Opioid Abuse Mitigation Programs & Policies

The Role of Government in Mitigating Opioid Abuse

Due to the complex issues surrounding opioid abuse and misuse, various national and state programs, policies, and laws have been put in place to help mitigate opioid abuse and misuse.

Prescription Drug Monitoring Programs (PDMPs)

PDMPs are in place in 49 states to help detect and reduce the risk of diversion and abuse of prescription drugs at the practice and retail levels. These state programs allow for the collection and analysis of prescription data.17 Proactive reporting through the use of PDMPs can help18:

  • Alert prescribers and pharmacists to potential prescription opioid abuse or diversion among their patients
  • Educate prescribers to make better decisions about prescribing controlled substances, thus improving patient care
  • Provide an opportunity to intervene and refer patients for substance use disorder treatment when appropriate

Schedules of Controlled Substances19

The DEA plays an important role in mitigating abuse and diversion of opioids. This federal agency enforces the controlled substance laws and regulations in the US, including the scheduling of controlled substances, such as opioids.19 Controlled substances are classified into five categories, or schedules, according to the accepted medical use and the potential for abuse.19 Schedule I drugs are considered the most dangerous, while Schedule V drugs are seen to have the least risk for abuse.19 Prescription opioid medications generally fall under Schedules II and III.19

SCHEDULE DESCRIPTION
I No accepted medical use and a high potential for abuse. Schedule I drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.
II Drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous
III Drugs with a moderate to low potential for physical and psychological dependence. Abuse potential is less than Schedule I and II, but greater than Schedule IV.
IV Drugs with a low potential for abuse and low risk of dependence
V Drugs with lower potential for abuse than Schedule IV, containing limited quantities of certain narcotics.

SCHEDULE & DESCRIPTION

    I
  • No accepted medical use and a high potential for abuse. Schedule I drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence.
    II
  • Drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.
    III
  • Drugs with a moderate to low potential for physical and psychological dependence. Abuse potential is less than Schedule I and II, but greater than Schedule IV.
    IV
  • Drugs with a low potential for abuse and low risk of dependence
    V
  • Drugs with lower potential for abuse than Schedule IV, containing limited quantities of certain narcotics

In addition to classifying potentially dangerous substances by schedule, the DEA's Office of Diversion Control requires physicians who intend to prescribe scheduled (controlled) medications to register in the state where they obtained a valid medical license.20 The goal of this initiative is to detect and investigate diversion of controlled substances from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.20

Risk Evaluation and Mitigation Strategies (REMS)

REMS are requirements set by the Food and Drug Administration (FDA) for pharmaceutical manufacturers to help ensure that the benefits outweigh the risks for certain drugs.16 There are several components of REMS that can be used by the pharmaceutical industry, including one or more of the following16:

Medication Guides or Patient Package Inserts

  • FDA-approved instructions for appropriate use and instructions for patients focused on avoiding serious adverse events

Communication Plans

  • A comprehensive plan for providing healthcare professionals with education, information, and increased awareness of risks associated with a drug

Elements To Assure Safe Use

  • Some products are required to have additional actions that healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient, known as Elements To Assure Safe Use (ETASU)

Implementation Systems

  • When ETASU are required as part of a REMS program, the FDA may also require pharmaceutical companies to create a plan to ensure prescribers are complying with ETASU

Timetables for Reporting REMS Assessments

  • REMS assessments are intended to determine if the REMS requirements are proving effective. Assessment results may be used to modify the REMS, or even eliminate it, if the assessment shows changes are needed or that the REMS have met its goals