false/misleading labeling - label does not contain required elements - failure to include adequate info for use - if pharmacy fills Rx w/o authorization from provider

Block 1 Flashcards by Daniel Allen

duty to warn

part of physician patient relationship

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case that dealt with duty not to fill?

Hooks Superrx v McLaughlin

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Evidence of misfiled prescription is sufficient for presumption of negligence.

a. true
b. false

a. true

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learned intermediary doctrine

physician is responsible for warning as the learned intermediary

originally developed as defense for manufacturers

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__ are laws enacted by congress at the federal level

statutes

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__ are laws passed below the state level

ordinances

city or county

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__ law deals with relationship between individuals and society

criminal

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__ law deals with relationship between individuals

civil

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__ is comparative negligence and is partial defense in which damages are apportioned according to the percentage of fault

contributory negligence

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__ issues detailed regulations to effect the comprehensive drug abuse prevention and control act

DEA

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__ issue detailed regulation to carry out the policy and procedures of state pharmacy acts

state board of pharmacy

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__ law is created by court decision

judicial

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__ law is created by executive branch

administrative

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Purchase invoices must be kept __ years

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misbranded drug

false/misleading labeling

label does not contain required elements
failure to include adequate info for use
if pharmacy fills Rx w/o authorization from provider

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Outsourcing facilities do not need to be licensed pharmacies because they are compounding sterile pharmaceuticals that are not patient specific

a. true
b. false

a. true

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Outsourcing facilities must report serious AEs within __ days and conduct follow up investigation and reporting similar to current drug manufacturers

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Ipecac syrup is only sold in __ mL containers

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What agency regulates advertising of OTC meds?

federal trade commission (FTC)

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Poison Prevention Packaging Act:

fail if > _% of child test group can open package within 10 mins and/or > __ % of adults tested within 5mins can’t open it

20, 10

unit dose packaging fails if children can open 8 units or > 20% of toxicity limit

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__ needs pre-market approval

a. compounding
b. manufacturing

b. manufacturing

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Who regulates OTC advertising?

federal trade commission (FTC)

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Patient request for PHI must be completed in __ days generally, and __ days under TX law

30, 15

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A patient amendment to their PHI must be done within _ days of the request

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What must be on OTC label for elderly exemption to Poison Prevention Packaging Act 1970?

this package is for households without young children

codeine max limit for schedule III?

1800mg/100ml 90mg/dosage unit

if any amount of codeine is added to robitussin AC it a schedule ___

III

What is max codeine conc. for schedule V?

200mg/100ml (2mg/ml)

What is max opium conc. for federal CV?

100mg/100ml

What is max opium conc. for TX CV?

50mg/100ml

Two organizations that add, delete, or reschedule controlled substances?

FCSA (federal/US attorney general) TCSA (state/Texas commissioner)

The DEA is under the authority of which department?

US Dept. of Justice

What DEA form is used to apply for DEA registration?

DEA 224 dispensers, retail pharmacies, hospitals/clinics, practitioners, mid level practitioners, teaching institutions

What DEA form is for ordering CIIs?

DEA 222 triplicate: - brown for supplier (copy 1) - green for DEA (copy 2) - blue for buyer (pharmacy)

What DEA form is for theft/loss of controlled substances?

106

What DEA form is for destruction of controlled substances?

Partial fills from the wholesaler of schedule II meds are permitted if the supplier sends the balance within __ days

FCSA requires schedule II inventory how often?

every 2 years

TSBP requires schedule II inventory how often?

every year

Exact counts necessary fro all schedule II drugs a. true b. false

a. true

Estimates on schedule III-IV permitted unless containers hold > _ tabs/caps

1000 eat counts necessary if container has been opened

What data can DEA NOT inspect without consent?

financial sales pricing

3 types of CII facsimile that may be used as original?

injectable CII narcotics LTCF for any CII CII narcotics for hospice

If a CII is dispensed by verbal order, must receive written Rx within __ days

CII may not be given for more than __ day total

CII "unable to supply" remainder must be given in what timeframe?

72hrs

CII partial fill for LTCF or terminally ill may be partially filled up to __ days

For CIII-IV can get up to __ full refills within __ months from the date of initial issuance if authorized by the practitioner

5, 6

What is needed on a controlled substance invoice?

initials of pharmacist | actual date of receipt

PAs and APNs are not allowed to prescribe CIIs unless they're in a hospital based practice for a pt who has been admitted to the hospital for intended length of stay of how long?

> 24hrs

What can therapeutic optometrists prescribe?

OTC oral meds ophthalmic devices certain topical ocular agents

Optometric glaucoma specialist can prescribe one __ day supply oral antibiotics one __ hour supply oral antihistamines a __ day supply NSAIDs one _ supply III-V analgesics

10, 72, 7, 3

A satellite pharmacy may only store prescription meds that have been previously verified and dispensed by provider pharmacy a. true b. false

a. true

Pharmacists must notify TSBP before engaging in drug therapy management (DTM) and must complete at least __ hours CE annually

6 12hr/2yr/license renewal cycle

DTM records must be kept how long?

2 years document all interventions and review protocol annually

Provider pharmacy for remote sites cannot supervise more than how many remote sites?

May not dispense CII at __ a. remote healthcare sites b. remote dispensing sites

b. remote dispensing sites

__ requires a technician a. remote healthcare sites b. remote dispensing sites

b. remote dispensing sites

CII cannot be emergency refilled a. true b. false

a. true

Can give __ hour emergency supply of CIII-V

72 must inform pt and notify prescriber

Can dispense __ day supply of emergency meds in governor declared emergency

The board cannot limit number of techs/trainees in class C pharmacy a. true b. false

a. true

The board contains __ pharmacists __ technicians __ public members

7, 1, 3 11 total pharmacists must be from class A and C pharmacies

What classes are the below pharmacies? ``` community nuclear hospital (institutional) clinic nonresident created by board rule ```

``` community = A nuclear = B hospital = C clinic = D E = nonresident F,G,H = created by board rule ```

Block 1 Flashcards

(64 cards)