Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
82 Cards in this Set
- Front
- Back
Kefauver-Harris Amendment to the Food, Drug and Cosmetic Act
|
All new drugs must be approved by the FDA as being both SAFE and EFFECTIVE.
|
|
Institutional Review Board (IRB)
|
Local scientists and non-scientists that oversee clinical research and approve the clinical trial protocols.
|
|
informed consent
|
a document, NOT a contract, that includes details (risks/benefits) of the clinical study for participants to know.
|
|
FDA's Division of Scientific Investigations (DSI)
|
conducts inspections of clinical study sites and makes sure study was conducted according to the plan.
|
|
Clinical Study Phase I
|
- small group of healthy subjects (20-80)
- safe dosage range, route, and adverse effects, safety, initial tolerable dose. |
|
Clinical Study Phase II
|
- 100 to 300 volunteers with disease.
- effectiveness, side effects, initial dose and usual dose - Most important phase. |
|
Clinical Study Phase III
|
- 1000-3000 volunteers
- verify effectiveness, monitor adverse reactions from long-term use. |
|
Clinical Study Phase IV
|
- Post-marketing surveillance (after the product has been approved)
|
|
Within how many days sponsors must report adverse drug events to FDA?
|
15 days.
|
|
Waxman-Hatch Act
|
provided for an Abbreviated New Drug Application (ANDA) and an accelerated procedure for approval of generic versions.
|
|
Orphan Drug Act (ODA)
|
Incentives for sponsors to develop products for rare diseases.
|
|
pharmaceutical care
|
the responsible provision of a drug therapy for achieving specific outcomes that improve a patient's quality of life.
|
|
Key differences between Orkin person and pharmacist?
|
- higher consequences of action
- autonomy |
|
What define a profession?
|
• Autonomy
• Specialized knowledge • Community sanction • Ethical codes • Culture that members subscribe to – professionalism • Prestige • Long schooling |
|
Role strain
|
Frustration due to lack of education/training, focusing on job instead of profession, automation technology.
|
|
Role Ambiguity
|
the job expectations are ill-defined
|
|
Person-role conflict
|
the values, attitudes or personal needs of the individual are not congruent or in opposition to the role expectations of a job.
|
|
Intrarole conflict
|
different individuals define the job expectations for a person
good guy - bad guy role, |
|
Interrole conflict
|
too many different roles to fulfill
|
|
seven processes that make up the medication-use system
|
1. Physician drug therapy decision process
2. Physician Order Process 3. Pharmacy Order Input Process 4. Pharmacy Dispensing Process 5. Medication Administration Process 6. Medication Use Documentation Process 7. Drug Therapy Outcome Evaluation Process. |
|
What is the strongest predictor of good health?
|
Education (part of Socioeconomic status)
|
|
Indicators of Socioeconomic status
|
Education
Occupational Status Income |
|
Main difference between medical model and biopsyschosocial model
|
Medical model doesn't include social well-being, while biopsychosocial model does include social well-being.
|
|
Parson's socio-cultural model
|
- health is defined as the capacity to function socially.
- illness is a disturbance of the capacity to perform expected tasks or roles. - illness is non-tolerated. - people can be optimal in functioning, and be biologically ill (Ex. diabetic worker) - Sick Role |
|
Stress model
|
stress is cumulative and may cause illness; degree of stress measured as a mount of readjustment.
|
|
definition of health
|
state of complete physical, mental, and social well being and not merely the absence of disease or infirmity.
|
|
medical model
|
health as the absence of signs and symptoms.
|
|
health behavior
|
things we do to prevent illness
|
|
illness behavior
|
things we do when we are ill.
|
|
4 aspects of Sick Role
|
1. Non-responsibility of the individual for the condition. (patient didn't choose to get sick)
2. Exemption from normal obligation (time off work) 3. Being sick is undesirable (must try to get better 1st thing) 4. Obligation to seek competent help. |
|
5 problems with illness behavior
|
1. Shopping for doctors
2. Fragmentation (treatment by different doctors) 3. Procrastination 4. Self-medication 5. Discontinuity (interrupting treatment) |
|
Suchman’s Stages of Illness and Medical Care Model
|
1. Symptom Experience
2. Assumption of Sick Role 3. Medical Care Contact 4. Dependent Patient Role 5. Recovery or Rehabilitation. |
|
Health Belief Model
|
health behavior theory that describes the likelihood an individual will take an action to change a behavior. Components of this theory include susceptibility and severity of disease, perceived benefits and barriers, cues to action, self-efficacy, and demographic, socio-psychological variables.
|
|
Social Cognitive Theory Model
|
Healthy behaviors are a function of individual's perception of the advantage of a a positive outcome. belief that a certain outcome will result from particular behavior
|
|
Readiness to Change Model
|
desires to change a patient's health behavior must be specific to the stage in which they are in.
|
|
Locus of Control Model
|
based on the idea that an individual's success at reaching a desired outcome is a function of whether or not he believes the outcome is within their control.
|
|
What core clinical services have the highest number of favorable association because they focus on a smaller group of patients.
|
1. Clinical Pharmacists
2. Decentralized Pharmacy 3. Drug Protocol Management |
|
In the early 20th century, many "patent medicines" were considered dangerous and fradulent in their claims and led to the passage of what act?
|
Pure Food and Drug Act
|
|
Dichter Institute Study commissioned by APhA
|
report found that most respondents saw pharmacists as businessmen rather than health care providers.
|
|
Durham-Humphrey Amendment to the Food, Drug and cosmetic Act
|
created the “legend” drug, required label to state that it could not be dispensed without a prescription
|
|
major piece of legislation to affect the efficacy of prescription drug
|
Food, Drug and Cosmetic Act of 1938
|
|
HIPAA
|
Health Insurance Portability and Accountability Act
enacted to decrease the number of uninsured person; specified that employers or insurers of new employees could impose a waiting period of no more than 12 month before covering them under the employer’s health plan. |
|
definition of quality
|
the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge
|
|
Millis Commission’s report
|
pharmacists inadequately prepared in systems analysis and management skills
|
|
Medicare Prescription Drug Improvement and Modernization Act (MMA 2003)
|
recognizes the need for medication therapy management services in ambulatory care; positions pharmacy to fulfill role in reducing drug-related morbidity and educating older adults on proper pharmacologic and nonpharmacologic management of comorbid diseases
|
|
JCAHO
|
Joint Commission on Accreditation of Health Organizations
|
|
T/F. drug ordering process is the single greatest source of preventable problems
|
True
|
|
Multidisciplinary care
|
many different professionals work for the good of the patient, albeit somewhat independently
|
|
Interdisciplinary care
|
many different professionals working together for the patient’s good also communicate effectively among themselves and with the patient
|
|
What is discounting?
|
the process of converting dollars, either paid out or received over time periods of more than one year, to their present value. the purpose is to incorporate the time preference for money into the analysis
|
|
Kerr-Mills Act
|
Amendments to the Social Security Act in 1960 provided health care coverage to elderly indigent individuals
Kerr-Mills did not provide health care coverage to the nonindigent elderly or the indigent nonelderly. |
|
4 P's of marketing
|
Product
Place Price Promotion |
|
One other thing that separates the pharmaceutical industry from other consumer goods is that purchase decisions are not made based on emotion, but on _________.
|
Knowledge!
|
|
Pharmacy Benefit Manager (PBM)
|
a company that adjudicates rx drug claims and manages the rx drug coverage for third party payer by containing costs and influencing the quality of services provided.
|
|
per diem
|
hospitals are paid a flat rate for each day of hospital care provided to covered individuals without regard to the actual costs incurred.
|
|
Managed Care Organization (MCO)
|
manage the cost and quality of health insurance program.
This vs. fee-for-service plans is the use of provider network. |
|
Steps for Conducting a pharmacoeconomic analysis
|
1. define problem/state objective
2. Perspective 3. Alternative Interventions 4. Identify and Measure outcomes 5. Identify Cost Elements 6. Measure and Value Costs |
|
What is Pharmacoeconomics?
|
one type of OUTCOMES RESEARCH that is useful in selecting among ALTERNATIVE INPUTS to achieve HEALTH AND ECONOMIC CONSEQUENCES often called OUTCOMES.
|
|
Four domains of Quality of Life
|
Physical
Psychological Social Economics |
|
What is need and why is need difficult to measure?
|
Need is the estimated amount of care based on the perceptions of an individual. If's difficult to measure because it's a perception.
|
|
disease management
|
process of case management of patients having selected chronic diseases at risk for high utilization of health care resources.
|
|
3 demand-side markets.
|
1. patient's demand for medical treatment
2. Institutional demand for manpower, capital, and supplies. 3. Demand for health professional education. |
|
3 supply-side markets
|
1. Physician's decision on which institutional setting to use.
2. Supply of manpower that is produced by training programs. 3. Implementation of health profession education programs. |
|
Education has what effect on demand for medical services?
|
Decreases
|
|
demand for health
|
health is like a consumption commodity: acquire it, consume it, and receive good outcome.
demand for health is behavioral. |
|
Barriers to disease management.
|
lack of time
lack of good information system third-party payer |
|
Donabedian's model of quality
|
Structure --> Process --> Outcome
Structure (availability of capital resources, leadership, management systems, policies, procedures Process (measurement of specific activity (error/100 dose dispensed) Outcome: population based - satisfaction, # of hospital readmissions |
|
quality assurance
|
measurement of the quality of care including both the assessment of care and feedback to the health care organization that recommends either a continuation or change in care
demonstrate that the service meets a set of pre-determined requirements or criteria |
|
quality control
|
ensuring that a product conforms to a desired standard by emphasizing monitoring and measurement
|
|
quality improvement
|
measurement of defects; ensure that the effects of change to correct a problem
The most common QI methodologies used in health care are PDSA (plan-do-study-act), six-sigma and lean strategies. |
|
Total Quality Management
|
a philosophy and management strategy.
|
|
Framework for improving quality
|
1. Design
2. Measure 3. Assess 4. Improve 5. Redesign |
|
PDSA
|
Plan
Do Study Act |
|
LEAN
|
LEAN focuses specifically on removing non-value activities which is called waste in Quality speak
|
|
what is an indicator?
|
A valid and reliable measurement.
|
|
benchmarking
|
process by which one organization identifies and studies superb performance of another organization and uses their performance as a standard to achieve.
|
|
root-cause analysis (RCA)
|
problems are best solved by correcting or eliminating the root cause rather than finding a quick fix that acts as a band-aid.
|
|
FMEA
|
Failure Mode and Effect Analysis
takes a broader view of the problem to see if there are external contributing factors. |
|
OBRA
|
Omnibus Budget Reconciliation Act: repeal capitation for health professionals
|
|
Prescription Drug Plan (PDP)
|
Medicare part D
PDP’s are private insurance companies that contract with a prescription benefit manager (PBM) to offer a drug benefit that can have several tiers depending on the coverage |
|
Iron Triangle of Health Care
|
access
quality cost Can't change one without changing the other. |
|
CDER
|
Center for Drug Evaluation and Research: make sure drugs are safe and effective.
|