Schedule 8 and Declared Schedule 4 Medicines Management Policy

(1)

This Policy may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory for the Department of Health and Human Services. PLEASE DESTROY PRINTED COPIES. The electronic version of this Policy is the approved and current version and is located on the Department of Health and Human Services’ Strategic Document Management System. Any printed version is uncontrolled and therefore not current.

Department of Health and Human Services

SYSTEM PURCHASING AND PERFORMANCE - MEDICATION STRATEGY AND REFORM

Schedule 8 and Declared Schedule 4 Medicines

Management Policy

SDMS Id Number: Policy ID (as assigned by Corporate Document and Information Services) Effective From: June 2014

Replaces Doc. No: Document title and number Custodian and Review

Responsibility: Medication Strategy and Reform

Contact: Director, Medication Strategy and Reform Applies to: THO-North, THO-South, THO-North West

Policy Type: DHHS Wide Policy

Review Date: April 2015

Keywords: Schedule 8, S8, Schedule 4 Declared, S4D, Medication, Safety, Prescribing, Routine Disclosure: Yes

Approval

Prepared by Sulfi Newbold Medicines Policy Officer 61661029 16 May 2014 Through Anita Thomas Senior Specialist Pharmacist – Quality _{Use of Medicine} 61661086 16 May 2014

Through

THO-N Medication Management and Safety Committee THO-NW Medication Safety & Improvement Committee THO-S Quality Use of Medicine Committee

16 May 2014

Cleared by

John Kirwan Karen Linegar Matthew Daly

THO-N Chief Executive Officer

THO-NW Acting Chief Executive Officer THO-S Acting Chief Executive Officer

6 June 2014 2 June 2014 3 June 2014

Revision History

Version Approved by name Approved by title Amendment notes

Name Position Title Name Position Title Name Position Title

(2)

Purpose

The purpose of this policy is to provide safe and legally compliant practices for the storage, documentation, prescribing, administration and destruction of Schedule 8 and Declared Schedule 4 Restricted Substances (S8 and S4D medicines) in Tasmanian public health services. This policy should be used to inform locally developed procedures, specific to each health service, pertaining to the safe and appropriate management of S8 and S4D medicines. The control and use of S8 and S4D medicines must be in accordance with the Poisons Act 1971 and the Poisons Regulations 2008, and satisfy the National Safety and Quality Health Service Standard 4 in Medication Safety.

Mandatory Requirements

Definitions:

S8 and S4D Medicines: Medicines that are listed in the Poisons Act as Schedule 8 or Declared Schedule 4 Restricted Substances, and are controlled by law due to the high-risk of addiction, misuse or diversion. Health Service: Any Tasmanian public health service or facility that is authorised to store and administer medicine. This includes major Tasmanian acute care public hospitals, other public inpatient facilities, rural health facilities, and community health services.

Acute Hospitals: This refers to Royal Hobart Hospital, Launceston General Hospital, North West Regional Hospital, and Mersey Community Hospital. Due to the increased volume of patients, visitors, staff, and medicine quantities in these facilities, there is also an increased risk of error or diversion of S8 and S4D medications. Therefore, in acute hospitals, where there is an increased availability of staff and other resources, extra safety controls are imposed by this policy (over and above Tasmanian legislative requirements) in the interests of patient, staff and visitor safety.

Pharmacy: The Pharmacy Department of acute hospitals within each Tasmanian Health Organisation, or the Pharmacy dispensary, where applicable, of other health services.

Patient Treatment Areas: This includes wards, clinics, and procedure rooms, or patients’ homes when visited by community health nurses.

Opened/Part Dose: Part of a tablet; a quantity of medicine within an open ampoule or vial; medicine that has been prepared for a patient that has subsequently been refused; or medicine that has been mishandled in such a way that renders the medicine unfit for consumption.

Unopened/Sealed Medicine: Any medicine that is contained safely within a blister-pack, ampoule, vial, flask, bag, or bottle, or any other original packaging.

Authorised Persons: Please refer to the Roles and Responsibilities/Delegates section of this policy. Patients’ Own Medication (POMs): Medication that is owned by the patient.

In health services where variations of practice exist due to staffing and/or resource constraints, local procedures that are specific to the requirements of that health service must be both legally compliant and documented as a detailed protocol.

(3)

Storage of S8 and S4D Medicines:

• In Pharmacy and patient treatment areas of all health services, S8 medicines must be stored in a cupboard or receptacle (a “safe”) that meets the requirements of the Poisons Regulations 2008. • In Pharmacy of all health services, S4D medicines must be in a secure area and not accessible to the

public or unauthorised staff.

• In patient treatment areas of all health services, S4D medicines must be stored in a cupboard or receptacle (a “safe”) that meets the requirements of the Poisons Regulations 2008.

• Installation of a new S8 safe or relocation of an existing safe must be done so in consultation with the relevant Pharmacy Site Manager within the Tasmanian Health Organisation (THO).

• In all health services, the S8 and S4D medicines safes must not be left unsecured if unattended. • In all acute hospitals, and wherever possible in other health services, two persons authorised to

handle S8 and S4D medicines, as defined in the Roles and Responsibilities/Delegates section of this policy, must be present whenever an S8 or S4D medicines safe is open.

• In all acute hospitals, only one key should exist for any S8 or S4D medicines safe that requires a key for access. Further instruction for the management of the S8 or S4D safe key should be detailed in a locally developed procedure.

• A swipe-card, pin code, or other method of security, may be considered an appropriate alternative to a key-locked S8 or S4D medicines safe.

• A swipe-card, a pin code, or any other security measure that protects access to any S8 or S4D medicines safe, is not transferrable between staff. The maintenance of such security is the responsibility of the manager of the area. (*Refer to Roles and Responsibilities/Delegations)

• In all other health services, the management of the S8 or S4D medicines safe, and all associated security measures, should be detailed in a locally developed protocol.

Documentation of S8 and S4D Medicines

• All transactions involving S8 medicines must be accurately recorded in a dedicated register in accordance with legislative requirements.

• In all patient treatment areas of all health services, all transactions involving S4D medicines must be accurately recorded in a dedicated register in the same manner as S8 medicines.

• Patient treatment areas of health services that administer S8 or S4D medicines from a Dose Administration Aid (DAA) should have a documented procedure for recording such administration. • All transactions involving S8 and/or S4D medicines, including but not limited to, acquisition of S8 and/or S4D medicines from Pharmacy, transfer of S8 and/or S4D medicines between patient treatment areas, and return of S8 and/or S4D medicines to Pharmacy, must be accompanied by appropriate paperwork such as to create an audit trail.

• In all acute hospitals, and wherever possible in other health services, all transactions (such as acquisition, transfers between wards, return to Pharmacy, or disposal) involving S8 and S4D medicines must be double-checked and double-signed by staff who are authorised to do

(4)

This Policy may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory for the Agency (Department of Health and Human Services and Tasmanian Health Organisations). PLEASE DESTROY PRINTED COPIES. The electronic version of this Policy is the approved and current version and is located on the Department of Health and Human Services’ Strategic Document Management System. Any printed version is uncontrolled and therefore not current.

so (i.e. Two authorised signatures must be recorded for all S8 and S4D medicine transactions in the appropriate S8 or S4D Register, and on any other relevant documentation.)

• In all acute hospitals, and wherever possible in other health services, the S8 and S4D Registers must be checked regularly by two persons authorised to handle S8 and S4D medicines, as defined in the Roles and Responsibilities/Delegates section of this policy, to ensure the quantity of medication in the safe is equal to the quantity of medication recorded in the Registers. Any discrepancies must be reported immediately to the nurse or pharmacist in charge, and also reported as an incident via the agency’s approved incident reporting system (Safety Reporting and Learning System (SRLS)), as soon as is practicable.

• Definitions of persons authorised to act as signatory to S8 and S4D medicine administration and/or other transactions are outlined in the Roles and Responsibilities/Delegates section of this policy.

• See also Administration of S8 and S4D Medicines of this policy. • See also Destruction of S8 and S4D Medicines of this policy.

• For instruction on the documentation of BENZODIAZAPINE administration refer to Best Practice Addendum – BENZODIAZAPINE ADMINISTRATION and

DOCUMENTATION of this policy.

Prescribing S8 and S4D Medicines

• S8 and S4D medicines must only be prescribed in a health service by:

o A registered medical practitioner, in accordance with Tasmanian legislation. o A registered nurse practitioner, in accordance with Tasmanian legislation. o A registered dental practitioner, in accordance with Tasmanian legislation.

o A registered eligible midwife who is also ‘schedule medicine endorsed’, in accordance with Tasmanian legislation.

• Prescriptions for S8 medicines must be correctly written, contain all necessary information, and include both the prescriber’s signature and the medicine order written in the prescriber’s own hand writing, in accordance with Tasmanian legislation.

• Electronic prescriptions for S8 or S4D medicines must be consistent with legislative requirements. • A discharge or outpatient prescription for an S8 medicine must only include ONE item:

o Other medicines required for the same patient, at the same time as an S8 medicine, must be written appropriately as a separate prescription.

o If multiple S8 medicines are required for the same patient, at the same time, a separate prescription must be written for each S8 medicine.

• An inpatient order for an S8 or S4D medicine should be written on the National Inpatient Medication Chart (NIMC), or approved ancillary chart, in accordance with SPP-MSR: The use of the National Inpatient Medication Chart Policy.

• Prescriptions must be written in such a way to deter fraudulent amendments being made (e.g. marking a line through blank sections of the prescription page.)

(5)

• When dispensing S8 or S4D medicines for outpatient or discharge supply, the prescriber’s name must be accurately recorded in the Pharmacy dispensing system.

• For further information, refer to SPP-MSR: Authority to Prescribe Medications Policy.

Administration of S8 and S4D Medicines

• In all health services, only persons authorised to do so may administer S8 or S4D medicines, in accordance with Tasmanian legislation.

• In all acute hospitals, to ensure patient safety and staff protection, the administration of S8 medicines must be witnessed and co-signed on the medication order by a second person authorised to do so, as defined in the Roles and Responsibilities/Delegates section of this policy (i.e. TWO authorised signatures must be present on the National Inpatient Medication Chart (NIMC) or other approved ancillary chart.) This practice should also occur wherever possible at other health services.

• At least one of the authorised persons to have signed S8 or S4D medicine out of the Register must also administer the medicine to the patient.

• In health services where a witness is not available for S8 administration, a note must be made on the medication order and/or in the S8 Register stating that no witness was available.

• For instruction on the documentation of BENZODIAZAPINE administration refer to Best Practice Addendum – BENZODIAZEPINE ADMINISTRATION and

DOCUMENTATION of this policy.

• Health services may consider the implementation of co-signing of medication orders for S4D medicine (other than BENZODIAZEPINE) administration (see dot point above) at their discretion. Local protocols should detail such requirements.

Anaesthetics:

• S8 medicines handed over to the possession of an anaesthetist must be signed for by the anaesthetist.

• The anaesthetic record must be signed by the anaesthetist and placed in the patient history. A counter-signature for this administration is not required.

Destruction of S8 and S4D Medicines

• Disposal methods of S8 medicines must meet legislative requirements and SPP-MSR: Management and Disposal of Unwanted Medicines Policy. S8 and S4D medicines must not be placed in general waste containers or sharps containers.

• Any spillage, breakage or unintentional destruction of an S8 or S4D medication must be recorded in the appropriate Register, reported immediately to the nurse or pharmacist in charge, and reported as an incident via the approved incident reporting system, as soon as is practicable.

Opened/Part Doses

• In patient treatment areas, any opened/part dose of S8 or S4D medicine, including but not limited to syringe or infusion flasks, vials, or oral preparations, should be rendered unusable and discarded immediately, prior to, or on the cessation of administration to the patient.

(6)

• In acute hospitals, and wherever else possible, the disposal of opened/part doses or unsealed containers of S8 and S4D medicines must be executed and witnessed by two authorised persons*, documented in the appropriate Register, and signed by both persons. (*See Roles and Responsibilities/Delegations).

• In community or remote health services, if a witness is not available to confirm and co-sign the S8 Register for a discarded open/part dose of S8 medicine, a note must be made on the medication order and/or S8 Register stating no witness was available.

Unopened/Sealed Medicines

• In all acute hospitals, all unopened/sealed unwanted or expired S8 or S4D medicines must be sent to Pharmacy from patient treatment areas with appropriate documentation, as determined by local procedures, so as to create an audit trail.

• Destruction of S8 medicines in Pharmacy may only be performed by: o Two registered Pharmacists, or

o One registered Pharmacist and ONE other Pharmacy staff member who has been approved as an authorised person by the DHHS Pharmaceutical Services Branch, in accordance with Tasmanian legislation. Such individual approval is to be sought by the Pharmacy Site Manager.

• For all health services outside the acute hospitals, in the interest of patient, staff and environmental safety, Pharmacy in each THO is the preferred centralised service for the management and disposal of all unopened/sealed S8 and S4D medicine that is unwanted or expired. Arrangements should be made in consultation with the Pharmacy Site Manager.

• Health services that do not have Pharmacy on site, and are unable to access secure transport to the THO Pharmacy, must manage the destruction of unopened/sealed S8 medicines in accordance with Tasmanian legislation. In these services, S8 medicines that have expired or are no longer required must be destroyed by TWO authorised persons, as defined in Roles and Responsibilities/Delegations.

• Unwanted S8 and S4D POMs may be disposed of by community health service staff (when requested by the patient to whom the medication belongs), or by the patients themselves, via disposal services available through community pharmacies. This disposal service is only appropriate for unwanted POMs (i.e. THO owned S8 and S4D medicine stock must not be disposed of via disposal services intended for community use only).

• All destruction of unopened/sealed S8 medicines must be accurately recorded in an approved Register which must be witnessed and signed by both authorised persons, as defined above.

Possession of S8 and S4D Medicines

• Persons authorised to handle S8 and S4D medicines, may have them in their possession when appropriate to their work duties, and within their scope of practice.

• Transit of S8 and S4D medicines must be as direct as practicable. Detours or breaks should not be taken by staff who are in possession of, and responsible for, S8 and S4D medicines.

• Health service staff who are authorised under Section 25a of the Poisons Act to be in possession of and transport S8 and S4D medicines must maintain an appropriate audit trail from the medication collection point to the destination. There is to be no intermediary in this delivery process, with one registered nurse required for the entire journey.

(7)

Roles and Responsibilities/Delegations

Authorised Persons for S8 and S4D medicines handling, administration, destruction of part doses of S8 and S4D medicines in patient treatment areas, and destruction of expired/unwanted S8 medicines (in health services where ‘return to Pharmacy’ is not possible):

• Registered Nurses and Midwives • Registered Nurse Practitioners • Registered Medical Practitioners • Registered Dental Practitioners • Registered Ambulance Officers

• Medication Endorsed Enrolled Nurses (ME EN)

o ME EN must be working under the direct supervision of another authorised person (listed above), and practicing in accordance with the DHHS: Enrolled Nurse Scope of Practice – Medication Administration and Intravenous Fluid Management Policy (link)

Authorised Persons for S8 and S4D medicines handling and destruction, but NOT administration (except in the circumstances of opioid dependence programs and other daily dosing programs as authorised by a registered medical practitioner), in accordance with Tasmanian legislation:

• Registered Pharmacists

Approved Second Persons for S8 and S4D medicines administration ONLY:

• In health services that cannot provide a second authorised person to act as witness for the administration of an S8 or S4D medicine (as defined above) due to staffing constraints, a responsible second person may be nominated to act in this capacity. The following roles are approved second persons under such circumstances:

o Non Medication Endorsed Enrolled Nurse o Health Care Assistant

• Any other nomination of an approved second person (as defined above) must be made by the nurse in charge, and detailed in a locally developed protocol.

Approved Second Persons for S8 and S4D medicines handling but NOT administration or destruction: • Pharmacy staff members who have been approved by the Pharmacy Site Manager to handle but not

administer or destroy S8 and S4D medicines, within their scope of practice, while working under the direct supervision of an authorised person. Details of such approval must be clearly stated in a locally developed protocol.

NB: An Approved Second Person is NOT approved to act as witness for the destruction of S8 medicines unless specifically authorised to do so by the DHHS Pharmaceutical Services Branch, as outlined in Destruction of S8 Medicines of this document.

It is the responsibility of all registered medical practitioners, nurse practitioners, and dental practitioners involved in the supply of S8 and S4D medicines to remain current and compliant with Tasmanian legislation pertaining to the prescribing of S8 and S4D medicines.

(8)

In patient treatment areas, the key (or other right of access) to the S8 or S4D medicines safe is the responsibility of the nurse in charge, or another authorised person, as delegated by the nurse in charge. In Pharmacy, the key (or other right of access) to the S8 safe is the responsibility of the Pharmacy Site Manager, or a delegate as authorised by the Pharmacy Site Manager, such as the Dispensary Manager or on-call pharmacist.

It is the responsibility of Pharmacy Managers and Nurse Managers to ensure all patient treatment and support staffs comply with the requirements of this policy at all times.

It is the responsibility of all staff involved in the handling of S8 and S4D medicines to uphold the mandatory requirements of this policy to ensure the safe and legally compliant management of these medicines.

Risk Implications

S8 and some S4D medicines are often identified as being addictive in nature and have a high potential for abuse. In addition, narcotics and sedative agents are also identified as being high-risk medications with which error or misadventure is more likely to result in devastating outcomes, as outlined in SPP-MSR: High Risk Medication Management Policy.

Measures taken for the control of these medicines in Tasmanian health services, as outlined by this policy, are imposed to ensure patient safety, maximum staff accountability, and to avoid access to medicines for abuse and illegal commerce.

Failure to comply with this policy, without providing a good reason for doing so, may lead to disciplinary action.

This is a state-wide policy and must not be re-interpreted so that subordinate policies exist. Should discreet operational differences exist, these should be expressed in the form of an operating procedure or protocol.

Training

All sites must provide adequate training to staff to ensure:

• All staff members involved with the management of S8 and S4D medicines are trained in identifying S8 and S4D medicines.

• All staff members involved with the management of S8 and S4D medicines are familiar and compliant with this statewide policy.

• All staff members involved with the management of S8 and S4D medicines are familiar and compliant with local protocols for the safe and legally compliant handling of S8 and S4D medicines.

Audit

All S8 and S4D Registers, and all documentation associated with ordering, transferring, and the destruction of S8 and S4D medicines, must be held for a minimum period of TWO years and made available for audit by external governance, such as the DHHS Pharmaceutical Services Branch, as required.

(9)

All such evidence of S8 and S4D medicines transactions must also be audited regularly and frequently by Pharmacy and Nurse Managers or delegates, in accordance with local protocols and legislative requirements.

Any deviation from this policy is considered to be a reportable incident and should be documented in the approved incident reporting system, as per DHHS policy.

Attachments

1. Best Practice Addendum – Benzodiazepine Administration and Documentation

2. DHHS: Enrolled Nurse Scope of Practice - Medication Administration and Intravenous Fluid Management Policy 3. DHHS: Incident Reporting and Management Policy

4. SPP-MSR: High-Risk Medication Management Policy 5. SPP-MSR: Storage of Medicines Policy

6. SPP-MSR: The use of the National Inpatient Medication Chart Policy 7. SPP-MSR: Management and Disposal of Unwanted Medicines Policy 8. SPP-MSR: High Risk Medication Management Policy

9. SPP-MSR: Authority to Prescribe Medications Policy. 10. Poisons Act 1971

11. Poisons Regulations 2008

Best Practice Addendum

Benzodiazepine Administration and Documentation

• In acute hospitals and wherever possible in other health services, to ensure patient safety and staff protection, the administration of BENZODIAZAPINE medicines must be witnessed and co-signed on the medication order by a second person authorised to do so, as defined in the Roles and Responsibilities/Delegates section of this policy (i.e. TWO authorised signatures must be present on the National Inpatient Medication Chart (NIMC) or other approved ancillary chart.) This practice should also occur wherever possible at all other health services.

This Best Practice Addendum is mandatory in Tasmanian Health Organisation South (THO-S) and Tasmanian Health Organisation North-West (THO-NW), and wherever practicable in Tasmanian Health Organisation North (THO-N).