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 adhoc 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.nysed.gov 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 ASHPaccredited 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 TakeBack 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 nonnurse co-lead. There is a need for non-nurse participation, particularly in Central NYS. More
information can be found from: http://futureofnursing-nys.org/ (“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 2 nd, 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.
b.
c.
d.
e.
f.
NYSASCP: none
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;
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
NYSCHP Chris Jadoch
i. Supports technician bill
ii. Immunizer bill will support with PSSNY
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
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