Other Flashcards

1
Q

sterility/pyrogen testing for high risk CSPs necessary if

A
  • batches >25 identical individual single dose packages
  • mult dose vials for admin to mult pts
  • product exposed longer than 12 hrs at refrigerator temps
  • product exposed to temp >refrigerator longer than 6 hrs
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2
Q

Exempt parties from PDMP

A
  • licensed/cert hospitals
  • PDO within hospital that dispenses CS pursuant to chart orders or dispenses no more than 24 hr supply
  • certified EMS
  • PDO with waiver from board
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3
Q

specialized prescription drug outlet

A

outlet located within LCTF which is owned and operated by a managing PDO located w/in CO

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4
Q

LCTF w/ SPDO closes - how soon must notify board

A

7 days (by managing PDO’s pharmacist)

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5
Q

drugs acceptable for use by limited license for the capture of wildlife or animals (17)

A

acepromazine, ketamine, xylazine, tiletamine and zolazepam, sodium pentobarbital, butorphanol, azaperone, medetomidine, midazolam, haloperidol, nalbuphine, atipazmezole, tolazoline, naltrexone, doxapram, yohimbe, diphenhydramine

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6
Q

registration posting in other outlet

A

licenses, registrations, last inspection by board, approved protocols, consultant pharmacist reports, other

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7
Q

how long does consultant pharmacist have to provide protocols to board upon request

A

30 days

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8
Q

quarterly inspections and visits needed for which other outlets

A

jails, county health departments, schools (K-12), hospitals, family planning clinics, hospices, medical clinics, ambulatory surgical centers

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9
Q

interim designated consultant pharmacist

A

notify board in 10 days;
designee can be consultant pharmacist for no more than 90 days (if > 90days, app for new consultant should be submitted w/in 30days following 90 day period)

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10
Q

unlawful possession of any qty of what drugs is a level 4 drug felony?

A

ketamine, cathinones, flunitrazepam, or C-I/C-II

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11
Q

unlawful possession of any qty of what drugs is a level 1 drug misdemeanor?

A

CIII-V (except flunitrazepam, ketamine)

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12
Q

MMJ card produced by

A

CO dept of public health and environment

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13
Q

possession limits MMJ

A

2 oz usable, 6 plants (< 3 mature)

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14
Q

MMJ approved conditions

A

cachexia/wasting, cancer, chronic pain, epilepsy/sz, glaucoma, HIV/AIDS, MS, nausea

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15
Q

MMJ for pts < 21 y/o

A

approval from 2 MDs

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16
Q

amendment for approval of recreational MJ

A

64

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17
Q

limitations recreational MJ

A

must be >= 21 y/o; 1oz, 6 plants

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18
Q

changes pharmacist CAN make to C-II Rx after consult prescriber

A

dosage form, strength, qty, directions, issue date

19
Q

CANNOT change on C-II

A

pt name, CS prescribed, signature of prescriber

20
Q

C-II multiple Rxs

A

CO: 1 prescription can be written for ANY days supply

21
Q

what is last digit in DEA number AU123456_

A

3

1+3+5=9
(2+4+6) x 2=24
9+24=33

22
Q

CS prescriptions must contain

A

date/signed by prescriber on date issued
pts name and address (not DOB)
practitioners name, address, DEA
drug name, strength, dosage form, qty, directions, refills auth

23
Q

partial fill od C-II

A

72 hrs

24
Q

partial fill of C-II for LTCF

A

60 days

25
Q

when an start dispensing CS

A

14 days after DEA receives notification of request

26
Q

partial order fills of CS from supplier

A

60 days

27
Q

copies of DEA 222 go to

A

1-supplier, 2-DEA, 3-retained

28
Q

ryan height act

A

online pharmacy must have modified DEA registration

29
Q

exceptions for prescribing opioids for addiction outside of DATA

A
  • 3 days tx admin by prescriber while arranging for tx

- hospitalized pts (for condition other than addiction)

30
Q

maintenance opioid treatment

A

> 21 days

31
Q

OTC label must have

A

drug name and pharm category, name and address of manuf/distributor, qty of package contents, cautions/warnings, drug fact panel, directions (dose, freq, duration, admin, onset, route, preparation)

32
Q

drug recall classes

A

I-serious, II-temporary harm, III-not likely to cause AE

33
Q

drug price competition and patent term restoration act

A

ANDA - approved generics bioequivalent

Patent life for new brand drugs: 5 years exclusive marketing after approval

34
Q

prescription drug marketing act

A
  • states must license wholesale distributors
  • bans sale, trade, purchase of samples
  • prohibits community pharamcies from receiving samples
35
Q

medical device act (& classes)

A

I-minor potential impact
II-moderate
III-major (requires premarket approval)

36
Q

poison prevention packaging act

A

child-resistant containers cannot reuse
CR for all Rx drugs
OTCs that require it: ASA, Fe, APAP, IBU, lidocaine, naproxen, Benadryl, loperamide
(exception if labeled appropriately - not CR, for households w.o children)

37
Q

child resistant def

A

85% of children < 5 cannot open w/in 5 mins

90% adults can open and close w/in 5 mins

38
Q

federal alcohol regulations

A

AFT form 11 for dealers stamp
don’t need for 190-proof ethyl alcohol
hospitals have special AFT permit for tax-free EtOH

39
Q

DEA Form 224

A

new retail pharmacy registration

40
Q

five percent rule

A

cannot distribute to another pharmacy >5% of all CS dispensed by pharmacy throughout yr

41
Q

how old to buy sudafed in CO

A

18

42
Q

form 224a

A

renewal of registration - pharmacy, hospital, clinic, teaching institution, prescriber, midlevel

43
Q

DEA form 225

A

manufacturer, importer, exporter, distributor, reverse distributor, researcher, canine handler, analytical lab

44
Q

DEA form 363

A

Narcotic treatment clinics