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Pharmacy Law > Oklahoma State Pharmacy Laws and Practice PT2 > Flashcards

Oklahoma State Pharmacy Laws and Practice PT2 Flashcards

1
Q

Pharmacist Responsibilities in Compounding

A
  1. Verify all critical processes to ensure procedure result in the expected qualities in the finished preparation
  2. Ensure stability evaluation is determined from literature for establishing reliable BUD
  3. Perform final check of preparation prior to their release from the pharmacy
  4. Reject and destroy all preparations that do not pass the final examination
  5. Document final preparation examinations prior to releasing
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2
Q

For the compounding of non-sterile products the PIC has what responsibility?

A

Ensure that all compounds meet requirements for:
1. Training
2. Testing
3. Education
for regulations and USP standards

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3
Q

Training of staff may consist of any combination of didactic and experiential methods which must convey proper technique, infection control procedures, etc. required by USP standards, what are the type of tests and frequency of exams?

A
  1. WRITTEN test shall be administered and passed
  2. Testing is conducted ANNUALLY
  3. Documentation by a pharmacist of training/testing shall be available for inspection
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4
Q

What is the preferred source for quality standard when performing non-sterile compounding?

A

The pharmacist shall FIRST attempt to use USP-NF drug substances and inactive components that have been made in a FDA registered facility (BEST case scenario)

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5
Q

If components are not obtainable from a FDA registered facility, what are acceptable alternative sources?

A

High quality components that are:
1. Chemically pure
2. Analytical reagent grade
3. American Chemical Society certified
4. Food Chemicals Codex grade

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6
Q

How should components for non-sterile compounding be stored?

A
  1. Off the flood
  2. Handled and stored to prevent contamination
  3. Rotated so the oldest stock is used first
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7
Q

What is the purpose of written procedures for drug compounding of non-sterile products?

A

To assure that the finished products have the identity, strength, quality, and purity they purport to have: procedures available in written form or electronically stored that is printable

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8
Q

What is the object of the documentation of drug compounding?

A

To allow another compounder to REPRODUCE an equivalent prescription at a future date

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9
Q

What are the 6 Elements of documentation needed for a non-sterile compounding preparation?

A
  1. Components
  2. Amounts (weight or volume)
  3. Order of component mixing
  4. Description of the compounding process
  5. Equipment and Utensils
  6. Container/Closure system
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10
Q

Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available FDA approved drug product is generally prohibited unless what?

A
  1. Patient specific medical need (allergy or compromised therapy)
  2. Drug Shortage
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11
Q

If compounding a copy with a specific patient need, what must be documented?

A
  1. Documentation provided by the prescribing physician of a patient specific medical need
  2. Unavailability of such drug products must be documented prior to compounding
  3. Available when requested by the Board
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12
Q

Reconstitution of commercial products is considered compounding true or false?

A

FALSE

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13
Q

Manipulation of commercially available products according to or beyond the manufacturers instructions of copying commercial products is considered compounding true or false?

A

TRUE

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14
Q

Non-Aqueous Formulation BUD

A

No later than the time remaining of the earliest expiration date or 6 MONTHS whichever is earlier

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15
Q

Water-Containing Formulation BUD

A

No later than 14 DAYS when stored at controlled cold temps

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16
Q

Water-Contains Topical/Dermal/and Mucosal Liquid and Semisolid Formulation BUD

A

No later than 30 DAYS

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17
Q

Non-Water Containing Topical/Dermal/and Mucosal Liquid and Semisolid Formulation BUD

A

No later than the time remaining of the earliest expiration date or 6 MONTHS whichever is earlier

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18
Q

What are the EIGHT required components of a non-sterile compounding record?

A
  1. Assigned name of the preparation
  2. Name and actual measured quantity of each ingredient used
  3. Lot number, expiration date, and manufacturer of each ingredient
  4. Total quantity compounded
  5. Name/Initials of the compounder and the supervising pharmacist
  6. Date the compound is prepared
  7. Lot/Batch number assigned to the prep
  8. The assigned BUD
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19
Q

If a component is transferred from the original container to another, the new container shall be identified with what?

A
  1. Component Name
  2. Lot and BUD
  3. Strength and/or Concentration
  4. Weight or Measure
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20
Q

Preparations prepared in anticipation will be labeled with what?

A
  1. Complete list of ingredients, prep name
  2. Prep date
  3. Assigned BUD: published data, testing, or USP
  4. Storage conditions
  5. Batch or Lot
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21
Q

What are the requirements for ALL OUTPATIENT non-sterile compounding products?

A
  1. Patient Name
  2. Prescriber Name
  3. Name and Address of pharmacy
  4. Directions for Use
  5. Date Filled
  6. BUD and Storage
  7. Compounded Rx Designation
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22
Q

All procedures and records of non-sterile compounding must be retained for the same period of time as required for prescription records which is what?

A

5 YEARS

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23
Q

Perpetual inventory is required for all CDS and bulk CDS meaning?

A

At any point in time you must know what your CDS inventory is

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24
Q

Non-Sterile Hazardous drugs shall include the NIOSH list and when it enters the pharmacy, what must be done?

A

The PIC shall be responsible to confirm that medical products have labeling on the outer container that can be understood by all workers who will be separating hazardous drugs

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25
Q

For areas that store hazardous drugs, what is required?

A

Sufficient general exhaust ventilation to dilute and remove any airborne contaminants, use a ventilated cabinet to reduce worker exposure

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26
Q

Do supplemental engineering or process controls like closed system drug transfer device substitute for ventilated cabinets in terms of hazardous drugs?

A

NO

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27
Q

Only a licensed practitioner may dispense dangerous drugs to their own patients, and they must keep a record for 5 YEARS of every dangerous drug dispensed, but these are samples so can they dispense it in a different box?

A

NO, a different box than the manufacturer’s requires them to register as a dispenser

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28
Q

A prescriber who dispenses professional samples to patients shall be exempt from the requirement of subsection B if what?

A
  1. The prescriber furnishes the professional samples to the patient in the package provided by the manufacturer
  2. No charge is made to the patient
  3. An appropriate record is entered in the patient’s chart
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29
Q

A Charitable Clinic Pharmacy Licensure can be issued if the clinic is operating as what?

A

Non-profit basis to furnish medical care to poor and underprivileged persons and in which drugs are dispensed or administered without charge to such persons on orders or prescriptions of prescribers authorized by law to prescribe or administer said drugs

30
Q

Is the minimum of 40 hours for a lock out pharmacy apply to charitable clinic pharmacies?

A

NO

31
Q

A charitable clinic pharmacy can be part of a medical clinic that utilizes a mobile clinic to provide medical services provided that what?

A
  1. The charitable clinic pharmacy has a permanent location where all dangerous drugs and records are stored
  2. ALL dangerous drugs are returned to the permanent location each day and stored there
  3. The permanent location is the address of record for the pharmacy
  4. Mobile clinics shall not have CDS
32
Q

Are mobile clinics allowed to carry, store, or dispense CDS?

A

NO

33
Q

Utilization of Unused Prescription Medications Act criteria in accepting unused meds:

A
  1. Only prescription drugs in their original seal unit dose packaging
  2. Unopened, UNLESS CANCER DRUGS
  3. Expired drugs shall NOT be accepted
  4. No acceptation of adulterer drugs
  5. NO CDS ALLOWED
  6. Medical assistance program and drug product donation program drugs can be accepted
34
Q

A pharmacy or charitable clinic which meets the eligibility requirements may:

A
  1. Dispense prescription drugs donated to persons who are medically indigent residents of Oklahoma
  2. Charge persons receiving donated prescription drugs a handling fee established by rule of the Board
35
Q

Can Oklahoma Nursing Homes donate prescription drugs under the Unused Prescription Medications Act?

A

YES, if they are licensed and in good standing

36
Q

Can Approved Licensed Assisted Living Centers ALC donate prescription drugs under the Unused Prescription Medications Act?

A

Yes, if there is an application completed by the consultant pharmacy of the ALC and documentation that the patient’s medication and been DC and AGREED to be donated

37
Q

All Donating Nursing Homes and ALC’s must have a consultant pharmacist true or false?

A

TRUE

38
Q

The consultant pharmacist is responsible for donating unused prescription by assuring what?

A
  1. Drugs have been kept under control of a healthcare professional
  2. Drugs have been stored properly
  3. Drugs can be identified
  4. Drugs are not adulterated
39
Q

For the donation of unused prescriptions what documentation MUST occur?

A
  1. Name of Consultant Pharmacist and Director of Nursing, Name of Nursing Home and the Name of the Receiving Pharmacy
  2. Name and Strength of the eligible prescription drug
  3. Expiration date of drug
  4. Number of tablets or volume
40
Q

How long must you keep the documentation of the donated unused prescription drugs?

A

2 YEARS

41
Q

What drugs are eligible for Unused Prescription Medications Act?

A

ALL FDA approved prescription drugs excluding CDS:
1. In original sealed unit dose
2. Unopened
3. No expired drugs
4. No lost identify or unknown drugs
5. No adulterated drugs
6. No drugs held outside of a licensed healthcare person’s control

42
Q

Are compounded drugs and cancer drugs eligible for Unused Prescription Medications Act?

A

Compounded = NO
Cancer = YES, IF approved by Board and ACS reps

43
Q

What type of Oklahoma Licensed Pharmacies may accept unused prescription drugs?

A
  1. Operated by County in OK
  2. Operated by Health Department in OK
  3. Operated by firm contact with Health Department in OK
  4. Operated by Charitable Clinic
  5. Operated by OK Mental Health and Substance Abuse Service
44
Q

What are the requirements for Eligible OK pharmacies dispensing unused prescription drugs?

A
  1. Maintain a current drug identification book, or may have a current computer program or online service
  2. Dispense unused prescription drugs only upon the valid prescription of an OK licensed healthcare prescriber
45
Q

Can medications be removed from bingo cards and placed in proper vial for dispensing?

A

YES, IF it is not a sample –> ALL samples must remain in original packaging

46
Q

Are Charitable pharmacies allowed to establish policies limiting the number of prescriptions per patient per visit/month to allow a greater number of individual access to medications?

A

YES

47
Q

Can eligible pharmacies transfer unused prescription drugs to another eligible pharmacy if they both keep the documentation for 2 YEARS?

A

YES

48
Q

The pharmacist manager of an eligible pharmacy is responsible for what?

A
  1. Coordination of retrieving donated drugs
  2. Check and resolve and discrepancies
  3. Store and secure
  4. Check for adulterations
  5. Assure expired, adulterated or lost identity drugs are not dispensed
  6. Destroy unacceptable drugs WITHIN 14 DAYS
  7. Assure safety in drug recalls
49
Q

Customized Adherence Medication Package CAMP

A

Means packaging for dispensed drugs that is composed of units containing two or more medications and designed to assist the user in administering or self-administering the drugs in accordance with directions for use

50
Q

When should drugs not be put into CAMPs?

A
  1. USP monograph or official labeling requires dispensing in the original container
  2. The drugs or dosage forms are incompatible with packaging components
  3. The drugs are therapeutically incompatible with administered together
  4. Look-a-Like/Sound-a-Like medications
51
Q

Can medications that have been dispensed in CAMP be eligible for donation?

A

NO

52
Q

What are the labeling requirements for CAMPs?

A
  1. Physical description of medication (imprint) or be separately packaged
  2. Expiration date
  3. Lot numbers
  4. Date and Time to be given
  5. Patient name
  6. Name and strength of the medication
53
Q

Non-Resident Pharmacy

A

Means a pharmacy not located in Oklahoma, which transacts or does business in Oklahoma by soliciting, receiving, dispensing, and/or delivering prescription medications and devices to Oklahoma residents

54
Q

For a Non-Resident Pharmacy, the pharmacist must be licensed how?

A

In Oklahoma if they are serving Oklahoma and submit a report every 24 MONTHS for approval

55
Q

Emergency Medication Kit Drugs

A
  1. The drugs shall remain the property of an Oklahoma licensed pharmacy
  2. Only ONE Oklahoma licensed pharmacy may provide emergency med kits to each facility –> nursing homes can only receive from ONE pharmacy, but that ONE pharmacy can provide to multiple nursing homes
  3. Drugs obtained must be approved by the medical director of the nursing home
  4. Medications can only be administered upon prescriber’s order and by a licensed nurse, physician, or PA
56
Q

The facility licensed nurse prior to use of emergency medication must what?

A
  1. Verbally transmit the order for an emergency drug to the PHARMACIST prior to removal from the emergency kit
  2. OR electronically transmit the order if that pharmacy has the proper technology and the PHARMACIST must release the medication for use
57
Q

Pharmacies providing emergency mediation kits, shall maintain a record for each dose administered with what information documented?

A
  1. Name of ordering prescriber
  2. Date and time of order
  3. Facility resident name
  4. Medication name and strength
  5. Name of person administering medication including date and time
  6. KEPT FOR 2 YEARS
58
Q

The pharmacy technician completes Phase I training before they may apply for an Oklahoma Pharmacy Tech permit however the technician has NOT met Board requirements until they what?

A

Successfully complete Phase II of pharmacy technician training

59
Q

How long does a pharmacy technician have to complete Phase II training?

A

90 DAYS, if not completed they have to start all over and lose their permit

60
Q

Lock Out pharmacy or Prescription Department

A

Means a prescription department that is to be operated for a period less than regular business hours of the entire store

61
Q

What are the minimum hours for a Lock Out Pharmacy?

A

40 hours per week 5 days a week

62
Q

The removal of expired drugs must occur within what time period via destruction or returned to supplier?

A

Within 6 MONTHS of expiration

63
Q

What are SIX scenarios in which are exceptions to the use of unlawful pick up station for prescription delivery?

A
  1. To the prescriber cause the patient does not have a home
  2. To the prescriber cause of special handling
  3. To the prescriber to be administered
  4. End Stage Renal Disease clinic to be administered
  5. Nuclear drugs to clinic
  6. IHS to be picked up by Native American patient
64
Q

Drug Supplier

A

Means a licensed retail pharmacy which supplies legend drugs to licensed prescribers for their office administration and/or which supplies legend drugs to hospitals and other licensed pharmacies for dispensing

65
Q

Drug Supplier annual sales cannot exceed what percent of the total annual sales of the pharmacy?

A

5%

66
Q

Pharmacy/Pharmacy License Permits

A

No more than one pharmacy license allowed in one location

67
Q

Pharmacy/Drug Supplier License Permits

A

Same location is allowed

68
Q

Pharmacy/Outsourcing Facility License Permits

A

Allowed when state and federal requirements are met

69
Q

Pharmacy/Sterile Compounding License Permits

A

Same location is allowed

70
Q

What are the goals and objectives of OPHP?

A

To eliminate alcohol and drug abuse among pharmacists and student pharmacists through education about chemical dependency as a disease

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