Statement regarding the responsible use of opioid-based medicines​

General considerations for the management of pain with any medication that contains an opioid mechanism of action.

All opioid medications are not authorized for all types of pain indication. Always refer to the product prescribing information

An individualized, patient-centered approach for the diagnosis and treatment of pain is essential to establish a therapeutic alliance between patient and clinician.(1)

To optimize opioid treatment :

  • It is important to optimally use multimodal, non-opioid approaches in acute and chronic pain before escalating to opioids or in conjunction with opioid  therapy (1)
  • Opioids should be used only when benefits for pain and function are expected to outweigh risks (2)
  • Consider patient variables that may affect opioid dose for each patient prior to opioid  use (1)
  • During ongoing opioid therapy, clinician should collaborate with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy and exercise care when increasing, continuing, or reducing opioid dosage (2)
  • Make a careful selection of patients, abuse risk factors evaluated, and regular monitoring and follow-up implemented to ensure that opioids are used appropriately and in alignment with treatment goals (pain intensity and functionality) as agreed with the patient (4-5)
  • Make patients aware of the potential side effects of opioids and the potential for developing tolerance, dependence and addiction (4-5).
  • Addiction is possible even when opioids are taken as directed (6)
  • Signs of opioid use disorder should be monitored and addressed (4-5)

If an opioid is authorized and selected for treatment of acute pain, please consider :

  • The use should be for the shortest necessary time (1)

If an opioid is authorized and selected for treatment of chronic pain, please consider :

  • To continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety (2)
  • Regular monitoring, clinical reviews , re-evaluations are required for long-term opioid treatment to assess pain control, impact on lifestyle, physical and psychological well-being, side effects and continued need for treatment (3-5)
  • How opioid therapy will be discontinued if benefits do not outweigh risks (CDC new ref), incl. tapering down the dose where possible (4-5)

Patients and the general public can benefit from clear educational materials and awareness interventions to support the responsible use of opioids (7)

 

References:

 

M-N/A-HQ-03-24-0021

Opioid Disclaimer

Grünenthal’s charter on the responsible medical use of opioids​

For Grünenthal’s charter on the responsible medical use of opioids, please open the following document.

Overview of medication that contains an opioid mechanism of action​

  • Product list
    Active ingredient / Technology  Brand name  Indication range*
    Tapentadol Palexia® 
     

    Prolonged-release tablet:
    Management of severe chronic pain in adults which can be adequately managed only with opioid analgesics.

    Film-coated tablet:
    Relief of moderate to severe acute pain in adults which can be adequately managed only with opioid analgesics.

    Oral solution:
    Relief of moderate to severe acute pain in children*** from 2 years of age and in adults, which can be adequately managed only with opioid analgesics.

    Tramadol Tramal® EU and Latin America indication:
    Treatment of moderate to severe pain.
    Fixed-dose combination of Tramadol and Paracetamol Zaldiar® Symptomatic treatment of moderate to severe pain; use should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
    Buprenorphine

    Transtec®
    Norspan®

    TranstecTM: Treatment of moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics. TranstecTM is not suitable for the treatment of acute pain.

    NorspanTM: Management of moderate to severe chronic pain in adults.# NorspanTM is not suitable for the treatment of acute pain.

    * Status: January 2024. If not otherwise mentioned the EU SmPC approved at the time of review is used as a basis. Please note that indications and formulations may vary from country to country.
    Please refer to the respective local product information or Summary of Product Characteristics (SmPC)
    *** in children restricted to hospital use where appropriate equipment to enable respiratory support is available and for a maximum treatment duration of 3 days
    # Please note that for NorspanTM Grünenthal is only the Market Authorisation Holder in Latin America