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Case Study: Reducing Narcotic Oversedation Across an Integrated Health System
The Joint Commission Journal on Quality and Patient Safety
5 Million Lives Campaign
Case Study: Reducing Narcotic Oversedation Across an Integrated Health System
Steven Meisel, Pharm.D. Pamela Phelps, Pharm.D. Mary Meisel, R.N., M.S., A.P.R.N., B.C.
F
airview Health Services, a fully integrated health system based in Minneapolis, is composed of 7 hospitals, 30 primary care clinics, 31 retail pharmacies, a home care and hospice agency, and various other programs. Fairview employs 10,900 full-time equivalents (FTEs) and has 2,600 medical staff members. In 2006 Fairview hospitals had 81,676 discharges and gross revenues of $3.3 billion. In December 1999, Fairview Southdale Hospital was devastated by the death of an otherwise healthy patient from an apparent narcotic-associated respiratory depression. This case was particularly troublesome because the doses administered were usual and customary, there were no identified medication errors, and patient monitoring was conducted within all standards at that time. To determine if this case was an isolated event or was part of a pattern, all naloxone administration during a two-month period was retrospectively reviewed. The review found 11 cases of serious oversedation, which prompted a major effort to understand and correct the factors associated with narcotic oversedation. This case study describes the effort undertaken at Fairview Health Services to reduce the rate of serious narcotic oversedation.
Efforts to Reduce Narcotic Oversedation In April 2000, a team was commissioned by Fairview Southdale Hospital’s administration with a charge to reduce serious narcotic oversedation by 75%. The team was composed of nurses, pharmacists, anesthetists, a house physician, respiratory therapists, anesthesiologists, and September 2007
quality resource staff. The vice president for medical affairs was the team’s sponsor, and a clinical nurse specialist served as the team’s chair. To measure progress, the team first needed to define serious narcotic oversedation. A literature review failed to find meaningful definitions or measures, so the team developed its own classification scheme (Table 1, page 544). The classification scheme was based on the acknowledgement that gross naloxone use is a poor measure because sometimes naloxone is used for intentional overdoses, for nonoversedation reasons (such as pruritis from epidural narcotics), and in complex medical situations where narcotics may be a minor component of the patient’s deterioration. The measure of progress was the rate of “serious”—class 3 and 4—events tracked monthly. Over the course of time, these rates were annualized and reframed as the number of discharges for every serious event. During the following 12 months, the team tested and implemented 34 changes (Table 2, page 545), which were framed in the contexts of patient assessment and monitoring, individualization of analgesic therapy, and interdisciplinary and interdepartmental communication. In recognition of the interdependence of actions within the operating room, recovery room (postanesthesia care unit), and the postoperative floors on patient outcomes, analysis and changes were made in all three of those care areas. By the middle of 2001, following four months in which there were no serious events, it was concluded that the team had achieved its goal of a 75% reduction in serious adverse drug events (ADEs) (Figure 1, page 544). The Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
543
The Joint Commission Journal on Quality and Patient Safety
Serious Narcotic Oversedation at Fairview Southdale, January 2000–April 2001
Figure 1. By the middle of 2001, following four months in which there were no serious (class 3 or 4) events, it was concluded that the team had achieved its goal—a 75% reduction.
team was disbanded, to be replaced by a pain management subcommittee of the pharmacy and therapeutics committee of the medical staff. Unfortunately, later in 2001, the rates of serious narcotic oversedation reverted to baseline. The team was reconstituted and again chartered to achieve the original goal to reduce the rates of serious narcotic oversedation by 75%. During the remainder of 2001 and into 2002, dedicated resources were allocated for a pain management team. Consisting of a 0.8 FTE clinical nurse specialist and 0.5 FTE clinical pharmacy specialist, the team reviewed the care of all postoperative surgical patients, offered consulta-
tion to nursing and medical staff as requested, provided extensive education, and developed and deployed 20 additional changes in care (Table 3, page 546). The team also reviewed every case where naloxone was used, looking for additional opportunities to improve. Results since late 2002 have been dramatic. From 2000 through 2002, Fairview Southdale averaged 0.45 class 3 and 4 events per 1,000 discharges, decreasing to 0.08 for 2003 through 2006—a decrease of 81.1% (Figure 2, page 548). On the basis of these results, in May 2003 Fairview Health Services set an aim for all of its hospitals to reduce their rates of serious narcotic oversedation to at least that of its Southdale hospital—0.25 per 1,000 discharges. The corporate director of clinical pharmacy services [P.P.] was assigned to lead this spread effort. A systemwide pain committee was established as a subcommittee of the Fairview formulary and drug use committee. Chaired by a clinical pharmacy pain specialist, this committee was responsible for the refinement of tools, the spread of best practices, the development of relevant computer decision support, and other aspects of safe narcotic use. A list of actions taken at a system level is provided in Table 4 (page 546). Since 2004, the number of serious narcotic oversedation cases at Fairview Southdale has fallen from 4 in 2004, to 0 in 2005—and 1 in 2006 (Figure 3, page 548). Despite this success, work to eliminate serious narcotic oversedation continues.
Table 1. Original Naloxone Harm Rating Classification Class 0
Description No adverse event. Naloxone was used but did not result in an improvement of the patient’s clinical condition.
1
Intentional overdose
2
Adverse drug event; naloxone use resulted in a measurable improvement in the patient’s clinical condition. However, an uneventful recovery without sequelae would likely have occurred without the use of naloxone. 2a—Improvement was incomplete. Adverse event was complicated by an underlying medical condition or other medication. 2b—Improvement was dramatic. Adverse event was clearly related to opioids.
544
3
Adverse drug event and a near miss; naloxone use resulted in a measurable improvement of the patient’s clinical condition. An uneventful recovery without sequelae would likely not have occurred without the use of naloxone.
4
Adverse drug event and sentinel event; naloxone use resulted in a measurable improvement of the patient’s clinical condition or would likely have if given earlier in the course of the adverse event or in a more aggressive fashion. Patient suffered significant harm, required transfer to a higher level of care, suffered a respiratory or cardiac arrest, or died.
September 2007
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
The Joint Commission Journal on Quality and Patient Safety
Table 2. Changes Tested and Implemented, 2000–2001* Patient Assessment and Monitoring
Interdisciplinary & Interdepartmental Communication
Individualization of Therapy
Operating Room
■ Highlight history of snoring & sleep apnea as part of history
■ Eliminate or reduce morphine dose at end of case ■ Reduce intraoperative doses of fentanyl ■ Increase use of regional anesthesia ■ Increase use of ketorolac
■ Communicate with PACU staff any sleep apnea history ■ Communicate with PACU staff any intraoperative use of naloxone ■ Reorganize structure of anesthesia department ■ Clarify accountabilities between nurse anesthetists and anesthesiologists ■ Standardize anesthesia practice
Recovery Room
■ Change discharge guidelines to ensure patient is stable upon transfer ■ Eliminate use of oxygen for comfort care, since it can mask hypoventilation. ■ Hold patients for at least 30 minutes following narcotic dose ■ Hold patients for at least 30 additional minutes if naloxone administered in OR or PACU
■ Lower doses of morphine used ■ Remove morphine syringes of > 4 mg from floor stock ■ Wait to start PCA until patient is on the floor for patients who are not alert enough to safely self-manage
■ Revise communication upon transfer to postoperative floor ■ Adopt a single set of PACU pain orders ■ Revise epidural analgesic orders ■ Standardize volume of epidural analgesic bags dispensed by the pharmacy
Postoperative Floor
■ Modify vital signs monitoring schedule ■ Test continuous pulse oximetry ■ Establish new vital signs flow sheet ■ Educate nurses against using narcotics to treat anxiety
■ Modify pain orders to reduce maximum dose of morphine ■ Modify PCA orders to discourage basal rate ■ Modify PCA orders to include a 1-hour limit ■ Modify pain orders to treat respirations < 8 from < 8 ■ Remove morphine syringes of > 2 mg from floor stock
■ Report all naloxone usage to house physician ■ Re-emphasize that oxygen is to be administered only upon a physician’s order ■ Improve preoperative education to manage patient’s expectations ■ Nurses to carry phones to enable one-to-one report from PACU staff
* PACU, postanesthesic care unit; PCA, patient-controlled analgesia; OR, operating room.
Success Factors The initial success followed by a return to baseline in 2000 and 2001 taught us a number of valuable lessons and insights, which have been essential to long term spread and sustainment: ■ Recognize there is a problem and that the problem is not a cost of doing business. At the early stages of work it was common to hear comments like, “Well, sometimes
September 2007
that happens; that’s why naloxone is on the market!” Sending the persistent message that these cases are preventable, along with case studies and data to demonstrate this, helps to overcome that perception. ■ Relying on other hospitals’ perceptions, performance, or benchmarks guarantees mediocrity. In the early stages of our work we found that other hospitals were having similar experiences; although they did not have any data,
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
545
The Joint Commission Journal on Quality and Patient Safety
Table 3. Changes Tested and Implemented, 2001–2002* Focus Area: Staff knowledge & critical thinking skills Changes: Skills day programs One-on-one staff education on postoperative units Mandatory epidural and PCA pump education Mandatory competency package Pharmacy pain management training Posters and wallet cards Modify postoperative pain and epidural orders Focus Area: Physician knowledge Changes: Grand rounds Pain education at specific clinics Revised postoperative pain orders Letters sent to all physicians Posters and wallet cards Pain management team available for consults Education at specified medical department meetings Focus Area: Documentation, sedation assessment, and pain assessment Changes: New policies for pain assessment New frequent vital signs form One-on-one staff education Nurse competency for pain management implemented Focus Area: Miscommunication Changes: Pain team assesses all patients on postoperative units. Surgical nurse has direct phone access for PACU staff. PACU and unit staff meet to discuss communication processes. Modify postoperative pain orders and epidural orders Prepackage hydromorphone syringes * Some of the changes are repeated among focus areas. PCA, patient-controlled analgesia; PACU, postanesthesic care unit.
the sense was that our performance was no worse than that of others. That could have led to complacency; instead, it required a commitment on the part of senior management that despite others’ experiences, serious oversedation is simply unacceptable. ■ Recognize there is no single quick fix. The improved performance required multiple changes in multiple areas. ■ Recognize that going after adverse events due to error is insufficient: most of the problems did not relate to overt error. ■ Policies, forms, learning packets, dose conversion charts, and so on are necessary but insufficient to improve outcomes. Changing practice requires a change in critical 546
September 2007
Table 4. Systemwide Actions Since 2004* ■ Implement a range order policy that prohibits any dosing range greater than two-fold ■ Standardize PCA orders, including default starting doses, hourly limits, lockout intervals, and reversal therapy, and to discourage basal rate dosing in most patients. ■ Establish guidelines for dosing and drug selection in renally impaired patients; incorporate these into order forms and alerts in the electronic medical administration record (eMAR) ■ Restrict overrides in the automated dispensing cabinets to the lowest dosing size available; larger doses are obtained only with the presence of an order reviewed and approved by pharmacy. ■ Standardize systemwide measurement plan ■ Standardize documentation on eMAR and flow sheets ■ Standardize pain assessment scales across all hospitals ■ Extensive education of physicians, nurses, and pharmacists ■ Restrict use and dosing of meperidine to such conditions as hiccups and rigors ■ Establish dosing guidelines for procedural sedation ■ Pharmacists review all orders for fentanyl patches to ensure appropriate starting doses and conversions from other opioids. ■ Pharmacists review all orders for basal rates on PCA therapy to ensure adherence to selection criteria. * PCA, patient-controlled analgesia
thinking and can only be achieved by one-on-one dialog, mentoring, and oversight. ■ We must measure to know if the aim is being achieved. Although measurement and chart review is time consuming, without it many opportunities may go unnoticed. ■ To achieve excellence, we must identify and correct all sources of failure no matter how uncommon: Attempts must be made to close every hole in the “Swiss cheese.”1 For example, while Fairview’s practice is to start with doses of hydromorphone of 0.2–0.4 mg, prefilled syringes are available from the manufacturer only in 1-mg or 2-mg sizes. To prevent the rare but possible decimal point error, the pharmacy agreed to bulk-prepare 0.2-mg syringes. ■ The initial impressions and prejudices regarding root causes are often incorrect. For example, many people blamed hydromorphone for the problems and suggested removing it from the formulary. However, we found that hydromorphone was only a minor determinant of harm.
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
The Joint Commission Journal on Quality and Patient Safety
Table 5. Revised Harm Index Rating Classification and Examples* Harm Category Description Category A Circumstances or events that have the capacity to cause error
Example ■ No change in patient status after naloxone administration ■ Bradycardia or hypotension without oversedation or decline in respiratory status
Category B
An error occurred but the error did not reach the patient
■ No relevant example for naloxone use
Category C
An error occurred that reached the patient but did not cause patient harm
■ Naloxone given when it was clearly not needed (i.e., naloxone given to treat nausea)
Category D
An error occurred that reached the patient and required monitoring or intervention to confirm that it resulted in no harm to the patient
■ Partial or incomplete response in which recovery would most likely occur without naloxone administration ■ Naloxone used to increase the level of consciousness in SDS or PACU prior to transfer or discharge ■ Respiratory depression requiring naloxone reversal and/or ambulatory bagging administered by qualified personnel designated by professional practice and location including OR, PACU, ICU, and ER special procedures
Category E
An event contributed to or resulted in temporary harm to the patient
■ Reversal with naloxone successful but recovery complicated by one or more comorbid medical conditions or concomitant medications ■ Early recognition of respiratory depression (O2 sats < 90% or RR < 10 breaths/minute) with appropriate administration of naloxone. No additional assistance required. ■ Deep sedation level requiring naloxone reversal despite normal respiratory status ■ Additional assistance from medical or nursing staff needed for naloxone administration but no ambulatory bagging required ■ Procedure delayed or stopped due to need for reversal with naloxone
Category F
An event contributed to or resulted in temporary harm to the patient and prolonged hospitalization
■ Increase in hospitalization for either prolonged treatment with naloxone to reverse the effects of long-acting opioids or metabolite accumulation ■ Unexpected admission from ER or outpatient procedure area due to need for additional monitoring for oversedation or respiratory depression ■ Additional monitoring or observation of patient on a non-ICU floor after naloxone reversal
Category G
An event contributed to or resulted in permanent patient harm
■ Permanent injury or disability resulting from prolonged respiratory depression caused by analgesics or sedatives
Category H
An event which required intervention to sustain life
■ Unexpected respiratory depression requiring ambulatory bagging and naloxone reversal in locations including non–ICU patient areas, MRI, ER, endoscopy, cardiac diagnostic services, and interventional radiology ■ Transfer to an ICU after naloxone administration for observation and monitoring ■ Severe respiratory depression requiring assistance for naloxone reversal and airway management from an emergency medical response team (i.e., Code Blue, Flying Squad) ■ Intubation and ventilator support temporarily needed for airway
management due to prolonged opioid or sedative effects Category I
An event which contributed to the patient’s death
■ Death resulting from prolonged respiratory depression caused by analgesics or sedatives
* For categories, see National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP): Types of Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html (last accessed Jul. 17, 2007). SDS, same day surgery; PACU, postanesthesia care unit; OR, operating room; ICU, intensive care unit; ER, emergency room; sats, saturations; RR, respiratory rate; MRI, magnetic resonance imaging.
September 2007
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
547
The Joint Commission Journal on Quality and Patient Safety
Serious Narcotic Oversedation at Fairview Southdale, January 2000– December 2006
evaporated after the original team was disbanded. ■ Active engagement by senior management is critical. Senior management can help by setting high goals, helping to break through barriers, and sending the message that the status quo is unacceptable and that this work is essential to the mission of the hospital. ■ Don’t be too eager to declare victory. While the initial data in 2000 and 2001 suggested improvement, that improvement was clearly unsustainable. Persistent, dogged measurement can help to differentiate short-term gains from sustained improvement.
Future Work Figure 2. In 2000–2002, Fairview Southdale averaged 0.45 serious events/1,000 discharges, which decreased in 2003–2006 by 81.1%, to 0.08/1,000 discharges.
Serious Narcotic Oversedation at Fairview Southdale, 2000–2006
The Fairview Pain Committee continues to identify opportunities for improvement. The severity coding system has been changed to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) system,2 which should help us identify additional opportunities for improvement (Table 5, page 547). Work is beginning on oversedation in procedural areas such as endoscopy, guidelines for the use of capnography are being developed, new patient-controlled analgesia and epidural pumps are being purchased that have greater inherent safety features, and order sets are undergoing continual refinement. We anticipate that work will continue for years to achieve maximal narcotic safety. J
References
Figure 3. The raw number of serious narcotic oversedation cases annually from 2000 through 2006 are shown.
Team leaders must be open to all possibilities, be resistant to popular folklore, and plan actions based on evidence. ■ Standardization is essential. Individual practice and unit-defined norms can lead to confusion and complicate care. Therefore, standardizing such elements as order sets, syringe sizes, sedation scales, and criteria for giving naloxone is an essential component of safe practice. ■ For achievement of this scope and magnitude, resources must be dedicated, potentially over the long term. This is evidenced by the fact that our initial improvements 548
September 2007
1. Reason J.: Human error: Models and management. BMJ 320(7237):768–770, Mar. 18, 2000. 2. National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP): Types of Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html (last accessed Jul. 17, 2007).
Steven Meisel, Pharm.D., is Director, Medication Safety, Fairview Health Services, Minneapolis. Pamela Phelps, Pharm.D., is Director, Clinical Pharmacy Services, Fairview Health Services, and Clinical Associate Professor of Pharmacy, University of Minnesota, Minneapolis. Mary Meisel, R.N., M.S., A.P.R.N., B.C., is a Certified Pain Management Nurse, Fairview Southdale Hospital, Edina, Minnesota. Please address correspondence to Steven Meisel, [email protected].
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
5 Million Lives Campaign
Case Study: Reducing Narcotic Oversedation Across an Integrated Health System
Steven Meisel, Pharm.D. Pamela Phelps, Pharm.D. Mary Meisel, R.N., M.S., A.P.R.N., B.C.
F
airview Health Services, a fully integrated health system based in Minneapolis, is composed of 7 hospitals, 30 primary care clinics, 31 retail pharmacies, a home care and hospice agency, and various other programs. Fairview employs 10,900 full-time equivalents (FTEs) and has 2,600 medical staff members. In 2006 Fairview hospitals had 81,676 discharges and gross revenues of $3.3 billion. In December 1999, Fairview Southdale Hospital was devastated by the death of an otherwise healthy patient from an apparent narcotic-associated respiratory depression. This case was particularly troublesome because the doses administered were usual and customary, there were no identified medication errors, and patient monitoring was conducted within all standards at that time. To determine if this case was an isolated event or was part of a pattern, all naloxone administration during a two-month period was retrospectively reviewed. The review found 11 cases of serious oversedation, which prompted a major effort to understand and correct the factors associated with narcotic oversedation. This case study describes the effort undertaken at Fairview Health Services to reduce the rate of serious narcotic oversedation.
Efforts to Reduce Narcotic Oversedation In April 2000, a team was commissioned by Fairview Southdale Hospital’s administration with a charge to reduce serious narcotic oversedation by 75%. The team was composed of nurses, pharmacists, anesthetists, a house physician, respiratory therapists, anesthesiologists, and September 2007
quality resource staff. The vice president for medical affairs was the team’s sponsor, and a clinical nurse specialist served as the team’s chair. To measure progress, the team first needed to define serious narcotic oversedation. A literature review failed to find meaningful definitions or measures, so the team developed its own classification scheme (Table 1, page 544). The classification scheme was based on the acknowledgement that gross naloxone use is a poor measure because sometimes naloxone is used for intentional overdoses, for nonoversedation reasons (such as pruritis from epidural narcotics), and in complex medical situations where narcotics may be a minor component of the patient’s deterioration. The measure of progress was the rate of “serious”—class 3 and 4—events tracked monthly. Over the course of time, these rates were annualized and reframed as the number of discharges for every serious event. During the following 12 months, the team tested and implemented 34 changes (Table 2, page 545), which were framed in the contexts of patient assessment and monitoring, individualization of analgesic therapy, and interdisciplinary and interdepartmental communication. In recognition of the interdependence of actions within the operating room, recovery room (postanesthesia care unit), and the postoperative floors on patient outcomes, analysis and changes were made in all three of those care areas. By the middle of 2001, following four months in which there were no serious events, it was concluded that the team had achieved its goal of a 75% reduction in serious adverse drug events (ADEs) (Figure 1, page 544). The Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
543
The Joint Commission Journal on Quality and Patient Safety
Serious Narcotic Oversedation at Fairview Southdale, January 2000–April 2001
Figure 1. By the middle of 2001, following four months in which there were no serious (class 3 or 4) events, it was concluded that the team had achieved its goal—a 75% reduction.
team was disbanded, to be replaced by a pain management subcommittee of the pharmacy and therapeutics committee of the medical staff. Unfortunately, later in 2001, the rates of serious narcotic oversedation reverted to baseline. The team was reconstituted and again chartered to achieve the original goal to reduce the rates of serious narcotic oversedation by 75%. During the remainder of 2001 and into 2002, dedicated resources were allocated for a pain management team. Consisting of a 0.8 FTE clinical nurse specialist and 0.5 FTE clinical pharmacy specialist, the team reviewed the care of all postoperative surgical patients, offered consulta-
tion to nursing and medical staff as requested, provided extensive education, and developed and deployed 20 additional changes in care (Table 3, page 546). The team also reviewed every case where naloxone was used, looking for additional opportunities to improve. Results since late 2002 have been dramatic. From 2000 through 2002, Fairview Southdale averaged 0.45 class 3 and 4 events per 1,000 discharges, decreasing to 0.08 for 2003 through 2006—a decrease of 81.1% (Figure 2, page 548). On the basis of these results, in May 2003 Fairview Health Services set an aim for all of its hospitals to reduce their rates of serious narcotic oversedation to at least that of its Southdale hospital—0.25 per 1,000 discharges. The corporate director of clinical pharmacy services [P.P.] was assigned to lead this spread effort. A systemwide pain committee was established as a subcommittee of the Fairview formulary and drug use committee. Chaired by a clinical pharmacy pain specialist, this committee was responsible for the refinement of tools, the spread of best practices, the development of relevant computer decision support, and other aspects of safe narcotic use. A list of actions taken at a system level is provided in Table 4 (page 546). Since 2004, the number of serious narcotic oversedation cases at Fairview Southdale has fallen from 4 in 2004, to 0 in 2005—and 1 in 2006 (Figure 3, page 548). Despite this success, work to eliminate serious narcotic oversedation continues.
Table 1. Original Naloxone Harm Rating Classification Class 0
Description No adverse event. Naloxone was used but did not result in an improvement of the patient’s clinical condition.
1
Intentional overdose
2
Adverse drug event; naloxone use resulted in a measurable improvement in the patient’s clinical condition. However, an uneventful recovery without sequelae would likely have occurred without the use of naloxone. 2a—Improvement was incomplete. Adverse event was complicated by an underlying medical condition or other medication. 2b—Improvement was dramatic. Adverse event was clearly related to opioids.
544
3
Adverse drug event and a near miss; naloxone use resulted in a measurable improvement of the patient’s clinical condition. An uneventful recovery without sequelae would likely not have occurred without the use of naloxone.
4
Adverse drug event and sentinel event; naloxone use resulted in a measurable improvement of the patient’s clinical condition or would likely have if given earlier in the course of the adverse event or in a more aggressive fashion. Patient suffered significant harm, required transfer to a higher level of care, suffered a respiratory or cardiac arrest, or died.
September 2007
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
The Joint Commission Journal on Quality and Patient Safety
Table 2. Changes Tested and Implemented, 2000–2001* Patient Assessment and Monitoring
Interdisciplinary & Interdepartmental Communication
Individualization of Therapy
Operating Room
■ Highlight history of snoring & sleep apnea as part of history
■ Eliminate or reduce morphine dose at end of case ■ Reduce intraoperative doses of fentanyl ■ Increase use of regional anesthesia ■ Increase use of ketorolac
■ Communicate with PACU staff any sleep apnea history ■ Communicate with PACU staff any intraoperative use of naloxone ■ Reorganize structure of anesthesia department ■ Clarify accountabilities between nurse anesthetists and anesthesiologists ■ Standardize anesthesia practice
Recovery Room
■ Change discharge guidelines to ensure patient is stable upon transfer ■ Eliminate use of oxygen for comfort care, since it can mask hypoventilation. ■ Hold patients for at least 30 minutes following narcotic dose ■ Hold patients for at least 30 additional minutes if naloxone administered in OR or PACU
■ Lower doses of morphine used ■ Remove morphine syringes of > 4 mg from floor stock ■ Wait to start PCA until patient is on the floor for patients who are not alert enough to safely self-manage
■ Revise communication upon transfer to postoperative floor ■ Adopt a single set of PACU pain orders ■ Revise epidural analgesic orders ■ Standardize volume of epidural analgesic bags dispensed by the pharmacy
Postoperative Floor
■ Modify vital signs monitoring schedule ■ Test continuous pulse oximetry ■ Establish new vital signs flow sheet ■ Educate nurses against using narcotics to treat anxiety
■ Modify pain orders to reduce maximum dose of morphine ■ Modify PCA orders to discourage basal rate ■ Modify PCA orders to include a 1-hour limit ■ Modify pain orders to treat respirations < 8 from < 8 ■ Remove morphine syringes of > 2 mg from floor stock
■ Report all naloxone usage to house physician ■ Re-emphasize that oxygen is to be administered only upon a physician’s order ■ Improve preoperative education to manage patient’s expectations ■ Nurses to carry phones to enable one-to-one report from PACU staff
* PACU, postanesthesic care unit; PCA, patient-controlled analgesia; OR, operating room.
Success Factors The initial success followed by a return to baseline in 2000 and 2001 taught us a number of valuable lessons and insights, which have been essential to long term spread and sustainment: ■ Recognize there is a problem and that the problem is not a cost of doing business. At the early stages of work it was common to hear comments like, “Well, sometimes
September 2007
that happens; that’s why naloxone is on the market!” Sending the persistent message that these cases are preventable, along with case studies and data to demonstrate this, helps to overcome that perception. ■ Relying on other hospitals’ perceptions, performance, or benchmarks guarantees mediocrity. In the early stages of our work we found that other hospitals were having similar experiences; although they did not have any data,
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
545
The Joint Commission Journal on Quality and Patient Safety
Table 3. Changes Tested and Implemented, 2001–2002* Focus Area: Staff knowledge & critical thinking skills Changes: Skills day programs One-on-one staff education on postoperative units Mandatory epidural and PCA pump education Mandatory competency package Pharmacy pain management training Posters and wallet cards Modify postoperative pain and epidural orders Focus Area: Physician knowledge Changes: Grand rounds Pain education at specific clinics Revised postoperative pain orders Letters sent to all physicians Posters and wallet cards Pain management team available for consults Education at specified medical department meetings Focus Area: Documentation, sedation assessment, and pain assessment Changes: New policies for pain assessment New frequent vital signs form One-on-one staff education Nurse competency for pain management implemented Focus Area: Miscommunication Changes: Pain team assesses all patients on postoperative units. Surgical nurse has direct phone access for PACU staff. PACU and unit staff meet to discuss communication processes. Modify postoperative pain orders and epidural orders Prepackage hydromorphone syringes * Some of the changes are repeated among focus areas. PCA, patient-controlled analgesia; PACU, postanesthesic care unit.
the sense was that our performance was no worse than that of others. That could have led to complacency; instead, it required a commitment on the part of senior management that despite others’ experiences, serious oversedation is simply unacceptable. ■ Recognize there is no single quick fix. The improved performance required multiple changes in multiple areas. ■ Recognize that going after adverse events due to error is insufficient: most of the problems did not relate to overt error. ■ Policies, forms, learning packets, dose conversion charts, and so on are necessary but insufficient to improve outcomes. Changing practice requires a change in critical 546
September 2007
Table 4. Systemwide Actions Since 2004* ■ Implement a range order policy that prohibits any dosing range greater than two-fold ■ Standardize PCA orders, including default starting doses, hourly limits, lockout intervals, and reversal therapy, and to discourage basal rate dosing in most patients. ■ Establish guidelines for dosing and drug selection in renally impaired patients; incorporate these into order forms and alerts in the electronic medical administration record (eMAR) ■ Restrict overrides in the automated dispensing cabinets to the lowest dosing size available; larger doses are obtained only with the presence of an order reviewed and approved by pharmacy. ■ Standardize systemwide measurement plan ■ Standardize documentation on eMAR and flow sheets ■ Standardize pain assessment scales across all hospitals ■ Extensive education of physicians, nurses, and pharmacists ■ Restrict use and dosing of meperidine to such conditions as hiccups and rigors ■ Establish dosing guidelines for procedural sedation ■ Pharmacists review all orders for fentanyl patches to ensure appropriate starting doses and conversions from other opioids. ■ Pharmacists review all orders for basal rates on PCA therapy to ensure adherence to selection criteria. * PCA, patient-controlled analgesia
thinking and can only be achieved by one-on-one dialog, mentoring, and oversight. ■ We must measure to know if the aim is being achieved. Although measurement and chart review is time consuming, without it many opportunities may go unnoticed. ■ To achieve excellence, we must identify and correct all sources of failure no matter how uncommon: Attempts must be made to close every hole in the “Swiss cheese.”1 For example, while Fairview’s practice is to start with doses of hydromorphone of 0.2–0.4 mg, prefilled syringes are available from the manufacturer only in 1-mg or 2-mg sizes. To prevent the rare but possible decimal point error, the pharmacy agreed to bulk-prepare 0.2-mg syringes. ■ The initial impressions and prejudices regarding root causes are often incorrect. For example, many people blamed hydromorphone for the problems and suggested removing it from the formulary. However, we found that hydromorphone was only a minor determinant of harm.
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
The Joint Commission Journal on Quality and Patient Safety
Table 5. Revised Harm Index Rating Classification and Examples* Harm Category Description Category A Circumstances or events that have the capacity to cause error
Example ■ No change in patient status after naloxone administration ■ Bradycardia or hypotension without oversedation or decline in respiratory status
Category B
An error occurred but the error did not reach the patient
■ No relevant example for naloxone use
Category C
An error occurred that reached the patient but did not cause patient harm
■ Naloxone given when it was clearly not needed (i.e., naloxone given to treat nausea)
Category D
An error occurred that reached the patient and required monitoring or intervention to confirm that it resulted in no harm to the patient
■ Partial or incomplete response in which recovery would most likely occur without naloxone administration ■ Naloxone used to increase the level of consciousness in SDS or PACU prior to transfer or discharge ■ Respiratory depression requiring naloxone reversal and/or ambulatory bagging administered by qualified personnel designated by professional practice and location including OR, PACU, ICU, and ER special procedures
Category E
An event contributed to or resulted in temporary harm to the patient
■ Reversal with naloxone successful but recovery complicated by one or more comorbid medical conditions or concomitant medications ■ Early recognition of respiratory depression (O2 sats < 90% or RR < 10 breaths/minute) with appropriate administration of naloxone. No additional assistance required. ■ Deep sedation level requiring naloxone reversal despite normal respiratory status ■ Additional assistance from medical or nursing staff needed for naloxone administration but no ambulatory bagging required ■ Procedure delayed or stopped due to need for reversal with naloxone
Category F
An event contributed to or resulted in temporary harm to the patient and prolonged hospitalization
■ Increase in hospitalization for either prolonged treatment with naloxone to reverse the effects of long-acting opioids or metabolite accumulation ■ Unexpected admission from ER or outpatient procedure area due to need for additional monitoring for oversedation or respiratory depression ■ Additional monitoring or observation of patient on a non-ICU floor after naloxone reversal
Category G
An event contributed to or resulted in permanent patient harm
■ Permanent injury or disability resulting from prolonged respiratory depression caused by analgesics or sedatives
Category H
An event which required intervention to sustain life
■ Unexpected respiratory depression requiring ambulatory bagging and naloxone reversal in locations including non–ICU patient areas, MRI, ER, endoscopy, cardiac diagnostic services, and interventional radiology ■ Transfer to an ICU after naloxone administration for observation and monitoring ■ Severe respiratory depression requiring assistance for naloxone reversal and airway management from an emergency medical response team (i.e., Code Blue, Flying Squad) ■ Intubation and ventilator support temporarily needed for airway
management due to prolonged opioid or sedative effects Category I
An event which contributed to the patient’s death
■ Death resulting from prolonged respiratory depression caused by analgesics or sedatives
* For categories, see National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP): Types of Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html (last accessed Jul. 17, 2007). SDS, same day surgery; PACU, postanesthesia care unit; OR, operating room; ICU, intensive care unit; ER, emergency room; sats, saturations; RR, respiratory rate; MRI, magnetic resonance imaging.
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Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations
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The Joint Commission Journal on Quality and Patient Safety
Serious Narcotic Oversedation at Fairview Southdale, January 2000– December 2006
evaporated after the original team was disbanded. ■ Active engagement by senior management is critical. Senior management can help by setting high goals, helping to break through barriers, and sending the message that the status quo is unacceptable and that this work is essential to the mission of the hospital. ■ Don’t be too eager to declare victory. While the initial data in 2000 and 2001 suggested improvement, that improvement was clearly unsustainable. Persistent, dogged measurement can help to differentiate short-term gains from sustained improvement.
Future Work Figure 2. In 2000–2002, Fairview Southdale averaged 0.45 serious events/1,000 discharges, which decreased in 2003–2006 by 81.1%, to 0.08/1,000 discharges.
Serious Narcotic Oversedation at Fairview Southdale, 2000–2006
The Fairview Pain Committee continues to identify opportunities for improvement. The severity coding system has been changed to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) system,2 which should help us identify additional opportunities for improvement (Table 5, page 547). Work is beginning on oversedation in procedural areas such as endoscopy, guidelines for the use of capnography are being developed, new patient-controlled analgesia and epidural pumps are being purchased that have greater inherent safety features, and order sets are undergoing continual refinement. We anticipate that work will continue for years to achieve maximal narcotic safety. J
References
Figure 3. The raw number of serious narcotic oversedation cases annually from 2000 through 2006 are shown.
Team leaders must be open to all possibilities, be resistant to popular folklore, and plan actions based on evidence. ■ Standardization is essential. Individual practice and unit-defined norms can lead to confusion and complicate care. Therefore, standardizing such elements as order sets, syringe sizes, sedation scales, and criteria for giving naloxone is an essential component of safe practice. ■ For achievement of this scope and magnitude, resources must be dedicated, potentially over the long term. This is evidenced by the fact that our initial improvements 548
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1. Reason J.: Human error: Models and management. BMJ 320(7237):768–770, Mar. 18, 2000. 2. National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP): Types of Medication Errors. http://www.nccmerp.org/medErrorCatIndex.html (last accessed Jul. 17, 2007).
Steven Meisel, Pharm.D., is Director, Medication Safety, Fairview Health Services, Minneapolis. Pamela Phelps, Pharm.D., is Director, Clinical Pharmacy Services, Fairview Health Services, and Clinical Associate Professor of Pharmacy, University of Minnesota, Minneapolis. Mary Meisel, R.N., M.S., A.P.R.N., B.C., is a Certified Pain Management Nurse, Fairview Southdale Hospital, Edina, Minnesota. Please address correspondence to Steven Meisel, [email protected].
Volume 33 Number 9
Copyright 2007 Joint Commission on Accreditation of Healthcare Organizations