In view of the increase in cases of opioid abuse and dependence reported in recent years, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has decided to reinforce the messages aimed at limiting these risks in the SPCs and patient information leaflets.
The reporting rate for opioid abuse and dependence in the European Union is relatively high. The PRAC therefore deemed it necessary to adopt new risk minimisation measures to improve awareness and recognition of the risk of opioid use disorder (OUD).
In medical practice, there is a consensus on the need to establish treatment goals and a discontinuation plan, as well as to educate the patient about the risks and signs of OUD prior and during treatment (Hauser 2021, Dowell 2016 & 2022). Regular reassessment during opioid treatment is necessary in view of potential changes over time in the individual patient's benefit-risk balance.
In addition, two large observational studies conducted in the USA (Edlund et al. 2014) and the UK (Bedson et al. 2019) showed that a higher dose and a prolonged treatment course for opioids were associated with an increased risk of developing OUD. To raise awareness among patients and caregivers, the patient information leaflet has been updated with signs of OUD based on DSM-5 criteria for substance use disorders.
As a result, most opioid's SPCs and patient information leaflets have been, or will be, adapted to include these recommendations and warnings.
These updates include:
- the need to set up a therapeutic strategy (duration of treatment and goals to be attained, as well as a plan to discontinue treatment) before starting opioid therapy;
- the recommendation to schedule regular discussions between doctor and patient to assess the need to continue treatment, consider discontinuation and adjust doses if need be;
- the prevention of withdrawal symptoms when treatment is stopped, by gradually reducing opioid doses;
- a warning about OUD (opioid use disorder), such as physical and/or psychological dependence or addiction (tolerance) following repeated opioid administration, the risk factors for developing OUD, and the need to inform patients of the risks and signs of OUD;
- the need to set up a monitoring system to detect possible signs of compulsive product-seeking behaviour. For patients exhibiting signs and symptoms of OUD, a visit to the addiction specialist should be considered.
We would also like to take this opportunity to remind you that the CBIP has published several e-learning modules on opioid use (available in French and Dutch).
More information
The patient information leaflets for medicines authorised in Belgium are available on the FAMHP website.
References
- Bedson J, Chen Y, Ashworth J, Hayward RA, Dunn KM, Jordan KP. Risk of adverse events in patients prescribed long-term opioids: A cohort study in the UK Clinical Practice Research Datalink. Eur J Pain. 2019 May;23(5):908-922. doi: 10.1002/ejp.1357. Epub 2019 Jan 31. PMID: 30620116.
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1. Erratum in: MMWR Recomm Rep. 2016;65(11):295. PMID: 26987082.
- Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95. doi: 10.15585/mmwr.rr7103a1. PMID: 36327391; PMCID: PMC9639433.
- Edlund MJ, Austen MA, Sullivan MD, Martin BC, Williams JS, Fortney JC, Hudson TJ. Patterns of opioid use for chronic noncancer pain in the Veterans Health Administration from 2009 to 2011. Pain. 2014 Nov;155(11):2337-43. doi: 10.1016/j.pain.2014.08.033. Epub 2014 Aug 29. PMID: 25180008; PMCID: PMC4252255.
- Häuser W, Morlion B, Vowles KE, Bannister K, Buchser E, Casale R, Chenot JF, Chumbley G, Drewes AM, Dom G, Jutila L, O'Brien T, Pogatzki-Zahn E, Rakusa M, Suarez-Serrano C, Tölle T, Krčevski Škvarč N. European* clinical practice recommendations on opioids for chronic noncancer pain - Part 1: Role of opioids in the management of chronic noncancer pain. Eur J Pain. 2021 May;25(5):949-968. doi: 10.1002/ejp.1736. Epub 2021 Mar 2. PMID: 33655607; PMCID: PMC8248186.
Reporting side effects
Patients and healthcare professionals are encouraged to report suspected side effects on the following website: https://www.famhp.be/en/side_effect