Spotlight Case

1. Spotlight Case Right Regimen, Wrong Cancer: Patient Catches Medical Error

2. Source and Credits • This presentation is based on the May 2013AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available • Commentary by: Joseph O. Jacobson, MD, MSc, and Saul N. Weingart, MD, PhD, Harvard Medical School • Editor, AHRQ WebM&M: Robert M. 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: • Appreciate that chemotherapy administration is hazardous and challenging • Describe the most common types of errors associated with chemotherapy administration • State why errors may be common when chemotherapy is administered in the inpatient setting • Describe the importance of understanding the chemotherapy administration process and the importance of standardizing it

4. Case: Right Regimen, Wrong Cancer A 48-year-old man with a history of metastatic penile cancer was admitted to an inpatient internal medicine service for his fourth round of chemotherapy. He had three previous uncomplicated admissions where he received a standard protocol of 3 days of paclitaxel, ifosfamide, and cisplatin. The patient received this regimen for 3 days with minimal adverse effects. On hospital day 4, based on his previous admissions for chemotherapy, the patient was expecting to go home.

5. Case: Right Regimen, Wrong Cancer (2) In the morning his bedside nurse for the day came in and stated that she would be giving him his fourth day of chemotherapy. The patient was surprised by this and, before the chemotherapy was administered, asked to speak with the oncology team who was directing his care. After speaking with the patient, the oncology fellow examined the orders in more detail and realized that the incorrect chemotherapy regimen had been ordered for the patient.

6. Case: Right Regimen, Wrong Cancer (3) Rather than the 3-day regimen for metastatic penile cancer, the order set for a higher dose 5-day regimen of paclitaxel, ifosfamide, and cisplatin for germ cell cancer had been ordered. She and the attending oncologist discussed this with the patient and he was discharged later that day with no adverse consequences.

7. Background: Chemotherapy • Chemotherapy administration is among the more hazardous and challenging activities in all of medicine • Chemotherapy can have toxic adverse effects • Oncology teams often work in different areas, hand off patients, and follow complex treatment regimens

8. Background: Errors & Chemotherapy • Surprisingly little evidence on extent or nature of errors in chemotherapy care • Such errors likely comprise only 1.4% to 4% of all medication errors • Error rates generally lower than non-chemotherapy medications • Errors with chemotherapy most commonly occurred in administration (56%) • Many are related to redundant, confusing, or incompletely specified orders See Notes for references.

9. Why Error Rates Are Low • Possibly, oncologists are focused on safety given the vulnerable patient population • Often, as in this case, cancer patients are acute observers of their own care and able to identify and intercept errors before they occur

10. Case: Right Regimen, Wrong Cancer (4) Formal review of the case determined that the outpatient oncologist (a specialist in penile cancers) recommended the appropriate 3-day regimen to the oncology fellow. This medical center had a functioning electronic health record (EHR) and computerized provider order entry (CPOE), but the chemotherapy order sets still existed on paper. In choosing the chemotherapy regimen, the oncology fellow inadvertently chose the wrong paper order set—he saw that the order set included the correct agents but failed to notice the higher dose and incorrect duration.

11. Case: Right Regimen, Wrong Cancer (5) The inpatient attending oncologist, who had not previously met the patient and was less familiar with penile cancer, co-signed the fellow's incorrect orders. Throughout the hospitalization, the primary internal medicine team copied and pasted the original oncology outpatient note, which stated the patient would receive the 3-day course of chemotherapy, even though this differed from the 5-day regimen that was ordered. None of the other safety checks that existed (including the presence of a chemotherapy pharmacist and chemotherapy nurse checking the orders) identified the dose and duration error.

12. Chemotherapy Safety Standards • In 2009, the American Society of Clinical Oncology (ASCO) and the American Nursing Society co-published a comprehensive set of chemotherapy safety standards • Updated in 2012 to focus on the inpatient setting • Divide the chemotherapy administration process into 7 distinct steps See Notes for references.

13. Steps in Chemo Administration • Review clinical information and select regimen • Treatment planning and informed consent • Ordering or prescribing • Drug preparation • Assessing treatment compliance • Administration and monitoring • Response and toxicity monitoring See Notes for references.

14. Inpatient Chemotherapy • There has been a national trend toward more outpatient chemotherapy • Better management of adverse effects, more effective anti-emetics, less toxic agents, improved technology • Has resulted in a disintegration of inpatient oncology services • Fewer dedicated nurses and pharmacists available to manage inpatients receiving chemotherapy See Notes for reference.

15. Inpatient Chemotherapy (2) • Dedicated oncology units staffed by oncologists have been replaced by teams of general internal medicine–trained hospitalist services • The lack of expertise and specialized experience certainly can increase the likelihood of errors • Many practices exist in a hybrid state in which ambulatory chemotherapy is ordered using an electronic system, but inpatient chemotherapy is ordered on paper

16. What Went Wrong in This Case • Error in current case reflected a series of process failures that resulted in ordering the wrong chemotherapy regimen • An Ishikawa diagram can help identify the major categories that contributed to the error (see next slide)

17. Handoffs Knowledge Fellow lack of knowledge about penile Ca regimens Inpatient fellow to inpatient oncology attending Rare cancer: inpatient attending lack of content expertise Outpatient oncologist to inpatient fellow Resident and team attending lack of oncology knowledge Wrong regimen ordered No requirement for outpatient attending to confirm regimen or evident system to guarantee safe handoff No apparent process to confirm that initial order set was correct Chemotherapy administration on a general internal medicine service rather than a subspecialty service ? low volume setting for chemotherapy administration System Care location

18. Failure to Recognize the Wrong Regimen • Numerous factors contributed to the error: • Multiple handoffs • Lack of content expertise by the inpatient fellow and inpatient attending • Lack of supervision by the attending oncologist • Location of the patient on a non-oncology unit

19. Preventing Future Chemotherapy Errors • Most important step hospital can take to prevent future errors is to completely understand the current process for ordering and administering inpatient chemotherapy • Understanding the process could allow for standardization

20. Standardizing Inpatient Chemotherapy • Ways to standardize the process involved with inpatient chemotherapy: • A structured handoff tool and process between the outpatient and inpatient providers • A checklist shared by the inpatient oncologists, nurses, and pharmacists to ensure proper dosing and administration • Structured documentation See Notes for reference.

21. Error in This Case • A standardized process may have prevented this error • Unfortunately, because it arose from a knowledge gap, it is not clear from the case that an electronic order entry system could have prevented the error

22. Take-Home Points • In many hospitals, chemotherapy administration in inpatient setting has become a "high-risk, low volume" procedure in which risk of failure is high. • This chemotherapy error occurred due to the lack of a high reliability framework and an over-reliance on vigilance and thoroughness. • An electronic order entry system would not necessarily have prevented the error. Electronic solutions alone cannot overcome process failures. • Informed patients can catch some errors, as in this case.