To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, a class of drugs used to treat narcolepsy, the US Food and Drug Administration (FDA) is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines.
The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers, according to a safety communication from the FDA.
Further, the FDA notes, individuals who are prescribed stimulants are often faced with requests to share their medication. Sharing these medicines with others can lead to the development of substance use disorder and addiction in those with whom these drugs are shared.
“Prescription stimulants can be an important treatment option for disorders for which they are indicated. However, even when prescribed to treat an indicated disorder, their use can lead to misuse or abuse. Misuse and abuse, also called nonmedical use, can include taking your own medicine differently than prescribed or using someone else’s medicine,” reads the FDA’s safety communication. “For this reason, sharing prescription stimulants with those for whom they are not prescribed is an important concern and a major contributor to nonmedical use and addiction.”
Misuse and abuse of prescription stimulants can result in overdose and death, and this risk is increased with higher doses or unapproved methods of taking the medicine such as snorting or injecting.
The FDA now is requiring the Boxed Warning, its most prominent warning, to be updated and is adding other information to the prescribing information for all prescription stimulants. The FDA is adding information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class.
The Boxed Warning also will advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction. Information on these risks is being required in several sections of the prescribing information, including the warnings and precautions, drug abuse and dependence, overdosage, and patient counseling sections. The FDA is also requiring updates to the existing patient medication guides to help educate patients and caregivers about these risks.
What Did the FDA Find?
The FDA reviewed medical literature published from January 2006 to May 2020 on misuse and abuse of prescription stimulants and associated adverse events. Overall, the most common source of prescription stimulants for nonmedical use in the general population came from friends or family members, with estimates generally ranging from 56% to 80%, usually provided for free.
Nonmedical use from their own prescription accounted for approximately 10% to 20% of people who report having used stimulants nonmedically in the past year. Less commonly reported sources included drug dealers or strangers accounting for 4% to 7% of people who report having used stimulants nonmedically in the past year, and the internet accounting for 1% to 2%.
The review found that nonmedical use has remained relatively stable over the past two decades, despite the increasing number of prescription stimulants dispensed. However, the past-year prevalence of nonmedical use of these medicines varies across specific subpopulations and is highest in the following groups: young adults ages 18 to 25 (estimates ranged from 4.1% to 7.5%), college students (4.3%), and adolescents and young adults diagnosed with ADHD (estimates ranged from 14% to 32%).
According to the available data, people who use prescription stimulants for nonmedical reasons have a higher risk of developing a substance use disorder than those who do not. The most serious harms were more commonly observed with nonmedical use by a non-oral route such as snorting or injecting.
What Should Health Care Professionals Do?
According to the FDA, health care providers should do the following:
- Assess patient risk of misuse, abuse, and addiction before prescribing stimulant medicines.
- Counsel patients not to give any of their medicine to anyone else and monitor for signs and symptoms of diversion such as requesting refills more frequently than needed. As many as half of youth with valid prescriptions for these medicines are approached by peers and other individuals in the person’s peer group to sell or give away their medicine.
- Throughout treatment with prescription stimulants, regularly assess and monitor for signs and symptoms of nonmedical use and addiction.
- Keep careful records of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal laws.
- Educate patients and caregivers on the importance of proper storage and disposal of prescription stimulants.
- Advise patients and caregivers that taking a prescription stimulant other than how it is
- prescribed, or together with alcohol or other controlled substances, could increase the risk of overdose and death.
- Inform patients and caregivers how to recognize the signs and symptoms of an overdose.
- Counsel patients that nonmedical use of prescription stimulants can cause anxiety, nervousness, loss of appetite, and sleep deprivation—all of which can interfere with studying and performance on exams.
- Encourage patients to read the Medication Guide they receive with their filled prescription(s). This important information will be included, as well as additional information about the medicine.
- To help FDA track safety issues with medicines, report adverse events involving prescription stimulants or other medicines to the FDA MedWatch program by calling 855-543-3784 (press 4) or emailing [email protected].
- Sign up for email alerts about Drug Safety Communications on medicines and medical specialties of interest to you.