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Healthcare > Exam 2 > Flashcards

Exam 2 Flashcards

1
Q

Establishes standards for vaccines and anti-toxins.
At the time, anti-toxins were made from inoculating horses and using their blood for serum. Children were dying because blood contained tetanus

A

Biologics Control Act (1902)

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2
Q

Prohibits the manufacture, sale, or transportation of adulterated or misbranded or poisonous food, drugs, medicines, or liquors

A

Food and Drug Act (1906)

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3
Q

FDA does not prevent companies from labeling remedies with any manner of false claims
Congress responds with ____________, which prohibits labeling of medicines with false claims to defraud purchaser

A

Sherley Amendment

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4
Q

Five factors of Fraud

A 
A false statement
Knowledge that it is false
Intent to deceive
Reliance on the statement by the consumer
Injury as a result
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5
Q

Manufacturers, importers, pharmacists and physicians handling or prescribing narcotics need to be licensed and taxed, while requiring a prescription for narcotics

A

Harrison Narcotic Tax Act (1914)

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6
Q

Establishes pharmacy as the sole outlet for liquor

A

Volstead Act (1920)

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7
Q

Compound created to treat throat infections in children, but caused a recall and over 100 deaths

A

Elixir Sulfanilamide (1937)

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8
Q

Elixir Sulfanilamide incident causes FDA to extend control to cosmetics and devices and requires new drugs to be proven safe.
Removes Sherley requirement of fraud in misbranding, while authorizing factory inspections

A

Food, Drug and Cosmetic Act (1938)

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9
Q

Officially creates prescription only category, drugs, or legend drugs, which must carry the label “Federal law prohibits dispensing without a prescription,” and refills require authorization.

A

Durham-Humphrey (1951)

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10
Q

Thalidomide developed by a German drug company for morning sickness was not given FDA approval, and after 6 years of use, it was linked to over 10,000 cases of birth deformities.
Safety and effectiveness must be proven to the FDA, as well as adverse effects must be reported

A

Kefauver-Harris Amendment (1962)

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11
Q

Controlled Substance Act which creates a modern day schedule of controlled substances including Schedule 1-5, as well as specific scheduling requirements, record keeping, inventory, and theft requirements

A

Comprehensive Drug Abuse Prevention and Control Act (1970)

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12
Q

Schedule I

A

No medical use, high potential for abuse (Heroin, LSD, Marijuana)

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13
Q

Schedule III

A

Moderate potential for abuse (Codeine, anabolic steroids)

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14
Q

Schedule IV

A

Low potential for abuse (Xanax, Valium, Ativan, Ambien, Tramadol)

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15
Q

Schedule II

A

High potential for abuse (Cocaine, Hydromorphone, Morphine)

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16
Q

Schedule V

A

Lowest potential abuse (Cough preparations with codeine)

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17
Q

Manufacturers required to perform packaging tests

A

Poison Prevention Packaging Act (1970)

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18
Q

Enacted to create financial incentives for drug companies to conduct research on diseases with smaller numbers of patients

A

Orphan Drug Act

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19
Q

Created abbreviated pathway for generic drug approval that did not require a redo of clinical drug trials as long as bio-equivalence could be proven, while granting 180 days of market exclusitivity to first company successful legally establishing a valid generic

A

Drug Price Competition and Patent-Term Restoration Act

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20
Q

Prohibits sale, purchasing, or trading in prescription drugs, while creating fines

A

Prescription Drug Marketing Act

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21
Q

Established Medicare Part D, and reimbursement options for MTM under Medicare

A

Medicare Improvement and Modernization Act of 2003

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22
Q

Product based care

A

Clinical pharmacy

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23
Q

Patient-centered care

A

Pharmaceutical care

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24
Q

Core of pharmaceutical care

A

Patient-centered, outcomes oriented pharmacy practice

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25
Q

5 key traits of clinical pharmacy

A
  • Product based care
  • Focused on the application of knowledge
  • Patient counseling
  • Therapeutic drug monitoring
  • “By pharmacist”
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26
Q

5 key traits of pharmaceutical care

A
  • Patient centered care
  • Outcomes oriented
  • Requires inter-professional cooperation
  • Disease management
  • MTM
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27
Q

Rationale from product based care to patient based care (3)

A
  1. Patient compliance is key to health outcomes
  2. Prevalent chronic conditions where patient’s quality of life became more important
  3. Focusing on preventative care to manage cost-containment strategy
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28
Q

Under OBRA ‘90, pharmacists are expected to offer an explanation of the prescription drug regarding (6)

A
  1. Purpose
  2. Proper administration
  3. Common adverse effects
  4. Potential interactions
  5. Contraindications
  6. Guidance on steps to take
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29
Q

General information about patient counseling (4)

A
  1. Final responsibility belongs to patient
  2. Required documentation regarding if the patient accepted counseling
  3. Follow-up is not required
  4. No formal compensation
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30
Q

Disease management (4)

A
  1. Inter-professional
  2. Focuses on specific chronic diseases
  3. Addresses drug, non drug, and lifestyle modifications
  4. Difficulty obtaining compensation
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31
Q

Law that introduced MTM

A

Medicare Prescription Drug Improvement and Modernization Act of 2003

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32
Q

Goal of MTM

A

Optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions

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33
Q

CMS eligiblity guidelines (3)

A
  1. Those with multiple chronic disease states
    AND
  2. Those taking multiple medications
    AND
  3. Those who spend more than the amount specified by the Secretary of Health and Human services on prescription medications ($3,507)
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34
Q

Five core elements of MTM

A
  1. Medication Therapy review (MTR)
  2. Personal Medication Record (PMR)
    - intended for patient use
  3. Medication-related Action Plan (MAP)
    - intended for patient use
  4. Intervention/referral
  5. Documentation and follow-up
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35
Q

What gaining the “provider status” means for pharmacists

A

Pharmacists are able to make claims directly to the third-party payer for services that they provide

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36
Q

Rationale for provider status (2)

A
  1. Newly insured individuals under ACA, there are great needs for primary care service providers
  2. Reimbursement is moving towards pay-for-performance through coordinated care, team-based approach, but pharmacist model is not established yet
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37
Q

Pathways to provider status (2)

A
  1. Federal: Amend Social Security Act related to Medicare B where it does not list pharmacists as providers
  2. State: Legislative change in the scope of pharmacy practice
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38
Q

Roles of pharmacist (3)

A
  1. Procurement of drugs insuring their strength, quality, purity and labeling
  2. Accurate interpretation and dispensing associated with a legal and legitimate
  3. Communicate with caregiver necessary and appropriate information regarding safe and effective medication use
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39
Q

APhA and effort

A

American Pharmacists
Association
-Provider status, MTM

40
Q

ASHP and effort

A

American Society of Health-System Pharmacists

-Drug Shortage

41
Q

NCPA and effort

A

National Community Pharmacist Association

-Drug Adherence, PBM transparency

42
Q

NABP and effort

A

National Association of Boards of Pharmacy

-CE credit tracking

43
Q

10 traits of professional

A
  1. Knowledge and skill
  2. Commitment to self-improvement
  3. Service orientation
  4. Pride in profession
  5. Covenental relationship with patient
  6. Creativity and innovation
  7. Conscious and trustworthiness
  8. Pride
  9. Ethically sound decision making
  10. Leadership
44
Q

18 PHI identifiers

A
  1. Names

2. Geographic location

45
Q

PBM

A

Pharmacy benefit manager

  • Third party administrator that contracts with retail pharmacies to create network of pharmacies from which patients can purchase their prescriptions
  • Formulary, claims, payment, cost management
46
Q

Role of drug wholesalers

A

Prime vendor concept that reduces invoices, increases volume and creates opportunity for financial incentive

47
Q

GPO and role

A

Group Purchasing Organization brings together a number of health organizations to provide volume for leveraging purchases

48
Q

Open channel drug distribution

  • Pros
  • Cons
A

Manufacturers utilize multiple distributors to drive distribution

  • Pros: maximizes access to drugs for patients with relatively common conditions/diseases
  • Cons: drug manufacturer has little control over inventory and is hard to forecast demand
49
Q

Pharmacy Benefit billing

A

Bill and Dispense - purchase, bill, dispense

50
Q

Medical Benefit billing

A

Buy and Bill - purchase, administer, bill

51
Q

Pharmacy Benefit drug coding

A

NDC

52
Q

Medical Benefit drug coding

A

HCPCS

53
Q

Pharmacy Benefit patient cost sharing

A

Copayment or coinsurance for drug

54
Q

Medical Benefit patient cost sharing

A

Often no cost-share for drug

55
Q

Pharmacy Benefit cost control mechanism

A

Better coverage for generic, quantity limits, prior authorization, step therapy

56
Q

Medical Benefit cost control mechanims

A

No price differentiation between generic and brand, generally weaker control

57
Q

Common characteristics of specialty drugs (3)

A
  1. High cost (>$600 per month)
  2. Commonly produced through biotech
  3. Requires therapy management by healthcare professionals
58
Q

Key drivers of specialty trend (2)

A
  1. High cost per patient

2. Increasing utilization

59
Q

Limited drug distribution

A

Manufacturers put their specialty drugs in exclusive or limited networks where they only allow dispensing from few specialty pharmacies or wholesalers

60
Q

What is REMS? How does it work?

A
  • Risk Evaluation and Mitigation Strategy
  • Risk minimization strategies beyond the professional labeling to ensure that the benefits of a drug outweigh the risks, where manufacturer develops REMS and FDA approves
  • Needs data on how the drugs are distributed, prescribed, dispensed, and taken
61
Q

Specialty pharmacy from a producer perspective (3)

A
  1. Consistent access to data
  2. Inventory is better controlled through limited distribution
  3. Greater access to patient through specialty pharmacy
62
Q

Specialty pharmacy from a payer perspective (2)

A
  1. Payers are gradually moving specialty drug coverage from medical to pharmacy in order to control costs
  2. Payers receive data from specialty pharmacy about how drugs are utilized
63
Q

Specialty pharmacy from a consumer perspective (6)

A
  1. Access to specialty drug is quick
  2. 24-hour access
  3. Patient assistance programs
  4. Member drug education
  5. Refill and monitoring calls
  6. Clinical programs such as disease management
64
Q

White bagging

A

Process by which physician administered drugs are dispensed by a specialty pharmacy for a specific patient, and shipped to the physician for administration. Specialty pharmacy bills insurer under pharmacy benefit, and physician neither buys nor bills for the drug

65
Q

Buy and Bill

A

Process where the provider purchases the medication on behalf of the patient, and bills the patient or health plan accordingly

66
Q

Brown Bagging

A

Patient is responsible for bringing in the medication to the site of administration

67
Q

Drug shortage

A

A situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the user level

68
Q

Cause of drug shortage (6)

A
  1. Unavailability of raw material
  2. Manufacturer decisions, merger, and acquisition
  3. Regulatory issues
  4. Unexpected demand
  5. Natural disasters
  6. Unknown
69
Q

Impact of drug shortage

A
  1. Health quality
  2. Financial impact
  3. Gray market created
70
Q

How do gray market vendors make a profit?

A

Gray market vendors buy up the remaining stock and aggressively market it to hospitals and pharmacies more than 80 times the typical price

71
Q

Prescription Drug Pedigree

A

A paper trail would have to exist for all drugs from the manufacturer

72
Q

VAWD

A

Verified-Accredited Wholesaler Distributors (basically audit)

73
Q

Why is pedigree/VAWD not working?

A
  • Lack of enforcement across all states
  • Disguising sales
  • Doesn’t necessarily affect purchases across state lines
74
Q

Public health definition with three key words

A

All organized measures to prevent disease, promote health, and prolong life among the population as a whole

  1. preventing disease
  2. promoting good health
  3. the population/groups of people
75
Q

Health promotion definition

A

The process of enabling people to improve their overall health

76
Q

Disease prevention

A

The process of preventing the occurrence/progression of a specific disease

77
Q

Primary prevention goal, rationale, target population, and typical activities

A

Goal: reduce number of new cases
Rationale: reducing risk factors and increasing resistance, number of new cases can be reduced
Target population: those who are most likely to be exposed to disease and have risk factors
Typical activity: Immunization

78
Q

Secondary prevention goal, rationale, target population, and typical activites

A

Goal: reduce number of new cases/severe cases
Rationale: Identifying a disease in its early stage can lead to early treatment to either stop the progression of the disease, or reduce its severity
Target population: those who have early symptoms of disease
Typical activities: Screening, Early Treatment

79
Q

Tertiary prevention goal, rationale, target population, and typical activites

A

Goal: reduce number of complications, long term disability, deaths
Rationale: reducing disease severity and increasing recovery, number of premature deaths or complications can be prevented
Target population: those who have disease and need treatment
Typical activities: Treatment tailored to patient, rehabilitation

80
Q

Prevalance

A

Proportion of existing cases in a population having a disease at or during a specified time

81
Q

Prevalence equation

A

(#existing) / (Total population

82
Q

Incidence

A

Proportion of newly diagnosed cases in a population during some specified time

83
Q

Incidence equation

A

(#new) / (Total population at risk)

84
Q

Sensitivity

A

A tests ability to correctly classify a person for having the disease

85
Q

Sensitivity equation

A

(True positives) / (# having the disease)

86
Q

Specificity

A

A test’s ability to correctly classify a person as not having a disease

87
Q

Specificity equation

A

(True negative) / (#not having disease)

88
Q

Positive Predictive Value (PPV)

A

Given that the result is positive, the likelihood of the patient having the disease

89
Q

PPV equation

A

(True Positive) / (Test positives)

90
Q

Negative Predictive Value

A

Given that the result is negative, the likelihood of the patient not having the disease

91
Q

NPV equation

A

(True negative) / (Test negative)

92
Q

Incidence reduction opioid policies (2)

A
  1. Prescription drug monitoring programs (PDMPs)

2. Abuse-deterrent drug formulations

93
Q

Harm reduction opioid policies (4)

A
  1. 911 Good Samaritan overdose law
  2. Increased access to naloxone
  3. Needle exchange programs
  4. Supervised injection sites
94
Q

PDMP background, goal, unintended consequence

A

Background: opioid abusers see multiple prescribers to obtain drugs illicitly (doctor shopping)
Goal: Enable practitioners to determine if patients are doctor shopping
Unintended consequence: Chilling effect

95
Q

Chilling effect

A

Reluctance to prescribe or dispense controlled substance for fear of legal retribution, which limits access to drug for appropriate medical care

96
Q

Abuse Deterrent Formulation background, goal, unintended consequence

A

Background: Many abusers seek to created dump effect, or rapid high, by altering drug formulation
Goal: Deter the user’s ability to physically alter the drug
Unintended consequence: May have increased heroin use

Healthcare (2 decks)

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