Safe Practices for Medication Safety and Communicating Critical Test Results in Physician Offices

1. Safe Practices for Medication Safety and Communicating Critical Test Results in Physician Offices/Ambulatory Settings Tejal K. Gandhi, MD MPH Director of Patient Safety Brigham and Women�s Hospital Massachusetts Medical Society February 12, 2004

2. Goals Discuss outpatient medication error and ADE rates Rates Strategies for prevention Discuss tracking and follow-up of outpatient test results Strategies for prevention

3. What is Different About Ambulatory Care? Long feedback loops Episodic (from provider perspective) Signal to noise ratio is low Widely distributed Limited resources, redundancy Patients and providers have many degrees of freedom

4. The Primary Care Encounter Average encounter 12 minutes Average time to first interruption--18 seconds 75% of patients leave with unanswered questions Little time to do all that needs to be done 75% of office visits to PCPs associated with initiation or continuation of a drug 48% of medication-related claims are in outpatients

5. Research Issues Ambulatory setting harder to study Therapy not directly observed Non-compliance issues Injuries not directly observed Injuries often not reported by patients Few data available on impact of outpatient computerized prescribing on errors

6. How common and serious are medication errors and ADE�s in the ambulatory area? Data from The Commonwealth Fund 2001 Health Care Quality Survey Nationally, the 22% error rate translates into an estimated 22.8 million people with at least one family member who experienced a mistake or were given wrong medication/wrong dose Data from The Commonwealth Fund 2001 Health Care Quality Survey Nationally, the 22% error rate translates into an estimated 22.8 million people with at least one family member who experienced a mistake or were given wrong medication/wrong dose

7. Ambulatory Drug Complications 18 percent of outpatients who had been prescribed a medication reported a complication. Of those, 48 percent sought medical attention and 5 percent with an ADE were hospitalized. One recent cross-sectional chart review and patient care survey found an adverse drug event (ADE) rate of 3% in adult primary care outpatients, and other evidence shows serious consequences including patient death as well as a sizable number of admissions to inpatient facilities and increases in emergency departments and physician office visits, all directly linked to ambulatory ADEs. Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, et.al. Drug complications in outpatients. Journal of General Internal Medicine. 2000;15:149-154. 18 percent of outpatients who had been prescribed a medication reported a complication. Of those, 48 percent sought medical attention and 5 percent with an ADE were hospitalized. One recent cross-sectional chart review and patient care survey found an adverse drug event (ADE) rate of 3% in adult primary care outpatients, and other evidence shows serious consequences including patient death as well as a sizable number of admissions to inpatient facilities and increases in emergency departments and physician office visits, all directly linked to ambulatory ADEs. Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, et.al. Drug complications in outpatients. Journal of General Internal Medicine. 2000;15:149-154.

8. Drug Complications (cont.) Clinical correlates of complications: Number of medical problems Number of medications Renal disease Non-clinical correlates Failure to have side effects explained Primary language other than English or Spanish Lower medication compliance

9. The Improving Medication Prescribing (IMP) Study (RMF) One participant from an ambulatory clinic associated with a Boston teaching hospital found that in 38% of ameliorable ADEs the patient failed to inform the physician of medication side effects and symptoms experienced, and in 62% of the cases the physician failed to act on the results of symptom monitoring and side effects experienced. Report by Tejal Gandhi to Coalition Ambulatory Medication Safety Consensus Group One participant from an ambulatory clinic associated with a Boston teaching hospital found that in 38% of ameliorable ADEs the patient failed to inform the physician of medication side effects and symptoms experienced, and in 62% of the cases the physician failed to act on the results of symptom monitoring and side effects experienced. Report by Tejal Gandhi to Coalition Ambulatory Medication Safety Consensus Group

10. The Improving Medication Prescribing (IMP) Study (RMF) Of 51 ameliorable adverse drug events: 63% of events - physician failed to act on medication related symptoms 37% of events - the patient failed to inform the physician of symptoms Of 20 preventable adverse drug events 9 due to inappropriate drug (including interaction & allergy) 2 wrong dose 2 wrong frequency of use Most due to prescribing errors

11. Types of ADEs ADEs Preventable ADEs CNS 33% 35% GI 22% 25% Cardiac 18% 18% Allergic/Derm 8% 6%

12. Medications and ADEs ADEs Preventable ADEs (n=182) (n=71) SSRIs 18 (10%) 12 (17%) Beta blockers 16 (9%) 8 (11%) ACE inhibitors 15 (8%) 8 (11%) NSAIDs 15 (8%) 7 (10%) Ca channel blockers 12 (7%) 8 (11%)

13. Results: Prevention More advanced computer prescribing checks with decision support would have prevented many more events 95% of potential ADEs Majority of prevention from complete prescriptions, drug-dose, and drug-frequency checking

14. Results: Prescription Review 1879 prescriptions reviewed Medication errors 143 (7.6%) Potential ADEs 62 (3%) Life threatening 1 (2%) Serious 15 (24%) Significant 46 (74%) Computerized sites had significantly fewer medication errors

15. Study Conclusions The medication error rate for outpatient prescriptions was 8% 25% of patients reported ADEs Basic computerized prescribing systems Reduced rates of medication errors Advanced decision support has even greater potential Monitoring for and acting upon ADE symptoms was unexpectedly important

16. Incidence and Preventability of ADE�s Among Older Persons in the Ambulatory Setting ARTICLE CITATION: Gurwitz JH, et. al. Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting. JAMA. March 5, 2003;289(9):1107-1116. Comparison of this to inpatient (Bates JAMA 1995) but for all, not just preventable: 1% fatal 12% life thre 30% serious 28% preventable Comparison to Gurwitz nursing home: 1 fatal 6% life threatening 38% serious 56% significant ARTICLE CITATION: Gurwitz JH, et. al. Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting. JAMA. March 5, 2003;289(9):1107-1116. Comparison of this to inpatient (Bates JAMA 1995) but for all, not just preventable: 1% fatal 12% life thre 30% serious 28% preventable Comparison to Gurwitz nursing home: 1 fatal 6% life threatening 38% serious 56% significant

17. In what phase do preventable errors occur? Errors associated with preventable ADEs 58.4% prescribing 60.8% monitoring 21.1% adherence More serious events are more likely to be preventable (42% vs. 19% of significant)

18. Preventable ADE�s Prescribing stage Wrong drug/wrong therapeutic choice 27% Wrong dose 24% Inadequate patient education 18% Drug-drug interaction 13% Monitoring stage Failure to act on available information 36.6% Inadequate monitoring 36.1%

19. Admissions Due to ADEs Few recent data Wide range: 0.5-21% of all admissions One recent study at BWH found 1.4% of admissions were due to ADEs Originate in outpatient setting 78% severe 28% preventable Jha, et al. Ann Pharmacother, 2001

20. Post-Hospitalization Issues 400 medical inpatients assessed 3 weeks after hospital discharge 19% of patients with an adverse event within 2 weeks of discharge 66% of the adverse events were ADEs 6% considered preventable 6% ameliorable Medication discrepancies after discharge showed errors of omission, doubling-up, and dosage errors. Patients especially vulnerable to injuries immediately post- discharge Forster et al. Ann Intern Med. 2003;138:161-167. Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.

21. Post-Hospitalization Issues Recommendations: 1. Careful evaluation at the time of discharge 2. Teaching patients about drug therapies Side effects What to do if a specific problem develops 3. Improve monitoring of therapies 4. Improve monitoring of patient�s overall condition Forster et al. Ann Intern Med. 2003;138:161-167. Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.

22. Systematic Approach to Safe Medication Practice 1. Create or maintain Home Medication List 2. Follow safe prescribing practices 3. Monitoring, esp. high risk medications, high risk patients 4. Communication to build �safety team� for patient Partner with patient Collaborate with other providers and health care team members 5. Error proof high risk activities

23. 1. Home Medication List Create a home medication list Key elements Name, purpose, dose, schedule, side effects to report Many samples available electronically AHRQ, AHIMA etc Review medications for accuracy at every visit Encourage patients to keep and carry an up-to-date medication list at all times; share it with other health providers

24. 2. Follow Safe Prescribing Practices Follow safe prescribing rules NO trailing �0�s, YES leading �0�s, NO �u�s Careful with qid, qod, qd, mg, ug Include indication with PRN�s Legibility (Like writing a check�) Have access to up-to-date medication information on-line or in an electronic organizer Electronic prescribing!!

25. 3. Monitor closely-Typical Errors Failure to act on available information, most common error (36.6%) Delayed response or failure to respond to signs or symptoms of drug toxicity or laboratory evidence of drug toxicity Example: Failure to respond promptly to symptoms suggestive of digoxin toxicity Inadequate laboratory monitoring of drug therapies (36.1%) Example: Inadequate frequency of monitoring warfarin Gurwitz JH, et. al. Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting. JAMA. March 5, 2003;289(9):1107-1116.

26. 3. Monitor closely Discuss adherence as part of every visit Use anticoagulation services Exercise special care with selected populations Those taking the multiple medications High-risk medications (SSRIs, Beta blockers, ACE inhibitors, NSAIDs, Ca channel blockers) Non-English speakers Vulnerable patients Elderly, small children, chronic illness Acute/severe episode

27. 4. Communicate/�Partner� with patients Make sure patients know what each drug is for Review potential side effects in advance Screen patients routinely about problems with medications, especially high risk patients or high risk medications Teach patients to call right away with selected medication-related symptoms Provide printed drug information Brown bag prescription bottle checks Don�t assume that different doctors have shared information Medication literacy screen for patients Patient web-sites

28. REMEMBER 2/3 of ameliorable ADEs in the IMP study occurred when MDs failed to act on patient-reported medication symptoms (esp. CNS, GI, cardiac symptoms) 1/3 of ameliorable ADEs occurred when patients failed to inform their MD of medication symptoms.

29. IMP Knowledge Results 10% of patients did not know the indications or gave indications considered definitely inaccurate for 1 or more of their medications More likely if older, less educated, and if taking multiple medications

30. Association of Polypharmacy and Knowledge of Indication

31. 4. Communicate with other members of health care team Identify if patient has a dedicated/preferred pharmacist � know who they are Pharmacists as part of care team Ask what other health care providers the patient has seen since the last visit Be sure you have identified yourself as the PCP for this patient Collaborate with nursing and office staff to streamline and coordinate information flow during each visit

32. 5. Error-proof high-risk activities Improve handoffs in care Standard templates for transitions Anticoagulation services Electronic medical records Medication reconciliation Dedicated pharmacist Up to date medication lists

33. Outpatient Medication System of the Future Providers write computerized orders Screened at time written Orders go electronically to pharmacy Pharmacist review, counseling for drugs Simple orders filled using automation ATM-like devices with simple fills Patient web sites with medication information Can track progress, report problems Option to use home dispensing devices that record when medications taking

34. Safe Practices for Communicating Critical Test Results in Physician Offices/Ambulatory Settings

35. Follow-up Issues - A Risk Management Time Bomb RMF data 1/4 of diagnosis-related malpractice cases were attributable to failures in the follow-up system. �Failure to diagnose� has been a rapidly rising cause of legal action AMQIP data 37.4% of women who did not receive guideline care did not complete a repeat mammogram within the time-frame suggested by the radiologist 31% of women with abnormal mammograms do not receive care consistent with established guidelines (Haas, 2000)

36. Abnormal Test Result Follow -up: Room for Improvement National data 35% of patients with abnormal pap smear are �lost� to follow-up (Marcus, 1998) 39% of abnormal TSH at BWH not followed up within 60 days (Solomon, 1996) The literature also offers a few examples of the extent of the problem. In the Ambulatory Quality Improvement Project, Dr. Haas documented that 31% of women with abnormal mammograms do not receive care consistent with established guidelines. In another study, 39% of patients with abnormal TSH at the Brigham do not get the appropriate follow-up within 60 days. National data also shows that about 1/3 of patients with abnormal pap smear are lost to follow-up. While there may be several reasons why follow-up of these results many not 100%, the significant quality gap documented by these studies does show that there is a problem to be addressedThe literature also offers a few examples of the extent of the problem. In the Ambulatory Quality Improvement Project, Dr. Haas documented that 31% of women with abnormal mammograms do not receive care consistent with established guidelines. In another study, 39% of patients with abnormal TSH at the Brigham do not get the appropriate follow-up within 60 days. National data also shows that about 1/3 of patients with abnormal pap smear are lost to follow-up. While there may be several reasons why follow-up of these results many not 100%, the significant quality gap documented by these studies does show that there is a problem to be addressed

37. Follow-up Tracking: Challenges for the PCP Patient non-compliance to follow-up plans Co-ordination of care: Specialty referrals Proliferation of outpatient tests and procedures Out of sight, out of mind! Increased expectations from patients Early diagnosis of cancer Timely communication of test results Increased expectations from payers HEDIS

38. Burden of Outpatient Test Result Management Per week, full-time PCP needs to review: 360 chemistry results (SMA7 = 7) 460 hematology results 12 pathology reports 40 radiology reports Average time spent managing test results per clinic-day = 72 minutes (SD = 46) 57% of attending physicians surveyed report being not satisfied with the way they manage test results And just in case anybody is not convinced why we need to improve on the result management systems, we tried to measure the level of pain experienced by clinicians as they manage results. Looking at a cohort of patients whose PCPs are in several BWH clinics, we determined that in a typical week�. Perhaps Explains why physicians have to spend more than 1 hour a day after seeing patients to review test results Unreimbursed time ? Cutting corners In any case, physicians know that they are not happy with their systems of result management. In the survey we administered to assess delays in result management, we also asked provders about their satisfaction level with the way they manage test results. 57% of them said that they were not even somewhat satisfied.And just in case anybody is not convinced why we need to improve on the result management systems, we tried to measure the level of pain experienced by clinicians as they manage results. Looking at a cohort of patients whose PCPs are in several BWH clinics, we determined that in a typical week�. Perhaps Explains why physicians have to spend more than 1 hour a day after seeing patients to review test results Unreimbursed time ? Cutting corners In any case, physicians know that they are not happy with their systems of result management. In the survey we administered to assess delays in result management, we also asked provders about their satisfaction level with the way they manage test results. 57% of them said that they were not even somewhat satisfied.

39. Q: How many times over the past 2 months have you reviewed test results you wish you had reviewed earlier? 78% of attending MDs admit to at least ONCE On average, this happened 2.5 times 17% of MDs this happened >= 5 times. 78% of attending MDs admit to at least ONCE On average, this happened 2.5 times 17% of MDs this happened >= 5 times.

40. Do �you� have a system... To provide test results To track abnormal test to patients: results on patients: *Personal system? *Personal system? *Site-wide system? *Site-wide system?

41. Key elements of a System for Results Management Captures all ordered tests with date, patient name, MR#, test name, time (if necessary) Tickler system functionalities Identifies test results not returned by deadlines Identifies if appropriate follow up not completed Clinical action and patient notification plan designed into workflow standardized letter templates phone calls texts set of action plans with time frames System supports responsibility assigned (entering and tracking) time allocated for review and communication reliability designed into system for 24/7, weekend, holiday and vacations

42. Conclusions about the communication of critical test results in the ambulatory area Lots of room for improvement Inpatient--key to identify responsible physician Outpatient--vital to ensure follow-up One size will not fit all But electronic and manual tracking systems show promise for improvement

43. Results Manager Home Page

44. Post-Hospitalization Issues: Additional Recommendations Request that discharge summaries include: Diagnostic testing results that are outstanding at the time of discharge Obtain specific information about What the follow-up physicians need to do When they should do it What they should watch for Schedule early follow-up appointment with patient Be sure patient knows who and when to call with specific problems after discharge Make it easy for the patient to contact the practice! Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.Vulnerability because still have functional impairment and because �discontinuities may occur at the interface of acute and ambulatory care. Two contribution causes likely but not statistically verified are increasingly shorter hospital stays (relased �quicker and sicker�) and rising use of hospitalists rather than PCPs. Note 4 aspects of system identified as meriting improvement: assessment and commun of unresolved probs at the time of dschg patient education regarding meds and other therapies monitoring of drug therapies after discharge monitoring of overall condition after discharge Source: Forster AJ, Harvey JM, Peteron JF, Gandhi TK, Bates DW. The Incidence and Severity of Adverse Events Affecting Patients after Discharge from the Hospital. Annals of Internal Medicine. 2003;128:161-167.

45. Outpatient Safety Concepts Important to focus on bigger picture as well as specific projects Many principles now coming into place in inpatient settings Need to transfer these to outpatient settings Creating a culture of safety is essential Must have a non-punitive environment Leadership support is essential Most errors are from good people working in bad systems (�not bad apples�)

46. Outpatient Safety Concepts Need methods to capture errors that occur Reporting systems Case reviews Need methods to analyze errors Systems approach to error using human factors Need accountability and resources for analysis and follow-up of events To ensure that changes actually occur!

47. Outpatient Safety Concepts In addition, specific projects are important Medication safety Electronic medical records Tracking and follow-up of test results Patient education and communication Transitions of care Better discharge planning How to prioritize all of these?

48. Ambulatory Safe Practices follow Inpatient Initiatives AHRQ Grant to the DPH Massachusetts Coalition for the Prevention of Medical Errors MHA Focus on patient safety initiative to reduce adverse events in Massachusetts using voluntary collaborative model Acute care hospital focus Medication Safety Best Practices for Medication Safety (1997) Reconciling Medications Communicating Critical Test Results

49. Working together, we can make inroads into improving ambulatory patient safety!