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Controlled Substances

Terms in this set (93)

Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 is also called what?
controlled substances act (CSA)
CSA:

This act established what?
A closed system for manuf, dist, and dispensing of CS; only persons registered with the DEA are allowed to engage in these activities
CSA:

Title I referee to?
Rehab program for drug abusers
CSA:

Title II refers to?
Registration and dist of CS
CSA:

Title III refers to?
Import and export regulations for CS
Authority for drug scheduling:

Federal level?
US attorney general per CSA but delegates this task to the DEA
Authority for drug scheduling:

Prior to scheduling, who must perform a medical evaluation of the drug and make recommendations?
Secretary of the department of HHS but delegates this task to the FDA
The federal CS scheduling process:

Scheduling may be initiated by who? (4)
DEA, FDA, congress, petition
The federal CS scheduling process:

Once a scheduling is initiated, what happens next?
AG/DEA requests HHS/FDA to perform a scientific and medical evaluation of the drug
The federal CS scheduling process:

What happens once the FDA recommends to NOT schedule a drug?
DEA must comply
FederaL: What are scheduled I drugs? (4)
Marijuana

Heroin

LSD

Peyote
Federal:

What are CII examples? (9)
Single entity narcotics/stimulants

Codeine

Morphine

Oxycodone

Fentanyl

Amphetamines

Methylphenidate

Combo hydrocodone products

Dronabinol (Syndros)
Federal:

CIII examples? (4)
Products containing limited quantities CII drugs in combo with other active ingredients

Tylenol w codeine

Dronabinol (Marinol)

Anabolic steroids: to discourage trafficking
Federal:

CIV examples? (5)
BZDs

Ambien

Lunesta

Tramadol

Carisoprodol
Federal:

CIV examples? (4)
Products containing limited quantities of narcotics/stimulants (generally for antitussive, anti diarrheal, analgesic purposes)

Lomotil

Tylenol w codeine elixir

Epidiolex (CBD oil)
Federal:

CII drugs: abuse may lead to what?
SEVERE physical or psychological dependence
Federal:

CIII drugs: abuse may lead to what?
MODERATE to LOW physical dependence, or

HIGH psychological dependence
Federal:

CIV drugs: abuse may lead to what?
LIMITED physical or psychological dependence relative to CIII drugs
Rule of thumb when is comes to narcotics?
ALL narcotics are CS but not all CS are narcotics
Opioid vs opiate?
- opioid: a general term defined as any drug, natural or synthetic, that has actions similar to those of morphine. A substance that binds to opioid receptors

- opiate: applies only to compounds present in opium (morphine and codeine)
The DEA limits the definition of narcotic to include what?
Opium and cocaine and all of their derivatives
Dispensing vs distributing?
Dispensing: delivering a CS to an ultimate user pursuant to a lawful order of a practitioner, including: prescribing and admin, packaging, labeling, and compounding, necessary to prepare for such delivery

Dist: delivering a CS other than by admin or dispensing
How is compounding CS different via DEA?
Pharmacies can compound CS if product does not have more than 20% of a narcotics substance
DEA definition of compounding (dispensing) and manufacturing is different from FDA if for office use or admin by prescriber?
This is seen as DISTRIBUTING
How often do manuf/wholesalers/dist renew DEA registration?
Annually
How often do pharmacies renew DEA registration?
Renewal every 3 years
How often do individual practitioners renew DEA registration?
Every 3 years
Who is exempt from DEA registration? (6)
agents or employees of registrants,

drug reps

common carriers or warehouse employees

ultimate users

prescribers and dispensers in the service of US govt

law enforcement (will need DEA number for private practice tho)
Describe the DEA number:

Examples AZ9754652
A: registration type

Z: first letter of last name or company name

975465: randomly generated

2: validity check
DEA number:

Dispensing registrants?
A, B, F, or G
Who are mid level practitioners? (6)
Homeo physicians

Naturop physicians

Optometrists

PA

Pharmacist

Registered NP
A prescriber is required to have an individual DEA registration for each location where the do the following regarding CS?
Prescribe AND

Administer, OR

Dispense
What are the three types of records that must be maintained?
Inventory

Records of drugs received (invoices, DEA 222)

Records of drugs dispensed (dispensed, transferred, sold, etc)
Ordering controlled substances:

Aka records of?
Records of receipt
What are examples of records of receipt?
Inventory records

Records of drugs received: invoices, DEA 222
What DEA form is used to order CS?
222
If the supplier partially fills the order of a DEA Form 222, the supplier has __ days from the date of execution of the Form 222 to supply the balance. After this time frame, the order form becomes invalid.
60 days
Who keeps the original DEA 222 form?
Supplier
What DEA form is used to order CIII-CV?
No form needed
Organizing invoices and forms:

What must be maintained separately from all other invoices?
CII invoices and completed DEA 222s
Organizing invoices and forms:

CIII-V invoices may organized how?
Separately from all other invoices OR

Combined with non CS invoices but marked with red C
How long do you have to retain CS order records?
3 years AZ

FDA is only 2 years

DQSA: 6 years (all inventory records)

Medicare: 10 years...... so 10 years since it is most strict!!!
Where must executed DEA 222 forms and annual CS inventory be maintained?
On site
Records must be readily retrievable is how many days?
DEA request within 2 business days
How can you store CS? (2)
In a securely locked, substantially constructed cabinet

Dispersed throughout the stock of unscheduled meds
When do you need to take inventory of CS stock?
Every year on may 1st for AZ

Federal law is every 2 years
What other circumstances would require a complete CS inventory? (8)
Opening a new pharmacy

D/c of a pharmacy

When your pharmacy accepts all CS stock from another store that is closing

Change in ownership

Within 10 days of change in PIC (AZ)

Within 10 days of incidence of theft (AZ)

As directed by ASBP (AZ)

When a drug is newly scheduled
When a change of PIC or incidence of theft happens, when does a CS inventory have to be completed?
Within 10 days
What do you need to include on the CS inventory? (4)
Drug name, strength, dosage form, quantity
How must you count CII for inventory?
Exact counts
How must you count CIII-V for inventory?
Containers >1000 dosage units require EXACT counts

<1000 may be estimated
How long do you retain CS inventory records?
On site for 3 years (AZ)

Medicare 10 years
What are records of dispersal? (7)
Any records that document the removal of drugs from the pharmacy:

Rx orders,

Non Rx CV sales

Dist from a pharmacy to another practitioner

Institutional med records

Disposal or destruction of CS'

Return of CS to pharmacies for disposal

Records of theft or loss
Expiration and refill limits:

CII?
No refills

90 days
Expiration and refill limits:

CIII and CIV?
<5 refills

6 months
Expiration and refill limits:

CV?
No limit but no PRN refills

1 year
Rules for writing multiple RX at a time? (3)
3 identical Rx orders can be written on the same date of issue

Limited to 90 DS total

The practitioner must write instructions on each Rx as to the earliest date on which Rx may be dispensed
Initial Rx for a CII opioid?
5 DS for acute pain

14 DS for after surgery
Dosing limitation for general treatment?
Can not exceed 90 MME
Naloxone must be co prescribed when?
When Rx is more than 90 MME/day
What is the exception to CII faxed rx?
The pharmacist must receive the original hard copy before releasing the CS med
When can a faxed CII rx serve as the ORIGINAL hard copy? (3)
CII narcotic for a compounded injectable solution and will be directly admin to patient

Any CII for a resident of LTCF

CII narcotic issued for patient enrolled in Medicare cert hospice care program
In an emergency a CII rx may be orally transmitted by a prescriber, however.....(3)
Quantity must be limited to the amount necessary to treat during emergency period (usually 72 hrs)

Prescribe must deliver written Rx within 7 days

Rx must have "authorization for emergency dispensing"
How many days must a prescriber deliver written CII Rx in emergency?
Within 7 days
All CII opioids MUST be prescribed how? Who is exempt?
E prescribed

Vets, out of state prescribers, federal facilities
What can a pharmacist NOT change on CS prescription?
Can not change: patients name, drug name, prescribers name
How many times can a CIII-V be transferred?
Only one time
How can you store CS prescription orders?
3 files: CII, CIII-V, non CS

2 file: CII, CIII-V and non CS but the CS must have red C
Electronic imaging record keeping system:

How long do you keep rx image?

What about CS?
7 years from the date of last dispensed

CS: original hard copy must be maintained for 7 years of last dispensed
How long do you have to retain CS prescription orders?
7 years from last fill; on site

Medicare is 10 years
CII partial fill: when must you fill the remainder if you are out of stock?
Within 72 hours then the balance of the rx is void
How must a CII opioid be dispensed in AZ?
Red cap and a warning label
Sale of non rx CV:

What are the limitation on quantity?
No more than 8 oz or 48 dosage units of an opium containing substance

No more than 4 oz or 24 dosage units of any other CS

No more than 100 dosage units of any single active ingredient ephedrine in any given 30 days period
Sale of non rx CV:

How long are these records kept?
3 years from last sale
What is the rule for distributing CS by pharmacies that do not have dist registration?
5% rule; total number of dosage units dist does not exceed 5% of the total number of CS dispensed and distributed in 1 calendar year

Ex. You sell another pharmacy your CS meds
What is DEA form 41?
Disposal of controlled substances
What DEA form for theft or significant loss?
106
What is DEA form 106?
Theft or loss of controlled substances
Who and when must a pharmacy notify when loss or theft of CS?
DEA within one business day of discovery

ASBP within 10 days

AZ DPS narcotic division
DEA audits: all records readily available within _____ hrs
48
DEA agents are prohibited from inspecting what? (3)
Financial data

Sales data, other than shipment data

Pricing data
Opioid treatment programs are accredited and certified by who?
SAMHSA
What buprenorphine products only have indication for treatment of pain?
Belbuca

Buprenex

Butrans
1sale of ephedrine, PSE and PPA:

Maintain logbook for how long?
At least 2 years
When must a prescriber check CSPMP?
Before prescribing opioid or a BZD listed CII-IV
What is DEA form 224?
New application for retail pharmacy, Hospital/Clinic practitioner Teaching insitution, or mid level practitioner
What DEA form is needed for a new pharmacy?
224
What DEA form is required for narcotic treatment centers?
363
What form must be filled out to revoked the POA?
Notice of revocation
Which copy of DEA 222s do pharmacies keep? (If triplicate)
Copy 3: blue
Who is responsible for reporting loss/theft if CII order never arrives at pharmacy?
Supplier, form 106
What is the allowed timeframe for a supplier to send a copy of DEA 222 to the DEA after filling an order?
By the end of the month in which the order was filled
What is DEA form 225?
Used for a new application to register manufacturers/wholesalers/distributors/importers
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