Exam 1 Flashcards
Describe the education training options available for pharmacists
Pharmacists
Residencies
Specialization licensure
Fellowships, graduate degrees
*Primarily practice in community pharmacies and hospitals
*More commonly practicing in non traditional pharmacy settings
(ambulatory care)
Describe the education/training and scope of practice of various healthcare professions
Physicians
Worse in underserved areas (rural and inner city)
Primary care vs specialty
Nurses
Entry level RN and LPN require MD supervision
Advanced practice –> Nurse practitioner (DNP)
PAs
Requires physician supervision
Important and growing roles in both primary and specialty care
Key components of pharmaceutical care
The responsible provision of drug therapy for the purpose of achieving outcomes that improve a patient’s quality of life
*Transition from product focus to service focus
*Activities involve (identifying actual or potential drug related problems, resolving actual problems, preventing potential problems)
Key components of medication therapy management
Comprehensive approach to helping patients maximize the benefits from drug therapy
Core elements:
-Medication therapy review
-Personal medication record
-Medication-related action plan
-Intervention and/or referral
-Documentation and follow-up
*shift to MTM reflects collaborative approach to care
Describe the education training options available for pharmacist techs
Training is not standardized
Techs can either be certified or registered (depending on the state)
Pharmacist patient care services
Services provided by pharmacists are delivered in collaboration with other health care providers
*These services may be provided in addition to or distinct froms the direct dispensing of prescription meds
pharmaceutical care
The responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patients quality of life
Medication Therapy management
Comprehensive approach to helping patients maximize the benefits from drug therapy
*shift to MTM reflects collaborative approach to care
Core elements of MTM
Medication therapy review
Personal Medication record
Medication related action plan
Intervention and or referral
Documentation and follow up
Key elements of MMS
Patient centered approach to care
Assessment of medication appropriateness, effectiveness, safety and adherence
Collaborative approach to care
Focus on health outcomes
Expected to deliver MMA using pharmacists patient care process
Medication Management Services
A spectrum of patient centered, pharmacist provided, collaborative services, that focus on medication appropriateness, effectiveness, safety and adherence with the goal of improving health outcomes
PCCP
Provides consistent process/framework for pharmacists when delivering patient care services
Collect info
Assess info for problems
Come up with Plan
Implement plan
Monitor and Evaluate plan
Barriers to patient care activities
Drug product focus
Services not visible to patients
Other health care professionals
Lack of payment
Logistical barriers
Pharmacy ignorance and inertia
pharmacy provider status
Refers to formal recognition of pharmacists as health care providers by orgs that pay for healthcare
Does not mean prescriptive authority
Med adherence
Promoting adherence is an essential pharmacist role in many health care settings
Non adherence is major problem
Due to costs
How do professions and occupations differ?
Professions are occupations that have systematic theory and body of knowledge, professional authority and special privileges, community sanction and social utility, ethical codes and internal control, and professional culture and organizations
Does health care constitute a special case of a profession?
Yes healthcare is a special case of profession because while providing an individualized and unstandardized service might be logical, providers sometimes fail to do this
What are the primary similarities shared between pharmacy and the other healthcare professions?
Pharmacy and medicine both have a variety of specialties available
What are the major differences between pharmacy and other healthcare professions?
Pharmacy is unique in that specialization is achieved after one is eligible to practice not before
How would you explain to a patient the benefits of interdisciplinary care over multidisciplinary care?
Interdisciplinary care is a collaborative approach that involves multiple healthcare professionals working together to address a patient’s needs
Multidisciplinary care involves multiple healthcare professionals from DIFFERENT working together to address a patient’s needs
For high-risk disease states pharmacists can reduce what
medication-related errors by collaborating with the team
pharmacy-led interventions have been shown to improve
medication compliance in hospitalized, heart failure, and post-heart attack patients
8 categories of drug-related problems that could arise and result in poorer health outcomes
untreated indications
improper drug selection
subtherapeutic dosage
failure to receive drugs
over dosage
adverse drug reactions
drug interactions
drug use without indications
outcomes that improve a patient’s quality of life
-cure of a disease
-elimination or reduction of a patient’s symptomatology
-arresting or slowing of a disease process
-preventing a disease or symptomatology
covenantal relationship between pharmacist and patient
-identifying potential and actual drug-related problems
-resolving actual drug-related problems
-preventing potential drug-related problems
pharmaceutical care practice domains
1.Risk management
2.Patient advocacy
3.Disease management
4.Pharmaceutical care services marketing
5.Business management
medication synchronization
all of a patient’s chronic medications are synchronized so that they are refilled one day each month
Improves patient outcomes but they also build efficiencies into a pharmacy’s workflow by reducing walk-in traffic
The Pharmacists’ Patient Care Process
- Collection of necessary subjective and objection info about the patient
- Assessment of the information collected
- Development of an individualized patient-centered care plan
- Implementation of the care plan
- Monitor and evaluation of the care plan and modify the plan if need be
Pharmacotherapy consults
Services provided by pharmacists on referral from other health care providers or other pharmacists
Disease management
Involve coordinated healthcare interventions for diseases in which patients must assume some responsibility for their care
Pharmacogenomics
pharmacists play a role in the interpretation and application of a patients genetic info to optimize a patient’s response to med therapy
Anticoagulation management
pharmacists provide services to patients who are taking oral blood thinning agents
Three essential components of healthcare systems
1.Cost
2.Access
3.Quality
Indemnity insurance
Insurance company reimburses subscribers not providers for a portion of their medical expenses
Now it refers to any health insurance program reimbursing on a fee for service basis with few cost controls
Healthcare system
A network of individuals and organizations that interact for the purpose of treating illnesses, preventing illnesses or maintaining health and financing care
General trends in health care
Diseases treated
Efficacy of care
Where care is provided
Who provides care
Payment for care
Historical evolution of the healthcare system
Prior to 20th century:
-Macro public issues
-Medical care was crude and unsophisticated
Early 20th century:
Role of the hospital: growth in importance as care centers
Rise in for-profit healthcare
Post WWII:
Failure of national health insurance reforms
-Creation of public programs
-Rise of private insurance
-Healthcare provided through “fee for service” system
Late 20th century
Managed care era
Strives to contain costs while delivering quality healthcare
Penalties for providing unnecessary care
21st century
Maturing managed care and controls
Self Pay (uninsured)
Pay as you go
Employer-sponsored insurance (private insurance)
Health insurance offered as a benefit of employment
-Part of premium paid by employer on employee’s behalf
Individual Health insurance
Purchased by individual/family
Health insurance marketplace created under the affordable care act
Government/public sponsored insurance
Government is the payee
Healthcare expenditures
How much money is being spent on healthcare
Expenditures = Price x Quantity
Emerging trends
Growing focus on value and quality of care
Mergers and partnerships
Evolution of managed care
Goal: provide high value cost-effective care
Value = Outcomes/cost
Seven basic functions of the FDA?
Drugs cannot be sold or marketed until FDA approved
*Must be safe and effective
1.Approval of drugs on basis of purity, safety, and effectiveness
2.Regulation of labeling for prescription and OTC drugs
3. Regulation of prescription drug advertising
4. Regulation of manufacturing processes, recalls
5. Regulation of bioequivalence for generics and biosimilars
6. Monitoring of drugs after approval for problems
7. Monitoring of the safety of nation’s blood supply
Steps for drug when going through development and approval
Can take many years and cost billions of dollars
1. Potential candidates (discovery)
2. Preclinical testing
3-5. Phase I, II, III clinical testing (Clinical testing)
6. FDA approval (approval)
7. Phase IV clinical trial (post clinical testing)
Phase I clinical trial
Must file Investigational New Drug (IND) application before
-How drug works, dosing, toxicities
-Small sample, healthy volunteers WITHOUT condition to be treated
Approval process for generic drugs
Abbreviated process
-Brand drug has already been proved to be safe and effective
Abbreviated NDA
-Submit proof of bioequivalence, bioavailability, PK and PD properties
*Very limited clinical testing
-Ensure the same or similar to reference product
Approval process for OTC
Over the counter switches
-NDA for new drug
OR
-Prescription to OTC application for drug with prior FDA approval
Implications for insurance coverage?
-Insurance less likely to cover prescription version
Biologics
-Large complex molecules created using BIOLOGICAL processes
-Often composed of proteins (antibodies)
-Expensive and difficult to produce (injections, infusions)
-NEARLY IMPOSSIBLE TO IDENTICALLY REPLICATE
Small molecule drugs
-small CHEMICALLY manufactured molecules
-relatively simple and cheap to produce
-refers to most “traditional” drugs (tablets, capsules)
-relatively simple to replicate
biosimiliar vs generic drugs
Biosimilars
Generally made from living sources
Complex process to produce
Very similar but not identical to original biologics (less expensive too)
Generics
Generally made from chemicals
Simple process to produce
Copy of brand drugs
Less expensive than brand name drugs
How do pharmaceutical manufacturers market their medications to prescribers and patients?
Marketing performed by drug manufacturers
Goals of marketing:
-Name/brand recognition
-Increase use of a particular company’s drug
One method is detailing
-Target prescribers
-Go to them and educate them on the merits of the product
-Impact on prescribing behavior
-Drug representatives, journal ads, “swag” etc…
-Some info provided has been proven to be false or incomplete
-Excessive marketing (luxury trips, dinners etc.)
Issues with direct-to-consumer advertising
-Targets patients
Promotes drug directly to patients
-Purpose is to get patients to use OTC or prescription meds
Types: Drug vs Disease focused
Issues:
Patients don’t have expertise to determine appropriate medical treatment and may contribute to higher costs of care
Phase II clinical trial
-Drug safety and effectiveness
-Small sample of patients WITH condition to be treated
Phase III clinical trial
-Drug safety and effectiveness via RCT
(compared to placebo and other drug)
-Large sample of patients with condition to be treated
New drug application (NDA)
Submitted before Phase IV clinical trial
-How drug works, how manufactured and marketed, labeling etc.
Phase IV clinical trial
“postmarking surveillance” -after drug approval
Monitor for potential adverse reactions, other problems
Summary of Generic Substitution
Generic (small molecule drugs)
-Can automatically substitute generic for brand version (unless specifically requested by prescriber or patient)
-Identical to brand version
Biosimilars
-Cannot be substituted without prescriber authorization
-Highly similar to brand version
Interchangeable biological product
-Can be substituted for the reference product without authorization
-Not all biosimilars are interchangeable biological products
-Nearly identical to brand version
Biosimilars and insurance
Biologic drugs and biosimilars typically fall under the specialty drug classification on a formulary
Biosimilars are intended to save money similar to generics so insurance plans treat them more like generics
Channel of distribution for Rx drugs
Manufacturers –> Wholesalers –> Pharmacies/pharmacists –> Patients / consumers / users
*Prescribers are an externality in the channel of distribution for prescription drugs
Brand name Manufacturers
-J and J, Merck etc..
-Research and development, drug discovery (main focus)
*Also called single source or patent protected drugs
*Role of patents is to create a unique product to a company and market it
*Play important roles in health care system
-Discover and produce innovative meds
-Info resources about new drugs
Generic Manufacturers
-Teva, Sandoz, Viatris, Sun Pharma etc…
*Also called off patent or multi-source drugs
*Limited research and development; (MAIN FOCUS IS EFFICIENT PRODUCTION)
*Price competitive markets
-Multiple competitors making same product
-Typically cheaper than brand drugs
Manufacturer trends
Increased use of generic drugs (account for large portion of prescription drugs, but small amount of drug spending)
Implications?
-Increase pressure to find new compounds
-More marketing, new indications, expand market, extend patents
-Stop selling branded version possibly?
Wholesalers
-McKesson, AmerisourceBergen, Cardinal Health
Purpose?
-Purchase, store and distribute drugs
-Technology solutions to improve efficiency
-Ensure integrity of drug distribution system?
**Drug pedigrees - identify each prior sale of the drug
Pharmacies
Many types
-Institutional (in patient)
-Community pharmacies
-Mail-order
-Specialty pharmacies
Community pharmacy trends
Steady growth of community pharmacies
-Growth in proportion of corporate owned chain pharmacies
-Location
*Many independent pharmacies in rural areas
Mail order pharmacies
Mail order prescriptions have increased
-Areas of debate
*Money away from community pharmacies
*Safety/quality of care
*More efficient/cost effective
Prescribers (Providers)
MDs, NPs, PAs, and PharmD in some settings
Decide what drugs will be used by patients
*“Directed demand”
*Don’t pay, possess, or dispense drugs
Act as agents for patients
Non-Distribution pathway (Insurance)
- Funders (employers/Government)
- Payers / Insurers
-PBMs work for payers and get reimbursement (point of corruption?) - Pharmacies or Pharmacists
- Patients, Consumers, Users
Pharmaceutical Benefit Managers (PBMs)
-CVS/Caremark, Express Scripts, OptumRx, Navitus
-Administer drug plan on behalf of INSURERS, EMPLOYERS
*Claims processing
*Establish controls in drug plans
-Buy prescription services from pharmacies
*Establish reimbursement levels to pharmacies for drugs
*Determine pharmacy networks
-Most PBMs own a mail order/specialty pharmacy
-Negotiate Rebates with Manufacturers
PBM trends
Large growth in Third Party coverage of prescriptions
Concentration of market power in PBM industry resulting in tension with pharmacies
-Reduction in reimbursement levels to pharmacies
-Narrow or tiered pharmacy networks
-Forced or incentivized use of PBM owned mail order pharmacy