Schedule I? Schedule V? Understanding US Drug Schedules
In last month’s article, we discussed the US Food and Drug Administration’s (FDA) new drug approval process. This process exists to protect customers by ensuring that the prescription and over-the-counter medications brought to market in the US are safe and effective.
There’s another layer of consumer protection built into our nation’s pharmaceutical industry: the Controlled Substances Act and FDA drug scheduling. The Controlled Substances Act was passed in 1970, and it divides all medications and other pharmacologically active substances into two general categories:
- Most medications are non-controlled. That means they have definite medical value, have few or minimal adverse effects on the body, and, most importantly, have little risk for addiction or abuse.
- Some medications are controlled, meaning they have limited or very specific medical value, can cause severe negative impacts if abused, and have a higher potential for abuse and addiction. The label of “controlled substance” also includes illicit drugs like LSD and ecstasy.
The FDA further divides controlled medications into five levels, or “schedules,” ranked according to their medical value, abuse risk, addiction risk, and potential hazards. This month, we’ll look at the various drug schedules, what each one means, and the types of drugs that the FDA has classified into each schedule.
Why Are Drugs Placed on a Schedule?
Most drugs aren’t on an FDA schedule. The majority of prescription medications and all over-the-counter medications are considered “non-controlled” or “unscheduled.” These drugs have been tested and have been shown to be very safe in almost all situations:
- They have a definite medical value but have little or no recreational value.
- A mild overdose, such as accidentally taking two doses, may cause side effects, but they’re not life-threatening.
- They have limited addiction potential.
Other substances don’t meet all of these criteria and are considered “controlled” or “scheduled.” A controlled drug:
- May or may not have medical value, but it usually has some recreational use or abuse potential
- Can cause severe, life-threatening impacts with even a mild overdose
- Has an elevated addiction potential
What Are the Five Drug Schedules?
The FDA maintains five lists, or schedules, of controlled substances. Each schedule is more tightly controlled than the one following it: Schedule I drugs are more tightly controlled than Schedule II drugs, and so on.
Schedule I Drugs: Illicit Substances
Schedule I is reserved for substances that have no medical value and high abuse potential. All Schedule I drugs are illegal according to federal law, so you will never be prescribed a Schedule I drug. Examples include ecstasy/molly, peyote, methaqualone, and heroin. Outside of a few very limited exceptions, possession of a Schedule I drug is a violation of federal law.
Schedule II Drugs: Highly Addictive Medications
Schedule II drugs have medical value when used correctly and under the care of a licensed physician but have the highest addiction and abuse risks of any medications. Schedule II drugs are tightly controlled by the FDA, including to-the-pill accounting requirements for pharmacies. Examples include cocaine, methamphetamine, oxycodone, barbiturates, and morphine. Prescriptions for Schedule II drugs are also tightly controlled and cannot be transmitted electronically or orally.
Schedule III Drugs: Moderately Addictive Medications
Drugs on Schedule III have a lower abuse or addiction potential than Schedule II. While still controlled substances, prescriptions for Schedule III drugs are less tightly controlled; in most places, these prescriptions can be electronic or oral. Examples of Schedule III drugs include ketamine, buprenorphine, paregoric, and some anabolic steroids.
Schedule IV Drugs: Medications With Low Addictive Potential
The drugs listed in Schedule IV have even less potential for abuse or addiction than those in Schedule III and generally require fewer controls at the pharmacy level. Many medications used to treat anxiety and sleeplessness fall into Schedule IV, including benzodiazepines such as Valium, the so-called Z-drugs such as Ambien, and some painkillers and sedatives like tramadol and chloral hydrate.
Schedule V Drugs: Medications With Limited Addictive Potential
The final schedule, Schedule V, contains the least tightly controlled medications covered by the Controlled Substances Act. These drugs have limited abuse potential, demonstrate low addictive potential, and are only marginally more controlled than unscheduled drugs. Examples include cough medications with small amounts of codeine, some anticonvulsants such as pregabalin, and a particular formulation of cannabidiol (CBD).
How Are Medications on a Drug Schedule Handled Differently?
For most patients, it’s easier to think about drug schedules as falling into three boxes:
- Schedule I drugs are entirely illegal and are not considered “medications.”
- Schedule II drugs have strict prescription limitations.
- Drugs on Schedules III, IV, and V have fewer limitations.
Drugs on Schedule II require some additional steps that most prescription drugs don’t:
- Prescriptions must be physically printed or written and cannot be electronically submitted or called in.
- Dispense quantities must be no higher than what the prescriber thinks will be necessary to treat the specific condition. For example, if a condition causing pain should be expected to be under control within three days, the doctor may only prescribe a three-day supply.
- Schedule II prescriptions cannot be refilled. Each new fill of the prescription requires a new physical prescription to be printed and physically carried to the dispensing pharmacy.
From a patient’s perspective, Schedule III-V drugs are handled much the same way as non-controlled medications:
- Prescriptions can be written, printed, called in, faxed, or submitted electronically.
- Doctors should still control dispensing quantities, but controls are not as strict.
- Prescriptions can be refilled according to the applicable refill laws or regulations of the state.
Angus Lake Healthcare provides full-service pharmaceutical services for residential care facilities throughout Middle Georgia, including the management of scheduled drugs.
Whatever your facility’s pharmaceutical needs, we can provide comprehensive pharmacy services for your residents. Schedule a consultation today to learn more: 478-233-1828.
Related Articles:
Is It Safe? How the Drug Approval Process Safeguards Patients
Generic vs. Brand-Name Drugs: Is There a Difference?
Prescription Services FAQs – Know the Details of Your Prescription