d5 burke - needs assessment - salon d
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A Needs Assessment of Drug
Formulary Review Processes
Across a Local Health
Integration Network (LHIN) in
Ontario
Natasha Burke1,2, Anne Holbrook1,2, James M Bowen1,2,
Sue Troyan1,2, Jathishinie Jegathisawaran1,2, Carolyn Gosse2,
Marita Tonkin3, Sandra Kagoma4, Sue Alderson3, Ron Goeree1,2
1McMaster University; 2St. Joseph’s Healthcare Hamilton; 3Hamilton Health Sciences; 4Brant Community Healthcare System
2013 CADTH Symposium, May 7, 2013
Division of Clinical
Pharmacology and Therapeutics
Division of Clinical
Pharmacology and Therapeutics
Disclosure and Acknowledgement
Supported by: Academic Health Science
Centres (AHSC) AFP Innovation Fund
(PI: Dr. Anne Holbrook)
2
Division of Clinical
Pharmacology and Therapeutics3
Background
Drugs approximately 16% of total health care
spending in Canada
Hospital drug expenditures estimated at $2.4B in
20091
Pharmacy and therapeutics (P&T) mandated
committee
• Evaluation of new drugs and current drug therapies for
inclusion or deletion from hospital formulary
• Drug use policies and procedures
Variable use of evidence-based methods to
assist in decision-making regarding drugs
1CIHI, Drivers of Prescription Drug Spending in Canada, 2012
Division of Clinical
Pharmacology and Therapeutics
Local Health Integration Network (LHIN)
4
In 2006, MOHLTC divided Ontario into 14 LHINs
Intended to plan, integrate and fund local health
services including hospitals, community care, long-
term care and mental health services
Division of Clinical
Pharmacology and Therapeutics
Project Objective
To examine current formulary review
processes and preferences related to a
potential collaborative drug review process
across P&T committees within the LHIN
5
Division of Clinical
Pharmacology and Therapeutics
Methods: Institutional Profile Survey
(Part 1)
6
To gather information regarding the structure of
current drug review processes at each hospital
• Profile of institutions
• Formulary characteristics
• P&T committee characteristics
• Formulary review submission process
• Evidence submitted for review
• Formulary review decision-making
Directors of Pharmacy asked to complete (n=10)
Response rate 100%
Division of Clinical
Pharmacology and Therapeutics
Methods: P&T Committee Member
Survey (Part 2)
7
To gather feedback from individual committee
members on process for new drug formulary
requests and preferences related to
centralization
5-point Likert scale; open-ended questions
Each Director of Pharmacy asked to distribute to
4-5 committee members
Anonymous survey responses returned
Response received from 28 members
Division of Clinical
Pharmacology and Therapeutics8
PART 1:
Institutional Profile Survey
Division of Clinical
Pharmacology and Therapeutics
LHIN 4 - Hamilton-Niagara-Haldimand-
Brant (HNHB)
9
Total Population: 1.3 million
Division of Clinical
Pharmacology and Therapeutics
Profile of Institutions within HNHB LHIN
10
10 Hospitals/Institutions
23 sites
• 15 community; 8 academic
• Setting: 17 inpatient/outpatient; 2 inpatient only;
4 outpatient only
3566 beds
Pharmacy Staff:
• 137 FTE pharmacists
• 201 FTE pharmacy technicians
• 10 FTE administrative support for pharmacy
P&T Committee & Drug Formulary (n=10)
11
Characteristic N (%)
P&T Committee:
P&T committee provides service for more than 1 site 4 (40%)
Frequency of committee meetings <6 times per year 4 (40%)
>10 committee members 7 (70%)
Subcommittees (medication safety, nursing/pharmacy,
antimicrobial, accreditation medical management)5 (50%)
Committee representation (mean)
35% medicine
29% nursing
25% pharmacy
0-7% other
Drug Formulary:
Major review of formulary within past 10 years 6 (60%)
On-line access to drug formulary 6 (60%)
P&T newsletter used to communicate changes to formulary 7 (70%)
Division of Clinical
Pharmacology and Therapeutics
Number of New Drug Formulary
Requests Reviewed Per Year
12
0
1
2
3
4
5
6
7
1-5 6-10 11-15
Ho
sp
ita
ls
No. Requests Per Year
Division of Clinical
Pharmacology and Therapeutics
P&T Resources Across the LHIN
13
Time commitment for new formulary
drug submissions/reviews:
Hours per
month
Pharmacists 96
Physicians 15
Administrative 9
Nursing 9
Technicians/assistants 4
Clerical 4
Total Hours Per Month 137
Total hours per year = 1,644
Equivalent to 0.84 FTE
0% 25% 50% 75% 100%
Education/communication plan
Ethical/social implications
Drug plan coverage (ODB)
Institutional impact assessment
Critical appraisal-economic evidence
Budget impact calculations
Hospital BIA
Economic evaluation
Critical appraisal-clinical evidence
Safety - detailed
Safety
Efficacy - detailed
Efficacy
Product & administration
Pharmacology & pharmacokinetics
Disease description
Formulary Submission: Evidence Requested
14
Clin
ical
Eco
no
mic
Oth
er
Division of Clinical
Pharmacology and Therapeutics
Formulary Submission: Evidence
Synthesis and Evaluation
15
N
Never, R
arely or
NA
Some-
times
Often or
Always
Primary literature searches are
conducted to identify clinical efficacy
& safety information
10 10% 50% 40%
Systematic review methods or
meta-analytic techniques are used
to summarize the evidence
9 44% 22% 33%
Economic evaluations are
conducted internally10 60% 20% 20%
Budget impact analyses are
conducted internally10 30% 30% 40%
Division of Clinical
Pharmacology and Therapeutics16
PART 2:
P&T Committee Member Survey
P&T Member Survey (n=28)
17
Committee Member Characteristics (those reporting) n (%)
Profession:
Pharmacist 15 (54%)
Medicine 5 (18%)
Nursing 4 (14%)
Other 4 (14%)
Number of years of practice, median (range) 19 (2-40)
Number of years experience on a drug review committee,
median (range)
5 (1-25)
Any formal/structured training:
Clinical pharmacology or therapeutics 22 (79%)
Evidenced-based medicine 14 (50%)
Systematic review 13 (46%)
Health economics 6 (21%)
Health technology assessment 5 (18%)
Formulary Review Submission Process
(n=28)
18
StatementDisagree or
Strongly
Disagree
Neither Agree
or Disagree
Agree or
Strongly Agree
Considering the current submission
process for a new drug formulary
request, the process captures all of the
information needed for the review
9 (32%) 3 (11%) 16 (57%)
StatementUncomfortable
or Slightly
Comfortable
Moderately
Comfortable
Very/
Extremely
Comfortable
How comfortable are you in evaluating
the quality of the submission or the
evidence provided?
5 (18%) 13 (46%) 10 (36%)
StatementUnsatisfied or
Slightly
Satisfied
Moderately
Satisfied
Very/
Extremely
Satisfied
Overall, how satisfied are you with your
institution’s drug formulary submission
process?
7 (25%) 13 (46%) 8 (29%)
Division of Clinical
Pharmacology and Therapeutics
Quality of Information Submitted (n=28)
19
In general, the evidence provided in the submission is
sufficiently comprehensive and detailed for decision making:
25%43% 36%
29%
21% 39%
46%36%
25%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Clinical Evidence
Economic Evidence
Organizational Impact
Analysis
Agree or Strongly Agree
Neither Agree or Disagree
Disagree or Strongly Disagree
Formulary Review Decision Making
20
Statement N (%)
Your committee currently has amongst its participating
members, sufficient clinical and economic expertise to make a
fully informed decision for all formulary requests (n=28)
9 (32%)
If no, what expertise is currently lacking (n = 19):
Health economics/ impact expertise 14 (74%)
Physician participation 5 (26%)
Evidence/critical appraisal expertise 3 (16%)
Other issues that impede the quality of formulary review at
your institution (n = 13):
Limited resources/ staff/ administrative support 6 (46%)
Limited / lack of information 5 (38%)
Incomplete/ brief submissions 2 (15%)
Time constraints 2 (15%)
Coordinated Review Process: Interest
21
Statement
Disagree
or
Strongly
Disagree
Neither
Agree
or
Disagree
Agree
or
Strongly
Agree
A standardized drug formulary submission process across
institutions in the LHIN would be beneficial.2 (7%) 1 (4%) 25 (89%)
A common drug formulary across the institutions in the
LHIN would be beneficial.6 (21%) 4 (14%) 18 (64%)
The institutional formularies should be synchronized with
ODB drug formulary listings.7 (25%) 5 (18%) 16 (57%)
The OPDP should expand its formulary process to evaluate
and decide on reimbursement for hospital-only drugs.0 (0%) 7 (25%) 21 (75%)
National and provincial formulary reviews should be used
to inform institutional formulary decisions.1 (4%) 1 (4%) 26 (93%)
Expansion of group purchasing contracts (e.g. MedBuy) to
negotiate discounts on all new drugs added to the
formulary would be beneficial.
0 (0%) 3 (11%) 24 (89%)
Division of Clinical
Pharmacology and Therapeutics22
What benefits would be obtained by
harmonizing or centralizing formulary
review processes within the LHIN?
Most common themes (n=25 responses) Frequency
Efficiency/ sharing of workload 15
More standardization/ reduce variation 11
Efficiency/ sharing of cost 9
Improve quality/ expertise in review 7
Division of Clinical
Pharmacology and Therapeutics23
What drawbacks would there be to
harmonizing or centralizing formulary
review processes within the LHIN?
Most common themes (n=24 responses) Frequency
Institution-specific population/ needs/ priorities 13
Equity across large and small sites 7
Physician autonomy/ buy-in 6
Time/cost of implementation 3
Institution-specific budget impact 3
Division of Clinical
Pharmacology and Therapeutics24
What do committee members need/want
from a centralized formulary review
process within the LHIN?
Most common theme (n=21 responses) Frequency
Shared review of clinical and/or economic evidence 8
Representation of members from across all sites 5
Standardized procedures 5
Individual decision-making/ local consideration 5
Division of Clinical
Pharmacology and Therapeutics
Summary
25
Review of formulary submissions across LHIN
represents 1 FTE annually
Resources still an issue across institutions
Gap in health economic and HTA expertise
Interest in centralized/coordinated process
• Concerns about adequate resources, equity across
institutions and specific needs of institutions (i.e.
special populations)
Use of national and provincial reviews supported
26
Natasha Burke, MSc
Program Manager, Programs for Assessment of Technology in Health (PATH)
Research Institute, St. Joseph’s Healthcare Hamilton
Research Associate, Department of Clinical Epidemiology & Biostatistics,
McMaster University
Telephone: (905) 523-7284
Fax: (905) 522-0568
Email: [email protected]
Website: http://www.path-hta.ca
PATH Research Institute
25 Main Street West, Suite 2000
Hamilton, ON, Canada L8P 1H1
Questions?