Spotlight Case

1. Spotlight Case One Toxic Drug Is Not Like Another

2. Source and Credits • This presentation is based on the February 2011 AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available • Commentary by: Eric S. Holmboe, MD, American Board of Internal Medicine • Editor, AHRQ WebM&M: Robert Wachter, MD • Spotlight Editor: John Q. Young, MD, MPP • Managing Editor: Erin Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Distinguish between the three distinct regulatory processes of board certification, medical licensure, and credentialing. • Appreciate how emerging maintenance of certification and licensure processes address physician competence and patient safety. • Understand limitations of physician self assessment of competence and the important role for external feedback and guidance.

4. Case: One Toxic Drug A 50-year-old man was diagnosed with chronic hepatitis C (viral load of 2,500,000 IU/mL) by his internist, who also was an oncologist. The physician was familiar with chemotherapeutic agents, and decided to treat this patient's hepatitis C virus (HCV) without referring him to a hepatologist. He saw the patient in the hospital's outpatient oncology unit. The physician started treatment with weekly injections of Pegylated Interferon (also used for some cancers) and daily oral Ribavirin.

5. This Case: Set-up for Error • Experienced physician in a different discipline • Familiar and comfortable with same toxic, high-risk medications required for this patient • Believes familiarity with indicated medications qualifies him to treat condition outside his primary scope

6. When outside one’s usual scope of practice … • Importance of ‘evaluation’ before initiating action: identify and remedy gaps in one’s understanding of patient’s condition, including treatment • Especially important for more experienced physicians, who may be overly confident in their knowledge base See Notes for references.

7. Physician Self Assessment: Challenges • Physicians do not accurately assess their own performance, especially when done in isolation • Incorporating external data and feedback improves the accuracy of physician self assessment • Effective self assessment is a complex task that requires time, skill, and often guidance from others See Notes for references.

8. Regulatory Processes: Credentialing • Usually a local process • Determines the privileges and scope of practice for the physician at a hospital or health plan • A physician most often requests privileges to a credentialing committee that makes the final determination

9. Regulatory Processes: Licensure • State-level process in the United States • Mandatory requirement for medical practice • Requirements vary from state to state • Not specialty specific in the US

10. Regulatory Processes: Certification (1) • Technically a voluntary process • Requires completion of an ACGME-approved training program and passage of a secure examination • Specialty-specific process • Most hospitals and health plans require certification as condition for employment or participation

11. Regulatory Processes: Certification (2) • Now time-limited with maintenance of certification (MOC) requirements in all specialties • MOC requires MD to self assess knowledge, evaluate performance, and pass exam every 10 years • ABIM’s practice improvement modules: Web-based tools for ongoing learning

12. Case: One Toxic Drug (2) Prior to therapy, the physician did not refer the patient for a liver biopsy nor a hepatitis C genotype, baseline CBC, or TSH. After 6 weeks of therapy, the HCV viral load was unchanged, and the patient exhibited pancytopenia. The physician responded by decreasing the Interferon dose to every 2 weeks but continued the Ribavirin at full dose. He didn’t obtain a viral load at 12 weeks. After 9 months of treatment, a viral load was repeated and was again found to be more than 2,000,000 IU/mL. Treatment was continued without change.

13. Case: One Toxic Drug (3) A few months later, the insurance company denied the hospital bill, and the medical director for case management was asked to prepare an appeal letter. In drafting it, the medical director realized that this patient’s care didn’t comport with HCV treatment guidelines. The improper care included: (i) no liver biopsy to see if the patient met the criteria for treatment; (ii) no genotype performed to help guide length of therapy; (iii) no baseline labs to see if the patient’s pancytopenia was preexisting or due to the medications; and (iv) no 12-week viral load to assess response.

14. Case: One Toxic Drug (4) Moreover, when the patient was found to have pancytopenia, Interferon was decreased to every other week rather than reducing the Ribavirin dose or continuing the Interferon at half strength weekly dosing, as per guidelines. When the viral load at 9 months showed no response, treatment was continued, exposing the patient to a toxic medication with little possibility of benefit.

15. Case: One Toxic Drug (5) Concerned for the patient’s safety and well being, the medical director instructed the clinic staff to discontinue the Interferon and insisted that the physician refer the patient to a hepatologist.

16. Consequences • Failure to recognize gaps in competence can result in patient harm • This case highlights the critical importance of ongoing assessment of MDs • Professional imperative: seek external guidance and input when practice outside defined or usual scope See Notes for references.

17. Certification Processes: Importance • Identify MDs with poorer levels of care • Help MDs identify and address gaps in competence • Challenge: improved methods for ongoing practice based assessment and learning See Notes for references.

18. Emerging Trends in MOC Processes • More continuous • Programs for specific focus (e.g., hospital medicine) within a specialty (e.g., internal medicine • More efficient and effective methods for self assessment • Alignment with future changes in maintenance of licensure See Notes for references.

19. Take-Home Points • All physicians must learn to question their own abilities and recognize when they may be moving outside their range of competence. • Colleagues must speak up when they see a peer providing potentially dangerous care, especially if that care appears to be out of scope of normal practice.

20. Take-Home Points (2) • All physicians need to routinely and regularly engage in self-directed assessment activities. • Maintenance of certification programs provide a systematic and robust mechanism to engage in meaningful self-directed assessment.