OPERATIONAL FTE JUSTIFICATION
INVESTIGATIONAL DRUG SERVICE
<Your Name>
<Date>
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TABLE OF CONTENTS
I.
Executive Summary
Page 3
II.
Introduction
Page 3-4
III.
Summary of Request
Page 4
IV.
Data Analysis
Page 4 -10
V.
Operational Impact and Summary of Service
Page 10 - 11
VI.
Financial Analysis
Page 11
VII.
Timeline for Implementation
Page 12
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I. EXECUTIVE SUMMARY
The Department of Pharmacy Services - Investigational Drug Service (IDS) at the Institution A is
responsible for ensuring drug study medication safety, patient safety, and local, state, national,
and federal regulatory compliance for all medication-related medical center research. This
document is a request for 1 FTE staff pharmacist and 1 FTE pharmacy technician to be added to
the IDS cost center during CY2010 based on the significant growth in active studies (139% since
2006), patient enrollment, and recent National Cancer Institute (NCI) designation which will
lead to growth in research. Approval of this request would increase the IDS staffing level from
4 to 6 FTEs which is the University HealthSystem Consortium’s (UHC) average staffing level
based on the number of active studies we oversee. The cost (salary and fringe) of these two
positions would total $188,106. The continuation of the high level of service IDS provides to
Institution A patients and researchers is predicated on obtaining additional resources to
support the growing research being done at our academic medical center.
II. INTRODUCTION
The Investigational Drug Service (IDS) at the Institution A is responsible for coordinating all
inpatient and the majority of our outpatient drug studies. Over the past 4 years, IDS has seen a
significant growth in the number of inpatient and outpatient drug studies. Currently, IDS has
approximately 285 active drug studies ongoing with an average of 5 new studies initiated per
month. This 139% increase in active studies is up from 119 in FY 2006. From FY 2006 through
FY 2009 we have seen an increase of 12% of inpatient doses dispensed and a 46% increase in
outpatient doses dispensed (see charts on page 7). Additionally, the complexity and
requirements of these studies have also increased which has escalated to an unrealistic
workload for the current staffing level.
The IDS staff consists of 2 FTE staff pharmacists and 2 FTE pharmacy technicians. This
operational request document outlines the need for an additional 1 FTE staff pharmacist and 1
FTE pharmacy technician based upon the current workload, future growth, and national
benchmarking information which would cost $188,106 annually (salary + fringe). UHC IDS
benchmark information states that based on the 285 active trials that with the approval of
these 2 FTEs requested, Institution A would be similar to the national UHC hospital average
(survey shown in chart on page 10).
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TABLE 1: IDS STAFFING LEVELS
FY 1999
Pharmacist
1 FTE
Pharmacy Technician
1 FTE
Administrative
0.6 FTE
support
TOTAL
2.6 FTE
FY 2003
1 FTE
2 FTE
0.6 FTE
FY 2008
2 FTE
2 FTE
--
3.6 FTE
4 FTE
In FY 2006 the Department of Pharmacy Services requested and received an additional 0.4 FTE
to add a pharmacist to our IDS team (Table 1). We combined this 0.4 FTE with a 0.6 FTE from a
retiring staff member for a total of a 1 FTE pharmacist position. We have only increased by 1.4
FTEs in the last 10 years with a growth of 139% in active studies since FY 2006. Our overtime
has drastically increased over the past couple years in which IDS averages 38 OT hours per
month and when annualized will cost the organization $24,976 for FY2010. We expect with the
addition of these 2 FTE to cut OT in half in FY 2011 which could offset salary cost by $12,488.
When looking at our coverage for expenses we fell short $182,883 during FY 2009. Over the
past many years our reimbursement has decreased compared to our dollars billed due to lack
of investigator funds to pay for our IDS fees. Over the last couple years we have received a
larger number of investigator initiated, federally funded, cooperative group, and
compassionate use studies which does not provide the investigator any funds for pharmacy
services. Overall, in FY 2008 we billed investigators $561,826 and in FY 2009 $624,376 for our
service fees which if reimbursed would adequately cover the expenses of IDS including the two
newly requested positions. In the spring of 2008, we instituted a new pricing structure for NEW
studies only that has helped to increase our reimbursement; however these structures do not
apply to existing studies.
IDS struggles to balance providing our pharmaceutical services and ensuring patient and
medication safety for all studies versus not providing our services for researchers that do not
have funds. If we were not to accept unfunded or underfunded studies than more than 50% of
our 285 studies would not go through IDS and risk patient safety and regulator compliance.
III. SUMMARY OF REQUEST
We respectfully request an additional 1 FTE staff pharmacist and 1 FTE pharmacy technician to
be added to the Investigational Drug Service based upon the current workload, recent and
future growth, and national benchmarking information. The cost association with the addition
of these positions would be $188,106. If additional staff are not approved the consideration of
future denial of studies would need to be considered.
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IV. DATA ANALYSIS
From FY 2006 to FY 2009 volume has increased by 166 studies (139%). Based on our average
number of new studies per month (5) with few studies closing, we project to have and
additional 50 to 60 new active studies along with the current 285 which would bring us to 335
to 345 active studies by the end of FY 2010.
IDS Active Studies
300
285
244
250
181
200
150
119
100
50
0
FY 2006
FY 2007
FY 2008
FY 2009
Institution B group is our largest “customer” of IDS services. Their growth is assured with
recent NCI designation.
Breakdown of HCC vs. General Clinical Research
Active Trials
General
Clinical
Research
52%
HCC trials
48%
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The table below demonstrates the number of active studies broken down by department.
Oncology (139) has the most active drug trials with neurosciences (21), rheumatology (19) and
the center for drug and alcohol programs (13) following.
IDS Active Studies by Department
Anesthesia
2
Cardiology
4
Center for Drug and Alcohol Programs
13
Clinical Neurosciences
11
Dental
1
Digestive Diseases
10
Endocrinology
4
Hematology
1
Infectious Diseases
3
Neurosciences
21
Nephrology
2
Nuclear
3
Ob/Gyn
4
Oncology
139
Pediatrics
9
Pediatric Cardiology
3
Pediatric Hematology/Oncology
2
Pediatric Neonatology
1
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Pediatric Neurosciences
2
Pulmonary
11
Psychiatry
6
Radiology
1
Rheumatology
19
Transplant
13
Over the past year the IDS service has seen an average of 5 new studies per month. The
initiation of new studies is time consuming and requires thorough protocol review,
investigational site visit and monthly visits thereafter, drug receipt and inventory control,
randomization, and cost estimations. Additional staff will improve turnaround time, quality of
study reviews and study initiation especially for NCI designated trials.
New IDS Studies per Month
6
6
5
5
5
4
5
4
3
3
3
2
2
3
2
2
1
1
0
9
-0
ov
N 09
ct
O 09
pSe 09
ug
A 9
l-0
Ju 09
nJu 09
ay
M 9
-0
pr
A 09
ar
M 09
bFe 9
0
nJa 08
ec
D
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In addition to study initiation and daily dispensing our IDS staff consistently meets with industry
study monitors. We average 7 visits per week that includes an hour of allotted time to each
visit which is taken away from other activities. However, the pharmaceutical companies have
cut many of their study monitors and therefore the auditing process in many cases is now the
responsibility of IDS to report electronically which sometimes takes longer than the onsite
visits.
Monitor Visits per Month
50
40
41
37
36
35
27
28
30
25
20
21
22
19
23
20
10
0
Dec- Jan- Feb- Mar- Apr- May- Jun- Jul- Aug- Sep- Oct- Nov08
09 09 09
09
09
09
09
09
09
09 09
Outpatient doses dispensed have increased 12% over the last year and 28% since 2006.
Outpatient Doses Dispensed
10000
8000
6750
7085
FY 2006
FY 2007
7713
8607
6000
4000
2000
0
FY 2008
FY 2009
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Inpatient doses have increased 46% over the last year and 117% since 2006.
Inpatient Doses Dispensed
2500
1987
2000
1361
1500
914
997
FY 2006
FY 2007
1000
500
0
FY 2008
FY 2009
REVENUE COLLECTIONS
IDS revenue collection improved drastically in 2006 due to changes put in place in billing
practices but have remained flat the last few years. This flat reimbursement despite higher
billing is due to lack of investigator funds to pay our IDS fees. The last two years we have
received a larger number of investigator initiated, federally funded, cooperative, and
compassionate use studies which do not provide the investigator funds for pharmacy services
and therefore no reimbursement for our services.
IDS Revenue Collections
$265,125
$300,000
$239,622
$253,913
FY 2007
FY 2008
$246,923
$250,000
$200,000
$150,000
$127,928
$84,482
$100,000
$50,000
$0
FY 2004
FY 2005
FY 2006
FY 2009
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Overall, in FY 2008 we billed investigators $561,826 and in FY 2009 $624,376 for our service
fees which if reimbursed based on billing our expenses including the request for these
additional 2 positions would be adequately covered. Our approximate collection rate is 60%.
FY 2005
FY 2006
FY 2007
FY 2008
FY 2009
Dollars
billed
$235,856.00
$505,250.00
$539,244.00
$561,826.00
$624,376.00
Dollars
reimbursed
$127,928.00
$265,125.00
$239,622.00
$253,913.00
$246,923.00
Variance
(-$107,928)
(-$240,125)
(-$299,622)
(-$307,913)
(-$377,453)
BENCHMARK DATA
The University HealthSystem Consortium (UHC) Pharmacy Council’s Research and Education
Committee published the 2007 Investigational Drug Services Survey that included information
from 50 UHC hospitals in regards to their investigational drug services. The report confirms
that the numbers of protocols are increasing at UHC member hospitals and that the rate of
increase is expected to continue to rise over the next several years. They stated between 2004
and 2007, IDS’s reported a 38.6% increase in protocols. Our IDS service has experienced this
trend.
The survey also outlines the future challenges for IDS’s and pharmacy departments. These
challenges consist of 5 common themes: financial, logistics, staffing, informatics, and legal.
Fifty-nine percent of respondents were concerned about financial issues including funding of
IDS, budget deficits, and un-billable activities. Reimbursement was a concern expressed based
on cutbacks of NIH and industry-sponsored study budgets as well as investigator’s inability to
adequately reimburse for investigator-initiated research. It is anticipated that this trend will
continue. Staffing shortages were expressed by 46% of respondents. The issue relating to
inadequate manpower includes increasing workload of the IDS staff.
Below is a table from the report regarding average IDS staffing per protocols managed. Based
on our current number of protocols (285), the average staffing is 3 FTE pharmacists and 3 FTE
technicians. Currently, the IDS has 2 FTE pharmacists and 2 FTE technicians. Based on our
request for an additional 1 FTE pharmacists and 1 FTE technician we would be staffed similarly
to the UHC member average. Additionally, with a projected increase of 60 new studies
initiated in FY 2010 the additional staffing is required for success.
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The below table lists the active studies, staffing levels by position, and FTE to study ratios for
other similar IDS divisions. Additionally, their NCI designation and other comments related to
their funding methods are included. We are similar in the number of trials to well respected
places such as Institution Z and College A with much less staff. Nationally, we continue to have
lower FTE to study ratios than College A and B. Institution B IDS has a lower number of FTEs
compared to studies than 10 of the 11 selected UHC hospitals listed below.
UHC
# Active Staffing levels
Organization Studies
Institution B
285
FTE:study
2
FTE 1 FTE:
pharmacists
studies
NCI
designation
71 Cancer center
2 FTE technicians
Institution Z
400
5
FTE 1
FTE:33 Comprehensive
pharmacists
studies
6 FTE technicians
1 FTE
manager
College A
275
4.4
pharm
FTE 1
FTE:28 Comprehensive
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UHC
# Active Staffing levels
Organization Studies
pharmacists
FTE:study
NCI
designation
studies
5 FTE technicians
0.2 FTE student
Institution C
1000
5
FTE 1
FTE:77 Comprehensive
pharmacists
studies
8 FTE technicians
Institution B
400
5
FTE 1
FTE:44 Comprehensive
pharmacists
studies
3 FTE technicians
1 FTE business
manger
Institution D
261
6
FTE 1
FTE:28 No designation
pharmacists
studies
2 FTE technicians
1 FTE
manager
pharm
0.2 FTE student
Institution E
210
3
FTE 1
FTE:35 Cancer center
pharmacists
studies
2 FTE technicians
1 FTE coordinator
Institution F
300
3
FTE 1
FTE:60 Comprehensive
pharmacists
studies
2 FTE technicians
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UHC
# Active Staffing levels
Organization Studies
College B
140
FTE:study
2
FTE 1FTE:35
pharmacists
studies
NCI
designation
Comprehensive
2 FTE technicians
Institution G
300
1.4
FTE 1FTE:55studies Comprehensive
pharmacists
2 FTE technicians
2 FTE pharm
coordinator
Institution H
120
2
FTE 1
FTE:30 No designation
pharmacists
studies
1 FTE technicians
1 FTE
manager
pharm
V. OPERATIONAL IMPACT / SUMMARY OF SERVICE
The investigational drug service is a specialized area that requires pharmacists and pharmacy
technicians to be well versed in outpatient and inpatient pharmacy procedures, research
methods, and regulations. The role of the investigational drug service consists of receiving,
compounding and dispensing drugs, providing education, reviewing protocols, conducting
administrative type tasks, documentation, customer communication, problem-solving,
attending meetings and trainings, and hosting site visits for monitors. Due to the highly
specialized nature of these jobs, these pharmacists and technicians are not easily substituted
and are therefore often the only pool of staff that can cover vacations, overtime or sick leave.
Because of this, they accrue much overtime which results in staff burnout. By increasing the
staff, the schedule will allow for expansion of times available for studies that are outside our
current business hours. Our four current employees are extremely valuable; turnover in this
area is very expensive and new employees take about a year to fully train.
During a December 2007 Food and Drug Administration (FDA) on-site inspection and FDA
investigator in her concluding remarks stated that the Institution A IDS is at the highest level of
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IDS’s that she has seen and that their work and documentation were outstanding. This
outstanding work however comes at a price in which the IDS team must focus on the everyday
requirements of dispensing drugs while never being able to catch up on other requirements
that would benefit the service, customers, and overall the patients. We want to continue to
work at this high-level but are unable to stay with the current pace due to the large growth,
complex trials, and study needs.
FUTURE ENVIRONMENT
Over the next year the Institution A IDS projects involvement within various new areas and
would like to expand our services to include a more thorough upfront review of protocols and
better attendance at planning and IRB meetings. As documented in the benchmarking section
of the plan, the market projects to have a continue growth in studies combined with a lack of
funding for services. Below is an outline of factors in the next year that would also support
additional staffing needs within IDS:









Project an increase of another 50 to 60 new studies in FY 2011 which would bring our
total to approximately 340 active studies. Moreover, we expect these new studies to be
more Phase I and II studies which require more preparation and maintenance. Also, we
will see more investigator initiated and federally funded studies which would not have
the funds to reimburse for IDS fees.
Initiate studies for stem cell and gene therapy that require additional training and
workload to setup and maintain.
Coordinate time to work more closely with IRB, study coordinators, and investigators to
improve customer service and protocol implementation and maintenance.
Improve customer service by meeting timeline requests.
Allow more flexibility in scheduling of staff when people are attending meetings,
continuing education, out sick, or on vacation.
Allow attendance at IRB meetings, coordinator meetings, inter-departmental site
initiation visits, and SCTR meetings.
Institute additional USP 797 and 795 compliance requirements.
Roll out an IDS educational plan for researchers/support staff.
Create IDS pharmacy and develop pharmacy coordinators to the other large clinical
trials offices.
FINANCIAL SUMMARY
Year 1: The billed and collected reimbursement figures are from FY09 year end information.
Expenses are FY09 expenses plus the addition of 2 FTEs as noted above ($188,806).
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Year 2 and Year 3 are assumed to have a 10% increase in billed reimbursement and a 10%
increase in expenses per year. The collection rate is expected to be higher in subsequent years
due to changes in pricing structure; therefore a 70 and 80% collection rate was used for year 2
and 3, respectively.
RETURN ON INVESTMENT
Description
Year 2
Year 3
TOTALS
Billed Reimbursement to $624,376
IDS
$686,813
$755,494
$2,066,683
Collected Reimbursement $246,923
to IDS
$480,769
$604,395
$1,332,087
Expenses
$617,912
$679,703
$747,673
$2,045,288
Loss to the Hospital
$370,969
$198,934
$143,278
COST TO BENEFIT RATIO
Year 1
1.5:1
Please note that this unfavorable cost to benefit ratio is based on reimbursement and expenses
and does not take into account The Joint Commission requirements for IDS services or most
importantly safety to our patients.
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VII. TIMELINE FOR IMPLEMENTATION
February:
Submit request for new positions to Administrative Operations
Group for approval
Apri:
Proceed with hiring procedures; review applications and interview
applicants
May/June:
Orientation and training
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