T6 - IE1 - Pharmacoepidemiology + Pharmacoeconomics - Seoane - Formulary Decision Making + Hospital Formulary Decision Making
Managed Care Decision-Making Process - Formulary Decision: Co-pay Level
Can be composed of 3-5 tiers (or more)
JC Certification
Disease-specific care certification available for clinical programs across the continuum of care
JC Accreditation
Hospitals: general, children's psychiatric, rehabilitation, and critical access Ambulatory care: group and office-based surgery practices Nursing care center: nursing homes and rehabilitation centers Behavioral health care and addiction services Home care: medical equipment, pharmacy, and hospice services Laboratory services: independent or freestanding clinical laborites
Managed Care Decision-Making Process - Formulary Decision: Prescription of Use
Indication Days supply Step-thearpy Use by specific professionals
The VA
Veteran Affairs
Examples of PBMs
express scripts CVS/caremark UnitedHealth Group (United Health / OptumRx / Catamaran)
PBM
pharmacy benefit manager
Prior authorization
the need to obtain permission from the for use of the medication through clinical proof
Pharmacy & Therapeutics (P&T) Committee - Functions: Formulary _________-_________
- (Formulary) decision-making
JC 2018 Safe and Effective Medication Use Standards: Managing _________ medications and medication ___________
- (Managing) emergency (medications) - (medication) orders
JC 2018 Safe and Effective Medication Use Standards: Mananging ___-_______ and ________ medications
- (Managing) high-alert - hazardous (medications)
PBM Functions: administer drug manufacturer ___________
- (administer drug manufacturer) rebates
Outline - Formulary Decision making is done at both the ________ and the government run ________
- (both the) PBMs - (government run) VA
VA pharmaceutical program provides both ________ ________ and _________
- (both) clinical services - pharmacy Lowest cost in the U.S.
JC 2018 Safe and Effective Medication Use Standards: Managing medications brought ____ by _________ / __________
- (brought) in - patients / families
PBM Functions: communicate with _________ and __________
- (communicate with) patients - physicians
Formulary Management: continual process of ______-_____; a formulary is a ________ list
- (continual process of) follow-up - dynamic (list)
The Joint Commission - Mission: to continuously __________ health care for the public, in collaboration with other ____________, by _________ health care organizations and inspiring them to excel in providing safe and effective care of the ___________ quality and value
- (continuously) improve (health care for the public) - (other) stakeholders - evaluating (health care organizations) - highest (quality and value)
ASHP Guidelines for Formulary - 3 Key Elements: a defined _________ staff (or physician-provider network) that _________ within that healthcare setting
- (defined) medical (staff) - practices (within that healthcare setting)
Economic variables in the formulary review process: drug ______ and overall health care _______
- (drug) cost - (overall health care) cost
PBM Functions: establish a _________ __________ ________
- (establish a) retail pharmacy network
P&T Committee (Hospital): responsible for formulary __________, ________ and __________
- (formulary) development - maintenance - approval
Disclosure of potential reporting bias: identify ____ investigators / authors and give _______ of their affiliations
- (identify) all (investigators / authors) - details (of their affiliations)
Role of Formulary - Submission Guidelines: informed selection of __________, ___________ and _________
- (informed selection of) drugs - biologicals - vaccines
Outpatient drug formulary: list of _________ with ________ therapeutic options
- (list of) drugs - limited (therapeutic options)
Department of Defense Pharmacoeconomics Center (VA): monitors ____ _______ and ____ ________
- (monitors) drug usage - cost trends
Role of Formulary - Submission Guidelines: making evidence and rationale supporting all choice(s) more _______ and __________ by decision makers
- (more) clear - evaluable (by decision makers)
Department of Defense Pharmacoeconomics Center (VA): performs _______________ analyses to support formulary _________, contracts, and clinical __________
- (performs) pharmacoeconomic (analyses) - (formulary) management - (clinical) guidelines
Managed Care Decision-Making Process - Formulary Decision: prior _______________
- (prior) authorization
PBM Functions: process _________ _______
- (process) pharmacy claims
Department of Defense Pharmacoeconomics Center (VA): provides 1 __________ ______ _____ per patient
- (provides 1) comprehensive drug profile (per patient)
Department of Defense Pharmacoeconomics Center (VA): supports provision of _______ _______ and the _________ of the pharmacy benefit
- (provision of) drug therapy - evaluation (of the pharmacy benefit)
Economic variables in the formulary review process - pharmacoeconomic relationship between ______ and __________
- (relationship between) cost - benefits
Outpatient drug formulary: payment for non-included drug is the responsibility of the ____________
- (responsibility of the) patient
PBM Functions: set up ___________ ________
- (set up) pharmacy benefits
AMCP Formulary Dossier - Goals: streamline ______ _______ and ______ ______ for health system staff pharmacists
- (streamline) data acquisition - review process
Department of Defense Pharmacoeconomics Center (VA): supports the ______ ______________ and ________ the formulary
- (supports the) P&T committee - manages (the formulary)
The Joint Commission: symbol of ________ that reflects an organization's commitment to meeting certain ___________ __________
- (symbol of) quality - (meeting certain) performance standards
ASHP Guidelines for Formulary - 3 Key Elements: ____________ work relationship among ______ ___________, such as occurs in an organized healthcare setting
- Collaborative (work relationship) - (among) health professionals
Pharmacy & Therapeutics (P&T) Committee - Functions: ______ __________ review and drug _________
- Drug utilization (review) - (drug) safety
PBM Functions: _____________ management
- Formulary (management)
JC 2018 Safe and Effective Medication Use Standards: _________ patients' reactions to medications
- Monitoring (patient's reactions)
The Joint Commission: _________ and ________ nearly 21,000 health care organizations and programs in the US
- accredits - certifies (nearly 21,000 health care organizations)
JC 2018 Safe and Effective Medication Use Standards: Responding to ________ _____ _____ and medication _______
- adverse drug events - (medication) errors
Department of Defense Pharmacoeconomics Center (VA): supports __________ prescription data
- centralized (prescription data)
Outpatient drug formulary: reimbursement only for drugs __________ in the formulary
- covered (in the formulary) i.e., patient must pay for drugs outside of the formulary
VA Formulary System Purpose: to _______ the role of drugs in therapy
- define (the role of drugs in therapy)
Steps recommended for the submission of new products: Step 4. Clinical staff assigned to the product will review the submission Step 5. Clinical pharmacists prepare a __________ summary for ______ review
- detailed (summary) - P&T (review) Step 6. Staff inform the manufacturer of the P&T recommendation
Department of Defense Pharmacoeconomics Center (VA): __________ clinical practice guidelines
- develops (clinical practice guidelines)
AMCP Formulary Dossier - Goals: _________ for pharmaceutical manufacturers concerning the nature and format of ________ information
- directions (for pharmaceutical manufacturers) - expected (information)
Disclosure of potential reporting bias: disclose for ___________ evaluation studies, _______ impact models and ________ of the submission dossier
- economic (evaluation) - budget (impact models) - authors (of the submission dossier) All must give affiliations to ensure a proper evaluation
Department of Defense Pharmacoeconomics Center (VA): conducts _________ activities
- education (activities)
AMCP Formulary Dossier - Goals: combining ______, _____ and ________ information for formulary decision-making
- efficacy - safety - cost (information for formulary decision-making)
Formulary system (hospital): method for __________ and ___________ suitable drug products for the formulary of an organized health-care setting
- evaluating - selecting (suitable drug products)
Formulary Management: systematic process for __________ and ________ of formulary medications
- evaluation - selection (of formulary medications)
Pharmacy & Therapeutics (P&T) Committee - Functions: __________ formulary interventions
- evaluation (formulary interventions)
AMCP Formulary Dossier - Goals: __________ _______ the completeness of submissions received
- formally evaluate (the completeness)
Pharmacy & Therapeutics (P&T) Committee - Functions: clinical __________ / __________ / __________
- guidelines - protocols - initiatives
Formulary system (hospital): involves the application of various techniques to ensure ______ quality and ____-________ drug therapy
- high (quality) - cost-effective (drug therapy)
Formulary Management: process begins with an _________ need
- identified (need) Continual process of follow-up
VA Formulary System Purpose: to ___________ _______ for its rational use in the VA
- identify parameters (for its rational use)
Disclosure of potential reporting bias: all financial or contractual relations that might _________ the independence of the investigators / authors
- impact (the independence of the investigators / authors)
AMCP Formulary Dossier - Goals: __________ the timeliness, scope, quality and relevance of information
- improve (the timeliness, scope, quality and relevance)
VA pharmaceutical program is ___-_________ model
- in-house (model) Provides both clinical services and pharmacy
The Joint Commission: An __________, _____-_____-________ organization
- independent - not-for-profit (organization)
Steps recommended for the submission of new products: Clinical pharmacists prepare a detailed summary for P&T Review Step 6. Staff _________ the manufacturer of the P&T _____________
- inform (the manufacturer) - (P&T) recommendation
Department of Defense Pharmacoeconomics Center (VA): develops __________ systems
- information (systems)
Steps recommended for the submission of new products: Step 1 - manufacturers should keep clinical pharmacy staff ________ of the status of drugs in their __________
- informed (of the status of drugs) - (their) pipeline i.e., 6 months prior to launch, pharmacy staff will issue a formal Unsolicited Request letter Step 2: initial pre-submission meeting
ASHP Guidelines for Formulary - 3 Key Elements: an _____________ P&T committee as a medical staff committee
- interdisciplinary (P&T committee)
Hospital formulary: _____ of drugs and associated information that are consider by the professional staff in a hospital setting to be the _________ ________ in patient care
- list (of drugs and associated information) - most useful (in patient care)
VA pharmaceutical program has the __________ cost in the U.S.
- lowest (cost in the U.S.)
PBM Functions: most PBMs provide a _______ _______ pharmacy and _________ pharmacy services
- mail order (pharmacy) - specialty (pharmacy services)
P&T Committee (Hospital): evaluates the performance of the _________ use process; reviews and ____________ policies related to the medication utilization process
- medication (use process) - (reviews and) approves (policies...)
Role of Formulary - Submission Guidelines: projecting their impact on __________ and enrolled _________ __________
- organization - (enrolled) patient population
P&T Committee (Hospital): _________ of the policies and procedures used to carry out its functions
- oversight (of the policies and procedures)
Pharmacy & Therapeutics (P&T) Committee: is composed of _________, ___________, and other ____________
- physicians - pharmacists - (other) professionals
P&T Committee (Hospital): composed of _________, ______, _______ and ______ involved in the medication _____ process
- physicians - nurses - pharmacists - staff - (medication) use (process)
Pharmacy & Therapeutics (P&T) Committee - Functions: determines the ________ and __________
- policies - procedures
Steps recommended for the submission of new products: Step 1 - manufacturers should keep clinical pharmacy staff informed of the status of drugs in their pipeline Step 2: initial ___-_________ metting
- pre-submission (meeting) Step 3. 2 months prior to the product review, the manufacturer present paper copy of the submission dossier
Managed Care Decision-Making Process - Formulary Decision: the drug can be made __________, ______ _________ or _________
- preferred - not preferred - excluded
Steps recommended for the submission of new products: Step 2: initial pre-submission meeting Step 3: 2 months prior to the product review, the manufacturer __________ paper copy of the submission _________
- present (paper copy) - (submission) dossier Clinical staff assigned to the product will review the submission
P&T Committee (Hospital): _______ drugs, drug classes and therapeutic areas
- review (drugs, drug classes and therapeutic areas)
Steps recommended for the submission of new products: Step 3. 2 months prior to the product review, the manufacturer present paper copy of the submission dossier Step 4. Clinical staff assigned to the product will _________ the submission
- review (the submission) Step 5: Clinical pharmacists prepare a detailed summary for P&T review
The Joint Commission - Mission: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing _____ and ____________ care of the highest quality and value.
- safe - effective (care of the highest quality and value)
VA Formulary System Purpose: to assess the _______, __________, ______, ____ and other __________ issues relevant to the VA National Formulary
- safety - tolerability - efficacy - cost - (other) pharmaceutical (issues)
JC 2018 Safe and Effective Medication Use Standards: _______, ________, and ______ medications
- selecting - procuring - storing (medications)
PBM Functions: ______ _____ clinical programs
- set up (clinical programs)
Role of Formulary - Submission Guidelines: ___________ and __________ product and supporting _________ _________ requirements
- standardizing - communicating - program information (requirements)
Formulary Management: __________ process for evaluation and selection of formulary medications
- systematic (process for evaluation and selection)
Formulary Decision Making: traditional decisions based on __________ information Need to include ______________ information
- traditional (information) - pharmacoeconomic (information)
Formulary Decision Making: an essential decision is _______ drugs should be __________ in a formulary
- which (drugs) - included (in a formulary)
Managed Care Decision-Making Process
1. Pharmaceutical company presents information in guideline format 2. Pharmacists study and complement the information and prepare a report 3. P&T Committee Evaluation 4. P&T Committee report to management: clinical and economic profile 5. Management negotiate discount and rebates and makes final decision
ASHP Guidelines for Formulary - 3 Key Elements
Collaborative work relationship among health professionals, such as occurs in an organized healthcare setting A defined medical staff (or physician-provider network) that practices within that healthcare setting An interdisciplinary P&T committee as a medical staff committee
Dossier Sections
Disease and Product Information Supporting Clinical and Economic Information Cost-effectiveness and Model Report Conclusions and recommendations Supporting information: reprints, bibliography, checklist, electronic media and appendices
Clinical Variables Used in the Formulary Review Process
Efficacy Safety - side effects - adverse effects - pregnancy category - drug interactions Monitoring parameters Complexity of use Therapeutic alternatives
JC Non-Compliant Standards - Medication Management Chart
Note: increasing measure of % non-compliance increasing in medication orders and storage/security of meds Also increase in non-compliance in preparing medications Relates to pharmacy
PPI 30-Day Equivalent Rxs VA (FY 1999-2005) Chart
Note: the data shows that there is a decrease in price when a generic or new PPI is released New PPI becomes new cost leader
Average cost / unit for PPIs VA (FY 1999-2005) Chart
Once an "equivalent" PPI becomes generic, it tends to reduce the price across the board
JC 2018 Safe and Effective Medication Use Standards Part 2
Preparing medications Labeling medications Dispensing medications Administering medications Retrieving recalled or discontinued medications Managing investigational medications
