Controlled Drugs Policy

Controlled Drugs Policy Controlled Drugs Policy Who Should Read This Policy Target Audience All Consultant/Senior Medical Staff All Junior Medical Staff All Non-Medical Prescribers All Pharmacy Staff All Ward/Unit Managers All Nursing Staff Version 3.0 November 2015

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 Version 3.0 November 2015 2

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 Version 3.0 November 2015 3

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) Version 3.0 November 2015 4

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 Black Country Partnership NHS Foundation Trust (hereafter referred to as 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 amphetamine s),remifentanil secobarbital, Schedule 3 Includes minor stimulants, temazepam, tramadol, diethylpropion, buprenorphine, flunitrazepam, Barbiturates except secobarbital Schedule 4, pt I Includes benzodiazepines 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 quinalbarbitone No No No Yes, with certain exemptions (see MEP) Version 3.0 November 2015 5

Prescription requirements (including handwriting*) apply to OP and discharge prescriptions Requisitions necessary? Records to be kept in CD register Pharmacist must ascertain the identity of the person collecting CD Emergency supplies allowed Validity of prescription Maximum duration that may be prescribed Yes Yes No No No Yes Yes No No No Yes No No No No Yes No No No No No No, except phenobarbitone for epilepsy Yes Yes Yes 28 days 28 days 28 days 28 days 6 mths (if POM) 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 Ordering Controlled Drug Stationery Ordering Stock Controlled Drugs Receiving Stock Controlled Drugs in Clinical Areas Controlled Drug Handover in Clinical Areas Out of Hours Supply of Controlled Drugs Prescribing Controlled Drugs on Inpatient Treatment Sheets Prescribing Controlled Drugs for Discharge Medication Prescribing Controlled Drugs on FP10 and Outpatient Prescriptions Obtaining a Controlled Drug for a Discharge Prescription Receiving, Storage and Re-issuing to Patient a Controlled Drug via Discharge or Leave of Prescription Safe Storage of Controlled Drugs in Clinical Areas Management of Controlled Drug Stationery in Clinical Areas Liquid Controlled Drug Checking by a Pharmacist on a Ward Temporary Closure or Transfer of Wards and Clinical Areas Administration of Controlled Drugs in Clinical Areas Administration of Oral Controlled Drugs in Patients Homes Administration of a Controlled Drug via a Syringe Driver Return of Controlled Drugs from Clinical Areas to SLA Provider Pharmacy Department by Pharmacist Removal, Storage, Recording and Reporting of Suspected Illicit Substances Discrepancies between Ward Stocks and Recorded Total in Controlled Drug Registers Version 3.0 November 2015 6

Destruction (Denature) of Patient's own Controlled Drugs in Clinical Areas Destruction (Denature) or Return of Patient's own Controlled Drugs in Patient's own Home Retention of Controlled Drug Records Controlled Drug Incidents Audit by Pharmacy Technician of Epact Data for Appropriate Prescribing of Controlled Drugs Quarterly Clinical Area Controlled Drug Audit Transportation of Controlled Drugs and Controlled Stationery between BCPFT Sites and SLA Provider Sites Collection of Patients own Controlled Drugs from a Pharmacist to the Patients Home Safe Use of Fentanyl and Buprenorphine Transdermal Patches 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 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. Version 3.0 November 2015 7

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 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. Version 3.0 November 2015 8

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 Clinical practice D1 and D2 for the administration of controlled/non controlled oral medication by one qualified nurse available on the intranet Wolverhampton City PCT Intranet - Clinical Practices and Assessment Guides - General 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 Clinical practice for administering controlled/non controlled oral medication by one qualified nurse Wolverhampton City PCT Intranet - Clinical Practices and Assessment Guides - General Clinical practice for administering a medicated transdermal patch Wolverhampton City PCT Intranet - Clinical Practices and Assessment Guides - General Authorisation for preparation and administration of drugs for subcutaneous infusion and subcutaneous injection in palliative care Wolverhampton City PCT Intranet - Clinical Practices and Assessment Guides - General General Medical Council Good practice in prescribed medicines (2008) September 2008GMC Good Practice in Prescribing Medicines Nursing and Midwifery Council of Great Britain 1 st November 2008 Standards for Medicines Management Nursing & Midwifery Council - Standards for medicines management - commencement date announced NHS England s Controlled Drugs Accountable Officers' Single Operating Model. National Patient Safety Agency (NPSA) Rapid Response Alert 4 th July 2008 reducing errors with Opioid Medicines. Reducing Dosing Errors with Opioid Medicines Royal Pharmaceutical Society of Great Britain, Law and Ethics Bulletin 29 th March 2008 Prescribing of CD s by pharmacist and nurse independent prescriber Version 3.0 November 2015 9

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 Chief Pharmacist Medicines Management Committee (MMC) Strategic Implementation Lead - Strategic overview and final responsibility for setting the direction of this policy - Ensure that it fulfils its statutory responsibilities to Controlled Drugs - 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 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 Version 3.0 November 2015 10

8.0 Training What aspect(s) of this policy will require staff training? Medicines Management Which staff groups require this training? Inpatient Nurses and Medical staff Is this training covered in the Trust s Mandatory and Risk Management Training Needs Analysis document? Yes If no, how will the training be delivered? Who will deliver the training? Learning and Development Team How often will staff require training Who will ensure and monitor that staff have this training? 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 EqualityImpact.assessment@bcpft.nhs.uk 10.0 Data Protection and Freedom of Information This statement reflects legal requirements incorporated within the Data Protection Act and Freedom of Information Act that apply to staff who work within the public sector. All staff have a responsibility to ensure that they do not disclose information about the Trust s activities in respect of service users in its care 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. Version 3.0 November 2015 11

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 Version 3.0 November 2015 12

Policy Details Title of Policy Unique Identifier for this policy State if policy is New or Revised Controlled Drugs Policy BCPFT-MM-POL-04 Revised Previous Policy Title where applicable Policy Category Clinical, HR, H&S, Infection Control etc. Executive Director whose portfolio this policy comes under Policy Lead/Author Job titles only Committee/Group responsible for the approval of this policy Month/year consultation process completed * N/A Pharmacy Medical Director Chief Pharmacist Medicines Management Committee October 2015 Month/year policy approved October 2015 Month/year policy ratified and issued November 2015 Next review date November 2018 Implementation Plan completed * Equality Impact Assessment completed * Previous version(s) archived * Disclosure status Key Words for this policy Yes Yes Yes B can be disclosed to patients and the public prescribing, errors, medicines, pharmacy, controlled drugs, accountable officer * 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 3.0 Nov 2015 Details of Change 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 Version 3.0 November 2015 13