PowerPoint Presentation

PSHP Presidents UpdatePSHP Annual AssemblyOctober 28, 2015Matt Scola, PharmD, MHA

Pharmacist Learning ObjectivesDescribe the current state and future direction of PSHPSummarize key points from the ASHP House of Delegates meetingDiscuss current trends in pharmacy practiceReview components of the Pennsylvania Pharmacy Technician billPharmacy Technician Learning ObjectivesDescribe the current state and future direction of PSHPSummarize key points from the ASHP House of Delegates meetingDiscuss current trends in pharmacy practice and opportunities for techniciansReview components of the Pennsylvania Pharmacy Technician bill

PSHP Current StateMonthly Board of Directors meetingsStrategic planning session prior to last years Annual AssemblyStrategic Planning session prior to this meetingMembership Committee, Public Relations Committee~500 active members

2015-2016 OfficersPast-President- Jennifer BelavicPresident- Matt ScolaPresident Elect- Bill OHaraTreasurer- Dave CecereBoard MembersElaine StraussBrad CooperJill RebuckLynne ByrneAble Management8/3/07- Contract signed between PSHP and Able Management7/10- PSHP notifies Able of intent not to renew contract11/1/10- Contract between Able and PSHP supposed to end3/31/11- Last communication from Able managementAble Management2/11 through 7/11- Able withdraws ~$99,000 from PSHP accounts8/11-Audit conducted of 2010 finances plus acquisition of detailed transactions for 20111/12- initial discussions with legal representation3/13- draft complaint createdAble Management12/30/13- complaint filed6/10/14- notice sent to Defendant11/18/14- default judgement granted12/19/14- Damages hearing12/30/14- 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 ManagementAs of 8/5/15- no assets on record for either Able Management or former ownerJudges decision good for 5 yrsCan renew/extend judgementGood in both Franklin and Delaware counties (OH)Could set up judgement debtor examRequires previous owner to show up in courtResult depends on cash assetsLow probability of successStrategic Planning Overview2012 eventFocused on business modelGoal= stabilizeJan. 2014 eventDeveloping a 3 yr planCreating more outreachDevelop future structureOct. 2014 eventBroadening of previous work into overarching goal structurePSHP Current StateAttendance at ASHP Presidential Officers RetreatOne of two regional meetings help~40 attendees- officers, executivesFocus on membership discussions- attraction and retentionBrief discussions on ASHPs Ambulatory Care Summit

PSHP Current StateIncreased social media presenceFacebook and LinkedInMember profiles in newslettersOverall newsletter contentGet a Member campaignEfforts to re-establish Western ChapterNorthcentral and Southcentral still inactive

PSHP FinancesPSHP- Next stepsMembershipOngoing actions to increase membership numbers and maintain member retentionLegislative actionsIncreasing presence and actions relative to legislation impacting professionASHP House of DelegatesLast met in June 2015Over 30 policies reviewed and voted uponSample TopicsProvider statusInsurance/coverage issuesSubstance abuseCapital punishmentBiosimilarsASHP Policy Process

1502 - Pharmacist Recognition as a Healthcare ProviderSource: Council on Public PolicyTo 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 (contd)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 PolicyTo 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 (contd)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 MedicationsSource: Council on Public PolicyTo 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 (contd)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 (contd)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 CompetenciesSource: Council on Education and Workforce DevelopmentTo 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 (contd)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 CertificationSource: Council on Education and Workforce DevelopmentTo 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 DelegatesNew process underwayShift towards perpetual process-more responsive processFocus on online commenting proceduresChanges in election timingFirst virtual voting to occur in NovemberAllows voting and passage of updates throughout the yearStill having onsite HOD at Annual Meeting

2015-2016 DelegatesNishaminy KasbekarPatricia KienleBill OHaraJean SchultzMatt ScolaAlternatesJennifer BelavicThao HuynhRichard PacittiCurrent Trends in Pharmacy PracticeProvider StatusDrug Supply Chain Security ActTransitions of Care340B RegulationsUSP 800Pharmacist Provider StatusPharmacists continue to lack recognition as health care providers in federal lawCurrent 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 ActHR 592 & S314Would allow for payment (and recognition as provider) for pharmacy services furnished by a licensed pharmacistLegally allowed to provide the serviceService would be otherwise covered if provided by a physician or incident toOccurs in medically underserved areas or medically underserved populationPharmacy and Medically Underserved Areas Enhancement ActAllows for payment of 80% of total charge or 85% of established fee, whichever is less225 cosponsors in the House (out of 435)33 cosponsors in the SenatePharmacy and Medically Underserved Areas Enhancement ActPennsylvania Representatives supporting:BarlettaCartwrightCostelloDentDoyleMeehanMurphyPerryShusterThompson

Pharmacy and Medically Underserved Areas Enhancement ActPennsylvania Representatives NOT supporting:BoyleBradyFattahFitzpatrickKellyMarinoPittsRothfusPharmacy and Medically Underserved Areas Enhancement ActPA Senators stance:Casey- CosponsorToomey- not yet sponsoredPharmacist Provider StatusResourcesPatient Access to Pharmacists Care Coalition- http://www.pharmacistscare.orgASHP- http://www.ashp.org/APhA- http://www.pharmacist.comUS Congress- http://www.congress.gov

Drug Supply Chain Security Act (DSCSA)Part of the Drug Quality and Security Act- signed into federal law on 11/17/13Outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs10 year implementation phaseFacilitate exchange of information at the individual package level about where in the supply chain a drug has beenDSCSAThe electronic system will Enable verification and legitimacy of drug product verification to the package levelEnhance detection and notification of illegitimate productsFacilitate more efficient drug recallsImpacts manufacturers (M), repackagers (R), wholesale drug distributors (W) and dispensers (D)Does not apply to reverse distributors

DSCSA- Key ProvisionsM & R put unique product identifiers on certain packagesM, W, R, & many Ds provide information about a drug and who handled it each time it is soldM, W, R, & many Ds establish systems and processes to be able to verify product identifier on certain prescription productsDSCSA- Key ProvisionsM, W, R & D to quarantine and promptly investigate a drug that has been identified as suspectM, W, R & D to establish systems and processes to notify FDA and other stakeholders if an illegitimate product is foundW report licensing and contact information to FDADSCSA- Key ProvisionsThird party logistics providers obtain state or federal licenseFDA is charged with oversight of DSCSADevelop standardsDevelop guidance documentsDevelop pilot programsDevelop schedule for implementationEnforcement for implementation delayed from 7/1/15 until 11/1/15DSCSA- Requirements for DispensersMaintain records for 6 yearsTransaction informationTransaction historyTransaction statementApplies to retail and hospital pharmaciesMust provide information to FDA within 2 business days when requestedDSCSA-Transaction InformationProprietary or established nameStrength and dosage formNDCContainer sizeNumber of containersLot NumberDate of transactionDate of shipmentBusiness name and address of person to whom ownership is transferredDSCSA-Transaction StatementComes from the sellerContains transaction informationAcknowledges seller received transaction information and statement from previous ownerAcknowledges seller did not knowingly ship counterfeit productAcknowledges seller has systems in place for complianceDSCSA- Requirements for DispensersDoes not apply:Intracompany transfersHealth systemsPublic health emergenciesDispenses to patientsSamplesMedications for office useSales to charitable organizations

Pennsylvania Pharmacy Technician BillPA has one of the LOWEST grades for technician rules and requirements (http://emilyjerryfoundation.org/ )Graded as F- actual zero points on the scorecard4 other states listed as 08 states ranked as F18 states ranked as A or B

Pennsylvania Pharmacy Technician BillHB854- sponsored by Anthony Deluca (D), Allegheny CountyAmends Pharmacy ActReferred to Consumer Protection and Professional Licensure Committee (6/12/15)

Pennsylvania Pharmacy Technician BillD. CostaKotikThomasMcNeiilCohenReadshawSchlossbergFabrizioLongiettiPashinskiDeasyBarrorMurtWatsonGibbonsCosponsorsPennsylvania Pharmacy Technician BillPharmacy Technician- individual who:Registers with SBOPMay assist in practice of pharmacy under direct and immediate personal supervision of a licensed pharmacist

Pennsylvania Pharmacy Technician BillPharmacy Technician Trainee- individual who:Issued temporary permit by SBOP that authorizes individual to perform duties of Pharmacy Technican

Pennsylvania Pharmacy Technician BillPharmacy Technician RegistrationRegister with SBOP bienniallyResponsible to licensed pharmacistAt least 17 years of ageHigh school diploma or equivalentCompletes SBOP approved training programCompletes criminal history background checkWear name tag identifying individual as Pharmacy TechnicianPennsylvania Pharmacy Technician BillSB456- sponsored by John Rafferty, Jr. (R), Berks, Chester and Montgomery countiesCosponsorsBrowne, Tartaglore, VanceVirtually same language and intentSuggests annual vs biennial registrationPost Test QuestionsAccording to the proposed legislation in both the PA House and Senate, Pharmacy Technicians are required to be PTCB certifiedTrueFalse

Post Test QuestionsThe DSCSA only requires transaction information and statements from wholesale drug distributorsTrueFalse

Questions