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Flashcards in Final Exam Review Deck (73):
1

• FDA Medwatch : National ADR Reporting

o Required by FDA to monitor/report ADRs of medical products in US
o Available to consumers & health care professionals

2

• Patient Safety Organizations

o Provide confidentiality & privilege protection to organizations
o ISMP : Institute for Safe Medication Practices
♣ FDA Medwatch partner
♣ Publishes safety alert newsletters

3

• Practice models

o Drug-Distribution Centered: Pharmacists stays in pharmacy; only dispenses
o Clinical pharmacist centered: Pharmacist plays active role

4

Indemnity:

patient pays up front & then requests reimbursement

5

• Medication Use Process

o Selection/Storage → Prescribing/Transcribing → Dispensing → Administration → Monitoring = Outcome

6

• Quality Improvement Model

o Plan : change or test
o Do : testing, carry out plan
o Study : summarize
o Act : adopt strategy, determine what changes are to be made

7

• Drug Scheduling Criteria:

♣ How much risk for addiction
♣ Is there an approved use?
♣ Is there appropriate safety data? (potential for dependence)

8

• Medication errors are preventable. True or False?

True

9

• Role of the pharmacist:

safety & equality

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APhA

o American Pharmacists Association
♣ Oldest & largest

11

NCPA

o National Community Pharmacists Association
♣ Independent Community Pharmacists

12

ASHP

o American Society of Health-system Pharmacists
♣ Hospital & health systems

13

NPhA

o National Pharmaceutical Association
♣ Minority representation

14

AAPS

o American Association of Pharmaceutical Scientists
♣ Drug discovery

15

ACCP

American College of Clinical Pharmacy
 Residencies & Fellowships
 Publication : Pharmacotherapy

16

ACPE

o Accreditation Council for Pharmacy Education
♣ Accredits pharmacy schools & C.E.

17

AMCP

o Academy of Managed Care Pharmacy
♣ Health care outcomes & affordability

18

AACP

o American Association of Colleges of Pharmacy
♣ For educators

19

ISPOR

International Society for Pharmacoeconomics & outcomes research

20

ASCP

o American Society of Consultant Pharmacists
♣ Pharmacists in nursing homes, assisted-living, hospice, hospital, community pharmacy, mental health facilities, & home health settings

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NACDS

National Association of Chain Drug Stores

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BPS

o Board of Pharmacy Specialties
♣ Recognizes 8 specialty practice areas
• Ambulatory care, nuclear, nutrition, oncology, pharmacotherapy, psychiatric, pediatric, critical care

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TPS

Tennessee Pharmacists Association

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NABP

o National Association of Boards of Pharmacy
♣ Represents pharmacists, technicians, students
♣ Administers NAPLEX & MPJE

25

Joint Commission

Accredits hospitals

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• Health Maintenance Models

Capitation, Group Model, Staff Model, Network Model, Independent Practice Association

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Capitation

predicting cost over a given span of time

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Group Model

HMO contracts with large medical group offering services exclusively to HMO members

29

Staff Model

HMO directly owns facilities & hires employees

30

Network Model

nonexclusive contract
♣ Network can service HMO members & other types of models

31

Independent Practice Association

physicians have own practice but cooperate with HMO, as well as other patients

32

Diagnosis Related Groups (DRGs):

insurance will only pay a provider so much to treat a particular disease/disorder, and if the patient is readmitted for the same thing shortly after, the provider will not receive any more money

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• Continuum of Care (primary, secondary, etc.)

o Guides & tracks patients through a comprehensive, integrated health service & care

34

• Roemer’s Model

Organization, Management, Resources, Delivery of Services, Economic
,

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o Organization

♣ Enterprises, private markets, voluntary agencies, ministry of health, CDC, National Institute of Health

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o Management

♣ Planning, regulation, administration
♣ Legislation : create policies
♣ Judicial : carry out policies
♣ Executive : hears infractions of policies

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o Resources

♣ Knowledge (training centers)
♣ Workforces, facilities, commodities
• HERSA : federally qualified health centers (low-income)

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o Delivery of service

♣ Primary Care : prevention
♣ Secondary Care : screening / early detection
♣ Tertiary Care : treatment
♣ Special Care : special pops (infants & elderly)

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o Economics

♣ Charity, insurance, gov’t sponsored, private pay

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Adverse selection

• waiting to get insurance until you get sick
o Insurance companies respond by;
♣ Benefit limits
♣ Underwriting
♣ Exclusion
o State responds to insurance by:
Community rating : average cost in pool

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• Medicare

o Part A : hospital, hospice, skilled care
o Part B : Medical (optional)
♣ Physician’s fees; medical supples
o Part D : Drugs & preventative care
o Paid for by trust fund (also social security)
o Covered Medications
♣ Generic drugs
♣ Medically necessary : caner, HIV/AIDS, antidepressants, antipsychotic anticonvulsive, immunosuppressants, barbituates (as of 2013)
o Not Covered Medications
♣ Weight loss, fertility, non rx, cosmetic, erectile dysfunction

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• Medicaid

o Eligibility : low-income, elderly, disabilities, pregnant women, children
o Required Coverage
♣ prenatal care, pediatrics, hospital services, nursing facilities, primary care, labs/x-rays, family planning
o Optional Coverage
♣ Physical & rehab therapy, optometry, out pt. drugs, prosthetic devices, transportation services, care facilities for the retarded
• Means test: whether or not your qualify for Medicaid
o Spend-down: patient spends so much on medical bills, may qualify for service (eg, medicaid)

43

Adverse Drug Reactions (ADR)

• any unexpected, unintended, undesired, or excessive response to a medication that requires some type of medical response or resulting in a negative outcome
o Not the same thing as a “side effect”:
♣ A negative / undesirable effect that occurs with normal use of a med

44

Adverse Drug Event (ADE):

an injury resulting from medical intervention related to a drug, which can be attributed to PREVENTABLE AND NON-PREVENTABLE causes

45

• Drug Formulary

o Key purpose: to discourage the use of marginally effective meds & treatments
o Managed by Pharmacy & Therapeutics Committee (P&T)
♣ Physician as chair
♣ Pharmacists, physicians, nurses, admin. as members

46

• 340B Drug Pricing Program

o requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices
o Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers

47

Use of ledgers (12 month period; plan for future expenses):

• Reduce cost / increase buying power
o Buy in bulk
o Buy weekly
o Group purchasing

48

Asynchronous Clinical Decision Support

• an alert that doesn’t pop-up at immediate time of entry; does not require immediate action

49

Synchronous Clinical Decision Support

immediate alert; requires immediate action

50

• 5 rights of medication administration

o Right Dose
o Right Patient
o Right Time
o Right Route
o Right Medicaiton

51

Just Culture:

a culture in which discipline is applied in a consistent manner based on the intentions of the individual & the circumstances in which he or she was working

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• Values of Healthcare System

o Access
o Quality
o Cost

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• Functions of Public Health

o Assessment
o Policy Development
o Assurance

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• FDA

o Under the dept. of health & human services

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Food & Drugs Act

o need regulation

56

Food, Drugs & Cosmetics Act

products must be safe (because of sulfanilamide)

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Durham-Humphrey

o must have prescription for certain meds

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Kefauver-Harris

products must be SAFE & EFFECTIVE

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o FDA Drug Approval Process:

♣ Pre-clinical Trials (1-2 years): drug discovery
♣ Clinical Trials: 4 Phases

60

Clinical Trials: Phase 1

• Phase 1 (~1 year): 20-100 healthy volunteers
o For safety & dose

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Clinical Trials: Phase 2

• Phase 2 (~2 years): 100-300 patient volunteers
o Begin testing for effectiveness

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Clinical Trials: Phase 3

• Phase 3 : 1000-3000 patients
o Blind studies: verify effectiveness

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Clinical Trials: Phase 4

• Phase 4 : after approval; long term safety

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• Pregnancy Drug Categories

o X = human fetal risk present
o New Categories
♣ 8.1 : from “Pregnancy” to “include labor & delivery”
♣ 8.2 : from “Labor & Delivery” to “Lactation”
♣ 8.3 : from “Nursing Mothers” to “Females & Males of Reproductive Potential”

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• Medication Therapy Management (MTM)

o medical care provided by pharmacists whose aim is to optimize drug therapy and improve therapeutic outcomes for patients

66

MTM, activities involved:

o Activities involved: performing patient assessment and/or a comprehensive medication review, formulating a medication treatment plan, monitoring efficacy and safety of medication therapy, enhancing medication adherence through patient empowerment and education, and documenting and communicating MTM services to prescribers in order to maintain comprehensive patient care

67

MTM, Five core components:

a medication therapy review (MTR), personal medication record (PMR), medication-related action plan (MAP), intervention and/or referral, and documentation and follow-up

68

“To Err is Human”

landmark report published by the Institute Of Medicine

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Drug Use Evaluation:

evaluation of data on drug use against predetermined criteria

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Meaningful Use:

• to be able to use CPOE
o Must use certified electronic health record

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o Main Components of CPOE:

♣ E-prescribing
♣ Electronic information exchange to improve quality of health care
♣ Electronic submission of clinical quality measures

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o List of specific objectives & quality measures that must be met:

• Accessibility
– Less time spent “chart chasing”
• Accuracy
– Pre-built order sets
– Improve regulatory compliance
– Proper use of evidence based medicine to improve patient outcomes
• Efficiency
– Decreased turnaround time for lab, radiology, and pharmacy orders
• Safety
– Reduced errors due to illegible or incomplete orders – Clinical decision support at the time of order entry

73

Value Base Purchasing:

incentive that rewards (or penalizes) acute-care hospitals with payments for excellence in health care delivery to medicare patients