Drug Safety

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					 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
  medications—are 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 poisoning—accidental
  overdose, wrong drugs given or taken in error, or
  drugs taken inadvertently.1
Components of drug safety
1)   Medical errors
2)   Poly pharmacy
3)   Medication Reconciliation
4)   High Alert Medications.
Reported Medical errors in 2010
in Cooper
       70     1                   1

       60

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Location of affected Patients
 Severity of errors

                           Severity

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                                                Types of errors




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Classes of medications involved in
medical errors
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                                                           Top Medications involved in




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                                      Primary process involved in
      Number of process involved in
      medical errors

          19, 8% 2, 1%



                                      1
                                      2
                         119, 53%     3
87, 38%
                                      4+
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 hydromorphone)
  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 system
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 infusions
• Was transferred to another facility
Some initiatives at Cooper
• Alaris smart pumps—these devices have guardrails
  which set limits and give alerts when limits are
  exceeded; these have been in use for about 3
  years.

• Bar coding to prevent errors at the point of
  administration—this has not been implemented, but
  is in the works through nursing informatics.

• Profiled omnicells—this 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 situations)
• 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.
Polypharmacy
   Definition
   Causes
   Consequences
   Prevention/management
Definition
Suboptimal prescribing

    Overuse = Poly pharmacy (Prescribing more
     drugs than clinically necessary)

    Inappropriate prescribing

    Under use

   Hanlon JT et al. JAGS. 2001;49: 200-9.
   Fisk D et al. Arch Intern Med. 2003;163: 2716-2724.
Causes
• 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% > 1med; 40% > 5meds;
  12% > 10meds.

 Highest number of drugs per person in greater
  than 80 yr olds.


 Gurwitz JH et al. JAMA. 2003;289(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 prescription.

 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.
ADRs
 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
  dosing.

Osterberg L, Blaschke T. NEJM. 2005; 353: 487-97.
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: 487-97.
Omori DM et al. Arch Intern Med. 1991; 151(8): 1562-4.
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
  noncompliance.
Indirect Cost
 10-30% elderly hospital admissions are drug-
  related.

 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): 545-50.
Institute of Medicine. National Academy Press. 2000.
Classen DC et al. JAMA. 1997;227:301-6.
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 physician’s 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 changed.4

• 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
  Reconciliation.5

• The medication reconciliation process involves
  three steps:
- Verification
- Clarification
- Reconciliation
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
  implementation.7
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
  significant.

• 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

• IHI’s 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
    appropriate.

-   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
    physician.

-   Ensure that antidotes and reversal agents are
    readily available.

-   Have rescue protocols available.
1)   Adverse Drug Events in U.S. Hospitals, 2004 April 2007;Anne Elixhauser, Ph.D.
     and Pamela P, Ph.D.
2)   www.ihi.org; Protecting 5 million lives.
3)   Rozich JD at al, medication safety: one organization’s approach to the
     challenge.JCOM. 2001;8(10):27-34
4)   Branowicki P. Sentinel events: opportunities for change. Presentation at
     Massachusetts coalition for the prevention of medical errors conference. November
     18, 2002.
5)   Reducing Risk Through Medication Reconciliation. Jeannette Yeznach Wick,
     RPh, MBA, FASCP. Published Online: March 1, 2007 - 12:00:00 AM (CST)
6)   Whittington J, Cohen H. OSF healthcare's journey in patient safety. Qual Manag
     Health Care. 2004;13:53-59.
7)   Michels RD, Meisel S. Program using pharmacy technicians to obtain medication
     histories. Am J Health-sys pharm. October 1, 2003; 60: 1982-1986
8)   Commission Sentinel Event Alert, November 19, 1999.
9)   Winterstein AG At al. Identifying clinically significant preventable adverse drug
     events through a hospital’s database of adverse drug rection reports. American
     Journal of Health-system Pharmacy.2002 Sep;59(18):1742-1749

				
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