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Kansas Law Flashcards

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1
Q

PIC

Can a pharmacists be a PIC at more than 1 pharmacy?

A

Not as more than one full time (30 or more hours) with pharmacy operations

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2
Q

Disposal/ Destruction of CS inventory

2 methods

A
  • 1 Registrant requests permission from the DEA
    • Complete form 41 listing everything
    • DEA will direct the method
  • 2 Registrant uses a reverse distributor
    • CIIs are transferred to the reverse via the Reverse distribu DEA form 222
    • CIII through V drugs must also be documented and record retained by the registrant
    • Reverse distibu must submit form 41 for the DEA disosal and destruction
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3
Q

CII partial

What needs to be written

A

Yes

Quantity, date of the partial and name of pharmacist filled on the face of the paper Rx

No dispensing can occur beyond 72 hours of the partial filling

If remaining portion is not able to be filled within 72 hours notify prescriber

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4
Q

Butalbital, APAP, Caffeine

A

Fioricet

Not controlled

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5
Q

Length of time a pharmacist has to verify the accuracy of the computer record for filling/refilling of a CIII and CIV

A

72 hours

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6
Q

partial filling of CIII and CVs

A
  • Yes
  • You must record the partials the same way as you record refills on the back of the paper Rx or however else its done
  • Quantity dispensed for ALL partials fills cannot exceed quantity prescribed (face quantity + refill)
  • No dispensing can occur beyond 6 months of the date of issuance
  • Partial fill doesnt = refill
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7
Q

Quantity of drug a pharmacist may dispense to a patient in a CII emergency prescription?

A

enough for the emergency

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8
Q

What can you add to a C-II in kansas with permission?

A
  • Date written
  • Patient’s address
  • Prescriber’s DEA number
  • Dosage form may be selected if one is not written
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9
Q

Number of CE hours required

A

30

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10
Q

BUDs for Non-sterile compounded preparations

A
  • Non aqueous formulations: earliest expiration date of individual component or 6 months whichever is earlier
  • Water containing oral formulations: 14 days stored at controlled cold temperature 36-46F
  • Water containing topical/dermal or mucosal liquid semisolids: BUD is no more than 30 days
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11
Q

A drug wholesaler acting as a supplier has how much time to complete a DEA form-222 before it becomes void?

A

60 days

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12
Q

Length of time in which a pharmacy must notify the local DEA diversion field office after discovery of a theft or significant loss of a CS?

A

within 1 business day

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13
Q

Dispensing previously dispensed medications

A

With the exception of specific programs all drugs that are sold to the end patient may not be resold

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14
Q

What Cs must be readily retrievable?

What records must be kept at the registration site for all?

A

CIII-CV

Executed paper DEA 222 forms • Prescriptions (paper) • Inventory records

These can be kept centrally: Financial and shipping records, if DEA notified • Electronic refill records

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15
Q

Methamaphetamine equivalence chart

A
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16
Q

What are the activities a technician can do?

A

Package, do manipulative repetitive or nondescretionary tasks related to Rx processing

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17
Q

Secobarbital Schedule?

A

2

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18
Q

Conditions concerning the sales of poisons

A
  • Definitions
  • Objective was to decrease childhood pooisoning
  • Enforced by the consumer product safety commision
  • Requires child-resistant packaging for all human oral prescriptions drugs
  • Most OTCs and some hazardous household substances
  • Failure to follow is misbranding
  • Responsibility of quality
  • Labeling requirements
    • Nore requirements to abide by federal packing and labeling laws regarding the sale of poisons
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19
Q

Script refill general information

A
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20
Q

CII-CV drug labeling

A
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21
Q

Combat Methamphetamine Act

Sale limitations

A

3.6 grams of product base per day regardless of transactions number

9 g per 30 days

7.5 g if purchased by mail

Must be 18 in KS

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22
Q

How does the transfer process occur for dispensing previously dispensed medications?

6 steps

and 3 steps

A

Each administrator of an adult care facility or medical care facility or the PIC of a mail service must determine the medications meet the following criteria

  1. Can be identified
  2. Is in the manufacturers sealed container, a pharmacy unit-dose package, or a hermetically sealed tamper-evident package from the pharmacy
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23
Q

Do technicians need to be registered with the board?

A

Yes

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24
Q

Verifying DEA numbers

A

The first letter is a code identifying the type of registrant. (Usually you see A, B or C) A has been retired <1985,>B is used for Doctors and Clinics, C is for Specialists.

The second letter is the first letter of the registrant’s (prescriber) last name.

Here are steps to verify a DEA number:
Step 1) add first, third, and fifth digits of the number.

Step 2) add the second, fourth, and sixth digits of the number.

Step 3) multiply the result of Step 2 by two.

Step 4) add the result of Step 1 to the result of Step 3.

The last digit of this sum must be the same as the last digit of the DEA number.

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25
Q

If the pharmacy operates for more than ___ days without a PIC?

A

30 days without a PIC the board may revoke, suspend or deny or place their pharmacy registration in probation status

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26
Q

record sales of CV OTC

A
  • Pt must be 18
  • Must have ID if unknown to pharmacist
  • Must document sale
    • Name/Address of purchaser • Name/Quantity of drug • Date of purchase • Name/initials of dispensing pharmacist
  • Dispensing must be done my pharmacist but non pharm can do the payment
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27
Q

Is CR packagin required for inpatients?

A

Yes if @ bedside

But otherwise no

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28
Q

Number of times a CII can be transferred?

A

0

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29
Q

CE audit determination

A

CPE monitoring service

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30
Q

Policies and Procedures for CPAs

Who is responsible?

What CPA cant be entered?

WHen must the physician be notified?

WHo needs to know?

A
  • Each pharmacists who engages in CDTM is reponsible for all aspects of the CDTM performed by the pharmacist
  • Pharmacists may not enter into a CPA that authorizes him o rher to perform any CDTm function that is not appropratie to the training and experience of the pharmacist or physiciain or boht
  • Within 48 hours of making any drug or drug therapy change to the pt treatment the pharmacist must initiate contact with the physician indentifying the change
  • As part of each pharmacists application to renew their individual license the pharmacist must advise the board if they have entered into a CPA
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31
Q

PAs prescription authority

A

Both controlled and non-controlled prescriptive authority pursuant to a written protocol with a supervising physician.

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32
Q

Lost or Stolen DEA 222 forms

Types?

A

Lost In Translation

  • Execute new form, execute statement noting serial number of lost form, date of lost form, list of drugs and fact drugs werent recieved
  • Retain copy number 3 with statement

Stolen Order Forms

  • Report to nearest DEA office stating the serial numbers of stolen and or date of issuance
  • Must Notify DEA if found
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33
Q

Hydrocodone/APAP

A

Norco, Vicoden

C2

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34
Q

Exceptions to CII partial fill limitations

A

Pts in LTCF

Terminally ill

  • Requirements
    • On Prescription Face: terminally ill or LTCF
    • On back or where appropriate: Date quantitiy dispensed, remaining quanitity, to be dispensed, ID of dispensing pharmacist
    • Limitation: 60 days from issue date
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35
Q

What is the accreditation for online pharmacies?

A

VIPPS Accreditation of Online Sites

  • The National Boards of Pharmacy VIPPS program accredits online pharmacies that comply with federal and state laws and regulations. The VIPPS seal on an online pharmacy website provides consumers with some assurance that the pharmacy has undergone and successfully completed the NABP application and accreditation process.
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36
Q

KS- Mid-level practitioners

A

**For PA’s: Indicate if RX is pursuant to direct order, protocol or due to emergency.

**For APRN’s: Scripts must be from class of drugs prescribed pursuant to protocol.

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37
Q

How many times can a Plastic CR container and lid be used?

A

Only once

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38
Q

Maximum amount of codeine per dosage unit combined with one or more active, non-narcotic ingredients to be a schedule III

A

90 mg

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39
Q

Combat methamphetamine Act of 2005 Logbook

Who does not need to be recorded in the book?

Can patients have direct access?

What are the 4 logbook provisions?

What do they need before selling?

How long does the logbook need to be kept?

A

If a pt buys 1 60mg ot 2 30 ms tabels of pseudoephedrine then they are not required to sign the logbook

Patients cannot have direct access to the medication which include (ephedrine, pseudoephedrine, or phenylpropanolamine)

  • Logbook provsions
    • must contain, product sold by name
    • Quantity sold,
    • name address and signature of purchasers
    • Date and time of sale
  • Seller may not sell the product unless the purchaser:
    • Presents a photo ID issued by a state or federal government or another acceptable document
    • Signs the written logbook with his or her name, address, time and date of sale
      • In the case of an electronic logbook, the device must capture the signature in an electronic format
      • In the case of a bound paper book, a printed sticker affixed to the book at the time of sale which displays the product, quantity name of purchaser date and address
      • In case of a printed document it must include a clear line for the purchasers signature and include product, quanity, name of purchaser date and address
      • LOGBOOK must be maintained for 2 years after the date of purchase
      • igbook nust be secure and information only be shown to local state or federal law enforcement
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40
Q

CV limits

A

Fed: May refill as Authorized

Kansas: No more than 5 times or 6 months after the date issue which ever come first

Refill record documented like above

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41
Q

Durham Humphrey

A
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42
Q

How long must controlled substance records be kept in kansas?

A

no less than 5 years

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43
Q

What does a physician have to do if he wants CIIs for office use?

A

A physician must use a DEA Form 222 in order to obtain C‐II drugs for office use from another registrant – usually pharmacy. A physician may NOT write a prescription to acquire C‐II drugs from a pharmacy for this purpose.

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44
Q

What needs to be on a CS prescription?

7 total

A
  • Prescriber name and address
  • Pts full name and address
  • date issued
  • Drug name, strength, dosage form, quantity and directions for use
  • Refill info
  • Prescriber name manually signed
  • DEA number
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45
Q

What happens if there is a recall for previously dispensed medications?

Can people charge for these medications?

A
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46
Q

DEA form for destruction or disposal of CS?

A

form 41

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47
Q

Fentanyl

A

Duragesic

C2

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48
Q

Allowable amount of time to complete a partial fill on a CII script for a patient diagnosed as terminally ill

A

60 days

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49
Q

Requirements for a CPA

  • Who signs it?
  • What must it include? 5
  • What cant be in it?
  • When must they be reveiwed?
  • What must be delivered and in what time frame?
A
  • Must be signed and dated y all pharmacists and physicians involved
  • Must include the following
    • general methods, procedures and decision criteria that the pharmacist is to follow in performing CDTM
    • Procedure that the pharmacist is to follow to document the CDTm decisions that are made
    • Procdure that the pharmacist is to follow to communicate with the phyician either of the followng:
      • Each change in a pt condition is identified by the pharmacist OR
      • Each CDTM decision made by the pharmacist
    • Situation in which the pharmacists is required tp initiate contact with the physician
    • Precedure to be followed by the pharmacist if an urgent situation invlvoing a [ts health occurs. Including identification of an alternative health care provider that the pharmacist should contact if the pharmacst cannot reach a physician
  • A CPA may not authorize a pharmacist to admisiter flu vaccines except persuant to KSA 65-1635a
  • CPA ust be reviewed and updated at least every 2 years
  • Signing pharmacist must deliver a copy (digital or paper) of eah CPA and update to the oard within 5 business days after the CPA or update has been signed by all parties
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50
Q

preparing for inspections

A
  • Proactively prepare. Maintain, review, and regularly update CS policies and procedures for compliance with DEA requirements
    • Share an audit plan with employees and conduct a practice drill
  • Examine agent(s)’ credentials, obtain their business cards, and ascertain the purpose.
  • Take detailed notes of what was said, done, and suggested by agents during the inspection.
  • Answer questions asked, but do not speculate. Silence is preferable to incriminating statements.
  • Everything said during an audit may be introduced in an administrative, civil, or criminal proceeding
  • Request a final discussion or exit interview with inspectors
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51
Q

Poison Prevention Act through medicare

A
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52
Q

CII script partial fills

What must be written?

When does the fill need to be completed?

What are the exceptions? 3 And how long can you refill?

What 4 things must be written on the bacK? 4

A
  • May do partial refill but quantity dispensed must be written on the face of the written prescription
  • The remaining amount needs to be filled with in 72 hours from the date of the first partial fill

Expections when partial fills can be dispensed for up to 60 days from the date of issue

  • patients in adult care facility
  • pts with medical diagnosis documenting a terminal illness
  • pharmacist must record on the precription that the patient is either terminally ill or in a LTCF

For each partial fill the pharmacist shall record on the BACK of the prescription or on another readily retreivable record:

  • The date of the partial filling
  • Quantity dispensed
  • Remaining quantity authorized to be dispensed
  • ID of the dispensing pharmacist
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53
Q

Central fill pharmacies and transmission of CII meds

Pharmacy transmitting the prescription

  • What needs to be written on the face? 4
  • How long must the original prescription be retained?
A

If CII the retail pharmacy transmitting the prescription must

  • Write on teh face of the orginal prescription
    • The word Central Fill
    • Name address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted
    • Name of the retail pharmacy pharmacist transmitting the presciption
    • And the date it was transmitted
  • Ensure that all required CS prescription information is transmitted to the central fill pharmacy
  • Maintain the original prescription for at least 2 years from the dat ethe prescription was filled
  • Keep a record of the receipt of the filled prescription including the date of receipt the method of delivery and the name od the retail pharmacy employee accepting delivery
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54
Q

Kefauver Harris and Medical devices

A
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55
Q

CS inventory Records

A
  • Initial: Right when they start dispensing
  • Biennial at least every 2 years, kansas is annual
  • Separate inventories for each registered site
  • Inventory CS on hand
  • Opening or closing of business
  • Newly controlled substances on effective date of scheduling published in the FR
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56
Q

What amount of potassium is exempt from PPPA packaging?

A

Unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid potassium and powder in unit dose packets containing not more than 50 meq per unit dose

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57
Q

Name tag info required

A

First Name & Title (Board recommends including last name or last initial - not required)

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58
Q

Number of time CIII, CIV or CV prescriptions with refills can be transferred in Kansas if the pharmacists do not share real-time computer system?

A

Once

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59
Q

Prescription transfer requirements general rules: 8

What cant be transfered?

How many times can others be transfered? Exception?

What can be shared?

What needs to be communicated and between who?

How long must records be held?

Who cant?

States?

A
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60
Q

Pregabalin

A

Lyrica

CV

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61
Q

Do technicians need CE?

A

Yes 20 hours

A certificate of completion shall be in a format approved by the board and include the following:

  • Registrant’s name
  • Title and date of approved CE program
  • The name of the provider
  • The # of CE clock-hours approved by the board
  • The # of CE clock-hours completed by the registrant
  • The approved program number issued by the board

The provider’s dated signature, certifying program completion

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62
Q

Who Audits CEs for techs?

How long must the record be retained?

A

CPE monitoring service

5 years

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63
Q

How long must CS records be kept

A

2 years fed 5 years kanasasfrom date of last entry

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64
Q

What may not be changed on a CII script?

How do we track any changes?

A
  • Patient Name
  • Date, if one is written
  • Prescribers name
  • Drug
  • **All information added/changed must be initialed dated and timed.
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65
Q

A CII script is valid for ___ from its take of issuance (KS)

A
  • 6 months
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66
Q

Computer for CIII and CIV Script records

A

Can be used as an alternative to hard copy but need to have thee requirements

  • Pharmacists verification of accuracy on hard copy or print out or bounf book or file
  • Date signed must be within 72 hours
  • Can print out any refill data to user pharmacy within 48 hours if kept central
  • Back up system
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67
Q

What may be CHANGED on a controlled substance prescription with permission?

A
  • Drug strength
  • Quantity
  • Directions for use
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68
Q

What is a new drug?

A

A drug that is not generally recognized as safe and effective

  • May become a new drug if:
    • It contains a new substance
    • It is a new combination of approved drugs
    • The proportion of ingredieants has changed
    • a new use
    • The dosage form, method of administration/duration or application has changed
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69
Q

Related regulations for online pharmacies

A
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70
Q

How many times can a glass bottom CR container and lid be used?

A

Bottom can be used once more

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71
Q

Nalbuphine Schedule

A

2

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72
Q

Out of state prescribers

A

A prescription CAN be filled from a non-Kansas prescriber if the prescriber is legally authorized to issue the prescription in the state/territory where the prescriber is licensed.

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73
Q

How do you terminate a pharmacy registration?

A
  • Notify nearest DEA office
  • Return DEA certification of registration and Unused voided 222 forms and explanation of disposal or transfer of all CSs
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74
Q

Dronabinol Liquid

A

C2

Syndros

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75
Q

In the absence of stability data non-sterile solid and liquid forms that are packaged in a single unit and unit dose container. What are the possible BUDs?

A
  1. One year from the date the drug is packaged into a single-unit or unit dose container
  2. The expiration date on the manufacturers container whichever is earlier
  3. Sterile multi use containers: one year or the manufactureres expiration date. Length of time established by the stability data may be used but cannot exceed manufacturers expiration date.
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76
Q

Androgel

A

Topical testosterone

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77
Q

DEA form for theft or loss?

A

Form 106

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78
Q

DEA pharmacy inspections

A

CSA authorized inspection of controlled premises

Inspections are usually drug accountability / compliance audits- so every ones knows the records are being kept correctly

  • DEA may inspect, copy, and verify records, reports, required forms, equipment, and CS
  • Cannot inspect financial, sales, pricing data, or personal records unless registrant provides written consent
  • • Cannot review patient charts
  • No right to interview witnesses, including registrant or employees
  • • May collect samples (usually will leave receipt)
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79
Q

Resale of Dispensed Prescription Drugs

What type can be resold?

A

only medications tat are in unit-dose systems that contain only one medication which have not reached the patient and are still intact

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80
Q

Following the initial CS inventory a registrant must conduct the next inventory within what time frame?

A

1 year at least 8 months apart

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81
Q

Alprazolam Schedule

A

4

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82
Q

Prescription dispensing

A
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83
Q

Can technicians hand out, dispense or distribute rx’s when no pharmacist is on duty?

A

No

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84
Q

Peyote

A

C1

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85
Q

OTPs

Maintenance?

When can methadone 40 mg tablets be used

A

Objective to treat an opioid dependent individual with stable opioid agonist therapy for a period in excess of 21 days

these are inforced by substance abuse and mental health services

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86
Q

Cocaine

A

C2

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87
Q

Parental Product Labeling 4 for kansas

A
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88
Q

What is exempt from law?

A

• Peyote (CI, psychoactive alkaloid, hallucinogen) is exempt from control when used in bona fide religious activities by the Native American Church. (Persons that manufacture and distribute must register, however.)

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89
Q

PIC change notification

A

within 5 days of ceasing to be the PIC

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90
Q

Who can authorize non-compliant packaging for all pts medications?

A

The patient is the only one

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91
Q

What must the transferring pharmacist record?

What to write on the face?

What to write on the back?

If what drug what needs to be recorded?

A
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92
Q

Shared order filling

A
  • Refers to the process whereby a pharmacy that receives an order sends it to another pharmacy to prepare, package, compound or label and returned the filled order to the requesting pharmacy for delivery to the patient or at the request of the requesting pharmacy directly to the pt
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93
Q

Non-US prescribers

A

Pharmacists MAY NOT fill prescriptions from a practitioner licensed in a foreign country or jurisdiction (Ex: Canada, Mexico) unless the practitioner is also licensed in a state or territory of the U.S. and is legally authorized to prescribe in that state/territory

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94
Q

Fax requirements

  • Issued for what purpose?
  • Transmitted to who?
  • Identify who?
  • Transmitted by who?
  • Whats the hard copy?
A
  • Shall be issued for a legitamte medcal purpose by the prescriber acting within the course of legit professional practice
  • Be transmitteed to a pharamcists in a licensed pharamcy of the patients choice
  • Identity the trasmitters phone number for verbal confimration, time and date of transmission and the identity of the pharmacy intended to receive the transmission, as well as any other information required by law
  • be transmitted by an aithorized prescriber or prescriber agent if the idnetity of the transmitting agent is included in the order
  • If communicated by electronic transmission, the prescription drug order shall be maintained in hard copy or as an electronic document for the time required by federal or state regulations whichever is longer
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95
Q

Can techs work in the pharmacy while waiting for registrations?

A

No

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96
Q

Emergency CII

Scripts

Criteria Needed

A
  • Need to take Immediately
  • No alt available
  • Not reasonably possible for prescriber to give written script
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97
Q

What is the pharmacist to technician ratio?

A

2:1 or 3:1 if two of the techs are certified

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98
Q

Misbranding or Adulterations?

A

Misbranding = Labeling Problem

  • Labeling false or misleading
  • Fails to meet label requirements (Active ingredients; quantity; inactive ingredients)
  • Fails to have “adequate directions for use” or “adequate information for use”
  • Packaging or labeling violates PPPA (Poison Prevention Packaging Act)

Adulteration = Product Problem

  • Contains filthy, putrid, decomposed substance or is prepared/packaged, held under unsanitary conditions
  • Preparation, packaging, and holding fails to meet GMP standards
  • Purports to meet USP/NF standards, but fails to meet them
  • Contains unsafe additive(s)

A While counting, a couple tablets fall on the floor and you pick them up and put them in the amber vial

to be dispensed to the patient.

M Dispensing a prescription medication without authorization.

A A drug’s manufacturing procedures do NOT conform to GMP standards.

M Medication is dispensed with non-child proof cap without patient consent.

M A drug’s label or labeling is false or misleading.

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99
Q

Statin Equivalent dosing

Pharmacists Rock At Saving Lives and Preventing Flu

A
  • Pitavastatin 2
  • Rosuvastatin (crestor) 5
  • Atorvastatin (lipitor) 10
  • Simvastatin (Zocor) 20
  • Lovastatin (Altoprev) 40
  • Pravastatin (pravachol) 40
  • Fluvastatin (lescol) 80
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100
Q

Definitions of the Food drug and Cosmetic act

Food

Drug

Cosmetics

Device

Supplememt

A
  • For the most part, same as the those found in federal law
  • New drug may not be marketed until approved for SAFETY by the FDA for use under labeling conditions
  • Label: must contain adequate directions for use, also expanded definitions of adulterations and misbranding. pre-38 drugs were grand father
    • Food: article used for food or drink for man or other animals, chewing gum and articles used fro components of products
    • Drug: Recognized in the official compendiem
      • intended to diagnose, cure, mitigate, treat, or prevent disease in man or animals
      • Other than food intended to affect structure and function of the body
      • Intended for use as a compoennet of the above 3 items
    • Cosmetic means: Intended to be rubbed, poured or sprinkles or otherwise applied to the human body, ie soap
    • Device: instrument appartatus, implement, machine, recognized in official compendium. effective without chemical action
    • Supplement: Intended for ingestions, may not be intended for diagnosis cure, mitigation or treatmnet or prevent disease
      • Note the definition of drug does not include amygadalin (laetrile)
      • Although not included in the full version of statutes and regs on the boards website, statute 65-6b09 prohibits any person, including a pharmacy from selling amygadalin without first obtaining a permit from the secretary of health and environment
    • Label vs labeling
    • New Drug
    • Imitation
    • Adulteration and misbranding (65-660-65-559)
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101
Q

Authorized prescribers in Kansas

Advanced practice registered nursed

A

Both controlled and non-controlled prescriptive authority pursuant to a written protocol with a supervising physician.

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102
Q

Prescription drug labels what schedules need this sticker

A
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103
Q

max amount of pseudoephedrine that can be sold in 30 days?

A

9 g

104
Q

KS immunization qualifications

Authorized vaccines

Qualifications

Notification renewal

Protocol expiration

Primary care provider (if different from the authorizing physician)

Authorizating protocol physician

KS licensed intern pharmacists

record retention

Immunization registery

May a pharmacist administer a vaccine pursuant to a prescription and not protocol?

A
105
Q

The pharmacies engaged i shared services also have prescription requirements

  1. What records are needed
  2. What must be reported to the board
  3. What mechanism?
  4. What mechanism?
  5. Provide?
  6. Obtain what?
A
  1. Records must be maintained that identify each pharmacist, tech, student and intern who took part in any of the processing, filling, dispensing and counseling functions
  2. Report tot he board any disciplinary action taken by another states board of pharmacy against any of the participating pharmacies
  3. Maintain a mechanism to track the order during each step of the process and filling
  4. Maintain a mechanism to identify on the prescription all pharmacies involved in the filling order
  5. Provide adequate confidentiiality of patient infomration
  6. Be able to obtain any record within 72 hours by request of the board
106
Q

What are the exceptions to registration with the controlled substances act?

A
  • Agents or Employees of a registrant acting within their scope of practice
    • Individual practicioners employed in a hospital, use internal code and DEA #
    • Pharmacists
107
Q

CS Inventory Counting

A

Exact count of CIIs CIIIs and CIV CV in containers more than 1000 doses

Estimate of CIII, CIV, CV in containers of 1000 or less

108
Q

Clonazepma (Klonopin)

Hydrocodone/APAP (Norco, Vicoden)

Buprenorphine/naloxone (Suboxone, Zubsolve)

Ketamine (Ketalar) inject

Dronabinol (Merinol) caps

Dronabinol (Syndros) liquid

Zolpidem (Ambien)

Fentanyl (Duragesic)

Butalbital, Aspirin, Caffeine (Fiorinol)

Armodafinil (Nuvigil)

Lorcaserin (Belviq)

Peyote

Ibuprofen/hydrocodone (Vicoprofen)

Phentermine (Adipex-P)

Carisprodol (Soma)

Diphenoxylate and Atropine (Lomotil)

Butalbital, APAP, Caffeine (Fioricet)

Pregabalin (Lyrica)

Cocaine

Sibutramine (Meridia)

Morphine (MS Contin)

A

Drug

Schedule

Clonazepma (Klonopin)

4

Hydrocodone/APAP (Norco, Vicoden)

2

Buprenorphine/naloxone (Suboxone, Zubsolve)

3

Ketamine (Ketalar) inject

3

Dronabinol (Merinol) caps

3

Dronabinol (Syndros) liquid

2

Zolpidem (Ambien)

4

Fentanyl (Duragesic)

2

Butalbital, Aspirin, Caffeine (Fiorinol)

3

Armodafinil (Nuvigil)

4

Lorcaserin (Belviq)

4

Peyote

1

Ibuprofen/hydrocodone (Vicoprofen)

2

Phentermine (Adipex-P)

4

Carisprodol (Soma)

4

Diphenoxylate and Atropine (Lomotil)

5

Butalbital, APAP, Caffeine (Fioricet)

Not Controlled

Pregabalin (Lyrica)

5

Cocaine

2

Sibutramine (Meridia)

4

Morphine (MS Contin)

2

109
Q

What is the renewal period for techs?

What is the renewal date?

A

2 years

October 31st

110
Q

What forms are needed for CS?s

A

DEA 222 Forms • Executed & unexecuted • Power of Attorney forms • DEA Registration certificate • Self‐certification certificate and PSE sales logbook • Logbook for sales of C‐V OTC products

111
Q

Labels for repackaging and prepackaging need what 5 things

A
  1. The generic name with the manufacturer and distributrs name or the brand names
  2. strength and quanitity
  3. Lot number and date repackaged and the person responsible for packaging
  4. Expiration date if applicable
  5. Auxillary labels if neccesary
112
Q

CS schedule for oral diphenoxylate with atropine?

A

CV

113
Q

Allowable amount of time to complete a partial fill for CII in a ambulatory care setting?

A
  • 72 hours
114
Q

Ryan Haight Online Act

A

Objective: To prevent illicit sales of CS over the Internet by “rogue” Web sites, while allowing the use of electronic communications for prescribing and dispensing CS for legitimate medical purposes.

  • Valid prescription: issued for legitimate purpose by practitioner who has conducted at least one in‐person patient evaluation.
  • Pharmacies that meet the definition of “online pharmacy” must obtain modification of their DEA registration for all Internet business
115
Q

Butalbital, Aspirin, Caffeine

A

Fiorinol

C3

116
Q

Non controlled substance prescription labeling

Kansas 11

A
117
Q

Who are the donating entities for dispensing previously used medications?

3 and what must be done?

A
  • Adult care homes
  • mail service pharmacies
  • and medical care facilities that elect to participate in the program
  • entity must submit a written notification to the board stating their intent and must be approved to the board
118
Q

Amphetamine use and the treatment of obesity

  1. What cannot be prescribed?
  2. What does the physician need to do?
  3. What other counseling is needed?
  4. What is the limit?
  5. When should a patient not be given more CS?
A

Must conform with the following

  1. Amphetamines shall not be dispensed or prescribed to treat obesity
  2. The phyician shall personally take a complete history and document it.
  3. The physician shall prescibed nutritional counseling, including behavior modification and exercise for wt loss and record these on the pt record
  4. The physician shall NOT dispense or prescribe more than a 30 day supply of controlled substance at one time
  5. Except as provided below the physician ma continuously dispense controlled substances to treat effects from the treatment. The significant benefit occurs when wt is reduced or wt loss maintained and any comorbidties are reduced. The physician must monitor the pt and record the findings in the pt record at each visit
    1. The EXCEPTION: the physician shall NOT dispense or prescribe additional controlled substances to treat obesity for a pt who has not acheived a wt loss of at least 5% of the patients initial wt during the initial 90 days of treatment using a CS
119
Q

What serves as the record for CIII CIVs and CVs?

A

The invoice or packing slip you do not need a DEA form but you have to file it separately and it must be readily retrievable

120
Q

CE qudit record retention

A

5 years

121
Q

Address change notification

A

within 30 days

122
Q

Prescription refill guidelines:

A
123
Q

Deceased, Retired or Inactive Practitioners

A

KS law does not definitively address the filling/refilling of prescriptions that were validly written before a prescriber passes away or stops practicing. Pharmacists should use their professional judgment in continuing to dispense refills. Patients should be advised to consult with another practitioner as soon as possible.

124
Q

Minimum age to purchase CV OTCs in kansas?

A

18 yo

125
Q

Use of methadone

Can be used for what two things and how?

How can pharmacies dispense them?

If a prescriber isnt certified with an OTP?

A
  • Can be used for detox or maintenance IF the pt is entrolled in an OTP
  • But pharmacists can other dispense methadone for pain not for detox or maintenance
  • Prescribers not entrolled in an OTP: MAY administer methadone for a maximum of 3 days – one day at a time – to maintain patient while enrolling in OTP (3‐day rule); • Administer to hospital inpatient while the patient is being treated for an illness or diagnosis outside of detox or maintenance
126
Q

Kansas Collaborative Practice Drug Therapy management definition

definition of collaborative practice agreement

A
  • Collaborative drug therapy management means a pratice of pharmacy in which a pharmacist performs certain pharmaceutical related patient care functions for a specific pt, and the functions have been delegated to the pharmacist by a physician
  • CPA: a signed agreement or protocol voluntarily entered into between one or more pharmacists and oe or more physicians that provides for collaborative drug therapy management
127
Q

Hydromorphone

A

Dilaudid

128
Q

Methylprednisolone?

A

in tablet form packages containing not more than 84 mg of the drug

129
Q

Phentermine

A

Adipex

C4

130
Q

Sale of drugs through vending machines

How many things can be in it?

What cannot be in it?

What needs to be on the machine?

A
  1. Limited to 12 different nonprescription drugs through one vending machine
  2. May NOT sell poison, prescription only drugs, drugs containing ephedrine alkaloids. Drugs intended for human use by hypodermic, injection through a vending machine
  3. Vending machines must be labeled with specific statements and information
    1. ID of owner of the machine
    2. Toll-free telephone number of the owner
    3. Statement advising purchaser to check the expiration date of product before using
    4. Telephone number of the State board of pharmacy
131
Q

How frequent must a community pharmacy submit dispensing data to KTRACs?

A

within 24 hours

132
Q

REcord retention

A
133
Q

CII script faxing

What do you need before dispensing?

What circumstances change these requirements?

What are special situations?

A

Can be done in the same way as all others except before dispensing to the patient you must have receive a signed original that is the HARD COPY except under the following circumstances

  • If the script is for a CII narcotic compounded for the direct administration to a pt by parenteral, IV, IM, SQ or intraspinal infusion. it may NOT be for oral therapy
  • If the script is for a pt residing in a LTCF it may be for oral or parental therapy
  • If the prescription is for a CII narcotic for a pt released by a registered instituion to a home hospice care program certififed by medicate under title XVII or licensed by the state

Emergency situation where a CII script may be dispensed before recieivng the original

  • In case of a emergency a CII script may be faxed to a pharmacy. The pharmacy must receive a signed prescription within 7 days. The faxed copy may not be used as the original
134
Q

Prednisone

A

in tablet form when dispensed in packages containing no more than 105 mg of the drug

135
Q

What must the receiving pharmacist record? 6

A
136
Q

CII script limits

A

No refills Valid for 6 months from date of issue (kansas)

137
Q

What form is needed to purchase CIIs?

A

Form 222

hard copy or electronic

with a CSOS

Currently a triplicate form however proposed single sheet format

Signed and dated by person authorized to sign a registration application

Know manual procedure for completing DEA 222 form

138
Q

Transfer of Business to another Registrant?

A
  • Notify area DEA Special Agent at least 14 days prior to transfer with specifics via certified mail (receipt requested) or in person
139
Q

Is a pt legally rquired to sign a request for non CR packaging?

A

No but its a good idea for liability purposes

140
Q

Rules for Multiple CIIs

A
  • You cant refill a single CII
  • But you can issue multiple scripts if:
    • Each Script is issued for a actual medical reasons
    • Provider provides written insturctions on each scriptexcept for the first one indicatin when they can be filled
    • Issuance is permissible under state law
    • The quantity of all doesnt exceed a 90 day supply
  • You cant fill it before the earliest day
141
Q

The CS schedule of a prescription containing not more than 50 mg of morphine per 100 ml or per 100 g combined with one or more active non-narcotic ingredients

A

CIII

142
Q

Drug approval process

Who is responsible for advertising regulations of pricing, OTCs, and Rxs

A
143
Q

Clonazepam

A

(Klonopin) 4

144
Q

How can you modify a registration?

A

Can request on line or on paper

Then DEA will issue a new one.

145
Q

Violations a subsequent penalties 65-657

A
146
Q

Drugs of Concern

A
  1. butalbital, acetaminophen, and caffeine; (Fioricet)
  2. ephedrine (exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors)
  3. pseudoephedrine ( exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors)
  4. promethazine with codeine
  5. gabapentin
147
Q

KS prescription limits (physicians)

A
148
Q

How can a central fill pharmacy fill prescriptions?

A

CANNOT fill directly from patients or individual practioner or to mail or otherwise deliver a filled prescription to a individual or individual practitioner

149
Q

Allowable number of times a kansas pharmacist can refill a CV

A

5 x or 6 months

150
Q

Physicians, Dentists, Veterinarians, Podiatrists & Optometrists

A

prescribe within their scope of practice

151
Q

How long does a pharmacist have to obtain the original prescription from a physician for an emergency CII?

A

7 days

152
Q

Drug recalls what are the 3 classes?

A

Manufacturer must issue a notice for class 1 to 11

Class 1- cause probable of serious health.death risk

C2 cause temporary or medically reversible adverse health consequence

C3 not likely to cause issue

153
Q

Central Fill Pharmacy CIII-CIV

A

Must include all infomration needed for CIIs plus:

  • Transmitting pharmacy must indicate in the information transmitted the number of refilled already dispensed and the number of refills remaining
  • Receiving pharmacy must record the dates of filling or refilling the prescription
154
Q

Armodafinil

A

Nuvigil

C4

155
Q

Combat Methamphetamine Act

A
  • Ephedrine, PSE, and phenylpropanolamine are considered scheduled listed chemical products
  • Regulated sellers must follow requirements for OTC sales
    • Exception of a single sale of 60 mg or less of PSE
  • Products must be behind the counter or in locked cabinet
  • Employer must self certify annually on DEA website and maintain documentation that each employee is trained
    *
156
Q

Adderall

A

Amphetamine/Dextroamphetamine

157
Q

What has to be maintain separately from all other records?

A

CIs and CIIs

158
Q

Adulteration

A
  • Consists of filthy putrid, decomposed substance or prepare/packaged, held under unsanitary conditions
  • Preparation, fails to follow GMP
  • says its meets USP but doesnt
  • Contains unsafe additives
159
Q

Maximum number of days supply that may be prescribed and dispensed on multiple CII scripts?

A

90 days

160
Q

Is it legal for a physician to prescribe their own medications?

A

Legal to prescribe (CS & Non-CS), however, it is discouraged by Board of Healing Arts.

161
Q

Amphetamine prescribing is restricted to what of the following disorders? 8

A
  1. Narcolepsy
  2. Drug induced brain dysfunction
  3. hyperkinesis
  4. Differential diagnostic psychiatric evaluation of depression
  5. Depression documented to be unresponsive to otehr forms of treatment
  6. Clinical investigation of drug effects (which, in addition to other guidelines iwll have to have approval of the board of healing arts)
  7. Treatmnet of obesity with controlled substances as may be defined by the rules and regulations
  8. Other disorders for which the drug is found to be useful after permission from the board of healing arts
162
Q

Zolpidem

A

Ambien

C4

163
Q

What types of pharmacies register as despensers?

What i the number of the form?

What can corporations use?

How long are these valid for?

A

Community pharmacies, hospital pharmacies, teaching institutions

  • 224
  • 224b
  • Valid for 3 years
  • Registration can be denie revoked
  • Costs 731 bucks lasts for 3 years
164
Q

What does the definition of online pharmacy exclude?

A
  • A DEA-registered pharmacy that fills or refills prescriptions in schedules III – V in accordance with practitioner instructions as part of a valid prescription issued for a legitimate medical purpose in the usual course of practice transmitted electronically in compliance with DEA e-prescribing regulations.
  • A DEA-registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of the transmission of prescription information between the pharmacy and an automated dispensing system located in a long term care facility when the registration of the automated dispensing system is held by that pharmacy.
  • Health care facilities owned and operated by an Indian tribe or tribal organization;
  • Hospital or medical care facility operated by an agency of the United States
165
Q

Length of time a Kansas pharmacist must keep CS records?

A

5 years

166
Q

Diertary through FDA Amendement

A
167
Q

Can a pharmacy operate without a PIC?

A

Yes but a new one must be designated within 30 days

168
Q

Morphine

A

C2

MS Contin

169
Q

Length of time a DEA dispenser registration is valid?

A

3 years

170
Q

Nitrate packaging?

A

Sublingual dosage forms

sublingual and chewable forms of isosorbide dinitrate in dosages of 10 mg or less

171
Q

Ryan Haight Online Pharmacy Consumer Protection Act

What is the purpose

A
172
Q

Drug Quality and Title III

A
173
Q

Inventory tracking

A
174
Q

In order for pharamcies to participate in shared services what is required 4 things

A
  • Each pharmacy must be registered by the board as either a resident or a non-resident pharmacy
  • The involved pharmacies must share a common electronic file or have appropraite tech to allow access to sufficient information to perform the service
  • Pharmaces must have either the same owner OR have a written contract outlining the services and shared responsibilities of each party
  • Adopt and maintain a joint P&P manual kept at each pharmacy that outlines how compliance with laws will be accomplished
175
Q

Manufacturing Exceptions?

What cant it exceed?

How is the pharmacy registered?

A

A pharmacy registered as a dispenser may manufacture or distribute to other practitioners an aqueous or oleaginous soln. or solid dosage form containing a narcotic substance in a preparation NOT exceeding 20% of the complete product

AS a dispenser

176
Q

A Pharmacist or Non-Pharmacist , as designated in a current and properly executed power of attorney.

AND

A Pharmacist or Non-Pharmacist, who signed the most recent DEA application for a CS registration.

When a DEA inspector conducts an audit of your controlled substances, what percent error are you allowed? Zero percent

A
177
Q

Name tags who needs them? 4

A

Pharmacists, Pharmacy Students, Interns & Pharmacy Technicians

178
Q

Renewal date for pharmacy license

A

June 30

179
Q

A registrant transferring a pharmacy business operation to another registrant must notify the nearest DEA office at least ___ days before the date of the proposed transfer?

A

14 days

180
Q

What are the manufacturing quotas?

A

QUOTAS for the amount of CIs and CIIs that can be produced giving them a ceiling and is published in the FR.

181
Q

How long does a dispensing registration form _____ last?

A
  • 224
  • lasts for 3 years
182
Q

Labeling and information requirements for selling non-prescription DMSO

A
  • Label shall contain a description of all contents of the solution, statement of purity, the percent of DMSO in the solution, the manufactures name and address
  • Seller or supplier muse provide addtional prointent material to the person receiving that provides adequate warning against use that may be dangerous to the health of the user
183
Q

Mis level practitioner Information?

A
184
Q

Naloxone Dispensing: Check to see if in date still

A
185
Q

Dronabinol caps

A

Merinol

C3

186
Q

Oxycontin

A

Oxycodone ER

187
Q

Diphenoxylate and Atropine

A

Lomotil

C5

188
Q

Ketamine

A

Ketalar

C3

189
Q

Can technicians accept a prescription for a noncontrol by phone?

A

no

190
Q

When can a Pharmacy (dispenser) act as a supplier?

A
  1. Returning CII drugs to a wholesaler (distributor) manufacturer or reverse distributor
  2. Selling a pharmacy business requires the seller to
    1. Inform the DEA 14 days prior to sale
    2. Transfer all CII drugs by use of DEA 222 form
  3. Distributing CII drugs between DEA registrants
191
Q

Records are required for allCSs that are?

A

Purchased • Dispensed • Distributed • Returned • Destroyed • Lost or Stolen • Inventoried (CS on hand)

192
Q

Federal food drug and cosmetic act

A
193
Q

DEA form 222

A

A DEA 222 form has 3 copies and is used for Schedule 2 drugs.

The top copy is Brown (color) and is the supplier copy.

The middle copy is Green (color) and is the DEA copy.

The last copy is Blue (color) and is the purchaser copy.

When a pharmacy makes a purchase from a wholesaler via a DEA 222, who sends the DEA it’s copy? The wholesaler (supplier)

When a pharmacy returns items via a DEA 222, who sends the DEA it’s copy? Purchaser (pharmacy)

Who has the authority to sign a triplicate DEA Form-222 in order to obtain C-II drugs from another registrant?

194
Q

Morphine brand names

A

MS contin, Kadian, Duramorph

195
Q

Addiction Treatment

Opioid Treatment Programs

Detoxification what is the objective?

A

Objective to achieve and opioid drug free state through use of decreasing does

196
Q

faxing CIII-CV scripts

A

May be transmitted to a pharmacy by fax and retaine as the HARD COPY as long as the above requirements are fulfilled

  • Shall be issued for a legitimate medical purpose by a prescriber acting within the course of legitimate professional practice;
  • Be transmitted to a pharmacist in a licensed pharmacy of the patient’s choice;
  • Identify the transmitter’s phone number for verbal confirmation, time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by law;
  • Be transmitted by an authorized prescriber or prescriber’s agent, if the identity of the transmitting agent is included in the order;
  • If communicated by electronic transmission, the prescription drug order shall be maintained in hard copy or as an electronic document for the time required by federal or state laws and regulations, whichever is longer.
197
Q

CS schedule for buprenorphine S.L

A

CIII

198
Q

Technician certification

A

New Pharmacy technician registration on or after July 1, 2017: (a) before the first renewal, required to pass either:

  • PTCB (with a scaled scored of at least a 1400)
  • NHA-ExCPT (with a score of at least 390)
    (b) If unable to take or pass, may submit a form (provided by the board) a request for a 6-month extension. Must be submitted to the board at least 30 days before the tech’s registration expiration date and shall provide the reason for the request
    (c) W/in 30 days after passing or before the first renewal period (whichever is earlier), tech shall submit to board proof of successful completion of the exam
199
Q
A
200
Q

CIII and CIV

Script limits

A

No more than 5 x or 6 months after the date of issue whichever is first

Refill record on back or other appropriate document date refilled quanitity pharmacist initials

Total number of refills must be retrievable

201
Q

Shared order processing

A

pharmacy that receives and prescription sends it to another pharmacy to interpret the script

202
Q

Percocet, Endocet

A

Oxycodone/Acetaminophen

203
Q

Administrative Inspection Warrant

A
  • Administrative Inspection Warrant differs from a Notice of Inspection
  • • DEA may obtain a warrant if registrant consent was withheld or withdrawn from an inspection
  • • Allows DEA to inspect during regular business hours – which does NOT mean at the convenience of the owner •
  • Entry/inspection must be permitted by the registrant
  • Refusal can carry fine and jail sentence
204
Q

Kansas Permit/license/Certificates required

A

Pharmacy Permit; License & Registrations of all pharmacists, interns and techs must be displayed

205
Q

License renewal period

A

2 years (Even/Odd year (last # of license))

206
Q

Lorcaserin

A

Belviq

C4

207
Q

How must pharmacies store their CS’s? II-V

A
  • Pharmacies (including hospital pharmacies) must store CII‐CVs in a securely locked, substantially constructed cabinet OR may disperse CII‐CVs among non‐CS stock
  • Physicians dont have this choice.
208
Q

Allowable number of refills for phentermine prescribed for treatment of obesity in kansas?

A
  • 0
209
Q

Kansas condition for sale of poisons

A

Must be colored in such a way to make them readily distinguishable from food products

210
Q

Max amount of codeine per 100 ml or 100 grams combined with one or more active, non-narcotic ingredients to be a CV?

A

200 mg

211
Q

Ultram

A

Tramadol

212
Q

Phenobarbital Schedule?

A

4

213
Q

Drug Addiction Treatment Act.

Office Based Treatment

What do the prescribers need?

What can they prescibe?

What drugs are currently prescribed for this purpose?

What worries might the pharmacist have?

A

Need Special education and DEA Number

Buprenorphine SL

Bup/Naloxone

is the prescriber qualified? Additional registrations and X number, Use of drugs for off label purposes? 3 day rule

214
Q

Controlled substance inventory requirements due to a change in PIC

A

completed within 72 hours of being the pic ALL schedules including 2-5 including PSE

215
Q

Phentermine

A

Adipex-P

216
Q

What is a BUD?

A

beyond use dating

  • Defined as that date after which a dispensed product should no longer be used.
  • BUDs should be placed on the labels of non-sterile and sterile repackaged and compounded products
  • Ingeneral the BUD must not exceed the manufactueres expiration date of any component that is within the compounded product
217
Q

A PIC must notify the board in writing within ___ of ceasing to be the PIC?

A

5 days

218
Q

Allowable amount of time to complete a partial fill for CII for a patient in a LTCF?

A

Within 60 days

219
Q

What Cs can be changed? What cant be changed?

A

CIII CIV and CVs

Need prescriber auth

cant change pts name drug (except generic) and prescribers signature

CIIs• A pharmacist may add a date if it is not written with consultation with the prescriber. A pharmacist may also change a drug strength, quantity, and directions for use after consulting with the prescriber. The patient’s address, prescriber’s DEA number may also be added. A dosage form may be selected if one is not written. All information added/changed must be initialed dated and timed.

220
Q

Emergency and Reuse prescriptions

A
221
Q

Emergency and Reuse

A
222
Q

Subaxone, Bunavail, Zubsolv

A

Buprenorphine/Naloxone

223
Q

How long is a CII script good for?

A

6 months

224
Q

Buprenorphine/naloxone

A

C3

(Suboxone, Zubsolve)

225
Q

CIiI- CV partial filling

How is the partial fill recorded? 4

How much can be given?

What does the fed not do?

A
  • Each partial fill must be recorded in the same manner as a refil
    • name and dosage form of CS (federal)
    • Date filled or refilled
    • Quantity dispensed
    • Initial of the dispensing pharmacist (in ks or intern) for each refill
  • Total quanitity dispensed in all the partial fillings does not exceed the total quanitity prescribed and no dispensing occurs after 6 months or after the date of issuance
    • Note federal law does not restrict CV scripts refills to 5 x or 6 months from the date of issuance but kansas does
226
Q

Within ___ of being a functioning PIC the PIC shall conducts a what?

A

within 72 hours of becoming a PIC the PIC shall conduct a CS inventory

227
Q

Gabapentin

A

Neurotin

228
Q

Can technicians accept written prescriptions from patients for dispensing when no pharmacist is on duty?

A

No

229
Q

A pharmacy registered as a dispenser can have what type of distribution exceptions?

A

A pharmacy registered as a dispenser may sell to other registrants without registering as a distributor as long as the total number of dosage units distributed does not exceed 5% of the total units of CS distributed and dispensed in one calendar year.

230
Q

Food drug and cosmetic act

When was it enacted what did it cover

A
  • Enacted in 1938 and then changed in 1962 that drugs must show effectiveness as well as safety
  • Drugs developed pre 1938 were grandfathered in
231
Q

What else needs to be done due to the Combat Methamphetamine Act

A

Logbook

  • Written or electonic and photo ID required for Sales Identifies:
    • Products purchased by name
    • Quantity Sold
    • Name, Address, signature of purchaser
    • Date and time of sale
    • Seller must determine that signature and ID match
    • Logbook has to give notice that false or misleading information may lead to criminal penalties..
232
Q

Notice Of Inpections

A
  • DEA investigators should present their DEA credentials and a Notice of Inspection (Form 82).
  • Consent must be informed and voluntary.
  • Registrant may withhold consent or withdraw it at any time.
  • • Anything incriminating said by registrant may be used against them
233
Q

Who accepts donated previously dispensed medications?

A

They are used by qualifying centers or clinics

234
Q

What is the definition of an online pharmacy?

A
  • Means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses or offers or attempts to deliver, distribute, or dispense a controlled substance via the Internet.
235
Q

Allowable number of times or length of time a pharmacists may refill a CI

II or CIV?

A

5 x or 6 months

236
Q

Maximum amount of pseudoephedrine base that may be sold to a purchaser in one day?

A

3.6 g

237
Q

Theft Or significant Loss of CS

A

Must tell DEA in writing within one day

Submit Form 106

What

Tell police

238
Q

Registration requirements for technicians?

A

Submit application including fee criminal history background check (with fingerprinting)

239
Q

Pharmacists may sell no more than ____ ml or ___ doses of codeine containing CV OTC in ____ hours

A

120 ml or 24 doses in 48 hours

240
Q

Sebutramine

A

Meridia

C4

241
Q

Central fill pharmacies

What is a central fill pharmacy?

A

Fill prescriptions on behalf of a retail pharmacy with whom it has a contractual agreement to provide such services or with pharmacies who share a common owner

242
Q

Number of days a physician may administer methadone to a patient while waiting for admission to a narcotic treatment program?

A

3 days one day at a time

243
Q

Filing of Cs

A
  1. Electronically searchable file(s)
  2. Manual filing: 3 methods
  • 3‐file method
  • 2‐file methods (Note: p. 278 of text)
  1. All CS together & all non‐CS together (“C” stamped on III, IV, & V)
  2. All CII together & all other CS + non‐CS together (“C” stamped on III, IV, & V)

Need red C but waived for electronic

244
Q

Misbranding

A
  • Label is false or misleading
  • Fails to meet labeling requirements
  • fails to provide adequate directions for use
  • Packaging or labeling violates PPA
  • Dispnesing or refilling violates “Rx” without authorization
  • Imitates a drug or sold under another name
245
Q

What activities can a technician not perform?

A

Counseling, Final Verification, DUR, or Receiving/Providing refill transfers

246
Q

Secure Responsible Drug Disposal Act

Who can be come ____ collectors? And what can they do?

What is done with registration?

A

Purpose: Disposal of CS returned from ultimate users or long term care facilities (LTCF) on behalf of their patients

  • retail pharmacies and hospitals or clinics pharmacies may voluntarily become authorized collectors and:
    • Administer mail back programs or
    • Maintain collection receptacles within the pharmacy
    • Or manage a collection receptacle at a LTCF
  • DEA requires modification of registration to become an authorized collector
  • Pharmacies May not co-mingle their inventory disposal/destruction w/these returns
247
Q

How many times can CIII, CIV, CV scripts be transferred?

A

ONce

Except if they share a real time data base then they can be refilled however many times its says up to 5

has to be a real pharmacist doing the transferr

248
Q

Carisprodol

A

Soma

C4

249
Q

What records must the central fill pharmacy receiving the prescription have?

What do they need to keep?

A
  • Keep a copy of the faxed prescription or an electronic record of the information transmitted by the retail pharmacy including:
    • Name, address and DEA number of the retail pharmacy transmitting the prescription
    • Date of receipt of transmission
    • Name of the pharmacist filling the prescription and date of filling
    • date the filled prescription was delivered to teh retail pharmacy and the method of delivery
250
Q

How can controlled substances be transmitted?

A
  • CIII-CV
  • Orally, faxed, or e script
  • first and last name of person doing transmission if not by prescriber
251
Q

Max number of doses (quantity) that may be prescribed and dispensed on a single CII script?

A

No limit both federal and state

252
Q

Once previously dispensed medications are accepted what must be done by the clinics?

A
253
Q

CSA Security Requirements

Who are registrants prohibited from employing that have access to CS’s?

But what can the registrant seek out?

A
  • Convicted of a felony related to a CS
  • had a DEA registration denied or revoked
  • Has surrendered a DEA registration for “cause”

Regestrant can try to get a waiver: which is based on a bunhc of factors listed in the pharmacy manual, and this must be granted before hiring.

254
Q

Vicoprofen

A

Ibuprofen/hydrocodone

C2

255
Q

What are the requirements for online pharmacies? 5 total

A

Law (2 decks)

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