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MPJE 2023 > Pages 51-90 in DS book > Flashcards

Pages 51-90 in DS book Flashcards

1
Q

What other 2 ways can an RPH offer to counsel if it cannot be made in person?

A

Writing with hours pharmacist is available and toll-free # for patient to call

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2
Q

What are the components of patient counseling? (10)

A

1.) Name/description of drug
2.) Dosage form, strength, dose, frequency, route of admin, duration of use
3.) Use and expected action
4.) Directions for use
5.) Common severe SE, adverse effects, interactions, and therapeutic CI
6.) Techniques for self-monitoring of drug therapy
7.) Proper storage and disposal
8.) Refill information
9.) Missed dose instructions
10.) Other comments RPH feels are relevant

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3
Q

Items included in prospective DUR checklist (9)

A

1.) Over-utilization/under-utilization
2.) Therapeutic duplication
3.) Drug-disease state CI
4.) Drug-drug interactions
5.) Incorrect drug dose
6.) Drug-allergy interaction
7.) Abuse/misuse
8.) Inappropriate duration of treatment
9.) Food/nutritional supplements-drug interactions

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4
Q

If a pharmacy changes the responsible pharmacist, when do they need to notify the board?

A

Within 10 days of the change

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5
Q

What must be done the day the responsible pharmacist change is in effect?

A

Controlled substance inventory

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6
Q

If a drug leaves the pharmacy and is re-dispensed what would it be considered?

A

Adulterated

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7
Q

If a drug is outdated what would it be considered?

A

Adulterated

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8
Q

There are 7 most common causes for misbranding, name them

A

1.) Drug dispensed without a prescription
2.) OTC without the proper labeling
3.) Improper refills
4.) False advertising
5.) Wrong drug dispensed
6.) Anything wrong on the prescription label
7.) Drugs without any way to ID them (code, marking, etc.)

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9
Q

What is an originating pharmacy?

A

One that uses a central fill pharmacy to fill or refill prescriptions

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10
Q

Who must maintain records if a central fill pharmacy fills a prescription for originating pharmacy?

A

The originating pharmacy

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11
Q

Requirements for prescription label of a centrally filled prescription (3 things)

A

1.) Name of originating pharmacy
2.) Address of originating pharmacy
3.) Name of Central fill pharmacy

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12
Q

What must be included if a prescriber agent is transmitting an e-script?

A

The agent’s full name

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13
Q

When using e-scripts and wanting DAW, does it need manually written still?

A

No, but it cannot be the default option (must have a way to select it manually)

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14
Q

What type of electronic prescription transmission systems do not require Board approval? What are 3 examples

A

Outpatient; Physician offices, ambulatory surgery centers, hospital outpatient department, etc.

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15
Q

Can you send e-scripts from computer to fax?

A

No only computer to computer; If they want to fax control substance, must manually print it out, sign it, then fax to pharmacy

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16
Q

What are the only two systems of electronic prescription transmission that require Board approval?

A

1.) One used for inpatient orders at institutional facilities
2.) For non-controlled prescriptions or orders that convert the prescription into a computer-generated fax or scanned image (closed system only, cannot do this otherwise)

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17
Q

How soon before discontinuing business as a pharmacy do you need to notify the Board?

A

At least 30 days in advance of closing

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18
Q

What must be included in notice to discontinue business? (3 bullets)

A

1.) Name, address, and terminal distributor’s number
2.) Same as #1, but for the place the drugs will be sold/transferred to
3.) Name and address of secure location where records will be kept and confidentiality must be assured

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19
Q

What must be done on the date the pharmacy is closing?

A

Controlled substance inventory as a final inventory that pharmacy is closing

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20
Q

What must the pharmacy return to the Board upon closing?

A

Terminal distributor’s license for cancellation

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21
Q

With drug loss who must be notified?

A

Board of pharmacy by telephone or online portal once any theft/significant loss is recognized (Must file report in online portal within 30 days)
DEA only if controlled substances + DEA 106 form filed in writing within one business day
Local authorities

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22
Q

What 3 entities can participate in drug repository programs?

A

Hospitals, any pharmacy, or non-profit clinics that are licensed as a TDD

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23
Q

Who can donate drugs to repository programs? (3)

A

1.) Licensed TDD
2.) Wholesaler distributor of dangerous drugs
3.) Person who was legally dispensed a dangerous drug BUT never took custody of the drug (cannot donate these even if its unit-dose packaged)

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24
Q

What drugs are included in the cancer drug repository program (3)

A

1.) Oral drugs used to treat cancer or cancer-related SEs
2.) Oral drugs used to treat SEs of a drug used to treat cancer
3.) Controlled substances in LA or ER form used to treat opioid dependence/addiction

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25
Q

Can oral cancer drugs that are not in original, sealed, tamper evident packaging be donated? If so what 6 requirements must be met for eligibility?

A

Yes, but the following must occur:
1.) The repository program has system to inspect drug is unadulterated/safe
2.) Drugs have been stored appropriately
3.) Exp. date of 6 months or longer
4.) No physical signs of tampering/adulteration
5.) No controlled substances or samples
6.) Drugs that require refrigeration, freezing, or storage at special temp are NOT eligible

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26
Q

Who must be notified if an adult 18 or older receives an immunization at the pharmacy? (2 potential entities)

A

1.) Family physician within 30 days
2.) If no family physician, then Board of Health within 30 days

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27
Q

Notifying an individual’s family physician or Board of Health is NOT required for what vaccine?

A

Flu vaccine

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28
Q

How many hours of a board of pharmacy approved course must a pharmacist complete to administer immunizations?

A

5 hours total with at least one hour of instruction and physical participation in administration techniques

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29
Q

How often must immunization protocols be reviewed with a physician?

A

Every 2 years

30
Q

How long must immunization records be kept?

A

3 years

31
Q

How often must an alarm system be tested?

A

Biannual basis

32
Q

Can a pharmacy make changes to an alarm system without notifying the board first?

A

No, any changes to alarm/security system must be approved by board before change is made
EXCEPTION: If the pharmacy also utilizes an approved physical barrier

33
Q

Name the insulin products that are prescription only (7)

A

1.) Insulin glargine (Lantus, Toujeo, Semglee, Basaglar)
2.) Insulin lispro (Humalog)
3.) Insulin aspart (Novolog)
4.) Insulin detemir
5.) Insulin glulisine (Apidra)
6.) Insulin human (inhaled, Afrezza (not available anymore))
7.) Admelog

34
Q

Temp requirements for fridge drugs

A

2 C - 8 C (36-46F)

35
Q

Is a standing order the same as a protocol?

A

Yes

36
Q

What drugs must be reported to OARRS (8 drugs/categories)

A

1.) C-II
2.) C-III
3.) C-IV
4.) C-V written on prescription
5.) C-V sold to prescriber at wholesale
6.) Gabapentin
7.) Ohio licensed dispensaries to report medical marijuana dispensing within FIVE MINUTES of a sale
8.) Naltrexone products ONLY if being used for treatment of alcohol dependence or prevention of relapse to opioid dependence (NOT something like Contrave)

37
Q

What information is required to be submitted for each prescription on OARRS? (21 items)

A

1.) Pharmacy DEA #
2.) Pharmacy name, address, and phone #
3.) Full patient name and DOB
4.) Patient address
5.) Patient telephone #
6.) Gender of patient
7.) Prescriber’s full name
8.) Prescriber’s DEA #
9.) Date prescription was written
10.) Date of dispensing
11.) Indication of new or refill
12.) Number of the refill being dispensed
13.) NDC number of drug dispensed
14.) Quantity dispensed
15.) Days supply indicated by prescriber or if missing, calculated by pharmacy
16.) Prescription #
17.) Source of payment
18.) Pharmacy’s NPI #
19.) Prescriber’s NPI # (unless a veterinarian)
20.) ICD-10 codes (first 4 characters min.)
21.) CDT code for dentists (If ICD or CDT not entered, RPH must enter NC (no code))

38
Q

How often must the information be submitted into OARRS?

A

Daily

39
Q

How long is information retained in OARRS?

A

2 years

40
Q

There are 4 people/entities that can obtain information from OARRS, who are they?

A

1.) RPH
2.) Prescriber
3.) Patient (own information only, special process through board of pharmacy)
4.) Government representative (law enforcement officer)

41
Q

If a government representative would like to obtain OARRS info, what requirements are necessary? (4 steps)

A

1.) Active case number assigned by department/approval by supervisor
2.) Complete request in online, secure OARRS system giving such info required by BOP
3.) Online requests are processed in real time
4.) Submit completed form to BOP in person, by mail, or by verified fax

42
Q

How can an individual obtain their personal OARRS info? (5 steps)

A

1.) Complete notarized request form giving info req. by BOP
2.) Submit completed form in person or by mail
3.) Pick up info in person at BOP office
4.) Individual must have ID with picture
5.) Individual must pay cost of printing

43
Q

There are 6 situations where a pharmacist must go back and review a patient’s OARRS report covering at least a one year time frame, what are they?

A

1.) Addition of a new/different OARRS reported drug to their therapy
2.) If an OARRS report has not been reviewed in the last 12 months
3.) If a prescriber is located outside the usual geographic area of the pharmacy
4.) If the patient is from outside the usual geographic area
5.) The pharmacist has reason to believe the patient has received prescriptions from more than one prescriber in previous 3 months for OARRS drugs
6.) Patient is showing signs of potential abuse or diversion (early refills, over-utilization, appears intoxictaed/overly-sedated, asks for specific drug by street name, markings, color, etc.)

44
Q

If an MD requests a copy of a patient’s OARRS report can you give it to them?

A

No, you can show them the report/talk with them about it, but they would have to request their own copy for their records

45
Q

What is the one situation where a patient could get their own OARRS report without requesting it directly from BOP?

A

If it is a part of their medical record, then it can be provided to the patient

46
Q

Wholesalers must report to OARRS when and how?

A

When selling controls to another pharmacy, physician, or terminal distributor you must register as a wholesaler and report transactions through OARRS
The reported transaction MUST be by # of packages, not doses (ex: 30 tablets of 100ct bottle would be 0.3, but full bottle would be 1)

47
Q

What is the threshold for MME/MED in ohio?

A

80

48
Q

When a patient reaches the threshold for MME what should be done?

A

RPH and physician should discuss/do careful analysis of patient’s pain killer therapy; does not prevent scripts from being filled/written for pain killers

49
Q

Equation to figure out MED/MME

A

Strength of drug x conversion factor x quantity/days supply

50
Q

Conversion factors for pain killers (7)

A

1.) Hydrocodone = 1
2.) Tramadol = 0.1
3.) Codeine = 0.15
4.) Fentanyl = 7.2
5.) Hydromorphone = 4
6.) Methadone and Oxymorphone = 3

51
Q

What are the 5 inclusions for when compounding can be done?

A

1.) For a prescription by a prescriber
2.) For modification of a prescription made in accordance with a CA
3.) For research, teaching activities, or chemical analysis
4.) For anticipatory compounding based on routine, regularly observed dispensing patterns
5.) For a request made by a prescriber for a drug that is to be used by professional for purpose of direct admin. to patients in course of professional’s practice

52
Q

What is a fluid therapy pharmacy?

A

Primary purpose of this pharmacy is to compound/dispense parenteral compounded sterile product prescriptions

53
Q

What is an outsourcing facility?

A

Facility located at one geographic location that is engaged in anticipatory compounding of sterile drugs and complies with section 503B

54
Q

What is a nonresident pharmacy?

A

Pharmacy outside of Ohio prohibited from shipping compounded drugs into Ohio unless it is pursuant to a patient specific prescription (needs to have some type of inspection report that is less than two years old for pt specific prescription shipping)

55
Q

Beyond use date for compounded liquid

A

14 days

56
Q

Beyond use date for aqueous-based topicals

A

30 days

57
Q

Beyond use date for gel-based topicals

A

6 months

58
Q

What is the max days supply for anticipatory compounding?

A

30 days

59
Q

What are the 5 requirements for pharmacies that compound prescriptions ahead of time in anticipation of a prescription drug order to follow?

A

1.) Name, strength, qty of each drug used in compounded prescription
2.) Identification of the re-packager by name or by final 7 digits of TD license
3.) Pharmacy control #
4.) Pharmacy’s exp. date/BUD
5.) “compounded drug product” or similar statement

60
Q

Any USP chapter under what # is considered federally enforceable?

A

Under 1000

61
Q

Recordkeeping required for compounding (8 things)

A

1.) Name of drugs, strength, and dosage form used
2.) Quantity of drugs added to each container
3.) Disposal of any unused drugs and amount during the process
4.) Lot # of ingredients used
5.) Generic manufacturer’s name if a generic is used
6.) Date of compounding
7.) Exp. date/BUD
8.) Positive ID of RPH responsible

62
Q

T/F: Bulk compounding of products to be sold to other pharmacies is manufacturing

A

True, need manufacturer’s license to do this and have it be legal; NOT considered compounding

63
Q

How soon must any compounding quality issues be reported to BOP if dispensed by the pharmacy?

A

72 hours

64
Q

What are the 3 possible things that could result in a product quality issue that would need reported to BOP?

A

1.) Any incident causing compounded drug or its labeling to be mistaken or applied to another drug
2.) Contamination of the compound (Fungal, mold, bacterial, etc.)
3.) Any significant chemical, physical, or other change/deterioration of compound within BUD

65
Q

What are the 3 situations in which drugs could be compounded by a pharmacy for use by veterinarian?

A

1.) Treating an emergency situation
2.) Unanticipated procedure for which a time delay would negatively affect outcomes
3.) For diagnostic purposes

66
Q

What 3 things would meet the definition of a limited quantity of drug being supplied to a veterinarian?

A

1.) Sufficient for that vet’s office use consistent with exp. date of product
2.) Reasonable considering intended use of compounded med + nature of the vet’s practice
3.) RPH use own professional judgement for appropriate amount

67
Q

How many days supply can a vet personally furnish if they deem failure to provide the drug would result in harm to an animal?

A

Up to a seven day supply

68
Q

Can a vet sell the compounded drug to another vet if needed?

A

No, only pharmacy to vet, not vet to vet or vet to pharmacy, etc.

69
Q

Labeling requirements for compounded prescriptions for vets (9)

A

1.) Proper storage conditions
2.) BUD
3.) Name of active/inactive ingredients
4.) Amount or % of active drug ingredients
5.) Quantity provided
6.) Route of admin.
7.) Pharmacy name, address, and phone #
8.) Pharmacy control # (Lot #)
9.) “Compounded drug product” statement

70
Q

What 3 requirements must a pharmacy meet to be considered a charitable pharmacy?

A

1.) Has terminal distributor’s license
2.) Is exempt from federal taxation
3.) Is not a hospital

MPJE 2023 (4 decks)

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