Transcript Legislative Update - New York State Council of Health

Legislative Update:
What Every Pharmacist Needs
to Know About Recent
Developments in New York
State Law and Regulation
Gina Garrison, Pharm.D.
Vice President of Public Policy, NYSCHP
James W. Lytle, Esq.
Partner, Manatt, Phelps & Phillips, LLP
NYSCHP Annual Assembly - Saturday May 8, 2010
Learning Objectives
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Explain recent legislative and regulatory
developments affecting the profession of
pharmacy.
Educate regarding the legislative and
regulatory process in New York State,
and the role that pharmacists play in
affecting change.
Collaborative Drug
Therapy Management
presented by
James W. Lytle
Manatt, Phelps and Phillips LLP
The CDTM Rationale:
Adverse Drug Reactions (ADRs)

Among the top 4 leading causes of death in the US:

106,000 deaths per year

ADRs cost per year
 $ 177 billion in US per year
 $ 639 million in NYS per year

28% of ADRs 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- 4th leading cause of death in US
Diabetes
Pneumonia
Pulmonary Disease
Adverse Drug
Reactions
Accidents
Stroke
Heart Disease
Cancer
Ref: JAMA 1998;279:1200-5.
Where’s the remedy?
Collaborative Drug Therapy
Management (CDTM)

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

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?

At least 46 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.
Collaborative Drug Therapy
Management
Current status:
 A6848 Canestrari/S 3292 LaValle
 In Senate, passed unanimously on
2/22/2010—for the fourth year in a row.
 In Assembly, remains in Committee, where
it has languished for the last several years.
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 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.
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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 BS 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.
Guidelines for protocol agreements

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

Department of Health could specify
diseases/disease states

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
Health care entities could generally
authorize CDTM arrangements, restrict or
decline them entirely
Patients consent is also necessary
Pharmacists liability

There have been no cases of malpractice
against pharmacists participating in CDTM.

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.

Literature shows medication errors decrease
and physician liability should also decrease.
Changes in 2010
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Economic Environment
State’s Fiscal Crisis
Continued support in Senate, despite
leadership, Committee and party changes
Growing support in Assembly with new
sponsors: Have a majority of members on
the Higher Education Committee in
support
Renewed commitment from Assemblyman
Canestrari to move the bill
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

Possibly 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)
Deans of NYS Pharmacy Schools
How to win legislative battles
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Persistent Advocacy
Constituent Contact
Political Activity
Broadening Coalition and Support
Media efforts
What can you do to make CDTM
a reality in NYS?
Contact NYS Legislators

Members are in Albany offices Monday-Wednesday
and District offices on Thursdays and Fridays

Urge members to sign on to the bill and vote in
support

Write thank you letters
Return with us to Albany on May 18
(NYSCHP Lobby Day)
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 (46
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 Votes
June 21, 2007
Aye: 61 Nay: 0 Excused: 1
June 24, 2008
Aye: 62 Nay: 0
September 10, 2009
Aye: 59 Nay: 0
February 22, 2010
Aye: 59 Nay: 0
Current Senate Sponsors
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LAVALLE, DeFRANCISCO, DIAZ,
FLANAGAN, FUSCHILLO,
KRUEGER, LARKIN, LITTLE,
MAZIARZ, MORAHAN, NOZZOLIO,
ONORATO, RANZENHOFER,
SERRANO, SEWARD,
STACHOWSKI, VOLKER
Assembly Sponsors
CANESTRARI, GOTTFRIED, COLTON,
ENGLEBRIGHT, PAULIN, BURLING, LIFTON,
ORTIZ, FIELDS, BROOK-KRASNY, GORDON,
GABRYSZAK, SKARTADOS, SCHROEDER,
MAYERSOHN, BRODSKY, HYER-SPENCER,
CASTELLI; M-S: Alfano, Amedore, Barra,
Benedetto, Boyland, Brennan, Butler,
Christensen, Conte, Crouch, Cymbrowitz,
DelMonte, Destito, Galef, Gantt, Hawley, Hevesi,
Jacobs, John, Koon, Latimer, Lavine, V. Lopez,
Lupardo, Magee, Markey, McDonough, McEneny,
J. Miller, Morelle, Peoples-Stokes, Pheffer,
Pretlow, Quinn, Raia, Sayward, Thiele, Wright
= 56 by latest count
Beyond CDTM
A host of other bills and issues of interest,
including but not limited to:
 Pharmacy Technician Certification
 Medical Marihuana
 DAW, e-prescribing
Gina Garrison, NYSCHP Vice President of
Public Policy will describe…
after a brief polling “quiz”…
What can each pharmacist do to
promote CDTM legislation?
(A6848; S3292)
A. Call your legislator to talk about benefits of CDTM,
and seek support for the bill.
B. Meet with your legislator in Albany or district office
to and seek support for the bill.
C. Help get “memos in support” of the bill from
colleague physicians and hospitals/facilities.
D. All of the above.
New York Legislative Update:
Other Issues Facing
Pharmacy Practice
Gina Garrison, Pharm.D.
Vice President of Public Policy
NYSCHP
Some other Legislative issues…
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Pharmacy Technician Certification
Medical Marihuana
DAW, e-prescribing
Citizenship Requirement
Emergency Contraception
Pharmacists Conscious Clause
Pharmaceutical Pedigree
Pharmaceutical Substitution
Pharmacy Technician Certification

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.
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A.5379 Englebright (MS)
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Last act: 1/6/10 referred to higher education
No Same in in Senate; Currently no Senate sponsor
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Senate version not picked up after senate coup last year
Senator Fuschillo previously sponsored, but he has not reintroduced since Republicans lost House majority.
Pharmacy Technician Certification
To qualify to be a pharmacy technician, an applicant shall
fulfill the following requirements:
(a) Application: file an application with the department;
(b) Education: have received an education, including:
(i) high school graduation or a general equivalency
diploma (GED); and
(ii) Successful completion of a board certification program;
(c) Experience: have experience satisfactory to the board
and in accordance with the commissioner's regulations;
d) Examination: pass an examination satisfactory to the
board and in accordance with the commissioners
regulations;
(e) Age: be at least eighteen years of age; and
(f) Character: be of good moral character as determined by
the department including having no felony or drug
related convictions.
Medical Marihuana
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Legalizes the possession, manufacture, use, delivery,
transfer, transport or administration of marihuana by a
certified patient or designated caregiver for a certified
medical use
Prescribes procedures for such possession,
manufacture, etc. including certification of patients by
their practitioner, and that, in the practitioner's
professional judgment, the serious condition should be
treated with the medical use of marihuana
Directs the department of health to monitor such use
and promulgate rules and regulations for registry
identification cards
Provides for reports by the department of health to the
governor and legislature on the medical use of
marihuana.
Medical Marihuana
A9016 Gottfried (MS)
-- Same as S 4041-B Duane
 provides that possession
or manufacture of
marihuana shall be lawful
under these provisions
provided that the
marihuana possessed
does not exceed a total
aggregate weight of 2.5
oz.
 Last Act: 01/12/10 reported
referred to codes
 Same-As S 4041
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Last Act: 01/06/10
REFERRED TO HEALTH
A7542 Gottfried (MS)
-- No same as
 provides that possession
or manufacture of
marihuana shall be lawful
under these provisions
provided that the
marihuana possessed
does not exceed 12
plants and a total
aggregate weight of 2.5
ounces
 Last Act: 01/06/10
referred to health
NY DAW e-prescribing
 Legislation
drafted to amend the
NY education law, in relation to
electronic prescriptions and
generic substitution
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Currently mandate prescriber’s handwriting in DAW box
on prescription
Would update current prescribing statute to reflect
nature of electronic prescribing
Would not alter current policies relating to generic
substitution
Currently seeking sponsorship of Health
Committee chairs
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Senator Tom Duane
Assemblyman Richard Gottfried
Draft: NY DAW e-prescribing
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PRESCRIPTION WILL BE FILLED GENERICALLY
UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX
 OR, in the case of electronic prescriptions,
inserts an electronic direction to dispense the
drug as written, the prescriber's signature or
electronic signature shall designate approval of
substitution by a pharmacist of a drug product
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DAW box shall be placed directly under the
signature line and shall be three-quarters inch in
length and one-half inch in height, or in
comparable form for an electronic prescription
as may be specified by regulation of the
commissioner
Federal Updates
Affecting NY
Federal update:
Controlled Substance E-Prescribing
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DEA Interim Final Rule
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Published March 31, 2010 in Federal Register
Includes 60-day comment period through
June 1, 2010.
 Effective June 1, 2010, subject to Congressional
review.
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DEA Interim Final Rule
Controlled Substance E-Prescribing
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Provide pharmacies, hospitals, and practitioners
with the ability to use modern technology for
controlled substance prescriptions
Adds to existing rules, not a replacement
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Would include stipulations to ensure that a closed
system of controls on controlled substances dispensing
is maintained.
Would allow prescribers the option to write prescriptions
for controlled substances electronically; and
Would allow pharmacies to receive, dispense, and
archive these electronic prescriptions.
Potential Impact of DEA
E-prescription Regulations
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Reduce prescription
forgery
Reduce number of
prescription errors
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illegible handwriting
misunderstood oral
prescriptions
Reduce paperwork for
DEA registrants who
dispense or prescribe
controlled substances
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Help both pharmacies
and hospitals
integrate prescription
records into other
medical records more
directly
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increase efficiency
reduce amount of time
patients spend waiting
to have prescriptions
filled.
Which of the following is NOT an expected
outcomes of rules for E-prescribing
controlled substances?
A.
B.
C.
D.
Limit illegal drug diversion.
Reduce prescription errors.
Increase controlled substances prescribing.
Integrate controlled substances directly into
electronic medical records.
Federal Healthcare Reform
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Increasing health care coverage
Part D changes to phase out “donut hole” gap
when Part D recipients have to pay for their
medications
Role of Pharmacist - Medication Therapy
Management (MTM)
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Goal of collaborative program is improve care quality
and decrease cost of chronic disease therapies
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Targeted to patients taking at least 4 medications OR those
with at least 2 chronic diseases and those who had transition
of care.
Details on applying for funds when grants/contracts available
beginning May 2010
Pharmacist MTM services
*As state law allows: Great pitch for CDTM in NYS!
 Assess the health and functional status of patients
 Formulate a medication treatment plan
 *Select, initiate, modify, or recommend changes to
medication therapy
 Monitor patients’ response to therapy
 Perform medication reviews
 Document the care delivered
 Educate and train patients on appropriate
medication use
 Provide means to enhance medication adherence
 Coordinate and integrate MTM services with other
healthcare services provided to the patient
Questions?