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PHRm 871 Final exam > Final- Exam 1 > Flashcards

Final- Exam 1 Flashcards

(70 cards)

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1
Q

Indiana representation

A

1 indiana senator
and
1 indiana representative

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2
Q

federal representation

A

2 US senators
and
1 US representative

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3
Q

general assembly

A

legislative body of indiana
consists of senators and representatives that meet in two sessions over two years

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4
Q
A
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5
Q

Short session

A

takes place during EVEN years and can last up to 30 days but end by march 15th

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6
Q

Federal law and federal regulation what is it and how do we site it

A

Federal law: USC
Title USC § Section (subsection)
Federal regulation: CFR
Title CFR § Section (subsection)

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7
Q

Indiana law and regulation what is it and how do we site

A

Law/statues: IC
IC title- article- chapter-section
Rules: IAC
Title IAC- article- chapter(rule)-section

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8
Q

What is criminal civil and administrative actions that can be taken on pharmacist

A

Criminal: when you break the law and get in trouble by government usually jail time or a fine

Civil: A private party sues another party because they believe they have been harmed by something

Administrative is when you get in trouble and the board of pharmacy either restricts you license or puts in on probation type

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9
Q

Offical compendia

A

USP
NF
HPUS

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10
Q

Adulteration

A

Generally is the product inside the bottle what it is inteneded to be if not adulterated!

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11
Q

banned devices

A

prosthetic hair fibers, powered gloves

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12
Q

Class 1 devices

A

not used for supporting life or preventing impairment
they show little to no risk of illness or injury

EX: alcohol swaps, cotton balls, stethascope

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13
Q

Class 2 devices

A

moderate risk to use
require special controls to assure safety and effectiveness of device

ex: MRI, CT scan

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14
Q

Class 3 device

A

High risk to use
generally used to sustain or support human life
high risk of illness or injurey
EX: Ventilator or Hemodialysis

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15
Q

Misbranding

A

does the package contain the product or what must accompany the product

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16
Q

Established name

A

Generic

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17
Q

Proprietary name

A

brand name

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18
Q

The sherley amendement

A

prohibited manufacurers from intentionally misleading population with false information about drug effectiveness

really didnt do much because needed to show that a company was inentionally doing it and not on accident

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19
Q

1938 federal food, drug, and cosmetic act

A

-required new drugs to show safety and efficacy
-authorized factory inspections
-Required selected dangerous drugs to be administered under the direction of a qualified expert (beginning requirement for prescription only medications)

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20
Q

1951: Durham-Humphrey Amendment

A

Over-the- counter medications could
be labeled with“adequate directions for use.”

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21
Q

Legend drug

A

a medication that is prescribed and dispensed under the upervision of a practitioner as a prescription drug and carry the statement:
“Caution federal law prophibits dispensing without a prescription”

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22
Q

Current good manufacturing practice

A

any manufacturer for drugs used in the united states must be registered with the FDA and undergo an inspection EVERY 2 years

if you dont comply with cGMP the product is adulterated

if you do not register with the FDA the product is adulterated and misbranded

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23
Q

503a
what is it and what requirments must they follow

A

Pharmacy or traditional compounding - compounding according to prescriptions

must register, pay annual fees, and be inspected by the FDA

if they follow this they do not need to comply with misbraning, cGMP, and new drug requirments

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24
Q

503b

A

outsourcing facilities: manufacturing large batches without a prescription to be sold to facilities for office use only

these have different controls to follow

product must contain all of the following
-the statement “this is a compounded drug”
-Name, address, and phone number of the
outsourcing facility
-Lot number or batch number
- Established name of the drug
- Dosage or strength
- Quantity or volume
- Beyond use date
- Storage and handling instructions
- NDC
- The statement “not for resale”
- A list of active and inactive ingredients

must follow cGMP, misbranding law, but not new drug requirements

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25
manufacturing
mass production of drug products that have been approved by the FDA must follow cGMP, misbranding law, new drug requirements
26
Grandfathered drugs
anything before 1938 these drugs have been on the market long enough they are assumed safe and effective
27
DESI drugs
Drugs between 1938-1962 these drugs are being investigated for efficacy but products are allowed to remain on the market until a decision is made some desi drugs include: adderall, nitroglycerin
28
Drug development stage 1 preclinical research
in vivo animal testing utilized to record data on toxicity and pharmacology of the product
29
Drug development stage two investigational new drug
if the drug shows possibility for safe and effective use manufactures submit an IND must contain - animal pharmacology and toxicology studies - manufacturing information - clinical protocols and investigator information Once the IND is submitted, the sponsor must wait 30 days before initiating any clinical trials to allow the FDA to review the IND for safety and unreasonable risk.
30
Drug development step 3: clinical research phase 1
evaluate the safety and dosage of the compound Baseline human pharmacokinetic and pharmacologic properties are also reviewed and reported.
31
Drug development step 3: clinical research phase 2
several hundered human volunteers who have disease or condition being studied this is used to determine the effectiveness of therapy
32
Drug development step 3 clinical research Phase 3
thousands of patients in different geographic locations goal is to demonstrate efficacy at a higher power and to expand information around adverse effects
33
Drug development new drug application
involves everything from preclinical data to the phase 3 trial data NDA must include - Proposed labeling - Safety updates - Drug abuse information - Patent information - Any data from studies that may have been conducted outside the United States Institutional review board compliance information - Directions for use FDA can take 6 to 10 months to review data and make a decision on drug approval.
34
drug development step 5: post marketing surveillance phase 4
FDA reviews MedWatch for trends among adverse events reported by health professionals and patients.
35
Poison Prevention Packaging Act (PPPA) Child resistant packaging and products covered
Child resistant means 20% of children or less can open product after 10 minutes and at least 90% of adults can open after 10 minutes Drugs for oral administration require special packaging including those OTC and prescription drugs to be exempt from special packaging must have -prescription by prescription waivers which can be given by prescriber or by patient and can be for life of a single prescription OR - blanket waivers which are patient authorization only and are for all products
36
some examples of drugs that are exempt from child resistant/special packaging
-Sublingual nitroglycerin -Oral contraceptives in mnemonic dispenser packages -Steroid dose packs -Some oral powder formulations -Unit-dose potassium
37
Class 1 recall
Recalls are something the company dose Drug product may cause serious adverse health consequences including death (pharmacies notify patients who received recalled drugs).
38
Class 2 recall
Drug may cause temporary or reversible effects, but the probability of serious health consequences is remote.
39
Class 3 recall
Drug product is unlikely to cause serious adverse health consequences this could be the company removing their product because the label is messed up
40
Seizure
this is something the FDA does
41
Package inserts
required as part of the labeling of a prescription and if the drug on the shelf does not have a PI it is misbranded
42
Pregnancy categories - federal law
3 categories pregnancy lactation females and males of reproductive potential
43
Patient package inserts
must be dispensed with the drug they corrospond to whenever dispended if not it is misbranding only drugs that require PPIs are estrogen and oral contraceptives
44
Medication guides
Must be provided with new and refill prescriptions for patients in an outpatient environment if not dispensed its misbranding
45
REMS types Patient friendly labeling
Medication Guides and Patient Package Inserts. Something to provide patients essential information about the drug
46
REMS types communication plans
information sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for patients
47
REMS types Elements to assure safe use
Required activities that must be done before prescribing, dispensing, or recieving the product
48
REMS types implementation systems
A quality assurance process to ensure that risks are being mitgated successfully
49
Patient labeling OTCs federal
Active Ingredient(s) * Purpose(s) * Use(s) * Warning(s) * Directions * Inactive Ingredients * Other Information
50
FDA form 3500 and FDA form 3500B
3500 is for reporting adverse events associated with a drug or FDA covered product by healthcare professionals 3500B is same type of reporting but done by patients
51
Federal prescription label requirements
1.The name and address of the dispenser 2. The serial number of the prescription (prescription number) 3. The date of the prescription or its filling 4. The name of the prescriber 5. If stated on the prescription, the name of the patient 6. If contained on the prescription, any directions for use 7. If contained on the prescription, any cautionary statements
52
OBRA' 90: prospective DUR
Pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness
53
OBRA ’90: Retrospective DUR
States must review medication use of drugs and compare how they are being used against accepted standards.
54
OBRA ’90: Patient Counseling
Law requires an offer to have a pharmacist counsel the patient be made Pharmacist should counsel on matters which, in the pharmacist’s professional judgement, are significant,
55
Dietary Supplement Labeling - federal law
Thenameoftheproductandthephrase“dietarysupplement” 2. The quantity of the contents 3. The manufacturer’s, packer’s, or distributor’s name and address 4. Directions for use 5. A supplement facts panel containing serving size, list of dietary ingredients, amount per serving size, and percent daily value if established.
56
PDMA Reimportation,Preferential Pricing,Samples and Coupons, and Wholesale Licensure
Reimportation - If a drug is exported from the US it cannot be reimported to the US UNLESS it is done by the manufacturer OR it is for emergency purpose and its actively reviewed by the FDA - bans the importation of american made drugs from foreign countries Preferential Pricing - Bans the sale, purchase, or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity - if the two entities have access to same preferential pricing they are allowed to trade with one another Samples and Coupons - Practitioners must ask for samples - must have recordkeeping, proper storage, and handling requirments Wholesale Licensure
57
Drug supply chain security act
manufacturers and repackagers to add barcodes or QR codes to prescription packages to allow for better tracing - manufacters and wholesalers must verify the legitimacy of product withing 24 hours of inquiry from a pharmacy - any illegitimate products must be brought to the FDA within 24 hours product tracking must be documented for all parts of the supply chain and maintained for 6 years
58
NDC number
55555-4444-22 first 5 are numbers identifying manufacturer 4 numbers in midle identify the drug, strength,dosage, and formulation of product last 2 identify package size If a section is short there should be a 0 at the begining of the section
59
Advertising to professionals
must include established drug name formula of the drug adverse event information contraindications effectiveness
60
HIPPA privacy rule: permitted use and disclosures
a covered entity must share PHI if patient requests it and and to HHS when it is undertaking an investigation or review or enforcement a covered entity may disclose PHi to the individual for tx, payment, and health care operations for an opportunity to agree or object for incidental use and disclosure for public interest and benefit activities for a limited data set
61
HIPPA security act
requires entities to have active and reasonable approaches to ensure the safety of PHI if breached - if this breach affects less than 500 people must report to secretary of health and human services within 60 of the end of the calendar year - if this breach affects 500 people or more must report withing 60 days of the breach and must report the br3each to the prominent media outlests serving the state
62
USP 795
focused on nonsterile compounding requires beyond use dates to be assigned to nonsterile products
63
USP 797
Sterile compounding
64
USP 800
hazardous drugs and the handeling of them in a healthcare setting
65
expiration date according to USP vs the beyond use date
The expiration date is the last date the product will meet the requirements of the USP monograph for strength or stability A BUD is a date after which a product should not be used. based on different factors like when product is opened stored reconsituted and all that
66
BUD based on formulation
non aqueous formulation - no more than 6 months or the experation date whichever is sooner Water containing formulation - no more than 14 days or the expiration date whichever is closer Water containing topical formulation, mucosal, semisolid form - no more than 30 days or experation date depending on which is sooner
67
DEA NOI
when requesting entry for inspection DEA must show an NOI or a DEA form 82 you can require the DEA get an AIW you have the right to refuse the inspection (DEA will come back with AIW) any incriminating evidence found can be taken and used against you in court of law you will receive a copy of the NOI and you have the right to withdrawal your consent to inspection at any time
68
DEA warrent types
AIW - easy to get Search warrants - harder to get
69
Board of pharmacy inspections
In indiana you cannot refuse these inspections and they can come in without a warrent
70
Therapeutic equivalent code
Pharmaceutical equivalence: active ingredient, dosage form, strength, route, labeling bio-equivalence: same results in vivo and in vitro to be therapetuically equivalent must have both A meants they are equivalent and you can switch B is not equivalent

PHRm 871 Final exam (2 decks)

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