Legislative Update: What Legislative Update: What Every Pharmacist Needs to Every Pharmacist Needs to

Know About Recent Know About Recent Developments in New York Developments in New York State Law and Regulation State Law and Regulation

Thomas P. Lombardi, Pharm.D., FASHP, Thomas P. Lombardi, Pharm.D., FASHP, VP Public Policy, NYSCHPVP Public Policy, NYSCHP

James W. Lytle, Esq.James W. Lytle, Esq.Partner, Manatt, Phelps & Phillips, LLPPartner, Manatt, Phelps & Phillips, LLP

ObjectivesObjectives To identify the current legislative initiatives that will affect the To identify the current legislative initiatives that will affect the

practice of pharmacy in New York State.practice of pharmacy in New York State. To formulate a plan for pharmacists to be more active in the To formulate a plan for pharmacists to be more active in the

legislative process concerning issues affecting the pharmacy legislative process concerning issues affecting the pharmacy practice in New York State.practice in New York State.

To discuss how the current statutes and regulations affecting the To discuss how the current statutes and regulations affecting the practice of pharmacy impact upon the ability of the pharmacist to practice of pharmacy impact upon the ability of the pharmacist to undertake his or her responsibilities.undertake his or her responsibilities.

To explain how the legislative, regulatory and political process in To explain how the legislative, regulatory and political process in New York addresses issues relating to the practice of pharmacy. New York addresses issues relating to the practice of pharmacy.

To discuss the interplay between the Legislature, the Governor’s To discuss the interplay between the Legislature, the Governor’s office, the State Education Department, and other state agencies office, the State Education Department, and other state agencies as it relates to the regulation of the professions and the health as it relates to the regulation of the professions and the health care system.care system.

To discuss recent legal developments as they relate to current To discuss recent legal developments as they relate to current issues of interest to the profession.issues of interest to the profession.

Collaborative Drug Collaborative Drug Therapy Management Therapy Management

presented bypresented by

James W. LytleJames W. Lytle

Manatt, Phelps and Phillips LLPManatt, Phelps and Phillips LLP

The CDTM Rationale:The CDTM Rationale:Adverse Drug ReactionsAdverse Drug Reactions

Among the top 4 leading causes of death in the Among the top 4 leading causes of death in the US: US:

106,000 deaths per year106,000 deaths per year

ADR cost per yearADR cost per year $ 177 billion in US per year$ 177 billion in US per year $ 639 million in NYS per year$ 639 million in NYS per year

28% of ADR’s are preventable28% of ADR’s are preventableRef: Arch Intern Med 1995;155:1949-56J Am Pharm Assoc 2001; 41; 192-199Am J Health Syst Pharm 1997; 54:554-8

Adverse Drug Adverse Drug Reactions-Reactions-The 4th leading cause of deathThe 4th leading cause of death

Accidents

Cancer

Heart Disease

Diabetes Adverse Drug ReactionsPneumonia

Pulmonary Disease

Stroke

Ref: JAMA 1998;279:1200-5.

What can be done to remedy What can be done to remedy problem?problem?

Collaborative Drug Therapy Collaborative Drug Therapy Management (CDTM)Management (CDTM)

Services provided by a pharmacists under Services provided by a pharmacists under protocol relating to review, evaluation, protocol relating to review, evaluation, modification, and implementation of drug modification, and implementation of drug therapytherapy

Expanding the role of Expanding the role of pharmacistspharmacists

Empirical evidence demonstratesEmpirical evidence demonstrates

Mortality decreased by 1.09 deaths/day/hospitalMortality decreased by 1.09 deaths/day/hospital Pharmacotherapy 2001;21(2) 129-141Pharmacotherapy 2001;21(2) 129-141

Medication Errors decreased by 286%Medication Errors decreased by 286% Pharmacotherapy 2002;22 (2):134-147Pharmacotherapy 2002;22 (2):134-147

Drug cost decreased by $137,000/ hospital/yearDrug cost decreased by $137,000/ hospital/year Pharmacotherapy 1999; 19 (12) 1354-1362Pharmacotherapy 1999; 19 (12) 1354-1362

Cost of care decreased by $1.7million/hospital/yearCost of care decreased by $1.7million/hospital/year Pharmacotherapy 2000; 20 (6):609-621Pharmacotherapy 2000; 20 (6):609-621

99% of pharmacist interventions accepted by 99% of pharmacist interventions accepted by physiciansphysicians

JAMA 1999; 282(3): 267-270JAMA 1999; 282(3): 267-270

Where is CDTM Currently Where is CDTM Currently Permitted? Permitted?

44 States currently permit CDTM 44 States currently permit CDTM Majority permit CDTM in hospitals and Majority permit CDTM in hospitals and

institutional health care facilitiesinstitutional health care facilities Others have extended CDTM to community Others have extended CDTM to community

based settings based settings Veteran’s AdministrationVeteran’s Administration

States Where Pharmacists May States Where Pharmacists May Enter into Collaborative Practice Enter into Collaborative Practice

AgreementsAgreements

Legend:

Authorized

Not Allowed

WA

OR

CA

AK

ID

NVUT

AZ NM

TX

OK

CO

WY

MT ND

SD

NE

KS

IA

MO

AR

LAMS AL GA

FL

SCNC

TN

KY

IL

MI

INOH

PA

WVVA

NY

VTNH

ME

MARI

CTNJDEMD

MNWI

HI

CDTM Legislation in NYSCDTM Legislation in NYSS.3292/A.6848S.3292/A.6848

Under protocol agreements with physicians or nurse Under protocol agreements with physicians or nurse practitioners, pharmacists would be allowed to:practitioners, pharmacists would be allowed to:

Implement, modify and manage patients drug regimens Implement, modify and manage patients drug regimens who are being treated for a disease state;who are being treated for a disease state;

Order clinical laboratory tests as necessary to implement Order clinical laboratory tests as necessary to implement protocol;protocol;

Allow for ordering/performing of routine patient monitoring Allow for ordering/performing of routine patient monitoring functions, such as patient history & vital signs.functions, such as patient history & vital signs.

Collaborating physician or nurse practitioner must be Collaborating physician or nurse practitioner must be employed/affiliated with the same facility as pharmacist.employed/affiliated with the same facility as pharmacist.

S.3292/A.6848S.3292/A.6848

Applies to general hospitals, residential health care facilities, Applies to general hospitals, residential health care facilities, diagnostic and treatment centers, outpatient hospital-based diagnostic and treatment centers, outpatient hospital-based clinics and up to seven community based practice sites.clinics and up to seven community based practice sites.

Pharmacists with MA/PharmD must have minimum of three Pharmacists with MA/PharmD must have minimum of three years of experience, with one year of clinical experience in a years of experience, with one year of clinical experience in a health care facility involving consultation with physicians or health care facility involving consultation with physicians or nurse practitioners with respect to drug therapy. Residencies nurse practitioners with respect to drug therapy. Residencies may count toward clinical experience.may count toward clinical experience.

Pharmacists with BA must have five years of experience within Pharmacists with BA must have five years of experience within the past seven years, with one year of clinical experience in a the past seven years, with one year of clinical experience in a health care facility involving consultation with physicians/nurse health care facility involving consultation with physicians/nurse practitioners with respect to drug therapy.practitioners with respect to drug therapy.

Pharmacists must note changes immediately in patient medical Pharmacists must note changes immediately in patient medical record and notify collaborating physicians/nurse practitioners record and notify collaborating physicians/nurse practitioners and other treating physicians/nurse practitionersand other treating physicians/nurse practitionersof modifications.of modifications.

Includes a four year sunset.Includes a four year sunset.

Changes in 2009Changes in 2009

Economic Fiscal EnvironmentEconomic Fiscal Environment Change of Senate Majority & LeadershipChange of Senate Majority & Leadership New Senate Higher Education ChairNew Senate Higher Education Chair Re-introduction of BillsRe-introduction of Bills Bills Re-circulated for SponsorshipBills Re-circulated for Sponsorship Changes to CDTMChanges to CDTM

Removed cap for residential health facilitiesRemoved cap for residential health facilities Included seven community based practice Included seven community based practice

sitessites

Guidelines for protocol agreementsGuidelines for protocol agreements

Legislation does not set forth exclusive list of Legislation does not set forth exclusive list of drugs or therapeutic categories which may be drugs or therapeutic categories which may be included in CDTM arrangements, but does included in CDTM arrangements, but does require that the protocol relate to a specific require that the protocol relate to a specific disease or disease statedisease or disease state

Department of Health could specify Department of Health could specify diseases/disease statesdiseases/disease states

CDTM protocol agreement must be within the CDTM protocol agreement must be within the limits of physicians and nurse practitioners scope limits of physicians and nurse practitioners scope of practiceof practice

CDTM is voluntary for all partiesCDTM is voluntary for all parties

Physicians, Nurse Practitioners and Physicians, Nurse Practitioners and Pharmacists must consent to engage in Pharmacists must consent to engage in CDTMCDTM

Health care entities could generally Health care entities could generally authorize CDTM arrangements, restrict or authorize CDTM arrangements, restrict or decline them entirelydecline them entirely

Patients consent is also necessaryPatients consent is also necessary

Pharmacists liabilityPharmacists liability

There haveThere have been no cases of malpractice been no cases of malpractice against pharmacists participating in CDTM.against pharmacists participating in CDTM.

The current bill does not mandate pharmacists The current bill does not mandate pharmacists to maintain adequate levels of malpractice to maintain adequate levels of malpractice insurance to participate in CDTM arrangements, insurance to participate in CDTM arrangements, but malpractice coverage would generally be in but malpractice coverage would generally be in place.place.

The literature shows medication errors decrease The literature shows medication errors decrease and physician liability should also decrease.and physician liability should also decrease.

CDTM Opponents ThenCDTM Opponents Then Medical Society of the State of New YorkMedical Society of the State of New York NYS Nurses AssociationNYS Nurses Association Nurse Practitioners Association of NYSNurse Practitioners Association of NYS PhRMAPhRMA Trial Lawyers AssociationTrial Lawyers Association New York State United TeachersNew York State United Teachers

CDTM Opponents NowCDTM Opponents Now Medical Society of the State of New YorkMedical Society of the State of New York

CDTM Supporters NowCDTM Supporters Now New York State Nurses AssociationNew York State Nurses Association Nurse Practitioners Association of NYSNurse Practitioners Association of NYS Greater New York Hospital AssociationGreater New York Hospital Association Healthcare Association of New York StateHealthcare Association of New York State New York Association of Homes and Services New York Association of Homes and Services

for the Agingfor the Aging Health Facilities AssociationHealth Facilities Association Health Plan AssociationHealth Plan Association 1199 SEIU1199 SEIU Pharmacists Society of the State of New YorkPharmacists Society of the State of New York NYS Chapter of American Society of Consultant NYS Chapter of American Society of Consultant

PharmacistsPharmacists Hospitalists (Society of Hospital Medicine)Hospitalists (Society of Hospital Medicine)

How to win legislative battlesHow to win legislative battles Persistent Advocacy Persistent Advocacy Constituent ContactConstituent Contact Political ActivityPolitical Activity Broadening Coalition and SupportBroadening Coalition and Support

What can What can youyou do to make CDTM do to make CDTM a reality in NYS?a reality in NYS?

Contact NYS LegislatorsContact NYS Legislators

Members are in Albany offices Monday-Wednesday Members are in Albany offices Monday-Wednesday and District offices on Thursdays and Fridays and District offices on Thursdays and Fridays

Urge members to sign on to the bill and vote in Urge members to sign on to the bill and vote in supportsupport

Write thank you lettersWrite thank you letters

ATTEND CDTM DAY: MAY 19, 2009ATTEND CDTM DAY: MAY 19, 2009

Key Talking Points to Solidify Key Talking Points to Solidify CDTM SupportCDTM Support

It is a collaborative agreement between the It is a collaborative agreement between the physician or nurse practitioner and pharmacist. physician or nurse practitioner and pharmacist.

It is completely voluntary for all parties. Patient It is completely voluntary for all parties. Patient consent is also necessary. consent is also necessary.

The protocol defines the parameters of the The protocol defines the parameters of the arrangement. arrangement.

Pharmacists are educated and trained to Pharmacists are educated and trained to collaboratively manage drug therapy. collaboratively manage drug therapy.

It is the state of the art in pharmacy practice (44 It is the state of the art in pharmacy practice (44 states currently permit). states currently permit).

Additional Talking PointsAdditional Talking Points

Patient care is enhanced as amply Patient care is enhanced as amply demonstrated by numerous published demonstrated by numerous published accounts:accounts: Adverse drug reactions are decreased,Adverse drug reactions are decreased, Adherence to prescribed regimen is enhanced,Adherence to prescribed regimen is enhanced, Improved outcomes. Improved outcomes.

Overall costs to the system will decrease.Overall costs to the system will decrease.

Senate 2007 & 2008 VotesSenate 2007 & 2008 Votes

June 21, 2007- June 21, 2007-

Aye: 61 Nay: 0 Excused: 1Aye: 61 Nay: 0 Excused: 1

June 24, 2008 -June 24, 2008 -

Aye: 62   Nay: 0Aye: 62   Nay: 0

2009 Senate Sponsors2009 Senate Sponsors

LAVALLE, DeFRANCISCO, DIAZ, LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN, FUSCHILLO, KRUEGER, FLANAGAN, FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORATO, NOZZOLIO, ONORATO, RANZENHOFER, SEWARD, RANZENHOFER, SEWARD, STACHOWSKI, VOLKER STACHOWSKI, VOLKER

2009 Assembly Sponsors2009 Assembly Sponsors

CANESTRARI, GOTTFRIED, COLTON, CANESTRARI, GOTTFRIED, COLTON, ENGLEBRIGHT, PAULIN, BURLING, LIFTON, ENGLEBRIGHT, PAULIN, BURLING, LIFTON, PERALTA, ORTIZ, FIELDS, BROOK-KRASNY; M-PERALTA, ORTIZ, FIELDS, BROOK-KRASNY; M-S: Alfano, Amedore, Barra, Boyland, Brennan, S: Alfano, Amedore, Barra, Boyland, Brennan, Christensen, Crouch, Cymbrowitz, DelMonte, Christensen, Crouch, Cymbrowitz, DelMonte, Eddington, Hawley, Jacobs, John, Koon, Magee, Eddington, Hawley, Jacobs, John, Koon, Magee, Markey, McDonough, McEneny, Miller, Morelle, Markey, McDonough, McEneny, Miller, Morelle, Pheffer, Pretlow, Raia, Sayward, WrightPheffer, Pretlow, Raia, Sayward, Wright

Thirty-six sponsors . . . And counting.Thirty-six sponsors . . . And counting.

(In 2008, there were 72)(In 2008, there were 72)

Legislative Update: Other Legislative Update: Other Issues Facing New York Issues Facing New York

Thomas P. Lombardi, Pharm.D., Thomas P. Lombardi, Pharm.D., FASHP, FASHP,

VP Public Policy, NYSCHPVP Public Policy, NYSCHP

Other prioritiesOther priorities 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 requirementCitizenship requirement S1925 MORAHAN, DIAZ, THOMPSON

02/09/09 REFERRED TO HIGHER EDUCATION

A1015 CAHILL, GOTTFRIED, JACOBS, V. LOPEZ, COOK, ROSENTHAL, PERRY, SCHROEDER,DINOWITZ, P. RIVERA; M-S: 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

Scope of the billScope of the bill 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 TechniciansPharmacy Technicians Senate -

STATUS – No sponsor to date A5379 - ENGLEBRIGHT, ALFANO; M-S:

Butler 02/13/09 referred to higher education

Scope of the BillScope of the Bill Establishes requirements for certification Establishes requirements for certification

as a pharmacy technician; establishes no as a pharmacy technician; establishes no person shall act as a pharmacy technician person shall act as a pharmacy technician unless registered by the state board of unless registered by the state board of pharmacy.pharmacy.

Pharmacy TechniciansPharmacy Technicians 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 DrugsSubstitution of Antiepileptic Drugs

Senate - 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 STATUS - Referred to Higher Education

Scope of the BillScope of the Bill 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.