J Korean Med Assoc.  2011 Feb;54(2):189-196. 10.5124/jkma.2011.54.2.189.

Designation of a new drug as a controlled substance

• Lee MS
• Ahn W

• KMID: 2189142
• DOI: http://doi.org/10.5124/jkma.2011.54.2.189

Abstract

Opioids are widely used as painkillers and anesthetics. Though we use opioids to relieve pain, these drugs can induce mood elevation, dependency, and withdrawal symptoms. This is why opioids are controlled-substances. Most physicians think that some substances should be controlled if they have opioid-like pharmacological properties, especially a long duration, preservation of respiration, and dependency. It is noteworthy that short-acting substances, such as midazolam and thiopental, are included in controlled substances. Their abuse is very dangerous because they frequently induce severe respiratory depression due to a narrow therapeutic window. Teaching point of this article is that designation of a new drug as a controlled substance requires scientific evidence of its link to dependency and/or withdrawal symptoms. However, this does not require abusers' convenience (long duration) or safety (maintenance of respiration). The authors present the addiction and abuse patterns of propofol as an reasons for the Korean Food and Drug Administration to designate propofol as a controlled substance. As a future study, an animal and/or a clinical model for dependency is needed to identify addictive substances. Though several neurotransmitters and their loci in the central nervous system have been studied, the precise mechanism for addiction is unknown. Also, it should be recognized that the potential for drug addiction and abuse could be masked in the early marketing period of a new drug. Physicians should monitor patients' responses carefully when they deal with the drug.

Keyword

Drug and narcotic control; Substance-related disorders; Propofol; Dependency

MeSH Terms

Aluminum Hydroxide
Analgesics, Opioid
Anesthetics
Animals
Carbonates
Central Nervous System
Controlled Substances
Dependency (Psychology)
Drug and Narcotic Control
Marketing
Masks
Midazolam
Neurotransmitter Agents
Organothiophosphorus Compounds
Propofol
Respiration
Respiratory Insufficiency
Substance Withdrawal Syndrome
Substance-Related Disorders
Thiopental
United States Food and Drug Administration
Aluminum Hydroxide
Analgesics, Opioid
Anesthetics
Carbonates
Controlled Substances
Midazolam
Neurotransmitter Agents
Organothiophosphorus Compounds
Propofol
Thiopental

Figure

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  Figure 1 Designation of a therapeutic agent as a controlled substance in Korea. The Korea Food and Drug Administration (KFDA) conducts the investigation of dependency and abuse of new drugs. The Central Pharmaceutical Affairs Council (CPAC) discusses and makes the final decision about designation of psychotropic drugs. KFDA submits the draft enforcement ordinance of controlled substances to the Ministry of Health and Welfare. After that, the Ministry of Health and Welfare enforces the legislative notice within 20 days. With collecting public opinion through legislative notice, a regulatory and legislative review is conducted by the Ministry of Government Legislation. After a meeting of cabinet ministers and vice ministers, the amendment is promulgated.

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