Before you prescribe

• Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
• Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hysingla ER.
• Addiction can occur at recommended doses and if the drug is misused or abused.
• Because extended-release products such as Hysingla EReliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.

• Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
• Abuse or misuse of Hysingla ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of hydrocodone and can result in overdose and death.
• Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of Hysingla ER for the proper management of pain in any given patient.
• Patients at increased risk may be prescribed opioids such as Hysingla ER, but use in such patients necessitates intensive counseling about the risks and proper use of Hysingla ER along with intensive monitoring for signs of addiction, abuse, and misuse.

• Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Hysingla ER, and monitor all patients receiving Hysingla ER for the development of these behaviors and conditions.
• Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Hysingla ER.
• Strategies that may reduce the risk of diversion include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug.
• Contact local and state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

• Abuse-deterrent properties do not prevent or reduce the risk of addiction.¹
• Abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.
• As an opioid, Hysingla ER exposes users to the risks of addiction, abuse, and misuse.

• Hysingla ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
• Opioids should be prescribed only if expected benefits outweigh risks—and in combination with non-pharmacologic and non-opioid therapy, as appropriate.²
• When starting opioid therapy for chronic pain, consider an immediate-release (IR) opioid first before prescribing an extended-release (ER) opioid.

PRIOR to initiating therapy with opioids, and periodically during therapy²

• Work with your patient to set realistic treatment goals, including a plan to discontinue opioid treatment if benefits do not outweigh risks

• Educate your patient about the realistic benefits and known risks of opioid therapy

• Discuss patient and clinician responsibilities for managing opioid treatment

• Evaluate risk factors for opioid-related harms—such as history of overdose, substance use disorder, high opioid dosages, or concurrent benzodiazepine use—and incorporate risk mitigation strategies

• Review state PDMP data to see if your patient is receiving opioid dosages or dangerous combinations that pose high risk for overdose

• Consider drug testing* to assess for prescribed opioid medications, other controlled prescription drugs, and illicit drugs

• Plan to evaluate benefits and harms with your patient within 1 to 4 weeks of starting therapy or dose escalation, and continually thereafter (every 3 months or more frequently)

• Avoid prescribing opioid pain medications and benzodiazepines concurrently whenever possible

*Not every urine drug test reliably detects synthetic or semisynthetic opioids, such as hydrocodone, especially those designed for in-office use. And many laboratories will report urine drug concentrations below a specified "cut-off" as "negative." Therefore, ensure that the assay's sensitivity and specificity are appropriate, and consider the urine drug test's limitations when interpreting results.^3-5

   PDMP=Prescription Drug Monitoring Program.