlled drugs;

When supplying controlled drugs, advise people how to safely dispose of unwanted or used controlled drugs.

https://www.gov.uk/drug-driving-law

https://www.gov.uk/government/collections/drug-driving#table-of-drugs-and-limits




6.16. Audit

The controlled drugs record books (ward stock and patient’s own) must be kept in the clinical area to which the record relates and be available for inspection at any time.

Particulars of stock, receipts and supplies made in relation to controlled drugs must be available and be provided on request by authorised persons.

Records relating to the procedures outlined within this Standard Operating Procedure (record books, order records, receipt records and invoices) must be kept for a minimum of two years from the date of the last entry or transaction.

Copies of the completed “Authorisation form for the ordering of controlled drugs for supply by another designated trust pharmacy under a supply service level agreement” must be collated and kept by the registered practitioner in charge of the department/ ward or unit, to be available for audit / inspection and as a reference of the specimen signatures.

The Pharmacy / Medicines Management Teams will complete a controlled drugs audit at least quarterly in locations where controlled drugs are stocked, with any required actions and feedback provided to the registered practitioner in charge of the department/ward or unit. The audit will include a stock check of controlled drugs against the controlled drugs record book.

7. References National Institute for Health and Care Excellence (NICE): Controlled drugs: safe

use and management; NICE guideline NG46. April 2016. Department of Health: Controlled Drugs (Supervision of management and use)

Regulations – Information about the Regulations. February 2013. NHS England: The Controlled Drugs (Supervision of Management and Use) Regulations

2013 Single Operating Model. November 2013. Nursing and Midwifery Council (NMC): Standards for medicines management 2010.

UKMI NICE Bites (87): A summary of prescribing recommendations from NICE guidance. Controlled drugs: safe use and management NG46. May 2016.

http://www.legislation.gov.uk/all?title=controlled%20drugs

http://www.cqc.org.uk/content/law-and-guidance-managing-controlled-drugs

NPSA Safer Practice Notice - NPSA/2006/12 Ensuring safer practice with high dose ampoules of diamorphine and morphine.

NPSA Rapid Response Report - NPSA/2008/RRR05 Reducing dosing errors with opioid medicines

NPSA Rapid Response Report - NPSA/2008/RRR011 Reducing risk of overdose with midazolam injection in adults

NHSE Patient Safety Alert - NHS/PSA/Re/2015/009 Support to minimise the risk of distress and death from inappropriate doses of naloxone

British National Formulary, BNF, current edition accessible online. Royal Pharmaceutical Society of Great Britain: Guidance for Pharmacists on the safe

destruction of Controlled Drugs England, Scotland and Wales. September 2007.

Royal Pharmaceutical Society of Great Britain: Medicines, Ethics and Practice – The professional guide for pharmacists. Edition 40. July 2016.

NEW Devon: Caring for Care Homes Guidance Sheet 2: Controlled Drugs (CDs). Version 4 2017. Accessed online 07/01/2019.

Audit South West: Northern Devon Healthcare Trust. Internal audit report: Controlled Drugs. Report reference: NDHCT29/14 Published July 2014.

https://www.nice.org.uk/guidance/ng46

https://www.nice.org.uk/guidance/ng46

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf

https://www.england.nhs.uk/wp-content/uploads/2013/11/som-cont-drugs.pdf

https://www.england.nhs.uk/wp-content/uploads/2013/11/som-cont-drugs.pdf

https://www.nmc.org.uk/standards/additional-standards/standards-for-medicines-management/

http://www.medicinesresources.nhs.uk/upload/documents/Health%20In%20Focus/NICEBites%20May%202016%20No%2087%20CDs.pdf

http://www.medicinesresources.nhs.uk/upload/documents/Health%20In%20Focus/NICEBites%20May%202016%20No%2087%20CDs.pdf

http://www.legislation.gov.uk/all?title=controlled%20drugs

http://www.cqc.org.uk/content/law-and-guidance-managing-controlled-drugs

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59803




http://www.nrls.npsa.nhs.uk/resources/?entryid45=59896&q=0%C2%ACmidazolam%C2%AC

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59896&q=0%C2%ACmidazolam%C2%AC

https://www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2015/10/psa-naloxone-stage2.pdf

https://www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2015/10/psa-naloxone-stage2.pdf

https://www.evidence.nhs.uk/formulary/bnf/current/guidance-on-prescribing/controlled-drugs-and-drug-dependence

http://filesdown.esecure.co.uk/NorthLancsPCT/Guidance_20for_20Pharmacists_20on_20the_20safe_20destruction_20of_20Controlled_20Drugs_20Appendix_204.pdf_09032009-1615-16.pdf

http://filesdown.esecure.co.uk/NorthLancsPCT/Guidance_20for_20Pharmacists_20on_20the_20safe_20destruction_20of_20Controlled_20Drugs_20Appendix_204.pdf_09032009-1615-16.pdf

https://www.newdevonccg.nhs.uk/caring-for-care-homes-guidance-sheets/guidance-sheets-00-to-10-102226




8. Associated Documentation

8.1. Northern Devon Healthcare NHS Trust Policies:

Trust Medicines Policy Controlled Drugs Policy Injectable Medicines Policy End of Life Policy for Adults and Paediatrics Administration Subcutaneous Medication via the T34 Syringe Pump

Policy and associated SOP Medicines Policy for Skilled Not Registered Staff Student Nurse and Student Midwife 3rd Year Final Placement Clinical

Skills Policy Clinical Record Keeping Policy Ward Level Pharmacist Prescribing Policy Waste Management Policy and Waste Management Manual Secure Environment Policy Incident Reporting and Management Policy

8.2. Northern Devon Healthcare NHS Trust Standard Operating Procedures:

Omitted and Delayed Medicines Standard Operating Procedure Self-administration of medicines in adults Standard Operating Procedure Just in Case Bags/Boxes for use in End of Life Care Standard Operating

Procedure Recording and Checking Patient Allergy to Medication Status Standard

Operating Procedure Preparing Injectable Medicines Standard Operating Procedure Administering Injectable Medicines Standard Operating Procedure Drugs of Diversion (Ordering, Receipt and Stock Management in

Community Hospitals, Minor Injury Units and Walk-In Centres) Standard Operating Procedure

8.3. Northern Devon Healthcare NHS Trust - Other Guidance:

April 2016: Internal Trust Patient Safety Alert number 31: Checking and Administering Controlled Drugs.

My Transdermal Patch Application Record – current version (copies also available from Pharmacy Team)




http://ndht.ndevon.swest.nhs.uk/end-of-life-care-adults-policy/

http://ndht.ndevon.swest.nhs.uk/end-of-life-care-contact-details/t34-syringe-pump-information/

http://ndht.ndevon.swest.nhs.uk/end-of-life-care-contact-details/t34-syringe-pump-information/


http://ndht.ndevon.swest.nhs.uk/student-nurse-and-student-midwife-3rd-year-final-placement-clinical-skills-policy/

http://ndht.ndevon.swest.nhs.uk/student-nurse-and-student-midwife-3rd-year-final-placement-clinical-skills-policy/

http://ndht.ndevon.swest.nhs.uk/clinical-record-keeping-policy/

http://ndht.ndevon.swest.nhs.uk/ward-level-pharmacist-prescribing-policy/

http://ndht.ndevon.swest.nhs.uk/waste-policy/

http://ndht.ndevon.swest.nhs.uk/secure-environment-policy/




http://ndht.ndevon.swest.nhs.uk/just-in-case-bagsboxes-for-use-in-end-of-life-care-standard-operating-procedure/

http://ndht.ndevon.swest.nhs.uk/just-in-case-bagsboxes-for-use-in-end-of-life-care-standard-operating-procedure/

http://ndht.ndevon.swest.nhs.uk/recording-checking-patient-allergy-to-medication-status-sop/

http://ndht.ndevon.swest.nhs.uk/recording-checking-patient-allergy-to-medication-status-sop/

http://ndht.ndevon.swest.nhs.uk/preparing-injectable-medicines-standard-operating-procedure-sop/

http://ndht.ndevon.swest.nhs.uk/administering-injectable-medicines-standard-operating-procedure-sop/

http://ndht.ndevon.swest.nhs.uk/drugs-of-diversion-ordering-receipt-and-stock-management-in-community-hospitals-minor-injury-units-and-walk-in-centres-sop/



http://ndht.ndevon.swest.nhs.uk/wp/wp-content/uploads/2012/10/Patient-safety-alert-31-CD-check-process-NR-MK-JD.pdf

http://ndht.ndevon.swest.nhs.uk/wp/wp-content/uploads/2011/10/FINAL-Transdermal-Patch-Application-Record-v2.0.pdf




Appendix 1: List of commonly prescribed Schedule 2 and Schedule 3 Controlled Drugs

Below is a list of the most commonly prescribing controlled drugs and Schedules. This list is not comprehensive but includes those most commonly prescribed:

* Oral morphine solution 10mg in 5mls is classified as a Schedule 5 controlled drug and is therefore not included in the above list but is subject to the requirements of this Standard Operating Procedure.

Schedule 2 controlled drugs: Schedule 3 controlled drugs:

Alfentanyl , fentanyl, remifentanyl Barbiturates

Cocaine Buprenorphine

Diamorphine Hydrochloride Diethylpropion

Dipipanone Hydrochloride (Diconal®) Flunitrazepam

Hydromorphone Hydrochloride (Palladone®) Midazolam

Ketamine Pentazocine

Lisdexamfetamine Temazepam

Methadone Tramadol

Methylphenidate Gabapentin (from March 2019)

Morphine Sulphate* Pregabalin (from March 2019)

Oxycodone

Papaveretum

Pethidine

Tapentadol




Appendix 2: Contacts for advice when changing opioid, route of administration, or when setting up a syringe driver

Northern Devon

North Devon Hospice 24hr advice line 01271 347214

Specialist Palliative Care Team NDDH 01271 311642

Pharmacy Medicines Information, North Devon District Hospital

01271 322393 (internal ext 2393), bleep number 117 or Email: [email protected]

Switchboard, North Devon District Hospital 01271 322577

Exeter Mid and East Devon

Hospiscare 24hr advice line 01392 688044

Pharmacy Medicines Information, Royal Devon and Exeter Hospital

01392 402450

Switchboard, Royal Devon and Exeter Hospital 01392 411611

Out of Hours (all areas)

Devon Doctors On Call 01392 824600 (0845 6710 270)

Or Pharmacy via On-Call Acute Trust Switchboards / On-Call Clinician (see numbers above)

mailto:[email protected]




Appendix 3: Prescribing requirements for Schedule 2 and Schedule 3 controlled drugs

Prescription requirements Prescriptions for Controlled Drugs that are subject to prescription requirements (all preparations in Schedules 2 and 3) must be indelible and must be signed by the prescriber, be dated, and specify the prescriber’s address. A machine-written prescription is acceptable, but the prescriber’s signature must be handwritten. Advanced electronic signatures can be accepted for Schedule 2 and 3 Controlled Drugs where the Electronic Prescribing Service (EPS) is used. All prescriptions for Controlled Drugs that are subject to the prescription requirements must always state:

the name and address of the patient;

in the case of a preparation, the form, (the dosage form e.g. tablets must be included on a

Controlled Drugs prescription irrespective of whether it is implicit in the proprietary name e.g.

MST Continus or whether only one form is available), and where appropriate the strength of

the preparation (when more than one strength of a preparation exists the strength required

must be specified);

for liquids, the total volume in millilitres (in both words and figures) of the preparation to be

supplied; for dosage units, the number (in both words and figures) of dosage units to be

supplied; in any other case, the total quantity (in both words and figures) of the Controlled

Drug to be supplied;

the dose (the instruction ‘one as directed’ constitutes a dose but ‘as directed’ does not);

the words ‘for dental treatment only’ if issued by a dentist.

A pharmacist is not allowed to dispense a Controlled Drug unless all the information required by law

is given on the prescription. In the case of a prescription for a Controlled Drug in Schedule 2 or 3, a

pharmacist can amend the prescription if it specifies the total quantity only in words or in figures or if it

contains minor typographical errors, provided that such amendments are indelible and clearly

attributable to the pharmacist. Failure to comply with the regulations concerning the writing of

prescriptions will result in inconvenience to patients and carers and delay in supplying the necessary

medicine. A prescription for a Controlled Drug in Schedules 2, 3, or 4 is valid for 28 days from the

date stated thereon (the prescriber may forward-date the prescription; the start date may also be

specified in the body of the prescription).

(Ref: British National Formulary : Controlled Drugs and drug dependence guidance in the front section of the latest version)

https://www.medicinescomplete.com/mc/bnf/current/PHP97239-controlled-drugs-and-drug-dependence.htm?q=controlled%20drugs&t=search&ss=text&tot=197&p=1#_hit




Appendix 4: GUIDANCE SUMMARY: Signing by a Medical Practitioner of Controlled Drug orders for ward / unit stock in community hospitals / units supplied under a Service level Agreement with another organisation.

Changes to the primary legislation and the Misuse of Drug Regulations 2001 were introduced by the Government to strengthen the governance arrangements for controlled drugs (CDs). This includes changes relating to the prescribing, record keeping and destruction of controlled drugs. The Health Act 2006 enabled Regulations to be laid relating to governance and monitoring of CDs. This came into effect in England on 1st January 2007.

These governance arrangements emphasise the roles and responsibilities of health care professionals involved in the management of controlled drugs. The Law in respect to the purchasing and supply of controlled drugs has not changed but the new legislation has made it clearer that there has been a lack of compliance with aspects of the law relating to ordering of CDs from acute trust pharmacies by community hospitals.

The law states:

‘Schedule 2 controlled drugs may be possessed by the person or acting person in charge of a hospital or nursing home which is wholly or mainly maintained by a public authority out of public funds or by a charity or by voluntary subscriptions. In other such circumstances a licence is required. Such requisitions must be countersigned by a doctor or dentist who work there.

This statement is further clarified by:

‘Where a hospice, community hospital or private hospital does not employ a pharmacist, the person or acting person in charge may obtain CDs via a requisition signed by a doctor (or dentist) employed or engaged there. This requisition may be presented to a wholesaler, community pharmacy or the pharmacy department of a NHS Trust with whom a service level agreement (SLA) is in place. Establishments with employed pharmacists can obtain CD stock via a requisition, which complies with the Regulations described earlier.

To ensure that we operate within the Law, the Controlled Drug Policy and Standard Operating Procedures developed by the Trust will reflect this requirement for all Schedule 2 and 3 controlled drugs.

Co-operation of all medical practitioners who provide medical cover to the community hospitals / units is therefore required in signing the Controlled Drug Order Book when requested by a member of the department/ward or unit staff. Without this signature the supplying Trust Pharmacy will not be able to supply the controlled drugs and ultimately patient care may suffer as a result of this action.

In order to facilitate this process a sample witnessed signature will need to be obtained from the medical prescriber using the approved proforma (Appendix 5) which must be returned to the supplying Trust Pharmacy for verification of signed orders.

The medical prescriber’s signature against the order for a specific CD preparation confirms that the registered practitioner ordering the controlled drug is employed on that ward /unit and that the controlled drug ordered was required for ward stock. The Trust will not hold medical prescribers responsible for any other aspect of CD stock management on the ward/unit.

* A list of Schedule 2 and 3 Controlled Drugs that must ordered with a medical prescriber’s counter signature is included as Appendix 1. Although not classed as a Schedule 2 or Schedule 3 controlled drug, morphine sulphate oral solution 10mg/5mls is subject to the requirements outlined above (and other requirements of this SOP). This has been agreed locally with the supplying Trust Pharmacy.

NB: Each ward / unit has an agreed controlled drug stock list, which must be kept up to date to reflect prescribing patterns / requirements of that ward or unit. The list includes a suggested stock level which the prescriber may find useful to reference when requested to counter sign a CD order.




Appendix 5: Approval of signatories / counter signatories for controlled drugs ordering:

AUTHORISATION FORM FOR THE ORDERING OF CONTROLLED DRUGS FOR SUPPLY BY ANOTHER DESIGNATED TRUST PHARMACY UNDER A SUPPLY SERVICE LEVEL AGREEMENT (SLA)

Due to the legal requirements for the supply of controlled drugs (CDs) by another Trust, ALL personnel involved in the requisitioning of CDs must have the prior approval of the supplying Trust Pharmacy by providing a sample signature using the form below.

Whilst a registered practitioner may initiate a requisition for a CD order and are responsible for the safe keeping and management of CDs, a supply can only be made when the order is countersigned by an authorised doctor, dentist or pharmacist working in that department/ward or unit.

To be completed annually by wards/departments/units supplied by the designated Trust Hospital Pharmacy

Name (block capitals)..............................................................................................................

Profession.............................................................. Registration no: ......................................

Employing Organisation: ..........................................................................................................

Ward(s) or Department(s) where ordering /signing for CDs:.....................................................

...................................................................................................................................................

Contact details: Tel no: .............................................Fax no: ..................................................

Email.........................................................................................................................................

I certify that I am currently authorised to order or counter sign controlled drugs for the above department(s), ward(s) or unit(s). I understand that I must inform the designated Acute Trust Hospital pharmacy immediately should this no longer be the case.

Specimen Signature (which must be distinct and attributable to you):

Date

Please note that orders will not be processed without a completed and in-date Authorisation Form.

All forms must be witnessed by: Clinical Matron, Pharmacist or Unit Manager:

Witness Name (Block letters)

Profession Registration Number

Signature Date

For Pharmacy Use only

Registration Verified By Date

A copy of this form is to be retained by the ward / department / unit by the matron

and the original submitted to the Acute Trust pharmacy.




Appendix 6: Patient’s Own Controlled Drugs Consent Form

Receipt and Consent form for Patient’s Own Controlled Drugs and Drugs of Diversion Patient Name: Patient NHS No. or Unique Identifying Number:

Date of Birth:

GP:

Ward:

Hospital / Unit:

Patient’s own medication (POD) can only be administered to the patient or self-administered if it is received in its original dispensed container.

All PODs for CDs and Drugs of Diversion (DODs) must be entered in POD CD/DOD book.

Patient consent is required for any controlled drugs (CDs) and (DODs) which need to be destroyed in the event that they are no longer required are no longer suitable for treatment or are deemed unsuitable for use.

I, the above named patient, freely give consent for the medications listed below to be destroyed in the event that they are no longer required or suitable for my treatment or are deemed unsuitable for use.

Patient signature:

Date:

Print name:

Recorded by Name/Role: Signature: Date/Time

Witnessed by

Name of Controlled Drug (CDs) / Drugs of Diversion (DoDs) Dose Form Directions

Quantity on admission

Quantity at the end of

stay

Tick if TTO*

(TO TAKE OUT) Discharge Medication

(Continue on another sheet if required)

Stored location:

The medicines listed above have been supplied/returned to patient* / destroyed* (*delete as appropriate)

Patient signature: Date:

Print name:

Supplied*/ Returned*/ destroyed* by

Name/Role: Signature: Date/Time

Witnessed by




Appendix 7: Methods of Denaturing Controlled Drugs

Adapted from guidance issued by the Royal Pharmaceutical Society of Great Britain

Solid dose formulations

Tablets and capsules can be removed from their outer packaging, removed from blister packaging and placed in a CD destruction kit. If a person is removing tablets / capsules from blister packs they should wear gloves.

Liquid dose formulations

A CD liquid can be poured from its container and added to an appropriately sized CD destruction kit where it will mix with the other waste materials, thus rendering it irretrievable.

Empty bottles must be rinsed with a small amount of water and the resultant liquid poured into the CD destruction kit. The empty bottle must then be placed in the pharmaceutical waste bin to ensure safe disposal.

Parenteral formulations

Liquid ampoules should be opened and as much of the content as possible emptied into the CD destruction kit. The ampoule should be disposed of in the sharps bin, along with any syringes and needles used in the drawing up process, according to the Trust Waste Management Policy and Waste Management Manual.

Ampoules containing the CD in a powder form can be opened, water added to dissolve the powder. The resultant liquid/mixture must be made irretrievable (be denatured) so that it cannot be used. This can be done by emptying the liquid/mixture into a CD destruction kit. If it is not possible or practical to use a CD destruction kit, small volumes of liquid/mixture (less than 10mls) may be disposed of by placing absorbent material in the appropriate disposal bin before adding the liquid/mixture, thus rendering it irretrievable. The ampoule can then be disposed of in the sharps bin, along with any syringes and needles used in the drawing up process. The sharps bin must be labelled according to the Trust Waste Management Policy and Waste Management Manual.

These are the ideal methods of denaturing ampoules. Suitable gloves should be worn by the person breaking open glass ampoules as a safety measure and to minimise the risk of injury from sharps.

Patches (fentanyl and buprenorphine)

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 the CD destruction kit. Gloves must be worn by the person destroying the CD to avoid exposure to the active ingredient.

Aerosol formulations

Aerosol formulations should be expelled into water (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 above guidance on destruction of liquid formulations.

Controlled Drug Destruction kits

A 250ml Controlled Drug Destruction kit (sometimes referred to as a “DOOP” kit - Destruction of Old Pharmaceuticals) will usually be sufficient for most routine CD destruction, unless large quantities of CDs are to be destroyed, in which case a larger volume kit (e.g. a 1000ml controlled drug destruction kit) will be required.

CD destruction kits can be ordered via the Trust ordering system.

NB: Instructions of controlled drugs destruction kits may vary – contact the Pharmacy / Medicines Management Team for advice if you are unsure or unclear about how to follow the instructions in relation to the denaturing and destruction of controlled drugs.

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