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5/6/2015
IMPACT OF A PHARMACIST MANAGED
GOUT CLINIC ON URIC ACID LEVELS
AND PATIENT OUTCOMES
Gout Background
• Most common form of inflammatory arthritis
• Associated with deposition of urate crystals in joints, tissues, and organs
• Hyperuricemia does not always result in gout
• ~8.3 million Americans are impacted, primarily men
• 2 major guidelines address management:
Margi Shah, Pharm.D.*
PGY2 Ambulatory Care Resident
John D. Dingell VA Medical Center
• American College of Rheumatology (ACR)
• European League Against Rheumatism (EULAR) guidelines
Khanna D, et al. Arthritis Care Res. 2012;64:1431-46.
Zhang W, et al. Ann Rheum Dis. May 2006; 65: 1312 – 24.
Zhu Y, et al. Arthritis Rheum. 2011; 63(10): 3136–3141
http://images.rheumatology.org/image_dir/album75676/md_01-14-0013.jpg
The speaker has no actual or potential conflict of interest in relation to this presentation
Gout Treatment Goals
• Achieve uric acid (UA) level ≤ 6 mg/dL
• Decrease frequency of gout flares
• Decrease size of existing tophi
• Improve quality of life in these patients
PHARMACOLOGICAL OPTIONS
Khanna D, et al. Arthritis Care Res. 2012;64:1431-46.
Zhang W, et al. Ann Rheum Dis. May 2006; 65: 1312 – 24.
Acute Gout Flare Treatment Options
Antigout Agent
Nonsteroidal
Anti-inflammatory
Drugs (NSAIDs)
Steroids
ACR Treatment Algorithm
• Colchicine (Colcrys®) (COL)
• Ibuprofen, naproxen, indomethacin, etc.
• Prednisone (Deltasone®)
• Methylprednisolone (Medrol®)
CHRONIC GOUT
DEFNITION:
- Tophus present
- ≥ 2 flares/year
- Nephrolithiasis Hx
ULT = urate-lowering therapy
COL = colchicine
Start ULT + COL
prophylaxis for
initial 3-12 mos
UA ≤ 6 mg/dL:
Cont. same ULT
dose
UA > 6 mg/dL:
↑ ULT dose
Khanna D, et al. Arthritis Care Res. 2012;64:1431-46.
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Chronic Gout Treatment: Urate-Lowering Therapy (ULT)
Xanthine Oxidase
Inhibitors (XOI)
• Allopurinol (Zyloprim®) (ALP)
• Febuxostat (Uloric®) (FEX)
Uricosuric Agents
• Probenecid (Benemid®)
Uricase Agents
• Pegloticase (Krystexxa®)
Gout Management in Veteran Population
Study Design
and Population
•Cohort, retrospective observational study
•n = 643 Veterans
•Newly started ULT
Study Purpose
• Evaluate prescribing & lab monitoring patterns
Baseline
Characteristics
• Most patients were older males
• Most followed in primary care, not specialty
GOUT MANAGEMENT IN PRIMARY
CARE: LITERATURE REVIEW
Gout Management in Veteran Population (cont.)
Medication
Use Results
• ~50% discontinued allopurinol at least once
• ~50% received prophylaxis with ULT initiation
• >50% never received a colchicine prescription
Lab
Monitoring
Results
• 24% monitored within 6 months of ULT initiation
Achievement
of Goal UA
Results
Singh JA, et al. Ann Rheum Dis. 2009 Aug: 68(8): 1265-70.
Use Of Prophylactic Colchicine
Study
Design and
Population
Study
Purpose
Definition of
Inappropriate
Colchicine
Use
• Cohort, retrospective observational study
• Prescribed prophylactic (ppx) colchicine
• n=126, Veteran population with diagnosed gout
• ~20% reached target UA
• 20% did not reach target UA
• 60% did not have UA checked
Singh JA, et al. Ann Rheum Dis. 2009 Aug: 68(8): 1265-70.
Use of Prophylactic Colchicine (cont.)
Results
• ~74% prescribed colchicine inappropriately
• Most: not at UA goal & no recent ULT titration
• 26% prescribed colchicine appropriately
Comparison
of Colchicine
Groups
•Appropriate pts: younger & better monitored
•Appropriate pts:  duration of colchicine use
• Evaluate if colchicine prescribing practices match
current guidelines
• No current ULT prescribed
• UA not at goal and ULT unchanged in 3 months
• UA goals met for > 1 year and no flares or tophi
George M, et al. Arth Care and Research. 2014 Aug: 66(8): 1258-62.
George M, et al. Arth Care and Research. 2014 Aug: 66(8): 1258-62.
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Patient Knowledge Concerning Gout
• Good knowledge of pathophysiology
Gout management is suboptimal for the
following reasons:
Lack of proper patient education regarding ULT
• Poor knowledge of ULT
Better adherence to symptomatic vs. disease-modifying treatment
• Unaware that ULT initiation can exacerbate gout
flares when initiated for short period
• Poor knowledge of dietary flare triggers
Inappropriate regimens (ex. ULT initiated without overlapping colchicine)
Lack of close follow-up and UA level monitoring
Lack of medication titration, specifically with ULT
Harold LR, et al. BMC Musculoskeletal Disorders. 2012: 13(180).
Detroit VA Medical Center Gout Clinic
JDDVAMC
PharmacistOverview:
Gout Clinic Overview:
Established intwice-monthly
1996
••Referral-based
clinic
JDDVAMC PHARMACIST-MANAGED
GOUT CLINIC
• ~330,000 Veterans seen yearly
•enhancement
Prescribing guided
project by national formulary
• Established in 2013 as a resident service
• 30 minute appointments
• Scope of practice for medications + labs
U.S. Department of Veterans Affairs. http://www.detroit.va.gov/about/index.asp. Accessed April 2, 2015.
Initial Visit
Establish patient history
Complete baseline labs
Follow-up Visit
Assess for symptoms, side effects, & adherence
Order updated labs (if needed)
Provide gout education about medication and lifestyle
Reinforce gout education
Assess patient (medication adherence and symptoms)
Initiate or titrate ULT if appropriate
Titrate medications based on symptoms & UA level
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5/6/2015
ACR Based Clinic Treatment Algorithm
Start ALP +
COL 0.6mg
daily for initial
3-12 mos
CHRONIC GOUT
DEFNITION:
- Tophus present
- ≥ 2 flares/year
- Nephrolithiasis Hx
Allergy to
ALP: Start
FEX + COL
daily for initial
3-12 mos
ALP = Allopurinol
COL = Colchicine
FEX = Febuxostat
UA ≤ 6 mg/dL:
Cont. same ALP
dose
UA > 6 mg/dL:
↑ ALP dose
IMPACT OF A PHARMACIST MANAGED
GOUT CLINIC ON URIC ACID LEVELS
AND PATIENT OUTCOMES
Margi Shah, Pharm.D.
Vanita Panjwani, Pharm.D.
Tracy Martinez, Pharm.D., BCACP
Jennifer Clemente, Pharm.D., BCACP
UA ≤ 6 mg/dL:
Cont. same FEX
dose
UA > 6 mg/dL:
↑ FEX dose
Khanna D, et al. Arthritis Care Res. 2012;64:1431-46.
Study Objectives
Primary Objective:
 To evaluate if pharmacist-managed gout results in patients
achieving goal serum UA, defined as ≤ 6 mg/dL
Secondary Objectives:
 Assess frequency of patient-reported gout attacks
 Evaluate interventions in pharmacist-managed gout clinic:
o Stopping, starting, or titrating gout medications
o Documenting ADRs
o Lifestyle counseling
o Evaluate for potential differential diagnosis
Statistical Analysis
Descriptive
Statistics
Methods
Study Design
 Single site, retrospective observational study
Study Population
 Veterans enrolled in the pharmacist-managed gout clinic at
the JDDVAMC
Inclusion Criteria
 Patients with gout enrolled in gout clinic
 Patients with at least 2 clinic encounters by 12/31/14
Patient Screening
73 patients
evaluated for
inclusion
31 patients
excluded from
study
27 patients
completed 3 visits
42 patients
were included
in the study
7 patients
completed 4 visits
2 patients
completed 5 visits
4
5/6/2015
Reasons for Exclusions
Baseline Patient Characteristics
Demographics
6 with
symptoms
inconsistent
with gout
18
completed
only one visit
• Mean age: 62.5 years old
• 42/42 (100%) male
• 31/42 (74%) black, 11/42 (26%) white
7 with
follow-up
outside date
parameters
Gout-Related Data
• Average flares in prior 12 months: 6.56 flares/patient
• Average UA: 8.3 mg/dL
prn = as needed; ppx = prophylactic
Results – Uric Acid Levels
Baseline Patient Characteristics (cont.)
60.0%
50.0%
% of patients
Medications
Medicatins
• 21/42 (50%) – no ULT prescribed
• 3/42 (7%) – ppx + prn colchicine only (no ULT)
• 21/42 (50%) – prescribed ULT
• 3/42 (7%) – ULT alone
• 8/42 (19%) – ULT + ppx + prn colchicine
• 10/42 (24%) – ULT + prn colchicine only
40.0%
Baseline
(n=42)
30.0%
End
(n=39)
20.0%
10.0%
0.0%
≤6
Results – Average Gout Flare Frequency
7
6.1-6.5
6.6-7
7.1-7.5
Uric Acid (mg/dL)
7.6-8
>8
Results – Clinic Interventions
n=39
Average # of flares/patient
6
40% - started on ULT with prophylactic COL
5
4
n=2
3
24% - titrated ULT dose
19% - initiated prophylactic COL with ULT at baseline
2
1
n=39
n=27
0
Baseline
Visit 2
Visit 3
7% - documented a previously experienced ADR, not charted
n=8
Visit 4
Visit 5
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5/6/2015
Results – PPX Colchicine Prescribing
42
included
patients
Results Summary
• % achieving goal UA increased from 11.9% to 51.3%
• 67% achieved UA ≤ 6.5 mg/dL
• Average number of gout flares per patient decreased:
Colchicine regimen at last
visit
2-without
ULT
23-ppx +
prn COL
12 – cont.
during ULT
titration
19-prn
COL only
3-cont.
since tophi
present
5-cont.
with flares
present
Results Compared to Primary Literature
Outcome
% UA monitored
% achieving goal
UA
% started on ppx
COL with or
before ULT start
% prescribed
ppx COL
appropriately
Study Results
93
51.3
39.3
19.6
100
26.3
95
26.2
Visit
1
2
3
Avg days since last visit ± SD
N/A
104 ± 117.5 (n=42)
112 ± 80.4 (n=27)
Avg flares ± SD
6.56 ± 6 in past 12m
0.56 ± 6 since LV
0.44 ± 0.9 since LV
Avg flares/30 days
0.54
0.16
0.12
4
5
146 ± 140.6 (n=7)
347 ± 84.1 (n=2)
0.13 ± 0 since LV
3 ± 0 since LV
0.03
0.26
Safety of Allopurinol
Primary Literature Results
• 14% (6/42) of patients experienced rash during duration of study
Singh JA, et al. Ann Rheum Dis. 2009 Aug: 68(8): 1265-70.
George M, et al. Arth Care and Research. 2014 Aug: 66(8): 1258-62.
Study Limitations
Future Directions
• Small sample size
• Evaluating change in UA levels in pharmacist-managed vs.
• Retrospective design
• No “usual care” comparison group
“usual care” patients
• Evaluating impact of lifestyle counseling alone on UA levels
• Single site gout clinic
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Conclusions
Self-Assessment Question #1
Pharmacists can improve gout management by:
 Providing close follow-up
 Monitoring UA appropriately
 Initiating and titrating ULT when indicated
 Prescribing colchicine when appropriate
 Providing patient education regarding medications and
lifestyle factors
If a urate-lowering therapy is initiated, concurrent daily
colchicine must also be initiated for at least how long?
Self-Assessment Question #2
JS reports 1 gout attack/year. His exam is negative for tophi and
there is no history of nephrolithiasis. His estimated creatinine
clearance is 75 mL/min and his current uric acid is 7.6 mg/dL, all
other labs are WNL. Which treatment option is most appropriate for
his gout?
A. Start allopurinol 100mg daily
B. Start allopurinol 100mg daily + colchicine 0.6mg daily
C. Start colchicine 0.6mg as needed for gout attack
D. Start colchicine 0.6mg daily
A. 0 months
B. 3 months
C. 6 months
D. 12 months
IMPACT OF A PHARMACIST MANAGED
GOUT CLINIC ON URIC ACID LEVELS
AND PATIENT OUTCOMES
Margi Shah, Pharm.D.
Vanita Panjwani, Pharm.D.
Tracy Martinez, Pharm.D., BCACP
Jennifer Clemente, Pharm.D., BCACP
7