Lecture 3

Question 1

Federal Controlled Substance Act

Answer 1

• 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.

Question 2

Addict

Answer 2

• 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

Question 3

Agent

Answer 3

Authorized person who acts on behalf of manufacturer, distributor, or dispenser

Question 4

Controlled Substance

Answer 4

Drug or substance or immediate predecessor in schedule I-V

Not spirits, tobacco, wine, malt drinks

Question 5

Depressant or Stimulant

Answer 5

• 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

Question 6

Dispense

Answer 6

• Delivery of a controlled substance to its ultimate user or research subject lawfully
• Includes appropriate packaging, labeling, etc. required

Question 7

DEA’s Mission

Answer 7

• 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

Question 8

Pharmacist Manual

Answer 8

• 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

Question 9

CI

Answer 9

• High risk for abuse

- No accepted medical use in treatment or lacks accepted safety for use under medical supervision

Question 10

CII

Answer 10

• High potential for abuse
• Accepted medical use
• May lead to severe psychic or physical dependence

Question 11

CIII

Answer 11

• Less potential for abuse than CI or CII
• Accepted medical use
• Moderate or low risk of physical dependence or high psychological dependence

Question 12

CIV

Answer 12

• Low potential for abuse compared to CIII
• Accepted medical use
• Limited physical or psychological dependence compared to CIII

Question 13

CV

Answer 13

• Accepted medical use

- Limited physical or psychological dependence compared to CIV

Question 14

SLCP

Answer 14

• Schedule Listed Chemical Product
• Non-Rx containing ephedrine, PSE, or PPA
• In NM, PSE is a CV

Question 15

DEA Number

Answer 15

• 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

Question 16

Inventory Requirement

Answer 16

1. DEA - requires biennial inventory (every 2 years)
2. 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**

Question 17

Storage

Answer 17

• 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

Question 18

CII Dispensing

Answer 18

1. Amount must be consistent with medical purpose (usual course of practice) and insurance limits to 7 or 30 days usually
2. Can issue up to 90 days in three 30 day prescriptions with the same written date and different earliest fill dates
3. Fill within 6 months of date written or earliest fill date

Question 19

CII Dispensing - Partial Fills

Answer 19

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)

Question 20

CII Dispensing - Initially filled after 30 days after date written

Answer 20

Can be partially filled if:

1. RPh is unable to dispense total prescribed
2. Amount is recorded on Rx
3. Remaining amount is filled in the next 72 hours
4. RPh notifies prescriber that remainder can’t be filled in 72 hours

Question 21

Dispensing CIII-CV

Answer 21

1. Can be dispensed up to 90 days
2. 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)
3. Continuing therapy for CIII-CV non-opiate may be written or faxed for a 30-90 day supply
4. PSE containing products are available OTC
   * *Store/pharmacy policy can vary on these**

Question 22

PSE

Answer 22

• 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

Question 23

CII Refills

Answer 23

• 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

Question 24

CIII-CV Refills

Answer 24

• 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

Question 25

Controlled Transfers

Answer 25

• 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