Transcript Legislative Update: Pounding The Pavement For Passage

Legislative Update: What
Every Pharmacist Needs to
Know About Recent
Developments in New York
State Law and Regulation
Thomas P. Lombardi, Pharm.D., FASHP,
VP Public Policy, NYSCHP
James W. Lytle, Esq.
Partner, Manatt, Phelps & Phillips, LLP
Objectives
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To identify the current legislative initiatives that will affect the
practice of pharmacy in New York State.
To formulate a plan for pharmacists to be more active in the
legislative process concerning issues affecting the pharmacy
practice in New York State.
To discuss how the current statutes and regulations affecting the
practice of pharmacy impact upon the ability of the pharmacist to
undertake his or her responsibilities.
To explain how the legislative, regulatory and political process in
New York addresses issues relating to the practice of pharmacy.
To discuss the interplay between the Legislature, the Governor’s
office, the State Education Department, and other state agencies
as it relates to the regulation of the professions and the health
care system.
To discuss recent legal developments as they relate to current
issues of interest to the profession.
Collaborative Drug
Therapy Management
presented by
James W. Lytle
Manatt, Phelps and Phillips LLP
The CDTM Rationale:
Adverse Drug Reactions
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Among the top 4 leading causes of death in the
US:
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106,000 deaths per year
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ADR cost per year
 $ 177 billion in US per year
 $ 639 million in NYS per year
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28% of ADR’s are preventable
Ref: Arch Intern Med 1995;155:1949-56
J Am Pharm Assoc 2001; 41; 192-199
Am J Health Syst Pharm 1997; 54:554-8
Adverse Drug Reactions-The 4th leading cause of death
Diabetes
Pneumonia
Pulmonary Disease
Adverse Drug
Reactions
Accidents
Stroke
Heart Disease
Cancer
Ref: JAMA 1998;279:1200-5.
What can be done to remedy
problem?
Collaborative Drug Therapy
Management (CDTM)
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Services provided by a pharmacists under
protocol relating to review, evaluation,
modification, and implementation of drug
therapy
Expanding the role of
pharmacists
Empirical evidence demonstrates
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Mortality decreased by 1.09 deaths/day/hospital
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Medication Errors decreased by 286%
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Pharmacotherapy 1999; 19 (12) 1354-1362
Cost of care decreased by $1.7million/hospital/year
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Pharmacotherapy 2002;22 (2):134-147
Drug cost decreased by $137,000/ hospital/year
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Pharmacotherapy 2001;21(2) 129-141
Pharmacotherapy 2000; 20 (6):609-621
99% of pharmacist interventions accepted by
physicians
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JAMA 1999; 282(3): 267-270
Where is CDTM Currently
Permitted?
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44 States currently permit CDTM
Majority permit CDTM in hospitals and
institutional health care facilities
 Others have extended CDTM to community
based settings
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Veteran’s Administration
States Where Pharmacists May
Enter into Collaborative Practice
Agreements
WA
MT
ND
MN
OR
ID
WY
NV
NH
VT ME
UT
CO
CA
AZ
AK
HI
NM
MA
NY
RI
SD
MI
CT
PA
NJ
IA
OH
NE
DE
IL IN
WV
MD
VA
MO
KS
KY
NC
TN
OK
AR
SC
Legend:
MS AL GA
LA
Authorized
TX
FL
WI
Not Allowed
CDTM Legislation in NYS
S.3292/A.6848
Under protocol agreements with physicians or nurse
practitioners, pharmacists would be allowed to:
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Implement, modify and manage patients drug regimens
who are being treated for a disease state;
Order clinical laboratory tests as necessary to implement
protocol;
Allow for ordering/performing of routine patient monitoring
functions, such as patient history & vital signs.
Collaborating physician or nurse practitioner must be
employed/affiliated with the same facility as pharmacist.
S.3292/A.6848
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Applies to general hospitals, residential health care facilities,
diagnostic and treatment centers, outpatient hospital-based
clinics and up to seven community based practice sites.
Pharmacists with MA/PharmD must have minimum of three
years of experience, with one year of clinical experience in a
health care facility involving consultation with physicians or
nurse practitioners with respect to drug therapy. Residencies
may count toward clinical experience.
Pharmacists with BA must have five years of experience
within the past seven years, with one year of clinical
experience in a health care facility involving consultation with
physicians/nurse practitioners with respect to drug therapy.
Pharmacists must note changes immediately in patient
medical record and notify collaborating physicians/nurse
practitioners and other treating physicians/nurse practitioners
of modifications.
Includes a four year sunset.
Changes in 2009
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Economic Fiscal Environment
Change of Senate Majority & Leadership
New Senate Higher Education Chair
Re-introduction of Bills
Bills Re-circulated for Sponsorship
Changes to CDTM
Removed cap for residential health facilities
 Included seven community based practice
sites
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Guidelines for protocol agreements
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Legislation does not set forth exclusive list of
drugs or therapeutic categories which may be
included in CDTM arrangements, but does
require that the protocol relate to a specific
disease or disease state
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Department of Health could specify
diseases/disease states
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CDTM protocol agreement must be within the
limits of physicians and nurse practitioners scope
of practice
CDTM is voluntary for all parties
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Physicians, Nurse Practitioners and
Pharmacists must consent to engage in
CDTM
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Health care entities could generally
authorize CDTM arrangements, restrict or
decline them entirely
Patients consent is also necessary
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Pharmacists liability
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There have been no cases of malpractice
against pharmacists participating in CDTM.
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The current bill does not mandate pharmacists
to maintain adequate levels of malpractice
insurance to participate in CDTM arrangements,
but malpractice coverage would generally be in
place.
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The literature shows medication errors decrease
and physician liability should also decrease.
CDTM Opponents Then
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Medical Society of the State of New York
NYS Nurses Association
Nurse Practitioners Association of NYS
PhRMA
Trial Lawyers Association
New York State United Teachers
CDTM Opponents Now
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Medical Society of the State of New York
CDTM Supporters Now
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New York State Nurses Association
Nurse Practitioners Association of NYS
Greater New York Hospital Association
Healthcare Association of New York State
New York Association of Homes and Services for
the Aging
Health Facilities Association
Health Plan Association
1199 SEIU
Pharmacists Society of the State of New York
NYS Chapter of American Society of Consultant
Pharmacists
Hospitalists (Society of Hospital Medicine)
How to win legislative battles
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Persistent Advocacy
Constituent Contact
Political Activity
Broadening Coalition and Support
What can you do to make CDTM
a reality in NYS?
Contact NYS Legislators
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Members are in Albany offices Monday-Wednesday
and District offices on Thursdays and Fridays
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Urge members to sign on to the bill and vote in
support
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Write thank you letters
ATTEND CDTM DAY: MAY 19, 2009
Key Talking Points to Solidify
CDTM Support
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It is a collaborative agreement between the
physician or nurse practitioner and pharmacist.
It is completely voluntary for all parties. Patient
consent is also necessary.
The protocol defines the parameters of the
arrangement.
Pharmacists are educated and trained to
collaboratively manage drug therapy.
It is the state of the art in pharmacy practice (44
states currently permit).
Additional Talking Points
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Patient care is enhanced as amply
demonstrated by numerous published
accounts:
Adverse drug reactions are decreased,
 Adherence to prescribed regimen is enhanced,
 Improved outcomes.
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Overall costs to the system will decrease.
Senate 2007 & 2008 Votes
June 21, 2007Aye: 61 Nay: 0 Excused: 1
June 24, 2008 Aye: 62 Nay: 0
2009 Senate Sponsors
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LAVALLE, DeFRANCISCO, DIAZ,
FLANAGAN, FUSCHILLO, KRUEGER,
LARKIN, LITTLE, MAZIARZ, MORAHAN,
NOZZOLIO, ONORATO,
RANZENHOFER, SEWARD,
STACHOWSKI, VOLKER
2009 Assembly Sponsors
CANESTRARI, GOTTFRIED, COLTON,
ENGLEBRIGHT, PAULIN, BURLING, LIFTON,
PERALTA, ORTIZ, FIELDS, BROOK-KRASNY; M-S:
Alfano, Amedore, Barra, Boyland, Brennan,
Christensen, Crouch, Cymbrowitz, DelMonte,
Eddington, Hawley, Jacobs, John, Koon, Magee,
Markey, McDonough, McEneny, Miller, Morelle,
Pheffer, Pretlow, Raia, Sayward, Wright
Thirty-six sponsors . . . And counting.
(In 2008, there were 72)
Legislative Update: Other
Issues Facing New York
Thomas P. Lombardi, Pharm.D.,
FASHP,
VP Public Policy, NYSCHP
Other priorities
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Citizenship Requirement
Pharmacy Technicians
Substitution of Antiepileptic Drugs
Dispensing of Emergency Contraception
Pedigree Legislation
Refusal to Fill a Prescription Based On Personal
Belief
Drug Guides for seniors
Counseling of patients with new medications
Dispensing of Contact Lens
Prohibition of sale of tobacco products at
pharmacies
Citizenship requirement
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S1925 MORAHAN, DIAZ, THOMPSON
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02/09/09 REFERRED TO HIGHER
EDUCATION
A1015 CAHILL, GOTTFRIED, JACOBS, V.
LOPEZ, COOK, ROSENTHAL, PERRY,
SCHROEDER,DINOWITZ, P. RIVERA; MS: Colton, Errigo, Glick, McEneny, Stirpe,
Weisenberg
01/07/09 referred to higher education
 02/03/09 reported
 02/05/09 advanced to third reading cal.59
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Scope of the bill
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Eliminates the licensure requirement of
citizenship or permanent residence where
such requirement presently exists in the
professions of certified shorthand
reporting, chiropractic, dental hygiene and
dentistry, landscape architecture, land
surveying, massage, medicine, midwifery,
pharmacy, professional engineering,
veterinary medicine and veterinary
technology.
Pharmacy Technicians
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Senate 
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STATUS – No sponsor to date
A5379 - ENGLEBRIGHT, ALFANO; M-S:
Butler
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02/13/09 referred to higher education
Scope of the Bill
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Establishes requirements for certification
as a pharmacy technician; establishes no
person shall act as a pharmacy technician
unless registered by the state board of
pharmacy.
Pharmacy Technicians
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Establishes requirements for certification
as a pharmacy technician; establishes no
person shall act as a pharmacy technician
unless registered by the state board of
pharmacy.
Substitution of Antiepileptic Drugs
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Senate 
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STATUS – No sponsor to date
A3528 - AUBRY, MOLINARO, ROSENTHAL,
GREENE, BENEDETTO, CLARK, SCHIMEL,
SPANO, PHEFFER, ERRIGO, MILLMAN,
ALFANO, ESPAILLAT; M-S: Boyland, Brennan,
Colton, Duprey, Eddington, Jaffee, Koon,
Latimer, Maisel, Markey, Reilly, J. Rivera,
Sayward, Scarborough, Seminerio, Thiele,
Towns, Weisenberg
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STATUS - Referred to Higher Education
Scope of the Bill
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Prohibits a pharmacist from substituting
any anti-epileptic drug for the prescribed
anti-epileptic drug without notification of
and the informed consent of the prescriber
and patient or such patient's parent,
guardian or spouse.