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Mpje Study Guide > Part 2 > Flashcards

Part 2 Flashcards

1
Q

Food and drug act of 1906

A

Prohibited interstate commerce of misbranded and adulterated drugs

MISBRANDED ADULTERATED

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2
Q

1938 Food Drug and Cosmetic Act

A
  1. New drugs must be safe prior to marketing
  2. Factory inspections allowed
  3. Safe tolerances for poisonous substances
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3
Q

Durham Humphrey Amendment of 1951

A
  1. Defines which medications can be used without medical supervision
  2. Requires a prescription from a practitioner

(OTC VS PRESCRIPTION)

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4
Q

Kefauver Harris act of 1962

A
  1. Ensures efficacy and safety prior to marketing
    (Came after Thalidomide)
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5
Q

Poison prevention packaging act (PPPA) 1970

A
  1. Protects children from accidental ingesting
  2. Requires childproof caps on prescriptions
  3. Dangerous chemicals need safe packaging
    Exceptions ntg, blister packs, no safety caps request
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6
Q

Medical Device Amendment 1976

A

Higher safety and efficacy standards started for medical devices
Enacted because of intrauterine device failures in women

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7
Q

Explain the classes of medical devices in the medical device amendment of 1976

A
  1. Class 1 - lower risk where significant injury or death is unlikely
  2. Class 2 - moderate risk
  3. Class 3 -high risk of significant injury or death
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8
Q

Tamper resistant packaging regulation of 1982

A

Became a crime to tamper with packaged consumer products

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9
Q

Orphan drug act of 1983

A

Enabled fda to promote research for rare diseases

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10
Q

How many people are affected to qualify as an orphan drug

A

200,000 or less

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11
Q

Another name for Hatch-Waxman Act 1984

A

Drug price competition and patent term restoration act

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12
Q

What did Hatch-Waxman Act do

A
  1. Generic drug system
  2. Abbreviated new drug application became easier
  3. Only need to prove bioequivalence
  4. Market exclusivity for a period of time
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13
Q

Prescription Drug Marketing Act 1987-1988

A
  1. Requires licensing of wholesalers
  2. Bans sale or trade of drug samples
  3. Bans diversion of prescription drugs from normal comercial channels - can’t sell your rx mds
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14
Q

Dietary Supplement Health and Education Act (DSHEA) 1994 (6 things)

A
  1. classified as food
  2. Good manufacturing process required
  3. Can’t be misbranded or adulterated
  4. Do not have to prove safety
  5. Cannot make specific claims for treating a specific illness
  6. Must be labeled as a dietary supplement(herbal, vitamin, etc)
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15
Q

Health Insurance portability and accountability act HIPAA -1996

A

1.Provides standards of handling PHI
2. Appropriate access for health care providers to do their jobs
2.no restrictions on use of disidentified PHI

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16
Q

FDA Modernization Act of 1997

A

Regulated advertising of off labeled uses of drugs
OFF LABEL

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17
Q

Medicare Prescription Drug Improvement and Modernization Act of 2003

A

Medicare part D started (implemented in 2006)

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18
Q

Affordable Care Act of 2010

A

Obamacare
Older children to remain in parents plan until age 26
Attempts to stop insurance companies from selecting patients without preexisting conditions
Established cms innovation center

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19
Q

Purpose of cms innovation center

A

Test healthcare delivery models to maximize cost and service (MTM included in this)

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20
Q

What does OSHA stand for

A

Occupational Safety and Health Administration

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21
Q

Who does OSHA PROTECT

A

Healthcare workers who could be exposed to hazardous drugs or blood Bourne pathogens - think chemo meds

22
Q

What safety procedures are included in OSHA?

A

HASDT
1. Handling
2. Administration
3. Storage
4. Disposal
5. Transportation

23
Q

What does MSDS stand for

A

Material Safety Data Sheets

24
Q

What agency oversees MSDSs?

A

OSHA

25
Q

Another name for MSDS

A

SDS (safety data sheets)

26
Q

OSHA requires employers who use hazardous substances to have what for each

A

Safety DAta Sheets - HASDT
Ie chemo agents will have an SDS

27
Q

What info is in an SDS?

A
  1. Name of chemical compound
  2. What to do if exposed
  3. Procedures for accidents
  4. Risks if exposed
  5. Protective equipment
    Name, EXPOSURE, accident, RISKS, PE
28
Q

What does NIOSH stand for

A

National Institute for Occupational Safety and Health

29
Q

What is listed in NIOSH

A

Hazardous drugs that may impact the health and safety of healthcare professionals who administer, compound, or dispense them
Ie chemo or hormonal drugs

30
Q

What type of equipment is often needed when working with medications that are on a NIOSH list

A

Personal Protective Equipment PPE

31
Q

What is the EPA

A

Environmental Protection Agency

32
Q

What is defined by the EPA

A

Hazardous waste and recommends how to dispose of it

33
Q

Hazardous waste must meet one the following categories

A

TIRC
T - toxic - harmful if ingested
I- ignitability
R - Reactivity - causes a dangerous chemical reaction
C - Corrosive - high or low ph that can cause damage to skin

34
Q

Which listed drugs require special disposal

A

P listed
Ie warfarin and nicotine

35
Q

Where are patients encouraged to take p listed medications when disposing of them

A

Sheriffs office or a pharmacy

36
Q

What is the EPAs method of disposal if there is no take back program?

A

1 remove from vial
2 combine with kitty litter or coffee grounds
3 put in a container that can be closed ie ziplock bag
4 remove phi
5 place in trash

37
Q

What is DMEPA

A

Division of Medication Error Prevention and Analysis

38
Q

What is DMEPA under the umbrella of?

A

CDER

39
Q

What does DMEPA do

A

Reviews medication error reports on prescriptions and otcs

40
Q

What institutes does DMEPA work closely with?

A

Institute of Safe Medicine Practices (ISMP) and United States Pharmacopia (USP)

41
Q

What is MERp

A

ISMP Medications Errors Reporting Program

42
Q

MERP is voluntary reporting where are the reports forwarded

A

To the FDA and possibly to the manufacturer if a change is needed (ie sound alike meds)

43
Q

What is MERPs culture of safety called

A

Just Culture

44
Q

MERPs just culture 3 goals

A
  1. Systems focused on patient safety
  2. Strive for continuous improvement
  3. Looks at work environment and processes improvement
45
Q

What is VERP

A

ISMP Vaccine Errors Reporting Program

46
Q

What’s reported in VERP

A

Voluntary
Vaccine errors and good catches

47
Q

What is VAERS

A

Vaccine Adverse Event Reporting System

48
Q

What is reported on VAERS

A

Non preventable adverse reactions

49
Q

What does VAERS do with the info they receive in the voluntary reporting

A

Analyze the data
Publish data for the public

50
Q

What department is VAERS under

A

Department of Health and Human Services

Mpje Study Guide (5 decks)

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