Summary of Product Characteristics

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:

1. DHHS Pain Management Best Practices Inter-Agency Taskforce Report May 2019 pmtf-final-report-2019-05-23.pdf (hhs.gov)
2. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 Recommendations and Reports / November 4, 2022 / 71(3);1–95 CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 | MMWR
3. O’Brien T et al. Eur J Pain 2017;21:3-192
4. Faculty of Pain Medicine, Opioids Aware Opioids Aware | Faculty of Pain Medicine (fpm.ac.uk) Accessed February 2024
5. Kosten TR et al, Scie Pract. Perspect 2002;1:13-20
6. Rosenblum A et al Exp. Clin. Psychopharmacol. 2008;16(5):405-41
7. OECD Health Policy. Addressing Problematic opioid use in OECD Countries May 2019 http://www.oecd.org/health/addressing-problematic-opioid-use-in-oecd-countries-a18286f0-en.htm