1
Q
Federal Controlled Substance Act
A
- 1970
- Claiming that controlled substances can have a legit, medical purpose that can increase the public’s welfare
- Illegal importation, manufacturing, distributing, and possessing of controlled substances is detrimental to the public
- Provides definitions of terms relating to controlled substances and their abuse, examples of classes of drugs that may be abused, dispensing and record laws, etc.
2
Q
Addict
A
- Any individual who habitually uses ANY narcotic so as to endanger the public morals, health, safety, or welfare
- Also those who have lost the power of self-control regarding addiction
3
Q
Agent
A
Authorized person who acts on behalf of manufacturer, distributor, or dispenser
4
Q
Controlled Substance
A
Drug or substance or immediate predecessor in schedule I-V
Not spirits, tobacco, wine, malt drinks
5
Q
Depressant or Stimulant
A
- Any drug with barbituric acid
- Drug with amphetamine
- Drug with lysergic acid diethylamide
- Drug with any amount of substance that could be potentially abused for its depressing or stimulating effects
6
Q
Dispense
A
- Delivery of a controlled substance to its ultimate user or research subject lawfully
- Includes appropriate packaging, labeling, etc. required
7
Q
DEA’s Mission
A
- Enforce the controlled substances law and regulation of the US
- Bring to the criminal and civil justice system of the US those involved in growing, manufacturing, or distributing substances destined for illicit trafficking in the US
8
Q
Pharmacist Manual
A
- Federal regulations and DEA law are extension and detailed, good place to find this info
- Guide to pharmacists specifically to aid pharmacy practice
- Compiles the pertinent information from Fed. Controlled Act
9
Q
CI
A
- High risk for abuse
- No accepted medical use in treatment or lacks accepted safety for use under medical supervision
10
Q
CII
A
- High potential for abuse
- Accepted medical use
- May lead to severe psychic or physical dependence
11
Q
CIII
A
- Less potential for abuse than CI or CII
- Accepted medical use
- Moderate or low risk of physical dependence or high psychological dependence
12
Q
CIV
A
- Low potential for abuse compared to CIII
- Accepted medical use
- Limited physical or psychological dependence compared to CIII
13
Q
CV
A
- Accepted medical use
- Limited physical or psychological dependence compared to CIV
14
Q
SLCP
A
- Schedule Listed Chemical Product
- Non-Rx containing ephedrine, PSE, or PPA
- In NM, PSE is a CV
15
Q
DEA Number
A
- 1st Letter = related to practitioner level (A, B, F, M are mid-level practitioners, X = suboxone)
- 2nd Letter = practitioner’s last name
- Sum 1 = First number + Third number + Fifth number
- Sum 2 = Second number + Fourth number + Sixth number
- Sum 3 = Sum 1 + 2 * Sum 2
- Last number of the DEA should be the last number of Sum 3
16
Q
Inventory Requirement
A
- DEA - requires biennial inventory (every 2 years)
- NM BoP - annual Cs inventory on May 1st, actual taking of inventory should be within 4 days of this date
- CII: actual counts
- CIII - CV: estimates are okay unless the container holds >1,000, then need to manually count
* *Pharmacy policy may require a running inventory and keeping track of counts in real time**
17
Q
Storage
A
- CII-CV: store in either securely locked cabinet or dispersed through stock
- CII usually kept in safe and CIII-CV usually found in stock
- PSE, Ephedrine, and PPA must be behind the counter or locked in a cabinet
18
Q
CII Dispensing
A
- Amount must be consistent with medical purpose (usual course of practice) and insurance limits to 7 or 30 days usually
- Can issue up to 90 days in three 30 day prescriptions with the same written date and different earliest fill dates
- Fill within 6 months of date written or earliest fill date
19
Q
CII Dispensing - Partial Fills
A
May occur if:
- Dispensed number doesn’t exceed the total prescribed
- Partial amount is recorded on written or electronic Rx
- Remaining portion filled before script’s 30 days after the date written (or earliest fill date)
20
Q
CII Dispensing - Initially filled after 30 days after date written
A
Can be partially filled if:
- RPh is unable to dispense total prescribed
- Amount is recorded on Rx
- Remaining amount is filled in the next 72 hours
- RPh notifies prescriber that remainder can’t be filled in 72 hours
21
Q
Dispensing CIII-CV
A
- Can be dispensed up to 90 days
- Can be telephoned in (exluding CIII-CV opiates) for up to a 10 day supply unless the same medication is on file from the last six months, NO REFILLS (Verbal authorizations or clarifications on refills don’t count towards this)
- Continuing therapy for CIII-CV non-opiate may be written or faxed for a 30-90 day supply
- PSE containing products are available OTC
* *Store/pharmacy policy can vary on these**
22
Q
PSE
A
- If buying OTC without Rx, must have a government issues, photo, valid ID
- Pharmacy must keep a log of purchases and submit the data to BoP agency every 7 days
- 3.6 g/day and 9 g/30 days
23
Q
CII Refills
A
- NO REFILLS
- Partial fills with remainder within 72 hours (call doctor if this isn’t possible)
- LTCF or “terminally ill” can be partially filled an unlimited number of times for 60 days up to total number of prescribed pills
24
Q
CIII-CV Refills
A
- Recorded in same manner as any refill
- May refill up to 5 times
- Valid for 6 months after date of issue
- Don’t refill before 75% of prescription’s days supply has past
25
Controlled Transfers
- CII: NO TRANSFERS
- CIII-CV: to another pharmacy with real-time, online database, may transfer for up to max refills permitted by law (Walgreens to Walgreens for example)
- To any other pharmacy, can only be transferred ONCE
817
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