additional controlled substance requirements

Question 1

where can you store controlled substances?

Answer 1

in a secure cabinet that is locked
dispersed throughout the non-controlled stock to deter theft

Question 2

how should you report theft or significant loss of controlled substances

Answer 2

write to the DEA within 1 business day
then send them DEA Form 106 within 45 days

Question 3

what should be included on DEA form 106

Answer 3

name/address/DEA# of registrant
date of theft
name & phone# of local police notified
type of theft
total value of what was stolen
list of what was stolen
NDC# of missing products
listing of mail-back packages or inner liners stolen

Question 4

how to report a loss of sudafed

Answer 4

DEA Form 107 within 15 calendar days

Question 5

when is this required:

“Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

Answer 5

all controlled substances CII-V

Question 6

how can you dispose of controlled substances

Answer 6

on-site destruction in a pharmacy: DEA Form 41 (not preferred)
send it to a reverse distributor

Question 7

rules for collection receptacles for controlled substances

Answer 7

• collector can’t count/inventory it
• collector can’t place it into the receptacle for a patient– pt do it themselves
• retail pharmacy: must be in immediate proximity
• hospital pharmacy: area regulated by employees, NOT near emergency care
• securely fasten to a permanent structure, locked, etc
• inner liner: waterproof, tamper evident, removable, immediately sealed upon removal– MUST HAVE A UNIQUE IDENTIFICATION NUMBER to allow tracking
• inner liner must be removed by at least 2 employees
• inner liner cannot be opened, x-rayed, etc

Question 8

rules for mail back of controlled substances

Answer 8

-pre-addressed to the collector’s address
- include prepaid shipping cost
-have a unique identification number for tracking
-include user instructions
-if a collector receives a package they did not make available– notify the DEA within 3 business days of receipt

Question 9

how do you waste a controlled substance

Answer 9

waste the quantity, have 2 witnesses, include date/quantity and method of disposal

THIS DOES NOT REQUIRE FORM 41 because a controlled substance was removed from the inventory per a physician’s order and was not entirely administered to the patient

Question 10

what should you do if a controlled substance spills/breaks that is not recoverable

Answer 10

document, DEA form 41, sign by 2 individuals

Question 11

does breakage/spillage of controlled substance need a DEA form 106

Answer 11

no- the registrant can account for the controlled substance

Question 12

when to inventory controlled substances

Answer 12

initial inventory the day the pharmacy is open for business- even if zero
then biennially (every 2 years)

Question 13

is a perpetual inventory of controlled substances required

Answer 13

no

Question 14

when must you perform an exact count for a controlled substance inventory

Answer 14

for all CIIs
for CIII-V if the container holds >1000 tablets (otherwise can do estimated count)

Question 15

what’s included in an inventory record

Answer 15

date
whether it was beginning or close of business
name
finished form
number of dosage units
number of commercial containers
count of the substance

Question 16

how long are controlled substance records kept

Answer 16

2 years

Question 17

how should you keep controlled substance records

Answer 17

keep CII records separate
CIII-V can have their own or be readily retrievable from other records

Question 18

how should electronic records of disbursement of controlled substances be documented

Answer 18

online retrieval– RPh document the refill data is correct– the system must be able to produce a hard copy printout of each day’s fills and the RPh is to verify the accuracy. This daily printout should be printed within 72 hours of dispensing.

MOST PEOPLE DON’T DO THAT!!

alternative: keep a logbook where the pharmacist involved in the day’s dispensing signs a statement verifying that the refill info is correct

Question 19

2-file storage systems for controlled substances: how will you tell apart the CIII-V from the non-controlls?

Answer 19

CIII-V must be stamped with red ink in the lower right corner with a “C” not less than one inch of height

Question 20

what if you want to keep controlled substance records at a central location?

Answer 20

sure– notify the DEA– if they don’t deny this in 14 days you can start keeping central records.

you CANNOT keep completed DEA 222 Forms there OR inventory records– those have to be kept at the actual pharmacy

Question 21

what controlled substances can optometrists (OD) prescribe?

Answer 21

codeine/acetaminophen and codeine/aspirin, hydrocodone/acetaminophen or hydrocodone/ibuprofen not to exceed a 72 hour supply, pentazocine, tramadol

Question 22

what can a PA prescribe

Answer 22

CII:
72 hour supply for initial
30 day supply for ongoing
must state initial or ongoing

Question 23

what can a CRNP prescribe

Answer 23

CII limited to 30 days
CIII-V limited to 90 days

Question 24

what can a nurse midwife prescribe

Answer 24

for a woman’s acute pain
CII limited to 72 hours
CIII-V limited to 30 days
psychotropic drugs can only be prescribed after consulting with the physician

Question 25

can you accept an out of state prescription

Answer 25

yes

Question 26

can you accept an out of country prescription

Answer 26

no- practitioners in other countries don't have DEA numbers

Question 27

can a designated agent verbally communicate an emergency CII prescription to a prescriber

Answer 27

NO-- this cannot be delegated

Question 28

can a delegated physician prepare a written Rx for signature by the prescriber?

Answer 28

yes

Question 29

can a designated agent communicate a prescription for a CIII-V

Answer 29

yes

Question 30

can a designated agent transmit a fax to the pharmacy for a signed written controlled substance

Answer 30

yes

Question 31

exemptions for mandatory electronic prescribing of controlled substances

Answer 31

veterinarians outside of PA no internet access not set up to process eRx technology failure emergency department/untimely delay hospice patient, nursing home emergency situations not required to report to PDMP

Question 32

when are verbal prescriptions valid for controlled substances

Answer 32

not valid for CII unless emergency valid for CIII-V

Question 33

when are faxed prescriptions valid for controlled substances

Answer 33

only limited circumstances for CII valid for CIII-V

Question 34

what is required on a written controlled substance prescription

Answer 34

manually signed by practitioner and dated on the date issued full name and address of patient drug name, strength, dosage form quantity directions for use # of refills (not for CII) name, address, DEA# of prescriber if CII to be filled at a later date: earliest fill date

Question 35

are preprinted DEA numbers allowed on prescription forms

Answer 35

no

Question 36

when are transfers allowed for controlled substances

Answer 36

allowed for refills of CIII-V allowed ELECTRONICALLY on a onetime basis for initial filling of CIII-V

Question 37

Ryan Haight Act

Answer 37

internet based prescribing valid if practitioner has conducted at least 1 in-person evaluation of the patient a covering physician can write an Rx for the practitioner who has made an examination (in person or tele) within the past 24 months who is unavailable

Question 38

can a CII be refilled

Answer 38

no

Question 39

how long do you have to fill a CII

Answer 39

6 months from the date of prescription- use professional judgment

Question 40

what is the quantity limit for a CII

Answer 40

NO QUANTITY LIMIT

Question 41

what is the limit for prescribing multiple CII prescriptions on the same day to be filled at a later date

Answer 41

90 days

Question 42

when are faxes allowed for a CII

Answer 42

patient undergoing home infusion/IV pain therapy patient in LTCF patient in hospice care

Question 43

rules for verbal emergency prescriptions of CIIs

Answer 43

has to be the prescriber calling it in-- not the designated agent the quantity is limited to the amount needed to treat the patient during the emergency period Rph to immediate reduce this to writing and the prescriber then has THREE DAYS to send the pharmacist a signed or electronic prescription the pharmacist has to notify the DEA if the prescriber does not deliver this

Question 44

rules for partial dispensing of CIIs

Answer 44

unable to supply= 72 hr rule patient/prescriber request= 30 day rule patient in LTCF= 60 day rule

Question 45

how many times can a CIII-V be refilled

Answer 45

5 times in 6 months

Question 46

can a retail pharmacy dispense methadone

Answer 46

only for pain

Question 47

who can dispense methadone 40 mg

Answer 47

only a narcotic treatment clinic-- they can dispense and administer, but NOT prescribe they can do short term (<30 days) or long term (30-180 days)

Question 48

can a hospital dispense methadone for addicts

Answer 48

only if the patient is being treated in the hospital for a condition other than addiction

Question 49

what if a patient can't be enrolled in a narcotic treatment program and needs methadone right now

Answer 49

a physician who is not part of a narcotic treatment program can administer methadone (not prescribe) but only for 3 days

Question 50

what can office-based prescribers prescribe for opiate dependence outside of a narcotic treatment facility

Answer 50

Subutex (buprenorphine) Suboxone (buprenorphine/naloxone)

Question 51

rules for sudafed

Answer 51

must be behind counter or in locked cabinet 3.6g/day, 9g/month mail: 7.5g/month must be in blister or unit dose packaging logbook purchaser to show ID, sign logbook, enter their name and address and date/time of sale

Question 52

do the sudafed rules apply to prescriptions

Answer 52

no

Question 53

how old do you have to be to buy sudafed

Answer 53

no age

Question 54

how old do you have to be to buy dextromethorphan

Answer 54

18

Question 55

when do you need proof of age for dextromethorphan

Answer 55

if the purchaser looks <25 years old

Question 56

does the dextromethorphan law apply to prescriptions

Answer 56

no

Question 57

when must you query PDMP

Answer 57

before dispensing opioid or benzo if: -new patient -pays cash when they have insurance -getting opioids or benzos from multiple prescribers -patient requests early refill (prior to insurance coverage OR more than 15% should remain) -reason to believe pt is getting opioids or benzos from more than one prescriber

Question 58

how long do you have to submit dispensing info to the PDMP

Answer 58

by the end of the next business day after dispensing it

Question 59

data elements required to be reported to the PDMP

Answer 59

-prescriber name and DEA# -date rx written and dispensed -pt name, address, and DOB -NDC# of drug dispensed -quantity and days supply -NPI and DEA# of dispenser -method of payment for Rx

Question 60

how many opioid CE hours do you need

Answer 60

initial- 4 renewal-2