CPJE Uworld

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252 Terms

1
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Time limit requirement for Keeping Record:

Hospital pharmacy chart orders for controlled substances

7 years

2
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Time limit requirement for Keeping Record:

Patient acknowledgement of HIPAA

6 years

3
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Time limit requirement for Keeping Record:

Transaction information, history, and statement for most prescription drugs (required under Drug Supply Chain Security Act)

6 years

4
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Time limit requirement for Keeping Record:

Certificate of completion for Continuing Education

4 years

5
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Time limit requirement for Keeping Record:

Community or clinic pharmacy prescriptions

3 years

6
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Time limit requirement for Keeping Record:

Hospital pharmacy chart orders for non-controlled drugs

3 years

7
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Time limit requirement for Keeping Record: Controlled susbtance inventories

3 years

8
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Time limit requirement for Keeping Record:

DEA forms 222, CSOS records, power of attorney forms

3 years

9
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Time limit requirement for Keeping Record: Purchase invoices for all prescription drugs

3 years

10
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Time limit requirement for Keeping Record:: Self-assessment forms

3 years

11
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Time limit requirement for Keeping Record: Documentation of the return of drugs to wholesaler or manufacturer

3 years

12
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Time limit requirement for Keeping Record: Documentation of transfers or sales to other pharmacies, licensees, & prescribers

3 years

13
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Time limit requirement for Keeping Record:: Theft and loss reports of controlled substances (DEA forms 106)

3 years

14
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Time limit requirement for Keeping Record: Sale logs of pseudoephedrine and ephedrine

3 years

15
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Time limit requirement for Keeping Record: Patient medication profiles

1 year

16
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Time limit requirement for Keeping Record:: Medication error/quality assurance reports

1 year

17
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Reporting requirements: Change of pharmacist address/name/email

within 30 days

18
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Reporting requirements: Change of pharmacist-in-charge, owners, or corporate officers

within 30 days

19
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Reporting requirements: changes in pharmacy permit

within 30 days

20
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Reporting requirements: theft by a licensee or impairment of a licensee

within 14 days

21
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Reporting requirements: loss/theft of controlled drugs

Report to DEA immediately (one business day). Report to California Board of Pharmacy within 30 days.

22
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Reporting requirements: bankruptcy, insolvency, receivership

immediately

23
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Frequency of pharmacy operation: Completion of self-assessment form

Every odd-numbered year before July 1. Within 30 days when new pharmacy permit/change in PIC/change in pharmacy location.

24
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Frequency of pharmacy operation: Controlled substances inventory (all schedules)(federal requirement)

every 2 years

25
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Frequency of pharmacy operation: Pharmacist continuing education (30 hrs)

every 2 years except first cycle

26
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Frequency of pharmacy operation: Inventory of Alprazolam 1 and 2 mg, Tramadol 50 mg, Promethazine/Codeine 6.25 mg/10mg per 5 mL

every year

27
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Frequency of pharmacy operation: Schedule II controlled substances inventory (state requirement)

every 3 months

28
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Frequency of pharmacy operation: Medication error investigation

Within 2 days of error

29
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Frequency of pharmacy operation: Submitting dispensing data to CURES

within 1 business day of dispensing any schedule II - V drug

30
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To be a licensed as a pharmacist, a candidate must have completed how many hours of pharmacy practice experience?

1500 hours of pharmacy practice experience

31
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When must all licensees join the board's email notification list?

Within 60 days of becoming licensesd

32
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How many hours of continuing education do all registered pharmacists need? Frequency?

30 hours of CE during each two-year license period

33
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How many hours of continuing education do advanced practice pharmacists need? Frequency?

10 hours of CE per cycle in addition to the 30 hours per licensed period

34
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What activities are pharmacy clerks allowed to complete? What are they NOT allowed to complete?

Type a prescription label and enter prescription information into a computer. Request and receive refill authorizations. Put medications back on the shelf and give prescriptions to patients. They are NOT allowed to pull drugs from shelf or fill prescriptions.

35
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if pharmacist suspects another pharmacist is impaired at work, they must report to board within

Within 14 days

36
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Inventory records of schedule II drugs must be kept ____ from all other controlled substances. There [is/is not] a requirement to submit a copy of the inventory to the DEA?

Separate; NOT a requirement

37
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True/false: Inventory should be performed during business hours

FALSE

38
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What documentation is required for pharmacies to store records off-site? Where is this documentation kept?

Waiver granted by the board; kept in the pharmacy

39
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Prescription records are kept for total three years. Prescriptions for non-controlled substances must be kept at the pharmacy for at least ______ After that, the prescriptions can be stored offsite for another _____.

1 year, 2 years

2 multiple choice options

40
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Prescription records are kept for total three years. Prescriptions for _____ must be kept at the pharmacy for at least 2 years. After that, the prescriptions can be stored off-site for another year.

controlled substances

2 multiple choice options

41
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______ is needed to bill Medicare for Durable Medical Equipment

Detailed Written Order (DWO)

42
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True/false: Medicare does not accept PRN refills.

TRUE

43
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If deliveries are made to a hospital pharmacy to through a central receiving location, the drugs or devices must be delivered to the licensed pharmacy premises within _________ day following the delivery.

Within one working day

44
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Adulteration

Drug quality compromised

45
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Misbranding

Incorrect or missing information on the label

46
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How often are hospital drug supplies inspected by a pharmacist/intern/technician?

Every 30 days at least

47
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Which types of drugs are assigned a beyond-use-date?

Repackaged or Resold drugs

48
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Drug Recall

When a drug is removed from the market because it is defective or potentially harmful. Issued by FDA or the drug manufacturer.

49
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True/false: The FDA mandates that the pharmacy contact the patient on drug recalls.

False

50
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In a class I recall, the _________ is responsible for determining which patients received the drug & notifying each __________. The _______ must decide whether to inform the patient.

Pharmacist; patient's prescriber; prescriber

51
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Class I recall

There is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

52
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Class II recall

use or exposure will cause temporary/reversible adverse health consequences, or where proability of harm is remote (ie possibility of particles in vials)

53
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Class III recall

Use of or exposure is NOT likely to cause adverse health consequences

54
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When drug recalled is a compounded product, pharmacy or outsourcing facility must contact the recipient if?

- use of or exposure to compounded drug can cause serious adverse health effects or death

- recalled drug was dispensed or is intended for use in California

55
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How quickly must pharmacies notify recipient and board of pharmacy of issuing a recall?

12 hours

56
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For a recall on a compounded product from an outsourcing facility, recent must be notified within?

24 hours

57
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If pharmacy is made aware that patient has been harmed by a compounded product prepared by the pharmacy, the pharmacy must report event to what program? How quickly for non-sterile products? How quickly for sterile products?

FDA Medwatch program

Within 72 hours for non sterile products

Within 12 hours for sterile products prepared in a hospital

Immediately for sterile products prepared by all other pharmacies

58
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If an outsourcing facility is made aware that patient has been harmed by a compounded product prepared by the facility, the facility must report event to what program? How quickly?

FDA Medwatch program

Within 15 calendar days

59
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FDA's Flush List examples

Buprenorphine

Diazepam rectal gel

Fentanyl-containing products

Hydrocodone-containing products

Hydromorphone

Methadone

Methylphenidate transdermal system (Daytrana patch)

Morphine

Oxycodone-containing products

Oxymorphone

Tapentadol

60
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Each person licensed by the BOP are "mandated reporters" of child abuse, elder abuse, and neglect. A report should be made when there is a reason to believe that a child/elder is a victim of abuse or neglect. The mandated reporters must phone law enforcement or protective services as soon as they can and prepare & send a written report within _____ working days or _____hrs of receiving the information concerning the incident. Failure to do so is a misdemeanor, punishable by up to 6 months in county jail &/or fine of $1,000.

Within 2 working days; 36 hours of receiving information

61
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Dispensed drugs with an Estrogenic component must include?

Package insert with risks vs. benefits associated with use of such medications

62
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Definition: Poison Prevention Packaging Act of 1970

Place ORAL (only) prescriptions meds in child-resistant safety containers

63
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What are some exceptions to the Poison Prevention Packaging Act of 1970?

NTG SL tab

Colestipol powder

Erythromycin ethylsuccinate granules for oral suspension

Oral contraceptives

64
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Ordering of Schedule II controlled substance requires

DEA Form 222

65
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How long must paper or electronic controlled substance records for based on federal standards?

2 years

3 multiple choice options

66
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How long must paper or electronic controlled substance records for based on state standards?

3 years

3 multiple choice options

67
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____ hours of the total CE hours must be on Law and Ethics from a course provided by the Board of Pharmacy

2 hours on Law & Ethics

3 multiple choice options

68
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____ hours of the total CE hours must be on Cultural Competency & Humility from a course provided by the Board of Pharmacy

1 hour on cultural competency & humility

69
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How long must you retain CE ceriticates?

4 years

70
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What is REMS? Purpose?

REMS: Risk Evaluation & Mitigation Strategy

Restricted access to meds that have shown serious side effects, teratogenicity, or potential for abuse

71
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REMS: Bosentan (TRACLEER) for Pulmonary HTN

Safety concern?

Hepatotoxicity/Teratogenic effects

72
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REMS: Subutex & Suboxone

Safety concern?

Abuse potential

73
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REMS: Clozapine (CLOZARIL)

Safety concern?

Neutropenia & aplastic anemia

74
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REMS: Isotretinoin (ACCUTANE)

Safety concern?

Teratogenic effects

75
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REMS: Natalizumab (TYSABRI)

Safety concern?

PML

76
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REMS: Zyprexa Relprevv

Safety concern?

Post injection delirium/sedation

77
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REMS: Sodium Oxybate (XYREM)

Safety concern?

Overuse, abuse, addiction potential

78
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REMS: Thalidomide (THALOMID)

Safety concern?

Teratogenic effects

79
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REMS: Bosentan (TRACLEER)

Enrollment?

Prescriber & Patient

3 multiple choice options

80
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REMS: Subutex & Suboxone

Enrollment?

Prescriber Certification

3 multiple choice options

81
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REMS: Clozapine (CLOZARIL)

Enrollment?

Prescriber & Pharmacy

3 multiple choice options

82
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REMS: Isotretinoin (ACCUTANTE)

Enrollment?

Prescriber/Patient/Pharmacy

3 multiple choice options

83
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REMS: Natalizumab (TYSABRI)

Enrollment?

Prescriber/Patient/Pharmacy

84
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REMS: Zyprexa Relprevv

Enrollment?

Prescriber/Patient/Pharmacy

85
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REMS: Sodium Oxybate (XYREM)

Enrollment?

Prescriber & patient

86
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REMS: Thalidomide (THALOMID)

Enrollment?

Prescriber/Patient/Pharmacy

87
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REMS: Bosentan (TRACLEER)

Program requirements?

Monitoring of liver function

Monitoring of pregnancy every month

88
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REMS: Subutex & Suboxone

Program requirements?

Special DEA number used (opioid dependence)

89
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REMS: Clozapine (CLOZARIL)

Program requirements?

Clozaril National Registry

Check WBC every 2-4 weeks

90
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REMS: Isotretinoin (ACCUTANE)

Program requirements?

iPLEDGE (2 pregnancy tests + 2 birth control)

91
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REMS: Natalizumab (TYSABRI)

Program requirements?

Must complete pre-infusion patient checklist

92
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REMS: Zyprexa Relprevv

Program requirements?

Zyprexa Relprevv Patient Care Program

93
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REMS: Sodium Oxybate (XYREM)

Program requirements?

Distribution to patient monitored

94
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REMS: Thalidomide (THALOMID)

Program requirements?

S.T.E.P.S. Program (Rx has authorization number)

95
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Definition: Market withdrawal

The firm removes the product from the market and/or corrects a minor violation

96
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Definition: Medical device safety alert

Unreasonable risk of substantial harm

97
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What is the Board of Pharmacy?

Agency authorized to enact rules & regulations pertaining to the practice of pharmacy

98
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True/False: Pharmacy Board Inspector must be an RPh

False

2 multiple choice options

99
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Any person /entity served with a citation may appeal to the Board in writing within

30 days

100
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The board must be notified within _____ days for:

change of ownership, address or name/pharmacist-in-charge/pharmacy permit/theft/diversion/drug loss

30 days