Download Schedule 8 and Declared Schedule 4 Medicines

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
6 June 2014
2 June 2014
3 June 2014
THO-N Chief Executive Officer
THO-NW Acting Chief Executive Officer
THO-S Acting Chief Executive Officer
Revision History
Version
Approved by name
Approved by title
Name
Position Title
Name
Position Title
Name
Position Title
Amendment notes
This Policy may be varied, withdrawn or replaced at any time.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.
Page 1 of 9
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.
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.
Page 2 of 9
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
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.
Page 3 of 9
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.)
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.
Page 4 of 9
•
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.
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.
Page 5 of 9
•
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.
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.
Page 6 of 9
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.
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.
Page 7 of 9
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 oncall 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.
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.
Page 8 of 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 cosigned 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).
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.
Page 9 of 9