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Legislative Update: What Every Pharmacist Needs to Know About Recent Developments in New York State Law and Regulation Thomas P. Lombardi, Pharm.D., FASHP,

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Presentation on theme: "Legislative Update: What Every Pharmacist Needs to Know About Recent Developments in New York State Law and Regulation Thomas P. Lombardi, Pharm.D., FASHP,"— Presentation transcript:

1 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

2 Objectives To identify the current legislative initiatives that will affect the practice of pharmacy in New York State. 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 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 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 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 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. To discuss recent legal developments as they relate to current issues of interest to the profession.

3 Collaborative Drug Therapy Management presented by James W. Lytle Manatt, Phelps and Phillips LLP

4 The CDTM Rationale: Adverse Drug Reactions Among the top 4 leading causes of death in the US: Among the top 4 leading causes of death in the US: 106,000 deaths per year 106,000 deaths per year ADR cost per year ADR 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 preventable 28% of ADR’s are preventable Ref: Arch Intern Med 1995;155: J Am Pharm Assoc 2001; 41; Am J Health Syst Pharm 1997; 54:554-8

5 Adverse Drug Reactions-The 4th leading cause of death Accidents Cancer Heart Disease Diabetes Adverse Drug Reactions Pneumonia Pulmonary Disease Stroke Ref: JAMA 1998;279:

6 What can be done to remedy problem? Collaborative Drug Therapy Management (CDTM) Services provided by a pharmacists under protocol relating to review, evaluation, modification, and implementation of drug therapy Services provided by a pharmacists under protocol relating to review, evaluation, modification, and implementation of drug therapy

7 Expanding the role of pharmacists Empirical evidence demonstrates Mortality decreased by 1.09 deaths/day/hospital Mortality decreased by 1.09 deaths/day/hospital Pharmacotherapy 2001;21(2) Pharmacotherapy 2001;21(2) Medication Errors decreased by 286% Medication Errors decreased by 286% Pharmacotherapy 2002;22 (2): Pharmacotherapy 2002;22 (2): Drug cost decreased by $137,000/ hospital/year Drug cost decreased by $137,000/ hospital/year Pharmacotherapy 1999; 19 (12) Pharmacotherapy 1999; 19 (12) Cost of care decreased by $1.7million/hospital/year Cost of care decreased by $1.7million/hospital/year Pharmacotherapy 2000; 20 (6): Pharmacotherapy 2000; 20 (6): % of pharmacist interventions accepted by physicians 99% of pharmacist interventions accepted by physicians JAMA 1999; 282(3): JAMA 1999; 282(3):

8 Where is CDTM Currently Permitted? 44 States currently permit CDTM 44 States currently permit CDTM Majority permit CDTM in hospitals and institutional health care facilities Majority permit CDTM in hospitals and institutional health care facilities Others have extended CDTM to community based settings Others have extended CDTM to community based settings Veteran’s Administration Veteran’s Administration

9 States Where Pharmacists May Enter into Collaborative Practice Agreements Legend: Authorized Not Allowed WA OR CA AK ID NV UT AZ NM TX OK CO WY MTND SD NE KS IA MO AR LA MSAL GA FL SC NC TN KY IL MI IN OH PA WV VA NY VT NH ME MA RI CT NJ DE MD MN WI HI

10 CDTM Legislation in NYS S.3292/A.6848 Under protocol agreements with physicians or nurse practitioners, pharmacists would be allowed to: Implement, modify and manage patients drug regimens who are being treated for a disease state; Implement, modify and manage patients drug regimens who are being treated for a disease state; Order clinical laboratory tests as necessary to implement protocol; Order clinical laboratory tests as necessary to implement protocol; Allow for ordering/performing of routine patient monitoring functions, such as patient history & vital signs. 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. Collaborating physician or nurse practitioner must be employed/affiliated with the same facility as pharmacist.

11 S.3292/A.6848 Applies to general hospitals, residential health care facilities, diagnostic and treatment centers, outpatient hospital-based clinics and up to seven community based practice sites. 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 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 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 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. Includes a four year sunset.

12 Changes in 2009 Economic Fiscal Environment Economic Fiscal Environment Change of Senate Majority & Leadership Change of Senate Majority & Leadership New Senate Higher Education Chair New Senate Higher Education Chair Re-introduction of Bills Re-introduction of Bills Bills Re-circulated for Sponsorship Bills Re-circulated for Sponsorship Changes to CDTM Changes to CDTM Removed cap for residential health facilities Removed cap for residential health facilities Included seven community based practice sites Included seven community based practice sites

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

14 CDTM is voluntary for all parties Physicians, Nurse Practitioners and Pharmacists must consent to engage in CDTM Physicians, Nurse Practitioners and Pharmacists must consent to engage in CDTM Health care entities could generally authorize CDTM arrangements, restrict or decline them entirely Health care entities could generally authorize CDTM arrangements, restrict or decline them entirely Patients consent is also necessary Patients consent is also necessary

15 Pharmacists liability There have been no cases of malpractice against pharmacists participating in CDTM. There have been no cases of malpractice against pharmacists participating in CDTM. 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. 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. The literature shows medication errors decrease and physician liability should also decrease. The literature shows medication errors decrease and physician liability should also decrease.

16 CDTM Opponents Then Medical Society of the State of New York Medical Society of the State of New York NYS Nurses Association NYS Nurses Association Nurse Practitioners Association of NYS Nurse Practitioners Association of NYS PhRMA PhRMA Trial Lawyers Association Trial Lawyers Association New York State United Teachers New York State United Teachers

17 CDTM Opponents Now Medical Society of the State of New York Medical Society of the State of New York

18 CDTM Supporters Now New York State Nurses Association New York State Nurses Association Nurse Practitioners Association of NYS Nurse Practitioners Association of NYS Greater New York Hospital Association Greater New York Hospital Association Healthcare Association of New York State Healthcare Association of New York State New York Association of Homes and Services for the Aging New York Association of Homes and Services for the Aging Health Facilities Association Health Facilities Association Health Plan Association Health Plan Association 1199 SEIU 1199 SEIU Pharmacists Society of the State of New York Pharmacists Society of the State of New York NYS Chapter of American Society of Consultant Pharmacists NYS Chapter of American Society of Consultant Pharmacists Hospitalists (Society of Hospital Medicine) Hospitalists (Society of Hospital Medicine)

19 How to win legislative battles Persistent Advocacy Persistent Advocacy Constituent Contact Constituent Contact Political Activity Political Activity Broadening Coalition and Support Broadening Coalition and Support

20 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 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 Urge members to sign on to the bill and vote in support Write thank you letters Write thank you letters ATTEND CDTM DAY: MAY 19, 2009

21 Key Talking Points to Solidify CDTM Support It is a collaborative agreement between the physician or nurse practitioner and pharmacist. 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. It is completely voluntary for all parties. Patient consent is also necessary. The protocol defines the parameters of the arrangement. The protocol defines the parameters of the arrangement. Pharmacists are educated and trained to collaboratively manage drug therapy. Pharmacists are educated and trained to collaboratively manage drug therapy. It is the state of the art in pharmacy practice (44 states currently permit). It is the state of the art in pharmacy practice (44 states currently permit).

22 Additional Talking Points Patient care is enhanced as amply demonstrated by numerous published accounts: Patient care is enhanced as amply demonstrated by numerous published 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.

23 Senate 2007 & 2008 Votes June 21, Aye: 61 Nay: 0 Excused: 1 June 24, Aye: 62 Nay: 0

24 2009 Senate Sponsors LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN, FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORATO, RANZENHOFER, SEWARD, STACHOWSKI, VOLKER LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN, FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORATO, RANZENHOFER, SEWARD, STACHOWSKI, VOLKER

25 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)

26 Legislative Update: Other Issues Facing New York Thomas P. Lombardi, Pharm.D., FASHP, VP Public Policy, NYSCHP

27 Other 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

28 Citizenship 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

29 Scope 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.

30 Pharmacy Technicians Senate - STATUS – No sponsor to date A ENGLEBRIGHT, ALFANO; M-S: Butler 02/13/09 referred to higher education

31 Scope of the Bill 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. 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.

32 Pharmacy 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.

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34 Substitution of Antiepileptic Drugs Senate - STATUS – No sponsor to date A 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

35 Scope 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.

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