Controlled Substances: Prescription Requirements

slides 68-83

CII prescriptions must be ____ and _____ have refills

written

cannot

What is the difference bt a prescription and an order for C2s?

Prescription is for a patient

Order is for an institution

How can an institutional pharmacist dispense C2s

Written prescription or a medication order for the ultimate user it is dispensed to

Oral prescriptions are allowed for C-2s if…

true emergency

What are the requirements for an emergency oral C-II prescription?

Must be limited to an emergency quantity

Must be reduced to writing immediately

Pharmacist must verify the prescriber if unknown (attempt is fine)

Within 7 days, written form must be sent to the pharmacy or the DEA should be notified

What must happen within 7 days after an emergency oral C-II prescription?

Prescriber must send a written prescription OR pharmacist must notify the DEA

What qualifies as an emergency for an oral C-II prescription?

Immediate admin is necessary

No approp. Alternative is available

Not reasonably possible to provide a written prescription

Are faxed prescriptions allowed for Schedule II drugs?

NO unless:

home infusion for parenteral use

LTCF pt

hospice pt

can C2 prescriptions have refills?

no

who qualifies for partial fills on C2s?

terminally ill pts

LTCF pts

What must be documented for each partial fill of a C-II prescription?

Date of partial fill

Quantity dispensed

Remaining quantity

Pharmacy ID

What is the time limit to complete partial fills of a C-II prescription?

(only for LTCF and hospice pts)

60 days

What did CARA (2016) change regarding partial fills of C-II prescriptions?

Allows partial fills for ALL patients (not just LTCF/hospice)

Who can request a partial fill of a C-II prescription under CARA?

patient or prescriber

What is the time limit to complete partial fills of a C-II prescription under CARA?

30 days from the date the prescription was written

What is the quantity limit for partial fills under CARA?

Total dispensed must not exceed the original prescribed amount

What information is required on a label for a C-II prescription?

• Date of filling

• Pharmacy name & address

• Prescription serial number

• Patient name

• Prescriber name

• Directions for use

• Controlled substance warning

• Other cautionary statements

C-II labeling requirements do NOT apply to institutions if…

supply is 7 days or less

patient does not possess the medication

institution maintains proper safeguards

pharmacist keeps adequate records

C-II labeling requirements do NOT apply to institutions if the pharmacist keeps records of…

supplier, product, patient, and other label requirements

what type of prescription(s) is/are required to dispense a C-III, C-IV, or C-V drug?

written

faxed

oral (if documented)

What is required for a faxed CIII–V prescription?

must be signed by the prescriber

sent from the prescribers office

What additional option do institutional settings have for CIII–V prescriptions?

May also use medication orders

How many refills are allowed for CIII and CIV prescriptions?

up to 5 refills within 6 months

How many refills are allowed for CV prescriptions?

federal vs state

federal: as many as written

state: up to 5 refills in 6 months

What must be documented for each refill of a CIII–CV prescription?

• Drug name & dosage form

• Date filled/refilled

• Quantity dispensed

• Pharmacist initials

• Total number of refills authorized

Can refills be added to a CIII–CV prescription after it is written?

yes but must be documented and follow laws on how many are allowed

What is the preferred approach instead of adding refills to a CIII–CV prescription?

issue a new prescription

What are the key requirements for computerized prescription record systems?

must be readily accessible

must be searchable in multiple ways

What is required for end-of-day reports in computerized prescription systems?

Must be signed by each pharmacist working that day

delete

delete

What are labeling requirements for CIII–CV prescriptions?

same as C2 requirements

Do CV drugs require a controlled substance warning label?

federal vs state

federal: no

state: maybe

labeling requirements do NOT apply for CIII–CV prescriptions if the pt is institutionalized and…

the supply is </= 34 days or 100 units

patient does not possess medication

proper safeguards and records exist

Can Schedule II prescriptions be transferred between pharmacies?

yes if its electronic AND not filled yet

(otherwise hell nah)

What can be transferred for CIII–CV prescriptions under federal law?

refills only

Can a partially filled CIII–CV prescription be transferred?

no must be completely filled at the original pharmacy

Can Schedule V drugs be dispensed without a prescription?

federal vs LA

federal: yes

LA: no

What are the requirements to dispense a CV without a prescription?

• Patient must be ≥ 18 years old

• Must be known to pharmacist or show ID

• Must sign a logbook

• Must provide required information

Is dispensing CV medications without a prescription common practice in Louisiana?

no