Applying the Evidence for Clinical Pharmacy Services to Pharmacy
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Applying the Evidence for
Clinical Pharmacy Services to
Pharmacy Practice
Provided by:
Michael G. Liebl, BS, PharmD, BCPS
Clinical Manager, Pharmacy Services
The Methodist Hospital
Houston, TX 77030
Pager: 281-735-5815
Phone: 713-441-6973
Email: mliebl@tmhs.org
Program Learning Objectives
At the completion of this program, the participant will be able to:
1. Review the pharmacy and medical literature that evaluates clinical
pharmacy services.
2. Identify key clinical pharmacy services demonstrated to improve
morbidity and mortality outcomes.
3. Estimate the relative pharmacoeconomic benefit of certain clinical
pharmacy services.
4. Relate the findings from the pharmacy and medical literature to an
institution's provision of clinical pharmacy services.
Disclosures:
• No financial interest in any entity or individual cited in the presentation
• Regarding disclosures for non-commercial content and conclusions within:
• Active memberships in ACCP, ASHP, TSHP, GCSHSP & SCCM
• My primary position: Manager, clinical pharmacy services
• Previous role: Clinical pharmacist MICU & CVICU
• Conducted and involved in clinical pharmacy research studies that
evaluating the value of clinical pharmacy services
• I have a significant (and financial) relationship with a clinical pharmacist
A timeline of our clinical pharmacy ancestry in the words
of leaders of the movement
W. Arthur Purdum
...within the new minimum standard lies the key to our first
objective: improving and extending the usefulness of the
hospital pharmacist.
…Today we are still recognized as a complementary service
department and we must continue our efforts until
pharmacy is regarded as essential.
1950
Fast Forward to 2008 and ask the tough questions…
• Is there an essential, established need for advanced clinical pharmacy
services?
• If yes, how great is the need? Is there a cost for not providing them?
• What type of clinical services make the greatest difference?
• What training is required to provide these services?
• How many providers for a given institution?
• Can the value of these services be measured?
• Is the difference realized significant to stakeholders?
• Patients
• Administrators
• Quality / regulatory agencies
• Others
• Has the call for advanced clinical pharmacy services been endorsed by:
our profession, administrators, quality / regulatory agencies & patients?
So, where to begin…
Is there an essential, established need for
advanced clinical pharmacy service?
...what is the problem or the void in healthcare?
Medications:
Estimated as the #4 Killer Annually
Heart disease 743,460 dead
Cancer 529,904 dead
Stroke 150,108 dead
Medications 137,000 dead
Pulmonary disease 101,077 dead
Accidents 90,523 dead
Pneumonia 75,719 dead
Lazarou, et al. JAMA 1998;279:1200-5
# of Events % of
How common are ADRs &
Patients with Comments
ADEs? (1000 pt days) ADRs
Cornish P. Arch Int Med 2005; 165: % of Patients with error: 53% 38% with moderate to severe
424-429. – Admission adverse event potential
Weiner B, Venarske JL, Yu M & % of meds with error pre: 62% 42% with moderate to severe
Mathis K. Spine 2008; % of meds with error post: 39% adverse event potential
Bowman L. Can J of Hosp Pharm 23.1% LOS 6.6 days; ~70% type
1994; 5: 209-216. (Wishard, IN) 10% severe ”A” Events
Classen DC. 2.4% Mortality 2%, LOS 2 days
JAMA. 1997; 277: 301-6 at a cost of $2,000/event
Moore N. 5.6 NR LOS 8.5 days;
Br J Clin Pharmacol 1998; 3: 301-8. 7.6% of all hosp days
Lazarou J. JAMA 1998; 279: 1200. NR 6.7% (total) Estimated as the 4th - 6th
(Meta-analysis of ADRs) 0.32% (fatal) leading cause of death
Vargas E. CCM 2003; 31: 694-98. NR 9.2% LOS 3.9 days
Cullen D. CCM 1997; 25: 1289-97. 9.7 NR NR
Holdsworth M. Arch Pediatr Adolesc 7.5 6% LOS 15.3 days
Med 2003; 157: 60-65.
Chaudhry S, Olofinboba K, J Gen NR 4.9% 1.9% of ADRs attributed to
Intern Med 2003; 18: 595-600. increased morbidity
Forester A. Ann Intern Med 2003; NR 7.9% Hospital readmissions due to
138: 161-167. medication events
Could these be the most dangerous
(and expensive) medical devices?
How Hazardous Is Health Care?
DANGEROUS REGULATE ULTRA-SAFE
(>1/1000) (<1/100K)
100,000 HealthCare
Annual Cost: Lives Lost
Driving
10,000
1,000
Scheduled
Airlines
100
Mountain Chemical European
Climbing Manufacturing Railroads
10
Bungee Chartered Nuclear
Jumping Flights Power
1
1 10 100 1,000 10,000 100,000 1,000,000 10,000,00
0
Number of encounters for each fatality
Source: Roger Resar, MD (Mayo Clinic) IHI Symposium 2001
Neil M. Davis
“…After studying the Institute of Medicine’s To Err Is Human, a suggestion for
improving might be that there should be a person who has expert knowledge
about drugs and drug therapy to review the entire drug selection and
monitoring aspects of patient care. In a world where there were no such
people as pharmacists, they would have to be invented. Perhaps, on that
planet, they would be called “medicationists”.
Well, our world does have drug experts. They are
called pharmacists, so there is no need to create
a new professional to fill that void.”
2000
Clinical Pharmacy Services That Impact Patient
Care Outcomes
• Specifics on individual services rendered
• Admitting Pharmacist Services
• Pharmacist Rounding
• ICU
• Acute Care
• Anticoagulation Services
• Pharmacokinetic Services
• High-risk populations
• Transplant
• Oncology
Admitting Pharmacy Services:
Addressing Medication Errors From the Start
Cornish P. Gleason K. Weiner, Venarske, Yu
Arch Int Med 2005 AJHP 2004 & Mathis; Spine 2008*
N = 523 N = 204
N = 82 & 87
Medication Error Rate 53.6% 54.6% 64%, 38%
Most Common Error Type – 46.4% 42.3% 22%, 40.4%
Omission
Harm Potential: 38.6% 45% 40%, 22%
Moderate to High
• Consistent finding of error rates
• Consistent estimation of harm potential
• Consistent finding of a meaningful improvement (reduction in error rate) with
pharmacist involvement in the process
*Two phases reported for this evaluation: Pre-intervention & post-intervention
Clinical Pharmacist Impact: Inpatient Rounds
Study (Population) Control Pharmacist RRR / ARR / NNT
Group / Period Group / Period (Defined Below)
Herfindal E. Drug Intel & Clin Trend toward decreased LOS in pharmacy period
Pharm. 1985 (CVICU) Trend toward decreased drug costs
Significant decrease in ABTX use
White CM. Hospital Pharmacy Evaluated 14 days of services in a 12 bed ICU: 6.14 interventions /day.
1998 (CVICU) Costs reduced and clinical benefits from interventions demonstrated
Montazeri M & Cook D. Crit Care 54 working days activities chronicled and analyzed
Med 1994 $67,000 annually in drug cost reduction estimated if 7 days per week.
Leap L. JAMA 1999 Serious ADRs: 10.4% 3.5% 66% / 7% / 14.2 pts
(CCU & MICU)
Lee A. Hospital Pharmacy 2007 Errors Identified: 54 256 No difference in LOS
(ICU) Omitted Drug: 9% 41%
Kucukarslan S. Arch Int Med Serious ADRs:10% 2.5% 78% / 7.5% / 13.3 pts
2003 (IM Acute Care)
Boyko WL. AJHP 1997 LOS – 5.5 Days 4.2 23% RRR
(IM Acute Care) Hosp cost/pt – 6,155 4,501 26% RRR
Pharm cost/pt – 782 481 38% RRR
RRR: Relative Risk Reduction
ARR: Absolute Risk Reduction
NNT: Number needed to treat = [(1/ARR)x100]
Pharmacy Consult Services: Findings
Inpatient Anticoagulation
Ellis RF. AJHP 1992. (Warfarin) Patients more likely to have PT “stability” at discharge (61% vs.
42%; Pharmacy vs. Control)
Dager WE. • Reduced LOS: 9.5 +/- 5.6 vs. 6.8 +/- 4.4 days (28% RR)
Annals of Pharmacotherapy 2000 • Reduced # patients & patient-days with INR >3.5 : 37 patients &
(Warfarin) 142 days vs. 16 patients & 29 days respectively
• Reduced number of patients & patient-days with INR >6.0. 20 pts
& 50 days vs. 2 pts & 6 days.
• Reduced bleeding complications
Rivey MP. Time to therapeutic PTT was less (20 vs. 40hrs; Pharm vs. control)
AJHP 1993. (Heparin) Fewer SUPRAtherapeutic PTTs: (1.7 vs. 5.5; Pharm vs. control)
No difference in bleeding rates (low event rate overall)
Bowden C. et al AJHP 1998. Pharmacoeconomic benefit to pharmacist managed heparin.
(Heparin) $843 per patient managed
Fugate S. AJHP 2008. (Heparin- HIT Management by pharmacy is effective and safe. Reduced
Induced Thrombocytopenia – HIT) events of potential harm from therapy mis-management
Tschol N. Can J Cardiol 2003 Pharmacist was equally effective to MDs for post CV Surgery
patients. Pharmacist had 5.9% fewer days with INR > 4.
Reduction in transfusions, morbidity (bleeding complications),
Bond CA. Pharmacotherapy 2004.*
patient charges and mortality for both heparin and warfarin services
(Warfarin & Heparin)
*Only 20% & 11% of hospitals have heparin & warfarin consult services respectively
Published Studies on Pharmacy Findings
Consult Services: Hospitals with the service vs.
Pharmacokinetic Services Hospitals without the service
Bond CA. AJHP 2005. Death rate was 1% less
(Vancomycin & Aminoglycosides) LOS: 1.4 days less
Renal complications: 11% less
Drug, Lab & Total hospital charges were less
ADE Frequency: Outpatient Setting Findings
Gandhi TK. • ADEs affected 25% of patients. 13% serious (of these,
Adverse Drug Events in Ambulatory Care 13% ameliorable and 11% preventable)
NEJM 2003 • ADEs increased 10% for each medication taken
• Number of medications per patient:
•No ADE: 1.45(0.04, 0-5)
•With ADE: 1.85 (0.09, 0-6)
Budnitz. National surveillance of ED visits for OP • 2.7% of ED admits were 2* to ADE
ADEs. JAMA 2006 • 6.7% of hospital admissions were ADE related
Samoy LJ. Drug-related hospitalization in a • 25% of admissions were ADE related
Tertiary Care IM Service of a Canadian Hospital: • 72.1% of these were considered preventable
A Prospective Study. Pharmacotherapy 2006 • 7% severe and 0.7% were fatal
Published Studies on Pharmacy Consult Services: Discharge Counseling
Study Interventions Findings
Schnipper J. Role of Pharmacist • Randomized patients to • Preventable ADEs
Counseling in Preventing Adverse receive discharge counseling reduced: 10%
Drug Events after Hospitalization. by a pharmacist and a re- (11% vs. 1%)
Arch Int Med 2006. education phone call within 5- NNT = 10
7 days
• Adverse Medication
• ADE Rate at 28 days Related ED Admissions
Reduced: 7%
(8% vs. 1%; NNT=14.2)
Delate T. Clinical Outcomes of a • Quasi experimental • All Cause Mortality:
Home-Based Medication prospective, controlled study 5.9 vs. 2.7% (NS)
Reconciliation Program After
Discharge from a Skilled Nursing • Pharmacist reconciled • Adjusted HR:
Facility. discharge medications and 0.22 (0.06 – 0.88)
Pharmacotherapy 2008 counseled patients as needed
• Review and intervention
session lasted on average 45
– 60 minutes
• Patients assessed for a death
at 60-days after discharge from
SNF
How many clinical pharmacists does one need?
• How few is too few?
• Opportunity loss costs?
• When are there too many?
• Diminishing marginal return?
• Where does one prioritize service?
Neil M. Davis
…The time needed for clinical activities can be gained from better utilization of
pharmacy technicians, bar coding, automation and a well-designed, fully
integrated CPOE. For some facilities, all of this will still not be enough to
substantially reduce the error problem and more pharmacists will have to be hired.
…Institutions will have to attract and retain pharmacists…
Junior high and high school students must be exposed to the
benefits of pharmacy as a career choice to ensure that there
is an adequate pool of bright and motivated students.
2000
Inpatient pharmacy staffing relationship to outcomes:
Mortality Rates
Donald E. Franke
...We see today that there are stirrings of a more objective approach
towards sound drug therapy and…the pharmacist plays an increasingly
important role.
…It seems to me that this trend which is gaining momentum constantly,
offers great opportunities for pharmacists to increase our professional
responsibilities through cooperative efforts with colleagues in the
medical profession, we can increase our value as professionals
benefiting not only to pharmacy but also to medicine, our hospital and
patients. These are indeed goals to which we should strive.
…I am confident that the hospital pharmacist
will…occupy an increasingly important position not
only in the selection and procurement of
pharmaceuticals but also as a valued consultant to
the physician.
1952
Sister Mary John
…We are beginning a new era…more medical cases will increase the
volume of drugs dispensed and paid for by a third party who will
want prices to reflect costs. Hospital revenue must equal
expenditures…so unnecessary expenditures must be curtailed.
...It is the pharmacist’s major duty to maintain rational therapeutics in
his hospital. He must keep himself well informed about drugs so
that he can withstand the flood of unsubstantiated claims often
made for new products.
…To challenge scientifically, one needs an equality
of knowledge. The doctor, so skilled in the
basic sciences, is still vulnerable to the high
pressured salesmanship of even
nonpharmacists.
1957
Pharmacoeconomics
• Description and analysis of the costs of drug therapy to health care
systems and society – it identifies, measures and compares the costs and
consequences of pharmaceutical products and services.
• Perspective is important…
• Cost center
• Department
• Institution Benefit
• System
• Patient
• Society
Cost
• A few issues are black and white (red or green in the example);
• Most are grey
Recent Cost of Adverse Events Data (ICU)
• Setting – 10 bed MICU and a 10 bed CCU at Brigham &
Women’s Hospital & Harvard Medical School
• Authors cited existing patient safety parameters already in
place:
• CPOE
• Pharmacist on rounds
• Nursing coverage nearly 1:1
• Just culture
• Intensivist physician staffing in place
• Finding: Costs of the pharmacist were NOT overcome by
savings from identifiable drug costs
• Setting:
• 480 bed Community Teaching Hospital
• 12 bed MICU, 11 Bed Surgical ICU
• Study Concerns:
• Part time position – 2 hrs per day
• Rotated days of the week
• Rotated hours of the day (intentionally)
• Excluded protocol management (intentionally)
• No interventions to add new drugs for untreated diseases
• TDM
• No interactions with MDs on rounds
Am J Hosp Pharm. 1991 Oct;48(10):2154-7
Pharmacy Staffing # of Dispensing Pharmacist / 100 Occupied Beds
Associations and total costs of
care in US Hospitals
Services Associated With
Reduced Hospital Costs # of Pharmacy Admin. / 100 Occupied Beds
Drug Evaluation Services (DUE / MUE)
Drug Information
Medical Rounds Participation
ADR Reporting
Drug Protocol Management # of Clinical Pharmacist / 100 Occupied Beds
Admission Drug Histories
ROI or Cost to Benefit Ratio for Clinical
Pharmacy Services
What Should Be Expected?
Please write down a number
Endorsements of Clinical Pharmacy Services:
(Not a comprehensive list...)
• ASHP & ACCP
• SCCM – Standards for pharmacy services in the ICU that include
various levels of clinical pharmacy activities: Fundamental, Desirable
& Optimal
• AHRQ – Several chapters (5, 7,8, & 9) on the benefit to quality and
cost for hospitals in areas such as ADE reduction, Medication error
reduction, Anticoagulation.
• Society for Hospital Medicine (SHM) & ASHP Joint Position Paper
• Infectious Diseases Society of America
• The Joint Commission
• UNOS
• Leapfrog Group
Where will the clinical pharmacists of tomorrow
come from?
• What experience or training is required?
• Who will train them?
Joe Smith
…Let me summarize this recommendation for an entry level residency program in
hospital pharmacy. 1st training in clinical (general) practice becomes the focus of
the program. 2nd a Pharm.D. degree should be a prerequisite for entry into the
program. 3rd the training program should provide meaningful experience in the
other important services and in the overall management of the department. 4th
this generalist entry-level residency should be a prerequisite for advanced
specialized residency programs. It is this level of training that we should set our
sights on for all pharmacists who are preparing for a future in hospital pharmacy
practice.
…Beyond this entry-level training program, there is a growing need for highly
specialized clinical training programs. I believe that there is now a much greater
demand for highly specialized clinicians than we can supply, and the demand
will likely increase.
…The leaders of a clinical profession must be committed to,
almost obsessed with, the idea of clinical practice.
And, most important, they will need to project that idea
into images that create excitement in other people
about that activity.
1988
ACCP White Paper
Estimated Needs:
Increase to 7,500 residency slots up from 1,250 offered today
in mostly general practice (PGY-1)
PGY2 offerings should increase similarly
An Institutional, Case-Based Application
• Setting:
• 1,300-bed Tertiary Care, Private Teaching Hospital
• Adult medical / surgical population with oncology, transplant,
psychiatry, women’s health and advanced heart failure populations
• Teaching Affiliations
• Medical, Nursing & Pharmacy Schools
• Patient Payor Mix
• Medicare / Medicaid: ~52%
• Private pay: ~45%
Pharmacy Department Overview:
• Highly automated: Robotics, automated dispensing cabinets, CPOE,
electronic medication tracking system, and knowledge based
medication administration pending
• Technician driven order entry
• Clinical pharmacy specialists in all major inpatient servicelines, nearly
all with PGY1 and/or PGY2 training and several with board certification
• Intensity of coverage M-F; 7AM – 5PM. Basic service commitments on
the weekends
• Code blue team response: 24/7
• On-site Drug information Center & formulary management
• PGY1 and PGY2 Pharmacy Residency Provider
• Active Doctor of Pharmacy externship program
• Active pharmacy and medical research initiatives
• ACPE Provider
Clinical Pharmacist - Resource Distribution
No. of Patients with Patient:Clin No. of Patients with Patient:Clin
Clin Clin Clin Clin Clinical Staff
Non-direct Patient Care Clin Specss & Support Clinical FTE
geted Daily Census Pharmacist Ratio Daily Census Pharmacist Ratio
Spec Spec Available Budgeted Spec Spec Pharmacist: Pharmacist: 0
Drug Information CS2
90%
DC Serviceline 2 Patient Beds 95% ADC 90%
1 1 95%2 90%
Patient Ratio 95% 90% 95% Patient Ratio
Medication Safety CS2 1
74 2
Neurology 0 74
82 78 74 37 2 39 0 36.9
74 78 37 39 36.9
Investigational Drugs CS2 1
Project Specialist* CS2 0.3
55 5
Cardiology 1 155
172 163 155 26 5 27 1 25.8
155 163 26 27 25.8
Clinical Pharmacy Research Coordinator 1
Secretary III - Clinical Pharmacy Section Focus 1
39 1
Heme/Onc 1 39
43 41 39 19 1 20 1 19.4
39 41 19 20 19.4
*Supports Direct Patient Care 20% TOTAL 2.3
11 10
IM 1 311
346 329 311 28 10 30 1 28.3
311 329 28 30 28.3
27 1
Transplant 1 27
30 29 27 14 1 14 1 13.5
27 29 14 14 13.5
08 2
General Sx 2 108
120 114 108 27 2 29 2 27.0
108 114 27 29 27.0
00 5
ICUs 0 100
111 105 100 20 5 21 0 20.0
100 105 20 21 20.0
tients ONCOLOGY Infusion center: 25-35 Patients
ervice Managed Daily. Breast Cancer Center Service
0 1 0 1
Pending
14 26
Total 7 904 814 25.4 26 26.87 25.4 25.4 26.8 25.4
y Patient Care
Total Clinical Pharmacists Involved in Daily Patient Care
33 28.5 30.1
33 29.6
* 28.5 30.1 29.6
*Ratio: Less 4.5 FTE for Weekend, Holiday & Vacation Coverage
Applying the Evidence:
Medication History Accuracy Improvements
Evaluation of Medication History Accuracy Patients without Patients with
after 2nd Intervention Period Pre-op Class Pre-op Class
Patients with completely accurate medications
on Patient Database - n (%) 3 (8.6%) 7 (17.1%)
Patients with at least one medication variance
on patient database – n (%) 32 (91.4%) 34 (82.9%)
Medications with variances on patient database 152 (42.8%) 132 (34.8%)
– n (%)
Severity of variances:
Level 2 - Moderate potential for harm 57 (36.8%) 48 (36.4%)
Level 3 - High potential for harm 10 (6.5%) 4 (3.0%)
Source of Patient Database variances:
Patient 42 (30%) 22 (17.3%)
Pre-op assessment nurse 88 (62.9%) 90 (70.9%)
Patient & Nurse 10 (7.1%) 15 (11.8%)
Internal Data: Sirimaturos M, Venarske J & Yu M.
Applying Evidence:
TMH Pharmacists’ Clinical Interventions: 2006
• Pharmacists documented approx 16,853 interventions in 2006
• Intervention quality was sustained with a noted increase in the % of level two
and level three interventions (up from 38% and 2% respectively)
Level 3
• Interventions by level:
2.4%
• Costs avoided per intervention by
significance level*:
• Level 1 – $70
• Level 2 – $500
• Level 3 – $4,685 Level 2 Level 1
Example: Patient identified with a platelet count43.8% 53.8%
decrease of greater than 50% from baseline &
was maintained on heparin therapy. Pharmacist
recommended antibody screen & treatment.
Subsequent testing demonstrated patient was
positive for Heparin antibodies and diagnosed with
HIT.
• Projected costs avoided approximately: $6.2 Million dollars
*Cost avoided values derived from internal benchmarking, published pharmacoeconomic & ADE avoidance
literature & medical malpractice claims higher in patients with preventable ADEs.
Estimated Clinical Pharmacy Consultation
Services Provided*
• Anticoagulation
• Warfarin – 150 pts
• Heparin – 130 pts
• Falls Prevention – 60 pts
• Polypharmacy – 30 pts
• Discharge counseling – 200 pts
• Pharmacokinetic – 2 pts
• TPN – 25 pts
• Renal dosing – 38 pts
• Severe Sepsis – 20 pts
• Other – 10 pts
*Based Upon Consult Orders Received per Month
A Pharmacoeconomic Estimation of Clinical
Pharmacy Services:
Estimated Annual
Clinical Service Domain Financial Return C
Medication formulary maintenance and drug use evaluation services $3,122,330
Direct patient care services $4,621,130
Medication use education & informational services $316,781
Standardized protocol development and management services $112,271
Continuous quality improvement initiatives of existing protocols ?$0
Regulatory compliance & Medication safety initiatives ?$0
Professional leadership and training programs $338,000
$8,510,512
ROI Range Estimate: 2.5 – 4
In closing, have we answered the questions?
• Is there an essential, established need for advanced clinical pharmacy
services?
• If yes, how great is the need? Is there a cost for not providing them?
• What types of clinical services make the greatest difference?
• Can the value of these services be measured?
• Is the difference realized significant to stakeholders?
• Patients, Administrators, Quality / regulatory agencies
• Others
• Has the call for advanced clinical pharmacy services been endorsed by:
our profession, administrators, quality / regulatory agencies & patients?
• What training is required to provide these services?
• How many providers for a given institution?
R. David Anderson
…pharmacists who are not in constant face-to-face contact with physicians,
nurses & particularly patients where they are being treated & who are unable
to see exactly how drugs work…are destined to know little more than a
myriad of unorganized details.
…The pattern most idealized of a professional pharmacist would be one who has
a close association with patients; a comprehensive awareness of previous
medication habits; knows allergies, sensitivities, & idiosyncrasies; extracts
information about them from charts, laboratory, x-ray, and other data; has
access to drug-oriented information; is able to correlate that information with
knowledge about the patient’s physiology & disease; & recommends to
physicians, nurses, & others the proper course to follow where drugs are
indicated. He emphasizes and insures safety and effectiveness of drugs.
…The hypothetical professional pharmacist would serve
as a counselor, advisor, teacher… & patient care
team member
…The model which comes closest to conformance with
this professional ideal is the clinical pharmacist.
1976
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