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Pharmacy Law > Exam 2 > Flashcards

Exam 2 Flashcards

Controlled Substances

1
Q

How long do DEA registration last for?

A

36 months/3 years

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2
Q

What is the DEA 224 form?

A

this applies to pharmacies
-for renewal of the pharmacy
-must be completed at least 60 days before expiration

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3
Q

Marijuana, LSD, heroin, mescaline are what schedule of drug?

A

C-1
-lack safety
-high potential for abuse

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4
Q

High potential for abuse that are allowed to be used?

A

C-2 drugs
-pure opiates:
–morphine, hydromorphone, oxcycodone
–methadone, fentanyl, cocaine

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5
Q

What drugs include C-2 drugs but compounded with other ingredients/have smaller dose?

A

C-3
-Less potential for abuse compared to C-1/C-2

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6
Q

Federal Government vs. NYS - classification of anabolic steroids?

A

Federal government: C-3

NYS (and other strict states): C-2

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7
Q

Benzodiazepines are classified as what controlled substances?

A

C-4
-low potential use
-possible limited physical or psychological dependence

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8
Q

Lowest potential for abuse is?

A

C-5 drugs
-lead to physical or psychological dependence
-pure opiates C-2 + limited quantities C-5
(divisible by 5)
-“exempt narcotics”: Robitussin AC dont need prescriptions

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9
Q

Rank from most to least possibility of substance abuse?

A

C-1 > C-2 > C-3 > C-4 > C-5

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10
Q

When can manufacturers apply to DEA for exemption of a controlled substance?

A

-in exempt substances, this can go from controlled substance status to non-controlled if it is UNLIKELY THAT THE PRODUCT WILL BE ABUSED

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11
Q

What is required in order to order and transfer C-1 and C-2 substances?

A

DEA form 222. this is REQUIRED to returned a C-2 to the supplier

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12
Q

Who is allowed to fill out the DEA 222 form?

A

only PHARMACISTS with power of attorney can sign

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13
Q

Can any prescriber prescribe controlled substances? If not, who can?

A

prescriber must be authorized to prescribe controlled substances
-must be registered with the DEA or exempt from registration pursuant to the CSA

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14
Q

What makes a controlled prescription valid?

A

RX must be issued for LEGITIMATE MEDICAL PURPOSE (proper treatment)

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15
Q

When can we not accept/dispense a controlled substance?

A

RX may not be issued in order to gain access by the MD for general dispensing to patients

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16
Q

How can MDs give patients controlled substances?

A

must get the medication directly from the wholesaler or manufacturer (this means they would be responsible and require documentation to prescribe and administer drug)

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17
Q

What are the must have requirements on a controlled substance RX?

A

-full NAME and ADDRESS of patient
-drug NAME, STRENGTH, and FORM
-QUANTITY
-SIG
-name, address, DEA number of MD
-DATED AND MANUALLY SIGNED ON THE DAY IT WAS WRITTEN (written RX)
-written in INK, INDELIBLE PENCIL, TYPEWRITE (written RX)

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18
Q

What are the NYS specific requirements in regards to e-RXs?

A

-ELECTRONIC RX required for C-2 products
-some exceptions where they can be paper

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19
Q

If a MD doesn’t have a personal DEA number, can. they still prescribe a controlled substance? If so, when is this allowed?

A

Yes!
-IF they work for a HOSPITAL, they must use the hospital DEA number and numerical suffix designated to the prescriber (usually residents)

-IF they work for the MILITARY OR PUBLIC HEALTH SERVICE, requirement to provide service identification number

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20
Q

Can all pharmacists fill controlled substances? Why or why not?

A

yes as long as they are acting in the usual course of his or her professional practice
-pharmacist must be registered with DEA (rare) or employed by a registered pharmacy (pharmacy locations are REQUIRED to have a DEA for that practice)

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21
Q

T/F: Prescribers are required to have a separate DEA registration to dispense AND administer?

A

False

PRACTITIONERS who dispense and administer are required to have separate DEA registration

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22
Q

if a physician isn’t registered to conduct treatment through prescribing medications, what can they do?

A

ADMINISTER drugs for acute withdrawal

-requires referral for treatment
-not more than 1 day of medication at a time and not more than 3 days

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23
Q

From a federal standpoint, does buprenorphine (Suboxone) require a special registration?

A

NOT ANYMORE

However, if the STATES require it or its considered the stricter law in that individual state, then YES, special registration is required.

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24
Q

In regards to ELECTRONIC (E-) controlled RXs, do presribers need to send in e-RXs for controlled substances?

A

Federally, NO it isn’t required

NYS: REQUIRED (few exceptions)

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25
Q

When receiving an electronic prescription for a controlled RX, are pharmacies required to accept it?

A

Federally, NO

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26
Q

If a pharmacy is to dispense a controlled substance, how are they able to verify that the prescription is allowed, verified, and not a fraudulent prescription?

A

through the use of certification of prescribing and dispensing systems

-computer programs are used in the pharmacy (and prescribers) to help detect if the RX is an approved certification body

-system is programed to determine if it is compliant with DEA requirements

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27
Q

how can the system determine and accept if the prescriber and what is being prescribed legal?

A

DEA requires that there is a “2-factor authentication” in place

-something you know (knowledge), have (hard token stored separately from the computer), are (biometric)

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28
Q

if dispensing a controlled substance without a RX, when is this allowed?

A

-must not require an RX; no sign of “federal legend”

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29
Q

If dispensing a controlled substance without an RX, how can this be dispensed? is the pharmacist only allowed to do this entire process?

A

only pharmacist can DISPENSE
but, CASHIER can RING UP at register

dispense < 240ml (48 dose units) of “exempt” opium in any given 48 hours

dispense < 120ml (24 dose units) of “exempt” product (cough syrup with codeine) in any giving 48 hours

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30
Q

A new patient to the area is coming to pick up a controlled substance without a RX. He is 21 years old, but doesn’t have any identification on him, can we dispense it to him?

A

NO!

yes patient indicates they are over 18 years old, BUT he is unknown to us, thus we don’t know if he really is 21 or over the age of 18.

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31
Q

A regular patient is coming into the pharmacy to pick up a controlled substance without an RX. We know he’s at least 18 years old, but he doesn’t have his identification on him, can we dispense it to him?

A

Yes.

we know him well, he’s over the age of 18, but he picks up at your pharmacy regularly.

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32
Q

A regular patient is picking up a controlled substance without an RX, what must be done in order to complete this transaction?

A

have a physical record keeping book OR if digital, scan ID to document all the required details:

-Name and address of purchaser
-name and quantity of the controlled substance
-date they bought it
-name OR initials of dispensing pharmacist

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33
Q

When we are requesting a destruction of controlled substances, is the pharmacy allowed to dispose of them in a medication drop-off box?

A

NO!

must obtain a DEA 41 form, which they MUST approve of before they can destroy anything

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34
Q

at the pharmacy you work at, they use an authorized distributor to destroy controlled medications. Is the DEA 41 for enough? why or why not?

A

YES!

BUT we would need to fill out a DEA 222 form if the drugs are specifically C-2!

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35
Q

Some locations have a “Blanket Authorization” to destroy controlled substances. Can they simply destroy them?

A

They would still need to have a DEA 41 form

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36
Q

the pharmacy you work at doesn’t have a C3-C5 medication a patient is looking for, can you get a transfer of said C-3-C5 from another pharmacy? why or why not?

A

YES, BUT both the sending and receiving pharmacy must be registered with the DEA, keep detailed records, and as long as no more then 5% of all Controlled substances distributed w/o a wholesaler permit from DEA are transferred out

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37
Q

If a pharmacy is transferring a C-2 to a different pharmacy, what is additionally required to do this?

A

usual requirement for controlled transfers, BUT require the use of a DEA 222 form to document to the DEA that the medication has been sent to that intended pharmacy

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38
Q

In order to transfer C3-5, _____ must be recorded to be a valid transfer

A

-Drug name
-dosage form
-strength
-quantity
-date transferred
-name, address, and DEA numbers of both pharmacies

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39
Q

what happens when a pharmacy/company is going out of business?

A

-must have complete inventory record
-filled out DEA 222 form for any C-2s
-receiving pharmacy must maintain records for 2 years

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40
Q

Medicare vs. Medicaid

A

Medicare: federal program

medicaid: federal/state program
–varies by state

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41
Q

What is the “Medicare programs and the prescription drug improvement and modernization act (MMA) of 2003?

A

-regularly revised

-4 programs:
–Part A: Hospital
–Part B: physician + services
–Part C: medicare advantage (managed care)
–Part D: Drugs

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42
Q

How does Prescription Drug Plan (PDP) work?

A

-Voluntary enrollment
-contract with private insurance
–rx only coverage
–can be part of medicare advantage
-premium and deductible = changes yearly

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43
Q

T/F: Spouses/beneficiaries can utilize the PDP too.

A

False

spouses/beneficiaries MUST have their own plan

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44
Q

Which tier covers most drugs/least expensive generic drug?

A

Tier 1

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45
Q

Tier 2 covers _____

A

preferred BRAND name drugs

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46
Q

T/F: expensive drugs are covered by tier 3 and 4

A

False

Tier 4 may cover high cost drugs

tier 3 may cover non-preferred brand name drugs

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47
Q

Once a beneficiary is enrolled, what dates can’t the premium and deductible change between?

A

Jan 1 - Dec 31

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48
Q

When is the only time co-pay’s can change?

A

if a drug is moved into a different tier

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49
Q

How often can beneficiaries change plans?

A

once a year

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50
Q

what time range can beneficiaries change their plans?

A

Nov 15 - Dec 31

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51
Q

When can beneficiaries change plans?

A

if they move or plan stops service

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52
Q

Under Medicare Part D, what day supply could be allowed to be dispensed by a pharmacy?

A

90 days

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53
Q

How are Pharmacists paid in regards to Part D?

A

Providing MTM services to enrolled patients

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54
Q

T/F: Plan sponsors must have MTM programs for patients with chronic multiple conditions.

if true, what type of conditions?

A

True

asthma, diabetes, hypertension, hyperlipidemia, etc.

55
Q

Will Part D cover drugs from Canada or other countries?

A

Yes, but only if HHS certifies that the importation poses NO ADDITIONAL RISK to the public

56
Q

T/F: “Off label” use of drugs may be acceptable

A

True

56
Q

T/F: insurer may change or remove specific drugs from formulary with timely notice

A

True

56
Q

What updates were made to the IRA (inflation reduction act) of 2022?

A

-vaccines = no co-pay
-insulin copay = <$35/month
-expanded subsidies
-elimination of 5% coinsurance for catastrophic phase
-renegotiation of drug price (limited)

56
Q

What are the 6 drug classes that require most drugs on the formulary?

A

-anticonvulsants
-antidepressants
-antineoplastics
-antipsychotics
-antiretrovirals
-immunosuppresants

56
Q

T/F: Med Part D covers research drugs w/o a medically accepted indication.

A

False

There must be a proper indication in order to be covered, otherwise, not covered

57
Q

T/F: Categories and classes of drugs can be changed throughout the year.

A

False

they can only be changed at the beginning of each plan year
EXCEPTION: new drug or new generic or new use

58
Q

T/F: Appeal processes for drugs that aren’t covered should be available for beneficiaries.

A

True

59
Q

What are some groups of drugs not usually covered (rare if it is) under Part D?

A

-barbiturates
-benzos
-weight loss/gain drugs
-hair growth drugs
-increasing fertility
-RX vitamins (not including Prenatal or fluoride products)
-outpatient drugs that REQUIRE monitoring

60
Q

When a drug is being removed or moving to a different tier, how long does the notice need to be gicen to CMS?

A

60 days

61
Q

T/F: if a patient is using an out-of-network pharmacy, patients pay U&C and submits a form for reimbursement

A

True

62
Q

How does the enrollment process work for Med Part D?

A

initial enrollment period begins the first day of the 3 month before eligibility begins and lasts 7 months (3 months before and 4 months after the month of their birthday)

63
Q

Are patients allowed to change their plans after enrollment of Med Part D?

A

NO! they are locked into the plan until next open enrollment

64
Q

What are the requirements for MTMs?

A

Part D sponsors must AUTOMATICALLY enroll qualified beneficiaries unless they opt out

beneficiaries = targeted for enrollment at least quarterly

65
Q

T/F: insurers require more than 3 chronic illnesses and must target at least 5 of 9 core chronic disease states.

A

False!

-they can’t require more than 3 chronic illnesses

66
Q

What are the 9 core chronic disease states?

A

-alzheimer’s
-hypertension
-CHF
-diabetes
-dyslipidemia
-ESRD
-respiratory disease
-bone disease
-mental health

67
Q

What are minimum intervention requirements of MTM?

A

–annual comprehensive medication review
-targeted medication review’s should be conducted at least quarterly
-interventions targeted to prescribers can be passive or interactive
-information about save disposal of prescription drugs that are controlled substances, drug take back, in home disposal and cost effective means

68
Q

What are CSOS electronic order forms?

A

-electronic orders for C-2’s
-must me maintained electronically for 2 years
-eliminates need for PAPER DEA 222 form

69
Q

What do CSOS and Public Key Infrastructure (PKI) Technology have to do with each other?

A

-CSOS utilize PKI to secure electronic transmission
-users required to get CSOS digital certificate for electronic ordering

70
Q

Who can become a CSOS Coordinator?

A

-digital certificates -> obtained by authorized personnel/power of attorney
-must be appointed a CSOS coordinator for managing digital certificates

71
Q

What does the CSOS coordinator do?

A

Serves as the recognized agent for issues related to digital certificates

72
Q

How long must the CSOS digital certificate be valid?

A

Until DEA registration expiration or revocation

73
Q

How can CSOS certificates be revoked?

A

under various circumstances

ex: -changes in authorization or compromise

74
Q

What form is required in order to DESTROY controlled substances?

A

DEA 41
-Letter to DEA requesting permission
-once each calendar year
-MUST WAIT until DEA says YES

75
Q

If we are forwarding a drug to an authorized distributor, what is required? Controlled 3-5? Controlled 2?

A

C3-5: need of DEA 41
C2: also need DEA 222

76
Q

What are requirements to transfer controlled substances between pharmacies?

A

-both have DEA registration (required to even CARRY C2-5)
-both must maintain records
-CANT transfer >5% of all controlled substances distributed w/o wholesaler’s permit from DEA

77
Q

T/F: In order to transfer C-2 drugs, a DEA 222 form is required.

A

True

78
Q

Who are considered MIDLEVEL practitioners?

A

-NP
-Midwives
-PA
-optometrist

79
Q

T/F: all Mid-level practitioners are allowed to prescribe controlled substances.

A

False!

Each state has different rules on who is allowed to prescribe CONTROLLED RX

80
Q

When given a C1-2, what is expected from pharmacists?

A

must keep C1-2 inventories SEPARATED FROM ALL OTHER RECORDS
-C1 and C2 must also be filed separately

81
Q

When given a C3-5, what is expected from pharmacists?

A

-must keep inventories separate/readily retrievable
-RX must be filed separately or readily retrievable
–Red “C” on the lower right hand of RX
–Red “C” not needed if computer assigns separate number system for Controls

82
Q

How long must inventory or other records be kept?

A

must be kept and available for at least 2 years from date of inventory

83
Q

Are C-2 records allowed to be kept with all other records?

A

No, they must be kept separately, but kept on site of the pharmacy

-only exception is if DEA says otherwise

84
Q

How often are controlled substance inventory to be taken?

A

At least every 2 years

85
Q

Why is a prescribers DEA number important for pharmacist to check?

A

to ensure that a prescription issued is written by an authorized person

86
Q

How to verify prescribers DEA number?
Ex: BJ3614511

A

1st letter:
-B (or also an F): determines if MD, dentists, vets, others.
-M: determines if mid-level practitioner

2 letter:
-First letter of last name

Number:
-add 1st, 3rd, 5th numbers
-add 2nd, 4th, 6th numbers and multiply that by 2

last number must match last number after you add them together

How to read the number:
(3+1+5)+2(6+4+1) = 31

87
Q

How is prescriber different in hospitals?

A

-similar to outpatient “MDs”
-MD must be authorized by state
-hospital needs to verify information by state
-hospital has a specific “HOSPITAL” DEA code

88
Q

Can all mid-level practitioners prescribe medication?

A

Sorta! check individual state laws

89
Q

Are pharmacies allowed to keep controlled substances with non-controlled substances?

A

Yes! only if they are dispersed throughout the shelves to avoid easy determination of what is controlled and not controlled

-electronic alarm system recommended

90
Q

Who can’t access controlled substance if they work in a pharmacy?

A

-convicted felons
-anyone who had their DEA registration denied, revoked, or surrendered

91
Q

Is there any exception to pharmacy employees who can access controlled substances?

A

-waivers can be requested by DEA and only if the DEA approves

92
Q

What must a pharmacy do if a controlled substance is stolen?

A

-Report to DEA diversion field office (phone, fax or written)
-contact local law enforcement authorities
-fill and submit DEA 106

93
Q

Why was the Combat Methamphetamine Epidemic Act (CMEA) created?

A

to stop the possible creation of Meth (usually can happen if you add a lot of ephedrine, pseudoephedrine, phenylpropanolamine)

94
Q

What drugs are considered “scheduled listed products” but nonprescription?

A

Ephedrine
Pseudoephedrine
Phenylporpanolamine

95
Q

Who are required to follow the CMEA?

A

Pharmacies
mobile retail units

96
Q

What does the CMEA do?

A

requires that some OTC cold and allergy meds be kept behind the counter

97
Q

what is the daily and monthly restrictions on ephedrine or pseudoephedrine per individual?

A

daily: 3.6 g/day
AND
9 grams every 30 days

98
Q

What is required to purchase ephedrine or pseudoephedrine products? for patients? for retailers?

A

-purchaser needs to present a photo ID

-retailers must keep information of purchase for 2 years

some states or local laws may add restrictions

99
Q

What specific record information must be kept on patients who purchase pseudoephedrine products?

A

-product name
-quantity sold
-name and address of purchaser
-date & time sale
-proof of ID
-signature of purchaser

100
Q

What is OBRA ‘90?

A

-Omnibus Budget Reconciliation Act of 1990
-a counseling law

100
Q

What does Medicaid have to do with OBRA ‘90?

A

-establishes conditions for the fed. government to reimburse states for outpatient Medicaid services
-in order for a state to get money for the Medicaid program, it must have a DUR program

101
Q

What is a DUR program?

A

-Drug Use/Utilization Review program
-must have a retrospective (past drug use) program and prospective (future drug use) program

102
Q

What is a “Prospective DUR”

A

-Review of patient’s written medical record and/or his medication profile before dispensing a prescription of the patient
-pharmacist must make a responsible effort to obtain and update a patient medication profile for every person receiving prescriptions

103
Q

What is required for a patients profile?

A

-patient name/address/number
-DOB
-sex
-medical concerns
-allergies
-previous medication
-any comments from pharmacists on patient’s drug therapy

104
Q

T/F: If a patient refuses to give any personal or medical history, the pharmacist must indicate the refusal.

A

True.

there needs to be detailed documentation

105
Q

Upon receiving a prescription, how should a prospective DUR be determined?

A

-Review RX and patient records for over and under utilization of drugs
-therapeutic duplication?
-incorrect dose/dosing regimens

106
Q

T/F: federal law states how much or what specific information is to be provided by a pharmacist.

A

False.

There is no law indicating how little or how much information is to be given

107
Q

If a patient refuses to be counseled, are pharmacists still required to counsel the patient?

A

No, if a patient refuses to be counseled, a pharmacist doesn’t have to counsel them

108
Q

What is retrospective DUR?

A

-not required for individual pharmacies
-done by individual states
-by a committee (healthcare providers)
-review of use of certain drugs over a period of time to ascertain whether appropriate therapy
-may result in recommendation that some prescribing habits of physicians be changed
-may result in board initiated education programs

108
Q

Are pharmacy interns allowed to counsel?

A

technically yes, but also is fully up to each state board of pharmacy

109
Q

What is the basics of law?

A

Enacted by Congress and signed by President Clinton in 1998
-authorizes the department of health and human services (DHHS) to enact regulations based on the law

109
Q

What is HIPAA?

A

-broad and complex law (some that don’t directly impact pharmacy practice)
-main intent of the law is to improve the portability and continuity of health insurance coverage and prohibit discrimination in health coverage

110
Q

What are the 4 major areas of HIPAA?

A

-transactions and code sets
-NPI number
-security
-privacy

111
Q

T/F: every healthcare provider who transmits patient health information electronically is covered under HIPAA (a covered entity)

A

True

112
Q

What does PHI stand for?

A

-Protected Health Information

113
Q

What are transactions and code sets?

A

uniform standards in the electronic submission of claims

114
Q

What is the use of “covered entity”?

A

to implement policy and procedures that protect information

114
Q

if a prescriber is covered by HIPAA, what are they required to have?

A

NPI

115
Q

What are privacy notices for?

A

-a notice of privacy practices to be given to each patient first receiving services
-this notice must be signed

115
Q

What are HIPAA privacy officers responsible for?

A

for HIPAA training of medical personnel

116
Q

How long must signed “privacy notice’s” be kept for?

A

minimum 6 years

116
Q

Who do patients report HIPAA violations to ?

A

DHHS office of civil rights

117
Q

who can sign privacy notices?

A

-parent/guardian

118
Q

who is not allowed to sign privacy notices?

A

-a friend

119
Q

T/F: patients friends aren’t allowed to pick up prescriptions.

A

False, they can pick up the prescription (they just can sign a privacy notice)

120
Q

What is the definition of manufacturing?

A

production, preparation, propagation, conversion, or processing of a drug/device, either directly/indirectly, by extracting from substances of natural origin or independently by means of chemical/biological synthesis

121
Q

What is included under “manufacturing”?

A

-packaging or repackaging
-promotion and marketing of drugs and devices
-preparation and promotion of items for resale in pharmacies and by others

122
Q

Who is compounding defined by?

A

-national association of boards of pharmacy (NABP)
-pharmacy compounding accreditation board
-FDA
-Federal law
-US Supreme Court

123
Q
A

Pharmacy Law (3 decks)

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