Safe Practices for Medication Safety and Communicating Critical Test Results in Physician OfficesAmb

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Safe Practices for Medication Safety and
Communicating Critical Test Results in Physician
Offices/Ambulatory Settings

• Tejal K. Gandhi, MD MPH
• Director of Patient Safety
• Brigham and Womens Hospital
• Massachusetts Medical Society
• February 12, 2004

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Goals

• Discuss outpatient medication error and ADE rates
• Rates
• Strategies for prevention
• Discuss tracking and follow-up of outpatient test
  results
• Strategies for prevention

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What is Different About Ambulatory Care?

• Long feedback loops
• Episodic (from provider perspective)
• Signal to noise ratio is low
• Widely distributed
• Limited resources, redundancy
• Patients and providers have many degrees of
  freedom

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The Primary Care Encounter

• Average encounter 12 minutes
• Average time to first interruption--18 seconds
• 75 of patients leave with unanswered questions
• Little time to do all that needs to be done
• 75 of office visits to PCPs associated with
  initiation or continuation of a drug
• 48 of medication-related claims are in
  outpatients

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Research Issues

• Ambulatory setting harder to study
• Therapy not directly observed
• Non-compliance issues
• Injuries not directly observed
• Injuries often not reported by patients
• Few data available on impact of outpatient
  computerized prescribing on errors

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How common and serious are medication
errors and ADEs in the ambulatory area?

• Patient reports
• More than one-fifth of adults reported they or
  family experienced a medical error or
  prescription drug error
• 16 were given wrong medication or wrong dose
• (The Commonwealth Fund 2001 Health
  Care Quality Survey)

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Ambulatory Drug Complications

• Chart review and patient survey at 11 Boston-area
  ambulatory clinics. (AMQIP Study)
• 2858 patients, 2248 (79) with prescription drug
  use
• 18 self report drug complications
• 3 had ADE documented in chart
• Patients reported
• 13 thought preventable
• 35 reported medication not changed
• 20 symptoms lasting longer than 3 months
• Discrepancy between patient report and documented
  event
• Gandhi TK, et al. Drug Complications in
  Outpatients. J of Genl Int Med. 2000.

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Drug Complications (cont.)

• Clinical correlates of complications
• Number of medical problems
• Number of medications
• Renal disease
• Non-clinical correlates
• Failure to have side effects explained
• Primary language other than English or Spanish
• Lower medication compliance

Gandhi TK, et al. Drug Complications in
Outpatients. J of Genl Int Med. 2000.
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The Improving Medication Prescribing (IMP) Study
(RMF)

• Prospective cohort study including patient
  survey/chart review from four adult primary care
  practices associated with a Boston teaching
  hospital
• 25 (162/661) primary care patients had an ADE
  total of 181 ADEs (27/100 pts)
• 13 (24) serious
• 11 (20) preventable
• 28 (51) ameliorable
• 6 (n13) both serious and preventable or
  ameliorable
• Gandhi TK, et al. Adverse Drug Events in
  Ambulatory Care, NEJM April 2003.

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The Improving Medication Prescribing (IMP) Study
(RMF)

• Of 51 ameliorable adverse drug events
• 63 of events - physician failed to act on
  medication related symptoms
• 37 of events - the patient failed to inform the
  physician of symptoms
• Of 20 preventable adverse drug events
• 9 due to inappropriate drug
• (including interaction allergy)
• 2 wrong dose
• 2 wrong frequency of use
• Most due to prescribing errors

Gandhi TK, et al. Adverse Drug Events in
Ambulatory Care, NEJM April 2003
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Types of ADEs

• ADEs Preventable ADEs
• CNS 33 35
• GI 22 25
• Cardiac 18 18
• Allergic/Derm 8 6

Gandhi TK, et al. Adverse Drug Events in
Ambulatory Care, NEJM April 2003.
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Medications and ADEs

• ADEs Preventable ADEs
• (n182) (n71)
• SSRIs 18 (10) 12 (17)
• Beta blockers 16 (9) 8 (11)
• ACE inhibitors 15 (8) 8 (11)
• NSAIDs 15 (8) 7 (10)
• Ca channel blockers 12 (7) 8 (11)

Gandhi TK, et al. Adverse Drug Events in
Ambulatory Care, NEJM April 2003.
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Results Prevention

• More advanced computer prescribing checks with
  decision support would have prevented many more
  events
• 95 of potential ADEs
• Majority of prevention from complete
  prescriptions, drug-dose, and drug-frequency
  checking

Gandhi TK, et al. Adverse Drug Events in
Ambulatory Care, NEJM April 2003. (check this
reference)
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Results Prescription Review

• 1879 prescriptions reviewed
• Medication errors 143 (7.6)
• Potential ADEs 62 (3)
• Life threatening 1 (2)
• Serious 15 (24)
• Significant 46 (74)
• Computerized sites had significantly fewer
  medication errors

Gandhi unpublished data
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Study Conclusions

• The medication error rate for outpatient
  prescriptions was 8
• 25 of patients reported ADEs
• Basic computerized prescribing systems
• Reduced rates of medication errors
• Advanced decision support has even greater
  potential
• Monitoring for and acting upon ADE symptoms was
  unexpectedly important

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Incidence and Preventability of ADEs Among Older
Persons in the Ambulatory Setting

• Cohort study of group practices Medicare
  patients in 1 year (30,397 person-years of
  observation)
• ADEs 50.1/1000 person years
• Preventable ADEs 13.8/1000 person years -27
• Fatal 1.2
• Life-threatening 17.1
• Serious 39.7
• Significant 42.0
• Gurwitz JH, et. al. Incidence and Preventability
  of Adverse Drug Events Among Older Persons in the
  Ambulatory Setting. JAMA. March 5,
  2003289(9)1107-1116.

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In what phase do preventable errors occur?

• Errors associated with preventable ADEs
• 58.4 prescribing
• 60.8 monitoring
• 21.1 adherence
• More serious events are more likely to be
  preventable (42 vs. 19 of significant)

Gurwitz JH, et. al. Incidence and Preventability
of Adverse Drug Events Among Older Persons in the
Ambulatory Setting. JAMA. March 5,
2003289(9)1107-1116.
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Preventable ADEs

• Prescribing stage
• Wrong drug/wrong therapeutic choice 27
• Wrong dose 24
• Inadequate patient education 18
• Drug-drug interaction 13
• Monitoring stage
• Failure to act on available information 36.6
• Inadequate monitoring 36.1

Gurwitz JH, et. al. Incidence and Preventability
of Adverse Drug Events Among Older Persons in the
Ambulatory Setting. JAMA. March 5,
2003289(9)1107-1116.
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Admissions Due to ADEs

• Few recent data
• Wide range 0.5-21 of all admissions
• One recent study at BWH found 1.4 of admissions
  were due to ADEs
• Originate in outpatient setting
• 78 severe
• 28 preventable
• Jha, et al. Ann Pharmacother, 2001

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Post-Hospitalization Issues

• 400 medical inpatients assessed 3 weeks after
  hospital discharge
• 19 of patients with an adverse event within 2
  weeks of discharge
• 66 of the adverse events were ADEs
• 6 considered preventable
• 6 ameliorable
• Medication discrepancies after discharge showed
  errors of omission, doubling-up, and dosage
  errors.
• Patients especially vulnerable to injuries
  immediately post- discharge
• Forster et al. Ann Intern Med. 2003138161-167.

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Post-Hospitalization Issues

• Recommendations
• 1. Careful evaluation at the time of discharge
• 2. Teaching patients about drug therapies
• Side effects
• What to do if a specific problem develops
• 3. Improve monitoring of therapies
• 4. Improve monitoring of patients overall
  condition
• Forster et al. Ann Intern Med. 2003138161-167.

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Systematic Approach to Safe Medication Practice

• 1. Create or maintain Home Medication List
• 2. Follow safe prescribing practices
• 3. Monitoring, esp. high risk medications, high
  risk patients
• 4. Communication to build safety team for
  patient
• Partner with patient
• Collaborate with other providers and health care
  team members
• 5. Error proof high risk activities

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1. Home Medication List

• Create a home medication list
• Key elements
• Name, purpose, dose, schedule, side effects to
  report
• Many samples available electronically
• AHRQ, AHIMA etc
• Review medications for accuracy at every visit
• Encourage patients to keep and carry an
  up-to-date medication list at all times share it
  with other health providers

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2. Follow Safe Prescribing Practices

• Follow safe prescribing rules
• NO trailing 0s, YES leading 0s, NO us
• Careful with qid, qod, qd, mg, ug
• Include indication with PRNs
• Legibility (Like writing a check)
• Have access to up-to-date medication information
  on-line or in an electronic organizer
• Electronic prescribing!!

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3. Monitor closely-Typical Errors

• Failure to act on available information, most
  common error (36.6)
• Delayed response or failure to respond to signs
  or symptoms of drug toxicity or laboratory
  evidence of drug toxicity
• Example Failure to respond promptly to symptoms
  suggestive of digoxin toxicity
• Inadequate laboratory monitoring of drug
  therapies (36.1)
• Example Inadequate frequency of monitoring
  warfarin
• Gurwitz JH, et. al. Incidence and Preventability
  of Adverse Drug Events Among Older Persons in the
  Ambulatory Setting. JAMA. March 5,
  2003289(9)1107-1116.

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3. Monitor closely

• Discuss adherence as part of every visit
• Use anticoagulation services
• Exercise special care with selected populations
• Those taking the multiple medications
• High-risk medications
• (SSRIs, Beta blockers, ACE inhibitors, NSAIDs, Ca
  channel blockers)
• Non-English speakers
• Vulnerable patients
• Elderly, small children, chronic illness
• Acute/severe episode

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4. Communicate/Partner with patients

• Make sure patients know what each drug is for
• Review potential side effects in advance
• Screen patients routinely about problems with
  medications, especially high risk patients or
  high risk medications
• Teach patients to call right away with selected
  medication-related symptoms
• Provide printed drug information
• Brown bag prescription bottle checks
• Dont assume that different doctors have shared
  information
• Medication literacy screen for patients
• Patient web-sites

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REMEMBER

• 2/3 of ameliorable ADEs in the IMP study occurred
  when MDs failed to act on patient-reported
  medication symptoms (esp. CNS, GI, cardiac
  symptoms)
• 1/3 of ameliorable ADEs occurred when patients
  failed to inform their MD of medication symptoms.

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IMP Knowledge Results

• 10 of patients did not know the indications or
  gave indications considered definitely inaccurate
  for 1 or more of their medications
• More likely if older, less educated, and if
  taking multiple medications

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Association of Polypharmacy and Knowledge of
Indication
p 0.001
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4. Communicate with other members of health
care team

• Identify if patient has a dedicated/preferred
  pharmacist know who they are
• Pharmacists as part of care team
• Ask what other health care providers the patient
  has seen since the last visit
• Be sure you have identified yourself as the PCP
  for this patient
• Collaborate with nursing and office staff to
  streamline and coordinate information flow during
  each visit

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5. Error-proof high-risk activities

• Improve handoffs in care
• Standard templates for transitions
• Anticoagulation services
• Electronic medical records
• Medication reconciliation
• Dedicated pharmacist
• Up to date medication lists

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Outpatient Medication System of the Future

• Providers write computerized orders
• Screened at time written
• Orders go electronically to pharmacy
• Pharmacist review, counseling for drugs
• Simple orders filled using automation
• ATM-like devices with simple fills
• Patient web sites with medication information
• Can track progress, report problems
• Option to use home dispensing devices that record
  when medications taking

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Safe Practices for Communicating Critical Test
Results in Physician Offices/Ambulatory Settings
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Follow-up Issues - A Risk Management Time Bomb

• RMF data
• 1/4 of diagnosis-related malpractice cases were
  attributable to failures in the follow-up system.
  
• Failure to diagnose has been a rapidly rising
  cause of legal action
• AMQIP data
• 37.4 of women who did not receive guideline care
  did not complete a repeat mammogram within the
  time-frame suggested by the radiologist
• 31 of women with abnormal mammograms do not
  receive care consistent with established
  guidelines (Haas, 2000)

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Abnormal Test Result Follow -up Room for
Improvement

• National data
• 35 of patients with abnormal pap smear are
  lost to follow-up (Marcus, 1998)
• 39 of abnormal TSH at BWH not followed up
  within 60 days
• (Solomon, 1996)

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Follow-up Tracking Challenges for the PCP

• Patient non-compliance to follow-up plans
• Co-ordination of care
• Specialty referrals
• Proliferation of outpatient tests and procedures
• Out of sight, out of mind!
• Increased expectations from patients
• Early diagnosis of cancer
• Timely communication of test results
• Increased expectations from payers
• HEDIS

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Burden of Outpatient Test Result Management

• Per week, full-time PCP needs to review
• 360 chemistry results (SMA7 7)
• 460 hematology results
• 12 pathology reports
• 40 radiology reports
• Average time spent managing test results per
  clinic-day 72 minutes (SD 46)
• 57 of attending physicians surveyed report being
  not satisfied with the way they manage test
  results

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Q How many times over the past 2 months have you
reviewed test results you wish you had reviewed
earlier?
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Do you have a system...

• To provide test results To track abnormal test
  to patients results on patients
• Personal system? Personal system?
• Site-wide system? Site-wide system?

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Key elements of a System for Results Management

• Captures all ordered tests with date, patient
  name, MR, test name, time (if necessary)
• Tickler system functionalities
• Identifies test results not returned by deadlines
• Identifies if appropriate follow up not completed
• Clinical action and patient notification plan
  designed into workflow
• standardized letter templates
• phone calls texts
• set of action plans with time frames
• System supports
• responsibility assigned (entering and tracking)
• time allocated for review and communication
• reliability designed into system for 24/7,
  weekend, holiday and vacations

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Conclusions about the communication of critical
test results in the ambulatory area

• Lots of room for improvement
• Inpatient--key to identify responsible physician
• Outpatient--vital to ensure follow-up
• One size will not fit all
• But electronic and manual tracking systems show
  promise for improvement

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Results Manager Home Page
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Post-Hospitalization Issues Additional
Recommendations

• Request that discharge summaries include
• Diagnostic testing results that are outstanding
  at the time of discharge
• Obtain specific information about
• What the follow-up physicians need to do
• When they should do it
• What they should watch for
• Schedule early follow-up appointment with patient
• Be sure patient knows who and when to call with
  specific problems after discharge
• Make it easy for the patient to contact the
  practice!

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Outpatient Safety Concepts

• Important to focus on bigger picture as well as
  specific projects
• Many principles now coming into place in
  inpatient settings
• Need to transfer these to outpatient settings
• Creating a culture of safety is essential
• Must have a non-punitive environment
• Leadership support is essential
• Most errors are from good people working in bad
  systems (not bad apples)

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Outpatient Safety Concepts

• Need methods to capture errors that occur
• Reporting systems
• Case reviews
• Need methods to analyze errors
• Systems approach to error using human factors
• Need accountability and resources for analysis
  and follow-up of events
• To ensure that changes actually occur!

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Outpatient Safety Concepts

• In addition, specific projects are important
• Medication safety
• Electronic medical records
• Tracking and follow-up of test results
• Patient education and communication
• Transitions of care
• Better discharge planning
• How to prioritize all of these?

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Ambulatory Safe Practices follow Inpatient
Initiatives

• AHRQ Grant to the DPH
• Massachusetts Coalition for the Prevention of
  Medical Errors
• MHA
• Focus on patient safety initiative to reduce
  adverse events in Massachusetts using voluntary
  collaborative model
• Acute care hospital focus
• Medication Safety
• Best Practices for Medication Safety (1997)
• Reconciling Medications
• Communicating Critical Test Results

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• Working together, we can make inroads into
  improving ambulatory patient safety!