CH 2 & 3 Pharmaceutical Development Flashcards

1
Q

Drugs may come from

A

natural resources or a laboratory

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2
Q

Drugs do not create new functions in the body as they only…

A

affect existing functions

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3
Q

The Pharmacy Technician
CAN

A

prepare, sell, compound, and dispense medications

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4
Q

The Pharmacy Technician
CANNOT

A

counsel patients or direct patient care

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5
Q

Pharmacy Staffing Ratios
May only have 1 technician if there are only

A

1 pharmacist

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6
Q

Pharmacy Staffing Ratios

If there are two or more pharmacists, then the ratio allowed is

A

2 technicians per pharmacist

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7
Q

Pharmacy Staffing Ratios

A pharmacist may not supervise more than

A

2 interns at a time in any setting

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8
Q

Clinical Trials
2 groups…

A

Control group receives either standard treatment or placebo

Intervention group receives the drug to be tested

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9
Q

Off-label use

A

Drugs can be used for purposes other than the ones approved by the FDA

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10
Q

Pharmacy Technician Responsibilities

A

Filling, transferring, and refilling prescriptions

Receiving prescriptions and refill requests

Preparing sterile IV and chemotherapy compounds

Purchasing medications including controlled substances

Establishing and updating patient profiles and information

Stocking medication and medical supplies or equipment

Assisting with clinical trials or drug studies

Conducting medication histories

Maintaining automated dispensing systems

Tracking and reporting errors

Assist with “tech-check-tech” programs

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11
Q

Consumer Medication Information (CMI)

A

Written info for consumers about Rx drugs given to consumers when they have prescriptions filled

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12
Q

Medication Guides

A

FDA requires a medication guide to be given to patients whenever certain drugs are dispensed to promote awareness and patient safety

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13
Q

FDA Recalls

Class I - III

A

I - serious adverse health consequences or death

II - temporary or reversible health consequences

III - not likely to cause adverse health consequences

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14
Q

BBW
Black Box Warnings

A

safety-related label that’s meant to highlight a drug’s major risks

Deemed safe enough to use but has known serious medical risks

Must weigh the risks vs benefits of using any medication

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15
Q

Controlled Substances
classified by…

A

schedules (C-I to C-V) based on their potential for abuse

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16
Q

BBW for NSAIDs such as ibuprofen (Motrin)

A

Cardiovascular & Gastrointestinal effects

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17
Q

Controlled Substances

C-I have ___ of Abuse Potential

A

highest potential
No accepted medical use

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18
Q

C-I drug ex’s…

A

Heroin, marijuana, peyote, LSD(mental, visual, and auditory hallucinations)

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19
Q

C-II have ___ of Abuse Potential

A

high possibility, which can lead to severe dependence

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20
Q

C-II drug ex’s…

h.m.c.h.o.m.o.f.

A

hydromorphone
meperidine
cocaine
hydrocodon
oxycodone,
Morphine,
opium
fentanyl

21
Q

C-III have ___ of Abuse Potential

A

less potential

22
Q

C-III drug ex’s…

A

Tylenol with codeine and anabolic steroids

23
Q

C-IV have ___ of Abuse Potential

A

low potential

24
Q

C-IV drug ex’s…

A

tramadol
Benzodiazepines

25
Q

C-V have the ___ of Abuse Potential

A

lowest potential

26
Q

C-V drug ex’s…

A

Liquid codeine preparations, Lyrica

27
Q

All controlled substance prescriptions must be filled and refilled within ____ months of the date written

A

6

28
Q

C-II
Prescriptions cannot be

A

refilled

29
Q

C-II
Prescriptions are purchased with a

A

DEA 222 form and kept for 2 years or CSOS

30
Q

C-III to C-IV
Cannot be refilled more than
_____ times & limited to a ____ day supply

A

5

120

31
Q

DEA numbers will typically have ___ letters and ___ numbers

A

2

7

32
Q

DEA 222 form used to purchase C-II
prescriptions copies are…

A

1st (brown) and 2nd (green) copies are sent to supplier and 3rd (blue) copy is kept in the pharmacy

33
Q

DEA 224 form is used for a pharmacy or practitioner to

“two two four to open your door”

A

apply for DEA registration which must be renewed every 3 years

34
Q

DEA 225 form is used for manufacturers or distributors to
“two two five to make or supply”

A

apply for DEA registration which must be renewed every 3 years

35
Q

DEA 106 form is used to document
“one oh six for theft’s fix”

A

significant loss or theft of controlled substances

36
Q

DEA 41 form is used to document
“forty-one, destructions done”

A

surrender of controlled substances to the DEA for disposal

37
Q

FDA
Food and Drug Admin

A

Responsible for recalling, regulating, and approving, monitoring all approved medications

38
Q

DEA
Drug Enforcement Admin

A

Responsible for distribution, and destruction of controlled substances

39
Q

Orange Book
‘official guide for generic or interchangeable drugs’

A

FDA-approved reference to ensure that generic products can be safely substituted for brand-name products

40
Q

Biologic drugs

A

Large, complex molecules created in a lab derived from living organisms such as bacteria, plants, insects, birds, and mammals

41
Q

Purple Book
‘purple for proteins’

A

lists biologics and the date they were licensed

42
Q

Red Book
‘red for retail prices’

A

drug pricing and description information

43
Q

New Drug Application (NDA) purpose is to

A

provide evidence of the drug’s safety and effectiveness before approval

44
Q

MedWatch is to report…

A

serious adverse reactions from medications to MedWatch

45
Q

Package Inserts (PIs)

Provides information

A

on dosing, contraindications, side effects, storage, stability, administration, black boxed warnings, etc

46
Q

Center for Disease Control and Prevention (CDC)

Provides information on

A

emergency preparedness, travel-related concerns, health alerts, common diseases, and treatment options, vaccine information,

47
Q

National Institute of Health (NIH)

Provides evidence-based health information on

A

clinical trial, research,
symptoms, diagnoses, and treatment

48
Q

Micromedex

Provides:

A

pregnancy and lactation categories, storage and stability information, pricing, dosing guidelines, side effects, contraindications, and pharmacokinetics