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MPJE Flashcards

1
Q

Exceptions for faxed CIIs

A

CII can actually be faxed a filled and can be given to pt if they bring in the original
-if the CII is used for compounding for direct admin by IV,IM, sub-q or intranspinal infusion
-resident of long term care facility
-hospice pt., must be noted on the fax
These faxes serve as the original and no further documention is required

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2
Q

When can a CII be written for a 90 day supply?

A
  • each RX must be seperate (one fro each month)
    each month must have a corresponding date to fill and can’t be filled before that date and there must be no known cause for abuse
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3
Q

who may write a controlled RX?

A 
Physicians
dentists
podiatrists
vets
residents
animal shelters
mid-level practitioners (all must have supervisors w/ DEAs) nurse practitioners, nurse midwives, ambulance services,nurse anesthetists, PA's optometrists, homeopathic physicians, nursing homes, euthenasia techs
*all must be registered w/ the DEA, prescribe within parameters- varies by state
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4
Q

Requirements for an RX

A

6- drug name, strength,dosage form, quantity,directions and number of refills
* if controlled must have 6: date, signature, DEA, full name of pt, address of pt, address and name of MD

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5
Q

DEA form 224

A

Registration form for the DEA, a renewal must be done every 3 years with the 224a form for an independant, for a coorporation it’s done with the 224b form. Can be renewed no more than 60 days prior to expiration

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6
Q

How many days to let the board know about transfer of business?

A

14 days before the date of the proposed transfer

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7
Q

DEA form 222

A

CI & CII order form and can be used as a transfer form that lets stores transfer CII’s back to the distributor, a company to destroy or to another pharmacy. Can be ordered www.DEAdiversion.ursdoj.gov. Must use DEA number, name and phone #. or can order by calling DEA office. Each book has 7 forms and a max of 6 books can be ordered at a time

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8
Q

closed-door pharmacy

A

pharmacies that distribute to institutions such as long term care or jails and not open to the public

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9
Q

DEA form 41

A

form that allows disposing of controlled substances for instances such as expiration or broken meds. This is usually filled out by the company who is doing the destroying and the pharmacy must fill out a 222form to give them the medication

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10
Q

How many days do you have to let the DEA know if there has been a theft or a significant loss?

A

1 business day of discovery. you must:
1- notify DEA and/or police in writing
2- complete the DEA for 106 that documents the entire experience

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11
Q

DEA form 106

A

makes them aware of a theft or significant loss

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12
Q

Who fills out the DEA 106 form?

A

In-transit loss- the supplier fills out
Central fill to pt- central fill pharmacy
Central fill to pharmacy- receiving pharmacy

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13
Q

The fed will get involved w/ a theft in these instances:

A

1- the replacement for meds in at least $500
2-interstate or foreign commerce was involved
3-a person was killed or suffered harm as a result of the crime

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14
Q

Recordkeeping. What must be kept?

A

These all must be kept for at least 2 years
1-DEA 222 forms
2-power of attorney forms
3-invoices for CIII-CVs
4-all inventory records for all controlled substances
5-record of all controlled substances distributed
6-records of RX dispensed & CV logbook
7-reports of theft DEA 106 form
8-records of drugs for disposal- DEA form 41
9-records of drugs trasnferred between pharmacies
10-DEA registration certificate
11-CMEA 2005 certificate

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15
Q

Paper RX recordkeeping

A

Option 1- 3 separate files (one for CII’s, one for controlled, one for non-controller)
Option2- 2 separate files (one for CIIs and one for non-controlled and CIII-CV (controlled designates with a red “c” on them)

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16
Q

Electronic RX records must be kept for?

A

Must be kept electronically and must be available at the registered pharmacy for 2 years from the date of creation

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17
Q

Inventory requirements

A

CII-actual count
other controlled- estimated count (unless the bottle holds more than 1000 pills, must be hand counted)
Inventory must be kept for at least 2 years, and CII inventory mist be kept separate. There is a recommendation to put name, address, DEA registration number and the person doing the on the forms

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18
Q

Required inventories for controled substances

A

Initial inventory-done when first opens

Biennial inventory- once every 2 years on any date . Doesn’t need to be submitted to DEA, just kept on record

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19
Q

DEA form 222-filling it out

A

Number of packages, the size of the package and the name of the item, Must be signed and dated by the authorized person that is granted power of attorney. When they are received, the Rph must document on the purchasers copy the number of packages received and date. Must keep copy for 3years

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20
Q

When a DEA 222 form is not accepted

A

a supplier may refuse to accept an order and they must return copies 1 and 2 of the 222 form and a statement explaining the refusal

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21
Q

DEA 222 form colors

A

Copy1 (Brown) goes to supplier
Copy2 (Green) goes to supplier then goes to DEA
Copy3 (Blue) purchaser keeps -us

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22
Q

Lost or stolen DEA form- a shipment was never received

A

Contact supplier and ask if they got form, if it was lost, fill out another one and attach a sheet w/ reference the old form with serial number and date and write that it was lost or stolen and never received and send that with new order to the supplier

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23
Q

Unacceptable DEA forms

A

(1) The order is not complete, legible, or properly prepared, executed, or endorsed.
(2) The order shows any alteration, erasure, or change of any description.

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24
Q

Receiving controlled III-V

A

Invoice that is dated and has a confirmation that the total amount was received

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25
Q

DEA registration numbers

A

Issued before 1985, DEA starts with A
After that, starts w/ B or F-dispenser of controlled substances
Midlevel practioners start w/ M
The next letter is usually the first letter of their last name then followed by 7 numbers

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26
Q

Refills for CIII-V

A

5 refills (original fill + 5) within 6 months after the date of issue. After whichever one occurs first a new RX is required

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27
Q

Manually keeping records of CIII-CV fills

A

If refilling a controlled med, each fill must be indicated on the back of the original script with initials of Rph, date filled and quantity filled on that date

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28
Q

Transferring a controlled RX between pharmacies

A

May only be done ONCE between pharmacies. Transferring between stores of the same company doesn’t count. Transferring rph must:

  • write “void” on the face of the invalid RX
  • record the name of the pharmacy, name of rph
  • record the date and name of pharmacist transferring RX
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29
Q

Incoming transfer requirements

A

The word “transfer” must be written on the top of RX

1) date of original RX
2) original # of refills authorized
3) date of original dispense
4) Number of refill remaining
5) Transferring pharmacy name, address, DEA, original RX number
6) name of Rph transferring
7) if different the name, DEA & address of the original pharmacy

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30
Q

RX label requirements

A

Date of fill
Pharmacy name and address
RX number
Name of pt
Name of prescriber
RX units
Drug and strength
Directions for use
Expiration date (if less than a year put that, if more than a year can just put 1yr from dispensing
If MD specifies-the symptom or purpose for RX
* every controlled label must say not to share meds and no ETOH

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31
Q

Emergency prescriptions for a CII

A

When a prescriber can’t give an RX at that time. This is telephoned in and MD must send the original within 72 hours in NV.

  • RX must only be written for the amount of days that emergency occurs
  • Must have all info for RX but sig not needed
  • The RX received in 3 days must have “Authorization for Emergency Dispensing” on it + the date of the oral order. Attach RX to verbal order RX
  • if MD doesn’t send , Rph must contact DEA (no specified time
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32
Q

Partial fills for CIIs

A

An RX may be partially dispensed if full amount is not in stock.Must write date and partial fill # on RX. The original RX may be dispensed in the next 72 hours, if not MD must be contacted

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33
Q

RX for LTC pts

A

RX must have “terminally ill” or “LTCF patient” on RX. If partial fills done, the fill must be written on back of RX w/ date, initials and qty including qty remaining. CII rx for these pts can be up to 60 days supply

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34
Q

Dispensing a controlled substance without an RX (robitussin)-AKA exempt narcotic

A

Dispensing is only done by the Rph, the purchaser is at least 21 yo, purchase must be recorded in bound record book, qty may not exceed 60ml and cannot give to same purchaser any sooner than 48hrs. (federal-240 ml of any substance containing opium is sold to the purchaser in any 48 hour period.24 dosage units of any other controlled substance (other than opium) is sold to the purchaser in a 48 hours period

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35
Q

Can controlled subsrances be shipped out of the country?

A

No unless the person sending it has a registered DEA as an “exporter” and has a permit to do so

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36
Q

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

A

Used to combat any “rogue internet sites” making it illegal to deliver, distribute, or dispense a controlled substance by means of internet use if they don’t have a DEA to do so

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37
Q

Online pharmacy rules

A

Must notify the DEA within 30 days of dispensing, delivering or distributing of a controlled substance and must inform each state board within each state where they will be sending meds to. They must also abide by the rules of each state. Each month they must send to the DEA a total qty of each controlled med over 100 RXs filled of more than 5,000units sold-reports are done by NDC due before or on the 15th of each month

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38
Q

Central fill pharmacy

A

When one pharmacy received the prescription and another pharmacy fills it. Records must be maintained by both pharmacies, they have the authority to fill CII’s

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39
Q

Long Term Care Facilities

A

Nursing home, retirement home, mental care or other facility that provides extended healthcare to residents. They are hot registered with the DEA

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40
Q

Narcotics Treatment Programs

A

MDs who are involved in prescribing and dispensing have to have a separate DEA to do so and must also get approval from SAMHSA

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41
Q

Five Percent Rule

A

A pharmacy can distribute controlled substances to a practitioner for general dispensing if the total number dispensed to them does not exceed 5% of all controlled substances dispensed by the pharmacy in a calendar year. If it exceeds that 5% they must register as a distributor

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42
Q

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

A

Sellers of ephedrine, PSE and phenylpropanolamine must abide by these rules and register every year. Must be behind counter, check ID and maintain a log (name,address,date,time and amount sold) and keep it for 2 years. Max 3.6 grams/day and 9grams per 30 days

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43
Q

Pt record must include

A

Full names, address, phone number, DOB, gender, medical condition, allergies, and Rph comments related to drug therapy…retain records for ???

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44
Q

Pharmacy Practice experience hour requirements for Nevada

A

1500 hours, can be an intern upon enrollment in pharmacy school

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45
Q

Foreign licenses in NV

A

Accepts degrees and must do 1500 hours of practical experiance

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46
Q

RPh renewal schedule in NV

A

Every 2 years-on odd years. Fee of $180 on Oct 31st, renewal sent out Sept 15th

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47
Q

CE requirements NV

A

30 hours within 2 years. 15 credits in accredited programs and either: 1hr in jurisprudence program (a-set up by board b-approved by board or c- earned by attending one), or1 full day of a board meeting (3hrs of CPE + 1 NV jurisprudence)

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48
Q

License disciplining in NV

A

Done by NV state board of pharmacy

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49
Q

Technician license in NV

A

NV doesn’t license or certify techs, they register them. Register every 2 years $40

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50
Q

Tech to pharmacist ratio

A

3:1. This includes 2 techs and 1 tech in training if those are the circumstances. Data input can only be done by licensed tech and the only thing a clerk can do is enter demographic info and insurance info on a new RX

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51
Q

Tech responsibilities

A

Can accept refills from Drs office, can prepare,package and compound medication for dispensing, stock supplies in the pharmacy, maintain inventories of drugs, maintain pharmacy records, transfer an rx through a computer network,but can’t transfer prescription orders (can initiate though)

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52
Q

Two types of Rph license catergories

A

Institutional and retail, $500 renewal fee due every 2 years

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53
Q

Wholesaler destirbuter liscense requirements

A

The NV BOP is responsible for licensure, they have authority of medical device distributors, must be renewed every 2 years

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54
Q

NV Board of PHarmacy controls these laws and regulations

A

Dangerous Drug Law, Controlled Substances Act. They also come up w/ laws/reg on dispensing RX medical devices, and medical O2

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55
Q

Preventing substitution on NV state drug formulary

A

MD must write “Dispense as Written” on the RX

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56
Q

Taking a non-controlled & controlled RX from out-of-state

A

Yes, but Rph must verify pt has seen the MD in the 6 months since date on RX and document it as “face to face” for a CII and record, name of the person who you spoke with, date and time and date of examination

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57
Q

Time limit on RX refills

A

1 year from the date written and 6 months for CIII-IV

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58
Q

Requirements for formatting on RX in NV

A

Electronically generated and signed RXs must be printed on security paper

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59
Q

Faxed RX rules

A

Can accept faxes for non-controlled and CIII-V and the fax has to state “Faxed Copy”. Prescriber’s info is required with a signature

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60
Q

Electronic RX info

A

Can receive from in state or out of state and ca only be seen by pharmacy or practitioner. Controlled RXs can be sent

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61
Q

Counseling requirements

A

For medicaid pts, new rxs and professional judgement used for refills. If pt is not there in person to counsel it may be done in writing

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62
Q

Prescribing authority in NV

A

PA-dependant prescribing authority
Advanced nurse practioner-dependant prescribing authority
Clinical nurse specialist- no authority
Nurse midwife or midwife-no authority
Nurse practitioner-no authority
Nurse anesthetist-no authority
Dr. of homeopathy-independant authority
Optometrist- independat authority but limited
EMT-no authority
Naturopathic MD-not licensed in this state

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63
Q

MD prescribing authority

A 
Dr. of osteopathic med-yes
MD-yes
Dentist-yes
Podiatrist-yes
Vet-yes
Dr. of homeopathy-yes
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64
Q

Who can possess non-controlled drugs in their practice?

A 
MD-yes
DO-yes
Dentist-yes
Podiatrist-yes
vet-yes
Dr. of homeopathy-no
PA-yes
Advanced nurse practitioner-yes
nurse specialist-no
midwife-no
nurse practitioner-no
optometrist- may dispense a med at no charge to pt if in scope of practice
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65
Q

Dr of optometry

A

OD

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66
Q

Dr of osteopathy

A

DO

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67
Q

Who can possess controlled legend drugs?

A 
MD-yes
DO-yes
Dentist-yes
podiatrist-yes
vet-yes
Dr of homeopathy-yes but at homeopathic doses
PA-yes
Advanced registered nurse-yes
nurse specialist-no
midwife-no
nurse practitioner-no
optometrist-no***
RPh-no
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68
Q

May RPh’s initiate,modify or D/C drug therapy?

A

Yes, in the hospital setting only

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69
Q

Can a prescriber own a pharmacy?

A

Yes but it can’t be more than 10% of the total interest of the pharmacy

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70
Q

Can RPh’s administer meds?

A

Yes but only when written approval, and we can do immunizations under protocol

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71
Q

Does NV allow the return and reuse of medications?

A

Yes???

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72
Q

Members of the board of pharmacy

A

6 members who are registered RPhs (have been for at least 5 years) and 1 person from the general public and are given terms of 3 years and cannot serve on the board for more than 3 consecutive terms all appointed by the governer. They meet every 6 months

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73
Q

Jobs of pharm techs

A

1)removal of drug from stock 2)counting,pouring or mixing of drugs 3)placing of drugs in containers 4)affixing labels on containers 5)packaging and repackaging of drugs

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74
Q

License display

A

Must be displayed where public can see in the pharmacy. If employeed in more than 1 pharmacy, the main license should be displayed in the main pharmacy and the a 8’’ by 10’ color photocopy of registration and a copy of the renewal receipt in the other pharmacy

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75
Q

Notice of new place of practice

A

If changing employers, the BOP must know within 10 days after changing jobs.

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76
Q

How many pharmacies may a manager be?

A

Only one pharmacy per pharmacy manager

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77
Q

Institutional pharmacy rules

A

A hospital with more than 100 beds requires a pharmacist on staff at all times. In less than 100, a pharmacist can work part of the day and designate to nurse practitioners authority to fill. same thing for corrections in pt <1500

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78
Q

How long does a DR have to sign an RX in a ot’s chart?

A

48 hrs from time the order was given

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79
Q

Requirements for mail order RXs

A

1) pt name 2) prescriber name 3)RX number 4)date of RX 5)the name of the drug 6)strength quantity and dose

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80
Q

Canadian Mail Order rules

A

CANNOT sell controlled substances, has to send meds approved by the FDA, cannot dispense meds stopped by the FDA and max 3 months supply at a given time

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81
Q

What the MD must do before writing an RX for a controlled substance

A

Must verify in a patient utilization report from the past 12 months through the Investigation Division of the Dept. of public Safety to make sure pt is not abusing controlled substances.

82
Q

A written prescription must contain

A

1) name and signature of the practitioner
2) classification of license
3) name of pt and address if not available to RPh
4) name, strength and qty of drug
5) symptom or purpose for the RX, if included by MD
6) directions for RX
7) date of issue

83
Q

Numbering and filling an RX

A

All RX’s must be numbered. CIIs must be filed alone and all filed RXs must be available for 2 years. Each RX must have the date it was originally filled & must be signed by the RPh who filled it

84
Q

People who have access to filed RXs

A

*these are not public record
a)pt RX was issued to
b)practitioner who prescribed RX
c)a new practitioner treating the pt
d)member of the board of FDA
e)an agency of the govn. responsible for the health of the pt
f)an insurance carrier w/ authorization from pt
g)any person from the district court
h)an inspector or investigator of any professional licensing board who licenses a practitioner
I)other BOPs if pertaining to misusing RXs
j)peace officer from the local govn
k)a county coroner to help id someone or determine cause of death

85
Q

Copy of an RX

A

If someone needs a copy of an RX, it should be clearly marked “COPY, Not refillable-for reference purposes only” and RPh must sign or initial

86
Q

Controlled substances records

A

A record for each refill of any prescription must either be kept on the back of the original RX or in a bound book and the record must include the date of each refill, the number of dosage units the signature of initial of RPH who filled it

87
Q

A controlled med needs to be refilled for a chronic condition and are unable to get a hold of the MD an RPh may

A

If the RPh feels that the pt needs the medication, can give the pt a sufficient supply of the med until there is a time where an MD can be found

88
Q

Mental or physical examination

A

If the Board believes that a license holder has become incompetent, they may designate a physician or psychiatrist to conduct an exam at the Board’s cost. The RPh may hire their own physician and must have that report in 10 after original psych report and a suspension may be put on the RPh until deemed competent. RPh can be placed on probation if they voluntarily enter a drug rehab program

89
Q

Notice of hearing

A

If someone has received a report for a crime, the Board has 30 days to have a hearing after RPh receives a report

90
Q

Hearing

A

Must be presided by a board member and 3 others. Any decision about hearing must be made by at least 3 members of the board and must be recorded

91
Q

Counseling in the hospital

A

Not required to inpatients where they are being administered their meds

92
Q

Reusing medications in a home and correctional institute

A

In the instance of a skilled nursing facility, if unit doses are not used or d/c’s for a pt, ins will be reimbursed and the meds will go back to the med stock for reissuance.

93
Q

laetrile

A

amygdalin

94
Q

Gerovital H3

A

procaine hcl w/ preservatives and stabilizers. Can be sold without an RX but name and address of person sold to needs to be kept, the amount sold, the signature of the pt and the signature of the RPh (only person who can sell it)

95
Q

May sell parenteral meds for personal in a medical facility

A

The pharmacy is selling it or a licensed practitioner, if there is an expiration date on the label and if someone is available at all times for immediate assistance

96
Q

It is illegal to resale or sell knowing

A

the med left the control of an RPh, has been damaged or subject to damage in heat,smoke,fire or water, has been obtained through bankruptcy or foreclosure, is no longer safe or effective for use, or has not been properly stored or refrigerated

97
Q

Can RPh’s or inteens sell contact lenses

A

No, cannot sell or fit lenses. Can sell prepackaged ones but not special order ones

98
Q

Products that are precursors to meth

A

pseudophedrine, ephedrine or phenylpropalamine

99
Q

If meth precursons are missing from the pharmacy

A

Make and oral report to the Dept of Safety, submit a written report within 15 days of finding out and a loss report filled out

100
Q

Things that can be changed on a controlled II RX

A

1) The strength of the med
2) the quantity of the drug prescribed
3) the directions for use
4) the date the RX was issued
* any change should be initialed, w/ date and time w/ reason for change

101
Q

Things that can’t be changed on a CII RX

A

1) The name of the pt (can add a last name-no changing)
2) the name of the controlled substance
3) The signature of the practitioner

102
Q

What to do if there is a CII and a non-controlled on the same RX

A

Make a copy of the RX and retain the original for the CII records and on each RX make a reference for the RX number for each

103
Q

How long does a new RPh manager have to do an inventory of controlled substances?

A

48hrs after first reporting to duty with the pharmacist who preceeded him. Both must sign the inventory

104
Q

CII’s

A

codeine powder, hydrocodone, ethylmorphine, powdered opium, concentrate of opium,piminodine, tapentadol, amphetamine salts, phenmetrazine, methylphenidate, pentobarbital, amobarbital, d. Tuinal pulvule, Amytal sodium, Seconal pulvule, Nembutal capsule

105
Q

CIII’s

A

benzphetamine, chlorphentermine, clortermine, phendimetrazine, chlorhexadol, any combo or mixture w/ pentobarbital, nalorphine, <300mg hydrocodone, testosterone, anabolic steroid, Ketamine, synthetic dronabinol, any combo w/ buprenorphine

106
Q

CIV’s

A

benzos, carisoprodol, chlorazepate, phenobarbital, triazolam,zaleplon, zolpidem, any combo w/ fenfluramine, any combo with phentermine

107
Q

CV’s

A

<100mg opium, pregabalin, lacosamide

108
Q

How long must a manufaturer maintain samples and records for their lots?

A

Those samples used to detect sterility must be kept for 2 years after distribution of the last lot or 1 year after the expiration date of the last drug lot

109
Q

What to do when there are controlled meds that need to be destroyed?

A

Must be kept separate from other returns and destruction is done by the board. A form 41 should be filled out and the destruction is done on a yearly basis.

110
Q

How soon does an RPh need to let the board know of an address change?

A

Within 10 days after changing residence or place of practice

111
Q

How soon does a pharmacy need to let the board know if there has been a change in ownership?

A

No less than 15 business days before a change of 50% or more of the beneficial interest of the pharmacy has been paid

112
Q

Requirements for a tech

A

Must be at least 18, must have graduated from high school or equiv, never been convicted of a felony or misdemeanor involving drugs, no history of drug abuse, or completed a tech program or trained 1,500 hrs of experience (within 3yrs of app) in NV and 350hrs of employment in a pharmacy, written statement from the managing RPh

113
Q

Schedule records must be kept for how long?

A

2 years

114
Q

A pharmacy tech may not

A

perform an action requiring judgment decision regarding a drug or interpretation of a RX, take new orders on the phone, dispence an RX unless the RPh has verified,

115
Q

What must be kept on file for each tech?

A

documentation of completion of orientation and training, evidence that the techs are familiar w/ state and federal laws. These must be available for at least 2 years

116
Q

Role of a pharmacy intern

A

1) selling controlled substances
2) compounding of meds
3) filling Rxs and dispensing them
4) preparing and maintaining records and reports
5) counseling pts
6) administer immunizations

117
Q

How long must CE providers keep a list of attendees?

A

4 years since CE class

118
Q

Remote sites

A

The telepharmacy attached must be located within NV, the RPh or practitioner must be in the telepharmacy at all times, if communication is lost, the remote site should NOT continue filling, the tech must have license for at least 1yr, can’t supervise more than 3 techs at once, RPh or practitioner must visit site once monthly

119
Q

Minimum age for immunization

A

14 years old (retail chains allow 11 yo)

120
Q

Admixture label requirements for institutional pharmacy

A

1) name of pt and ID number
2) name and amount of drugs added
3) name of the basic solution (NS)
4) Name, initials or ID code for RPh
5) expiration date of the solution

121
Q

Prepackaging label requirements

A

1) generic or tradename of the med
2) lot number
3) expiration date of the drug
4) qty of the drug

122
Q

If a drug is withdrawn from an institution w/ out an RPh present how long does the RPh have to verify?

A

Medical facility- 72 hrs
Correctional institute- 96 hours
Part-time pharmacist absent-90 days

123
Q

If a controlled medication is not fully used in a intermediate care facility what is done with it?

A

It is to be delivered to the director of nurses for destruction. This must be recorded and filed under pts name for 2 yrs. Destroying occurs from director or consulting RPh and is done once monthly

124
Q

How are controlled meds to be destroyed in facilities?

A

1) flushed down the toilet
2) place in H20 then in a waste container
3) break ampule or container and contents to be placed in waste container

125
Q

Ownership of a pharmacy-choosing someone in charge

A

Has done 6,000 hrs in a pharmacy, has passed the law exam, is at least 21 years old, must be emplyeed full time, must be present in the pharmacy during work hours

126
Q

Annual inspections from the board

A

A self inspection form needs to be done by the manager and will go through it with a member of the board. Any reports of inspection must be kept for 2 years

127
Q

What pharmacies must carry as far as law and references

A

1) must carry current state statutes and regulations for controlled drugs
2) Reference materials- prep. and compounding, biologic or therapeutic equivalencies, pharmacology and PK, indications and usage of drugs, CI or SE, dosage and administration of drugs and overdosage of drugs

128
Q

Class A & B packaging expiration date compared to class C

A

Class A and B- expire 12 months from packaging

Class C- 60 days from packaging

129
Q

Required temp in fridge and freezer

A

Fridge- 3-46 F

Freezer- -32 F

130
Q

Requirements for bathrooms

A

A pharmacy or remodeled built after Nov, 1 1996 must have a bathroom within the pharmacy.

131
Q

How long does a pharmacy need to let the board know when their is a termination of employment?

A

Must let the board know if an RPh, intern, tech, tech in training has been terminated within 10 days

132
Q

How long does a pharmacy have once it has voluntarily closed to deal with controlled substances?

A

A licensee has 60 days after date of closure to make arrangements for the lawful sale or disposition of controlled substances

133
Q

Voluntary closure

A

Whenever a pharmacy is not open longer than 5 days the board must be notified no more than 5 days after closure and state the reasons for the temp closure. If the licensee of the pharmacy dies or becomes disabled, the board will take custody of all controlled drugs

134
Q

Permanent closure of the pharmacy

A

1) Must place a sign in the front door stating the pharmacy and address where records have been transfered and be placed there for 30 days
2) Return the pharmacy license
3) Inventory controlled meds
4) transfer rxs and make sure they have sufficient info about refills

135
Q

Nuclear RPh requirements

A

1) be certified by the Board of Pharmaceutical Specialties
2) meet the min standards of training for radioactive material & licensed by the Nuclear Regulatory Commission
3) Min 200 contact hrs of instruction in nuclear pharmacy and safety
4) MIn 500 hrs clinical or practical training

136
Q

RX for nuclear pharmacy must contain

A

1) Name if the institution & the prescriber
2) date of dispensation and the calibration time
3) Name of the procedure
4) name of the radiopharmaceutical
5) dose or qty of radiopharmaceutical
6) rx number
7) instructions from the prescriber
8) initial of person who received the order
9) initial of the person who dispensed the order
10) name of the pt if necessary

137
Q

Label for a radiopharmaceutical container

A

1) Name and address of pharmacy
2) name of the prescriber
3) date of dispensation
4) RX number
5) radiation symbol
6) “CAUTION RADIOACTIVE MATERIAL”
7) name of the procedure
8) the radionucleotide and chemical form
9) the amount and date of calibration
10) volume, weight or # of ampules
11) the molybdenum
12) name of pt

138
Q

Requirements for the representative of a wholesaler

A

1) must have 6000hrs in a pharmacy or wholesaler that has dispensed drugs
2) has received a score of at least 75 fromthe board
3) at least 21 yo
4) must work full time and be actively involved in daily practices
5) may only serve one wholesaler at a time
* notify board in 48hrs if this person is gone

139
Q

Cessation of operation of a warehouse

A

Board must be told 30 days before the intend on ceasing operation

140
Q

CHanging ownership of a facility

A

The board must know within 5 days of changing ownership

141
Q

Storage of RX drugs within a warehouse

A

Must follow temp and storage rules adopted by United States Pharmacopeia-National Formulary

142
Q

Compounding pharmacy and requirements for records

A

1) name of the compounded med
2) a list of components & quantities (including lot and expiration date of each ing.)
3) the internal control number assigned by the RPh
4) beyond use date
5) date of prep
6) initials of RPh or tech that compounded med
7) qty of the final product

143
Q

Expiration date for compounded meds

A

non-aqueous liquid and solid formulations- 6months
non-sterile H20-14 days after it was made
other compounds-30 days after the date

144
Q

Environment for compounding sterile products

A

Compounding sterile products should be in an ISO class 5 environment. If a laminar flow hood is to be maintained in an ISO 5, the room it is located in that has an ISO 7, and an ante-area close to entrance of the room should maintain ISO-8

145
Q

Cleaning an ISO 5 environment

A

Done at the beginning of each work shift, before the compounding of each batch, at least every 30min after each compounding activity. The floors and counters around the hood are cleaned daily. The walls, ceiling, storage and shelves are to be cleaned once monthly

146
Q

Tests for competency and proficiency in personnel

A

Retest at least once a year in low-risk sterile compounding

Retest at least twice each year if compounding high-risk products

147
Q

Records for compounding pharmacies

A

The record must be maintained for at least 6 months after the date the product was compounded

148
Q

Re-writting expiration date if a vial is opened in sterile environment

A

Time and date must be marked & container used:

  • within 1 hr in a worse than ISO 5 environment or stored in a worse than ISO 7environment
  • within 6hrs if opened in an ISO 5 environment or stored in an ISO 7environment
  • within 24hrs if opened in better than ISO 5 and stored in better than ISO 5 environment
149
Q

The period of storage before admin of a low-risk compounded product

A
  • 48hrs in a room temp at least 20- 25 C
  • 14 days at 2-8C (fridge)
  • 45 days in solid frozen state -10 C or colder
150
Q

The period of storage before admin of med-risk compounded products

A
  • 30hrs at room temp 20-25 C
  • 9 days at 2-8C
  • 45 days in solid frozen state -10 C or colder
151
Q

The period of storage before admin of high-risk compounded products

A
  • 24hrs at room temp 20-25 C
  • 3 days at 2-8C
  • 45 days in solid frozen state -10 C or colder
152
Q

Drugs usually compounded in ISO 5 environment

A

1) antineoplastics
2) radiopharmaceutical drug
3) a drug whose manufacturer recommends it

153
Q

Medical products administrator

A

Must have a high school diploma, 1500 hr work experience relating to medical products, must work 40hr/week, board must know within 3 days after cessation of employment and within 3 days of new hire and wholesaler may not operate if no administrator for 10 days

154
Q

Maintenance of records for medical supply RXs

A

Kept in a file in reference to pt name,retained for at least 5 years from date order was made

155
Q

These are the things that can only be done by an RPh or intern

A

1) take new orders over the telephone
2) identify and interpret an RX
3) interpret medical data on a chart
4) consult with a nurse or MD
5) take responsibility of techs
6) counsel a pt or giving advise
7) determine efficacy of a drug or drug substitution
8) professional judgement in the pharmacy

156
Q

Jobs a clerk can do

A
  • Enter info into the system other than info contained on a new RX
  • processing sales
  • stocking shelves
  • delivering meds
157
Q

Topics to discuss during consultation

A

name and description of med, form of dosage, dose, route, intended uses of drug and expected responses, and special directions, common SE, CI or interactions, techniques for use, proper storage, info about refills

158
Q

DUR includes determining

A

1) over utilization of a med
2) under-utilization of a med
3) therapeutic duplications
4) interactions between drugs & other drugs, diseases and allergies
5) incorrect dosage and treatment

159
Q

Records for counseling

A

Must be maintained for at least 2 years, list all rxs dispensed to pt

160
Q

An RX submitted electronically must include

A

DEA of MD if controlled, phone # of MD, time and date of transmission, name of pharmacy sent to and all other requirements for an RX

161
Q

What is on the label of every cell in a counting machine?

A

1) generic name of trade name of device
2) lot number
3) expiration date
4) name of the manufacturer
5) strength of the medication
6) initials of the RPh who filled the device or oversaw a tech do so

162
Q

When an RX doesn’t need a safety cap

A

1) when the pt is at least 18yrs old
2) specific request an easy open container
3) signs a document saying they don’t want safety cap

163
Q

Dispensing tech

A

Someone under the observation of a prescriber that is allowed to dispense meds. This person may be certified if worked over 500hrs w/ practitioner and verification from practitioner that they work to satisfaction. They will not have access to meds unless they have completed those hrs. If locations have been changed 200 more hrs need to be done under that new practitioner

164
Q

Reasons for an RPh to deny an RX

A

1) reason to believe it would be unlawful to fill
2) the filling of the rx would be harmful
3) the rx is fraudulent
4) the RX is not for a legitimate medical purpose
* must discuss with prescribed before denying

165
Q

A prescription for a controlled substance shall be written with

A

Ink, indelible pencil, typewriter, non-erasable ball-point pen

166
Q

The DEA is a component of the

A

Dept. of Justice. DEA also controls to Controlled Substance Act

167
Q

“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This statement is required as part of the prescription label for

A

CII-CIV - not required for CV

168
Q

Controlled drugs definitions

A

C-II-Drugs which have a currently accepted medical use in the US and have a high abuse potential with severe psychic or physical dependence liability
C-III-Drugs which have a currently accepted medical use in the US and have a potential for abuse which may lead to moderate or low physical and psychological dependence
C-IV- Drugs which have a currently accepted medical use in the US and have an abuse potential which may lead to limited physical or psychological dependence
CV-Drugs which have a currently accepted medical use in the US and have a low abuse potential and limited physical or psychological dependence

169
Q

The person having authority to reschedule a controlled substance or remove controls

A

Attorney general

170
Q

Federal regulations permit the partial filling of a C-II substance. The balance of the Rx may be supplied to a patient in a nursing home within

A

60 days

171
Q

Manufacturers and distributors of controlled substances are required to register with the DEA:

A

Every 3 years

172
Q

Which of the following among other things, must be recorded on the retained copy of the federal order form when a C-II substance is received by the purchaser (pharmacist)?

A

Number of packages received and date on which received

173
Q

According to federal regulations, if a vendor cannot supply the entire order for a C-II drug product, within what period of time may the balance of said order be shipped to the purchaser?

A

60 days from date order was issued by the purchaser

174
Q

You make a mistake on a DEA 222 form by indicating the right quantity but the wrong medication on one line. Everything else on the form is filled out correctly. How does the DEA law advise you to handle this situation?

A

Void the entire form and retain copies 1, 2, and 3

175
Q

Which of the following DEA authorized registrants is permitted to purchase reasonable quantities of either etorphine HCl or diprenorphine using the DEA 222 form?

A

Veterinarian engaged in exotic animal practice

176
Q

If an order for a C-II substance cannot be filled for any reason, the supplier shall

A

Return copies 1 and 2 to purchaser and explain why the order was not filled

177
Q

Copy 2 of the DEA 222 form for C-I drug shall be forwarded by the supplier to the DEA

A

At the close of the month in which shipment was made to the purchaser

178
Q

The DEA 222 form is not valid beyond ____ after its execution by the purchaser

A

60 days

179
Q

A purchaser may cancel part or all of an order for a C-II drug by

A

Notify the supplier in writing

180
Q

Which of the following controlled substances must be ordered by themselves when a DEA form 222 is used?

A

Carfentanil, Diprenorphine HCl, Etorphine HCl, Marijuana

181
Q

What is the supplier required to do if part or all of the C-II drug order is cancelled by the purchaser?

A

Indicate the cancellation of the order on the original and copy 2

182
Q

Unless the registrant is informed by the DEA that the permission to keep central records is denied, the registrant may begin to maintain such central records of controlled substances ____ after notifying the DEA:

A

14 days

183
Q

A DEA registrant who elects to maintain central records of controlled substances is required to deliver all or any part of such records to the registered location within ____ business days after a written request by the DEA

A

2 days

184
Q

Which of the following amendments to the FD&C Act required that a drug be safe and effective before it could be marketed in the US?

A

Kefauver-Harris

185
Q

The reporting to FDA of any developments that may affect the safety and effectiveness of a drug product is known as:

A

Drug Experience Reports

186
Q

Which amendments to the FD&C Act established the legal difference between prescription and nonprescription drugs?

A

Durham-Humphrey

187
Q

The advertising of OTC drug products is regulated by

A

FTC-Federal Trade Commission

188
Q

The advertising of Rx drugs is regulated by the

A

FDA

189
Q

Certain types of Rx drug advertising are exempt by the FDA from fully disclosing prescribing info about the advertised RX drug product. Such ads are referred to as:

A

Reminder Ads

190
Q

When a drug’s patent expires

A

A generic drug manufacturer may file an ANDA

191
Q

The Drug Price Competition and Patent Term Restoration Act is also known as the

A

Waxman-Hatch Amendments-Permits marketing of off-patent post 1962 drugs in the US. Includes patent extension for innovator drug companies

192
Q

The amendments to the FD&C Act that granted authority to the FDA to issue regulations with the force and effect of law are known by the name of:

A

Wheeler-Lea

193
Q

The established name of a drug is its

A

Generic name

194
Q

A notice of adverse finding letter to a pharmaceutical manufacturer generally requests the firm to respond to the FDA within:

A

30 calendar days

195
Q

A regulatory letter from the FDA to a manufacturer of a drug generally requests that the firm respond within

A

10 days

196
Q

The organization responsible for setting standards in human antibiotics is:

A

USP-United States Pharmacopeia

197
Q

Which federal government agency compiles the National Drug Code Directory?

A

FDA

198
Q

Which federal government agency is responsible for implementing the Poison Prevention Packaging Act of 1970?

A

NABP-National Association of Boards of Pharmacy

199
Q

Can a CII RX be written for more than a 1 month supply

A

There is no limit on how much drug can prescribed for a CII

200
Q

Can a prescribing practitioner prescribe medication for a family member?

A

A prescribing practitioner cannot prescribe a CII (except in cases of emergency) for: Himself;
His spouse; OR His children
A prescribing practitioner can prescribe any other controlled substance or dangerous drug for the practitioner or the practitioner’s family.

Brand-generic (2 decks)

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