-
high potential for abuse; no accepted medical use in US
Scheduel I drugs
-
high potential for abuse; severe physical/psychological dependence potential
*accepted US medical use
Schedule II drugs
-
7 examples of Schedule I drugs
- 1) heroin
- 2) LSD
- 3) peyote
- 4) marijuana
- 5) MDMA
- 6) mescaline
- 7) unapproved GHB
-
physical dependence is severe
CS II
-
physical dependence is moderate
CS III
-
physical dependence is low/limited
CS IV
-
physical dependence is extremely low
CS V
-
3 things the RPh CANNOT change on a on a CS II Rx
- 1) patient name
- 2) CS prescribed (except to generic, per CO law)
- 3) signature
-
high psychological dependence potential
Schedule III drugs
-
5 examples of CS III drugs
- 1) Fiorinal ((w/ ASA)
- 2) THC
- 3) Tylenol 3
- 4) Vicodin (hydrocodone + APAP)
- 5) anabolic steroids
-
hydrocodone vs. hydrocodone+APAP
- hydrocodone: CS II
- hydrocodone + APAP: CS III
-
Fiorinal vs. Fiorocet
- Fiorinal: butalbital, caffeine, & ASA; CS III
- Fiorocet: butalbital, caffeine, & APAP; non-controlled
-
required to register with the DEA if involved in dispensing a controlled substance (6)
- 1) pharmacy
- 2) manufacturers
- 3) distributors
- 4) individual practitioners (IP; prescribers)
- 5) exporters/importers
- 6) researchers
-
registration with the DEA must be renewed every ____.
3 years
-
how hospital IPs allowed to prescribe CS
hospital assigns specific internal code number to the IP as a suffix to the institution's DEA number
-
types of Rx drugs that can be mailed
all
-
conditions for mailing of CS
- 2 wrappers:
- inner container: sealed, labeled w/ pharmacy name & address
- outer container: no markings to indicate contents
-
"A Rx for a CS to be effective must be issued __________ by an IP acting in the usual course of his professional practice."
...for a legitimate medical purpose...
-
labeling requirements under Federal CSA (7)
- 1) pharmacy name/address
- 2) Rx serial #
- 3) Rx fill date
- 4) IP name
- 5) pt name
- 6) directions for use
- 7) cautionary statements
-
which drugs require this label?
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
CS II-IV
-
3 kinds of required CS records
- 1) inventory
- 2) receipt
- 3) dispensing
-
record of new CS inventory (of existing stock) required every ____.
2 years
-
details required in inventory (3)
- 1) date
- 2) time
- 3) drug (strength, form, number)
-
when estimated inventory counts are acceptable
CS III-V if container holds <1000
-
when exact inventory counts are required
- CS II
- CS III-V if container holds >1000 and is opened
-
CO requirements for dispensing record keeping
- 3 separate Rx dispensing files:
- 1) CS II
- 2) CS III-V
- 3) all non-CS drugs
-
form required for any distribution of C-I and C-II drugs
DEA Form 222
-
practitioners who can prescribe CS without a DEA # (3)
- 1) PHS
- 2) Bureau of Prison
- 3) military physicians
-
if CS III-V are shared on a real-time, online database, how many times can it be transferred?
# max refills permitted
-
3 exceptions to written CS II prescriptions
- 1) fax
- 2) emergency
- 3) partial dispensing
-
when fax CS II Rx are allowed (3)
- 1) home infusion/IV pain
- 2) long term facility care (LTFC)
- 3) hospice
-
in emergency situations pharmacist may dispense CS II on oral/fax prescriber authorization if (4):
- 1) Rx immediately written (except for Dr's signature)
- 2) qty is limited to tx during emergency period
- 3) pharmacist attempts to verify authenticity
- 4) IP must provide signed, written Rx to pharmacist w/in 7 days (or pharmacist must notify DEA) -> 72hrs in CO
-
when partial dispensing of CS II is allowed (4):
- 1) full qty not available
- 2) must dispense balance w/in 72hr or IP must write new Rx
- 3) qty dispensed noted on front of Rx
- 4) LTCF or "terminally ill" pt - partial fill allowed for max 60 days
-
what must be included in the note on an Rx for a partially dispensed CS II (4)?
- pharmacist name
- date
- # dispensed
- # left
-
transfer, delivery, or distribution of Rx to non-consumers
casual sale
-
amount of CS allowed to be sold as casual sale
 5% of dispensed CS in a calendar year
-
form that must be filled out upon significant loss/drug theft of CS
- DEA Form-106
- 2 copies to DEA, 1 copy in pharmacy
-
4 differences between Fed & CO CSA
- 1) CO does NOT allow OTC sale of CS V
- 2) CO does NOT allow unlimited refills of CS V (5 refills or 6mos)
- 3) CO only has ONE method to file Rx's involving controlled & non-controlled drugs (Fed has 3)
- 4) CO requires IP of oral emergency CS II to provide signed, written Rx to pharmacist w/in 72hr (Fed allows 7 days)
-
7 types of medical professionals allowed to prescribe medication under CO law
- 1) Advanced Practice Nurse
- 2) Dentist
- 3) Optometrist
- 4) Physician
- 5) PA
- 6) Podiatrist
- 7) Vet
-
(5) requirements for an APN/RN/CNP to hold CO Rx authorization
- 1) listed on Board of Nursing APN Registry
- 2) written collaborative agreement w/ CO doc
- 3) RXN # from Board of Nursing
- 4) own DEA#
- 5) w/in nurse's practice area
-
3 characteristics of CO Rx authorized DDS/DMD
- 1) CO license
- 2) any drug necessary to proper practice of dentistry
- 3) NO CS II for self/family
-
3 characteristics of CO Rx authorized OD
- 1) CO license
- 2) certified as TPA (therapeutic optometrist)
- 3) NO CS II's
-
3 characteristics of CO Rx authorized PA
- 1) CO Certification by Board of Medical Examiners
- 2) written Rx on supervising physician's Rx forms w/ preprinted name, address, telephone # of supervising MD & PA
- 3) own DEA #
-
required to be in child-resistant containers
- 1) all oral Rx drugs
- 2) some OTCs (ASA, Fe, APAP, IBU, lidocaine, napoxen, diphenhydramine, loperamide)
-
exception for child-resistant containers (4)
- 1) elderly/handicapped if labeled
- 2) rapid access (angina) meds
- 3) IP requests
- 4) pt requests
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