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Howard Shaps, MD, MBA Medical Director Health Care Excel March 5, 2013

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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 1

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 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 2 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

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 10SOW-KY-POPHEALTH

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