R E V I E W S & A N A LY S E S Analysis of the Multiple Risks Involving the Use of IV FentaNYL Mohammed Aseeri, BS, PharmD, BCPS INTRODUCTION Patient Safety Analyst FentaNYL is a lipophilic, short-acting synthetic opioid that was synthesized to produce Matthew Grissinger, RPh, FISMP, FASCP an opioid analgesic with potent analgesic activity and potentially fewer side effects in Manager of Medication Safety Analysis comparison with meperidine or morphine.1,2 Injectable forms of fentaNYL have been Pennsylvania Patient Safety Authority in clinical practice for more than 40 years as a component of anesthetic analgesic regimens and for the management of acute pain by different routes of administration.2 The drug has strong affinity for the mu opioid receptor, binding at many sites within the central nervous system (CNS), increasing pain threshold, altering pain reception, ABSTRACT inhibiting ascending pain pathways, and producing an analgesic effect, as well as FentaNYL is a synthetic opioid analgesic adverse effects such as nausea, vomiting, and respiratory depression.1,3,4 with potent analgesic activity and fewer When fentaNYL is administered intravenously (IV), it has a short onset of action (one side effects in comparison with mor- to two minutes), making it an ideal analgesic when rapid pain relief is required. This phine whose rapid onset of action has rapid onset of action explains why fentaNYL has been used with increasing frequency led to increasing use in postanesthesia in postanesthesia care units (PACUs) and emergency departments (EDs).3,5 Within care units (PACUs) and emergency three to five minutes of administration, the drug reaches its peak effect, yet it has a departments (EDs). Analysts reviewed relatively short duration of action of 30 to 60 minutes. The short duration of action medication errors and adverse drug makes fentaNYL an ideal agent when the goal is to have a short recovery time, such as reactions (ADRs) involving intravenous in outpatient procedures. It should be noted that the elimination half-life of fentaNYL (IV) fentaNYL that were reported to the ranges between two to four hours and is influenced by the extent of storage into fatty Pennsylvania Patient Safety Authority. issue.2,3 FentaNYL is thought to be 80 to 100 times as potent as parenteral morphine The predominant medication error event for acute pain in patients who are opioid-naïve.3,5 Some studies show that 25 mcg/hr of types associated with IV fentaNYL were parenteral fentaNYL is equal to 1 mg/hr of parenteral morphine.3 wrong-dose/overdosage events and wrong-drug events. Of the reported Although medication errors with opioid analgesics are common,6 Pennsylvania Patient wrong-dose/overdosage events Safety Authority analysts found no specific studies addressing medication errors originating in the administration node, associated solely with IV fentaNYL. An examination of medication errors in PACUs almost 68% mention breakdowns dur- reported over a seven-year period to MEDMARX (Quantros, Milpitas, California), an ing the pump-programming process. Internet-accessible medication error reporting system available to subscribing hospitals High-alert medications were involved in and related health systems, found that the most common medications mentioned almost 70% of wrong-drug events with were morphine, meperidine, HYDROmorphone, and fentaNYL.7 In a separate study fentaNYL. The most common catego- of pediatric medication errors in the PACU reported over a six-year period to MED- ries of care areas cited in ADR reports MARX, researchers reported that 20% of the medication errors were harmful, with include procedural areas (43.2%), half of the errors involving morphine, acetaminophen, meperidine, or fentaNYL.8 surgical areas (19.9%), and intensive An adverse drug event (ADE) is defined by the Joint Commission as “any incident in care units (12.5%). Effective risk reduc- which the use of a medication (drug or biologic) at any dose, a medical device, or a tion strategies include restricting the special nutritional product (e.g., dietary supplement, infant formula, medical food) may use of patient-controlled analgesia with have resulted in an adverse outcome in a patient.”9 ADEs can be divided into two catego- fentaNYL to anesthesia or pain man- ries: (1) medication errors, which are considered to be preventable ADEs, and (2) adverse agement team members, establishing drug reactions (ADRs), which are considered to be unpreventable ADEs. Despite this standardized protocols and order sets distinct difference in definition, ADR reports may be a source of potentially preventable for pain management, and requiring events, even though reporters thought the ADE could not have been prevented. an independent double check before The following analysis addresses medication errors and ADRs specifically involving administering IV fentaNYL doses. (Pa IV fentaNYL reported to the Authority and the predominant types of reported events Patient Saf Advis 2012 Dec;9[4]:122-9.) involving IV fentaNYL. METHODOLOGY Analysts queried the event description field of all event types in the Authority’s Penn- sylvania Patient Safety Reporting System database from June 2004 to March 2012 for “fentanyl.” The search also included the “medication prescribed” and “medication administered” fields in medication error events and the “suspected medication” field Page 122 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority in ADR events. The initial query yielded FOCUSED EVENT TYPE ANALYSIS (59.4%, n = 82) or wrong drug concentra- 3,857 reports. To focus on events involv- tion (19.6%, n = 27). ing only IV doses of fentaNYL, analysts Wrong Dose/Overdosage The patient’s epidural infusion was excluded reports (n = 1,538) involving Review of the descriptions of the events ordered for 8 mL/hr. The patient’s other dosage forms, including transdermal submitted to the Authority show that level of sensation and ability to move systems (e.g., Duragesic®) and oral formu- the most common nodes associated with extremities were normal for the first lations (e.g., Actiq®, Fentora®). The final wrong-dose/overdosage events involving two hours. The patient then became data set included 2,319 events involving IV fentaNYL were administration (58.5%, nauseated, felt fatigued, and [had the use of IV fentaNYL. n = 203), prescribing (15.2%, n = 53), and low] blood pressure. ePHEDrine dispensing (6.3%, n = 22). In addition, was administered. When moving the AGGREGATE ANALYSIS OF most of the wrong-dose/overdosage events patient’s position, the patient had EVENTS INVOLVING IV (38.9%, n=135) reached the patient and difficulty positioning his arms. An FENTANYL required monitoring and/or required additional dose of ePHEDrine was intervention to preclude harm to the administered. It was at this time that Categorization of the reports by harm patient (harm score = D). Categorization the [infusion] rate was noted to be set score, which is adapted from the National of the harm revealed that 4.6% (n = 16) of at 88 mL/hr. The pump was shut off Coordinating Council for Medication the wrong-dose/overdosage events resulted and the physician was notified. . . . Error Reporting and Prevention (NCC in patient harm (harm score = E to I). The patient was monitored. MERP) harm index,10 shows that 74.6% (n = 1,729) of the events reached the When looking at care areas, the most The patient was found lethargic with patient (harm score = C to I), 33.1% (n commonly cited care areas were ICUs shallow respirations. A fentaNYL = 768) of the events reached the patient (30.8%, n = 107) and units caring for drip was infusing at 25 mL/hr and required monitoring to confirm that pediatric patients (e.g., pediatric ICU, (250 mcg/ hr) instead of 5 mL/ hr it resulted in no harm to the patient and/ neonatal ICU, pediatric units) (21.0%, (50 mcg/hr). The infusion was or required intervention to preclude harm n = 73), followed by obstetrics and gyne- immediately stopped, the patient was (harm score = D), and 3.2% (n = 74) of cology (5.2%, n = 18) and surgical areas placed on 100% oxygen, and 0.2 mg the events resulted in patient harm (harm (e.g., PACU, operating rooms [ORs], anes- Narcan® was given. score = E to I). thesia) (4.6%, n = 16). A fentaNYL infusion was ordered to The care areas in which the events Pump programming. Of the events run at 20 mcg/hr. The infusion was occurred were distributed across many originating in the administration process, programmed at 40 mcg/hr. Further units. No individually mentioned unit almost 68% (n = 138) mention break- investigation showed that the medica- represented more than 8% of reports. The downs during the pump-programming tion concentration had been changed most often cited care areas include pedi- process. Further analysis of the events from 10 mcg/mL to 20 mcg/mL, but atric intensive care units (ICUs) (7.8%, that occurred during the administration the pump setting was not adjusted n = 180), pharmacy (6.6%, n = 154), of IV fentaNYL by infusion pump shows accordingly when the new syringe medical-surgical units (6.6%, n = 152), that most of the reported cases involved was hung. PACUs (4.9%, n = 114), and neonatal programming the wrong rate of infusion ICUs (4.8%, n = 112). More than 85% (n = 1,972) of reports involving IV fentaNYL were reported as medication errors, 10.4% Table. Predominant Event Types Associated with the Use of IV FentaNYL (N = 2,319), (n = 241) were reported as ADRs, and the June 2004 to March 2012 remaining events were submitted as other EVENT TYPE NO. OF % OF TOTAL types of reportable events. Besides the REPORTS REPORTS event type of “medication error, other” Medication error, wrong dose/overdosage 347 15.0 (16.6%, n = 385), the predominant event Medication error, wrong drug 243 10.5 types reported mentioning IV fentaNYL Medication error, wrong rate 134 5.8 (see Table) were “medication error, Medication error, wrong strength or concentration 96 4.1 wrong dose/overdosage” (15.0%, Medication error, wrong patient 70 3.0 n = 347), “medication error, wrong drug” Medication error, other 385 16.6 (10.5%, n = 243), and “ADR, other” (7.6%, n = 177). Adverse drug reaction, other 177 7.6 Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 123 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Administering. The descriptions of events Prescribing. Of the wrong-dose/overdos- of causing significant patient harm when that occurred during the administration age events originating in the prescribing used in error,11,12 were involved in almost node and did not involve the program- node, analysis shows that 35.8% (n = 19) 70% (n = 170) of drug mix-ups with ming of an infusion pump (n = 78) did involved orders exceeding the normal fentaNYL. Four medications accounted not provide enough detail to determine therapeutic dosing range, followed by for nearly half (47.7%, n = 116) of the specifically what went wrong. Most duplicate therapy (30.2%, n = 16) and mix-ups with fentanyl, including HYDRO- reports (56.4%, n =44) simply stated that mix-ups between the dosage units of mg morphone (15.6%, n = 38), morphine the patient received a higher or wrong and mcg (17 %, n = 9). (13.6%, n = 33), midazolam (11.1%, dose than what was intended. However, An order [was] written for a two- n = 27), and the combination fentaNYL/ analysts were able to determine that the month-old patient for fentaNYL bupivacaine (7.4%, n = 18). package size of the vials or ampules 1 mcg/kg/dose, but the [patient’s] Examples of the events involving mix-ups and/or that the available concentration weight was entered incorrectly as with fentaNYL include the following: (50 mcg/mL) of IV fentaNYL may have 70 kg. The patient actually weighs contributed in these errors, especially for Patient was admitted to the ED for 3.7 kg. The dose was ordered by multiple trauma. The ED physician the pediatric population. anesthesia as 70 mcg instead of was going to intubate the patient, During a trauma care, the physician 4 mcg. The fentaNYL was given and nursing brought the requested gave a verbal order for fentaNYL in the OR, but the dose [was] not medications for the intubation, 25 mcg IV push for one dose. The recorded. . . . The pharmacy saw this including midazolam, fentaNYL, and first nurse drew up the entire vial of order in PACU and halted the order succinylcholine. The succinylcholine fentaNYL (5 mL = 250 mcg) into a immediately. had been drawn up in a syringe and syringe. She did not label the syringe An order was received for a fen- labeled. The physician decided not in any way. She handed the syringe taNYL infusion for a patient who to intubate but ordered the nurse to to the second nurse and instructed was already on a morphine infusion. give fentaNYL for pain. The nurse him to push 25 mcg without telling Upon calling the PACU, I questioned picked up the syringe and adminis- him how much was in the syringe. the fact that this patient was already tered 0.5 mL when he realized it was The second nurse pushed the entire on morphine at 5 mg/hr. The equiva- succinylcholine. syringe, which was 250 mcg, a lent dose of fentaNYL would be [tenfold] overdose from what was A physician, in the labor and delivery 50 mcg/hr. The order was written for area, ordered ampicillin and fen- prescribed. The error was immediately fentaNYL at 200 mcg/hr. The order noticed by the first nurse when the taNYL at the same time. The nurse was corrected, and the morphine infu- prepared the medications at the same second nurse returned with an empty sion was discontinued. syringe. Physician [was made] aware, time. The fentaNYL for the epidural and patient was closely monitored for was hung in place of the ampicillin; Wrong Drug the nurse noted the error after approx- any adverse effects. Almost one-third of wrong-drug events imately 5 mL were given. A six-month-old infant was admitted (29.6%, n = 72) involving IV fentaNYL to the hospital for head trauma. In Anesthesia signs out a drug box each reached the patient and required moni- preparation for a head CAT morning, which contains fentaNYL toring and/or required intervention to [computerized axial tomography] scan and ketamine. The ketamine was confirm that it resulted in no harm (harm to evaluate the status of his injury, recently added to the drug box. The index = D). Roughly 5.3% of events the baby was to be given fentaNYL doctor stated she was not aware that (n = 13) resulted in patient harm (harm 5 mcg. The nurse caring for the child ketamine was in the box. She drew up score = E to I). The care areas most often drew up 1 mL of fentaNYL (50 mcg) the ketamine but labeled and admin- cited with IV fentaNYL wrong-drug events with the intention of administering istered [it] as if it were fentaNYL. include ICUs (22.2%, n = 54), surgical 0.1 mL (5 mcg); however, a nurse Patient [was] not arousing in the areas (20.2%, n = 49), pediatric units orientee working with the nurse recovery area as anticipated, and doc- (11.1%, n = 27), and procedural areas administered the entire syringe. The tor [was] informed of this. Error [was] (e.g., endoscopy/gastrointestinal lab, imag- error was immediately noticed and realized when the medication box was ing) (4.9%, n = 12). the child was given Narcan 0.2 mg. checked back in by a staff nurse. The Analysts determined that high-alert medi- fentaNYL and the ketamine counts cations, drugs that bear a heightened risk were incorrect. Page 124 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority The patient was agitated and submitted to the Authority to determine Anecdotal examples of events that appear attempting to self-extubate. A nurse if there were cases that may have been pre- to be preventable events include: grabbed a syringe at the bedside and ventable (e.g., errors caused by an excess Patient scheduled for ERCP thought it was fentaNYL. The nurse dose of IV fentaNYL, use of concomitant [endoscopic retrograde cholangiopan- asked the respiratory therapist at the respiratory/CNS depression drugs ). creatography]. Patient received initial bedside to place the patient back on Analysts searched for “fentanyl” in the medications consisting of midazolam the vent. At that time, the patient “suspected medication,” “additional 3 mg, fentaNYL 80 mcg, and diphen- was no longer breathing and was suspected drug medication,” and event hydrAMINE 40 mg. The patient tachycardic. The nurse looked at the description fields to find ADR reports was still awake, so additional doses syringe in which they pulled the dose that may have involved IV fentaNYL of midazolam 2 mg and fentaNYL and saw it to be pancuronium. alone or in combination with other 40 mcg were given. Within 10 min- Roughly 8.2% (n = 20) of wrong-drug medications. utes, the patient became somnolent events with IV fentaNYL involved There were 318 ADR reports submit- and the oxygen saturation fell into the retrieving the incorrect drug from the ted to the Authority between June 2004 70s. Narcan was given. automated dispensing cabinet (ADC) or and March 2012 related to the use of IV Patient was admitted for a colonos- stocking the wrong drug in the drawers of fentaNYL. Analysts excluded reports that copy and was given sedation for the those cabinets. would not have resulted from dosing- procedure. Shortly after the colo- Went to the ADC to get a HYDRO- related problems that were categorized as noscopy began, the patient became morphone PCA [patient-controlled skin reactions (24.2%, n = 77) from the dusky, respirations decreased, and she analgesia] syringe, pulled the analysis, resulting in 241 reports. Almost became unresponsive, with a pulse medication, went to patient’s room 82.2% (n = 198) of the ADR reports oximetry [reading] of 65%. She had with syringe, and before loading it indicated that the patient received the received a total of 5 mg of midazolam into the PCA pump, I checked the medication and required monitoring and 250 mcg of fentaNYL in titrated medication, and it was fentaNYL. and/or required intervention to confirm doses. She was given Narcan 1.2 mg I informed the charge nurse, who that it resulted in no harm (harm score in divided doses and bagged with an checked the ADC and found that = D), with nearly 8% (n = 19) of ADRs Ambu bag. She immediately recovered the HYDROmorphone drawer had resulting in patient harm (harm score a pulse oximetry [reading] of 96% fentaNYL and that the fentaNYL = E to I). Specific care areas most often and became awake and alert. The drawer had HYDROmorphone. cited in ADR reports involving fentaNYL procedure was able to be completed, include the endoscopy/gastroenterology and the patient was monitored in the Nearly 12% (n = 29) of wrong-drug events lab (24.1%, n = 58), OR (7.9%, n = 19), with IV fentaNYL involved epidural PCA recovery area for two hours prior to and PACU (7.5%, n = 18). The most com- discharge. therapy. mon categories of care areas cited include Patient was connected to an epidural procedural areas (43.2%, n = 104), sur- A 71-year-old patient received a total infusion in the OR by anesthesia. gical areas (19.9%, n = 48), and ICUs of fentaNYL 120 mcg and mid- It was discontinued at the time (12.4%, n = 30). azolam 4 mg for ERCP procedure. of transport to the PACU. In the The patient became less responsive, The most common categories of reactions the respiratory rate was 8 and pulse PACU, the physician went to restart described in the narratives include respi- the infusion and it was determined oximetry [reading] was 72% despite ratory depression (50.2%, n = 121) and repositioning of head and increased that the medication in the bag was mental status changes (10.8%, n = 26). morphine sulfate for PCA use only oxygen. 0.3mg Narcan given. Roughly 22% (n = 52) of the reports did and the medication was not restarted. not give enough information to discern An epidural infusion with fentaNYL RISK REDUCTION STRATEGIES the types of reaction. Since fentaNYL is was started. a primary drug for conscious sedation, Healthcare facilities can strive to identify determining preventability is difficult in system-based causes of errors with the use Adverse Drug Reaction these events without knowing the details of IV fentaNYL and other opioids and Similar to the analysis of HYDROmor- of the procedure (e.g., length of the proce- implement effective types of risk reduc- phone ADR reports published in the dure), as multiple doses of fentaNYL may tion strategies to prevent harm to patients. September 2010 Pennsylvania Patient Safety be needed for longer cases. Risk reduction strategies such as con- Advisory,13 analysts reviewed ADR reports straints and standardization, which focus Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 125 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S on system improvement, will be more management, including a standard administering IV fentaNYL doses. effective than education alone, which pain scale for assessment, guidelines Since nurses routinely obtain nar- relies on individual performance.14,15 Con- for the use of specific analgesics, cotics from floor stock, the typical sider the strategies described below, which standard order forms and screens, pharmacist-nurse double check is not are based on a review of the literature and guidelines outlining conditions in place (as it is with specific patient of events submitted to the Authority, as that require a dose reduction, and doses dispensed from the pharmacy). well as observations from the Institute for requirements for monitoring.17 Some ADCs can be programmed Safe Medication Practices. — Match the sequence of information to require a witness when selected that appears on fentaNYL PCA med- narcotics are removed or when the Constraints ication labels and order sets with the override feature is used to access — Prescribing sequence of information that must selected narcotics. Reminders can be entered into the PCA pump.15 also appear on the screen.17 Consider restricting fentaNYL PCA use to anesthesia or pain — Establish one standard concentra- tion for IV fentaNYL used for PCA.16 Patient Monitoring management team members only.16 — Establish guidelines for appropri- — Establish protocols for reversal ate monitoring of patients who Consider requiring prescribers agents that can be administered with- are receiving fentaNYL, including to undergo a privileging process out additional physician orders when frequent assessment of the quality to verify proficiency with PCA warranted.19 of respirations (not just a respira- pain management.17 — In standard order forms, guide pre- tory rate), the type of equipment to Implement standard order sets scribers to an appropriate dose based be used for monitoring respirations for PCA therapy, with all sec- on age and opioid tolerance by pro- (e.g., capnography), and specific signs tions completed, and limit verbal viding default doses for three types of oversedation. Ensure resources— orders to dose changes.16 of patients: (1) most patients; both personnel and equipment—are Take into consideration impor- (2) patients older than 64 years or available to monitor patients per tant information about the those with sleep apnea; and established guidelines.18 patient that could affect the (3) opioid-tolerant patients.20 — Use standardized formats for prescribing of IV fentaNYL (e.g., documenting pain control and moni- patient’s current medication pro- Differentiation toring parameters.18 file for drugs with additive CNS — Clearly label infusion bags that contain epidural fentaNYL with — Ensure that oxygen and naloxone or respiratory depressant side “For Epidural Use Only” in a large are available where opioids are effects, age, drug-drug interaction, font. Use color and design to dif- administered.18 total current opioid therapy). ferentiate these products from IV — Establish a process to screen patients — Storage medications.16 for obstructive sleep apnea before Reduce stock amounts of IV initiation of fentaNYL PCA therapy, fentaNYL wherever possible, — For epidural infusions, use pumps that look different than pumps used with further assessment by a respira- and eliminate it from floor stock tory therapist if the screening reveals entirely if usage is low. for IV infusions and clearly label pumps used to deliver epidural medi- two or more risk factors.19 Store each medication in a sepa- cations as “Epidural Only.”16 rate, lock-lidded bin or drawer Education and Information in the ADC to help prevent — Use yellow-lined tubing without — Require annual competence assess- drug-selection errors. In the injection ports for epidural infusions ments for all professionals who pharmacy, segregate prefilled to set its appearance apart from typi- prescribe, dispense, administer, or syringes and vials of these drugs, cal IV tubing. Never use yellow-lined monitor the effects of fentaNYL.16 especially if they contain the tubing for anything other than epi- dural administration.21 — Create mandatory education pro- same concentration.18 grams for all practitioners potentially Redundancies involved with IV fentaNYL use. Standardization Include all aspects of safe use; — Establish and mandate the use of — Where possible, require an inde- pendent double check before accepted prescribing practices, standardized protocols for pain Page 126 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority including those related to the man- reviewing ADR reports, as well as the Analysis of medication errors and ADRs agement of the opioid-naïve patient; use of “trigger” drugs (e.g., naloxone) involving IV fentaNYL reveal that the dosing norms; assessment param- used to reverse the effects of opioids, predominant medication error event types eters; and monitoring techniques. to obtain outcome measures to get a associated with IV fentaNYL were wrong- — Provide staff with safety information broader picture of the harm resulting dose/overdosage events and wrong-drug on the use of potent narcotics via from the misuse of IV fentaNYL. events, which could lead to patient harm. newsletters, during in-services, or — Consider measures other than practi- More than two-thirds of reported overdos- through material available on their tioner reporting of medication errors age events mention breakdowns during preferred form of technology (e.g., to evaluate your organization’s pro- the pump-programming process, and smartphones, tablets). cesses with the use of IV fentaNYL, high-alert medications were involved in including assessing core processes almost 7 out of 10 wrong-drug events with Monitoring of ADRs associated with IV fentaNYL. fentaNYL. Effective risk reduction strate- — As demonstrated by previous analysis gies to prevent patient harm could include of ADR reports submitted to the CONCLUSION restricting fentaNYL PCA use to anesthe- Authority,12 these types of reports sia or pain management team members, FentaNYL is a potent, synthetic opioid serve as a potentially rich source of establishing standardized protocols and analgesic with fewer side effects in com- information to identify risk with the order sets for pain management, and parison with morphine whose rapid onset use of IV fentaNYL, as well as other requiring an independent double check of action has led to increasing use in many opioids, in the facility. Consider before administering IV fentaNYL doses. care areas including PACUs and EDs. NOTES 1. Peng PW, Sandler AN. A review of official handbook (CAMH). Update 2. 15. Institute for Safe Medication Practices. the use of fentanyl analgesia in the Oakbrook Terrace (IL): Joint Commission Medication error prevention “toolbox.” management of acute pain in adults. Resources; 2012 Sep. ISMP Med Saf Alert Acute Care 1999 Jun Anesthesiology 1999 Feb;90(2):576-99. 10. National Coordinating Council for Medi- 2;4(11):1. 2. Prommer E. The role of fentanyl in cation Error Reporting and Prevention. 16. Institute for Safe Medication Practices. cancer-related pain. J Palliat Med 2009 NCC MERP index for categorizing medi- Misprogram a PCA pump? It’s easy! Oct;12(10):947-54. cation errors [online]. 2001 Feb [cited ISMP Med Saf Alert Acute Care 2004 Jul 3. Pasero C. Fentanyl for acute pain 2012 Aug 2]. http://www.nccmerp.org/ 29;9(15):1-2. management. J Perianesth Nurs 2005 medErrorCatIndex.html. 17. Institute for Safe Medication Practices. Aug;20(4):279-84. 11. Institute for Safe Medication Practices. Safety issues with patient-controlled 4. Lexicomp Online. Fentanyl [online]. ISMP 2007 survey on high-alert medica- analgesia. Part II—how to prevent errors. 2012 [cited 2012 Jul]. Available with tions: differences between nursing and ISMP Med Saf Alert Acute Care 2003 Jul subscription at http://online.lexi. pharmacy perspectives still prevalent. 24;8(15):1-2. com/lco/action/doc/retrieve/docid/ ISMP Med Saf Alert Acute Care 2007 May 18. Institute for Safe Medication Practices. patch_f/6903#pha. 17;12(10):1-3. Risk of deadly mix-up exists in most hos- 5. Conti G, Costa R, Pellegrini A, et al. 12. Institute for Safe Medication Practices. pitals. ISMP Med Saf Alert Acute Care 2004 Analgesia in PACU: intravenous opioids. ISMP’s list of high-alert medications Jul 1;9(12):1-2. Curr Drug Targets 2005 Nov;6(7):767-71. [online]. 2012 [cited 2012 Aug 8]. 19. Institute for Safe Medication Practices. 6. Bates DW, Spell N, Cullen DJ, et al. http://www.ismp.org/Tools/ High alert medication feature: reducing highAlertMedications.asp. patient harm from opioids. ISMP Med Saf The costs of adverse drug events in hos- pitalized patients. Adverse Drug Events 13. Adverse drug events with HYDRO- Alert Acute Care 2007 Feb 22;12(4):2-3. Prevention Study Group. JAMA 1997 Jan morphone: how preventable are they? 20. Institute for Safe Medication Practices. 22-29;277(4):307-11. PA PSRS Patient Saf Advis [online] 2010 Beware of basal opioid infusions with Sep [cited 2012 Aug 8]. http://www. PCA therapy. ISMP Med Saf Alert Acute 7. Hicks RW, Becker SC, Windle PE, et al. Medication Errors in the PACU. J Peri- patientsafetyauthority.org/ADVISORIES/ Care 2009 Mar 12;14(5):1-2. AdvisoryLibrary/2010/Sep7(3)/Pages/69. anesth Nurs 2007 Dec;22(6):413-19. 21. Institute for Safe Medication Practices. aspx. Don’t use epidural tubing for an IV solu- 8. Payne CH, Smith CR, Newkirk LE, et al. Pediatric medication errors in the postan- 14. Cohen MR, Smetzer JL, Tuohy NR, et tion. ISMP Med Saf Alert Acute Care 2008 esthesia care unit: analysis of MEDMARX al. High-alert medications: safeguarding Jan 17;13(1):3. data. AORN J 2007 Apr;85(4):731-40. against errors. Chapter 14. In: Cohen MR, ed. Medication errors, 2nd ed. 9. Glossary. In: Joint Commission. Compre- Washington (DC): American Pharmacists hensive accreditation manual for hospitals: the Association; 2007. Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 127 ©2012 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S LEARNING OBJECTIVES SELF-ASSESSMENT QUESTIONS — Recognize the risks associated with The following questions about this article may be useful for internal education and the dosing of intravenous (IV) assessment. You may use the following examples or develop your own questions. fentaNYL. A physician writes an order for 500 mcg of IV fentaNYL for a 39-year-old who complains of — Recognize the types of medication pain after a laparoscopic procedure. After receiving this dose, the patient was found unresponsive errors that are associated with IV with low oxygen saturation and respiratory rate. fentaNYL. 1. What is the equivalent dose of morphine IV for this patient? — Identify common reported adverse a. 10 mg drug reactions with the use of IV b. 20 mg fentaNYL. c. 50 mg — Select appropriate strategies to d. 75 mg promote the safe prescribing, dis- 2. Which of the following statements best describes why IV fentaNYL has been con- pensing, and administering of IV sidered to be an ideal analgesic agent in outpatient procedures, where the goal is fentaNYL. to have a short recovery time? a. IV fentaNYL has fewer side effects compared with other analgesics. b. IV fentaNYL has a rapid onset of action. c. IV fentaNYL is safer than other analgesics. d. IV fentaNYL is more potent than other analgesics. 3. Which of the following is the type of medication error involving the use of IV fentaNYL most commonly reported to the Pennsylvania Patient Safety Authority? a. Wrong drug selection b. Wrong rate of infusion c. Wrong dose/overdosage d. Monitoring error/documented allergy 4. Which of the following is the area of care with medication errors involving the use of IV fentaNYL most commonly reported to the Authority? a. Intensive care unit b. Postanesthesia care unit c. Emergency department d. Medical-surgical unit 5. Which of the following is the adverse drug reaction related to IV fentaNYL most commonly reported to the Authority? a. Bradycardia b. Hypotension c. Central nervous system depression d. Respiratory depression Page 128 Pennsylvania Patient Safety Advisory Vol. 9, No. 4—December 2012 ©2012 Pennsylvania Patient Safety Authority SELF-ASSESSMENT QUESTIONS (CONTINUED) A facility’s pain team evaluated a patient at 10 a.m. and increased the basal rate of the fen- taNYL patient-controlled analgesia (PCA) to 20 mcg/hr from 12 mcg/hr. Three hours later, the palliative care team saw the patient and increased the basal rate of the PCA to 100 mcg/hr. Early the next morning, the patient needed a dose of naloxone, and fentaNYL basal rate was decreased to 50 mcg/hr by the hospitalist. 6. Based on this scenario, which of the following is the least effective strategy to miti- gate the risk of harm with IV fentaNYL? a. Provide staff with safety information on the use of IV fentaNYL via newsletters and in-services. b. Restrict the use of fentaNYL PCA to anesthesia or pain management team members. c. Establish standardized protocols and order sets for pain management. d. Implement processes with double checks during the administration phase of IV fentaNYL. Vol. 9, No. 4—December 2012 Pennsylvania Patient Safety Advisory Page 129 ©2012 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 9, No. 4—December 2012. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2012 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s An Independent Agency of the Commonwealth of Pennsylvania website at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and indepen- dence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions. 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