Department f Health and Human Services SYSTEM PURCHASING AND PERFORMANCE - MEDICATION STRATEGY AND REFORM User Applied Labelling f Injectable Medicines, Fluids and Lines Plicy SDMS Id Number: Effective Frm: June 2014 Replaces Dc. N: Custdian and Review Respnsibility: Cntact: Applies t: Plicy Type: Plicy ID (as assigned by Crprate Dcument and Infrmatin Services) P2011/0014-001 Review Date: July 2017 Keywrds: Rutine Disclsure: SPP Medicatin Strategy and Refrm Directr, Medicatin Strategy and Refrm THO-Nrth, THO-Suth, THO-Nrth West DHHS wide Plicy Injectable medicines, safety, fluids, medicatin lines, labelling Yes Apprval Prepared by Sulfi Newbld Medicines Plicy Officer 61661029 16 May 2014 Thrugh Thrugh Cleared by Anita Thmas Senir Specialist Pharmacist Quality Use f Medicine THO-N Medicatin Management and Safety Cmmittee THO-NW Medicatin Safety & Imprvement Cmmittee THO-S Quality Use f Medicine Cmmittee Jhn Kirwan Karen Linegar Matthew Daly THO-N Chief Executive Officer THO-NW Acting Chief Executive Officer THO-S Acting Chief Executive Officer 61661086 16 May 2014 16 May 2014 6 June 2014 2 June 2014 3 June 2014 Revisin Histry Versin Apprved by name Apprved by title Amendment ntes Psitin Title Psitin Title Psitin Title This Plicy may be varied, withdrawn r replaced at any time. Cmpliance with this directive is mandatry fr the Department f Health and Human Services. PLEASE DESTROY PRINTED COPIES. The electrnic versin f this Plicy is the apprved and current versin and is lcated n the Department f Health and Human Services Strategic Dcument Management System. Any printed versin is uncntrlled and therefre nt current. Page 1 f 5
Purpse The Natinal Recmmendatins fr User Applied Labelling f Injectable Medicines, Fluids and Lines (Labelling Recmmendatins) were develped by the Australian Cmmissin n Safety and Quality in Healthcare (ACSQHC) between 2009 and 2010, and apprved by the Australian Health Ministers n 12 Nvember 2010. The key purpse f implementing the principles f the Labelling Recmmendatins in all THO clinical services is t enhance patient safety, and imprve health utcmes, by reducing the incidence f administratin errrs related t injectable medicines. Mandatry Requirements Key Definitins: Injectable medicine refers t any sterile medicine r fluid intended fr administratin by blus injectin, perfusin r infusin, including but nt limited t the fllwing rutes: intravenus, intramuscular, intrathecal, intra-arterial, subcutaneus, intradermal, intraventricular, epidural, intravascular, intravitreal, intraplueral, and intracular. THO refers t the Tasmanian Health Organisatins - Nrth, Nrth West and Suth. Clinical services refers t all health service delivery areas and peratinal units within the THO. Labelling Recmmendatins refers t the Natinal Recmmendatins fr User Applied Labelling f Injectable Medicines, Fluids and Lines prepared by the Australian Cmmissin n Safety and Quality in Healthcare (ACSQHC). All clinical services that administer injectable medicines must cmply with the Labelling Recmmendatins. All health prfessinals with respnsibility fr the safe use f medicines must be aware f the Labelling Recmmendatins. All cntainers (e.g. intravenus bags, bttles, r syringes) cntaining medicines, leaving the hands f the persn preparing the medicine, must be labelled. (Sme exemptins apply see belw.) The user may chse t apply labelling even if the cntainer des nt leave their hands. Only ne injectable medicine at a time shuld be prepared and labelled befre the preparatin and labelling f a subsequent medicine. Any injectable medicine that cannt be identified (e.g. an unlabelled syringe r ther cntainer) shuld be cnsidered unsafe and discarded. This plicy prvides the minimum requirements fr labelling and des nt remve the need fr ther quality and safety prcesses that cntribute t the safe administratin f injectable medicines. This Plicy may be varied, withdrawn r replaced at any time. Cmpliance with this directive is mandatry fr the Department f Health and Human Services. PLEASE DESTROY PRINTED COPIES. The electrnic versin f this Plicy is the apprved and current versin and is lcated n the Department f Health and Human Services Strategic Dcument Management System. Any printed versin is uncntrlled and therefre nt current. Page 2 f 5
Rute f administratin must be identified n all administratin lines that are cnnected t the patient, even if nly ne line is in-situ. Invasive mnitring lines must be labelled even if nt intended fr medicine administratin. The design f lcally available user applied labels shuld be based n thse described by the Labelling Recmmendatins, and implemented n a statewide basis, including: a standardised clur system identifying rute f intended administratin label infrmatin including ttal amunt f active ingredient, vlume f fluid and cncentratin (units/ml), and label placement fr bags and syringes. A range f labels that represents the full extent f likely administratin rutes is required fr each individual ward/unit. Label stcks at the individual ward/unit level must be maintained t ensure they are easily available when required. Implementatin shuld be based n the Labelling Recmmendatins and the assciated explanatry ntes and implementatin guide. Exemptins: Injectable medicines prepared by Pharmacy departments, external manufacturers, r cmpunding centres (e.g. pre-mixed ptassium bags, fluids labelled by manufacturer with n further additives, ttal parenteral nutritin) are utside the scpe f this plicy 1. The labelling f any cntainer which cannt be directly administered t a patient (e.g. ampules and individual patient multi-dse vials) is utside the scpe f this plicy 1. AS/NZS 4375: User applied labels fr use n syringes cntaining anaesthesia prvides guidance n drugs given via syringes in anaesthesia. This is a statewide plicy and must nt be re-interpreted s that subrdinate plicies exist. Shuld discreet peratinal differences exist, these shuld be expressed in the frm f an perating prcedure r prtcl. Failure t cmply with this plicy, withut prviding a gd reasn fr ding s, may lead t disciplinary actin Rles and Respnsibilities/Delegatins Medicatin Strategy and Refrm Create, and review the plicy, with sufficient input frm THO stakehlders Assist THOs in the audit f the plicy and facilitate statewide benchmarking Assist implementatin within THO. This Plicy may be varied, withdrawn r replaced at any time. Cmpliance with this directive is mandatry fr the Department f Health and Human Services. PLEASE DESTROY PRINTED COPIES. The electrnic versin f this Plicy is the apprved and current versin and is lcated n the Department f Health and Human Services Strategic Dcument Management System. Any printed versin is uncntrlled and therefre nt current. Page 3 f 5
THO CEO Nurse Unit Managers r ther managers f perating areas Clinical Staff Purchasing departments Ensure that the plicy is implemented and supprted acrss their area f respnsibility. Ensure that the plicy is disseminated t applicable staff. Prvide resurces t implement the plicy (including access t training, required labels). Participate in auditing f the plicy as required. Fllw the plicy and reprt nn-cmpliance within the apprved incident reprting system. Ensure that the full range f labels is available fr perating units t rder withut supply interruptin. Risk Implicatins Harm and death frm medicine administratin errrs as a result f inadequate labelling is a recgnised issue acrss the wrld, and has been identified in Australia as a cntributry factr t administratin errrs 1. Medicine labelling is als a cntributr t the frequent errrs related t administratin f injectable medicines in anaesthetic practice 1. Inadequate labelling f injectable medicines and lines leads t a number f different types f errrs including: medicine swaps where the incrrect drug is given wrng rute f administratin, and administratin t the wrng patient. It has been shwn that errrs in injectable medicine administratin are less likely t ccur when a single persn is respnsible fr preparing and labelling each injectables medicine, and that medicines in well labelled syringes are mre likely t have been prepared crrectly 1. A standardised prcess, and clear labelling f injectable medicines and fluids accrding t the Labelling Recmmendatins, will reduce the risk f medicine administratin incidents relating t injectables, and imprve health utcmes. Training All clinical service staff wh handled medicatin must be aware f, and apprpriately trained in, the principles f the Labelling Recmmendatins. Audit Audits t assess plicy cmpliance must be undertaken annually using the apprved audit tl, available thrugh Medicatin Strategy and Refrm. This Plicy may be varied, withdrawn r replaced at any time. Cmpliance with this directive is mandatry fr the Agency (Department f Health and Human Services and Tasmanian Health Organisatins). PLEASE DESTROY PRINTED COPIES. The electrnic versin f this Plicy is the apprved and current versin and is lcated n the Department f Health and Human Services Strategic Dcument Management System. Any printed versin is uncntrlled and therefre nt current. Page 4 f 5
This plicy will be included in the wrk prgram f the DHHS Internal Audit functin. This wrk prgram is apprved by the Audit and Risk Cmmittee and will assess underlying systems and prcedures fr cmpliance with the requirements f this plicy. The verall fcus f this assessment will be ne f cntinuus imprvement t DHHS activities. Attachments 1 Australian Cmmissin n Safety & Quality in Healthcare. Natinal Recmmendatins fr User Applied Labelling f Injectable Medicines, Fluids and Lines Cmmnwealth f Australia, Darlinghurst, 2010. This Plicy may be varied, withdrawn r replaced at any time. Cmpliance with this directive is mandatry fr the Agency (Department f Health and Human Services and Tasmanian Health Organisatins). PLEASE DESTROY PRINTED COPIES. The electrnic versin f this Plicy is the apprved and current versin and is lcated n the Department f Health and Human Services Strategic Dcument Management System. Any printed versin is uncntrlled and therefre nt current. Page 5 f 5