Ethical, Legal,

1
Ethical, Legal, Financial Rationale for the
Transition to
Preferred Drug Formulations(Speaker Insights)
2
Objectives Why are you Doing This?

• Patient safety is an issue that impacts your
  institution from an economic, legal, and ethical
  standpoint every day.
• Patient safety starts with a top-down
  approach(C-Suite) and should be an institutional
  objective.
• C-Suite executives may not be aware of the true
  impact of patient safety on your institution.
• Obtaining buy-in and support from decision makers
  will jump-start a proactive approach to patient
  safety.
• Convey to the C-Suite that one way to improve
  patient safety is to reduce medication errors
  through the use of manufacturer produced
  ready-to-use formulations.

3
Questions to Consider whenPreparing your
Presentation

• Do you find your C-Suite proactive or reactive
  towards safety initiatives?
• Has a safety culture taken hold at your
  institution?
• Does your leadership haveall of the information
  neededto make a decision?

4
What do you Consider ImportantInformation for a
Call to Action?

• ASHP Safety Summit
• Consensus Conference
• USP lt797gt
• Joint Commission
• CMS Never Events
• Recent Safety Issue

5
Why are you the Most Qualified Personto Relay
this Information?

• Pharmacy is the lead in medication delivery
  safety
• Leverage expert stature/training
• Have implemented/are implementingsystem-wide
  medication safety initiatives
• Valued and trusted member of institution

Lacaria K, Balen RM, Frighetto L, Lau TTY,
Naumann TL, Jewesson PJ. Perceptions of the
Professional Pharmacy Services in a Major
Canadian Hospital A Comparison of Stakeholder
Groups. Longwoods Review. 20042(1)819. Saad L.
2008 Gallup Honesty and Ethics Poll. Nurses
Shine, Bankers Slump in Ethics Rating press
release. Available at http//www.gallup.com/poll
/112264/Nurses-Shine-While-Bankers-Slump-Ethics-Ra
tings.aspx. Accessed June 11, 2009.
6
A Model Presentation for your C-Suite

• The following slides can be used in total or you
  can select only the ones that you need.
• The slides have speaker notes and are fully
  referenced.

7
Ethical, Legal, Financial Rationale for the
Transition to
Preferred Drug Formulations(Actual C-Suite
Presentation)
8
Todays Objectives

• Present the recommendations and support from
  organizations and guidelines regarding the
  conversion and benefits of ready-to-use, premixed
  medications.
• Present information on the ethical, legal, and
  financial risks and consequences associated
  with medication errors and discuss how they can
  impact our hospital.
• Discuss and form consensus on the purchase,
  expansion, or continuance of using ready-to-use,
  premixed medications and the impact on medication
  error reduction.

9
Topics for Discussion

• Joint Commission, NPSG, and ASHP drivers of
  medication error reduction
• Medication errors impact on staff morale and PR
• The financial impact of medication errors
• Our recommendations moving forward

10
Ready-to-administer Products are Recommended by

• The Joint Commission

To reduce compounding and labeling errors, the
hospital uses only oral unit dose products,
pre-filled syringes, or pre-mixed infusion bags
when these types of products are available.
The Joint Commission Accreditation Program
Hospital. National Patient Safety Goals. The
Joint Commission Web site. Available at
http//www.jointcommission.org/NR/rdonlyres/31666E
86-E7F4-423E-9BE8-F05BD1CB0AA8/0/HAP_NPSG.pdf.
Accessed July 10, 2009.
11
Ready-to-administer Products are Recommended by
(cont.)

• A 2008 multidisciplinary panel representing
  medicine, nursing, pharmacy, and governmental and
  patient safety organizations

Dispense IV medications and admixtures in
ready-to-administer form.
ASHP. Proceedings of a summit on preventing
patient harm and death from i.v. medication
errors. Am J Health-Syst Pharm. 2008652367-2379.
12
Timing is Everything
ASHP REPORTS I.V. medication errors
Table 2. Short-Term Actions to Support Safe I.V. Medication Practices Table 2. Short-Term Actions to Support Safe I.V. Medication Practices Table 2. Short-Term Actions to Support Safe I.V. Medication Practices
Recommended Action Proposed Primary Stakeholder Groups Time Frame
Create business case for chief executive officer, health care leadership, and payers about the need to improve i.v. medication safety by providing a framework for a medication safety committee based on best practices Professional organizations, health care executives, or hospital boards and trustees 12 mo

• Summit took place July 1415, 2008 . . .
• . . . the time is now!

ASHP. Proceedings of a summit on preventing
patient harm and death from i.v. medication
errors, Am J Health-Syst Pharm. 2008652367-2379.
13
Key Points

• Patient safety is the 1 priority of hospital
  CEOs, yet medication errors are common.
• Many of the parenteral medications involved in
  medication errors are available in
  ready-to-administer form.
• Errors involving parenteral medications can have
  a major financial impact on hospitals.

14
Risks

• Ethical
• Legal
• Financial

15
Ethical Risks

• Do No Harm
• Hippocrates, 4th century BC

16
Top 5 Priorities of Healthcare CEOs
Priority Percent Selected
Quality/Patient Safety 69
Physician Recruitment/Retention 43
Reimbursement 29
Consumer Satisfaction 25
Construction/Capital Improvements 25
Adapted from HealthLeaders Media Industry Survey
2009. HealthLeaders Media survey. Available at
http//www.healthleadersmedia.com/pdf/survey_proje
ct/2008-2009/CEO_final.pdf. Accessed July 10,
2009.
17
But Medication Errors Remain Common
Deaths from Intravenous Colchicine Resulting from
a Compounding Pharmacy ErrorOregon and
Washington, 2007
1 in 10 patients gets drug error Study examines
six community hospitals in Mass.
18
The Human Cost of Medication Errors

• The patient
• I was frightened to complain any more . . . I
  was scared that I would get more mistreated.1

• The clinician
• You get that sinking feeling probably on a
  daily basis almost.2

1. Delbanco T, Bell SK. Guilty, Afraid, and
AloneStruggling with Medical Error. N Engl J
Med. 2007357(17)1682-1683. 2. Gallagher TH,
Waterman AD, Ebers AG, et al. Patients' and
Physicians' Attitudes Regarding the Disclosure of
Medical Errors. JAMA. 2003289(8)1001-1007.
19
Risks

• Ethical
• Legal
• Financial

20
Medication Errors can beHighly Publicized and
Costly
Jury awards 2M in wrongful death suit to family
of Methuen woman . . . Jan 23, 2009 . . . the
kind of damage that can be caused by a medication
error in a hospital," said . . . the jury
Overdose Nurse Charged In Patient's Death,
Hospital Held Liable . . . can be held liable in
a civil lawsuit. However, that which harmed the
patient, the nurse's medication error itself,
amounted to civil negligence . . .
IV medication error payout Feb 10, 2009 . . .
Intravenous news A jury has awarded 5 million
in a Pennsylvania malpractice lawsuit filed over
a hospital medication error where a woman . . .
21
Top Medical Claims20022006
N1,164 claims
Adapted from CRICO/RMF. High Risk Medication.
Available at http//www.rmf.harvard.edu/high-risk
-areas/medication/index.aspx. Accessed July 13,
2009.
22
Legal Fees and Awards
Per Settled Claim
100 were medication-related 17 were
medication-related
Rothschild JM, Federico FA, Gandhi TK, Kaushal R,
Williams DH, Bates DW. Analysis of
Medication-Related Malpractice Claims. Arch
Intern Med. 2002162(21)2414-2420. Studdert DM,
Mello MM, Gawande AA, et al. Claims, Errors, and
Compensation Payments in Medical Malpractice
Litigation. N Engl J Med. 2006354(19)2024-2033.
23
Medications Most Commonly Associatedwith a
Malpractice Claim

• Antibiotics
• Antidepressants/Antipsychotics
• Cardiovascular drugs
• Blood coagulation modifiers
• Opioids
• Anxiolytics/Sedative hypnotics
• Insulin

Rothschild JM, Federico FA, Gandhi TK, Kaushal R,
Williams DH, Bates DW. Analysis of
Medication-Related Malpractice Claims. Arch
Intern Med. 2002162(21)2414-2420. ASHP.
Proceedings of a summit on preventing patient
harm and death from i.v. medication errors. Am J
Health-Syst Pharm. 2008652367-2379.
24
Medications Most Commonly Associatedwith a
Malpractice Claim

• Antibiotics
• Antidepressants/Antipsychotics
• Cardiovascular drugs
• Blood coagulation modifiers
• Opioids
• Anxiolytics/Sedative hypnotics
• Insulin

Available inready-to-administer form for use in
hospitalized patients
Rothschild JM, Federico FA, Gandhi TK, Kaushal R,
Williams DH, Bates DW. Analysis of
Medication-Related Malpractice Claims. Arch
Intern Med. 2002162(21)2414-2420. ASHP.
Proceedings of a summit on preventing patient
harm and death from i.v. medication errors. Am J
Health-Syst Pharm. 2008652367-2379.
25
Risks

• Ethical
• Legal
• Financial

26
Hospitals are Responding to theEconomic
Challenges
Percent of hospitals reporting a
moderate-to-significant decreasein total and
operating margin
39
28
26
29
2009 calendar year-to-date versus same period
last year
Adapted from American Hospital Association. The
Economic Crisis The Toll on the Patients and
Communities Hospitals Serve. Available at
http//www.aha.org/aha/content/2009/pdf/090427econ
crisisreport.pdf. Accessed June 26, 2009.
27
Hospitals are Responding to the Economic
ChallengesReducing Overhead
90
80
Percent of hospitals making changes in response
toeconomic concerns since September 2008
48
39
22
9
8
Percent of hospitals making at least one of the
changes to weather the economic storm.
Adapted from American Hospital Association. The
Economic Crisis The Toll on the Patients and
Communities Hospitals Serve. Available at
http//www.aha.org/aha/content/2009/pdf/090427econ
crisisreport.pdf. Accessed June 26, 2009.
28
Hospital Pharmacies are AlsoMaking Changes

• 2009 survey of pharmacy directors to
• Assess the impact of the current economy on
  pharmacy services in hospitals and health systems
• 66 had been required to reduce their drug budget
• gt50 had taken some action to manage expenses
• 37 had reduced staff within the last 6 months
• 29 had postponed/reduced/eliminated planned
  facility improvements to comply with USP Chapter
  lt797gt

Chen D. Impact of the current economy on pharmacy
services in hospitals and health systems.
American Society of Health-System Pharmacists.
Available at http//www.ashp.org/economy-survey.
Accessed July 13, 2009.
29
But Patient Safety Remainsa Major Problem
1. Institute of Medicine To Err Is Human
Building a Safer Health System. Available at
http//www.iom.edu/Object.File/Master/4/117/ToErr
-8pager.pdf. Accessed July 14, 2009. 2. Institute
for Healthcare Improvement. Available at
http//www.ihi.org/IHI/Programs/Campaign/Campaign.
htm?TabId6. Accessed July 14,
2009. 3. HealthGrades. Available at
http//www.healthgrades.com/media/dms/pdf/PatientS
afetyInAmericanHospitalsStudy2009.pdf. Accessed
July 14, 2009.
30
Financial Impact of Medication Errors
Retrospective review of medical records of all
discharges from three community hospitals (N
123,281)
Event Events Days/Event Cost/Event Total Days Total Cost
Total 11,936 0.43 749 4,854 8,370,937
Medication 4,543 0.52 913 2,364 4,149,346
Medication errors on average increase costs and
LOS
Adapted from Paradis AR, Stewart VT, Bayley KB,
Brown A, Bennett AJ. Excess Cost and Length of
Stay Associated With Voluntary Patient Safety
Event Reports in Hospitals. Am J Med Qual.
200924(1)53-60.
31
Financial Impact of IntravenousMedication-related
Adverse Events
Retrospective review of computerized medical
records ofICU patients (N 4604) 397
intravenous medication-related adverse events
Hospital type Excess Cost vs Controls Excess Length of Stay vs Controls
Non-academic 188 -0.3 days
Academic 6,647 4.8 days
Medication errors in academic hospital ICUs
aremajor cost and LOS modifiers
Nuckols TK, Paddock SM, Bower AG, et al. Costs of
intravenous adverse drug events in academic and
nonacademic intensive care units. Med Care.
200846(1)17-24.
32
The Financial Cascade of Medication Errors

• ? Utilization of Services
• Workload

? Cost
? Length Of Stay
Medication Errors
Finances
? Risk for PSE
? Reimbursement

• Patient
• Satisfaction

Seek Care Elsewhere
PSE Patient Safety Event
Seek Litigation
33
Summary

• Medication errors can leadto a host of ethical,
  legal, and financialnegative consequences

34
A Solution

• One approach to reduce medication errors is to
  use sterile medications in a ready-to-administer
  form as recommended by numerous independent
  groups
• and/or
• Maintain or expand the current portfolio of
  manufacturer, ready-to-administer medications

35
References

• 1. About Lawsuits. IV medication error payout.
  Available at http//www.ivteam.com/iv-medication-
  error-payout/. Accessed July 14, 2009.
• 2. American Hospital Association. The Economic
  Crisis The Toll on the Patients and Communities
  Hospitals Serve. Available at http//www.aha.org
  /aha/content/2009/pdf/090427econcrisisreport.pdf.
  Accessed June 26, 2009.
• 3. ASHP. Proceedings of a summit on preventing
  patient harm and death from i.v. medication
  errors. Am J Health-Syst Pharm.
  2008652367-2379.
• 4. Barker KN, Flynn EA, Pepper GA, Bates DW,
  Mikeal RL. Medication Errors Observed in 36
  Health Care Facilities. Arch Intern Med.
  2002162(16)1897-1903.
• 5. Centers for Medicare and Medicaid Services.
  CMS improves patient safety for medicare and
  medicaid by addressing never events. Available
  at http//www.workforce.com/tools/misc/fs11_never
  _events_081001.pdf. Accessed June 11, 2009.
• 6. Chen D. Impact of the current economy on
  pharmacy services in hospitals and health
  systems. American Society of Health-System
  Pharmacists. Available at http//www.ashp.org/e
  conomy-survey. Accessed July 13, 2009.
• 7. Consumers Union. To err is humanTo delay is
  deadly. Available at http//www.safepatientproje
  ct.org/safepatientproject.org/pdf/safepatientproje
  ct.org-ToDelayIsDeadly.pdf. Accessed July 10,
  2009.
• 8. CRICO/RMF. High risk areas. Medication.
  Available at http//www.rmf.harvard.edu/high-risk
  -areas/medication/index.aspx. Accessed July 13,
  2009.
• 9. Delbanco T, Bell SK. Guilty, Afraid, and
  AloneStruggling with Medical Error. N Engl J
  Med. 2007357(17)1682-1683.

36
References (cont.)

• 10. Gallagher TH, Waterman AD, Ebers AG, et al.
  Patients' and Physicians' Attitudes Regarding the
  Disclosure of Medical Errors. JAMA.
  2003289(8)1001-1007.
• 11. Gershman MD, Kennedy DJ, Noble-Wang J, et al.
  Multistate outbreak of Pseudomonas fluorescens
  bloodstream infection after exposure to
  contaminated heparinized saline flush prepared by
  a compounding pharmacy. Clin Infect Dis.
  200847(11)1372-1379.
• 12. HealthGrades. The Sixth Annual HealthGrades
  Patient Safety in American Hospitals Study.
  Available at http//www.healthgrades.com/media/d
  ms/pdf/PatientSafetyInAmericanHospitalsStudy2009.p
  df. Accessed July 14, 2009.
• 13. HealthLeaders Media Industry Survey 2009.
  Available at http//www.healthleadersmedia.com/pd
  f/survey_project/2008- 2009/CEO_final.pdf.
  Accessed July 10, 2009.
• 14. Hicks RW, Becker SC. An Overview of
  Intravenous-related Medication Administration
  Errors as Reported to MEDMARX, a National
  Medication Error-reporting Program. J Infus
  Nurs. 200629(1)20-27.
• 15. Institute of Medicine. To Err Is Human
  Building a Safer Health System. Available at
  http//www.iom.edu/Object.File/Master/4/117/ToErr-
  8pager.pdf. Accessed July 14, 2009.
• 16. Institute for Healthcare Improvement.
  Protecting 5 Million Lives From Harm. Available
  at http//www.ihi.org/IHI/Programs/Campaign/Camp
  aign.htm?TabId6. Accessed July 14, 2009.
• 17. Institute of Medicine. Report brief-July
  2006. Preventing medication errors. Available at
  http//www.iom.edu/Object.File/Master/35/943/medi
  cation20errors20new.pdf. Accessed June 11,
  2009.

37
References (cont.)

• 18. Lacaria K, Balen RM, Frighetto L, Lau TTY,
  Naumann TL, Jewsson PJ. Perceptions of the
  Professional Pharmacy Services in a Major
  Canadian Hospital A Comparison of Stakeholder
  Groups. Longwoods Review. 20042(1)8-19.
• 19. Legal Eagle. Overdose Nurse charged in
  patients death, hospital held liable. Available
  at http//www.nursinglaw.com/overdose.pdf.
  Accessed July 14, 2009.
• 20. Maragakis LL, Chaiwarith R, Srinivasan A, et
  al. Sphingomonas paucimobilis bloodstream
  infections associated with contaminated
  intravenous fentanyl. Emerg Infect Dis.
  200915(1)12-18.
• 21. Nuckols TK, Paddock SM, Bower AG, et al.
  Costs of intravenous adverse drug events in
  academic and nonacademic intensive care units.
  Med Care. 200846(1)17-24.
• 22. Paradis AR, Stewart VT, Bayley KB, Brown A,
  Bennett AJ. Excess Cost and Length of Stay
  Associated With Voluntary Patient Safety Event
  Reports in Hospitals. Am J Med Qual.
  200924(1)53-60.
• 23. Parshuram CS, To T, Seto W, Trope A, Koren G,
  Laupacis A. Systematic evaluation of errors
  occurring during the preparation of intravenous
  medication. CMAJ. 2008178(1)42-48.
• 24. Rothschild JM, Federico FA, Gandhi TK,
  Kaushal R, Williams DH, Bates DW. Analysis of
  medication-related malpractice claims causes,
  preventability, and costs. Arch Intern Med.
  2002162(21)2414-2420.
• 25. Saad L. 2008 Gallup Honesty and Ethics Poll.
  Nurses Shine, Bankers Slump in Ethics Rating
  press release. Available at http//www.gallup.
  com/poll/112264/Nurses-Shine-While-Bankers-Slump-E
  thics-Ratings.aspx. Accessed on June 11, 2009.
• 26. Studdert DM, Mello MM, Gawande AA, et al.
  Claims, errors, and compensation payments in
  medical malpractice litigation. N Engl J Med.
  2006354(19)2024-2033.

38
References (cont.)

• 27. The Joint Commission Accredited Program
  Hospital. National Patient Safety Goals. The
  Joint Commission Website. Available at
  http//www.jointcommission.org/PatientSafety/Nati
  onalPatientSafetyGoals/09_hap_npsgs.htm Accessed
  July 10, 2009.
• 28. US Centers for Disease Control and
  Prevention. Deaths from intravenous colchicine
  resulting from a compounding pharmacy
  error-- Oregon and Washington, 2007. MMWR Morb
  Mortal Wkly Rep. 200756(40)1050-1052.
• 29. Valentin A, Capuzzo M, Guidet B, et al.
  Errors in administration of parenteral drugs in
  intensive care units multinational prospective
  study. BMJ. 20093381-8.
• 30. Vogler ME. Jury awards 2M in wrongful death
  suit to family of Methuen woman. Available at
  http//www.eagletribune.com/punews/local_story_02
  3011843.html. Accessed July 14, 2009.
• 31. Wen P. 1 in 10 patients gets drug error.
  Study examine six community hospitals in Mass.
  Available at http//www.boston.com/news/local/ar
  ticles/2008/02/14/1_in_10_patients_gets_drug_error
  /. Accessed July 10, 2009.
• 32. Wheeler DW, Degnan BA, Sehmi JS, Burnstein
  RM, Menon DK, Gupta AK. Variability in the
  concentrations of intravenous drug infusions
  prepared in a critical care unit. Intensive Care
  Med. 200834(8)1441-1447.