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National Guidelines on High Alert Medications (2021)

THE NATIONAL GUIDELINES

ON HIGH ALERT MEDICATIONS

11 August 2021

ACKNOWLEDGEMENTS

The National Guidelines on High Alert Medications 2021 has been developed by the High Alert Medication (HAM) Workgroup (see Table A- 1 for composition) under the National Medication Safety Committee (NMSC) 2017 - 2021 term (see Table A- 2 for composition). The HAM workgroup would like to thank the nominated contributors who participated in the guideline drafting (listed in Table A- 3 ), resource persons (listed in Table A- 4 ) for their assistance in providing medication error data and institutions’ HAM policies as well as nursing representatives from various public healthcare institutions (PHIs) for their inputs to the guidelines. Table A- 1. Composition of High Alert Medication Workgroup, July 2017 – June 2021 Name Institution Designation Dr Loh Seow Siang (Lead) KTPH Senior consultant, A&E Mr Wu Tuck Seng (Co-lead) NUH Director, Pharmacy Department Prof Ding Zee Pin NHC Senior Consultant, Department of Cardiology; Chairperson, Pharmacy & Therapeutics Committee Dr Kurumbian Chandran NTFGH Director of Endocrinology; Co-chair of the Medication Safety Committee Table A- 2. Composition of the National Medication Safety Committee, July 2017 – June 202 1 Name Institution Designation Members Adj Assoc Prof Augustine Tee (Chairperson) CGH Chief, Department of Medicine; Deputy Chairman Medical Board (Medical Disciplines) Mr Wu Tuck Seng NUH Director, Pharmacy Department Dr Liew Mei Fong AH Director, Intensive Care Unit Dr Chua Mei Chien KKH Head and Senior Consultant, Department of Neonatology; Chair of the Medication Safety Committee KKH Dr Loh Seow Siang KTPH Senior Consultant, A&E

Table A- 3. List of guideline contributors Name Institution Designation Ms Thng Shu Hui NHCS Senior Clinical Pharmacist, Department of Pharmacy Ms Hon Jin Shing NHCS Senior Principal Clinical Pharmacist, Department of Pharmacy Ms Tan Yuen Ming NTFGH Principal Pharmacist, Department of Pharmacy Ms Jasmine Shew Sew Hong NTFGH Assistant Nursing Clinician, Department of Nursing Ms Masdiana Mohamed Yusof NTFGH Senior Staff Nurse, Department of Nursing Ms Michelle Loh Zhiao Chien NUH Senior Pharmacist, Department of Pharmacy Ms Chua Hui Min NCIS/NUH Senior Clinical Pharmacist, Department of Pharmacy Table A- 4. List of Resource Persons for the High Alert Medication Workgroup Name Institution Designation Ms Yasmin Ng CGH Senior Principal Pharmacist, Department of Pharmacy Mr Mohammed Nazri Bin Abdul Ghani KKH Medication Safety Officer; Principal Pharmacist, Department of Pharmacy Dr Adeline Wee KTPH Principal Clinical Pharmacist, Department of Pharmacy Ms Stephanie Chong SGH Principal Pharmacist, Department of Pharmacy Ms Jade Wong TTSH Senior Pharmacist, Department of Pharmacy Ms Tan Yuen Ming NTFGH Principal Pharmacist, Department of Pharmacy Ms Cheryl Char NHG Pharmacy Senior Pharmacist (Clinical) Ms Jenny Oo St Luke’s Hospital Deputy Director, Department of Pharmacy

INTRODUCTION

In March 2017, the World Health Organisation (WHO) launched ‘Medication without Harm: the third global patient safety challenge’ with the goal to reduce severe, avoidable medication related harm by 50% over the next 5 years. One key focus of this was to promulgate guidance on safe use of High Alert Medications (HAMs). In line with the WHO’s goal, the National Medication Safety Committee (NMSC), which was reconvened in July 2017, has developed the National Medication Safety Strategy and identified HAM risk mitigation as one of its key initiatives to reduce avoidable medication related harm. To provide reference for best recommendations in managing the risk associated with HAMs, the HAM workgroup has come up with a set of guidelines for HAM usage based on findings from current practices in institutions and actual medication safety events. The HAM workgroup looked at HAM related medication events (2015- 2018 ) and reviewed the failed processes for incidents in each HAM category to identify gaps within the mitigation strategies to be addressed in the guidelines. In 2019, the Institute for Safe Medication Practices (ISMP) Medication Safety Self-Assessment® for HAM was also conducted in 22 PHIs and the Workgroup reviewed the aggregate reports to distil relevant recommendations to be included in the guidelines. Built upon the “ National Medication Safety Guidelines Manual” published by the Ministry of Health in June 2013, the updated guidelines contain recommendations which were developed with the aim of promoting safe use of HAMs in the local and current context, to set the minimum safety standard to close identified gaps.

1. HAM REFERENCE LIST AND GENERAL HAM RECOMMENDATIONS

1.1 Overview and the 5 Core HAM Categories HAMs are medications that bear a heightened risk of causing significant patient harm when used wrongly. Although errors with these drugs may not be common, the consequences of such errors can be devastating to patients. In 2016, at the Serious Reportable Events (SRE) forum which discussed medication error related SREs, MOH shared that the HAM list cited in the National Medication Safety Guidelines 2013 could be used as a base on which institutions’ HAM lists could be built upon. After the forum, all institutions were requested to share their institutional HAM lists and accompanying precautionary measures via a questionnaire. Replies from institutions suggested inconsistent HAM lists and non-compliance with the 2013 guidelines on the adoption of the Standardized HAMs Reference List. As MOH continues to receive incident reports related to HAM medications, there is an urgent need to push for safety recommendations in this area. Based on local medication error data, the National Medication Safety Committee (NMSC) identified 5 core HAMs with the highest numbers of locally reported errors, and issued an advisory to inform PHIs of the core HAM categories on 3 February 2021 :

1. Insulin
2. Anticoagulants
3. Opioids^1
4. Concentrated electrolytes
5. Cytotoxics, chemotherapeutic agents (^1) Opioids include opiates and synthetic opioids e.g. Fentanyl, Hydrocodone, Oxycodone and Methadone, but may exclude tramadol based on each institution’s own risk assessment. The previous MOH HAM list only contained opiates, instead of the larger drug class of “opioids” listed within the Institute for Safe Medication Practices (ISMP) HAM list, however, NMSC noted that the largest number of medication errors were related to Fentanyl (opioid) overdose. Given the high incidence of medication errors, NMSC recommends aligning with ISMP HAM listing and classify “Opioids” instead of “Opiates” as HAM.

1.2 Standardized HAM Reference List The updated HAM Reference List reflects the core HAMs (see Table 1.1), which are highlighted due to their higher propensity for error as reflected in local medication error incidents, and thus are deemed to pose greater risk as compared to the non-core HAMs. The core HAMs encompass all oral and parenteral formulations for Insulin, Anticoagulants, Opioids, Cytotoxics and Chemotherapeutic Agents. For concentrated electrolytes, please refer to the reference list in Table 1.2. Table 1.1 High Alert Medications Reference List S/N MOH HAM Reference Categories Core HAM Categories 1 Insulin 2 Anticoagulants 3 Opioids 4 Concentrated Electrolytes 5 Cytotoxics, chemotherapeutic agents Non-core HAM Categories 6 Neuromuscular agents 7 Anaesthetic agents 8 Inotropes 9 Sedatives 10 Hypoglycaemic agents 11 Vasopressors 12 Radio-contrast agents Table 1.2 Reference List for Concentrated Electrolytes S/N Description Concentration (Volume) 1 Calcium chloride injection 10% (10ml) 2 Calcium gluconate injection 10% (10ml) 3 Magnesium Sulphate 49.3% injection 2 mmol/ml 4 Potassium Chloride 7.45% injection 1 mmol/ml

1. 3 General Recommendations for HAM Management There are three primary principles that healthcare organizations can use to safeguard against medication errors that might result from HAM: a) Eliminate or reduce the possibility of error - Ward stocks should be kept in automatic dispensing cabinets that limit access to specific drugs whenever possible, otherwise, storage areas for HAM should be clearly demarcated - Limiting the available concentrations and volumes, either for the whole institution or for specific sites - Use of auxiliary warning labels or HAM stickers to differentiate and highlight HAM from other drugs - To employ closed loop medication management e.g. barcode scanning verification upon administration, whenever possible - To use assistive technologies (e.g. barcode technology) in drug-related logistics when topping up, or returning unused drug to storage areas b) Make errors visible through detection - Conduct independent double-checking prior to administration of HAM to catch errors before they reach the patient. - Information technology systems used in the hospital (e.g., pharmacy computer system, computerized prescriber order entry system, smart pump technology, automated compounding devices) are routinely tested to assure that maximum and minimum dose alerts are present and functional for high-alert drugs, and alerts are built for those that do not have them. c) Minimize the harm consequences of errors - Change practices to reduce the adverse effects of errors that do occur (e.g. close monitoring to improve early detection of errors and institute prompt remedial action) In addition, to prevent recurrence of harm due to identified failed processes, PHIs are highly encouraged to develop robust recommendations and explore utilizing human

factor analysis as part of Root Cause Analysis for HAM related errors as much as possible. Incorporating a human factor perspective can help with identifying failed processes that are due to human error, and devising appropriate mitigating strategies to guard against future recurrences.

S/N Stage Common gaps identified

• Miscommunication of insulin doses served when adjusting insulin orders are prescribed, resulting in higher doses of insulin administered than intended
• Non-insulin syringe used to administer insulin in the management of hyperkalaemia resulting in insulin overdose and hypoglycaemia
• Knowledge gaps amongst staff with respect to new technologies in insulin administration that may have resulted in errors
• Wrong route of insulin administration (e.g. intravenous instead of subcutaneous administration) 2.3 Recommended precautionary measures Institutions are strongly encouraged to adopt both the general and specific recommendations below. 2.3.1 General recommendations Evidence-based insulin protocols Institutions to develop and utilize evidence-based insulin protocols for the following: a) Transitions from intravenous to subcutaneous insulin b) Management of insulin (or insulin secretagogues) during planned and unplanned interruptions of oral, enteral, and parenteral nutrition (e.g. patients being fasted for procedure or surgery) c) Management of concentrated insulin d) Management of patients with clinically significant episodes of hyper- and hypoglycaemia e) Management of severe electrolyte imbalances, e.g. hyperkalemia f) Management of pregnant and postpartum patients with pre-existing Type 1 or Type 2 diabetes g) Management of patients receiving glucocorticoid therapy

h) Post-discharge insulin management Considerations prior to transitions of care Prior to transitions of care, a process is in place to ensure that patients will have a) Sufficient supply of prescribed insulin and consumables b) Clear instructions for all prescribed insulin and blood glucose monitoring and c) Clear follow-up care plan d) Timely medication reconciliation conducted (refer to The National Guidelines on Medication Reconciliation ( 2018 )). 2.3.2 Specific recommendations Recommendations specific for insulin management at different stages of the patient journey are listed in Table 2.2 below. Table 2.2 Recommendations for insulin at different stages of the patient journey S/N Stage Recommendations 1 Storage Institutions are to have: a) Clear policies and procedures for the uniform storage of insulin products throughout the institution. b) Processes to allow storage of insulin products in secured areas, and for clear differentiation of various types and strengths of insulin products. c) Guidelines or policies for safe and secure storage of patient-specific insulin during inpatient stay. d) Processes for storage of different types of syringes (e.g. similar-looking syringes, such as tuberculin and insulin syringes). 2 Prescribing Prescriber to: a) Check with patient or carer on the type, dose, frequency and device through which insulin is administered where possible, and not rely solely on electronic health records.

S/N Stage Recommendations 3 Labelling and dispensing (not applicable for insulins dispensed to patients for home use) When labelling and dispensing insulin pens or vials, institutions are to: a) Provide guidance on safe labelling techniques , like affixing patient’s label on the barrel of the insulin pen instead of the cap or the box, to avoid risk of insulin mix- up. b) Have all information on pharmacy label, and pertinent product information from the manufacturer readily visible. c) Ideally have a tamper-evident seal affixed over the cap and barrel of unused insulin pens, to allow easy differentiation of used and unused pens returned to pharmacy. d) Where possible, dispense insulin pens to the clinical units with a patient-specific barcode label. 4 Administration a) Institutions to have standard protocols that consider the following: i. Steps to prepare and administer insulin. ii. Need to label pre-drawn syringes of insulin if not to be immediately administered to patient (refer to The National Standards for Labelling of Injectables in Healthcare Facilities ( 2018 )). iii. Processes should avoid use of verbal communication of point-of-care blood glucose values to determine insulin doses where possible. iv. Steps for staff to follow prior to subcutaneous insulin administration, which should include the following:

• Confirm that there is an appropriate indication.
• Assess the patient’s most current blood glucose value, time and dosage of insulin during the last round of administration, and if the patient has symptoms of hypoglycaemia.
• Inform the patient, where possible of their most current blood glucose level, their dose, the full

S/N Stage Recommendations name of the insulin and the insulin’s intended action. v. Use of appropriate delivery device for the right insulin concentration, especially concentrated insulin. b) Syringes are never used to draw insulin from a prefilled pen or refill cartridge. c) Individual insulin pen is not to be used on more than one patient. d) Where possible, barcode scanning is used to verify that the correct insulin is administered to the correct patient. 5 Patient education Patients on insulin (and caregivers, where applicable) are to be educated on knowledge and skills required for self- care management, including: a) Type, dose and frequency of insulin that they are prescribed with and device used for administration. b) Injection technique. c) Recommended storage method based on pharmaceutical company guidelines. d) Self blood glucose monitoring technique, interpretation of blood glucose readings and glucose targets. e) Timing insulin doses with mealtimes. f) Recognition, treatment and prevention of hyper- and hypoglycaemia, and consult with care providers where needed. g) Common types of errors possible with their insulin therapy and how to prevent or detect these errors, where feasible.

S/N Stage Common gaps identified awareness of discrepancies in CrCl due to the differences between absolute and adjusted body weight 2 Dispensing (^) • Majority of dispensing errors involve wrong strength errors 3 Administration (^) • Duplicate doses or missed doses 4 Patient education

• Inadequate patient education on potential drug interactions (warfarin can interact with many common drugs (e.g. aspirin-containing medications, antacids or laxatives, antibiotics, paracetemol-containing medications) and food/drinks (e.g. Vitamin K rich foods (kale, spinach), alcohol, grapefruit/cranberry juice)
• Lack of means for ad-hoc INR checks 3.3 Recommended precautionary measures Errors that have occurred are mostly preventable through the implementation of precautionary measures, improved communication, close monitoring and education of both patients and healthcare professionals. Table 3.2 Recommended risk mitigation measures for anticoagulants S/N Stage Recommendations 1 Procurement a) Only commercially prepared, premixed IV solutions of unfractionated heparin to be used in the facility (where available). 2 Storage a) Number of strengths available for each HAM anticoagulant to be minimised if possible, otherwise, to limit the number of strengths kept as ward stock with corresponding mitigation measures if more than one strength is kept. 3 Prescribing a) Prescribing and dosing protocols for each anticoagulant should be available. b) Institutions may wish to restrict prescribing of specific drugs to selected specialties only.

S/N Stage Recommendations c) Institutions to develop protocols to guide the rounding of doses for certain anticoagulants (e.g., enoxaparin 83 mg could be rounded to 80 mg, a weight-based heparin bolus dose of 2,485 units could be rounded to 2,500 units). d) If handling a substantial pool of patients on long-term anticoagulants, to establish an anticoagulation service. e) Electronic prompts for HAM anticoagulants may be built into the electronic prescribing system e.g. interaction checker for duplicate anticoagulants, renal dosing adjustment requirements. f) Order only in units. Do not use “U” for ordering. Write out “units” in full. g) Standardised ordering doses (including dilution strengths) should be available for selection in the electronic prescribing system. 4 Administration a) Smart pumps should be used for the parenteral administration of HAM anticoagulants, whenever possible (refer to The National Guidelines on the Safe Use of Infusion Pumps in Healthcare Facilities (2019) for recommendations on safe usage of infusion pumps and smart pumps). 5 Patient education a) Patient to be provided with detailed patient counselling for initiation or switching of anticoagulants. b) Patient to be provided with patient information (including potential drug / food / supplement interactions, drug indication, dosage and timing for consumption; contact information for enquiries on anticoagulation (where feasible) medication and monitoring; and a recommended means for ad-hoc INR checking). c) It is highly encouraged to make medication alert identification (e.g. card available for patients on long term anticoagulation).