CHAPTER 5 - BURNS

What is the definition of a prescription from the CSA?

order for medication which is dispensed to or for ultimate user but does NOT include medication order dispensed for immediate administration to ultimate user (hospital order)

• BASICALLY A PRESCRIPTION IS NOT A MED ORDER IN A HOSPITAL

A prescription must be for who? office use?

an ULTIMATE USER—> FOR OFFICE USE RX ARE NOT ALLOWED

Who can prescribe a CS? requirements?

individual practitioners that are

1. authorized to prescribe CS IN THAT STATE

2. registered under the CSA (some exemptions)

Examples of individual practitioners? (recognize not memorize)

• physicians

• dentist

• vets

• mid-level prescribers (check with state)

Can prescriptive authority be delegated?

NO!!!!!!!!!!!!!!! agents/employees can communicate/prepare rx

Answer the following about DEA numbers:

• how many characters?

• how many letters? digits?

• meaning of the 1st letter?

• meaning of the 2nd letter?

• 9 characters

• 2 alphabet letters, 7 digits

• 1st letter—> prescribers can be A, B, F, G, midlevel’s M, distributors P or R

• 2nd letter—> usually registrant’s last name

How do you check the validity of a DEA #?

• step 1: add 1st, 3rd, and 5th digits

• step 2: add 2nd, 4th, and 6th digits then multiply by 2

• step 3: add both of those steps together

• step 4: look at the right most digit and see if it matches the 9th digit of the DEA #

Is this a valid DEA #?

Dr. Bill Nash, DEA# AN1257318

• step 1: 1+ 5+ 3= 9

• step 2: (2+7+1) x 2 = 20

• step 3: 20 + 9 = 29

• step 4: compare last digit of DEA number to the right most digit (8=9)

• Answer: NO!!!!!!!!!!! NOT A VALID #

True or False: verifying a DEA number is the only factor to consider in determining the validity of a rx

FALSE—> forgers are smart, should look at all red flags

__________ law dictates who can dispense CS.

a. federal

b. state

b

Do pharmacies/pharmacists have to register to dispense?

YES!!!! either individually registered or employed by a pharmacy that is registered.

A CS prescription MUST contain what information?

(know these—> I bet burns will do a select all that apply)

• dated on the date of issuance

• full name/ address of patient

• name/ address/ DEA # of prescriber

• drug name, strength, dosage form

• quantity prescribed

• directions for use

• prescribers signature (for written/electronic rx)

Before filing a CS prescription, what must the pharmacist put on the prescription?

• pharmacist’s initials

• date dispensed

• # / quantity dispensed

True or False: pre and post dating are allowed on CS prescriptions.

FALSE

Correcting Prescriptions:

For CIII, CIV, and CV rx what can and can’t the pharmacist fix?

(memorize what you CAN’T fix)

• CAN—> pt’s address, dosage form, strength, drug quantity, directions for use, issue date

  • after consulting with the prescriber ofc

• CAN’T—> PATIENT NAME, DRUG NAME (except for generic), PRESCRIBER’S SIGNATURE

For correcting CII prescriptions refer to…

state law

A CS prescription must be issued for a LEGITIMATE MEDICAL PURPOSE. Does that include pain?

YES

Purpose of the corresponding responsibility doctrine?

means that pharmacists share equal responsibility with prescribers to ensure that controlled substances (CS) are dispensed for a legitimate medical purpose

Is the corresponding responsibility doctrine absolute? (from book)

not absolute because the regulation states that a violation occurs when the pharmacist “knowingly” dispenses an improper prescription

Examples of red flags in a prescription:

(recognize, don’t memorize)

• large quantities or # of refills

• antagonistic drugs

• pts. frequently returning

• presenting rx orders for other ppl

• strangers

It is illegal to prescribe and dispense narcotic drugs for what unless approved under one of the limited exceptions like OTPs, and DATA2000.

for maintaining an addiction or detoxifying an addict

Are refills allowed on CS prescriptions? (CII, CIII, CIV, CV)

• CII—> NO REFILLS

• CIII, CIV—> up to 5 times w/in 6 months of issuance

• CV—> federal law silent

What does federal law say about the date a CII must be filled and quantity limits on dispensing?

SILENT!!!!!!!!!!!—> look to state

How can CS prescriptions be given?

(oral, written, faxed, electronic?)

(CII vs. the others?)

• CII- written, electronic (oral in some exceptions)

• CIII- written, electronic, oral, faxed

Oral CII rx are only allowed in some emergency situations.

What are the requirements for this exception?

• qty prescribed/dispensed limited to amount necessary for ER period

• contains all needed info BUT prescriber signature

• prescriber MUST give RPh a written rx within 7 days

  • must include “auth for emergency dispensing” and date of oral order on it

Faxed CII can be accepted as the original in 3 situations.

What are they?

• narcotic CII to be compounded for direct administration to pt. by parenteral infusion

• CII for a resident of LTCF (any CII, not just narcotic)

• narcotic CII for hospice pt

What rule allows partial fills of CII in 3 situations?

CARA 2016

CARA 2016 allows partial fills of a CII up to ______ days from the date of the rx.

30

In what situations are partial fills of a CII up to 60 days from the date of the prescription allowed?

• LTCFs

• terminal illness

Partial fills can be requested by…

patient OR prescriber (before or after rx is written)

No refills are allowed for CIIs, how do doctors get around this?

preparing multiple prescriptions on same day for same drug with written instructions to be filled on different days

• NOTE: SAME DRUG, DIFFERENT DAYS

What are the requirements for multiple rx on the same day?

• each rx issued on?

• total qty?

• each rx issued on separate prescription blank

• total QTY CANNOT EXCEED 90 DAY SUPPLY

• all CII requirements must be met

• prescriber writes instructions on each rx

• state law must allow this

What are the partial fill requirements for CIII-CV?

• allowed—> no dispensing after 6 months

What must be on the pharmacy label for CII, CIII, CIV, CV?

• date of filling (CII) or date of initial fill and refill (CIII-CV)

• pharmacy name, address

• rx #

• pt. name

• prescriber name

• directions for use

• caution disclaimer

Electronic CS are only mandated in what situation?

medicare Part D CS prescriptions

If the transmission of an electronic prescription fails… what does the provider and pharmacy do?

• provider—> manually sign and state transmission failed

• pharmacy—> verify not e-received/dispensed

Assuming the CS has REFILLs, what are the transfer limits?

THIS IS ASSUMING THE RX WAS ALREADY FILLED AT ANOTHER PHARMACY AND THIS IS A REFILL.

CIII-V can be transferred ONE time

When a CS with REFILLS, is being transferred what should the transferring pharmacist and the receiving pharmacist do?

THIS IS ASSUMING THE RX WAS ALREADY FILLED AT ANOTHER PHARMACY AND THIS IS A REFILL.

• transferring pharmacist- write void on rx, record all the info of the pharmacy its being transferred to (date, name, address, DEA #, name of pharmacist)

• receiving pharmacist- write transfer on rx, all info from previous pharmacy

• keep both records 2 years from date of last refill

For INITIAL DISPENSING, what are the transfer limits?

What form MUST the rx be in?

• CII-V can be transferred ONE time

• TRANSFER MUST BE DONE ELECTRONICALLY

(NOTE HOW THIS INCLUDES CII, NOT THIS IS FOR UNFILLED ORIGINAL RX)

Can a pharmacist transfer an original CII rx received in paper?

NOOOOOOO—→ ELECTRONIC ONLYYYYYYYYYYYYYYY

In order for a pharmacy to accept returns of CS what must they do?

REGISTER AS A COLLECTOR

If a patient brings a CS from home to a hospital setting, can the hospital take possession of the CS?

ultimately—>NO

• meds to continue— hospital can allow pt to keep securely locked

• meds to not continue—> hospital may have policy against bringing outside meds in

How do central fill pharmacies work?

1. pharmacy 1 sends to central fill pharmacy

2. central fill pharmacy delivers back to pharmacy 1

3. pharmacy 1 dispenses to pt.

Answer the following about central fill rx:

• label requirements?

• who keeps documents?

(not that imp)

• label must contain identifier of central fill pharmacy

• both pharmacies keep records

• p.s. central fill pharmacies can also be regular retail pharmacies as well

What amendment sets requirements for INTERNET PHARMACIES?

What does the amendment require?

• Ryan Haight Amendment

• says CS to be issued for legit medical purpose by practitioner who has CONDUCTED AT LEAST 1 IN PERSON MED EVALUATION

Prescription drug monitoring programs are implemented at the ________ level.

a. federal

b. state

b

Do all LTCF have to register with the DEA?

no!!!! but the pharmacy serving the LTCF will be

What kind of records must be kept in a pharmacy?

• records of inventory

• records of drugs received

• records of drugs dispersed

In general, ALL records should be kept for __ years.

2

Some records can be kept centrally if you notify the DEA within ___ days. (and assuming your not denied)

14

If records are kept centrally and they are requested, the pharmacy must provide them within ___ business days.

2

What type of records can be kept centrally? which can’t?

• CAN—> invoices, packing slips

• CAN’T—> order forms, inventory records, paper prescriptions

Can CS records be kept together?

• CI and CII—> MUST BE MAINTAINED SEPERATELY

• CIII, CIV, CV records don’t have to be maintained separately—> but readily retrievable

Federal law mandates pharmacies must take inventory when?

what time of day?

• before starting business

• thereafter—> biennial/ EVERY 2 YEARS

• taken at beginning or ending of business day

When taking inventory of CS, when is an exact count required? estimate?

• CI and CII—> EXACT COUNT

• CIII-V—> estimate is allowed, EXCEPT if the container holds more than 1,000 units then exact count

Examples of records of receipt/ dispersal? (idk how important)

• CIII-V —> invoices

• CI and CII—> DEA Form 222

Prescriptions can be filled 2 ways. What are they?

1. using 3 separate files

   • 1st file—> CII

   • 2nd file—> CIII-V

   • 3rd file—> NC

2. using 2 separate files

   • 1st file—> CII

   • 2nd file—> CIII-V+ NC, must mark CS with C or ID

For OTC CV—> dispensing must be done by who? sale can be done by who?

• dispensing must be done by pharmacist

• sale can be done by non-rph

What are the quantity limits on OTC CV?

What other info is required when doing these sales?

• no more than 240ml or 48 dosage units w opium OR

• 120ml or 24 dosage units of other CS within 48 hours

• INFO REQUIRED:

  • purchaser must be 18

  • ID required

  • pharmacy must keep bound record book

In order to DISPOSE OF a CS what form is needed?

(note this is DIFFERENT than just collecting—> were disposing now)

DEA FORM 41

For theft or significant loss—> must notify the DEA within how many days? What form?

within 1 business day, form 106

Any distribution of a CI or CII requires form ____.

a. 41

b. 106

c. 224

d. 222

d

Are 222 forms single sheets or triplicate forms?

single sheets

For form 222, who keeps the original form? who keeps the copy?

• pharmacy fills out the 222 form and KEEPS A COPY

• sends to supplier where they KEEP THE ORIGINAL and fill out what they supplied

• when pharmacy receives the CS they fill out on their COPY what they received

What’s an alternative electronic order system for CI and CII’s?

CSOS

The person who signed the DEA registration is not always around and you might need to order CII’s… what’s a fix? (from book)

grant a power of attorney (POA)