management of controlled drugs part 1 p1-6 070117 · 2017-01-09 · this circular draws attention...

Class A (drugs in this class are considered the most harmful)Examples include morphine, diamorphine, cocaine, pethidine, fentanyl and methadone.

Class B This class includes codeine, cannabis, dihydrocodeine, barbiturates and ketamine.

Class C This class includes buprenorphine, tramadol hydrochloride and most benzodiazepines, such as temazepam, midazolam and diazepam.

Standard 26, and specific legislation in Annexe 1. The Code, published in 2015, has a new section on medicines, part of which refers specifically to controlled drugs (section 18.2).

Various other resources, as well as national networks, are also invaluable. For example, the British National Formulary (BNF) has a useful chapter on “Controlled drugs and drug dependence” which includes an overview of the regulations and classifications of controlled drugs (BNF, 2016); see also the British National Formulary for Children (BNFC, 2016). The website of the Care Quality Commission (CQC) also includes sections on responsibilities in relation to controlled drugs, including the role of Accountable Officers (see page 2 below). Accountable Officers form part of the membership of the Controlled Drug National Group, which is led by the CQC (CQC, 2016a). Medication Safety Officers in large organisations such as NHS trusts, will also belong to the National Medication Safety Network and support local medication error reporting (NHS England/MHRA, 2014). The aim is to keep patients safe and assist in learning from medication errors, many of which involve high-risk medicines such as controlled drugs. The National Institute for Health and Care Excellence (NICE, 2016) has reinforced the need for standard operating procedures (SOPs) governing the safe storage, management and destruction of controlled drugs, as well as the requirements for documentation and subsequent archiving.

See also other clinicalskills.net procedures in the Administration of Medicines category, including, “Administration of medicines: key principles” and “Legal, professional and ethical aspects of medicines administration”.

Controlled drugs are medicines, available in a variety of formulations, that are subject to specific legislation to monitor their safe storage, management and administration. These drugs are generally powerful analgesics or sedatives that may be addictive or sold and used for recreational purposes. They include those commonly used in health care, such as the analgesics diamorphine, morphine, fentanyl and codeine, and the benzodiazepines such as diazepam and temazepam. Healthcare organisations and staff, such as nurses and pharmacists, must ensure that procedures are in place and followed to meet the legislative requirements for the safe storage and use of these drugs. This procedure forms Part 1 of a two-part series on “Management of controlled drugs”. It outlines the legislation governing the safe management and handling of controlled drugs in practice and discusses the different categories of controlled drugs and their safe and appropriate use in the hospital environment. Part 1 should be read in conjunction with Part 2, which covers prescription and administration of controlled drugs, including self-administration of controlled drugs. Although the term “medicines” rather than “drugs” is commonly used, this procedure refers to “controlled drugs”, in line with the terminology used in relevant legislation.

Nursing staff working in an area where controlled drugs are stored have a professional responsibility to be aware of and understand the local policies and procedures associated with controlled drugs, and to ensure that these are adhered to. Nurses also need to be aware of Standards for Medicines Management, published by the Nursing and Midwifery Council (NMC, 2010), and the NMC Code (NMC, 2015). The standards cover controlled drugs in

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Medicines Act 1968 CHAPTER 67

ARRANGEMENT OF SECTIONSPART I ADMINISTRATION

PART IILICENCES AND CERTIFICATES RELATING TO

MEDICINAL PRODUCTSGeneral provisions and exemptions

Section 1. Ministers responsible for administration of Act.

2. Establishment of Medicines Commission.

3. General functions of Commission.

4. Establishment of committees.

5. Suplementary provisions as to Commission and com-

mittees.

Misuse of Drugs Act 1971

CHAPTER 38

ARRANGEMENT OF SECTIONS

The Advisory Council on the Misuse of Drugs

Section 1. The Advisory Council on the Misuse of Drugs

Controlled drugs and their classification

2. Controlled drugs and their classification for purposes of

this Act.

Restrictions relating to controlled drugs etc.

3. Restriction of importation and exportation of controlled

drugs.

4. Restriction of posession and supply of controlled drugs.

5. Restriction of posession of controlled drugs.

6. Restriction of cultivation of cannabis plant.

7. Authorisation of activities otherwise unlawful under fore-

going provisions.

Miscellaneous offences of controlled drugs etc.

8. Occupiers etc. of premises to be punishable for permitting

certain activities to take place there.

9. Prohibition of certain activities etc. relating to opium.

Powers of Secretary of State for preventing

of controlled drugs etc.

10. Power to make regulations for preventing misuse of

controlled drugs

Administration of MedicinesAdults

Management of controlled drugsPart 1: Legal aspects and safe handling

Demonstrated by Richard Hatchett, Education Consultant, Clinical Skills Ltd; formerly Head of Education and Standards, Nursing and Midwifery Council, and formerly Deputy Head of School, The Royal Marsden School

©2017 Clinical Skills Limited. All rights reserved

Do not undertake or attempt any procedure unless you are, or have supervision from, a properly trained, experienced and competent person.Always first explain the procedure to the patient and obtain his/her consent, in line with the policies of your employer or educational institution.

Controlled drugs are regulated in the United Kingdom (UK) under the Misuse of Drugs Act 1971 and subsequent published amendments. They appear in schedule 2 of the act, which is readily available online. The Medicines Act 1968 is also relevant: it outlines the legal sale, supply and administration of medicines.

The Misuse of Drugs Act classifies controlled drugs into three classes: A, B and C (see above). The classification relates to the potential harm of the drug when misused and to the sentencing that may be imposed for breach of the Act. In addition, the Act provides restrictions on the manufacture, sale, import and export of controlled drugs.

Misuse of Drugs Act 1971 Categories of controlled drugs

Schedule 1: These drugs have no recognised medicinal use. Available to people licensed by the Home Office to possess for research purposes. Includes cannabis, lysergide acid diethylamide (LSD) and cocoa leaf.Schedule 2: These drugs are subject to safe-custody requirements. Includes diamorphine, morphine, cocaine, methadone, fentanyl and pethidine.Schedule 3: Some of these drugs are exempt from safe-custody requirements. Includes buprenorphine and temazepam.Schedule 4: Subject to less-stringent controls. Includes benzodiazepines and anabolic steroids.Schedule 5: Subject to minimal controls due to their low strength. Includes co-codamol and co-dydramol.

The 2006 regulations, along with the Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007, introduced the need for an Accountable Officer to oversee the safe use, management and destruction of controlled drugs, as well as changes to record keeping. In addition, NHS England and the Medicines and Healthcare Products Regulatory Agency recommend that all large healthcare providers have an identified Medication Safety Officer, often a pharmacist (NHS England/MHRA, 2014).

CONTROLLED DRUGS

Every TuesdayWhen checking the cd levels on a night shift every Tuesday can youmeasure all the liquid cds using the measuring conmtainers provided.

Important information for all medicine wardsTramadol (in all forms injection/oral) is to be legally classified as a controlled drug (schedule 3CDno reg., please see the attached memo for details).

As of Tuesday 10th June the following changes apply:

• Tramadol for use in wards/departments MUST be ordered in a CD requisition book.

• Prescriptions (discharge and out-patient) for Tramadol will require an accompanying requisition hand-signed by the prescriber.

Please noite that it is however, exempt from CD ‘safe custody regulations’:

• There is no requirement for Tramadol to be recorded in the CD register or a running balance maintained.

• Locally it has been decided that Tramadol should be treated as oramorph and therefore both the injection and capsules should be kept in a locked CD cupboard on medicine wards.

GlugaGen hypo kit 1mgR

Glucagon hydrochloride 1 mg

Powder and solvent for solution for injection

SC, IM use

This pack contains: A vial

contaiuning

Glucagon hydrochloride (rDNA) 1

mg(1/IU), lactose, hydrochloric acid

and/or sodium hydroxide.

A syringe containing 1ml water for

injections.

Keep out of reach and sight of

children

Store at 2 to 8°C (in a refigerator). Do not freeze

Sore in the original package

Reconstitute with solvent before use

Use immediately after reconstitution

Do not store for later use

Read the package leaflet before use

To be used as directed by the

physician

POM PL 4668/0027 (Glugagen 1mg)

8-9402-01-207-3

EXP/Batch:

01/2017AW60397

EMERGENCY HYPOGLYCAEMIC KIT

Administration of Medicines

Adults

Management of controlled drugs Part 1: Legal aspects and safe handling

Page 2 of 6


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Home Office See more information about this Correspondence

GOV.UK

Correspondence

Circular 019/2015: Misuse of Drugs(Amendment No. 2) (England, Wales andScotland) Regulations 2015 (S.I.2015/891)Published 20 May 2015

ContentsSummaryLegislative backgroundPolicy contextSpecific AmendmentsEnquiries

SummaryThis circular draws attention to the contents of the above StatutoryInstrument (SI), S.1.2015/891which cimes into force at 00:01 on 1 June 2015, save for the delayedprovisions set out in paragraphs 21 & 22, 24 & 25 and 28 & 29

The Misuse of Drugs (Amendment No. 2) (England, Wales and Scotland) Regulations2015 amends the Misuse of Drugs Regulations 2001 (as amended) ( the 2001Regulations) (S.I. 2001/3998) as follows:

Search

The Daily PeopleShipman killed 215 patients Former GP Harold Shipman killed at least 215 of his patients, an official report has concluded. The finding confirms 56-year-old Shipman as Britain's worst serial killer.

Shipman was convicted in January 2000 of killing 15 of his patients with lethal heroin injections and was sentenced to life imprisonment for each of the murders. He betrayed their trust in a way and to an extent I believe is unparalleled in history

Dame Janet SmithBut an inquiry into the case, by High Court judge Dame Janet Smith, has found that a further 200 deaths were "highly suspicious" while there was a "real suspicion" he could have claimed a further 45 victims.

She said: "He betrayed their trust in a way and to an extent I believe is unparalleled in history."

In Hyde, where many of the victims lived, church bells were rung 215 times on Friday morning in memory of those murdered.

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Edgar Horne WdOXYCODONInjection10 mg/ml

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® 200 microgram

Sublingual tabletsBuprenorphine (as hydrochloride) PO

M

This sterile solution contains:

Morphine sulphate 1mg/ml SodiumChloride and Water for injection

THIS MEDICINE CAN MAKEYOU FEEL SLEEPYDo not drive while taking thismedicine until you know how itmakes you feel. See the leafletinsidfe for more information.

SINGLE USE ONLYThs product should be usedimmediately the rubber bung is first punctured. It should only beused for one patient or procedure.Discard any remaining solution

Store below 25°C. Keep container intheouter carton. Use as directed bythe physician. Keep out of sightand reach of children.

Aurum Pharmaceuticals LtdRomford Essex

1mg/ml 50mlMorphine sulphate








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Effentora 100 microgram

sbuccal tablets

Fentanyl

Edgar Horne Wd FENTANYL CITRATE (EFFEBuccal Tablets100 micrograms

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KEEP ALL MEDICINES OUT OF THE REACH OF


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Alfentanil500 m

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lsolution for injection

1mg in 2m

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Alfentanil500 m

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Edgar Horne WdOXYCODONInjection50 mg in 1/ml

Store in

Stock1 x 5

KEEP ALL MEDICINES

Edgar Horne WdALFENTANIL # 102mlInjection

Store in a controlled

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KEEP ALL MEDICINES

Edgar Horne WdOXYCODONE (IMRELEASE) #Capsules10 mg

Temporary stock1 x 56

KEEP ALL MEDICINES

56 Imm




5mg



KEEP ALL MEDICINES

Misuse of Drugs Regulations 2001 Effect of the Shipman Inquiry

Accountable officers 2015 amendments to the Misuse of Drugs Act

Familiarise yourself with policies and procedures Familiarise yourself with controlled drugs used locally

The Misuse of Drugs Regulations 2001 divide controlled drugs into five schedules, striking a balance between the medicinal or therapeutic benefit of the drug and the harm when misused. For each level, the schedules dictate requirements such as ordering, storage, completing prescriptions and record keeping. The controls are higher for Schedule 1 controlled drugs than for schedule 5. Controlled drugs in Schedule 2 are those most commonly seen in clinical practice, and must be stored in a locked cupboard. The only requirement for Schedule 5 drugs is to retain invoices for two years.

The Government brought in new legislation following the case of Harold Shipman, the British general practitioner who had used controlled drugs to kill his patients. In response to the Shipman Inquiry Fourth Report (2004), which recommended strengthening the governance arrangements for controlled drugs, the Government introduced the Controlled Drugs (Supervision of Management and Use) Regulations 2006 (revised in 2013). The 2013 regulations apply in England and Scotland only. Wales and Northern Ireland have their own equivalent, but separate, regulations.

In July 2015, further amendments to the Misuse of Drugs Act came into force to reflect current policy and changes in the way controlled drugs are now managed in practice. The changes included: the introduction of electronic prescribing for schedule 2 and 3 drugs; mandatory use of specific forms in the community for requisitioning schedule 2 and 3 drugs; the requirement for midwifery supply orders to be patient-specific; and rescheduling ketamine as a class B and schedule 2 drug, due to increasing concern over its misuse.

It is your responsibility, if dealing with controlled drugs, to make sure you are familiar with the policies and procedures of the clinical area and organisation. These policies will align with the legislative requirements described above and you must follow them at all times. Local incidents such as thefts can contribute to stricter policies and procedures for some controlled drugs than the legislation requires, for example in relation to the storage of morphine oral solution, codeine or some benzodiazepines.

Controlled drugs come in a variety of formulations. Continue to become familiar with those used within your clinical area, including usual dose, strength, side-effects and how they are safely prepared. Resources such as the BNF (in hard copy or online), and local prescribing guidelines, offer invaluable advice on the use of controlled drugs.

Victoria and Beckham University Hospitals NHSNHS Trust

Su LiAccountable Officer

Expiry Date: 22/ 7/20

ID Number: 264149467

0 1 7 3 9 2 4

Always follow local procedures for ordering and receiving controlled drugs. Each area must have only one order book in use at any one time. Schedule 2 and 3 drugs require a specific order book with duplicate pages which must be kept for two years. All relevant stationery must be stored securely in a locked cupboard to reduce the risk of theft and fraudulent misuse. Only those drugs listed in the departmental stock list may be routinely requisitioned, reflecting the patterns of usage in the department (NMC, 2010; Standard 26.14).


Adults


Page 3 of 6


Controlled drugs: authorised signatory list

Date

Clinical area:............................

Name Role SignatureCharge nurse

Staff nurseStaff nurse

Staff nurse

Senior staff nurse

Consultant nurse

Staff nurse

MONIQUE SATAY

ANGELA RUDGE

CHRISTINE DRISCOLL

DEBBIE CASS

LEIGH NUTTALL

AMIR AHMEDGINA BOSCO

16/3/16

Ward 3b

16/3/16

16/3/16

16/3/16

16/3/16

27/5/16

14/7/16

Victoria and Beckham University Hospitals

NHS Trust

NHS

CONTROLLED DRUGS









GlugaGen hypo kit 1mg


Powder and solvent for solution for

injection


contaiuning

Glucagon hydrochloride (rDNA)

1 mg(1/IU), lactose, hydrochloric

acidand/or sodium hydroxide.

A syringe containing 1ml water

forinjections.

Keep out of reach and sight Do not freeze


Reconstitute with solvent before

useUse immediately after

reconstitution


Read the package leaflet before

useTo be used as directed by the

8-9402-01-207-3

EXP/Batch:

01/2017AW60397


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8-9402-01-207-3

EXP/Batch:

01/2017AW60397


ISSUED TO:

DATE ISSUED:

BOOK NO:

pharmarcyPlease order CDs by 12 noonMon-Fri to meety delivery

in CD trolleyAll CD orders must now be signed byTwo registered nurses or midwiveswhose name and signature isrecorded in the register kept withpharmacy

Please keep this controlledorder book on the ward for 2years from the date of the lastentry. It can then be disposedof in accordance with Trustwaste policy i.e. madeirretrievable by shredding

PLEASE PRINT NAME IN BLOCKCAPITALS AS WELL AS SIGNINGWHEN ORDERING CD’S

3b

21/08/16

A995

3b wardCD WARD ORDER BOOKA995

Store in a locked medicine cupboardBook should be retained on the ward for 2 yearsBook Number

Stock 21-Aug-20161 x 1KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

90-500

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WebTracker CD Book Label

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ISSUED TO:

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3b

21/08/16

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90-500

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CONTROLLED DRUGS











Powder and solvent for solution for

injection


contaiuning

Glucagon hydrochloride (rDNA)

1 mg(1/IU), lactose, hydrochloric

acidand/or sodium hydroxide.

A syringe containing 1ml water

forinjections.

Keep out of reach and sight Do not freeze


Reconstitute with solvent before

useUse immediately after

reconstitution


Read the package leaflet before

useTo be used as directed by the

8-9402-01-207-3

EXP/Batch:

01/2017AW60397


BECKHAM AND VICTORIA HOSPITAL

TRANSFUSION

NURSE SPECIALIST

MONIQUE CHITUKU

0 1 7 3 9 2 4

The role of the nurse in charge Controlled-drugs cupboard

Ordering controlled drugs: specific order book Ordering controlled drugs: authorised signatories

Receiving controlled drugs Checking the delivery against the order

The nurse in charge of the area where controlled drugs are stored has overall responsibility for their safe storage and use, as well as for ordering the controlled drugs for that area. The controlled-drugs keys need to be held separately from other keys. Other registered nurses or operating department practitioners can hold the keys, and order controlled drugs if delegated to do so, but the legal responsibility belongs to the nurse in charge. See Section 11 in the NMC Code with regard to appropriate delegation (NMC, 2015).

Controlled drugs must be kept in a locked and securely attached cupboard that is used only for storing controlled drugs and associated paperwork (to avoid the potential for tampering with records). The cupboard must meet the specifications of the Misuse of Drugs (Safe Custody) Regulations 1975 and conform with BS2881 (BSI, 1989). Manufacturers will outline how they meet these requirements. The cupboard must be kept locked at all times unless in use, and keys kept with an authorised person and readily available.

The pharmacy will have copies of all the names and signatures of those staff authorised to order controlled drugs (NMC, 2010) and will carefully check these against the order form when processing an order. Controlled drugs are not kept within emergency drugs cupboards. If you need controlled drugs unexpectedly when the pharmacy is closed follow the local policy. It is usually possible to obtain a single dose from another ward or clinical area, with an entry made in the controlled-drug book of that area, as well as the receiving department. Stock should not be transferred between wards/clinical areas.

0 1 7 3 9 2 4

Always follow the local procedure for receipt of controlled drugs, which will define the appropriate persons permitted to receive controlled drugs and how to identify them—normally a registered nurse, or other appropriate person, such as an operating department practitioner, with a clear identity badge. The pharmacy will send the drugs in a locked or sealed box or container. Controlled drugs will never be left unattended.

As a matter of good practice, the receiving person should not be the same person who ordered the controlled drugs (DH, 2007). On arrival, the receiving person will open the box and check the number of individual drugs against the order in the ward controlled-drugs order book.

Patient’s Name Amount given

NAME, FORM OF PREPARATION AND STRENGTH................................................ ........................................................................ 14

Carried forward from page number............................................................


Adults


Page 4 of 6


ORDER FOR CONTROLLED DRUGS

Serial No. 033........................................................................................Hospital

Ward or Department..............................................................................

Name of Preparation Strength Quantity

(Each preparation to be ordered on a separate page)

Ordered by............................................................................................................................................... Date............................. (Signature of Nurse in Charge/Acting Nurse in Charge) (Print name above)

Supplied by.............................................................................................................................................. Date............................. (Pharmacist’s Signature) (Print name above)

Accepted for delivery.............................................................................................................................. Date............................. (Signature of messenger) (Print name above)

Received by............................................................................................................................................ Date............................. (Signature of recipient) (Print name above)

Victoria and Beckham

ANGELA RUDGE

RAVI CHAKRA

DAVID SMETHURST

LEIGH NUTTALL

14/8/16

14/8/16

14/8/16

14/8/16

MORPHINE SULFATE CAPSULES MR 30 mg 30 CAPSULES

3b

Amount Date Time Patient’s Name Amount given

Carried forward from page number..................................................................

Balance on transfer

Date Received Requisition

of Serial No. Given by

(Signature) (Signature)Witnessed by STOCK

BALANCEAMOUNT(S) OBTAINED AMOUNT(S) ADMINISTERED

60 Tablets 1/8/16 243 45 from previous book closed on 9/8/16

MORPHINE SULFATE (MR) CAPSULES 30 mg

NAME, FORM OF PREPARATION AND STRENGTH....................................................................................................... 3

30 mg30 mg 22 Capsules

23 Capsules24 Capsules

Eileen DowlingEileen Dowling

30 mgEmma Burton11/8/16 12.00

21 Capsules12/8/16 18.00

19.00

10/8/16 12.00

30 mgJuan Cruz20 Capsules13/8/16 22.00

50 CapsulesReceived thirty capsules from pharmacy

033 14/8/16

Receiving person signs the order book Recording the new stock is witnessed

If the number of drugs delivered is correct, then the receiving person will sign the relevant sheet in the ward controlled-drugs order book in the “received by” section (NMC, 2010). NICE (2016) highlights the requirements for information that should be shown on the order form for controlled drugs.

The receiving person will then take the ward controlled-drugs record book (not the order book) and enter the new stock into it, recording the date, the serial number of the requisition, the amount and form of the drug and the new stock balance. He or she (and a witness) will sign the book, then lock the book and the new stock in the cupboard. Follow local policy, but, generally, words (not numbers) are used to record the controlled drugs received from pharmacy, to reduce the chance of subsequent fraudulent alterations (NMC, 2010).

The controlled-drugs record book provides a log of all Schedule 2 controlled drugs received and issued in the department or ward. It will have separate pages for each preparation. All entries should be signed by two registrants, or (for administration only) one registrant and a second competent practitioner, as defined by local policy. The latter may be a student nurse (NMC, 2010; Standard 26.34). Errors must stay legible—either bracketed (DH, 2007) or crossed out with a single line, then signed and dated by two registrants (NMC, 2010); follow local policy. An explanation may be added (see CQC, 2016b). Once a page of the book is full, the balance must be transferred to another page, the number of the continuation page added to the bottom of the finished page, and the index updated (inset, left). Once the record book is finished, it should be sealed and kept on the ward for another two years, with notes on the front cover as shown (inset, right).



Balance on transfer



of Serial No. Given by

(Signature) (Signature)Witnessed by STOCK

BALANCEPatient’s Name Amount given

Balance on transfer

(Signature) Given by

(Signature)Witnessed by STOCK

BALANCE

AMOUNT(S) OBTAINED AMOUNT(S) ADMINISTERED

3

MORPHINE SULFATE (MR) CAPSULES 30 mg

NAME, FORM OF PREPARATION AND STRENGTH..................................................................................................... 15NAME, FORM OF PREPARATION AND STRENGTH................................................ ........................................................................ 14


30 mg

30 mg28 Capsules29 Capsules

30 Capsules

Eileen DowlingKofi Dimka

30 mgEmma Burton

18/8/16 14.00

27 Capsules19/8/16 18.00

50 mLMegan Challon20/8/16 23.10 20 mg

30 mg

18/8/16 12.00

30 mgEmma Burton26 Capsules

20/8/16 18.15

25 CapsulesJuan Cruz20/8/16 23.15

Separate pages for each controlled drug and each formulation

This is a continuation page for morphine sulfate (MR) capsules 30 mg, formerly recorded on page 3

Each entry relating to receiving and issuing a controlled drug, must be signed and dated, and witnessed

The controlled-drugs record book must be a bound book: most local policies do not permit use of loose-leaf pages

Once a controlled-drugs record book is finished, it must be sealed and stored securely on the ward. Write the date of the last entry on the cover, and the date (two years later) on which it can be destroyed Name of preparation Page Nos.

INDEX

14// 15

The index must be kept up to date. It will show the numberof the current page to turn to for each drug and formulation

13678910111213

Oxycodone hydrochloride injection 50 mg/1 mLMorphine Sulfate MR 30 mg capsulesAlfentanyl 1 mg/2 mLTramadol hydrochloride 50 mg capsulesBuprenorphine 10 microgram patchOxycodone hydrochloride liquid 5 mg/5 mLFentanyl patch 25 microgramsOxycodone hydrochloride MR 10 mg tabletsOxycodone hydrochloride 10 mg/1 mL injectionOxycodone hydrochloride MR 5 mg tablets

Morphine oral solution

20/8/16

20/8/16

entered on wrong pageErrors must remain legible: bracketed or crossed out with a single line. Two registrants must sign and date the error and give the reason

The controlled-drugs record book

AMOUNT(S) OBTAINED AMOUNTS(S) ADMINISTERED


NAME, FORM OF PREPARATION AND STRENGTH........................................................................................................................

12


Balance on transfer

Date Received


Adults


Page 5 of 6


S / N 30000000111LOTEXP

48E024029/05/16

48E024029/05/16

S / N 30000000111LOTEXP

48E024029/05/16

48E024029/05/16

5. Are appropriate security measures applied to the storage of the medicines below? (for each medicine, please tick the appropriate response)

CDs Internal medicines External medicines Refrigerator/freezer medicines Intravenous fluids and sterile topical fluids Flammable liquids and medical gasses TTOs/TTAs Emergency medicines (crash trolleys/anaphylaxis kits)

6. Are all cupboards, closed storage units (i.e. with doors) and refrigerators in which medicines are stored lockable?

7. Are keys providing access to medicine cupoboards in the possession of an authorised person or securely stored at all times and easily traceable?

8. Are doors leading to security sensitive areas where medicines are stored access controlled?

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ISSUED TO:

DATE ISSUED:

BOOK NO:





3b

21/08/16

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STOCK CHECKS 1. All appropriate action must be taken to report and resolve any discrepancies. It is NOT sufficient to only record them on this page and take no further action

Notes:

Date Time Checked by Checked by Witness Witness All items Details of any discrepancies and

21/8/16 Jean Crowther Ping Lee Yes Nil 11:45 Staff Nurse Senior Staff Nurse

22/8/16 Angela Rudge Afta Begum Yes Nil 14:30 Staff Nurse Charge Nurse

23/8/16 Gina Bosco Ping Lee Yes Nil 15:05 Staff Nurse Senior Staff Nurse

(signature & (print name) (signature & (print name) correct action taken designation) designation) (Yes or No) (include Datix number)

1

Stock checks of controlled drugs Stock checks are witnessed

Security audits Return and disposal of controlled drugs

Regular stock checks will take place. The frequency will vary according to local policy but may be every 24 hours. Perform these checks at a time when you will not easily be disturbed; follow local policy. Check the cupboard stock against that recorded in the book, not the other way round. You do not need to open boxes/packets that have tamper-proof seals. Liquid controlled drugs are normally checked once a week and whenever a discrepancy is noted or suspected. Generally, volume discrepancies larger than 5 mL per 100 mL are considered significant and must be reported.

Note where stock checks are recorded. For example, this may be on a page at the back of the bound record book or in a separate bound book (not on loose sheets). Stock check records can also be made on individual pages of the record book.The person conducting the stock check will sign, together with the witness, stating that a stock check has been undertaken, with the date. If there is a discrepancy, check again for an error; follow local policy, including completing an incident form, and informing pharmacy, the department manager and the ward pharmacist (where available).

Be aware that pharmacy also carry out regular audits and will ask for the keys to do this. The information collected will help to inform whether the governance arrangements in relation to controlled drugs are sufficient and identify any areas for improvement (see also: CQC, 2016a; NHS Protect, 2015).

Follow the local policy carefully for managing expired or unused controlled drugs (see DH, 2007). These will be returned to pharmacy, usually with the pharmacist as one of the signatories, who will sign them back in at the pharmacy. The local policy for secure return will be similar to that for delivery of controlled drugs. Regular pharmacy audits will identify any surplus stocks of controlled drugs that need to be returned.

If it becomes necessary to return controlled drugs to the pharmacy, this will be recorded in the controlled-drugs book, and the entry witnessed. The record will include the date, the reason for return and a correction to the stock balance, together with the two signatures.

Disposal of controlled drugs can occur in the clinical area following local policy. This may be necessary if less medication is administered than was prepared, for example, or if a patient requires a lower dose than that available in an ampoule.

WARNING DO NOT FILL ABOVE THE LINE

CONTAMINATED SHARPS ONLY

TO BE INCINERATEDDANGER

TRAM

ADO

L




12


Balance on transfer


of Serial No.



BALANCE

5 mg25/05/1625/05/16

11.15

11.30Jason Asquith

23

Thirty tablets returned to pharmacy - drug expired

42 tablets43 tablets

12 tablets

Return of controlled drugs is witnessed Immediate disposal of controlled drugs




12


Balance on transfer


Received

If the keys cannot be accounted for, follow local policy. You will normally need to inform security (who may need to contact the police), the pharmacy or the on-call pharmacist, the Accountable Officer and the Director of Nursing. You will be issued with a duplicate set of keys for access but the lock on the cupboard needs to be changed urgently. Monitor the cupboard closely until the lock is changed, or move the stock and paperwork to another secure place in the interim. Complete an incident form, following local policy.

Support your local independent pharmacy

Providing healthcare

to the community

P

h arm

acy


Adults


Page 6 of 6





12


Balance on transfer



of Serial No.



BALANCE

2.5 mg21/10/16 10.30 Ella Akehurst

30

2.5 mg of 5 mg ampoule disposed of in sharps bin

19 ampoules

20 ampoules

Immediate disposal of controlled drugs is witnessed Lost controlled-drugs keys: (a)

(b) Lost controlled-drugs stationery

Discharge medicines of controlled drugs Illicit substances

Disposal of controlled drugs in the clinical area must be witnessed and recorded in the controlled-drugs record book, stating the amount given to the patient and the amount wasted (NICE, 2016). The person disposing of the drug must sign the book, together with any witness. Record the new stock balance.

The keys for the controlled-drugs cupboard must be accounted for at all times. If the keys appear to be missing, inform the nurse in charge immediately. Contact all staff who have had the keys since the team was last aware of their location. If necessary, contact staff who are now off duty. If someone has taken the keys off the premises, he or she will need to return them immediately. If this is not possible, the person must return them as soon as practicable and a duplicate set will be obtained from pharmacy.

If controlled-drugs paperwork is missing, follow the same procedure as for lost keys. If the controlled-drugs record book cannot be located, start a new book and check and record the stock. Be aware that a missing book may be an attempt to cover for missing stock and the police may need to be involved.

When the patient is being discharged with controlled drugs to take home, these will be ordered and transferred from the pharmacy as for ward stock. If necessary, store the controlled drugs to take home in the locked controlled-drugs cupboard. (These should not be recorded as ward stock.) Do not leave controlled drugs unattended at the bedside.

If you suspect that a patient is using prohibited drugs for non-medical use on the premises, follow local policy and inform the nurse in charge in a professional manner. You may need to inform the Accountable Officer, the Director of Nursing and security, as well as the medical team and the patient’s consultant. It may be necessary to involve the police.

PoliceSecurity On-call

pharmacist

Director of Nursing

Accountable Officer

management of controlled drugs part 1 p1-6 070117 · 2017-01-09 · this circular draws attention...

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