Opioid Adverse Drug Event Prevention Gap Analysis Component of Mediation Management Assessment Speifi Ation(s) Speifi Ation plan(s) inluding persons responsible and timeline to omplete. Prevention and Mitigation Strategies 1) Systems and proesses for opioid monitoring praties The faility has proesses in plae to eliminate errors in opioid storage, preparation, and dispensing, whih inlude: 1a) Strategies to prevent errors aused by mixing up onentrated and dilute oral liquid narotis. 1b) Standardizing the hoies of epidural infusions per organization/servie line and minimizing the formulary. 1) Established dose equivaleny onversion tools are readily available and utilized. 1d) Established pediatri dose guidelines are widely available and utilized. N/A: 1e) Pediatri dose guidelines are inorporated into the eletroni health reord. N/A: 1f) Pediatri dosage forms are separated from adult dosage forms. N/A: 1g) An independent double hek (two liensed providers) is performed for all naroti infusions prepared in the pharmay. A pharmaist or pain provider provides oversight for all dosing of: 1h) Methadone. 1i) Fentanyl pathes (at mediation initiation only). 1j) Transmuosal immediate release fentanyl pathes (TIRFs) (at mediation initiation only). 2) Management presribing praties The faility s opioid praties learly speify the following: 2a) Opioids are not used to treat anxiety. 2b) Meperidine use is minimized or eliminated. 2) Opioid administration is not routinely aompanied by sedatives or antiholinergi drugs suh as hydroxyzine. 2d) Opioid dose ranges do not exeed 4x (four times) the original dose. (Consider limiting to 2x the original dose.) Page 1 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.
Speifi Ation(s) Speifi Ation plan(s) inluding persons responsible and timeline to omplete. 2e) Intramusular (IM) opioid use is minimized. 2f) Oxygen is used only if therapeutially neessary and only upon a physiian order. 3) Management administration and monitoring praties The faility has opioid administration and monitoring pratie guidelines in plae, whih inlude: 3a) Vital signs monitoring, inluding pain, is defined for all linial situations (oral narotis, patient-ontrolled analgesia [PCA], epidural, IV injetion). 3b) Continuous pulse oximetry for all patients (exluding end-of-life patients) reeiving IV narotis. 3) Capnography monitors are used when patient is reeiving supplemental oxygen (exluding end-of-life patients) and reeiving IV naroti infusion, epidural, PCA, or frequent IV naroti injetions. 3d) Monitor alarms an be heard at the nursing station for pulse oximetry and apnography and annot be turned off. 3e) Monitor alarms automatially default to hospital-defined thresholds. 3f) Where appropriate, only dose forms that are needed for starting doses are available as override items in automated dispensing abinets (e.g., morphine 2 mg syringes are available but 4 mg syringes are not available on override). 3g) Nursing pratie guidelines address how and when to transition opioid therapy (e.g., PCA to oral: If patient is not NPO [nothing by mouth] and is able to tolerate, oral pain mediations are used). 4) Management infusion praties The faility has safety mehanisms in plae for epidural opioid infusion proesses whih ensure: 4a) Epidural pumps are used only for epidural infusion therapy. 4b) Epidural tubing is pre-onneted in pharmay when possible, and is inompatible with non-epidural pumps. 4) Epidural bags and bottles are learly differentiated from IV infusions or piggybaks. The faility uses smart infusion pumps with drug libraries for the IV administration of all opioids (inluding PCA and epidural infusions), with funtionality employed to: 4d) Interept and prevent wrong dose errors. 4e) Interept and prevent wrong infusion rate errors. The faility s nursing pratie inludes a proess to double hek opioid pump programming: 4f) At the start of their shift. Page 2 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.
Speifi Ation(s) Speifi Ation plan(s) inluding persons responsible and timeline to omplete. 4g) With new naroti infusion and PCA starts. 4h) With setting hanges initiation of bag, bag hange, and shift hange. Assessment and Detetion Strategies 5) Management handoffs and transitions The faility has a post-anesthesia are unit (PACU) disharge proess in plae to ensure patient is stable upon transfer whih inludes: 5a) Holding patients in PACU for at least 15 minutes following naroti dose. 5b) Holding patients until safely leared for transport ( at least 30 additional minutes) if naloxone administered in operating room (OR) or PACU. A standard hand-off/transition ommuniation proess is in plae for all patients reeiving opioids whih inludes the following information, at minimum: 5) History of snoring, obesity, and sleep apnea. 5d) Drug and dose history for the previous shift. 6) Management over-sedation management praties A protool is followed whih guides the reversal of opioids and inludes the following: 6a) Reversal protools are ative on all patients mediation administration reords (MARs) if there is an ative order for a naroti. 6b) Nurses are allowed to administer reversal agents without prior physiian order. 6) Strategies are in plae to guard against dose staking. 6d) The faility utilizes a rapid response team to assist with possible naroti oversedation events. If an oversedation event ours, the faility has a learning proess in plae whih inludes: 6e) All oversedation events are reviewed by expert staff members and analyzed to identify improvement opportunities. 6f) A root ause analysis is ompleted any time the use of a reversal agent results in a transfer to a higher level of are. 6g) Data are olleted and widely available on the rate of naloxone-reversal oded as an adverse drug event. 6h) Colleting and reviewing data to assess ompliane with dose guidelines and monitoring requirements. Page 3 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.
Speifi Ation(s) Therapeuti Strategies Speifi Ation plan(s) inluding persons responsible and timeline to omplete. 7) Management therapeuti praties The faility has standard poliies and praties in plae for managing the initiation and maintenane of opioid therapy whih inlude: 7a) Identifying the need for a onsultative pain assessment by a qualified pain pratitioner (e.g., pain management physiian, nurse pratitioner, linial pharmay speialist, or linial nurse speialist [CNS] foused on pain.) 7b) Defining and identifying if patient is opioid tolerant vs. opioid naïve. 7) Reviewing of onomitant mediations prior to presribing opioids. 7d) Colleting a history of snoring, obesity, and sleep apnea. 7e) Conduting a full-body skin assessment of patients prior to administering a new opioid to rule out the possibility that the patient has an applied fentanyl path or implanted drug delivery system or infusion pump. 7f) Guidelines to address how and when to supplement opioid doses when range orders are used. 7g) Dosing and frequeny of opioids in proedural areas suh as endosopy. 7h) Standardized pain order sets within linial praties/ speialties (e.g., orthopedis, vasular surgery, onology, labor and delivery, et.). 7i) PCA and patient-ontrolled epidural analgesia (PCEA) orders prohibit the routine use of basal dosing in the opiate naïve patient. Pratie guidelines for morphine inlude: 7j) Starting doses of IV push morphine do not exeed 2 mg IV morphine equivalent in the opiate naïve adult patient. 7k) Titration guidelines for appropriate and safe linial response. Pratie guidelines for hydromorphone inlude: 7l) Starting doses of IV push hydromorphone do not exeed 0.4 mg in the opiate naïve adult patient. 7m) Titration guidelines for appropriate and safe linial response. 7n) Pharmay repakages hydromorphone into 0.2, 0.4, or 0.5 mg syringes. 7o) The faility s renal opioid dosing program inludes morphine, meperidine (if used), and oxyodone. Page 4 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.
Speifi Ation(s) Speifi Ation plan(s) inluding persons responsible and timeline to omplete. 8) Management pain management praties The faility has a pain management proess in plae, whih inludes: 8a) A pain management speialist is available for onsultation, either onsite or external, whih provides mentoring as well as speifi onsults. 8b) A pain mediation stewardship program is in plae (e.g. proesses for identifiation and implementation of best praties, daily monitoring of adherene to best praties, plan for intervention of deviation from best praties, proesses for monitoring patient pain management satisfation sores). 8) Standardized pain assessment sales are used throughout the faility. 8d) There is a proess in plae to disuss and agree upon speifi pain goals and strategies with the patient prior to a surgial proedure. The faility has pratie guidelines in plae for appropriate use of tatis to redue opioid use, whih inlude: 8e) Non-naroti mediations (e.g., NSAIDs, aetaminophen, regional infusions of loal anesthetis, steroids, gabapentinoids, et.) are routinely used as a tati to redue opioid administration on the patient are units. 8f) Non-pharmaologi therapy (e.g., healing touh, massage, musi, guided imagery, aromatherapy, et.) is offered and maximized, when possible, as tatis to redue opioid administration. Critial Thinking and Knowledge Strategies 9) Implement appropriate ritial thinking and knowledge strategies The faility provides interdisiplinary eduation on opioid therapy, whih inludes: 9a) Initial training for new hires and existing staff members, inluding protools and guidelines. 9b) Post test inorporating a ase-study approah to demonstrate profiieny; overs topis suh as dose staking, dose equivaleny, interpretation of vital signs, and monitoring equipment. 9) Plan for targeting gaps in knowledge. 9d) Ongoing opioid eduation is provided when new relevant information is available. Page 5 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.
Speifi Ation(s) Patient Eduation Speifi Ation plan(s) inluding persons responsible and timeline to omplete. 10) Provide patient and family eduation When initiating opioid therapy, patients/aregivers reeive verbal and written information on purpose, ation, side effets, and monitoring, inluding: 10a) The various generi and brand names, formulations, and routes of administration of opioids in order to prevent onfusion and redue the aidental dupliation of opioid presriptions. 10b) The prinipal risks and side effets of opioids (e.g., onstipation, the risk of falls, nausea, and vomiting). 10) The impat of opioid therapy on psyhomotor and ognitive funtion (whih may affet driving and work safety). 10d) The potential for serious interations with alohol and other entral nervous system depressants. 10e) The potential risks of tolerane, addition, physial dependeny, and withdrawal symptoms assoiated with opioid therapy. 10f) The speifi dangers as a result of the potentiating effets when opioids are used in ombination, suh as oral and transdermal (fentanyl pathes). 10g) The safe and seure storage of opioid analgesis in the home. This Material was adapted by Health Servies Advisory Group, the Mediare Quality Improvement Organization for Arizona, California, Florida, Ohio, and the U.S. Virgin Islands, under ontrat with the Centers for Mediare & Mediaid Servies (CMS), an ageny of the U.S. Department of Health and Human Servies, from material originally prepared by Minnesota Hospital Assoiation. 2012/2013 Minnesota Hospital Assoiation. Used with permission. The ontents presented do not neessarily reflet CMS poliy. Publiation No. AZ-11SOW-C.3-07062015-02 Page 6 Opioid Adverse Drug Event Prevention Gap Analysis Component of the Mediation Management Assessment 2012 Minnesota Hospital Assoiation. Used with permission.