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OU Eth & Law Fall 2018 > State Law Wilson Exam 3 > Flashcards

State Law Wilson Exam 3 Flashcards

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1
Q

define administer

A

direct application of a drug to the body of patient- by injection, inhalation, ingestion or any other means

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2
Q

define dispense or dispensing

A
  • interpretation, evaluation, and implementation of a prescription drug order, including the preparation & delivery of a drug or device to a patient or a patient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient
  • includes sell, distribute, leave with, give away, dispose of, deliver or supply
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3
Q

define licensed practitioner

A

allopathic physician, osteopathic physician, podiatric physician, dentist, veterinarian or optometrist licensed to practice & authorized to prescribe dangerous drugs

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4
Q

define prescriber

A

person licensed in this state who is authorized to prescribe dangerous drugs within the scope of practice of the person’s profession (MD, DO, APRN, CRNA, PA)

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5
Q

define supportive personnel

A

technicians & auxiliary supportive persons who are regularly paid employees of a pharmacy who work & perform tasks in the pharmacy as authorized

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6
Q

What is a licensed practitioner?

A

allopathic physician, osteopathic physician, podiatric physician, dentist, veterinarian or optometrist licensed to practice & authorized to prescribe dangerous drugs

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7
Q

What is a prescriber?

A

person licensed in this state who is authorized to prescribe dangerous drugs within the scope of practice of the person’s profession (MD, DO, APRN, CRNA, PA)

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8
Q

What are supportive personnel?

A

technicians & auxiliary supportive persons who are regularly paid employees of a pharmacy who work & perform tasks in the pharmacy as authorized

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9
Q

Define drugs

A

All medicinal substances & preparations recognized by the US Pharmacopoeia & National Formulary, or any revision thereof, and all substances & preparations intended for external &/or internal use in the cure, diagnosis, mitigation, treatment or prevention of disease in humans or animals & all substances & preparations, other than food, intended to affect the structure or any function of the body of a human or animals

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10
Q

Define medicine

A

Any drug or combination of drugs which has the property or curing, preventing, treating diagnosing or mitigating diseases, or which is used for that purpose

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11
Q

What does the Oklahoma law book contain?

A

both statutes passed by the legislature and regulations promulgated by the State Board of Pharmacy and also regulations promulgated by the Bureau of Narcotics and Dangerous Drug Control

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12
Q

The Board of Pharmacy panel consists of who?

A
  • 6 members

- 5 pharmacists and 1 non-pharmacists

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13
Q

What are the powers and duties of the board of pharmacy?

A

– Regulate the practice of pharmacy
– Regulate the sale & distribution of drugs
– Regulate the dispensing of drugs in all places
– Examine and license pharmacists
– See the rest in the book – wide range of authority

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14
Q

Operations of the Board

A
  • Required to have at least one regular meeting and one meeting for examinations per year
  • Hold meetings it deems necessary
  • You may request to appear before the board
  • Board may hold individual proceedings
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15
Q

When can the board immediately suspend a license?

A

when they find imminent danger to the public; they can schedule the hearing right after suspension

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16
Q

How and when will you receive notice if you are requested to appear before the board?

A

you will receive notice either in person or by certified mail at least 10 days before the hearing

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17
Q

What is standard of proof?

A

clear and convincing evidence

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18
Q

What happens if you fail to appear before the board?

A

May act as a waiver of your rights to present your side of the story

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19
Q

Violations of the OK Pharmacy Act are considered to be what?

A

misdemeanor

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20
Q

Perjury is considered to be what?

A

felony

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21
Q

Under what conditions can you have your licensed revoked / suspended?

A
  • If you violate any provisions of the OK Pharmacy Act, applicable state or federal law, or provisions of the CDSA
  • Convicted of a felony or pleaded guilty or no contest to a felony
  • Engages in pharmacy practice while incapacitated
  • Conducts themselves in a manner that will lower public esteem for the profession of pharmacy
  • Conduct and habits inconsistent with the rules of professional conduct
  • Disciplined by another state BoP
  • Be mentally incompetent
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22
Q

What are the options that the board have to punishment?

A
  • Revoke permanently or suspend certificate, license, permit
  • Reprimand or place on probation any holder of above
  • Set an administrative fine for each count convicted
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23
Q

What is required as an intern for their license?

A
  • 1500 hrs required prior to RPh licensure
  • Must have a license displayed in training area and abide by regulations
  • Have to be enrolled in accredited school of pharmacy and be in good standing (C average)
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24
Q

Qualifications for pharmacists licensure

A

– Pass a State Board approved licensure examination
– Good moral character
– Graduate of an accredited School or College of Pharmacy approved by the Board (or received an FPGEC equivalency certification by NABP if foreign)
– Has attained experience in the practice of pharmacy
– 1500 intern hours
– Pass a board approved jurisprudence exam (MPJE)
– Pass a licensure exam (NAPLEX): Two failed attempts allowed before additional education required

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25
Q

How many hours of CE is required for annual renewal of license?

A

15

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26
Q

How soon should you notify the board when you have a change in address?

A

within 10 days

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27
Q

What are duties only a pharmacist can do?

A 
– Interpret the original prescription 
– Perform prospective DUR 
– Determine product selection 
– Prepare certain IV or sterile products 
– Certify the completed prescription 
– Provide patient counseling
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28
Q

When should preceptor submit intern progress report?

A

end of each 240 hours

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29
Q

requirements for training areas

A
  • must have certificate on display
  • subject to Board inspection
  • cannot be on probation or suspension
  • must submit all reports as required by the Board
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30
Q

technician requirements

A 
– Completed High School education or have G.E.D. 
– Good moral character 
– Non-impaired 
– Adequate education to perform duties 
– Complete on-the-job training
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31
Q

technician duties

A

– All auxiliary staff duties
– Count medications
– Prepackage and properly label medications
– Affix the prescription label to the container
– Reconstitution of medications
– Not an all inclusive list

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32
Q

What is an auxiliary personnel?

A

All persons, other than pharmacists, interns, and technicians, who work or perform tasks in the pharmacy that do not require a permit or license

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33
Q

What can an auxiliary personnel do?

A 
– Retrieve prescriptions or files 
– Clerical or secretarial tasks 
– Accounting tasks 
– Inventory control 
– Cleaning and organization
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34
Q

What is the requirements for pharmacy licensure (for the pharmacy itself)?

A

– Size: at least 125 square feet, commercial location
– Sanitary: sink with hot and cold running water (not part of restroom)
– Balances: capacity form 1/10 grain to at least 1 ounce (exception if proves no weighing will occur)
– Graduates: scaled in both metric and apothecary
– Spatulas, Mortars and pestles
– Refrigeration capabilities
– Exempt narcotic book (if needed)
– Poison book (if needed)
– Filing: for prescriptions
– Library

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35
Q

What must be included in a pharmacy’s library?

A

• OK state law
• Dangerous Drugs Control Rules.
• A recent copy of ANY 2 of the following
– see law for full list
– USP/NF (3 years or latest edition)
– Merck Manual (3 years or latest edition)
– Facts and Comparisons (2 years)
– ASHP, American Hospital Formulary Service (AHFS) Drug Information (2 years)
– Drug Information Handbook (2 years)
– Thomson Micromedex, USP-DI (2 years)
– Current computer professional pharmacy reference program, approved by the Board (not duplicating a hard copy reference)

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36
Q

What are the responsibilities of the pharmacy?

A

– Provide adequate staffing

– Allow for routine inspections and investigations during reasonable business hours

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37
Q

What are the responsibilities of the pharmacist in charge?

A

– Supervision of employees
– Establishing policies and procedures for safekeeping pharmaceuticals
– Proper record keeping
– Proper license displaying
– Controlled substance inventories
– Maintaining prescription files
– One PIC may only serve only one store at a time
– Present in the store at least 20 hours weekly or 50% of time open if less than 40 hours weekly.

38
Q

What are the responsibilities of both the pharmacy and pharmacist in charge?

A

– Ensure filler of prescription is known
– Establish and maintain effective controls against misfills or errors
– Notify board if employment changes caused by drug or pharmacy-related issues
– Responsible for automated pharmacy systems
– Responsible for personnel identification
– Establish and maintain effective controls against diversion
– Supervision of all employees as they relate to the practice of pharmacy
– Implement and follow a written drug diversion policy

39
Q

What are Unlawful / Prohibited acts related to pharmacists?

A
  • Allow anyone other than a licensed pharmacist to certify a prescription
  • Institute or manage a pharmacy other than a licensed pharmacist or without one in charge
  • A licensed pharmacist may only manage, supervise, or be in charge of 1 pharmacy
  • Cannot substitute without authority of prescriber or purchaser
  • Only a pharmacist can practice pharmacy
  • No person can subvert the authority of the PIC
40
Q

What are examples of professional conduct?

A
  • Comply with laws
  • Substitute only with authority of prescriber or purchaser
  • Conduct themselves at all times in a manner which will entitle them to the respect and confidence of the community in which they practice
  • No unprofessional promotion
  • Fair fee for professional services
  • Maintain confidentiality within legal requirements
  • Refrain from practicing medicine
  • Oppose secret arrangements between pharmacist and any practitioner/physician
  • Promote the profession
  • Make professional services available in projects beneficial to public health or the welfare or defense of the country
  • Recognize the State Board of Pharmacy as the governing body of the practice of pharmacy in Oklahoma
41
Q

What are considered violations to professional conduct?

A
  • Directly or indirectly violate Title 59 and related laws
  • Failure to establish and maintain controls against diversion
  • Submitting fraudulent insurance claims
  • Not attempting to address the possible addiction or dependency of a patient
  • Discrimination between patients or groups of patients
  • Violating patient confidentiality
  • Knowingly dispensing prescription drug refills after the death of a physician
  • Failure to establish and maintain effective controls to prevent errors or misfills
  • Departing from standard of care
  • Allowing non-pharmacist to perform duties of pharmacists
  • Failure to adequately supervise support staff
42
Q

What is required of a PIC?

A
  • Competency training for: Preparation and sterilization of parental medications, Medicine incompatibilities
  • HIPAA and confidentiality training
  • Repackaging drug products
  • Establishing procedures for procurement of medicines
  • Participating in development and maintenance of a formulary
  • Meeting all requirements of the Oklahoma Pharmacy Act
  • Establishing guidelines for safe and effective distribution of medicines
43
Q

What are the parts of prospective DUR?

A

– Overutilization or underutilization
– Therapeutic duplication
– Drug disease contraindications, if disease is known
– Drug drug contraindications
– Incorrect drug dosage or duration of drug treatment
– Drug allergy interactions
– Clinical abuse/misuse

44
Q

When is counseling performed?

A

– When deemed appropriate in the pharmacist’s professional judgement or when required by applicable federal or state laws and rules
– Upon receipt of a new prescription and following review of the patient’s record

45
Q

What are elements to include during a counseling session?

A

– Name and description of the drug
– Dosage form, dose, route of admin, and duration of therapy
– Intended use, if known, and expected action
– Special directions and precautions
– Common severe side effects or interactions or contraindications
– Techniques for self-monitoring drug therapy
– Proper storage
– Refill information
– Action to take if dose is missed
– Additional comments by the pharmacist

46
Q

What is required for prescriptions that are phoned in?

A

Promptly recorded in writing by the pharmacist which shall constitute as the original prescription

47
Q

Who does prescriptions belong to?

A

the patient

48
Q

What are out-patient labeling requirements?

A
  • Name and address of the pharmacy
  • Date of filling
  • Name of patient
  • Name of prescriber
  • Directions for use
  • Prescription number
  • Trade or generic name of drug
  • Prescribed quantity
  • Strength of drug (except with otherwise directed by the prescriber)
49
Q

Which patient information should you have for each patient on their profile?

A
  • Name, address, telephone number, date of birth or age, and gender
  • Individual history where significant: allergies, Comprehensive medicine and device list
  • Additional relevant comments regarding the patient’s drug use (including failure to accept pharmacist’s offer to counsel)
50
Q

T/F; Prescription medications shall not be left outside the prescription area when the pharmacist is not in attendance

A

T

51
Q

How long should original and transferred prescription be maintained for?

A

5 years from the date of the last refill

52
Q

What do you do to a transferred prescription?

A
  • write “Void” on the face of the prescription
  • write the following information on the back of the prescription:
    • Name and address of pharmacy transferred to
    • Last name of registration number of the pharmacist transferring
    • Date of the transfer
53
Q

How many times can a controlled (CIII-V) prescription be transferred?

A
  • one time only

- if real-time online database, may transfer up to the maximum number of refills permitted by law and the prescription”

54
Q

When can emergency dispensing happen?

A
  • Occurs when the governor declares a disaster or emergency and the Board finds the disaster or emergency disrupts the normal prescription drug distribution channels in Oklahoma
  • For non controlled prescription, if cannot get a hold of prescriber and pharmacist deems it necessary, can give 30d supply; mark rx as emergency
    • For CDS, if the prescriber cannot be reached, the DEA and OBN must confirm the emergency dispensing of CDS has been approved
    • If approved AND the pharmacist feels the medication is essential to the patient’s health and safety, a 10 day supply can be dispensed
55
Q

With respect to compounding, what is the PIC’s responsibility?

A

– To ensure that all compounders meet the training, testing, and education requirements (must be renewed annually)
– Have written policies and procedures for all steps: storage, handling, clothing, personal hygiene, hand washing, quality assurance, expiration dating

56
Q

Requirements of compounded products (process of)

A

– Ensure product strength, quality, and purity
– Review all compounding records and check for errors
– Ensure proper beyond-use dating
– Ensure proper maintenance, cleanliness, and use of all equipment
– Accuracy of calculations
– Use of proper solutions and additives
– Absence of particulate matter, precipitates, turbidity, discoloration, and evidence of contamination

57
Q

Who can substitute a medication for its generic?

A

Only a prescriber or purchaser may substitute a medication for its generic (NOT by a pharmacist)

58
Q

What needs to happen when a night cabinet is accessed?

A
  • need written physician orders and proof of use

- inventory and review of activity conducted at least monthly

59
Q

When should a pharmacist exercise professional judgement?

A

– Determining the legitimacy of a prescription
– Counseling
– Supplying controlled substances for emergencies

60
Q

T/F; The law does not require a pharmacist to dispense a prescription if the pharmacist doubts its origin or if they believe that the prescription may not have been issued for a legitimate medical purpose

A

T

61
Q

When is a time when a pharmacist does not have to keep their patient’s information confidential?

A

– Responding to legal requirements

– It is in the best interest of the patient

62
Q

What kind of agreement is required for pharmacists to provide immunizations?

A

collaborative agreement

63
Q

What is required of a pharmacist in order for him/her to provide immunizations?

A

– Complete approved training
– Receive registration from board
– Be CPR certified
– Keep appropriate records

64
Q

What are physician dispensing requirements?

A
  • Must be licensed as a dispenser
  • Dispense in container with appropriate labeling
  • Keep record for at least 5 years
65
Q

What are records that need to be kept for 5 years?

A

– Prescription and immunization records

– Nightly reports

66
Q

What are records that need to be kept for 2 years?

A

– Patient records

– Invoices and inventory records

67
Q

Nightly reports

A

– Required for all controlled substances
– Shall be verified, signed, and dated by the pharmacist
– These reports must be kept for 5 years

68
Q

For record keeping requirements, what must be on the patient’s record?

A

– Full name of the patient
– Address and telephone number
– Age or date of birth
– A list of all prescription drug orders obtained by the patient at that pharmacy during the previous 6 months, showing the prescription number, the name of the drug/device, its strength, quantity and date received, and the name of the prescriber
– Any pharmacist comments relevant to the patient’s drug therapy

69
Q

Should CS inventory be estimated or exact count?

A

according to state law, MUST be exact count

70
Q

How often should CS inventory be done?

A

every two years

71
Q

If a drug is newly added as a CS, what must happen?

A

inventory of all CS

72
Q

For CS rx, what must the prescription contain?

A
  • Practitioner name, address, DEA #
  • Date of issuance
  • Name of medication, dosage, strength
  • Name and address of patient
  • Directions for use
  • Cautionary statements
  • Refills allotted, if any
  • For veterinary, must include species, name and address of owner
73
Q

What can a pharmacist add to a CS prescription (without confirmation with prescriber)?

A
  • Patient’s address or age (all schedules)
  • Prescriber’s DEA # (CIII-CV)
  • Generic name, if used (all schedules)
74
Q

What can a pharmacist add to a CS prescription (after confirmation with prescriber)?

A
  • Strength, dosage form, quantity, directions

- Must call prescriber and confirm to add DEA # on C-IIs

75
Q

T/F; Each CS prescription should be written on a single prescription form with no other prescriptions on the same form

A

T

76
Q

When can a fax for a CII serve as the original?

A
  • Being filled by a home infusion pharmacy
  • The patient is in a long-term care facility
  • The patient is in a hospice program
77
Q

How has the law in Nov 2018 affect the issuance of a CS prescription?

A

– Initial fills for acute and chronic pain
– Limit of 7 day supply initially
– Patient-provider agreement established
– Review the PMP
– Second Rx no sooner than 7 days
– Third Rx required a pain management agreement

78
Q

When can a partial fill for a CII be allowed?

A
  • Permissible if pharmacy is unable to supply full quantity

* Pharmacy must supply remaining quantity within 72 hours

79
Q

What must be included in log book wen selling CV without a prescription?

A
  • Name and address of purchaser
  • Date of each purchase
  • Name or initials of pharmacist
80
Q

What are the opium 48h limits?

A

160 mg

81
Q

What are the morphine 48h limits?

A

20 mg

82
Q

What are the codeine 48h limits?

A

80 mg

83
Q

Within 5 minutes of dispensing CS, what must be submitted to OBNDD?

A
  • Recipient’s name
  • Recipient’s identification number (e.g., DL #)
  • NDC
  • Date of dispensing
  • Quantity
  • Prescriber’s DEA #
  • Dispenser’s registration number and location
84
Q

Pseudoephedrine sale limits

A

– 3.6 grams per day
– 7.2 grams per 30 days
– 60 grams per year

85
Q

Pseudoephedrine sale requirements

A

Purchaser must show valid ID and be approved through submitting the purchase request to the electronic log and Methamphetamine Registry

86
Q

Midlevel practitioner prescribing limits

A

– Supervising physician on blank for PA and APNs
– May NOT dispense or prescribe CDS for themselves or immediate family members
– Only midlevel practitioners licensed in OK may prescribe for controlled substances
– Must follow prescribing limit rules according to their degree

87
Q

Physician’s Assistant prescribing authority

A
  • CII: Limited to orders for immediate or ongoing administration
  • CIII-V: 30d supplies, no refills
  • Legend drug for new diagnosis: 30 day supply with 2 refills
  • Legend drug for established diagnosis: 90 day supply with 3 refills
88
Q

Advanced Practice Nurses prescribing authority

A
  • CII: not allowed
  • CIII-V: 30d supplies, no refills; May be less than a 30 day supply will refills, but not to exceed a total of 30 days’ supply
89
Q

Certified Registered Nurse Anesthetists prescribing authority

A

– May select, order, obtain, and administer drugs ONLY in perioperative and periobstetrical periods
– C-II through C-V
– May not write outpatient prescriptions

90
Q

Certified Registered Nurse Anesthetists prescribing authority

A

– May select, order, obtain, and administer drugs ONLY in perioperative and periobstetrical periods
– C-II through C-V
– May not write outpatient prescriptions

91
Q

Optometrists prescribing authority

A

– Hydrocodone-containing products: Up to a 5 day supply
– C-III, C-IV, C-V: Up to a 7 day supply, No refills without follow-up exam
– Must be for abnormalities of the eye

92
Q

Practitioner prescribing authority

A
  • Practitioner MAY NOT prescribe a CS for a patient within the 1st or 2nd degree, whether by blood or marriage
  • Practitioner MAY prescribe a CS for a patient within the 3rd degree or below

OU Eth & Law Fall 2018 (12 decks)

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