Background: In 1970 the US Congress enacted the Controlled Substances Act which allowed the scheduling of drugs based on abuse potential and accepted medical use: Schedule I drugs are substances with no currently accepted medical use and a high potential for abuse. Examples: heroin (diamorphine) and marijuana (cannabis). Schedule II have a high potential for abuse and accepted medical use: cocaine, oxycodone, hydromorphone, and fentanyl. Schedule III: acetaminophen with codeine, products with < 90 mgs of codeine, and buprenorphine. Schedule IV and V drugs have a low potential for abuse and low risk of dependence: tramadol, benzodiazepines and antiepileptics. Unscheduled substances include alcohol, tobacco, hemp and acetaminophen.
Objectives: To evaluate the most common medications associated with drug abuse and substance abuse as reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) data.
Methods: We used the results from the 2020 Substance Use and Mental Health Indicators in the United States: Results from the 2020 National Survey on Drug Use and Health (SAMSA) report and a FAERS query performed on January 22, 2023, which included all “drug abuse” and “substance abuse” cases overall and in 2020 and compared the misuse data to the FAERs reports.
Results: There are 25 million reports in FAERS; the most frequent suspect drug for substance abuse include: oxycodone (34%); cocaine (16%) buprenorphine HCL/naloxone HCL (15%) morphine (13%); alcohol (12%) diamorphine (12%) cannabis (11%) and alprazolam (9%). The distribution for drug abuse: alprazolam (15%), oxycodone HCL (15%), fentanyl (11%), diazepam (8%), alcohol (8%), acetaminophen (4%) and cannabis (3%). When FAERS 2020 event data was compared to SAMSA misuse data, 138 million responded to have used alcohol in the past month, alcohol was reported as the suspect drug in 8.4% for drug abuse and 9% for substance abuse in FAERS. Marijuana is reported to have over 50 million persons exposed in 2020 with 3% drug abuse and 3% substance abuse cases of cannabis reported in FAERS. Prescription pain reliever was reported in 9.3 million: these medications cross all scheduling categories and have the most reports of drug abuse in FAERS. Prescription tranquilizer or sedative (6.2M) has a very high reporting of drug and substance abuse in FAERS; alprazolam represents 15% of drug abuse and 13% substance abuse. Cocaine 5.2M represents 16% of all the substance abuse and 8% drug abuse cases in FAERS and was a suspect product for death in 68% of the cases.
Conclusions: it is evident that the United States currently faces a significant gap in monitoring the exposure and potential adverse effects of schedule I drugs, particularly cannabis, which ranks as the second most commonly consumed substance after alcohol. To address this crucial issue and facilitate informed public health interventions, the urgent implementation of a dedicated adverse event reporting tool tailored specifically for cannabis is imperative. Such a tool (www.budsinfo,com) would provide a systematic process to comprehensively collect and analyze data regarding the effects of cannabis, thereby ensuring a more proactive approach to public health management.
