D5 burke - needs assessment - salon d

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: nburke@mcmaster.ca

Website: http://www.path-hta.ca

PATH Research Institute

25 Main Street West, Suite 2000

Hamilton, ON, Canada L8P 1H1

Questions?