Version 3.1 October 2019

Controlled Drugs

Target Audience

Who Should Read This Policy

All Consultant/Senior Medical Staff

All Junior Medical Staff

All Non-Medical Prescribers

All Pharmacy Staff All Ward/Unit Managers All Nursing Staff

Controlled Drugs Policy

Version 3.1 October 2019

Ref. Contents Page

1.0 Introduction 5

2.0 Purpose 5

3.0 Objectives 5

4.0 Process 5

4.1 Table 1 5

5.0 Procedures connected to this policy 6

6.0 Links to Relevant Legislation 7

6.1 Links to Relevant National Standards 8

6.2 Links to Other Key Policy/s 8

6.3 References 9

7.0 Roles and Responsibilities for this policy 10

8.0 Training 11

9.0 Equality Impact Assessment 11

10.0 Data Protection Act and Freedom of Information Act 11

11.0 Monitoring this Policy is Working in Practice 12

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Explanation of terms used in this policy Controlled Drug Accountable Officer (CDAO) - Officer in a health care organisation who is

responsible for the safe and effective use of and management of controlled drugs. Appointment

required by Controlled Drugs (Supervision and Management of Use) Regulations 2006

Administer - To give a medicine either by introduction into the body, whether by direct contact with the body or not, (e.g. orally or by injection) or by external application (e.g. application of an

impregnated dressing). There are specific definitions in meds legislation as follows:

“External Use" - Application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye,

vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that

such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal

drops, nasal sprays, nasal inhalations or teething preparations;

"Parenteral Administration" - Administration by breach of the skin or mucous membrane

Controlled Drug (CD) - The drugs listed in schedules 1-5 of the Misuse of Drugs Regulations 2001 (as amended)

Drugs listed in different schedules are subject to differing levels of control but all are Controlled Drugs (see 4.1 Table 1)

CD Record Book (CDRB) - Bound book in which records are made of CDs received and

administered in wards, theatres and departments

CD Register - A “register” as specified in the Misuse of Drugs Regulations 2001 (as amended) means

either a bound book, which does not include any form of loose leaf register or card index, or a computerised system which is in accordance with best practice guidance endorsed by the Secretary of

State under section 2 of the National Health Service Act 1977

Designated Body/Bodies - Health care organisations e.g. hospital trusts defined in the Controlled

Drugs (Supervision and Management of Use) Regulations 2006

Discrepancy - Difference between the amount shown in the register or record book and the amount that is physically present

Dispense, dispensing - Dispensing of Controlled Drugs, preparation (including compounding, dissolving, diluting, packing and labelling) and giving out of medicines for individual patients

Diversion - Removal of CDs for unauthorised use; theft

Duty Pharmacist - Senior pharmacist on duty for the time being

Health Care Organisations - Organisations responsible for the delivery of healthcare. Includes NHS Trust hospitals and independent hospitals

Local Intelligence Network - A network established by the Accountable Officer of a CCG/ Area

Team for sharing information regarding the management and use of controlled drugs

“May” - Used in this document in connection with recommendations concerned with good practice if

they are relevant to local circumstances

Misuse of Drugs Regulations (MDR) - Regulations made under the Misuse of Drugs Act (1971)

“Must” or “Should” - Used in this document in connection with legal requirements e.g. “records of

schedule 2 CDs received and supplied by a pharmacy must be kept in a CD register”

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Order - To order Controlled Drugs

To make a formal order for Controlled Drugs. Can only be done by someone who is entitled to be in possession of CDs (as defined in current MDR). Must be addressed to a suitable pharmaceutical

supplier

Patient Group Directions (PGD) - Written directions from a senior doctor (or dentist) and a senior

pharmacist and a representative of the appropriate organisation giving registered nurses, pharmacists and other specified health professionals a general authority to supply and administer specified

medicines to patients, who are not individually identifiable, in specified clinical situations

Patient-Controlled Analgesia (PCA) – Any method of allowing a person in pain to administer their

own pain relief. The infusion is programmable by the prescriber. If it is programmed and functioning as intended, the machine is unlikely to deliver an overdose of medication

Patient’s own drugs (PODs) - In this context - CDs brought into the hospital by the patient on

admission

Prescribe - Prescribing is the ordering of a medicine for an individual patient. In medicines

legislation, certain medicines may be supplied only in accordance with a prescription by a doctor, dentist or other appropriate practitioner, and which meets the conditions specified in the Prescription

Only Medicines (Human Use) Order 1997. The term has however become commonly used to describe authorising - by means of an NHS prescription - the supply of any medicine (Prescription Only

Medicine, Pharmacy or General Sales List medicine) at public expense to a named patient

Registered Nurse, Midwife or ODP in Charge - The registered nurse, registered midwife or

registered operating department practitioner (ODP) who is in charge for the time being (senior registered nurse, midwife or ODP on duty) and is therefore responsible for management of Controlled

Drugs

Registered Operating Department Practitioner - Operating Department Practitioner whose

name is on the register of the Health Care and Professions Council (HCPC) and should be a member of the College of Operating Department Practitioners

Registered Pharmacist - Person registered in the register of pharmacists maintained by the General

Pharmaceutical Council (GPhC)

Registered Pharmacy Technician - Pharmacy technician whose name is on the register held by

the General Pharmaceutical Council (GPhC)

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1.0 Introduction In response to the fourth report of the Shipman enquiry, the government strengthened governance arrangements and made legislative changes for the management of controlled drugs (CDs). CDs are subject to special legislative controls because there is a potential for them to be abused, misused or diverted, causing possible harm. The Department of Health produced ‘Safer Management of Controlled Drugs: A guide to good practice in secondary care (England)’ in October 2007, ‘Safer management of Controlled Drugs: Guidance on Standard Operating Procedures for Controlled Drugs in January 2007 (ref 2), and The Controlled Drugs (Supervision of Management and Use Regulations 2013 These documents clearly set out how the governments’ changes apply to the use and management of CDs in secondary care settings and guide its implementation.

2.0 Purpose The purpose of this procedure is to ensure that all CDs are used in a safe, secure and effective way and that all processes involving CDs adhere to current regulations across the Trust.

3.0 Objectives Provide a clear Framework for the management of Controlled Drugs within the Trust. This framework is via an overarching policy containing regularly reviewed and ratified Standard Operating Procedures (SOPs) for all processes involving CDs within the Trust. 4.0 Process Please refer to individual Standard Operating Procedures (SOPs) listed in section 5 that can be accessed via the Trust’s Intranet. 4.1 Table 1 Summary of legal requirements that apply to controlled drugs in Schedules 2, 3, 4 and 5 of the Misuse of Drugs Regulations: Schedule (refers to schedules of the Misuse of Drugs Regulations)

Schedule 2 Includes – Opioids, (e.g. diamorphine, morphine, methadone), major stimulants (eg amphetamines),remi-fentanil secobarbital,

Schedule 3 Includes minor stimulants, temazepam, tramadol, diethylpropion, buprenorphine, flunitrazepam, Barbiturates except secobarbital

Schedule 4, pt I Includes benzo-diazepines

Schedule 4, pt II Includes anabolic steroids, clenbuterol, growth hormones

Schedule 5 Includes low strength opioids

Designation CD CD No Reg CD Benz CD Anab CD Inv

Safe custody Yes, except quinal-barbitone

Yes, with certain exemptions (see MEP)

No No No

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Prescription requirements (including handwriting*) – apply to OP and discharge prescriptions

Yes Yes No No No

Requisitions necessary?

Yes Yes No No No

Records to be kept in CD register

Yes No No No No

Pharmacist must ascertain the identity of the person collecting CD

Yes No No No No

Emergency supplies allowed

No No, except phenobarbitone for epilepsy

Yes Yes Yes

Validity of prescription

28 days 28 days 28 days 28 days 6 mths (if POM)

Maximum duration that may be prescribed

30 Days as good practice

* Prescriptions for schedule 2 and 3 CDs may be typed or computer generated but must be signed by the prescriber. (SI 2005 No.2864) 5.0 Procedures Connected to this Policy

Medication - Controlled Drugs - SOP 01 - Ordering Controlled Drug Stationery

Medication - Controlled Drugs - SOP 02 - Ordering Stock Controlled Drugs

Medication - Controlled Drugs - SOP 03 - Receiving Stock Controlled Drugs in Clinical Areas

Medication - Controlled Drugs - SOP 04 - Controlled Drug Handover in Clinical Areas

Medication - Controlled Drugs - SOP 05 - Out of Hours Supply of Controlled Drugs

Medication - Controlled Drugs - SOP 06 - Prescribing Controlled Drugs on Inpatient Treatment Sheets

Medication - Controlled Drugs - SOP 07 - Prescribing Controlled Drugs for Discharge Medication

Medication - Controlled Drugs - SOP 08 - Prescribing Controlled Drugs on FP10 and Outpatient Prescriptions

Medication - Controlled Drugs - SOP 09 - Obtaining a Controlled Drug for a Discharge Prescription

Medication - Controlled Drugs - SOP 10 - Receiving, Storage and Re-issuing to Patient a Controlled Drug via Discharge or Leave of Prescription

Medication - Controlled Drugs - SOP 11 - Safe Storage of Controlled Drugs in Clinical Areas

Medication - Controlled Drugs - SOP 12 - Management of Controlled Drug Stationery in Clinical Areas

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Medication - Controlled Drugs - SOP 13 - Liquid Controlled Drug Checking by a Pharmacist on a Ward

Medication - Controlled Drugs - SOP 14 - Temporary Closure or Transfer of Wards and Clinical Areas

Medication - Controlled Drugs - SOP 15 - Administration of Controlled Drugs in Clinical Areas

Medication - Controlled Drugs - SOP 16 - Administration of Oral Controlled Drugs in Patients Homes

Medication - Controlled Drugs - SOP 17 - Administration of a Controlled Drug via a Syringe Driver

Medication - Controlled Drugs - SOP 18 - Transport of Controlled Drugs by a Pharmacist between Clinical Sites

Medication - Controlled Drugs - SOP 19 - Removal, Storage, Recording and Reporting of Suspected Illicit Substances

Medication - Controlled Drugs - SOP 20 - Discrepancies between Ward Stocks and Recorded Total in Controlled Drug Registers

Medication - Controlled Drugs - SOP 21 - Destruction (Denaturing) of Patient’s Own and Stock Controlled Drugs in Clinical Areas

Medication - Controlled Drugs - SOP 22 - Destruction (Denature) or Return of Patient's own Controlled Drugs in Patient's own Home

Medication - Controlled Drugs - SOP 23 - Retention of Controlled Drug Records

Medication - Controlled Drugs - SOP 24 - Controlled Drug Incidents

Medication - Controlled Drugs - SOP 25 - Quarterly Clinical Area Controlled Drug Audit

Medication - Controlled Drugs - SOP 26 - Transportation of Controlled Drugs and Controlled Stationery between BCPFT Sites and SLA Provider Sites

Medication - Controlled Drugs - SOP 27 - Collection of Patients own Controlled Drugs from a Pharmacist to the Patients Home

6.0 Links to Relevant Legislation Health Act 2006 As part of the new regulations made under the Health Act 2006 each healthcare organisation had to appoint an Accountable Officer who would be responsible for the safe and effective use of controlled drugs in their organisation. The regulations also introduced SOPs for the use and management of CDs. All SOPs will sit below the Trust Medicines Policy.

The new regulations require Accountable Officers to ensure that his or her organisation has adequate and up-to-date SOPs in relation to the use of CDs. Misuse of Drugs Act 1971 This act is intended to prevent the non-medical use of certain drugs. For this reason it controls not just medicinal drugs (which will also be in the Medicines Act) but also drugs with no current medical uses. Offences under this Act overwhelmingly involve the general public, and even when the same drug and a similar offence are involved, penalties are far tougher. Drugs subject to this Act are known as ‘controlled’ drugs. The law defines a series of offences, including unlawful supply, intent to supply, import or export (all these are collectively known as ‘trafficking’ offences), and unlawful production. The main difference from the Medicines Act is that the Misuse of

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Drugs Act also prohibits unlawful possession. To enforce this law the police have the special powers to stop, detain and search people on ‘reasonable suspicion’ that they are in possession of a controlled drug. Medicines Act 1968 This law governs the manufacture and supply of medicine. It divides medical drugs into three categories. Prescription only medicines are the most restricted. They can only be sold or supplied by a pharmacist if supplied by a doctor. Pharmacy medicines can be sold without a prescription but only by a pharmacist. General Sales List medicines can be sold by any shop, not just a pharmacy. However, even here advertising, labelling and production restrictions apply. The enforcement of the Medicines Act rarely affects the general public. 6.1 Links to Relevant National Standards Controlled Drugs (Supervision of Management and Use Regulations) 2013 The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (“the 2013 Regulations”) came into force in England and Scotland on 1 April 2013. The purpose of this document is to support the changes made in legislation and continue to promote good governance concerning the safe management and use of Controlled Drugs across England and Scotland. This information is intended to be of use for organisations that have a responsibility for appointing a Controlled Drugs Accountable Officer (CDAO) and ensuring that systems are in place for the safe and effective management and use of CDs and that these systems are working effectively. Human Medicines Regulations 2012 The new Regulations implement Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (the 'Medicines Directive'). The Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. Misuse of Drugs Regulations 2001 The Misuse of Drugs Regulations 2001 divide Controlled Drugs (CDs) into five schedules corresponding to their therapeutic usefulness and misuse potential. A number of changes affecting the prescribing, record keeping and destruction of CDs have been introduced as a result of amendments to the Misuse of Drugs Regulations 2001. 6.2 Links to other Key Policies Medicines – Administration Policy The aim of the policy is to ensure that all nurses, including bank and agency staff and other health care individuals, follow safe and best practice in all activities relating to

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the administration of medicines within inpatient, outpatient, community and residential settings. Medicines – Prescribing Policy The aim of this policy is to describe the procedures and good practice that should be used by staff when prescribing medication to people who use our services and to make clear the legal and professional standards that are expected from them. Medicines – Supply, Storage and Disposal Policy The aim of this policy is to inform all health professionals that have any involvement with medicines of the correct procedures for the safe handling, ordering, storage, transportation, and safe disposal of medicines. Medicines Security SOP The purpose of this SOP is to ensure processes are in place to control access to medicines to appropriate personnel. By implementing safe systems to control access and effectively manage ward closures and minimise any associated risks, we can ensure the most appropriate and effective use of medicines. 6.3 References

Safer Management of Controlled Drugs: A guide to good practice in secondary care (England) DOH October 2007 gateway ref: 8913 Safer management of controlled drugs: a guide to good practice in secondary care (England) : Department of Health - Publications

Safer Management of Controlled Drugs: Guidance on Standard Operating Procedures for Controlled Drugs DOH January 2007 gateway ref: 7585 available on internet Safer management of controlled drugs: guidance on Standard Operating Procedures for controlled drugs : Department of Health - Publications

The Controlled Drugs (Supervision of Management and Use Regulations 2013.

Clinical practice for ensuring the safe handling, storage and administration of patients own drugs for hospital inpatients available on the intranet Wolverhampton City PCT Intranet - Clinical Practices and Assessment Guides - General

Good practice in prescribing and managing medicines and devices, GMC (2013) Good practice in prescribing and managing medicines and devices, GMC (2013)

NHS England’s Controlled Drugs Accountable Officers' Single Operating Model.

Independent prescribing of controlled drugs, Royal Pharmaceutical Society of GB April 2012

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7.0 Roles and Responsibilities for this Policy

Title Role Key Responsibilities

Medical Director Executive Lead - Trust strategic direction for this policy

- Agree action plans to address issues relating to this policy

- Update the Trust Board regularly on issues relating to Safeguarding Adults at Risk

Trust Board Strategic - Strategic overview and final responsibility for setting the direction of this policy - Ensure that it fulfils its statutory responsibilities to Controlled Drugs

Chief Pharmacist Implementation Lead

- Appointed Controlled Drugs Accountable Officer (CDAO) in accordance with Health Act 2006. Contactable via email - gurjinder.bhella@bcpft.nhs.uk

- Ensure the safe and effective use of CDs within the Trust - Ensure that the Trust has adequate and up-to-date SOPs in relation to the use of CDs

- Ensure safe systems of working with CDs - Monitor and audit safe systems of working with CDs

- Investigate and report any incidents or concerns involving CDs

- Ensure adequate training for all staff involved with CDs - The Trust will report regularly to the CCG and will collaborate with the Local Intelligence Network (LIN) to share

information about potential CD offences and potential or actual systems failures

Medicines Management Committee (MMC)

Responsible - Identify the SOPs required for the use of CDs - Responsible for the development, review and approval of the SOPs and the dissemination and implementation across the

Trust

Nurse in Charge Implementation - Ensure the safe and appropriate use of CDs and CD stationery on that ward

Prescribers Operational - Ensure that their CD prescriptions comply with the necessary legal requirements A pharmacist is not allowed by law to dispense a CD unless all the information required by law is given on the prescription

Pharmacy Staff Operational - Promote the safe and legal handling of CDs within the Trust

- Produce a quarterly ward CD audit and relevant security audits

All Staff involved in CDs Adherence - Maintain their competence in managing CDs

- Follow the processes in this policy and the Standard Operating Procedures (SOPs) relevant to their area of work - Highlight any areas of concern or difficulties in following the policy or SOPs

- Report any near-miss or incidents involving CD’s via Datix, and must also report it to the CDAO promptly. Any CD

discrepancies must be investigated immediately and reported to the senior nurse on duty at the time, then to pharmacist and CDAO

- Inform their line manager and then the CDAO if they have a concern about the use of CDs within the Trust

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8.0 Training

What aspect(s) of this policy will

require staff training?

Which staff groups require this

training?

Is this training covered in the Trust’s Mandatory & Specialist Mandatory

Training Needs Analysis document?

If no, how will the training be delivered?

Who will deliver the training?

How often will staff require

training

Who will ensure and monitor that staff have

this training?

Medicines

Management

Inpatient Nurses

and Medical staff

Yes Learning and

Development Team

2 yearly Workforce Development

Group

9.0 Equality Impact Assessment Black Country Partnership NHS Foundation Trust is committed to ensuring that the way we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the Intranet. If you require this in a different format e.g. larger print, Braille, different languages or audio tape, please contact the Equality & Diversity Team on Ext. 8067 or email bcpft.equalityimpactassessment@nhs.net 10.0 Data Protection and Freedom of Information Data Protection Act provides controls for the way information is handled and to gives legal rights to individuals in relation to the use of their data. It sets out strict rules for people who use or store data about individuals and gives rights to those people whose data has been collected. The law applies to all personal data held including electronic and manual records. The Information Commissioner’s Office has powers to enforce the Data Protection Act and can do this through the use of compulsory audits, warrants, notices and monetary penalties which can be up to €20million or 4% of the Trusts annual turnover for serious breaches of the Data Protection Act. In addition to this the Information Commissioner can limit or stop data processing activities where there has been a serious breach of the Act and there remains a risk to the data. The Freedom of Information Act provides public access to information held by public authorities. The main principle behind freedom of information legislation is that people have a right to know about the activities of public authorities; unless there is a good reason for them not to. The Freedom of Information Act applies to corporate data and personal data generally cannot be released under this Act. All staffs have a responsibility to ensure that they do not disclose information about the Trust’s activities; this includes information about service users in its care, staff members and corporate documentation to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. The Trust seeks to ensure a high level of transparency in all its business activities but reserves the right not to disclose information where relevant legislation applies. The Information Governance Team provides a central point for release of information under Data Protection and Freedom of Information following formal requests for information; any queries about the disclosure of information can be forwarded to the Information Governance Team.

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11.0 Monitoring this Policy is Working in Practice

What key elements will be monitored?

(measurable policy objectives)

Where described in

policy?

How will they be monitored?

(method + sample size)

Who will undertake this

monitoring?

How Frequently

?

Group/Committee that will receive and

review results

Group/Committee to ensure actions are

completed

Evidence this has

happened

Review of incident reports

involving CDs and number of

incident reports completed to show a breach of SOPs

n/a Audit of incidents

involving CDs

Accountable Officer

(Chief Pharmacist)

Every three

months

Local CD Local

Intelligence Network

(LIN)

Accountable officer is

responsible for

ensuring actions are put in place to ensure

adherence to SOPs

Minutes of

meetings/

Action plan signed off

Completion of CD storage audits by pharmacy

n/a Audit of CD storage audits

Accountable Officer (Chief Pharmacist)

Every three months

Local CD Local Intelligence Network

(LIN)

Accountable officer is responsible for

ensuring actions are

put in place to ensure adherence to SOPs

Minutes of meetings/

Action plan

signed off

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Policy Details

* For more information on the consultation process, implementation plan, equality impact

assessment, or archiving arrangements, please contact Corporate Governance

Review and Amendment Log

Version Date Details of Change

3.1 Oct 2019 Policy fully reviewed with minor amendments to section 5.0, 6.0, 9.0 and 10.0

3.0 Nov 2015 Review and Amendments in line with new regulatory guidance and new policy format

2.0 Oct 2012 Amendments to comply with new Policy for Policies

1.0 Jul 2012 Policy for the new organisational BCPFT

Title of Policy Controlled Drugs Policy

Unique Identifier for this policy BCPFT-MM-POL-04

State if policy is New or Revised Revised

Previous Policy Title where applicable N/A

Policy Category Clinical, HR, H&S, Infection Control etc.

Pharmacy

Executive Director whose portfolio this policy comes under

Medical Director

Policy Lead/Author Job titles only

Chief Pharmacist

Committee/Group responsible for the approval of this policy

Medicines Management Committee

Month/year consultation process completed *

n/a

Month/year policy approved October 2019

Month/year policy ratified and issued November 2019

Next review date October 2022

Implementation Plan completed * Yes

Equality Impact Assessment completed * Yes

Previous version(s) archived * Yes

Disclosure status ‘B’ can be disclosed to patients and the public

Key Words for this policy prescribing, errors, medicines, pharmacy, controlled drugs, accountable officer