ISMP Targeted Medication Safety Best Practices. Christina Michalek, BS, RPh, FASHP

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1 ISMP Targeted Medication Safety Best Practices Christina Michalek, BS, RPh, FASHP

2 Objectives At the completion of this activity, you will be able to: Describe the most and least implemented Best Practices from the lsmp Targeted Medication Safety Best Practices for Hospitals and reported barriers to overcome. List the three new ISMP Targeted Medication Safety Best Practices for Hospitals. Identify the medication safety issues the new Best Practices are designed to help prevent.

3 Disclosure Presentation: ISMP Targeted Medication Safety Best Practices Given by: Christina Michalek, BS, RPh, FASHP I have no financial relationship to disclose, AND I will not discuss off label use and/or investigational use in my presentation.

4 ISMP Best Practices Identify, Inspire, Mobilize adoption of consensus-based best practices Despite repeated warnings these issues continue to cause fatal and harmful errors Reviewed by an external expert panel and approved by the ISMP Board of Trustees

5 NEW Best Practices 12. Eliminate the prescribing of fentanyl patches for opioidnaïve patients and/or patients with acute pain. 13. Eliminate injectable promethazine from the hospital. 14. Seek out and use information about medication safety risks and errors that have occurred in other organizations outside of your facility, and take action to prevent similar errors. New for Image courtesy of samarttiw at FreeDigitalPhotos.net

6 Common Barriers to Implementation Unwillingness to change practice; lack of perceived risk Lack of buy-in from physicians, nurses, organizational leaders and pharmacy staff Limitations of the electronic health record and/or limited information technology support Concerns about workload; takes too much time Space limitations Need perfection in order to implement

7 ISMP Targeted Medication Safety Best Practices Adoption Rates Over Time

8 Best Practice 1 vinca alkaloids DISPENSE VINCRISTINE AND OTHER VINCA ALKALOIDS IN A MINIBAG ONLY 100% 86% 80% 60% 40% 20% 0% 73% 53% 50% 37% 30% 20% 20% 10% 7% 8% 6% Feb 2014 Feb 2016 Oct 2016 July 2017 None Partial Full

9 Best Practice 2a - methotrexate 80% 70% 60% 50% 40% 30% 20% 10% 0% 53% USE A WEEKLY DRUG REGIMEN DEFAULT FOR ORAL METHOTREXATE 19% 28% 27% 30% 43% Feb 2014 Feb 2016 Oct 2016 July % None Partial Full 67% 14% 14% 7% 79%

10 Best Practice 4 dispensing oral liquids NON-U/D ORAL LIQUIDS DISPENSED BY PHARMACY IN ORAL SYRINGE 80% 70% 60% 50% 40% 30% 52% 34% 36% 57% 68% 25% 23% 72% 20% 10% 14% 7% 7% 6% 0% Feb 2014 Feb 2016 Oct 2016 July 2017 None Partial Full Revised for to include use of ENFit syringes Added statement: Bulk oral solutions of medications are not stocked on patient care units

11 Best Practice 5 liquid measuring devices USE ORAL LIQUID DOSING DEVICES IN METRIC UNITS ONLY 80% 70% 60% 50% 40% 30% 20% 10% 0% 72% 53% 44% 39% 36% 17% 17% 17% 11% 11% 8% Feb 2014 Feb 2016 Oct 2016 July 2017 None Partial Full 75% Image courtesy of KEKO64 at FreeDigitalPhotos.net

12 Best Practice 6 glacial acetic acid 100% 80% ELIMINATE GLACIAL ACETIC ACID FROM ALL AREAS OF THE HOSPITAL 74% 75% 94% 94% 60% 40% 20% 0% 28% 12% 13% 8% 5% 1% 4% 2% Feb 2014 Feb 2016 Oct 2016 July 2017 None Partial Full

13 Best Practice 7 neuromuscular blocking agents 70% 60% 50% 40% 30% 20% 10% 0% SEGREGATE, SEQUESTER, DIFFERENTIATE NEUROMUSCULAR BLOCKER STORAGE 54% 27% 19% 19% 34% 57% Feb 2016 Oct 2016 July 2017 None Partial Full Eliminate the storage of neuromuscular blocking agents in areas of the hospital where they are not routinely needed. 9% 21% 70%

14 Best Practice 7 Revised for : Differentiate these products by placing an auxiliary label on all storage bins and final medication containers (e.g., vials, syringes and IV bags) of NMBs that state: WARNING: PARALYZING AGENT-CAUSES RESPIRATORY ARREST-PATIENT MUST BE VENTILATED to clearly communicate that respiratory paralysis will occur and ventilation is required. Exception: Excludes anesthesia-prepared syringes of neuromuscular blocking agents.

15 Best Practice 8- high alert medications and smart infusion pumps 80% 70% 60% 50% 40% 30% 20% 10% 0% ADMINISTER HIGH ALERT IV DRUGS BY SMART PUMP (W/DERS) ONLY 9% 48% 44% 14% 14% 6% 8% Feb 2016 Oct 2016 July % None Partial Full 78% DERS: dose error reduction system

16 Best Practice 10- sterile water bags STORE 1 LITER BAGS OF STERILE WATER IN PHARMACY ONLY 80% 70% 60% 50% 40% 30% 20% 10% 0% 66% 44% 37% 19% 20% 14% 16% 8% Feb 2016 Oct 2016 July 2017 None Partial Full 76%

17 Best Practices with Low Adoption Rates ANTIDOTES, REVERSAL AND RESCUE AGENTS AVAILABLE WITH PROTOCOLS AND INSTRUCTIONS 70% 60% 70% 57% 50% 40% 38% 38% 39% 30% 20% 10% 11% 19% 24% 5% 0% Feb 2016 Oct 2016 July 2017 None Partial Full Best Practice 9

18 Best Practices with Low Adoption Rates VERIFY INGREDIENTS & AMOUNT PRIOR TO ADDITION TO IV BAG 50% 40% 38% 48% 41% 33% 42% 39% 30% 26% 20% 14% 20% 10% 0% Best Practice 11 Feb 2016 Oct 2016 July 2017 None Partial Full

19 Best Practices with Low Adoption Rates Best Practice 3a and 3b

20 Best Practices with Low Adoption Rates HARD STOP VERIFICATION OF DAILY ORAL METHOTREXATE ORDERS FOR ONCOLOGIC INDICATION 60% 50% 40% 30% 20% 53% 19% 28% 34% 36% 30% 47% 18% 35% 28% 30% 42% 10% 0% Feb 2014 Feb 2016 Oct 2016 July 2017 None Partial Full

21 Best Practices with Low Adoption Rates Best Practice 2c

22 Methotrexate: We re Not There Yet Accidental daily dosing intended for weekly administration is still occurring An elderly man with rheumatoid arthritis was admitted to the hospital A physician noticed that the methotrexate the patient took at home was not on the medication list The physician added it, but documented it as twice daily instead of twice weekly A pharmacist identified the mistake and corrected it The home medication list remained unchanged Upon discharge, it was ordered daily A little over a week later the man presented to the hospital with severe neutropenia, mucositis, and a mental status change

23 Focus for Due to low rates of compliance, ISMP is asking hospitals to focus on these existing best practices: 2b: Clarifying daily orders for oral methotrexate 2c: Improve discharge education for patients receiving oral methotrexate 3a: Obtaining an actual patient weight 3b: Weighing and documenting weights in metric units 9: Antidotes/reversal/rescue agents available w/protocols & instructions 11: Verifying ingredients & amount prior to addition to IV bag when sterile compounding

24 New ISMP Best Practices

25 FentaNYL transdermal ISMP continues to receive errors reports (including fatalities) due to prescribing, dispensing, and administration of fentanyl patches GOAL: prevent death and serious harm from inappropriate use Use only in patients: who are opioid tolerant with persistent, moderate-to-severe chronic pain requiring continuous, around-the-clock opioid administration for an extended period of time that cannot be managed by other means Opioid tolerant may be defined by the following markers: Patients receiving, for 1 week or longer: 60 mg oral morphine/day; 25 mcg transdermal fentanyl/hr; 30 mg oral oxycodone/day; 8 mg oral HYDROmorphone/day; 25 mg oral oxymorphone/ day; 60 mg oral HYDROcodone/day; or an equianalgesic dose of another opioid, including heroin and/or non-prescribed opioids.

26 Case Reports US FDA signals in ,890 reports of serious injury with fentanyl patches 61% of these were medication errors Prescribing errors Patient application errors Accidental exposure by children or caregivers (this has led to fatalities) Patient admitted through the emergency department; patient s home medication list includes fentanyl 100 mcg patch; the patch was ordered to continue on admission Pharmacist review of the patient s medication history identified that the patient had not used fentanyl patches in the prior 4 months At the pharmacist s request, nursing confirmed that the patient was not wearing a patch; the order was discontinued Several examples of fentanyl patches being used to treat acute pain

27 New Best Practice 12 Eliminate the prescribing of fentanyl patches for acute pain and in opioid-naïve patients. Ensure the organization has a process in place to routinely document the patient s opioid status (naïve versus tolerant) and type of pain (acute versus chronic) in the health record or prescriber orders. Ensure there is an implemented process to prevent or verify orders for fentanyl patches in patients who are opioid-naïve or with acute pain. Examples include: use of hard stops, alerts, automatic interchange, and pharmacy interventions with prescribers. Eliminate the storage of fentanyl patches in automated dispensing cabinets or as floor stock in clinical locations where acute pain is primarily treated (for example, in the emergency department, operating room, post-anesthesia care unit, in procedural areas).

28 Promethazine injection ISMP first brought attention to this serious issue in in 5 practitioners surveyed reported awareness of an occurrence in their facility within the past 5 years US FDA added stronger boxed warning calling attention to possibility of gangrene and subsequent amputation when promethazine was unintentionally injected into an artery GOAL: eliminate the risk of serious tissue injuries and amputations from the inadvertent arterial injection or IV extravasation of injectable promethazine

29 Case Reports A 19 year old woman presented to an emergency department with flu-like symptoms and was given IV promethazine to treat nausea; during the injection she yelled out in pain, the patient s arm and fingers became purple and blotchy A physician reported seeing a patient who presented with extreme pain and gangrene of two digits after receiving an IV injection of promethazine at another hospital A patient sustained serious tissue injury and thrombophlebitis after receiving IV promethazine via a peripheral vein in the hand Several years prior to this event, the organization s Pharmacy and Therapeutics Committee attempted to remove promethazine from formulary; however, one physician voiced loud opposition, therefore, it remained available for use

30 New Best Practice 13 Eliminate injectable promethazine from the hospital. Remove injectable promethazine from all areas of the hospital including the pharmacy. Classify injectable promethazine as a non-stocked, non-formulary drug. Implement a medical staff-approved automatic therapeutic substitution policy to convert all injectable promethazine orders to another antiemetic. Remove injectable promethazine from all computerized medication order screens and order sets and protocols.

31 Learning from Others and Taking Action Déjà vu - the feeling of already having lived something/feeling of recollection One of the most important ways to prevent errors is to learn about problems from others and use that information to prevent similar problems at your practice site Experience has shown that medication errors reported in one organization is also likely to occur in another GOAL: Use information about external errors to identify, prevent, and minimize harm from similar events

32 Case Reports We have all heard about tragic medication events Our initial reactions: surprise, sadness, anxious, unsettled, angry Trade initial feelings with reasoning that these are irrelevant to my site Why? False beliefs Good outcomes are result of skill; bad outcomes bad luck We see mistakes as personal flaws of others which we don t have ourselves We tend to be over optimistic (or overconfident) in our abilities and systems when considering our own vulnerability to the error

33 New Best Practice 14 Seek out and use information about medication safety risks and errors that have occurred in other organizations besides your own, and take action to prevent similar errors. Appoint a single health care professional (preferably a medication safety officer) to be responsible for oversight of this entire activity in the hospital. Establish a formal process for monthly review of medication risks and external errors with a new or existing multidisciplinary team or committee responsible for medication safety. Determine appropriate actions to be taken to minimize the risk of these types of errors occurring in the hospital. Document the decisions reached, gain approval for necessary resources as necessary, and begin implementation. Once implemented, periodically monitor the actions selected to ensure they are still being implemented and are effective in achieving the desired risk reduction. Widely share the results and lessons learned within the facility.

34 Additional Literature/References References used to develop the ISMP Targeted Medication Safety Best Practices for Hospitals can be found in the Tools and Resources, Guidelines section of the ISMP website: Additional information related to high-alert medications included in the ISMP Medication Safety Self Assessment for High-Alert Medications can be found in the Tools and Resources, Self Assessments section of the ISMP website: A Call to Action: The Case for Medication Safety Officers (MSO) provides additional information related to recommendations for implementing new Best Practice 14. The document is available on the ISMP website:

35 Questions?

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