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Ohio Law Time > General Pharmacy Laws and Rules Pt 3 > Flashcards

General Pharmacy Laws and Rules Pt 3 Flashcards

Pages 98-130

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1
Q

What non-self-injectable drugs are pharmacist prohibited from dispensing?
Hint - 3 categories

A

Drugs that meet all of the following criteria:
1) Indicated for the treatment of cancer or cancer-related illness
2) Must be administered via IV or SubQ
3) Cannot reasonably be self-administered by the pt or person assisting pt with self-administrations

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2
Q

What are the 3 exceptions to the non-self-injectable cancer drug rule?

A

1) Pt lives in a nursing home, residential care facility, rehab facility, or similar institution
2) Pt is an adult and a hospice pt or client of a home health agency and pharmacy has been informed about staff administration by the pt, prescriber, or prescriber’s agent
3) Pt is a minor and a hospice pt or client of a home health agency and pharmacy has been informed about staff administration by the prescriber, prescriber’s agent, or parent/guardian

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3
Q

T/F: All prescribers are required to obtain explicit informed consent if prescribing an opioid to a minor.

A

True (exceptions for emergencies, surgery incidents, facilities, and pt harm)

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4
Q

The informed consent for prescribing opioids to a minor must contain what 3 components?

A

1) Assessment of minor’s mental health and substance abuse history
2) Discussing risk of opioids with minor and minor’s parents/guardians
3) Signature of parent/guardian

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5
Q

If an authorized adult (other than a parent/guardian) signs the consent form for a minor to receive an opioid, what is the max days supply that can be dispensed for that opioid?

A

72 hour supply

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6
Q

To store records off-site, a request must be submitted to the board of pharmacy that contains what 4 items?

A

1) The terminal distributor number of the pharmacy
2) License number of the requestor
3) Name and address of the off-site location
4) Time frame of the records to be moved off-site

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7
Q

T/F: A pharmacy cannot make sales of naloxone at wholesale.

A

False, can make occasional sales of naloxone at wholesale to state and local law enforcement agencies

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8
Q

T/F: The 5% limit does not apply to naloxone wholesale.

A

True

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9
Q

What counseling points are pharmacists/interns required to include in naloxone education materials?
Hint - 8 points

A

1) Risk factors for opioid overdose
2) Strategies to prevent opioid overdose
3) Signs of opioid overdose
4) Steps in responding to an overdose
5) Info on naloxone
6) Procedures for administering naloxone
7) Proper storage and expiration of product
8) Info on where to obtain a referral for substance abuse treatment

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10
Q

T/F: A physician approved protocol for naloxone is required to dispense naloxone without a prescription.

A

True (I don’t think this has changed)

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11
Q

T/F: A pharmacist/intern can fit and measure pts for therapeutic diabetic shoes.

A

True

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12
Q

What 5 types of injectable medications can a pharmacist administer so long as they have an ongoing relationship with the prescriber?

A

1) LA or ER opioid antagonists
2) LA or ER antipsychotics
3) Hydroxyprogesterone caproate for pregnant women
4) Medroxyprogesterone acetate for non-pregnant women
5) B12 injections (cobalmin, cyanocobalmin, etc.)

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13
Q

In order to administer an injectable medication, what 3 criteria must a pharmacist meet?

A

1) Must complete a course in administration of these drugs
2) Must have BLS certification
3) Must practice in accordance with a protocol

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14
Q

If an injectable medication is given, when must the physician be notified by?

A

Within 7 days of the encounter

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15
Q

T/F: A pharmacist must have a physician established protocol to administer injectable medications.

A

True, and it must be signed every 2 years

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16
Q

How long must records of injections be kept for?

A

3 years

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17
Q

T/F: A pharmacy intern can administer injections (not vaccines) under supervision of a pharmacist.

A

False, only pharmacists can administer injections

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18
Q

What 6 forms of communication are considered acceptable ways to notify a provider?

A

1) Email
2) Interoperable electronic medical record system
3) Fax
4) Electronic prescribing system
5) Electronic pharmacy record system
6) Documented verbal communication

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19
Q

Define medication therapy management (MTM)

A

A distinct group of services intended to optimize therapeutic outcomes of a pt - includes appropriate med use, med adherence, ADR detection, etc.

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20
Q

In the state of Ohio, who can provide MTM?

A

An Ohio licensed pharmacist, supervised intern, or a pharmacist practicing in another state practicing within that state’s laws

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21
Q

How many interns per pharmacist can be engaged in MTM?

A

Max of 2 interns per pharmacist (unless otherwise approved by the board)

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22
Q

How long must MTM records be maintained for?

A

3 years

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23
Q

T/F: A terminal distributor is subject to an onsite inspection/investigation without notice from the board.

A

True

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24
Q

If a violation is found during an inspection, written notice of the actions the licensee has taken to correct the violations must be submitted to the board within what time frame?

A

30 days

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25
Q

T/F: Hospital self-service kiosks are available for use by the public.

A

False, they are to be used by hospital employees and their family members only

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26
Q

T/F: Refrigerated meds cannot be stored in hospital self–service kiosks.

A

True

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27
Q

Hospital self-service kiosks must be continuously monitored by video camera. How long must the video footage be kept for?

A

90 days

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28
Q

T/F: Drugs kept in a self-service kiosk that have not been picked up can be returned to stock.

A

True

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29
Q

Suspicious orders (identified by wholesalers) must be reported to the board within how many days of the order being identified as suspicious?

A

5 days

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30
Q

If no suspicious orders are identified by a wholesaler within a month, what must be submitted to the board?

A

A zero report must be filed by the 15th of the next month

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31
Q

Pharmacists are required to self-report criminal convictions, felonies, medical errors as a result of recklessness/unprofessionalism etc. to the board within how many days of the event?

A

10 days

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32
Q

T/F: A pharmacist can dispense naltrexone without a prescription.

A

True, under the following circumstances:
1) Can verify the pt has a record of injectable LA naltrexone with no refills (can be at another pharmacy as long as that pharmacy is contacted)
2) Pharmacist is unable to obtain refill auth at that time
3) The pharmacist judges that the drug is needed to continue therapy and failure to dispense the drug could result in pt harm

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33
Q

If oral naltrexone is dispensed w/o a prescription, what is the max days supply that can be dispensed?

A

5 day supply

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34
Q

If naltrexone is dispensed w/o a prescription, when must the pharmacist notify the prescriber by?

A

Within 5 days

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35
Q

T/F: There is no limit to the number of times naltrexone can be dispensed w/o a prescription or additional refills.

A

True, but professional judgement should be used

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36
Q

T/F: When dispensing naltrexone w/o a prescription, it must be reported to OARRS.

A

True

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37
Q

T/F: A pharmacist can dispense an Epipen without a prescription.

A

True (with a physician-established protocol and pt counseling provided)

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38
Q

When reporting elder abuse, what 4 items must be included in the report?

A

1) Elder adult’s name, address, and approx. age
2) Caregiver’s name and address (if known)
3) Nature and extent of alleged abuse, neglect, or exploitation
4) Basis of the pharmacist’s belief that this has occurred

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39
Q

What 2 methods can be used to ensure proper fridge/freezer temps?

A

1) Temp logs with at least daily observations
2) A temp monitoring system capable of alerting staff of a temp excursion

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40
Q

T/F: Food can be stored in the same fridge/freezer as drug products.

A

False, don’t do it

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41
Q

How long must fridge/freezer temp records be maintained for?

A

3 years

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42
Q

A pharmacist must verify the accuracy of all drugs dispensed by an automated pharmacy system for how long?

A

45 days (continuous)

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43
Q

What accuracy must an automated pharmacy system have?

A

99.985% accuracy

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44
Q

Quality assurance to review an automated pharmacy system must review how many prescriptions to ensure accuracy?

A

At least 5% of all dispensed prescriptions

45
Q

If an automated pharmacy system selects an incorrect drug, what must occur until the problem is fixed?

A

A pharmacist must verify 100% of the drugs dispensed by the system

46
Q

T/F: Remote prescription processing includes dispensing.

A

False, it only includes receiving, interpreting, evaluating, clarifying, prescription approval, and order processing (DUR, therapeutic interventions, etc.)

47
Q

T/F: Remote prescription processing must be done in the United States.

A

True

48
Q

T/F: Remote prescription processing must be done in Ohio if the outpatient pharmacy is located in Ohio.

A

False, it can be done in any state as long as they abide by that state’s laws

49
Q

What tasks are included in technician remote prescription entry?

A

Prescription entry, prescription clarification, processing insurance coverage, and other data entry

50
Q

What types of tech(s) can perform remote prescription entry?

A

Trainees, registered, and certified techs (and interns)

51
Q

Which medications are not included in the dispensing nicotine replacement therapy (NRT) laws?

A

Chantix and Zyban

52
Q

T/F: A pharmacist can dispense prescription nicotine replacement therapy products without a prescription (per the NRT law).

A

True (with a physician-signed protocol)

53
Q

If a NRT is dispensed w/o a prescription, the pharmacist must notify the pt’s provider within what time frame?

A

72 hours

54
Q

Define drug of abuse

A

Any prescription drug

55
Q

Define controlled substance

A

Any schedule I, II, III, IV, or V product

56
Q

When can schedule I drugs be used?

A

They can only be used for reasearch

57
Q

Define poppy straw

A

All parts of the poppy plant, except the seeds

58
Q

What forms of a prescription are considered to be original prescriptions?

A

Written, oral, fax, or electronic

59
Q

What is a registry number?

A

DEA number

60
Q

Define opioid analgesic

A

A controlled substance that has analgesic pharmacologic activity at the opioid receptors of the CNS and includes drugs, their salt forms, and chemical congeners

61
Q

What are characteristics of CI drugs?

A

No medicinal use and cannot be prescribed, only used for research

62
Q

What are characteristics of CII drugs?

A

High potential for abuse and severe psychological or physical dependence

63
Q

What are characteristics of CIII drugs?

A

Moderate potential for abuse, high risk for psychological dependence, or mod-low risk for physical dependence

64
Q

What are characteristics of CIV drugs?

A

Lower potential for abuse and limited psychological/physical dependence

65
Q

Opioid scripts must be filled within __________ of the date written or do not fill date.

A

14 days (except refills of CIII-CV meds)

66
Q

What is the max days supply that can be dispensed for an opioid analgesic?

A

90 day supply (nothing is stopping a prescriber from writing for more than 90 days; it is up to the pharmacist to enforce this)

67
Q

T/F: Buprenorphine used for addiction, dependence, or antidiarrheal is not classified as an opioid analgesic.

A

True

68
Q

If an opioid CII is partial filled and the initial fill was within the 14 day limit, how long can the remainder be dispensed?

A

The remaining amount can be dispensed within 30 days of the date issued/written

69
Q

T/F: A pharmacist can change the issue date of a controlled prescription.

A

True, after consultation with and agreement of the prescriber

70
Q

When prescribing opioids for acute pain for adults, what is the maximum days supply that can be dispensed?

A

7 days

71
Q

When prescribing opioids for acute pain for minors (with parental/guardian consent), what is the maximum days supply that can be dispensed?

A

5 days

72
Q

For acute pain management with opioids, the total morphine equivalent dose cannot exceed what?

A

An average of 30 MED per day

73
Q

Limitations to opioid dose and days supply for acute pain management do not apply to which patient populations?

A

Opioids prescribed for cancer, palliative care, hospice/end-of-life care, medication assisted treatment for addiction, and any scripts written by vets

74
Q

Prescribers must indicate days supply on prescriptions for which medications?

A

Controlled substances and gabapentin

75
Q

New law states all CII scripts must be issued electronically except in what cases?
Hint - 7 cases

A

1) Temporary technical, electrical, or broadband failure
2) Nursing home residents or hospice care pts
3) Prescriber is employed by/under contract with the same entity that operates the pharmacy
4) Prescriber feels an e-script cannot be issued in a timely manner or pt’s condition is at risk
5) When an Rx is issued from a health care facility or ED and the prescriber determines it would be impractical or delay care that could impact the pt’s condition
6) The law doesn’t apply to prescribers that issue <50 CII scripts per year
7) The law doesn’t apply to vets

76
Q

T/F: Under federal law, all Medicare Part D and Medicare Advantage Plans require all controlled substance prescriptions to be issued electronically.

A

True (as of 1/1/23)

77
Q

If a partial CII is dispensed due to the pharmacy being out of stock of the medication, when must the remainder be filled by?

A

72 hours

78
Q

What form is used to order CII medications?

A

DEA 222 form

79
Q

What are the 3 things a pharmacist cannot change or clarify on a CII script?

A

1) Patient’s name
2) Prescriber’s signature
3) Drug prescribed

80
Q

For a non-opioid CII medication, when must the first fill occur by?

A

Must be filled within 6 months of the date written
(14 days only applies to opioids)

81
Q

If an emergency oral prescription for a CII is given, the pharmacist must receive the written prescription from the provider within __________.

A

7 days

82
Q

If a pharmacist does not receive a written script to go with an emergency oral script within the expected time frame, who must be notified?

A

The local DEA office

83
Q

A written prescription that is sent in after an emergency oral prescription must be marked with what statement?

A

“Authorization for Emergency Dispensing”

84
Q

If a wholesaler does not have a CII product in stock, how much time do they have to fill the order before a new form is needed?

A

60 days

85
Q

T/F: If a mistake is made filling out a DEA 222 form, the whole form must be voided.

A

True, you cannot erase and rewrite it

86
Q

If CII drugs are ordered electronically via the DEA’s Controlled Substance Ordering System (CSOS), how long must the order records be maintained for?

A

2 years

87
Q

T/F: CII medications can be stored dispersed throughout the rest of the non-controlled pharmacy stock.

A

False, CII medications must be stored in a securely locked, substantially constructed cabinet or safe

88
Q

T/F: CIII-CV drugs can be stored with CII drugs

A

True

89
Q

T/F: CIII-CV medications can be stored dispersed throughout the rest of the non-controlled pharmacy stock.

A

True

90
Q

How many refills can be written for a CV substance?

A

1 year’s worth of refills

91
Q

How many refills can be written for a CIII-CIV substance?

A

5 refills or 6 months worth of refills
If partial fills are being used, the patient can receive more than 5 refills (up to the total number of tablets prescribed) as long as it is all dispensed within 6 months

92
Q

T/F: Long-term care nurses can fax or call-in oral CIII-CV prescriptions.

A

True

93
Q

T/F: A CV med cannot be dispensed OTC if written previously as a prescription within 6 months.

A

True

94
Q

How much of a CV can be dispensed OTC in a given time?

A

Only one preparation can be dispensed every 48 hours

95
Q

How old do you have to be to purchase a CV med OTC?

A

18+ years old

96
Q

What DEA form is used to register for a DEA license?

A

DEA form 224
(form 224a to re-register)

97
Q

What DEA form is used to get a license to manufacture controlled substances?

A

DEA form 225

98
Q

What DEA form is used in the disposal of controlled substances?

A

DEA form 41

99
Q

What DEA form is used in the theft or loss of controlled substances?

A

DEA form 106

100
Q

Per Ohio law, how often must an inventory of controlled substances be completed?

A

Annually (must be completed within 13 months of the previous inventory)

101
Q

Per federal law, how often must an inventory of controlled substances be completed?

A

Every 2 years

102
Q

When taking an inventory count of all controlled substances, which drugs can you estimate the count for (not required to physically count)?

A

CIII-CV drugs in package sizes less than or equal to 1000 count

103
Q

When taking an inventory count of all controlled substances, which drugs must be physically counted?

A

All CII drugs
CIII-CV drugs in package sizes greater than 1000 count

104
Q

T/F: Records of controlled substances received, administered, dispensed, sold, or used can be kept electronically.

A

True, as long as the method is approved by the board

105
Q

When must an inventory count be performed for a specific drug?

A

If a non-controlled substance becomes a controlled substance OR a controlled substance moves to a higher schedule, the drug must be counted on the date it was changed

106
Q

T/F: Only licensed clinics can dispense methadone.

A

False - only licensed clinics can dispense methadone for drug abuse; anyone can dispense methadone for pain

107
Q

A pharmacist can partial dispense a CII script for up to 60 days in what 2 situations?

A

1) Terminally ill pt
2) Pt in a long-term care facility or nursing home
This information must be written on the prescription
Any tablets remaining on the script after 60 days are lost

108
Q

For pts not terminally ill or in a nursing home/LTC, a pharmacist can partial dispense a CII drug for up to how many days?

A

30 days from the date written

109
Q

Scripts for CII meds cannot be faxed in EXCEPT for what 3 circumstances?

A

1) Pt is a resident of a nursing home or long term care facility
2) Pt is a hospice pt (indicated on the script) and the script is for a narcotic
3) The script is for a compounded sterile product for a narcotic substance

Ohio Law Time (8 decks)

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