New York State Pharmacy Conference



New York State Pharmacy Conference

June 15, 2012: 10:30 AM – 2:30 PM

****PSSNY Board Room ****

210 Washington Avenue Extension

Albany, NY 12205

Minutes

1. Welcome and Introductions: Conference Chair – Dr. Stuart Feldman – Touro

Excused (Janet Elkind, Joseph Brocavich, Joseph Etzel, John Marraffa, Debra Feinberg)

2. Approval of Minutes/Sign In – March minutes approved unanimously

3. Announcements - none

4. Items for Discussion

a. Follow-up on “Biosimilars”– Darren Triller

i. FDA adopted new guidance on reviewing and approval of biologics into 2 categories: either biosimilar or interchangeable. Approval process separate from approval of drug products that are chemically identical. Therefore, biosimilars are NOT generics. Issues include DAW, formulary, etc. An ad-hoc group met this morning (Tom Lombardi, Darren Triller, Amy BartonPai, Sarah Scarpace, Anne Myrka) to discuss an approach for the issue on behalf of the NYS Pharmacy Conference. Summary and action items from meeting are attached. Action items: (1) Darren will track on FDA site how many products are in pipeline and share with group (2) Hold a multi-disciplinary stakeholder meeting to discuss (health care professionals and hospital administrators). Legislators should also be included. Board interested in participating but cannot lead due to staffing. Will also discuss with NYSCHP to lead the effort. (3) Inform FDA of outcome of the NYS meeting (4) create a standing advisory board (5) requesting REMS or other standard process for biologics. The importance of including payors was emphasized.

b. Access/Storage of NY State Pharmacy Conference Minutes – Craig will post on PSSNY site in open-access area.

c. AACP Report – Argus Commission 2010-2011 – Sarah Scarpace – Schools and organizations could systematically promote ‘the New American Pharmacist.” Promoting the Walgreens’ model so that the typical interaction with public at the pharmacy changes in conjunction with press releases etc. Quality measures for community pharmacies. Changing public expectations about their encounters at community pharmacists. We need to avoid the term “retail” pharmacy and use “community” pharmacy. Pharmacists have been well-respected by public for 20 years as most trusted professional – so problem may not be with the public but with other health care professionals and payors. Shift should be on population health with outcomes tied to care that pharmacist provides. Media opportunities when new drugs come out or “ask your pharmacist.” Other opportunities: health care plan association, reporting outcomes from NYSCHP/ACCP on CDTM; interprofessional education outcomes; county health officials.

5. Reports by State and Governmental Agencies

a. EPIC Update: Diane Reed

i. 1/1/2013 – EPIC will be restored “closely” to what it was in 2011; fee and deductible program; only available to those with Medicare Part D; secondary coverage for part D covered drugs and primary for excluded drugs; will not cover claims during Medicare Part D deductible phase if a participant has them. Participants will be notified in August; pharmacies will be notified first. Office will be moving to downtown Albany at 1 Commerce Plaza today. EPIC will continue to provide support for the premium and has slightly raised the income limits.

b. Pharmacist as Immunizer Data/ DOH – Priya Sharma, Delia Easton (not present)– only 47% of certified pharmacists reported according to Craig but survey did not ask if the pharmacist actually gave a shot; survey will be corrected and likely administered again this summer.

c. NYS Board Of Pharmacy – Larry Mokhiber

i. Kim Leonard joined as supervisor of pharmacy practice and registration

ii. Next mtg: 9/27-28/2012 at UB for the inauguration of new facilities

iii. Limited English Proficiency – seeking input on requiring process to delivering services in more than 1 language. No hearings will be held but Board will gather input. Input will be gathered by BOP and Board of Medicine. Will be an informal process, not a formal hearing. Will collect informal feedback at the UB meeting. Very few areas for discretion but some include (1) defining “regions” of the state (2) cleaning up the label. Recommendation has been to print both English and the second language but this has not been finalized. The threshold is 1% of population speaks a specific language by census data. Blank will also have a check-box for provider to indicate patient is LEP even though no regulation for providers

iv. Immunization – exceed 7500 immunizers in state now; monitoring change in legislation to include Zostivax; if passed Board will commit to make these emergency regulations and in place asap (within 90 days versus usual 6-12 months)

v. CDTM – moving along; Kim Zammit is a new Board member and Chair of the CDTM committee – separate email address; CDTM@mail. to report outcomes on CDTM. Goes to both Mr. Mokhiber’s office and to Kim. Larry will share the story of an editorial written by a patient who said that the CDTM effort by the pharmacist saved him.

vi. Wholesalers – bill moved from Assembly Higher Ed to Assembly Codes; cautiously optimistic that the bill will move. Bill is meant to reduce opportunities for counterfeiting

vii. Part 3 Exam – administered at 6 sites last week at 660+ candidates.

viii. Specialty drugs for Medicaid program – special committee of the Board convened and looked at health dept criteria and took a more narrow view, sent back to DOH and reiterated that since there is no specialty designation for pharmacies

ix. Pharmacy wanted to open to fill only foreign prescriptions – Board declined the application

x. Drug retail price list is being updated and will be out this summer

xi. New executive director for Board of Nursing - Suzanne Sullivan – nurse and attorney

xii. Drug return and reuse – looking at regulations to amend regarding the “less than 90 day supply” rule

xiii. Compounding pharmacies that morph into manufacturer violates NYS law – refer to case on Frank’s Pharmacy in Florida and ophthalmic drugs and shipped around country including NYS

xiv. Technicians – in Senate Higher Ed but both amended to be the agreed-to bill and there doesn’t appear to be any opposition; if it passes, Board will convene immediately to develop regulations – calls for registration of technicians for 3-4 years and that all technicians would have to be registered and then by 2016 would need to be certified, minimum age of 18; background checks by Dept of Education; high school or GED; preparation for certification could be formal or on-site

xv. E-prescribing – regs published in state register; Regents will be presented with a package to approve or not on Tuesday 6/19; if approved, will take effect on July 11, 2012. Will comply with language in 6810 – remove requirement for DAW box; for non-controlled substance, SED requirement updated so that all records could be kept electronically

d. DOH Bureau of Narcotic Enforcement: Terrence O’Leary – new director for last 6 months – iSTOP ACT is out – see attachment from PSSNY; includes right for prescribers to have designees check the database; pharmacists now have access to the PMP when you want; data will be purged in 5 years; effective dates are 1 year; need regulations and don’t know how to enter pharmacists since use DEA number; recommendation is to get an HCS account; pharmacists will have access before the prescriber designees; access for pharmacists is not mandatory; Part 2 of bill: December 2014 requires all prescriptions to be electronic, not just controlled substances; workgroup creates awareness about prescription drug abuse, makes recommendations regard continuing education, educate professional communities about iSTOP; workgroup will be put together by September 1, 2012. Section 3 of bill is scheduling changes – hydrocodone will move to schedule II; tramadol is now a schedule IV – effective 180 days after enactment – governor has not signed yet. Soma and Lucedra moved to schedule IV with 90 day effective dates; Part D defines workgroup tasks; final part is about safe disposal – have licensed 2000 sites and 500 take-back programs/year. BNE now gives ability to law enforcement to have a box at their stations.

e. DOH: Office of Medicaid Inspector General- no report

f. CMS/ Medicaid: Medicare Part D program: John Cocchiara – no report

g. DOH Division of Quality and Patient Safety: Ed Dombroski – Drug Shortages

i. see 3 attachments

ii. Worked with FDA as has BNE on daily basis; feels that FDA was best single source of information. PSC has provided guidance in one of the attachments. President Executive Order 13588 was issued for early warning with no fines imposed if they fail to comply; 4 steps (1) broader reporting US 350C (2) expedited review (3) work with Department of Justice if there was price gauging

iii. Department encourages pharmacists and prescribers to notify when they encounter a shortage

iv. BNE has a Commissioner’s ruling on their webpage that allows pharmacists to obtain controlled substances from another pharmacy if needed. Major problem has been with Emergency Medical Services trucks

h. DOH Medicaid: Mary Carroll for Janet Elkind –

i. List of drugs that are limited for exclusive distribution plan – developed a workgroup of pharmacists to develop criteria for drugs that are currently excluded by the managed care plans; was sent out for public comments and now updating based on feedback; intent was to implement July 1 but not likely due to volume of comments received. Questions regarding coordination of delivery. Calls should go to the office of Medicaid managed care division. Recommendation was to start with the plans themselves.

ii. AAC – department will survey all enrolled pharmacies for acquisition costs for drugs and other dispensing costs; met in May with stakeholders and received comments; having some technical issues with the chain pharmacy surveys; working to develop surveys that involve technical barriers – so piloting and testing the surveys; believe they have a final draft; had hoped to issue the survey in June but still having some technical issues but should be no later than July 10, 2012 and will need to submit through the HCS. Will administer pilot study to 380 pharmacies by stratified random selection to represent all different business types. Cost of dispensing will be annual; the acquisition cost will be random monthly. Pharmacies will be contacted by the department through HCS.

------------------------------Lunch: 12:42pm -1:05pm----------------------------------------------

i. IPRO: Darren Triller/Anne Myrka

i. Anticoagulation safety- NYS anticoagulation coalition meets quarterly with over 100 multidisciplinary members. Contact Darren if interested. New website will include SAS-coded tables to analyze their lab data.

1. NYS Health Facilities Organizations – assessing their anticoagulation programs in 12 facilities. Have seen a lot of variability in outcomes

ii. Pharmacy Quality Alliance – working with CDC to educate about pharmacy metrics on clinical topics

iii. HANYS – federal funding under Partnership for Patients to work on medication reconciliation in high-risk drugs

iv. Prevention Team – MDs and others at IPRO to help private practices adopt electronic medical records and looking at outcomes related to cancer screening and American Heart Association goals

v. Health Information Management NYS chapter is looking for pharmacist members. Darren and a faculty from St. John’s is on the group and will create a directory of pharmacy organizations and pharmacy contacts for them.

6. Reports by Colleges of Pharmacy

a. Albany College of Pharmacy and Health Sciences (Sarah Scarpace)

1- Provost/Dean Mehdi Boroujerdi has resigned effected July 1, 2012

2- Angela Dominelli, PhD, has been appointed interim Dean of the School of Pharmacy and Pharmaceutical Sciences. She will also continue in her role as the Associate Vice President of Institutional Effectiveness

3- John Denio, MBA, has been appointed Interim Provost of the College.  He will also continue in his role as the Dean of Students

4- We graduated 212 PharmD; 9 BS Pharmaceutical Sciences; 4 MS Pharmaceutical Sciences; 19 BS Biomedical Technology; 2 BS/MS Biotechnology/Cytotechnology; 6 MS Biotechnology; 1 MS Cytotechnology/Molecular Cytology; 1 MS Health Outcomes Research students on May 12, 2012

5- ASHP accredited ACPHS’s PGY1 Pharmacy Practice Residency in community pharmacy (a shared residency with Price Chopper Pharmacy) in April for 3 years.  This is the first ASHP-accredited residency program offered by ACPHS

6- The NYS Department of Education has approved the registration of a BS in Microbiology which will be offered by the School of Arts and Sciences of the College

7- The APhA-ASP chapter with the Albany Police Department held a medication “Drive Up and Drop Off” Medication take-back event on 4/28 in recognition of National Medication Take-Back Day. 648 units of OTCs, 1320 units of non-controlled prescription medications, 133 units of controlled non-narcotic prescription medications, and 26 units of narcotic prescriptions were collected.

8- Sarah Scarpace was appointed the non-nurse co-lead of the Northeast Region for the NYS Future of Nursing/Robert Wood Johnson Foundation initiative.  The goal of the initiative is to promote the advancement of the nursing profession. Each region of NYS has a nurse and non-nurse co-lead. There is a need for non-nurse participation, particularly in Central NYS. More information can be found from: (“Recommendations” tab has the key goal areas for the intiative). If interested, please contact Sarah. This initiative is mentioned in the Argus commission report (attached) as one which pharmacy could model to promote the New American Pharmacist

b. D’Youville College of Pharmacy (Chris Jadoch)

i. Admitting 3rd class for this fall

ii. 2 students recognized at APhA for Generation Rx who will receive tuition for the Utah Alcohol and Substance Abuse program this summer

iii. 1 Social Administrative Science faculty needed

iv. Next ACPE visit in Spring 2013

v. Drug disposal day with UB with over 12,000 pounds collected and 4600 participants;154,000 units controlled substances collected, including 52,000 hydrocodones worth over $680k. Did a study to determine where the excess was coming from. Only conclusions that were statistically significant were that the more drugs they take, the more they return and that consumers prefer to return drugs to community pharmacies, hospitals 2nd, and police stations last. Popular places were suburban hospitals.

c. Long Island University- (Joe Bova)

i. May 14 – 125th commencement – 204 PharmD, 60 MS, 4 PhD

ii. MTM program through the health center with APPE students

iii. Clinical sites and vigilance to make sure can provide sites to students

d. St. John Fisher-Wegmans (Rich O’Brocta)

i. Graduated 3rd class – 66 PharmD

ii. Joint PharmD/MBA program filed with State Ed

e. St. John’s University None

f. Touro College (Stuart Feldman)

i. Graduated 1st class – 63 students

ii. See Daily News story on 2 of their graduates

iii. Program requires a BS for admission

iv. Last 2 years are APPE

v. Big focus on public health

vi. PharmD/MPH has been filed with State Education Department

g. University at Buffalo (Karl D. Fiebelkorn)

i. Finished 125th anniversary

ii. Opening new building; Grand opening 9/27-9/28

iii. New curriculum has been approved and will be implemented

iv. Now a 3+4 program

v. Graduated 134 mixed degree with 114 PharmD; 4 PharmD/MS; 1 PharmD/JD

vi. New PharmD/MS in pharmaceutics, pharmacology, and other programs in addition to PharmD/MPH, PharmD/MBA, PharmD/JD

vii. 134 pharmacists trained to be immunizers

viii. UB has opened Bailing Simulation Center with nursing, dental, pharmacy, and medical school involved with multidisciplinary teams so all students will be trained in that section

ix. New student organization that will be inter-professional – 20 students each pharmacy, dental, medicine

x. Working with an HMO company for MTM

7. Reports by Associations

a. NYSASCP: none

b. Chain Pharmacy Association of NY: Marcy Savage

i. Monitoring LEP

ii. AAC

iii. Specialty Drug criteria

iv. iSTOP bill implementation

v. Immunization bill seems like good momentum

vi. Technician bill

vii. NPlex bill – to track pseudoephedrine precursors hopes to pass in Senate next week but unsure status in Assembly and would take place 4 months from signage by Governor if passes

viii. Antiepilepsy generic substitution – being held in Assembly higher ed committee – opposed to this bill and think DAW should address

ix. Any willing pharmacy bill – for worker’s comp – payment at the fee schedule and first fill limited to 14 days and on floor of both houses;

c. NYSACCP: Amy Barton Pai

i. Annual fall meeting 10/8/2012 at ACPHS – program is designed to support CDTM and clinical updates

First annual separate student meeting – residents with advanced scope, pediatrics, residency round table

ii. Grant to support CDTM – competitive application

d. NYSCHP Chris Jadoch

i. Supports technician bill

ii. Immunizer bill will support with PSSNY

e. PSSNY Craig Burridge

i. 134th annual convention in NYC with over 20 hours CE

ii. Consultant pharmacists who are being carved out of their health care plans can enroll in PSSNY’s program as long as they have a DBA

iii. iSTOP – added LEP language in e-prescribing to check off primary language

iv. could have a “reverse legislative day” in community pharmacies to show them what pharmacists do

v. PBMs as fiduciaries passed for the 4th time

vi. Increase criminal penalties for diverting non-controlled substances such as HIV and other expensive drugs – in Codes committee in the Assembly

vii. New bill to standardize prior authorizations so that must have an answer in 48 hours

viii. New bill to change pharmacy benefit in Medicaid Managed Care restores prescriber prevails

f. AMCP – Lisa Ansizi

i. Sent letter to FDA to address the biosimilars (1) needs to be definitions about what would be interchangeable (2) education and resources need to be available

ii. Pharmacist prescribing language and OTC paradigm shift

iii. Managed care companies do often cover pharmacist administered vaccines in community pharmacies

8. Next meeting: September 14, 2012

9. Adjourn – 2:11pm

Respectfully submitted,

Sarah Scarpace

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