Lect 5 Controlled Substances Flashcards
Federal controlled substances Act
- enforced by DEA
- created closed system
Three Sections
Title 1) estabishes rehab programs for abusers
Title 2) provides for the registration and distribution of CS
Title 3) address importation and exportation of CS
Authority for scheduling
- vested in the AG, however must request medical evaulation of the drug and recommendation from secretary of DHHS
- secretary’s rec is binding on AG unless when AG finds drug must be placed in C-I
C-I
- no accepted medical use
- marijuana legal in some states but still supreme court has upheld illegal
C-II
-High potential for abuse and abuse may lead to severe physical or psychological dependence
C-III
- lesser potential for abuse, abuse may lead to moderate or low physical dependence or high psychological dependence
- barbitals in suppository
- codeine
C-IV
- lower potential for abuse and abuse may lead to limited physical/psychological dependence
C-V
- low potential for abuse and abuse may lead to even more limited physical/psychological dependence
- anti-tussive codeine (2mg/ml)
- antidiarrheal opiates (1mg/ml)
Indicators of “potential for abuse”
1) evidence that drug creates a hazard to health/safety of individuals/community
2) Significant diversion of drug from legitimate channels
3) Drug use is occuring on the initiative of user rather than MD
4) new drug is related in action to known drug w/potential for abuse
Considerations for scheduling
1) drug’s potential for abuse
2) scientific evidence of the pharmacological effect
3) state of current scientific knowledge on drug
4) pattern of abuse
5) scope, duration and significance of abuse
6) pubic health risk?
7) dependence liability
8) immediate precursor of CS
Addiction; DEA perspective
- defined as compulsive drug-seeking behavior where aquiring and using a drug becomes the most important activity in the user’s life
- this implies loss of control regarding drug use, and the adict will continue to use a drug despite serious medical and/or social consequences
Addiction: ASAM
- a primary, chronic disease of brain reward, motivation, memory and related circuits
- dysfunction in the circuits leads to characteristic biological, psychological, social, and spiritual manifestations
- this is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behavior
C-II example
-now includes all hydrocodone
C-III example
-anabolic steroids
C-IV examples
- carisoprodol
- tramadol
- ambien, lunesta
C-V examples
- antiepileptics (pregabalin)
- ezogabine (potiga)
- lacosamide (vimpat)
CS activities requiring registration
- dispensing
- manufacturing
- distributing (or reverse)
- conducting research
- opioid treatment program
- chemical analysis
- import/export
CSA: registration frequency
- manu/dist must register annualy
- dispensers q3y
CSA: registration exemptions
- agents or employees of registrants
- common carriers
- end user
- prescribers and dispensers in the service of US gov’t
- law enforcement
Individual practitioners
- physicians
- dentists
- vets
- or other licensed to dispense by state
Institutional practitiioners
hospital or other person licensed, registered, or otherwise permitted
CSA definition of dispensing….
includes prescribing, administering, and dispensing
Constructive delivery
- delivering compounded CS to a prescriber for administration to a patient
- DEA views it as either manufacturing or distribution (5%)
Seperate registration requirements
-Each principal place of business where CS are administered, dispensed, or stored require seperate registration (chain stores)
Notice of Inspection
- NOI must have name of owner or PIC, name and address of business, date and time of inspection
- Inspector must get written consent by PIC or owner
- Consent must be voluntary and can be rescinded at any time
- PIC/Owner can grant limited consent
