Ritesh Patel, MD
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
• 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
70 1 1
Location of affected Patients
Severity of errors
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Number of process involved in
19, 8% 2, 1%
119, 53% 3
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
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
• 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
• 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.
Overuse = Poly pharmacy (Prescribing more
drugs than clinically necessary)
Hanlon JT et al. JAGS. 2001;49: 200-9.
Fisk D et al. Arch Intern Med. 2003;163: 2716-2724.
• Age and chronic disease
• Drug regimen changes
Causes: Age and Chronic Dz
Increased prevalence of somatic complaints and
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-
Causes: Drug regimen changes
Any transition of care- discharges,ER
New meds, different doses…
Changes from generic to brand-
nomenclature, color and/or shape
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.
Complications of polypharmacy
Increased incidence of side effects and
adverse drug reactions (ADRs)
Noncompliance or non adherence
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
Due to : drug-drug interactions, drug-dz
interactions, drug-herbal interactions, drug-food
interactions, rxn to pharmacokinetics or dynamics,
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-
Not taking meds as prescribed.
Correlates more strongly with number of meds,
rather than age.
The greater the number of meds, the greater the
Adherence inversely proportional to frequency of
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.
Those over 65 make up 12-13% of the US
population and consume roughly 35-40% of
Drug prices continue to rise– drug costs often drive
pt choices of health plan and discretionary
10-30% elderly hospital admissions are drug-
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
Avoid errors- prescribe carefully
Give verbal and written instructions
Understand obstacles (cost, memory loss…)
Make sure there is good follow up
• ―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
• 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
Impact of medication
• 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
• 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
- 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
- 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
4) Branowicki P. Sentinel events: opportunities for change. Presentation at
Massachusetts coalition for the prevention of medical errors conference. November
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