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Medication Safety SELF ASSESSMENT for Antithrombotic Therapy in Australian Hospitals

Medication Safety Self Assessment® for Australian Hospitals

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Medication SafetySELF ASSESSMENTfor Antithrombotic Therapy in Australian Hospitals

Medication SafetySELF ASSESSMENTfor Antithrombotic Therapy in Australian Hospitals

� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

Safe and appropriate use of medicines is critical to ensuring patient safety in hospitals. A 2002 report from the Australian Council for Safety and Quality in Healthcare estimated that there were approximately 140,000 hospital admissions each year associated with problems with the use of medicines. The cost of these errors was estimated at $380 million per year in public hospitals alone.1

Much is known about the causes and prevention of medication errors. Many organisations have made important breakthroughs in the design and performance of safer systems in healthcare over the past several years. Advances in both patient safety and efficiency have been reported as a result of the effective use of guidelines, protocols and evidence-based medicine, the use of computerised medical records and the use of technology.

Tools are available to assist hospitals in developing safer medication systems. One such tool is the Medication Safety Self Assessment® for Antithrombotic Therapy in Australian Hospitals which was originally developed by the Institute for Safe Medication Practices (www.ismp.org).The NSW Therapeutic Advisory Group (NSW TAG) with the support of the NSW Clinical Excellence Commission (CEC) and the permission of ISMP has adapted the tool for use in Australia. Adaptation has included extensive field testing in a range of hospitals across Australia including public, private, metropolitan and rural hospitals. A web-based program has been developed by CEC to allow hospitals to enter their data online. This program will be available to all hospitals across Australia.

Appropriate use of antithrombotic therapy can result in significant benefit to a large number of patients. However, antithrombotic medicines have a narrow therapeutic index, that is, the difference between a therapeutic dose and a toxic dose is small. Medication errors associated with antithrombotic therapy can be catastrophic. It therefore makes good sense to implement systems that specifically focus on the safe use of these medicines. We encourage hospitals to use this tool in addition to the Medication Safety Self Assessment for Australian Hospitals, so that safe systems for the use of antithrombotic therapy in hospitals can be assured.

This tool will help you assess the medication safety practices in your institution surrounding the use of antithrombotic therapy, identify opportunities for improvement and compare your experience with the aggregate experience of demographically similar hospitals. Antithrombotic use is a complex, multidisciplinary process. Many characteristics of your hospital’s systems must be assessed from the perspective of various practitioners in order to understand and improve the process. The self assessment should therefore be completed by a multidisciplinary team. We encourage you to implement this self assessment program as part of your ongoing quality improvement activities.

We strongly urge all Australian hospitals to participate. For more information on the use of the Medication Safety Self Assessment for Antithrombotic Therapy in Australia send an email in the first instance to [email protected].

Sincerely,

Karen Kaye Clifford Hughes Executive Officer Chief Executive Officer NSW Therapeutic Advisory Group Clinical Excellence Commission

1. Safety and Quality Council (July 2002) Second National Report on Patient Safety: Improving Medication Safety. Commonwealth Department of Health, Canberra

Foreword

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | �

Introduction to the CEC, NSW TAG and ISMP . . . . . . . . . . . . . . . . . 4

Australian Adaptation and Acknowledgements . . . . . . . . . . . . . . 6

About the Medication Safety Self Assessment for Antithrombotic Therapy In Australian Hospitals . . . . . . . . . . . 8

Instructions for Conducting the Self Assessment . . . . . . . . . . . .10

Key Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Demographic Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Survey Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Contents

� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

About The Clinical Excellence Commission (CEC)The core mission of the CEC is to identify issues of a systemic nature that affect patient safety and clinical quality in the NSW health system and to develop and advise on implementation strategies to address these issues. Part of the role of the CEC is to acquire and share information about how well the NSW health system is performing and to use this information to improve the performance of the system.

The formation of the CEC comes at a time when we are developing a new way of looking at, and an understanding of, health care. Although the standard of health care available to the public is now better than it has ever been, health professionals and their agencies have a greater appreciation of where things can go wrong and acknowledge the role the entire system can play in this.

Today, analysis of quality and safety in health care looks directly at the nature of human and system error. There is also a change in culture from that of individuals working on their craft to teams of professionals working together.

In addition to addressing safety and quality issues the CEC is charged with identifying, developing and sharing information about safe practices in health care.

This includes developing, providing and promoting training and education programs as well as identifying priorities for, and promoting research into, better health care practices.

The CEC reports annually to the NSW Minister for Health with a focus on:

• Promoting and supporting improvement in clinical quality and patient safety;

• Consulting broadly with health professionals and members of the community;

• Identifying and sharing information about safe health care practices across the State via training and education programs; and

• Monitoring clinical quality and safety processes in Area Health Services.

The CEC has been established as a statutory health corporation under the Health Services Act 1997.

For more information, visit CEC online at www.cec.health.nsw.gov.au

Introduction to the CEC, NSW TAG and ISMP

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | �

About NSW TAGThe New South Wales Therapeutic Advisory Group Inc (NSW TAG) is an independent, not-for-profit association representing Drug & Therapeutics Committees in NSW hospitals. Its members include clinical pharmacologists, pharmacists, nurses and other clinicians from NSW hospitals and affiliated academic units. NSW TAG was formally incorporated as a not-for-profit association in 1994. It receives funding from the NSW Department of Health.

The goal of NSW TAG is to achieve quality use of medicines in NSW, through involvement of all stakeholders. In pursuing this goal NSW TAG focuses on providing information, advice and support to decision-makers in NSW public hospitals, the NSW Department of Health and other relevant organisations.

The objectives of NSW TAG are:

• To investigate and evaluate new initiatives in therapeutics

• To support Drug and Therapeutics Committees

• To promote rational, high quality, safe and cost-effective use of medicines in public hospitals and the wider community.

For more information, visit NSW TAG online at www.nswtag.org.au

About ISMPThe Institute for Safe Medication Practices (ISMP), based in Philadelphia, is the USA’s only not-for-profit organisation devoted entirely to medication error prevention and safe medication use. The organisation is known and respected worldwide as the premier resource for impartial, timely, and accurate medication safety information. ISMP was formally incorporated as a not-for-profit organisation in 1994. ISMP organisations now also exist in Canada and Spain.

The Institute’s medication error prevention efforts began in 1975 with a groundbreaking and continuing column in Hospital Pharmacy that increases understanding and educates healthcare professionals and others about medication error prevention. An adapted version of this column, the Medication Safety Series, is now published in Australia in the Journal of Pharmacy Practice & Research. See www.shpa.org.au for access.

Today, a continuously expanding core of knowledge in medication safety fuels the Institute’s highly effective initiatives to improve the medication use process. These initiatives, which are built upon a non-punitive approach and system-based solutions, fall into five key areas: knowledge, analysis, education, cooperation, and communication.

More than 25 years ago, ISMP started a cornerstone of its medication error prevention efforts – a voluntary practitioner error-reporting program to learn about errors happening across the USA, understand their causes, and share “lessons learned” with the healthcare community. Each

year, the national Medication Errors Reporting Program (MERP), operated by the United States Pharmacopeia (USP) in conjunction with ISMP, receives hundreds of error reports from healthcare professionals. In addition, ISMP’s wholly owned corporate subsidiary, Med-E.R.R.S (Medical Error Recognition and Revision Strategies), works directly and confidentially with the pharmaceutical industry to prevent errors that stem from confusing or misleading drug names, labels, and packages.

The Institute’s other initiatives include publishing four medication safety newsletters for healthcare professionals and consumers that reach more than 3.5 million readers; presenting frequent educational programs, including teleconferences, on current medication use issues; offering posters, videos, patient brochures, books and other resources; and providing confidential consultation services to healthcare systems to proactively evaluate medication systems or analyse medication-related sentinel events.

ISMP collaborates on a continuing basis with a wide variety of healthcare practitioners, legislative and regulatory bodies, healthcare institutions, healthcare professional organisations, regulatory and accrediting agencies, employer and insurer groups, and the pharmaceutical industry.

As an independent watchdog organisation, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its lifesaving work.

For more information, visit ISMP online at www.ismp.org.

� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

ISMP has given approval to New South Wales Therapeutic Advisory Group (NSW TAG) to adapt the US version of the ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Hospitals, so as to make it suitable for use in Australian Hospitals. In adapting the ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Hospitals the advisory team considered differences between the North American and Australian environments in terms of hospital practice, drug distribution systems, legislation and product availability. Some questions that were not applicable to Australian conditions were removed. Some other questions relate to systems which are not yet widely adopted in Australian hospitals but are desirable and feasible in the future. These questions have been retained in the Australian adaptation.

NSW TAG and CEC gratefully acknowledge the contribution of the following individuals who provided direction for the Australian adapted version of the ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Hospitals.

Institute for Safe Medication Practices (ISMP)Allen Vaida PharmD, FASHP Executive Director Institute for Safe Medication Practices, USA

Matthew P. Fricker, Jr MS RPh Program Director Institute for Safe Medication Practices, USA

David U B.Sc.Phm, M.Sc.Phm. President and Chief Executive Officer Institute for Safe Medication Practices, Canada

Australian Advisory PanelKaren Kaye B Pharm Dip Hosp Pharm FSHP Executive Officer, NSW TAG, Sydney

Maria Kelly B Pharm Dip Ed Executive Officer, NSW TAG, Sydney

Amanda Thomson MBBS FRACP FRCPA Senior staff specialist, Dept of Haematology and Transfusion, Royal North Shore Hospital, Sydney

Meredith Verge B Pharm Dip HPharm BCPS Education and Training Pharmacist Royal North Shore Hospital, Sydney

Joanne Joseph MBBS MD FRACP FRCPA Staff Specialist Department of Haematology St Vincent’s Hospital, Sydney

Australian Adaptation and Acknowledgements

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | �

Project Steering CommitteeAndrea Mant (Chair) QUM Advisor, South Eastern Sydney and Illawarra Area Health Service

Yvonne Allinson Chief Executive Officer, The Society of Hospital Pharmacists of Australia

Margaret Arblaster Associate Director, Improving Performance, Quality and Safety Branch, NSW Health

George Bearham Deputy Chief Executive Officer, Clinical Excellence Commission

Rosemary Burke Director of Pharmacy, Concord Repatriation General Hospital

Andre Jenkins Director, Information Management, Clinical Excellence Commission

Margaret Duguid Director of Pharmacy, Royal North Shore Hospital

Penny Thornton Pharmacy Services Manager, The Children’s Hospital at Westmead

Gabrielle Couch Acting Area Pharmacist, Greater Southern Area Health Service

Maureen Robinson General Manager, Improvement Practice, Communio and formerly Executive Manager, Development, the Australian Council on Healthcare Standards

Christine Farraway Team Leader - Performance and Outcomes Service, the Australian Council on Healthcare Standards (ACHS)

Roger Boyd Director, Boyd Health Management and Chairman, National Prescribing Service

David Hutton Director, Clinical Governance, North Coast Area Health Service

Madlen Gazarian Paediatric Clinical Pharmacologist & Rheumatologist, Sydney Children’s Hospital

Jeanette Upton Quality Manager, Newcastle Mater Misericordiae Hospital

Lynn Weekes Chief Executive Officer, National Prescribing Service

Noelene Burt Consumer representative, Consumer Health Forum

Richard McCluskey Consumer representative, Consumer Health Forum

NSW TAG Project TeamKaren Kaye Executive Officer, NSW TAG

Maria Kelly Executive Officer, NSW TAG

Helen Stark Project Officer, NSW TAG

Jocelyn Lowinger Project Officer, NSW TAG

Field Test HospitalsBankstown-Lidcombe Hospital, NSW

Boonah Hospital, QLD

Broken Hill Base Hospital, NSW

Campbelltown Hospital, NSW

Concord Repatriation General Hospital, NSW

Goulburn Base Hospital, NSW

Orange Base Hospital, NSW

Royal Hobart Hospital, TAS

St Vincent’s Private Hospital, NSW

Sydney Adventist Hospital, NSW

The Alfred Hospital, VIC

� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

The ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Australian Hospitals is designed to:

Heighten awareness of items related to the safe use of antithrombotic agents and create a baseline of hospital efforts to enhance safety with these agents and evaluate these efforts over time.

The self assessment is divided into eight key elements that significantly influence safe use of antithrombotic agents. Each key element is defined by one or more core characteristics of a safe medication system. Self assessment items are provided to help you evaluate your success with achieving each core characteristic.

The Medication Safety Self Assessment® for Antithrombotic Therapy in Australian Hospitals (MSSA-AT) is subject to copyright in the name of ISMP and has been adapted by NSW TAG with the permission of ISMP for use in the Australian health care environment. It may not be used in whole or in part for any other purpose or by any other entity except for self assessment by Australian hospitals.

ISMP and NSW TAG are not standards-setting organisations. As such, the self assessment items in this document are not purported to represent a minimum standard of practice and should not be considered as such. In fact, some of the self assessment criteria represent innovative practices and system enhancements that are not widely implemented in most hospitals today. However, their value in reducing errors is grounded in scientific research and expert analysis of medication errors and their causes.

About the Medication Safety Self Assessment for Antithrombotic Therapy In Australian Hospitals

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | �

Abbreviations

aPTT activated partial thromboplastin time

HIT heparin-induced thrombocytopaenia

INR international normalised ratio

LMW heparin

low molecular weight heparin

PT prothrombin time

Glossary (for purposes of this self assessment)

ANTITHROMBOTIC AGENTS include warfarin, heparin(s), heparinoids, Factor Xa inhibitors, direct thrombin inhibitors, thrombolytics, and glycoprotein IIb-IIIa inhibitors.

DIRECT THROMBIN INHIBITORSargatroban

bivalirudin (Angiomax®)

lepirudin (Refludan®)

THROMBOLYTICS (FIBRINOLYTICS)alteplase (Actilyse®)

reteplase (Rapilysin®)

streptokinase (Streptase®)

tenecteplase (Metalyse®)

GLYCOPROTEIN (GP) IIb-IIIa INHIBITORSabciximab (ReoPro®)

eptifibatide (Integrilin®)

tirofiban (Aggrastat®)

HEPARINOIDSdanaparoid (Orgaran®)

FACTOR Xa INHIBITORSfondaparinux (Arixtra®)

HEPARIN(S)unfractionated heparin

• sodium heparin

• calcium heparin

low molecular weight heparins• dalteparin (Fragmin®)

• enoxaparin (Clexane®)

• tinzaparin (Innohep®)

10 | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

1 Establish a multidisciplinary team to complete the Self Assessment. The team should at a minimum consist of appropriate representatives from medical, pharmacy and nursing professions. Ideally the following personnel should be included :

• At least one active staff doctor, preferably a haematologist

• At least two nurses from different specialty areas who administer antithrombotic drugs

• At least one pharmacist who is involved in antithrombotic therapy

• Representative from the antithrombotic team and/or clinic (if team or clinic exists)

• Representative from clinical informatics and/or IT

• Patient safety officer

• Senior hospital administrator.

Your team should appoint a team leader who will be responsible for coordinating self assessment team activities.

Your team should be provided with sufficient time to complete the self assessment and be charged with responsibility to evaluate, accurately and honestly, the current status of medication practices in your facility. Because medication use is a complex, multidisciplinary process, the value and accuracy of the self assessment is significantly reduced if it is completed by a single discipline. We estimate that it will take three team meetings to complete the self assessment.

2 Read and review the self assessment document. Each team member should read and review the self assessment in its entirety before the assessment process begins. The copyright allows you to make copies of the self assessment for internal use.

3 Complete the “Demographic Information” section. The team leader should verify the responses in this section with the hospital’s administration.

4 Convene the first team meeting.

5 Discuss each core characteristic and evaluate the hospital’s success with implementing the self assessment items. As necessary, investigate and verify the level of implementation with other healthcare practitioners outside your team. When a consensus on the level of implementation for each self assessment item has been reached, place a checkmark (√) in the appropriate column using the following scoring key.

Instructions for Conducting the Self Assessment

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | 11

Important Scoring GuidelinesFor all self assessment items: Unless otherwise stated, self assessment items refer to medications prescribed, dispensed, and administered to all inpatients and outpatients, including patients admitted to the emergency department and ambulatory surgery/procedure units.

For self assessment items with multiple components: Full implementation (score D or E) is evidenced only if all components are present in some or all areas of the organisation. If only one or some of the components have been partially or fully IMPLEMENTED throughout the organisation, self assessment scores should not exceed level C.

For self assessment items with two or more distinct elements, each separated with the word, “OR” and labelled (A) and (B): Answer either part (A) OR part (B), but not both.

For self assessment items that offer an option for “Not Applicable”: Select “Not Applicable” only if the item does not correspond to any services you provide in your hospital, either to inpatients or outpatients. Scores will not be negatively affected for selecting “Not Applicable” where appropriate.

6 Repeat the process for all self assessment items.

If you have questions, please refer to the Frequently Asked Questions (FAQ) section of this document or go to the Frequently Asked Questions section of our website at http://www.cec.health.nsw.gov.au/mssa. If you require additional assistance please send your enquiry to [email protected].

7 Take advantage of the web-based program. This program provides hospitals with a report based on a weighted scoring system developed by ISMP. Once the self assessment has been completed by the team, send an email to [email protected] to obtain a password to access the web-based program. (For more information about ISMP’s weighted scoring system refer to the FAQ section of this document).

Once you have received your password, you can submit data from the completed self assessment to the CEC electronically through the secure web site at http://www.cec.health.nsw.gov.au/mssa. The Medication Safety Self Assessment page has a tab entitled Enter Survey/See Results. On this page is the field to enter your password and access the MSSA-AT. The special web-based survey tool will immediately download the information onto a database maintained by CEC and provide you with an online report for your hospital. If you subsequently repeat the self assessment process, you will be able to compare your results online. If you wish, you can also compare your results with geographically or demographically similar hospitals. No data will be maintained on the Internet survey form after it has been submitted. Confidentiality will be assured.

Scoring Key

Score Interpretation

A There has been no activity to implement this item, that is, this item has never been considered.

B This item has been formally discussed and considered, but it has not been implemented.

C This item has been partially implemented in the organisation for some or all areas,patients, drugs, and/or staff.

D This item is fully implemented in the organisation for some areas, patients, drugs, and/or staff.

E This item is fully implemented throughout the organisation for all patients, drugs, and/or staff.

1� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

CAREGIVERFamily member, friend, or other person assisting or monitoring the patient’s adherence to instructions in the outpatient setting.

COMPUTERISED PRESCRIBER ORDER ENTRY (CPOE)A computer-based system of ordering medications. Prescribers directly enter orders into a computer system that can have varying levels of sophistication. Also known as “e-prescribing”. (In the USA the acronym relates to Computerised Physician Order Entry and may refer to systems for other orders e.g. diagnostic tests as well as medications).

DRUG AND THERAPEUTICS COMMITTEE (DTC)A multidisciplinary committee that convenes on a scheduled basis, or when necessary, to review the safety, use, efficacy, and monitoring of medications that will be available for use in the hospital. The committee also sets policy and procedures, on behalf of the medical staff and hospital administration, on safety of medication use processes.

ERROR-PRONE ABBREVIATIONSCertain medical abbreviations, symbols, and dose designations that are considered dangerous and have often contributed to serious medication errors. A complete list can be found at www.ismp.org. (An Australian guide to error-prone abbreviations is available at www.nswtag.org.au).

HIGH-ALERT MEDICATIONS Medications that have a high risk of causing serious injury or death to a patient if they are misused. Errors with these products are not necessarily more common, but their results can be more devastating. Examples of HIGH-ALERT medications include warfarin and intravenous (IV) antithrombotics, insulin, chemotherapy, concentrated electrolytes, IV digoxin, opiate narcotics, neuromuscular blocking agents, and adrenergic agonists. A complete list can be found at www.ismp.org.

IMPLEMENTEDAccomplished or achieved in practice, not just policy; carried into effect.

INDEPENDENT DOUBLE CHECKA procedure in which two individuals, preferably two registered practitioners, separately check each component of the work process. An example would be one person calculating a medication dose for a specific patient and a second individual independently performing the same calculation (not just verifying the calculation) and matching the results. This would involve for example, checking the accuracy of the dose/kg and the weight being used in the calculation. In the case of receiving a telephone order an INDEPENDENT DOUBLE CHECK means that the order must be read back to the prescriber (in figures and words – eg 50mg: fifty milligrams, five 0 mg). As a further check, the prescriber should repeat the order to a second person.

Key Definitions (for purposes of the self assessment tool)

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | 1�

INTERFACEDA direct link between two information systems in which information from one system is immediately available to the user of the second system, and integrated in a way that supports clinical decision making (e.g. interfacing the laboratory and pharmacy computer systems would immediately provide corresponding laboratory data to the pharmacist while he/she is entering a specific medication order). This may or may not include a bi-directional interface of the systems to allow communication in both directions.

MACHINE-READABLE CODINGAny encoded identifying mark (e.g. bar code) representing data that can be read with a computerised reading device, such as a scanner or imager.

MEDICATION Medication includes: prescription medications; herbal remedies; vitamins; nutraceuticals; over-the-counter medicines; vaccines; diagnostic and contrast agents used on or administered to persons to diagnose, treat, or prevent disease or other abnormal conditions; radioactive medications; respiratory therapy treatments; parenteral nutrition; blood derivatives; intravenous solutions (plain, with electrolytes and/or drugs); and any product designated by the Therapeutic Goods Administration (TGA) as a drug. The definition of medication does not include enteral nutrition solutions (which are considered food products), oxygen, and other medical gases.

MEDICATION ADMINISTRATION RECORD (MAR)The medication administration record provides a documentation of medication administration. In the USA and in many electronic medication management systems, the doctor’s prescription is on a separate document or screen and the medications are transferred (either manually or electronically) onto a separate record of medication administration. Currently, in Australia when medications are prescribed manually, the medication chart combines the doctor’s prescription and the medication administration record in the one document.

MEDICATION DEVICESEquipment such as infusion pumps, implantable pumps, syringes, tubing, patient controlled analgesia pumps, automated compounding devices, robotics, and other related devices that are used for medication preparation, dispensing, and administration.

ORDER SETSA set group of medicines which according to protocol are standard treatment for a specific condition and are prescribed as a complete set.

PRACTITIONERA registered healthcare professional such as a doctor, nurse or pharmacist.

SMART INFUSION PUMPAn infusion pump with computer software that is capable of alerting the user to unsafe dose limits and programming errors if standard concentrations and dose limits have been programmed into the pump’s library.

UNIT-DOSEUnit dose is a system of packaging whereby each dosage unit is separately packed in a protectively sealed unit and labelled with the name of the medicine, strength, dose contained within the pack, batch number and expiry date. The presentation should minimise or eliminate the preparation required for the medicine to be administered. Unit dose packaging should be consistent with requirements of the Society of Hospitals Pharmacists of Australia Drug Design and Presentation Guidelines. The advantage of a unit dose system is that each dosage unit is identifiable up to the point of administration. Dosage integrity minimises wastage as unused doses may be reissued. (For more information, refer to the Society of Hospital Pharmacists of Australia Standards of Practice for the Distribution of Medicines in Australian Hospitals. June 2006, J Pharm Pract Res 2006; 36(2): 143-9).

WARD or IMPREST STOCKMedications that are not labelled or stored for a specific patient that are available outside the pharmacy. This would include medications stored in medication rooms, storage cabinets, and automated dispensing cabinets for potential administration to various patients.

Key terms with definitions are designated throughout the text with CAPITAL LETTERS.

1� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

General QuestionsWhat are the benefits of completing the assessment and submitting data online?

Aggregate results from a large pool of respondents will provide Australian hospitals with important information about the status of the medication use system that can set a new baseline for future years. Such data will be useful in advising hospitals about ongoing medication system improvements.

There is community concern about medication safety in Australian hospitals. Use of self assessment tools can help by demonstrating that hospitals are being proactive in identifying safe practices and are able to track aggregate progress over time.

Use of this tool will be of significant assistance to hospital managers and clinicians who seek to identify areas of weakness in their organisation related to medication use and lead improvements in these critical areas.

The tool will provide hospital administrators, Area Health Services, health departments, quality and safety organisations and standards organisations with the ability to identify common medication system weaknesses in Australian hospitals, identify new areas of focus, and offer practical system enhancements, including those that are thought to provide the highest leverage for overall error reduction. Organisations will be able to focus additional educational efforts and design useful programs to help hospitals implement strategies that can positively impact patient safety.

How many team meetings should we schedule and do we need senior administrative staff on our team?

On the basis of feedback from hospitals that participated in the Australian field test of the Medication Safety Self Assessment® for Antithrombotic Therapy in Australian Hospitals we suggest that you schedule three team meetings of at least two hours duration. Some participants completed the assessment in less time and some have needed more than two hours at scheduled meetings. It is important to have a senior administrator at these meetings because the assessment contains many items that challenge or inquire about your organisation’s overall commitment to patient safety. Depending on the size of your organisation the attendance of the CEO may not be possible at all meetings, but a senior administrator for hospital operations should be in attendance for all meetings if possible.

What if a specific item doesn’t apply to the services provided in my hospital?

A few items list Not Applicable as a choice if the item doesn’t apply to services provided in your hospital. For example, if you don’t provide epidural anaesthesia in your hospital, you can answer Not Applicable to this question. There are also questions pertaining to the use of Glycoprotein (GP) IIb-IIIa inhibitors which have a Not Applicable option available for hospitals that do not use these products. However, for some smaller hospitals there will be questions where there is no Not Applicable option available (eg. provision of point-of-care testing services). For these items hospitals that do not provide these services should answer A or B.

FAQs for the 2006 ISMP Medication Safety Self Assessment® for Antithrombotic Therapy in Australian Hospitals

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | 1�

We are an Area Health Service with three hospitals that share many corporate functions (e.g. one DRUG AND THERAPEUTICS COMMITTEE, Risk Management, Information Technology, shared policies and procedures). Should we complete just one assessment for all three hospitals?

It is important that each hospital in a multi-hospital system complete the assessment individually and submit their data separately. The items in the assessment ask questions well beyond governance and policies and procedures that are in place. Each hospital will truly benefit if they complete the assessment individually and obtain their own individual set of scores.

How are individual items scored?

ISMP assigns a weight to each question for the purpose of working out an absolute score for the self assessment for each item, core characteristic, key element and the self assessment as a whole. These scores can be used to compare performance on repeated self assessments over time, for aggregrate comparisons across hospitals or for a specific group analysis.

Each item in the self assessment has a maximum score that ranges from 4 to 16 depending on the impact and long lasting effect of full implementation of each item on medication safety. Maximum scores for each question can only be achieved when items are fully implemented (score of E).

The scoring is not the same for all characteristics, as some identify situations representing a higher safety risk than others. Full implementation of some items provides a substantial reduction in risk so these items receive a higher potential score. ISMP bases decisions on how items should be weighted on data generated by the voluntary error-reporting program and the experience of ISMP staff in consultation with external expert groups.

Therefore, the self assessment items with the highest weight are those that:

• Target the system, not the workforce;

• Do not rely heavily upon human memory and vigilance;

• Demonstrate through scientific evidence that they are effective in reducing serious medication errors;

• Solve several medication-error related problems at the same time;

• Prevent errors with high-alert medications that have the greatest potential to cause patient harm;

• Simplify complex, error-prone processes;

• Safeguard high-risk patient populations; and

• Make it hard for healthcare practitioners to do their job incorrectly and easy for them to do it right.

An indication of how each weight is assigned follows:

Items that score a maximum of 16 often have a “forcing function” (see definition on following page) and/or a long lasting impact on safety. Examples include: computerised decision support systems that warn prescribers about unsafe orders (e.g. Adverse Drug Reactions including allergies, maximum doses, interactions); infusion pumps with smart pump technology; and items with demonstrated evidence that they are effective in reducing serious medication errors such as clinical pharmacy services.

Items that score a maximum of 12 have a slightly lower impact or long lasting effect on medication safety than items that score 16. Examples include: Computerised Prescriber Order entry (CPOE) system that is directly interfaced with the laboratory computer system; use of unit dose drug distribution systems; and independent double checks.

Items that score a maximum of 8 are of intermediate importance or impact. Examples include: use of preprinted forms to guide prescribing; use of prefilled syringes rather than vials or ampoules; and inability to enter orders into the pharmacy or CPOE system until patient’s weight and allergies have been entered.

Items that score a maximum of 4 do not carry as much long lasting effect or impact as the other categories. They usually involve human tasks and include: storage systems; prescribing tasks; staff training; and education.

NOTE: Some of the self assessment items are weighted in a way that results in no numerical score (zero value) unless there is full implementation of the item throughout the organisation.

Scores may range this way:

A B C D E0 1 2 3 4

0 2 4 6 8

0 3 6 9 12

0 1 8 12 16

Some questions may only provide a weight when the item is performed 100% of the time:

A B C D E0 0 0 0 4

0 0 0 0 8

0 0 0 0 12

0 0 0 0 16

1� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

Principles underpinning ISMP’s weighted scoring system

Avoid reliance on memory

The Institute of Medicine 2000 Report “To Err is Human: Building a Safer Health System”1 recommends that healthcare organisations use protocols and checklists wisely whenever appropriate. Rapid increases in knowledge and changing technology require that there is a process in place to ensure that protocols are regularly updated. Checklists should be constructed so that the usual state is answered as yes. Protocols for chemotherapy regimens and the use of heparin and insulin, for example, have been developed by many hospitals.

Other commonly used measures to reduce reliance on memory are the use of drug-drug interaction checking software and dosing cards (e.g. laminated cards that can be posted at nursing stations or carried in the pocket) that include standard order times, doses of antibiotics, formulas for calculating paediatric doses, and common chemotherapy protocols.

Constraints and Forcing Functions

Constraints and forcing functions are utilised to guide the user to the next appropriate action or decision and to structure critical tasks so that errors can’t be made. They are important in designing defaults for devices and for processes such as diagnostic and therapeutic ordering. When a device fails, it should always default to the safest mode; for example an infusion pump should default to shutoff, rather than free flow.

Examples of the use of constraints or forcing functions in ordering medications are e-prescribing systems that will not allow an order to be entered unless allergy information and patient weight are entered first. Another forcing function is the use of special luer lock connections for syringes and indwelling lines that have to be matched before fluid can be infused. Removal of concentrated potassium chloride from ward or imprest stock is a forcing function. Removing the agent from the wards has a much greater potential to prevent errors when compared with educating staff about its safe use.

1. Institute of Medicine: To err is human: Building a Safer Health System. Washington, D.C.:National Academy Press, 1999.

Questions related to specific self assessment items and demographic information

Demographic Information

Are there guidelines available for the choices in this section?

Hospital administration should be contacted for the correct responses when completing the demographic questions. Answers to questions such as staffed inpatient beds, type of organisation, type of services provided, shared ownership with a healthcare system, and location should be consistent with the responses your organisation submits to government agencies and on accreditation surveys and applications.

Specific self assessment items

1.8 What does “PRACTITIONER responsible for the patient” mean? Our laboratory notifies nurses immediately of all critical laboratory results.

The responsible PRACTITIONER would usually be the doctor who is responsible for the care of the patient and can write orders. The organisation should have a procedure that requires that the doctor caring for the patient is notified within an established timeframe.

1.12 and 1.13 What type of laboratory tests do these questions refer to?

These questions refer to laboratory tests carried out by external suppliers. Many hospitals have ambulatory areas and the laboratory values done by outpatient suppliers cannot be accessed. In scoring this question hospitals should consider accessibility to laboratory data specifically from external suppliers.

1.15 What is meant by “dosing-corrected weight”?

For certain patients, ideal body weight or actual weight cannot be used to safely calculate the appropriate dose for an antithrombotic agent. The organisation should have a medical staff approved formula that identifies these patients (e.g. a patient whose ideal or actual body weight falls outside of an established range) and provides a calculation for an adjusted weight that is used to provide the appropriate dose for the patient.

1.31 What is meant by the term “bridged” in this item?

When some patients are discharged on warfarin but have not yet achieved a therapeutic INR, doctors

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | 1�

for Australia and New Zealand”. The 3rd Edition was released in July 2005.

Hospitals may choose to adapt the ANZ guidelines and use them as the basis for developing local VTE prophylaxis policies and local VTE risk assessment tools. The development of local policies and guidelines on VTE prophylaxis is an important step in the implementation of effective systems to support best practice VTE prophylaxis. (Refer to National Institute of Clinical Studies (NICS) 2003 commissioned systematic literature review of effective interventions to improve uptake of VTE prophylaxis in hospitals which is available on the NICS website at www.nicsl.com.au).

2.20A and 2.20B What are some examples of dose range checks that should be performed by computer systems?

Examples of medication orders to perform testing on your computer system can be found below. These examples do not represent an exhaustive check of computer systems but can be used to identify categories (e.g. allergy checks, drug-drug interactions, maximum doses) of routine medication testing.

will prescribe a LMW heparin to be administered to the patient at home along with their warfarin therapy to provide adequate anticoagulation until their INR reaches a therapeutic level. The anticoagulation provided by the LMW heparin is often referred to as a “bridge” to the long-term anticoagulation that will be provided by warfarin. The organisation should develop protocols that define when bridge therapy would be prescribed. Often the decision is based on the patient’s diagnosis or type of surgical procedure that has been performed, (e.g. total joint replacement).

1.33 Where can I find appropriate guidelines for Venous Thromboembolism (VTE) prophylaxis and risk assessment?

There are many guidelines on VTE prophylaxis. One of the most commonly cited guidelines for VTE prophylaxis and the most comprehensive and authoritative one is the American College of Chest Physicians (ACCP) guidelines for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). These guidelines have been updated at regular intervals since they were first published and are currently in their 7th Edition (See Chest 2004; 126:338S-400S).

In Australia, the Australia and New Zealand Working Party on the Management and Prevention of Venous Thromboembolism produces a regular summary of the ACCP guidelines in a document titled “Prevention of Venous Thromboembolism Best Practice Guidelines

Sample Medication Orders for Computer Testing(The following are examples only. If you do not have the medications in the sample test orders on your formulary then use other medication examples that may fit the category listed.)

Allergies and cross allergies Enoxaparin 40 mg subcutaneously every 12 hours (patient with a heparin allergy)

Herbal-Drug Interactions Patient taking chamomile and also receiving warfarin Patient taking St. John’s Wort and also receiving warfarin

Contraindications/dose limits based on laboratory studies

Warfarin 5 mg daily (reported INR is 6)

Contraindications/dose limits based on patient age/weight

Fondaparinux 5 mg subcutaneously for 30 kg patient. (Fondaparinux should not be used in patients less than 50 kg.)

Single dose limit Eptifibatide 30 mg IV bolus

Contraindicated route of administration

Heparin 5,000 units IM Fondaparinux 5 mg IM

Therapeutic duplication within a drug class

Heparin infusion at a rate of 1,000 units/hr (patient on enoxaparin) Heparin 25,000 units in 250 mL Glucose 5% infuse at 1000 units/hr (patient received enoxaparin in emergency department within past 2 hours).

1� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

2.21 and 2.22 Our computer system doesn’t include enteral nutrition products so cannot provide an alert for these interactions? What should we do?

In Australia currently there is no interface between the nutrition and dietetics department and the pharmacy and the pharmacy computer system will not pick up drug-nutritional product interactions. In the absence of a computerised alert system hospitals should have a protocol in place to ensure that all staff working in relevant units are aware of potential interactions between antithrombotic agents and enteral feeds. For example, enteral feeds should be stopped three hours before warfarin dosing.

2.24 and 2.25 Where can I find information on protocols to guide the reversal of supra-therapeutic INR values?

Consensus guidelines for warfarin reversal were produced by the Warfarin Reversal Consensus Group on behalf of the Australasian Society of Thrombosis and Haemostasis in 2004.

MJA 2004;181(9):492:497 or go to MJA online: http://www.mja.com.au/public/issues/181_09_011104/bak10441_fm.html

3.1A All of our prescribers directly enter orders into our CPOE system. Do I answer E for this item?

Unless your CPOE system is integrated or directly interfaced (See Key Definitions section for a formal definition of interfaced) with your pharmacy computer system your answer should not exceed level C for this item. If pharmacy receives printed copies of orders from your CPOE system and/or must re-enter orders into the pharmacy system then your system is not fully integrated or interfaced.

3.2 Does this mean that any PRACTITIONER can screen medication orders in a computer system?

The intent of this item is that all new patient medication orders are entered and screened against the patient’s total medication profile in an electronic system by a pharmacist before the medication is dispensed and administered unless it is an emergency lifesaving situation (e.g. cardiac arrest). In a hospital without 24-hour pharmacy service this process should be performed by a doctor or appropriately trained nurse when a pharmacist is not available.

4.5A and 4.5B Pharmacy supplies the majority of GPIIb-IIIa solutions, either premixed products or pharmacy prepared, but we also prepare medications in the patient care area when pharmacy services are not available. Should I answer part (A) or part (B) of this item?

If you use manufacturer-prepared premixed GPIIb-IIIa platelet inhibitors and/or pharmacy-prepared GPIIb-IIIa platelet inhibitors then you should answer part 4.5A. If you also prepare these products in the patient care area then you should not answer higher than a C or a D for this item.

Answer part 4.5B if the pharmacy does not dispense a manufacturer-prepared premixed product and/or the pharmacy does NOT prepare the product.

Answer N/A if your hospital does not use GPIIb-IIIa inhibitors at all.

4.6B and 4.7B What do you mean by a disease-specific “kit” containing the protocol, drug, supplies needed for preparation, and preparation instructions?

We mean a ‘kit’ that contains the drug, diluents and any other equipment required to make up the preparation including labels, instructions for mixing and labelling according to the exact use. This is usually pre-prepared by the pharmacy in a kit (container or large bag) when pharmacy staff are not available to mix it. ISMP receives many reports of errors from improper mixing, dilution and administration of these drugs when someone is not familiar with the use for a particular disease state. This is especially true for those hospitals that “only” use it one way and then someone orders it for another indication and it is mixed and/or administered incorrectly. Even if hospitals only use it for one indication now they should be specific in the ‘kit’ for the indication (disease state).

4.10 Why should warfarin administration be scheduled for the same time each day, after INR results are available?

A standard dose time of 1600 (4pm) is recommended as this allows the medical team caring for the patient to order the next dose based on INR results, rather than leaving it for after-hours staff to do. In hospitals without resident medical staff a standard dose time should be determined by the hospital so that the dose can be ordered by the doctor responsible for the patient’s care.

8.4 We have a multidisciplinary team that shares error experiences but we do not routinely convene in person. Should we still answer E for this item?

In our experience, organisations that have set a routine time to meet for the purpose of sharing and analysing external and internal errors are more successful than those organisations that seldom meet or only meet when a sentinel event occurs. If you do not have routine face-to-face meetings your answer should not exceed C or D.

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | 1�

All questions in the demographic section must be completed unless otherwise noted as optional. We would hope that all questions are completed in order for us to better analyse the aggregate data and provide more concise demographic comparisons for hospitals.

1. Please tick the one category that best describes the number of inpatient beds currently set up and staffed for use in your hospital.

10 or less beds

> 10 to 50 beds

> 50 to 100 beds

> 100 to 200 beds

> 200 to 500 beds

More than 500 beds

2. Please tick the one category that best describes the type of organisation that is responsible for establishing policy for the overall operation of your hospital.

Public sector

Private sector

3. Please tick the one category that best describes the type of service that your hospital provides to the majority of its admissions.

General medical and surgical

Specialty: ENT

Specialty: Oncology

Specialty: Ophthalmology

Specialty: Paediatric

Specialty: Psychiatric

Specialty: Rehabilitation

Specialty: Women’s

Specialty: Women’s and Children’s

Other: ___________________________

Demographic Information

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4. Does your hospital also provide the following services? (tick all that apply)

Oncology services (tick even if chemotherapy is administered infrequently)

Paediatrics services (tick even if paediatric care is provided only in the emergency department and/or outpatient surgery)

Neonatal intensive care unit (tick for any level of service)

Trauma services (tick for any level of service)

Organ transplant services eg., liver, heart, lung, kidney etc

Maternity

Psychiatric

ENT

Ophthalmology

Other: ________________________________

5. Does your hospital provide venous duplex ultrasound imaging services 24 hours per day and 7 days per week?

Yes

No

6. Does your organisation have an inpatient antithrombosis team to manage patients with complicated thrombotic episodes?

Yes

Does the team include the following types of healthcare providers? (check all that apply)

Doctor

Pharmacist

Nurse

Dietician

Laboratory Technician

No

7. Does your hospital have an outpatient anticoagulation service/clinic affiliation?

Yes

Is the clinic/service staffed with the following healthcare providers? (check all that apply)

Doctor

Pharmacist

Nurse

Dietician

Laboratory Technician

No

8. Is your hospital one of several hospitals in a larger healthcare system with common ownership and/or governance?

Yes

How many hospitals comprise your health system?

2-5

6-10

Greater than 10

No

9. Please tick the one category that best describes the location of your hospital.

Metropolitan

Regional / Base

Rural / remote

10. How are pharmacy services managed in your organisation?

Internally

Externally

11. Does your hospital have a CLINICAL PHARMACY SERVICE?

Yes

No

12. Please tell us the State or Territory and the Area Health Service in which your hospital is located.

NSW

Greater Southern

Greater Western

Hunter/New England

North Coast

Northern Sydney/Central Coast

South Eastern Sydney/Illawarra

Sydney South West

Sydney West

Other

ACT

NT

QLD

SA

TAS

VIC

WA

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Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | �1

©2007 Institute For Safe Medication Practices®

1 PATIENT INFORMATIONA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 1

Essential patient information is obtained and readily available in a useful form when prescribing, dispensing and administering antithrombotic therapy.

A B C D E

1.1 A baseline haemoglobin, haematocrit, serum creatinine, PT, aPTT and platelet count are obtained prior to initiating antithrombotic therapy (inpatient or outpatient) with unfractionated heparin or low molecular weight (LMW) heparin.

1.2 During antithrombotic therapy (inpatient and outpatient) of more than 3 to 5 days with unfractionated heparin, a platelet count is repeated every 3 days during the first 2 weeks of therapy. For LMW heparin a platelet count is repeated weekly during the first 2 weeks of therapy.

1.3 After initiating a heparin infusion, an aPTT test is obtained 4 to 6 hours after the start of the infusion (unless bleeding occurs).

1.4 The INR is the only laboratory test used to monitor and adjust warfarin therapy.

1.5 Blood specimens for INRs are drawn at approximately the same time of day so the results are available to doctors before warfarin doses are prescribed. For inpatient therapy blood specimens should be drawn in the morning so that warfarin administration can occur at 4 pm in line with the National Inpatient Medication Chart recommendations.

1.6 The hospital provides urgent laboratory test results 24 hours per day eg. INR, PT, aPTT.

1.7 The organisation has defined the acceptable length of time between the ordering of critical haematological tests (e.g. INR, aPTT) and reporting of the test results, and between the availability of the results and receipt by a responsible PRACTITIONER.

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1 PATIENT INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

1.8 All haematological lab values defined as critical by the laboratory are reported directly to the PRACTITIONER responsible for the patient within the timeframe established by the organisation.

FAQ - see page 14

1.9 Doctors, pharmacists, and nurses are informed when laboratory reagents that are used to measure the aPTT or other haematologic tests are changed; and dosing protocols and nomograms are modified as needed (e.g. weight-based heparin protocols).

1.10 Doctors and nurses can easily and electronically access inpatient laboratory results (e.g. haemoglobin, haematocrit, liver function tests, serum creatinine, INR, aPTT, platelet count, anti-factor Xa levels) to guide antithrombotic therapy.

1.11 Pharmacists can easily and electronically access inpatient laboratory results (e.g. haemoglobin, haematocrit, liver function tests, serum creatinine, INR, aPTT, platelet count, anti-factor Xa levels) to guide antithrombotic therapy.

1.12 Doctors and nurses can easily and electronically access outpatient laboratory results (e.g. haemoglobin, haematocrit, liver function tests, serum creatinine, INR, aPTT, platelet count, anti-factor Xa levels) to guide antithrombotic therapy.

FAQ - see page 14

1.13 Pharmacists can easily and electronically access outpatient laboratory results (e.g. haemoglobin, haematocrit, liver function tests, serum creatinine, INR, aPTT, platelet count, anti-factor Xa levels) to guide antithrombotic therapy.

FAQ - see page 14

1.14 The computer system used for medication order entry is directly INTERFACED with the laboratory system to automatically alert PRACTITIONERS to abnormal values, indicating a potential need to modify antithrombotic therapy.

1.15 All weight-based guidelines or protocols identify whether the patient’s ideal body weight, actual weight, or a medical staff-approved dosing-corrected weight is to be used in the calculations.

FAQ - see page 14

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©2007 Institute For Safe Medication Practices®

1 PATIENT INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

1.16 Antithrombotic orders cannot be entered into the pharmacy computer system until the patient’s weight and height have been entered. (Weight and height are required fields).

1.17 Prior to initiating antithrombotic therapy, healthcare PRACTITIONERS screen patients for co-existing diseases or conditions (eg., hepatic impairment, hypothyroidism, hyperthyroidism, congestive heart failure, renal failure, hypoalbuminaemia, high vitamin K intake) that could affect the dose requirements for antithrombotic therapy; and, if encountered, these conditions are documented on the medical record and clearly visible to healthcare providers who prescribe, dispense, or administer antithrombotic therapy.

1.18 Prior to initiating antithrombotic therapy, healthcare PRACTITIONERS question patients about recent trauma, surgery, or bleeding problems experienced while receiving any previous antithrombotic therapy; and, if encountered, these conditions are documented on the medical record and clearly visible to healthcare providers who prescribe, dispense, or administer antithrombotic therapy.

1.19 Prior to ordering any heparin product (including LMW heparin), doctors specifically ask patients if they have a known history of Heparin Induced Thrombocytopaenia (HIT) and/or an allergy to heparin; and positive responses are documented on the medical record and clearly visible to healthcare PRACTITIONERS who prescribe, dispense, or administer heparin.

1.20 Prior to initiating the use of heparin for arterial line infusions, or heparin-coated catheters or instruments, patients are specifically asked if they have a known history of Heparin Induced Thrombocytopaenia (HIT) and/or an allergy to heparin; and positive responses are documented on the medical record, clearly visible to healthcare providers who prescribe, dispense, or administer heparin and there is a hospital-approved protocol for the management of these patients.

1.21 All antithrombotic ORDER SETS (including those used electronically) and drug administration flow sheets contain prompts or fields to document and display the patient’s diagnosis, allergies, height, actual body weight, and most recent pertinent laboratory data; and these fields are consistently populated with the required information.

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©2007 Institute For Safe Medication Practices®

1 PATIENT INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

1.22 MACHINE-READABLE CODING (e.g. bar coding) that utilises at least two patient identifiers (e.g. name and birth date, name and medical record number, name and account number) is used to verify patient identity before administration of oral and intravenous antithrombotic agents.

1.23 When warfarin is prescribed, nurses, pharmacists, and doctors monitor all INR values to ensure that the range is maintained between 2 and 3 or at a level consistent with recommendations or protocols for the specific disease or condition for which antithrombotic therapy is prescribed.

1.24 When intravenous heparin is prescribed for therapeutic anticoagulation, nurses, pharmacists, and doctors monitor all aPTT laboratory values to ensure that the range is maintained within the therapeutic range as defined by hospital-approved policy or protocol, or between 1.5 to 2.5 times the control value.

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | ��

©2007 Institute For Safe Medication Practices®

1 PATIENT INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 2

Essential patient information is used to monitor and manage the effects of antithrombotic therapy, and to adjust the treatment plan when indicated by evidence-based practices.

A B C D E

1.25 The indication and therapeutic goal for antithrombotic therapy is documented in the patient’s medical record and medication chart and communicated to pharmacy for monitoring and managing patient therapy.

1.26 Pharmacists or nurses directly contact the prescriber within a hospital-defined timeframe to discuss lab values below or above the target range and potential modifications of antithrombotic therapy.

1.27 A doctor or other credentialled PRACTITIONER routinely adjusts the doses of LMW heparin and Factor Xa inhibitors for patients with renal impairment, extremes of body weight, pregnancy, and in other special populations such as infants or neonates.

1.28 Doctors routinely order initial doses of warfarin between 2.5 mg and 5 mg for patients 65 years and older, or for patients less than 65 who have co-morbid conditions (e.g. liver disease, thyroid disease) that would affect their response to warfarin.

1.29 If a patient’s platelet count decreases to less than 100x109/L or less than 50% of the baseline, there is a mechanism in place to ensure that the patient is evaluated for HIT; and that all sources of heparin (including LMW heparin, heparin used for arterial line infusions or catheter flushes, and heparin-coated catheters or instruments) are discontinued.

1.30 When warfarin therapy is initiated for a patient with active thrombosis, heparin or LMW heparin therapy is continued until warfarin has been administered for a minimum of 4 days and the INR reaches a therapeutic level for 2 consecutive days.

1.31 Patients on warfarin therapy who are being discharged with a subtherapeutic INR are consistently evaluated regarding the need for LMW heparin until a therapeutic INR is reached; and when appropriate, patients are maintained or “bridged” with LMW heparin until therapeutic INR levels are reached.

FAQ - see page 14

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©2007 Institute For Safe Medication Practices®

1 PATIENT INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

1.32 If surgery is significantly delayed or postponed, a reliable process is in place to consistently remind the prescriber to evaluate the need to resume antithrombotic therapy for all patients who had previously been receiving such therapy.

1.33 Prior to initiating thromboprophylactic therapy, healthcare PRACTITIONERS have access to venous thromboembolism (VTE) risk assessment tools which are used to assess the risk of VTE. Risk assessment tools facilitate screening for VTE risk and provide for regular recording of risk assessment and documentation of appropriate prophylactic measures to minimise risk according to the institution’s policies. The VTE risk assessment and management documentation is located in a highly visible and prominent position and decisions about the type of prophylaxis are documented in the medication chart.

FAQ - see page 14

Request a password or get help with the MSSA-AT by sending a message via email to [email protected]

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | ��

©2007 Institute For Safe Medication Practices®

2 DRUG INFORMATION A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 3

Essential drug information is readily available in a useful form and considered when ordering, dispensing and administering antithrombotic therapy.

A B C D E

2.1 A complete history of medication use (including prescription and over-the-counter drugs, vitamins, herbal products, and illicit drugs) and other pertinent health issues, such as smoking and ethanol use, is obtained and documented on every inpatient and outpatient upon admission or initial encounter; and the information is verified upon each subsequent encounter.

2.2 Warfarin and parenteral antithrombotics are included in the organisation’s defined list of HIGH-ALERT MEDICATIONS, which has been communicated to all healthcare PRACTITIONERS.

2.3 Current protocols, pathways, guidelines, nomograms, ORDER SETS, flow sheets and/or checklists for antithrombotic therapy are readily accessible, in print or electronic form, to doctors, pharmacists, and nurses; and used when antithrombotics are prescribed, dispensed, and administered.

2.4 All protocols, pathways, guidelines, nomograms, ORDER SETS, flow sheets, and/or checklists for antithrombotic therapy undergo a formal approval process by, for example, by the hospital’s DRUG AND THERAPEUTICS COMMITTEE, before use, which includes at a minimum, review by a pharmacist and those who will be using the tool.

2.5 All protocols, pathways, guidelines, nomograms, ORDER SETS, flow sheets, and/or checklists for antithrombotic therapy are reviewed at least annually and revised when significant, new information becomes available.

2.6 There is an effective system in place to promptly retrieve outdated protocols, pathways, guidelines, nomograms, ORDER SETS, flow sheets, and/or checklists throughout the facility and in doctors’ offices; and to replace outdated protocols with updated versions.

2.7 Disease-specific protocols (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism) are readily available and used to guide appropriate and safe warfarin therapy; and the different protocols are clearly labelled to ensure proper identification and use.

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©2007 Institute For Safe Medication Practices®

2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

2.8 Disease-specific protocols (e.g. stroke, cardiac disease, deep vein thrombosis) are readily available and used to guide appropriate and safe use of heparin and thrombolytics; and the different protocols are clearly labelled to ensure proper identification and use.

2.9 Protocols direct doctors to employ a continuous infusion (not intermittent IV administration) when intravenous heparin is prescribed to achieve a therapeutic aPTT.

2.10 Disease-specific protocols for antithrombotic therapy are readily available for reference in the pharmacy (and after-hours drug storage areas if the pharmacy is closed) and in all patient care areas where these medications are administered.

2.11 When intravenous heparin or direct thrombin inhibitors are prescribed, a standardised weight-based protocol is readily available and used to guide dosing and dose adjustments based on aPTT results.

2.12 Tables that list doses and corresponding infusion rates for standard concentrations of antithrombotic infusions (e.g. heparin, direct thrombin inhibitors) are readily available in patient care units where these agents are administered, to reduce reliance on mathematical calculations.

2.13 A protocol or guideline exists for safely managing the care and removal of epidural catheters placed during regional anaesthesia when LMW heparin has been administered for surgical prophylaxis.

Scoring guideline: Select NOT APPLICABLE if you do not offer epidural anaesthesia in your hospital. NOT APPLICABLE

2.14 A protocol or guideline exists for monitoring and/or discontinuing antithrombotic therapy prior to invasive procedures.

2.15 Warnings appear on protocols, pathways, ORDER SETS, pharmacy order-entry screens and automated dispensing cabinet monitors to review all medications the patient has received in the past 24 hours (including in the emergency department) to ensure that adequate time has elapsed between doses of the same or different antithrombotics (e.g. LMW heparin given in the emergency department, and heparin or fondaparinux prescribed upon admission to the hospital).

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | ��

©2007 Institute For Safe Medication Practices®

2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

2.16A In hospitals WITHOUT computerised prescriber order entry (CPOE) systems: The pharmacy computer system alerts healthcare PRACTITIONERS to the duplication of class orders for antithrombotics (for two or more drugs within the same class).HIGH-ALERT drugs used within the organisation have been defined, identified, and communicated to all PRACTITIONERS who prescribe, dispense, and administer the products.

OR OR

2.16B In hospitals WITH computerised prescriber order entry (CPOE) systems: The pharmacy computer system and the CPOE system alert healthcare PRACTITIONERS to the duplication of class orders for antithrombotics (for two or more drugs within the same class).

Scoring guideline: Score C if the pharmacy computer system provides this alert, but the CPOE system does not. Note: The weighted score for C is equal to the weighted score for E in 2.16A.

2.17A In hospitals WITHOUT computerised prescriber order entry (CPOE) systems: The pharmacy computer system alerts healthcare PRACTITIONERS to drug interactions that can affect the dose of antithrombotic therapy.

OR OR

2.17B In hospitals WITH computerised prescriber order entry (CPOE) systems: The pharmacy computer system and the computerised prescriber order entry system alert healthcare PRACTITIONERS to drug interactions that can affect the dose of antithrombotic therapy.

Scoring guideline: Score C if the pharmacy computer system provides this alert, but the CPOE system does not. Note: The weighted score for C is equal to the weighted score for E in 2.17A.

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©2007 Institute For Safe Medication Practices®

2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

2.18A In hospitals WITHOUT computerised physician order entry (CPOE) systems: The pharmacy computer system provides an alert and an electronic abstract or reference when drug-herbal interactions with prescribed antithrombotic therapy are detected.

OR OR

2.18B In hospitals WITH computerised prescriber order entry (CPOE) systems: The pharmacy computer system and the CPOE system provide an alert and an electronic abstract or reference when drug-herbal interactions with prescribed antithrombotic therapy are detected.

Scoring guideline: Score C if the pharmacy computer system provides this alert, but the CPOE system does not. Note: The weighted score for C is equal to the weighted score for E in 2.18A.

2.19A In hospitals WITHOUT computerised prescriber order entry (CPOE) systems: The pharmacy computer system alerts healthcare PRACTITIONERS if aspirin, other non-steroidal anti-inflammatory agents or other agents with an antiplatelet action including complementary medicines are prescribed for PRN use in patients who are receiving antithrombotic therapy.

OR OR

2.19B In hospitals WITH computerised prescriber order entry (CPOE) systems: The pharmacy computer system and the CPOE system alert healthcare PRACTITIONERS if aspirin, other non-steroidal anti-inflammatory or other agents with an antiplatelet action including complementary medicines are prescribed for PRN use in patients who are receiving antithrombotic therapy.

Scoring guideline: Score C if the pharmacy computer system provides this alert, but the CPOE system does not. Note: The weighted score for C is equal to the weighted score for E in 2.19A.

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2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

2.20A In hospitals WITHOUT computerised prescriber order entry (CPOE) systems: The pharmacy computer system performs dose range checks and warns PRACTITIONERS about antithrombotic overdoses and underdoses.

FAQ - see page 14

OR OR

2.20B In hospitals WITH computerised prescriber order entry (CPOE) systems: The pharmacy computer system and the CPOE system perform dose range checks and warn PRACTITIONERS about antithrombotic overdoses and underdoses.

Scoring guideline: Score C if the pharmacy computer system provides this alert, but the CPOE system does not. Note: The weighted score for C is equal to the weighted score for E in 2.20A.

FAQ - see page 14

2.21 The pharmacy computer system provides an alert and an electronic abstract or reference when a drug-food/nutritional product interaction with prescribed antithrombotic therapy is detected.

FAQ - see page 14

2.22 The pharmacy computer system provides an alert and an electronic abstract or reference for drug-nutritional product interactions between enteral nutrition products and antithrombotic therapy.

FAQ - see page 14

2.23 The pharmacist directly reports significant dose concerns, drug interactions, contraindications, and duplicate drug therapy to the prescriber, within a hospital-defined timeframe, along with recommendations for alternative therapy or additional monitoring.

�� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

©2007 Institute For Safe Medication Practices®

2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 4

Essential drug information is readily available in a useful form to guide the management of adverse drug reactions that may occur when antithrombotic agents are prescribed.

A B C D E

2.24 A protocol exists to guide the reversal of supra-therapeutic INR values while taking into consideration the INR value, the absence or presence of clinically significant bleeding, and other factors that gauge necessity and urgency of reversal.

FAQ - see page 14

2.25 Unless rapid reduction of a supra-therapeutic INR is required, protocols direct doctors to order oral phytomenadione (Konakion ®) (vitamin K1).

FAQ - see page 14

2.26 If intravenous vitamin K1 is required (e.g. life-threatening warfarin overdose or rapid reduction of a supra-therapeutic INR accompanied by life-threatening bleeding), the dose is administered by slow intravenous injection according to the manufacturer’s directions. (Konakion MM ® should not be mixed with infusion solutions).

2.27 If HIT is suspected or diagnosed, there is a mechanism in place to ensure that all sources of heparin (including LMW heparin, heparin used for arterial lines or catheter flushes, heparin-coated catheters or instruments) are discontinued.

2.28 If HIT is suspected or diagnosed, there is a mechanism in place to ensure that a prominent notation is placed on the patient’s medical record, pharmacy patient profile, and MEDICATION ADMINISTRATION RECORD to alert staff to avoid the administration of, or exposure to, heparin in any form (including LMW heparin, heparin used for arterial line infusions or catheter flushes, heparin-coated catheters or instruments).

2.29 Medical staff-approved protocols or procedures exist to treat patients with known or suspected HIT with direct thrombin inhibitors (e.g. argatroban, lepirudin, bivalirudin) or danaparoid if antithrombotic therapy is required.

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2 DRUG INFORMATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

2.30 If HIT is suspected, patient evaluation criteria consistently include laboratory testing for the HIT antibody.

2.31 If HIT is diagnosed, this adverse reaction and the date on which it occurred are documented in the patient’s medical record.

2.32 In patients with HIT, protocols permit warfarin therapy only if the patient is also receiving danaparoid or a direct thrombin inhibitor such as lepirudin and the platelet count has substantially recovered to at least 100x109/L.

2.33 When combination therapy with warfarin and a direct thrombin inhibitor or danaparoid is used to treat HIT, protocols permit the discontinuation of the direct thrombin inhibitor or danaparoid only after the patient has achieved a therapeutic INR for at least 2 days.

2.34 Initial orders for antithrombotic agents include a comment indicating if this therapy is a new treatment or a continuation of previous antithrombotic therapy.

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3 COMMUNICATION OF DRUG ORDERS ANDOTHER DRUG INFORMATION

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 5

Methods of communicating orders for antithrombotics and other essential drug information are standardised and automated to minimise the risk for error.

A B C D E

3.1A Doctors enter all antithrombotic orders into a computerised prescriber order entry (CPOE) system that is directly INTERFACED with the pharmacy computer system.

Scoring guideline: Do not choose D or E if doctors enter orders into a CPOE system that is not directly INTERFACED with the pharmacy computer.

FAQ - see page 14

OR OR

3.1B In hospitals without CPOE prescribing, the doctor or nurse alerts the pharmacist when there is a new antithrombotic order.

3.2 Antithrombotic therapy is entered into the pharmacy computer and screened electronically against the patient’s clinical profile for contraindications, interactions, and dose appropriateness before drug(s) are administered. (Exception: life threatening situations such as those that require rapid administration of thrombolytics.)

FAQ - see page 14

3.3 A protocol permits and guides the rounding of doses for certain antithrombotic agents (e.g. enoxaparin 73 mg could be rounded to 70 mg, a weight-based heparin bolus dose of 2,485 units could be rounded to 2,500 units).

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3 COMMUNICATION OF DRUG ORDERS ANDOTHER DRUG INFORMATION continued

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

3.4 A list of ERROR-PRONE ABBREVIATIONS and dose expressions that should never be used is established and IMPLEMENTED for all forms of communicating antithrombotic therapy in orders, during transcription, and on medication administration records, pharmacy-affixed labels, computer screens, and drug storage bins.

3.5 Upon inpatient admission, all medications (including once only doses) administered in the emergency department or other outpatient setting (e.g. cardiac catheterisation lab, radiology, pre-hospital emergency care) are immediately communicated to the pharmacy and entered (or readily available) in the pharmacy computer system in a manner that facilitates an automated alert for duplicate therapy, contraindications, and drug interactions when antithrombotics are prescribed.

3.6 When an antithrombotic agent is administered in the emergency department or other outpatient settings (e.g. cardiac catheterisation lab, radiology), the chart and MEDICATION ADMINISTRATION RECORD are boldly labelled to communicate this information to other PRACTITIONERS.

3.7 A notation that identifies the specific interventions, treatments, or drugs that must be avoided (e.g. intramuscular injections, certain vascular access procedures) is recorded in the medical record, pharmacy profile, and the MEDICATION ADMINISTRATION RECORD for patients receiving antithrombotics.

3.8 For inpatients, a process is in place to notify the food and nutrition department when patients are receiving warfarin therapy so that foods containing vitamin K can be provided in a similar pattern to home consumption.

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4 DRUG STORAGE, STOCK, STANDARDISATION AND DISTRIBUTION

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 6

Antithrombotic concentrations, doses and administration times are standardised whenever possible.

A B C D E

4.1 Standard concentrations are used throughout the facility for IV antithrombotic infusions.

4.2 The formulary limits the variety of heparin concentrations and vial sizes.

4.3A Vials of heparin are not stocked in any patient care unit.

OR OR

4.3B If heparin vials are stocked in patient care units, a limited variety of strengths and vial sizes are available, based on unit-specific patient needs.

4.4 Only commercially prepared, premixed IV solutions of heparin are used in the facility.

4.5A Commercially prepared, premixed IV solutions of GPIIb-IIIa platelet inhibitors are used when available, or the solutions are prepared in the pharmacy if not available commercially.

Scoring guideline: Score NOT APPLICABLE if you do not use GPIIb-IIIa inhibitors.

FAQ - see page 14 NOT APPLICABLE

OR

4.5B

OR

IV infusions of GPIIb-IIIa platelet inhibitors are prepared in patient care units by trained PRACTITIONERS only, using a kit containing the drug, supplies needed for preparation, and preparation instructions.

Scoring guideline: Score NOT APPLICABLE if you do not use GPIIb-IIIa inhibitors

FAQ - see page 14 NOT APPLICABLE

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4 DRUG STORAGE, STOCK, STANDARDISATION AND DISTRIBUTION continued

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

4.6A Pharmacists prepare all thrombolytic bolus doses.

OR OR

4.6B Thrombolytic bolus doses are prepared by trained PRACTITIONERS only, using a disease-specific kit, (e.g. stroke, acute myocardial infarction) containing the protocol, drug, supplies needed for preparation and preparation instructions.

FAQ - see page 14

4.7A Pharmacists prepare all thrombolytic infusions.

OR OR

4.7B Thrombolytic infusions are prepared by trained PRACTITIONERS only, using a disease-specific kit, (e.g. stroke, acute myocardial infarction) containing the protocol, drug, supplies needed for preparation and preparation instructions.

FAQ - see page 14

4.8 All strengths of warfarin tablets dispensed within the facility are purchased from a single manufacturer to promote consistent bioavailability (warfarin is a narrow therapeutic index drug).

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©2007 Institute For Safe Medication Practices®

4 DRUG STORAGE, STOCK, STANDARDISATION AND DISTRIBUTION continued

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

4.9A In hospitals WITHOUT automated dispensing cabinets: Warfarin is not available in ward stock.

OR OR

4.9B In hospitals WITH automated dispensing cabinets: Warfarin is available only in automated dispensing cabinets that are INTERFACED with the pharmacy information system; and warfarin doses cannot be removed from the cabinet until the order has been reviewed by pharmacy (not available via an override feature).

Scoring guideline: Score A or B if all automated dispensing cabinets are not INTERFACED with the pharmacy information system; If automated dispensing cabinets are INTERFACED with the pharmacy information system, score no higher than D if warfarin is available via override during hours when pharmacy services are not available.

4.10 Warfarin administration is scheduled for the same time each day, after INR results are available (e.g. afternoon, early evening). For inpatient therapy warfarin administration should usually occur at 4pm in line with National Inpatient Medication Chart recommendations.

FAQ - see page 14

Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | ��

©2007 Institute For Safe Medication Practices®

5 MEDICATION DEVICE ACQUISITION, USE AND MONITORING

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 7

The potential for human error is mitigated through careful procurement, maintenance, use and standardisation of devices used to deliver medications and provide test results.

A B C D E

5.1A General infusion pumps are used for the administration of all IV infusions of all antithrombotics (including platelet inhibitors).

OR OR

5.1B SMART INFUSION PUMPS are used for the IV administration of all antithrombotics (including platelet inhibitors), with functionality employed to intercept and prevent wrong dose/wrong infusion rate errors due to misprogramming the pump, miscalculation, or an inaccurately prescribed medication.

Scoring guideline: If SMART INFUSION PUMPS are used in some patient care units, but not all areas where antithrombotics are administered, score D.

5.2 When multiple parenteral infusions are being administered, the ends of all tubing (and the pump channels, if multiple-channel pumps are used) are clearly and boldly labelled adjacent to the injection port(s) to identify the product being administered, so as to prevent line mix-ups.

5.3 When a new lot of reagent is received, point-of-care testing and monitoring devices used during antithrombotic therapy (e.g. activated clotting time, INR) are checked and recalibrated.

Scoring guideline: Hospitals that do not provide point-of-care testing should score A or B.

5.4 When a new lot of reagent is used, an electronic quality control test and a liquid sample quality control test are performed on a predetermined schedule (e.g. weekly).

Scoring guideline: Hospitals that do not provide point-of-care testing should score A or B.

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6 COMPETENCY AND STAFF EDUCATIONA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 8

PRACTITIONERS receive sufficient orientation to antithrombotic therapy, and undergo baseline and ongoing competency evaluation of knowledge and skills related to safe medication practices.

A B C D E

6.1 All PRACTITIONERS who prescribe, dispense, administer, and/or monitor antithrombotic therapy receive initial training, and undergo baseline competency evaluation to demonstrate proficiency with their role in this drug therapy, before practising independently.

6.2 PRACTITIONERS who prescribe, dispense, administer, and/or monitor antithrombotic therapy are provided with the necessary support and time to attend internal and external educational programs related to management of this drug therapy.

6.3 PRACTITIONERS who prescribe, dispense, administer, and/or monitor antithrombotic therapy are educated about any related new drugs added to the formulary and associated protocols/guidelines and restrictions before the drugs are used in the hospital.

6.4 Pharmacists provide nurses with important information about nonformulary antithrombotic drugs on dispensing the products to patient care areas for administration.

6.5 A trained, multidisciplinary antithrombosis team is available 24 hours each day, and 7 days each week, to manage patients with complicated thrombotic episodes.

Scoring guideline: Do not score E if the antithrombosis team is not, at a minimum, available on-call 24 hours each day and 7 days each week. Hospitals should score A or B if they don’t function as antithrombotic teams.

6.6 Staff members who educate patients about the proper use of point-of-care self-testing devices (e.g. activated clotting time, INR) have demonstrated proficiency with the use and maintenance of the instruments.

Scoring guideline: Hospitals that do not provide point-of-care testing should score A or B.

6.7 PRACTITIONERS who prescribe, dispense, administer, and/or monitor antithrombotic therapy receive ongoing information about related errors that occur within the organisation, error-prone situations, errors occurring in other healthcare facilities, and strategies to prevent such errors.

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7 PATIENT EDUCATIONA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core characteristic 9

Patients and/or their carers are included as active partners in their antithrombotic therapy through education about their medications and ways to avert errors.

A B C D E

7.1 When initiating antithrombotic therapy, patients and/or their CAREGIVERS receive information about the purpose, action, and side effects of the therapy; and information about the specific drugs being used, including the generic and brand (if applicable) names, strength/dose, and frequency/duration of use.

7.2 All patient/CAREGIVER education for antithrombotic therapy is documented on a multidisciplinary patient education record or other appropriate record, which is kept at the bedside or in the patient’s medical record for reference.

7.3 Inpatients and outpatients on warfarin, and/or their CAREGIVERS, receive verbal and up-to-date written information about proper dietary measures and their effect on overall therapy goals.

7.4 Inpatients and outpatients on antithrombotic therapy, and/or their CAREGIVERS, receive verbal and up-to-date written information about how their antithrombotic therapy is monitored and the need for close medical supervision and adherence to prescribed treatment.

7.5 Inpatients and outpatients on antithrombotic therapy, and/or their CAREGIVERS, receive verbal and up-to-date written information about the signs and symptoms of bleeding or thromboembolic complications.

7.6 Inpatients and outpatients on antithrombotic therapy, and/or their CAREGIVERS, receive verbal and up-to-date written information about drug and herbal interactions, and are provided examples of over-the-counter drugs, nutritional supplements, and herbal products to avoid.

7.7 Inpatients and outpatients on warfarin are informed that Coumadin®, Marevan® and warfarin contain the same ingredients, to avoid the potential for duplicate therapy if the drug is prescribed using both brand and generic names.

7.8 Inpatients and outpatients on warfarin are instructed that their dose may change during the course of treatment based on their laboratory results.

�� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

©2007 Institute For Safe Medication Practices®

7 PATIENT EDUCATION continuedA No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS A B C D E

7.9 Inpatients and outpatients on warfarin are instructed on how to manage dose changes safely, once at home, when their existing tablet strength differs from a newly prescribed dose.

7.10 Inpatients and outpatients (or CAREGIVERS) who will be administering heparin products via the subcutaneous route at home demonstrate proficiency with the techniques and methods of drug administration prior to discharge or leaving the facility.

7.11 Inpatients and outpatients (or CAREGIVERS) who will use point-of-care testing devices demonstrate proficiency with operation of the device prior to discharge or leaving the facility.

Scoring guideline: Hospitals that do not provide point-of-care testing should score A or B.

7.12 Facility-approved instructional tools such as videos, drug information booklets, and special brochures are routinely used to complement patient education about antithrombotic therapy.

7.13 For inpatients, education about antithrombotics begins when therapy is initiated; and most of the information about their antithrombotic therapy after discharge is presented at least 24 hours prior to discharge.

7.14 Prior to discharge, inpatients on warfarin therapy have a confirmed appointment scheduled with their General Practitioner, or antithrombotic clinic; and the importance of keeping follow-up appointments is stressed.

7.15 Patients diagnosed with HIT are instructed to communicate this information to all doctors and other healthcare providers.

7.16 Pharmacists are available for consultations to assist with patient education when any healthcare PRACTITIONER (doctor, pharmacist, nurse) identifies a patient who is at risk for non-adherence with their prescribed antithrombotic therapy.

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Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals | ��

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8 QUALITY PROCESSES AND RISK MANAGEMENT

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 10

PRACTITIONERS are stimulated to detect and report errors, and multidisciplinary teams regularly analyse errors that have occurred within the organisation and in other organisations for the purpose of redesigning systems to best support safe PRACTITIONER performance.

A B C D E

8.1 In addition to PRACTITIONER reporting systems, computer markers or triggers for selected drug orders (e.g. reversal agents such as vitamin K1 and protamine) are tracked and used to enhance detection of potential adverse drug events (both medication errors and adverse drug reactions).

8.2 In addition to PRACTITIONER reporting systems, computer markers or triggers for selected laboratory tests (e.g. aPTT greater than 100 seconds, INR greater than “x” as defined by facility, platelet count less than 100x109/L) are used to enhance detection of potential adverse drug events (both medication errors and adverse drug reactions).

8.3 A convened multidisciplinary team routinely analyses and uses internal error experiences to target improvements in the use of antithrombotic agents.

8.4 A convened multidisciplinary team routinely analyses and uses external published error experiences from other organisations to proactively target improvements in the use of antithrombotic agents.

FAQ - see page 14

8.5 A convened multidisciplinary team routinely evaluates the literature for new evidence-based practices and technologies that have been proven to be effective in reducing antithrombotic errors and improving patient outcomes to determine if it can improve its own antithrombotic therapy.

8.6 On a regular basis a convened multidisciplinary team retrospectively reviews cases in which an aPTT or INR falls outside of predetermined values; and the team makes organisation-wide process recommendations aimed at reducing the variation in achieving and maintaining therapeutic drug levels.

8.7 The organisation performs ongoing review of compliance with established antithrombotic protocols; and a convened multidisciplinary team recommends and facilitates action to reduce noncompliance.

�� | Medication Safety Self Assessment for Antithrombotic Therapy in Australian Hospitals

©2007 Institute For Safe Medication Practices®

8 QUALITY PROCESSES AND RISK MANAGEMENT continued

A No activity to implement

B Considered, but not implemented

C Partially implemented in some or all areas

D Fully implemented in some areas

E Fully implemented for all

SELF ASSESSMENT ITEMS

Core Characteristic 11

Simple redundancies that support a system of INDEPENDENT DOUBLE CHECKS are used for vulnerable parts of the antithrombotic therapy to detect and correct serious errors before they reach patients.

A B C D E

8.8 Pharmacists perform and document an INDEPENDENT DOUBLE CHECK of all calculations, preparations, and labelling of antithrombotic agents, using a copy of the order for verification, prior to dispensing the drugs.

8.9 Antithrombotic agents removed from ward stock and/or automated dispensing cabinets are independently double checked against the actual order by another PRACTITIONER prior to drug administration; and the double check is documented.

8.10 With each new bag/bottle, or change in the rate of infusion for IV antithrombotics (including platelet inhibitors), one PRACTITIONER prepares the solution for administration and another PRACTITIONER independently verifies and documents that the correct drug, drug concentration, rate of infusion, patient, channel selection (for multiple-channel pumps), and line attachments have been selected before starting the infusion.

8.11 MACHINE-READABLE CODING (e.g. bar coding) is used to verify the selection of antithrombotic agents prior to preparing and/or dispensing these medications (includes robotic dispensing).

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Clinical Excellence Commission

Telephone: 02 9382 7600 Fax: 02 9382 7615

Postal Address: GPO Box 1614 Sydney NSW 2001

Main office location: Level 3, 65 Martin Place Sydney NSW 2000

Additional Facilities: 1st Floor Administration Building Sydney Hospital & Sydney Eye Hospital 8 Macquarie Street Sydney NSW 2000