PSHP Annual Assembly
October 28, 2015
Matt Scola, PharmD, MHA
Pharmacist Learning Objectives
 Describe the current state and future direction of
PSHP
 Summarize key points from the ASHP House of
Delegates meeting
 Discuss current trends in pharmacy practice
 Review components of the Pennsylvania Pharmacy
Technician bill
Pharmacy Technician Learning
Objectives
 Describe the current state and future direction of
PSHP
 Summarize key points from the ASHP House of
Delegates meeting
 Discuss current trends in pharmacy practice and
opportunities for technicians
 Review components of the Pennsylvania Pharmacy
Technician bill
PSHP Current State
 Monthly Board of Directors meetings
 Strategic planning session prior to last year’s Annual
Assembly
 Strategic Planning session prior to this meeting
 Membership Committee, Public Relations Committee
 ~500 active members
2015-2016 Officers
 Past-President- Jennifer Belavic
 President- Matt Scola
 President Elect- Bill O’Hara
 Treasurer- Dave Cecere
 Board Members
 Elaine Strauss
 Brad Cooper
 Jill Rebuck
 Lynne Byrne
Able Management
 8/3/07- Contract signed between PSHP and Able
Management
 7/10- PSHP notifies Able of intent not to renew
contract
 11/1/10- Contract between Able and PSHP supposed to
end
 3/31/11- Last communication from Able management
Able Management
 2/11 through 7/11- Able withdraws ~$99,000 from PSHP
accounts
 8/11-Audit conducted of 2010 finances plus acquisition
of detailed transactions for 2011
 1/12- initial discussions with legal representation
 3/13- draft complaint created
Able Management
 12/30/13- complaint filed
 6/10/14- notice sent to Defendant
 11/18/14- default judgement granted
 12/19/14- Damages hearing
 12/30/14- Decision of damages granted- ~109,720 ($99k
plus interest)
 3/27/15- Judgements of lien on file in both Franklin
and Delaware County (OH)
Able Management
 As of 8/5/15- no assets on record for either Able
Management or former owner
 Judge’s decision good for 5 yrs
 Can renew/extend judgement
 Good in both Franklin and Delaware counties (OH)
 Could set up judgement debtor exam
 Requires previous owner to show up in court
 Result depends on cash assets
 Low probability of success
Strategic Planning Overview
 2012 event
 Focused on business model
 Goal= stabilize
 Jan. 2014 event
 Developing a 3 yr plan
 Creating more outreach
 Develop future structure
 Oct. 2014 event
 Broadening of previous work into overarching goal
structure
PSHP Current State
 Attendance at ASHP Presidential Officer’s Retreat
 One of two regional meetings help
 ~40 attendees- officers, executives
 Focus on membership discussions- attraction and
retention
 Brief discussions on ASHP’s Ambulatory Care Summit
PSHP Current State
 Increased social media presence
 Facebook and LinkedIn
 Member profiles in newsletters
 Overall newsletter content
 “Get a Member” campaign
 Efforts to re-establish Western Chapter
 Northcentral and Southcentral still inactive
4/1/2015
1/1/2015
10/1/2014
7/1/2014
4/1/2014
1/1/2014
10/1/2013
7/1/2013
4/1/2013
1/1/2013
10/1/2012
7/1/2012
4/1/2012
1/1/2012
10/1/2011
7/1/2011
4/1/2011
1/1/2011
PSHP Finances
Total Assets
$350,000
$300,000
$250,000
$200,000
$150,000
$100,000
$50,000
$0
PSHP- Next steps
 Membership
 Ongoing actions to increase membership numbers and
maintain member retention
 Legislative actions
 Increasing presence and actions relative to legislation
impacting profession
ASHP House of Delegates
 Last met in June 2015
 Over 30 policies reviewed and voted upon
 Sample Topics
 Provider status
 Insurance/coverage issues
 Substance abuse
 Capital punishment
 Biosimilars
ASHP Policy Process
Governance
ASHP Professional Policy
House of Delegates
Operations
Board of Directors
Councils
Other Appointed
Groups
Members
Component
Groups
1502 - Pharmacist Recognition as a Healthcare Provider
Source: Council on Public Policy
To advocate for changes in federal (e.g., Social Security Act), state, and third-party
payment programs to define pharmacists as healthcare providers; further,
To affirm that pharmacists, as medication-use experts, provide safe, accessible,
high-quality care that is cost effective, resulting in improved patient outcomes;
further,
To recognize that pharmacists, as healthcare providers, improve access to patient
care and bridge existing gaps in healthcare; further,
To collaborate with key stakeholders to describe the covered direct patient-care
services provided by pharmacists; further,
1502 - Pharmacist Recognition as a Healthcare Provider (cont’d)
To advocate for sustainable compensation and standardized billing processes used
by payers for pharmacist services by all available payment programs.
This policy supersedes ASHP policy 1307.
1503 - Pharmaceutical Product and Supply Chain Integrity
Source: Council on Public Policy
To encourage the Food and Drug Administration (FDA) and relevant state
authorities to take the steps necessary to ensure that (1) all drug products
entering the supply chain are thoroughly inspected and tested to establish
that they have not been adulterated or misbranded and (2) patients will not
receive improperly labeled and packaged, deteriorated, outdated, counterfeit,
adulterated, or unapproved drug products; further,
To encourage FDA and relevant state authorities to develop and implement
regulations to (1) restrict or prohibit licensed drug distributors (drug
wholesalers, repackagers, and manufacturers) from purchasing legend drugs
from unlicensed entities and (2) ensure accurate documentation at any point
in the distribution chain of the original source of drug products and chain of
custody from the manufacturer to the pharmacy; further,
1503 - Pharmaceutical Product and Supply Chain Integrity (cont’d)
To advocate for the establishment of meaningful penalties for companies that
violate current good manufacturing practices (cGMPs) intended to ensure the
quality, identity, strength, and purity of their marketed drug product(s) and raw
materials; further,
To advocate for improved transparency so that drug product labeling include a
readily available means to retrieve the name and location of the facility that
manufactured the specific lot of the product; further,
To advocate that this readily retrievable manufacturing information be available
prospectively to aid purchasers in determining the quality of a drug product and
its raw materials; further,
To urge Congress and state legislatures to provide adequate funding, or authority
to impose user fees, to accomplish these objectives.
This policy supersedes ASHP policy 0907.
1509 - Approval of Biosimilar Medications
Source: Council on Public Policy
To encourage the development of safe and effective biosimilar medications in
order to make such medications more affordable and accessible; further,
To encourage research on the safety, effectiveness, and interchangeability of
biosimilar medications; further,
To support legislation and regulation to allow Food and Drug Administration
(FDA) approval of biosimilar medications; further,
To support legislation and regulation to allow FDA approval of biosimilar
medications that are also determined by the FDA to be interchangeable and
therefore may be substituted for the reference product without the
intervention of the prescriber; further,
1509 - Approval of Biosimilar Medications (cont’d)
To oppose the implementation of any state laws regarding biosimilar
interchangeability prior to finalization of FDA guidance; further,
To oppose any state legislation that would require a pharmacist to notify a
prescriber when a biosimilar deemed to be interchangeable by the FDA is
dispensed; further,
To require postmarketing surveillance for all biosimilar medications to ensure
their continued safety, effectiveness, purity, quality, identity, and strength;
further,
To advocate for adequate reimbursement for biosimilar medications that are
deemed interchangeable; further,
1509 - Approval of Biosimilar Medications (cont’d)
To promote and develop ASHP-directed education of pharmacists about
biosimilar medications and their appropriate use within hospitals and health
systems; further,
To advocate and encourage pharmacist evaluation and the application of the
formulary system before biosimilar medications are used in hospitals and
health systems.
This policy supersedes ASHP policy 1409.
1518 - Developing Leadership Competencies
Source: Council on Education and Workforce Development
To work with healthcare organization leadership to foster opportunities for
pharmacy practitioners to move into leadership roles; further,
To encourage leaders to seek out and mentor pharmacy practitioners in
developing administrative, managerial, and leadership skills; further,
To encourage pharmacy practitioners to obtain the skills necessary to pursue
administrative, managerial, and leadership roles; further,
To encourage colleges of pharmacy and ASHP state affiliates to collaborate in
fostering student leadership skills through development of co-curricular
leadership opportunities, leadership conferences, and other leadership promotion
programs; further,
1518 - Developing Leadership Competencies (cont’d)
To reaffirm that residency programs should develop leadership skills through
mentoring, training, and leadership opportunities; further,
To foster leadership skills for pharmacists to use on a daily basis in their roles as
leaders in patient care.
This policy supersedes ASHP policy 0509.
1519 - Pharmacy Technician Training and Certification
Source: Council on Education and Workforce Development
To support the position that by the year 2020, the completion of a pharmacy
technician training program accredited by ASHP and the Accreditation Council
for Pharmacy Education (ACPE) be required to obtain Pharmacy Technician
Certification Board certification for all new pharmacy technicians entering the
workforce; further,
To foster expansion of ASHP-ACPE accredited pharmacy technician training
programs.
This policy supersedes ASHP policies 1015 and 0702.
ASHP House of Delegates
 New process underway
 Shift towards perpetual process-more responsive process
 Focus on online commenting procedures
 Changes in election timing
 First virtual voting to occur in November
 Allows voting and passage of updates throughout the
year
 Still having onsite HOD at Annual Meeting
2015-2016 Delegates
 Nishaminy Kasbekar
 Patricia Kienle
 Bill O’Hara
 Jean Schultz
 Matt Scola
 Alternates
 Jennifer Belavic
 Thao Huynh
 Richard Pacitti
Current Trends in Pharmacy
Practice
 Provider Status
 Drug Supply Chain Security Act
 Transitions of Care
 340B Regulations
 USP 800
Pharmacist Provider Status
 Pharmacists continue to lack recognition as health
care providers in federal law
 Current push to amend the Social Security Act to allow
Medicare beneficiaries to access pharmacist provided
services under Medicare Part B
Pharmacy and Medically Underserved
Areas Enhancement Act
 HR 592 & S314
 Would allow for payment (and recognition as
provider) for pharmacy services furnished by a
licensed pharmacist
 Legally allowed to provide the service
 Service would be otherwise covered if provided by a
physician or incident to
 Occurs in medically underserved areas or medically
underserved population
Pharmacy and Medically
Underserved Areas Enhancement Act
 Allows for payment of 80% of total charge or 85% of
established fee, whichever is less
 225 cosponsors in the House (out of 435)
 33 cosponsors in the Senate
Pharmacy and Medically
Underserved Areas Enhancement Act
 Pennsylvania Representatives supporting:
 Barletta
 Cartwright
 Costello
 Dent
 Doyle
 Meehan
 Murphy
 Perry
 Shuster
 Thompson
Pharmacy and Medically
Underserved Areas Enhancement Act
 Pennsylvania Representatives NOT supporting:
 Boyle
 Brady
 Fattah
 Fitzpatrick
 Kelly
 Marino
 Pitts
 Rothfus
Pharmacy and Medically
Underserved Areas Enhancement Act
 PA Senators stance:
 Casey- Cosponsor
 Toomey- not yet sponsored
Pharmacist Provider Status
 Resources
 Patient Access to Pharmacists’ Care Coalitionhttp://www.pharmacistscare.org
 ASHP- http://www.ashp.org/
 APhA- http://www.pharmacist.com
 US Congress- http://www.congress.gov
Drug Supply Chain Security Act
(DSCSA)
 Part of the Drug Quality and Security Act- signed into
federal law on 11/17/13
 Outlines critical steps to build an electronic,
interoperable system to identify and trace certain
prescription drugs
 10 year implementation phase
 Facilitate exchange of information at the individual
package level about where in the supply chain a drug has
been
DSCSA
 The electronic system will
 Enable verification and legitimacy of drug product
verification to the package level
 Enhance detection and notification of illegitimate
products
 Facilitate more efficient drug recalls
 Impacts manufacturers (M), repackagers (R),
wholesale drug distributors (W) and dispensers (D)
 Does not apply to reverse distributors
DSCSA- Key Provisions
 M & R put unique product identifiers on certain
packages
 M, W, R, & many D’s provide information about a drug
and who handled it each time it is sold
 M, W, R, & many D’s establish systems and processes
to be able to verify product identifier on certain
prescription products
DSCSA- Key Provisions
 M, W, R & D to quarantine and promptly investigate a
drug that has been identified as suspect
 M, W, R & D to establish systems and processes to
notify FDA and other stakeholders if an illegitimate
product is found
 W report licensing and contact information to FDA
DSCSA- Key Provisions
 Third party logistics providers obtain state or federal
license
 FDA is charged with oversight of DSCSA
 Develop standards
 Develop guidance documents
 Develop pilot programs
 Develop schedule for implementation
 Enforcement for implementation delayed from 7/1/15
until 11/1/15
DSCSA- Requirements for
Dispensers
 Maintain records for 6 years
 Transaction information
 Transaction history
 Transaction statement
 Applies to retail and hospital pharmacies
 Must provide information to FDA within 2 business
days when requested
DSCSA-Transaction Information









Proprietary or established name
Strength and dosage form
NDC
Container size
Number of containers
Lot Number
Date of transaction
Date of shipment
Business name and address of person to whom
ownership is transferred
DSCSA-Transaction Statement
 Comes from the “seller”
 Contains transaction information
 Acknowledges “seller” received transaction
information and statement from previous owner
 Acknowledges “seller” did not knowingly ship
counterfeit product
 Acknowledges “seller” has systems in place for
compliance
DSCSA- Requirements for
Dispensers
 Does not apply:
 Intracompany transfers
 Health systems
 Public health emergencies
 Dispenses to patients
 Samples
 Medications for office use
 Sales to charitable organizations
Pennsylvania Pharmacy Technician
Bill
 PA has one of the LOWEST grades for technician rules
and requirements (http://emilyjerryfoundation.org/ )
 Graded as “F”- actual zero points on the scorecard
 4 other states listed as “0”
 8 states ranked as “F”
 18 states ranked as “A” or “B”
Pennsylvania Pharmacy Technician
Bill
 HB854- sponsored by Anthony Deluca (D), Allegheny
County
 Amends Pharmacy Act
 Referred to Consumer Protection and Professional
Licensure Committee (6/12/15)
Pennsylvania Pharmacy Technician
Bill
Cosponsors
 D. Costa
 Fabrizio
 Kotik
 Longietti
 Thomas
 Pashinski
 McNeiil
 Deasy
 Cohen
 Barror
 Readshaw
 Murt
 Schlossberg
 Watson
 Gibbons
Pennsylvania Pharmacy Technician
Bill
 “Pharmacy Technician”- individual who:
 Registers with SBOP
 May assist in practice of pharmacy under direct and
immediate personal supervision of a licensed
pharmacist
Pennsylvania Pharmacy Technician
Bill
 “Pharmacy Technician Trainee”- individual who:
 Issued temporary permit by SBOP that authorizes
individual to perform duties of Pharmacy Technican
Pennsylvania Pharmacy Technician
Bill
 Pharmacy Technician Registration
 Register with SBOP biennially
 Responsible to licensed pharmacist
 At least 17 years of age
 High school diploma or equivalent
 Completes SBOP approved training program
 Completes criminal history background check
 Wear name tag identifying individual as Pharmacy
Technician
Pennsylvania Pharmacy Technician
Bill
 SB456- sponsored by John Rafferty, Jr. (R), Berks,
Chester and Montgomery counties
 Cosponsors
 Browne, Tartaglore, Vance
 Virtually same language and intent
 Suggests annual vs biennial registration
Post Test Questions
 According to the proposed legislation in both the PA
House and Senate, Pharmacy Technicians are required
to be PTCB certified
 True
 False
Post Test Questions
 The DSCSA only requires transaction information and
statements from wholesale drug distributors
 True
 False
Questions