Medication safety for look-alike, sound-alike medicines PDF

Medication safety for look-alike, sound-alike medicines  Medication safety for look-alike, sound-alike medicines Medication safety for look-alike, sound-alike medicines ISBN 978-92-4-005889-7 (electronic version) ISBN 978-92-4-005890-3 (print version) © World Health Organization...

Medication safety for look-alike, sound-alike medicines  Medication safety for look-alike, sound-alike medicines Medication safety for look-alike, sound-alike medicines ISBN 978-92-4-005889-7 (electronic version) ISBN 978-92-4-005890-3 (print version) © World Health Organization 2023 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Photo credits: Figure 1a, 1b and Figure 2 – WHO Patient Safety Flagship Design and layout: Macro Graphics Pvt. Ltd., India  Contents Acknowledgementsiv Acronymsv Executive summary 1 1. Background 3 1.1 Purpose and methods 3 1.2 Look-alike, sound-alike (LASA) errors  4 2. The problem  5 2.1 Introduction  5 2.2 Examples 5 2.3 Scale of errors  8 3. Causes and impact of LASA errors  9 3.1 Stages of medication use at which LASA errors can occur 9 3.1.1 Prescribing 9 3.1.2 Transcribing or documenting 9 3.1.3 Dispensing 9 3.1.4 Administering 10 3.1.5 Monitoring 10 3.2 Clinical impact of LASA errors and vulnerable patients 10 4. Addressing LASA errors 11 4.1 Medicines as products to be addressed 11 4.1.1 Developing and updating the list of LASA medicines  12 4.1.2 “Tall man” lettering 12 4.1.3 Clear labelling, segregating storage and colour coding  13 4.2 Roles of patients and family members in preventing LASA errors  14 4.3 Roles of health and care workers in preventing LASA errors  14 4.3.1 Training of health and care workers 14 4.3.2 Roles of regulators, naming bodies and manufacturers  15 4.4 Health care systems and practices to be addressed 15 4.5 Additional points for consideration by member states and organizations 17 5. Barriers and enablers  18 5.1 Barriers  18 5.2 Enablers  18 References 19 Annex: glossary  23 Contents | iii |  Acknowledgements Development of this document was coordinated by Neelam Dhingra-Kumar, Unit Head, Patient Safety Flagship, World Health Organization (WHO) headquarters, Geneva, Switzerland. The principal writing and editorial team at WHO headquarters: Priyadarshani Galappatthy, Alpana Mair, Neelam Dhingra-Kumar, Minna Häkkinen-Wu, Ayda Taha, and Fumihito Takanashi. Peer reviewers and other contributors, WHO headquarters: Pradeep Kumar Dua, Nikhil Gupta, Maki Kajiwara, Aradhana Kohli, Shanthi Narayan Pal, Irina Papieva, Liu Qin, Kim Sungchol and Isabelle Wachsmuth. Contributors from international organizations: Michael R Cohen, Institute for Safe Medication Practices, USA; Helen Dowling, Australian Commission on Safety and Quality in health care; Carolyn Hoffman, Institute for Safe Medication Practices, Canada; Zuzana Kusynová, International Pharmaceutical Federation; Caroline Samer, International Union of Basic and Clinical Pharmacology; David U, International Medication Safety Network; and Steve Waller, Australian Commission on Safety and Quality in health care. Contributors from WHO regional offices: Gertrude Avortri (WHO Regional Office for Africa), Mafaten Chaouali (WHO Regional Office for Europe), Jonas Gonseth-Garcia (WHO Regional Office for the Americas), Hyppolite Kalambay Ntembwa (WHO Regional Office for Africa), Pierre Claver Kariyo (WHO Regional Office for Africa), Angeliki Katsapi (WHO Regional Office for Europe), Mondher Letaief (WHO Regional Office for the Eastern Mediterranean), Nittita Prasopa-Plaizier (WHO Regional Office for the Western Pacific), Joao Joaquim Rodrigues da Silva Breda (WHO Regional Office for Europe), Aparna Singh Shah (WHO Regional Office for South-East Asia), Tomas Zapata (WHO Regional Office for Europe) and Evgeny Zheleznyakov (WHO Regional Office for Africa). The external peer reviewers: Loubna Alj, Morocco; Nana Kwame Asiamah, Ghana; Shane Byrnes, Ireland; Mahesh Devnani, India; Lind Grant-Oyeye, Canada; Partha Gurumurthy, Botswana; Jesus Palacio Lapuente, Spain; Nagwa Metwally, Egypt; Victor Mosweu, Botswana; Abeer Muhanna, Saudi Arabia; Andrew Smith, United Kingdom; and Kazumi Tanaka, Japan. | iv | Medication safety for look-alike, sound-alike medicines  Acronyms CPOE computerized prescriber order entry HICs high-income countries ISMP Institute for Safe Medication Practices LASA look-alike, sound-alike LMICs low- and middle-income countries T&CM traditional and complementary medicines TML “tall man” lettering USA United States of America WHO World Health Organization Acronyms |v|  Executive summary Medication errors are a leading cause of patient harm not colour coding of different strengths, and storage of globally. Look-alike, sound-alike (LASA) medicines are LASA medicine pairs close to one another can result in a well-recognized cause of medication errors that are LASA errors during dispensing. Unclear instructions for due to orthographic (look-alike) and phonetic (sound- administration, failure to double-check the order and alike) similarities between medicines that can thus be failure to monitor the patient after administration can confused. Look-alike medicines appear visually the lead to administration and monitoring errors. Failure to same with respect to packaging, shape, colour and/ engage patients in their treatment at each stage of the or size, while sound-alike medicines are similar in the medication use process results in LASA errors reaching phonetics of their names, doses and/or strengths. the patients. Confusions can occur between brand–brand, brand– The potential outcomes of LASA errors include generic or generic–generic names. The similarities overdosing, underdosing or inappropriate dosing of could also occur with products coming under unintended or intended medications. The impact on traditional and complementary medicines (T&CM). the patient will depend on the medicine administered The appearance of medicines can be misleading, both and patient factors. Patients in extremes of age or with because different medicines appear to be the same or organ dysfunction are more vulnerable to errors and because the same medicines appear to be different. severe harm because of their particular physiology. This document provides information based on the best Furthermore, they are more prone to make errors and available evidence on the extent of this problem, the be subjected to errors when dose modifications are underlying causes and how to address them to prevent required. The impact of LASA errors involving high-risk harm. (high-alert) medicines will be serious and can cause severe patient harm, including death. LASA errors can occur at any stage of medication use: prescribing, transcribing or documenting, dispensing, Table 1 lists the main actions that can be taken on administering and monitoring. Poorly legible medicines as products, by patients, health and care handwritten prescriptions, verbal orders, use of error- workers, health care institutions, facilities and countries prone abbreviations and selection of a LASA medicine to prevent or minimize LASA errors. Some of the in computerized prescriber order entry (CPOE) are actions are common to more than one area but are some of the main reasons for errors during prescribing. listed under only one, and several approaches may be Similar appearance of medicines and their packaging, necessary. Executive summary |1| Table 1: Actions suggested for reducing LASA errors Actions by health care Actions on medicines as Actions by patients, Actions by health facilities, institutions products families and caregivers and care workers and countries 1. Use “tall man” lettering 1. Know each medicine 1. Educate themselves 1. Promote a just, trusting (TML) to label medicines prescribed, dispensed and the patients about culture in facilities so with which a risk has and administered, the LASA medicines that staff are at ease in been identified. including the name, that are prone to errors, discussing and reporting indication, strengths of and address them in LASA medication errors 2. Segregate storage of medicines dispensed and practice. (The section on and near misses. identified LASA medicine the dose to be used. improving medication pairs or groups. 2. Identify the most safety of the WHO patient 2. Be aware of potential common pairs of LASA 3. Develop and use tools safety curriculum guide errors with LASA medicines in the country and skills to identify is a good resource for this medicines, and be or organization, and LASA medicine pairs to purpose). vigilant about such update the list regularly. prevent registration of errors. 2. Pay attention to LASA such products, minimize 3. Label clearly, use TML, medicines when approval of several 3. Learn to label and store and segregate storage of prescribing, dispensing strengths of the same medicines appropriately LASA medicines. and administering medicine, and approve at home to avoid LASA medicines and during 4. Take measures to only dosage forms and errors with the medicines medication reconciliation avoid interrupting and strengths with different dispensed to the patient. at transitions of care. distracting health and appearances and 4. Check with the care workers while they packaging. 3. Use generic names health care provider are dispensing and during prescribing and 4. Identify LASA medicines if in doubt, about a administering medicines. transcribing to minimize when including them in prescribed, dispensed errors due to brand name 5. Include technology- formularies and during or administered LASA confusion. based solutions, such purchase for institutions medicine. as CPOE and barcoded and countries. 4. Write legibly when dispensing, to avoid prescribing and 5. Prioritize LASA errors LASA errors. transcribing. involving high-risk 6. Apply quality control medicines with greater 5. Attach clear labels for measures to ensure potential for severe harm. LASA medicines, with proper use of authentic TML for medicines that 6. Label all raw and herbal medicines. could be confused. processed T&CM products including the botanical names of plants Each facility or institution should consider the barriers to in LASA errors. Engaging patients and families in and enablers of implementing the activities suggested. recognizing LASA errors, developing a positive reporting They will be specific to each facility and institution. Some culture, and establishing systems and practices for active barriers that facilities and institutions could consider consideration of LASA medicines, (from procurement to include a “blame culture”, staff fatigue, limited resources use of medicines by patients) would also reduce LASA and the additional time necessary for staff for TML, errors. labelling and segregating storage. A further barrier is the absence of processes to identify many confusing This publication on medication safety for LASA formulations or multiple strengths of the same medicine. medicines is based on the best currently available evidence for action, which is presented when available. Enablers for reducing LASA errors include the support For most of the proposed solutions, however, the of institutions, regulators and manufacturers for evidence was based on work conducted in controlled considering LASA medicines as products that can be environments, and the suggestions are based mainly on confused and staff training in LASA errors, including expert consensus. More evidence, especially from real- sharing information with patients and carers about life settings, would allow evidence-based strategies that lettering, packaging and storage that could result could reduce errors due to LASA medicines. |2| Medication safety for look-alike, sound-alike medicines  1 Background In recognition of the scale of avoidable harm linked with unsafe medication practices and medication errors, 1.1 Purpose and methods WHO launched the third Global Patient Safety Challenge: This publication is part of a technical series on solutions Medication without harm, in 2017, with the goal of to ensure medication safety. It is meant to provide a reducing severe, avoidable medication-related harm resource for health and care workers, policymakers, by 50% over 5 years, globally (1). The Challenge created health care facilities, institutions and patient care the opportunity for leaders to drive change and work organizations to understand the problem and impact together to make a real difference to the lives of patients, of LASA medicines and to detect, address and prevent families and front-line health workers. Furthermore, to LASA errors. It also includes points for consideration consolidate the activities of the Challenge, “Medication by Member States, organizations, manufacturers and safety” was selected as the theme for World Patient regulators. Safety Day 2022, with the slogan “Medication without harm”. A literature search was conducted up to March 2023 in PubMed, Google Scholar, Google and WHO publications Interventions are necessary at global, regional, national with the keywords: look-alike sound-alike medicines, and facility levels and on the front line to address LASA medicines, medication errors and serious harm. the Challenge, as the causes of medication errors The relevant references in the reference lists of key are complex, with many contributing factors. Unsafe published articles on LASA medicines were retrieved medication practices leading to medication errors and reviewed. Information related to LASA medicines jeopardize patient safety. A medication error is defined available on the websites of major medicines regulatory “as any preventable event that may cause or lead to authorities and of other relevant organizations, such as inappropriate medication use or patient harm while the Institute for Safe Medication Practices (ISMP), were the medication is in the control of the health care also reviewed. professional, patient, or consumer. Such events may be related to professional practice, health care products, Expert opinion was obtained from relevant WHO procedures, and systems, including prescribing, order units, WHO regional advisors and content experts. communication, product labelling, packaging and An advanced draft was sent for critical review to a nomenclature, compounding, dispensing, distribution, wider group of reviewers and patients’ representatives administration, education, monitoring, and use” (2, 3). identified from the Global Patient Safety Network, representing all WHO regions, including low- and Background |3| middle-income countries (LMICs). All comments received between brand or generic names. Sound-alike errors are were considered in revising the document. All external due to medicines with names that can easily be mistaken contributors and reviewers provided declarations for those of others, especially when verbal orders are of interests and signed confidentiality agreements, given (4). There is, however, no universally accepted, which were reviewed before they were invited to make clear definition of LASA errors. The appearance of contributions. medicines can be misleading because other medicines may look the same; conversely, the same medicine from a different source may look different. LASA medication 1.2 Look-alike, sound-alike errors can occur due to similarities in the medicine (LASA) errors name, dosage form, strength or product packaging. These errors often occur due to selection of the wrong Medication errors that occur when medicines have medicine from a shelf or even from an electronic list. similar-looking or similar-sounding names, and/or shared features of products or packaging are called Adverse events may also arise during the use of T&CM LASA errors (4). LASA errors occur when the names of products due to mistaken use of the wrong species of pairs or groups of medicines, such as cephalosporins, are medicinal plants leading to incorrect dosing of raw herbs similar in both their written forms (orthography) or their or finished products. spoken names (phonology). Confusion can also occur |4| Medication safety for look-alike, sound-alike medicines  2 The problem 2.1 Introduction countries, both high-income countries (HICs) and LMICs now identify LASA medicines lists for their own LASA errors constitute a high proportion of all settings (7–11). medication errors that can lead to significant patient harm (4). In recognition of the problem, the Food and Drug Administration in the USA initiated a project 2.2 Examples for name differentiation in 2001 to evaluate post- LASA errors often occur due to similarities in the letters marketing reports of confusion of name pairs (5). that make up the names of different medicines or Identification of LASA medicines is a requirement in products, at the beginning, middle or end of the name medication management standards in many countries (Table 2). Table 3 lists LASA medicine pairs identified and health care settings. The ISMP issues a regularly in several countries, while Figure 1a and 1b presents updated list of LASA medicines, which can be used some examples of LASA medicines identified in clinical as a guide to identify LASA medicine pairs (6). Many settings. Table 2: Mistaken letters in names of medicines Location in the name Letters Examples of medicines Beginning Am Amiloride, Amitriptyline, Amlodipine, Amiodarone Az Azathioprine, Azithromycin Carb Carbimazole, Carbamazepine Pr Prochlorperazine, Propranolol, Prednisolone, Promethazine Middle gaba Pregabalin, Vigabatrin End azole Metronidazole, Omeprazole The problem |5| Table 3: Examples of LASA medicine pairs identified in selected countries (non-proprietary or generic name is in parentheses) Country Brand name (generic name) Brand name (generic name) Australia Avanza (mirtazapine) Avandia (rosiglitazone) Losec (omeprazole) Lasix (furosemide) Bangladesh Maprocin (ciprofloxacin) Macrocin (erythromycin) Brazil Losec (omeprazole) Lasix (furosemide) Quelicin (succinilcolina) Keflin (cefalotina) Canada Celebrex (celecoxib) Celexa (citalopram) Losec (omeprazole) Lasix (furosemide) France (fluoxetine) (fluvoxamine) India Bandy (albendazole) Candy (clindamycin) Ireland Losec (omeprazole) Lasix (furosemide) (morphine) (hydromorphine) Italy Diamox (acetazolamide) Zimox (amoxicillin trihidrato) Flomax (morniflumato) Volmax (salbutamolo solfato) Japan Almarl (arotinolol) Amaryl (glimepiride) Taxotere (docetaxel) Taxol (paclitaxel) Morocco Prazol (omeprazole) Prozac (fluoxetine) Endoxan (cyclophosphamide) Triaxon (ceftriaxone) Spain Dianben (metformin) Diovan (valsartan) Sweden Avastin (bevacizumab) Avaxium (hepatitis A vaccine) Lantus (insulin glargine) Lanvis (toguanine) Source: WHO (12). Figure 1a: Examples of some injectable products of LASA medicines identified Ketamine hydrochloride (general anaesthetic and sedative) and Bupivacaine (local anaesthetic) and sodium chloride (intravenous midazolam (benzodiazepine used as a sedative, and anxiolytic) fluid used as a diluent or to flush after intravenous cannulation) |6| Medication safety for look-alike, sound-alike medicines Figure 1b: Examples of tablets of LASA medicines identified from LMIC settings Diclofenac sodium 50 mg (nonsteroidal anti-inflammatory drug Gliclazide 80mg (anti diabetic medicine) and enalapril 5 mg (used used for pain relief) and bisoprolol 5 mg (beta-blocker used for for hypertension and heart failure) These medicines are re-packed cardiac failure and hypertension) from the original bulk packaging and kept for dispensing Ciprofloxacin, levofloxacin (antibiotics) and several other medicines with similar appearance kept for dispensing LASA errors can occur due to confusion of the following With respect to the clinical impact of confusion of name combinations; most LASA pairs are reciprocal. these medicines pairs, giving propranolol instead of  generic–generic names; for example, propranolol prednisolone to a patient with asthma has caused and prednisolone, carbamazepine and carbimazole; exacerbation of asthma and hypotension, due to propranolol aggravating bronchoconstriction and  brand–brand names, for example, Oxynorm and reducing blood pressure. Dispensing carbimazole, Oxycontin, Losec and Lasix; Celebrex and Cerebryx; and an antithyroid medicine to a patient prescribed  brand–generic names, for example, Malarone and carbamazepine for epilepsy can have potentially mefloquine. severe consequences as the patient can develop The problem |7| hypothyroidism and loss of seizure control. The brand– in different languages in different parts of the world, brand confusion between Oxynorm and Oxycontin is an which could lead to wrong identification. example of potential overdose if the modified release preparation (Oxycontin) is given in place of the normal Figure 2: An example of look-alike different strengths release product (Oxynorm) at regular intervals. In the of warfarin, an anticoagulant and a high-risk medicine brand–generic example of Malarone and mefloquine, although both are used against malaria, harm has been seen when mefloquine used weekly was given daily instead of weekly. Losec is a brand name for omeprazole, an antiulcer treatment, while Lasix is a brand name for frusemide, a diuretic. Celebrex is a brand name for celecoxib, an anti-inflammatory medicine, while Cerebryx is a brand name for fosphenytoin, an anticonvulsant, which could also be confused with Celexa, a brand name for citalopram, an antidepressant. In these situations, a completely different medicine from what was intended could be dispensed if the prescription provides only the brand name, which could have serious consequences for the patient. Furthermore, the same brand name in the same or a different country could have different active ingredients Note: Warfarin tablets of 1, 3 and 5 mg of the same colour were and may result in administration of a completely different supplied to hospitals in bulk containers in a LMIC and dispensed to patients as loose tablets. A patient was admitted with bleeding and an medicine. For example, the brand name Medzol has been international normalizing ratio of 14. given to both pantoprazole and midazolam, two different medicines with different active ingredients (pantoprazole, an antiulcer medicine and midazolam, a sedative). 2.3 Scale of errors Sometimes, confusion can occur between two strengths LASA errors are estimated to be responsible for of the same medicine. For example, warfarin is available 6.2–14.7% of all medication errors, with the prevalence in strengths ranging from 1 to 10 mg, which are usually of LASA errors in prescriptions varying from 0.00003% to colour coded. If colour coding is not used, serious errors 0.0022% (4). In the United Kingdom, where over 1 billion could occur if 5-mg tablets are mistaken for 1-mg tablets prescriptions are issued each year, this error incidence or vice versa (Figure 2). was estimated to result in up to 2.2 million LASA errors annually (4). LASA errors could also occur with T&CM products, which are primarily based on medicinal plants. The confusions LASA errors often lead to administration of the wrong could occur with raw herbs (root, stem or leaf of plants), medicine at the wrong or incorrect dose of the intended processed herbs (powders, extracts or infusions) or medicine, leading to toxic effects or other adverse finished products (syrups, fermented liquids, or polyherbal effects (13,14). External environmental factors are not formulations). Similarity in the colour, consistency, aroma the cause, although they can increase the risk of an error and the taste of the pieces of raw herbs, powders or liquid due to LASA medicines (15). herbal preparations and colour, shape, size of the tablets and capsules can contribute to LASA errors. Several Quantitative evidence of the prevalence of LASA errors is medicinal plants are known by dissimilar common names limited, and various figures have been reported (Table 4). Table 4: Reported prevalence rates of LASA errors Rate of medication error due to LASA Type of study and reference medicines 7% of medication near misses Systematic evaluation of 2044 near misses (16) 15% of vaccine errors Analysis of 607 error reports over 3 years in the USA (17) 0.0022% brand name confusion Total of 244 brand name confusions among 113 346 errors reported in a study in Delhi, India (18). |8| Medication safety for look-alike, sound-alike medicines  3 Causes and impact of LASA errors To address the errors due to LASA medicines, the and lithium carbonate was dispensed instead of instances in which they can occur must be identified. calcium carbonate, resulting in development of LASA errors occur during all stages of medication use. lithium toxicity requiring dialysis. Writing only “U” for ‘units’ has led to misinterpretation of “6U insulin” as “60 units insulin”, which resulted in severe 3.1 Stages of medication use at hypoglycaemia.); which LASA errors can occur  Use of a trailing zero (for example, 5.0 mg can be interpreted as 50 mg) or non use of a zero (for LASA errors can occur at the stages of prescribing, example,.5 mg instead of 0.5 mg can be interpreted transcribing or documenting, dispensing, administering as 5 mg), leading to dosing errors. and monitoring (19). The common causes of LASA errors at each of these stages are listed below. 3.1.2 Transcribing or documenting 3.1.1 Prescribing  Incorrect transcription of a LASA medicine name;  Illegible or poorly legible handwritten prescriptions  Use of inappropriate abbreviations in transcribing, or orders, resulting in wrong interpretation leading to errors due to wrong interpretation of the (particularly in LMICs, where handwritten abbreviation; prescriptions are still used in most settings);  Incorrect interpretation of sound-alike LASA  Verbal and telephone orders for medications, medicines due to lack of a read-back mechanism resulting in potential confusion of sound-alike during verbal and telephone orders. medications;  Non engagement of patients and families in 3.1.3 Dispensing understanding and confirming the name and  Selection of products according to where they purpose of the medication; are stored in the pharmacy or according to the  Incorrect selection of medicines from look-alike packaging rather than the name and strength of the products during CPOE; product;  Inappropriate use of error-prone abbreviations; for  Storage of LASA medicines on the same shelf next example, MSO4 can be interpreted as magnesium to each other, which may be picked up incorrectly sulphate or morphine sulphate, resulting in serious during dispensing; errors. (In one instance, CaCO3 was interpreted as  Changing the appearance or packaging of LiCO3 on an unclearly handwritten prescription, medicines, making them similar to other products; Causes and impact of LASA errors |9|  Non use of colour coding for different strengths and failure to recognize any changes in the usual 3.2 Clinical impact of LASA strength or appearance of a product during errors and vulnerable patients dispensing; The impact on the patient will depend on the medicine  Failure to engage with patients to communicate the administered and the condition of the patient. LASA name and purpose of the medication; errors can result in toxicity due to overdosing of a  Failure to double-check accurately during medicine, adverse effects of an unintended medicine, dispensing due to time pressure, especially in LMICs and exacerbation of the disease for which the intended when medicines are dispensed to a large number of medicine was not given. Some errors are detected patients during one session; before the medicine is administered to a patient, while others are not found until much later. Errors might be  Failure to communicate any changes in the more common where there is lack of familiarity with the appearance of medicines to patients. products used (20). 3.1.4 Administering Some patient groups are more vulnerable to medication errors than others, for example due to their physiology  Unclear instructions for administration, for example, in extremes of age, kidney or liver impairment, or frailty. use of “as directed”, leaving instructions open to Potential for harm is higher in paediatric or elderly misinterpretation; patients because of differences in physiology causing  Unfamiliarity with medicines, leading to selection of differences in pharmacodynamics and pharmacokinetics. a look-alike product; Some factors related to the type of medicines also  Selection of a product according to familiarity with make the patients more vulnerable to severe harm the packaging or strength rather than confirming due to errors. These include medicines with a narrow and double-checking the medicine name and the therapeutic index, high-risk medicines, and medicines dose; that are relatively more toxic, such as cancer medicines. The use of acronyms or nicknames to refer to cancer  Failure to engage patients during administration of chemotherapy agents is also a potential source of error medicines. (21). Patients in intensive care units and emergency departments are also particularly vulnerable to errors. 3.1.5 Monitoring  Failure to monitor outcomes of medication by relevant clinical observations or biochemistry. | 10 | Medication safety for look-alike, sound-alike medicines  4 Addressing LASA errors Limited evidence is available on the effectiveness of encourage reporting, monitoring and evaluation of solutions for addressing the impact of LASA errors (4). common LASA errors, with regular review and revision Although some regulatory bodies have taken steps to of common, country-specific pairs of LASA medicines. minimize allocation of LASA names and appearances to new products, situations can still arise in which similar Strategies to address LASA errors are considered below names or appearances are assigned to medicines. under the four domains of the WHO third Global Patient Idiomatic variation can also result in LASA errors in Safety Challenge: Medication without harm: different pairs, depending on the country. Similar  Medicines: medicines as products; packaging should also be considered a potential cause  Patients and the public: role of patients and family of error. As LASA products are already on the market, members in preventing LASA errors; targeted strategies are necessary to reduce the risk of human error, with greater focus on a systems approach  Health care professionals: role of health and care rather than a person-centred approach to human workers in preventing LASA errors; errors (22).  Systems and practices of medication: health care systems and practices to be addressed. A systems approach has been shown to be more effective in identifying the factors that are primarily responsible for a risk of error, known as “latent 4.1 Medicines as products to conditions” (22). Latent conditions can result in two kinds of adverse effects: error-provoking conditions in be addressed the workplace (such as time pressure, understaffing, The most common reason for LASA errors is similarity inadequate equipment, fatigue and inexperience) in names and packaging. Regulators and the and long-lasting gaps or weaknesses in defences pharmaceutical industry both play roles in naming and (for example, untrustworthy alarms and indicators, packaging medicines. Many errors could be prevented unworkable procedures, and design and construction if manufacturers considered risks for LASA errors when deficiencies). Member States, in collaboration with naming and designing packaging of medicines by regulators, can develop programmes to encourage adherence to regulatory guidance. This is especially their health and care institutions to address such latent important for risks that have already been identified. conditions. National systems should be in place to Addressing LASA errors | 11 | 4.1.1 Developing and updating to draw attention to dissimilarities between confusable names. the list of LASA medicines Regulatory authorities determine whether TML could be Each country or Member State needs to identify the used to help differentiate similar names after evaluating most common pairs of LASA medicines in their country post-marketing reports of name pair confusion (5). Many or organizations that cause errors and update them factors, such as the degree of similarity of the names regularly. Systematic methods have been used by in a pair, the risks associated with name confusion, countries and organizations to compile lists of such reports of medication errors, and causes or contributory medicines (4-8). Separate lists of LASA medicines can factors, are considered during evaluation of name pairs. be identified for different specialities and settings After evaluation, manufacturers can be requested to (for example, for emergency care, intensive care voluntarily revise their labels by using TML (25,26). ISMP, units, maternal and newborn care, oncology units or which updates the LASA list regularly (24), recommends community pharmacy settings). If compilation of a use of TML in bold (Table 5). The list includes mostly customized list is not possible, lists that have been generic–generic medicine name pairs, although some developed by organizations such as the ISMP can be brand–brand or brand–generic name pairs are also used (6). Organizations and countries can issue and listed, for voluntary use by health care workers, to circulate regular bulletins to institutions to highlight and prevent LASA errors (26). Additional variations of TML, address any issues as they arise (23). such as having letters in bold or in different colours, can be used for easy identification. 4.1.2 “Tall man” lettering TML is the only intervention that has been evaluated One widely adopted approach for differentiating LASA for efficacy in preventing LASA errors in randomized medicine pairs is the use of TML, a term coined by controlled trials. Although the intervention is ISMP (24). TML assists in differentiating LASA medicine recommended and widely used, a systematic review of names by the use of upper-case lettering for certain such trials found limited efficacy and concluded that letters of medicines names. This has often been applied TML is marginally effective for reducing LASA to syllables or groups of letters within a medicine name errors (13). Table 5: Some LASA medicine names recommended for “tall man” lettering Established name Recommended “tall man” lettering Acetohexamide acetoHEXAMIDE Acetazolamide acetaZOLAMIDE Bupropion buPROPion Buspirone busPIRone Chlorpromazine chlorproMAZINE Chlorpropamide chlorproPAMIDE Clomiphene clomiPHENE Clomipramine clomiPRAMINE Cyclosporine cycloSPORINE Cycloserine cycloSERINE Daunorubicin DAUNOrubicin Doxorubicin DOXOrubicin Hydralazine hydrALAZINE Hydroxyzine hydrOXYzine Hydromorphone HYDROmorphone Medroxyprogesterone medroxyPROGESTERone Methylprednisolone methylPREDNISolone Methyltestosterone methylTESTOSTERone Source: Food and Drug Administration (5) and ISMP (6). | 12 | Medication safety for look-alike, sound-alike medicines 4.1.3 Clear labelling, segregating should be appropriately labelled to prevent errors in selection. storage and colour coding Figure 3: Labelling for LASA medicines in which “tall- The methods considered for addressing LASA errors are man” lettering cannot be applied based mainly on expert opinion and consensus (4,13). Those who use the policies are encouraged to collect evidence of their impact to contribute to the evidence base. If TML cannot be used (for example, for vaccines and immunoglobulins for a particular disease), the trade name on the label could differentiate the two products. Labelling that indicates possible LASA confusion can also help to identify medicines for which TML cannot be applied (Figure 3). Segregated storage of LASA medicine pairs may also help to avoid errors (Figure 4) (27). The few studies on use of a colour coding system provide little evidence that it reduces the risk of errors due to look-alike medicines (28). There are far more look-alike medicines or medicine groups than there are colours that could be used. Most importantly, the evidence suggests that, when colour coding is used, health and care workers may rely solely on the colour of labels and not read them at all (29,30). Despite the lack of evidence, an international standard recommends colour coding of medicines used in anaesthesia, and it appears to be the most widely used strategy for labelling such medicines in many countries, including Australia, New Zealand and the United Kingdom (30–32). In T&CM products the common name of every Source: Pharmaceutical Services Division, Ministry of Health, medicinal plant written in English need to be Malaysia (27) supported by its scientific/botanical name on the label. The small pieces of raw herbs used for making infusions Note: Proprietary (brand or trademark) names may be added to distinguish medications. Non-proprietary names should be in larger and decoctions, processed herbs and finished products font size than brand names. Figure 4: Storage of LASA medicine pairs separately Source: Pharmaceutical Services Division, Ministry of Health, Malaysia (27) Note: Whenever possible, avoid storing LASA medicines close together. Addressing LASA errors | 13 | 4.2 Roles of patients 4.3.1 Training of health and care and family members in workers preventing LASA errors Lack of training or staff fatigue can contribute to LASA Poor medication literacy among patients may errors. The section on “improving medication safety” in contribute to LASA errors. In a study conducted the WHO publication, Patient safety curriculum guide, in a French region, 768 patients were interviewed. multi-professional edition (35) is a good resource for Although most patients identified medicines by their teaching and learning, as it addresses common causes of brand name (50%) and generic name (21%), some medication errors and strategies for preventing patient identified medicines by the physical appearance of the harm. Potential LASA errors should be included in box (16%), tablet (7%) or blister packaging (3%) (33). graduate and postgraduate educational curricula and in The factors considered most likely to cause confusion continuing professional development for all categories were the appearance of medicines, including look- of health care providers. Health and care workers from alike tablets (28%), look-alike boxes (20%) and all backgrounds should consider LASA errors when look-alike blister packaging (13%) (33). Studies from selecting medicines during prescribing, dispensing and LMICs indicate that patients in LMICs had much less when administering medicines. Research, including knowledge than those in HICs about the medicines systematic reviews that included low-resource settings, they took with only 42% identifying the medicines by has shown that, when users are aware of the purpose their name (34). and use of TML, they are less likely to confuse look- alike names and more likely to derive benefit from TML Patients and families should learn about the medicines (20,36,37). Health and care workers should improve the prescribed to them and be vigilant about LASA errors, understanding of patients of potential LASA errors at for their own safety. Patient safety organizations can home, thus helping to prevent such errors. Development educate patients about possible LASA errors. Reporting of a culture in which health and care workers listen to of LASA errors by patients to the relevant authorities patients and their carers when they share information can assist the authorities in learning from errors and in about administration of their medicines is important in identifying local LASA pairs to prevent similar errors. preventing LASA errors (38). Patients should also appreciate that the same medicine Health care professionals, especially pharmacists and from different sources may have different appearances. nurses, should be trained in attaching clear labels with This will help patients to avoid overdosing by taking TML for LASA medicines and storing different strengths the same medicine from two sources and with different of the same medicine with similar packaging separately physical appearances and may also help to improve to avoid errors, especially for high-risk medicines. TML adherence to a medicine with a familiar appearance that should be used when a risk has been identified and not is different when manufactured by another source. in all circumstances (41). Among consumers, there is a widespread misconception that T&CM products are ‘natural’ and hence ‘safe’ and To engage patients and families, health and care workers can: carry no risk. However, errors in selection of T&CM products and usage of incorrect and inappropriate T&CM  educate patients, families and caregivers about products can lead to unwanted effects and public should potential LASA errors and remind them to double- be aware of this. check the names of their medicines;  teach them about use of TML on labels to help them 4.3 Roles of health and care identify the names clearly, even at home; workers in preventing LASA  educate them about the names used for their errors medicines, (brand name and generic name, as well as the clinical indication) so that patients are Health and care workers around the world should engaged in ensuring that they receive the correct be aware of LASA medicines and prevent errors in medication; their practice. They should attach clear labelling  support patients, families and caregivers in and segregate storage of LASA medicines to ensure speaking about their medicines if they suspect any differentiation. unexpected change; | 14 | Medication safety for look-alike, sound-alike medicines  educate patients about the problems of LASA encourages generic manufacturers of the same medicine names so that they are aware before medicine to ensure that their products have similar ordering medicines via the internet or in physical characteristics (44). Regulatory authorities pharmacies, and encourage them to purchase recommend that sufficient visibility be given to medicines from regulated, authorized premises; and generic names to facilitate identification, even if the  encourage patients to enquire about medicines proprietary name is different (45). from their community pharmacists or health and care workers, to seek information about LASA medicines, and to keep a list of the medicines they 4.4 Health care systems and are prescribed to prevent LASA errors related to practices to be addressed their medications. A just and trusting culture is fundamental to patient safety in an organization. By ensuring that staff are at 4.3.2 Roles of regulators, naming ease in discussing and reporting potential LASA errors, bodies and manufacturers the organization can prevent the same or similar types of error from occurring. Staff must also be supported in Regulators, naming bodies and manufacturers play vital proposing contributing factors and underlying reasons, roles in ensuring that factors related to LASA medicines such as a high workload, psychological aspects and are considered during product development and approval. identifying products prone to errors in their clinical settings. Addressing such areas encourages health  Regulators are responsible for monitoring the workers to report errors and near misses (43). A whole- naming and packaging of new products to avoid systems approach should be applied in identifying LASA medicine errors. They are supported by an and addressing situations throughout the health care international approach and discussion that allows system that could increase the likelihood of a LASA error. LASA medicine pairs to be identified at the pre- An example is an emergency department or a busy marketing stage (40). pharmacy, where more LASA errors could occur due to  Phonetic and orthographic computer analysis time constraints and a heavy workload. Steps to improve can assist in naming new products, including systems and practices can contribute to preventing consideration of variations in the products used errors in these high-risk situations. in different countries. Phonetic and orthographic Actions to address errors due to LASA medicines that computer analysis does not, however, address the could be implemented throughout a health care system problem posed by existing products. are given below.  The medicines regulatory authority in a country can prevent registration of products with the same Avoid interruptions, distractions and verbal orders (15, brand names but that contain different active 25, 46, 47): ingredients or different strengths of medicines  If verbal orders cannot be avoided, repeat the name having the same appearance (see Figure. 2). out loud to confirm the exact verbal order and  Naming bodies, such the WHO International Non- clarify the name. proprietary Names programme and the British  Use signs stating “do not disturb” or “no interruptions” Pharmacopoeia, can prevent designation of highly during medicines dispensing and administration; this confusable name pairs (41,42). intervention has had various degrees of success, and  Manufacturers and suppliers should consider LASA there is also concern that it could discourage patients errors when naming and packaging generic and from asking relevant questions. branded medicines.  Use reminders and alerts for LASA medicines.  Regulators can develop tools and skills to identify  Be aware that high-intensity environments, such as medication errors from reports of adverse incidents emergency departments, operating theaters and from health care facilities and investigate their intensive care units, are particularly prone to LASA preventability (43). errors.  Ensuring a similar appearance of generic products of Write legible prescriptions, and avoid use of error- the same medicine would also aid in identification prone abbreviations (48-50). of the same medicines from different sources.  If feasible, reduce the number of handwritten orders. The Food and Drug Administration in the USA Addressing LASA errors | 15 |  Write the names of medicines, dosage directions prominent places, especially in pharmacies and and route of administration legibly and consider critical care areas. adding the indication to prescriptions to check the Change the storage of medicines (46,56). appropriateness of the prescription and to ensure that LASA medicines are not confused.  Change the sequence of storage of medicines with similar sounding names, especially those with a  Verify prescriptions, for example by checking with narrow therapeutic ratio. the patient and reviewing the indication before dispensing and administration.  Segregate LASA medicines pairs or groups of medicines, such as cephalosporins.  Record the identification of the prescriber (for example, by using a seal) in both government and  Use stickers with techniques such as TML, boldface private sectors to facilitate clarifying any doubts and colour differences to reduce the confusion about a prescription. associated with LASA medicines on labels, storage bins, shelves, computer screens, automated  Be aware that poorly legible prescriptions and use of dispensing devices and medication administration error-prone abbreviations are particular problems in records. LMICs, where most prescriptions are written by hand.  Use colour coding to differentiate medicines, Address packaging and labelling of LASA although a combination of techniques is advisable, medicines, and provide information, education and especially for people who are colour blind. communication material (51–55). Review LASA medicines during registration of  Use typographic interventions, such as TML. products, when including products in formularies, or  Use stickers with symbols or pictograms on during procurement of medicines (24,54). packaging or signage on pharmacy shelves.  Review potential problems before registering new  Relabel medicines to include brand and generic products or adding them to a formulary, including names and use clear signage on pharmacy shelves. when introducing changes because of medicines shortages.  If possible, request manufacturers and suppliers to revise the labelling, appearance and packaging of  Avoid adding several dosage forms of the same their products, when similarities are noted medicine and limit the number of dosage forms and (see figure 5). strengths available for adult and for paediatric use.  Display information, education and communication  When procuring medicines, avoid purchasing material about LASA errors and how to address medicines with similar packaging and appearance them on boards, posters and other media at if possible; when introducing new products or packages, compare them with existing packaging. Figure 5: Revision of labelling and appearance of LASA medicines to minimize the risk of potential serious errors Panel A Panel B Source: Gangakhedkar et al. (56). Note: Three high-risk medicines – rocuronium (muscle relaxant used in anaesthesia), midazolam (sedative) and heparin (anticoagulant) – in similar bottles, (Panel A) with their appearances changed by differences in labelling and having caps of different colours after recognition of their similarity and the ensuing risks (Panel B). | 16 | Medication safety for look-alike, sound-alike medicines Use technology-based solutions to address LASA Report medication error incidents (43,47). medicines (57–61)  Report medication error incidents and near misses  Design CPOE systems to ensure that LASA medicines in health care facilities by health and care workers are not placed next to each other on the computer and by patients to the relevant authorities, in a “no drop-down options and use other algorithms that blame” culture. can reduce errors.  Perform root cause analysis by a multidisciplinary  Use indication alerts to intercept errors in medicine team to learn from errors and to implement names and exercise caution to avoid alert fatigue coordinated actions to prevent common errors. during CPOE.  Strengthen pharmacovigilance programmes and  Use barcoding during dispensing to correlate patient safety organizations to ensure that they physical selection of a product with that on the report medication errors and near misses. screen; however, checks should still be made, as this  Report errors related to T&CM products to learn will not address errors occurring before dispensing, from those and to take preventive actions. such as during prescribing.  Consider use of automated dispensing cabinets and robotic dispensing as a possibly useful intervention 4.5 Additional points for to prevent dispensing errors. consideration by Member  Use barcoding technology during administration (when barcodes are added to products and to unit States and organizations dosages) with international standards for coding. Additional advocacy that can be taken to address LASA  Use a system for identifying pharmaceutical medicines is as follows: products, when available, to reduce error;  Ensure that organizations responsible for procuring establishment of a global pharmaceutical product medicines include considerations of potential LASA identification system is being discussed in the WHO errors in acquisition of new products. Identification of Medicinal Products initiative  Be aware that a single brand name may be (60, 61). associated with different medicines in different Undertake medication review and medication countries. reconciliation (62,63).  Advocate for increased emphasis on patient safety  Perform a medication review when initiating in the naming of medicines and for elimination medications and at transitions of care. of LASA names by participating in national and international regulatory, standards and advisory  Train pharmacists and other health and care workers boards. to address potential LASA errors on the wards and at points of transition by performing medication  Collaborate with international regulatory agencies reconciliation, sharing information with patients and and industries to develop a uniform naming process staff. and safety culture (64). This would require: Ensure that all staff are properly trained and are aware ™™ a universal medicine naming convention; of possible LASA errors and interventions to avoid them. ™™ screening of existing medicines names for potential confusion with a new medicine name Employ qualified, competent individuals for all steps in before approval of the latter; medication use and management in health care settings. ™™ standardized suffixes (for example, for sustained-  Be aware that shortage of staff in many LMICs release medicines); has required the use of (often untrained and unqualified) informal health care providers to assist ™™ ensuring that potential LASA confusions are health and care workers, increasing the risk of LASA considered when medicines are introduced; and errors; training of all categories of staff, including ™™ considering possible LASA errors due to informal health care providers involved in handling similarities in packaging. medicines is required, on possible LASA errors and ways of preventing them. Addressing LASA errors | 17 |  5 Barriers and enablers Each facility or institution should consider the barriers  physicians’ preference for prescribing brand rather to and enablers of implementation of solutions to LASA than generic names; and errors. The lists below are not exhaustive, but facilities  insufficient evidence on solutions for LASA errors. and institutions may consider them when developing solutions to LASA errors. 5.2 Enablers 5.1 Barriers  staff training, including sharing information about  blame culture; lettering and packaging with patients and carers to minimize errors;  inadequate staff resources for TML and segregation of LASA medicine pairs in storage;  a positive reporting culture;  lack of appropriate formulations or strengths (for  active consideration of LASA errors when procuring example, paediatric doses or formulations and medicines; different bolus and maintenance formulations);  commitment of policy-makers and health care  inadequate resources, especially in LMICs, to leaders to minimize LASA errors; and implement technological solutions such as CPOE  collaboration among regulatory authorities and and barcoding; responsible organizations to avoid LASA errors  wide variation in pharmaceutical regulations among during naming and packaging of medicines. countries;  lack of a standard method for TML; | 18 | Medication safety for look-alike, sound-alike medicines  References 1. 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