13 - Career opportunities for pharmacists Flashcards
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
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
*
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
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.
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
- 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
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
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
•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
- 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)
•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
-
•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
- 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
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
- •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
