Controlled Substances Regulations Quiz

Controlled Substances

• This section is crucial for the MPJE exam, as it assesses the understanding and knowledge of pharmacy law, particularly regarding controlled substances, which are substances regulated by law due to their potential for abuse or addiction.
• New Jersey law differs from federal law in over 20 areas related to controlled substances, highlighting the significance of state-specific regulations that may impose stricter standards than federal guidelines. This legal distinction is essential for pharmacists and healthcare professionals practicing in New Jersey, as non-compliance can lead to legal repercussions.
• Schedules are divided based on dependence and abuse potential, with five classifications that reflect the varying degrees of risk associated with each substance. The scheduling system guides the legal use of these substances in the medical community.

Schedules

• Schedule I: No currently accepted medical use. Substances classified in this schedule are strictly prohibited for medical purposes and are primarily used illicitly. This classification indicates the highest potential for abuse with no recognized therapeutic benefit.
  • Examples: Methaqualone, Heroin, Mescaline, GHB (Gamma-Hydroxybutyrate), THC (Tetrahydrocannabinol), LSD (Lysergic Acid Diethylamide), Marijuana, Peyote. These drugs are often associated with severe psychological or physical dependence.
• Schedule II: High potential for abuse and dependence. These substances are available through prescription but have strict regulations governing their distribution and use due to their addictive nature.
  • Examples: Cocaine (used as a local anesthetic in some medical procedures), Methamphetamine (commonly abused), Pentobarbital (Nembutal, utilized for its sedative properties), Fentanyl (a powerful synthetic opioid), Amobarbital, Oxycodone (often prescribed for pain management), among others. Physicians must be very judicious when prescribing these medications, and their use is highly monitored.
• Schedule III: Moderate potential for abuse and dependence, distinguishing it from the higher schedules by allowing for some level of medical usage.
  • Examples: Alprazolam (Xanax, often prescribed for anxiety), Butorphanol (Stadol, used for pain relief), Chloral Hydrate (Noctec, utilized for sedation). While these drugs can be effective, they still carry a risk of dependency and misuse.
• Schedule IV: Low potential for abuse and dependence. Drugs in this category are often prescribed for common ailments and are less politically contentious than higher-scheduled substances. They still require regulation to prevent misuse.
  • Examples: Chlordiazepoxide (Librium, used for anxiety), Clonazepam (Klonopin, prescribed for seizure disorders), Diazepam (Valium, a muscle relaxant and for anxiety treatment), Flurazepam (Dalmane, a sleep aid), Lorazepam (Ativan, also prescribed for anxiety), Oxazepam (Serax, used for anxiety treatment). Their lower scheduling reflects both their medical utility and lower potential for abuse.
• Schedule V: Low potential for abuse and dependence. This schedule primarily consists of medications that can be dispensed with fewer regulations compared to higher-scheduled drugs.
  • Examples: Actifed/Codeine (used as a cough suppressant), Lomotil (anti-diarrheal), Novahistine Expectorant (for relief of cough and cold symptoms). These products are commonly available over-the-counter in certain formulations, though some variations may still require a prescription.

Schedule II Combination Products

• Hydrocodone-combination products changed from Schedule III to Schedule II effective October 6, 2014. This change was implemented to address rising concerns about the opioid epidemic and to enhance tracking and regulation of these potent pain relievers.
• Schedule II suppositories became Schedule III substances. This alteration reflects an ongoing assessment of how medications are classified based on their risk vs. therapeutic validity.

Scheduling Authority

• The Attorney General has the final say about scheduling these substances; however, this authority is not absolute. They must obtain scientific and medical input from the Department of Health and Human Services (HHS), ensuring that decisions are informed by the latest research and medical practices.
• The Attorney General can bypass HHS if there's an “imminent hazard to public safety” concerning a drug. Such cases prioritize public health and safety, allowing for quicker regulatory action in response to emergent issues. This provision highlights the balance between regulatory oversight and the need for prompt action in critical situations.

Emergency Dispensing of Schedule II Drugs

• Allowed in emergencies when immediate administration is needed, if no alternative treatment exists, or when only a 72-hour supply is required. This emergency provision assists healthcare providers in responding to urgent medical needs without the delay of obtaining a conventional prescription.
• An emergency period is limited to a 72-hour supply. This cap helps mitigate the potential for abuse while still providing timely access to necessary medications for acute care scenarios.
• The prescription must be documented (in writing) within 7 days. This requirement ensures accountability and maintains an accurate record for regulatory purposes, promoting responsible prescribing practices and reducing the potential for diversion.

Partial Filling of Schedules II-V

• Partial fillings are allowed for many schedules; excellent regulatory provision exists for specific situations in which a patient may not require the entire quantity of a prescribed medication at once or may need to receive their medication over a period of time.
• Schedule II partial fills are permissible for a limited 60-day supply under certain conditions; this flexibility enables better management of chronic pain and other conditions requiring ongoing treatment while decreasing the risks of drug dependence and abuse.
• Special rules exist for terminally ill patients in long-term care (LTC). These regulations ensure that patients facing life-limiting diagnoses receive compassionate care while also maintaining checks against potential misuse of controlled substances.

This quiz tests your knowledge on the regulations surrounding controlled substances, specifically focusing on Central Record Keeping and DEA requirements. You will explore various aspects of DEA Form 222, CSOS technology, and notification procedures necessary for compliance. Prepare to apply your understanding to ensure compliance in your practice.