Issuance & Dispensing Procedures Flashcards

1
Q

Issuance & Dispensing Procedures

What practitioner(s) are authorized to diagnose and prescribe, based on prescriptive authority within protocols?

Prescribing in South Carolina

A
  • Certified NPs
  • PAs

CIIs (some limitations); CIII-CV

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2
Q

Issuance & Dispensing Procedures

Who is authorized to diagnose and prescribe, acting in regular courses of professional practice?

A
  • Physician (MD)
  • Osteopath (DO)
  • Podiatrist
  • Dentist
  • Vet
  • Optometrist (limitations)

Optometrists: CII HCP only; CIII-V limitations

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3
Q

Issuance & Dispensing Procedures

Who are considered mid-level practitioners?

South Carolina Authorization

A
  • Optometrists
  • PAs
  • NPs, CNMs, CNSs

Certified Nurse-Midwife & Clinical Nurse Specialist

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4
Q

Issuance & Dispensing Procedures

What drug classes can “diagnostically certified” optometrists prescribe?

Prescriptive Authority & Limitations

A
  • Anesthetics (PO, topical)
  • Antihistamines
  • Antimicrobials
  • Antiglaucoma agents
  • OTCs

3 Anti-, Anes-, & OTC

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5
Q

Issuance & Dispensing Procedures

Optometrists may purchase, possess, administer, supply, and prescribe pharmaceutical agents

True or False

A

True

“Diagnostically certified” optometrists’ prescriptive authority

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6
Q

Issuance & Dispensing Procedures

Optometrists may administer medications by IV, IM, or SC

True or False

A

False
no meds may be administered intravenously or by injection

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7
Q

Issuance & Dispensing Procedures

Optometrists are limited to prescribing 21-day supplies for topical steroids

True or False

A

True
21 day supply or less

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8
Q

Issuance & Dispensing Procedures

Optometrists are limited to prescribing 5-day supplies for controlled substances

True or False

A

False - 7 day supply or less
* CIII-V analgesics
* CII Hydrocodone Combination Products (HCPs)

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9
Q

Issuance & Dispensing Procedures

For NPs with prescriptive authority, their prescriptions must include their physician’s information, and the refills must be specified (including none)

True or False

A

True

shall comply with all state and federal laws

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10
Q

Issuance & Dispensing Procedures

For NPs with prescriptive authority, their prescriptions are not limited to common well-defined medical problems within their specialty field

True or False

A

False!
NPs are limited to their field, physician authorization, & approved written protocols

Authorized by the physician and listed in approved written protocols

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11
Q

Issuance & Dispensing Procedures

NPs have no CIII-V limitations, even if their physician’s practice agreement states otherwise

True or False

A

False!
* Based on practice agreement with physician
* No CIII-V limitations beyond standard requirements

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12
Q

Issuance & Dispensing Procedures

What are NPs’ CII prescribing limitations?

Narcotic vs. Non-Narotic

A
  • Narcotic: 5-day supply & subsequent Rxs require written agreement with physician (hospice/palliative care exception!)
  • Non-Narcotic: 30-day supply

Narcotics in hospice/palliative care: 30-day supply

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13
Q

Issuance & Dispensing Procedures

In order for PAs to prescribe, who must they be certified & registered by?

Legend & CII-V

A
  • SC Medical Board certification
  • CII-V: DHEC / DEA registration

Compliance is onus on physician and PA

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14
Q

Issuance & Dispensing Procedures

For PAs, what are the prescribing limitations for CII Narcotics?

Oral Doses & Parenteral Doses

A
  • PO: initial 5-day supply; subsequent Rxs > 5 days in consultation with physician
  • Parenteral: initial 1x administration in 24 hr period

Compliance is onus on physician and PA; no limits on CII non-narcotics

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15
Q

Issuance & Dispensing Procedures

On a prescription drug order, what patient information is required?

A

Full name & address

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16
Q

Issuance & Dispensing Procedures

On a prescription drug order, what prescriber information is required?

A
  • Name (actual, legal) & Degree
  • Address & Phone
  • License number
  • DEA number (“where required by law” - controls)
  • if mid-level, supervising physician’s info also required
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17
Q

Issuance & Dispensing Procedures

What are the 5 general requirements for South Carolina Rxs?

Prescription Drug Orders

A
  1. Patient Info
  2. Prescriber Info
  3. Date of Issuance
  4. Drug Info
  5. 2 signature lines

2 lines: signed on “Dispense as Written” or “Substitution Permitted”

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18
Q

Issuance & Dispensing Procedures

For controls, the prescription drug order must be dated/signed on the date of issue

True or False

A

True

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19
Q

Issuance & Dispensing Procedures

The date on the Rx must be for the date of issuance

True or False

A

True
If there is no date, MUST call prescriber to document date

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20
Q

Issuance & Dispensing Procedures

For prescription drug orders, what drug information is required?

A
  • Name
  • Strength
  • Dosage Form
  • Quantity
  • Directions for use
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21
Q

Issuance & Dispensing Procedures

How does Board Policy #66 create corresponding responsibilities for all prescriptions?

Practitioners & Pharmacists

A
  • Practitioner is responsible for the integrity of the Rx
  • Pharmacist is responsible for checking with practitioner if there is any doubt of validity
  • Use professional judgement in accepting/refusing to fill Rx
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22
Q

Issuance & Dispensing Procedures

Preprinted Prescription Blanks are prohibited for both non-controls and controls?

True or False

A

False
* Prohibited for controls only
* Non-CS: one drug / set of instructions per blank

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23
Q

Issuance & Dispensing Procedures

PRN refills for non-controls are good for ____

Legend/OTCs ~ how long is Rx Valid?

A

2 years

Number of refills allowed is not specified!

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24
Q

Issuance & Dispensing Procedures

How long are CII Rxs valid? How many CII refills are allowed?

A
  • Dispense within 90 days or void
  • No refills

31-day supply (except transdermal patch, surgical implant drug delivery)

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25
Q

Issuance & Dispensing Procedures

How long are CIII-V Rxs valid? How many refills are allowed?

A
  • Dispense within 6 mo or void
  • 5 refills allowed

Must not exceed 90 day supply!

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26
Q

Issuance & Dispensing Procedures

Prescription

Basic Definition

A
  • Verbal or written order for a legitimate medical purpose within the practitioner’s usual course of practice, including orders from collaborative pharmacy practice
  • Given individually for the specific person for whom prescribed
  • Directly from the prescriber or prescriber’s agent to a pharmacist or pharmacist’s agent
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27
Q

Issuance & Dispensing Procedures

Which of the following requirements must be met for a controlled substance prescription to be valid?
Select ALL that apply:

  1. Must be manually signed if it a paper or faxed Rx
  2. Must be issued for a legitimate medical purpose
  3. Must be prescribed in the usual course of medical treatment
  4. Must be issued to an individual practitioner for the purpose of general dispensing to patients
  5. Must be dated and signed on the fill date
A
  1. Must be manually signed if it a paper or faxed Rx
  2. Must be issued for a legitimate medical purpose
  3. Must be prescribed in the usual course of medical treatment

not fill date; ISSUE date

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28
Q

Issuance & Dispensing Procedures

Which of the following prescriptions would likely be out of the scope of practice for a dentist?

  1. Tylenol #3
  2. Amoxicillin
  3. Lorazepam
  4. Atorvastatin
  5. None of the above; dentists are not limited to scope of practice
A

Atorvastatin

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29
Q

Issuance & Dispensing Procedures

All of the folloiwing are required on a prescription order, EXCEPT:

  1. Patient’s address
  2. Prescriber’s license number
  3. Drug quantity
  4. Date of issuance
  5. Patient’s phone number
A

Patient’s phone number

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30
Q

Issuance & Dispensing Procedures

A patient receives a prescription for valacyclovir with directions to take as needed for cold sores. A pharmacist may refill this prescription for up to __ year(s).

  1. 1
  2. 2
  3. 3
  4. 4
  5. unlimited
A

2 years

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31
Q

Issuance & Dispensing Procedures

A pharmacist receives a non-controlled Rx with a specified number of refills. The drug is prescribed for scheduled use (rather than as needed). What the time limit for refills for this prescription?

  1. 6 months
  2. 1 year
  3. 2 years
  4. 3 years
  5. No limit
A

No limit!
* Non-controlled, scheduled Rxs do not expire
* PRN time limit is 2 years

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32
Q

Issuance & Dispensing Procedures

Which of the following prescribers has unlimited, independent prescribing authority?
1. Vet
2. Dentist
3. Physician
4. NP
5. Podiatrist

A

Physician

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33
Q

Issuance & Dispensing Procedures

An optometrist may prescribe which of the following medications?
Select ALL that apply:

  1. Prednisolone eye drops
  2. Ciprofloxacin
  3. Amphetamine-dextroamphetamine
  4. Hydrocodone-acetaminophen
  5. Fentanyl
A

Prednisolone eye drops, Ciprofloxacin, & Hydrocodone-APAP

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34
Q

Issuance & Dispensing Procedures

Given the patient is not in hospice or palliative care, a Schedule II narcotic prescription written by a NP is limited to __ - day supply.
1. 3
2. 5
3. 10
4. 14
5. 30

A

5-day supply

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35
Q

Issuance & Dispensing Procedures

A PA may prescribe if certified by which Board?
1. SC Board of Pharmacy
2. SC Medical Board
3. SC Board of Nursing
4. SC Department of Health & Environmental Control
5. SC Board of Optometry

A

SC Medical Board

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36
Q

Issuance & Dispensing Procedures

An optometrist writes for Tylenol #3 for the treatment of eye pain. Since Tylenol #3 is an analgesic, the Rx is limited to a __ - day supply.
1. 2
2. 5
3. 7
4. 14
5. 30

A

7-day supply

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37
Q

Issuance & Dispensing Procedures

What prescriber information is required on a Rx order for a non-controlled substance?
Select ALL that apply:
1. Prescriber’s name
2. Prescriber’s address
3. Prescriber’s license number
4. Prescriber’s phone number
5. Prescriber’s fax number

A

1, 2, 3, & 4 - all BUT fax number

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38
Q

Issuance & Dispensing Procedures

What information is required on a Rx order for a controlled substance?
Select ALL that apply:
1. Patient’s drug allergies
2. Prescriber’s name
3. Prescriber’s DEA number
4. Drug quantity in numeric and written formats
5. Patient’s full name

A

2, 3, 4, & 5 - all BUT drug allergies

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39
Q

Issuance & Dispensing Procedures

A pharmacist receives a written Rx for levothyroxine. However, the pharmacist is unable to tell if the prescriber signed on the “dispense as written” line or the “substitution permitted” line. What is an appropriate next step?
1. Dispense brand name
2. Dispense generic
3. Call the prescriber’s office to obtain clarification
4. Discard the Rx because it is not valid
5. Check if the patient has filled levothyroxine before and fill whatever was last dispensed

A

Call the prescriber’s office to obtain clarification

40
Q

Issuance & Dispensing Procedures

Which of the following is true about electronic prescriptions?
1. The Rx shall be transmitted to the pharmacy of the patient’s choice
2. A practitioner can electronically trasmit a Rx for a patient before establishing a valid practitioner-patient relationship
3. If an e-script is printed, then a handwritten signature is not required
4. The Rx is exempt from signatures, including digital or key codes
5. An e-script must include the practitioner’s fax number

A

The Rx shall be transmitted to the pharmacy of the patient’s choice

41
Q

Issuance & Dispensing Procedures

Which of the following is true regarding generic substitutions?
1. A patient/caregiver can authorize a blanket consent to allow generic substitutions for all drugs prescribed
2. Therapeutically equivalent drug products can be different dosage forms, as long as the efficacies are the same
3. The patient/caregiver must consent to receive a substituted drug
4. For verbal scripts, the practitioner is not required to instruct the pharmacist as to whether or not substitution is authorized
5. When a prescriber orders “dispense brand only” for a prescription, the patient can request a generic substitution

A

The patient/caregiver must consent to receive a substituted drug

42
Q

Issuance & Dispensing Procedures

An initial opioid prescription for acute or post-operative pain is limited for up to what days supply?
1. 3 days
2. 7 days
3. 10 days
4. 30 days
5. 90 days

A

7 days

43
Q

Issuance & Dispensing Procedures

How many times can a non-controlled prescription be transferred?
1. None
2. Once
3. up to 5 times
4. up to 11 times in a 12-month period
5. up to the number of authorized refills

A

Up to the number of authorized refills

44
Q

Issuance & Dispensing Procedures

What are the 4 main requirements for electronic prescribing?

Prescription Information Privacy Act

A
  1. Patient-practitioner relationship
  2. Rx IDs transmitter & recipient - transmitter’s phone number, time & date of transmission, and the pharmacy intended to receive the transmission
  3. Pharmacy of patient’s choice
  4. Secure prescriber signature

Prescriber’s electronic/digital signature or key code (ID/code #)

45
Q

Issuance & Dispensing Procedures

Electronic prescriptions may be securely signed by the prescriber if or when stating: “electronically signed by…”

True or False

A

False - needs electronic/digital signature or key code

46
Q

Issuance & Dispensing Procedures

The pharmacy is to notify the prescriber if they receive an Rx not intended for that pharmacy.

True or False

A

True

47
Q

Issuance & Dispensing Procedures

If an electronic prescription is printed out and given to the patient, it must possess an orginial handwritten signature.

True or False

A

True

48
Q

Issuance & Dispensing Procedures

An electronic prescription may not have 2 signature lines

True or False

A

True!
Must have designation for brand or generic substitution

49
Q

Issuance & Dispensing Procedures

For electronic prescriptions, who does the routing companies need to be registered with?

A

Board of Pharmacy

50
Q

Issuance & Dispensing Procedures

Pharmacies may incentivize e-prescribers for the commitment of their business.

True or False

A

False - no incentivizing

51
Q

Issuance & Dispensing Procedures

Electronic prescriptions must be printed out for the prescription files.

True or False

A

True!
Provides all required script info, plus unique transmission ID number, transmitter information, and physician identifiers

52
Q

Issuance & Dispensing Procedures

If all information is not on the transmitted electronic prescription, what next steps must be taken?

A
  • Practitioner must be called for verification
  • Documentation of changes must be made on the prescription with the responsible pharmacist’s identification
53
Q

Issuance & Dispensing Procedures

If the pharmacist suspects that the patient was not physically seen by the physician, what must the pharmacist do?

A

Must verify, if necessary, to determine if the patient was physically seen by the physician

54
Q

Issuance & Dispensing Procedures

SC CSA allows for controlled substances to be electronically prescribed, once ____ requirements for prescriber and pharmacy are met.

A

DEA security requirements are met

55
Q

Issuance & Dispensing Procedures

Electronic prescriptions are required for CII-V substances

True or False

A

True!
However, there are some exceptions, and pharmacists/dispensers are not required to verify these exceptions and may continue to dispense previously accepted Rx formats.

Valid written, verbal, faxed, or electronic prescriptions

56
Q

Issuance & Dispensing Procedures

For the electronic prescribing of controlled substances, what are valid exceptions to send via fax, written, or verbal formats?

A
  • Practitioner other than a pharmacist is dispensing it to the patient
  • Administrating it to patients in a hospital, nursing home, hospice, home infusion/dialysis, or residential care facility
  • Technological failures prevent prescriber’s e-scribe
  • Patient is being discharged from hospital, ER, or urgent care
  • Veterinarians
57
Q

Issuance & Dispensing Procedures

Administer

Basic Definition

A

Direct application of a drug or device to the body of a patient

Pursuant to a lawful order of a practitioner

58
Q

Issuance & Dispensing Procedures

What patient age does the state protocol allow pharmacists & interns to administer influenza vaccines without a prescription?

A
  • State protocol for patients 3 years and older
  • Patient specific prescriptions for patients at any age
59
Q

Issuance & Dispensing Procedures

What patient age does the state protocol allow pharmacists & interns to administer vaccinations (other than influenza) without a prescription?

A
  • State protocol for patients 18 yrs and older (H. influenzae, Hep A/B, HPV, MMR, Meningococcal, Pneumococcal, Td/Tdap, Varicella, Zoster)
  • Patient specific prescription for patients at any age
60
Q

Issuance & Dispensing Procedures

What are the requirements to be completed by pharmacists & interns for the state protocol for immunizations?

A
  • Appropriate immunization training program
  • BLS/CPR
  • Annual 1 hour of CE

Maintain current copy of protocol and required supplies/equipment

61
Q

Issuance & Dispensing Procedures

The state protocol for immunizations require a signed consent of patient or guardian.

True or False

A

True

62
Q

Issuance & Dispensing Procedures

Vaccination records are to be maintained for at least ___ years for 18+ yo patients and ___ years for < 18 yo patients.

A
  • 10 years for 18+ yo
  • 13 years for < 18 yo

Documentation of administration with copy given to patient/guardian

63
Q

Issuance & Dispensing Procedures

The state protocol for immunizations requires notification to the patient’s PCP and immunization registry of vaccine administration.

True or False

A

True

64
Q

Issuance & Dispensing Procedures

The state protocol for immunizations require adverse events to be reported to whom?

A

VAERS

65
Q

Issuance & Dispensing Procedures

What patient/caregiver education is given when a prescriber issues an opioid antidote Rx?

SC Overdose Prevention Act

A
  • Overdose prevention & recognition
  • Antidote dosage & administration
  • Importance of calling 911
  • Care for overdose victime after antidote administration

Prescribers may also issue standing orders for first responders

66
Q

Issuance & Dispensing Procedures

Who may dispense opioid antidotes pursuant to written prescriptions or standing orders by a prescriber or by state protocol?

SC Overdose Prevention Act

A

Pharmacists only - may not be delegated to a tech, intern/extern, or clerk

67
Q

Issuance & Dispensing Procedures

What patient/caregiver education is given when a pharmacist dispenses an opioid antidote Rx or standing order?

SC Overdose Prevention Act

A

Notify PCP

Pharmacist education: Guidelines to determine appropriate caregiver

68
Q

Issuance & Dispensing Procedures

Eligible Recipients for Naloxone

Naloxone Protocol

A
  • Persons who voluntarily request it and are (or the caregivers of those) at risk of experiencing opioid-related overdose
  • Persons from an opioid detoxification and mandatory abstinence program
  • Persons entering methadone maintenance treatment programs (for addiction or pain)
  • Persons who may have difficulty accessing emergency medical services
69
Q

Issuance & Dispensing Procedures

Who are those defined as eligible recipients for Naloxone at risk of experiencing opioid-related overdoses?

Naloxone Protocol

A
  • Current illicit or non-medical opioid users or persons with a history of such use
  • Persons with a history of opioid intoxication or overdose and/or emergency medical care for acute opioid poisoning
  • Persons with an opioid prescription, especially those who have known or suspected concurrent alcohol abuse, COPD or other respiratory illnesses/obstruction, smoke, renal dysfunction, hepatic disease, cardiac disease, HIV/AIDS, or concurrent benzodiazepine Rx
70
Q

Issuance & Dispensing Procedures

What act states that under a standing order with a prescriber, pharmacists may dispense hormonal contraceptives without a prescription?

A

Pharmacy Access Act 2022

71
Q

Issuance & Dispensing Procedures

Under a joint protocol (standing order by a prescriber), pharmacists may dispense self-administered hormonal contraceptives or administer an injectable hormonal contraceptive

True or False

A

True

72
Q

Issuance & Dispensing Procedures

The Pharmacy Access Act includes a joint protocol with a self-screening questionaire that is either utilized as is, or changed by the pharmacist to be utilized for their specific patient-population

True or False

A

False!
questionnaire must be utilized; cannot be changed

73
Q

Issuance & Dispensing Procedures

Annual CE related to hormonal contraceptives is not required for pharmacists dispensing pursuant to a prescription

Pharmacy Access Act 2022

A

True

74
Q

Issuance & Dispensing Procedures

What requirements are needed for pharmacists who dispense/administer under the Pharmacy Access Protocol?

Pharmacy Access Protocol

A

Initial certificate training, then 1 hour CE related to hormonal contraceptives annually

75
Q

Issuance & Dispensing Procedures

Patients must be 12 years of age or older to be assessed for hormonal contraceptives under the Pharmacy Access Protocol

True or False

A

False - 18 years or older

76
Q

Issuance & Dispensing Procedures

The Pharmacy Access Protocol counseling requirements include abstinence

True or False

A

True

77
Q

Issuance & Dispensing Procedures

Under the Pharmacy Access Protocol, if pharmacist assessment concludes contraceptives to be unsafe, what next steps should be taken?

A
  • Patient must be referred to a practitioner
  • Pharmacist may not dispense for 24 months
  • Patient must provide evidence of consulting with a practitioner
78
Q

Issuance & Dispensing Procedures

Central fill pharmacies are now allowed in South Carolina because it was signed into law under the Pharmacy Access Act 2022

True or False

A

True
* Rx is filled by another pharmacy and then delivered to “originating” pharmacy for dispensing to patient
* Permits central fill pharmacies to operate in SC with establishing Central Fill pharmacy permit

Pharmacy Access Act 2022 - also hormonal contraceptives

79
Q

Issuance & Dispensing Procedures

Central fill pharmacies allow the filling of CII Rxs

True or False

A

False - prohibits filling CII prescriptions

80
Q

Issuance & Dispensing Procedures

Central fill pharmacies may not engage in actions of a mail order pharmacy

True or False

A

True
* The patient receiving the Rx from the originating/initial pharmacy is a key differentiator from a mail order pharmacy

MO Rxs received from patient/prescriber & delivered directly to patient

81
Q

Issuance & Dispensing Procedures

Pharmacy Access Act has liability

True or False

A

True

82
Q

Issuance & Dispensing Procedures

Under the Pharmacy Access Act, originating pharmacies must notify patients about what specifically?

Centrall Fill Pharmacies

A
  • Notify patients that Rxs may be filled by another pharmacy
  • Provide central pharmacy to patient
  • Label must identify both pharmacies and which one filled Rx
83
Q

Issuance & Dispensing Procedures

When utilizing central fill pharmacies, the originating pharmacy’s label must only identify the central fill pharmacy information.

True or False

A

False! Label must identify both pharmacies and which one filled Rx

84
Q

Issuance & Dispensing Procedures

Nitroglycerin - SL is exempt from the Poison Prevention Packaging Act

True or False

A

True

85
Q

Issuance & Dispensing Procedures

What formulation of Isosorbide dinitrate is exempt from the Poison Prevention Packaging Act?

A

SL/Chew </= 10mg

86
Q

Issuance & Dispensing Procedures

What formulation of ASA or APAP is exempt from the Poison Prevention Packaging Act?

A

Effervescent or Granules

87
Q

Issuance & Dispensing Procedures

Unit dose packagings of potassium supplements are exempt from the Poison Prevention Packaging Act

True or False

A

True

88
Q

Issuance & Dispensing Procedures

What type of inhalation therapy is exempt from the Poison Prevention Packaging Act?

A

Aerosol containers

89
Q

Issuance & Dispensing Procedures

Oral contraceptives in ___ packaging are exempt from the Poison Prevention Packaging Act

A

Dialpacks

90
Q

Issuance & Dispensing Procedures

Anhydrous cholestyramine or colestipol packets are exempt from the Poison Prevention Packaging Act

A

True

91
Q

Issuance & Dispensing Procedures

What is name of the restricted distribution program for thalidomide? For isotretinoin?

A
  • STEPS - thalidomide
  • iPLEDGE - isotretinoin
92
Q

Issuance & Dispensing Procedures

Why does the FDA require restricted distribution programs for certain drugs? Who are these programs established by?

A

Established by manufacturers for drugs with special safety concerns

93
Q

Issuance & Dispensing Procedures

What is the name is the restricted distribution program for clozapine?

A

Clozaril National Registry

94
Q

Issuance & Dispensing Procedures

What do these acronyms stand for:
* PPL
* TAP
* TIPS
* EPASS
* REACH

Restricted Distribution Programs

A
  • Prescribing Program for Lotronex (PPL)
  • Tracleer Access Program (TAP)
  • Tikosyn in Pharmacy Systems (TIPS)
  • Exjade Patient Assistance & Support Services (EPASS)
  • Resources for Expert Assistance & Care Helpline (REACH)
95
Q

Issuance & Dispensing Procedures

What are the 4 lawful reasons that support pharmacists’ rights to refuse to fill or refill a prescription?

Prescription Drug Order Requirements

A
  • Rx suspected as forgery or ficitious
  • RPh would violate the law by filling it
  • Not in stock
  • RPh believes it may be harmful to the patient

NOTHING abridges right to refuse; pharmacists’ right and duty to judge

96
Q

Slides 77 - 103

A