Spotlight Case

1. Spotlight Case Multifactorial Medication Mishap

2. Source and Credits • This presentation is based on the February 2014AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available • Commentary by: Annie Yang, PharmD, BCPSNYU Langone Medical Center • Editor, AHRQ WebM&M: Robert Wachter, MD • Spotlight Editor: Bradley A. Sharpe, MD • Managing Editor: Erin Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Understand the system-based causes of medication errors • Describe a model for a systems approach to error analysis • Identify weaknesses or failures in key elements of the medication-use system • Select effective risk-reduction strategies to prevent medication errors

4. Case: Multifactorial Medication Mishap A previously healthy 50-year-old man was hospitalized while recovering from an uncomplicated spine surgery. Although he remained in moderate pain, clinicians planned to transition him from intravenous to oral opioids prior to discharge. The patient experienced nausea with pills but told the bedside nurse he had taken liquid opioids in the past without difficulty. The nurse informed the physician that the patient was having significant pain and liquid opioids had been effective in the past.

5. Case: Multifactorial Medication Mishap (2) When the physician searched for liquid oxycodone in the computerized prescriber order entry (CPOE) system, multiple options appeared on the list: two formulations for tablets and two for liquid (the standard 5 mg per 5 mL concentration and a more concentrated 20 mg per mL formulation). At this hospital, the CPOE system listed each choice twice, one entry with the generic name and one entry with a brand name. In all, the physician saw eight different choices for oxycodone products. The physician chose the concentrated oxycodone liquid product and ordered a 5 mg dose.

6. Case: Multifactorial Medication Mishap (3) At this hospital, all medication orders had to be verified by a pharmacist. The pharmacist recognized that the higher concentration was atypical for inpatients but assumed it was chosen to limit the volume of fluid given to the patient. To minimize the risk of error, the pharmacist added a comment to both the eMARand the patient-specific label that the volume to be given was 0.25 mL (5 mg). For added safety, the pharmacist personally retrieved, labeled, and delivered the drug and a calibrated syringe to the bedside nurse to clarify that this was a high concentration formulation for which the volume to administer was 0.25 mL (a smaller volume than would typically be delivered).

7. Case: Multifactorial Medication Mishap (4) Shortly thereafter, the nurse administered 2.5 mL (50 mg) of the liquid oxycodone (a volume she was more used to giving) and then left for her break. A covering nurse checked on the patient and found him unconscious—a code blue was called. The patient was given naloxone (an agent that reverses the effect of opioids) and responded well. He was transferred to the intensive care unit for ongoing monitoring and an infusion of naloxone. By the following morning, the patient had returned to his baseline with no apparent adverse effects.

8. Background Medication errors in the hospital are all too common Medication errors are rarely caused by failure of a single element or a single practitioner For example, a root cause analysis of a fatal medication error identified multiple contributing factors and more than 15 suggested changes

9. Systems Approach to Medication Errors The goal of a systems-based analysis of errors is to identify system failures The Institute for Safe Medication Practices (ISMP) has identified 10 key system elements that have the greatest influence on safe medication use (see next slide) This framework can be used to analyze medication errors (as in this case)

10. ISMP Key Elements Patient information Drug information Communication of drug information Drug labeling, packaging, and nomenclature Drug standardization, storage, and distribution Medication device acquisition, use, and monitoring Environmental factors, workflow, and staffing Staff competency and education Patient education Quality processes and risk management

11. Developing Risk-Reduction Strategies • Identifying errors in system may indicate where changes need to be made • There are two objectives of safe system design: • Make it difficult for providers to make mistakes • Permit the detection and correction of errors before harm occurs

12. Developing Risk-Reduction Strategies (2) Error-reduction strategies can range from low-level (“weak”) to higher-leverage (“strong”) strategies “Weak” interventions such as simply telling the nurse to read the label and eMAR more carefully or the physician to “be more careful” using CPOE are often ineffective “Strong” strategies create lasting change in the system

13. Developing Risk-Reduction Strategies (3) • Examples of higher-leverage (“strong”) strategies include: • Fail-safes (e.g., prevent malfunctioning or unintentional operation by reverting back to a safe state if failure occurs) • Constraints (e.g., restrict access to medications that require special handling or training) • Forcing functions (e.g., procedures that create a “hard stop” during a process)

14. System-Based Analysis • Rigorous analysis of medication errors should use the ISMP model (see slide 10) • Applying the framework to this case reveals numerous failures and possible solutions • Patient information • Both pharmacist and physician were likely unaware of key patient information such as his specific opioid-use history • Solution: • Institutions should ensure information about diagnoses, allergies, and adverse reactions to medications is available

15. System-Based Analysis (2) • Drug Information • All three providers lacked pertinent drug information to make safe decisions • Physician was unaware that liquid oxycodone comes in two concentrations and pharmacist was unaware that the concentrated product was not appropriate for an opioid-naïve patient • Solutions: • A pain order set or protocol for when a patient is ready for escalation to more potent pain medications • Prescribing of certain medications could be limited to specialized practitioners (e.g., a pain specialty)

16. System-Based Analysis (3) • Communication of Drug Information • The list of choices for oxycodone in the CPOE system was confusing • Pharmacist and prescriber did not communicate to clear up confusion • Solutions: • When new products are added to the formulary, the user interface should be examined closely • If medications are restricted to certain patient populations, it should be reflected in CPOE system

17. System-Based Analysis (4) • Drug Standardization, Storage, and Distribution • The way the medications were stored and distributed clearly contributed to the error in this case as well • Solutions: • Pharmacies should dispense medications in most ready-to-use form to minimize manipulation by nurse • Ideally, pharmacies should dispense liquid medications in unit-dose cups or oral syringes

18. System-Based Analysis (5) • Staff Competency and Education • It is not clear if physician, pharmacist, and nurse had adequate training on optimal, safe use of opioids for acute pain • According to one study, providers at all levels had a weak understanding of safe opioid use • Solutions: • Organizations should assess staff knowledge of safe opioid prescribing and educate where necessary

19. System-Based Analysis (6) • Patient Education • Although not discussed directly in case, the patient may not have been aware of the medication he was taking • Solutions: • Patients and families should be empowered to ask questions about their medications and their purpose

20. System-Based Analysis (7) • Quality Processes and Risk Management • More robust quality control processes may reduce likelihood of this type of error • Independent double-checks can detect up to 95% of errors • Solutions: • Organizations should use errors and near-misses to identify systems issues • Proactive risk-assessment tools such as failure mode and effects analysis (FMEA) may help

21. This Case • This case highlights the multiple systems failures. A few key factors include: • Absence of prescribing criteria for and restriction of oxycodone • Lack of standard dispensing practice that minimized manipulation • Need for staff education and guidance on high-risk medications

22. Summary In medication errors such as this, the ISMP Key Elements framework should be used When designing changes, systems should adopt high-leverage (“strong”) interventions when possible

23. Take-Home Points Medication errors are multifactorial; they are rarely due to only one failure mode or individual When analyzing medication errors, employ a systems approach by identifying weaknesses throughout the medication-use system When choosing risk-reduction strategies to implement, focus on those that do not rely on human vigilance or memory Whenever new medications, processes, and services are implemented, use proactive risk assessment tools to prevent errors