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Drug Safety


Drug Safety Ritesh Patel, MD 08/25/2010 Courtesy: Heidi Auerbach, MD Stephanie Polli, Pharm.D. Medications are among the most frequently used interventions to improve ... – PowerPoint PPT presentation

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Title: Drug Safety

Drug Safety
  • Ritesh Patel, MD
  • 08/25/2010
  • Courtesy Heidi Auerbach, MD Stephanie
    Polli, Pharm.D.

  • Medications are among the most frequently used
    interventions to improve patient health.
  • So it should come as no surprise that adverse
    drug events (ADEs)injuries caused by the use of
    medicationsare a common cause of preventable
    harm to hospitalized patients
  • Pharmacovigilance is the pharmacologic science
    relating to the detection, assessment,
    understanding and prevention of adverse effects,
    particularly long term and short term side
    effects of medicine.

  • In 2004, adverse drug events (ADEs) were noted in
    over 1.2 million hospital stays in the U.S.,
    about 3.1 percent of all stays. 1
  • From Dec 06 to Dec 08, 5 million reported
    incidents of medical harm from meds.2
  • Most ADEs (90.3) were listed as adverse effects
    of drugs properly administered. About 8.6 percent
    of ADEs were drug poisoningaccidental overdose,
    wrong drugs given or taken in error, or drugs
    taken inadvertently.1

Components of drug safety
  • Medical errors
  • Poly pharmacy
  • Medication Reconciliation
  • High Alert Medications.

Reported Medical errors in 2010 in Cooper
Location of affected Patients
Severity of errors
Types of errors
Classes of medications involved in medical errors
Top Medications involved in medical errors
Primary process involved in medical errors
Number of process involved in medical errors
Specific errors omnicell related
  • Oxycodone 10mg extended release rather than
    immediate release removed from omnicell and
    administered to pediatric patient for 3 doses.
  • Lorazepam 0.5mg rather than alprazolam 0.5mg
    removed from omnicell and administered to adult
    patient for 5 doses.
  • Hydromorphone 4mg rather than morphine 4mg
    removed and administered (order was for 5mg
    morphine patient received 1mg morphine and 4 mg

Specific errors Chemotherapy
  • Etoposide written order unclear and did not match
    order in Epic resulted in prolonged infusion
    over several hours rather than 2 hours
  • Cytarabine administration delayed- order comments
    not seen by nursing progress note and written/
    Epic order had a discrepancy on when to start
    based on methotrexate level
  • Contributing factors few checks in place
    pharmacist enters and verifies the order no
    second pharmacist check no attending signature/
    co signature required hybrid paper/ electronic

Specific errors Dofetilide
  • Patient did not receive his dofetilide despite
    him telling the service he needed it
  • He was shocked several times by his ICD
  • Went to CCU and required amiodarone and lidocaine
  • Was transferred to another facility

Some initiatives at Cooper
  • Alaris smart pumpsthese devices have guardrails
    which set limits and give alerts when limits are
    exceeded these have been in use for about 3
  • Bar coding to prevent errors at the point of
    administrationthis has not been implemented, but
    is in the works through nursing informatics.
  • Profiled omnicellsthis has not been implemented
    yet, but there are discussions ongoing meds can
    be obtained only with an active, pharmacist
    verified order (there are some meds that will
    have the ability to be overridden for emergent

  • Medication reconciliation- Cooper is
    participating in a collaborative with other
    institutions in NJ to work on this process.  We
    are also looking for additional resources so a
    process can be developed to deal with this issue.
     It is a big one and the implications are
    potentially serious.
  • We participate in a med safety team with the NJ
    Council of teaching hospitals.  The council is
    developing a medication safety dashboard that
    contains 6 items.  We are reporting our data for
    3 of the 6 items.  These will be collated and
    reported anonymously so we can see where other
    institutions in NJ stand.

  • Definition
  • Causes
  • Consequences
  • Prevention/management

  • Suboptimal prescribing
  • Overuse Poly pharmacy (Prescribing more drugs
    than clinically necessary)
  • Inappropriate prescribing
  • Under use
  • Hanlon JT et al. JAGS. 200149 200-9.
  • Fisk D et al. Arch Intern Med. 2003163

  • Age and chronic disease
  • Drug regimen changes
  • Providers/Patients

Causes Age and Chronic Dz
  • Increased prevalence of somatic complaints and
    chronic disease
  • Community elders- 90 gt 1med 40 gt 5meds 12 gt
  • Highest number of drugs per person in greater
    than 80 yr olds.
  • Gurwitz JH et al. JAMA. 2003289(9) 1107-1116.

Causes Drug regimen changes
  • Any transition of care- discharges,ER
  • New meds, different doses
  • Changes from generic to brand- nomenclature,
    color and/or shape

Causes Providers/Patients
  • The more the providers and visits, the more the
    meds pt takes.
  • 2/3 of all physician visits end with a
  • Expectations to receive medication.
  • Not communicating with PCP about med changes.
  • Self-treatment.

Complications of polypharmacy
  • Increased incidence of side effects and adverse
    drug reactions (ADRs)
  • Noncompliance or non adherence
  • Increased cost

Side effects and ADRs
  • Side effects considered minor enough to allow
    continuation of therapy.
  • Adverse Drug Reactions (ADRs) May necessitate
    discontinuation of drug and require treatment of
    adverse event.
  • Due to drug-drug interactions, drug-dz
    interactions, drug-herbal interactions, drug-food
    interactions, rxn to pharmacokinetics or
    dynamics, idiosyncratic.

  • Elderly 7 times more likely to have unwanted side
    effect and 2-3 times more likely to have ADRs.
  • Multiple meds is the factor most strongly
    correlated with increased risk of ADRs.
  • Exponential increase in ADRs with addition of
    more drugs to a regimen (2 drugs-15, 5
    drugs-50-60 ).

Noncompliance/Non adherence Definition
  • Not taking meds as prescribed.
  • Correlates more strongly with number of meds,
    rather than age.
  • The greater the number of meds, the greater the
    non adherence.
  • Adherence inversely proportional to frequency of
  • Osterberg L, Blaschke T. NEJM. 2005 353

Statistics of Non adherence
  • Elderly 26-59 with non adherence.
  • 33-69 of drug-related admissions result from non
    adherence (for all pts).
  • Patients discharged with 4 or more meds- over 50
    error rate
  • Osterberg NJ, Blaschke T. NEJM. 2005 353
  • Omori DM et al. Arch Intern Med. 1991 151(8)

Direct Cost
  • Those over 65 make up 12-13 of the US population
    and consume roughly 35-40 of prescription drugs.
  • Drug prices continue to rise drug costs often
    drive pt choices of health plan and discretionary

Indirect Cost
  • 10-30 elderly hospital admissions are
  • ADEs in 20 of patients on transfers.
  • Estimated 7000 deaths per yr from ADEs.
  • Mean length of stay, cost and mortality double
    for pts with ADEs.
  • Bookvar K et al. Arch Intern Med. 2004 164(5)
  • Institute of Medicine. National Academy Press.
  • Classen DC et al. JAMA. 1997227301-6.

Solutions to polypharmacy
  • Review medication
  • Anticipate ADEs
  • Avoid errors- prescribe carefully
  • Give verbal and written instructions
  • Simplify
  • Understand obstacles (cost, memory loss)
  • Enlist family/nursing/PCP
  • Make sure there is good follow up

Medication Reconciliation
  • Medication reconciliation is the process of
    creating the most accurate list possible of all
    medications a patient is taking-including drug
    name, dosage, frequency and route- and comparing
    that list against the physicians admission,
    transfer, and/or discharge orders, with the goal
    of providing correct medications to the patient
    at all transition points within the hospital.

  • Medication errors are one of the leading causes
    of injury to hospital patients, and chart reviews
    reveal that over half of all hospital medication
    errors occur at interfaces of care.3
  • Experience from Luther Midelfort-Mayo Health
    system, in Eau Claire, Winsonsin, has shown that
    poor communication of medical information at
    transition point at responsible for as many as
    50 of all medication errors in the hospital and
    up to 20 of adverse drug events.

  • Scripps Mercy Hospital reported that patients had
    a 50 adherence rate to their medication regimen
    48 to 72 hours after discharge. At 30 days after
    discharge, the adherence rate dropped to 30.
  • A multidisciplinary check of medication orders
    for pediatric cancer patients revealed that 42
    of the orders being reviewed needed to be
  • At any cost, an up-to date and accurate
    medication list is essential to ensure safe
    prescribing in any setting.

  • In 2006, the Joint Commission on Accreditation of
    Healthcare Organizations (JCAHO) started the new
    year with a mandate for accredited organizations
    to implement an innovative initiative Medication
  • The medication reconciliation process involves
    three steps
  • Verification
  • Clarification
  • Reconciliation

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Impact of medication reconciliation
  • A series of interventions, including medication
    reconciliation, introduced over a seven-month
    period, successfully decreased the rate of
    medication errors by 70 and reduced adverse drug
    event by 15.6
  • In another study, utilization of pharmacy
    technicians to initiate the reconciling process
    by obtaining medication histories for the
    scheduled surgical population reduced potential
    adverse drug events by 80 within three months of

High Alert Medications
  • High alert medications are medications that are
    most likely to cause significant harm to the
    patient, even when used as intended.
  • The Institute for Safe Medication Practices
    (ISMP) reports that, although mistakes may not be
    more common in the use of these medications, when
    errors occur the impact on the patient can be
  • JCAHO describes high-alert medications as those
    that have the highest risk of causing injury
    when misused.8

  • According to a review of events in an adverse
    drug reaction database of 317 preventable ADEs,
    analysis and categorization by type of error and
    outcome suggested that three high-priority
    preventable ADEs accounted for 50 of all
    reports Anticoagulants, Opiates and Insulin.9
  • IHIs campaign has chosen to focus on four groups
    on high alert medications- Anticoagulants,
    narcotics and opiates, insulins and sedatives.
  • The most common types of harm associated with
    hypotension, bleeding, hypoglycemia, delirium,
    lethargy and bradycardia.

General Principles to reduce harm
  • Hospitals and other care settings should employ
    the following principles of a safe system
  • 1) Design process to prevent errors and harm
  • 2) Design methods to identify errors and harm
    when they occurs
  • 3)Design methods to mitigate the harm that may
    results from errors

  • Methods to prevent harm include
  • Develop order sets, preprinted order forms and
    clinical pathways or protocols to reflect a
    standardized approach to treat patients with
    similar problems, disease states or needs.
  • Minimize variability by standardizing
    concentrations and dose strengths.
  • Consider centralized pharmacist or nurse run
    anticoagulation services.
  • Appropriate monitoring parameters in order sets,
    protocols and flow sheets.
  • Consider protocol for vulnerable populations such
    as elderly, pediatric, and obese patients.

  • Methods to identify errors and harm include
  • Include reminders and information about
    appropriate monitoring parameters in order sets,
    protocols and flow sheets.
  • Ensure that critical lab information is available
    to those who can take action.
  • Implement independent double checks where
  • Instruct patients on symptoms to monitor and when
    to contact health care provider for assistance.

  • Methods to mitigate harm include
  • Develop protocols allowing for the administration
    of reversal agents without having to contact the
  • Ensure that antidotes and reversal agents are
    readily available.
  • Have rescue protocols available.

  • Adverse Drug Events in U.S. Hospitals, 2004 April
    2007Anne Elixhauser, Ph.D. and Pamela P, Ph.D.
  • www.ihi.org Protecting 5 million lives.
  • Rozich JD at al, medication safety one
    organizations approach to the challenge.JCOM.
  • Branowicki P. Sentinel events opportunities for
    change. Presentation at Massachusetts coalition
    for the prevention of medical errors conference.
    November 18, 2002.
  • Reducing Risk Through Medication Reconciliation.
    Jeannette Yeznach Wick, RPh, MBA, FASCP.
    Published Online March 1, 2007 - 120000 AM
  • Whittington J, Cohen H. OSF healthcare's journey
    in patient safety. Qual Manag Health Care.
  • Michels RD, Meisel S. Program using pharmacy
    technicians to obtain medication histories. Am J
    Health-sys pharm. October 1, 2003 60 1982-1986
  • Commission Sentinel Event Alert, November 19,
  • Winterstein AG At al. Identifying clinically
    significant preventable adverse drug events
    through a hospitals database of adverse drug
    rection reports. American Journal of
    Health-system Pharmacy.2002 Sep59(18)1742-1749
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