Pharm Law Test 2

Front 1

pharmacy must register as distributor/manufacturer if

Back 1

- distributor when exceeds 5% of total units per year
- manufacturer when prepares solution/solid dose form narcotic controlled substance exceeding 20% of completed product

Front 2

factors for filling out dea form 106

Back 2

- robbery
- excessive volume
- suspicion
- quantities missing
- police involvement

Front 3

what cannot be kept at a central location

Back 3

- 222 forms
- prescription records
- inventory records

Front 4

are all prescribers required to keep records

Back 4

- not required to keep records of prescribed drugs or administered drugs.
- required for dispensed drugs (controlled substances) but not for samples

Front 5

how should a pharmacy maintain records of inventories and records of controlled substances

Back 5

inventories - on file in central location and minimum of 2 yeras
controlled substances _ 322 system

Front 6

when is the red stamp C requirement waived

Back 6

when electronic record keeping it used

Front 7

why is inventory so important

Back 7

inventory+ records of receipt - quantity dispensed = controlled substances on hand

- determines inventory
- needed for audit

Front 8

Inventories must be

Back 8

- initial and biannual (every 2 years)
- complete and accurate

Front 9

when must inventory be taken

Back 9

- Prior to or at the end of the business day (document time taken)
- prior engaging in business (initial)
- every 2 years after initial
- newly controlled substances on effective date

Front 10

what are exact counts required

Back 10

- exact counts (manual) needed for C2

- estimates allowed for C3-C5 when bottle has less than 1000 count and has been opened. >1000 need exact count

Front 11

DEA Form 222
required information

C2 only

Back 11

- Supplier name/address
- date of order
- # packages
- size of packages
- name of items
- # lines completed and signature

Front 12

signature on Form 222

Back 12

only by person whose name is on DEA. If absent then need power of attorney

Front 13

how to obtain 222 forms

Back 13

- get them when register on form 224
- from nearest DEA office on request

Front 14

Who can issue a prescription

Back 14

Individual practitioner that is authorized to prescribe in state of licensure to practice and authorized or exempt from registering (military base, public health, etc)

Front 15

who can communicate the prescription to the pharmacist?

Back 15

employee or agent granted prescriptive authority under the law or delagate they comminucate it to (normally nurse or PA)

Front 16

Purpose of issuing prescription

Back 16

RX issues for legitimate medical purpose by ind. practitioner acting in usual course of practice.

Front 17

corresponding responsibility” rule?

Back 17

Both prescriber and dispenser are legally responsible for proper prescribing & dispensing of controlled substances.
 

Front 18

What do you do if a prescriber requests to obtain controlled substances for office use?

Back 18

Let them know that it’s not a valid or legitimate prescription, but that they can order through us and we can distribute by invoice a supply to them (if the amount is <5% of our total C.S. volume annually).

Front 19

What if you receive a prescription for maintenance treatment?

Back 19

Maintenance treatment for a drug addiction must be through a registered treatment program –OR- the narcotic treatment must be for another medical condition other than addiction. There is a limited exception under a law (DATA 2000) that allows an approved drug – now only suboxone and subutex to be ordered by a physician that meets criteria (education, etc), and it can be filled at the pharmacy. The prescriber will have a unique identifier (DEA number) to write these. Check out this site to read more about this exception http://buprenorphine.samhsa.gov/titlexxxv.html and we can discuss further if needed.

Front 20

requirements for controlled substance prescription

Back 20

- must be original or verbal emergency script with 7-day fup for C2 (fax/efax for C3-C5)
- patient name/address
- drug name
- dose form
- strength
- quantity
# refills (Not for C2)
- practitioner name/address/dea#
- sign and date

Front 21

what if things are missing on schedule C scripts

Back 21

not valid script if not signed so do not fill it

Front 22

can retail pharm put automate dispense machines in LTCF

Back 22

yes - separate registration required at LTCF locations

Front 23

rules for CII prescriptions

Back 23

- written/signed by practitoiner (emergncy exception)
- fax allowed for LTCF, hospice, direct administration only
- no refills
- dispense 90 day supply but need to write "do not fill date"

Front 24

partial fill

Back 24

- able to if fill remaining within 72 hours. (due to low stock)
- LTCF or hospice

Front 25

Rules for CIIs – Labeling by he Pharmacy

Back 25

1. Pharmacy name & address
2. Rx #
3. Date of filling / dispensing
4. Pt name
5. Practitioner name
6. Directions for use
7. Caution of transfer to another pt, other caution labels if any
 

 

Front 26

what other CII limits

Back 26

1. The CII is not in the possession of the ultimate user prior to administration
2. The institution has proper safeguards and records for the proper administration, control, dispensing, and storage of the CII
3. Must identify the supplier, product, patient, & set for the directions for use, and any cautionary statements.

Front 27

never can be changed on C2 script

Back 27

- Pt’s name,
- the controlled substance prescribed (except as generic),
- prescriber’s signature.
 

Front 28

can be changed on C2 script

Back 28

- pt’s address,
-drug strength, quantity, direction, or dosage form.
- Document time and date prescriber was called.
 

Front 29

how can prescriber order C3-C5

Back 29

-verbal
- fax
- written
- electronic

Front 30

C3-C4 fill times

Back 30

not more than 6 months or 5 times from date of issue (whichever comes first)

Front 31

refill info must be documented

Back 31

*on back of script
- RPh initials
- date of fill
- partial fill amt
-

Front 32

C3-C5 transfer to another pharmacy

Back 32

- allowed 1 time
- pharmacies sharing online database is considered refill as written within 6 months

Front 33

documentation on transferred prescription

Back 33

The same info required on a valid Rx: Pt’s full name, address, practitioner’s name & address, DEA#, drug name, strength, dosage form, quantity, directions, # of refills., pharmacy that filled it first and the pharmacy now transferring must also get information about each pharmacy and it must be cancelled at initial pharmacy.

Front 34

C3-C5 dispensing requirements

Back 34

- ID person picking up
- signature
- over 18
- valid medical need for drug

Front 35

C5 quantity limits

Back 35

per 48 hours
- opium 8 ounces
- others see book

Front 36

- methamphetamine restrictions on purchases?

Back 36

- pseudoephedrine products
- ephedrine products