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Preventing medication errors in anesthesia and critical care (abbreviated version)
Accepted Manuscript Title: Preventing Medication Errors in Anesthesia and Critical Care (abbreviated version) Author: Vincent Piriou Alexandre Theissen S´egol`ene Arzalier-Daret Marie Marcel Pierre Trouiller St´ephanie Parat Catherine Stamm R´emy Collomp PII: DOI: Reference:
S2352-5568(17)30094-2 http://dx.doi.org/doi:10.1016/j.accpm.2017.04.002 ACCPM 247
To appear in: Please cite this article as: Vincent PiriouAlexandre TheissenS´egol`ene ArzalierDaretMarie MarcelPierre TrouillerSt´ephanie ParatCatherine StammR´emy Collomp Preventing Medication Errors in Anesthesia and Critical Care (abbreviated version) (2017), http://dx.doi.org/10.1016/j.accpm.2017.04.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Preventing Medication Errors in Anesthesia and Critical Care (abbreviated version)* *Overview of recommendations developed by the French Society for Anesthesia and Critical Care (SFAR) in partnership with the
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French Society for Clinical Pharmacy (SFPC) and validated by the boards of each of these societies.
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On behalf of the Risk Management Analysis Committee of the French Society for Anesthesia and Critical Care (SFAR): Vincent Piriou1, Alexandre Theissen2, Ségolène Arzalier-Daret3, Marie Marcel4, Pierre Trouiller5,6 On behalf of the French Society for Clinical Pharmacy (SFPC): Stéphanie Parat7, Catherine Stamm8, Rémy Collomp9
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1. Université Lyon 1, groupement hospitalier Sud, hospices civils de Lyon, anesthésie-réanimation, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 2. Centre hospitalier Princesse-Grace, anesthésie-réanimation, avenue Pasteur, 98000 Monaco, France 3. Centre hospitalier universitaire de Caen, service d'anesthésie-réanimation, avenue de la Côte-de-Nacre, 14000 Caen, France 4. Groupement hospitalier Sud, hospices civils de Lyon, service d'anesthésieréanimation, IADE, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 5. Groupement hospitalier Est (HCL), OMEDIT Rhône-Alpes, 49, boulevard Pinel, 69777 Bron cedex, France 6. Hôpitaux universitaires Paris-Sud, hôpital Antoine-Béclère, service de réanimation polyvalente, unité de surveillance continue, 157, rue de la Porte-de-Trivaux, 92140 Clamart, France 7. Groupement hospitalier Sud, hospices civils de Lyon, pharmacie, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 8. Hospices civils de Lyon, système de management de la qualité de la prise en charge médicamenteuse du patient, BP 2251, 3 quai des Célestins, 69229 Lyon cedex 02, France 9. Centre hospitalier universitaire de Nice, hôpital l'Archet, pôle pharmacie stérilisation, 151, route Saint-Antoine-de-Ginestière, 06200 Nice, France
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The 2016 recommendations were developed jointly by the French Society for Anesthesia and Critical Care (Société française d’anesthésie et de réanimation, SFAR) and the French Society for Clinical Pharmacy (Société Française de pharmacie clinique, SFPC):
Steering committee: Vincent PIRIOU
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Coordinators: Rémy COLLOMP and Alexandre THEISSEN
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Auteur correspondant : Vincent Piriou ([email protected])
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Multidisciplinary task force and authors Ségolène ARZALIER-DARET, anesthesiologist/intensivist, CHU de Caen, SFAR Remy COLLOMP, pharmacist, CHU de Nice, Vice-president of the SFPC Marie MARCEL, anesthesiology nurse HCL, CHU Lyon Sud, SFAR Stéphanie PARAT, pharmacist, HCL, CHU Lyon Sud, SFPC Vincent PIRIOU, anesthesiologist/intensivist, HCL, CHU Lyon Sud, SFAR Catherine STAMM, pharmacist, in charge of the medication management quality-assurance system, HCL, CHU Lyon, SFPC Alexandre THEISSEN, anesthesiologist/intensivist, CH Princesse Grace de Monaco, SFAR Pierre TROUILLER, anesthesiologist/intensivist, Hôpital Antoine Béclère, APHP, Clamart, SFAR
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Revision by the Risk Analysis and Control Committee of the SFAR: Ségolène ARZALIER-DARET, anesthesiologist/intensivist, CHU de Caen Frédéric AUBRUN, anesthesiologist/intensivist, HCL, CHU La Croix-Rousse, Lyon Gilles BOCCARA, Hôpital américain, Neuilly sur Seine Marie-Paule CHARIOT, anesthesiologist/intensivist, Clinique des Cèdres, Cornebarrieu Didier FRESSARD, anesthesiologist/intensivist, CHG d’Arcachon Benjamin GAFSOU, anesthesiologist/intensivist, CMCO d’Evry Jean LEMARIE, anesthesiologist/intensivist, Clinique Saint Léonard, Trélazé Vincent PIRIOU, anesthesiologist/intensivist, HCL, CHU Lyon Sud Guillaume de SAINT MAURICE, anesthesiologist/intensivist, HIA Percy, Clamart Pierre TROUILLER, anesthesiologist/intensivist, Hôpital Antoine Béclère, APHP, Clamart Alexandre THEISSEN, anesthesiologist/intensivist, CH Princesse Grace de Monaco Patrick-Georges YAVORDIOS, anesthesiologist/intensivist, Clinique Convert, Bourg en Bresse Revision by the Risk Management Task Force of the SFPC: Brigitte BONAN, pharmacist, Hôpital Foch, Suresnes Virginie CHASSEIGNE, pharmacist, CHU de Nîmes Edith DUFAY, pharmacist, CH de Lunéville Bénédicte GOURIEUX, pharmacist, CHU de Strasbourg Clarisse ROUX, pharmacist, CHU de Nîmes Rémi VARIN, pharmacist, CHU de Rouen, president of the SFPC
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The high frequency, potential severity, and preventable nature of medication errors in anesthesia and critical care warrant an update of practical recommendations designed for healthcare professionals and risk managers.
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Consequently, the French Society for Anesthesia and Critical Care (Société française d’anesthésie et de réanimation, SFAR), in partnership with the French Society for Clinical Pharmacy (Société française de pharmacie clinique, SFPC), conducted an in-depth review of its recommendations issued in 2006. The key points of this review are presented here. A detailed version developed for teaching purposes is available also.
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To facilitate the implementation of these recommendations, a specific evaluation grid has been developed. This grid can be used for self-evaluation, cross audits, and external assessments. It is well suited to a variety of situations including risk assessments, preparation for accreditation by the French National Authority for Health (HAS), and evaluations of professional practices.
1. As part of strategic planning, a healthcare facility that provides anesthesia and/or critical
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care must consistently implement measures specific to these patient-care areas and aimed at preventing and managing medication errors and must provide feedback about experience with medication errors. These measures must be set out in writing and must be fully consistent with institutional policy.
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As part of strategic planning, a healthcare facility that provides anesthesia and/or critical care must adopt a continuous process of appraising the measures needed to prevent medication errors in these patient-care areas of particularly high risk. These measures must include assistance in reporting unwanted, preventable, actual or potential medication events. This appraisal process must lead to the implementation of specific measures aimed at preventing and managing medication errors, notably by assessing these errors using validated techniques (REMED, ALARM, RMM) perhaps add a footnote for the international version? and at providing feedback about experience with medication errors. These measures must be set out in writing. They must be fully consistent with the measures implemented in the other sectors of the institution. Close coordination with the person in charge of medication management quality assurance is crucial. The impact of the measures must be assessed and the measures themselves reappraised regularly. Overall, this approach contributes to develop a culture of safety among healthcare professionals in all disciplines. 2. As part of the organizational approach adopted by the institution, a multidisciplinary
team dedicated to optimizing medication management safety must review the entire anesthesia/critical care patient-management process, throughout the trajectory of the patient in the institution, using validated methodological techniques, with a priori and a posteriori analyses. Page 3
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As part of the organizational management of the institution, a multidisciplinary team dedicated to medication management safety must be set up. The team must include at least an anesthesiologist/intensivist, a healthcare professional manager, a registered anesthesiology nurse, and a registered post-anesthesia care unit nurse. The entire management process from the prescription to the administration of medications must be analyzed throughout the trajectory of the patient in the institution, from admission to discharge. This analysis can be expected to significantly diminish medication errors in anesthesia and intensive care units. This approach is part of an overall policy of fostering quality assurance and a culture of safety in the institution, both for a priori risk management (risk projections based on published data and in situ analyses) and a posteriori (analysis of medication errors).
3. Risks associated with managing each patient’s medications (including those taken
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chronically), high-risk medications, never events, and computerized prescription systems and their interfaces must be given special attention, together with human and organizational factors, including interruptions of personnel during tasks.
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Careful attention must be directed to risks related to managing and ensuring the continuity of each patient’s pharmacological treatments (including medications taken chronically), to high-risk medications [1-5], to never events [6], and to computerized medication prescription systems. Human and organizational factors must also be analyzed. Interruptions of personnel during tasks deserve in-depth assessments, as they may occur at any step of the process [7].
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Educational tools can play a major role in improving patient safety and medication management safety. They include simulators, e-learning tools, and scenario-based learning activities that mimic events in a patient’s room [8] or crash-cart assembly errors.
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Preventing anesthesia errors related to chronic patient medications requires a high level of alertness on the part of all professionals, not only during the procedure but also during the pre-procedural anesthesiologist visit. Efforts must start upstream of the procedure, with strong involvement of the patient and healthcare professionals (usual physician, specialists, and pharmacists) to ensure medication reconciliation using appropriate tools, including the creation of a pharmaceutical record during the pre-procedural anesthesiologist visit.
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Within the institution, the roles of the surgeons and anesthesiologists in the wards must be defined, notably regarding prescriptions of medications and the handling of the patient’s personal treatment. All professionals must be aware of the organizational system that is chosen. Similar attention must be directed to formally defining the roles of all those potentially involved in managing chronic medications (e.g., via medication reconciliation), including nurses and pharmacists. 4.
Professionals in these patient-care areas should be offered multidisciplinary continuing education regarding risk management and the appropriate use of management devices. Attention should be directed specifically to preventing errors in medication preparation, reconstitution, and administration in anesthesia and critical care. Preference should be given to simulation-based tools for teaching in the healthcare field.
Multidisciplinary continuing education is particularly likely to prove effective in the area of risk management. Page 4
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In this area, many internal and external, university-affiliated and community training programs are available. Among points of special interest for healthcare providers are the operation of power pumps and injectors, infusion lines and their accessories, adverse mechanical events, the humanmachine interface, and the ergonomics of inappropriate equipment.
5. Specific aspects in critical care
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international color coding of labels [9-15] for syringes, administration routes [14], preparation bags, patient-controlled analgesia and patient-controlled epidural analgesia devices, medication carts, and medication storage devices; careful reading of labels before administration [16]; application of the five-rights rule (right medication, in the right dose, at the right time, via the right route, to the right patient) [17]; using error-reduction devices and bar-code readers [18]; establishing protocols for preparing and administering medications; limiting the list of medications delivered and avoiding similarities in shape, color, and name; reporting and analyzing medication errors.
Other recommendations are specific of critical care:
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regular involvement of a pharmacist in the unit [19,20]; use of programmable power syringes connected to a computer; optimal organization of the crash-cart and/or emergency kit; high level of vigilance for sedative and vasoactive agents, which are involved in most medication errors in the intensive care unit.
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The general recommendations are fully relevant to the field of critical care. They include the following:
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6. Preventing medication errors in anesthesia and critical care requires a combination of
active checking measures (relying both on humans and on computers, e.g., bar codes) and of passive measures (labeling, mechanical systems), aimed at enhancing efficiency and minimizing opportunities for errors, particularly substitution errors.
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Preventing preparation errors relies chiefly on the active checking of information on the medication packaging, which must be read carefully; on the extemporaneous preparation of medications; and on passive measures designed to minimize selection errors. Preventing administration errors rests primarily on active measures including medication preparation and administration by the same person and application of the five rights rule (right medication, in the right dose, at the right time, via the right route, to the right patient [17], which involves carefully reading the international color coding on syringe labels [16]. Passive measures include international color coding of syringes and drug classes, and protocols for preparing anesthesia trays. Other active measures that may be effective are having the label read by a second person before the injection and using bar-code labeled syringes that are read before the injection by a device that displays numerical data and/or the name of the medication [21]. Preventing administration route errors chiefly involves active checking of the injection site and of the entire line before the injection. Passive measures consist of labeling the administration routes (using colors specific of each route), absence of hubs and connectors on regional anesthesia catheters and lines, and physical systems designed to minimize errors (error-reduction devices that Page 5
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use different connectors depending on the route of administration). Unfortunately, these systems were not yet commercially available in France at the time of this writing. An international standard (ISO TC210 JWG4 “Small Bore Connectors”) is being developed under the aegis of the Food and Drug Administration (FDA) and Association for the Advancement of Medical Instrumentation (AAMI), in connection with the French Standards Agency (Association française de normalisation, Afnor) [22-24]. An alternative may consist in using catheters and/or lines of different colors or shapes.
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7. The storage system must be clear, formally defined, and shared by all sites including
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emergency care supplies, regional anesthesia cart, crash cart, and anesthesia table and trays. The professionals responsible for preparing and checking medication carts and cabinets must be clearly identified, and their verifications must be carried out at predefined intervals and must be recorded. Only medications that are absolutely necessary should be available. Medications should not be prepared in advance, and measures should be applied to prevent confusing medications.
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Only medications and concentrations that are used regularly should be available. For anesthesia, only those medications that are strictly necessary should be available. Similarities in shape, color, and name among specialties available in a given environment must be routinely identified and reported. The co-existence of medications exhibiting such similarities must be avoided to the extent possible.
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To the extent possible, high risk medications such as KCl [1-5] should not be stored. If high-risk medications are stored then special precautions must be implemented regarding their storage, shelving, labeling, and delivery, and the personnel must be made aware of the risks.
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In addition to the above-described passive measures designed to minimize reconstitution errors, a continuous appraisal process must be carried out regarding medication storage in operating rooms, post-anesthesia care units, and intensive care units, to maintain a policy consistent with the general rules followed in the institution. At the same time, depending on the activities and operation modalities specific of each institution, protocols for managing life-threatening emergencies and regional anesthesia must be developed. Institutions may choose to prepare specific carts:
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a cart for life-threatening emergencies, whose qualitative and quantitative composition must be identical to that defined for the entire institution and must be governed by a specific procedure; a cart for regional anesthesia with a rule for separating drawers or compartments (one drawer/compartment for one medication in one dosage) given the frequent packaging similarities. The professionals must be aware of procedures for managing overdoses of regional anesthesia drugs, which must be kept on hand.
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When no specific cart is prepared, medications for life-threatening emergencies (e.g., atropine and adrenaline) should be available on anesthesia tables, and a specific location of the drug cabinet labeled “EMERGENCY MEDICATIONS”, or as a second choice specifically identified compartments, must be designated for storing these medications. Kits containing medications and medical devices appropriate for specific situations and intended for the management of emergencies such as local anesthetic poisoning, malignant hyperthermia, and anaphylactic shock can be created, together with a procedure for each situation.
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8. Specific labels will diminish the risk of reconstitution and administration errors:
standardized labels specific of each administration route and syringes labeled according to pharmacological class (international color coding); labeling of bags and preparations for patient-controlled analgesia, patient-controlled epidural analgesia, and power syringes; and labeling of storage areas. Specific labels decrease the risk of reconstitution and administration errors.
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8.a. Identifying administration routes
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The use of colored labels with a distinctive border to identify administration routes is recommended. The administration route should be written in full on each label [14]. These labels should be placed proximally, near the injection site, and distally, near the insertion site.
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Each label is specific of an administration route (or monitoring line), shows identifying wording, and has a distinctive background color and border, as well as a blank space for recording the necessary information.
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8.b. Identifying syringes using international color coding
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To minimize administration errors (involving selecting the wrong syringe), each syringe must routinely be identified using labels on which international color and background coding [9-15] indicates the pharmacological class of each intravenous medication.
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The technical characteristics of syringe labels are regulated by the ISO 26825 standard. Each label has a preprinted blank space for recording the concentration (dose in volume) of the medication, with the unit.
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Special attention must be directed to neuromuscular blocking agents. Despite appropriate labeling, syringes may be inadvertently switched (e.g., between a neuromuscular blocking agent and midazolam, as the label colors are similar). Additional labeling is therefore in order for neuromuscular blocking agents, such as the addition of one or two labels on the syringe plunger [25], at the base of the plunger [26], or overlapping the syringe and the needle [27].
8.c. Labeling preparation bags and bottles Each bag or bottle to which a medication is added must be labeled and identified immediately after the addition. This label, which is specific of the administration route, serves to clearly record and track, in a standardized manner, the following data: the drug (identified by its International Non-proprietary Name), the amount or concentration of the drug (dose in volume), the preparation date and time and the name of the person who performed the preparation, the date and time at which administration of the preparation was initiated, Page 7
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and the bar-code label, bearing details of the patient’s identity, which should be placed on the label on the bottle. 8.d. Labeling preparations for patient-controlled analgesia, patient-controlled epidural analgesia, and power syringes
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The label provides details on the patient’s identity, the added medication with the dose in units (e.g., mg), the total volume of the solution (mL), the nature of the solvent/diluent, the concentration of the preparation (unit/mL), the date and time the medication was prepared, details on the person who performed the preparation, and the time the administration was initiated. The label must indicate the route of administration and must bear the color corresponding to the flag label identifying the administration route.
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8.e. Labeling carts and medication storage sites
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In addition to the above-discussed passive measures designed to limit reconstitution errors, a continuous process must be implemented to appraise medication storage systems in operating rooms, post-anesthesia care units, and intensive care units. These systems must comply with the general rules applied in the institution.
9. Validated procedures and protocols must be in place for prescribing, preparing, and
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administering medications used in anesthesia and critical care. In particular, they must specify the dilution; solvent; and duration, rate, and route of administration.
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A standardized system governing the preparation and dilution of medications, the modes of administration, and the containers (e.g., size of the syringes and volume of solvent) must be formally established within the department to ensure practice uniformity at a given site. A description of this system must be available in all rooms where anesthesia trays are prepared (e.g., operating suite and post-anesthesia care unit).
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Anesthesia trays are thus prepared in a standardized manner, according to a pre-established protocol applied throughout the department. Each tray must be labeled with the date and time of preparation, the person who performed the preparation, and the label of the patient for whom the medications are intended. Except when absolutely indispensable, a given medication should not be available in more than one concentration on the same anesthesia tray. Pre-filled syringes should be preferred for emergency medications that are not used routinely, such as atropine, ephedrine, and phenylephrine [28]. A high level of vigilance is in order when performing spinal anesthesia, epidural anesthesia, and surgical procedures to avoid confusion between antiseptics (notably chlorhexidine) and injectable anesthetics (or saline). The proximity of two products that are similar in appearance or are placed in similar sterile cups results in a high risk of confusion during administration. The patient may suffer serious consequences if an antiseptic is injected instead of an anesthetic [29]. Only colored antiseptics should be used. When performing spinal or epidural anesthesia, information on the analgesics and anesthetics should be read out loud twice, by the person providing the medications and the person receiving them under sterile conditions, before the medication syringe is prepared. Page 8
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The information read out loud twice must include the International Nonproprietary Name (INN) of the drug, the amount of drug, the volume, and the concentration.
10. In the event of an actual or potential medication error, the event must be analyzed using a
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validated method (e.g., REMED). Feedback about the event must be provided to the team involved and, if appropriate, to other departments. Regular links must be established between the feedback committee and risk projection models in order to fine-tune the existing preventive and curative measures.
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As specified in recommendation 1, a medication error management system must be developed and implemented [30,31] using a systemic, retrospective, collective, multidisciplinary method for analyzing these events with the goal of developing appropriate risk reduction strategies.
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This analysis must be carried out by trained professionals, using a validated method such as ALARM or REMED. REMED (Revue des erreurs liées aux médicaments et aux dispositifs médicaux associés) was developed by the French Society for Clinical Pharmacy (SFPC) in collaboration with the French Society for Risk Management in Healthcare Institutions (Société française de gestion des risques en établissement de santé, SOFGRES) and the French Society for Geriatrics and Gerontology (Société française de gériatrie et gérontologie, SFGG). It enables an indepth analysis of specific causes of medication errors [32].
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The medication errors subjected to this management strategy must include, at the least, errors associated with serious patient harm, never events (events that should never happen) [6] listed by the French National Drug Agency (Agence nationale de sécurité du médicament, ANSM), and errors identified as potentially associated with risks. Furthermore, medication errors that caused patient harm must be reported to the pharmacovigilance center (Centre régional de pharmacovigilance, CRPV). Any actual or potential medication error that caused no adverse events must be reported, directly by the professional involved or his/her superiors or institution, to the medication errors registry (Guichet erreurs médicamenteuses) on the ANSM site (ansm.sante.fr).
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Feedback about the experience must be provided to the teams involved in the incident and, if appropriate, to other teams. The goal is to draw lessons from the experience and, in some cases, to develop new recommendations and practices.
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Several modalities exist for providing feedback about adverse events related to medication errors in anesthesia and critical care. Depending on the institution, a feedback committee may be established or more conventional methods used such as morbidity and mortality reviews or dedicated staff meetings. A feedback committee or similar entity relies on the following: - strong commitment of the institutional medical committee and department heads; - an organization including regular planned meetings for fact-based reports prepared immediately after the event and disseminated promptly (avoid unnecessary meetings); - a multidisciplinary team including an anesthesiologist, a surgeon, a pharmacist, a pharmaceutical assistant, a nurse, a managing nurse, a midwife, a quality-assurance specialist, and a risk management coordinator; - and a starting point such as an event chosen once a month among reported events or based on recent reports. Regular links between the feedback committee and the risk projection model must be established to fine-tune the existing preventive and curative measures. Page 9
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[16] Westbrook JI, Rob MI, Woods A, Parry D. Errors in the administration of intravenous medications in hospital and the role of correct procedures and nurse experience. BMJ Qual Saf 2011; 20: 1027-34. [17] HAS 2013 http://www.has-sante.fr/guide/SITE/5B.htm
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[21] Merry AF, Webster CS, Hannam J, Mitchell SJ, Henderson R, Reid P, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anesthesia: prospective randomised clinical evaluation. BMJ 2011; 343: d5543.
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[22] Preventing Tubing and Luer Misconnections. FDA. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ [23] Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors Intended for Enteral Applications Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumen ts/UCM313385.pdf
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[30] Arrêté du 6 avril 2011 relatif au management de la qualité de la prise en charge médicamenteuse et aux médicaments dans les établissements de santé https://www.legifrance.gouv.fr/eli/arrete/2011/4/6/ETSH1109848A/jo [31] Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med 2009; 361: 1368-75.
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[32] Documents relatifs à la REMED, SFPC, 2013 http://www.sfpc.eu/fr/comite-scientifique/149documents-relatifs-a-la-remed.html
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S2352-5568(17)30094-2 http://dx.doi.org/doi:10.1016/j.accpm.2017.04.002 ACCPM 247
To appear in: Please cite this article as: Vincent PiriouAlexandre TheissenS´egol`ene ArzalierDaretMarie MarcelPierre TrouillerSt´ephanie ParatCatherine StammR´emy Collomp Preventing Medication Errors in Anesthesia and Critical Care (abbreviated version) (2017), http://dx.doi.org/10.1016/j.accpm.2017.04.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Preventing Medication Errors in Anesthesia and Critical Care (abbreviated version)* *Overview of recommendations developed by the French Society for Anesthesia and Critical Care (SFAR) in partnership with the
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French Society for Clinical Pharmacy (SFPC) and validated by the boards of each of these societies.
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On behalf of the Risk Management Analysis Committee of the French Society for Anesthesia and Critical Care (SFAR): Vincent Piriou1, Alexandre Theissen2, Ségolène Arzalier-Daret3, Marie Marcel4, Pierre Trouiller5,6 On behalf of the French Society for Clinical Pharmacy (SFPC): Stéphanie Parat7, Catherine Stamm8, Rémy Collomp9
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1. Université Lyon 1, groupement hospitalier Sud, hospices civils de Lyon, anesthésie-réanimation, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 2. Centre hospitalier Princesse-Grace, anesthésie-réanimation, avenue Pasteur, 98000 Monaco, France 3. Centre hospitalier universitaire de Caen, service d'anesthésie-réanimation, avenue de la Côte-de-Nacre, 14000 Caen, France 4. Groupement hospitalier Sud, hospices civils de Lyon, service d'anesthésieréanimation, IADE, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 5. Groupement hospitalier Est (HCL), OMEDIT Rhône-Alpes, 49, boulevard Pinel, 69777 Bron cedex, France 6. Hôpitaux universitaires Paris-Sud, hôpital Antoine-Béclère, service de réanimation polyvalente, unité de surveillance continue, 157, rue de la Porte-de-Trivaux, 92140 Clamart, France 7. Groupement hospitalier Sud, hospices civils de Lyon, pharmacie, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France 8. Hospices civils de Lyon, système de management de la qualité de la prise en charge médicamenteuse du patient, BP 2251, 3 quai des Célestins, 69229 Lyon cedex 02, France 9. Centre hospitalier universitaire de Nice, hôpital l'Archet, pôle pharmacie stérilisation, 151, route Saint-Antoine-de-Ginestière, 06200 Nice, France
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The 2016 recommendations were developed jointly by the French Society for Anesthesia and Critical Care (Société française d’anesthésie et de réanimation, SFAR) and the French Society for Clinical Pharmacy (Société Française de pharmacie clinique, SFPC):
Steering committee: Vincent PIRIOU
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Coordinators: Rémy COLLOMP and Alexandre THEISSEN
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Auteur correspondant : Vincent Piriou ([email protected])
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Multidisciplinary task force and authors Ségolène ARZALIER-DARET, anesthesiologist/intensivist, CHU de Caen, SFAR Remy COLLOMP, pharmacist, CHU de Nice, Vice-president of the SFPC Marie MARCEL, anesthesiology nurse HCL, CHU Lyon Sud, SFAR Stéphanie PARAT, pharmacist, HCL, CHU Lyon Sud, SFPC Vincent PIRIOU, anesthesiologist/intensivist, HCL, CHU Lyon Sud, SFAR Catherine STAMM, pharmacist, in charge of the medication management quality-assurance system, HCL, CHU Lyon, SFPC Alexandre THEISSEN, anesthesiologist/intensivist, CH Princesse Grace de Monaco, SFAR Pierre TROUILLER, anesthesiologist/intensivist, Hôpital Antoine Béclère, APHP, Clamart, SFAR
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Revision by the Risk Analysis and Control Committee of the SFAR: Ségolène ARZALIER-DARET, anesthesiologist/intensivist, CHU de Caen Frédéric AUBRUN, anesthesiologist/intensivist, HCL, CHU La Croix-Rousse, Lyon Gilles BOCCARA, Hôpital américain, Neuilly sur Seine Marie-Paule CHARIOT, anesthesiologist/intensivist, Clinique des Cèdres, Cornebarrieu Didier FRESSARD, anesthesiologist/intensivist, CHG d’Arcachon Benjamin GAFSOU, anesthesiologist/intensivist, CMCO d’Evry Jean LEMARIE, anesthesiologist/intensivist, Clinique Saint Léonard, Trélazé Vincent PIRIOU, anesthesiologist/intensivist, HCL, CHU Lyon Sud Guillaume de SAINT MAURICE, anesthesiologist/intensivist, HIA Percy, Clamart Pierre TROUILLER, anesthesiologist/intensivist, Hôpital Antoine Béclère, APHP, Clamart Alexandre THEISSEN, anesthesiologist/intensivist, CH Princesse Grace de Monaco Patrick-Georges YAVORDIOS, anesthesiologist/intensivist, Clinique Convert, Bourg en Bresse Revision by the Risk Management Task Force of the SFPC: Brigitte BONAN, pharmacist, Hôpital Foch, Suresnes Virginie CHASSEIGNE, pharmacist, CHU de Nîmes Edith DUFAY, pharmacist, CH de Lunéville Bénédicte GOURIEUX, pharmacist, CHU de Strasbourg Clarisse ROUX, pharmacist, CHU de Nîmes Rémi VARIN, pharmacist, CHU de Rouen, president of the SFPC
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The high frequency, potential severity, and preventable nature of medication errors in anesthesia and critical care warrant an update of practical recommendations designed for healthcare professionals and risk managers.
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Consequently, the French Society for Anesthesia and Critical Care (Société française d’anesthésie et de réanimation, SFAR), in partnership with the French Society for Clinical Pharmacy (Société française de pharmacie clinique, SFPC), conducted an in-depth review of its recommendations issued in 2006. The key points of this review are presented here. A detailed version developed for teaching purposes is available also.
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To facilitate the implementation of these recommendations, a specific evaluation grid has been developed. This grid can be used for self-evaluation, cross audits, and external assessments. It is well suited to a variety of situations including risk assessments, preparation for accreditation by the French National Authority for Health (HAS), and evaluations of professional practices.
1. As part of strategic planning, a healthcare facility that provides anesthesia and/or critical
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care must consistently implement measures specific to these patient-care areas and aimed at preventing and managing medication errors and must provide feedback about experience with medication errors. These measures must be set out in writing and must be fully consistent with institutional policy.
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As part of strategic planning, a healthcare facility that provides anesthesia and/or critical care must adopt a continuous process of appraising the measures needed to prevent medication errors in these patient-care areas of particularly high risk. These measures must include assistance in reporting unwanted, preventable, actual or potential medication events. This appraisal process must lead to the implementation of specific measures aimed at preventing and managing medication errors, notably by assessing these errors using validated techniques (REMED, ALARM, RMM) perhaps add a footnote for the international version? and at providing feedback about experience with medication errors. These measures must be set out in writing. They must be fully consistent with the measures implemented in the other sectors of the institution. Close coordination with the person in charge of medication management quality assurance is crucial. The impact of the measures must be assessed and the measures themselves reappraised regularly. Overall, this approach contributes to develop a culture of safety among healthcare professionals in all disciplines. 2. As part of the organizational approach adopted by the institution, a multidisciplinary
team dedicated to optimizing medication management safety must review the entire anesthesia/critical care patient-management process, throughout the trajectory of the patient in the institution, using validated methodological techniques, with a priori and a posteriori analyses. Page 3
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As part of the organizational management of the institution, a multidisciplinary team dedicated to medication management safety must be set up. The team must include at least an anesthesiologist/intensivist, a healthcare professional manager, a registered anesthesiology nurse, and a registered post-anesthesia care unit nurse. The entire management process from the prescription to the administration of medications must be analyzed throughout the trajectory of the patient in the institution, from admission to discharge. This analysis can be expected to significantly diminish medication errors in anesthesia and intensive care units. This approach is part of an overall policy of fostering quality assurance and a culture of safety in the institution, both for a priori risk management (risk projections based on published data and in situ analyses) and a posteriori (analysis of medication errors).
3. Risks associated with managing each patient’s medications (including those taken
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chronically), high-risk medications, never events, and computerized prescription systems and their interfaces must be given special attention, together with human and organizational factors, including interruptions of personnel during tasks.
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Careful attention must be directed to risks related to managing and ensuring the continuity of each patient’s pharmacological treatments (including medications taken chronically), to high-risk medications [1-5], to never events [6], and to computerized medication prescription systems. Human and organizational factors must also be analyzed. Interruptions of personnel during tasks deserve in-depth assessments, as they may occur at any step of the process [7].
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Educational tools can play a major role in improving patient safety and medication management safety. They include simulators, e-learning tools, and scenario-based learning activities that mimic events in a patient’s room [8] or crash-cart assembly errors.
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Preventing anesthesia errors related to chronic patient medications requires a high level of alertness on the part of all professionals, not only during the procedure but also during the pre-procedural anesthesiologist visit. Efforts must start upstream of the procedure, with strong involvement of the patient and healthcare professionals (usual physician, specialists, and pharmacists) to ensure medication reconciliation using appropriate tools, including the creation of a pharmaceutical record during the pre-procedural anesthesiologist visit.
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Within the institution, the roles of the surgeons and anesthesiologists in the wards must be defined, notably regarding prescriptions of medications and the handling of the patient’s personal treatment. All professionals must be aware of the organizational system that is chosen. Similar attention must be directed to formally defining the roles of all those potentially involved in managing chronic medications (e.g., via medication reconciliation), including nurses and pharmacists. 4.
Professionals in these patient-care areas should be offered multidisciplinary continuing education regarding risk management and the appropriate use of management devices. Attention should be directed specifically to preventing errors in medication preparation, reconstitution, and administration in anesthesia and critical care. Preference should be given to simulation-based tools for teaching in the healthcare field.
Multidisciplinary continuing education is particularly likely to prove effective in the area of risk management. Page 4
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In this area, many internal and external, university-affiliated and community training programs are available. Among points of special interest for healthcare providers are the operation of power pumps and injectors, infusion lines and their accessories, adverse mechanical events, the humanmachine interface, and the ergonomics of inappropriate equipment.
5. Specific aspects in critical care
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international color coding of labels [9-15] for syringes, administration routes [14], preparation bags, patient-controlled analgesia and patient-controlled epidural analgesia devices, medication carts, and medication storage devices; careful reading of labels before administration [16]; application of the five-rights rule (right medication, in the right dose, at the right time, via the right route, to the right patient) [17]; using error-reduction devices and bar-code readers [18]; establishing protocols for preparing and administering medications; limiting the list of medications delivered and avoiding similarities in shape, color, and name; reporting and analyzing medication errors.
Other recommendations are specific of critical care:
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regular involvement of a pharmacist in the unit [19,20]; use of programmable power syringes connected to a computer; optimal organization of the crash-cart and/or emergency kit; high level of vigilance for sedative and vasoactive agents, which are involved in most medication errors in the intensive care unit.
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The general recommendations are fully relevant to the field of critical care. They include the following:
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6. Preventing medication errors in anesthesia and critical care requires a combination of
active checking measures (relying both on humans and on computers, e.g., bar codes) and of passive measures (labeling, mechanical systems), aimed at enhancing efficiency and minimizing opportunities for errors, particularly substitution errors.
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Preventing preparation errors relies chiefly on the active checking of information on the medication packaging, which must be read carefully; on the extemporaneous preparation of medications; and on passive measures designed to minimize selection errors. Preventing administration errors rests primarily on active measures including medication preparation and administration by the same person and application of the five rights rule (right medication, in the right dose, at the right time, via the right route, to the right patient [17], which involves carefully reading the international color coding on syringe labels [16]. Passive measures include international color coding of syringes and drug classes, and protocols for preparing anesthesia trays. Other active measures that may be effective are having the label read by a second person before the injection and using bar-code labeled syringes that are read before the injection by a device that displays numerical data and/or the name of the medication [21]. Preventing administration route errors chiefly involves active checking of the injection site and of the entire line before the injection. Passive measures consist of labeling the administration routes (using colors specific of each route), absence of hubs and connectors on regional anesthesia catheters and lines, and physical systems designed to minimize errors (error-reduction devices that Page 5
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use different connectors depending on the route of administration). Unfortunately, these systems were not yet commercially available in France at the time of this writing. An international standard (ISO TC210 JWG4 “Small Bore Connectors”) is being developed under the aegis of the Food and Drug Administration (FDA) and Association for the Advancement of Medical Instrumentation (AAMI), in connection with the French Standards Agency (Association française de normalisation, Afnor) [22-24]. An alternative may consist in using catheters and/or lines of different colors or shapes.
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7. The storage system must be clear, formally defined, and shared by all sites including
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emergency care supplies, regional anesthesia cart, crash cart, and anesthesia table and trays. The professionals responsible for preparing and checking medication carts and cabinets must be clearly identified, and their verifications must be carried out at predefined intervals and must be recorded. Only medications that are absolutely necessary should be available. Medications should not be prepared in advance, and measures should be applied to prevent confusing medications.
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Only medications and concentrations that are used regularly should be available. For anesthesia, only those medications that are strictly necessary should be available. Similarities in shape, color, and name among specialties available in a given environment must be routinely identified and reported. The co-existence of medications exhibiting such similarities must be avoided to the extent possible.
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To the extent possible, high risk medications such as KCl [1-5] should not be stored. If high-risk medications are stored then special precautions must be implemented regarding their storage, shelving, labeling, and delivery, and the personnel must be made aware of the risks.
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In addition to the above-described passive measures designed to minimize reconstitution errors, a continuous appraisal process must be carried out regarding medication storage in operating rooms, post-anesthesia care units, and intensive care units, to maintain a policy consistent with the general rules followed in the institution. At the same time, depending on the activities and operation modalities specific of each institution, protocols for managing life-threatening emergencies and regional anesthesia must be developed. Institutions may choose to prepare specific carts:
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a cart for life-threatening emergencies, whose qualitative and quantitative composition must be identical to that defined for the entire institution and must be governed by a specific procedure; a cart for regional anesthesia with a rule for separating drawers or compartments (one drawer/compartment for one medication in one dosage) given the frequent packaging similarities. The professionals must be aware of procedures for managing overdoses of regional anesthesia drugs, which must be kept on hand.
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When no specific cart is prepared, medications for life-threatening emergencies (e.g., atropine and adrenaline) should be available on anesthesia tables, and a specific location of the drug cabinet labeled “EMERGENCY MEDICATIONS”, or as a second choice specifically identified compartments, must be designated for storing these medications. Kits containing medications and medical devices appropriate for specific situations and intended for the management of emergencies such as local anesthetic poisoning, malignant hyperthermia, and anaphylactic shock can be created, together with a procedure for each situation.
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8. Specific labels will diminish the risk of reconstitution and administration errors:
standardized labels specific of each administration route and syringes labeled according to pharmacological class (international color coding); labeling of bags and preparations for patient-controlled analgesia, patient-controlled epidural analgesia, and power syringes; and labeling of storage areas. Specific labels decrease the risk of reconstitution and administration errors.
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8.a. Identifying administration routes
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The use of colored labels with a distinctive border to identify administration routes is recommended. The administration route should be written in full on each label [14]. These labels should be placed proximally, near the injection site, and distally, near the insertion site.
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Each label is specific of an administration route (or monitoring line), shows identifying wording, and has a distinctive background color and border, as well as a blank space for recording the necessary information.
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8.b. Identifying syringes using international color coding
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To minimize administration errors (involving selecting the wrong syringe), each syringe must routinely be identified using labels on which international color and background coding [9-15] indicates the pharmacological class of each intravenous medication.
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The technical characteristics of syringe labels are regulated by the ISO 26825 standard. Each label has a preprinted blank space for recording the concentration (dose in volume) of the medication, with the unit.
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Special attention must be directed to neuromuscular blocking agents. Despite appropriate labeling, syringes may be inadvertently switched (e.g., between a neuromuscular blocking agent and midazolam, as the label colors are similar). Additional labeling is therefore in order for neuromuscular blocking agents, such as the addition of one or two labels on the syringe plunger [25], at the base of the plunger [26], or overlapping the syringe and the needle [27].
8.c. Labeling preparation bags and bottles Each bag or bottle to which a medication is added must be labeled and identified immediately after the addition. This label, which is specific of the administration route, serves to clearly record and track, in a standardized manner, the following data: the drug (identified by its International Non-proprietary Name), the amount or concentration of the drug (dose in volume), the preparation date and time and the name of the person who performed the preparation, the date and time at which administration of the preparation was initiated, Page 7
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and the bar-code label, bearing details of the patient’s identity, which should be placed on the label on the bottle. 8.d. Labeling preparations for patient-controlled analgesia, patient-controlled epidural analgesia, and power syringes
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The label provides details on the patient’s identity, the added medication with the dose in units (e.g., mg), the total volume of the solution (mL), the nature of the solvent/diluent, the concentration of the preparation (unit/mL), the date and time the medication was prepared, details on the person who performed the preparation, and the time the administration was initiated. The label must indicate the route of administration and must bear the color corresponding to the flag label identifying the administration route.
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8.e. Labeling carts and medication storage sites
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In addition to the above-discussed passive measures designed to limit reconstitution errors, a continuous process must be implemented to appraise medication storage systems in operating rooms, post-anesthesia care units, and intensive care units. These systems must comply with the general rules applied in the institution.
9. Validated procedures and protocols must be in place for prescribing, preparing, and
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administering medications used in anesthesia and critical care. In particular, they must specify the dilution; solvent; and duration, rate, and route of administration.
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A standardized system governing the preparation and dilution of medications, the modes of administration, and the containers (e.g., size of the syringes and volume of solvent) must be formally established within the department to ensure practice uniformity at a given site. A description of this system must be available in all rooms where anesthesia trays are prepared (e.g., operating suite and post-anesthesia care unit).
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Anesthesia trays are thus prepared in a standardized manner, according to a pre-established protocol applied throughout the department. Each tray must be labeled with the date and time of preparation, the person who performed the preparation, and the label of the patient for whom the medications are intended. Except when absolutely indispensable, a given medication should not be available in more than one concentration on the same anesthesia tray. Pre-filled syringes should be preferred for emergency medications that are not used routinely, such as atropine, ephedrine, and phenylephrine [28]. A high level of vigilance is in order when performing spinal anesthesia, epidural anesthesia, and surgical procedures to avoid confusion between antiseptics (notably chlorhexidine) and injectable anesthetics (or saline). The proximity of two products that are similar in appearance or are placed in similar sterile cups results in a high risk of confusion during administration. The patient may suffer serious consequences if an antiseptic is injected instead of an anesthetic [29]. Only colored antiseptics should be used. When performing spinal or epidural anesthesia, information on the analgesics and anesthetics should be read out loud twice, by the person providing the medications and the person receiving them under sterile conditions, before the medication syringe is prepared. Page 8
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The information read out loud twice must include the International Nonproprietary Name (INN) of the drug, the amount of drug, the volume, and the concentration.
10. In the event of an actual or potential medication error, the event must be analyzed using a
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validated method (e.g., REMED). Feedback about the event must be provided to the team involved and, if appropriate, to other departments. Regular links must be established between the feedback committee and risk projection models in order to fine-tune the existing preventive and curative measures.
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As specified in recommendation 1, a medication error management system must be developed and implemented [30,31] using a systemic, retrospective, collective, multidisciplinary method for analyzing these events with the goal of developing appropriate risk reduction strategies.
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This analysis must be carried out by trained professionals, using a validated method such as ALARM or REMED. REMED (Revue des erreurs liées aux médicaments et aux dispositifs médicaux associés) was developed by the French Society for Clinical Pharmacy (SFPC) in collaboration with the French Society for Risk Management in Healthcare Institutions (Société française de gestion des risques en établissement de santé, SOFGRES) and the French Society for Geriatrics and Gerontology (Société française de gériatrie et gérontologie, SFGG). It enables an indepth analysis of specific causes of medication errors [32].
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The medication errors subjected to this management strategy must include, at the least, errors associated with serious patient harm, never events (events that should never happen) [6] listed by the French National Drug Agency (Agence nationale de sécurité du médicament, ANSM), and errors identified as potentially associated with risks. Furthermore, medication errors that caused patient harm must be reported to the pharmacovigilance center (Centre régional de pharmacovigilance, CRPV). Any actual or potential medication error that caused no adverse events must be reported, directly by the professional involved or his/her superiors or institution, to the medication errors registry (Guichet erreurs médicamenteuses) on the ANSM site (ansm.sante.fr).
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Feedback about the experience must be provided to the teams involved in the incident and, if appropriate, to other teams. The goal is to draw lessons from the experience and, in some cases, to develop new recommendations and practices.
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Several modalities exist for providing feedback about adverse events related to medication errors in anesthesia and critical care. Depending on the institution, a feedback committee may be established or more conventional methods used such as morbidity and mortality reviews or dedicated staff meetings. A feedback committee or similar entity relies on the following: - strong commitment of the institutional medical committee and department heads; - an organization including regular planned meetings for fact-based reports prepared immediately after the event and disseminated promptly (avoid unnecessary meetings); - a multidisciplinary team including an anesthesiologist, a surgeon, a pharmacist, a pharmaceutical assistant, a nurse, a managing nurse, a midwife, a quality-assurance specialist, and a risk management coordinator; - and a starting point such as an event chosen once a month among reported events or based on recent reports. Regular links between the feedback committee and the risk projection model must be established to fine-tune the existing preventive and curative measures. Page 9
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References
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[16] Westbrook JI, Rob MI, Woods A, Parry D. Errors in the administration of intravenous medications in hospital and the role of correct procedures and nurse experience. BMJ Qual Saf 2011; 20: 1027-34. [17] HAS 2013 http://www.has-sante.fr/guide/SITE/5B.htm
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[21] Merry AF, Webster CS, Hannam J, Mitchell SJ, Henderson R, Reid P, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anesthesia: prospective randomised clinical evaluation. BMJ 2011; 343: d5543.
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[22] Preventing Tubing and Luer Misconnections. FDA. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ [23] Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors Intended for Enteral Applications Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumen ts/UCM313385.pdf
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[30] Arrêté du 6 avril 2011 relatif au management de la qualité de la prise en charge médicamenteuse et aux médicaments dans les établissements de santé https://www.legifrance.gouv.fr/eli/arrete/2011/4/6/ETSH1109848A/jo [31] Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med 2009; 361: 1368-75.
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[32] Documents relatifs à la REMED, SFPC, 2013 http://www.sfpc.eu/fr/comite-scientifique/149documents-relatifs-a-la-remed.html
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