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MPJE > Review > Flashcards

Review Flashcards

0
Q

Products containing PSE and EPH must be packaged in blister packs with each blister containing not more than _______ dosage units or in unit dose packets not containing more than _______ mg of PSE or EPH

A

2 dosage units

3000 mg

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1
Q

CS scheduling is automatically made uniform with fed law how many days after fed scheduling

A

30 days

unless DHS objects and hearing is held to place in different schedule

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2
Q

record keeping for PSE/EPH

A 
Name and address of purchaser
date and time
brand 
product name
quantity of PSE/EPH
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3
Q

witness to dispose Cs

A 
licensed physician
pharmacist 
mid level practitioner
nurse
a state or local law enforcement officer or other auth person
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4
Q

dea form 41

A

submit 3 copies of that form to agent in charge in area
prepared in quadruplicate
copies must be sent to local DEA diversion office after the destruction
can request help

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5
Q

True or False. Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction.

A

TRUE!!!!

Illinois law

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6
Q

Notification of theft or loss to dea within _____ business days

A

1 business day of discovery

by phone, fax or written message

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7
Q

notify who of theft or losss

A

DEA, local police

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8
Q

form used when theft or loss of CS’ and who to send it to

A

DEA form 106

send to DEA, IDPR

send copy to both!!!

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9
Q

DEA form 106 must include:

A

Name and address of firm (pharmacy)
DEA reg. #
Date of theft
Name and # of local police notified
Type of theft (robber, night break in etc)
Listing of symbols or cost code used by pharmacy in marking containers if any
Listing of CS’ missing from theft or sig. loss

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10
Q

If not theft or loss found what to do

A

notify DEA in writing why there is no form 106 being filled out
what happened?

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11
Q

who shall have access to LTCF emergency kit

A

Director of nursing, RN on duty, Licensed practical nurse on duty, consultant pharmacist or consultant physician

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12
Q

maintenance treatment vs detox treatment

A

< 21 days = detox (narcotic drug -free state is goal)

> 21 days = maintenance (heroin,morphine like drug)

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13
Q

True or False. When a person is on methadone for detox, no methadone can be prescribed for analgesic purposes.

A

True!!!!!!!!!!

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14
Q

Waived the requirement for a separate DEA registration as a opiod treatment program for practitioners who dispense or prescribe FDA approved schedules III-V narcotic controlled substances for use in maintenance or detoxification treatment. allows office-based setting addiction treatment

A

Buprenorphine drugs allowed (suboxone, subutex)

DEA # and DEA waiver # starting with an X

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15
Q

LTCF shall transmit patient medication profiles to PMP monthly

A

n

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16
Q

is it MISBRANDING OR ADULTERATION if:

the dosage, frequency, duration or route of administration suggested in the labeling is DANGEROUS

A

MISBRANDING

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17
Q

true or false. misbranding occurs when a pharmacist dispenses without an RX or authorized refill

A

TRUE!!!!

18
Q

misbranding can apply to pharmacist too!!! how

A

pharmacist dispenses drug w/o rx or auth refill

pharm misfills an rx (technically no rx for that drug)

19
Q

labeling includes

A

package insert
drug advertisements
info in publication as PDR
promotional materials, including newsletters and literature used in promotion

20
Q

what kind of recall if may cause temporary or medically reversible adverse health consequence

A

Class II recall

21
Q

Not likely to cause serious adverse health consequences

A

class III recall

22
Q

can cause serious adverse health consequences or death

A

Class I recall

23
Q

Step 1

A

in vivo ANIMAL STUDIES

24
Q

STEP 2

A

IND

25
Q

STEP 3

A

CLINICAL TRIALS
PHASE 1
PHASE 2
PHASE 3

26
Q

PHASE 1

A

SMALL HEALTHY GROUP;

TOXICOLOGY
PK
SAFETY

27
Q

PHASE 2

A

LARGER GROUP (100) WITH DISEASE OR SYMPTOMS

EFFECTIVENESS
DOSING
SAFETY
ADVERSE EFFECTS

28
Q

PHASE 3

A

LARGE GROUPS IN DIFFERENT GEOGRAPHICAL LOCATIONS (CONTROLLED CLINICAL TRIALS)

DRUG EFFECTIVENESS COMPARED TO PLACEBO
DOUBLE BLINDED (MOSTLY)
29
Q

STEP 4

A

NDA

30
Q

PHASE 4 STUDIES

A

POST MARKET SURVEILLANCE

SAFETY
EFFECTIVENESS
SUBMIT TO FDA YEARLY
MFG TO REPORT ADVERSE EFFECTS MANDATORY!!!!!!

31
Q

ipecac syrup

A

1 fluid ounce without RX
‘FOR EMERGENCY USE TO CAUSE VOMITING IN POISONING. BEFORE USING, CALL PHYSICIAN, THE POSING CONTROL CENTER OR HOSPITAL IMMEDIATELY FOR ADVICE
***DOSE 1 TABLESPOON IN PERSONS OVER 1 YEAR OF AGE

32
Q

EFFERVESCENT PREPARATIONS AND PREPARATIONS CONTAINING PARA-AMINOSALICYLATE AS THE ONLY SALICYLATE INGREDIENT ARE EXEMPTED FROM THE REQUIREMENT OF LABELING “KEEP OUT OF REACH OF CHILDREN (HIGHTLIGHTED IN BOLD) IN CASE OF OVERDOSAGE GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY

A

TRUE

33
Q

CANNOT PRESCRIBE IN ILLINOIS

A 
CHIROPRACTORS
NAPRAPATHS
PHYSICAL THERAPISTS 
OCCUPATIONAL THERAPISTS
REGISTERED NURSES 
LICENSED PRACTICAL NURSE
PSYCHOLOGISTS
PHARMACISTS
34
Q

WHAT CIIS CAN BE DELEGATED BY PRACTIONER TO MID LEVEL

A

ORAL TOPICAL OR TRANDERMAL

** NO INJECTION OR OTHER ROUTES!!!!!!

35
Q

PHYSICIAN ASSISTANT must discuss the condition of patients for whom a controlled substances is prescribed monthly

A

monthly

36
Q

how many hours for physician assistant prescribing rights

A

45 hours in pharmacology (for C-II)

5 hours of continuing education in pharmacology (ANNUALLY)

37
Q

PHYSICIANS ASSISTANT

ADVANCED NURSE PRACTITIONER

A 
PA = SUPERVISION
ANP = COLLABORATIVE
38
Q

RX REQUIREMENTS WHEN ANP OR PA

A

must have delegating practitioners name

dea # (if CS) and signature of MID - LEVEL practitioner

39
Q

optometrist can prescribe what CS? and how much

A

CIII-CV ((**no CII**)

only up to 72 hour supply

40
Q

board of pharmacy

A 
9 members:
• 7 pharmacists (must ≥5 years experience, licensed bs or pharmd)
• 2 non-pharmacist public members
appointed by governer
5 year terms
max 12 year consecutive years
meet quarterly
41
Q

pharmacy coordinator and investigators

A

1 chief
2 deputies

appointed by DPR director
cannot be member of board
registered pharmacist
≥ 5 year experience immediately prior to appointment

42
Q

must be at least 4 pharmacy invesitgators

A

true

MPJE (2 decks)

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