Collaborative Drug Therapy Management in NYS:

Impact on Pharmacy Practice

Kimberly Zammit, PharmD, BCPS, FASHPNYS Board of Pharmacy

Chair, CDTM Implementation Committee

September 23, 2014

Disclosures None to report

Collaborative Drug Therapy ManagementACCP 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

Any setting

Health-systems

Very limited in any setting

No CDTM

CDTM in the U.S. 2012

http://www.cdc.gov/dhdsp/pubs/docs/Pharmacist_State_Law.PDF

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 GeneralObjectives 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

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

Report to the Surgeon GeneralEconomic Benefit

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

CDTM Implementation Committee

Kimberly Zammit, PharmD, BCPS, FASHP

Leigh Briscoe-Dwyer, PharmD, BCPS, FASHP

Lawrence Mohkiber, RPh, MS

Kimberly Leonard, RPh

Participant Representatives 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 ProgramAnthony Jordan Health Center / Rochester DiabetesBassett Healthcare Network / Cooperstown AnticoagulationBronx-Lebanon Hospital Center / Bronx Heart Failure

Brooklyn Hospital Brooklyn

AnticoagulationAsthma

DiabetesHeart Failure

HIV

Kingsbrook Jewish Medical Center / Brooklyn Anticoagulation

Memorial Sloan Kettering Cancer Center / New York Oncology

Montefiore Medical Center / Bronx Heart FailureRochester General Hospital / Rochester DiabetesRoswell Park Cancer Institute / Buffalo OncologyUnited Health Services / Binghamton AnticoagulationUpstate Medical Center / Syracuse Diabetes

* Programs submitting data

CDTM Demonstration Project Results

Program Number of Patients

Results

Anticoagulation 841

TTR 71 – 84% Low rate of adverse effects

Asthma 25100% patients receiving therapy demonstrated to improve disease control

Diabetes 195

HbA1C Control22 – 39% at goal 7 – 15 % decrease in 4 – 12 months

Heart Failure 7830 Day Hospitalization: 0 – 9 %ACEI / ARB: 88%Beta Blocker: 95%

HIV 864 visitsInterventions optimized efficacy, safety and adherence

Oncology2304

interventions12 patients

Interventions optimized efficacy, safety and adherence

Anticoagulation

Anticoagulation ManagementTime 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 Quality-Adjusted Life Years Gained

863 1606

Healthcare Dollars Saved (per 67,000 patients)

$15.9 million $29.7 million

Rose AJ, et al. Circ Cardiovasc Qual Outcomes. 2011; 4:416-424.

Anticoagulation ManagementBassett

Healthcare

Brooklyn Hospital

Kingsbrook Jewish

United Health

Usual Care

Number of Patients

503 174 43 121

Age Range (years)

25-97 23-91 22-88 35-88

Medicaid (N)

6 16 NR 25

Medicare (N)

393 60 19 95

ADEs (per 100 patients)

4.97 3.45 2.32 0.82 19.5

TTR 84.6% 75.1% 71.2%Unable

to report57.4%

Anticoagulation Participants Kelly Rudd, PharmD,

BCPS,CACP Bassett Healthcare

Valery L. Chu, PharmD, BCACP, CACP Kingsbrook Jewish Medical

Center Henry Cohen, MS, PharmD,

FCCM, BCPP, CGP Kingsbrook Jewish Medical

Center Lindsey Wormuth, PharmD

United Health Services Hospitals

Rebecca Arcebido, PharmD, BCACP Patient Centered Medical

Home The Brooklyn Hospital Center 

Julie Anne Billedo, 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

Site 1 Baseline

Site 1 12 months

Site 2 Baseline

Site 2 12 months

Site 3 Baseline

Site 3 4 months

0%

10%

20%

30%

40%

50%

60%

70%

25%

53%

24%

63%

32%

54%

Perc

en

t P

ati

en

ts w

ith

H

bA

1c<

8%

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 SDAge 59 64.2 years 12.8Gender: Male 32 (54%) n/a n/aEjection fraction (EF) 57 (97%) 34.1% 11.6N-terminal Pro-BNP 48 (81%) 7165.5

pg/mL 11128

Serum creatinine 52 (88%) 1.7 mg/dL 1.4

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

Corrected improper use of medications

Reconciled duplicate medications

Switched patient to appropriate therapy

Discontinued expired/inappropriate medications

Addressed adherence

0 10 20 30 40 50 60

Therapy Optimization

Initiated ACEI/ARB

Uptitrated ACEI/ARB

Uptitrated Beta blocker

Initiated Diuretic

Uptitrated Diuretic

Initiated AA

Initiated ISDN/Hydralazine

0 5 10 15 20 25 30 35 40

Adherence Problems Resolved

Does not un-derstand direc-tionsPrefers not to take medicationForgets to take medicationDrug is unavailable Patient cannot af-ford 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 N = 1408(% of total)

Optimization of therapy by indication 532(37.8)

Unnecessary Drug Treatment 66 (4.6)

Need for Additional Treatment 466 (33)

Optimization of effectiveness 146(10.4)

Inadequate Dose 146(10.4)

Optimization of Safety 165(11.7)

Adverse Reaction (prevented/identified) 112 (8)

Excessive Dose 53 (3.8)

Adherence 444(31.5)

Patient Satisfaction

0

1

2

3

4

3.74 3.64 3.62

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 InterventionsMemorial Sloan Kettering Cancer Center

Intervention CategoryN = 2392

(% of total)

Optimization of therapy by indication 1235(51.6)

Discontinue Unnecessary Drug Treatment 482 (20.1)Discontinue Duplicative Therapy 37 (1.5)

Initiate Therapy for Untreated Indication 716 (29.9)

Optimization of effectiveness 694(16.5)

Incorrect Dose 627 (26.2)Inappropriate route 67 (2.8)

Optimization of Safety 363(15.1)

Excessive Dose 119 (5)Dangerous Drug Interactions 244 (10.2)

Provider SatisfactionMSKCC

Improves Efficiency

Optimizes Care

Reinforces physician/pharmacist relationship

Overall Satisfied with CDTM program

0 25 50 75 100

Agree Column1

Pharmacist InterventionsRoswell Park Cancer Institute

Advised patient to con-tinue therapyPatient medication counselingAdded new therapeutic agentChanged medication dose

Provider SatisfactionRPCI

Overall Satisfaction with CDTM Services

CDTM Services allows me more time to see patients

Clinical Pharmacy Specialist displayed adequate knowledge

CDTM Services should be continued

CDTM Services improves quality of care

0 10 20 30 40 50 60 70 80 90 100

Very Satisfied/Strongly Agree/ Definitely YesSatisfied/Agree/ProbablyUndecidedDissatified/Disagree/Probably notVery Dissatified/Strongly Disagree/Definitely Not

Patient SatisfactionRPCI

Likelihood of scheduling another pharmacist visit

Pharmacist follow up was appreciated

Pharmacist was well informed and able to answer my questions

Comfortable talking to the pharmacist / asking medication questions

Overall Rating of Pharmacist Services

0 20 40 60 80 100

Very Satisfied/Strongly Agree/ DefinitelySatisfied/Agree/ProbablyUndecidedDissatified/Disagree/Probably NotVery Dissatified/Strongly Disagree/Definitely Not

Oncology Participants Elizabeth Hansen PharmD,

BCOP Roswell Park Cancer

Institute

Richard Tizon, PharmD, BCOP Memorial Sloan-Kettering

Cancer Center

Asthma

Pharmacist InterventionsParameter Frequency

Receiving a controller medication 25(100%)

Rescue medication prescribed 25(100%)

Asthma action plan reviewed and educated 25(100%)

Medication directions reinforced(Patient did not initially demonstrate understanding)

25(100%)

Optimization of Medication Therapy

Additional medication needed to optimize therapy 2(8%)

Unnecessary medication discontinued 1(4%)

Potentially harmful medication discontinued 1(4%)

Asthma Participant Robert DiGregorio, PharmD, BCACP

The Brooklyn Hospital Center

Economic Outcomes

CDTM Demonstration ResultsEconomic Impact

Asthma

Anticoagulation

Heart Failure

Diabetes

0 200 400 600 800 1000 1200 1400 1600

Estimated Annual Savings (millions)

Patient Satisfaction Survey

CDTM Demonstration ResultsPatient Satisfaction Survey

Yes; 96%

No; 1% Unsure; 3%

Care Improved with Pharmacist on Healthcare Team (n=124)

CDTM Demonstration ResultsPatient Satisfaction Survey

Pharmacist Relationship

Disease or Medication Understanding

Adequate time spent with patient

Overall quality of care

Excellent Very Good Good

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, FASHPNYS 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) 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 Commission for Certification in Geriatric

Pharmacy 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

Generalist Practitioner

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

Breadth of patient / practice focus

http://www.pharmacycredentialing.org/Contemporary_Pharmacy_Practice.pdf

Level o

f know

ledge, skills a

nd

experie

nce

Bro

ad

Narro

wEntr

y level

Advanced

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 Direct patient care and practice management

Supported by ACCP and ASHP 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

portfolioPharmacotherapy 2009;29(12):399e–407e

PGY 1 Residency TrainingSupply vs. Demand

Current Legislation Status