Optimal Prescribing Update and
Support (OPUS)
Make-Up Session
January 19, 2012
Session Opening
Dr. Keith White, MD
Opus enters the ‘marketplace of ideas’
Agenda
 1:00
Session Opening (10 min)
 1:10
Initial thoughts on the patient lists (15 min)
 1:25
Statins (35 min)
 1:55
Statins Table discussion (35 min)
 2:25
Break
 2:35
PPIs (25 min)
 3:00
PPs Table Discussion (30 min)
 3:30
Break
 3:40
Action Planning (60 min)
 4:40
Evaluation and Next Steps (10 min)
 5:00
Adjournment
4
Triple Aim of OPUS and Pre-approval
 Divisions' Triple Aim
› Outcomes
› Experience
› Costs
 Pre-Approved Special Authority
5
Aims of this OPUS session
 Reflect on our prescribing in light of evidence
 How to use OPUS Registries to pull charts of patients
who might benefit from a change in prescribing
 How to discuss medication changes with patients
 Introduce Special Authority Pre-Approval pilot study
 What do OPUS leaders need to facilitate sessions?
6
OPUS Steps
Session Lead & QLS: Session Lead, Action Period Patient visit: Follow-up QLS:
Medical Office GPs, MOAs discuss GP self-audit of handout or discuss process
Asst prepare portraits & actions charts
key message lessons & results
1
2
Some GPs sign
Special Auth’ty
Pre-Approval
2b
3
3b
4
5
Engage community
pharmacist in Best
Possible Med. Hist.
7
Initial Thoughts on Patient List
Dr. Shakeel Bhatti, PharmD.
Your ‘Patient List’ with OPUS Column
1 Subset of Hypertension Registry
2 ‘Hyperlidemia’ Registry
3 Cardiovascular Registry Subset
4 Cardiovascular / Anticoagulation
5 Osteoarthritis Registry Subset
9
Statins
Dr. Keith White, MD
Dr. Malcolm Maclure, Sc.D
Survey
• How do you prescribe statins?
• For secondary prevention?
• For primary prevention?
• For women?
• What percent of your patients are started by
you versus others, e.g. specialists?
• How do you use lipid tests?
• What is your philosophy on statin evidence?
11
What is your philosophy on evidence?
MECHANISM [on a scale: 1 to 10]
1
2
3
4
5
6
7
Treat-to-Target
Use Risk Calculator
SOME SPECIALISTS
GUIDELINES & PROTOCOLS
PROVEN OUTCOMES
8
9
10
Stick with RCTs
PAD
EQIP
12
EQIP
Statin
Portrait
13
Statins for SECONDARY prevention
14
Statins for SECONDARY prevention
11.3%
9.5%
1.8%
55
Death: Male: NNT = 55 ( ~5 yr)
Female: NNT = undefined
15
Statins for PRIMARY prevention
7.7%
MI:
5.7%
2.0%
Male: NNT = 50 (4.3 yr)
50
4.3%
4.1%
Female: NNT= undefined
16
What is your philosophy on NNTs?
Peptic ulcer: Triple Therapy  H. Pylori eradication
NNT = 1.1
(for 8 wk)
Peptic ulcer:
NNT = 6
PPI 
Prevent recurrent bleeding
(for 8 wk)
Atrial Fibrillation: Amiodarone  Convert to sinus rhythm in 24 hr
NNT = 2
(for 24 hr)
MI (within 24 hr): Streptokinase (or aspirin)  Prevent death
NNT = 33
(for 5 wk)
17
Examples of NNTs for 1 year
Schizophrenia: Chlorpromazine  Prevent relapse
NNT = 4 (for 1 yr)
AIDS: Ritonavir  Prevent death
NNT = 14 (for 1 yr)
MI: Warfarin (+ASA)  Prevent CHD events
NNT = 80 (for 1 yr)
2 yr
4 yr
18
NNTs for 1 year: Statins for secondary prevention
CVD (Male):
Statin  Prevent Major CHD
NNT = 135 (for 1 yr)
[ NNT = 27 for 5 yr ]
2 yr
4 yr
19
Male NNTs for Primary Prevention of CHD with statins
No CVD (Male):
Statin  Prevent CHD
NNT = 210
(for 1 yr)
[ NNT = 50
for 4.3 yr ]
4 yr
2 yr
20
Females: no evidence for statin effectiveness for primary prevention
NNT = undefined
?
?
?
?
?
5 yr
“What about the JUPITER trial?”
21
Ratios mislead. Decisions use Risk Differences.
Statin
Controls
Deaths
1419
1518
Pop’n
42,887
36,608
3.30%
4.14%
RD = 0.84%
NNT = 120
RR = 0.80
(RRR = 20%)
‘Thought Experiment’
1419
1518
42,887* 2
36,608 * 2
1.65%
2.07%
RD = 0.42%
NNT = 240
RR = 0.80
“What about the CMAJ meta-analysis?”
22
STATIN EVIDENCE SUMMARY
PRIMARY PREVENTION  major coronary events reduced in men
SECONDARY PREVENTION  major coronary events reduced in men & women; all-cause
mortality reduced in men
23
MAJOR CORONARY EVENTS
Broader composites endpoints are now commonly
used in statin trials  multiple outcomes often with
variable clinical significance
Narrow composite  non-fatal MI plus CHD death
Most consistently reported in statin trials
Considered an appropriate combination of
clinically important outcomes
Includes events considered less susceptible to
medical decision-making bias
http://ti.ubc.ca/letter77; http://www.hta.ac.uk/fullmono/mon1114.pdf;
http://cme.medicine.dal.ca/ad_resources.htm#statins; Lim E. Ann Int Med 2008:149:612-17
24
FOCUSED QUESTIONS
PRIMARY PREVENTION  which men?
PRIMARY & SECONDARY PREVENTION  which statin? which dose?
25
PRIMARY PREVENTION DECISION MAKING
Primary prevention RCTs  heterogenous patient populations, range
of (estimated & observed) CHD risk
Participants were not recruited into statin studies on the basis of
estimated CHD risk
RCT evidence is not supportive of a definitive threshold of CHD risk
at which individual patients assuredly would benefit Manuel 2005
Based on baseline characteristics in pivotal, primary prevention
trials:
average male participant
estimated 10-year risk of major coronary events
ranged from approximately 10 - 30%
Manuel D et al. CMAJ 2005:172:1027-31
26
PRIMARY PREVENTION DECISION
MAKING
Categorical risk levels (low, moderate, high) in CPGs
 arbitrary, oversimplify decision making Grover 2011
Do not account for patient & clinician values, comorbidities, life expectancy
Decision making should be informed by the probable
size of the absolute treatment benefits Jackson 2005
Supported by estimates of an individual’s predicted
risk of major coronary events
Grover. Can J Cardiol 2011:27:481-7; Jackson R et al. Lancet 2005:365:434-41; http://therapeuticseducation.org/
27
PRIMARY PREVENTION DECISION
MAKING
Framingham Heart Study’s Hard Coronary Heart
Disease risk score
http://www.framinghamheartstudy.org/risk/hrdcoronary.html
Predictors  age, total cholesterol, HDL, SBP,
treatment for HTN, smoking status
Outcome  major coronary events 10-year risk
Brugts J et al. BMJ 2009:338:b2376
28
Dr Chris Cates’ EBM Web Site http://www.nntonline.net/
29
adapted from: Goodyear-Smith F et al. Ann Fam Med 2008:6:213-17
30
STATIN COMPARISONS
Insufficient direct comparative evidence to support the
superior clinical efficacy or safety of one statin over
another
In primary prevention, indirect comparisons of “highpotency” statins (atorvastatin, rosuvastatin) vs. “lowpotency” statins (fluvastatin, lovastatin, pravastatin,
simvastatin) did not demonstrate differences in clinical
outcomes (all-cause mortality, MI, stroke) Tonelli 2011
In secondary prevention, direct comparisons of statins
(atorvastatin vs. pravastatin or simvastatin) did not
demonstrate differences in major coronary events or allcause mortality Canon 2004; Pedersen 2005
Tonelli M. CMAJ 2011:183:E1189-1202; Canon C. NEJM 2004:350:1495-504;
Pedersen T. JAMA 2005:294:2437-45
31
TREATING TO LDL-TARGET
STRATEGY
The interventions in statin studies are fixed doses of
statins, not LDL treatment targets Hayward 2006
Insufficient prospective evidence to conclude that
“the degree to which LDL cholesterol responds to a
statin independently predicts the degree of
cardiovascular risk reduction” Hayward 2006
It is unclear if proposed LDL targets are attainable
Hayward 2006
“no trial has yet examined progressively lowering or
shown that combination therapy improves patient
outcomes” Krumholz 2010
Hayward R. Ann Intern Med 2006:145:520-30; Krumholz K. BMJ 2010:341:332-3
32
COMBINATION THERAPY
2010 Systematic Review Sharma Ann Intern Med 2009:151:622-30
Combinations of lipid-lowering agents do not
improve CVD outcomes more than statin
monotherapy
ACCORD LIPID (type 2 diabetes) NEJM 2010:362:1563-74
Simvastatin + fenofibrate did not improve CVD
outcomes more than simvastatin alone
AIM-HIGH NEJM 2011:10.1056/NEJMoa1107579
Simvastatin (± ezetimibe) + niacin did not improve
CVD outcomes more than simvastatin alone
(terminated early)
33
FIXED-DOSE STRATEGY
Select doses on the basis of clinical trial evidence for benefits on major
coronary events.
Examples of fixed doses:
http://derp.ohsu.edu/about/final-document-display.cfm;
Cholesterol Treatment Trialists’ Collaboration. Lancet 2010:376:1670-81
34
Statins Q & A:
 Additional issues re: women, elderly, diabetes, etc.
 Benefit not associated with lipid levels, so what is the
appropriate dose?
35
Table discussions
 What are your reactions to what you heard in the presentation?
 What do you agree with?
 What do you disagree with?
 What concerns do you have about stopping statin therapy for
someone who is low risk?
 How do you currently approach the decision to start a patient on a
statin as primary prevention?
 What are some strategies for communicating with a patient about
quitting statins?
 Report out: What is one sentence that summarises a key
message or insight from your conversation?
36
BREAK
(10 minutes)
37
Proton Pump Inhibitors (PPIs)
Dr. David Blair, MD
EQIP Clinical Lead
My Objectives Today
 Global thinking about prescribing and physician’s decisions
 Finding tools to more effectively manage prescribing practice
Optimize prescribing to patient needs and:
› Control excessive use
› Address cost issues
› Recognize impact of high costs on health care system
39
Questions for me:
 How do I treat GERD and dyspepsia?
 How do I prescribe proton pump inhibitors?
 When do I think about duration of therapy for these conditions?
 How do I taper a chronic user from PPIs?
40
Why PPIs? “The broader impact of success”
 Effectiveness and reliability
 Common condition and common symptom presentation
 Weighing impact – both clinical and monetary of early use of PPIs
› Resetting expectations for ourselves and our patients
› Paying the bill – long term adverse outcomes, dollar costs
 ? $60,000,000 annually in BC
41
Emerging issues with PPIs
 Short term:
› necessity to treat
› selection of first drug
› dosage
› cost
 Long term:
› risks
› costs
› alternatives
42
PPIs: How do you taper off a chronic user?
43
PPIs Duration
Assuming a negative H. pylori test, PPI therapy should be
revisited at 4 weeks for most patients
 Only a few conditions will require long-term chronic use of PPIs:
GERD with ongoing symptoms or complications such as Barrett’s
esophagus, severe peptic ulcer disease with recurrent episodes,
and the uncommon Zollinger-Ellison Syndrome.
44
PPIs: Duration
45
Feedback?
 Our approach today?
 This topic as a prototype?
 Is your personalized EQIP portrait helpful?
 Initial thoughts on PPI usage and our current practice?
46
Emerging Issues:
 Potential serious adverse outcomes:
› Rebound Acid Hypersecretion Syndrome (RAHS)
› Fracture risk
› Infection risk
› Magnesium deficiency
› Drug/drug issues – clopidogrel
› B12 deficiency
› Interstitial nephritis
47
PPIs: Dosing
48
49
50
51
52
Cost considerations: Typical BC daily cost*
 Pariet $1.39
generic rabeprazole $0.97*
 Losec $1.19
generic omeprazole $0.95*
 Nexium $2.33
generic esomeprazole ?$2.00
 Pantoloc $2.18
generic pantoprazole $0.87*
 Prevacid $2.16
generic lansoprazole $0.86*
 Tecta $0.81
53
Review of PPI portraits
 Review your personal prescribing portrait.
 It is recommended that you NOT show others.
 The goal is self-audit and self-improvement
 Discussion will focus on 3 anonymous portraits of PPI
prescribing in BC:
 1) a median portrait
 2) a portrait more consistent with evidence
 3) a portrait less consistent with evidence
54
Comments on PPIs
 Do you think we can address these issues?
 Alternative approaches to prepare physicians?
 Acceptance amongst our colleagues?
 Report out: What is one sentence that summarizes a key
message or insight from your conversation?
55
Table discussion
1. When reviewing a patient’s PPI therapy at 4 weeks,
what are some considerations that would lead you to
continue or stop treatment?
2. How does the message that PPIs have an increased
rate of side effects compared to H2RAs compare with
the reality of your practice?
3. How often do you start a patient on a free sample of a
PPI?
56
Table discussion (continued)
4. What are some strategies for communicating with a
patient about their tapering from the PPI? How do you
approach possible discomfort associated?
5. How comfortable would you be switching a patient to a
less expensive PPI?
6. What has your experience been?
57
BREAK
(10 minutes)
58
Planning for the
Action Period
Christina Southey
59
Aims: your goal
for Action Period
Measures: How
am I progressing?
Change Ideas:
What you plan to
do/test
Start Small
and Grow
60
We want to provide the most
appropriate drug at the right time for
the most appropriate duration.
61
What does OPUS
mean for you?
62
Action Period Expectations
Photos courtesy of jscreationzs
63
Aims: What are we trying to accomplish?
Answer the following questions:
Which medications?
Statins and PPIs
What do you want to achieve?
Review for appropriateness
For whom? (everyone or just a subpopulation)
All regular patients
By When? (commit to a date)
March 1st, 2012
64
Examples
 To improve the prescribing of statins and PPI’s for Dr.
McConville’s regular patients, such that all patients who are
currently on a Statin or PPI are reviewed for appropriateness by
March 1st 2012.
To prescribe a Statin for all patients who meet indications but are
not currently on a Statin and have not previously declined or not
tolerated Statin use.
 By March 31st, 2012, we aim to improve the duration of PPI
treatment for Dr. Blair’s patients, such that all patients who are
prescribed a PPI are reviewed within 4-8 weeks of commencing
treatment for:
› Continuation,
› Change, or
› Discontinuation
65
Practice measures:
How will you know a change is an improvement?
Examples:
Count patients for whom statin is changed.
Count number of PPIs tapered, stopped, switched.
Count number of antihypertensives switched.
Count number of patients who start anticoagulant.
66
Examples – Dr. McConville
 % of patients currently on a Statin or PPI who have had their
medication reviewed during an office visit.
 % of patients who have had PPI or Statin reviewed for whom
medication was discontinued.
 % of patients who meet indications for statin who are prescribed a
statin.
Note: Excluding those who have declined previously or
discontinued use.
67
Examples – Dr. Blair
 % of patients who are listed as being on PPI treatment for over 48wks from EQIP portrait whose PPI is reviewed.
 % of patients whose medication is reviewed that have:
› No change
› Attempted discontinuation
› Recommended for gastroscopy
68
Where will you record your counts?
 Make notes in margin of registry-patient list?
 Make a bar chart? Check boxes on the bar chart?
 Can you use your EMR? How will you output the results?
 Counts on a tick sheet (e.g. back of patient handout pad)? (see
examples)
 How will you display and share your data? (preferably graphs)
69
Change ideas:
What changes can you
make that will result in
improvement?
70
71
Examples – Dr. McConville
What will you try?
Who needs to be involved?
When will you Start?
Dr. McConville
December 1st
Review patient list for those
that should be on statin and
are not.
Review PPI and statin
Dr. McConville
patients for those that need
to have a discontinuation or
change discussion.
Flag charts for follow-up
MOA
conversation on statin or PPI Dr. McConville
December 1st
December 12th
72
Examples – Dr. Blair
What will you try?
Review the patient list and
compare patients who:
 Meet guidelines
 Don’t meet but need to
be review
 Need to be discontinued
Flag charts for those that
need a review of PPI at next
visit.
Discuss changing or
discontinuing PPIs with
flagged patients.
Who needs to be involved?
When will you start?
Dr. Blair
December 1st
Dr. Blair – List of patients to
flag
MOA – flag charts
Dr. Blair
December 12th
December 13th (or first
flagged patient to come in)
73
What is your Action Plan?
What is your Aim?
Which medications?
Time frame that is reasonable
A goal to shoot for
What are your Measures?
Keep it to a manageable number
Leverage data you have available to you
How will you collect your data
What are your next steps?
Who needs to be involved
Commit to a start date
Start Small
74
Example of an Action Period test of change
What will you do with your statin patients?
1. Review patient in OPUS Lists #2 or #3 and
identify patients who could start or stop statins.
2. Flag patient charts or call in patients you think
would benefit from medication review.
3. Discuss the benefit of statins with patients using
patient handouts.
75
Example of an Action Period test of change
What will you do with PPI patients?
1. Review patient on OPUS List #5 and confirm
patients on a PPI for longer than 8 weeks
2. Flag patient charts or call in patients you think
would benefit from medication review
3. Discuss with patients the idea of tapering and
eventually stopping their PPI therapy
•
•
Patient hand-out: Put Out the Fire (RxFacts, Harvard)
Alternate Rx pad: Step-down of medicines (NPS)
76
Action period expectations
 Try tests of change.
 Track your progress.
 EQIP resources available via phone.
 Monthly support call.
 Materials available at:
http://www.gpscbc.ca/psp_opus
77
Examine your OPUS Patient Registries before QLS

Your patient list is NOT to be viewed by others.

Did your list reflect your practice reasonably well?

Were you surprised by the number of patients listed?

Do you have any questions about the list?
78
Patient list with OPUS column
1 Subset of Hypertension Registry
2 ‘Hyperlidemia’ Registry
3 Cardiovascular Registry Subset
4 Cardiovascular / Anticoagulation
5 Osteoarthritis Registry Subset
79
Table discussions: What patients do you want listed?
Lists #2 and #3: ‘Hyperlipidemia’ Registry
 Discuss 3 types of patients:
 Women with no previous CVD events, taking statins.
 Low-risk men with no CVD events, taking statins.
 Men or women with CVD history not taking statins.
80
Table discussions: What patients do you want listed?
List #5: ‘GERD/dyspepsia’
 Discuss 3 types of patients:
 Long-term regular users of PPIs, without NSAIDs.
 Long-term regular users of PPIs, with NSAIDs.*
 Long-term episodic users of PPIs.
* e.g. Osteoarthritis Registry, not Rheumatoid Arthritis
81
Patient perspective

How will these practice changes you have just
identified impact your patients?
› Direct costs to patient
›
Patient preferences and barriers to changing
medication
›
Relationship with you or other care givers
›
What else?
82
Communicating changes to patients

How will you contact the patient about changing the
prescription?

Suggested wording to discuss the prescription change
with the patient, including addressing their concerns
and discussing how drug change will occur

What patient materials do you need to help make
practice changes?

What barriers do you expect to encounter?
83
Evaluation and Next Steps
Dr. Keith White
Next steps






Complete evaluation forms
Complete payment forms
Listserv: l_hlth_opus@lists.gov.bc.ca
Monthly support call – February 15
Follow-up training session – Wednesday, March 7
Contact information for support
Telephone support during the action period:
Call Dr. Malcolm Maclure’s cell: 250-507-9614
malcolm.maclure@ubc.ca
Schedule call with his assistant:
Kerry Patriarche: 250-405-1940
85