Drug Enforcement Administration Drug Scheduling

Article Author:
Michael Lopez
Article Editor:
Prasanna Tadi
Updated:
4/20/2020 10:42:03 AM
PubMed Link:
Drug Enforcement Administration Drug Scheduling

Definition/Introduction

Drug scheduling became mandated under The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (also known as the Controlled Substances Act). The law addresses controlled substances within Title II. Based upon this law, the United States Drug Enforcement Agency (DEA) maintains a list of controlled medications and illicit substances that are categorized from scheduled I to V. The five categories have their basis on the medication’s proper and beneficial medical use and the medication’s potential for dependency and abuse. The purpose of the law is to provide government oversight over the manufacturing and distribution of these types of substances. Prescribers and dispensers are required to have a DEA license to supply these drugs. The licensing provides links to users, prescribers, and distributors.[1][2][3]

Issues of Concern

The schedules range from Schedule I to V. Schedule I drugs are considered to have the highest risk of abuse while Schedule V drugs have the lowest potential for abuse. Other factors considered by the DEA include pharmacological effect, evidenced-based knowledge of the drug, risk to public health, trends in the use of the drug, and whether or not the drug has the potential to be made more dangerous with minor chemical modifications. 

Schedule I:

  • "High abuse potential with no accepted medical use; medications within this schedule may not be prescribed, dispensed, or administered"[1] 
  •  Examples of include marijuana (cannabis), heroin, mescaline (peyote), lysergic acid diethylamide (LSD), methylenedioxymethamphetamine (MDMA), and methaqualone.

Schedule II:

  • "High abuse potential with severe psychological or physical dependence; however, these medications have an accepted medical use and may be prescribed, dispensed, or administered"[1] 
  •  Examples include fentanyl, oxycodone (OxyContin), morphine, methylphenidate (Ritalin), hydromorphone (Dilaudid), amphetamine (Adderall), methamphetamine (meth),   pentobarbital, and secobarbital.
  •  schedule II drugs may not receive a refill

Schedule III:

  • "Intermediate abuse potential (i.e., less than Schedule II but more than Schedule IV medications)"[1] 
  •  examples include anabolic steroids, testosterone, and ketamine

Schedule IV:

  • "Abuse potential less than Schedule II but more than Schedule V medications"[1] 
  •  examples include diazepam (Valium), alprazolam (Xanax), and tramadol

Schedule V:

  • "Medications with the least potential for abuse among the controlled substances." [1] 
  •  examples include pregabalin (Lyrica), Diphenoxylate/atropine (Lomotil), dextromethorphan (Robitussin)

 See Table 1 for information regarding registration, records, prescriptions, refills, distribution, security, and theft or significant loss of controlled substances.

 See Table 2 for information regarding DEA forms 106, 222, 224, and 224a.

Clinical Significance

Medications are routinely added to the list and can be moved from one category to another as our knowledge and understanding of the medications advances. The DEA maintains a current list on its website under the diversion control division heading. Prescribers may prescribe, as allowed by their DEA and state controlled-substance or medical license, Schedule II through V medications. Not all prescribers are licensed to prescribe all levels of controlled substances as their individual state or DEA licenses limit some, and some are under limitations by their professions, such as advanced practice providers in many states. It is the responsibility of the provider and the fulfilling pharmacist to be aware of each medication's category and ensure that only properly licensed individuals are prescribing the medications. It is essential to understand the DEA controlled-substance scheduling both to ensure adequate caution when prescribing medications with high abuse potential and also to ensure against prescribing outside of one's authority.[4][5]

The Controlled Substances Act has great potential to improve patient safety by providing federal oversight for drugs with a high potential for abuse. Providers of scheduled substances (physicians, dentists, podiatrists, advanced practitioners) may have links to the distribution of these substances. They are required to have a DEA license and record prescription of scheduled drugs. This licensing prevents overprescribing and obligates providers to be wary of potential drug-seeking patients. The dispenser must also be aware of a patient's medication history and be mindful of the potential for polypharmacy if a patient seeks multiple providers. The current opioid epidemic is a time where federal oversight and interdisciplinary coordination have the potential to reduce harm to patients prescribed scheduled drugs drastically. It will, however, take further time and evaluation to know if drug scheduling actually reduces abuse, addiction, and overdose.[6][7][8][9][10]



  • Adapted from Department of Justice website https://www.deadiversion.usdoj.gov/
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    • Image 12383 Not availableImage 12383 Not available
      Adapted from Department of Justice website https://www.deadiversion.usdoj.gov/

  • Adapted from https://www.deadiversion.usdoj.gov/, the website is work of the U.S. Government and is not subject to copyright protection in the United States.
    (Move Mouse on Image to Enlarge)
    • Image 12572 Not availableImage 12572 Not available
      Adapted from https://www.deadiversion.usdoj.gov/, the website is work of the U.S. Government and is not subject to copyright protection in the United States.

References

[1] Gabay M, The federal controlled substances act: schedules and pharmacy registration. Hospital pharmacy. 2013 Jun;     [PubMed PMID: 24421507]
[2] Larrat EP,Marcoux RM,Vogenberg FR, Implications of recent controlled substance policy initiatives. P     [PubMed PMID: 24669180]
[3] Gabay M, Federal controlled substances act: controlled substances prescriptions. Hospital pharmacy. 2013 Sep;     [PubMed PMID: 24421533]
[4] Preuss CV,Kalava A,King KC, Prescription of Controlled Substances: Benefits and Risks 2019 Jan;     [PubMed PMID: 30726003]
[5] Weyandt LL,Oster DR,Marraccini ME,Gudmundsdottir BG,Munro BA,Rathkey ES,McCallum A, Prescription stimulant medication misuse: Where are we and where do we go from here? Experimental and clinical psychopharmacology. 2016 Oct;     [PubMed PMID: 27690507]
[6] Clinton HA,Hunter AA,Logan SB,Lapidus GD, Evaluating opioid overdose using the National Violent Death Reporting System, 2016. Drug and alcohol dependence. 2019 Jan 1;     [PubMed PMID: 30481691]
[7] Rose AJ,McBain R,Schuler MS,LaRochelle MR,Ganz DA,Kilambi V,Stein BD,Bernson D,Chui KKH,Land T,Walley AY,Stopka TJ, Effect of Age on Opioid Prescribing, Overdose, and Mortality in Massachusetts, 2011 to 2015. Journal of the American Geriatrics Society. 2019 Jan;     [PubMed PMID: 30471102]
[8] Jones CM,Lurie PG,Throckmorton DC, Effect of US Drug Enforcement Administration's Rescheduling of Hydrocodone Combination Analgesic Products on Opioid Analgesic Prescribing. JAMA internal medicine. 2016 Mar;     [PubMed PMID: 26809459]
[9] Schedules of controlled substances: rescheduling of hydrocodone combination products from schedule III to schedule II. Final rule. Federal register. 2014 Aug 22;     [PubMed PMID: 25167591]
[10] Chen JH,Humphreys K,Shah NH,Lembke A, Distribution of Opioids by Different Types of Medicare Prescribers. JAMA internal medicine. 2016 Feb;     [PubMed PMID: 26658497]