Collaborative Drug Therapy
Management in NYS:
Impact on Pharmacy Practice
Kimberly Zammit, PharmD, BCPS, FASHP
NYS Board of Pharmacy
Chair, CDTM Implementation Committee
September 23, 2014
Disclosures

None to report
Collaborative Drug Therapy Management
ACCP Position Statement


Agreement between one or more physicians and
pharmacists
Qualified pharmacists working within the context of a
defined protocol are permitted to assume professional
responsibility for:




Performing patient assessments
Ordering drug therapy-related laboratory tests
Administering drugs
Selecting, initiating, monitoring, continuing, and adjusting drug
regimens. (aka prescribing)
Pharmacotherapy 2003;23:1210-1225
CDTM in the U.S. 2012
Any
setting
Healthsystems
Very limited
in any
setting
http://www.cdc.gov/dhdsp/pubs/docs/Pharmacist_State_Law.PDF
No
CDTM
Giberson S,Yoder S, Lee MP. Improving Patient and Health System Outcomes through
Advanced Pharmacy Practice. A Report to the U.S. Surgeon General.
Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.
http://www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx
Report to the Surgeon General
Objectives

Obtain advocacy from the U.S. Surgeon General to:




Acknowledge pharmacists that manage disease through medication
use and deliver patient care services, as an accepted and successful
model of health care delivery in the United States, based on
evidence-based outcomes, performance-based data and the benefits
to patients and other health system consumers.
Recognize pharmacists, who manage disease and deliver many patient
care services, as health care providers. One such action is advocate
to amend the Social Security Act to include pharmacists among
health care professionals classified as “health care providers.”
Have pharmacists recognized by CMS as Non-Physician Practitioners
in CMS documents, policies, and compensation tables commensurate
with other providers, based on the level of care provided.
Advance beyond discussion (and numerous demonstration
projects) of the expanded roles of pharmacist-delivered patient care
and move toward health system implementation
Report to the Surgeon General
Economic Benefit
Benefit to
Cost Ratio
(US dollars)
1988 - 1995
1996 - 2000
2001 - 2005
Lowest
1.08 : 1
1.70 : 1
1.02 : 1
Highest
75.84 : 1
17.01 : 1
34.61 : 1
Median
4.09 : 1
4.68 : 1
4.81 : 1
Mean
16.70 : 1
5.54 : 1
7.98 : 1
Response from the Surgeon General


Publically supports the role of pharmacists in
collaborative practice
Evidence and outcomes presented support the following:




Health-care leadership and policy makers should explore ways
to optimize the role of pharmacists through collaborative
practice
Collaborative practice will improve quality, contain costs and
increase access to care
Recognition of pharmacists as health care providers, clinicians
and an essential part of the health care team is appropriate
given the level of care they provide in many settings
Compensation models reflective of the range of care provided
are needed for sustainability
http://www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx
NYS CDTM Demonstration Project
NYS CDTM Demonstration Project Report

CDTM legislation passed in 2011required the
development of a report:




Review the extent to which CDTM was implemented in New
York State
Examine whether and the extent to which CDTM contributed
to the improvement of quality of care for patients, reduced the
risk of medication error, reduced unnecessary health care
expenditures and was otherwise in the public interest.
Make recommendations regarding the extension, alteration
and/or expansion of these provisions
Make any other recommendations related to the
implementation of CDTM
http://www.op.nysed.gov/news/cdtmreportmay2014final.pdf
CDTM Report Writing Committee

Board of Pharmacy

Participant Representatives

CDTM Implementation
Committee


Kimberly Zammit, PharmD,
BCPS, FASHP
Leigh Briscoe-Dwyer, PharmD,
BCPS, FASHP
Lawrence Mohkiber, RPh, MS
Kimberly Leonard, RPh





Kelly Rudd, PharmD, BCPS,CACP
 Bassett Healthcare
Lisa Phillips, PharmD, CACP, BAAP
 Upstate Medical Center
Mark Sinnett, PharmD, FASHP
 Montefiore Medical Center
CDTM Demonstration Sites*
Institution / Location
Anthony Jordan Health Center / Rochester
Bassett Healthcare Network / Cooperstown
Bronx-Lebanon Hospital Center / Bronx
Brooklyn Hospital
Brooklyn
Kingsbrook Jewish Medical Center / Brooklyn
Memorial Sloan Kettering Cancer Center / New York
Montefiore Medical Center / Bronx
Rochester General Hospital / Rochester
Roswell Park Cancer Institute / Buffalo
United Health Services / Binghamton
Upstate Medical Center / Syracuse
* Programs submitting data
Program
Diabetes
Anticoagulation
Heart Failure
Anticoagulation
Asthma
Diabetes
Heart Failure
HIV
Anticoagulation
Oncology
Heart Failure
Diabetes
Oncology
Anticoagulation
Diabetes
CDTM Demonstration Project
Results
Program
Number of
Patients
Results
Anticoagulation
841
TTR 71 – 84%
Low rate of adverse effects
Asthma
25
100% patients receiving therapy
demonstrated to improve disease control
195
HbA1C Control
22 – 39% at goal
7 – 15 % decrease in 4 – 12 months
78
30 Day Hospitalization: 0 – 9 %
ACEI / ARB: 88%
Beta Blocker: 95%
Diabetes
Heart Failure
HIV
Oncology
864 visits
Interventions optimized efficacy, safety
and adherence
2304 interventions
12 patients
Interventions optimized efficacy, safety
and adherence
Anticoagulation
Anticoagulation Management
Time in Target Range
Measure
Outcome at 5%
increase in TTR
Outcome at 10%
increase in TTR
Adverse Events Prevented
1114
2087
Number of Deaths
Avoided
662
1233
Number of QualityAdjusted Life Years Gained
863
1606
$15.9 million
$29.7 million
Healthcare Dollars Saved
(per 67,000 patients)
Rose AJ, et al. Circ Cardiovasc Qual Outcomes. 2011; 4:416-424.
Anticoagulation Management
Number
of Patients
Age Range
(years)
Medicaid
(N)
Medicare
(N)
ADEs
(per 100
patients)
TTR
Bassett
Healthcare
Brooklyn
Hospital
Kingsbrook
Jewish
United
Health
Usual
Care
503
174
43
121
25-97
23-91
22-88
35-88
6
16
NR
25
393
60
19
95
4.97
3.45
2.32
0.82
19.5
84.6%
75.1%
71.2%
Unable to
report
57.4%
Anticoagulation Participants

Kelly Rudd, PharmD, BCPS,CACP


Kingsbrook Jewish Medical Center

Henry Cohen, MS, PharmD, FCCM,
BCPP, CGP


Bassett Healthcare
Valery L. Chu, PharmD, BCACP,
CACP




United Health Services Hospitals

Patient Centered Medical Home

The Brooklyn Hospital Center
Julie Anne Billedo, PharmD,
BCACP

Kingsbrook Jewish Medical Center
Lindsey Wormuth, PharmD
Rebecca Arcebido, PharmD,
BCACP


Patient Centered Medical Home
The Brooklyn Hospital Center
Robert DiGregorio, PharmD,
BCACP

The Brooklyn Hospital Center
Diabetes
Demographics
Site
Number of
Patients
Average Patient Age +/- SD
(range)
AJHC
60
60.4 ± 10.2 (38 – 83)
Upstate
76
54 ± 11 (29-86)
RGH
24
58.9 + 7.99 (52-70 )
Brooklyn
35
NR
Target Hemoglobin A1C
70%
63%
Percent Patients with
HbA1c<8%
60%
54%
53%
50%
40%
31.80%
30%
25%
23.60%
20%
10%
0%
Site 1
Baseline
Site 1
12 months
Site 2
Baseline
Site 2
12 months
Site 3
Baseline
Site 3
4 months
Change in Hemoglobin A1C
Diabetes Participants



Lisa Phillips, PharmD, CACP, BAAP
 St John Fisher College / WSOP
 Upstate Medical University
Mary Jo Lakomski, BS Pharm, CDE,
BCACP
 Upstate University Hospital
Robert DiGregorio, PharmD,
BCACP

The Brooklyn Hospital Center


Alex DeLucenay, PharmD, BCACP
 St John Fisher College, WSOP
 Rochester General Hospital
Asim M. Abu-Baker, PharmD, CDE
 St. John Fisher College, WSOF
 Anthony Jordan Health Center
Heart Failure
Demographics
Number (%)
Mean
SD
59
64.2 years
12.8
Gender: Male
32 (54%)
n/a
n/a
Ejection fraction (EF)
57 (97%)
34.1%
11.6
48 (81%)
7165.5
pg/mL
11128
52 (88%)
1.7 mg/dL
1.4
Age
N-terminal Pro-BNP
Serum creatinine
Re-Hospitalization

30 days


Among 22 patients who were seen at the clinic within two
weeks after discharge, the 30-day readmission rate was 9%
(2 /22).
90 days

42 patients had at least one hospitalization in the prior 3 mos



Five patients (12%) have not reached the three month time point
28 patients (67%) were not hospitalized
In comparison to the previous 3 months:



Three patients (7%) had one less hospitalization
Two patients (4.5%) had one more hospitalization
Four patients (9.5%) had one hospitalization prior to and one
hospitalization after their clinic visits
Pharmacist Interventions
Addressed adherence
Discontinued expired/inappropriate
medications
Switched patient to appropriate therapy
Reconciled duplicate medications
Corrected improper use of medications
0
10
20
30
40
50
60
Therapy Optimization
Initiated ISDN/Hydralazine
Initiated AA
Uptitrated Diuretic
Initiated Diuretic
Uptitrated Beta blocker
Uptitrated ACEI/ARB
Initiated ACEI/ARB
0
5
10
15
20
25
30
35
40
Adherence Problems Resolved
Does not understand
directions
Prefers not to take
medication
Forgets to take
medication
Drug is unavailable
Patient cannot afford
medication
Heart Failure Participants


Angela Cheng, PharmD, BCPS
 Montefiore Medical Center
Danielle Garcia, PharmD, BCPS
 Montefiore Medical Group –
Bronx East

Charnicia E. Huggins, PharmD, MS
 Touro College of Pharmacy
 Bronx Lebanon Hospital
HIV
Pharmacist Interventions
Intervention Category
Optimization of therapy by indication
N = 1408
(% of total)
532
(37.8)
Unnecessary Drug Treatment
66 (4.6)
Need for Additional Treatment
466 (33)
Optimization of effectiveness
146
(10.4)
Inadequate Dose
Optimization of Safety
146(10.4)
165
(11.7)
Adverse Reaction (prevented/identified)
112 (8)
Excessive Dose
53 (3.8)
Adherence
444
(31.5)
Patient Satisfaction
4
3
2
3.74
3.64
3.62
1
0
The pharmacy team plays an Pharmacists at this clinic help A pharmacy team at this clinic
important role in my care at me better understand how to has helped me to make sure I
this clinic
take medications and what to
do not miss doses of my
expect when taking them
medications
1 = Strongly disagree 2 = Somewhat disagree 3 = Somewhat agree 4 = Strongly agree
HIV Participant

Agnes Cha, PharmD, AAHIVP, BCACP
 Arnold and Marie Schwartz School of Pharmacy and Health Sciences /
Long Island University
 The Brooklyn Hospital Center
Oncology
Pharmacist Interventions
Memorial Sloan Kettering Cancer Center
Intervention Category
Optimization of therapy by indication
Discontinue Unnecessary Drug Treatment
Discontinue Duplicative Therapy
Initiate Therapy for Untreated Indication
Optimization of effectiveness
Incorrect Dose
Inappropriate route
Optimization of Safety
Excessive Dose
Dangerous Drug Interactions
N = 2392
(% of total)
1235
(51.6)
482 (20.1)
37 (1.5)
716 (29.9)
694
(16.5)
627 (26.2)
67 (2.8)
363
(15.1)
119 (5)
244 (10.2)
Provider Satisfaction
MSKCC
Overall Satisfied with CDTM program
Reinforces physician/pharmacist
relationship
Optimizes Care
Improves Efficiency
0
Strongly Agree
25
Agree
50
75
100
Pharmacist Interventions
Roswell Park Cancer Institute
Advised patient to
continue therapy
Patient medication
counseling
Added new therapeutic
agent
Changed medication
dose
Provider Satisfaction
RPCI
CDTM Services improves quality of care
CDTM Services should be continued
Clinical Pharmacy Specialist displayed
adequate knowledge
CDTM Services allows me more time to see
patients
Overall Satisfaction with CDTM Services
0
20
40
60
Very Satisfied/Strongly Agree/ Definitely Yes
Satisfied/Agree/Probably
Undecided
Dissatified/Disagree/Probably not
Very Dissatified/Strongly Disagree/Definitely Not
80
100
Patient Satisfaction
RPCI
Overall Rating of Pharmacist Services
Comfortable talking to the pharmacist /
asking medication questions
Pharmacist was well informed and able to
answer my questions
Pharmacist follow up was appreciated
Likelihood of scheduling another
pharmacist visit
0
20
40
60
Very Satisfied/Strongly Agree/ Definitely
Satisfied/Agree/Probably
Undecided
Dissatified/Disagree/Probably Not
Very Dissatified/Strongly Disagree/Definitely Not
80
100
Oncology Participants

Elizabeth Hansen PharmD, BCOP
 Roswell Park Cancer Institute

Richard Tizon, PharmD, BCOP
 Memorial Sloan-Kettering
Cancer Center
Asthma
Pharmacist Interventions
Parameter
Receiving a controller medication
Rescue medication prescribed
Asthma action plan reviewed and educated
Medication directions reinforced
(Patient did not initially demonstrate understanding)
Frequency
25
(100%)
25
(100%)
25
(100%)
25
(100%)
Optimization of Medication Therapy
Additional medication needed to optimize therapy
Unnecessary medication discontinued
Potentially harmful medication discontinued
2
(8%)
1
(4%)
1
(4%)
Asthma Participant

Robert DiGregorio, PharmD, BCACP

The Brooklyn Hospital Center
Economic Outcomes
CDTM Demonstration Results
Economic Impact
Estimated Annual Savings (millions)
Diabetes
Heart Failure
Anticoagulation
Asthma
0
200
400
600
800
1000
1200
1400
1600
Patient Satisfaction Survey
CDTM Demonstration Results
Patient Satisfaction Survey
Care Improved with Pharmacist on Healthcare Team
(n=124)
Unsure, 3%
No, 1%
Yes, 96%
CDTM Demonstration Results
Patient Satisfaction Survey
Overall quality of care
Adequate time spent with
patient
Disease or Medication
Understanding
Pharmacist Relationship
Excellent
0
50
Very Good
Good
100
Patient Satisfaction Comments
“Exceptional personnel”
“Feeling better since being here”
“I get to know more about my medication and its effectiveness”
“My care is exceptional from my pharmacist”
“Saved my life. Saved my sister’s life. I'm thankful for the
patience and taking the time with me”
“Pharmacists give you a better understanding of what your meds
is supposed to do”
“She is very patient and understanding with me. I enjoy her
being the one helping me”
Conclusions

Collaborative management drug therapy services
provided in this pilot program demonstrated:






Ability of pharmacists to meet or exceed efficacy endpoints
Reduced risk of adverse reactions and hospitalizations
Optimized medication management
Reduced expenditures to the health care system
High rates of satisfaction by both patients and physicians
Recommendations

CDTM should be expanded to allow all qualified pharmacists
to participate
Collaborative Drug Therapy
Management in NYS:
Proposed Legislation
Leigh Briscoe-Dwyer, PharmD, BCPS, FASHP
NYS Board of Pharmacy
CDTM Implementation Committee
September 23, 2014
Proposed Legislation

Would add additional practitioners who may enter into
CDTM agreements with pharmacists



NPs
PAs
Adds the term “Facility”
Proposed Legislation


CDTM can take place in any facility or practice
Facility is defined as







Hospital
Diagnostic Center
Treatment Center
Hospital based outpatient department
Residential Health Care Facility
Nursing Home
Practice shall mean a place or situation in which
physicians, physician assistants and nurse practitioners,
either alone or in group practices, provide diagnostic and
treatment care for patients
Proposed Legislation





Includes verbiage on “prescribing” in order to adjust or
manage a drug regimen of a patient, pursuant to a patient
specific order or non-patient specific protocol.
Evaluating and ordering disease state and laboratory tests
related to drug therapy management of the disease or
disease states specified within a protocol
Performing routine patient monitoring functions as may
be necessary (Vitals)
No Informed Consent
No Sunset
Pharmacist Credentials


Must have a current unrestricted license in NY
Satisfy any two (2) of the following:


Certification in a relevant area of practice from an organization
recognized by ACPE or another entity recognized by the State
Education Department
Postgraduate residency through an accredited postgraduate
institute



At least 50% of the experience includes the provision of direct patient
care with interdisciplinary teams
Have provided clinical services to patients for at least 1 year
Pharmacists who meet the experience requirements will
be certified by State Education Department to enter into
CDTM agreements
Pharmacist Credentials:
Experience

Provision of clinical services to patients for at least one
year



Under a collaborative practice agreement with a physician or
other recognized provider, OR
Has documented experience in the provision of clinical
services to patients for at least one year and deemed
acceptable to the department upon recommendation of the
board of pharmacy
A licensed pharmacist may engage in CDTM under the
supervision of a CDTM pharmacist in order to gain
experience necessary to qualify to participate
Why credentialing in pharmacy?

Increasing complexity in healthcare




Technology advancement
Expectation of pharmacist involvement in patient care teams
Participation / management of advanced practice activities
Demand for safe, effective and high quality care



IOM report – licensure/CE inadequate
Consumer group/public demand
Scrutiny by hospital quality and risk departments
Credentialing

Credentialing “Ensures”:



Documented evidence of professional qualifications
Demonstration that they possess the knowledge to manage
certain disease states
Examples:




Academic degrees
State licensure
Residency diplomas
Certifications


eg. BCPS, BCOP, BCPP, BCNSP, BCNP, BCACP, CDE, AE-C, CACP
Certificate Programs

(ASHP, ACCP, NYSCHP)
Board Certification

Pharmacist-only

Board of Pharmaceutical Specialties (BPS)




Commission for Certification in Geriatric Pharmacy


Ambulatory, Cardiology (AQ), ID (AQ), Nuclear, Nutrition Support ,
Oncology, Pharmacotherapy, Psychiatry
BPS is by the National Commission for Certifying Agencies
Pediatric and Critical Care Fall 2015
Certified Geriatric Pharmacist
Multidisciplinary

Various certification bodies

Anticoagulation, Asthma, BLS/ACLS, Clinical Pharmacology, Diabetes
(education and management), Health Information Technology, HIV,
Lipids, Pain (education and management), Poison information,
Toxicology
http://www.pharmacycredentialing.org/Files/CertificationPrograms.pdf
http://www.pharmacycredentialing.org/Files/CertificationPrograms.pdf
Spectrum of Clinical Practitioners
Narrow
Broad
Breadth of patient / practice focus
Focused Practitioner
Wide variety of patients and
diseases; minor ailments to
more complex conditions
Wide variety of diseases in a
unique setting or population, or
a narrow disease focus
Advanced Generalist
Practitioner
Advanced Focused
Practitioner
Wide variety of patients and
diseases; complex healthcare
issues
Focused patient populations;
medically complex patients,
therapies, and/or technology
Level of knowledge, skills and experience
Generalist Practitioner
Entry
level
Advanced
http://www.pharmacycredentialing.org/Contemporary_Pharmacy_Practice.pdf
Why Residency Training?


Allows training as a licensed practitioner under the
supervision of an experienced preceptor
Develops skills specific to the management of drug
therapy in a systematic fashion


Supported by ACCP and ASHP



Direct patient care and practice management
2020 Goal: All pharmacists that provide direct patient care will
have completed a PGY1 residency
Expansion of residency programs will be necessary to
achieve this goal
Residency equivalency process / practice portfolio
Pharmacotherapy 2009;29(12):399e–407e
PGY 1 Residency Training
Supply vs. Demand
Current Legislation Status