P706 Exam
Explain quality adjusted life years (QALYs). Calculate the QALYs for treatment A (utility ~ 0.8) and treatment B (utility ~ 0.9) associated with a 3 year window of time (neither treatment affects survival time). This is just an example of something you may see on a test
(3*0.9) - (3*0.8) = 0.3 QALYs Treatment B is associated with 0.3 more QALYs after 3 years of treatment
Understand how to perform a RCA.
- Always looks backwards in time Process: 1. Identify adverse event 2. Organize a team to investigate 3. Develop an initial flow diagram 4. Develop an event story map 5. Develop a cause and effect diagram 6. Identify root cause contributing factors 7. Develop corrective actions 8. Measure outcomes 9. Communicate results
patient-reported health outcomes (PROs) concept - strengths, weaknesses, and uses
- PROs are any report of the status of a patient's health that comes directly from the patient, without interpretation of the pt's response by a clinicians ex. health related quality of life, presenteeism, satisfaction/patient experience
what is a surrogate outcome measure?
- a physical measurement of a specific outcome which is considered to be a valid predictor of the real outcome or final result - problems with surrogate outcomes is that change in surrogate may not lead to changes in real outcomes
What are the primary cost components associated with dispensing medications?
- cost of the drug (AWP, MAC, WAC, AMP, WAP) - Cost of preparing the medication - Profit - Dispensing costs (direct and indirect expenses, personnel)
economic health outcomes concept - strengths, weaknesses, and uses
- costs compared with the consequences of medical treatment alternatives - direct medical costs: hospitalization, outpatient visits, procedure & tests, devices, services (home care, nursing care), medication - direct non-medical costs: transportation, services (social assistance, home helper), devices and investments (ex. adaptation of house), informal care by relatives - indirect costs: costs associated with illness that are not immediate costs of care (work related: early mortality (lost wages and productivity), early or permanent disability, absenteeism at work)
List sources of data for p.epid studies
- real world data (e.g. EMRs, data from insurers including pharmacy claims data, registries, social media) - Pharmacy administrative data claims - Patient-powered research networks (e.g. patientslikeme, etc)
Clinical health outcomes concept - strengths, weaknesses, and uses
-physiologic or psychological measures of disease control - often the end-point of outcomes assessments (BP, cholesterol) - may be considered a surrogate outcome (ex. BP or cholesterol are surrogate markers for stroke) Weakness - not perfect, changes in surrogates may not lead to changes in real outcomes (ex. HRT may improve cholesterol but leads to increased risk of stroke and CV events)
Describe the various types of p.epid study designs and strengths/weakness of each. Given a scenario, be able to describe the type of p.epid study design it used.
1. Case reports: report of events observed in a single pt or small group of pts - Strength: cheap and easy method for generating a hypothesis - Weakness: cannot be used for testing a hypothesis. 2. Case series: collection of pts, all of whom have a single exposure, whose clinical outcomes are then evaluated and described; can also be looking at collection of pts with a single exposure and looking at their antecedent exposure - Strength: quantifies the incidence of an adverse reaction, determine a particular ADR of concern does NOT occur in a population which is larger than that studied prior to drug marketing - Weakness: often from a single hospital of medical practice 3. Ecological studies (secular trend analysis) - ■ Trends in an exposure that is a presumed cause and trends in a disease that is a presumed effect and test whether the trends coincide ■ Can be used to rapidly support or refute a hypothesis ● BUT, they lack specific data, only aggregated data are used, so unable to control for CONFOUNDERS (factors that may also influence the outcome) ■ Example: ● Oral contraceptive sales data were compared to death rates from venous thromboembolism, using recorded vital statistics. Mortality rates from venous thromboembolism were seen to increase in parallel with increasing oral contraceptive sales, but only in women of reproductive age, not older women or in men of any age 4. Case-control studies; compare cases w a disease to control without the disease, looking for differences in antecedent exposures ■ Useful to study multiple possible causes of a single disease ● Also useful to study a relatively rare disease ● Generally retrospective study, recreating events that happened in the past ● Information on past exposure to potential risk factors is generally obtained by abstracting medical records or surveys ■ Potential strengths: ● Have more control over confounders than case series and secular trend analysis ■ Potential problems: ● Validity of data collected retrospectively ● Selection of controls can lead to selection bias 5. Cohort studies: compare exposed patients to unexposed patients; identify subsets of a defined pop and follow them over time, looking for diff in their outcome 6. Observational studies ■ All the study designs previously discussed are considered observational studies (another term is non-experimental study design) ■ The investigator does not control the therapy, but simply observes and evaluates the results of ongoing medical care ■ Case reports, case series, and analyses of secular trends also called descriptive studies ● Case control and cohort studies are considered analytic studies
Describe the steps of the MUE process
1. Select a MUE: Focused MUE, ensure enough patients, determine type of MUE 2. Identify criteria and data elements to measure 3. Develop a data collection tool (e.g. excel) 4. Collect data 5. Analyze data results 6. Identify limitations 7. Develop conclusions/recommendations 8. Standard place for documentation 9. Updating order sets 10. Changes to the product build (education, present conclusions/recommendations to the hospital oversight committee)
Explain the steps in the medication use process and the medication related problems that can occur at each step.
1/ Prescribing - prescribed inappropriate medication 2/ Dispensing - dispensing wrong medication (e.g. dosage errors, therapeutic errors) 3/ Administering - unsafe storage and disposal/ low health literacy to understood appropriate administration 4. Monitoring - clinical outcomes not monitored
Identify outcomes measures associated with population health assessment and interventions
>Access to Health Services •Persons with medical insurance (AHS-1.1) •Persons with a usual primary care provider (AHS-3) >Clinical Preventive Services •Adults receiving colorectal cancer screening based on the most recent guidelines (C-16) •Adults with hypertension whose blood pressure is under control (HDS-12) •Persons with diagnosed diabetes whose A1c value is greater than 9% (D-5.1) •Children receiving the recommended doses of DTaP, polio, MMR, Hib, HepB, varicella and PCV vaccines by age 19-35 months (IID-8) >Environmental Quality •Air Quality Index >100 (EH-1) •Children exposed to secondhand smoke (TU-11.1) >Injury and Violence •Injury deaths (IVP-1.1) •Homicides (IVP-29) >Maternal Infant and Child Health •All Infant deaths (MICH-1.3) •Total preterm live births (MICH-9.1) >Mental Health •Suicide (MHMD-1) •Adolescents with a major depressive episode in the past 12 months (MHMD-4.1) >Nutrition, Physical Activity, and Obesity •Adults meeting aerobic physical activity and muscle-strengthening objectives (PA-2.4) •Obesity among adults (NWS-9) •Obesity among children and adolescents (NWS-10.4) •Mean daily intake of total vegetables (NWS-15.1) >Oral Health •Children, adolescents, and adults who visited the dentist in the past year (OH-7) >Reproductive and Sexual Health •Sexually active females receiving reproductive health services (FP-7.1) •Knowledge of serostatus among HIV-positive persons (HIV-13) >Social Determinants •Students graduating from high school 4 years after starting 9th grade (AH-5.1) ?Substance Abuse •Adolescents using alcohol or illicit drugs in past 30 days (SA-13.1) •Binge drinking in past month—Adults (SA-14.3) >Tobacco •Adult cigarette smoking (TU-1.1) •Adolescent cigarette smoking in past 30 days (TU-2.2)
A person lives for 3 years with a disease and the current standard of care means they live with a utility level of 0.7. What is their QUALY? That person takes Med A which increases their utility level to 0.9 and they live for 3 years. What is their QUALY? Med B prolongs the patient's life by 2 years, at a utility level of 0.7.
A) 3 years of life x 0.7 utility value = 2.1 QALYs B) 3 years of life x 0.9 utility value = 2.7 QALYs 3 years of life x (0.9-0.7 utility value) = 0.6 QALYs → benefit of Med A over SOC is 0.6 QALYs C) 2 years of life x 0.7 utility value = 1.4 QALYs → Med B provides additional 1.4 QALYs → Overall QALY = 2.1 + 1.4 = 3.5
Define population health
An APPROACH to health that aims to IMPROVE the HEALTH of an entire human population The health outcomes of a group of individuals including the distribution of outcomes within the group
Know what construct and content validity are. How is construct validity assessed? How is content validity assessed?
Construct validity ■ The extent to which relationships among measures follow predictable patterns ■ Hypothesizing how a measure will behave and confirming via cross-sectional and/or longitudinal studies Content validity: ■ Extent to which a measure samples a representative range of the content under study ■ Face validity ■ Sensibility
Describe the concept and role of pharmacoeconomics in healthcare
Costs --> minimization , effectiveness (natural units), benefit (dollars $$$), utility (utilities)
Understand the history of Medication Use Evaluations (MUE) from DUR to MUE
DUR > AUR > DUE > MUE ○ Drug Utilization Review (DUR): retrospective evaluation to monitor medication trends and patterns ○ Antibiotic Utilization Review (AUR): retrospective evaluation of antibiotic use ○ Drug Use Evaluation (DUE): expanded AUR to all drugs; concurrent evaluation of prescribing and outcomes; multidisciplinary ○ Medication Use Evaluation (MUE): expanded DUE to all drugs and all aspects of medication use
Explain discounting and why it is important to include in a pharmacoeconomic model. Give an example of a typical rate that authors will use`
Discount rate: discounting of costs and outcomes is performed if the costs and effectiveness outcomes are considered beyond 12 month time periods. The present value of money, as well as better health, is higher than future costs and outcomes. Typical rate: 3% is often used
Define Quality Assurance
Documents outcomes and accuracy, adherence to policies, and procedures/standards •Proactive, aiming to prevent problems •Process oriented •Designing processes to minimize problems (Standard Operating Procedures) •Snapshots of important activities >How medications are used relative to clinical practice guidelines >Studying medication turnaround time >Assessment of patient satisfaction with medication counseling
Name data sources for population health assessment
Lab, pharmacy, and clinician documented information (EHR) Health insurance claims Self-reported questionnaires ● Combine/use data from all 3 sources above, analyze, and use to make changes/recommendations
Construct a CMA analysis for a simple medication or pharmacy related comparison
Lyrica vs pregabalin (same efficacy, different costs)
Learn one tool that can be universally used to assess quality, including each of its steps.
PDSA: Plan-Do-Study-Act model For ex: Missing meds on the nursing units - Identify the problem - Why is this important: pts aren't getting their meds? - Where are we now: current condition is not having enough meds - Where you we want to be: have enough meds - Root cause analysis: what are the causes?
In outcomes assessment, what is the importance of "perspective" - whose perspective are you taking when conducting an outcomes assessment? What are the 3 most common perspectives to take in outcomes assessment?
Patient, Payer, Society
Describe a QALY. How is it used?
Quality Adjusted Life Year (QALY): health outcome measurement unit that combines duration + quality of life # of QALYs in one year is: where Q is the health-related quality of life weight attached to the relevant year of life Used to primarily correct someone's life expectancy based on the levels of health-related quality of life they are predicted to experience throughout the course of their life, or part of it Purpose: a means of quantifying the health effect of a medical intervention/prevention program ultimately to help payer allocate healthcare resources QUALY= (Utility value) x (relevant year of life)
What are the differences between randomized controlled trials and real-world data?
Randomized clinical trials: - controlled setting - academic/research institutes - limited number of sites - narrower inclusion criteria - typically shorter follow-up - clinical and safety - well established tool Real world data: - real world, reflect actual practice - various treatment settings, e.g. community, public, academic - many treatment centers - broad inclusion/disease based - typically longer follow up - also real world HCRU (health care resource utilization) and cost - opportunity to develop new tools
Demonstrate how ICER is derived and explain what it means. Be able to calculate an ICER for a comparison between two or three drugs, given the cost and the outcome/efficacy (QALY) value
Simple Incremental Cost Effectiveness Ratio (ICER) = Cost/QALY (cost(C)+ADR cost(C))/outcome decrease(C) (or increase) = Cc (cost(B)+ADR cost(B))/outcome decrease(B) (or increase) = Cb Ec = outcome of C; Eb = outcome of B (Cc-Cb)/(Ec-Eb)= additional cost for an additional unit of effectiveness
Donabedian model - QUALITY IMPROVEMENT
Structure (inputs) - static characteristics - patients, equipment, supplies, training, environment (e.g. 24 H CCM coverage) Processes (steps) - coordination, physician orders, nursing/resp rx (e.g. VAP, sepsis, EGDT) - guidelines, techniques used, wait times. Outcomes of Care (outputs) - clinical outcomes, functional status, satisfaction, costs (e.g. mortaliity)
Andersen Aday Model
Structure: - environment (health system, ext environment) - population characteristics (predisposing, enabling, need) Process - Health behavior (personal health practices, use of health services) Outcome - outcomes (perceived health status, evaluated health status, satisfaction)
T/F CBA is not used much in clinical literature because of its limitations
T
T/F CMA is the simplest of the 4 types of analyses
T
T/F most post-marketing surveillance programs are based on case series design
T
T/F CBA is rarely used in formulary decision making
True
T/F Population health does not equal distribution of health
True
Explain the difference between true outcomes and surrogate outcomes and why you would need to use the latter.
True outcomes or clinical outcomes directly measure whether a person in a trial feel or function better or live longer. Surrogate outcomes may be used to substitute clinical outcomes because they are reasonably likely to predict clinical benefit (ex. BP) May be used in place of clinical outcomes when: 1. clinical outcomes take a very long time to study 2. clinical benefit of improving surrogate endpoint is well understood (BP) 3. conducting a clinical endpoint study would be unethical
Explain the common models used to describe the relationship between patient, environment, social, system, and global factors with outcomes
Wilson-Clearly Andersen Donabedian
A _______ would account for all societal benefits and costs
cost-benefit analysis
T/F Perspective of the study will guide you in choosing which costs to use
direct medical costs direct non medical costs indirect costs (opportunity cost)
Describe the Quality-Cost Relationship
excessive care/harmful excessive care/not harmful insufficient care/not harmful insufficient care/harmful
Wilson-Clearly model
individual characteristics Biologic & physiologic variables Symptom status Functional status General health perceptions Overall quality of life characteristics of the environment Non-medical factors
Briefly describe the basic principles of Markov modeling
modeling procedure used to "calculate" costs when: ● Disease progresses over time ● Events can happen more than once Assumption: patient is always in one of a finite number of discrete health states Evaluation process: ● Different options exist ● Monte Carlo (also serves as sensitivity analysis) ○ Based sampling distributions of all model inputs ○ Computer randomly simulates 10,000 iterations through the model
Who develops guidelines and MUE criteria for use?
multidisciplinary
Explain utilities and how authors of a pharmacoeconomic study determine them
the desirability of or preference for a particular state of health - An attempt to evaluate the quality of a state of health - Expressed as a fraction 0 to 1 - Several methods to obtain: - Rating scales - Direct measurement - Time trade off (TTO) - Offered choice of Y time in current state of health (ill) or X time in perfect health - X/Y, conceptually, is the utility - Standard gamble (SG): 2 choices - A - stay in current state of health - B - treatment that will either produce perfect health (p) or death (1-p) - The probability (p) where patient is indifferent, conceptually, is the utility
Define the time horizon for a pharmacoeconomic study
the duration of time evaluated by a model. Short term is often 1-3 years. Longer time horizons are often preferred for societal perspective models
Explain what is meant by a base case in an economic analysis.
the most likely or expected case in a PE model. Typically, results of the model using the "average" of parameters
Explain what is meant by the perspective in a pharmacoeconomic model
the viewpoint used to design the analysis. Common perspectives include: patient, provider, payer, society. The most comprehensive is societal
List the 8 essential medication related responsibilities linked to improving patient safety (APhA)
•Ensure access to medication •Supply medication information •Evaluate medication appropriateness •Improve medication adherence •Assess health status •Provide health and wellness services •Medication management Coordinating care transitions
Continuous Quality Improvement
•Process of becoming better by building upon traditional quality assurance methods and emphasizing the organization and systems •Ongoing monitoring •30 day readmission rates •Compliance with non-formulary drug policy •When problems occur, work to identify root causes of the problems •Identify and conduct interventions to eliminate the causes of the problem •Measure again, to see if problems were impacted
Quality Control or Quality Assessment
•The procedure undertaken to ensure the identify and purity of a pharmaceutical product/calibration and maintenance of equipment/ensure the quality of a system, such as the medication use process •Reactive, identifying problems that have occurred •Testing products, evaluating error reports. •Standardized assessment of equipment/products •End product testing of compounded products •Calibration of scales, running maintenance for software updates, user testing of EMR order entry software, bubble point testing of filters after use •Quality control must be documented and accessible in the event performance is called into question
List patient and healthcare/professional related risk factors associated with medication related problems
•the number of medications used by the patient, •increased patient age, •the number of comorbidities, •use of anticoagulants, •cases where more than one physician was involved in patients' care •care being provided by family physicians/general practitioners.
Difference between cohort and case-control studies
■ Based on recruitment strategy: ● Cohort studies are based on the presence or absence of an exposure, then subsequent disease course is then studied ● Case control studies are based on the presence or absence of a disease, and their antecedent exposures are then studied
Examples of CMA analyses:
■ Comparison of brand vs generic versions of the same product ■ Comparison of different routes of administration of the same drug ■ Comparison of the use of the same drug in two different settings, such as the use of TPN in the hospital vs at home ■ Often CMA is conducted "in-house" by a hospital, clinic, or health plan to determine the least costly option. For example, policies on inpatient vs outpatient care delivery; policy initiation for tiered copay requirements for expense drugs within a class of drugs
What is the difference between convergent construct validity and discriminant construct validity?
■ Convergent validity - evidence from different sources indicate that the same meaning of the domain or construct is being measured ■ Discriminant validity - evidence from different sources indicate that the domain or construct does not correlate with other measures that are intended to be different
CMA - equivalence studies vs superiority studies:
■ Equivalence studies: look to demonstrate that the true difference between two therapies is unlikely to be outside a predetermined range. That is, the results of two or more interventions are within a range that would be considered clinically equivalent ■ Superiority studies: demonstrate that at least one intervention is superior in its results compared to one or more other interventions. If is considered clinically superior
What is the Triple Aim and how is it related to measuring outcomes?
■ Improving the patient experience of care (including quality and satisfaction) ■ Improving the health of populations ■ Reducing the per capita cost of health care
What does it mean when a survey scale or question has good responsiveness?
■ Instrument's ability to detect change ■ Presence of ceiling or floor effects influences an instruments responsiveness ● ceiling effect - scores of a group tend to congregate around the highest or best possible score ● Floor effect - scores of a group tend to congregate around the lowest or worse possible score ■ Example: SF-36 scores in relatively healthy younger sample ● SF-36 are 36 items selected from a larger pool of times used by RAND in the Medical Outcomes Study; two versions; developed from a longitudinal observational student - examined influence of characteristics of providers, patients, and health systems on outcomes of care
Problems with demand in pharmacy
■ Moral hazard: The additional quantity of health care demanded due to a decrease in the net price of health care attributable to insurance ● Potential solutions to moral hazard: Cost Sharing, Utilization Review, or Gatekeepers ■ Asymmetric information: Do consumers understand the costs and benefits of a drug therapy? Adverse selection: Occurs when "high-risk" consumers enroll in a plan composed of lower-risk individuals to secure low premiums, or vice-versa ● Potential solutions to adverse selection: Risk rating or Universal coverage
Describe the strengths and weaknesses of CMA - where it is most useful
■ Strength: simplest of the 4 analyses ■ Weakness: do not incorporate the distribution of costs and outcomes among different patient groups, analysis themselves are costly to perform
Supply and Demand curves, what is demand shift? What happens to price when demand changes, all other things being equal?
■ The amount of healthcare we buy depends on its price: If the price goes down, we demand/buy more; If the price goes up, we demand/buy less ■ Demand shift" refers to a shift in the demand curve (pls use common sense[1] ) ● Essential needs are inelastic - consumer will use at any price ● Optional services are elastic - consider will only use at a lower price
Where do outcomes data come from?
■ The patient ■ The medical record ■ Health system data warehouse ■ Administrative claims data ■ Large nationally representative surveys ■ Registries ■ MUE activities
Determine relevant methods to obtain data to use in CMA analysis
○ CMA data sources: ■ Your own ● Conduct a utilization review to obtain data on the utilization and outcomes associated with your own institution or clinical practice ■ literature ● Use of randomized controlled trials, observational studies, non-randomized trials, and other post-marketing studies
Compare CMA to other basic types of pharmacoeconomic analyses
○ CMA: effect of two intervention is the same; valuation is in dollars ○ Cost-effectiveness evaluation (CEA): effect of one intervention is superior, outcome measured in natural units, valuation in dollars ○ Cost -utility evaluation (CUA): effect of one intervention is superior, outcome in healthy years, quality adjusted life years, valuation in dollars ○ Cost-benefit evaluation (CBA): effect of one intervention is superior, outcomes expressed in dollars, valuation in dollars
Who uses p.econ information?
○ Clinicians ○ Pharmacy administration ○ Managed care pharmacists ○ Drug info pharmacists ○ Leaders and best
What is confounding and why is it important in p epid analysis?
○ Confounding: direct interdependency on treatment choice with health status, severity of disease, and prognosis ■ It's the real world you're analyzing! ○ Challenges arise when not all confounding variables are available within the data you are using ○ Example: ■ Medication adherence studies using administrative claims data ● Patient age, gender only ● Pharmacy claim for a dispensing that includes quantity, days supply, and information about the medication dispensed such as name, strength, dosage form ● What other factors are necessary to include if you want to determine reasons for nonadherence in a population using claims data to general a medication possession ratio or proportion of days covered?
Understand the difference between the various types of pharmacoeconomic modeling designs and briefly describe each of the study types below, focusing on the outcome measure that the results will produce.
○ Cost Minimization Analysis (CMA): comparison of costs of 2 or more alternative therapies assuming that they have equivalent (identical) outcomes. Goal is to find the least expensive alternative. Total cost is key unit. ○ Cost Benefit Analysis (CBA): compares value of resources consumed (costs) in providing an intervention or program against the value of the outcome (benefits) from the intervention or program ■ Applications: most common application is to determine relative value of different programs or services. Rarely used in formulary decision making. ■ Limitations: ● Difficult to value in dollars intangible health benefits or clinical outcomes ● Methods to assign dollar values to lives saved or outcomes are controversial ● Not used much in clinical literature because of these limitations ○ Cost Effectiveness Analysis (CEA): a form of economic valuation in which the goal is to identify and compare the relevant costs and consequences of competing drug regimens and interventions ■ Costs are reported as the mount spent to achieve a particular outcome ■ No intrinsic value is placed on the outcome ■ Advantages: ● Compares different treatments with similar outcomes ● Cost-effectiveness is based on the best value ■ Key outcome of CEA is whatever parameter you wish to measure ■ Outcomes can be natural units or synthetic ■ Incremental cost-effectiveness: assesses the additional cost that one option imposes over another option compared with the additional benefits it provides ■ Limitations: ● Does not address the question of whether a particular outcome is worth pursuing in the 1st place ● Leaves interpretation up to the end-user as to whether the amount spent per outcome is worth it ● Often assumptions must be made in analysis ○ Cost Utility Analysis (CUA): subset of CEA ■ Be aware that many use the terms CEA and CUA interchangeably ■ If utilities or QALYs are used in the analysis, it is CUA ■ Utilizes a methodology that the outcome should be adjusted based on preferences or beliefs about the merits of different outcomes ■ Incorporates people preferences or beliefs about the outcome ■ Results shown as cost per utility or cost per QALY
Explain two economic models and how they can be applied in the pharmacy setting
○ Decision analysis ○ Markov models ■ Used indecision trees to help simplify, or "debush" ■ Used when patients transition between distinct disease states ■ Key items to identify: health states, allowable transitions, cycle length, transitional probabilities, outcome values ○ Willingness to pay ○ Threshold analysis
What is discounting and be able to describe why it is used
○ Discounting is when you take future costs and modify them to reflect future dollars in terms of current dollar values ■ One example is the use of the Consumer Price Index (CPI) for the year of the start of the intervention. All future costs are multiplied by the CPI
Understand the three basic components of the ECHO model and how it applies to medication utilization and pharmacy practice. Be able to provide examples of measures for each of the three components of the ECHO model that you would include in a study to determine the outcome of some intervention.
○ ECHO = Economic, Clinical and Humanistic Outcomes ■ Clinical outcomes: medical events that occurs as a result of disease or treatment ● Clinical outcomes and indicators may be affected by "treatment modifiers" (compliance to therapy, provider/pt relationship) ■ Economic outcomes: direct, indirect, and intangible costs compared with the consequences of medical treatment alternatives ■ Humanistic outcomes: consequence of disease or treatment on patient functional status or quality of life ○ Example: Diabetes ■ Clinical: A1c, BG ■ Economic: out of pocket cost to patient for medication, BG related hospital or ER visits, costs associated with MTM, labs ■ Humanistic: side effects of therapy, satisfaction with treatment and monitoring, beliefs ■ Process: foot exam, eye exam ○ Purpose ■ Depict value of a pharmaceutical product/service as a combination of traditional clinical-based outcomes with more contemporary measures of economic efficiency ■ Used to assist healthcare professionals in planning, conducting, and evaluating pharmaceutical products/services from a multidimensional perspective
Define health related quality of life. What are dimensions of health related quality of life that are commonly measured in either general or disease specific measures? Who is most likely to provide the most accurate assessment of a patient's health related quality of life?
○ Health related quality of life (HQL): ■ Patient-reported outcome assessing the outcome of treatment ■ Valid supplementary endpoint to biologic and physiologic endpoints ■ Primary endpoint ■ Varies by disease and/or treatment ■ Can predict response to treatment, resource utilization, and mortality ■ HQL is a patient-derived measurement that complements physiologic and clinical marker of illness and/or treatment ■ Measurement of HQL can benefit health services research (HSR) by providing advanced theoretical and empirical approaches for studying outcomes ■ Health status measures provide a way to move from measuring outcomes to improving care for groups and individual patients ○ Dimensions of HQL: ■ Physical health ■ Mental or emotional health ■ Social ■ General health ■ Overall well-being ■ Self-related health
What is MedWatch?
○ MedWatch: FDA adverse event monitoring program ■ Spontaneous reports of adverse reactions ■ Provides monthly updated data about ADRs and mandated label changes to approved products ■ Gave the FDA more information about medication related problems once a medication approved for use ■ 51% of medications approved by FDA have serious adverse effects not detected before approval
What is the role of the P and T committee and drug formulary in the MUE process?
○ P & T committee ■ The Pharmacy and Therapeutics (P&T) Committee is charged with monitoring and evaluating drugs and drug therapy within the University of Michigan Health System (UMHS) ■ P&T will review and make recommendations regarding drug use with consideration of clinical efficacy, safety, and cost ■ The MUE Committee is a subcommittee of P&T ○ The formulary ■ Medications can be added to formulary with restrictions to: ● Specific indications/conditions/criteria for use ● Specific prescribers ● Specific units ● Inpatient vs outpatient ■ Medication restrictions are often used for medications that are: ● High-cost ● Narrow therapeutic windows or serious adverse events ● High potential for misuse/off-label use
Define pharmacoepidemiology (p epid).
○ P epid: study of the use and effects of drugs in large numbers of people ■ Quantify drug use patterns and adverse events ■ Tied to outcomes of drug use
Define MUE, describe the types of MUEs
○ Performance improvement method that focuses on evaluating and improving medication-use processes with the goal of optimal patient outcomes ○ MUEs can focus on a medication or therapeutic class, disease state or condition, medication use processes such as prescribing, dispensing, administration, and monitoring, and various practice settings within a health system ○ Types of MUEs ■ Retrospective: a review of a medication after the patient has received it ■ Concurrent: ongoing review of a medication during the course of treatment ■ Prospective: Review of a medication before the patient has received it
Why are open ended questions useful in a survey? What are some problems associated with using open ended questions?
○ Pros: ■ If little known about the concept ■ Gives respondents a chance to present strong opinions ■ Useful after close ended question to gain additional information ■ Useful to gain an estimate rather than exact data ■ Targeted single concept is needed (i.e. What state do you live in?) ○ Cons: ■ Do not provide choices to select ■ Can be very demanding on the respondent ■ May produce highly varied responses ■ Rarely provide consistent information ■ Time intensive to enter into a dataset
What are the primary findings of the RAND Health Insurance Experiment?
○ The RAND HIE Results: ■ Cost sharing reduced spending for all health care services ■ Participants with cost sharing made fewer medical visits and were admitted to hospitals less frequently ■ On average, cost sharing had no adverse effects on participants' health outcomes ■ Cost sharing did have a negative impact on the sickest and poorest patients ○ The RAND HIE Conclusions: ■ Cost sharing can cut costs and reduce waste without reducing health or quality of care for most people. ■ So, why should the RAND findings not be used to justify higher cost-sharing for everyone? ● Care worsened for the sickest and poorest patients. ● Cost sharing may not help those in most need
What are the 2 basic types of adverse drug effects (type A and B) and explain
○ Type A: those that tend to be common, dose-related, predictable and less serious ■ Usually treated by simply reducing the dose of the drug or withdrawing therapy ■ Tend to occur in patients that: ● Receive more of the drug that is generally required ● May have received conventional amount of drug but they metabolize or excrete the drug unusually slow ● Have normal drug levels, but are overly sensitive to them ○ Type B: tend to be uncommon, not related to dose, unpredictable, and potentially more serious ■ Usually require cessation of the drug ■ May be due to hypersensitivity reactions or immunological reactions ■ May be some other idiosyncratic reaction to the drug ● Genetic susceptibility - glucose 6 phosphate dehydrogenase deficiency ■ Most difficult to predict ● These are the ADRs that often show up only after many thousands or even millions of people have been treated with the medication after approval of use
What are the differences between general and disease specific health related quality of life instruments?
○ Types of health-related quality of life instruments: ■ General vs disease specific ● General: ○ Broad in scope of measurement ○ Can be applied across disease states/treatments ● Disease specific: ○ Focused on issues related to disease or treatment
Understand the rationale and usefulness of MUEs in the health care setting
○ We do MUEs to ensure safe and effective use of medications and to improve patient outcomes. ○ Joint Commission MM.08.01.01 - the organization evaluates the effectiveness of its medication management system ○ Compliance with institutional criteria ○ Cost containment ○ Identify areas of improvement in the medication use process
What does it mean when a survey scale or question has good test-retest reliability?
○ test-retest reliability: ■ The relationship between scores obtained by the same person on two or more separate occasions ■ Estimated using the intraclass9 correlation coefficient (ICC) or Pearson correlation coefficient
Describe a patient-centered medical home and how including pharmacists have improved population health
● A team is working on a patient in a medical home → is a comprehensive, patient-centered, coordinated, accessible primary care delivery system (delivery of GOOD care!!!) ○ Physician-led, team-based ○ Considered "whole-person-oriented" care ● Promotes evidence-based, high quality care ● Promotes value-based payments for Tx → OVERALL PCMHs SAVE THE HEALTH SYSTEM MONEY (due to decreased hospitalizations/ER visits) ● Is possible with the use of health information technology (EHRs and stuff help track and communicate with patients) and continuous quality improvement strategies ● How pharmacists improve population health by working on this team: ○ Conducts comprehensive med review ○ Promotes collaborative medication management and interventions ○ Assesses/ensures adherence ○ Ensures quality and safety of care ■ E.g., for HTN and diabetes → ordering labs, using appropriate medications, foot exam, immunizations, etc. ○ Can help determine SDOH that impacts patient's health
Identify individual, social, system factors associated with population health
● Individual factors ○ Diet ○ Activity level/exercise ○ Alcohol consumption ○ Self-identity ● Social factors ○ SDOH: food and pharmacy deserts, housing ○ Racism ○ Education ● System factors ○ Access to healthcare (insurance, health services locations) ○ Politics
What types of medications are typically used for MUE?
● Medications with restrictions recently added to formulary ● Medications that have a high cost for the institution ● Medications with a high rate of adverse events at the institution ● Medications with high potential for safety events (significant drug-drug interactions, drug-food interactions, adverse events)
Name a population health indicator in Healthy People 2030 that pharmacy could impact
● Nutrition, physical activity, and obesity → educating patients on the importance of lifestyle in managing chronic conditions ● Tobacco use → counseling on cessation and in some states, pharmacists prescribe cessation agents ● Substance abuse → knowing resources for help/rehabilitation ● BP control → pharmacists screening for HTN ● New cases of diagnosed diabetes → pharmacists screening for diabetes ● CV event → cholesterol treatment (recommend statin), BP control/screening, promoting adherence ● Hospitalizations → educating patients how to properly manage and monitor their chronic conditions ● Oral health → screening for ADRs of xerostomia, counseling patients to rinse mouth after ICS inhaler use
Conceptualize how pharmacy and pharmacists can impact population health
● Pharmacy ○ Responsible for dispensing medications that help patients manage all health conditions ● Pharmacists can impact population health by... ○ Counseling patients on chronic condition management (and general counseling about medications) ○ Knowing resources that will help patients with SDOH needs ○ Counseling/inquiring about smoking cessation ○ POC (point of care) testing patients for chronic conditions (HTN, diabetes) and other diseases/infections (HIV)
Utility value (quality of life)
● Ranges from 1 (perfect health) to 0 (dead) ● Various methods of determining utility value: ○ Time trade off (TTO): respondents choose between remaining in an ill state or being restored to perfect health with a shorter life expectancy ○ Standard Gamble (SG): respondents choose between remaining in an ill state or choosing a medical intervention which has a chance of restoring them to perfect health or killing them ○ Visual analogue scale (VAS): Most subjective. Respondents rate a state of ill health on a scale of 0-100. 0 = dead and 100 = perfect health ○ Standard descriptive systems (ex. EQ-5D): questionnaire which categorizes health into five dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression)
Name the different levels of intervention for population health assessment and intervention and provide examples
● System level: requires large scale action to address a problem and facilitates change in organizations, policies, laws, structures, etc; creates a long-lasting effect on individuals ○ Example: state-wide smoke-free air law ● Community/social level: focuses on an entire community or just certain groups within that community; forms partnerships within a community and aims to change norms, attitudes, awareness, practices, and behaviors. ○ Example: social marketing campaign to get COVID-19 vaccines ● Individual and family level: intervention is targeted at members of an "at-risk" population; protects communities from threats to health caused by an individual's actions; aims to change behaviors, attitudes, skills and knowledge ○ Example: promoting breastfeeding among families in the WIC (women, infant, children) program of Michigan