hospital/health-system pharmacy cpe session 3a · cpe session 3a hospital/health-system pharmacy...
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NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
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A Hospital/Health-System PharmacyFriday, 10:30 am - 11:30 am
ACPE: #0128-0000-16-328-L04-P/T 0.1 CEU/1.0 Hour Knowledge-Based Activity
Drug Compounding Regulatory Update: Here We Go!Learning Objectives for Pharmacists and Pharmacy Technicians:Upon completion of this CPE activity, participants should be able to:1. Review the current regulatory changes (in place and proposed) for compounding drugs.2. Discuss proposed Sterile Compounding regulatory changes: USP <797> Proposals.3. Outline expectations for hazardous drug compounding: USP <800>Final Chapter.
Speaker: Fred Massoomi, PharmD, FASHPDr. Firouzan ‘Fred’ Massoomi, PharmD., FASHP, is the acting Pharmacy Operations Coordinator with the Department of Pharmacy at Nebraska Methodist Hospital in Omaha, Nebraska. In this position Dr. Massoomi has responsibilities for oversight of pharmacy practices at Nebraska Methodist Hospital, Methodist Women’s Hospital, Methodist Home Infusion, Methodist Easterbrook Cancer Center, and Midwest Surgical Hospital. Utilizing his broad range of experiences, Dr. Massoomi was instrumental with integrating the pharmacy practices at Nebraska Methodist Hospital with the Accountable Care Organization Nebraska Health Alliance. Additionally, he has overseen the updating of the pharmacy departments to current practice standards as defi ned by the American Society of Health-System Pharmacists, Occupational Safety and Health Administration, and United States Pharmacopeia (USP) <795>, <797> and <800>. Dr. Massoomi has lectured internationally on implementation strategies for compliance with USP <797> and USP <800>, proper hazardous drug management as outlined in the Centers for Disease Control’s National Institute of Occupational Safety and Health Alert, and proper disposal of pharmaceutical drug waste.
Th rough numerous presentations and publications, Dr. Massoomi has shared his passion for the practice of pharmacy with the goal of promoting the important role that individual pharmacists play in public safety. Dr. Massoomi was honored with the Health-System Pharmacist of the Year award from the Nebraska Pharmacists Association and the United Way Health-System Volunteer of the Year Award for his work with emergency preparedness for city of Omaha and State of Nebraska in 2004, selected as a Fellow for the American Society of Health-System Pharmacists in 2006, and awarded Innovative Pharmacist of the Year by the Nebraska Pharmacists Association in 2007. In 2009, Dr. Massoomi testifi ed in front to the House of Representatives, Committee on Natural Resources, Subcommittee of Insular Aff airs, Oceans, and Wildlife as a panel member for “Overdose: How Drugs and Chemicals in Water Supplies and the Environment are Harming our Fish and Wildlife”.
Dr. Massoomi was Nebraska's District II Board representative of the Nebraska Pharmacists Association for 8 years and was President of the Nebraska Pharmacists Association in 2013.
Speaker Disclosure: Fred Massoomi reports no actual or potential confl icts of interest in relation to this CPE activity.
US Regulatory Changes for Medications
Fred Massoomi, Pharm.D., FASHPNebraska Methodist Hospital
Department of Pharmacy ServicesOmaha, Nebraska
Secure Safe Disposal Act 2010
Guidance on controlled substance disposal ‘Irrecoverable’
Pharmacies
Long Term Care Facilities
Public
Drug Quality and Security Act 2013
The Drug Quality and Security Act (DQSA) signed into law on November 27, 2013
• Public Law 113‐54
• Law Consists of Two Sections
Title I: Compounding Quality Act
Title II: Drug Supply Chain Security Act
Compounding Quality Act 2013
State Board of PharmacyHospitals
Retail PharmaciesCompounding Pharmacies
FDAOutsourcing Manufactures
Drug Supply Chain Security Act 2013FDA, CMS, Joint Commission
“Track & Traceability Act”
“Pedigree Act”
Transaction History (TH) Owners
Transaction Information (TI) identifies the product
(NDC, Lot Number, Date of Transaction, etc.)
Transaction Statement (TS) attests that the TI and TH
information is accurate
CMS Conditions of Participation 2015
Harmonize with USP
Storage of medications
High alert medications Safety guidelines
Preparing Sterile Drugs outside of pharmacy Anesthesia Etc.
Effective date January 2016
Prescription Drug Safety Act 2015
USP 795 & 797
Hospitals RX register Sterile compounding survey
RX Techs certified
Effective January 1, 2017
CMS JW-Modifier Requirement Modifier JW – Drug amount
discarded/not administered to any patient.
Amount ordered, administered, and discarded MUST be documented in med
record
Delayed until January 1, 2017
Source: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf
Appropriate ExampleEPA Hazardous Wastes Standards
EPA Oversight Published September 1, 2015 Comment December 31, 2015
Expected compliance 2017’ish
No drugs down the drain
Requires manual sorting Biohazardous Non-hazardous Hazardous RCRA Hazardous RCRA Reactive Aerosols Controlled Substances - DEA
National Hazardous Drug CompoundingUnited States Pharmacopeia <800>
First Release March 2014 Second Release December 2014 Publish Date February 2016 Official Compliance Date July 1, 2018
FDA Guidance on Compounding
“Compounded drugs…pose a higher risk to patients than FDA-approved drugs”
FDA identified many pharmacies that compounded drug products under insanitary conditions
Anticipatory compounding is done in limited quantities No more than 30 day supply
Does not include “office use”
Records of all calculations and supplies/ingredients used
Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496286.pdf
FDA Sterile Compounding for Hospitals
FDA limited interaction pharmacists and physicians
Drugs distributed to healthcare facilities owned and by the same entity and located within a 1 mile of compounding pharmacy
Health system have a broader geographic area could function as a large manufacturing facility
Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf
FDA Guidance on Bulk Drugs
Describes the conditions that must be satisfied for human drug products compounded
Comply with United States Pharmacopeia (USP) or National Formulary (NF)
Bulk drug must be manufactured registered under 510 of FD&C Act
Bulk drug substance must be accompanied by a valid certificate of analysis
Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf
National Sterile CompoundingUnited States Pharmacopeia <797>
Posting Date September 25, 2015
Comment Deadline January 31, 2016
Goal Publish Date 2018’ish
Hazardous Drug Handling:Pregnancy and Breastfeeding
Source: CFR Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices page 3601-2
The List of Changes Secure Safe Disposal Act 2010 Drug Quality and Security Act 2013 Compounding Quality Act 2013 Drug Supply Chain Security Act 2013 CMS Conditions of Participation 2015 CMS JW-Modifier Requirement 2017 LB 37 Prescription Drug Safety Act 2017 EPA Hazardous Wastes Standards 2017 United States Pharmacopeia <800> 2018 FDA Guidance on Compounding FDA Guidance on Sterile Compounding for Hospitals FDA Guidance on Bulk Drugs United States Pharmacopeia <797> 2018’ish Hazardous Drug Handling: Pregnancy and Breastfeeding
US Regulatory Changes for Medications
Fred Massoomi, Pharm.D., FASHPNebraska Methodist Hospital
Department of Pharmacy ServicesOmaha, Nebraska
NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
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A Hospital/Health-System PharmacyLearning Assessment
Drug Compounding Regulatory Update: Here We Go!
1. Pharmacy Practice Act of 2015 (LB 37 Nebraska) require which of the following:a. Compliance with USP <795> compounding standards for non-sterile drugs.b. Certifi cation of pharmacy technicians by either a national or state of Nebraska approved program.c. Compliance with USP <797> compounding standards for sterile drugs.d. All of the above.
2. Th e Drug Quality and Safety act of 2013 created the following:a. Guidelines for states to monitor sterile compounding for hospitals under 503A.b. Requirements for tracking and tracing all drugs sold to a pharmacy.c. Guidelines for the establishment of compounding manufacturers under 503B.d. All of the above.
Answers: 1. d; 2. d
NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
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A Hospital/Health-System PharmacyFriday, 10:30 am - 11:30 am
ACPE: #0128-0000-16-328-L04-P/T 0.1 CEU/1.0 Hour Knowledge-Based Activity
Challenges in Managing Medication Use & CostLearning Objectives for Pharmacists and Pharmacy Technicians:Upon completion of this CPE activity, participants should be able to:1. Describe the cost pressure aff ecting institutional providers.2. Identify key challenges in managing costs.3. Explain potential strategies to manage costs.
Speaker: Michael Powell, RP, MS, FASHPMr. Mike Powell is the Executive Director of Pharmaceutical and Nutrition Care and Th e Nebraska Poison Control Center at the Nebraska Medicine. He is also an Associate Professor and Associate Dean for Hospital Aff airs in the College of Pharmacy. He also chairs the pharmacy committees for the Nebraska Health Network and the Regional Provider Network.
Mr. Powell’s primary interests are in evaluating the eff ectiveness of Pharmacy and Th erapeutics Committees and clinical outcomes of direct care by pharmacists. He directs research at Th e Nebraska Medical Center to quantify clinical and economic outcomes of formulary management strategies and pharmacist practice on resource consumption in the healthcare delivery system. His primary teaching interests are in post-graduate training programs for which he provides instruction in the areas of ethics, health systems policy and institutional pharmacy practice.
Aft er receiving his Bachelor of Science in Pharmacy degree from Ohio State University College of Pharmacy in Columbus, Mr. Powell went on to earn his Master of Science degree in Institutional Pharmacy from the University of Maryland at Baltimore. He completed his residency in Institutional Pharmacy at the University of Maryland Hospital in Baltimore, and was a Fellow at the Leonard Davis Institute of the Wharton School of Business at the University of Pennsylvania in Philadelphia. He also completed a Health Care Advisory Board Leadership Executive Program as a Fellow in Washington, DC. He is licensed to practice pharmacy in both Nebraska and Ohio.
Mr. Powell is a member of the American Society of Health-System Pharmacists and the Nebraska Pharmacists Association. Over the years, he has held many positions within these societies. He has been a reviewer for several journals, and has authored numerous articles published in the American Journal of Health-System Pharmacy, Hospital Pharmacy, Hospital Formulary, American Journal of Hospital Pharmacy, and Clinical Pharmacy, among others.
Speaker Disclosure: Michael Powell reports no actual or potential confl icts of interest in relation to this CPE activity.
Challenges In Managing Medication Use and CostMichael F. Powell, MS, FASHPExecutive Director, Pharmacy & Nutrition Svcs., AndAssociate Dean for Hospital Affairs. University of Nebraska Medical Center, College of Pharmacy
Factors impacting cost of drug use1. Price2. Patient mix3. Utilization4. Innovation5. Competition
Factors impacting cost of drug usePrice
– Price increases– Patent expiration– Inpatient vs. outpatient services
• Infusion centers• Retail• Inpatient services
Factors impacting cost of drug usePatient mix
– Clinical Services• Acuity of services• Intensity of care• Specialty Services
– Referral centers• Destination care
Factors impacting cost of drug useUtilization
– Affected by patient mix– Duration of care– Delivery methods– Environment of care– Stage of care– Prognosis– Outcomes
Factors impacting cost of drug useInnovation
– Tertiary care facilities vs. community hospitals
– Investigational drug services
Factors impacting cost of drug useCompetition
– Available therapies by indication– Multisource drugs
• Patent expirations– Biosimilar drugs
Strategies to manage drug use costs• Eliminate unnecessary therapies• Minimize futile therapies• Reduce LOS, Readmissions, • Stewardship strategies• Improve medication adherence• Standardization of therapies• Automation of distribution processes
Strategies to manage drug use costsEliminate unnecessary therapiesMinimize futile therapiesReduce LOS, Readmissions,
– All about appropriate care– 20-30% of drug therapy is unnecessary
due to duplication or duration of care
Strategies to manage drug use costs• Stewardship strategies• Improve medication adherence• Standardization of therapies
– Focus on managing outcomes of drug therapy
– Minimizing impact of adverse events– Will require collaborative efforts
Strategies to manage drug use costs• What won’t help
– Current approaches to contracting• GPO’s no longer a conduit to lower
pricing• Large GPO’s no longer able to
differentiate by offering sales volume• Need strategies that align incentives
between Pharmaceutical industry and Providers and Institutions
Strategies to manage drug use costsHow will we achieve:
– More universal inpatient formularies• Disease specific approvals• Increasing restriction of use to
environment of care, clinicians– Comparative cost modeling– Comparative outcome tracking– Increased use of clinical decision support
to affect prescriber choice
Strategies to manage drug use costs• How will we achieve (continued):
– Insertion of pharmacists into transitional care roles
• Disease based stewardship• Pharmaceutical case management• Pharmaceutical care clinics
– Remote surveillance of patient consumption– Utilization based PBM’s– GPO’s must move to outcomes based
contracting
Strategies to manage drug use costs• Why won’t currents approaches work:
– Performance base contracts incentivize:• Purchasers to buy more drug product• Sales volume to achieve back end
rebates– No Risk to the Manufacturers– Does Nothing to Improve Outcomes
Opportunities to manage drug use costs• Opportunities for providers
– Create data to clearly establish links between outcomes and best practices
– Pool data – Compare outcomes
Opportunities to manage drug use costs• Opportunities for GPO’s
– Conduit for standardization of care– Leverage large numbers of providers
• Create expert panels• Create tools to manage compliance with
standards– Promote outcomes
• Avoidance of treatment failures• Avoidance of adverse events
– Standardize environment of care• Data showing outcomes• Conduit for interface with manufacturers
Opportunities to manage drug costsOpportunities for Manufacturers
– Head-to-head trials• Comparative outcomes
– Assume some shared risk• Based on comparative outcomes:
provider vs. provider– Differentiation by outcome– Secure place in the market
Risks of Failure• Price controls
– Increased regulation– Conditions for NIH funding/ pubic
funding for R&D• Restriction of access to marketplace
– Limitation of patent protection• Costs of care unsustainable• Transference of all risk to manufacturer
References1. Islam, I. Health Affairs Blog: Rising cost of drugs:
where do we go from here? http:// healthaffairs.org/blog/2015/08/31/rising-cost-of-drugs-where-do-we-go-from-here/
2. Bachp and Pearson sd. Payer and policy maker steps to support value-based pricing for drugs. http://jama-jamanetwork.com. Nov., 30, 2015.
3. Schondelmeyers. Trends in Retail prices of generic prescription drugs widely used by older americans, 2016-2013. AARP Public Policy Institute. May 2015
NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
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A Hospital/Health-System PharmacyLearning Assessment
Challenges in Managing Medication Use & Cost
1. Identify 3 factors impacting the cost of pharmaceuticals in institutions.
2. What are three barriers to eff ectively managing pharmaceutical costs in institutions.
3. Defi ne 2 key strategies to managing medication costs in institutions.
Answers: 1. Price, patient mix, utilization, innovation, competition (any 3).
2. Unnecessary therapies or futile therapies; increased length of stay; and readmissions.
3. Eliminate unnecessary therapies, minimize futile therapies, reduce LOS, readmissions, stewardship strategies, improve medication adherence, standardizationof therapies, automation of distribution processes.
NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
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A Hospital/Health-System PharmacyFriday, 10:30 am - 11:30 am
ACPE: #0128-0000-16-328-L04-P/T 0.1 CEU/1.0 Hour Knowledge-Based Activity
Advanced Practice Initiative (API) - Improving the PPMI InitiativeLearning Objectives for Pharmacists and Pharmacy Technicians:Upon completion of this CPE activity, participants should be able to:1. Explain the importance of creating a new practice model.2. Defi ne the fi ve drivers impacting the pharmacy practice.
Speaker: Jerome Wohleb, PharmD, MBADr. Jerome Wohleb, PharmD, MBA, has experience in several areas of pharmacy practice over the last 35 years. Th is experience includes Administrative Management responsibilities for four health systems over the last 20 years.
Dr. Wohleb graduated from the University of Nebraska College of Pharmacy and completed his Master of Business Administration from the University of Utah. Dr. Wohleb is an active member of the American Society of Health-System Pharmacists; the Hospital/Health-System Network Chair of the Nebraska Pharmacists Association's Board of Directors; and is strongly supporting the Clinical Pharmacy Practice expansion in Nebraska.
Speaker Disclosure: Jerome Wohleb reports no actual or potential confl icts of interest in relation to this CPE activity.
ORPHARMACY PRACTICE
MODEL INITIATIVE (PPMI)
ADVANCED PRACTICE INITIATIVE (API)
Jerome Wohleb, Pharm.D., MBA, FASHPNPA Hospital/Health-System Network Chair
“The future depends on what we do in the present.”
Mahatma Gandhi
BURNING PLATFORM• Pharmacists must move closer to patients
• We must embrace and expand the role of pharmacy technicians • Sterile products compounding can be delegated to well-trained technicians with
well-documented procedures
• …and technology
• We must be accountable for patient outcomes• Accountability versus Responsibility?
• Drug therapy management services for all patients
• Can’t provide “some services for some patients”
• Requirements of being accountable don’t mesh well with the scheduling expectations of new practitioners and many pharmacists with advanced residency training
BURNING PLATFORM
• Improving operational efficiency is paramount
• So is improving our financial acumen and accountability
• Integration is key • Need to define where pharmacists with specialized training provide maximal
value, but assure all pharmacists provide a high level of care
• Must be more patient-focused, and less physician- and pharmacist-focused
• Training, education and credentialing of our workforce is very important
OVERCOMING OUR GREAT DIVIDES
• Clinical vs. Distributive
• Practice vs. Academia
• Leadership vs. Clinicians
• Hospital vs. Community?
• Perhaps we should get the words
“clinical” and “specialist” out of our
vocabulary?
Steve Rough, RPh, MSDirector of Pharmacy
University of Wisconsin Hospital and Clinics
THE PERFECT STORM FOR PHARMACY
• Value Proposition = Increase Quality + Affordability
• Access
• Cost
• Service
• Outcomes
A RELATIVELY SMALL PORTION OF THE POPULATION CONSUMES THE MAJORITY OF
HEALTH EXPENDITURES
1% of the population accounts for 30% of spending ($200,000 avg.)
Half the population consumes only 2% of total spending ($200 avg.)
10% of the population accounts for 72% of spending ($40,000 avg.)
HEALTHCARE: UNSUSTAINABLE COSTSSTRATEGIC POSITIONING - US
Congressional Budget Office (2007) “The Long-Term Budget Outlook”
INTEGRATION TRENDSMULTIPLE DRIVERS WILL CONTINUE TO ALIGN HOSPITALS, PAYERS AND PHYSICIANS
Cost
Service
VALUE
Quality
Physician Drivers
Reimbursement pressure and overall income security
Demanding call schedule
Rising practice costs
Rising malpractice premiums
Challenges with work life balance
Access to technology
Turf issues
Lack of autonomy
Payer Drivers
Cost pressures from employers
Growing access demands
Increasing regulatory pressures for transparency
Pressure for improved quality and outcomes
High competition for service elements
Hospital Drivers
Pressure to demonstrate performance
Securing call coverage
Challenges recruiting
Physician competition
Physician productivity changes
Aging workforce
Turnover and retention
Fewer physicians spend time in the hospital
Alignment around quality, cost, and service performance
Old Pharmacy Design
(Fee-for-Service)
1) Maximize Doses Dispensed
2) Support Production Focus (revenue department)
3) Strong Quality Assurance Methods (QA focus)
4) No regional or national competition (for quality or comparison)
5) Inpatient focus (LOS longer)
6) Departmental focus (Less integration required for care)
7) Physician centric
WHY CHANGE MODELS—(OLD VS. NEW)
New Pharmacy Design (Outcomes)
1) Best Drug Selection--Critical
2) Reduce Medications (primary source of expense)
3) Quality Focus Improvement Methods (Required)
4) National compare groups (CMS, Third Party “star system”, VBP)
5) Outpatient focus (Eliminate or reduce acute care stay)
6) Organizational focus (Highly integrated & technology needed)
7) Team/Service Based – Patient centered
WHAT ARE YOU GOING TO DO?
•Are you part of the solution
or part of the problem?
VALUE PROPOSITION:CURRENT VS. LABOR VS. PROVIDER
$23,000,000 $23,500,000 $24,000,000 $24,500,000 $25,000,000 $25,500,000 $26,000,000 $26,500,000
New Proposal (Total Expense)
FTE Target Model (TotalExpense)
Current Model (Total Expense)
Total Pharmacy Department Expense
$0 $5,000,000 $10,000,000 $15,000,000 $20,000,000 $25,000,000
New Proposal (total expense)
FTE Target Model (total expense)35% Goal
Current Model (total expense)
Drug Expense Salary Expense
Data Collection
Five year strategic goals were defined by Bryan Health and the Medical Center to meet predicted Healthcare Reform changes.
Metrics defined included:
Quality Initiatives
Patient satisfaction
Physician satisfaction
Employee satisfaction
Financial targets (overall expense reduction)
Financial targets (improved net operating income)
During this review, pharmacy looked at programs that would specifically target organizational metrics such as medication reconciliation, physician efficiencies with CPOM, employee surveys, quality targets for CMS including Value Based Purchasing and core measures and defined fiscal goals, including:
• Total Expense/APD• Drug Expense/APD• Total Expense/FTE• Total Expense/Discharge• Operating Margin/APD• Operating Margin/FTE• Revenue/FTE.
Data Analysis
Data
Descriptive statistics
Defining new Pharmacy Service Metrics, a welcome outcome from Healthcare ReformJ. Wohleb, K. Jones, D. Reese
Bryan Medical Center, Lincoln, Nebraska
• Healthcare reform has created two very interesting approaches to Health-System Pharmacy leadership. One approach is to use the traditional metrics which often mimic current resource constraints related to declines in labor and reimbursement. Several organizations feel this is the correct approach. However, patient care services, quality goals, financial growth, physician satisfaction, employee satisfaction and departmental growth require compromise to sustain these services. Another approach is to embrace healthcare reform and place the pharmacist in a value proposition that supports organizational needs. We have embraced the use of non-traditional metrics to create a value proposition for multiple stakeholders while positioning a future for pharmacy and organizational growth by avoiding the traditional “widget” mentality while embracing and aligning pharmacy directly to our organizations strategic goals. A new method is required as pharmacy’s role evolves away from production to a value-stream focus.
Disclosure Authors of this presentation have nothing to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.
Session/Board5-012
INTRODUCTION METHODS
OBJECTIVES
RESULTS
CONCLUSIONS
FINANCIAL METRICS
• Primary objective:• Convert labor standards from a
manufacturing methodology to a total expense model.
• Secondary objective:• Compliment organizational goals
by leveraging pharmacy metrics to tactically embrace Healthcare reform.
PATIENT METRICS
-1000
4000
0100200300400500600
Jul-1
1A
ug-1
1S
ep-1
1O
ct-1
1N
ov-
11D
ec-
11Ja
n-12
Feb
-12
Mar
-12
Apr
-12
May
-12
Jun-
12Ju
l-12
Aug
-12
Sep
-12
Oct
-12
No
v-12
De
c-12
Jan-
13F
eb-1
3M
ar-1
3A
pr-1
3M
ay-1
3Ju
n-13
Pharmacist Interventions
Cost containment or formulary…Therapeutic recommendations,…
FUTURE DIRECTION
PHYSICIAN SATISFACTION
EMPLOYEE SATISFACTION
Pharmacy labor increase reduced the overall departmental expense as related to APD. Quality, expense management, and satisfaction are key metric drivers that require strategic leveraging for inclusion by pharmacy leaders in organizational dashboards to C-Suite.
Current data only reflects limited periods. Additional results and research will provide new pharmacy opportunities.
• Pharmacy Practice Model Initiative• Joint initiative
• American Society of Health-System Pharmacists (ASHP)
• ASHP Research & Education Foundation• Practice model to utilize pharmacists as direct
patient care providers• Instill passion, commitment, and action among
hospital and health-system practice leaders
ADVANCED PRACTICE INITIATIVE (API or PPMI)
To significantly advance the health and wellbeing of patients by supporting futuristic
practice models that support the most effective use of pharmacists as direct patient care
providers.
GOAL OF API (PPMI) INITIATIVE
KEY RECOMMENDATIONS1. All patients should have a right to receive the care of a pharmacist.
2. Hospital and health-system pharmacists must be responsible and
accountable for patients’ medication-related outcomes.
3. Every pharmacy department should develop a plan to reallocate its
resources to devote significantly more pharmacist time to medication management services.
4. Pharmacists who provide drug therapy management should be certified
through the most appropriate board of pharmacy specialties.
5. Pharmacist-provided drug therapy management should be prioritized
using a patient medication complexity index.
KEY RECOMMENDATIONS (CONT.)6. A patient medication complexity index should be developed that includes factors such as
severity of illness, number of medications, and comorbidities.
7. In optimal pharmacy practice models, individual pharmacists must accept responsibility for both the clinical and the distributive activities of the pharmacy department.
8. Sufficient pharmacy resources must be available to safely develop, implement, and maintain technology-related medication-use safety standards.
9. By 2015, the Pharmacy Technician Certification Board should require completion of an
accredited training program before an individual can take the certification examination.
10. To support optimal pharmacy practice models, technicians must be licensed by state
boards of pharmacy.
PHARMACY PRACTICE MODELS
Model 4 (Comprehensive pharmacy services model)
Model 3 (Patient‐centered integrated model)
Model 2 (Clinical pharmacist‐centered model)
Model 1(Drug‐distribution centered model)
Adopted from Pedersen CA, Schneider PJ, Scheckelhoff DJ. Survey of pharmacy practice in hospital settings: Dispensing and administration-2008. Am J Health Syst Pharm. 2009;66:926-46.
TEAM BASED MEDICINE
Adopted from Pedersen CA, Schneider PJ, Scheckelhoff DJ. Survey of pharmacy practice in hospital settings: Dispensing and administration-2008. Am J Health Syst Pharm. 2009;66:926-46.
• Pharmacists’ efforts
• Participate with Medical Staff on floors (provider efficiencies)
• Collaborate with Nursing (admissions, care continuum, discharge process)
• Interact with other professionals (social services, respiratory,
others)
• Collaborate with patients & families (support educational efforts &
med info)
• Various other programs
Must Have Should Have
All Inpatient Areas (following services) Drug Information (RN, MD)
Order Entry Patient assessment5 patient rightsCorrect treatment
Meaningful Use (Stage 2)eMAR, barcoding, & eRx
Collaborative PracticeMedication Reconciliation
Anticoagulation Program
Procedures (Rx to Dose)Vancomycin ServiceAminoglycoside ServiceTherapeutic InterchangesIV to Oral ConversionsRenal Dosing ServiceMeropenem/Zosyn dosingInsulin Dosing Service?
Procedures (Rx to Dose)More IV to oral conversions?Warfarin Dosing Service
New Practice Model: ServicesMust Have Should Have
HIE-Portal Medication List Inpatient MTM program?
Meaningful Use (Stage 1)Medication ListMedication Allergy ListDrug-drug & allergy checksDrug formulary checks?Negative charting @ discharge
Collaborative PracticeOrthopedic Service?Pain Management Service?Bowel Care Service?Antiemetic Service?Nutrition Service (TPNs)?
Antibiotic Stewardship Service Cardiac Outpatient Service
Core Measures (CMS)SCIP, AMI, Pneumonia, CHF, VTE, Anticoag, Mental Health
Formulary Management Program Outpatient Formulary (cost reduction strategy)?
Falls (Medication Program)? Mental Health Clinic Atypical Antipsychotics Txt Service?
Clozapine Monitoring Program Pharmacy Residency
Epidural Monitoring Program Tech-Check-Tech program?
New Practice Model: Services
Must Have Should Have
Drug Level Monitoring Service Outpatient Services
REMS Program (expanding)? Vaccine Management?
Physician Rounding Barcode Stocking (Pyxis)
Discharge PlanningTarget Drug Education?
Retail PharmacyDischarge Medication Program?
Bariatric Service Recruitment Program (student training)
Readmission Prevention Congestive Heart FailurePneumonia Acute Myocardial Infarction (AMI)Behavioral Medicine
Transition of Care Program ?Post-discharge?Pre-admission program ?Technician Discharge Call Service?
Drug Shortage Program
Specialty Pharmacy Service?
Multi-disciplinary Team/Nurse Rounding ?
New Practice Model: ServicesWHAT ARE YOU DOING?
How can I help?
REFERENCES (PARTIAL LISTING)• 1. White SJ. Leadership: successful alchemy. Am J Health-Syst Pharm. 2006; 63:1497-503.
• 2. Anderson RW. Health-system pharmacy: new practice framework and leadership model. Am J Health-Syst Pharm. 2002; 59:1163-72.
• 3. Ivey MF. Rationale for having a chief pharmacy officer in a health care organization. Am J Health-Syst Pharm. 2005; 62:975-8.
• 4. ASHP statement on the roles and responsibilities of the pharmacy executive. American Society of Health-System Pharmacists.
www.ashp.org/DocLibrary/BestPractices/MgmtStPharmExec.aspx (accessed 2011 Feb 28).
• 5. National Quality Forum. Safe practices for better healthcare—2009 update. www.qualityforum.org/Publications/2009/03/Safe_Pract ices_for_Bet ter_
• Healthcare%e2%80%932009_Update.aspx (accessed 2011 Feb 28).
• 6. Veterans Health Administration. Pharmacy general requirements.
www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1678 (accessed 2010 May 29).
• 7. Pickette SG, Muncey L, Wham D. Implementation of a standard pharmacy clinical practice model in a multihospital system. Am J
Health-Syst Pharm. 2010; 67:751-6.
• 8. Zilz DA, Woodward BW, Thielke TS et al. Leadership skills for a high-performance pharmacy practice. Am J Health-Syst Pharm. 2004;
61:2562-74.
• 9. ASHP Foundation. Conversations with health-system pharmacy’s most influential leaders. www.ashpfoundation.org/Main
MenuCategories/CenterforPharmacy Leadership/LeadershipVideos.aspx (accessed 2010 Jun 18)
Jerome Wohleb, Pharm.D., MBA, FASHP
Pharmacy Director
Bryan Medical Center
Email: [email protected]
General information about PPMI
http://www.ashpmedia.org/pai/
TOOLS & RESOURCES
NPA Annual Convention, July 15, 2016 Th e Cornhusker Hotel, Lincoln, Nebraska
CP
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n 3
A Hospital/Health-System PharmacyLearning Assessment
Advanced Practice Initiative (API) - Improving the PPMI Initiative
1. What is API?a. Average Price Indexb. Average Pharmacist Incomec. Advanced Practice Initiatived. Advanced Physician Interaction
2. What are some considerations for improving the practice of pharmacy at your location?a. Team-based medicineb. Working with your leadership to change how your Pharmacy value is being measuredc. Initiate clinical pharmacy programs that will compliment leadership needs at your organizationd. All of the above
3. Pharmacy does not need to do anything diff erently since we have a role in healthcare in the future.a. Trueb. False
Answers: 1. c; 2. d; 3 b