Pennsylvania Patient Safety Advisory Adverse Drug Events with HYDROmorphone: How Preventable are They? ABSTRACT morphine and HYDROmorphone are scarce.5 How- Despite the fact that HYDROmorphone (Dilaudid®) is ever, studies have shown that HYDROmorphone, widely used, there appear to be gaps in understand- by any route, is a much more potent mu-opioid ing its efficacy and potency, which can lead to seri- receptor agonist than morphine.5 This difference ous medication errors. Analysts reviewed medication in potency makes it difficult to compare morphine errors and adverse drug reactions (ADR) involving and IV HYDROmorphone. Most of the doses in HYDROmorphone that were reported to the Pennsyl- equi-analgesic charts are, often times, based on single vania Patient Safety Authority. Seventy percent of the dose studies, and the exact potency equivalence ratios wrong drug reports involved mix-ups with morphine. are uncertain.4 The estimated relative potency of IV Wrong dose/overdosage medication error reports HYDROmorphone compared to IV morphine is show that the most common nodes associated with 7.5:1; recent reviews of opioid conversions find ratios this event type are administering, prescribing, and ranging from around 4:1 to as high as 8:1.5 For exam- dispensing. Review of ADR reports shows that the most ple, an order for an opioid-naïve patient for 2.5 mg to common reactions reported involved central nervous 5 mg of IV morphine would be equivalent to 0.3 mg system reactions and/or respiratory complications. to 0.67 mg of HYDROmorphone. Sixty-five percent of these adverse reactions appear to have been preventable events. Effective risk reduction The literature has various and inconsistent recom- strategies include establishing standardized proto- mendations about the appropriate starting dose and cols for pain management and protocols for reversal frequency of administration for HYDROmorphone. agents that can be administered without additional For example, HYDROmorphone’s product label physician orders when warranted, as well as requiring states that the initial IV dose for opioid-naive patients an independent double check before administering is 1 mg to 2 mg IV (slowly) every four to six hours intravenous HYDROmorphone doses. (Pa Patient Saf as needed.7 However, there is literature that recom- Advis 2010 Sep;7[3]:69-75.) mends against using 2 mg IV as a starting dose even in nonelderly patients. Chang et al. showed that one-third of adult, nonelderly patients who received Introduction 2 mg presented to the emergency department (ED) HYDROmorphone (Dilaudid®) is a semisynthetic complaining of acute severe pain and developed oxy- opioid agonist and a derivative of morphine. It gen desaturation.8 In 2002, one drug information differs pharmacodynamically from its parent drug reference publisher, Lexi-Comp, revised its HYDRO- in potency, onset, duration, and the presence of an morphone dosing recommendations based on advice active metabolite, but the analgesic effect is the same.1 from clinical experts. For opioid-naïve patients, the revised monograph states: “IV: Initial: 0.2-0.6 mg HYDROmorphone is used for moderate to severe every 2-3 hours as needed; patients with prior opioid pain. Historically, it was only used to treat chronic exposure may tolerate higher initial doses. Patient con- pain (e.g., cancer pain), but it is now widely used in trolled analgesia (PCA): Initial: Opioid-naive: the management of acute pain, including postopera- Consider lower end of dosing range; after loading: tive pain, acute trauma pain, and other indications.2,3 0.05-0.4 mg/dose; usual lockout range: 5-10 minutes.”9 HYDROmorphone is usually used as an alternative for morphine in patients who cannot tolerate mor- The lack of knowledge about HYDROmorphone phine or cannot achieve adequate analgesia with potency and the difference in potency between mor- morphine. Although HYDROmorphone is a potent phine and HYDROmorphone has frequently led to analgesic, to date, there is no evidence to support its serious medication errors, especially when a patient is superiority over morphine for the management of switched from morphine to HYDROmorphone.10 moderate to severe pain.2 In a prospective, randomized, double-blind, clinical trial conducted in an academic medical center of HYDROmorphone can be administered by various 198 adult patients presenting to the ED with acute routes including intravenous (IV), intramuscular (IM), severe pain, Chang et al. observed that many of the epidural, and oral routes.4 The onset of action after center’s emergency physicians and nurses were hesi- an IV dose is 5 minutes and peaks in approximately tant to give 7 mg to 10 mg of morphine as an initial 20 minutes, which is useful in postoperative patients IV dose. In contrast, they observed that these same who require postoperative analgesia.5 The duration of healthcare providers were not similarly reluctant to action ranges from four to five hours.6 administer a roughly equi-analgesic dose of HYDRO- Despite the fact that HYDROmorphone has been morphone (1 mg to 1.5 mg), perhaps because the around for decades and is widely used, there appear more potent HYDROmorphone is given in much to be gaps in understanding the efficacy and potency smaller milligram quantities than morphine, thus of HYDROmorphone.2 Clinical studies comparing IV providing the illusion that substantially less opioid is Vol. 7, No. 3—September 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 69 Pennsylvania Patient Safety Advisory being administered to the patient.11 In a prospective the most commonly involved drug pair was morphine interventional cohort study to evaluate the safety and and HYDROmorphone.15 Present analysis of wrong efficacy of 2 mg IV HYDROmorphone administered drug medication errors mentioning HYDROmor- to nonelderly adult (i.e., 21 to 64 years of age) ED phone reveals that 70% involve mix-ups with mor- patients in acute severe pain, Chang et al. noted that phine. (See Table 2.) the lower milligram amount of HYDROmorphone causes less concern among providers and leads, albeit Facilities did not enter enough detail into most of the inadvertently, to better analgesia for patients.8 How- event descriptions to determine all the reasons why ever, this difference in perception could contribute these events took place. It was not possible to cat- to harm to patients. In its 2007 Advisory, the Com- egorize and determine the most common types (e.g., monwealth of Massachusetts Board of Registration in wrong drug written by prescriber, wrong drug selected Medicine reported four patient deaths resulting from during order entry, wrong drug retrieved from the administration of 2 mg to 4 mg of HYDROmor- stock, drug mislabeled in the pharmacy) of reported phone as a bolus, with repeat doses of 1 mg to 4 mg.12 wrong-drug errors. Examples of reports with limited An adverse drug event (ADE) is defined by the Joint information regarding the causes and contributing Commission as “any incident in which the use of a factors of the events include the following: medication (drug or biologic) at any dose, a medical Patient was inadvertently given Dilaudid 1 mg by device, or a special nutritional product (e.g., dietary intravenous push (IVP) instead of morphine 2 mg supplement, infant formula, medical food) may have resulted in an adverse outcome in a patient.”13 ADEs IVP as ordered. can be divided into two categories: (1) medication Patient prescribed Dilaudid 1mg IV but was given errors, which are considered to be preventable ADEs Demerol® 2.5 mg IV. and (2) adverse drug reactions (ADR), which are considered to be unpreventable ADEs. Despite this Analysts were able to determine the following: distinct difference in definition, ADR reports may ■ Of the reports of wrong drug HYDROmorphone be a source of potentially preventable events, even errors, 146 (78.9%) specifically mentioned that the though the reporter thought the ADE could not have breakdown occurred in the administration node. been prevented. This article presents an analysis of both medication errors and ADRs involving HYDRO- morphone reported to the Pennsylvania Patient Safety Table 1. Predominant Medication Error Authority and discusses the predominant types of Event Types Associated with the Use of events involving HYDROmorphone. HYDROmorphone (n = 1,135, 67%), January 2008 to October 2009 Medication Errors with HYDROmorphone % OF TOTAL Pennsylvania healthcare facilities submitted 1,694 REPORTS medication error reports to the Authority from Janu- EVENT TYPE NUMBER (N = 1,694) ary 2008 to October 2009 that described medication Wrong dose/overdosage 287 16.9% errors involving the use of HYDROmorphone. Cat- Wrong drug 185 10.9 egorization of the reports by harm score, which is Monitoring error/ 137 8.1 adapted from the National Coordinating Council for documented allergy Medication Error Reporting and Prevention (NCC Wrong route 131 7.7 MERP) harm index,14 shows that 68.2% (n = 1,155) Wrong dose/underdosage 106 6.3 of the events reached the patient (harm index = C to Other (specify) 289 17.1 I) and 1.8% (n = 30) of the events resulted in patient harm (harm index = E to I). The care areas most often cited in these reports include medical/surgical units (26.5%, n = 449), pharmacy (15.1%, n = 255), Table 2. Predominant Medications and ED (5.8%, n = 99). The majority of the reports, Associated with Wrong Drug Errors involving almost 70% (n = 1,179), involved the adult population HYDROmorphone (n = 146, 78.9%), January between the ages of 17 and 64, while 1.7% (n = 28) 2008 to October 2009 involved pediatric patients (ages less than 17 years). % OF The predominant medication error event types asso- TOTAL MEDICATION MEDICATION REPORTS ciated with HYDROmorphone (see Table 1) were PRESCRIBED ADMINISTERED NUMBER (N = 185) wrong dose/overdosage (16.9%, n = 287), wrong drug HYDROmorphone morphine 66 35.7% (10.9%, n = 185), and monitoring error/documented allergy (8.1%, n = 137). morphine HYDROmorphone 63 34.1 HYDROmorphone lorazepam 6 3.2 Wrong-Drug Errors with HYDROmorphone HYDROmorphone meperidine 6 3.2 In 2007, a review of 8,400 wrong drug medication oxycodone HYDROmorphone 5 2.7 error reports submitted to the Authority showed that Page 70 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 3—September 2010 Pennsylvania Patient Safety Advisory A patient was admitted to the ED for chest pain. Fifty-seven (29.2%) reports involved programming The ED physician ordered morphine 2 mg, but the errors or failure to change the program of an infusion patient instead received Dilaudid 2 mg. The mor- device (both PCA and general infusion pumps). phine and Dilaudid were located next to each other The patient was on a standard 1 mg/mL of Dilau- in the narcotic drawer. did, but an automatic substitution of a 5 mg/mL ■ Twenty-seven (14.6%) of the reports involved the concentration was sent due to the high dose require- dispensing or storage of the wrong medication by ment of patient. The nurse did not reprogram PCA the pharmacy. pump, which led [to respiratory distress]. A nurse went to administer a “prn” dose of Dilaudid Nineteen (9.7%) reports mentioned problems to the patient. The nurse found 24 vials of medica- documenting and/or witnessing “wasting” amounts tion in the drawer: 20 were Dilaudid, but 4 were of HYDROmorphone. morphine sulfate. The RN [registered nurse] had pre- Prescribing. A majority of the HYDROmorphone viously given patient a “prn” dose of Dilaudid but is overdoses that occurred during the prescribing node not sure if the dose was Dilaudid or morphine. involved orders for a wrong dose (79.6%, n = 43), fol- lowed by an incorrect frequency (18.5%, n = 10). For The pharmacist dispensed morphine PCA example, some reports indicated orders were written [patient-controlled analgesia] (as seen on manu- without designating that HYDROmorphone should facturer’s labeling) with a pharmacy label for be given “as needed,” which could have led to the HYDROmorphone PCA. The patient was to have administration of this medication more frequently HYDROmorphone. The nurse receiving the PCA than was needed. did not catch it, but another nurse, who was about to hang it on the patient, did catch it. The morphine The prescriber wrote for every five-minute dosing of did not reach patient. hydromorphone tablets (2 mg) prn. When contacted, the physician assistant prescriber intended “every 6-hour ■ Thirty-five (18.9%) of wrong drug administration PRN” dosing. The order was discontinued and rewritten. errors involved PCA therapy. An order was written for 1.5 mg/hour of hydromor- At the beginning of night shift, the nurse noticed the phone with a 1.5 mg bolus every 10 minutes instead patient was very sleepy and found it hard to keep the of a bolus of 0.3 mg every 10 minutes. The patient patient awake. The nurse notified the resident on call received 16.8 mg over a six-hour period and then was and received a verbal order to change the rate of the found unresponsive. morphine PCA from a basal rate of 2.8 mg/hr to 1 mg/hr and to continue the “as needed” dose at An order was written for a postoperative patient to 1 mg every five minutes. When the nurse and the receive 1 mg Dilaudid PCA every 15 minutes with a verifying nurse opened the PCA machine to change 16 mg 4-hour dose limit. This was a high dose (usual the settings, the nurses saw that instead of the syringe 0.1 mg to 0.2 mg), which was dispensed; the nurse ques- being morphine 1 mg/mL, [it] was HYDROmor- tioned the order. The original prescriber insisted on the phone 0.2 mg/mL. The infusion was immediately dose, and the nurse then brought the order to the atten- stopped and vital signs were taken, which were stable. tion of the director of anesthesia, who did not change the order. The patient received the dose as ordered and Wrong Dose/Overdosage Errors became difficult to arouse. The PCA order was changed Wrong dose/overdosage medication error reports by another prescriber to 0.2 mg every 8 minutes. involving HYDROmorphone show that the most It should be noted that 14.8% (n = 8) of the wrong common nodes associated with this event type are dose prescribing errors involved dangerous dose administering (67.9%, n = 195), prescribing (18.8%, designations, such as failure to write a dose with a n = 54), and dispensing (6.6%, n = 19). leading zero. Administration. Analysis of the descriptions of events An order was written for “Dilaudid .2 mg IV q 1hr that occurred during the administration node shows prn pain” without a leading zero, and it was difficult that most of the reported cases did not give enough to see if there was a decimal point. The ordering phy- detail to determine specifically what went wrong but sim- sician was called but was no longer in the hospital. ply stated that the patient received a higher dose than The covering physician returned the call and asked what was intended (57.4%, n = 112). However, analysts for clarification. That physician asked what is usu- were able to determine the following for wrong drug/ ally given and the nurse replied “2 mg,” so the order overdosage events occurring in administration node: was clarified as “2 mg.” The nurse administered the 2 mg, which led to severe respiratory depression. The Fifty-two (26.7%) reports involved PCA therapy. covering physician contacted the ordering physician, A patient had an order for a PCA pump. The pump who intended for the order to be “0.2 mg.” was programmed for morphine (1 mg/mL) instead of Dilaudid (0.2 mg/mL). Dilaudid was the prescribed ADR Reports medication. We are unsure of how much medication the HYDROmorphone has the typical opioid associated patient received because all of the settings were not right. side effects, including light-headedness, dizziness, Vol. 7, No. 3—September 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 71 Pennsylvania Patient Safety Advisory sedation, nausea, vomiting, sweating, flushing, Table 3. Predominant Adverse Drug dysphoria, euphoria, dry mouth, and pruritus.7 Reaction Categories Associated with the HYDROmorphone binds to mu-receptors to produce Use of HYDROmorphone, June 2004 to its analgesic effect. However, it also binds to mu- October 2009 receptors in the respiratory centers of the medulla, % OF TOTAL which can lead to clinically significant respiratory REPORTS depression.16 Some of the factors that raise patients’ EVENT TYPE NUMBER (N = 937) risk of harm from opioid-induced respiratory depres- Central nervous system and/ 449 47.9 sion include older age (i.e., 65 years of age or older), or respiratory depression diseases affecting the respiratory (e.g., asthma, chronic Allergic reactions 361 38.5 obstructive pulmonary disease) or cardiovascular Nausea/vomiting 39 4.2 systems, concomitant use of respiratory-function Unknown/reaction not 34 3.6 depressants other than opioids, opioid-naïve patients specified who are overweight, and patients with sleep disorders (e.g., sleep apnea).17 Analysts reviewed ADR reports submitted to the Analyses of these events reveal problems with the Authority to determine if there were cases that may prescribing of inappropriate doses and multiple have been preventable (e.g., errors caused by an medications that have sedative properties. Of the excess dose of HYDROmorphone). Analysts searched reported central nervous system and respiratory for “HYDROmorphone” or “Dilaudid” in the sus- adverse reactions, 292 (65%) appear to have been pected medication, other medication, and the event preventable events, in which patients received a description fields to find ADR reports that may have dose in excess of what would be needed to resolve involved HYDROmorphone alone or in combination pain symptoms or in which HYDROmorphone was with other medications. prescribed and administered with other medications that would lead to additive sedative effects. There were 937 ADR reports submitted to the Overall, 205 (70.2%) of the identified preventable Authority between June 2004 and October 2009. ADR reports that mentioned central nervous Almost 90% (n = 842) of the ADR reports discussed system and/or respiratory depressive type reactions events that were considered to have not harmed to HYDROmorphone were due to inappropriate patients. The three most common broad categories doses, with 44 (15.1%) of the reports demonstrating of reactions described in the narratives include aller- problems due to a combination of inappropriate gic reactions, respiratory depression, and central dosing and the prescribing of multiple medications nervous system effects (see Table 3). It was expected with a sedative side effect profile. (See Table 4.) that the most common reported type of reactions would have been allergic reactions (38.5%, n=361); Examples of identified “preventable” ADR reports for example, patients that experienced itching, rashes, include the following: and hives. However, the most common types of reac- An elderly patient was admitted with left leg edema tions reported were events (47.9%, n = 449) in which ulcerations with significant pain. Within an eight- patients experienced central nervous system reactions hour period, the patient received morphine 2 mg (e.g., decreased level of consciousness, oversedation, IV, Dilaudid 2 mg IV two times, and was started mental status changes) and/or respiratory complica- on a Duragesic® (fentanyl) patch. One hour later, tions (e.g., shortness of breath, respiratory depression, the patient was found unresponsive. Narcan® was respiratory arrest), a known consequence of the drug. given, and the patient responded immediately; pulse Reports that specifically mentioned a central nervous oximetry was monitored and was 100%. The Dilau- system and/or respiratory ADR were analyzed to did prn order was discontinued, the Duragesic patch determine if the reaction could have been preventable remained on, and the patient had no further episodes (e.g., caused by an inappropriate dose ordered, caused of unresponsiveness. by a combination of medications with additive An adult patient was admitted with a right ureter sedative effects with HYDROmorphone). For this stone. An order was written for Dilaudid 4 mg IV analysis, an inappropriate dose was considered to be a every three hours prn. The patient received a total of dose that was one of the following: three doses within a six-hour time period. Two hours ■ Greater than a 1 mg dose for the general adult later, the patient was speaking with staff, but within population for an opioid-naïve patient a half hour, the patient was found unresponsive with shallow breathing and a faint heart rate of 40. A ■ 1 mg or greater for an elderly patient who was code was called, and atropine and Narcan (naloxone) opioid-naïve was administered with good response. The patient was transferred to the intensive care unit for further care. ■ A frequency of administration that allowed for the administration of HYDROmorphone too fre- An adult patient was admitted with abdominal pain quently for that patient population and received Demerol® (meperidine) 25 mg IV push Page 72 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 3—September 2010 Pennsylvania Patient Safety Advisory Table 4. Common “Preventable” Adverse — Implement standard order sets for PCA Drug Reaction Categories Associated with therapy, with all sections completed, and limit the Use of HYDROmorphone (n = 284, verbal orders to dose changes.18 97.3%), June 2004 to October 2009 — Avoid the use of basal rates with PCA for pain % OF TOTAL control of an opioid-naïve patient.19,20 REPORTS EVENT TYPE NUMBER (N = 292) — Take into consideration important information Inappropriate doses 205 70.2% about the patient that could affect the pre- scribing of HYDROmorphone (e.g., patient’s Inappropriate doses and 44 15.1 multiple drugs current medication profile for drugs with Multiple drugs 26 8.9 additive central nervous system or respiratory depressant side effects, age, renal function, total Inappropriate doses and 9 3.1 contraindicated current opioid therapy). For a list of HYDRO- morphone’s contraindications for use and other warnings, see “Prescribing Considerations for HYDROmorphone” available at http://www. at noon and 2 p.m., followed by Dilaudid 2 mg IV patientsafetyauthority.org/EducationalTools/ push at 2 p.m., 3 p.m., 4 p.m., and 6 p.m. At 7 p.m., PatientSafetyTools/Pages/home.aspx. the patient was found with shallow respirations and ■ Storage difficult to arouse. The patient responded to Narcan, and the orders were changed to Dilaudid 1 mg IV — Reduce stock amounts of HYDROmorphone every 2 hours prn. wherever possible, and eliminate it from floor An elderly postoperative patient received Ativan® stock entirely if usage is low.21 0.5 mg IV at 4:20 p.m. and Dilaudid 2 mg IV at — Avoid stocking morphine and HYDROmor- 6 p.m. and 9 p.m. At 11 p.m., the patient experi- phone in the same strength if both drugs are enced decreased level of consciousness and required available in patient care units. For example, 2 mg of Narcan IV with immediate response. since both drugs are available in 2 mg and An elderly patient in the postanesthesia care unit, fol- 4 mg prefilled syringes, stock HYDROmor- lowing a left laparoscopic colectomy, received fentanyl phone 2 mg and morphine 4 mg (but not vice 125 mcg, Dilaudid 2 mg, and morphine 4 mg within versa, since 4 mg of HYDROmorphone would a one-hour time period. Four hours later, on the post- be an excessive dose for most patients, espe- operative surgical unit, the patient required Narcan cially opioid-naïve patients).21 1 mg for decreased respirations and oversomnolence. — If the drugs are stored in an automated dis- An elderly patient, admitted with back pain, received pensing cabinet (ADC), consider allowing morphine 4 mg and a total of 2 mg of Dilaudid within access to morphine via an override function a six-hour period in the ED. When the patient arrived in emergencies, but require pharmacy order to the nursing unit, the patient’s heart rate was 120 review before removing an initial dose of and oxygen saturation was 80% on room air. The staff HYDROmorphone.21 was unable to keep the patient awake. The patient was — Store each medication in a separate, individual transferred to a monitored bed for closer monitoring. bin or drawer in the cabinet to help prevent drug selection errors. In the pharmacy, segregate Risk Reduction Strategies prefilled syringes and vials of these drugs, espe- Healthcare facilities can strive to identify system-based cially if they contain the same concentration.21 causes of wrong drug and wrong dose/overdose errors with the use of HYDROmorphone and other opi- Standardization oids and implement effective types of risk reduction ■ Establish protocols for pain management, includ- strategies to prevent harm to patients. Risk reduction ing a standard pain scale for assessment, guidelines strategies such as constraints and standardization, for the use of specific analgesics, standard order which focus on system improvement, will be more forms and screens, guidelines outlining conditions effective than education alone, which relies on indi- that require a dose reduction, and requirements for vidual performance. Consider the strategies described monitoring.21 below, which are based on a review of events submitted ■ Establish protocols for reversal agents that can be to the Authority, observations at the Institute for Safe administered without additional physician orders Medication Practices, and the literature. when warranted.19 Constraints ■ In standard order forms, guide prescribers to an ■ Prescribing appropriate dose based on age and opioid tolerance — Consider requiring prescribers to undergo a by providing default doses for three types of patients: privileging process to verify proficiency with (1) most patients, (2) patients older than 64 years or PCA pain management.18 with sleep apnea, and (3) opioid-tolerant patients.20 Vol. 7, No. 3—September 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 73 Pennsylvania Patient Safety Advisory ■ Consider other medications that the patient has Educate staff about the differences between received (e.g., analgesics taken at home, intraopera- HYDROmorphone and morphine, as some of the tive medications) or currently has been prescribed reported mix-ups have been due to the mistaken (e.g., antihistamines, nighttime sedatives) when belief that HYDROmorphone is the generic name determining appropriate doses.18 for morphine.21 Differentiation Monitoring of ADRs ■ When able, use tall man lettering to emphasize ■ As demonstrated by the analysis of ADR reports the “HYDRO” portion of HYDROmorphone submitted to the Authority, these reports serve as on pharmacy labels, auxiliary labels, medication a potentially rich source of information to identify administration records, and drug listings on com- risk with the use of HYDROmorphone, as well as puter screens or ADCs.21 other opioids in the facility. Consider reviewing ■ Consider adding label reminders on HYDRO- ADR reports, as well as the use of “trigger” drugs morphone indicating the brand name equivalent, used to reverse the effects of opioids, like naloxone, “DILAUDID,” to help prevent confusion with to get a broader picture of the harm resulting from other drugs such as morphine. Some ADCs the misuse of HYDROmorphone. may also offer the capability of asking “This is ■ Consider measures other than practitioner DILAUDID. Is that correct?” when nurses retrieve reporting of medication errors to evaluate your HYDROmorphone.21 organization’s safe use of HYDROmorphone, Redundancies including assessing core processes associated with ■ Require an independent double check before HYDROmorphone use by using process measures. administering IV HYDROmorphone doses. Since Visit the Authority’s Web site at http://www. nurses routinely obtain narcotics from floor stock, patientsafetyauthority.org/EducationalTools/ the typical pharmacist-nurse double check is not PatientSafetyTools/Pages/home.aspx to view or down- in place (as it is with specific patient doses dis- load a sample tool that can be used to identify and pensed from the pharmacy). Some ADCs can be monitor actual or potential problems with the use of programmed to require a witness when selected HYDROmorphone. narcotics are removed or when the override feature Notes is used to access selected narcotics. Reminders can also appear on the screen.21 1. Hill HF, Coda B, Tanaka A, et al. Multiple-dose evaluation of intravenous hydromorphone pharmaco- Patient Monitoring kinetics in normal human subjects. Anesth Analg 1991 ■ Establish guidelines for appropriate monitoring Mar;72(3):330-6. of patients who are receiving opioids, including 2. Quigley C. Hydromorphone for acute and chronic pain. frequent assessment of the quality of respirations Cochrane Database Syst Rev 2002;(1):CD003447. (not just a respiratory rate) and specific signs of oversedation. Ensure resources—both personnel 3. Murray A, Hagen N. Hydromorphone. J Pain Symptom and equipment—are available to monitor patients Manage 2005 May;29 (5 Suppl):S57-66. per established guidelines.19 4. Sarhill N, Walsh D, Nelson KA. Hydromorphone: phar- macology and clinical applications in cancer patients. ■ Use standardized formats for documenting pain Support Care Cancer 2001 Mar;9(2):84-96. control and monitoring parameters.19 5. Hong D, Flood P, Diaz G. The side effects of morphine ■ Ensure that oxygen and naloxone are available and hydromorphone patient-controlled analgesia. Anesth where opioids are administered.19 Analg 2008 Oct;107(4):1384-9. ■Establish a process to screen patients for obstruc- 6. Lexi-Comp Online. Hydromorphone [online]. 2010 tive sleep apnea before initiation of PCA therapy, [cited 2010 Jul 8]. Available from Internet: http:// with further assessment by a respiratory therapist if online.lexi.com/crlsql/servlet/crlonline. the screening reveals two or more risk factors.20 7. Purdue Pharma Pharmaceuticals, Inc. Dilaudid® (hydro- Education and Information morphone) [full prescribing information online]. 2008 ■ Require annual competence assessments for all Jun [cited 2010 Jul 15]. Available from Internet: http:// professionals who prescribe, dispense, and admin- www.purduepharma.com/pi/prescription/DilaudidHP_ ister PCA.18 Injection_Lyophilized_Powder_PI.pdf. ■ Create mandatory education programs for all practitio- 8. Chang AK, Bijur PE, Napolitano A, et al. Two mil- ners potentially involved with HYDROmorphone use. ligrams i.v. hdyromorphone is efficacious for treating Include all aspects of safe use; accepted prescribing pain but is associated with oxygen desaturation. J Opioid practices, including those related to the management Manag 2009 Mar-Apr;5(2):75-80. of the opioid-naïve patient; dosing norms; assessment 9. Institute for Safe Medication Practices (ISMP). Safety parameters; and monitoring techniques. brief. ISMP Med Saf Alert 2002 Oct 30;7(22):1. ■ Provide staff with safety information on the use 10. Inadvertent mix-up of morphine and hydromorphone: of potent narcotics via newsletters and in-services. a potent error. PA PSRS Patient Saf Advis [online] 2007 Page 74 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 3—September 2010 Pennsylvania Patient Safety Advisory Sep [cited 2010 Jun 17]. Available from Internet: http:// Internet: http://www.patientsafetyauthority.org/ www.patientsafetyauthority.org/ADVISORIES/ ADVISORIES/AdvisoryLibrary/2007/sep4(3)/ AdvisoryLibrary/2007/sep4(3)/Pages/86.aspx. Pages/89.aspx. 11. Chang AK, Bijur PE, Meyer RH, et al. Safety and effi- 16. Smith LH. Opioid safety: is your patient at risk for cacy of hydromorphone as an analgesic alternative to respiratory depression? Clin J Oncol Nurs 2007 morphine in acute pain: a randomized clinical trial. Apr;11(2):293-6. Ann Emerg Med 2006 Aug;48(2):164-72. 17. Pergolizzi J, Boger RH, Budd K, et al. Opioids and the 12. Commonwealth of Massachusetts Board of Registration management of chronic severe pain in the elderly: con- in Medicine. Hydromorphone: Patient safety concerns sensus statement of an International Expert Panel with with hydromorphone versus morphine [online]. focus on the six clinically most often used World Health Advisory 2007 May [cited 2010 Jul 8]. Available from Organization Step III opioids (buprenorphine, fentanyl, Internet: http://www.massmedboard.org/pca/pdf/ hydromorphone, methadone, morphine, oxycodone). hydromorphone_advisory.pdf. Pain Pract 2008 Jul-Aug;8(4):287-313. 13. Joint Commission. Sentinel event glossary of terms 18. Institute for Safe Medication Practices (ISMP). Safety [online]. Sentinel Event Alert 2006 Jan 26 [cited 2010 issues with patient-controlled analgesia. Part II—how to Jun 18]. Available from Internet: http://www. prevent errors. ISMP Med Saf Alert 2003 Jul 24;8(15):1-2. jointcommission.org/sentinelevents/se_glossary.htm. 19. Institute for Safe Medication Practices (ISMP). High- 14. National Coordinating Council for Medication Error alert medication feature: reducing patient harm from Reporting and Prevention. NCC MERP index for cat- opioids. ISMP Med Saf Alert 2007 Feb 22;12(4):2-3. egorizing medication errors [online]. 2001 [cited 2010 20. Institute for Safe Medication Practices (ISMP). Beware ? Jun 18]. Available from Internet: http://www.nccmerp. of basal opioid infusions with PCA therapy. ISMP Med org/medErrorCatIndex.html. Saf Alert 2009 Mar 12;14(5): 1-2. 15. Common medication pairs that contribute to wrong 21. Institute for Safe Medication Practices (ISMP). Risk of drug errors. PA PSRS Patient Saf Advis [online] deadly mix-up exists in most hospitals. ISMP Med Saf 2007 Sep [cited 2010 Jun 17]. Available from Alert 2004 Jul 1;9(12):1-2. ? Self-Assessment Questions The following questions about this article may be useful for inter- nal education and assessment. You may use the following examples 3. The most commonly reported type of medication error involving the prescribing of HYDROmorphone was: or come up with your own. a. Prescribing HYDROmorphone for patients with a pre- A physician wrote an order for a 67-year-old opioid-naïve existing documented allergy to an opioid patient for HYDROmorphone 4 mg intravenous (IV) b. Prescribing HYDROmorphone when it is administration as needed for pain. The patient received contraindicated for that patient one dose and was later found with a low oxygen saturation, c. Prescribing a wrong dose of HYDROmorphone low respiratory rate, and decreased responsiveness. The d. Prescribing HYDROmorphone for the wrong patient doctor was notified, and naloxone IV was administered to this patient. 4. The most commonly reported type of adverse drug reaction related to HYDROmorphone was: 1. What is the equianalgesic dose of morphine IV for a. Allergic reaction this patient? b. Central nervous system/respiratory events a. 4 mg c. Nausea and vomiting b. 7 mg d. Seizures c. 15 mg 5. The following strategies may help to mitigate the risk of harm from HYDROmorphone. Select the least effective d. 30 mg strategy. 2. HYDROmorphone is to be started at lower doses when a. Adding label reminders on HYDROmorphone administered to all of the following patient populations indicating the brand name equivalent, “DILAUDID,” EXCEPT: to help prevent confusion with other drugs such as a. Elderly patients morphine. b. Separating the storage of look-alike opioids. b. Patients with respiratory diseases (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea) c. Standardize protocols and concentrations for HYDROmorphone. c. Diabetic patients d. Implement redundancies and double checks in the d. Opioid-naïve patients administration process of HYDROmorphone. Vol. 7, No. 3—September 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 75 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 7, No. 3—September 2010. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2010 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 Web site 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 Web An Independent Agency of the Commonwealth of Pennsylvania site 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 nearly 40 years, ECRI Institute marries experience and independence 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.