APC EXAM 2- Gilmore

5 lectures

What is a risk?

anything that threatens the ability of a person or organization to accomplish its mission—> associated with negative outcomes

What are the 2 types of risk? (from an insurance perspective)

• speculative—> chance of gain OR loss

• pure—> only a chance of loss (ex: fire, theft)

What is a way to help manage risk?

insurance (but must meet criteria)

A risk management process involves what 2 things?

identifying potential risks and assessing/managing those risks

What are the steps to the risk management process?

1. establish the context

2. identify/ analyze risks

3. evaluate and prioritize the risks

4. select an appropriate risk management strategy and implement the technique

5. monitor decisions and update risk management program

What are some techniques to manage risks?

1. risk avoidance

2. risk prevention/modification

3. risk absorption/retention

4. risk sharing or transfer

OBRA 90 required pharmacists to do what?

What did the learned intermediary doctrine do?

• idk how imp

• OBRA 90 requires prospective DUR, patient counseling, and to maintain pt. records

• learned intermediary doctrine held that the duty to warn against ADRs and other problems was with the physician

What does HIPPA 1996 protect?

all individually identifiable health information

There are many risks associated with technology in the pharmacy including…

• strategic risk

• performance risk (technology might not work as intended)

• operational risk (risks with day-to-day use)

• psychosocial risk (stress/burnout from tech use)

Describe the factors that affect performance risk of an information technology system used in pharmacies:

• system requirements (technical and operational needs the IT system must meet to function properly in a pharmacy setting)

• modularity (how well different components of the system (e.g., inventory, EHR, billing) integrate and communicate)

Effective medication error prevention should focus on what factors that contribute to error?

a. blunt end/ latent end

b. front end/ active end

a. “blunt end” or “latent end” (blunt end is hidden systemic factors that create conditions for errors to occur vs. front/active end is immediate actions by frontline staff where errors become visible—> should focus on blunt end)

Which approach to risk provides a better understanding of risks in terms of both cause and outcome?

a. qualitative

b. quantitative

a.

What is Just Culture?

a framework that supports a learning environment by balancing accountability with system design

“Just Culture” distinguishes between what 3 types of behaviors?

• human-error: inadvertent actions, slips, lapses, mistakes

• at-risk behavior: risky actions that are mistakenly believed to be justified

• reckless behavior: conscious disregard of substantial risk

What is Pharmacoeconomics?

What does it identify, measure, and compare?

• assessing the clinical effectiveness of any new health care intervention—> is a TOOL not the FINAL ANSWER

• description and analysis of the costs of drug therapy to health care systems and soceity

• identifies, measures, and compares COSTS and CONSEQUENCES of pharm products and services

Based on the picture, which # is a cost analysis? which # is a clinical/outcomes study? which is a PE analysis?

1. cost analysis

2. clinical/outcomes study

3. PE analysis

PRACTICE:

A health services research plan to study the total cost burden of Type 2 Diabetes on society.

• The costs will include:

  • Prevention

  • All treatments including medications

  • Losses from morbidity and mortality

Would this be a PE analysis?

No—> not a PE analysis… the study focuses on the disease NOT the intervention

• a PE analysis requires measuring and comparing the cost of a pharm intervention and its resulting outcomes

Pharmacoeconomics can look at interventions made at the individual, hospital/health plan level, and societal level. What are examples of interventions made at each level?

• individual

  • determine at patient-patient level what the best tx is

  • looks at demographics, clinical considerations, economics

• health/health plan level

  • hospital systems create a formulary

  • insurance, creates formularies, tiers of coverage, copays

• societal

  • federal government’s role in paying for health care services

  • some countries play a role in price negotiation, setting, and formulary management at national level

What are the 4 basic types of pharmacoeconomic studies?

• Cost-minimization analysis (CMA)

• cost-effectiveness analysis (CEA

• cost-utility analysis (CUA)

• cost-benefit analysis (CBA)

What is the similarity between all 4 types of pharmacoeconomic studies? difference?

each measure costs in $ but differ in how they measure/compare health outcomes

Which PE study type is easiest to conduct, but cannot be used when outcomes of each intervention are different?

a. CUA

b. CBA

c. CEA

d. CMA

d.

Answer the following about a cost-minimization analysis:

• How does a CMA measure outcomes?

• costs of what are compared?

• cannot be used when?

• examples/applications?

• outcomes assumed to be equivalent

• only costs of interventions are compared—> can’t be used when outcomes are different or for comparing different classes of medications

• ex:

  • comparing 2 generic medications that are rated FDA equivalent

  • comparing cost of 2 therapeutically equivalent products in the same class (lisinopril vs. ramipril)

  • cost comparison of the same drug in different settings (lisinopril in the ER vs. at a community pharm)

What is the most common type of PE analysis?

a. CUA

b. CBA

c. CEA

d. CMA

c. cost-effectiveness analysis

Answer the following about a cost-effectiveness analysis:

• How does a CEA measure outcomes?

• advantages?

• disadvantages?

• measures outcomes in natural units (ex: mmHG, cholesterol levels, symptom free days)

• advantage: outcomes easier to quantify compared to a CBA or CUA

• disadvantage:

  • can’t compare programs with different types of outcomes (ex: cost-effectiveness of opening a diabetes clinic vs. HIV clinic)

  • hard to combine differences in medications other than effectiveness (like ADRs) (ex: when comparing 1st and 2nd gen antihistamines one gen might be more effective in relieving allergy symptoms, but not accounting for ADRs like drowsiness)

What are the 2 methods of reporting in cost-effectiveness analysis’s (CEA)?

1. average cost effectiveness ratio (CER)

   • CER = Total Cost of Intervention / Total Effectiveness of Intervention

2. incremental cost-effective ratio (ICER)

   • ICER = (Cost of B – Cost of A) / (Effectiveness of B – Effectiveness of A)

Answer the following about a cost-utility analysis:

• How does a CUA measure outcomes?

• applications?

• measures outcomes using Quality-adjust life year (QALY) or other utilities

  • basically takes into account length and quality of life

• applications

  • useful when outcomes effect quality of life (ex: cancer tx might prolong life but with severe side effects)

advantages/disadvantages of CUAs?

• advantages

  • combines morbidity (quality) + mortality (length of life)

  • compares unrelated interventions (e.g., diabetes drugs vs. knee surgeries).

  • Uses cost/QALY thresholds (e.g., $50,000 per QALY) for objective decisions.

• disadvantages

  • Utility weights are subjective estimates (no consensus on calculation).

  • May oversimplify complex health states (e.g., mental health impacts).

Answer the following about a cost-benefit analysis:

• How does a CBA measure outcomes?

• why is it unique?

• advantages?

• disadvantages?

• measures outcomes using $

• unique bc looks at $ but also benefits

• advantages:

  • measuring both costs and benefits allows clinicians/decision makers to compare multiple programs or interventions with similar or unrelated outcomes

  • can see if benefits > cost of implementation

• disadvantages:

  • hard to put $ value on health outcomes

Review table of PE types:

Difference between direct medical and nonmedical costs?

• idk how imp

• direct medical—> cost of tx

• direct nonmedical—> costs to pts./families associated with tx, but not medical

Define each of the following:

• indirect costs

• indirect benefits

• intangible costs

• intangible benefits

idk how imp

• indirect costs- costs that involve the loss of productivity because of illness/death

• indirect benefits- opposite of indirect costs

• intangible costs- costs of pain, suffering, etc. from illness/tx

• intangible benefits- avoidance of intangible costs

What are societal costs?

• idk how imp

costs to insurance company, pt. provider/institution, and others based on loss of productivity

What is a sensitivity analysis used for?

to determine the effect of data uncertainty or assumptions on the conclusions of the study

• aka—> uncertainty in the data= run a sens analysis

What are the 4 types of sensitivity analysis?

1. simple

2. threshold

3. analysis of extremes

4. monte carlo

Describe the characteristics of each type of sensitivity analysis:

Type of Analysis	Characteristics
Simple sensitivity
Threshold analysis
Analysis of extremes
Monte carlo simulation

Type of Analysis	Characteristics
Simple sensitivity	most used useful for generalizing results 1 way or multiway
Threshold analysis	finds point at which 2 options are equal need actual data doesn’t work well with ratios
Analysis of extremes	compares best and worst scenarios useful if extremes of data are known
Monte carlo simulation	varies multiple variables within plausible ranges needs to rely on computers

What is the use of a tornado diagram? What is it?

• “graph of a one-way sensitivity analysis from the variables which change the answer the most to those variables that have the least impact on the answer”- gilmore

  • explained:

    • a visual tool ranking variables by their impact on an outcome

    • Widest bars = most influential factors.

    • Used in pharmacoeconomics to prioritize cost-effectiveness drivers

What is a decision analysis?

• application of an analytical method for systemically comparing different decision options

• graphical representation of allows calculation of values needed to compare different options

• helps selecting the best/most cost-effective alternative

What are the steps to a decision analysis?

1. identify the specific decision (ex: should we include a new abx to our formulary?)

2. specify alternatives (ex: compare new abx to current standard of care)

3. draw the decision analysis structure (decision tree)

4. specify possible costs, outcomes, and probabilities

5. perform calculations

6. conduct a sensitivity analysis

Difference between choice, chance, and terminal nodes in a decision tree?

• choice nodes: choice is allowed (ex: new abx vs. standard abx)

• chance nodes: chance comes into equation (success vs. failure or ADR vs. no ADR)

• terminal node: final outcome of interest for each option

In decision analysis, trees are simple and easy to use, but many diseases are very complex. What type of modeling can be used for a more accurate presentation of complex health scenarios that happen over a number of cycles or intervals?

Markov modeling

What are Markov states?

when we assume that a patient is in one of a finite number of health states

What are the components of a simple markov modeling process?

• each state is represented by a circle

• arrows between states are transitions

What’s the major difference between decision tree analysis and a markov modeling?

Decision analysis uses trees for simple comparisons and Markov models for complex, long-term scenarios

What is a managed care pharmacy and what are its 3 major goals?

• managed care pharmacy—> focus is on drug therapy and pharm care

• 3 goals

  • contain costs

  • improve outcomes/QOL

  • improve quality/accessibility of healthcare

What is the value equation in pharmaceuticals?

• define each component in the equation

• VALUE= quality/cost

• quality: defined as evidence-based medicine demonstrating measurable results in outcomes

• cost: cost of drug

If quality remains constant, and cost increases, the value _____________.

a. increases

b. decreases

b.

If quality increases, and cost remains constant, the value _____________.

a. increases

b. decreases

a.

What are the 3 prime components in formulary development process in managed care?

• clinical

• financial (includes rebates)

• other

What are rebates?

a discount provided by the pharm manufacturer to the insurer as part of a formulary status agreement

In managed care, negotiation is all about leverage.

What are some leverage opportunities?

• drug uniqueness

• organization size

• shifts in clinical picture

• generic availability

• formulary type/restrictiveness

• working relationship

• product portfolio

What is the definition of off-label use?

use of a drug for indications, dosage forms or regimens, or others not stated in the product labeling approved by the FDA

What are the issues with off-label use?

• compromises definitive clinical trial data, evidence-based medicine, safety/efficacy standards

• off-label uses may be potentially harmful and/or lead to ineffective results

What are some areas where off-label products are used a lot?

• pediatrics

• oncology

What is the FDA’s policy regarding off-label use?

• drug manufacturers the only ones that CANNOT discuss or provide material on off-label uses

• prescribers can use off-label if appropriate

What is prior authorization?

protocols placed on meds to prevent prescribing unless defined and specific criteria are met (ex: high cost/potential for misuse)

What is a hospital chargemaster?

• computerized, coded list of all items that will be charged in the hospital

• problems: issues with connection to actual cost and raising pharm charges at same rate as other supplies

What are CPT codes?

• type of billing terminology

• describes complexity of the visit, type of visit

• each code may require specific documentation

• ex: 99211- physician not required or 90471- immunizations

What is CPT Code 99490?

chronic care management services can be reimbursed for 20 minutes of clinical staff type per calendar month

Can pharmacists become “providers” under the social security act? what does that mean?

no, as of now pharmacists cannot become a provider. being a provider means that you can participate in part B of Medicare and bill them for your services.

In a drug pricing hearing in 2019 where many CEOs of pharm companies testified, what did the pharma companies say? who did they blame?

• pharma defends medical breakthroughs and needing room for further innovation

• BLAME GOES TO PBMS AND INSURERS

• potential HHS rebate reform rules earns pharm praise

• need to move towards value-based arrangements, stronger biosimilar market

In a 2012 IPSOS global reputation center survey, what did consumers say pharm companies can do to better demonstrate their corporate citizenship?

• develop innovative drugs to fight diseases

• ensure the safety of drugs produced in other countries

• develop assistance programs that provide less expensive drugs to low-income families

Each drug company has a public affairs office that is responsible for…

• government relations

• intelligence gathering

• investor information

• PACs supporting candidates

• donates/support

• unpredictable events—> bad pr, media relations

PHRMA code on interactions with healthcare professionals was introduced in 2009.

What are some codes drug companies have to follow when interacting with medical professionals and vice versa?

• both risks and benefits are presented

• provide modest meals-in office

• gifts—> only educational items that are worth up to $100 are okay

• not allowed to do recreational events as part of promotion

• encourages practitioners to disclose financial relationships

• elimination of company-sponsored pens, notepads, and other reminders bearing company logo

• drug samples still okay

• reps can’t TALK about off-label uses, but can give reprints of articles in many situations

The physicians payments sunshine act in the affordable care act require drug manufacturers to do what?

requires manufacturers of drugs, biologics, and devices to report transfers of value to physicians and teaching hospitals on a public website

In recent years marketing of drug makers has shifted from healthcare providers to _____.

direct to consumer advertising (DTCA)—> includes magazines, journals, television, social media

Does PhRMA spend more on marketing or research?

marketing (x3)

Is there any evidence that DTCA benefits healthcare quality?

no

What is the definition of disease mongering? disease awareness?

• disease mongering: “The selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments”

• disease awareness: industry term for disease mongering

What is an effective tool for pharmacists to use when meeting with pharm sales reps?

“PEACEFUL”

Why do doctors and drug companies like drug samples?

What is the REAL purpose of samples?

Drug Companies	increases “new starts” on a new drug encourages switches patients usually stay on sample increases rx’s of the most expensive, most promoted drugs
Doctors	start tx immediately test tolerance of new drug reduce total cost of rx provide free meds
REAL PURPOSE OF SAMPLES	gain access to physicians habituate physicians to prescribing targeted drugs increase goodwill serve as unacknowledged gifts to physicians