Laura J. Haynes, PharmD, BCPS Clinical Pharmacy Specialist, Medication Safety

1. INSTITUTE OF SAFE MEDICATION PRACTICES (ISMP)2016-2017 TARGETED MEDICATION SAFETY BEST PRACTICES FOR HOSPITALS Laura J. Haynes, PharmD, BCPS Clinical Pharmacy Specialist, Medication Safety Hospital of the University of Pennsylvania Department of Pharmacy October 12th, 2016

2. DISCLOSURE • There are no disclosures to report at this time.

3. OBJECTIVES PHARMACIST PHARMACY TECHNICIAN Identify the 2016-2017 ISMP standards associated with high alert medications Understand the reasoning behind the new 2016-2017 ISMP standards Examine the current recommendations as options to consider for implementation into their hospital/practice sites Recognize opportunities for technicians to become involved in implementation from the new ISMP standards reviewed • Identify the 2016-2017 ISMP standards • Understand the literature behind all of the 2016-2017 ISMP standards • Evaluate the current recommendations prepared by ISMP for deficiencies in their practice sites • Find new ISMP standards to execute into their practice site

4. ISMP BACKGROUND

5. Institute of Safe Medication Practices. About ISMP. Available at: http://www.ismp.org/about/default.aspx. Accessed April 20, 2016. HISTORY OF ISMP • Only nonprofit organization devoted entirely to prevention of medication errors and safe use of medications. • Mission - Identify common medication errors, to perform root cause analyses, and to make recommendations to health care providers, health systems, and pharmaceutical industries to reduce medication errors.

6. Institute of Safe Medication Practices. Historical Timeline. Available at: http://www.ismp.org/about/timeline.aspx. Accessed April 20, 2016. HISTORY OF ISMP

7. ISMP RESOURCES Institute of Safe Medication Practices. Learn About Us. Available at: http://www.ismp.org/about/ismp-decade.pdf.Accessed April 20, 2016.

8. TARGETED MEDICATION SAFETY BEST PRACTICES 2016-2017

9. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. 2016-2017 TARGETED MEDICATION SAFETY BEST PRACTICES • Dispense vinCRIStine in a minibag, not syringes • Safe administration and error prevention of oral methotrexate • Record patient weight in kilograms • Dispense oral liquids in unit doses or oral syringes • Oral liquid dosing devices should only display metric units • Eliminate glacial acetic acid from all areas of hospital • Segregate, sequester, and differentiate neuromuscular blocking agents • Administer high-alert IV medications via programmable infusion pumps • All antidotes, reversal agents, and rescue agents must be readily available • Eliminate all 1L bags of sterile water • Appropriate verification techniques when preparing compounded sterile products

10. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 1 • Dispense vinCRIStine (and other vinca alkaloids) in a minibag of a compatible solution and not in a syringe.

11. Clin J OncolNurs 2006;10(2):271-3 ISMP. Fatal Misadministration of IV Vincristine. ISMP Medication Safety Alert! Acute Care 2005. ISSN 1550-6312 Woods K. The Prevention of IntrathecalMedication Errors. London, UK: UK Department of Health. 2001. 1-24. RATIONALE • VinCRIStine has been accidentally administered intrathecally. • When given this route, the results are often fatal. • If patients do survive, they suffer from permanent neurological damage. • This error can occur often since vinca alkaloids are routinely ordered with medications that are administered intrathecally. • By diluting medication into a minibag, errors and confusion with intrathecal syringes can be prevented.

12. Clin J OncolNurs 2006;10(2):271-3. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Vincaalkaloids should be placed into minibags to stop the confusion of syringes. • Minibags should be diluted to 25mL for pediatric patients and 50mL for adults. • Labels should be placed onto bags saying “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES”

13. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 2 • Use a weekly dosage regimen default for oral methotrexate in electronic systems when medication orders are entered. • Require a hard stop verification of an appropriate oncologic indication for all daily oral methotrexate orders. • Provide specific patient and/or family education for all oral methotrexate discharge orders.

14. Methotrexate. Lexi-Drugs. Lexicomp. WoltersKluwer Health, Inc. Hudson, OH. Available at:http://online.lexi.com.  Accessed April 20, 2016. RATIONALE

15. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Incorporate hard stop verification when ordering oral MTX • Default ordering should be weekly dosing • Clarify all daily orders with physicians, especially for patients with no oncologic indication listed • Provide patients with ISMP high-alert medication consumer leaflet • Provide written and verbal instructions regarding MTX • Double check all med lists and discharge instructions

16. ISMP. Methotrextate. Available at: http://www.ismp.org/tools/highalertMedications/methotrexate.pdf Accessed on April 20, 2016.

17. ASSESSMENT Which of the following would NOT be good practices to ensure safe methotrexate usage for patients? • Default electronic ordering for daily methotrexate dosing • Requirement for indication for use within medication order • Education to patients about how to take medication as prescribed • Communicate side effects to patients be aware of when taking methotrexate

18. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 3 • Weigh each patient as soon as possible on admission and during each appropriate outpatient or emergency department encounter. Avoid the use of a stated, estimated, or historical weight. • Measure and document patient weights in metric units only.

19. Emergency Nurses Association. Weighing Patients in Kilograms. 2012. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. RATIONALE • In 2012, the Emergency Nurses Association and the American Academy of Emergency Medicine released a joint statement requesting for weights to be measured only in kilograms. • Emergency rooms have the one of the highest medical error rates. • Additionally, up to 18% of preventable medication errors are due to not having essential information at the time of prescribing, dispensing, and administering medications, such as weight. • Additionally, drug dosing typically uses kilograms to appropriately dose patients.

20. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Remove or replace all scales that cannot weigh patients in kilograms. • In electronic medical records, remove the ability to record weights in pounds. • When speaking to patients, disclose their weight in kilograms.

21. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 4: • Ensure that all oral liquids that are not commercially available as unit dose products are dispensed by the pharmacy in an oral syringe. • Use syringes that either have “Oral Use Only” marked or use an auxiliary stating “Oral Use Only”

22. ISMP. Avoiding Inadvertent IV Injection Of Oral Liquids. 2012. Available at: http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=29. Accessed April 20, 2016. RATIONALE • In 2012, ISMP published “Avoiding Inadvertent IV Injection of Oral Liquids” • It is very easy for nurses to confuse regular syringes and oral syringes. • Although there is an inability to connect oral syringes to the IV port, misadministration still occurs and can cause deleterious effects. • When administering an oral liquid via IV, there is a risk of embolus, infection, and possible presence of unsafe ingredients in the vasculature.

23. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. ISMP. Avoiding Inadvertent IV Injection Of Oral Liquids. 2012. Available at: http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=29. Accessed April 20, 2016. PRACTICE RECOMMENDATIONS • ISMP makes the following suggestions to prevent misadministration of oral liquids: • Use different colored syringes to differentiate between oral syringes and parenteral syringes. • Place auxiliary labels on oral syringes which state “FOR ORAL USE ONLY”. • Purchase syringes that are unable to connect to IV ports. • Commercially available bulk bottles should never be dispensed. • Educate newly graduated nurses about the perils of misadministration of oral liquids.

24. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 5 • Purchase oral liquid dosing devices (oral syringes/cups/droppers) that only display the metric scale. • If patients are being discharged with oral liquids, ensure they receive oral syringes and are educated about measuring medication in mL.

25. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. RATIONALE • “A teaspoon” can be confused and can mean different things to patients. • Can be complicated further if a patient has poor health literacy or does not speak English as their first language • Example: • Augmentin 125mg/5mL - Take 2 teaspoons by mouth every 12 hours

26. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Metric units (such as mL) should be the only measurements used, rather than teaspoons and non-metric measurements. • This jargon should be updated within electronic ordering systems and other electronic systems. • Ensure that prescribers are also prescribing in metric units. • Provide patients with the proper measuring cups or syringes so that they can properly administer oral liquids at home. • Teach patients how to properly use and clean devices. • Ask patients to teach back to you. • For oral liquids, patient weights should be measured and expressed in kilograms.

27. ASSESSMENT Which of the following would be an ISMP recommended measurement unit for medication ordering/dosing/administration? • Pounds (lbs) • Kilograms (kg) • Grains (gr) • Teaspoon/Tablespoons (tsp/tbsp) • Milliliters (mL) • More than one of the above

28. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 6 • Eliminate glacial acetic acid (99.5%) from all clinical areas of the hospital.

29. National Alert Network. WARNING! Severe Burns and Permanent Scarring After Glacial Acetic Acid (>99.5%) mistakenly applied topically. Available at: http://www.ismp.org/NAN/files/20130121.pdf. Accessed on: April 20, 2016. RATIONALE • In January 2013, a warning was issued regarding glacial acetic acid and its ability to cause 3rd degree burns and tissue damage. • This error occurred due to confusing labeling regarding glacial acetic acid.

30. National Alert Network. WARNING! Severe Burns and Permanent Scarring After Glacial Acetic Acid (>99.5%) mistakenly applied topically. Available at: http://www.ismp.org/NAN/files/20130121.pdf. Accessed on: April 20, 2016. PRACTICE RECOMMENDATIONS

31. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 7 • Segregate, sequester, and differentiate all neuromuscular blocking agents (NMBs) from other medications, wherever they are stored in the organization.

32. ISMP. Paralyzed By Mistakes: Preventing Errors with Neuromuscular Blocking Agents. ISMP Medication Safety Alert! Acute Care 2005. Available at: https://www.ismp.org/newsletters/acutecare/articles/20050922.asp. Accessed on April 20, 2016 RATIONALE

33. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Utilize modalities to prevent unintended use • Classify these medications as high alert • Sequester all NMBs away from other medications • Warnings and prompts in electronic ordering systems • Warning labels should beplaced on all vials

34. QUESTION 3 Name a method(s) to reduce errors relating to neuromuscular blocking agents (NMBs). • Store NMBs separate from other medications • Label these medications as high-alert • Place labels and stickers on vials or syringes of medication to avoid confusion • All of the above

35. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 8 • Administer high-alert intravenous (IV) medication infusions via a programmable infusion pump utilizing dose-reduction software.

36. ISMP. ISMP List of High-Alert Medications in Acute Care Settings. Available at: http://www.ismp.org/Tools/institutionalhighAlert.asp. Accessed on April 20, 2016. HIGH ALERT MEDICATIONS

37. ISMP. Smart Pumps Are Not Smart On Their Own. ISMP Medication Safety Alert! Acute Care 2007. Available at: https://www.ismp.org/newsletters/acutecare/articles/20070419.asp. Accessed on April 20, 2016 RATIONALE • ISMP states that high alert medications are have a “heightened risk of causing significant patient harm when used in error.” • In 2007, ISMP published an article, “Smart pumps are not smart on their own”, discussing the limitations of using smart pumps. • Although they can help reduce errors in dosing, they are not fool-proof • Bypassing dosing warnings can lead to serious patient harm and dire consequences

38. https://www.ismp.org/newsletters/acutecare/articles/20070419.asphttps://www.ismp.org/newsletters/acutecare/articles/20070419.asp PRACTICE RECOMMENDATIONS • Create a culture of safety • Ask colleagues to report unsafe behaviors, such as bypassing dose checks. • Ensure that alerts are appropriate and useful • Update dosing and alerts often to ensure that they align with hospital guidelines ISMP. Smart Pumps Are Not Smart On Their Own. ISMP Medication Safety Alert! Acute Care 2007. Available at: https://www.ismp.org/newsletters/acutecare/articles/20070419.asp. Accessed on April 20, 2016

39. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 9 • Ensure all appropriate antidotes, reversal agents, and rescue agents are readily available. • Have standardized protocols and/or coupled order sets in place that permit the emergency administration of all appropriate antidotes, reversal agents, and rescue agents used in the facility. • Have directions for use/administration readily available in all clinical areas where the antidotes, reversal agents, and rescue agents are used.

40. ANTIDOTES & REVERSAL AGENTS

41. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. RATIONALE • There are two major concerns related to antidotes, reversal agents, and rescue agents: • If there is a delay in administration of these agents, there can be fatal consequences to patients. • With incorrect administration (and even proper dosing), these high-alert agents can cause adverse reactions that can also cause harm or be fatal.

42. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Store reversal agents in a safe space where they are readily available, but protected. • Create protocols that allow these medications to be retrieved without prescriber orders • Ensure that directions for use are readily available to avoid delays or improper use

43. ASSESSMENT True or False: Antidotes and reversal agents cannot be accessed without an order from a provideraccordingly to current pharmacy law and The Joint Commission Medication Management Standards. • False

44. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 10 • Eliminate all 1,000 mL bags of sterile water (labeled for “injection,” “irrigation,” or “inhalation”) from all areas outside of the pharmacy.

45. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. ISMP. Hazard Alert! Don’t Give Large Volumes of Sterile Water IV. ISMP Medication Safety Alert! Nurse Advise-ERR 2007. Available at: https://www.ismp.org/newsletters/acutecare/articles/20070419.asp. Accessed on April 20, 2016 RATIONALE • Can cause life threatening hemolysis • 1L bags of sterile water look very similar to 1L bags of normal saline and dextrose. • These can be easily confused and can cause harm to patients.

46. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • ISMP recommends to remove all 1 L bags of sterile water from patient care areas. • Only store in the pharmacy to prevent inadvertent misadministration. • Consider ordering 2 L IV bags instead. • If bags cannot be removed from patient care units, then continual education is key! • Physicians, nurses, and pharmacists need to understand the implications and uses of different IV fluids. • Place large labels on bags that state “NOT FOR DIRECT INFUSION”, “FOR DILUENT USE ONLY”.

47. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. BEST PRACTICE 11 • When compounding sterile preparations, perform an independent verification to ensure that the proper ingredients (medications and diluents) are added, including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container.

48. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. ISMP. Technology and Error-Prevention Strategies: Why are we still overlooking the IV room? ISMP Medication Safety Alert! Acute Care. 2015. Available at: http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=98. Accessed on April 20, 2016 RATIONALE • Even with standards and guidance (USP <797>), there is wide variability between various practices leading to errors. • Errors that occur due to improper sterile compounding can lead to fatalities. • “Syringe pull-back method” cannot detect all errors that may occur with sterile compounding. • This method can overlook: • Wrong medication • Wrong diluent • Wrong container of medication

49. ISMP. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. Available at: http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf. Accessed on April 20, 2016. PRACTICE RECOMMENDATIONS • Per the 2013 ISMP Guidelines for SAFE Preparation of Sterile Compounds, the following recommendations were made:

50. ASSESSMENT Which of the following would NOT be a safe sterile compounding technique? • Purchase pre-mixed IV products when available • Record and verify beyond use dates, calculations, & volumes • Utilize proxy methods, like syringe pull-back method • Document any near-miss errors that may occur • Place drugs, supplies, syringes, etc. to be used in a separate bin for each preparation