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MPJE > HAR 95 > Flashcards

HAR 95 Flashcards

1
Q

where and when must you have license?

A

display licenses at place of business

have evidence of current validation in the holders possession at all times

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2
Q

Who’s practice license must be on display in the pharmacy?

A

names and licesnses of alll emmployed RPHs and owners information

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3
Q

Closure of pharmacy process?

A

notify board in writing within 10 days and return all indication of licensure

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4
Q

requirements for RPH by examination

A 
age of majority
ACPE accredited degree
1500 hrs experience
NAPLEX passing of 75
MPJE of 75
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5
Q

requirements for RPH by reciprocity

A 
evidence of current/valid license
info on disciplinary action taken, and pending investigations
1500 hrs experience (w/in 5 years)
NABP license application w/in 90 days
*other state must offer reciprocity*
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6
Q

requirements for intern permit

A

verification currently enrolled/graduated (transcript or registrar/dean letter)
provide name/license of supervisit rph and name/address of pharmacy

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7
Q

requirements for pharmacy permit

A 
-file app in duplicate 15 days prior to board meeting
floor plan
list of all employed rphs
bill of sale/letter of verification
registered with BREG
library
enough equipment/supplies
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8
Q

what must be depicted on the pharmacy permit floor plan?

A 
locked cabinet
library
sink - hot/cold
sewage outlet
refrigeration storage equipment
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9
Q

BREG evidence of registration proof?

A

> 1 year: “certificate of good standing”
<1 year: “file-stamped” copy of document filed with BREG

included with pharmacy permit application

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10
Q

library requirements for pharmacy permit

A 
USP national formulary and all supplements
Federal DEA regs
SUCSA laws (329 HRS)
state food and drug laws (328 HRS)
state pharm law (HRS 461, HAR 16-95)
Prescription files
Drug F&C
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11
Q

minimum technical equipment required for pharmacy permit

A 
class A prescription balance
mortar and pestle (glass or porcelin)
refridgerator
bottles and vials (assorted sizes)
gradates
Rx labels
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12
Q

requirements in app for wholesale distributor license

A
  • applicant name/age/mailing&resident address/SSN/education history &evidence
  • convictions of any pharm-related crime
  • state of current licenses/discipline/
  • citizen or alien with US authorization
  • BERG: corp is register, what name its registered as
  • list of all employed rphs
  • list of all responsible for distributation
  • any felony CONVICTIONS at all
  • each persons past experience in mfr/distrb of rx drugs
  • discipline action/pending infest of any license for distrb/mfr
  • verification of >1 year exp in distr/handling of drugs
  • list of officers/directors/managers
  • map of facility
  • DOH clearance
  • written policies/procedures
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13
Q

what permit/license is the DOH involved in?

A

BOP requests that DOH involved/ensure for wholesale permit

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14
Q

what does the DOH ensure /enforce in a wholesale permit?

A
  • suitable facility size/construction for cleaning/maintenance/operations
  • storage areas design to provide ventilation, temperature, sanitation, humidity, space, equipment and security
  • quarantine area available
    -maintained in clean/orderly fashion
  • pest infestation-free
  • secure from unauthorized entry
  • outside perimeter is well-lighted
  • entry is limited
  • equipped with alarm system after hours
  • security system to prevent theft/diversion
  • drugs stored at appropriate temps
  • manual/electromechanical, electronic temp/humidity recording equipment
  • all incoming/outgoing totes are inspected for accuracy
  • ## all appropriate drugs are quarantined
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15
Q

what must the map include in the application for a wholesaler?

A
  • storage area for drugs
  • storage area for quarantined drugs
  • placement of lighting, ventilation and temperature
  • control equipment
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16
Q

what are the written policies and procedures the BOP inspects during an application for a wholesaler license?

A
  • procedure for rotating old/new stock
  • recalls/withdrawals
  • prepares for/protects against/handles properly and crisis that affects security in strike/fire/flood/natural disaster/emergency
    ensure outdate drugs are segregated
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17
Q

Does a criminal conviction harm you?

A

copies of any court records, judgments, orders must be included, along with sentence imposed and record of compliance with sentence

affidavits from parole/employer/others who can attest to a firm belief that the applicant has been sufficiently rehabbed to warrant public trust

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18
Q

fees and rejected application?

A

fails to pay within 60 days

check bounces on first attempt

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19
Q

How do you document education for a pharmacists license?

A

certified copy of official transcript or

letter from registrar or dean prior to graduation with expected date and official transcript after graduation

FPGEE:
certified copy of the foreign diploma or certified copy of transcript with graduation date
and certified copy/origiional of FPGEE exam

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20
Q

experience requirement for pharmacists license?

A

1500 hours

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21
Q

what may consitute experience for pharmacists license?

A

post grad work
supervised practice during vacations
experience gained concurrent with attendance at school
experience gained during pharmacy school coordinated externships and clinical clerkship programs

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22
Q

Extern vs clerkship

A

extern: in licensed pharmacies for broad experience
clerkship: patient care settings with direct patient care with clinical service (outpt or inpt)

both are for school credit

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23
Q

who can submit work experience on behalf of an applicant? what must be included?

A

licensing official of another state, pharmacy school, employing pharmacy, supervising pharmacist

beginning and ending dates of the applicant’s practical experience and the total number of hours worked

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24
Q

can the board accept pro gratis practical experience?

A

No

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25
Q

how can a reciprocity applicant prove experience?

A

good standing form state BOP + employer letter (standard form)

self employment attestation

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26
Q

when do each of the following licenses renew?

interns, technicians, pharmacists, wholsalers, pharmacies, misc?

A

all expire on 12/31 of odd numbered years

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27
Q

penalty for missed payment of renewal?

A

automatic forefeiture

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28
Q

how long can you restore a forefited persons license?

A

up to 3 years

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29
Q

conditions for restoring a forfeited persons license?

A

within first year:

  • applies for restoration on appropriate form
  • pays penalty, current and renewal fees
  • complies with CE requirements
Within 2nd/3rd year:
- applies for restoration form
- submits official statement that applicant was working 1500 hours inn last 5 years
- old licensing info (MA/PA/NY/etc)
- pass MPJE
pays penalty, biennial, renewal fees
- CE requirements
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30
Q

how long can you restore a forfeited permit

A

3 years

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31
Q

conditions for restoring a forfeited permit

A

appplicationpay all fees
signed statement to report changes
pass a facility inspection (DOH) - distributor only

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32
Q

why might a forfeited permit be denied?

A

if the permit holder engaged in any activities identified

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33
Q

what if permit/license fall outside 3 years?

A

is considered a new applicant

34
Q

Can a pharmacist supervise remotely?

A

no must be present physically during hours of operation

35
Q

when the pharmacist is off site, who can access the pharmacy?

A

no one. access should be controlled only by the pharmacist

36
Q

what is an on-call pharmacist?

A

when policies/procedures have been established by a institutional facilty to use a night cabinet

37
Q

what are the requirements for a night cabinet?

A
  • secured to deny access to unauthorized person by force
  • all drugs labled, only packed drugs are in amounts for immedate requirements
  • providers rx regarding the drug dispensing exists
  • prompt removal of any recalled drug
38
Q

when can the pharmacy be accessed to remove drugs without a pharmacist? what are the conditions?

A

if a drug is not on the floor or in night cabinets

  • authorized persons are designated in writing by organization
  • the AP has been instructed by the rph on procedures
  • the AP fills out a form with name/room/drug/strength/dose/qty/date/time/signature
39
Q

What is a night cabinet and when is it used?

A

used to access non-floor drugs during off hours

40
Q

what is an emergency kt and when is it used?

A

provided to an institutional facility which does not have an institutional pharmacy to meet the immediate therapeutic needs of patient

41
Q

who determines the drugs in an emergency kit?

A

rph and medical staff of facility

42
Q

labeling requirements of each drug in emergency kit?

A

name, strength, ROA (if not PO) , qty, source, mfr, if generic, lot, exp date

43
Q

how soon must the institutions notify the rph when a drug is used from an emergency kit?

A

within 24 hours

44
Q

minimum information requirements for a valid prescription

A 
Date
provider signature
providers name/business address
drug name/strength/qty/ directions
name of pt
address of pt (unless on file)
number of refills
room number and ROA if institutional use
45
Q

are phone rx’s allowed?

A

yes, must provide phone number

46
Q

who can receive a phone order?

A

pharmacist or intern only

47
Q

can rx’s be faxed?

A

yes- only non controlled rx’s

48
Q

how long do oral rxs need to be kept for?

A

5 years

49
Q

how long do faxed rxs need to be kept for?

A

5 years

50
Q

can rph substitute any medications?

A

not without express consent of prescriber

51
Q

what rx’s can be transferred?

A

new or refill rx’s

52
Q

responsibilities of rph sending transfer?

A 
provides all info for a valid rx
records on rx during transfer: 
- name/location of pharmacy receiving
- name of receiving rph
- date of transfer
- name of sending rph
- notes that the rx is inactivated/void for future refills
53
Q

responsibilities of receiving rph transfer rx?

A 
name of sending rph,
name of sending pharmacy's name/location
original rx number
original date
number of refills/qty remaining
date last filled
54
Q

how long do you have to keep transferred rxs?

A

5 years from the date of filling or refilling

55
Q

what can an intern do in a pharmacy?

A

anything the pharmacist can do except the final drug verification prior to dispensing

56
Q

what is the scope of a pharmacy technician?

A

process prescription labels, drug packaging, stocking, delivery, record keeping, pricing, documentation of 3rd party reimbursement, compounding, storing and providing medication

57
Q

can technicians prepare medicaiton?

A

only if has working knowledge of terms/symbols/abbreviations

  • calculations
  • duties/responsibilities
  • drugs/doses/ROAs
  • procedures/operations of mfr/pkg/labeling drug products
  • procedures/operations related to aseptic and parenteral admixture compounding
58
Q

may any returns/exchanges of drugs occur? when?

A

none can be returned or exchanged after taken from premises

59
Q

how long do records for original rx’s need to be kept on file? how about for refills?

A

5 years; 5 years

60
Q

what do records on RXs have to have?

A 
qty prescribed
qty dispensed
date of dispensing
serial number
RPH identification
record of refills to date

patient chart/MAR that shows this meets the requirement

61
Q

when using an ADP system, how much time does the system have to provide the rph with rx records?

A

72 hours (3 days)

62
Q

when the ADP goes down, how long do rphs have to enter in missed information into the ADP system once it’s back up?

A

96 hours (4 days)

63
Q

how long do wholesale records need to be kept?

A

5 years

64
Q

if records are kept off-site, how long do you have to produce those records if requested?

A

within two business days

65
Q

when advertising drugs, what are some things that are permitted and restricted?

A
  • may put out a price poster with references
  • must display 3 commonly prescribed quantities
  • advertised prices must not be blow cost
  • any advertised prices will be accurate as long as prices are advertised
66
Q

what are the pharmacy-related services that may be advertised?

A
  • Personal Medication Record
  • Professional consultations
  • Emergency prescription services
67
Q

what are the requirements for advertising a PMR?

A

a system must be maintained that allows immediate retrieval regarding an individual pharmacy patient. Must show all patient information necessary to assist rph in ddrs, ddis, and inappropriate use

68
Q

what are the requirements for advertising a professional provider consultation

A

acting as a drug info specialist to discuss with providers drug effects, side effects and drugs of choice/standard of care

69
Q

what are the requirements for advertising patient consultation

A

informs the patient directly or indirectly about the drug

what it is, how to take it, what to expect, any precautions, storage, etc.

70
Q

what are the requirements for advertising emergency prescription services?

A

providing all services after usual hours. including a pharmacy that can be readily contacted and can respond any hour day or night

71
Q

can controlled substances be advertised?

A

no, never

72
Q

if your application for license/permit/reinstatement is denied, how long do you have to demand a hearing?

A

must be filed with the board within 60 days of the date of denial

73
Q

if you wish to give oral testimony, when do you have to notify the board?

A

48 hours before the meeting

74
Q

can the board specifically ask someone for oral testimony?

A

yes

75
Q

can the board limit the time you are allowed to speak within oral testimony?

A

yes; but not to be less than 5 minutes; and must be notified before they start

76
Q

can the board refuse any oral testimony?

A

yes, any testimony that is immaterial, unduly repetitious, or irrelevant

77
Q

what forms to be filed if starting a collaborative practice agreement for emergency contraception?

A

form provided by the board; and delivered ot the board by the licensed rph within 10 days of execution

78
Q

what are the requirements of a pharmacist in an EC PCA?

A

ACPE training course, curriculum based program from ACPE college, or state/local health department, or board program

79
Q

how long is an EC PCA valid for?

A

at least 2 years from delivery to the board unless rescinded in writing by either physician or rph; then it is month to month

80
Q

when can planB not be given in an ECPCA?

A

when planb is unavailable, not covered or patient chooses another after all risks are explained and told that plan b has less side effects

81
Q

what does an EC CPA require on it?

A

rph info: name/address/phonenumber
physician: name/address/phonenumber + signature

“to permit EC drug therapy within 120 hrs of unprotecte dsexual contact and recieve info from rph”

rph will refer patient to a physician

rx label will contain rph and MD names

informed consent

screening checklist

82
Q

how long does someone have to notify the board of any changes to an EC CPA?

A

10 working day s prior to the intended implementation of changed agreement

MPJE (6 decks)

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