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Legislative Update: What Every Pharmacist Needs to Know About Recent Developments in New York State Law and Regulation Gina Garrison, Pharm.D. Vice President.

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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 Gina Garrison, Pharm.D. Vice President."— Presentation transcript:

1 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

2 Learning Objectives Explain recent legislative and regulatory developments affecting the profession of pharmacy. 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. Educate regarding the legislative and regulatory process in New York State, and the role that pharmacists play in affecting change.

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

4 The CDTM Rationale: Adverse Drug Reactions (ADRs) 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 ADRs cost per year ADRs 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 ADRs are preventable 28% of ADRs 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- 4th leading cause of death in US Accidents Cancer Heart Disease Diabetes Adverse Drug Reactions Pneumonia Pulmonary Disease Stroke Ref: JAMA 1998;279:

6 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 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? At least 46 States currently permit CDTM At least 46 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 Collaborative Drug Therapy Management Current status: A6848 Canestrari/S 3292 LaValle A6848 Canestrari/S 3292 LaValle In Senate, passed unanimously on 2/22/2010—for the fourth year in a row. 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. In Assembly, remains in Committee, where it has languished for the last several years.

12 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 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. 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.

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. 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. 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. Literature shows medication errors decrease and physician liability should also decrease.

16 Changes in 2010 Economic Environment Economic Environment State’s Fiscal Crisis State’s Fiscal Crisis Continued support in Senate, despite leadership, Committee and party changes 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 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 Renewed commitment from Assemblyman Canestrari to move the bill

17 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

18 CDTM Opponents Now Possibly Medical Society of the State of New York Possibly Medical Society of the State of New York

19 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) Deans of NYS Pharmacy Schools Deans of NYS Pharmacy Schools

20 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 Media efforts Media efforts

21 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 Return with us to Albany on May 18 (NYSCHP Lobby Day)

22 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 (46 states currently permit). It is the state of the art in pharmacy practice (46 states currently permit).

23 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.

24 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

25 Current Senate Sponsors LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN, FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORATO, RANZENHOFER, SERRANO, SEWARD, STACHOWSKI, VOLKER LAVALLE, DeFRANCISCO, DIAZ, FLANAGAN, FUSCHILLO, KRUEGER, LARKIN, LITTLE, MAZIARZ, MORAHAN, NOZZOLIO, ONORATO, RANZENHOFER, SERRANO, SEWARD, STACHOWSKI, VOLKER

26 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 = 56 by latest count

27 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”…

28 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.

29 New York Legislative Update: Other Issues Facing Pharmacy Practice Gina Garrison, Pharm.D. Vice President of Public Policy NYSCHP

30 Some other Legislative issues… Pharmacy Technician Certification Medical Marihuana DAW, e-prescribing Citizenship Requirement Emergency Contraception Pharmacists Conscious Clause Pharmaceutical Pedigree Pharmaceutical Substitution

31 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. 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. A.5379 Englebright (MS) A.5379 Englebright (MS) Last act: 1/6/10 referred to higher education Last act: 1/6/10 referred to higher education No Same in in Senate; Currently no Senate sponsor No Same in in Senate; Currently no Senate sponsor Senate version not picked up after senate coup last year Senate version not picked up after senate coup last year Senator Fuschillo previously sponsored, but he has not re- introduced since Republicans lost House majority. Senator Fuschillo previously sponsored, but he has not re- introduced since Republicans lost House majority.

32 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: (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.

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34 Medical Marihuana Legalizes the possession, manufacture, use, delivery, transfer, transport or administration of marihuana by a certified patient or designated caregiver for a certified medical use 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 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 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. Provides for reports by the department of health to the governor and legislature on the medical use of marihuana.

35 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. 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 Last Act: 01/12/10 reported referred to codes Same-As S 4041 Same-As S 4041 Last Act: 01/06/10 REFERRED TO HEALTH 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

36 NY DAW e-prescribing Legislation drafted to amend the NY education law, in relation to electronic prescriptions and generic substitution Legislation drafted to amend the NY education law, in relation to electronic prescriptions and generic substitution Currently mandate prescriber’s handwriting in DAW box on prescription Currently mandate prescriber’s handwriting in DAW box on prescription Would update current prescribing statute to reflect nature of electronic prescribing Would update current prescribing statute to reflect nature of electronic prescribing Would not alter current policies relating to generic substitution Would not alter current policies relating to generic substitution Currently seeking sponsorship of Health Committee chairs Currently seeking sponsorship of Health Committee chairs Senator Tom Duane Senator Tom Duane Assemblyman Richard Gottfried Assemblyman Richard Gottfried

37 Draft: NY DAW e-prescribing PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX 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 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 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 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

38 Federal Updates Affecting NY

39 Federal update: Controlled Substance E-Prescribing DEA Interim Final Rule DEA Interim Final Rule Published March 31, 2010 in Federal Register Published March 31, 2010 in Federal Register Includes 60-day comment period through June 1, Includes 60-day comment period through June 1, Effective June 1, 2010, subject to Congressional review. Effective June 1, 2010, subject to Congressional review.

40 DEA Interim Final Rule Controlled Substance E-Prescribing Provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions Provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions Adds to existing rules, not a replacement Adds to existing rules, not a replacement Would include stipulations to ensure that a closed system of controls on controlled substances dispensing is maintained. 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 prescribers the option to write prescriptions for controlled substances electronically; and Would allow pharmacies to receive, dispense, and archive these electronic prescriptions. Would allow pharmacies to receive, dispense, and archive these electronic prescriptions.

41 Potential Impact of DEA E-prescription Regulations Reduce prescription forgery Reduce prescription forgery Reduce number of prescription errors Reduce number of prescription errors illegible handwriting illegible handwriting misunderstood oral prescriptions misunderstood oral prescriptions Reduce paperwork for DEA registrants who dispense or prescribe controlled substances Reduce paperwork for DEA registrants who dispense or prescribe controlled substances Help both pharmacies and hospitals integrate prescription records into other medical records more directly increase efficiency reduce amount of time patients spend waiting to have prescriptions filled.

42 Which of the following is NOT an expected outcomes of rules for E-prescribing controlled substances? A. Limit A. Limit illegal drug diversion. B. Reduce prescription errors. C. Increase controlled substances prescribing. D. Integrate controlled substances directly into electronic medical records.

43 Federal Healthcare Reform Increasing health care coverage Increasing health care coverage Part D changes to phase out “donut hole” gap when Part D recipients have to pay for their medications 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) Role of Pharmacist - Medication Therapy Management (MTM) Goal of collaborative program is improve care quality and decrease cost of chronic disease therapies Goal of collaborative program is improve care quality and decrease cost of chronic disease therapies Targeted to patients taking at least 4 medications OR those with at least 2 chronic diseases and those who had transition of care. 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 Details on applying for funds when grants/contracts available beginning May 2010

44 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

45 Questions?


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