By Scott LaNeve

In April 2019, the Food and Drug Administration (FDA) issued a safety communication requiring opioid labeling changes to guide prescribers and patients on gradual, individualized tapering. The change was made after reports of serious harm in patients physically dependent on opioid pain medicines suddenly having the medicines discontinued or the dose rapidly decreased. Discontinuing or rapidly decreasing dose in dependent patients can cause serious withdrawal symptoms, uncontrolled pain, psychological distress and suicide.

Providers are now instructed not to abruptly discontinue opioids in a patient who is physically dependent. They are advised to gradually taper the dose of the opioid using a patient-specific plan. Patients are also advised that they should not suddenly stop taking their medication and slowly decrease the dose after discussing the plan with the healthcare provider.

To read the entire safety communication, visit https://www.fda.gov/media/122935/download.

In July 2019, the Food and Drug Administration (FDA) also proposed new draft guidance for the drug abuse and dependence section of opioid pain medication labeling. The FDA said its goal in providing the new labeling guidance is “to ensure that information in product labeling on abuse, misuse, addiction, physical dependence, and tolerance is clear, concise, useful and informative.”

The draft guidance advises that the terms abuse, misuse, addiction, physical dependence, and tolerance be defined in the medication’s labeling. They explain that defining the terms creates a common understanding and provides recommended definitions and examples.

Specific information on misuse is provided in the guidance including a definition and examples. The FDA defines misuse as “the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.” Examples of misuse include intentionally taking a drug at a different dose or different dosing interval and intentionally using a drug for therapeutic purposes for which it was not prescribed.

The guidance also advises additional information be included regarding addiction, such as clinical presentation of addition to the drug and risk factors that may cause a person to be particularly vulnerable to addiction, as well as adverse effects associated with addiction to the drug. The FDA defines addiction as “a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.”

To read the entire document, visit  https://www.fda.gov/media/128443/download. Comments are being accepted on the draft guidance through September 3, 2019.

Whether tapering or prescribing an opioid medication, patient monitoring using PDMP checks and toxicology testing is an important part of preventing and detecting misuse. Request a demo to learn more about how hc1 Opioid hcAdvisor™ can simplify patient monitoring as part of the prescribing workflow.

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