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Pharmacy Law > Oklahoma State Pharmacy Laws and Practice PT1 > Flashcards

Oklahoma State Pharmacy Laws and Practice PT1 Flashcards

1
Q

Certified Medication Order

A

Means a filled prescription that has been reviewed and certified by a pharmacy

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2
Q

Director of Pharmacy

A

Means a pharmacist licensed to engage in the practice of pharmacy in Oklahoma who is thoroughly familiar with the specialized functions of a hospital pharmacy and directs the actinides of a hospital pharmacy

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3
Q

Drug Room

A

Means a secured room where drug inventories are maintained for use in a facility licensed and regulated by the Oklahoma Health Department, and which may be inspected by the Board

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4
Q

Minimum Hours of a Drug Room

A

A hospital pharmacy shall be staffed with licensed pharmacist and be open for a minimum of four days a week and for a minimum for at least 32 hrs per week

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5
Q

Pharmacy Tech Qualifications

A

At minimum, a pharmacy tech must complete a technician on the job training OJT program

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6
Q

Supervision of Pharmacy Technicians

A
  1. All tasks performed by techs in the pharmacy must be accomplished under the immediate supervision of an Oklahoma currently licensed pharmacist
  2. Immediate supervision is any task that are directly upstream of dispensing
  3. Whenever the pharmacist leaves the pharmacy, all dispensing shall cease
  4. A licensed pharmacy intern shall NOT supervise pharmacy technicians
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7
Q

What is the maximum ratio of pharmacy technicians to pharmacist in the state of Oklahoma?

A

4 techs : 1 supervising pharmacist
-A director of pharmacy can make the ratio lower but it cannot exceed 4:1

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8
Q

How does a pharmacist demonstrate certification and final check of tasks performed by a technician?

A
  1. Signature
  2. Initial
  3. Other identifying mark on a record
    All on the medication order/and or label
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9
Q

What are Pharmacy Technician Tasks that are allowed in the hospital?

A
  1. Affix the prescription label to the final container
  2. Affix auxiliary labels to the container as directed by the pharmacist
  3. Assist in the management of controlled dangerous substance CDS inventory
  4. Fill automated dispensing systems
  5. Prepackage and label multi-dose and unit-dose packages
  6. Perform bulk reconstitution of non-injectable meds
  7. Perform bulk compounding, including sterile IV, irrigations, etc.
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10
Q

If a pharmacy technician is aiding in the management of controlled substances CDS inventory within the hospital, where does the supervision and responsibility lie?

A

A pharmacist remains responsible for completeness and accuracy

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11
Q

In the ABSENCE of a Pharmacist at a hospital what must be done?

A

Arrangements shall be made in advance by the Director of Pharmacy for provision of drugs to an AUTHORIZED personnel of the hospital facility by the use of NIGHT CABINETS

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12
Q

What must happen during ALL Absences of a Pharmacist at the hospital?

A

A pharmacist MUST be ON CALL

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13
Q

Night Cabinets

A
  1. Controlled drugs shall be kept in locked cabinets or other enclosure
  2. Located OUTSIDE of the pharmacy area
  3. ONLY specific authorized personnel may obtain access by key or combination
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14
Q

For drugs kept OUTSIDE the pharmacy located in a night cabinet they must what?

A
  1. Properly Labeled
  2. May only have prepackaged drugs in amounts sufficient for immediate therapeutic requirements
  3. Authorized personnel ONLY
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15
Q

For Night Cabinets, how often must a FULL inventory and review be completed?

A

MONTHLY

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16
Q

If a Night Cabinet is utilized, what must be documented?

A
  1. WRITTEN physician order
  2. PROOF of use
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17
Q

A hospital pharmacy MUST contain FOUR current references that are NOT more than 2 yrs old and electronic sources may be substituted for TWO hard copy sources. List the possible references

A
  1. Drug Interactions
  2. Drug Compatibility
  3. Poison and Antidote Information
  4. Toxicology
  5. Pharmacology
  6. Bacteriology
  7. Patient Counseling
  8. Rational Therapy
  9. Dispensing Information
  10. Available USP Standards
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18
Q

For the STORAGE of medications, what must be done within a hospital?

A
  1. Stored in designated area to insure proper environmental controls (temperature)
  2. Security under the direct supervision of a pharmacist
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19
Q

For Alcohol and Flammables, what must be done within a hospital?

A
  1. Stored in areas meeting basic local building code requirements
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20
Q

For UNATTENDED AREAS, what must be done within a hospital?

A
  1. Locked and inspected MONTHLY
  2. Must be documented
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21
Q

For SECURITY, what must be done within a hospital?

A

For ALL areas occupied by a hospital pharmacy shall be capable of being locked by key or combination to prevent access by unauthorized personnel

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22
Q

What are the GENERAL responsibilities of a Director of Pharmacy in a hospital?

A
  1. Safe and Efficient purchasing
  2. Acquisition
  3. Monitoring
  4. Distribution
  5. Control
  6. Security
  7. Accountability of ALL drugs
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23
Q

An Adverse Drug Event Program falls under the responsibility of the Director of Pharmacy and entails what?

A
  1. Pharmacist Interventions
  2. Medication Errors
  3. Adverse Drug Reactions for ALL medications utilized in the hospital
  4. Tracking, Review, and Outcome of ALL adverse drug events AVAILABLE for inspection
  5. Sentinel events, direct impact findings, root cause analysis, and medication management of the Joint Commission
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24
Q

Sentinel Event

A

An event that causes severe harm or death to a patient

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25
Q

An Investigational Drug Program falls under the responsibility of the Director of Pharmacy and entails what?

A

Maintain a file for review by the Board of ALL investigational drug protocols open and closed, approved by the hospital IRB

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26
Q

A Discontinued Drug Order falls under the responsibility of the Director of Pharmacy and entails what?

A

Ensure that discontinued drugs, outdated drugs, and containers with worn, illegible or missing labels are returned for proper disposition

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27
Q

A Controlled Drug Accountability falls under the responsibility of the Director of Pharmacy and entails what?

A

Maintain records regarding use and accountability of controlled substances as directed by the OBNDD and DEA
-Includes inside and outside the pharmacy
-AKA admin of IV drug by nurse on the floor, there has to be a protocol on what happens to a medication if the entire dose was not given

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28
Q

A Drug Recall Procedure falls under the responsibility of the Director of Pharmacy and entails what?

A

Develop and implement a written recall procedure which assure that drugs involved, inside or OUTSIDE of the facility are returned to the pharmacy for proper disposal

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29
Q

ALL actions within a Drug Recall Procedure must what?

A

ALL actions are taken must be documented and MAINTAINED for 36 MONTHS for Board Review

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30
Q

An Automated Dispensing System falls under the responsibility of the Director of Pharmacy and entails what?

A

The director of pharmacy shall maintain CONTROL to insure that DIRECT pharmacist intervention and responsibility is present and consistent in any cycle of automated dispensing from acquisition of product

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31
Q

What are the RULES that apply to hospital pharmacies regarding prescriber Medication ORDERS?

A
  1. Drugs may be dispensed to specific patients ONLY upon the written or verbal prescription or medication order of an authorized physician
  2. Order for drugs for OUTPATIENT shall be considered PRESCRIPTIONS and must fulfill requirements of a prescription (discharge)
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32
Q

When can an OVERRIDE be given on a Medication Order within a hospital?

A

OR, where physician can administer a medication utilizing an override

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33
Q

For sterile compounded admixtures within a hospital, what are the labeling requirements?

A
  1. Name and amount of the drug added
  2. Date and time of such addition
  3. Expiration date and time
  4. Initial of persons: preparer and verifier that are responsible for the mixture
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34
Q

Administration of Drugs to Patients are generally in accordance with policies and procedures of the facility, however what are the requirements for SELF Administration?

A

Self-administration of drugs by patients shall be permitted only when specifically authorized by the prescribing physician, provided a pharmacist or physician has identified the drugs

35
Q

When obtaining medication from other sources outside the pharmacy, what must be done?

A

Arrangement shall be made to ensure the safety of the patients and property serves the need of the hospital and that it is properly labeled for recall purposes

36
Q

Medications from HOME within a hospital must be what?

A

Shall NOT be administered unless they can be precisely identified and the physician has specifically indicated on the patient CHART that the patient is to take their own medication

37
Q

The State Board allows for medications from home to be administered at a hospital if requirements are met but does that require the hospital HAVE to do it?

A

NO, the hospital can deny the use of home medications if stated in protocol

38
Q

The Director of Pharmacy is responsible for assuring safe use of drugs for good patient outcomes, therefore the Board recommends that they do what to ensure Performance Improvement?

A
  1. Serve as a voting member of the hospital wide performance improvement committee
  2. Assume a leadership role within the hospital across the continuum of care
  3. Work in collaboration with patients, prescribers, nurses, and providers in improving medication use
39
Q

What are the factors that play a role in Performance Improvement?

A
  1. Measurement: systemic process to collect data
  2. Assessment: identify ways to improve medication use
  3. Documentation: recorded and documented
40
Q

Monthly Inspections within a hospital pharmacy are conducted by the Director of Pharmacy or Designee, where the inspection shall include but not limited to:

A
  1. Drugs for Internal Use are stored separately from drugs and disinfectants for external use
  2. Drugs requiring special storage are properly stored
  3. No outdated drugs are stocked
  4. Distribution, Administration, and Waste of controlled substances are documented and reported
  5. Emergency Drugs are in proper supply
  6. ALL necessary and required security/storage standards are met
  7. Conversion tables are reasonably available
  8. Polices and Procedures are followed
41
Q

What is the minimum requirement for pharmacist oversight for a hospital pharmacy drug room?

A

At a minimum there shall be a consultant pharmacist on duty as required by the rules of the OK Department of Health
-Drugs in the drug room shall be administered only to patients in the facility hospital

42
Q

For a drug room manned by a PIC/consultant pharmacist, what are the requirements on pharmacist visits?

A
  1. Document a minimum of 52 routine in-house visits per year to be made to a hospital with a drug room
  2. No more than 2 visits in any 7-day period shall be counted towards this minimum
  3. Visits in any calendar month shall be no less than 2
43
Q

For the equipment and materials within a hospital drug room, a library shall be maintained as mentioned but what are the requirements for compounded sterile prep?

A
  1. Laminar hood if used must comply
  2. Laminar hood not used, then a closed system must be used for parenteral admixtures
44
Q

If there is a immediate need of a patient, and the drug is not present in the night cabinet and access to the drug room is needed in the absence of a pharmacist/PIC/supervisor what is allowed?

A
  1. ONLY ONE supervisory registered nurse in ANY given shift is responsible for removing drugs from the hospital drug room
  2. This nurse is designated in writing by committee
  3. The PIC must check record an removal of drug and
45
Q

If the registered nurse removed a drug from the drug room in the absence of PIC, the record of the removal must contain what?

A
  1. Patient Name
  2. Room Number
  3. Name of Drug
  4. Strength
  5. Amount
  6. Date
  7. Time
  8. Signature of Nurse
46
Q

PECs should be left on continuously, if it was turned off allow the blowers to run continuously how long prior to use?

A

30 minutes

47
Q

When should the ISO Class 5 be cleaned?

A
  1. At the beginning of each shift
  2. Before each batch
  3. No longer than 30 minutes during active compounding
  4. After spills
  5. Surface contamination is known or suspected
48
Q

When should counters and easily cleanable work surfaces be cleaned?

49
Q

When should floors be cleaned?

50
Q

When should walls, ceiling, storage shelving be cleaned?

51
Q

For drug compounding each preparation shall contain what?

A

NOT less than 90% and NOT more than 110% of the theoretically calculated and labeled quantity of active ingredient per unit weight or volume and per unit of the preparation

52
Q

Adequacy of drug compounding of mixing to assure uniformity and homogeneity is determined by what?

A
  1. Clarity
  2. Completeness
  3. pH of Solution
53
Q

BUD Chemical Stability is determined by what?

A
  1. Established by manufacturer
  2. Listed in current authoritative reference
  3. Established by direct testing following USP standards or equivalent
54
Q

BUD is determined by the combination of what?

A
  1. Chemical Stability
  2. Microbial Limits of Sterility USP 797
55
Q

BUD at Room Temp ISO 7 for Immediate Use

56
Q

BUD at Room Temp ISO 7 for Low Risk

57
Q

BUD at Room Temp ISO 7 for Low Risk w/less BUD

58
Q

BUD at Room Temp ISO 7 for Medium Risk

59
Q

BUD at Room Temp ISO 7 for High Risk

60
Q

Occupational exposure to hazardous drug can result in what?

A
  1. Acute effects (skin rash)
  2. Chronic effect (reproductive event)
  3. Possible cancer
61
Q

If you are packing, unpacking, preparing, handling a hazardous drug what must be worn?

A

Chemotherapy Gloves

62
Q

Hazardous Drugs contains at least 6 of the following criteria:

A
  1. Carcinogenicity
  2. Teratogenicity/Developmental Toxicity
  3. Reproductive Toxicity
  4. Organ Toxicity
  5. Genotoxicity
  6. A new or investigational drug
  7. Recognized by NIOSH
63
Q

Where should hazardous sterile drugs be prepared?

A

ISO Class 5 with protective engineering controls and the compounding area shall maintain negative pressure

64
Q

When is it ok to prepare a hazardous drug with the use of two tier containment instead of negative pressure?

A

Low volume facilities that prepare no more than 2 hazardous drugs per day

65
Q

What is the appropriate PPE when compounding hazardous drugs?

A
  1. Gowns
  2. Face Mask
  3. Eye Protection
  4. Hair Cover
  5. Shoe Cover
  6. Chemotherapy Gloves
66
Q

Training for hazardous compounding must be completed ANNUALLY and include:

A
  1. Safe aseptic manipulation practice
  2. Negative pressure techniques when utilizing BSC or powder containment hood of CACI
  3. Correct use of CSTD device
  4. Containment, cleanup, disposal
  5. Treatment of personnel contact/exposure
67
Q

Compounding Veterinary Sterile Preparations must consider what?

A
  1. Must comply with federal statues, rules, and FDA guidelines
  2. Copying commercial products not allowed in inordinate quantities
  3. Compounding with bulk chemicals for food producing animals is not permitted
  4. CANNOT exceed 120 hrs supply
  5. May NOT transfer compounded medications to any other party
68
Q

Automated Dispensing System

A

Means a mechanical system controlled by a computer that perform operations relative to the storage, packaging, compounding, labeling, dispensing, administration, or distribution of medications

69
Q

If you want to install or remove a automated dispensing system a written notice including what must be given to the Board?

A
  1. Name and address of pharmacy
  2. Name of PIC
  3. Name of the manufacturer and model of system
70
Q

A pharmacist must verify anything completed by an automated dispensing system and the verification requirements are what?

A
  1. Individual unit-dose, bar coded medications are employed by the automated system
  2. The process of filling/loading the system includes bar-code verification to prevent errors
  3. The process includes a pharmacist verification step either prior to or after loading the automated system
71
Q

Remote Order Processing: Remote Medication Order Processing RMOP

A

Means the processing of a medication order for a hospital facility by a pharmacist located in a remote medication order processing pharmacy

72
Q

When is a RMOP beneficial?

A

Hospital Rules ONLY
Advantageous for smaller pharmacy that has a full time pharmacist during the day but switch to RMOP in the evening

73
Q

Remote Medication Order Processing Pharmacy RMOPP

A

Means a pharmacy which does not stock, own, or dispense any prescription medications and whose sole business consists of entry and/or review and/or verification of physicians orders and consulting services under contract for hospitals licensed in Oklahoma or any other state

74
Q

What are the responsibilities of RMOP pharmacies and PIC?

A
  1. Confidentiality
  2. Record Keeping
75
Q

Sterile Compounded Preparations Pharmacy

A

Means a licensed RETAIL pharmacy with an additional specialized board approved sterile preparation permit to allow the compounding and dispensing of sterile preparations by an Oklahoma Licensed Pharmacist

76
Q

What are the requirements for a Sterile Compounding Preparation Permit?

A
  1. Valid retail license and the applicant must have a valid retail pharmacy license
  2. Equipment and supplies
  3. Pharmacy Manager will have sufficient knowledge and experience in the practice of sterile compounding preparation pharmacy
77
Q

A Sterile Compounding Preparation Pharmacy shall have in addition to the library material required for retail license ONE or MORE materials from the following list:

A
  1. Handbook of Injectable Drugs
  2. King’s Guide to Parenteral Admixtures
  3. MicroMedex
  4. Lexicomp
  5. Applicable USP Standards
78
Q

A pharmacy manager of a Sterile Compounding Preparation Pharmacy shall obtain the following prior to dispensing medications:

A
  1. Training
  2. Nurses
  3. 24 hour service
  4. Laboratory data
  5. Side effects and potential drug interactions
  6. Patient histories
79
Q

An Outsourcing Facility shall be licensed by the secretary of the DHHS/FDA and where can they be located?

A

May be located in a facility where a retail pharmacy licensed by the Board is located aka a retail dispensing in the same place as an outsourcing facility is allowed

80
Q

No pharmacist can serve as the PIC for more than one outsourcing facility and/or pharmacy at a time unless what?

A

They are located at the same physical address and are dually licensed with the Board

81
Q

Qualified Nuclear Pharmacist

A

Listed as an authorized user on a radioactive material users license or certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties

82
Q

What are the requirements of a Qualified Nuclear Pharmacist?

A
  1. Minimal standards of training for status as an ANP
  2. 200 contact hours
    from an accredited college of pharmacy
  3. 500 clinical/practical hours in a nuclear pharmacy
83
Q

A permit to operate a nuclear pharmacy shall only be issued to a person who is or employs a qualified nuclear pharmacist and it is only effective for what?

A

As long as the pharmacy also holds a current RAM license issued by the OK Department of Environment Quality Control

84
Q

Consultant Pharmacist, any practicing pharmacist may serve as one, but services can be provided to:

A
  1. Hospitals
  2. Hospices
  3. Home Care Agencies
  4. Long Term Care Facilities

Pharmacy Law (13 decks)

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