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LAW MPJE OHIO > Law Part 1 > Flashcards

Law Part 1 Flashcards

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1
Q

Define who has access to drug stock

A

includes individuals with not only physical access but also influence over the handling of prescription drugs including: purchases, inventories, issuance of medical order.

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2
Q

Define Act of Moral Turpitude

A

Act or behavior that gravely violates moral sentiment or accepted moral standards of the community and is a morally culpable quality held to be present in some criminal offenses as distinguished from others.

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3
Q

A drug is defined as:

A

USP recognized article for use in diagnosis, cure, treatment, or prevention of disease in humans or animals.

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4
Q

A faxed prescription form in any situation must be _____

A

manually signed by the prescriber. Faxed refill authorizations must be manually signed as well.

  • must also include the identification number of the fax machine used to transmit the prescription
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5
Q

If an “agent” is sending prescriptions via faxed what should also be on the script?

A

besides the providers signature it should also have the agents full name

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6
Q

Most Computer to Fax prescriptions are now considered…

A

illegal, there are a few exceptions

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7
Q

Define a “closed system” where a compute to fax prescription can be done

A

the scripts are transmitted directly between companies/entities under common ownership and control one or more contracted companies

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8
Q

Other than a closed system computer to fax prescription set up, what is one other way that this viewed as legal?

A

in a situation where there is a temporary telecommunication outage of the third party intermediate (NON CONTROLLED ONLY)

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9
Q

Pharmacists must disclose drug price information for all drugs except for?

A

Class 2 drugs

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10
Q

what is defined as readily retrievable?

A

records that can be produced for review within 3 business days

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11
Q

What is denying original or continued licensure for a period of at least 24 months referred to as?

A

Refuse to grant or renew

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12
Q

A pharmacy that dispenses (sells) drugs at retail (other than for own use as with a practitioner) - Includes laboratories

A

terminal distributor

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13
Q

Third Party Logistics Provider

A

contracts with a manufacturer or wholesaler to provide or coordinate warehousing, distribution, or other services on their behalf but does not take title of prescription drugs or have the responsibility for their sale disposition

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14
Q

Wholesaler Sale

A

Any sale that is made with the purpose of the purchaser to resell the article purchased or received

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15
Q

Occasional Sale is when

A

a wholesale sale of a commercially available prescription drug to another terminal distributor or person exempted from being a terminal distributor

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16
Q

the 5% limitation to occasional sales does not apply to the sales, transfers, or deliveries or prescription drugs considered:

A
  • as intracompany (between pharmacies under the same ownership)
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17
Q

what is the federal law definition of a prescription drug?

A

a drug that is unsafe for use except under the supervision of a practitioner because of toxicity, mode of use, or any other measures necessary to use the drug

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18
Q

Name 5 of the 11 minimum standards for a pharmacy under the pharmacy practice act

A
  1. Library
  2. Equipment
  3. stock of drugs
  4. prescription containers
  5. space and fixtures
  6. pharmacy hours posted
  7. personnel and staffing
  8. catch all: additional minimum standards for specialized pharmacy practices
  9. internet access
  10. name tags that include job title
  11. institutional: quality assurance program
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19
Q

In the pharmacy practice act a pharmacist is required to have internet access to what 4 sources?

A
  1. the board of pharmacies website
  2. LA Writer Ohio Laws and Rules
  3. the code of laws of the United States of America
  4. the code of federal regulations
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20
Q

What is evaluated by the required quality assurance program that is required for institutional pharmacies via the Pharmacy Practice Act (4)

A
  1. quality and appropriateness of patient care
  2. pursue opportunities to improve patient care
  3. prevention and detection of drug diversion
  4. resolve ID problems
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21
Q

When a prescription is returned to stock after a patient fails to pick it up what is the BUD?

A

1 year from date the script was dispensed or whenever the bottle used expires (soonest).

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22
Q

Can you remove the label from a prescription bottle (not OG packaging) that is returned to stock?

A

No! - you may add or modify the existing label is the drug name, dose, and original expiration date are maintained

You may be able to place a new label over the existing one if the drug is verified by a pharmacist or electronic verification system after the admin of a new label

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23
Q

If there is a drug recall, all medication on the shelf that was previously dispensed in a patient bottle should be -

A

removed from the shelfs unless the pharmacy can determine that medications exact lot number

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24
Q

What are the two conditions that a patient container can be returned to stock after a delivery agent brings them back?

A

(only needs to meet one)

  1. it had to have been dispensed in a tamper evident container or package prior to leaving the pharmacy
  2. dispensed in the manufacturers original tamper evident packaging
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25
Q

What are the two conditions that a patient container can be returned to stock after a delivery agent brings them back?

A

(only needs to meet one)

  1. it had to have been dispensed in a tamper evident container or package prior to leaving the pharmacy
  2. dispensed in the manufacturers original tamper evident packaging
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26
Q

How long is a consult agreement valid for?

A

2 years

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27
Q

Who can pharmacists enter a consult agreement with?

A

Physicians

Physician assistants, if entering into a consult agreement is authorized by one or more supervising physician

Clinical nurse specialists, certified nurse-midwives, or certified nurse practitioners, if entering into a consult agreement is authorized by one or more collaborating physicians.

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28
Q

Consult agreements must be in writing and must include:

A

1.the diagnosis and the diseases being managed

2.description of drugs or categories the agreement involves

3.description of the procedures, decision criteria, and plan the pharmacist is supposed to follow

4.description of how the pharmacist is to comply with the records of each action taken

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29
Q

Comorbid Disease is….

A

an additional disease that co-occurs with a primary disease. A co-morbid disease may be related to or occur independently of the primary disease

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30
Q

Define Primary Disease

A

disease that arises spontaneously and is not associate with or caused be a previous disease, but may lead to a co-morbid disease

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31
Q

A consent must be “communicated” to each patient participating in a consult agreement. It must include what 4 things?

A
  1. A pharmacist may be utilized in the management of the patients care
  2. the patient has the right to participate or withdraw from the consult agreement
  3. this consent may be part of the patient’s initial onset to treatment
  4. managing pharmacist means a pharmacist managing a patient’s drug therapy pursuant to a consult agreement
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32
Q

Inside a consent agreement what can be outlined in regards to training of pharmacists?

A

A consent agreement can outline training and experience criteria for the managing pharmacists to manage drug therapy under the agreement.

Can include: privileging or credentials, board certs, CE, etc

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33
Q

Once the consult agreement is completed a pharmacist is consider one of two things:

A
  1. Prescriber authorized to issue new or refill drug orders in writing, orally, fax, or electronic prescribing

OR

  1. Agent of the prescriber
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34
Q

If a pharmacist is an AGENT of a prescriber with a consult agreement the pharmacist must ______

A

-include required prescriber information of the consulting prescriber (name, address, etc)

  • telephone # of where the managing pharmacist can be contacted during business hours
  • all positive identification (including manual signature) on the prescription shall be of the managing pharmacist on behalf of the consulting provider
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35
Q

When should you notify the board if a pharmacist is no longer authorized to prescribe controlled substances per the consult agreement?

A

Within 5 days. The BOP will then void their controlled substance prescriber license

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36
Q

When should a pharmacist’s DEA number from the federal government be submitted to the board by?

A

must be done within 30 days, or at any point changes are made

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37
Q

When should a pharmacist managing a patient’s drug therapy via consult agreement request and review OARRS report covering one year ? (2)

A
  • adds a controlled substance to the patient’s drug therapy
  • adjusts a controlled substances, strength, dose, dosage form, route, or frequency of administration
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38
Q

A practitioner is defined as:

A

licensed health care professional authorized to prescribe drugs

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39
Q

A pharmacist can dispense or sell a dangerous all drugs EXCEPT ____ without a prescription from a licensed health care professional authorized to prescribe medications …..

A

Schedule 2

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40
Q

What things are needed in order for a pharmacist to dispense or sell a dangerous drug without a prescription?

(8 things)

A
  1. pharmacy record of a RX with no RF or expired for pt
  2. RPh is unable to contact the prescriber for refills
  3. in PharmD’s judgement that drug is essential to sustain life - or failure to dispense can cause harm to the patient
  4. decision of 72 hr or 30 d supply
  5. record of dispensing and notifying prescriber within 72 hours
  6. keep records of dispense x 1 yr
  7. must create a new rx for the emergency refill
  8. the law does NOT specify that the record for the RX be specific for that pharmacy.
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41
Q

When can a 30 day emergency dispense be considered?

A

if the patient has been on consistent drug therapy demonstrated by records maintained by the pharmacy. The drug dispensed cannot exceed a 30 day supply OR the standard unit available for the drug if the standard unit exceeds 30 days

(inhaler meant to last 60 days - with instructions)

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42
Q

Can you redispense a medication for a patient after you’ve already dispensed a 30-day emergency fill?

A

Yes, you can dispense up to a 7 day supply a SECOND AND THIRD time within a 12 month period

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43
Q

When can a pharmacy not charge a patient’s medication to a copay/co-insurance health plan?

A

when the plan co-pay is more than the cash price! the pharmacy must inform the patient of this cost -savings

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44
Q

What are the 7 criteria for “Registration of Pharmacists” ?

A
  1. 18 yo
  2. good moral character
  3. attended an accredited pharmacy program
  4. met minimum intern requirements determined
  5. passed licensures
  6. completed naplex + mpje in at most 5 attempts
  7. any disciplinary action taken by any board of pharmacy must be reported to all boards the person is licensed in
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45
Q

How many members are on the board of pharmacy?

A

9 that are appointed by the governor

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46
Q

Of the 9 members on the board, how many are pharmacists?

A

8 !
the 9th individual must be a consumer of at least 60 yo

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47
Q

How long is a term on the board of pharmacy?

A

4 years! you may be reappointed for one additional four year term

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48
Q

When is the term start date for the board of pharmacy?

A

July 1st

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49
Q

What type of prescription can an intern not partake in during a transfer?

A

Controlled Substances - Pharmacist only

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50
Q

What schedule drug can have refills good for 1 year?

A

C-V

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51
Q

Can an intern consult a patient prior to dispensing simultaneous refills?

A

No, the law prohibits this and requires that only a pharmacist does this

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52
Q

Who can use the words “pharmacy” or “drug store”

A

Terminal distributors

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53
Q

When can a pharmacist not dispense a generic?

A

When the provider has written in their own handwriting in any way that portrays DAW.

A verbal DAW wording reference

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54
Q

When must a pharmacist notify a provider when a biological product was switched for a patient? (provide the additional information they must also give)

A

5 days

Must also tell them the product name and the manufacturer

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55
Q

Orange Book

A

FDA generic bioequivalence book

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56
Q

Purple Book

A

FDA list of licensed biological products
includes exclusivity and biosimilarity or interchangeability evaluation

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57
Q

Name on an RX label for a pet

A

Last Name of Owner, Name of Animal, Species

EX: McCrory, Lacy Jo, Canine

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58
Q

A small label that is usually placed on a multi dose container must include: (2)

A

RX number and patient name

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59
Q

When can a patient self medicate at bedside in the hospital?

A

When it is the same directions as the outpatient label

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60
Q

What must be on a label of a sample provided by prescriber?

A

Name of the prescriber
Patient Name
Directions

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61
Q

Max Days supply limit for patient medication packages:

A

31 days

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62
Q

Max Expiration date for patient specific medication packages

A

6 months

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63
Q

When a change in status for a provider occurs what is the max days supply for a non controlled substance that can be dispensed?

A

30 days or the standard unit of dispensing

**only valid if the script was written PRIOR to the change of status

64
Q

When a change in status for a provider occurs what is the max days supply for a Controlled substance that can be dispensed?

A

72 hour supply

** only valid if the script was written PRIOR to the change of status

65
Q

After a pharmacist provides the maximum days supply to a patient after a provider change of status what must they do to the remaining refills/qtys?

A

Must invalidate the remaining portions of the prescription and the remaining portion of the RX.

66
Q

Define Prospective DUR

A

conducted at the time a prescription is dispensed

67
Q

Which DUR is required by law?

A

PROSPECTIVE

68
Q

How long is the temporary permission that the BOP gives a pharmacist to be the responsible pharmacist for more than one pharmacy?

A

Given UP TO 60 days by a board employee until the FULL board decides. Once permission is given it is only good for 1 year.

69
Q

When must the BOP be notified in a change in responsible pharmacist?

A

10 days!
A complete inventory must be taken of ALL controlled substances by the new pharmacist on the date of the change

70
Q

All pharmacists working in a pharmacy must have access to all:

A

current federal and state laws, regulations and rules governing the legal distributions of drugs in ohio

need nearest poison center number

71
Q

If a drug leaves the pharmacy and is then re-dispensed it is:

A

Adulterated

72
Q

All central pharmacy providing central prescription filling processing services to pharmacies in Ohio MUST:

A

Be licensed as a terminal distributor of dangerous drugs

73
Q

Which form of electronic prescriptions for controlled substances considered acceptable?

  • Computer to computer
  • Computer to Fax
A

Computer to Computer!

74
Q

If a prescriber wants to fax a controlled substance what must they do?

A

Must manually print it out, sign it, and then fax it to the pharmacy

75
Q

Form that must be sent to the DEA within 1 business day with suspected theft?

A

DEA Form 106

76
Q

What vaccine does not need to be reported to a PCP or BoH within 30 days of administration?

A

Flu Vaccines

77
Q

How long is the course that pharmacists need to complete in order to give vaccines in Ohio?

A

5 hours with 1 hour of that time being in person physical participation (technique focused)

78
Q

In order to give vaccines a pharmacist must have a Physician established protocol…. What does that entail?

A

Review Q2Y

  • length of observation time after admin
  • what to do in emergency situations
  • method to notify BOH or PCP within 30 days
  • be able to immediately provide information to BOP
79
Q

Finite details for the Physician established vaccine protocol in regards to the vaccine must include…. (7)

A
  • name / strength
  • precautions / CI
  • intended audience or patient population
  • appropriate dosage
  • administration schedules
  • routes of admin
  • injection sites
80
Q

T/F: A practitioner can request the drug name be omitted from the label.

A

True

81
Q

Records from the past 36 months need to be produced in what time frame?

A

3 business days.

If it is 12 months or less then it needs to be available immediately

82
Q

T/F: protocol and treatment guidelines must be approved by the BOP?

A

True

83
Q

Protocol Definition

A

definitive set of written treatment guidelines that include definitive orders for drugs and their specific dosages which have been authorized by a prescriber to be used by licensed HCP when administering biologics or vaccines

84
Q

What types of Naltrexone products should be reported to OARRS?

A
  • if used for OuD, AuD
  • if it is a combo product IT DOES NOT NEED TO BE REPORTED
85
Q

Other than OARRS being able to calculate a patient’s possible risk for OD and Addiction, What other features does it hold? (3)

A
  • ability to message other providers
  • ability to search for local addiction treatment providers
  • red flags to alert prescribers of patient safety issues
86
Q

T/F: do emergency rooms have to report to OARRS CS that were dispensed to patients?

A

True

  • so do physicians who dispense their own meds
87
Q

If a pharmacy sells CS as a wholesaler to other pharmacies or physician offices what must they do in OARRS?

A

They must also register themselves as a wholesaler so that those sales can be reported to OARRS

88
Q

In OARRS as a wholesaler what must you report the amount sold as? What about as a TDD?

A

Wholesaler: Packages
TDD: Total quantity

WS: 100 pill bottle –> sold 30 pills –> 0.3

89
Q

MED Equation

A 
             DS
90
Q

Describe the MED for Ohio

A

In ohio the threshold is 80. You can surpass this amount using clinical judgement. This can change daily!!! If a medication is DC’d then it is still calculated in here.

If a patient has an RX still available - once the DS runs out then it is deducted from the MED.

91
Q

CF for Methadone

A

3

92
Q

CF for Fentanyl

A

7.2

93
Q

CF for Hydrocodone

A

1

94
Q

CF for Tramadol

A

0.1

95
Q

CF for Codeine

A

0.15

96
Q

CF for Hydromorphone

A

4

97
Q

CF for Oxymorphone

A

3

98
Q

BUD for compounded liquid

A

14 days

99
Q

BUD for a Aqueous based topical liquid

A

30 days

100
Q

BUD for gel-based topicals

A

6 months

101
Q

Manufacturing requires licensing with:

A

The FDA and compliance with cGMP. Allows you to produce and sell manufactured medications (in bulk) without patient specific prescriptions

102
Q

When can you compound commercially available products?

A

In an event of shortage

103
Q

If there is a Quality issue when compounding when should the board be notified?

A

72 hours - utilize the Quality Reporting Form

Done in any event that product quality issue it attributed to a compounded drug dispensed by the pharmacy

104
Q

Registered Pharmacy Technicians Licenses expire_____

A

March 31st on every even numbered year

105
Q

Certified Pharmacy Technicians Licenses Expire ___

A

September 30th on every even number year

106
Q

Retailers are prohibited from selling DEXTROMETHORPHAN to people < 18 yo. Who should be carded?

A

Anyone that looks to be under the age of 25.

107
Q

If a patients (<18 yo) guardian is not the one who gives consent to dispense an opioid how much can the pharmacist dispense?

A

72 hour supply

108
Q

What must be included in a letter to the BoP for record kept off site
(request)

A

TDD # of the pharmacy
License # of the requestor
Name and Address of the alternative address
Time frame in which the records will be moved off site

109
Q

If a pharmacy dispenses naloxone must notify the BoP within __ of establishing an approved protocol. If a pharmacy is no longer dispensing naloxone, they must notify the board within ___ of d/c.

A

30 days, 30 days

110
Q

The 5% limit does not apply to:

A

The selling of naloxone
- wholesale to state and local law enforcement agencies

111
Q

What are the five types of vaccines that a pharmacist can administer?

A

LAI
Hydroxyprogesterone - pregnant
Medroxyprogesterone - non pregnant
B 12
Medications used for addiction

112
Q

When must a provider be notified after doing a pharmacist administered injection? (not a vaccine)

A

7 days

113
Q

The 5 + injections that a pharmacist may inject requires what training?

A

At least 1.5 hr of live or home study coursework for EACH of the five types of administered by a pharmacist. (7.5 total)

MINIMUM of 30 minutes live or home study MUST include a review of sterile technique in injectable dosage preparation and administration

114
Q

A Pharmacist must SELF report within 10 days of:

A
  1. any criminal conviction
  2. convicted or pled guilty, subject to a judicial finding of eligibility for intervention in lieu of conviction or the equivalent in another jurisdiction
  3. granted entry into a diversion program, deferred prosecution program, or equivalent
  4. Any disciplinary action taken by another state
  5. Any medical error result of reckless behavior
115
Q

T/F: A Pyxis machine is considered an automated pharmacy system

A

FALSE!
APS - performs operations or activities relative to storage, packaging, compounding, and dispensing, or distributions

116
Q

A pharmacist must verify the APS has a 99.985% that needs to be continuous for ____

A

45 days

117
Q

Limited Category 2 Pharmacies

A

Are TDD that DO NOT DISPENSE

118
Q

In order for a pharmacist to dispense NRT without a prescription they must_____

A

take an approved course

And

Must notify the patients PCP within 72 hours

119
Q

If a partial fill is done for a C-II how long do you have to do the remainder of the prescription?

A

30 days of the date issued

120
Q

All C-2’s are required to be issued electronically except in what situations?

A
  1. Temp technical, electrical, or broadband failure
  2. Nursing home & hospice patients
  3. prescriber is employed by /under contract with the same entity as the pharmacy
  4. prescriber does not feel that a electronic rx cannot be issued in a timely manner and pt’s condition is at risk
  5. RX issued in a health care facility & prescriber determines that an electronic RX would be impractical or would cause delay that would adversely impacts the pt’s medical condition
121
Q

The C-2 of ONLY electronic prescribing LAW DOES NOT APPLY TO:

A

prescribers who write 50 or less C-2 a year

122
Q

T/F: Federal law requires that ALL medicare part D and Medicare Advantage Prescription Drug Plans require ALL controlled substances prescriptions to be issued electronically

A

True

123
Q

What 3 things can never be changed on a C-2?

A

Patient Name
Prescriber Signature
Drug Prescribed

124
Q

What happens when a pharmacist receives an oral C-2 RX:

A

The Qty prescribed and dispensed should be enough for the emergency period (may not be 72 hr)

Pharmacists must receive the written RX from the prescriber within 7 days

the oral and written must be attached together with a statement of “authorization for emergency dispensing”

125
Q

Form 222

A

Ordering of C-2

126
Q

Form 224

A

original registration for DEA license

127
Q

Form 225

A

license to manufacture control substances

128
Q

Form 224a

A

DEA re-registration form

129
Q

Form 41

A

disposal of controlled substances

130
Q

Form 106

A

Theft or Loss of controlled substances

131
Q

By ohio law how often should inventories be conducted?

A

13 months

132
Q

Schedule III, IV, and V drugs in package sizes LESS THAN OR EQUAL TO 1000 can be:

A

estimated for inventory

133
Q

Schedule III, IV, and V drugs in a package size GREATER THAN 1000 MUST BE :

A

Must be counted for inventory

134
Q

Can a C-II qty be estimated?

A

NO must have a physical and exact amount

135
Q

When can you receive a fax for a C-2

A
  1. nursing home or LTC patients
  2. hospice pts (will note hospice on rx)
  3. Compounded sterile product prescription for a narcotic substance
136
Q

Poisons are deleterious to adult life in quantities of ___ grams or less.

A

4

137
Q

PA can prescribe chronic weight loss medications starting ____

A

with the 4th visit (after 3 visits with the doctor

138
Q

Can PA prescribe short term weight loss medications?

A

NO

139
Q

At what point can a provider write refills for weight loss medications?

A

after the 3rd FtF visit - can only do 5 times within a 6 month time period

140
Q

Any changes to the hospital DEA number should be sent to the BOP within:

A

5 days

141
Q

What section must a sterile compounding outsourcing facility be registered as “outsourcing facility” under Section:

A

503B

142
Q

Define a Class 1 medical Device

A

good manufacturing practices
pre marketing review; safety
proper labeling trustful advertising

Ex: ice bags, crutches, blood pressure kits

143
Q

Define Class 2 medical Device

A

Class 1 + performance standards

Ex: tampons, contact lens, heating pads

(good manufacturing practices
pre marketing review; safety
proper labeling trustful advertising )

144
Q

Define Class 3 Medical Devices

A

Class 2 + pre-marketing approval
Manufacturers must demonstrate safety and efficacy

EX: IUD, Pacemakers, heart valves, artificial hips

145
Q

What 3 security features do medicaid prescriptions require?

A
  • prevent unauthorized copying (blank/completed)
  • Prevent erasure or modifying of written info
  • Prevent the use of counterfeit RX forms

(thermochromic ink, tamper resistant background, triplicate blanks, numbered blanks)

146
Q

Who decides the scheduling of drugs?

A

Attorney. General

147
Q

Class 1 Drug Recalls

A

Will cause serious ADR or death

148
Q

Class 2 Drug Recalls

A

May temporarily or medically reversible ADR on health or where probability of serious ADR is remote

149
Q

Class 3 Drug Recalls

A

Exposure is not likely to cause any ADR

150
Q

Purple Book

A

Biosimilar lists and interchangeable biological products

151
Q

DEA Numbers that start with M

A

APN
Optometrist

152
Q

What is the ONE PO steroid that an optometrist can prescribe?

A

Methylprednisolone (pt has to be 18+, treating an allergy, during episode of illness)

153
Q

Optometrists cannot prescribe more than (CS)

A

60 mg of Codeine per dosage unit or 7.5 mg of hydrocodone per dosage unit

MUST BE IN COMBO WITH NON NARCOTIC INGREDIENTS

  • 4 DS MAXXXX (for a single episode of illness)
154
Q

Max pseudoephedrine that is limited in a DAY

A

3.6 g

155
Q

Max pseudoephedrine that is max per MONTH

A

9 g

LAW MPJE OHIO (1 decks)

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