1. Howard Shaps, MD, MBA Medical Director Health Care Excel March 5, 2013
Adverse Drug Events
Howard Shaps, MD, MBA
Medical Director
Health Care Excel
March 5, 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://

5. Medication Errors
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:

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 ; 6798):

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
1 Med Care 2000;38(3):261-71
2http://
3Am J Health Syst Pharm ; 67(8):

14. Statistics
ADEs are injuries resulting from the use of medications.
Mediation Safety Basics. CDC
Facts
82% of adults take at least one medication 29% take five or more
700,000 emergency department visits and 120,000 hospitalizations are due to ADEs annually
$3.5 billion spent annually on the extra medical costs associated with ADEs
At least 40% of costs of ambulatory ADEs are preventable

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)

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 grow due to:
Mediation Safety Program. Basics. CDC
Discovery of new uses for older medications
Increased coverage for prescription medications
Aging American population
Increase in the use of medications for disease prevention
Development of new medications

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 Iowa
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):

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 ( ) fewer office visits
Cost savings of $402,619
Arch Intern Med. 2009;169(16):

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.”
Why?
Make Appropriate Prescribing Decisions
Avoid Medication Errors
When?
All Transition Points
New Orders
Revised/Rewritten Orders

37. Medication Reconciliation
Medication Reconciliation can be used to prevent ADEs
Medication Reconciliation has positive impact on patient outcomes
Reduced medication errors by 70 percent
Reduced ADEs by more than 15 percent

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).
American Medical Association 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 ; 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

51. Challenges in Medication Reconciliation
A Review of 15 Grantees Using Health IT for medication reconciliation identified the following challenges:
Using Data Provided by Patients
EHR System Readiness
Care Transitions
Organizational Roles & Responsibilities 52
Samarth A, Grant E. Using Health Information Technology to Perform Medication Reconciliation: Findings from the AHRQ
Health IT Portfolio (Prepared by the AHRQ National Resource Center for Health Information Technology under contract no.
) AHRQ Publication No EF, Rockville, MD. February 2010

52. Medication Reconciliation
Recommendations
Pharmacists should review admission medication list and review medications prior to discharge
All hospitals need to have a formal process to ensure its use
Compliance of use - needs to be tracked
Skilled Nursing Facilities should adopt its use
Helpful when patients are transferred
Should be standard with use of EHRs

54. Compliance Tracking
Medication compliance is high while a patient is in the hospital
Outpatient compliance lags
Resources are available for patients and practitioners to increase medication compliance
Internet resources
Personal reminder products – pill boxes
Written logs
Alarms – watches
Mobile applications
EHRs for practitioners – alert when a medicine needs to be refilled

55. Compliance Tracking Promotion of self management is important
Health literacy
Telephone follow up after hospital discharge
Utilizing health coaches – social workers, nurses
Pharmacist intervention
Helpful after patient discharge
Can monitor compliance
Can verify the patient
Has access to medicines
Can afford the medicines

58. Health Literacy
Health literacy is the ability to read, understand, and act on health care information
Patients with low health literacy may have:
Limited ability to distinguish medicines
Difficulty in understanding dosages and timing
Problems understanding side effects
Lack of understanding of labels

59. Health Literacy Statistics
The health of 90 million people in the U.S. may be at risk because of the difficulty some patients experience in understanding and acting upon health information
Literacy skills are a stronger predictor of an individual’s health status than age, income, employment status, education level, or racial/ethnic group
One out of five American adults reads at the 5th grade level or below, and the average American reads at the 8th to 9th grade level, yet most health care materials are written above the 10th grade level
Limited health literacy increases the disparity in health care access among exceptionally vulnerable populations (such as racial/ethnic minorities and the elderly)
More than 66% of US adults age 60 and over have either inadequate or marginal literacy skills

61. Health Literacy Statistics
Annual health care costs for individuals with low literacy skills are 4 times higher than those with higher literacy skills
Problems with patient compliance and medical errors may be based on poor understanding of health care information
Only about 50% of all patients take medications as directed
Patients with low health literacy and chronic diseases have less knowledge of their disease and its treatment
Difficulty with self-management skills than literate patients
Patients with low literacy skills were observed to have a 50% increased risk of hospitalization
Compared with patients who had adequate literacy skills
Research suggests that people with low literacy:
Make more medication or treatment errors
Are less able to comply with treatments
Lack the skills needed to successfully negotiate the health care system
Are at a higher risk for hospitalization than people with adequate literacy skills

64. Patient Education Tools – Provider Challenges
Provider Challenges for Medication Counseling
Time constraints
Use of medical jargon
Unaware of patients’ multiple sources for medication
Patients taking multiple medications

65. Specific Educational Techniques
Use plain language
Material should be written at a 6th grade level or lower
Repeat key messages
Teach-back or Show-me
Effectively solicit questions
Use patient friendly materials
Kripalani S, Weiss BD. Journal of General Internal Medicine. 2006;21(8):
Weiss BD. Health Literacy: A Manual for Clinicians. American Medical Association and American Medical Association Foundation; 2003

66. Medication Review Process
Review at beginning and end of each visit
Give clear written instructions
Use appropriate pictures
Provide demonstrations
Discuss non prescription medicines

67. Medication Review Process
What are the names of your medicines?
What is each one for?
When do you take each one?
Do you think you need all of them?
Do you ever forget to take them?
How do you feel when you forget?
What do you do if you forget to take your medicine?
What questions do you have?

68. Teamwork Important Local clinical pharmacy representation
Clinician involvement
Hospitals, nursing homes, primary care clinics, specialty clinics, federally funded clinics
Clinic and hospital senior leadership

70. Multiple Roles of the Pharmacist
Counselor
Drug-drug interactions
Drug-disease interactions
Educator
Dosage
Timing
Coordinator
Tracks dates for refills
Assists with medication compliance
Intimate involvement with CPOE
Involvement with the Medication Reconciliation Form

71. Outpatient Pharmacists
Archives of Internal Medicine
2009
Methods: Randomized control study
Pharmacist intervention relating to ADEs and medication errors
EHRs evaluated
Population: 800 participants with hypertension
Results: Risk of any event was 34% lower in the intervention group
Risk ratio (95% confidence interval )
Conclusion: Pharmacist intervention to improve medication use in outpatients with cardiovascular disease decreases the risk of ADEs and medication errors
Murray, MD, et al. Arch Intern Med Apr 27;169(8):757-63

72. Pharmacist Counseling
Archives of Internal Medicine
2006
Methods: Randomized Trial
Pharmacist counseling patients 3-5 days after hospital discharge
Clarifying medication regimens
Reviewing indications, directions and potential side effects
Screening for barriers to adherence
Primary outcome: Rate of ADEs
Results: Preventable ADEs detected in 11% of patients in the control group and 1% in the intervention group
p < .01
Conclusions: Pharmacist review and patient counseling reduces preventable ADEs 30 days after hospital discharge
Schnipper, JL., Arch Intern Med ; 166:

73. Relationships: Clinic & Community Pharmacists
Critical link in the health team, especially in clinics without in-house pharmacy
Partner in health care team
Pharmacist is extension of health care team in the community
Outreach to local pharmacies, pharmacists, and pharmacy boards

75. Contact Information
Howard Shaps, MD, MBA Medical Director Health Care Excel 1941 Bishop Lane, Suite 400 Louisville, Kentucky x 2202
This material was prepared by Health Care Excel, the Medicare Quality Improvement Organization for Kentucky, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Created on February
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