Adverse Drug Events

1. Adverse Drug Events Hasan Shabbir MD Assistant Professor of Medicine Emory Hospital Medicine May 2008

2. The Burden of Medical Injuries Medical injuries account for 44,000 - 98,000 deaths per year in the United States More people die from medical injuries than from breast cancer or AIDS or motor vehicle accidents Brennan et al. New Engl J Med 1991 Thomas et al. 1999 Direct health care costs totaling $9 - 15 billion per year Thomas et al. 1999 Johnson et al. 1992 Slide Format based on Intermountain ATP Course

3. High frequency injuries sources • 1. Adverse drug events (ADEs, ADRs) • 2. Iatrogenic infections • post-operative deep wound infections • urinary tract infections (UTI) • lower respiratory infections (pneumonia or bronchitis) • bacteremias and septicemias • 3. Pressure injuries • 4. Mechanical Device Failures • 5. Complications and central and peripheral IV lines • 6. Deep venous thrombosis (DVT) / pulmonary embolism (PE) • 7. Strength, agility and cognition (injuries and restraints) • 8. Blood product transfusion • 9. Patient transitions • Slide Format based on Intermountain ATP Course

4. Adverse Drug Events • Overdoses • allergic / idiosyncratic reactions, • drug-drug interactions, or errors in route, rate, timing, or patient • 2% of hospitalized patients suffer preventable ADEs • At a cost of $2,400 - 4,700 per ADE • Classen et al. 1994 • Bates et al. 1997 • Slide Format based on Intermountain ATP Course

5. What have we learned? • “immense reservoir of creativity and motivation among healthcare workers of all kinds.” • “leadership is an essential ingredient of success in the search for safety, as it is throughout the enterprise of quality improvement.” • “efforts will be fragmentary and uncoordinated and will have only minor effects” • “although individual doctors, pharmacists, or nurses can, by their enthusiasm, motivate others to make improvements, major systems changes require direction and support from the top leaders who communicate their own commitment by insisting on safety as an explicit organizational goal backed by adequate resources. • From Berwyck 2000, BMJ

6. What have we learned? (cont.) • “medical error is not fundamentally due to lack of knowledge.” • “culture of blame and guilt too often shackles us.” • “Achieving the culture we need one of learning, trust, curiosity, systems thinking, and executive responsibility will be immensely difficult.” • Berwyck, BMJ, 2000

7. Key findings in IOM report: • Errors occur because of system failures • Preventing errors means designing safer systems of care • Organizations, not individual physicians and nurses, control those systems of care • Committee on Quality of Health Care in America. To Err is Human. Institute of Medicine, 2000. • Slide Format based on Intermountain ATP Course

8. Why don’t we pick these up? • #1 Don’t associate symptom with medications • #2 Fear Slide Format from Intermountain ATP course

9. A punishment free system is key to reducing adverse drug events. AHRQ website 2008

10. Shared beliefs and values about the health care delivery system Recruitment and training with patient safety in mind Organizational commitment to detecting and analyzing patient injuries and near misses; Open communication regarding patient injury results, both within and outside the organization The establishment of a "just" culture. Slide format from Intermountain ATP course A Culture of Safety

11. Let's talk about error Leaders should take responsibility for mistakes • “a typical airline handles customers' baggage at a far lower error rate than we handle the administration of drugs to patients” • “we tend to view most errors as human errors and attribute them to laziness, inattention, or incompetence on the part of those identified as committing the errors. As a result….we seek to place blame.” • Reinertsen, J 2000, BMJ

12. We can do better • A series of interventions, including medication reconciliation, introduced over a seven-month period, successfully decreased the rate of medication errors by 70% and reduced adverse drug events by over 15%. • Whittington J, Cohen H. OSF Healthcare’s journey in patient safety. Quality Management in Health Care. 2004;13(1):53-59.

13. Med Reconciliation • A successful reconciling process also reduces work and re-work associated with the management of medication orders. After implementation, nursing time at admission was reduced by over 20 minutes per patient. The amount of time that pharmacists were involved in discharge was reduced by over 40 minutes. • Rozich JD, Resar RK, et. al. Standardization as a mechanism to improve safety in health care: Impact of sliding scale insulin protocol and reconciliation of medications initiatives. Joint Commission Journal on Quality and Safety. 2004;30(1):5-14.

14. Clinical Pharmacists are Vital • Brigham and Women’s ICU • Baseline 33 ADE’s/1000 patient days • After Pharmacist started to round with docs: • Down to 11.6 ADE’s/1000 patient days • Leape, JAMA 1999

15. Traditional voluntary error detection systems underdetect by a factor of 10-100

17. ADE Rates using IHI Global trigger tool • Most hospitals – • 100injuries/1000 patient days • Hospital with protocols for insulin, anticoagulants, and PCA pumps- • 80 injuries/1000 patient days • IHI Website 2008

18. The Importance of Tracking • Hospital chose to purchase Vancomycin from new company, estimated cost savings $5000/yr • Tracking revealed $50,000 increased cost with cheaper brand of Vancomycin • Bottom line- hospital costs went up by $45,000 • Classen, JAMA 1997

19. Simple criteria for detecting ADEs • use of naloxone • use of benadryl • use of lomotil • nurse reports of rash/itching • use of loperamide • test for C. difficile toxin • digoxin level > 2 • abrupt med stop or reduction • use of vitamin K • doubling of serum creatinine • use of kaopectate • use of flumazenil

20. Beers List

21. Results from analysis of 384 hospitals • Of the 493,971 patients, 49% received at least 1 PIM, and 6% received 3 or more, most commonly promethazine, diphenhydramine, and propoxyphene. • For high-severity PIMs, internists and hospitalists (33%), cardiologists (48%), geriatricians (24%). • The proportion of elders receiving PIMs ranged from 34% in the Northeast to 55% in the South, and variation at the individual hospital level was extreme. • At 7 hospitals, PIMs were never prescribed. • Rothberg. Potentially Inappropriate Medication Use in hospitalized Elders. Journal of Hospital Medicine. April 2008 pp 91-102

22. Team for Reducing ADE’s • Needs at least 3 people -One leader -2 reviewers for IHI global trigger system -4hrs each reviewer, every two weeks • Improve trigger system

23. CPOE? • Among 937 hospital admissions, 483 clinically significant inpatient ADEs were identified- • 70 ADEs per 1000 patient-days • One quarter of the hospitalizations -at least 1 ADE. • Of all ADEs, 9% serious harm, 22% in additional monitoring and interventions, 32% in interventions alone, and 11% in monitoring alone; 27% should have resulted in additional interventions or monitoring. • Errors associated with ADEs occurred in the following stages: 61% ordering, 25% monitoring, 13% administration, 1% dispensing, and 0% transcription. The medical record reflected recognition of 76% of the ADEs. • High Rates of Adverse Drug Events in a Highly Computerized Hospital Jonathan R. Nebeker, MS, MD; Arch Intern Med. 2005;165:1111-1116.

24. Summary • ADE’s are common, costly, and often cause harm ( our oath?) • ADE’s are not well reported • ADE’s can be reduced by up to 50% • Tracking ADE’s is essential for improvement • Once again, improving quality of patient care reduces cost