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1

What type of Pharmacist?
work @ Health plans = MCOs // PBMs

Formulary System Management

Drug Distribution Process

Patient SAFETY / QA / MTM

Clinical PROGRAM development

Plan Benefit Design // Business Management

MANAGED CARE PHARMACIST

2

Early Phase Clinical Development

Pharmacy involvement

PHARMACIST INVOLVEMENT:

pre-clinical studies --> Phase 1/2

•1) Regulatory Affairs, 2) Data Management, 3) Drug Supply Management, and 4) Pre-clinical

  • •Implementing and managing clinical trials
  • •Authoring study protocols
  • •Selecting primary investigators and trial sites
  • •Ensuring proper data collection and interpretation
  • •Determining the best dose of the medication for later studies
  • •Reporting serious adverse events (SAEs)
  • •Publishing
  •  

3

Late Phase Clinical Development

Pharmacist Involvement

Phase 2--> Phase 3

multidisciplinary team
PK / PD / DDI
 --> study design
requires:
Organziational / Writing / Communication / Presentation Abilities

  • Planning investigator meetings
  • •Chairing international clinical trial team meetings
  • •Overseeing deliverables from various external contractors

4

What type of Pharmacist?

discovery, development, manufacturing, governmental approval, commercial distribution, advertising and promotion of medicinal products

Gather key learnings from Health Authority interactions to guide the project team on how to file and conduct trials for a drug program, register a product and gain approval and track the progress of a product.

 

REGULATORY AFFAIRS

  • •Develop and provide Regulatory strategy
  • •Create and compile submissions to Health Authorities including Investigational New Drug (IND) Applications and New Drug Applications (NDA)
  • •Interact with FDA (Food & Drug Administration) and Global Health Authorities such as the EMA (Europe) and MHW (Japan)
  • •Lead Health Authority Communications related to FDA Meetings and Advisory Committee Meetings
  • •Develop and revise labeling
  • Review and approve advertising and promotional material
  • •Maintain approved products through IND and NDA Annual Reports, FDA submissions, labeling and line extensions.

5

What type of Pharmacist Function?

Develop programs, sales materials, and product advertising that drive healthcare providers’ awareness of products and promote optimal medication utilization.

•Create strategies and tactics to support the life cycle of the product.

MARKETING

 

6

  • What type of Pharmacist Fxn?
     
  • Acquire information from various sources outside of the company to create an overall market “snapshot.”
  • •PharmD Roles may include:
    • Analyzing past and present market data to monitor current and future trends (forecasting)
    • •Creating patient population evaluation models
    • •Identifying unmet medical needs

Market Research & Business Analytics

7

What type of Pharmacist Fxn?

•Develop strategies to evaluate the value of a product, enhance product market share versus competition
, optimize reimbursement from third-party payers or insurance companies.

MANAGED MARKETS

8

What type of Pharmacist?

  • •IND Annual Reports
  • •REMS (Risk Evaluation and Mitigation Strategy) and RMP (Risk Management Plan)
  • Evaluating a product’s safety profile throughout its development and into its post-marketing stage
  • •Participating in clinical development team discussions relating to adverse events
  • •Integrating information from pre-clinical safety trials to ongoing trials
  • •Contributing to ongoing safety documents submitted to health authorities
    • •Periodic and Annual Safety Reports (post-marketing)

Drug Safety / Pharmacovigilance

9

Utilize clinical knowledge in the development of content for healthcare-related publications, meetings, and digital media for an array of audiences, including healthcare professionals and consumers.

Part of a multidisciplinary team:
1) Brand Medical Directors, 2) Clinical Development teams, 3) Biostatistics, 4) Product Strategy teams, 5) Marketing, 6) Legal/ Compliance, and 7) Field Medical teams.

•Requires excellent organizational, writing, communication, and presentation abilities.

Medical Affairs:
Communications / Education / Information

AMCP Dossiers

CE Programs

10

•Identify, measure, and compare the costs and consequences of health-related decisions to assign a “perceived” value to a pharmaceutical intervention. The value proposition is integral to determining the price of pharmaceutical product.

•Integral part of a multidisciplinary Global team.

•Training beyond the PharmD is typically required in this area of the industry.

•Those with further training (MS or PhD) have roles that may include:

Prospective and retrospective studies of clinical outcomes data

•Prospective and retrospective real-world evidence studies (including quality of life)

•Create budget impact models and cost-effectiveness analyses

•Responsible for populating Section 4 of the AMCP dossier (Economic Value and Modeling Report) and provide data for formulary decision on a global level

Health Economics and Outcomes Research (HEOR)

11

•are therapeutic specialists who coordinate the communication of clinical information between pharmaceutical companies and medical experts in the field.

Limited to 1-2 Therapeutic areas

•These are field-based roles and often require advanced training beyond the PharmD.

Developing and cultivating relationships with experts

•Ensuring experts are aware of the Investigator-initiated research programs and clinical trials enrolling patients

•Training speakers and the sales force

•Gathering insight from the Field and communicating that to the Medical Affairs group

Medical Affairs:
MSL

Medical Science Liason

12

  • •are cross-therapeutic specialists
    who coordinate the communication of clinical information between pharmaceutical companies and managed care companies, PBMs, IDNs and ACOs.
  • •Prior experience working in managed care companies, PBMs, IDNs, ACOs, etc. is typically required.
  • •Training typically involves knowing clinical trial and HEOR data across all therapeutic areas the company has products.
  •  involve more business expertise, as well as expertise in quality measures and population health

Medical Affairs:

PAYER MSL
medical science liason

13

•are only common in larger companies (smaller ones may combine all 3 of these roles).

Often requires advanced training (fellowship, MS, PhD

•Serve as HEOR expert in the field to support MSLs and Payer MSLs with HEOR needs

•Conduct outcomes research with Payer MSL customers

FIELD HEOR

Medical Affairs

health economics and outcomes researcher

14

good at Evaluating Literature

SERVE P&T COMMITEES

  • •Where do they work
    • –Academic drug information centers
    • –Pharmacy benefit managers (PBMs)
    • –Managed care organizations
    • –Pharmaceutical industry
  • •Pharmacist Roles
    • –Service to P&T committees
    • –Preparing medication-use policies and procedures
    • –Medication use evaluations
    • –Education
    • –Creating and disseminating newsletters

DRUG INFORMATION PHARMACIST

15

  • •Pharmacist Roles
    • –Drug distribution
    • –Clinical program development
    • –Adherence monitoring and interventions
    • –Education
    • –Inventory management
  • •Provides specialized medications for complex, rare, genetic and chronic health conditions
    • –Cancer
    • –Cystic Fibrosis
    • –Inflammatory Bowel Disease
    • –Hepatitis
    • –Multiple Sclerosis
    • –Rheumatoid Arthritis
    • –Infertility
  • •Medications are:
    • –High cost
    • –Given by infusion
    • –Have special storage or handling requirements
    • –Require special support programs (e.g. adherence monitoring programs)

 

SPECIALTY PHARMACY

FASTEST GROWING AREA OF PHARMACY

16

  • Government pharmacist
  •  
  • –Uniformed service that is part of the Department of Health and Human Services
  • –Mission
  • •rapid and effective response to public health needs
  • •leadership and excellence in public health practices
  • •advancement of public health science

work in the

USPHS

US Public Health Service

17

  • •Pharmacist Roles
    • –Run operations of the organization
    • –Lead organizational initiatives
    • –Advocacy
    • –Communication activities
    • –Governmental affairs
    • –Support organization leadership

Professional and Trade Organizations

18

  • •Where do they work?
    • –(nursing home)
    • –Hospice programs
    • –Mental health institutions
  • •Roles
    • –Drug regimen review
    • –Nutrition assessment and support
    • –Patient counseling
    • –Therapeutic drug monitoring
    • –Drug information services
    • –Quality assurance programs
    • –Medication delivery systems

LONG TERM CARE

19

  • •Pharmacist Roles
    • –Drug product selection
    • –Clinical services related to delivery of total parenteral nutrition
    • –Patient and nurse education
    • –Patient monitoring and management
    • –Administration and management
    • Coordinate care with hospice organizations, visiting nurses

HOME CARE PHARMACIST

work @ Home Health Agencies

Home Infusion Providers

20

  • •Where do they work?
    • –Hospitals
    • –Information system companies
    • –Governmental agencies
    • –Academia
    • –“Knowledge vendors” (e.g. First DataBank, Multum, etc.)
  • •Roles
    • Dealing with and implementing information technology
    • •E-prescribing, CPOE, EMRs, BCMA, automated dispensing cabinets
    • –Work collaboratively with other healthcare professionals and IT

INFORMATICS

also a FAST GROWING field (with specialty)

21

Health System Pharmacy Department
Responsibilities

  • •Acquire drug products
  • Review medication orders for safety and effectiveness
  • •Prepare medications in the doses and dosage forms needed
  • •Distribute medications to inpatients
  • –Dispense medications to outpatients if outpatient pharmacy part of system
  • •Manage medication therapy for individual patients
    • •Leadership role in developing medication use policies

      •Provision of quality drug information used by caregivers

      •Influence drug administration processes

      •Conduct quality and economic reviews of medication utilization in hospital patients

      •Continue to improve the quality of the medication use process

      –Lead/influence decisions about technology and automated processes in the medication use process

22

Health System Pharmacy Work Force

•Pharmacists

•Technicians

•Other support staff

–Purchasing agent

–IT specialist

–HR specialist

–Finance specialist

 

23

Pharmacy Practice Models

•Drug-distribution-centered-model
Focused on drug distribution; reactive order processing; little accountability for outcomes

•Clinical-pharmacist-centered model
Clinical pharmacists only provide clinical services; distributive pharmacists more traditional activities

•Patient-centered integrated model
Same pharmacists have responsibility for both clinical and distributive activities

•Comprehensive model
Employs distributive, generalist, and specialist pharmacist

24

Pharmacy Practice Model Initiative
(PPMI)

 

–To significantly advance the health and well being of patients in hospitals and health systems by developing and disseminating optimal pharmacy practice models that are based on the effective use of pharmacists as direct patient care providers

25

PPMI
Basic Tenets

Pharmacy Practice Model Initiative

Take RESPONSIBILITY for PATIENT OUTCOMES

 

•Pharmacists provide patient-centered care – practice at the “top” of their license

•Utilize better-trained technicians to assume some of current activities performed by pharmacists (tech check tech)

•Utilize technology/automation to reduce pharmacist/technician workload

 

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