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how soon to report abuse/neglect
2 working days of 36 hours of receiving info. failure to report is misdemeanor
exceptions to 3 year record keeping requirement?
hospital pharmacy chart order for controlled substances - 7 years
patient acknowledgement of hipaa - 6 years
transaction info for prescription drugs - 6 years
continuing education certificates - 4 years
patient medication profiles - 1 year
medication error/ quality assurance reports - 1 year
when to report patient harm form compounded products to FDA MedWatch
within 72 hours for nonsterile, 12 hours for sterile products. immediately for sterile products from another pharmacy
15 days for outsourcing facilities
optometrist prescribing limitations
topical and oral ok.
3 days for codeine, hydrocodone, or tramadol
no oral or topical anti-glaucoma meds or oral steroids under 18 years old
naturopath limitations
need NDF on license. independently can prescribe epi, hormones, OTC. dependently can prescribe C3-5
NO C2's
CNM, NP, PA
must be dependent authority for C2-5
what if prescriber dies?
rx still valid until expire or refills gone
out of state rx
allowed if license is equivalent to CA prescriber.
C2 must be mailed to pt home address (cannot hand to pt)
how long to keep records in hospital
3 years for noncontrolled, 7 years for controlled
when do non-controlled rx expire?
technically, never. standard of practice is 1 year
when do c2-5 rx expire
6 months
quantity limit for c3-4?
5 refills in 6 months, and max 120 day supply (whichever is less)
-C5 no refill limits
-prn refills on noncontrolled= expire in 1 year
auto refill renewal
enroll yearly
emergency refill limits
must have contacted prescriber, and lack of supply may cause adverse events
-only c3-5 and legend
-notify prescriber
-c3-5 only quantity needed to cover emergency period
-pharmacist judgment qty for legend drugs
transfer limits
c3-5 can only be transferred once (unless share database)
c2 cant be transferred
30->90 day fill
if noncontrolled and not psychiatric, and after an initial 30 day supply
-notify prescriber
where to look for therapeutic equivalence
orange book, ab1 rated.
purple book for interchangeable biologics
when unit dose packaging expire
6 months
PEP
-truvada (emtricit/TDF) + raltegravir (isentriss BID) or dolutegravir (tivicay QD).
- darunavir (prezista) and ritonavir (norvir ) QD
-Biktarvy (bictegravir/emtricit/TAF) QD
-take for 4 weeks, then get HIV test
PrEP
emtricit + TDF (truvada) or TAF (descovy)
how much pharmacy can sell to other DEA registrants
<5%
if return controlled drugs to supplier: what dea form?
dea 222 form or csos (like selling). pharmacy keep original, send copy to DEA, supplier keep copy
if dispose controlled drugs to reverse distributor
dea form 41. reverse distributor submits form to DEA
if lost dea form 222
notify dea field office immediately, with serial number or date issued
if controlled drugs lost in shipment
purchaser alert supplier, sign statement that order not received
if loss in pharmacy:
if by employee: notify ca bop in 14 days. all employee theft is significant
if insignificant, repor to CA BOP in 30 days
-if missing drugs, notify dea in 1 day and 45 days to investigate and submit form 106
if missing controlled drugs
notify dea in 1 day of discovery. then 45 days to investigate and submit dea form 106
who doesnt need dea number
practitioners at hospitals, or federal gov practitioners
dea 224 form
initial registration for pharmacy, hospital, institution, practitioners
224a
registration renewal form - done by PIC every 3 years
225
registration for manufacturers, distributors
363
narcotic treatment program registration
222
ordering, distributing, transferring schedule 1 & 2. used by dea registrant or POA.
limit of 20 items, only schedule 1 &2. (CSOS has no limit)
106
report theft
41
destroy controlled substance
actiq, fentora
fentanyl c2
hysingla ER, vicodin,
Lortab
hydrocodone, c2
dilaudid
hydromorphone
demerol
mepheridine c2
intensol, methadose
methadone c2
ms contin
morphine
oxycontin, roxicodone, xtampza er, endocet, percocet, percodan
oxycodone
tapentadol
nucynta/er c2
dynavel xr
amphetamine c2
focalin
dexmethylphenidate c2
dexedrine
dextroamphetamines
concerta, daytrana, quillichew, quillivant, ritalin, jornay
methylphenidate
other c2
dronabinol (syndros solution), cocaine for topical anesthesia, barbiturates (pentobarb, secobarb alone - c3 if suppository or if combo), codeine alone
fiorinal
butalbital/aspirin/caffeine C3
marinol
dronabinol capsules c3
fycompa
perampanel c3
xyrem
sodium oxybate c3
testosterone
c3
librium
chlordiazepoxide c4
onfi
clobazem c4
tranxene
clorazepate c4
diastat, valium
diazepam c4
versed
midazolam c4
restoril
temazepam c4
halcion
triazolam c4
belsomra
suvorexant c4
sonata
zaleplon c4
adipex
phentermine c4
qsymia
phentermine/topiramate c4
nuvigil
armodafinil c4
provigil
modafinil c4
soma
carisoprodol c4
ultracet
tramadol c4
schedule 5:
codeine cough syrup, lomotil (diphenoxylate/atropine), vimpat (lacosamide) pregablin