Adverse Drug Events

1. Adverse Drug Events Howard Shaps, MD, MBA Medical Director Health Care Excel February 27, 2013

2. Overview Definitions Statistics and Facts Prevention and Detection Electronic Health Records and Meaningful Use Medication Reconciliation Compliance Pharmacist Involvement

4. What is an Adverse Drug Event (ADE) ? • Any injury resulting from medical interventions related to a drug whose outcome is unexpected and unacceptable to the patient and healthcare provider1 • ADEs secondary to medication therapy • Most common type of health care associated adverse event • ADEs may results from medication errors • Most do not 1http://www.pharmsolutions.org

5. MedicationErrors A preventable event that may cause or lead to patient harm while the medication is in the control of a health care professional, patient, or consumer A mishap that can lead to an ADE Does not always lead to an injury

6. Other Definitions • Potential Adverse Drug Event (pADE) – medication errors that are stopped before harm can occur • Near misses • Adverse Drug Reaction – harm caused by a drug at a normal doses during normal use • Side effect

9. ADEs - Examples Rash Respiratory rate changes Bradycardia or tachycardia Mental status changes Seizure Diarrhea Anaphylaxis Fever Dystonic reactions

10. Medication Errors • Missed dose • Wrong technique • Illegible order • Duplicate therapy • Drug-drug interaction • Equipment failure • Inadequate monitoring • Preparation error • 1% of Medication Errors result in ADEs • 99% of Medication Errors are potential ADEs • Approximately 25% of ADEs are due to medication errors1 1Nebecker et al. Ann Intern Med 2004; 140: 795-801

11. http://www.ahrq.gov/

12. Statistics • More than 4 million visits to emergency departments, doctor’s offices, or other outpatient settings each year are due to ADEs1 • There are almost 10 ADEs per month for every 100 residents in long-term-care1 • ADEs increase length of hospital stay from 1.7 to 2.2 days 2 • ADEs increase hospital costs2 • $2,103 to $3,244 per visit 1www.fda.gov 2Am J Health Syst Pharm. 2010; 6798):613-620

13. Statistics • 9.7 percent of ADEs cause permanent disability1 • National hospital expenses to treat patients who suffer ADEs during hospitalization2 • Estimated between $1.56 and $5.6 billion annually • Mortality rates for patients who experienced an ADE were found to be significantly higher versus those that did not experience an ADE3 • 3.5% v. 1.1% • p < 0.001 1Med Care 2000;38(3):261-71 2http://www.ahrq.gov 3Am J Health Syst Pharm. 2010; 679(8):613-620

14. Statistics ADEs are injuries resulting from the use of medications. Mediation Safety Basics. CDC. 2012 http://www.cdc.gov/medicationsafety/basics.html

15. Adverse Drug Events • Cannot be predicted by • Patient characteristics • Type of drug • Disproportionate share occurs in those older than 65 years • ADEs are more likely to result in life-threatening consequences in intensive care unit patients than in others

16. Adverse Drug Events • Although older age, severity of illness, intensity of treatment, and polypharmacy have been associated with ADEs… • No cause and effect relationship is known to exist between patients who suffer ADEs and… • Age • Number of comorbidities • Number of drugs received

17. Medications and ADEs • Medication type is not currently a predictor • Certain medicines are more commonly found to be associated with ADEs • Agency for Healthcare Research and Quality (AHRQ) • Antibiotics (19-30 percent of ADEs) • Analgesics or pain medications (7-30 percent) • Electrolyte concentrates (1-10 percent) • Cardiovascular drugs (8-18 percent) • Sedatives (4-8 percent) • Antineoplastic drugs (7-8 percent) • Anticoagulants or blood-thinning drugs (1.3-3 percent) www.arhq.gov

18. http://www.ahrq.gov/

19. Medications and ADEs • Gastrointestinal medicines • Antipsychotics • Antihypertensives • Antidepressant • Antihistamines • Diabetes medications • Diuretics • Corticosteroids • Antiemetics

20. ADEs in the Future The numbers of ADEs is likely to growdue to: Mediation Safety Program. Basics. CDC. 2012 http://www.cdc.gov/medicationsafety/basics.html

23. ADEs can be Prevented and Detected • AHRQ Research - Computerized systems can reduce medication errors and prevent ADEs • These studies indicate that anywhere from 28 to 95 percent of ADEs can be prevented • 42-60 percent of ADEs to excessive drug dosage for the patient's age, weight, underlying condition, and renal function1,2 • Systems are available that prompt doctors to take these factors into consideration when ordering medications • University of Iowa3 • Computerized systems significantly increased the number of potential ADE alerts for pharmacist review and the number of true-positive ADE alerts identified per 1000 admissions • 1Classen DC, et al.. JAMA 1997;277(4):301-6 • 2Evans RS, et al. Proc Annu Symp Comput Appl Med Care 1992:437-41 • 3Roberts, LL, et al. Am J Health System Pharm 2010; Nov 1;67(21):1838-46

25. Physician Order Entry (POE) • Brigham and Women's Hospital • Computerized medication order entry had the potential to prevent an estimated 84 percent of dose, frequency, and route errors • Eliminates illegible orders that lead to medication errors • Requires the name of the medication, dosage, route, and frequency of administration to be entered • Errors that arise from omission of critical information are eliminated • General Accounting Office (U.S.). Adverse Drug Events. GAO/HEHS-00-21; Jan 2000

26. Physician Order Entry • Programmed within the computer system • Algorithms that check dosage frequency • Medication interactions • Patient allergies • Once an order is entered, this computerized system also provides physicians with information • Consequences of therapy • Benefits • Risks • Contraindications

28. Electronic Health Records (EHRs) • Electronic Health Records and Physician Order Entry • Clinical information repository to track diagnoses, allergies, height, weight, and vital signs • Medication order management with formulary presentation • Including Medicare Part-D formularies • Automatic drug utilization review for drug interactions • Drug-to-drug • Drug-to-allergy • Drug-to-condition

29. Electronic Health Records • Intuitive user interface • Capability and benefits • Automatic routing capability for prescription approval and fulfillment • Renewal order processing • Scheduling and approval • Clinical and administrative reporting capability • Quality indicator reporting • Web browser support to allow remote access from outside the facility • Can incorporate pharmacists in the process to ensure safety and accuracy of medication use • Integration with the facility’s financial system, pharmacies and pharmacy benefit managers

30. 2006 Long-Term Care Health Information Technology Summit The Valley View Center for Nursing and Rehabilitation (NY)

31. EHR and Medication Safety Alerts • 279,476 alerted prescriptions written by 2321 Massachusetts ambulatory care clinicians using a single commercial e-prescribing system from January 1 through June 30, 2006 • Electronic drug alerts likely prevented • 402 ADEs • 49 (14-130) potentially serious • 125 (34-307) significant • 228 (85-409) minor ADEs • Accepted alerts may have prevented • Death in 3 cases • Permanent disability in 14 (3-18) • Temporary disability in 31 (10-97) • Alerts potentially resulted in • 39 fewer hospitalizations • 34 fewer emergency department visits • 267 (105-541) fewer office visits • Cost savings of $402,619 Arch Intern Med. 2009;169(16):1465-1473

33. Meaningful Use • Promote the spread of EHRs to improve health care in the United States • The benefits of the meaningful use of EHRs include: • Complete and accurate information - Providers will know more about their patients and their health history before they walk into the examination room • Better access to information -Diagnose health problems earlier and improve the health outcomes of their patients • Patient empowerment - Patients can receive electronic copies of their medical records and share their health information securely over the Internet with their families • Incentive programs available through Stage 2

36. What is Medication Reconciliation? As defined by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Medication reconciliation is “The process of comparing a patient's medication orders to all of the medications that the patient has been taking.”

37. Medication Reconciliation http://www.ihi.org/explore/adesmedicationreconciliation/Pages/default.aspx http://www.nationalprioritiespartnership.org/uploadedFiles/NPP/Priorities/4.pdf

39. Medication Reconciliation Process The medication reconciliation process comprises five steps: • Develop a list of current medications • Develop a list of medications to be prescribed • Compare the medications on the two lists • Make clinical decisions based on the comparison • Communicate the new list to appropriate caregivers and to the patient

40. MEDICATION RECONCILIATION CHECKLIST • Discharge Summary reviewed • Hospital MAR, Order Reconciliation Report reviewed • Home Medications (OTC) reviewed • Natural/Homeopathic/Vitamins, etc… reviewed • Multiple physician reviewed • (i.e.., orthopedic surgeon)

41. Medication Reconciliation • Patients admitted to a hospital commonly • Receive new medications • Have changes made to their existing medications • Hospital-based clinicians may • Not be able to easily access patients‘complete medication lists • Be unaware of recent medication changes • As a result, the new medication regimen prescribed at the time of discharge may • Inadvertently omit needed medications • Unnecessarily duplicate existing therapies • Contain incorrect dosages

42. Medication Reconciliation • Such unintended inconsistencies in medication regimens may occur at any point of transition in care • Transfer from an intensive care unit to a step down unit or hospital floor • Hospital admission • Discharge to home, skilled nursing facility, long-term care facility

43. Medication Reconciliation in Care Coordination Interruptions in the continuity of care and information gaps in patient health records are common and significantly affect patient outcomes Poor communication of medical information at transitional times in care is responsible for: • As many as 50% of all medication errors in the hospital • And up to 20% of ADEs Institute for Healthcare Improvement. (2005).100K Lives Campaign. How-to guide: Adverse drug events (medication reconciliation). http://www.wapatientsafety.org/downloads/Medication_ReconADEGuideIHI.pdf American Medical Association. 2007. The physician’s role in medication reconciliation: Issues, strategies and safety principles 43

44. Medication Reconciliation • Unintended medication discrepancies occur in approximately • 33% of patients at admission • 33% at the time of transfer from one site of care within a hospital • 14% of patients at hospital discharge

46. Medication Reconciliation • Errors reduced in a Wisconsin hospital… • Before implementation: Number of errors 213 per 100 admissions • After implementation: Number of errors 63 per 100 admissions • Medication reconciliation was put in process upon admission, transfer and discharge Rozich JD, Resar RK. Medication safety: One organizations approach to the challenge. JCOM. 2001; 8:27-34

48. Medication Reconciliation – Literature Themes • The potential for medication errors and patient harm exists • Medication histories are inaccurate • Medication histories are incomplete • Subsequently used to generate medication regimens for hospitalized patients • CPOE relies on the accuracy of data entered into the system • As patient’s health care records become available electronically, data initially entered into the patient’s electronic medical record (EMR) • Will likely “follow” the patient from admission to admission • Appropriate verification/validation of the patient’s actual medication regimen is essential

49. Medication Reconciliation – Literature Themes • Incorporating a medication reconciliation process at all transition points or “interfaces of care” • May reduce medication errors • May reduce the potential for patient harm • Complement current technologies, such as CPOE • Admission, transfer, and discharge

50. www.ahrq.gov