Adverse Drug Events - K

Adverse Drug Events
Howard Shaps, MD, MBA
Medical Director
Health Care Excel
March 5, 2013
• Definitions
• Statistics and Facts
• Prevention and Detection
• Electronic Health Records and Meaningful Use
• Medication Reconciliation
• Compliance
• Pharmacist Involvement
What is an Adverse Drug Event (ADE) ?
• Any
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
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
• A mishap that can lead to an ADE
• Does not always lead to an injury
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
• Side effect
ADEs - Examples
• Rash
• Respiratory rate changes
• Bradycardia or tachycardia
• Mental status changes
• Seizure
• Diarrhea
• Anaphylaxis
• Fever
• Dystonic reactions
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
• 99% of Medication Errors are
potential ADEs
• Approximately 25% of ADEs are due
to medication errors1
et al. Ann Intern Med 2004; 140: 795-801
• 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
J Health Syst Pharm. 2010; 6798):613-620
• 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
Med Care 2000;38(3):261-71
3Am J Health Syst Pharm. 2010; 67(8):613-620
ADEs are injuries resulting from the use of medications.
82% of adults take
at least one
medication 29%
take five or more
department visits
and 120,000
are due to ADEs
$3.5 billion spent
annually on the
extra medical
costs associated
with ADEs
At least 40% of
costs of
ambulatory ADEs
are preventable
Mediation Safety Basics. CDC. 2012
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
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
• Age
• Number of comorbidities
• Number of drugs received
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)
Medications and ADEs
 Gastrointestinal medicines
• Diabetes medications
 Antipsychotics
• Diuretics
 Antihypertensives
• Corticosteroids
 Antidepressant
• Antiemetics
 Antihistamines
ADEs in the Future
The numbers of ADEs is likely to grow due to:
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
Mediation Safety Program. Basics. CDC. 2012
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
DC, et al.. JAMA 1997;277(4):301-6
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
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
• Errors that arise from omission of critical information are eliminated
General Accounting Office (U.S.). Adverse Drug Events. GAO/HEHS-00-21; Jan 2000
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
Consequences of therapy
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
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
2006 Long-Term Care Health Information Technology Summit
The Valley View Center for Nursing and Rehabilitation (NY)
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
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
What is Medication Reconciliation?
As defined by the Joint Commission on the Accreditation of Healthcare Organizations
Medication reconciliation is “The process of comparing a patient's medication orders to all of
the medications that the patient has been taking.”
• Make Appropriate Prescribing Decisions
• Avoid Medication Errors
• All Transition Points
• New Orders
• Revised/Rewritten Orders
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
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
 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)
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
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
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. 2007. The physician’s role in medication reconciliation: Issues, strategies and safety principles
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
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
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
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
Challenges in Medication Reconciliation
• A Review of 15 Grantees Using Health IT for medication reconciliation identified the following
Using Data Provided by Patients
EHR System Readiness
Care Transitions
Organizational Roles & Responsibilities
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.
290-04-0016) AHRQ Publication No. 10-0051-EF, Rockville, MD. February 2010
Medication Reconciliation
• Recommendations
• Pharmacists should review admission medication list and review medications prior to
• 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
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
Internet resources
Personal reminder products – pill boxes
Written logs
Alarms – watches
Mobile applications
EHRs for practitioners – alert when a medicine needs to be refilled
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
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
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
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
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
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):888-890
Weiss BD. Health Literacy: A Manual for Clinicians. American Medical Association and American Medical Association Foundation; 2003
Medication Review Process
• Review at beginning and end of each visit
• Give clear written instructions
• Use appropriate pictures
• Provide demonstrations
• Discuss non prescription medicines
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?
Teamwork Important
• Local clinical pharmacy representation
• Clinician involvement
• Hospitals, nursing homes, primary care clinics, specialty clinics, federally funded clinics
• Clinic and hospital senior leadership
Multiple Roles of the Pharmacist
• Counselor
• Drug-drug interactions
• Drug-disease interactions
• Educator
• Dosage
• Timing
Tracks dates for refills
Assists with medication compliance
Intimate involvement with CPOE
Involvement with the Medication Reconciliation Form
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 - 0.6 (95% confidence interval 0.5-0.88)
• 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. 2009 Apr 27;169(8):757-63
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. 2006; 166:565-571.
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
Contact Information
Howard Shaps, MD, MBA
Medical Director
Health Care Excel
1941 Bishop Lane, Suite 400
Louisville, Kentucky 40218
502.454.5112 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 22 2013.
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