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Controlled Substances: What DEA and State Drug Schedules Mean for Pharmacists

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Amphetamines can control ADHD but can also be abused.

Prescription amphetamines to control attention-deficit/hyperactivity disorder are Schedule II drugs, signifying their potential for abuse and misuse.

Photo courtesy of DEA
Definition:

Many effective and widely prescribed medications produce narcotic and potentially fatal adverse effects. Pharmacists, other health care providers and government and law enforcement officials must ensure patients with legitimate medical needs have access to those drugs while keeping people who would abuse the medications from getting them.

Controlled substance schedules categorize drugs and chemicals according to their recognized health benefits, risks to users and likelihood for nonmedical use. The federal Controlled Substances Act gives the U.S. Drug Enforcement Administration authority for maintaining a national drug schedule. Each state also has its own schedule.

What the Schedule Number Indicates

The DEA divides controlled substances into five categories:

  • Schedule I -- High abuse potential, significant risks and no federally recognized medical use. Substances in Schedule I include marijuana, LSD, Spice (synthetic cannabis) and Ecstasy (MDMA, short for methylenedioxymethamphetamine).
  • Schedule II -- High abuse, dependence and addiction potential, along with common severe side effects. Schedule II includes opiates and opioids, including the narcotic painkillers fentanyl (e.g., Duragesic from Janssen) and OxyContin (extended-release oxycodone from Purdue Pharma); cocaine; and attention-deficit/hyperactivity disorder medications like Adderall (amphetamine from Shire) and Ritalin (methylphenidate from Novartis).
  • Schedule III -- Moderate likelihood for physical addiction but known high risks to health and potential for mental dependence. Schedule III includes some anabolic steroids, ketamine and low-dose combination narcotic analgesics such as Vicodin (acetaminophen and hydrocodone from Abbott Laboratories).
  • Schedule IV -- Limited abuse, dependence or addiction potential. Schedule IV includes sedatives such Xanax (alprazolam from Pfizer) and Valium (diazepam from Roche).
  • Schedule V -- Very low abuse potential and minor health risks despite containing small amounts of narcotics. Schedule V includes codeine cough syrups.

How States Controlled Substance Schedules Differ

States often diverge from DEA rules and guidance on controlled substances. This can put pharmacists and patients at risk for federal prosecution, as often happens in states that permit medical use of marijuana. On the other hand, states usually act ahead of the DEA to control drugs newly recognized as posing risks. Oregon made pseudoephedrine available by prescription only in order to curb illegal methamphetamine production years before any federal PSE control laws existed. In 2011, Virginia was among the first states to place Spice in Schedule I. Regularly checking with the National Association of State Controlled Substances Authorities is a good way to stay current on state drug scheduling decisions.

DEA License Required

Pharmacists and pharmacies that dispense controlled drugs must hold DEA licenses, as must doctors and nurses who prescribe the medications. No controlled drug prescription order should be filled or dispensed until a prescriber’s DEA number gets confirmed as valid. Visit the agency’s "How Do I …" website to get license application and renewal details, along with information on confirming prescribers’ numbers. Be aware that the state where you practice may impose additional requirements, particularly regarding medical marijuana.

Also Known As: Scheduled substances, controlled drugs, drugs of abuse
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