NC MPJE
which drugs/products are exempt from the track and trace documenting system for drug distribution?
OTC drugs, devices, APIs, veterinary drugs, blood products, radioactive drugs, imaging drugs, medical gases, homeopathic drugs
the first letter on a DEA number for manufacturers, distributors, researchers, abs, importers/exporters, reverse distributors, and narcotic tx programs may be one of the following:
P, R
prescriptions for CII and III drugs are limited to a 30 d supply for which profession?
PA
which practitioners have dependent prescribing authority?
PA, NP, CPP, nurse midwife, midwife, advanced registered nurse practitioner
which vaccines can be given persuant to a written protocol to pts 18 and older?
PCV, PPSV, HZV, HBV, Td, Tdap, meningitis vaccines (other non-flu vaccines also requrie a prescription to be given)
if a prescriber writes ___ as the amount of refills for an rx then that rx shall not be refilled more than 1 year after issued unless otherwise specified (e.g. wrote ___ x 2 y)
PRN
T/F if a rx is created, signed, transmitted and received electronically, all records related to the rx must be retained electronically
T - electronic records must be sortable by pt/prescriber name, drug name, date dispesned
T/F under the PPPA a new plastic container and closure must be used for each rx dispensed
T
who is authorized to prescribe controlled substances?
MD/DO, DDS, DMD, DPM, DVM, NP, PA, agent or employee of hospital/institution acting with scope of practice under registration of hospital/institution
examples of CI drugs
MDMA, GHB, heroin, LSD, marijuana/THC/CBD, mescaline, peyote
practitioners must register with DEA to prescribe CS. list practitioners
MDs, dentists, vets, NP, PA, clinical pharmacist practitioners, nurse midwives, podiatrists
class 2 recall
May cause temporary or medically reversible adverse health consequences
designated agent who transmits rx by phone or fax must have his/her name on the rx T/F
T
if pharmacy signs for shipment and discovers loss, pharmacy must complete dea 106 T/F
T
pharmacists must have documented HIPAA training T/F
T
psuedoephedrine shall be sold only in blister package t/f
T
t/f NC posts a sign for pseudoephedrine purchase
T
t/f free clinics can apply for a limited service pharmacy permit that lets them dispense donated drugs
T
consultant pharmacist in nursing home must conduct retrospective drug review how often>
at least monthly
how frequently should a consulting pharmacist review drugs dispensed by an NP or PA?
at least weekly
which pharmacies can accept donated unused drugs?
any pharmacy or free clinic holding an NC pharmacy permit; must notify BOP in writing at initiation and upon permit renewal
a CSOS order is invalid if
any required data field is missing, if not signed with a DEA sanctioned digital certificate, if certificate is expired, or if purchaser's public key will not validate the digital signature
targeted controlled substances refers to
any schedule II opioid and select CIIIs (e.g. codeine combo)
owner and proposed pharmacist manager must ___ before receiving pharmacy permit
appear before BOP
medication or chart orders are/are not considered rxs
are not, per the DEA
Nuvigil
armodafinil, CIV
when the pharmacy is closing permanently
arrange for disposition of CS, notify BOP and DEA, return permit within 10 d of close date, notify public 30 d before and 15 d after permanent closure; transfer rx files to another pharmacy and inform public if pts do not transfer rxs
common hazardous drugs listed by NIOSH
chemo drugs, pregnancy category X, hormones, transplant drugs
pharmacists are mandatory reporters of the following cases of abuse/neglect:
child or elder abuse - report to social services, law enforcement, or state's toll free reporting hotline
which practitioners do NOT have prescriptive authority in NC?
chiropractors, clinical nurse specialists, CRNA, homeopath, EMT paramedic, nautropath
which class of devices is controlled by the FDA and includes ice bags, crutches, and nasal bulbs?
class I
containment requirements for nonsterile HD
class I BSC or CVE; class II BSC or CACI can be used
which class of devices includes Syringes, heating pads, lens solution and is subject to performance standards?
class II
Which class of devices is subject to premarket approval?
class III
registry for clinical trials
clinicaltrials.gov
CII codeine formulations
codeine 15, 30, 60 mg tablet, codeine soln 30 mg/5 mL
four parts of a REMS program
communication plans, elements to assure safe use, implementation systems, medguides
requirements for dietary supplement label
descriptive name of product, wording of supplement or dietary supplement, name and and address of manufacturer, packer or distributor, complete list of ingredients and net contents/amount, Supplement Facts box
Dexedrine
dextroamphetamine, CII
Tenuate
diethylpropion, CIV
Mofeten
difenoxin/atropine, CIV
registrant ordering through CSOS must keep ___ atr registered location
digital certificate (used to sign order for CS)
what is an alternative to using 2 factor authentication to sign EPCS?
digital certificate issued by DEA
if CS shipping and financial records are stored offsite they must be retrievable within ___ business days at request of DEA or allow DEA to inspect central location without a warrant
2
a pharmacist may not supervise more than __ techs at a time in a pharmacy
2 (2:1 ratio)
DEA registration renewals are sent __ days prior to expiration
60
LTC or terminally ill pts can receive partial fills on CIIs for up to __d from written date
60
it is unlawful to practice pharmacy more than __ days after the exp date without renewing the license
60
orders made thru CSOS must be filled within __ d of the date of the order
60 (supplier can void all or part of order)
max BUD for med paks
60 d from when it was prepared
each book of DEA form 222 contains __ forms
7
prescriber has __ d to get a written signed rx for a emergency CII
7 (must be postmarked within 7 d if mailed)
all drugs containing ___ must be dispensed with a patient package insert
estrogen
which drugs require PPI with dispensing?
estrogen containing drugs and OCs; must be given with each package dispensed outpatient and with first dose and every 30 d inpatient
how often should inventory of CS be made after intitial inventory?
every 2 years
how often must dispensers/pharmacies and practitioners renew DEA registration?
every 3 years
which documents regarding CS cannot be stored centrally?
executed 222 forms, prescriptions, inventory records
BUD for a multiple use container
exp date on manufacturer's container or one year from date of dispensing (whichever is earlier)
comprehensive addiction and recovery act of 2016
extends time frame in which CIIs can be partially filled; allows NPs and PAs to apply for waiver to prescribe buprenorphine; CIIs can be partial filled for up to 30 d from written date
storage room requirements for HDs and HD ingredients
externally ventilated, negative pressure room with at least 12 air changes per hour
Potiga
ezogabine, CV
do pharmacists working in pharmacies operiating outside the state which ships, mails, or delivers in any manner a dispensed legend drug into NC have to be licensed in NC?
no, but must be licensed where dispensing is occuring?
can pharmacist managers serve same role for more than one pharmacy?
no, except for limited service pharmacies e.g. charitable or dept of health pharmacy
does an offer to counsel need to be made for refilled rx?
no, just for new or transferred
When CIII-V drugs are returned, is a DEA form 222 required?
no, may be transferred with an invoice (form 222 is only for CI and CII)
can patients receive controlled drug quantities larger than the amount written on the rx?
no, this is only allowed for noncontrolled drugs and nonpsychiatric drugs and cannot exceed the total amount authorized
does the agent who phones in prescriptions on the doctor's behalf need to be licensed or have special training?
no; but communication must be done under supervision of prescriber
can an LTCF nurse call in an emergency CII oral prescription to a pharmacy?
no; but they can fax a CII rx or call in CIII-V
are pharmacy students/interns required to register with the BOP?
no; may perform all acts constituting the practice of pharmacy when working under preceptor/supervisor
do NC schedule VI drugs have a currently accepted medical use?
no; need further and continuing study; distributed only for scientific and research purposes
Can a pharmacy promote the compounding of any specific drug, drug class, or type of drug through advertising?
nope - you must be a manufacturer in order to do this
if a pt is out of refills and the pharmacist is unable to obtain refill authoriztion from the prescriber, the pharmacist may dispense a one time emergency refill of up to 30 d supply provided the following
not for a CII, essential for maintenance of life or continuing tx of chronic condition, interruption may cause adverse health consequences, dispensing pharmacist creates written order with all rx info and signs it, dispensing pharmacist notifies prescriber/office within 72 h
class 3 recall
not likely to cause adverse health consequences
how would a supplier void all or part of a CII order?
notifies purchaser in writing and draws a line through cancelled items on copies 1 and 2 of form 222 and prints VOID in space provided for number of items shipped
how would a purchaser cancel all or part of a CII order?
notifies supplier in writing. Supplier indicates cancellation on copies 1 and 2 by drawing through cancelled items and writing cancelled in space where they would put number of items shipped
if a pharmacy is closing for 14 d or more
notify public 30 d before, 15 d after
policy on prescribing for self or family
only for minor illnesses and emergencies; must keep record of this; shall not prescribe controlled substances for themselves, supervising physicians, immediate family, anyone at their residence, or sexual partner
mobile pharmacy permits
only one permit is required but locations where drugs are dispensed must be reported to BOP
do ophthalmologists or optometrists have an MD?
ophthalmologists
the thirty day limit for controlled drugs in TN is limited to which controlled drugs?
opiates and benzos. this means there is not a thirty day limit to amphetamines.
DEA form 222
ordering CI and CII drugs
DEA form 222
ordering CIIs
info required to be retrievable from electronic prescribing system
original rx number, date of issuance, pt full name and address, prescriber DEA/address/full name, drug info, number of refills authorized
orphan drugs are developed under FDA office of
orphan products development
rules for packaging CS being mailed to patient
outside should not contain any identifiable marks, inner labeling must have required information in accordance with labeling requirements. Drug can be returned to stock if it has not left control of pharmacy (still in original sealed package) and patient refused delivery or was unable to find location
the DEA requires a monthly report of the total quantity of each controlled substance dispensed if over ___ rxs have been filled or if ___ or more dose units have been filled of all controlled substances through an internet pharmacy
over 100 rxs, over 5000 dose units
Percodan
oxycodone and aspirin
four programs designed to speed development of needed new drugs
fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation
each phase of public rulemaking process in OTC drug approval requires publication in the
federal register
Abstral
fentanyl
Actiq
fentanyl
Fentory
fentanyl
Lazanda
fentanyl
Onsolis
fentanyl
Subsys
fentanyl
which products should be flushed down the toilet?
fentanyl patches and pretty much all other opioids, buprenorphine, Diastat, Daytrana, and Xyrem
causes of drug adulteration
filthy, putrid or decomposed; has been prepared, packed or stored under unsanitary conditions where it may have been contaminated or became dangerous to a person's health. includes lack of adequate controls during manufacturing or lack of quality control tests; contains drug recognized in official compendia but strength is different from official standards or purity/quality is lower than official standards. contains drug not recognized in official compendia but its strength is different from that listed on label, or purity/quality is different from that listed
DEA number of MLP
first letter M
color of copy 2 form 222
green
what must a non-pharmacist do if they wish to obtain a pharmacy permit?
have name of pharmacist manager and personnel in permit application
drugs that cannot be delivered by pneumatic/vacuum tube
hazardous compounds (e.g. chemo), combustible products (incl. gels and sprays), protein products that can be damaged by agitation (e.g. insulin and immunoglobulins)
schedule I drugs
highest potential for abuse, no accepted medical use
An electronic rx for a controlled substance of any schedule may/may NOT be forwarded from one DEA registered pharmacy to another if it has not been filled
may NOT; i.e. there is no current mechanism for transferring 'on file' prescriptions
causes of misbranding
lack of required information on package/label (incl weight, count, warnings, use in specific groups, unsafe doses, methods of use, tx duration); false or misleading information; lack of special precautions needed to prevent decomposition that must be specified on label (e.g. storage conditions); illegible, no proprietary or established common name, differ from std of strength, quality or purity listed in USP monograph, does not contain manufacturer and business locations and packer/distributor, improper packaging/labeling, deficiency in packaging according to PPPA
Vimpat
lacosamide, CV
how may pharmacies store CS?
may disperse through stock of noncontrolled substances
activities that require DEA registration
manufacturing, distributing, dispensing, prescribing, reverse distributing, research, narcotic tx, importing/exporting, chemical analysis
permits are considered lapsed if not renewed by
march 1
examples of schedule I drugs
marijuana, LSD, peyote, mescaline, heroin, bath salts, THC
NC schedule VI drugs
marijuana, tetrahydrocannabinols, synthetic cannabinoids
what if supplier receives "lost" form?
mark "not accepted" on face of form and return copy 1 and 2 to purchaser who attaches it to copy three and statement
federal law on pseudoephedrine
max of 3.6 grams per day, 9 grams per 30 days, 7.5 grams per 30 days if mail order
requirements for practitioners to administer/dispense/prescribe CS under hospital DEA
must be done in usual course of professional practice, must be authorized to do so in state where they practice (and this is verified by hospital), inistitution assigns internal code number to practitioner as a suffix
requirements for CS rx
must be for legitimate medical purpose by individual practitioner in usual course of practice - means physical/medical exam needed; must be in scope of prescriber's practice
class 3 medical devices
pacemakers, heart valves, stents; require premarket approval as a life-sustaining device, important in preventing impairment of health or potential risk of illness or injury
biologics price competition and innovation act
part of ACA 2010; allows a pathway for biosimilar approval
PHI includes what?
past, present or future physical or mental health or condition (e.g. medical record), healthcare provided to pt (tests, surgery), payment for providing healthcare (e.g. bill), identifiers e.g. name, address, DOB, SSN
DEA form 224
new registration form for retail pharmacies, hospitals/clinics, practitioners, teaching institutions, or mid-level practitioners
can CIIs be refilled?
no
can a nurse at a health dept clinic dispense CS?
no
can a physician make a blanked waiver request for non-child resistant containers?
no
can pharmacist managers serve as PMs for multiple retail pharmacies e.g. for a chain?
no
can you skip lines on a 222 form?
no
do CV medications have a limit on exp date or amount of refills?
no
do certified techs have to complete employer sponsored training within 180d?
no
do compounded drugs have NDC numbers?
no
is a form 222 required if CII drugs are transferred from central to retail pharmacy?
no
is a personal appearance in front of the BOP required for re-application for pharmacy permit?
no
is a prescriber's signature needed for a refill order sent by phone or fax?
no
is it required to have written waiver of child resistant caps?
no
is maintaining an addiction a legitimate medical purpose for a CS rx?
no
is pharmacy phone number required on rx label?
no
is refill info required on label for a noncontrolled drug?
no
is there a quantity limit on CIIs per federal law?
no
manufacturer substitutions for NTI drugs must be agreed upon by __ and ___
patient and prescriber
PA or NP must personally connsult with supervising physician prior to prescribing a targeted CS when the following apply:
facility engages in pain tx, use of targeted CS exceeds 30 d; if continually prescribed, must consult every 90 d
medical device amendments of 1976
established criteria for classifying devices into one of three classes
durham humphrey amendment of 1951
established two classes of meds (rx and OTC) and authorize oral rx and refills of rx drugs; introduced label requirements for pharmacies
how should CIII-V be counted in inventory?
estimate is permissible unless container holds more than 1000 tabs/caps (then exact count needed)
an rx should minimally contain the following:
patient name, prescriber name, license designation, address, drug name/strength/dose form/quantity, sig, refills, issue date, and signature
when are partial fills of CIIs allowed?
pharmacy has insufficient stock, partial fill of emergency oral rx, partial fill requested by pt or practitioner that wrote the rx, terminally ill pt, LTC pt
what must be included on a controlled substance rx?
pt full name and address, prescriber full name, business address, DEA number, drug name/strength/dose form/quantity/directions for use, number of refills
how are form 222s requested?
request on form 224 (application for DEA registration), through DEA website, calling DEA office, or form 222a
is NDC required on OTC drugs?
requested but not required
FDA modernization act of 97
required establishment of registry for clinical trials, approved labeling changes for foods and drugs, enabled manufacturer to discuss off label drug use when requested
Pure Food and Drug Act (1906)
required ingredients to meet standards of strength, quality, and purity in the USP and NF; required food or drug label to not be false or misleading; presence of dangerous ingredients must be listed; required no adulterated or misbranded drugs could be sent through interstate commerce
poison prevention and packaging act of 1970
requires household substances and drugs to be packaged in child resistant packaging
purpose of phase II trial
safety and efficacy
purpose of phase 1 trial
safety, adverse effects, PK/PD
manufacturing and outsourcing facilities are regulated by the FDA whereas compounding is regulated by
state boards
the BOP writes an annual report to
the governor and presiding officer of each house of the general assembly
who develops REMS?
the manufacturer develops it and the FDA reviews and approves it
the PPPA allows manufacturers to package one size of an OTC product in a non-compliant easy open container provided the following:
the package is also available in a CR container and the package has warning "this package is for households without young children" or "package not child resistant"
form 222 must be signed and dated by
the person authorized to sign registration application or who has been granted power of attorney
active suspension
the pharmacist does not practice during a specified period of time
stayed suspension
the pharmacist/pharmacy must not violate any pharmacy laws during specified amount of time but is allowed to practice (usually after active suspension is over)
it is permissible to share PHI with the following:
the pt, other healthcare providers providing care to pt, persons needing info for tx, payment, or operational purposes, others when authorized by pt, limited/de-identified info for research, public health or institutional operations, law enforcement (e.g. the DEA, FDA, board inspectors)
purpose of sNDA
to change a label, add new indication, add new dosage, or change manufacturing procedures
pharmacies from out of state must have ___ provided to patients for contacting the pharmacist
toll free number
Conzip
tramadol, CIV
what information must be retained with regards to distribution history of an rx drug?
transaction information, transaction hx, a transaction statement; kept for 6 years
type of application used for change in ownership/controlling entities
transfer of ownership
definitions for orphan drugs
treat disease that affects less than 200,000 ppl in US or for products with no reasonable expectation that costs will be recovered
What is Expedited Partner Therapy (EPT)?
treating sex partners of pts diagnosed with chlamydia or gonorrhea by providing rx to pt to take to partner without exam - legal in NC
how long are digital certificates for CSOS valid?
until DEA registration expires
class II recall
use or exposure can cause temporary or reversible adverse health consequences or where probability of harm is remote e.g. possibility of particulate in a vial
how are drugs removed from an emergency kit auxiliary med inventory?
valid rx is necessary for removal
are CPPs required to wear a name tag with title?
yes
can multiple power of attorneys be granted?
yes
can noncontrolled drugs be transferred by fax?
yes
can offer to counsel be made by ancillary staff
yes
can other medications be written on the same rx as CII meds?
yes
can pharmacists leave voicemails regarding meds on pt home machine?
yes
can unlicensed individuals be given power of attorney?
yes
do power of attorneys need to be renewed with each DEA registration renewal?
yes
does the DEA allow controlled substances in emergency kits at LTCFs?
yes
is a new pharmacy permit needed if pharmacy changes ownership?
yes
can the NDC field be left blank on form 222?
yes - allows supplier to sub a different package size or manufacturer. permissible as long as quantity ordered is not exceeded
fee to change pharmacist manager or pharmacy personnel
$35
examples of misbranding
- labeling falsely or misleading - fails to meet label requirements - fails to have "adequate directions for use" - violates PPPA - dispensed without refill or rx - dispensing wrong strength - lack of tamper resistant packaging on OTC drugs
3 instances where a pharmacist can legally receive a faxed CII rx where it serves as original
- narcotic to be compounded for immediate admin by parenteral, IV, IM, SC, intraspinal fusion - resident of LTC - hospice patient (must be noted on rx)
to run for election, BOP candidates must have petition signed by __ pharmacists from their district
10
if change of ownership or pharmacist manager occurs, CS inventory must occur within __ d
10 (written record, signed and dated, kept for 3 y)
registrant must notify the DEA within ___ d of discovery of any significant loss of any CS
1 business day
immediate use CSP BUD room temp
1 h
to be admitted to a comprehensive maintenance program, narcotic dependent patients must be addicted for how long?
1 year
exp date of transferred prescriptions
1 year (6 mos for CIII and CIV)
theft or loss of a controlled substance should be reported with DEA form
106
how many digits are in NDC number?
11 (5-4-2)
BOP must convene at least __ times per year
2
how long are DEA numbers valid before renewal?
3 years
how long must ID records be kept?
3 years
how long must original rx orders be kept
3 years
review period for most drugs with NDA/BLA
10 mos
medicare part d requires rx records to be retained for __
10 y
to be CV, not more than ___ mg/100 mL or 100 g can be present of dihydrocodeine in combo drugs
100
a practitioner is required to issue electronic targeted CS prescriptions beginning when?
1/1/2020 (except if dispensing directly to ultimate user, inpatient admin, tech/electrical failure, dispensed by pharmacy on federal property, written by a vet - pharmacists are not required to verify if they receive paper rx)
record of drugs removed from auxiliary med inventory or pharmacy inventory shall be kept for how long?
3 years
Disasters, accidents, theft, emergencies that could affect purity, strength, or labeling of drugs must be reported to NCBOP within __ days
10
if CPP continues working, they must notify BOP with ___ d
10
DEA form 363
new registration form for narcotic treatment programs
what are the exceptions where a faxed rx can serve as the original rx for a CII drug?
1. drug is compounded for administration by IV, IM, SC, IT route
if given notice by BOP, pharmacy must provide documentation within __ d of any alleged med error or incident in past 12 mos resulting in dr visit, ED visit, hospitalization, or death
10
pharmacist manager must notify NCBOP within __ d of any CS theft or significant loss
10
options for filing paper prescriptions
1. all CII, all CIII-V, all others
requirements for becoming CPP
1. board certification or geriatric certification with 2 years exp 2. ASHP residency with 2 years exp 3. PharmD, 3 years exp, and 1 ACPE certificate 4. BS pharmacy, 5 years exp, 2 ACPE certificates
segments of an NDC:
11 digits: labeler code with 5 digits identifies the manufacturer/repackager/distributor; assigned by FDA; product code with 4 digits identifies the strength, dosage, and formulation; determined by labeler; package code with 2 digits identifies package size and type
permit holder shall not require pharmacist to work more than __ h per day
12
how much Robitussin AC can be sold without rx?
120 mL (24 dosage units) within a 48 h period, must be 18+ yo
If drug dispensed by out of state pharmacy contributes to death of a patient, pharmacy must report it to NCBOP within ___ days
14
if a registrant wishes to transfer its buisness operations to another pharmacy, a proposal must be submitted to DEA at least __ d prior to transfer
14
min age for flu shot
14
pharmacies must be given __ d notice before an audit by an insurance company/PBM/etc
14
pharmacist manager must report to BOP within __ d of becoming aware of drug dispensed that caused death
14
registrants can begin storing shipping and financial records at a central location __ days after the DEA receives notification that a pharmacy will store records off-site
14
BUD for aqueous nonsterile oral formulations
14 d
low risk CSP BUD refrigerated
14 d
___ hours of approved CE required each year
15
BOP deems ___ hour practical pharmacy experience to be satisfied by completion of an accredited doctor of pharmacy program as certified by the school
1500
number of intern hours required for license in NC
1500 (1000 must be in hospital or community pharmacy)
loss or theft of pseudoephedrine must be reported to local DEA office within __ d
15; no need for form 106
reporting of CS dispensed by internet pharmacies must be submitted monthly to DEA by the __ of each month
15th
age limit for Sudafed
18 y
who is allowed to possess hemp extract/CBD (classified as marijuana in NC)?
18+ yo 'caregiver' who is a parent, guardian or custodian of a patient with intractable epilepsy with written statement signed and dated by a neurologist who says pt may benefit; pharmacies and pharmacists may NOT possess or dispense
requirements for purchaser to obtain Cheratussin AC
18+ yo, suitable ID
how many pairs of gloves required for HD preparation?
2 pairs of chemotherapy gloves
how long must pseudoephedrine sales records be kept
2 y
electronic prescriptions must be stored for how long?
2 years
how long are records kept in NPLEX?
2 years
how long must wholesale distributors maintain records and inventories of rx drug transactions?
2 years per NC law, but drug supply chain act requires 6 years
how long must copy 3 of form 222 be kept by purchaser?
2 years. all records related to CII drugs (e.g. orders, invoices, rxs, inventory records) kept separate from other forms
records of CS destruction must be sent to DEA and retained for how long?
3 years; must also fill out form 41
pharmacist manager must respond with a corrective action plan regarding severe/significant deficiencies following BOP inspection within ___ d and will be reinspected within __ d
30, 90
number of patients in phase III trial
300-3000 patients with disease
pharmacist manager must be present for at least 1/2 of the hours of operation up to __ h per week
32
each CPP shall earn __ h practice relevant CE each year
35
number of subjects in phase II trial
35-100 pts with disease
practitioners wishing to prescribe and dispense methadone for addiction must obtain a separate DEA registration via DEA form
363
how long should records of med errors be kept in healthcare facility?
3years
__ members needed to make a quorum
4
the breakage, damage, or spillage of controlled substances is reported on DEA form
41 - is not considered a loss -dispose through a reverse distributor ; if breakage/spillage is not recoverable, the registrant must document what happened in inventory and DEA form 41 is NOT to be filled out
CSP BUD freezer
45 d for low, med and high risk
pharmacies must provide documents stored at a central facility within __ h of the DEA's request
48
components of product tracing information required by Drug Supply Chain Security Act
3 Ts: transaction hx, transaction info, transaction statements
high risk CSP BUD refrigerated
3 d
CE requirements for immunizing pharmacist
3 h vaccine CE every 2 years
low risk CSP BUD at room temp
48 h
ADD records of transactions must be kept for how long?
3 years
number subjects in phase 1 trial
20-80 healthy subjects
annual renewal fee for pharmacy permit
200
mobile pharmacies dispense rx drugs at no/reduced charge to pts less than ___% of federal poverty level and have no type of insurance
200
to be CV, not more than __ mg/100 mL or 100 g can be present of codeine in combo with other drugs
200
form ___ is required for distribution, purchase or transfer of CII and CI drugs
222
if selling CII to a practitioner, what form must be used?
222
schedule II drugs require completion of DEA form __ when drugs change location
222
individuals and institutions submit DEA form ___ to apply for a DEA number
224
dispensers must have systems in place to identify and quarantine suspect/illegitimate products and notify the FDA/trading partners within __ h
24
when dispensing medical oxygen, ____ h supply must be provided as emergency backup
24
high risk CSP BUD at room temp
24 h
if a pharmacist is not on duty in a health care facility and an authorized nurse removes a drug/device from the pharmacy during the pharmacist's absence, how long does the pharmacist have to verify the order?
24 h
max day supply of med dispensed by nurse or physician in an ER in the absence of a 24 h outpt pharmacy
24 h (must be from ED formulary set by pharmacist, prepackaged and labeled by pharmacist)
max amount of Cheratussin AC sold OTC
240 mL/8 oz or 48 dose units of opium containing product or 120 mL/4 oz or 24 dose units of any other CS may be dispensed to the same purchaser within a 48 hour period
after treating 100 pts/y, qualified physicians can treat up to __ pts/year for opioid addiction
275
executed 222 forms must be maintained separately from all other records and retained for __ years under NC law at registered location
3
how many tamper resistant security features are required on rxs federally?
3
in order for outpatient drugs to be paid for by Medicaid, written rxs must be on tamper resistant forms that contain at least __ tamper resistant features
3
original and transferred rx must be kept for __ y after dispensing
3
pharmacists must keep records of CE for __ years
3
supervising physician may not supervise more than __ pharmacists
3
__ hours of CE must be live
5
a pharmacy can sell controlled substances to other pharmacies or prescribers without being registered as a distributor as long as the total number of dosage units does not exceed ___% of total number of controlled substance dosage units dispensed per year
5
if out of state pharmacy is disciplined by another BOP, they must notify NCBOP within __ days
5
a qualifying physician under DATA 2000 must not treat more than __ pts in the first year; then can petition for up to 100/y
30
all licensees must give BOP notice of change of name, mailing address, or change of place of employment within __ d after the change - includes technicians
30
pharmacist manager must notify BOP within ___ days of change in personnel (techs or pharmacists)
30
pharmacist managers shall notify BOP of change in personnel within __ d
30
pharmacists must register with CSRS within __ d of obtaining or renewing pharmacist license
30
techs are required to register with the BOP within __ d of employment
30
BUD for aqueous nonsterile topical/dermal/mucosal liquid and semisolid preparations
30 d
if a medical order is dispensed from a health care facility and there is no indicated quantity or facility policy on stop dates, pharmacist should assume order is good for __ d supply
30 d
readily retrievable records of med compounding and dispensing in a healthcare facility must be kept for how long?
30 d
how long does a pharmacist have to fill the remainder of a CII before getting a new rx?
30 d (unless emergency fill then 72 h)
if an internet pharmacy dispenses CS they must notify DEA and state boards intent of dispensing within __ d
30 d of starting
max of __ attempts on NAPLEX and MPJE
5
medium risk CSP BUD at room temp
30 h
a pharmacy or physician who ceases accepting drug donations must notify board within __ d
30
a DEA registered reverse distributor is responsible for filling out form ___ when controlled substances are destroyed
41
what form should be used for breakage or spillage of CS?
41
pharmacies are not considered distributors as long as the total number of CS dose units distributed and transfers between pharmacies do not exceed __% of total sales/dispensing
5
__ mg methadone is restricted to NTF by manufacturers
40
late renewal fee for pharmacy permit
400
A facility shall not be permitted to possess more than __ doses of each controlled substance entity for each 50 licensed beds or fraction thereof in a CS emergency kit
5 (5 doses can be the same or different concentrations)
acute pain (i.e. for 3 mos or less) rx may not exceed __ d supply initially
5 (does not include inpt admin for hospital, nursing home, hospice, LTCF - pharmacists are immune if they dispense in violation of this)
NC medicaid requires pharmacists to maintain hardcopies of rx for
5 years
how many years of patent exclusivity provided to brand manufacturer before generics can be approved?
5 years
if more than __ people are affected by a HIPAA breach the pharmacy must notify the media and DHHS no later than 60 d after discovery
500
initial fee for pharmacy permit
500
transfer of ownership fee for pharmacy permit
500
out of practice 2-5 years
500 h internship, 15 h/year out of practice CE with 8 h live/yr, pass MPJE
facilities can register as outsourcing facilities under __ if they compound sterile drugs
503b
total number of dosage units distributed to practitioners must not exceed ) __% of total number of dosage units of CS distributed and dispensed by the pharmacy during the calendar year
5; otherwise they must be registered as distributor
according to Drug Supply Chain security act, pharmacies must be able to capture and maintain transaction information, transaction hx, and a transaction statement in paper or electronic form for each drug received for __ years from date of transaction
6
no CII shall be dispensed persuant to a written or electronic rx more than __ mos after date it was prescribed
6
pharmacist working longer than ___ h per day shall be allowed to take 30 min meal break and one addtl 15 min break
6
separate from dispensing stock all drug products more than __ mos out of date
6
there are __ BOP members
6
review period for priority drugs with NDA/BLA
6 mos
BUD for repackaging nonsterile oral solids and liquid drug products in unit dose or single unit nonPVC containers
6 mos or 25% of time remaining between date of repackaging and exp date
HIPAA signed privacy disclosures must be kept for how long?
6 years
how long does NC CSRS keep info?
6 years
how long must records of HIPAA breaches be kept
6 years
how long must tracing information be maintained in pharmacy?
6 years
if CII rx is a emergency oral rx, pharmacist has ___ h to fill remainder of a partial fill
72
pharmacist responsible for completeness and accuracy of data entered into systemm signs acknowledgement within __ h of dispensing
72
pharmacy must provide ID records to ppl authorized to receive info from CSRS within ___ h
72
the North Carolina Immunization Registry must be accessed before admin; vaccines except flu must be added within ___ h
72
the patient's PCP must be notified with in __ h for any vaccine
72
if an emergency oral rx is given for a CII, the prescriber must provide thee original rx by the __ day following the fill date
7th
med risk CSP BUD refrigerated
9 d
a pharmacist may serve temporarily as pharmacist manager for not more than __ d and must be present at least 20 hours per week
90
the pharmacy must be closed if the pharmacist is not present for ___ min or more
90
a pharmacist may issue a one time __ d supply of non-CII medication if the pharmacist is unable to readily obtain refill authorization as a result of the prescriber's inability to provide medical services (e.g. vacation, death, natural disaster)
90 (if pharmacist is unable to get RF authorization and prescriber is fine, they can give 30 d non-CII emergency fill)
codeine and dihydrocodeinestrength cannot be greater than ___ mg/dose unit when combined with another drug to be CIII
90 mg/du or 1.8 g/100 mL
the first letter on a DEA number for hospitals, clinics, practitioners, teaching institutions, or pharmacies may be one of the following:
A, B, F, G
physician DEA numbers
A, B, F, or G first letter, second letter usu first letter of last name
title for the purple book
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Inerchangeability Evaluations
T/F technicians must be certified to receive called in rx or call for RF authorizations
T
rx drug advertising is regulated by the
FDA
what is the national agency for accreditation of professional degree programs in pharmacy and for providers of CPEs
ACPE (accreditation council for pharmacy education)
which form is used for tax free alcohol?
ATF-1447
examples of drugs requiring a med guide
Accutane, Oxycontin, Abilify, Ritalin
REMS programs were established under what legislation?
FDA amendments act of 2007
the __ application represents the FDA's permission to begin the phase I clinical studies in human subjects
IND
T/F the first license renewal cycle post-graduation is exempt from CPE requirements
T
phase one of OTC monograph approval
FDA forms advisory panel to review active ingredients, determine if generally recognized as safe and effective, recommend labeling; published as advance notice of proposed rulemaking (ANPR)
the first letter on a DEA number for mid level practitioners
M
OTC drug advertising is regulated by the
FTC
title for the orange book
Approved Drug Products with Therapeutic Equivalence Evaluations
what is included in USP DI volume III?
Approved drug products with therapeutic equivalence evaluations - orange book info, USP/NF definitions and regulations, portions of the controlled substances act
physicians who wish to dispense meds must register with the ___ and follow all laws pertaining to pharmacist dispensing
BOP
PAs/NPs who dispense under pharmacist supervision must register with the
BOP - drugs dispensed must be pre labeled by pharmacist with all info requied by law except name of pt and sig
class 2 medical devices
BP cuffs, syringes, percutaneous catheters; requires specific controls e.g. performance standards, post-marketing surveillance
narrow therapeutic index drugs that must be filled with same manufacturer
CBZ, cyclosporine, ethosuximide, levothyroxine sodium, lithium, PHT, procainamide, tacrolimus, theophylline, warfarin
which division of the FDA evaluates the NDA or BLA after submission?
CDER (center for drug evaluation and research)
Tussicaps
CII
Tussionex
CII
all ___ records and inventories must be kept separately from all other pharmacy records
CII
cocaine
CII
levo-alpha acetyl methadol or LAAM
CII
when does an exact count need to be made for inventory?
CII
carfentanil
CII (vet use only)
which prescriptions require ID for pickup?
CII and codeine containing CIIIs; can be ID of person designated by pt; pharmacy must document ID number, type, and person's name
codeine
CII by itself
etorphine
CII, vet use only
Fioricet with codeine
CIII
Fiorinal with Codeine
CIII
Marinol
CIII
nalorphine
CIII
Fiorinal
CIII (butalbital, ASA, caffeine)
Tylenol with codeine
CIII (true for #3 and #4)
which schedules may not be refilled more than 6 mos from the date of issuance or 5 times, whichever comes first
CIII-IV (note CIIs cannot be dispensed more than 6 mos from written date but no refills)
pharmacies who share a real time on line database may transfer which schedules of meds up to the max number of refills
CIII-V (if there is no shared database, it can be transferred one time only)
Ambien
CIV
Belsomra
CIV
Lunesta
CIV
Soma
CIV
Sonata
CIV
Ultracet
CIV
Ultram
CIV
benzodiazepines schedule
CIV
chloral hydrate
CIV
fenfluramine
CIV
mazindol
CIV
meprobamate
CIV
pemoline
CIV
phenobarbital
CIV
propoxyphene
CIV
sibutramine
CIV
which drugs can NOT be accepted for donation?
CS, restricted distribution items (i.e. REMS), biologics unless donated by wholesaler, compounded or parenteral drugs, refrigerated drugs (unless donated by manufacturer/wholesaler/pharmacy with proper storage)
Lomotil
CV
Lyrica
CV
codeine syrups/liquids
CV
what are examples of OTC CV drugs?
Cheratussin AC, codeine and opium preparations
which act distinguished between traditional compounders and outsourcing facilities?
Compounding Quality Act (part of the Drug Quality and Security Act of 2013)
when a copy of a rx for a CS is given it must say the following
Copy - for information only
if a practitioner is authorized to prescribe narcotics for opioid addiction treatment, the practitioner will receive a ___ number
DATA 2000 waiver unique identification number
which practitioners have prescribing privileges limited to scope of practice
DDS, podiatrists, optometrists, DVM
facilities containing CS emergency kits must register with the
DEA
how does registrant inform DEA of theft/loss?
DEA form 106
when CII drugs are sent to reverse distributor because they are expired, damaged, or unusable, what form should be used?
DEA form 222
types of IDs allowed to pick up rx
DL, DMV issued ID, military ID, passport
there is a 60 day grace period following (date) of all licenses, registrations, and permits
Dec 31
which act requires documents to prevent counterfeit drugs from entering market?
Drug Supply Chain Security Act (part of Drug Quality and Security Act of 2013)
T/F drug manufacturers and representatives can initiate conversations with healthcare providers about off-label use for one of their drugs
F - they can only discuss it if the healthcare provider voluntarily of their own initiative requested information
T/F pharmacies can sell compounded products made from ethanol purchased with form ATF-1447
FALSE
manufacturers of bulk products used in compounding must be registered with the __
FDA
When are MedGuides required by the FDA?
For certain products posing a "serious and significant concern" other than estrogen-containing products if FDA finds a. Pt labeling could help prevent serious adverse effects b. Product has serious risks that patient could benefit from knowing c. Pt adherence must be approved by FDA
legislative body responsible for licensure of pharmacists
General Assembly of NC
which schedules need an exact count?
I-II (any count) and III-V containers holding more than 1000 dosage units
cocaine schedule
II
which schedules can be ordered using CSOS?
II thru V (note 222 forms are for CIIs only)
schedules reported in CSRS
II-V
which schedules can be estimated for inventory?
III, IV and V containers holding less than 1000 dosage units
containment requirements for sterile HD
ISO class 5 or better air e.g. Class II or III BSC or CACI; secondary control may be ISO class 7 buffer room with class 7 anteroom or an unclassified containment segregated compounding area
what must be written on rx of LTC or terminal pt receiving partial CII fill?
LTCF patient or terminally ill
manufacturers and repackagers shipping to NC must register with
NC dept of agriculture's food and drug division
wholesale distributors get licenses and renew annually from
NC dept of agriculture's food and drug protection division
out of state pharmacies sending drugs to NC must keep records of
NC pharmacy permit, rx drugs dispensed to NC residents
which does a pharmacy need first, DEA registration or permit from NCBOP?
NCBOP permit
organization that identifies hazardous drugs
NIOSH
which MLPs can prescribe CS under CPA?
NP, PA, CPP
system required to check before sale of pseudoephedrine
NPLEX
which form of plan B can be sold OTC without restriction?
Plan B one step (levonorgestrel 1.5 mg)
levonorgestrel
Plan B, Take Action, Next Choice, My Way
drugs that DO NOT require CR packaging
SL dose forms of nitroglycerin, SL and chewable forms of ISDN in dose strengths of 10 mg or less, OCs, powder packets of drugs (e.g. cholestyramine, erythromycin), steroid tablets (betamethasone, prednisone, methylprednisolone up to a certain strength)
buprenorphine
Suboxone, Subutex, CIII
T/F a separate registration with DEA is required for each location where CS are manufactured, distributed, stored, administered, or dispensed
T
T/F every community/retail pharmacy must be registered with DEA
T
T/F it is acceptable to deliver controlled substances through USPS
T
T/F pharmacies can sell compounded products made from ethanol purchased with form ATF-11
T
T/F selling drugs from one hospital to another is currently only allowed to help manage drug shortages
T
T/F if after initial notification to the DEA that theft or loss did not occur, DEA form 106 does not need to be filled out
T - registrant should contact DEA to resolve initial report and explain why 106 was not filled out
t/f pharmacies can dispense methadone
T for pain only, not for addiction
T/F pharmacies must have auxillary method for recording RFs if computers go down
T; also all computers must have method for printing out refill data for any CS
Federal Anti-Tampering Act of 1982
Tylenol adulteration and poisoning -> made federal crime to tamper with OTC products, required tamper-resistant features on OTC medications
which chapter deals with HDs?
USP 800
Primary Engineering Control (C-PEC)
a device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs).
what is a power of attorney?
a legal document that gives the person the registrant has chosen the power to act in the registrant's place
which drugs cannot be substituted/switched to different brand?
a pharmacist may substitute A-rated products and use his judgment on unrated products except for antiepileptic drugs used to treat patients with epilepsy or seizures
the board shall elect from its members the following:
a president, VP, and other officers as needed; serve 1 year term for these offices
requirements of OTC drug facts label
adequate directions for use required: must include safety in *pregnancy and breast feeding*, calcium, sodium, magnesium, and potassium content, product contact info in US to report adverse events
what is included in USP DI volume II?
advice for the patient
phase two of OTC monograph approval
agency review of active ingredients in each class of drugs, public comments, any new data; published as tentative final monograph (TFM)
who is exempt from DEA registration?
agents or employees of registrants, drug reps, common carriers, ultimate users, prescribers and dispensers in the service of US govt, law enforcement (will need DEA number for private practice tho)
CS act of 1970
aka comprehensive drug abuse prevention and control act. establishes regulations surrounding controlled substances. established closed system of manufacturing, distribution, and dispensing of CS with purpose of reducing diversion
drugs that require CR packaging
all PO rx drugs, liquid anesthetics, OTC NSAIDs and salicylates, any OTC iron supplement, MVI/mineral with iron and natural products with iron, loperamide, minoxidil, rx drugs that were converted to OTC, mouthwash and fluoride containing mouth rinses, oral and non-oral investigational drugs for outpatient use (unless there is data that the amount being used would not harm a young child)
anabolic steroids act of 2004
all anabolic steroids are schedule II
federal law regarding controlled rx if a prescriber dies
all controlled rx are null and void because their DEA number is no longer valid
which schedules can be ordered through CSOS?
all of them, CI-V
comprehensive addiction and recovery act (CARA 2000)
allowed NPs and PAs to tx patients for opioid dependence
DATA 2000
allows office based opioid addiction tx
Comprehensive Addiction and Recovery Act of 2016
allows partial CII filling upon patient or prescriber request for up to 30 d; added NPs and PAs as eligible practitioners that can prescribe CIII-V drugs fro tx of opioid dependence
what things may void a 222 form?
alteration, erasure, incomplete, illegible, or improperly prepared; errors
Drug Listing Act of 1972
amended FDCA to require drug establishments that are engaged in manufacturing, prep, propagation, compounding, or processing of drugs to register all drugs with FDA; required NDC numbers
Amytal
amobarbital, CII
legend drug aka
an rx drug
what is the one exception to not allowing transfers of CIIs?
an unfilled electronic rx can be transferred
AndroGel
anabolic steroid, CIII
how often must manufacturers and distributors renew DEA registration?
annually
BOP inspection schedule
annually to every 4 years
which drugs require medication guides with dispensing?
antidepressants, antipsychotics, anticonvulsants, most antiarrhythmics, NSAIDs, others
if a healthcare provider or patient reports AEs of a drug to the manufacturer, they are required to send collected reports to the FDA when?
at quarterly intervals for the first three years the drug is marketed (part of phase IV)
when can easy-open caps be used?
at the patient's or prescriber's request - prescriber can request this for one rx at a time - patient can provide a blanket waiver for all dispensed rx (document with signature). child resistant packaging is also waived when a healthcare provider directly administers drug
what must be written on the face of an original rx for an emergency oral CII drug?
authorization for emergency dispensing
what must appear on face of written signed emergency CII rx
authorization for emergency dispensing + date of oral order
Orphan Drug Act of 1983
authorized incentives to manufacturers to develop orphan drugs - tax credit for 50% of clinical testing costs; drugs given 7 year period of exclusivity
automated dispensing devices must be located in a facility with a pharmacy permit, otherwise they can only be used as an
auxiliary medication inventory
"readily retrievable"
available within 48 h of BOP request
syringe sales in NC
available without rx OTC
prescription drug marketing act of 1987
bans sale, trade, or purchase of rx drug samples. established sales restrictions and recordkeeping requirements for samples. prohibits hospitals and other healthcare entities from reselling rx drugs to other businesses. requires state licensing of wholesalers; bans re-importation of rx drugs except by manufacturers
records and inventories of CIII-V must be maintained separately or
be readily retreivable from ordinary records with marking that distinguishes them from other items
when during the day should CS inventory be done?
beginning or end of day; note on inventory
Regimex
benzphetamine, CIII
color of copy 3 form 222
blue
credentials of a qualified nuclear pharmacist (person who can apply for nuclear pharmacy permit)
board certified OR meets minimum standards of training for authorized user status by the US Nuclear Regulatory Commission (includes 200 contact hours in nuclear pharmacy from a college of pharmacy and min 500 h of clinical nuclear pharmacy training under qualified nuclear pharmacist)
in lieu of a DEA number, practitioners in armed service, public health service, or bureau of prisons must annotate the following on rx
branch of service/agency, service ID number
minimum requirements by FDA for what an rx ad must contain
brand and generic name, at least one FDA approved use, most significant risks
Briviact
brivaracetam, CV
color of copy 1 form 222
brown
Butisol
butabarbital, CIII
Stadol
butorphanol, CIV
when must the supplier send copy 2 to the DEA?
by the end of the month during which the order was fulfilled
what minerals are required to be listed with their amounts on OTC drug labels?
calcium, sodium, magnesium, and potassium content
what are examples of incidental disclosures that do not qualify as a HIPAA violation?
calling a pt name in a pharmacy, discussion of pt care during rounds, using pt sign in sheets in waiting rooms
a dispensing physician registered with the BOP who provides services at a free clinic without a pharmacy permit can/cannot accept and dispense donated drugs
can
when can CII rx be faxed
can be faxed for pharmacist to prepare order so it is ready ahead of pt arrival; must get original before dispensing; fax is not considered valid
what if a supplier cannot fulfill a CII order within a month?
can endorse order to another supplier to fill
how should pharmacists label rxs for expedited partner therapy?
can label as john doe partner 1 or other unique identifier; do not need to obtain pt name/address, etc; counseling can be bypassed
a pharmacist or free clinic can/cannot resell donated items
cannot
if not registered with the DEA, LTCFs can/cannot keep stock of CS
cannot
prescribers can/cannot restrict where rxs are sent
cannot
retail pharmacies can/cannot receive drug samples
cannot
when is dronabinol CIII?
capsule form (Marinol)
hazardous drug classes/qualities
carcinogenic, teratogenic, reproductive toxin, low dose organ toxicity, genotoxic, looks/acts like known HD
CII, III, and IV drugs are required to have the following written on the container
caution: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed
label requirements for CII-IV
caution: federal law prohibits transfer of this drug to any person other than for whom it was prescribed
DEA form 224b
chain pharmacy renewal
a pharmacy may compound a preparation containing CII-V drugs provided the following:
compound is aqueous, oleaginous, or solid dose form, does not contain more than 20% of controlled substance, only distributed to prescribers authorized to dispense controlled substances
PPPA is enforced by which division of govt?
consumer product safety comission
federal comprehensive drug abuse prevention and control act of 1970 aka
controlled substances act
brown copy of 222
copy 1
the registrant supplying drugs keeps which copy of form 222?
copy 1 (brown)
green copy of 222
copy 2
the registrant supplying drugs forwards which copy of form 222 to DEA?
copy 2 (green)
blue copy of 222
copy 3
the registrant requesting or receiving CII drugs keeps which copy of 222?
copy 3 (blue) is kept, copies 1 and 2 are sent to supplier
pharmacist manager must report all personnel incl ___ annually and within 30 d of change
corporate officers, owners, pharmacists, supportive personnel with license numbers
there must be a separate/quarantined area in the pharmacy for which drugs so they cannot be sold?
counterfeit, adulterated, expired, and investigational new drugs
pharmacist must audit drugs placed into ADD by pharmacy tech how often?
daily
methods for refills on controlled substances with electronic prescribing of CIII and CIV
daily hard copy printout of refills provided within 72 h of date dispensed, or bound logbook or separate file documenting each day's refills
for CII rx in NC, the pharmacist may add or change the following missing or incorrect info after consulting with practitioner and documenting on rx:
date issued (added only), pt address, drug strength, drug dose form, drug quantity, directions for use
prescription requirements
date issued, name AND address of pt, drug name, strength, dose form, quantity, directions, number of refills or stop date (for hospitals), route of admin, name/address/phone of prescriber, legal signature of prescriber written on date of issue, DEA number of prescriber/institution
special things to put on transferred rx if for CS
date of original dispensing, pharmacy name, address, DEA, rx number, dates and locations where filled
what must be recorded for each partial fill of a CII for LTC/terminal pt
date of partial fill, quantity dispensed, quant remaining, ID of dispensing pharmacist; may be in compunter or on back of rx
which dates must be written on a CII rx to be filled for future use?
date rx was written and earliest acceptable fill date
what does the receiving pharmacy need to dispense a transferred rx?
date written, number of refills, date first dispensed, number refills remaining, pharmacy name/address/DEA number/rx number, name of pharmacist
records of controlled drugs must be kept for 2 years from date last ___
dispensed/refilled
information in CSRS
dispenser DEA, full name, address, phone, and dob of pt, date rx written, date rx filled, rx number, whether rx is new or rf, quantity of dispensed drug, days supply of drug, NDC of drug, prescriber DEA, method of payment for rx
DEA form 224
dispenser registration (incl prescribing, administering and dispensing - retail pharmacies, hospitals, physicians, and MLPs)
practice of pharmacy defined as pharmacist performing the following tasks:
dispensing meds, compounding, storing drugs, maintaining records, controlling pharmacy goods and services, advising and educating pts or healthcare providers, report ADRs, take, record, monitor, assess medication/device hx, perform DUR, administer immunizations, collaborate with physicians as a clinical pharmacist practitioner
DEA form 41
disposal or destruction of CS
P or R is the first letter of the DEA number for the following:
distributors
pharmacists do/do not need to complete CE for first renewal if licensed by examination that year
do not
recordkeeping for refusals of counseling
document and keep for 3 years
breakage or spillage of CS does/does not count as a loss
does not; form 106 should not be filled out
Syndros
dronabinol soln, CII
DATA 2000 stands for
drug addiction treatment act
written material that is considered to be part of package labeling for a drug
drug container, consumer medication information (not approved by FDA), package inserts and medication guides (approved by FDA), and any paperwork related to REMS
what is included in USP DI volume I?
drug information for healthcare professionals
prescription drug user fee act of 92
drug manufacturers required to pay fees when submitting an NDA
requirements for drug return, reuse, donation, and recycling (e.g. Dispensary of Hope)
drug must be in original unopened tamper evident unit dose packaging, not expired, visible exp date at least 6 mos from donation date, controlled drugs cannot be donated, pharmacist is part of verification and distribution process, pt receiving donated drugs requires valid prescription
what must be recorded on form 41?
drug name, NDC, strength, dose form, package quantity, number of full packages, partial package count of each CS disposed
info required on record of receipt of CIII thru V
drug name, dose form, strength, number of dose units/volume per container, number containers, date of receipt, name/address/DEA registration number of supplier
pt wishing to use IND under right to try legislation must sign consent prepared by physician stating:
drug name, potential best/worst outcomes, possible sx, pt is liable for expenses unless contract with manufacturer, manufacturer/prescriber not liable
information required on a unit dose label
drug name, quantity of API, BUD, lot number, name of manufacturer/packager/distributor, required cautionary statements
facilities can operate as an outsourcing facility under section 503b if the following requirements are met:
drugs are compounded in accordance with cGMP, facility is licensed as outsourcing facility by FDA, facility is subject to inspection by FDA, preparations are made by or under supervision of licensed pharmacist, facility meets labeling, drug reporting, and AE reporting requirements
kefauver harris amdt of 1962
drugs must be proven effective, transferred rx drug advertising from the FTC to the FDA. established GMPs; required informed consent of research participants and reporting of ADRs (thalidomide)
three conditions that make drug available only by rx according to Durham Humphrey amendment
drugs that are habit-forming, drugs considered unsafe except under expert supervision due to toxicity concerns, drugs limited to rx use only under manufacturer's NDA
controlled substances defined
drugs with potential for addiction and abuse
toll free phone number reqs for mail order pharmacy
during pharmacy's regular hours of operation, at least 6 d/week and 40 h/week, disclosed on rx label
requirements for safe storage/preventing deterioration of drugs in med paks
each container must comply with moisture permeation requirements for class B single unit or unit dose container, each container must show evidence of having been opened or is not re-sealable
how are items written on 222 form?
each item must be written on separate line with total of 10 lines on each form - max of 10 items can be ordered
how are the 5 pharmacist BOP members chosen?
each represents a district of NC and are elected by pharmacists in that district
when must patient package inserts be given for drugs that require one with dispensing?
each time drug is dispensed in outpt setting, with initial fill, and with refills in community. in institution, must be given prior to first dose and every 30 d thereafter.
purpose of phase III trial
efficacy for treating condition vs. gold standard or placebo; manufacturer files NDA or BLA if successful
methods for OTC approval
either through an NDA or through a three phase public rulemaking process
Viberzi
eluxadoline, CIV
who can communicate CS rx?
employees or agents of the prescriber
when can a CII fax be received?
for LTC pts, for hospice patients, and for the purposes of preparing an rx before the pt arrives (cannot dispense this until the actual rx is received)
when should a pharmacy with an existing permit need to apply for new permit?
for a new location, change to new business entity, change resulting in different person or entity owning more than 50 percent interest in permit holder or any entity in the chain of ownership above the permit holder
which form is used to report in-transit losses of controlled substances?
form 106
codeine is classified as CV if
formulated as part of a combo SYRUP
codeine is classified as CIII if
formulated as part of a combo TABLET or CAPSULE
___ drug approval requires an ANDA
generic
label on compounded product should include
generic name, quantity/concenration of each API, BUD, storage conditions, rx/control number, container used in dispensing, aux labels, statement that product is compounded, packaging and storage reqs
the most common error made by pharmacists
giving the wrong drug to a patient
categories required in prescribing information/package insert approved by FDA
highlights, followed by: indications and usage, dosage and administration, dosage forms and strengths, boxed warnings, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations (inc. pregnancy, nursing, peds, and geri), description, clinical pharmacology, clinical studies, references, how supplied/storage and handling, patient counseling information
what does the DEA number of a medical intern/resident prescribing under the hospital look like?
hospital's DEA number followed by suffix with physician's hospital code number
which setting must include bar coding on prescriptions/drugs?
hospitals
Hyslinga ER
hydrocodone
Zohydro ER
hydrocodone
when can a LTCF have CS on premises without DEA registration?
if ADD is installed by retail pharmacy registered with the DEA; retail pharmacy must have separate DEA registration at LTCF location; pharmacy can keep ADD records at the pharmacy
when will form 222 be sent back?
if alterations or cross outs are present, if the drug name/strength/size/quantity is missing or if date or signature is missing. minor spelling errors may be corrected by distributor but should be avoided (e.g. methodone instead of methadone)
when can a container be reused?
if made of glass or threaded plastic and given new top
out of state pharmacies dispensing to NC must develop policies for
if pt med is not available at out of state pharmacy or delivery is delayed, receipt of rx for acute illness, pt med has not been received within normal delivery time and pt is out of med
reasons a pharmacist may partially fill a CII rx
if pt or prescriber requests, total quantity dispensed in all partial fills does not exceed the total quantity prescribed, total amount filled no later than 30 d from written date
when must institution provide a med guide
if pt requests or is a REMS drug requiring a med guide
when must written authorization be provided to share PHI?
if release of info is not for purposes of tx, payment, or operations. authorization must include pt signature, parties involved, information released, exp date
when can a returned medication be combined with a stock bottle (e.g. with return to stock unclaimed meds)?
if they have the same lot number. must have exp date on return to stock bottles
when can tax free alcohol be dispensed to patients?
if used in compounded products provided to patients free of charge for nonprofit clinic use
in emergency situations an rx for a CII can be called in to the pharmacy. what defines an emergency?
immediate admin of the med is necessary, no appropriate alternative tx available, it is not possible for prescriber to proved rx before drug is dispensed
when do you need to report significant losses of controlled substances?
immediately, within 1 business day to DEA (through form 106) and to BOP
what are the most common causes of disciplinary action
impairment, drug theft, and diversion
when can a pharmacist accept a donated med?
in original, unopened, sealed, tamper evident packaging, unit dose packaging is sealed; exp date is later than 6 mos after date donated; no adulterated or misbranded
how must practitioners store CS?
in securely locked cabinet
an unapproved drug will have an NDC but will not be listed where?
in the Orange book
OBRA-90
includes prospective drug review, patient counseling, and patient profiles
what does it mean when license is surrendered?
individual agrees to voluntarily give up license (often to avoid penalties or criminal charges)
BOP has __ authority, meaning they can prevent someone from practicing
injunctive
how must an rx be written?
ink, indelible pencil, or typewritten, or prepared by prescriber's agent.
when must the remainder of a partial fill CII rx be given for emergency oral rx or insufficient stock drugs?
insufficient stock: within 72 h after first partial fill
a pharmacist receiving an rx for a biologic can dispense any ___ drug product
interchangeable
if permit for out of state pharmacy is revoked or suspended by home state, then it is/is not automatically revoked or suspended in NC
is
define interchangeable
is biosimilar plus can be expected to produce same clinical result and does not have difference in safety/efficacy risk
there is/is not a limit on the number of times a noncontrolled rx can be transferred
is not
codeine classified as CII if
it is a single agent
what if a drug is not dispensed with required pt package insert (e.g. estrogen)?
it is considered misbranded
what if a product does not have an exp date?
it is misbranded, may be considered expired, and should not be dispensed
what to do when pharmacist completes form 222
keep copy 3 (blue) and send copy 1 and 2 to supplier - must keep copies 1 and 2 together with carbon intact
what should pharmacy do for nonCII CS sent to reverse distributor?
keep record of distribution on an invoice
Ketalar
ketamine, CIII
two FDA approved EC pills
levonorgestrel (rx and OTC) and ulipristal (rx only)
what does it mean when a license is suspended?
license is inactive and may be reinstated after conditions are met
what does it mean when a license is revoked?
license is taken away
instances where CSRS reporting is not required
licensed hospital or LTCF that dispenses them for inpt admin, wholesale distributor, DVM, dispensed directly to ultimate user for up to 48 h supply, samples of CV nonnarcotic, nonanorectic drugs
what are examples of class III devices?
life support/sustaining devices
Vyvanse
lisdexamfetamine
Belviq
lorcaserin, CIV
Durham Humphrey Amendment of 1951
made distinction between OTC and rx drugs, and required OTC drug facts label, set requirements for unit-dose labeling
permissions for dietary supplement claims
manufacturer is allowed to claim product addresses nutrient deficiency, supports health, or is linked to body functions. supplement CANNOT claim that it cures, prevents, corrects, or treats disease (health claim is reserved for drugs)
who can prescribe meds under the DEA registration of a hospital or institution?
medical interns, residents, and visiting physicians in a hospital/institution
which drugs are eligible for use under the right to try act?
meds that have completed phase I trial but are not FDA approved
term limits for BOP members
members can serve up to two consecutive 5 year terms
Dolophine
methadone
DEA form 363
methadone for addiction
M is the first letter of the DEA number for the following:
midlevel practitioners
false or misleading statements in advertisement of rx drugs are considered ___
misbranding
it is considered __ is a pharmacist labels a branded drug as the generic and vice versa
misbranding
Provigil
modafinil, CIV
how often must supervising physician and CPP meet?
monthly for the first 6 mos then every 6 mos thereafter
Arymo ER
morphine
Infumorph
morphine
MorphaBond ER
morphine
requirements to be a qualifying physician for prescribing opioid addiction tx
must apply for waiver, be registered with DEA, have unique ID (X DEA), board certified in addiction psychiatry/medicine, complete addiction certificate, at least 8 h approved training
restrictions for use of tax free alcohol
must be for medical or scientific use, may NOT be sold or loaned to other pharmacies/physician's offices, may NOT be sold to outpatients, MUST KEEP INVENTORY, must store securely in pharmacy
requirements for shipping an rx to another state
must be licensed with BOP in that state
restrictions for narrow therapeutic index drugs
must be refilled with same manufacturer
requirements for CR packaging
must be significantly difficult for children under 5 to open within a reasonable time, and not difficult for normal adults to use properly
requirements for consumer medication information
must be supplied with each new rx, should be simplified for pt understanding and reflect package insert, should explain how to use drug and what to expect, is not reviewed/approved by FDA
pharmacy requirements for receiving e-rx
must digitally sign and archive e-rx, may change after receipt but must sign and annotate/archive this electronically; must back up records daily and keep internal audit trail
extra reqs for NPs/PAs to qualify for tx of opioid addiction
must do 16 more hours of training on top of 8 h required of physicians, must be supervised or work in collaboration with a qualifying physician
prescriber requriements for e-signing rx
must have 2 out of 3: what they know, are, have (PW, biometric, token/USB)
requirements for noncertified tech
must have high school diploma or equivalent or be currently enrolled in program which awards one, must complete required training program provided by supervising PM within 180 d of hire
reference library requirements
must have state and federal pharmacy statutes and rules; DDIs, AEs, therapeutic use, dosing and tox, pt-oriented reference materials for counseling, equivalent drug products (e.g Orange book), any reference materials otherwise required by state or federal law
what are components of 2 factor authentication?
must have two of the following:
ledger requirements for Robitussin AC
must keep bound ledger for 2 years with name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser
recordkeeping for CIII-V orders
must keep receipt (invoice or packing slip) of drugs received and confirm accuracy; must be maintained in a readily retrievable manner; if invoice contains noncontrolled substances the CS must be identified in readily retrievable manner
requirements for electronic prescribing software for controlled substances
must pass DEA sanctioned audit by third party for electronic prescriptions for controlled substances, prescribers must use 2 factor authentication to sign and transmit rx
what if a supplier refuses to fill an order?
must provide purchaser with statement of occurrence. purchaser must electronically link statement to original order and keep electronic copy of voided order
what must be done in order for a site to legally sell controlled substances online?
must register with DEA as a pharmacy and complete application for modification for online pharmacies, notify DEA within 30 d of selling to a state, include verbage on website, list physical location of pharmacy/employees/contact info with degrees and license numbers
requirements to become a validating technican
must register with NCBOP, be certified tech, hold associate's degree in pharmacy technology
what to do if business closes with DEA registration
must return certificate of registration, unused 222 forms to DEA
requirements to be certified tech
must take nationally recognized PTCB exam (not necessarily PTCB itself) and obtain/maintain certification
Cesamet
nabilone, CII
federal law requires the following info on the dispensed rx label:
name and address of dispenser, serial or rx number, date of fill, prescriber's name, pt name, directions for use, cautionary statements
DEA form 225
new registration form for manufacturers, distributors, researchers, analytical labs, importers, exporters
pharmacy label requirements
name and address of pharmacy, serial no of rx, date of rx, name of prescriber, name of pt, name/strength of drug, generic name of drug, directions for use, appropriate cautionary statements, filled by/dispensed by with name of pharmacist (at least first initital and full last name), warning re. alcohol with sedatives, discard date; do not obscure exp and storage info on original container
which of the following may be stored in a readily retrievable file in lieu of appearing on rx?
name and address of pt, number of refills authorized, route of admin, name/address/phone of prescriber, DEA number
bound book record needed for sale of Cheratussin AC
name and address of purchaser, name and quantity of CS, date, name/initials of pharmacist
required info on 222 form
name and address of supplier, name of substance, dose form, number of units/volume in container, number of containers ordered, NDC, signed and dated by person authorized/power of attorney
information in refills that must be recorded in computer or on back of rx
name and dose of CS, date filled or RF, quantity dispensed, initials of dispensing pharmacist, total # refills
med paks/customized pt packaging for adherence (e.g. pillpack, monthly pill cards, etc) labeling requirements
name of pt, serial/rx number for pack itself and for each drug, drug name, strength, physical description, quantity, directions for use and cautionary statements for each drug, required storage instructions, name of prescriber for each drug, date of rx on med pak and BUD assigned to med pak (max 60 d), name, address, phone number of pharmacy, pharmacy DEA if CS are included, required warnings/statements for drugs. if separation of each blister is allowed, need drug names on each container/blister
master formulation record should contain the following:
name, strength, dose form, calculations, description and quantity of ingredients, compatibility, stability and storage info with references, equipment needed for preparation, mixing instructions with order of mixing, mixing temps/environment controls, duration of mixing
inventory reqs for donated drugs
name, strength, dose form, number of units, lot, exp date name, address, phone or donor kept for 3 years
things that can be included in pt counseling according to OBRA 90
name/description of drug, rout, dose form, dose, duration of tx, how to prep for admin, self-monitoring techniques, common and/or severe ADRs/DDIs, missed dose, refills, adherence, storage
reports of disease outbreaks may be related to bio-terrorism. Reports may be sent to what system to monitor, control and prevent disease?
national electronic disease surveillance system (NEDSS)
do practitioners need more than one DEA registration if they prescribe from multiple offices?
no (administering, dispensing, or keeping CS in each office would require more than one registration)
can controlled substances be removed from a pharmacy in the absence of a pharmacist?
no (but they can be removed from auxiliary medication inventory)
can an order be endorsed to another supplier through CSOS?
no (it CAN be endorsed to another supplier with form 222, however)
does the CSOS have limits to how many controlled drugs can be ordered at once?
no (max is 10 on form 222)
does compounding require cGMPs?
no (unless outsourcing facility)
is basaglar a biosimilar to lantus?
no - only dispense basaglar if prescriber wrote for it
can the prescriber's agent date the prescription?
no - the prescriber must sign and date
is there a specific exp date for noncontrolled drug rx?
no - there is no date before which noncontrolled drugs must be filled after prescribed
if you are licensed, residing, and practicing in another state, do you need to complete NC's CE requirement?
no but you must pay renewal fee
are oral rxs of CIIs allowed?
no except in emergencies
requirements to purchase emergency contraception
no gender or age requirement or ID requirement; should be placed in aisle with other OTCs
when must dispenser report to CSRS after dispensing?
no later than close of next business day
rules for controlled nonprescription drugs
no more than 8 oz may be sold within a 48 h period, purchaser is at least 18 with an ID, and bound log book is kept with name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance
food drug and cosmetic act of 1938
no new drugs can be marketed until proven safe and approved by FDA; labels must contain adequate directions for use and warnings about habit forming properties (sulfanilamide)
what is not required in an ANDA as apposed to an NDA/BLA?
no pre-clinical studies or clinical studies; bioavailability is replaced with bioequivalency analysis
when can a manufacturer distribute a complimentary sample of a CS?
only after practitioner makes written request with names and addresses of manufacturer and practitioner and name and quantity of drug; must keep request for 2 years
what must a supplier put on copies 1 and 2 of a 222?
number of containers for each item and date shipped; may void or cancel all or part of order for any reason (in which case they send copies 1 and 2 back to purchaser)
what must the purchaser put on copy 3 of 222 when order arrives?
number of containers received of each item and date received
there are three columns for each drug on form 222:
number of packages, size of package, name (brand or generic) and dose
election day for BOP members
october 31
counseling reqs in NC
offer to counsel shall be made on new or transfer prescriptions at the time the rx is dispensed or delivered to pt or representative
compounding record or log book should contain the following:
official or assigned name, strength and dose of preparation, MF record reference, names and quantities of components, sources, lot numbers, and exp dates for components, total quantity compounded, name of person who prepared the preparation, name of person who performed quality control, name of compounding pharmacist, date of preparation, assigned control or rx number, assigned BUD, duplicate container label, description of final preparation, results of quality control procedures, documentation of quality control issues/AEs or preparation problems
when are privacy notices required?
on first day service is provided, pharmacy must make effort to get written acknowledgement
out of state pharmacies must place toll free number where?
on rx label
when should newly scheduled drugs be inventoried?
on the day they become scheduled
pharmacies must report significant losses and all thefts of controlled substances to the local DEA office in writing within ___d of discover and complete DEA form ___ when circumstances of loss/theft are known
one business day, 106
Talwin
pentazocine, CIV
Nembutal
pentobarbital, CII
Fycompa
perampanel, CIII
when is a new pharmacy permit not required?
permit holder is publicy traded corporation, permit holder is a wholly owned subsidiary corporation
DATA 2000
permits physicians to prescribe and dispense CS in office-based setting to tx opioid dependence
what does a DATA 2000 waiver do?
permits physicians to prescribe and dispense schedule III - V drugs to tx opioid addiction outside of opioid tx clinic (grants X DEA number)
what to do when CII drugs are received by pharmacy
pharmacist checks in order and records number of packages received and date received on blue copy
permits are issued persuant to joint application of __ and __
pharmacist manager and owner
federal requirements to document refills of CIII and CIV drugs
pharmacist must notate on back of rx with initials, date dispensed, and amount dispensed
who can dispense Cheratussin AC over the counter?
pharmacist only; though nonpharmacists can do the register transaction
who can transfer non controlled rxs?
pharmacist, intern, certified tech
requirements of OBRA 90
pharmacists must perform a prospective DUR and counseling for all medicaid beneficiaries before dispensing the rx to the patient. states are also required to perform a retrospective DUR
after march 31 if pharmacy has not renewed permit
pharmacy must be closed and must re-apply for new permit if they have not renewed
how is pharmacy stock stored at a LTCF in an ADC registered with the DEA
pharmacy must have separate DEA registration for ADS located at LTCF; drugs are considered pharmacy stock before being dispensed
reqs for CS inventory
pharmacy name and address, name, strength, dose form of CS, date of inventory, open vs close of business, signature of pharmacists in charge conducting inventory
Under Board rules, an automated dispensing device may only be installed at a facility holding a ____. It is the consensus of the Board that limited service permits may be obtained for the installation of automated dispensing systems in long term care facilities.
pharmacy permit
Pregnancy and Nursing Labeling Final Rule 2014
phases out drug pregnancy categories and restructures into three categories of Pregnancy, Lactation, and Females and Males of Reproductive Potential
PCP
phencyclidine, CII
Bontril PDM
phendimetrazine, CIII
Qsymia
phentermine and topiramate, CIV
Adipex-P
phentermine, CIV
Suprenza
phentermine, CIV
only __ have unlimited independent prescribing authority in all states
physicians
A, B, F is first letter of DEA number for the following:
physicians, dentists, vets, hospitals, and pharmacies
which form of plan B requires a prescription if younger than 17 (can be OTC if over 17)?
plan B 0.75 mg
what is 'fair balance' in rx drug advertising?
positive info about drug must be balanced with negative information; side effects and safety concerns must be presented in a manner designed to have a similar impact to drug benefit
purpose of phase IV trial
post marketing surveillance, monitoring in high risk groups, long-term effects of drug exposure
requirements for writing multiple rxs for a CII in one office visit
practitioner determines legitimate med purpose, each rx is on separate blank, total quant does not exceed 90 d supply, writes earliest fill date on each rx "do not fill until", multiple rxs do not create an undue risk of diversion or abuse
Dietary Supplement Health and Education Act (DSHEA) of 94
premarket review is required for all NEW dietary ingredients. FDA approval is not needed prior to release otherwise. Product must have disclaimer that FDA has not evaluated claim and must have research to back up claims.
requirements for if electronic transmission of prescriptions fail
prescriber may print copy of rx and manually sign; must indicate rx was originally transmitted to pharmacy and failed; considered a written rx; pharmacist must make sure transmitted rx was not received and dispensed
what number must appear on NP/PA/CPP prescriptions?
prescribing/license/approval number; NP/PA must also have supervising physician name
CMS required security features for rxs must include at least one feature from each of the following three categories:
prevents duplication (e.g. void pantograph)prevents erasure or modification (quantity check box, refill indicators, or chemically reactive ppr), prevents use of counterfeit forms (e.g. serial number or watermark)
what is required on an OTC label for it to not be misbranded?
principal display label with font large enough to accommodate all mandatory label info, statement of identity with name of drug followed by statement of general pharmacologic category, quantity of contents, name and address of manufacturer/packer/distributor, directions for use, drug facts panel
if using electronic system to record refills that provides a printout of the day's CS refills, what must the pharmacist do?
printout must be verified, dated, signed by each pharmacist who refilled rxs within 72 hours; may keep logbook or file in lieu of a printout where pharmacist signs statement verifying CS rx refilled
pure food and drug act of 1906
prohibited the adulteration and misbranding of foods and drugs in interstate commerce
prescription drug marketing act f 1987
prohibits reimportation of drugs manufactured in US, sent to foreign country, and returned to US for sale (exception for product's manufacturer). prohibits sale of drug coupons (may be given for free). drug samples may be given at no cost.
DUR requirements of OBRA 90
prospective DUR by dispensing pharmacist and retrospective DUR performed by state for medicaid pts
orphan drug act of 1983
provides tax and licensing incentives for manufacturers who develop drugs for less than 200K americans
do psychiatrists or psychologists have an MD?
psychiatrists
requirements for pt to receive rx/DME at no cost in the event of a disaster or emergency
pt must be uninsured and have one of the following: new rx, current rx bottle, rx called in by healthcare provider, proof of existing rx
what cannot be changed on a CII rx by the pharmacist?
pt name, CS name (except generic sub), prescriber signature
information required in a patient profile
pt name, address, phone number, DOB, gender, disease state info, drug allergies/intolerances, ADRs, list of meds/devices previously dispensed, relevant pharmacist comments
which three items cannot be changed on controlled substance rxs?
pt name, drug name (except generic sub), and prescriber's signature
who can request dispensing meds in nonchild resistant container
pt or prescriber
exceptions to rule against prescription of narcotics to maintain addiction
pt part of narcotic tx facility (methadone), qualifying practitioners prescribing buprenorphine, narcotic drug admin for up to 3 d while arrangements are made for referral with 1 d supply given at a time, hospitalized pts incidental to tx condition other than addiction
phase three of OTC monograph approval
publication of the final OTC drug monograph; establishes conditions under which the OTC drug has been generally recognized as safe and effective
where do 222 forms go?
purchaser keeps copy 3 (blue) and sends copies 1 and 2 to supplier; supplier keeps copy 1 (brown) and sends copy 2 (green) to DEA
what if unfilled DEA form 222 gets lost?
purchaser must execute another 222 form with statement containing serial number of lost form, date of lost form, and that CIIs were not received; send statement to supplier
what if a form 222 is lost or stolen?
purchaser must re-order with new form and prepare statement that order was not received, and include serial number of lost/stolen form and date of loss. attach statement to new order form and send to supplier. file new and original forms together. if supplier subsequently receives original form, it is marked as 'not accepted' and returned to purchaser
what if a mistake is made on form 222?
purchaser must write VOID on form 222 and begin again with new form
pharmacy must record the following for pseudoephedrine sale
purchaser name, address, product sold, quant, date/time of sale, ID, signature
which color book provides guidance on biosimilar vs interchangeable status
purple book
patients cannot buy drugs from outside US with these exceptions:
quantity is for 90 d or less and is for patient, and effective treatment is not available in US, condition is serious, and drug imported has no unreasonable risk
type of application used for change in address of pharmacy
re-registration
class 1 recall
reasonable probability for serious AEs or death
class I recall
reasonable probability that use or exposure will cause serious adverse consequences or death, e.g. too high strength of drug
purchaser must link __ and ___ when receiving order from CSOS
receipt of CS with original order
recommended time window for ulipristal (Ella)
recommended within 72-120 h (rx only)
DEA form 41
record of controlled substances destroyed
- Pharmacists can be punished by BOP by
reprimand, suspension, revocation, restriction, or denial of licensure. Can also suspend registration
record keeping for med paks
record shall be made of each med pak dispensed containing pt name and address, rx number for each drug, name of manufacturer/labeler and lot number for each drug, info identifying or describing design/characteristics of med pack to allow subsequent preparation, date of preparation and BUD, labeling instructions, name or initials of pharmacist who prepared it
label requirements for CIII-V
refills should be labeled with date of initial fill and date of dispensing
out of state pharmacies conducting business in NC must
register and renew annually with the NCBOP
prescribers who dispense drugs for a fee must
register annually with the BOP
if you want to compound for office use you must
register as an outsourcing facilty
what to do when controlled drugs are recieved
registrant must keep receipt/invoice/packing slip with recorded date of arrival and confirmation that order was accurate
what if insignificant CS loss occurs?
registrant places record of occurrence in a theft and loss file for future reference
DEA form 225
registration for manufacturers, distributors, researchers, labs, importers/exporters
DEA form 363
registration for narcotic tx programs
DEA form 224
registration for pharmacies, hospitals/clinics/institutions, and prescribers
which types of insulin can be sold OTC?
regular and NPH insulin
if no disposal instructions are given on the drug labeling and no take-back program is available, pts should dispose of drugs in the household trash following these steps:
remove drug from original container and mix with undesirable substance such as cat litter or coffee grounds. place mixture in sealed bag, can, or container and discard in trash
DEA form 224a
renewal dispenser registration
DEA form 224a
renewal registration for retail pharmacies, hospitals/clinics, practitioners, teaching institutions, or mid-level practitioners
DEA form 225a
renewal registration form for manufacturers, distributors, researchers, analytical labs, importers, exporters
DEA form 363a
renewal registration form for narcotic tx programs
what must be on the container of a centrally filled rx container?
retail pharmacy name and address, unique identifier e.g. central fill pharmacy DEA number
what form should be used for reverse distribution of CS for disposal?
reverse distributor fills out form 41; if CII are included, reverse distributor issues form 222 to sender
failure to pay child support can result in
revocation of license
secondary engineering controls
room where C-PEC is located
when a medication error occurs a ___ should be performed
root cause analysis
how can techs be used during pharmacist breaks?
rx may be received and assembly can occur, certified techs can receive phone orders, rx which have been previously prepared may be picked up by pts or their representative (log of dispensed rx required in case pt counseling needed)
FDAMA of 97 shortened labeling requirement from "caution: federal law prohibits dispensing without a rx" to
rx only
resale of rx drugs from HMOs or hospitals to pharmacies is prohibited except when
sales or purchases are made to other facilities in the same organization, sales made to nonprofit affiliates, emergency situations
out of practice 5+ years
same as 2-5 years except 1500 hours experience and pass NAPLEX and MPJE, appear before the BOP
what does a DATA 2000 number look like?
same as DEA number but 'X' replaces first letter
who can receive drug samples from the manufacturer?
samples can only be given to prescribers or to a hospital pharmacy or other healthcare entity at written request of prescriber. pharmacies CANNOT receive drug samples
pharmacies may fill rx for epinephrine pen written by healthcare provider for a ___
school (may have rx label with school name, nurse name, or both)
three components of prospective DUR
screening, counseling, pt profile/documentation
Seconal
secobarbital, CII
who is authorized to designate the official name for a new drug?
secretary of HHS
who can prepare CS rx?
secretary or agent can write all components but only prescriber can sign
training for pseudoephedrine sales
sellers must annually engage in self-certification, employees must be trained
how should samples be stored?
separately from other drug inventory
the board shall employ a pharmacist to serve as the executive director who does the following:
serves as secretary-treasurer, performs administrative functions, may conduct investigations, file a complaint, and prosecute the offender in a board meeting
A controlled substance emergency kit, whether an automated dispensing device or another implementation, can contain no more than __ controlled (II-V) drug entities in unit dose form
seven (7)
how should open drug containers be identified and stored?
should be identified from sealed containers (usually with an x) and kept physically separated from the unopened containers if sent to be destroyed or returned
CS intital inventory requirements
should have date, drug name, dose form, strength, bottle size, number of containers, count of substance
HDs should/should not be placed in automated counting or packaging machines
should not
how can prescribers ensure pt gets brand drug
signs on DAW line or writes dispense as written or DAW on rx; states it orally
which products are exempt from requiring tamper resistant features?
skin products, insulin, lozenges, and tooth cleaning powder
Xyrem
sodium oxybate, CIII
federal regs require labeling of ___ content per dose unit if it exceeds threshold set by FDA
sodium, calcium, magnesium, potassium
when is dronabinol CII?
solution form (Syndros)
what must be posted conspicuously?
specific hours pharmacist is on duty, every pharmacist manager's license, every permit, and every current permit renewal (licenses and license renewals of other pharmacists must be readily available)
labeling requirements for inner container of radiopharmaceutical
standard labeling reqs plus radiation symbol, CAUTION-RADIOACTIVE MATERIALS, radionuclide, chemical form of drug, amount of radioactivity, date and time of exp of drug, volume or number of capsules, number of ampules/vials/syringes if a gas, name/address/phone of pharamcy, rx lot number, name of pharmaceutical
who issued a statewide standing order allowing pharmacists and other practitioners to dispense naloxone?
state health director
class 1 medical devices
stethoscopes, bandages, crutches; manufacturers only need to provide general controls during the production of the device
permissible activities of a validating technician
stocking pt care unit medication inventories, stocking of ancillary drug cabinet inventories, stocking of automated dispensing or drug supply devices, stocking of emergency kits, prepakcaging of rx drugs within hospital pharmacy, validate other registered pharm techs in filling floor stock and unit dose distribution systems
Hatch Waxman act of 1984
streamlined drug approval for generics and granted patent protection for drug innovators; generic manufacturers can file ANDA or 502(b) application
drug price competition and patent term restoration act aka Waxman Hatch amendment
streamlined the generic drug approval process while giving patent extensions for innovative drugs
requirements of ANDA
study data to establish drug has same API, route of admin, dose form, and strength and is bioequivalent
Sufenta
sufentanil, CII
FDCA of 1938
sulfanilamide tragedy -> manufacturer must prove safety of drug before it could be marketed; authorized FDA to conduct manufacturer and distributor inspections, established penalties for misleading labeling, required listing all ingredients with accurate claims. provided definitions for food, drugs, dietary supplements, cosmetics, and devices
what is sNDA?
supplemental new drug application
what if a supplier cannot fulfill an order or if order is illegible/incomplete/altered?
supplier returns copies 1 and 2 with rationale for not filling order. purchaser keeps all 3 copies
1 BOP member is a resident appointed by
the governor (cannot be connected to healthcare)
prior to dispensing a target CS, pharmacists must review and document the following in the CSRS report for the last 12 mos
suspect pt is using drug nonmedically, prescriber/pt outside usual geographic area serviced by pharmacy, pt pays cash despite having insurance on file, pt shows potential misuse by over utilization, early fill requests, multiple prescribers, appearing overly sedated or intoxicated, request by unfamiliar patient using specific name, street name, color, or marks of opioid drug
T/F orders written for direct admin to pts in facilities are not considered rxs and do not need to meet reqs
t
t/f a buprenorphine rx can be written for off-label tx of pain by any prescriber
t
t/f a pharmacist may disclose any information to any person only when they reasonably determine the disclosure is needed to protect the life or health of any person
t
t/f an automated dispensing system can be used as an auxiliary medication inventory or emergency kit
t
t/f prescribing controlled substances for pain via telemedicine is inappropriate
t
the pharmacy file copy of rx must contain name and manufacturer of drug dispensed
t
t/f PAs and NPs can only dispense under supervision of a pharmacist (not a dispensing physician)
t (exception: drug samples or starter packs)
t/f the reason for a partial fill for a CII rx must be written on the rx
t - for each partial fill, the pharmacist must indicate the date of partial fill, amt dispensed, remaining amount, name of dispensing pharmacist.
t/f medication orders must be prospectively verified by the PharmD before the nurse removes the drug from an ADC
t, unless it is override or physician controlled medication, in which case the pharmacist retrospectively reviews the order
labeling requirements for outer container of radiopharmaceutical
tamper sealed with standard radiation symbol, CAUTION-RADIOACTIVE MATERIAL, radionuclide and chemical form, volume if in liquid, requested activity and calibration date and time, rx number, pt name if a blood product, name and address of pharmacy, name of end authorized user (must be a prescriber), lot number
Nucynta
tapentadol, CII
Kefauver-Harris amendment of 1962
thalidomide birth defects in Europe -> manufacturers must prove drug is safe and effective before approval by FDA. manufacturers must continue to report serious side effects to FDA after approval. individuals must give informed consent when they are study subjects. FDA had to conduct retrospective evaluation of the effectiveness of drugs approved between 1938 and 1962. allowed FDA to establish CGMPs
who has the federal authority for determining which schedule a drug goes into?
the Attorney General of the US
summary suspension
the BOP gives this to a license which immediately suspends their license before a hearing
an out of state remote med order processing pharmacy must be registered with the BOP as an out of state pharmacy and pharmacists must be licensed with
the NCBOP (e.g. remote order entry pharmacists)
what is the NDA for biologics?
the biologics license application (BLA)
what statement re. alcohol must be added with tranquilizers or sedatives labels
the consumption of alcoholic beverages while on this medication can be harmful to your health
the second letter of a DEA number signifies
the first letter of the prescriber's last name
what if a pharmacist just signs and dates the bac of an rx or annotates the rx record on a refill?
the full face amount of the rx is considered filled
what if an unfulfilled order from form 222 or CSOS is lost?
the purchaser must provide the supplier with the unique tracking number, date of loss, and statement that the goods from the first order were ever received. new and old orders must be electronically linked
what if a suppler cannot fill all or part of an order made through CSOS?
the purchaser will issue a new electronic order to a different supplier - suppliers DO NOT endorse orders to other suppliers
what if there is not stock of controlled substances on hand?
the registrant needs a record that shows zero inventory
if appropriate a pt may receive upon request drug quantities in excess of the face amount of the rx for a noncontrolled drug up to
the total amount authorized; not allowed for CS or pscyhotherapeutic drugs without prior auth
what is written on the last line of form 222?
the total number of different items ordered
DEA form 106
theft or loss
DEA form 106
theft or significant loss of controlled substances
purpose of prospective DUR is to look for
therapeutic duplication, incorrect dosing, incorrect tx, duration, CIs to drug, interactions between drug, disease state, or allergy, abuse or misuse
internet pharmacies may only obtain pharmacy permit in NC if
they are VIPPS verified
what if power of attorney documents are not submitted to the DEA?
they must be filed with completed forms 222 and should be readily retreivable in the ivent that the pharmacy needs to provide them to an inspector
e rx systems must be approved by
third party audit or DEA approved entity certification
how often does NCBOP meet
third tuesday of each month except Aug and Dec
which healthcare providers are exempt from DEA registration?
those in the US public health service, federal bureau of prisons and US armed forces, institutions and employees of Indian healthcare facilities
what kind of drugs are dispensed with medication guides?
those with risk for serious and significant health concerns
two options for filing paper rxs
three files: all CII, CIII-V, non controlled two files: all CII and all other drugs, but with red C at least 1 inch tall on lower right corner of the face of the rx CIII-V (exception if computerized system)
BUD for nonaqueous nonsterile formulations
time until earliest exp date or 6 mos
transfers must be completed by means of direct communication between ____ for CIII-V
two licensed pharmacists
form 222 must be completed with which writing implement?
typewriter, ink, or indelible pencil
pharmacist manager at health dept clinic must review dispensing records how frequently?
weekly
when must a medication guide be given?
when dispensed in outpt setting with each new fill and refills, the first time a drug is dispensed to healthcare provider for administration to pt in outpt setting, when pt/caregiver requests it, if Medguide has been revise, if drug is subject to REMS
when must community pharmacies provide a med guide
when the med is dispensed, when pt requests it, when material in guide changes
class III recall
when use or exposure is not likely to cause adverse effects e.g. coloring applied inconsistently
what info re compounding must be included with all pharmacy permits and renewals?
whether they compound, estimate of percentage of compounded products dispensed, whether they do sterile/non-sterile compounding, risk level of CSPs
DEA form 510
wholesale distribution of scheduled listed chemical products (SLCP, eg. pseudoephedrine)
DEA form 510 is neede for
wholesale distributors of SLCPs (sheduled listed chemical products)
outsourcing/503b facilities must register as a __ in NC
wholesaler
when should inventory be done if new pharmacist manarger/change of ownership?
within 10 days
when must a supplier report a transaction to the DEA made through CSOS?
within 2 business days of filling the order
when must the remainder of a partial fill CII rx be filled for requests made by pt or practitioner?
within 30 d after issue date - can only partially fill once per rx
when must the remainder of a partial CII rx be filled for a terminally ill or LTC pt?
within 60 d after issue date
recommended time window for levonorgestrel
within 72 h; but can be recommended for up to 120 h
what must a receiving pharmacy put on transferred rx
write TRANSFER on the face, reduce to writing, date and time of transfer, date of issue, original number refills, number of refills remaining plus date of last RF, transferring pharmacy name, address, DEA, rx number, transferring pharmacist/tech/intern, manufacturer/brand of dispensed drug
what must a transferring pharmacy put on the rx
write VOID on the face, record name, address, DEA number of pharmacy where transferred plus person's name receiving the rx, date of transfer, pharmacists' names
what to do with prescription hard copy of transferred rx
write void on the face and write the following on the back: pharmacy name, business address, DEA number, name of transferring pharmacist, name of receiving pharmacist, date of transfer
how can a non-CII rx be received by a pharmacy? (i.e. CIII-V)
written, faxed, electronic, or oral
can a practitioner without a DATA 2000 waiver administer tx for opioid abuse
yes - can dispense but not prescribe a day's worth of treatment at one time to a patient while proper referral is arranged for up to 3 d
do you need to note if the dispensed drug on an rx was donated?
yes - write on written prescription or annotate electronically
death, retirement, or loss of license of prescriber - is the rx valid?
yes after prescriber dies, loses license, or retires; assuming it was written when license was still valid
is a prescription with a specific number of refills good for more than one year?
yes as long as it is not controlled and refills have not been used up
can pharmacists fill rx written by foreign prescriber?
yes as long as pharmacist believes there is appropriate pt-physician relationship AND it is for noncontrolled drug
can suppliers substitute packages of CIIs?
yes as long as quantity is the same
can a pharmacist offer an emergency 30 d fill of a controlled substance?
yes but ONLY for CIII-V
can an agent of prescriber enter an e-rx?
yes but cannot have authentication factors or sign rx
are pharmacy techs who work solely at free clinics required to register, renew, complete training?
yes but fee is waived
can i dispense rx written by out of state prescriber
yes if noncontrolled if controlled, practitioner must also be licensed in NC
can CIII-V meds be partial filled?
yes, as long as partial fill is recorded the same as a refill and no dispensing occurs after 6 mos from written date (for CIII-IV)
can a pharmacist petition the BOP to increase the pharmacist:tech ratio
yes, but additional techs must be certified
is it allowable to fill rxs faxed in on rx paper that show void pantograph?
yes, pharmacist must use professional judgement
can shipping and financial records (invoices and packing slips) for CS be stored offsite?
yes, with notification and approval from the DEA; can begin storing offsite 14 d after DEA is notified
does TN law require updating controlled substances inventory with the changing of PICs?
yes. Federal law does not require this.
can a prescriber sign multiple electronic prescriptions for controlled drugs for a single patient with one signature?
yes; but not for different patients
can a pharmacy place an emergency kit with controlled substances in a non-DEA registered LTCF?
yes; but the pharmacy must be registered with DEA and the kit is treated as an auxiliary med inventory
can pharmacists/personnel demand, inspect and/or record ID for any prescription pickup?
yes; can also refuse to fill (note on rx)
is a pharmacy permit required at LTCFs that have an ADD on the premises
yes; can apply for limited service permit
are oral rxs of CIII-V allowed?
yes; reduce to writing