State Law Exam 1

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Title 26, Chapter 3: Standards, Labeling, and Adulteration of Drugs and Cosmetics

Definitions

Prohibited Acts

  • Manufacturing or providing for sale or delivery any drug, device, cosmetic that is adulterated or misbranded
  • Committing an act that will result in adulteration or misbranding of any drug, device, or cosmetic
  • Disseminating false advertisement
  • Refusing to permit entry or inspection or taking a sample
  • Giving a guarantee or undertaking which is false
  • Removing or disposing of a detained or embargoed article
2

Title 26, Chapter 3: Standards, Labeling, and Adulteration of Drugs and Cosmetics

Inspection of factories, warehouses, establishments, or vehicles

  • Board of Pharmacy (BOP) or its agents have free access at all times to factories, warehouses, establishments, or vehicles for the purpose of conducting an inspection and securing samples, if applicable.
  • Is a misdemeanor for impeding, obstructing, hindering, or preventing an agent from performing his/her duty.
3

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 1: General Provisions

  • Practice of Pharmacy
  • Interpreting, evaluating, or dispensing of prescription drug orders in patient's best interest;
  • Participating in drug and device selection, drug administration, drug regimen reviews, and drug or drug related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmacy care;
  • Performing capillary blood tests and interpreting results as a means to screen for or monitor disease risk factors and facilitate patient education, and a pharmacist performs such functions shall report the results obtained from such blood tests to the patient's physician of choice;
  • Compounding and labeling of drug devices
4

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy (BOP)

  • BOP has duties, powers, and authority granted by or necessary for enforcement of Title 26, Chapter 4
  • BOP is under the jurisdiction of the Secretary of State and is a division of the Department of Community Health
5

The Georgia Board of Pharmacy is comprised of ___ pharmacist(s) and ____ consumer member (s)

7 pharmacists and 1 consumer member

6

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy

  • Eligibility requirements for BOP membrers

7 pharmacist members

  • GA resident for at least 6 months
  • Currently licensed to practice in GA and in good standing
  • Be actively engaged in the practice of pharmacy in GA
  • Have 5 years experience in GA after licensure
  • Not officially employed as FT faculty of a school/college of pharmacy

1 consumer member

  • Resident of GA of majority age
  • No connection to pharmaceutical industry
7

Who are the members selected by?

The Governor

8

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy

  • Power, duties, and authority for control and regulation of the practice of pharmacy in Georgia
  • License pharmacists (exam, transfer, renewal), pharmacy interns, and pharmacies
  • Regulate other employees in the Rx Department (technicians)
  • Determine and issue standards for recognition and approval of degree programs and enforcement of requirements of practical training
  • Enforce provision s related to conduct or competence of RPhs (license suspension, revocation, or restriction)
  • Right to seize drugs and devices fount to be an imminent danger to public health and welfare
  • Establish minimum specifications for physical facilities, technical equipment, environment, supplies, personnel, and procedures for storage, compounding, and dispensing
  • Regulate and establish minimum standards for the use and operation of remote automated systems (e.g. skilled nursing facilities and hospices)
  • Issue and renew licenses or permits for those engaged in the manufacture and distribution of drugs, devices, and DMA (e.g. manufacturers, wholesalers, reverse drug distributors)
  • Inspect licensed persons to determine if laws governing legal distribution of drugs/devices or the practice of pharmacy is being violated
  • Identify substances that could be potentially dangerous to public safety if dispensed without a prescription
  • Expunge pharmacy related practice records of any pharmacist whose records consists of EtOH impairment ONLY and hose record has been clean for 5 years
  • Restrict inspection or examination of records or access to any area licensed to BOP, GDNA, DEA, Department of Community Health or other federal agencies entitled to inspect by law, subpoena, or court order
  • Serve as the sole authority to approve or recognize accreditation or certification programs for specialty practice
  • Issue cease and desist order
  • Refer cases for criminal prosecution
9

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy

  • Notification to board of convictions
  • Licensee, registration holder or permit holder convicted of a felony must notify the board within 10 days of conviction
  • Failure to notify the board will be considered grounds for license revocation
10

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy

  • Georgia Drugs and Narcotics Agency (GDNA)
  • Agents are registered RPh's in GA
  • BOP appoints director
  • Director and/or agents have the power to:
    • Visit and inspect where drugs, devices, or cosmetics are manufactured, processed, packaged, and sold
    • Enter and inspect any vehicle used to transport or hold drugs, devices, or cosmetics
    • Investigate alleged violations of laws and regulations regarding drugs, devices, or cosmetics
    • Take samples
    • Seize and take possession of articles declared to be contraband
    • Compel witnesses to appear and produce evidence via subpoena
11

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 2: State Board of Pharmacy

  • Georgia Drugs and Narcotics Agency (GDNA)
  • Agents have the same authority and power of a sheriff to make arrests
    • Transfer person arrested to the county sheriff's custody where the alleged offense took place
  • Prepare "the Dangerous Drugs List" - list of prescription drugs that is approved by the State of Georgia each year
12

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Unlawful to practice pharmacy without license
  • Practitioners authorized to compound and dispense to patients in their respective profession are not required to be licensed by the BOP
  • Must meet the same standards, record-keeping requirements, and all other requirements for dispensing as pharmacists
13

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Qualifications for license
  • Submit an application to the board and pay a fee
  • Be of majority age and good moral character
  • Be a graduate of an approved school/college of pharmacy
  • Complete an internship or other program that meets the board's requirement for experiential education
  • Successfully pass required licensure exams
14

In order for a candidate to be licensed in the state of Georgia, what is the minimum score he/she is required to make on the NAPLEX examination?

75

15

In order for a candidate to be licensed in the state of Georgia, what is the minimum score he/she is required to make on the jurisprudence examination?

75

16

In order for a candidate to be licensed in the state of Georgia, what is the minimum score he/she is required to make on the Georgia Practical examination?

75

17

A score of less than ___ on any section of the Georgia Practical examination invalidates all the scores from that administration of the Georgia Practical examination.

70

18

AT is a graduate of an generally recognized school or college of pharmacy that is approved by ACPE. AT has applied for licensure in Georgia. AT took the NAPLEX, MPJE and Georgia Practical exams on the following dates and AT's exam results are listed below. Is AT eligible to take the Georgia Practical exam again?

NAPLEX: June 1 (failed); July 15 (passed)

MPJE: June 15 (failed); August 1(passed)

Georgia Practical: June 10 (failed); August 15 (failed)

Yes

19

Who may be granted a temporary pharmacist license? Select all that apply.

  • A pharmacy resident who has submitted evidence he/she has accepted a pharmacy resident position in the state.
  • A member of our military service or military spouse.
20

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Qualifications for examination
  • Licensing exams are available at least 2 times each year
    • BOP determines content and subject matter, place, time and date of exam
    • Exam measures competence of applicant to engage in practice of pharmacy
    • Anyone who takes the board and fails, may repeat the exam at regular intervals (it is administered 4 times a year: January, March, June, and August)
      • May not take exam more than 3 times without permission from BOP
      • Anyone who has taken and failed exam 3 times, may NOT practice as a pharmacy intern
      • Must successfully complete the exam and become licensed within 2 years of the exam date or the exam results are invalid
        • If you have not completed at least one of the exams by the 2 year deadline, all of your scores are deleted and you will have to take every exam again.
21

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • License transfers
  • RPh's are eligible to transfer licensure from another state to GA so long as the state that the license was issued in grants licensure transfers to GA RPh's
  • RPh's licensed in another state wanting to obtain licensure in GA must:
    • Apply for licensure in GA and pay a fee
    • Be of majority age and good moral character
    • Provide proof of initial licensure by exam and proof their licensure in good standing
    • Provide proof that license(s) in other state(s) has/have not been suspended, revoked, or restricted EXCEPT for non-renewal or failure to obtain required CE
    • At the time of initial licensure, have all the qualifications necessary to have been eligible for licensure in GA
    • Successfully pass required exams for licensure in GA
22

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • License transfers
  • RPh's who have graduated from a pharmacy school recognized by the Foreign Pharmacy Graduate Examination Committee of NABP must:
    • Successfully complete of all required exams
    • Be issued an equivalency certifcate by NABP
    • Undergo an individual evaluation by the BOP for proficiency in the English language
23

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Temporary licenses
  • May be issued by the BOP if an applicant produces satisfactory evidence of fulfilling the requirements for licensure except by examination and evidence of an emergency situation justifying a temporary license
    • Temporary (~90 days), may not be reissued or renewed
    • Pharmacy residents may be issued a temporary license
24

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Renewal of licenses
    • RPh's licenses must be renewed biennially (q2y)
    • Must pay fee and meet continuing education requirements
      • 30 hours of approved CE
    • Failure to renew license requires RPh to apply for reinstatement
  • Inactive license
    • RPh may apply to have their license listed as "inactive"
    • Inactive RPh are exempt from CE requirements
25

A pharmacist licensed before or during the first six (6) months of the biennium (January to June) is required to obtain 30 hours of CE. A pharmacist licensed during the following twelve (12) months (June to July) is required to obtain 15 hours of CE. A pharmacist licensed during the last six (6) months of the biennium is exempt from CE requirements for that biennium only.

A pharmacist's license is renewed every even numbered year. Assume you are licensed in June 2022. How many CE credits would you have to earn in order to renew you license by December 2022?

A pharmacist who is licensed in January 2021 - June 2021 is required to earn 30 hours of CE before renewing his/her license in December 2022.

A pharmacist who is licensed in July 2021 - June 2022 is required to earn 15 hours of CE before renewing his/her license in December 2022.

A pharmacist who is licensed in July 2022 - December 2022 is not required to earn any CE hours before renewing his/her license in December 2022.

26

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy: Pharmacy Interns

  • Required to submit an application and pay a fee
  • Be of majority age and good moral character
  • Be currently enrolled in a school/college of pharmacy
  • Be a graduate of an approved school/college obtaining practical experience required for licensure
  • Be an individual who completed all requirements of the Foreign Equivalency Certification Program
  • Expires 5 years after issuance, when an intern is expelled, suspended, dismissed or withdraws from pharmacy school, when an intern fails the board exam for the 3rd time
27

Which of the following is/are true regarding persons who may register as pharmacy interns?

Candidate who graduated from a school or college of pharmacy in another country and who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee certificate.

28

Which of the following is/are true regarding pharmacy intern licenses? Select all that apply.

  • Licenses may be renewed at the discretion of the Board.
  • Licenses become invalid when a candidate has taken and failed the Board examination for the third time.
  • Licenses become invalid when a candidate becomes a licensed pharmacist.
29

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Drug researcher permit
  • Anyone who is not a pharmacist, pharmacy, drug wholesaler, distributor, supplier, or practitioner may handle, possess, utilize controlled substances and/or dangerous drugs if they are conducting research, analysis, animal training, or drug education
  • Must register with the BOP for a drug researcher permit
  • May not engage in the sale, distribution, or dispensing of controlled substances or dangerous drugs
30

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Drug therapy modification certification
  • Drug therapy modification certification
    • No RPh is authorized to modify drug therapy unless:
      • They are a licensed RPh in GA
      • Have successfully completed a board approved course in drug therapy modification
      • Complete board approved CE on drug therapy modification annually
      • Age certified by the board in drug therapy modification
31

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 3: State Board of Pharmacy

  • Drug researcher permit
  • Anyone who supplies DME and submits a 3rd part claim for reimbursement must have a DME supplier license
  • Pharmacies, RPh's, hospitals, AmCare surgery centers, SNF's, and ALF's are exempt from DME supplier license requirement.
32

True or False:

Personnel engaged in the delivery of or in-home maintenance and repair of durable medical equipment (DME) are not required to provide counseling or instruction to a patient or patient's caregiver about the proper use of such equipment. The physician or the physician's agent is responsible for providing counseling or instruction on how to use and/or repair the equipment.

False

33

A durable medical equipment supplier must maintain records of all equipment and devices shipped, mailed, or delivered to patient in Georgia for a period of at least __ years.

2 years

34

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 4: Discipline

  • Grounds for suspension, revocation and refusal of license
  • Engaging in unprofessional, immoral, unethical, deceptive, or deleterious conduct or practice harmful to the public
  • Incapacitated and unable to engage in practice of pharmacy with reasonable skill, competence, and safety to the public
  • Convicted of a felony, any crime involving moral turpitude, or guilty of violations of pharmacy or drug laws
35

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 4: Discipline

  • Grounds for suspension, revocation and refusal of license
  • Failing to pay costs associated in a disciplinary hearing
  • Becoming unfit or incompetent to practice because of the use of the alcohol , narcotics, habit-forming drugs, or stimulants or any abnormal physical or mental condition
  • Deemed mentally incompetent by a court
  • Violating rules and regulations of the BOP
  • Regularly using the mail or other common carrier to sell, distribute, and deliver a Rx to a patient (exceptions to the rule do exist)
  • Dispensing different drug (or brand) from what was prescribed without prior authorization from the prescriber
36

Title 26, Chapter 4: Pharmacists and Pharmacies

Article 4: Discipline

  • Grounds for suspension, revocation and refusal of license
  • BOP may suspend or revoke the PIC's license when a complete and accurate record of all controlled substances on hand, received, manufactured, sold, and dispensed has not been kept or does not meet inventory requirements
  • BOP may suspend or revoke a RPh's license for failure to pay child support or for defaulting on a student loans
  • Anyone whose license has been suspended, revoked, or restricted may petition the board for reinstatement at regular intervals
37

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • License required for practice of pharmacy
    • Anyone engaged in the practice of pharmacy MUST be licensed
    • Prescriptions may be dispensed only pursuant to a valid prescription order
      • You have been requested to provide this medication or device to a patient by a licensed prescriber
    • RPh;s have the same CORRESPONDING LIABILITY for Rx's as the issuing prescriber
    • Valid Rx's include those by a physician, dentist, podiatrist, veterinarian, or other licensed person authorized by law to prescribe
    • Rx's may be accepted by a RPh or pharmacy intern/extern that is either written, oral, via electronic visual image (fax), or electronic data prescription drug order
38

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Dispensing prescription drugs
    • A hard copy Rx that has a visual image of the prescriber's electronic signature that is not faxed to the pharmacy, MUST be printed on security paper
    • Rx's transmitted electronically must be sent to the patient's pharmacy of choice with no intervening person having access to the prescription
39

Prescription drug orders transmitted or received by facsimile or other electronic means must include which of the following? Select all that apply.

  • Name, address and telephone number of the prescriber
  • Name and address of the patient
  • Time and date of transmission
  • Prescriber's NPI
40

Transmission of prescriptions to answering machines and electronic voice recording devices can be retrieved by whom? Select all that apply.

  • A licensed pharmacist
  • A pharmacy intern
  • A pharmacy extern
41

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Electronic Rx's transmitted by fax or computer must include:
    • Complete name and address of prescriber
    • DEA registration of prescriber, if Rx is for a controlled substance.
    • Prescriber's telephone number
    • Patient's name and address
    • Transmission time and date
    • Full name of person transmitting Rx
    • Practitioner's signature
  • RPh must exercise professional judgement regarding the accuracy and authenticity of any electronically transmitted, issued or produced Rx
42

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

Electronic Rx's transmitted by fax or computer

  • Name of the person transmitting the prescription drug order is not required for Rx's transmitted by fax or computer in the institutional setting
    • Ex: Hospital pharmacies, nursing home pharmacies, clinic pharmacies, or pharmacies owned or operated directly by HMO's
43

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Remote prescription order entry
    • Hospital pharmacies may use remote order entry for Rx drug orders when: RPh is not physically present in the hospital, the hospital pharmacy is closed, and a licensed RPh will be present in the hospital within 24 hours
    • At least 1 RPh is physically present in the hospital
    • At least 1 RPh is physically present in another hospital within GA which remotely serves...on weekends <4 hospitals under the same ownership and have average daily census of <12 acute patients
    • Applies to rural part of Georgia with very small hospitals or acute care hospitals
      • They must get approval from the BOP.
    • Before a hospital can engage in remote entry, the pharmacy director must submit written polices and procedures to the BOP for approval
44

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Patient profile
    • Information in the patient's medication record is confidential and can only be released to:
  • Patient
  • Patient's authorized representative
  • Prescriber
  • Other licensed practitioners caring for the patient
  • Another RPh
  • Board of Pharmacy, or
  • Any other person duly authorized to receive such information
45

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Prescription refills
  • Rx's may not be refilled without authorization from the prescriber
  • When refills are dispensed pursuant to authorization contained on the original Rx or when no refills are authorized on the original Rx but refills are subsequently authorized, the refill authorization must be recorded on the original Rx or some other uniformly maintained record (e.g. computer system)
  • Dispensing RPh must record refill date, quantity dispensed, and dispensing RPh's initials
46

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Prescription refills (26-4-80)
  • Original Rx's for Schedule III, IV, or V controlled substances which contain no refill information may not be authorized to be refilled more than 5 times or after 6 months from the date of issuance, whichever comes first.
  • Any authorization for additional refills for Schedule III, IV, or V controlled substances in excess of 5 refills or after 6 months from the date of issuance shall be treated as a new Rx
47

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Prescription refills (26-4-80)
  • When filling/refilling a Rx, the RPh must exercise professional judgement
    • No Rx shall be filled/refilled with greater frequency than the approximate interval of time than the dosage regimen would indicate unless there are extenuating circumstances
    • When a patient no longer seeks treatment from a practitioner, the patient-practitioner relationship is terminated
      • Rx's are invalid 6 months after the patient-practitioner relationship is terminated
        • Patient has 6 months to establish a new relationship and get a new Rx
48

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Prescription refills (26-4-80)
  • To prevent unintended interruptions in drug therapy for topical ophthalmic products
    • A RPh may permit refills without refill authorization or obtaining a new Rx, refills at 70% of the predicted days supply
    • At the patient's request, practitioner's may authorize refills earlier than 70% of the predicted days supply
49

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • When may an RPh dispense up to a 72-hour supply of a prescribed medication when he/she are unable to contact the prescriber to get a refill authorization?
  • Rx is not a controlled substance
  • In the RPh's professional judgement, interruption of therapy may produce undesirable health consequence s or physical/mental discomfort
  • RPh notifies the prescriber within 7 days of dispensing
  • RPh records the dispensing as a separate non-refillable Rx. Rx is filled with all other Rx's and has all required Rx information including the Rx number from which the Rx was dispensed
  • RPh records in the patient's record and on the new Rx the circumstance(s) which warranted dispensing
  • RPh does not employ this provision regularly for the same patient for the same medication
50

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Prescription refills (26-4-80)
  • All out-patient Rx's dispensed must be labeled appropriately
  • Pharmacy name and address
  • Prescriber's name
  • Directions for use
  • Initials or identifying code of dispensing RPh
  • Prescription number
  • Patient's name
  • Fill/refill date
  • Any other information necessary, or in the RPh's professional judgement, appropriate
51

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Schedule II Controlled Substance Prescriptions
  • Security paper requirements do not apply to:
    • Rx's transmitted by phone, fax, or other electronic means
    • Rx's for hospital inpatinets, nursing home residents, mental facility inpatients/resident, or prisoners
  • Person picking up the Rx must present a government-issued photo ID and the RPh must document the full name of the person taking possession of the Rx
52

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Drug substitution
  • RPh's may substitute:
    • A drug with the same generic name in the same strength, quantity, dose and dosage form as the prescribed name brand product so long as it is therapeutically and pharmaceutically equivalent
    • A biological with interchangeable biological product
  • If a prescriber writes for a generic product, the RPh must:
    • Dispense the lowest retail priced drug in stock which is equivalent
53

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Drug substitution
  • Whenever a substitution is made, the RPh must record it on the original Rx
  • The words "generic for..." or "interchangeable biological product for..." or other similar language must appear on the Rx label or an auxiliary label on the medication
    • Does not apply to medications dispensed to hospital in-patients or medications in specialty packaging
54

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Drug substitution
  • Patients may request the RPh not to substitute a generic product in lieu of the brand name
  • A prescriber may instruct the RPh not to substitute a generic in lieu of the brand name by writing "Brand Necessary" on the Rx
    • Must be in the prescriber's handwriting
    • Cannot be pre-printed or stamped on the Rx
  • When the Rx is electronic, "Brand Necessary" must be on the Rx in some way
  • Substitution can only occur with the prescriber's expressed consent if Brand Necessary has been conveyed
55

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Prescription Drugs

  • Biological Drug Substitution
  • Within 48 hours of dispensing an interchangeable biological, the RPh must communicate to the prescriber the specific product dispensed
  • Must include the name of the product and manufacturer
    • Do not have to communicate with the prescriber if it is a refill and the product dispensed is the same that was previously dispensed
56

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Duties requiring professional judgement

  • When dispensing, only a licensed RPh can perform duties or functions that require professional judgement
    • RPh's responsibility to ensure no other pharmacy employee performs or functions that require professional judgement
  • RPh's responsibility to ensure that only a RPh, intern/extern provides counseling to patients or with other licensed healthcare professionals
  • RPh's responsibility to ensure that only a RPh, intern/extern accepts telephone Rxs or provides information relative to a prescription or prescription drugs
57

Title 26, Chapter 4: Practice of Pharmacies

Article 5: Functions which require professional judgment

  • The following functions require professional judgment and may not be performed by a pharmacy technician:
    • Acceptance of initial oral prescriptions
    • Certification of a filled or finished prescription drug order
    • Weighing or measuring active ingredients without a mechanism of verification
    • Reconstitution of prefabricated medication without a mechanism of verification
    • Verification of the constituents of final IV admixtures for accuracy, efficacy, and patient utilization
    • Order entry on patient profiles without verification by a RPh
    • Provision of drug information that has not been prepared by or approved by the pharmacist
58

Title 26, Chapter 4: Practice of Pharmacy

Article 5: Responsibilities of the pharmacist

When dispensing a drug:

  • RPh must be present and personally supervising all technician activities
  • RPh is responsible for all activities involving preparation of a drug for delivery
  • When electronic systems are used, technicians may enter information into the system and prepare labels, BUT it is the RPh's responsibility to verify accuracy of information entered and label produced compared to the Rx
  • RPh is required to review all refills for appropriate information and determine whether to refill the Rx
  • Technicians in the dispensing are must be easily identifiable.
59

Title 26, Chapter 4: Practice of Pharmacy

Article 5: Responsibilities of the pharmacist

  • BOP regulates the RPh to tech ratio
  • RPh to tech ratio is 2:1
  • RPh tech ratio may be 3:1 so long at least one technician is certified.
    • Obtain certification by passing a BOP approved certificate program, employer's training and assessment program approved by the Board, or certification through PTCB or other nationally recognized body.
  • BOP may consider and approve applications to increase RPh to tech ratio in hospitals if a request is received in writing
  • In addition to technicians, RPh may be assisted by and directly supervise one pharmacy intern and one pharmacy extern
60

The pharmacist to registered technician ratio shall not exceed one pharmacist providing direct supervision of _____ registered pharmacy technicians at any given time.

The pharmacist to registered technician ratio shall not exceed one pharmacist providing direct supervision of _____ registered technicians if at least _____ technician is certified.

In addition to pharmacy technicians, a pharmacist may also be assisted by and directly supervise _____ pharmacy intern(s), _____ pharmacy extern(s), and _____ pharmacy observer(s) at any

The pharmacist to registered technician ratio shall not exceed one pharmacist providing direct supervision of 2 registered pharmacy technicians at any given time.

The pharmacist to registered technician ratio shall not exceed one pharmacist providing direct supervision of 3 registered technicians if at least 1 technician is certified.

In addition to pharmacy technicians, a pharmacist may also be assisted by and directly supervise 1 pharmacy intern(s), 1 pharmacy extern(s), and 1 pharmacy observer(s) at any

61

Title 26, Chapter 4: Practice of Pharmacy

  • Article 5: Patient record systems
  • Pharmacies must have a patient record system that allows for immediate retrieval of information to identify previously dispensed drugs at the time a Rx is presented for dispensing
  • Must make reasonable effort to obtain, record, and maintain:
    • Patient's full name
    • Patient's address and telephone number
    • Patient's date of birth
    • Patient's gender
    • Patient's known allergies, reactions, or idiosyncrasies
    • Patient's chronic disease sites
    • Any other drugs, including OTC's, the patient may take
62

How long must a pharmacist maintain patient records?

At least 2 years

63

What must be included in patient records?

  • List of all prescriptions dispensed
  • Rx number
  • Name
  • Strength of medication
  • Quantity and date dispensed
  • Name of dispensing RPh
64

True or False: RPh must review the patient record and each Rx presented for dispensing

True

65

What does the pharmacist look for when assessing patient records?

  • Overutilization or underutilization
  • Drug-disease contraindications
  • Incorrect dose, dosage form, or duration
  • Clinical abuse or misuse
  • Therapeutic duplication
  • Drug-drug interactions
  • Drug-allergy interactions
66

What happens when a pharmacist fails to review a patient record?

Disciplinary action (suspension, revocation, or restriction)

67

Who must personally offer patient counseling?

Pharmacist, intern, and extern

68

True or false: Patient counseling can occur in person AND by telephone.

True

69

What must patient counseling include?

  • Name and description of drug
  • Dosage form, dose, route, and duration
  • Intended use and expected action or result
  • Any special directions or precautions for preparation, administration or use by the patient
  • Common severe side effects or adverse effects
  • Techniques for self-monitoring
  • Proper storage
  • Refill information
  • Action to take in the event of a missed dose
  • Any other relevant information
70

Which of the following duties or functions may be performed by a registered pharmacy technician? Select all that apply.

Reconstitute a prefabricated medication so long as there is a mechanism for verification.

Weigh or measure active ingredients so long as there is a mechanism for verification.

Enter an order on patient medication profiles with verification by a pharmacist.

71

Who is patient counseling not for?

  • Hospital in-patients or other institutions where other HCPs are authorized to administer medications
  • Inmates/prisoners
  • Patients receiving medication from the DPH
  • Patients or caregivers who refuse consultation or counseling
72

Who establishes the rules that govern compounding and distribution to ensure compliance with USP-NF standards?

The BOP

73

What must all products compounded by a licensed outsourcing facility be compounded in accordance with?

Good Manufacturing Practices established by the FDA.

74

Title 26, Chapter 4: Practice of Pharmacy

Article 5: Compounding and drug distribution

Compounds for nonpatient-specific sterile products to be provided to practitioners for use in patient care or altering or repackaging drugs for practitioners to use in their office must be done by an outsourcing facility.

75

Title 26, Chapter 4: Practice of Pharmacy

Article 6: Pharmacy licenses

True or false: All facilities involved in the manufacture, production, sale, or distribution of drugs or devices used in pharmacy practice are required to be licensed by the BOP.

True

76

True or False: Each pharmacy must have a pharmacist-in-charge (PIC)

True

77

Glossary of Terms for Title 16: Chapter 13: Controlled Substances

  • Knowingly - having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object; or having reasonable grounds to believe that, to the average person, any such object is a drug related item
  • Controlled Substance - a drug, substance, or immediate precursor in Schedules I through V
  • Dangerous Drug - any drug, other than a controlled substance, which cannot be dispensed without a valid prescription order
    • Anything that is NOT in a controlled substance schedule.
  • Dispense - to deliver to the ultimate user by lawful order of a practitioner
78

Glossary of Terms for Title 16: Chapter 13: Controlled Substances

Dependent, dependency, physical dependency, psychological dependency, or psychic dependency

  • State of dependence by an individual upon a substance, arising from the use of that substance, that is characterized by behavioral and other responses that include the loss of self-control or a strong compulsion to use the substance on a continuous basis in order to experience some effect.
79

Glossary of Terms for Title 16: Chapter 13: Controlled Substances

  • A practitioner is defined as:
    • A physician, dentist, pharmacist, podiatrist, veterinarian, or other person licensed and registered who is authorized to distribute, dispense, or administer a controlled substance in the course of professional practice
    • A pharmacy, hospital, or other institution licensed and registered authorized to distribute, dispense, or administer a controlled substance in the course of professional practice
  • Advanced practice registered nurse (APRN) acting under his/her nurse protocol authorized and registered with the federal Drug Enforcement Administration and appropriate state authorities
  • A physician's assistant (PA) acting under his/her protocol authorized and registered with the federal Drug Enforcement Administration and appropriate state authorities
80

Glossary of Terms for Title 16: Chapter 13: Controlled Substances

  • Ultimate user or end user is the person who lawfully possesses a controlled substance or dangerous drug for his or her own use, for the use by a member of his or her household, or for administering to an animal owned by him or her or by a member of his or her household.
    • The end user can be anyone, not just the person who is actually taking the drug. This includes the caregiver.
81

Pursuant

"In accordance with the law (a law or legal document)"

82

When the BOP decides to add a substance to Article 2, they consider:

  • Actual or relative potential for abuse
  • Scientific evidence of a substances’ pharmacological effect, if known
  • State of current scientific knowledge regarding the substance
  • History and current pattern of abuse;
  • Scope, duration, and significance of abuse
  • Risk to the public health
  • Potential of the substance to produce psychic or physiological dependence liability
  • Whether the substance is an immediate precursor to a substance already controlled under Article 2
  • Designation, deletion, or rescheduling of a substance under federal law(s) that “control” controlled substances
83

Exempt Schedule V Sales

  • It is unlawful for one to obtain, sell, dispense or dispose of Schedule V non-pseudoephedrine (non-PSE) substances
84

Exempt Schedule V Sales

  • Exceptions to this rule include:
  • A physician may dispense Schedule V substances for legitimate medical purposes in the normal course of professional practice
  • A licensed pharmacist may sell/dispense an exempt non-PSE Schedule V substance without a prescription
85

What is the most that a pharmacist may dispense of a non-pseudoephdrine substance to an individual?

  • A pharmacist may not dispense more than 4oz or 32 dosage units of any exempt non-PSE substance to an individual within a 48-hour period
    • The pharmacist must apply reasonable means and effort to determine that the purchase is being used for a legitimate medical purpose
86

Where must the sale of ALL non-PSE Schedule V substances be recorded?

  • All sales of non-PSE Schedule V substances must be recorded in the pharmacy’s Exempt Narcotic Sales log
87

What must be contained within the Exempt Narcotic Sales Log Records?

  • Name, address, city, state and zip code of the purchaser
  • Date of transaction
  • Name, kind, quantity and intended use of Schedule V substance to be purchased
  • Signature of the purchaser and dispensing pharmacist
88

When is it appropriate NOT to sell a Non-PSE Schedule V substance without a prescription?

  • The product's manufacturer packaging is greater than 4 oz or contains more than 32 dosage units
    • You cannot "break" a larger package size
  • If the label contains a Federal Caution or Warning Statement
    • If the package contains any Legend, Warning, or Rx only indication, then a prescription is required
89

Ephedrine & Pseudoephedrine

  • It is unlawful to possess >300 dosage units or 9gm, of ephedrine or pseudoephedrine (PSE) whichever is smaller
  • It is unlawful to possess any amount of ephedrine or PSE with the intent of manufacturing amphetamine/methamphetamine (meth)
  • Sales of products containing ephedrine and PSE are restricted by law
90

Where must all PSE containing products be stored?

"Behind" the pharmacy's prescription department counter

91

What must ALL personnel who sell PSE-containing products complete as required by the Combat Methamphetamine Epidemic Act of 2005?

DEA's self-certification training

92

What must products, where the sole ingredient is PSE, be in?

blister packaging

93

What are the restrictions placed on a pharmacist when selling or dispensing ephedrine & PSE products without a prescription?

  • A pharmacist may sell or dispense to an individual, without a prescription, up to 3.6g every 24 hours, or a maximum of 9g every 30 days, of a PSE-containing product if:
    • After applying reasonable means it is determined that the purchased product will be used for legitimate medical purposes
    • Proper record keeping procedures (written or electronic) are followed
94

What must be produced by a purchaser of PSE-containing products?

A valid government-issued photo ID to use in verifying the patient's name on the photo-ID matches the name in the logbook.

95

It is against the law (unlawful) to sell how many packages of any PSE-containing product?

Greater than (>) 3 packages of ANY PSE containing product

96

Real-Time Electronic Logging System

  • Pharmacies shall, BEFORE completing a sale of a nonprescription product which contains ephedrine or pseudoephedrine, electronically track all such sales and submit the required information to a real-time electronic logging system.
  • A pharmacy shall not complete the sale of a nonprescription product which contains ephedrine or pseudoephedrine if the real-time electronic logging system generates a stop sale alert
97

What are pharmacies able to do in the event that there is a mechanical or electronic failure of the real-time electronic logging system?

The pharmacy shall maintain a written log or an alternative electronic recording mechanism UNTIL the pharmacy is able to comply with the electronic logging requirement

98

What must all controlled substance prescriptions include?

  • Name and address of the person for whom it is prescribed
  • Drug name, strength and quantity to be dispensed
  • Directions for use
  • Signature, name, address, telephone number, and DEA number of the prescribing practitioner
  • Number of refills authorized, if applicable (not allowed for Schedule II drugs)
  • Date prescription was written
99

What MUST a pharmacist do when receiving a Schedule III, IV, and V verbal prescription order?

Reduced it in writing upon receipt

100

True or False: Prescription orders for Schedule III, IV, and V drugs may be written, electronic, transmitted via facsimile (faxed), or provided verbally to the pharmacist.

True

101

True or False: Schedule III, IV, or V prescription orders MAY be filled or refilled more than 6 months from the date written or refilled more than 5 times, whichever comes first.

False

  • There can be a total of 6 fills (5 refills + 1 fill of the original prescription)
  • There may only be refilled or filled within a 6 month period and refilled 5 times.
102

What must Schedule II Prescriptions be written on in the state of Georgia?

tamper proof paper

103

When can a faxed C-II prescription serve as the original hard-copy?

When a prescription drug order is for terminally ill patients in hospice care or for patients residing in a long-term care facility.

  • The prescription must meet all requirements
    • There must be two-step verification
    • Registration process
    • Systems must meet all standards
104

What are the guidelines for a pharmacist dispensing an emergency C-II prescription orally?

  • A situation in which the prescribing practitioner determines that:
    • Immediate administration of a Schedule II drug is necessary
    • There is no appropriate alternative treatment
    • It is not reasonably possible for the practitioner to provide a written drug order prior to dispensing
105

What must a pharmacist do when receiving an emergency C-II drug order?

Reduce it in writing immediately

106

True or False: The quantity dispensed for an emergency C-II prescription is NOT limited to the emergency period.

False

  • The quantity prescribed and dispensed must be limited to the "emergency period"
107

What must the prescriber do within 7 days of oral authorization of a C-II prescription?

He/she must produce a written prescription and deliver it to the pharmacy for the emergency quantity prescribed

108

What must a written prescription for an emergency authorization have written on it?

"Authorization for Emergency Dispensing" written across its face and the date of the oral order

109

Who must be notified if the prescriber fails to produce a written prescription within 7 days?

GDNA (Georgia Drugs and Narcotics)

110

GDNA Agents are allowed to:

  • Carry firearms while performing official duties
  • Execute/serve search warrants arrest warrants, administrative inspect on warrants, subpoenas, and summons issued by the state
  • Make arrests without warrant for any offense under Article 2 of Title 15 committed in their presence, or if there is probable cause to believe that the person has committed or is committing a violation which may constitute a felony
  • Make seizures of property, pursuant to Article 2, Chapter 13, Title 16
  • Perform other law enforcement duties as the State Board of Pharmacy or the director of the Georgia Drugs and Narcotics Agency designates
111

A warrant must be executed and returned within ___ days of issuance

10

112

Administrative Inspections and Warrants

  • If probable cause exists, an administrative warrant may be issued by a judge authorizing the inspection and seizure of property
113

What must the warrant identify?

The area, premises, building, registrant (pharmacy or pharmacist) or conveyance, to be inspected, the purpose of the inspection, and if appropriate, the type of property to be inspected and/or seized, and designate the judicial officer to whom it shall be returned to

114

When authorized by an inspection warrant, GDNA agents may:

  • Inspect and copy records required by law to be kept
  • Inspect all pertinent equipment, materials, containers and label
  • Inventory controlled substance stock
115

What may GDNA agents inspect without a warrant?

  • Any books and records if the owner, operator or person in charge consents
  • Any situation that present imminent danger to health or safety
  • In an exceptional or emergency situation where time or opportunity to apply for a warrant is lacking
  • All other situations in which warrant is not constitutionally required
116

Programs and Research on Controlled Substance Abuse and Prevention

  • The BOP and GDNA have programs designed to prevent and deter the misuse and abuse of controlled substances
  • The BOP and GDNA actively encourages research on the misuse and use of controlled substances
  • Methadone treatment programs, narcotic treatment programs and opioid treatment programs are available
117

What are the 3 programs available from the BOP and GDNA that prevent or deter misuse and abuse of controlled substances?

Methadone, narcotic, and opioid

118

What is OTP?

OTP (opioid treatment programs) is an opioid replacement program or narcotic treatment program licensed and/or authorized by the State of GA Department of Human Resources, the Substance Abuse and Mental Health Services Administration and the DEA (Drug Enforcement Administration)

119

What are the actions of OTP (opioid treatment programs)?

Use narcotic replacement procedures for individuals dependent on opium, morphine, heroin or nay derivative or similar synthetic drug

120

What must ALL OTP clinics have?

  • An on-site pharmacy licensed with the BOP
  • Must have sufficient floor space to ensure that drugs are prepared in sanitary, well-lit, and enclosed space
    • Space must be at least 150 square feet
  • Other physical requirements are similar to retail pharmacy requirements
    • EXCEPT OTP must have an adequate supply of drugs used in OTP clinic setting rather than rather than commonly used drugs
121

How much space must an OTP clinic have?

At least 150 square feet

122

What is the purpose of PDMP? (Georgia Prescription Drug Monitoring Program)

  • Reducing the abuse of controlled substances
  • Encouraging a better quality of healthcare by promoting the proper use of medication to treat pain and terminal illness
  • Reducing duplicative prescribing and overprescribing of controlled substances
123

When were all prescribers with DEA numbers required to be registered with PDMP?

January 1, 2018

124

When must those prescribers who received a DEA number after January 1, 2018 be registered with the PDMP?

30 days from the date they receive their DEA number

125

When shall a prescriber who is prescribing a controlled substance review PDMP? (On and after July 1, 2018)

The first time he/she prescribes a controlled substance and at least once every 90 days thereafter

126

When is a prescriber not required to check PDMP?

  • Rx is for no more than a 3 days supply and no more than 26 pills
  • Patient is in a hospital or healthcare facility
  • Patient had outpatient surgery and Rx is for 10 days supply or less and for no more than 40 pills
  • Patient is terminally ill or being supervised by Hospice
  • Patient is receiving treatment for cancer
127

True or False: Dispensers ARE required to obtain information about a patient from PDMP.

False

  • Dispensers are encouraged to obtain such information while keeping in mind that the purpose of such data base includes reducing duplicative prescribing and overprescribing of controlled substances
    • We have all liability removed from us as dispensers if we do not check for the person on PDMP
128

True or False: Dispensers do NOT have a duty and shall not be held civilly liable for NOT seeking or obtaining information from PDMP

True

  • Dispensers shall not have a duty and shall not be held civilly liable for damages to any person in any civil or administrative action or criminally responsible for injury, death, or loss to person or property on the basis that the dispenser did or did not seek or obtain information from the PDMP
129

What is the definition of a dangerous drug?

  • Any drug other than a drug listed in any schedule of Article 2, which under the Federal Food, Drug and Cosmetic Act requires a prescription
  • Any other drug or substance declared so by the GA General Assembly to be a dangerous drug
130

True or False: BOP may delete drugs from the dangerous drugs list

True

131

What does the BOP consider before deleting a drug from the dangerous drugs list?

  • Actual or relative potential for abuse
  • Scientific evidence of pharmacological effect
  • State of current scientific knowledge about the drug
  • History and current pattern of abuse, if any
  • Scope, duration and significance of abuse
  • Potential to produce psychic or physiological dependency
  • Whether the drug is listed under the Food Drug and Cosmetic Act
132

What must be contained on written prescription drug orders for dangerous drugs?

  • Date of issuance
  • Name and address of the patient
  • Name, strength and quantity of drug to be dispensed
  • Directions for use
  • Number of refills permitted
  • Printed name, address, and telephone of the prescriber
  • Prescriber's signature
133

What be information must be placed on the container (label) for a dangerous drug?

  • Patient's name
  • Name of physician prescribing the drug
  • Expiration date, if applicable
  • Name and address of the dispensing pharmacy
  • Date prescription was dispensed
134

Who may sell or exchange dangerous drugs?

  • By a drug manufacturer, wholesaler, distributor or supplier who holds a license/registration issued in accordance with the Federal Food, Drug and Cosmetic Act and has a permit issued by the BOP
  • By a pharmacy, but drugs can only be distributed by a licensed pharmacist
  • By a practitioner of the healing arts (prescribers or persons who can write prescriptions
  • By a manufacturer's sales representative when a written request is made by a practitioner for a complimentary sample
135

How long must records be kept for all dangerous drugs received, purchased, manufactured, sold or dispensed?

At least two years

136

True or False: It is unlawful to sell, give away, barter, exchange, distribute or possess any dangerous drugs unless authorized to do so.

True

137

True or False: All controlled substances and/or dangerous drugs must be kept in the original container in which they were dispensed in by the pharmacist or practitioner of the healing arts

True

138

Fraud, Forgery or Concealment

  • No one should obtain, attempt to obtain, or have administered any dangerous drug by means of:
    • Fraud, deceit, or misrepresentation
    • Forgery or alteration of any prescription
    • Concealment of material fact
    • Use of a false name or giving a false address
139

Who may prescribe or order the use of a dangerous drug?

A registered prescriber

140

What are the requirements for a registered prescriber who is prescribing or ordering a dangerous drug?

  • Licensed and/or authorized by the state to prescribe dangerous drugs
  • Acting in the usual course of professional practice
  • Prescribing or ordering a dangerous drug for a legitimate medical purpose
141

When must an individual notify the appropriate licensing authority who is convicted of a criminal offense (manufacture, distribution, sale or possession of a controlled substance or marijuana)?

Within 10 days of the conviction

142

What will the licensing authority do in response?

  • Upon notification, the licensing authority will suspend or revoke the license, permit, registration or certification as follows:
    • 1st conviction: license is suspended for a period of not less than 3 months. If the conviction is for a misdemeanor, the licensing authority may impose a lesser sanction or no sanction at all
    • 2nd conviction or subsequent conviction - license is revoked
143

What happens if an individual fails to notify the licensing authority of a conviction?

  • This is considered grounds for revocation of the license, permit, registration, or certification
144

How may a licensed individual go about becoming reinstated?

  • A licensed individual may be entitled to reinstatement of his/her license upon completion of an approved drug abuse treatment and education program
145

True or false: Suspension and revocation are intended to be the minimum sanctions employed

True

146

Who is allowed to remove dangerous drugs from Article 3?

Georgia General Assembly

147

Who oversees Article 3?

Georgia General Assembly

148

What MAY the Georgia Board of Pharmacy do between Article 2 and Article 3?

They may transfer a drug on Article 3 (Dangerous Drugs List) and put it on Article 2 (Controlled-Substances List)

149

Article 2 is overseen ONLY by whom?

The Georgia Board of Pharmacy

150

What does "exempt" mean for a non-PSE containing Schedule V substance? (For example: Cheratussin AC)

It means that it this drug may be sold without a prescription.

  • Professional judgement must used to determine that a legitimate medical purpose exists, the total sale volume must not exceed 4 oz, and the sale is record in the pharmacy's Exempt Narcotics Sale Log
151

AJ is a longstanding patient at your pharmacy and has been taking metformin 500mg, bid, for the last 15 years. He comes into the pharmacy asking for a refill on his metformin. Upon review of his profile, you notice that he does not have a refill remaining on his prescription and his doctor's office is already closed for the weekend. What are you legally allowed to do help AJ?

  • It must be a new, non-refillable prescription for a 72-hour supply of metformin
  • It must be reduced to writing
  • The hardcopy references the prescription number of the original prescription that no longer has refills
152

VM enters your pharmacy to have a prescription filled for a 30-day supply of alprazolam 1 mg (a schedule III-controlled substance) for her panic attacks written by Dr. Jones today. The prescription has 3 additional refills. Describe the legal requirements pertaining to use of prescritpion drug monitoring program (PDMP)

The physician must check PDMP prior to filling the prescription today and again in 90 days prior to dispensing the third refill to VM.

  • The physician must check PDMP the first time they fill a controlled substance (before they prescribe it) for a patient and subsequently every 90 days after.
  • Pharmacists do not have to check PDMP but they are encouraged to check PDMP and will not be held responsible for not checking PDMP or for checking PDMP.