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Spring 2022: Pharmacy Law > Reading 17/18 > Flashcards

Reading 17/18 Flashcards

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1
Q

If we aren’t communicating __________, we technically aren’t meeting the definition of counseling

A

effectively

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2
Q

What duties are included in “the practice of pharmacy”?

A
  1. The offering of or performing of those acts, service operations, or transactions incidental to the interpretation, evaluation, and implementation of prescriptions or drug orders.
  2. The compounding, labeling, administering, dispensing, or selling of drugs and devices, including radioactive substances, whether dispensed under a practitioner’s prescription or drug order or sold or given directly to the ultimate consumer.
  3. The proper and safe storage and distribution of drugs and devices.
  4. The maintenance of proper records of the receipt, storage, sale, and dispensing of drugs and devices.
  5. Counseling, advising, and educating patients, patients’ caregivers, and health care providers and professionals, as necessary, as to the contents, therapeutic values, uses, significant problems, risks, and appropriate manner of use of drugs and devices.
  6. Assessing, recording, and reporting events related to the use of drugs or devices.
  7. Provision of the professional acts, professional decisions, and professional services necessary to maintain all areas of a patient’s pharmacy related care as specifically authorized to a pharmacist under this article.
  8. Provision of medication therapy management.
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3
Q

What is the Indiana Board of Pharmacy makeup?

A

6 pharmacists (1 must be a hospital pharmacist) and 1 non-pharmacist

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4
Q

What is the term duration for Board of Pharmacy members?

A

4 years (can serve multiple terms)

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5
Q

By law, the Indiana Board of Pharmacy must meet at least __ times per year.

A

8

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6
Q

The law allows for Indiana Board of Pharmacy meetings to continue for no more than ___ days in a row.

A

5

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7
Q

When do Board of Pharmacy members elect a president and vice president?

A

during the first meeting of every year

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8
Q

What is the Board of Pharmacy quorum?

A

4 members

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9
Q

What MUST the Board of Pharmacy do?

A
  • establish pharmacy practice standards
  • establish pharmacy counseling standards
  • establish procedures for returning expired drugs
  • adopt rules and procedures regarding the electronic transmission of prescriptions
  • adopt rules/emergency rules concerning the OTC sale of ephedrine or pseudoephedrine products
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10
Q

What agency does the Board of Pharmacy work with to help impaired pharmacists?

A

Indiana Professionals Recovery Program (IPRP)

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11
Q

IPRP is confidential, except in what circumstance?

A

if the pharmacist is non-compliant with the rehabilitation program; IPRP must immediately report to the board and give the name of any impaired pharmacist it believes may be an imminent danger to the public or themselves and must report any impaired pharmacists who refuse to cooperate with the program, refuse to submit to treatment, or whose impairment is not substantially alleviated through treatment.

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12
Q

What must pharmacy interns prove for licensure?

A

that they are either actively enrolled in an ACPE-accredited pharmacy program, have obtained the Foreign Pharmacy Graduate Examination Committee (FPGEC) certificate, or are qualified applicants awaiting examination for pharmacist licensure

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13
Q

How long are intern registrations valid for?

A

1 year (and may be renewed)

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14
Q

Can pharmacists review pharmacy intern work remotely?

A

no; must be done in-person

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15
Q

What are the 3 things you must show to the board to be eligible for pharmacist licensure?

A
  1. that you are at least 18
  2. that you don’t have a conviction for a crime that would have direct bearing on your ability to competently practice
  3. that you have graduated from an ACPE-accredited college of pharmacy, a Canadian Council on Pharmacy Accreditation (CCPA) program approved by the board and obtained the FPGEC Certificate, or you have graduated with a degree from outside of the US or Canada, provided the board with verification of your academic record and graduation, and obtained the FPGEC Certificate
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16
Q

How do you get licensed as a pharmacist in Indiana if you already hold licensure if another state?

A
  1. register and be approved by the NABP
  2. have graduated from an ACPE accredited college of pharmacy, a Canadian Council on Pharmacy Accreditation (CCPA) program approved by the board and obtained the FPGEC Certificate, or have graduated with a degree from outside of the US or Canada, provided the board with verification of your academic record and graduation, and obtained the FPGEC Certificate
  3. successfully complete an examination administered by the board concerning federal statutes and regulations and the Indiana statutes and rules governing pharmacy practice
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17
Q

In Indiana, pharmacists can be classified as __________ or __________.

A

active; inactive

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18
Q

Inactive pharmacists can maintain their license by paying fees, but don’t need to meet the _______ requirements of licensure.

A

continuing education (CE)

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19
Q

Pharmacists’ licenses expire biennially on _______ of even-numbered years (meaning that they are valid for two years).

A

June 30

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20
Q

If we fail to renew our license before the renewal date, our license becomes ___________.

A

invalid (NOT inactive)

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21
Q

Which takes more work to reinstate: an invalid or inactive license?

A

invalid (because it’s expired)

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22
Q

How do you reinstate a pharmacist’s license that has been expire for less than 3 years?

A
  1. submit renewal application
  2. pay renewal fee to the board
  3. pay reinstatement fee to IPLA
  4. submit a signed statement that they have met all continuing education requirements unless they’ve received a hardship waiver
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23
Q

How do you reinstate a pharmacist’s license that has been expired for more than 3 years?

A
  1. submit renewal application
  2. pay renewal fee to the board
  3. pay a reinstatement fee to IPLA
  4. submit a signed statement that they have met all continuing education requirements unless they’ve received a hardship waiver
  5. complete any remediation/additional training necessary
  6. complete anything else provided in the law or rules not related to fees
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24
Q

Pharmacy permits expire every ____ years.

A

2

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25
Q

When are pharmacists allowed to break HIPAA and share patient information?

A
  • when it’s in the best interest of the patient
  • when it’s requested by the board, its representatives, or a law enforcement officer charged with enforcing laws about drugs, devices, or the practice of pharmacy
  • when it’s in connection with a criminal prosecution or proceeding or in connection with a proceeding in front of the board, to which the person to whom the information related is a party
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26
Q

What is the only situation in which technicians are allowed to release HIPAA information?

A

when connected with a criminal prosecution or proceeding, and the person to whom the information relates is a party

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27
Q

When are pharmacists allowed to refuse to fill a prescription?

A
  • if we believe it would be contrary to law
  • if we believe it would be against the patient’s best interest
  • if it would aid/abet an addiction/habit
  • if it would be contrary to the patient’s health and safety
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28
Q

How many classes of pharmacy permits are there?

A

3 (named category I, II, and III)

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29
Q

What pharmacies fall into Category I?

A

pharmacies that dispense drugs to the public (retail, and can serve LTC facilities, health facilities, or other housing locations)

30
Q

What pharmacies fall into Category II?

A

institutional pharmacies like hospitals, clinics, health care facilities, sanitariums, nursing homes, or dispensaries that dispense drugs to inpatients under drug orders or to an outpatient of the institution under a prescription

31
Q

True or false: Category II pharmacies are allowed to operate remote locations without filing an additional application.

A

false; pharmacies with this class of permit are allowed to operate remote locations after filing an application with the board, having each remote location inspected by the board, and obtaining approval from the board

32
Q

What pharmacies fall into Category III?

A

provide closed-door, central fill, mail order, or other processing functions that are not open to the public. They may perform traditional or nontraditional pharmacy functions like nuclear, infusion, or sterile compounding. One of the most important things to remember is these pharmacies are not open to the public.

33
Q

“New” Category II is equivalent to which “old” category or categories?

A

II

34
Q

“New” Category III is equivalent to which “old” category or categories?

A

III-VI

35
Q

True or false: one pharmacy can use the same qualifying pharmacist for multiple sites.

A

false; each site needs a different qualifying pharmacist

36
Q

Once an application for a pharmacy permit is submitted, the board has ____ days to grant an application.

A

120

37
Q

What is the one circumstance in which a pharmacy can use the same qualifying pharmacist for multiple sites?

A

when a Category II pharmacy can’t find a qualifying pharmacist, the board may allow a pharmacist to qualify for two category II pharmacies if the permit holder shows they have made a reasonable effort, without success, to obtain a qualifying pharmacist who isn’t already a qualifying pharmacist and if they show that pharmacist can effectively fulfill the duties of the qualifying pharmacist at both locations

38
Q

Along with qualifying pharmacist information, what other information must be submitted to the board for pharmacy permit approval?

A
  1. individuals at the location will actually be practicing pharmacy, and the number of hours each week the pharmacy is open to the public
  2. a sufficient stock of emergency and frequently prescribed drugs will be at the location
  3. a RPh will be in personal attendance and on duty when pharmacy is being practiced at the location, and that pharmacist will be responsible for the lawful conduct of the pharmacy
  4. the pharmacy will be separate from areas containing merchandise not offered for sale under the permit (meaning OTC and non-drug items)
    1. must be stationary
    2. must have security in either electronic, physical, or combination of forms that can detect and deter entry when the pharmacy is closed
    3. must be well-lit and -ventilated with clean and sanitary surroundings
    4. must have a sink with hot and cold water
    5. must have proper sewage outlet
    6. must have refrigeration
    7. must have a prescription filling area large enough to permit the practice of pharmacy practiced at that location
    8. must have additional fixtures/facilities/equipment required by the board
39
Q

At this time, a pharmacist can supervise, within reasonable visual and vocal distance, up to ____ pharmacy technicians, technicians-in-training, or interns at any one time.

A

8 (and only up to 3 of those 8 can be techs-in-training)

40
Q

Although a pharmacy must be closed if a pharmacist is not present, how can a pharmacy gain approval from the board to stay open?

A
  1. All legend drugs and other merchandise that can only be dispensed by a pharmacist are securely locked or secured by an alternative system approved by the board when the pharmacist is absent.
  2. There is a sign at least 20 x 30 inches prominently displayed in the prescription department stating – “Prescription Department Closed, No Pharmacist on Duty.”
  3. Only a pharmacist has access to the secured area
41
Q

The law says (IC 25-26-13-21) that an application to transfer ownership must be submitted no later than ___ days after the change of ownership.

A

10

42
Q

____ days after the board makes its decision regarding a pharmacy permit after ownership change, the old permit expires and must be returned to the board by the new owner.

A

10

43
Q

What document must be sent with an application of pharmacy permit after ownership change?

A

a signed and dated certificate of sale

44
Q

True or false: if a permit owner wants to move their pharmacy to a new location, they don’t need to get a new permit.

A

false; the permit is non-transferable and they must apply for a new one

45
Q

If a pharmacy is closed for ___ consecutive days or more, the permit holder must notify the board, secure the drug stock, and take any steps the board indicates to ensure the drugs are secure.

A

5

46
Q

What must the pharmacy owner/qualifying pharmacist do in the event of a permanent pharmacy closure?

A
  1. Notify the board at least 20 days before the transfer of controlled substances and submit a copy of the inventory form required by the DEA with the name, address, and DEA registration number of the person the drugs will be transferred to.
  2. Remove all legend drugs from stock either by returning them to the wholesaler or manufacturer, transferring them to another pharmacy, or destroying them in the presence of a representative appointed by the board.
  3. Dispose of all controlled drugs and legend drugs as described in 1 and 2 and submit the licensed premises for inspection by the board’s representative before disposing of any other merchandise in the pharmacy.
  4. Remove from inside and outside the licensed area all symbols and signs with the words drugs, drugstore, prescriptions, pharmacy, pharmacy department, apothecary, apothecary shop, or any combination of terms.
  5. Return the pharmacy permit for cancellation within 10 days of all legend drugs, controlled drugs, and devices being removed from the premises.
47
Q

True or false: the Board of Pharmacy is required to have copies of all standing orders, prescriptions, and protocols on their website.

A

true (even though they suck at it)

48
Q

What is the INDIANA rule for controlled substance prescription transfer?

A

Controlled substance prescriptions must have been filled at least once before we can transfer them

this is stricter than the federal requirement, FYI

49
Q

A pharmacist can initiate an emergency refill for a prescription that is out of refills or expired if:

A
  1. The pharmacist has made a reasonable effort to contact the original prescriber or someone on call.
  2. The pharmacist believes not providing the medication would be seriously detrimental to the patient’s health.
  3. The original prescription had refills, and all have been dispensed, or the prescription is expired.
  4. The prescription was last filled at your pharmacy or a pharmacy in your same chain where you have access to the patient’s entire prescription history and can see things update in real-time (shared database).
  5. The drug is prescribed for continuous use, and the pharmacist has determined the patient is using the medication correctly. We can’t provide an emergency refill for an as needed medication (PRN) or a medication a patient isn’t taking appropriately.
  6. The pharmacist documents refill information, the time(s) and date(s) they attempted to contact the doctor or a prescriber on call, and the fact that they dispensed a refill without authorization.
50
Q

If a pharmacist initiates an emergency refill, when must they notify the prescriber by?

A

the next business day

51
Q

Pharmacists are only allowed to provide one emergency refill per prescription in a __-month period and can now provide a refill of a 30 days supply or the amount of the most recent fill, whichever is less.

A

6

52
Q

True or false: in Indiana, prescriptions for controlled substances can be emergency refilled.

A

false

53
Q

True or false: a refill record must include the quantity dispensed if other than the original quantity.

A

true; when typing in a prescription into any computer system, we must list the face amount or original quantity in our computer systems, even if the patient requests a different amount.

54
Q

We can dispense a 90-day supply of a medication at a patient’s request even if the prescriber didn’t write for 90 days, so long as ____________.

A

the patient has been on the prescription for at least 30 days

55
Q

Can we do 90-day supplies for controls if a prescriber didn’t write for 90 days?

A

no

56
Q

A patient comes in for their insulin, but you are aware that their prescriber recently passed away. Can you fill this prescription anyway?

A

technically yes, if we believe that it is in the best interest of the patient’s health and there is low likelihood that the patient will be able to see another provider soon

57
Q

Can you fill a prescription for a patient who has died?

A

no (duh)

58
Q

we cannot accept and reuse controlled substances at category __ or __ pharmacies.

A

I; III

59
Q

True or false: it is allowed for pharmacists to change small drug name components on a prescription without notifying/consulting with the prescriber (i.e. changing doxycycline hyclate to monohydrate)

A

false; these are different drugs, not just different dosage forms

60
Q

________ are things we may do and ________ are things we must do.

A

powers; duties

61
Q

True or false: pharmacists can prescribe spacers and nebulizers.

A

true

62
Q

True or false: pharmacists can prescribe glucose testing supplies, pen needles, and syringes needed for medications.

A

true

63
Q

True or false: pharmacists should use their DEA number to prescribe medical device supplies.

A

false; use our/our pharmacy’s NPI number

64
Q

Pharmacies cannot dispense epinephrine and glucagon to patients if they have an expiration date of fewer than ___ months from the date dispensed, unless the patient consents to a shorter expiration date.

A

12

65
Q

What must be done for a pharmacist to dispense epinephrine on a standing order?

A

the person must present a certificate of completion that indicates that they have training on administration and who’s in a position to help individuals experiencing anaphylaxis AND we must provide instructions on administration and instructions to call emergency services before/after use

66
Q

List the vaccines pharmacists can administer.

A
  1. flu
  2. shingles
  3. pneumonia
  4. Tdap
  5. HPV
  6. meningitis
  7. MMR
  8. varicella
  9. hepatitis A
  10. hepatitis B
  11. Hib
  12. coronavirus
67
Q

If the administration is under a protocol, we can only provide immunizations for those __ years of age and older, except for pneumonia.

A

11

68
Q

True or false: if we obtain consent from a parent or legal guardian, that person must be present at the time of immunization.

A

true

69
Q

If we administer an immunization, we must notify the prescribing practitioner and patient’s PCP within ___ days of administration.

A

14

70
Q

Who can supervise pharmacy interns immunizing?

A
  • pharmacist
  • physician
  • PA
  • APRN
  • RN
71
Q

True or false: during states of emergency, the board is allowed to suspend any law or rule in this article that would limit our ability to deliver pharmaceutical care.

A

true

Spring 2022: Pharmacy Law (20 decks)

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