MPJE NV Law Exam/183
Questions with Verified Answers
Requirements for valid prescriptions - -Patient info (full name & street
address)
Prescriber info (name, LICENSE designation, address)
Drug info (name, strength, dosage form, quantity)
Directions for use, refills, issue date
Prescriber's signature
-Tamper resistant security forms for Medicare beneficiaries - -Must
contain at least (3) tamper-resistant security features and must include
at least (1) feature from EACH of the following categories:
1. Prevents duplication (ie, "VOID" appears when photocopied or faxed)
2. Prevents erasure or modification (ie, quantity checkboxes, refill
indicators, or with chemically reactive paper that changes color when
eraser is applied)
3. Prevents use of counterfeit forms (ie, pre-printed serial numbers,
watermarks, or microprint signature line)
-Valid prescriber/patient relationship - -- Pt has medical compliant
- Medical hx has been taken
- Face-to-face physical examination or telemedicine exam
- Logical connection exists b/w medical complaint, medical hx, physical
exam, and drug prescribed
-Prescriptions from retired/deceased prescribers - -Immediately invalid
(NV)
-Prescription records must be maintained for: - -At least 2 years
-Federal law requirements for labels - -1. Pt name
2. Directions for use
3. Prescriber's name
4. Name and address of dispenser
5. Serial or prescription number
6. Date of filling
7. Cautionary statements (ie, required statement for controlled drugs
prohibiting transfer to any person other than the pt)
-Drug utilization reviews (DUR) - -Prospective DUR: evaluation of drug
tx PRIOR to dispensing (performed by dispensing pharmacist) --> must
be performed for individual Medicaid pts
- looks for therapeutic duplication, incorrect dosing, incorrect tx
duration, CIs of drug, DDI, drug-dz interaction, drug-allergy interactions
Retrospective DUR: evaluation of drug tx AFTER medication dispensing
(performed by STATE)
,-Written material included in drug labeling - -NOT approved by the FDA:
Consumer Medication Information (CMI)
Approved: Pt package inserts (PPI), instructions for use (IFU),
MedGuides, any paperwork required as a part of REMS
-Required MedGuides: - -NSAIDs
Antidepressants
Antipsychotics
Retinoids (ie, isotretinoin, acitretin)
Anticonvulsants
Most antiarrythmics (ie, amio, dofetilide, dronedarone)
Anticoagulants
Must be given at:
- initial fill and refills in outpatient setting
- 1st time drug dispensed to a HCP for admin to a pt in an outpt setting
- when pt/caregiver asks for it
- when MedGuide has been revised
Drug subject to REMS that requires a Medguide
-Signed HIPAA privacy disclosure forms must be kept for: - -6 years
-Using the Orange Book - -For Therapeutically Equivalent Drugs
If the first letter is A, then the drug is therapeutically equivalent to the
RLD (reference listed drug)
- 3 character code: when a number is added to the end of the 2 letters
- assigned when there is more than 1 RLD of the same strength under
the same heading
-FDA Flush List - -Should not be flushed down the sink or toilet UNLESS
it's on the flush list AND a DEA-authorized collector or take-back
program is not available
- Fentanyl-containing products
-Hydrocodone-containing products
-Oxycodone-containing
basically opioids lol
If no disposal program available, mix w/ undesirable substance (ie, kitty
litter, coffee grounds) and put in a sealable bag/empty container
-Compounding - Engineering Controls - -Primary (PEC): ISO 5 for making
compounded sterile products (CSPs)
- can use sterile hood/LAFW
- compounding aseptic isolator (CAI) often in a segregated compounding
area (SCA), referred to as a glovebox
,Secondary (SEC): ISO 7, commonly called the buffer area
Anteroom - ISO 8 if opens into positive-pressure (non-hazardous) OR ISO
7 if negative-pressure (hazardous)
- garbing, handwashing takes place prior to entering SEC
--> air NOT classified
-Reporting controlled substance loss or theft - -Must report to local DEA
office, in writing, within (1) BUSINESS DAY of discovery and submit
FORM 106
NV --> must report to THE DIVISION (on forms they provide) within (10)
DAYS after discovery of theft/loss
-Registrants sending CS to a reverse distributor - -Reverse distributor =
company that disposes of CS
- RD must issue Form 222 or the electronic equivalent to a pharmacy
that is transferring C2s for disposal
--> if transferring C3-C5s, then record (ie, receipt or invoice) must be
maintained w/ following info: drug name, dosage form, strength,
quantity, date transferred
DEA FORM 41 used to document the DESTRUCTION of CS
- RD will submit form 41 to the DEA once CS have been destroyed
-Broken, damaged, or spilled drugs - -If it is not recoverable, not
considered a "loss"
- must document incident in inventory record
If recoverable, must be disposed of and DEA form 41 must be submitted
to document
-Inventory for CS - -Sealed, unopened containers - require exact count
Opened containers:
- All C1/C2s need exact count
C3-C5 holding </=1000 dosage units can be estimated
-- holding >1000 dosage units need exact count
-Records that must be kept by a pharmacy for (2) years - -- Completed
and blank DEA Form 222 or CSOS equivalents
- Power of Attorney Forms
Receipts and/or invoices for C3-5s
- Records of transfers of CS b/w pharmacies
- Records of distribution (ie, sales to other registrants, returns to
vendors, distributions to reverse distributors)
- Records of dispensing
- Reports of theft or significant loss (DEA Form 106)
- Inventory of drugs surrendered for disposal (DEA Form 41)
- DEA registration certificate
, - Self-certification certificate and paper/electronic logbook for
pseudoephedrine sales
-Exception for faxing C2s - -Faxed Rx can serve as the original copy for
a C2 if:
- Drug compounded for admin to a pt by parenteral, IV, IM, SC, or
intraspinal route
- Rx for resident of a LTCF (long term care facility)
- Rx for a pt enrolled in a hospice program
-For C2s, (4) items that CANNOT be changed or added: - -- Pt name
- Prescribed drug (except for generic substitutions)
- Prescriber signature
- DEA #
-Time limit that C2 must be filled from date of issue - -Within 14 days of
issue or "do not fill until" date
--> 14 day rule
-Max qty or days' supply that a pt can receive for C2s - -For acute pain:
14 days or less of use and 90 MME or less for opioid-naive pts
-Multiple Rxs for C2s - -Can issue multiple Rxs at one time
- filled sequentially but CANNOT EXCEED A 90 DAY SUPPLY
- Rx cannot be post-dated
- Must include (2) dates: date Rx is written (ie, issue date) AND the
earliest acceptable fill date
-Partial fills for C2s - -If pharmacy cannot supply full qty
- qty supplied must be documented and must be filled within 72hrs of
partial filling (if after 72hrs, new Rx is required)
- if not or cannot be filled w/in 72hrs, notify prescriber
2. Under 2016 CARA, can be partially filled up to 30 days from date Rx
was issued (with no limit)
--> DIFFERENCE: within 60 days after date for terminally ill or LTCF
--> RPh must document "terminally ill" or "LTCF pt" on Rx
-Emergency filling for C2s - -PO Rx may be dispensed if drug's
immediate admin is necessary to avoid pt harm
- Central fil pharmacies are prohibited from preparing emergency fills
under any circumstance
Criteria for dispensing:
- dispense minimum amt necessary
- prescriber must provide the ORIGINAL Rx within 72 HRS of oral
authorization (NV - federal is 7d)
- must include "Authorization for Emergency Dispensing" and date of PO
Rx
- Rph must attach written Rx to emergency PO Rx
Questions with Verified Answers
Requirements for valid prescriptions - -Patient info (full name & street
address)
Prescriber info (name, LICENSE designation, address)
Drug info (name, strength, dosage form, quantity)
Directions for use, refills, issue date
Prescriber's signature
-Tamper resistant security forms for Medicare beneficiaries - -Must
contain at least (3) tamper-resistant security features and must include
at least (1) feature from EACH of the following categories:
1. Prevents duplication (ie, "VOID" appears when photocopied or faxed)
2. Prevents erasure or modification (ie, quantity checkboxes, refill
indicators, or with chemically reactive paper that changes color when
eraser is applied)
3. Prevents use of counterfeit forms (ie, pre-printed serial numbers,
watermarks, or microprint signature line)
-Valid prescriber/patient relationship - -- Pt has medical compliant
- Medical hx has been taken
- Face-to-face physical examination or telemedicine exam
- Logical connection exists b/w medical complaint, medical hx, physical
exam, and drug prescribed
-Prescriptions from retired/deceased prescribers - -Immediately invalid
(NV)
-Prescription records must be maintained for: - -At least 2 years
-Federal law requirements for labels - -1. Pt name
2. Directions for use
3. Prescriber's name
4. Name and address of dispenser
5. Serial or prescription number
6. Date of filling
7. Cautionary statements (ie, required statement for controlled drugs
prohibiting transfer to any person other than the pt)
-Drug utilization reviews (DUR) - -Prospective DUR: evaluation of drug
tx PRIOR to dispensing (performed by dispensing pharmacist) --> must
be performed for individual Medicaid pts
- looks for therapeutic duplication, incorrect dosing, incorrect tx
duration, CIs of drug, DDI, drug-dz interaction, drug-allergy interactions
Retrospective DUR: evaluation of drug tx AFTER medication dispensing
(performed by STATE)
,-Written material included in drug labeling - -NOT approved by the FDA:
Consumer Medication Information (CMI)
Approved: Pt package inserts (PPI), instructions for use (IFU),
MedGuides, any paperwork required as a part of REMS
-Required MedGuides: - -NSAIDs
Antidepressants
Antipsychotics
Retinoids (ie, isotretinoin, acitretin)
Anticonvulsants
Most antiarrythmics (ie, amio, dofetilide, dronedarone)
Anticoagulants
Must be given at:
- initial fill and refills in outpatient setting
- 1st time drug dispensed to a HCP for admin to a pt in an outpt setting
- when pt/caregiver asks for it
- when MedGuide has been revised
Drug subject to REMS that requires a Medguide
-Signed HIPAA privacy disclosure forms must be kept for: - -6 years
-Using the Orange Book - -For Therapeutically Equivalent Drugs
If the first letter is A, then the drug is therapeutically equivalent to the
RLD (reference listed drug)
- 3 character code: when a number is added to the end of the 2 letters
- assigned when there is more than 1 RLD of the same strength under
the same heading
-FDA Flush List - -Should not be flushed down the sink or toilet UNLESS
it's on the flush list AND a DEA-authorized collector or take-back
program is not available
- Fentanyl-containing products
-Hydrocodone-containing products
-Oxycodone-containing
basically opioids lol
If no disposal program available, mix w/ undesirable substance (ie, kitty
litter, coffee grounds) and put in a sealable bag/empty container
-Compounding - Engineering Controls - -Primary (PEC): ISO 5 for making
compounded sterile products (CSPs)
- can use sterile hood/LAFW
- compounding aseptic isolator (CAI) often in a segregated compounding
area (SCA), referred to as a glovebox
,Secondary (SEC): ISO 7, commonly called the buffer area
Anteroom - ISO 8 if opens into positive-pressure (non-hazardous) OR ISO
7 if negative-pressure (hazardous)
- garbing, handwashing takes place prior to entering SEC
--> air NOT classified
-Reporting controlled substance loss or theft - -Must report to local DEA
office, in writing, within (1) BUSINESS DAY of discovery and submit
FORM 106
NV --> must report to THE DIVISION (on forms they provide) within (10)
DAYS after discovery of theft/loss
-Registrants sending CS to a reverse distributor - -Reverse distributor =
company that disposes of CS
- RD must issue Form 222 or the electronic equivalent to a pharmacy
that is transferring C2s for disposal
--> if transferring C3-C5s, then record (ie, receipt or invoice) must be
maintained w/ following info: drug name, dosage form, strength,
quantity, date transferred
DEA FORM 41 used to document the DESTRUCTION of CS
- RD will submit form 41 to the DEA once CS have been destroyed
-Broken, damaged, or spilled drugs - -If it is not recoverable, not
considered a "loss"
- must document incident in inventory record
If recoverable, must be disposed of and DEA form 41 must be submitted
to document
-Inventory for CS - -Sealed, unopened containers - require exact count
Opened containers:
- All C1/C2s need exact count
C3-C5 holding </=1000 dosage units can be estimated
-- holding >1000 dosage units need exact count
-Records that must be kept by a pharmacy for (2) years - -- Completed
and blank DEA Form 222 or CSOS equivalents
- Power of Attorney Forms
Receipts and/or invoices for C3-5s
- Records of transfers of CS b/w pharmacies
- Records of distribution (ie, sales to other registrants, returns to
vendors, distributions to reverse distributors)
- Records of dispensing
- Reports of theft or significant loss (DEA Form 106)
- Inventory of drugs surrendered for disposal (DEA Form 41)
- DEA registration certificate
, - Self-certification certificate and paper/electronic logbook for
pseudoephedrine sales
-Exception for faxing C2s - -Faxed Rx can serve as the original copy for
a C2 if:
- Drug compounded for admin to a pt by parenteral, IV, IM, SC, or
intraspinal route
- Rx for resident of a LTCF (long term care facility)
- Rx for a pt enrolled in a hospice program
-For C2s, (4) items that CANNOT be changed or added: - -- Pt name
- Prescribed drug (except for generic substitutions)
- Prescriber signature
- DEA #
-Time limit that C2 must be filled from date of issue - -Within 14 days of
issue or "do not fill until" date
--> 14 day rule
-Max qty or days' supply that a pt can receive for C2s - -For acute pain:
14 days or less of use and 90 MME or less for opioid-naive pts
-Multiple Rxs for C2s - -Can issue multiple Rxs at one time
- filled sequentially but CANNOT EXCEED A 90 DAY SUPPLY
- Rx cannot be post-dated
- Must include (2) dates: date Rx is written (ie, issue date) AND the
earliest acceptable fill date
-Partial fills for C2s - -If pharmacy cannot supply full qty
- qty supplied must be documented and must be filled within 72hrs of
partial filling (if after 72hrs, new Rx is required)
- if not or cannot be filled w/in 72hrs, notify prescriber
2. Under 2016 CARA, can be partially filled up to 30 days from date Rx
was issued (with no limit)
--> DIFFERENCE: within 60 days after date for terminally ill or LTCF
--> RPh must document "terminally ill" or "LTCF pt" on Rx
-Emergency filling for C2s - -PO Rx may be dispensed if drug's
immediate admin is necessary to avoid pt harm
- Central fil pharmacies are prohibited from preparing emergency fills
under any circumstance
Criteria for dispensing:
- dispense minimum amt necessary
- prescriber must provide the ORIGINAL Rx within 72 HRS of oral
authorization (NV - federal is 7d)
- must include "Authorization for Emergency Dispensing" and date of PO
Rx
- Rph must attach written Rx to emergency PO Rx
