Exam I - Intro, Trials, Careers Flashcards
What does it mean that US healthcare is moving from fee for service to value based care?
Rather than reimbursing physicians for their services. There are now outcome metrics for the reimbursement process.
i.e. poor metrics mean less money made by the physician
In 2017 US health expenditures totaled $3.5 trillion (18% GDP), What are the top three healthcare expenses that the US profits the most from?
- Hospitalizations
- Physician services
- Prescription drugs
Top four types of insurance that people have. Who pays the medical bills?
- Private insurance
- Medicare
- Medicaid
- Out of pocket
HMO vs PPO
HMO (health maintenance organization) - Lower monthly premium, lower out of pocket costs, smaller network, does not pay for out of network treatment, Require PCP
PPO (preferred provider organization - Higher monthly premium, out of network coverage, no referrals needed
Asians vs Blacks vs Whites. Children not seen in timely manner for routine checkup?
Asians 13%
Blacks 8.8%
Whites 4.3%
Asian vs White. Worse, same or better access to healthcare?
7/19 reported same and better access than white people
5/19 reported worse access to care
American Indian or Alaska Native vs White. Worse, better or same access to healthcare?
7/11 reported the same
4/11 reported worse access
Native Hawaiian/Pacific Islander vs White. Worse, better or same access to healthcare?
4/4 reported the same access to healthcare
Hispanic vs non hispanic white. Worse, better or same access to healthcare?
14/20 reported worse access to healthcare
What does OECD stand for? What countries make up this organization?
Organization for Economic Co-operation and Development
United States Australia Canada Germany France the Netherlands New Zealand Norway Sweden Switzerland United Kingdom
^ several but not all
US has the highest %GDP but has the highest percentage in what four categories between the countries in OECD?
- Chronic diseases
- Obesity rate
- Hospitalized with diabetes mellitus
- Hospitalized with hypertension
US has the highest %GDP but has the lowest percentage in what three categories between the countries in OECD?
- Life expectancy
- # of md visits/yr
- # of MDs
Name the three types of Pharmacy Practice Models.
- Drug Product Distribution-Centered Model
- Pharmacist Patient Process Model
- Pharmacist Patient Care Integrative Model
Drug Product Distribution-Centered Model
Major role for pharmacist has historically been to dispense drugs.
Acquire, store, prepare, label, dispense
Safety and accuracy
Patient counseling
Pharmacist Patient Care Process Model
High quality, cost-effective and accessible healthcare achieved through team-based, patient-centered care
Experts of appropriate use of medication
Collect, Assess, Plan, Implement, Monitor Evaluate and follow up
Within the Pharmacist Patient Care Process Model. Explain Collect, Assess, Plan, Implement up until Monitor, Evaluate and follow-up.
Collect: Medication/medical/ social history, socioeconomic barriers
Assess: Each medication (appropriate/effective/safe)
Plan: Develop an individualized patient-centered care plan
Implement: in collaboration with other healthcare professionals
Monitor, evaluate and follow-up
Proven advantages of Pharmacist Patient Care Integrative Model
Improved medication adherence
Reduced hospitalization rates
Reduced ER visits
What is the purpose of Medication Therapy Management (MTM)?
Included as an essential Medicare Part D outpatient prescription drug benefit in 2006
The purpose is to help you and your doctor make sure that your medications are working to improve your health
Part D contracts with multiple approved MTM programs. What three types of medicare plans are contracted with Medicare part D?
- Medicare Advantage prescription drug plans
- stand-alone prescription drug plans (PDPs)
- Medicare-Medicaid Plans (MMPs)
Eligibility criteria for MTM program
- Part D enrollee with multiple chronic diseases (2-3 minimum)
- Take multiple Part D drugs (2-8 minimum)
- Likely to incur annual cost of at least $3,507 for covered Part D drugs
Top five providers of MTMs. (Qualified only)
Pharmacists Registered nurse Physician Nurse Practitioner Physician's Assistant
What is CMR and its purposes?
Annual comprehensive medication review (CMR)
- Collect pt info, assess medications, create plan and collaborate with pt and provider
- Improve health literacy
- Identify and discuss the patient’s problems or concerns
- Empower the patient to self-manage their medications and overall health
CMR vs TMR
Annual comprehensive medication review (CMR) - comprehensive, real-time, interactive medication review
Quarterly targeted medication review (TMR) - Focuses on specific, actual or potential medication-related problems
This act is an amendment to a section of the Social Security Act which would add pharmacists to the list of recognized healthcare providers.
The Pharmacy and Medically Underserved Areas Enhancement Act
What committee(s) was referred to review and consider the The Pharmacy and Medically Underserved Areas Enhancement Act?
Committee on Energy and Commerce
Committee on Ways and Means
Omnibus Budget Reconciliation Act of 1990 (OBRA 90) requires …?
Requires the pharmacist to conduct prospective and retrospective DUR for each outpatient prescription dispensed to a Medicaid patient
Asians vs. White. Adults not seen in timely manner for routine checkup?
Asians 25.3%
Whites 12.6%
Core of the pharmacy profession is …?
Safety and accuracy
Pharmacist Patient Care Integrative Model
Merges the best aspects of both practice models directly in the clinical facility
- Pharmacy physically connected to the clinic
- Pharmacists directly collaborate with providers for patient centered plans
Top four providers of MTMs. (Qualified and non qualified included)
Pharmacists
Pharmacy Interns
Registered nurses
Pharmacy Tech
MTM minimum requirements between provider and part D enrollees
- Enrollee and prescriber interventions
- Annual comprehensive medication review (CMR)
- Quarterly targeted medication review (TMR) with intervention if indicated
Under this act, pharmacists would be able to participate in the medicare Part B plan program and bill medicare for services allowed under their state scope of practice.
Social Security Act
What is a DUR and what is its purpose?
Drug Under Review (DUR)
Structured, ongoing review of a medication’s prescribing, dispensing and use
- Ensure appropriate medication decision-making and positive patient outcomes
- Provide corrective action, prescriber feedback and further evaluations
Top three fields that pharmacists work in?
50% Community practice
27.8% Hospital/health system settings
6% Ambulatory care practice
Clinical pharmacy services can only be offered in a hospital setting. (True/False)
False
Clinical pharmacy services can be provided in any setting.
Countless opportunities to talk to patients, counsel, educate and remove barriers to healthcare even in a community pharmacy setting.
Advantages and disadvantages of community pharmacies within hospitals.
Advantages: Potential for innovative patient services (“Meds to Beds”, discharge counseling)
Disadvantages: most are small, little room for non-drug products (prescription and OTC medicines; some home diagnostic aids like glucometers, blood pressure cuffs etc.
What are the four types of community pharmacies? (List in order of number)
- Traditional Chains
- Independents
- Supermarket/convenience store
- “Big box” (e.g., Walmart)
What is the “Med to bed” program offered at some hospitals with retail pharmacies?
“Meds to bed” can deliver medication to patients at discharge and are able to counsel because retail pharmacist is present
What do Pharmacy Benefit Managers do?
Manage prescription drug benefits for health insurers
- Determine drug costs for patients
- Negotiate with manufacturers for rebates
- Set drug cost and dispensing fees for pharmacies
What is step therapy?
Trying less expensive options before “stepping up” to drugs that cost more.
What specific aspects of pharmacy benefits do PBMs control that cause them to be criticized for driving up costs?
- Formularies
- Patient adherence programs
- Prior authorization
- Step therapy
- Tiers of coverage
PBMs are criticized for DIR policies. What is a DIR fee?
Direct and Indirect Remuneration (DIR)
A blanket term that covers the money that a Medicare Part D plan may collect to offset (lower) member costs.
These DIRs lower the amount of money you (the Pharmacist) get from the prescription. In some instances, a pharmacy can discover that they lost money from filling a Medicare part D drug.
How do rebates work in pharmacy?
- Drug company sets a list price for a medication
- Drug company may offer a rebate, or a discount on the list price to a PBM
- Insurance companies use PBMs to manage their prescription benefits.
ie. A company can offer a higher rebate on a brand name drug so they can get preference on a formulary (like Tier 1 coverage)
This would encourage the patient to use the drug company’s medication over others.
- Drug companies pay the PBM a rebate whenever their product is sold.
- It is up to the PBMs discretion to share some or all the rebate money with the insurance company to lower insurance costs and premiums for enrollees.
Do rebates directly lower the out of pocket costs that patients pay for a drug?
No, what patients pay is based on the list price not the rebate price.
DIR was initially a term coined by…?
DIR was initially a term coined by the
Centers for Medicare and Medicaid Services (CMS)
Three PBMs.
Caremark (CVS Health)/Aetna
OptumRx (United Health)
Express Scripts
What are some reasons that the number of independent pharmacies are decreasing in the US?
- Prescription drugs account for 93% of independent pharmacy sales - (as opposed to retail with front store sales supplement pharmacy losts)
- DIR fees
- Do not have the patient volume or buying power to purchase in bulk to save money
Traditional chain pharmacies (i.e. CVS, Walgreens) fill approximately what percentage of retail-based prescriptions?
Traditional chain pharmacies fill about 50% of retail-based prescriptions
List the in order the community pharmacies by the percentage of prescriptions they sale on a retail level.
- Traditional chain (i.e. CVS, Walgreens)
- Independent and Franchise pharmacies (i.e. Medicine Shoppe)
- Big box pharmacies (i.e. Walmart, Target)
- Supermarket based pharmacies
In terms of market share, which chain is larger CVS or Walgreens?
- CVS Health (24.5% of market share)
2. Walgreens Boots Alliance (18.9%)
Under the Affordable Care Act (ACA) and managed care, what effort has been taken to prevent hospital readmissions and cut costs?
Provide more healthcare services in the outpatient setting.
- Ambulatory Care Clinics
- Retail and Hospital-based Clinics
- Urgent Care Centers
- Outpatient Surgical Centers (e.g., endoscopies and colonoscopies, minor surgeries)
Why is there a need for Transitions of Care (TOC) pharmacists?
Mediation errors occur more frequently as patients transition between inpatient and outpatient settings
Approximately 20% of patients are readmitted within 30 days of discharge
What are some of the main causes for medication errors as patients transition from inpatient to outpatient?
- Poor communication between health care providers
- Lack of patient follow-up
- Poor patient education
- Poor medication reconciliation
What can pharmacists do to minimize the medication errors that occur as patients transition between inpatient and outpatient settings?
Medication reconciliation
Medication therapy management
Patient counseling and education
Why don’t all healthcare systems add pharmacists to the transition of care team?
- Pharmacists are expensive
- Controlled studies are still needed to demonstrate cost-effectiveness (medication error reduction, decreased 30-day readmission rates, etc.)
What can be prescribed to NPO patients to prevent stress ulcers?
An H2 blocker like famotidine or a proton pump inhibitor
Retail clinics are intended to..?
- Target patients with chronic diseases to increase healthcare access, patient education and empowerment, and medication adherence
- Decrease hospital readmissions and reduce healthcare costs
State regulations for retail clinics differ per state. Give two examples.
Some states prohibit patients under 18 years of age
Some require a “standing” (or pre-arranged) order from a physician
Advantages of pharmacist-provided immunizations.
- Walk-in typically accepted
- Average cost of an adult vaccination: pharmacy $54.98, physician office $65.69
- Vaccination rates have improved as pharmacist-administered vaccinations have expanded
New Jersey regulations for pharmacist administered vaccines (age).
- No vaccines for children under 7 y/o
- Flu vaccine is the only vaccine that can be given to children 7-12 y/o (with parent’s written consent)
- Any permitted vaccines can be administered to children 12-17 y/o (with parent’s written consent)
Purpose of specialty pharmacies.
Specialize in high cost, complex medication therapies (biologics, injectables) for patients with complicated or rare chronic diseases such as cancer, rheumatoid arthritis, multiple sclerosis and genetic disorders
Dispense orphan drugs and drugs within a REMS program
Top two retail clinics in the US by number.
- Minute Clinic (1,000+)
2. Healthcare Clinic at Select Walgreens (400+)
What are the top four specialty pharmacies by revenue?
- CVSSpecialty($43.9 billion)
- Accredo/Freedom Fertility ($32.1 billion)
- AllianceRx Walgreens Prime ($21.2 billion)
- OptumSpecialtyPharmacy ($17.8 billion)
What is an orphan drug?
Intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States.
These are dispensed at Specialty pharmacies
What incentive does the FDA give to the producers in order to continue developing orphan drugs?
Added 7-9 years of marketing exclusivity on top of the 20 year patent timespan because these drugs are not profitable
What does REM stand for and what is it?
Risk Evaluation and Mitigation Strategies (REMS) Programs
It is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks
When does the FDA impose a REMS requirement for a drug?
It is imposed as either a condition of initial approval or based on Phase IV post-marketing studies and Adverse event (AE) reporting.
What is cisapride?
A drug a part of a REMS program due to reports of ventricular arrhythmia and sudden cardiac death after FDA approval.
It is used as an alternative to metoclopramide (reglan) to treat GERD.
It increases motility in the upper GI tract.
Duties of hospital pharmacists.
- Drug preparation (e.g., IV medications) and dispensing
- Purchasing drugs
- Monitoring of drug therapy, including interpretation of lab results
- Overseeing drug administration
- Responding to problems (e.g., missing or wasted doses, adverse drug events)
- Responding to codes (respiratory or cardiac arrest)
Types of staff pharmacist stations in a hospital.
- Centralized pharmacies - pharmacists interact regularly with physicians and nurses, but less so with patients
- Satellites pharmacies (e.g., oncology, pediatrics, critical care) - often have a hybrid position, responsible for patient rounding and clinical pharmacy activities as time allows
- Dedicated clinical pharmacists - generally do not include drug dispensing responsibilities; typically based in one or more patient care areas and are a member of the multidisciplinary healthcare rounding team
What is a Unit Dose Systems?
Max of 24-hour supply to each patient in unit-of-use packaging (wrapped in singles)
Medication cabinets can be filled by technicians or automated/robotic technology
What are Automated Dispensing Cabinets?
e.g., Pyxis® Medication Stations
Decentralized medication distribution systems that provide computer-controlled storage, dispensing, and tracking of medications
What is the purpose of Antibiotic Stewardship Programs?
Designed to manage and reduce antibiotic resistance
What measures do Antibiotic Stewardship Programs take to be effective?
- Identify inappropriate use, excessive cost
- Designate certain antimicrobials for restricted use
- Monitor and report antimicrobial resistance patterns
- Work closely with the Pharmacy and Therapeutics (P&T) Committee - which must vote to impose drug restrictions, add new antimicrobials, etc
What two types of medical professionals head Antibiotic Stewardship Programs?
Chaired by an Infectious Diseases (ID) physician
Co-Chaired by an ID-trained (e.g., PGY-2 residency) Clinical Pharmacist
Explain what Pharmacokinetics (PK) Services are in a hospital.
- PK consults involve drugs with a narrow therapeutic index
- Clinical or Staff Pharmacists interpret the drug concentration and consult with the prescriber to adjust the dose or temporarily discontinue the medication
What does it mean when a drug has a narrow therapeutic index? Give some examples of drugs in this category.
There is a small difference in dose or blood concentration that may lead to serious therapeutic failures or adverse drug reactions.
Examples include Warfarin, Phenytoin, Gentamicin, Vancomycin
Give a brief timeline of the drug approval process from R&D to Marketing.
- R&D - discover new molecular entities (NMEs), patent potential new drug candidates
- Pre-clinical testing
- Investigational New Drug (IND) application
- Clinical Trials
- New Drug Application (NDA)
- If FDA-approved, Marketing—manufacture, distribute approved drugs (recoup investment)
What is a drug target?
A biological receptor or enzyme a molecule can bind to for activity.
What is done in pre-clinical testing?
- Short and long-term toxicity studies in at least 2 animal species
- Manufacturing process
- Indications of disease effect
- Investigational New Drug (IND) application
What is the focus in each phase of the clinical trials?
Phase I—safety, PK/PD
Phase II—safety, PK/PD, preliminary efficacy
Phase III—statistically prove safety and efficacy
What is the purpose of Phase IV studies?
Post marketing trials to continue monitoring drug after it goes into the market
Average time from NME discovery to FDA approval is how many years and costs about how much money?
10 years
Average cost is $2.6 billion
What two parts are clinical trials are considered crucial go/ no go points?
Phase 1b, Phase 2b—make ”go/no go” decision as early as possible
