- Email: [email protected]
Medication Errors Involving Neuromuscular Blocking Agents
USP Medication Safety Forum
Medication Errors Involving Neuromuscular Blocking Agents
John P. Santell, M.S., R.Ph.
Department Editor: James G. Stevenson, Pharm.D., College of Pharmacy, University of Michigan, and University of Michigan Hospitals. This department features medication error issues based on data collected by the United States Pharmacopeia (USP). euromuscular blocking agents (NMBAs) are commonly used to relax skeletal muscles during surgery that is conducted under general anesthesia. These agents are also used in emergency departments (EDs), intensive care units (ICUs), interventional radiology areas, and even medical and surgical units for patients requiring intubation airway management. Because these agents paralyze respiratory muscles, misuse can lead to serious harm or death. Medication errors involving NMBAs have occurred in multiple areas within a hospital or health system.1,2 NMBAs should only be administered by staff with experience in maintaining an adequate airway and respiratory support in facilities where intubation can readily be performed, oxygen can be administered, and respiratory support can be provided. Between January 1, 2000 through December 2005, 651 medication errors involving NMBAs were reported to the United States Pharmacopeia’s (USP) MEDMARX® program.* One-third of the reported errors were intercepted (Category B) before reaching the patient (Table 1, page 471). However, 51% (n = 332) of these errors did ultimately reach the patient (Categories C–I), and 9.4% (n = 61) resulted in some level of patient harm (Categories E–I). Among the harmful errors, 65% (n = 40) resulted in
N
* MEDMARX® is an Internet-accessible, voluntary medication error and adverse drug reaction reporting program that incorporates a nationally recognized taxonomy allowing subscribing hospitals and health systems to collect, analyze, and interpret adverse drug events and medication errors.
470
August 2006
temporary harm (Category E), whereas 11 were sentinel events (Categories G–I), including one fatality.
Findings Node Where Error Originated The medication use process has traditionally been described and studied as a continuum of activity composed of specific nodes—prescribing a medication, transcribing or documenting the medication order, preparing and dispensing the medication, administering the medication, and monitoring the effect of the drug on the patient. Of the 549 errors that actually occurred (that is, excluding Category A errors, which represent potential error events), most of the errors were reported to have originated during drug dispensing or drug administration activities (Figure 1, page 471).
Types of Error There were 599 MEDMARX records in which at least one type of error was identified, with a total of 648 types of error selected (more than one type of error was involved in some cases). The most common types of error were improper dose/quantity and unauthorized drug, both of which accounted for 56% of the selections (Table 2, page 472).
Causes and Factors Contributing to Errors At least one cause of error was identified in 627 records, with 1,242 causes of error selected (more than
Volume 32 Number 8
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 1. Severity of Harm in Errors Involving Neuromuscular Blocking Agents Error Category* Potential Error A Intercepted Error B Error Reaches Patient, No Harm C D Error Reaches Patient, Harm E F G H Error, Death I Total
n
%
102
15.6
217
33.3
183 88
28.1 13.5
40 10 0 10
6.1 1.5 0 1.5
1 651
<1 100
* For complete error category definitions see National Coordinating Council for Medication Error Reporting and Prevention: About Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html.
one cause of error was identified in many cases). The single most common cause of error was performance deficit, which was identified as a cause of error in 43.7% of the records involving NMBAs. Other common causes of error were procedure/protocol not followed (22.5%), communication (11%), calculation error (10%), knowledge deficit (9.6%), and documentation (9.4%). Two hundred forty-three contributing factors were identified in 160 records. When a contributing factor was identified, distractions was the most frequently reported selection (n = 60), comprising 37% of the 160 records. Emergency situation and increased workload each contributed to the error in 31% and 25% of the cases, respectively. Inexperienced staff were thought to contribute to the error in 31 (19%) of the cases.
Locations of Error Events and Personnel Involved Medication errors involving NMBAs were reported to have occurred in 24 different locations within hospitals and health systems. Six locations comprised the vast majority of where errors were reported to have originated: ICUs, inpatient pharmacy, nursing (patient care) unit,
August 2006
Node Where Error Originated
Figure 1. Of the 549 errors that actually occurred (that is, excluding Category A errors, which represent potential error events), most of the errors were reported to have originated during drug dispensing or drug administration activities.
ICUs (neonatal/pediatric), ED, and operating room (OR) (Table 3, page 473). ICUs (coronary, general, medical, and surgical) were the location of many NMBA errors (n = 173; 32%), followed by the inpatient pharmacy department (n = 122; 22%). Another 17% (n = 92) of errors were made on a nursing (patient care) unit. Other errors occurred in the pediatric and neonatal ICUs (11%), ED (8%), and the OR (7%). Most (44%) of the errors involving NMBAs were made by registered nurses, with only 5% of errors made by nurse anesthetists (a difference possibly related to the greater experience of nurse anesthetists with these drugs). Twenty percent and 13% of the errors were made by pharmacists and pharmacy technicians, respectively. Twelve percent of the errors were attributed to physicians. Examining both the location of where errors originate and the staff involved reminds us that health care practitioners often work across departmental areas and that errors can be made by any staff person in any patient care area. For example, some hospitals have dedicated pharmacy satellites or pharmacists to specifically service ICU areas, surgical suites, and the ED. Therefore, errors can be made by pharmacy staff that occur in areas outside the central pharmacy department. Many hospitals, in particular small and rural hospitals, do not have
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471
Table 2. Types of Error Involving Neuromuscular Blocking Agents Type of Error Improper dose/quantity Unauthorized/wrong drug Prescribing error Drug prepared incorrectly Omission error Wrong time Wrong patient Extra dose Wrong administration technique Expired product Wrong route Mislabeling Wrong dosage form Deteriorated product
n 169 166 69 61 51 37 23 18 14 10 9 8 7 6
%* 28.2 27.7 11.5 10.2 8.5 6.2 3.8 3.0 2.3 1.7 1.5 1.3 1.2 1.0
* The percentages do not add up to 100% because more than one type of error was involved in some cases. There were 648 types of errors identified in 599 MEDMARX error records.
an on-site pharmacy that is open 24 hours, seven days a week. In these circumstances, nursing staff may be involved in making a medication error when entering the central pharmacy to retrieve needed medications for patients who are admitted when the pharmacy is “closed.” Devising risk-reduction strategies for NMBAs should take into account both the multiple locations in which they are used and the different health care professionals and supportive staff who may be involved in handling these products. The high percentage of reported errors originating with dispensing functions, combined with the large number of errors attributed to the inpatient pharmacy, and specifically pharmacy staff, suggest that pharmacy dispensing activities involving NMBAs are problematic. A review of these error events revealed several recurring issues— improper dose/quantity errors, unauthorized/wrong drug errors, and incorrectly prepared or labeled drug products (Table 4, page 474).
Products Involved in Errors More than one third (35%; n = 256) of medication errors involving NMBAs reported to MEDMARX
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involved vecuronium. Fewer errors involved cisatracurium (17.6%; n = 128), succinylcholine (15.9%; n = 116), pancuronium (14.4%; n = 105), rocuronium (10.2%; n = 74), atracurium (4.5%; n = 33), mivacurium (< 1%; n = 6), and doxacurium (< 1%; n = 4). The reasons for these differences are unknown, although differences in volume of use of various products may be a determining factor.
Case Examples The following case examples, based on records in the MEDMARX database, highlight several common risks associated with the use of NMBAs. Case 1. A nurse administered an unauthorized intravenous (IV) admixture of vecuronium to her patient after mistaking it for a penicillin G IV admixture that was stored in the same refrigerator (the vecuronium was intended for another patient). The patient was already on life support and was receiving dopamine by IV infusion when the error occurred. He was monitored for adverse effects from the vecuronium. An increase in the fraction of inspired oxygen was required. The patient’s heart rate increased and his blood pressure decreased, necessitating an increase in the dopamine infusion rate for a short time. There were no long-term sequellae from the error. Case 2. An order was written for Norcuron (vecuronium), and the written order was then verbally relayed over the phone to the pharmacy. The pharmacy inadvertently prepared an admixture of norepinephrine, which was sent to the nursing (patient care) unit and administered. The patient’s systolic and diastolic blood pressures increased to 198 mmHg and 85 mmHg, respectively. The blood pressure elevation was corrected by giving two doses of hydralazine 5 mg by IV push and labetalol 10 mg by IV push. Case 3. An order was written for cisatracurium 3 mcg/kg/min or 1.8 mg/hr for a child weighing 10 kg. The nurse calculated an administration rate of 18 mg/hr, which is a tenfold overdose. The error was detected and corrected when the patient became agitated and short of breath. These symptoms resolved after the administration of oxygen. Case 4. A physician removed vials of midazolam and rocuronium from a medication cart in the OR, labeled
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Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 3. Locations and Personnel Most Frequently Associated with NMBA Errors* Level of Staff Identified as Making the Initial Error
Intensive Care Units (General, Coronary, Medical, Surgical) Nurse, Registered 97 Pharmacist 19 Physician 35 Pharmacy Technician 6 Anesthesia Provider 1 Pharmacy Personnel, nonspecific 2 Other (miscellaneous) 13 Totals 173
Pharmacy, Nursing Inpatient (Patient Care) Unit 2 59 52 7 0 17 51 6 1 0 16 1 0 2 122 92
Intensive Care Unit (Neonatal, Pediatric) 38 2 10 4 0 0 5 59
Emergency Operating Department Room 31 2 7 3 0 0 0 43
3 0 7 4 23 0 2 39
* NMBAs, neuromuscular blocking agents.
two empty syringes with the respective drug names, and was interrupted while drawing up the two different drugs into the syringes. When he returned, he administered the content of one of the syringes (thought to be midazolam) to his patient in the preoperative holding area. Shortly after, the physician was called away to answer a page and on his return, found the patient unresponsive. The patient was resuscitated, given neostigmine to reverse the respiratory paralysis, and an airway was established and oxygen administered. The patient’s surgery was canceled. It was later determined that the physician had administered the rocuronium-containing syringe instead of the intended midazolam.
Recommendations to Improve the Safe Use of NMBAs Certain packaging requirements for NMBAs are outlined within USP’s official compendial standards and became mandatory on October 1, 2005.3 These requirements mandate that both the ferrules (metal bands around the tops of vials) and overseals of NMBAs contain the words “Warning: Paralyzing Agent” or “Paralyzing Agent” (depending on the size of the closure system). Both the container cap ferrule and the cap overseal must bear the warning in black or white print (whichever provides the greatest color contrast with the ferrule or cap color). USP’s Safe Medication Use Expert Committee has published an extensive list of recommendations to improve safe use of NMBAs.2 The following suggestions are based, in part, on those recommendations:
August 2006
1. Conduct a Failure Mode and Effects Analysis (FMEA) on all NMBAs before they are added to the formulary to minimize the addition of products with poor labeling and packaging. 2. Avoid stocking NMBAs that are similar in appearance to other medications that are used in the institution. 3. Store NMBAs separately from other medications. 4. Limit the availability of NMBAs to the pharmacy and those selected patient care areas where mechanically ventilated patients are treated. 5. Conduct a review of the pharmacy computer order entry system for standard order sets involving NMBAs to identify problematic mnemonic auto-fill entries and subsequent label generation. Evaluate if pharmacy-generated labels for NMBAs are clear and accurate, and contain all necessary information and warnings. 6. Review the policies and procedures around drug preparation and labeling of IV infusions and syringes. Establish a formal training program to evaluate competency for all staff who are involved in the preparation of NMBA infusions. 7. Do not dispense NMBAs in unit-dose medication carts. 8. Do not allow NMBAs to be stored in a multicassette, automated dispensing device drawer. The storage bin/drawer where the NMBA is located should only allow access to a single item. 9. Establish policies and procedures to ensure that medications in unlabeled syringes are not administered, unless the dose is prepared and immediately administered.
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Table 4. Examples of Improper Dose/Quantity Errors, Unauthorized/Wrong Drug, and Drug Prepared or Labeled Incorrectly* Improper Dose/Quantity Errors ■ Cisatracurium (Nimbex) 20-mg vial (2 mg/mL) ordered but instead a 200-mg vial (10 mg/mL) was dispensed. ■ Intubation boxes/kits, which are replenished by the pharmacy, were missing NMBAs such as rocuronium and succinycholine. ■ Automated dispensing cabinets misfilled with wrong strength of product (e.g., rocuronium 50 mg/5 mL and 100 mg/10 mL vials were placed in the same drawer). Unauthorized/Wrong Drug ■ Look-alike and/or sound-alike drug names, labeling, or packaging leading to preparing and dispensing the wrong product or stocking automated drug-dispensing cabinets with the wrong product: ● Rocuronium was ordered and entered into the pharmacy computer system as such, but pancuronium was inadvertently dispensed. ● Doxazosin (a cardiovascular agent) 1 mg orally every day was prescribed but entered into the pharmacy computer system as doxacurium (an NMBA). ● Norcuron (vecuronium) was inadvertently entered into the pharmacy computer system for a patient who was ordered Nimbex (cisatracurium). ● Vecuronium, 10-gm vials, were stocked in the automated drug dispensing cabinet located in the operating room suite with vancomycin (an antibiotic) 1-gm vials. ● Narcan (naloxone) IV infusion was ordered but pharmacy prepared and sent a Norcuron (vecuronium) IV infusion.
●
● ●
Pavulon (pancuronium) infusion was ordered, but pharmacy inadvertently prepared and dispensed a papaverine (a vasodilator) infusion. Atracurium infusion was ordered but a vecuronium infusion was prepared and dispensed. Cisplatin (an oncolotyic agent) 127 mg in 1,000 mL of normal saline to be infused over 2 hours was ordered, but during entry of this order into the pharmacy computer system, the mnemonic computer rule completed the drug field name with cisatracurium, thereby generating a label with cisatracurium, which was prepared and dispensed.
Drug Prepared or Labeled Incorrectly ■ A 500-mL tracrium IV infusion was prepared but labeled as 50 mL. ■ An NMBA IV infusion was labeled as 1,000 micrograms/mL, but the actual concentration was 800 micrograms/mL. ■ A syringe containing theophylline (intended for patient “A”) was labeled as containing pancuronium (intended for patient “B”). After investigation, it was discovered that the computer-generated labels were printed at the same time and, therefore, the two different products were likely prepared at the same time, and a mix-up occurred during labeling. ■ A standard, prebuilt order in the pharmacy computer system for vecuronium 10 mg in dextrose 5% in water lists the final concentration as 0.5 mg/mL, which is subsequently printed on the label, but the correct concentration is actually 0.2 mg/mL.
* NMBAs, neuromuscular blocking agents; IV, intravenous.
10. Require that a brightly colored alert label stating “Warning: Paralyzing Agent” appear on all syringes or infusion containers prepared by the facility. 11. Review the prescribing practices for ordering NMBAs and establish automatic discontinue orders when the patient is transferred out of the critical care areas. 12. Use bar code technology to improve the accuracy of identifying both the product and patient prior to administration.
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August 2006
13. Use sophisticated, programmable infusion devices (“smart pumps”) to deliver selected drug dosages when and where appropriate. 14. Educate health care professionals who administer NMBAs about the usual dosages and institutional policies and procedures for safe handling of these medications.
Conclusion Errors involving NMBAs have a significant potential to cause patient harm if improperly used. Many of these
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Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
errors were reported to have originated in the dispensing or administration of the drug product. The wrong dose and the wrong drug were the most common types of error, often caused by performance, procedure, and communication failures. Efforts to increase health care practitioners’ knowledge of and adherence to proper handling procedures and proper dosing of these agents may reduce the incidence of harmful errors. J John P. Santell, M.S., R.Ph., is Director, Practitioner Programs and Services, United States Pharmacopeia (USP), Rockville, Maryland. Please send correspondence to John Santell, [email protected].
August 2006
References 1. Phillips M.S., Williams R.L.: Improving the safety of neuromuscular blocking agents: A statement from the USP Safe Medication Use Expert Committee. Am J Health-Syst Pharm 63:139–142, Jan. 15, 2006. 2. Smetzer J.L., Cohen M.R.: Preventing errors with neuromuscular blocking agents. Jt Comm J Qual Patient Saf 32:56–59, Jan. 2006. 3. The United States Pharmacopeia–National Formulary (USP 29NF 24), General Chapter <1> Injections; Packaging/Containers for Injections/Neuromuscular Blocking and Paralyzing Agents; 2457; 2006.
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Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
475
Medication Errors Involving Neuromuscular Blocking Agents
John P. Santell, M.S., R.Ph.
Department Editor: James G. Stevenson, Pharm.D., College of Pharmacy, University of Michigan, and University of Michigan Hospitals. This department features medication error issues based on data collected by the United States Pharmacopeia (USP). euromuscular blocking agents (NMBAs) are commonly used to relax skeletal muscles during surgery that is conducted under general anesthesia. These agents are also used in emergency departments (EDs), intensive care units (ICUs), interventional radiology areas, and even medical and surgical units for patients requiring intubation airway management. Because these agents paralyze respiratory muscles, misuse can lead to serious harm or death. Medication errors involving NMBAs have occurred in multiple areas within a hospital or health system.1,2 NMBAs should only be administered by staff with experience in maintaining an adequate airway and respiratory support in facilities where intubation can readily be performed, oxygen can be administered, and respiratory support can be provided. Between January 1, 2000 through December 2005, 651 medication errors involving NMBAs were reported to the United States Pharmacopeia’s (USP) MEDMARX® program.* One-third of the reported errors were intercepted (Category B) before reaching the patient (Table 1, page 471). However, 51% (n = 332) of these errors did ultimately reach the patient (Categories C–I), and 9.4% (n = 61) resulted in some level of patient harm (Categories E–I). Among the harmful errors, 65% (n = 40) resulted in
N
* MEDMARX® is an Internet-accessible, voluntary medication error and adverse drug reaction reporting program that incorporates a nationally recognized taxonomy allowing subscribing hospitals and health systems to collect, analyze, and interpret adverse drug events and medication errors.
470
August 2006
temporary harm (Category E), whereas 11 were sentinel events (Categories G–I), including one fatality.
Findings Node Where Error Originated The medication use process has traditionally been described and studied as a continuum of activity composed of specific nodes—prescribing a medication, transcribing or documenting the medication order, preparing and dispensing the medication, administering the medication, and monitoring the effect of the drug on the patient. Of the 549 errors that actually occurred (that is, excluding Category A errors, which represent potential error events), most of the errors were reported to have originated during drug dispensing or drug administration activities (Figure 1, page 471).
Types of Error There were 599 MEDMARX records in which at least one type of error was identified, with a total of 648 types of error selected (more than one type of error was involved in some cases). The most common types of error were improper dose/quantity and unauthorized drug, both of which accounted for 56% of the selections (Table 2, page 472).
Causes and Factors Contributing to Errors At least one cause of error was identified in 627 records, with 1,242 causes of error selected (more than
Volume 32 Number 8
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 1. Severity of Harm in Errors Involving Neuromuscular Blocking Agents Error Category* Potential Error A Intercepted Error B Error Reaches Patient, No Harm C D Error Reaches Patient, Harm E F G H Error, Death I Total
n
%
102
15.6
217
33.3
183 88
28.1 13.5
40 10 0 10
6.1 1.5 0 1.5
1 651
<1 100
* For complete error category definitions see National Coordinating Council for Medication Error Reporting and Prevention: About Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html.
one cause of error was identified in many cases). The single most common cause of error was performance deficit, which was identified as a cause of error in 43.7% of the records involving NMBAs. Other common causes of error were procedure/protocol not followed (22.5%), communication (11%), calculation error (10%), knowledge deficit (9.6%), and documentation (9.4%). Two hundred forty-three contributing factors were identified in 160 records. When a contributing factor was identified, distractions was the most frequently reported selection (n = 60), comprising 37% of the 160 records. Emergency situation and increased workload each contributed to the error in 31% and 25% of the cases, respectively. Inexperienced staff were thought to contribute to the error in 31 (19%) of the cases.
Locations of Error Events and Personnel Involved Medication errors involving NMBAs were reported to have occurred in 24 different locations within hospitals and health systems. Six locations comprised the vast majority of where errors were reported to have originated: ICUs, inpatient pharmacy, nursing (patient care) unit,
August 2006
Node Where Error Originated
Figure 1. Of the 549 errors that actually occurred (that is, excluding Category A errors, which represent potential error events), most of the errors were reported to have originated during drug dispensing or drug administration activities.
ICUs (neonatal/pediatric), ED, and operating room (OR) (Table 3, page 473). ICUs (coronary, general, medical, and surgical) were the location of many NMBA errors (n = 173; 32%), followed by the inpatient pharmacy department (n = 122; 22%). Another 17% (n = 92) of errors were made on a nursing (patient care) unit. Other errors occurred in the pediatric and neonatal ICUs (11%), ED (8%), and the OR (7%). Most (44%) of the errors involving NMBAs were made by registered nurses, with only 5% of errors made by nurse anesthetists (a difference possibly related to the greater experience of nurse anesthetists with these drugs). Twenty percent and 13% of the errors were made by pharmacists and pharmacy technicians, respectively. Twelve percent of the errors were attributed to physicians. Examining both the location of where errors originate and the staff involved reminds us that health care practitioners often work across departmental areas and that errors can be made by any staff person in any patient care area. For example, some hospitals have dedicated pharmacy satellites or pharmacists to specifically service ICU areas, surgical suites, and the ED. Therefore, errors can be made by pharmacy staff that occur in areas outside the central pharmacy department. Many hospitals, in particular small and rural hospitals, do not have
Volume 32 Number 8
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
471
Table 2. Types of Error Involving Neuromuscular Blocking Agents Type of Error Improper dose/quantity Unauthorized/wrong drug Prescribing error Drug prepared incorrectly Omission error Wrong time Wrong patient Extra dose Wrong administration technique Expired product Wrong route Mislabeling Wrong dosage form Deteriorated product
n 169 166 69 61 51 37 23 18 14 10 9 8 7 6
%* 28.2 27.7 11.5 10.2 8.5 6.2 3.8 3.0 2.3 1.7 1.5 1.3 1.2 1.0
* The percentages do not add up to 100% because more than one type of error was involved in some cases. There were 648 types of errors identified in 599 MEDMARX error records.
an on-site pharmacy that is open 24 hours, seven days a week. In these circumstances, nursing staff may be involved in making a medication error when entering the central pharmacy to retrieve needed medications for patients who are admitted when the pharmacy is “closed.” Devising risk-reduction strategies for NMBAs should take into account both the multiple locations in which they are used and the different health care professionals and supportive staff who may be involved in handling these products. The high percentage of reported errors originating with dispensing functions, combined with the large number of errors attributed to the inpatient pharmacy, and specifically pharmacy staff, suggest that pharmacy dispensing activities involving NMBAs are problematic. A review of these error events revealed several recurring issues— improper dose/quantity errors, unauthorized/wrong drug errors, and incorrectly prepared or labeled drug products (Table 4, page 474).
Products Involved in Errors More than one third (35%; n = 256) of medication errors involving NMBAs reported to MEDMARX
472
August 2006
involved vecuronium. Fewer errors involved cisatracurium (17.6%; n = 128), succinylcholine (15.9%; n = 116), pancuronium (14.4%; n = 105), rocuronium (10.2%; n = 74), atracurium (4.5%; n = 33), mivacurium (< 1%; n = 6), and doxacurium (< 1%; n = 4). The reasons for these differences are unknown, although differences in volume of use of various products may be a determining factor.
Case Examples The following case examples, based on records in the MEDMARX database, highlight several common risks associated with the use of NMBAs. Case 1. A nurse administered an unauthorized intravenous (IV) admixture of vecuronium to her patient after mistaking it for a penicillin G IV admixture that was stored in the same refrigerator (the vecuronium was intended for another patient). The patient was already on life support and was receiving dopamine by IV infusion when the error occurred. He was monitored for adverse effects from the vecuronium. An increase in the fraction of inspired oxygen was required. The patient’s heart rate increased and his blood pressure decreased, necessitating an increase in the dopamine infusion rate for a short time. There were no long-term sequellae from the error. Case 2. An order was written for Norcuron (vecuronium), and the written order was then verbally relayed over the phone to the pharmacy. The pharmacy inadvertently prepared an admixture of norepinephrine, which was sent to the nursing (patient care) unit and administered. The patient’s systolic and diastolic blood pressures increased to 198 mmHg and 85 mmHg, respectively. The blood pressure elevation was corrected by giving two doses of hydralazine 5 mg by IV push and labetalol 10 mg by IV push. Case 3. An order was written for cisatracurium 3 mcg/kg/min or 1.8 mg/hr for a child weighing 10 kg. The nurse calculated an administration rate of 18 mg/hr, which is a tenfold overdose. The error was detected and corrected when the patient became agitated and short of breath. These symptoms resolved after the administration of oxygen. Case 4. A physician removed vials of midazolam and rocuronium from a medication cart in the OR, labeled
Volume 32 Number 8
Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
Table 3. Locations and Personnel Most Frequently Associated with NMBA Errors* Level of Staff Identified as Making the Initial Error
Intensive Care Units (General, Coronary, Medical, Surgical) Nurse, Registered 97 Pharmacist 19 Physician 35 Pharmacy Technician 6 Anesthesia Provider 1 Pharmacy Personnel, nonspecific 2 Other (miscellaneous) 13 Totals 173
Pharmacy, Nursing Inpatient (Patient Care) Unit 2 59 52 7 0 17 51 6 1 0 16 1 0 2 122 92
Intensive Care Unit (Neonatal, Pediatric) 38 2 10 4 0 0 5 59
Emergency Operating Department Room 31 2 7 3 0 0 0 43
3 0 7 4 23 0 2 39
* NMBAs, neuromuscular blocking agents.
two empty syringes with the respective drug names, and was interrupted while drawing up the two different drugs into the syringes. When he returned, he administered the content of one of the syringes (thought to be midazolam) to his patient in the preoperative holding area. Shortly after, the physician was called away to answer a page and on his return, found the patient unresponsive. The patient was resuscitated, given neostigmine to reverse the respiratory paralysis, and an airway was established and oxygen administered. The patient’s surgery was canceled. It was later determined that the physician had administered the rocuronium-containing syringe instead of the intended midazolam.
Recommendations to Improve the Safe Use of NMBAs Certain packaging requirements for NMBAs are outlined within USP’s official compendial standards and became mandatory on October 1, 2005.3 These requirements mandate that both the ferrules (metal bands around the tops of vials) and overseals of NMBAs contain the words “Warning: Paralyzing Agent” or “Paralyzing Agent” (depending on the size of the closure system). Both the container cap ferrule and the cap overseal must bear the warning in black or white print (whichever provides the greatest color contrast with the ferrule or cap color). USP’s Safe Medication Use Expert Committee has published an extensive list of recommendations to improve safe use of NMBAs.2 The following suggestions are based, in part, on those recommendations:
August 2006
1. Conduct a Failure Mode and Effects Analysis (FMEA) on all NMBAs before they are added to the formulary to minimize the addition of products with poor labeling and packaging. 2. Avoid stocking NMBAs that are similar in appearance to other medications that are used in the institution. 3. Store NMBAs separately from other medications. 4. Limit the availability of NMBAs to the pharmacy and those selected patient care areas where mechanically ventilated patients are treated. 5. Conduct a review of the pharmacy computer order entry system for standard order sets involving NMBAs to identify problematic mnemonic auto-fill entries and subsequent label generation. Evaluate if pharmacy-generated labels for NMBAs are clear and accurate, and contain all necessary information and warnings. 6. Review the policies and procedures around drug preparation and labeling of IV infusions and syringes. Establish a formal training program to evaluate competency for all staff who are involved in the preparation of NMBA infusions. 7. Do not dispense NMBAs in unit-dose medication carts. 8. Do not allow NMBAs to be stored in a multicassette, automated dispensing device drawer. The storage bin/drawer where the NMBA is located should only allow access to a single item. 9. Establish policies and procedures to ensure that medications in unlabeled syringes are not administered, unless the dose is prepared and immediately administered.
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Copyright 2006 Joint Commission on Accreditation of Healthcare Organizations
473
Table 4. Examples of Improper Dose/Quantity Errors, Unauthorized/Wrong Drug, and Drug Prepared or Labeled Incorrectly* Improper Dose/Quantity Errors ■ Cisatracurium (Nimbex) 20-mg vial (2 mg/mL) ordered but instead a 200-mg vial (10 mg/mL) was dispensed. ■ Intubation boxes/kits, which are replenished by the pharmacy, were missing NMBAs such as rocuronium and succinycholine. ■ Automated dispensing cabinets misfilled with wrong strength of product (e.g., rocuronium 50 mg/5 mL and 100 mg/10 mL vials were placed in the same drawer). Unauthorized/Wrong Drug ■ Look-alike and/or sound-alike drug names, labeling, or packaging leading to preparing and dispensing the wrong product or stocking automated drug-dispensing cabinets with the wrong product: ● Rocuronium was ordered and entered into the pharmacy computer system as such, but pancuronium was inadvertently dispensed. ● Doxazosin (a cardiovascular agent) 1 mg orally every day was prescribed but entered into the pharmacy computer system as doxacurium (an NMBA). ● Norcuron (vecuronium) was inadvertently entered into the pharmacy computer system for a patient who was ordered Nimbex (cisatracurium). ● Vecuronium, 10-gm vials, were stocked in the automated drug dispensing cabinet located in the operating room suite with vancomycin (an antibiotic) 1-gm vials. ● Narcan (naloxone) IV infusion was ordered but pharmacy prepared and sent a Norcuron (vecuronium) IV infusion.
●
● ●
Pavulon (pancuronium) infusion was ordered, but pharmacy inadvertently prepared and dispensed a papaverine (a vasodilator) infusion. Atracurium infusion was ordered but a vecuronium infusion was prepared and dispensed. Cisplatin (an oncolotyic agent) 127 mg in 1,000 mL of normal saline to be infused over 2 hours was ordered, but during entry of this order into the pharmacy computer system, the mnemonic computer rule completed the drug field name with cisatracurium, thereby generating a label with cisatracurium, which was prepared and dispensed.
Drug Prepared or Labeled Incorrectly ■ A 500-mL tracrium IV infusion was prepared but labeled as 50 mL. ■ An NMBA IV infusion was labeled as 1,000 micrograms/mL, but the actual concentration was 800 micrograms/mL. ■ A syringe containing theophylline (intended for patient “A”) was labeled as containing pancuronium (intended for patient “B”). After investigation, it was discovered that the computer-generated labels were printed at the same time and, therefore, the two different products were likely prepared at the same time, and a mix-up occurred during labeling. ■ A standard, prebuilt order in the pharmacy computer system for vecuronium 10 mg in dextrose 5% in water lists the final concentration as 0.5 mg/mL, which is subsequently printed on the label, but the correct concentration is actually 0.2 mg/mL.
* NMBAs, neuromuscular blocking agents; IV, intravenous.
10. Require that a brightly colored alert label stating “Warning: Paralyzing Agent” appear on all syringes or infusion containers prepared by the facility. 11. Review the prescribing practices for ordering NMBAs and establish automatic discontinue orders when the patient is transferred out of the critical care areas. 12. Use bar code technology to improve the accuracy of identifying both the product and patient prior to administration.
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13. Use sophisticated, programmable infusion devices (“smart pumps”) to deliver selected drug dosages when and where appropriate. 14. Educate health care professionals who administer NMBAs about the usual dosages and institutional policies and procedures for safe handling of these medications.
Conclusion Errors involving NMBAs have a significant potential to cause patient harm if improperly used. Many of these
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errors were reported to have originated in the dispensing or administration of the drug product. The wrong dose and the wrong drug were the most common types of error, often caused by performance, procedure, and communication failures. Efforts to increase health care practitioners’ knowledge of and adherence to proper handling procedures and proper dosing of these agents may reduce the incidence of harmful errors. J John P. Santell, M.S., R.Ph., is Director, Practitioner Programs and Services, United States Pharmacopeia (USP), Rockville, Maryland. Please send correspondence to John Santell, [email protected].
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References 1. Phillips M.S., Williams R.L.: Improving the safety of neuromuscular blocking agents: A statement from the USP Safe Medication Use Expert Committee. Am J Health-Syst Pharm 63:139–142, Jan. 15, 2006. 2. Smetzer J.L., Cohen M.R.: Preventing errors with neuromuscular blocking agents. Jt Comm J Qual Patient Saf 32:56–59, Jan. 2006. 3. The United States Pharmacopeia–National Formulary (USP 29NF 24), General Chapter <1> Injections; Packaging/Containers for Injections/Neuromuscular Blocking and Paralyzing Agents; 2457; 2006.
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