Regulators in the UK are strengthening opioid addiction and dependence warnings on patient information labels and leaflets.
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that opioid medications in the UK will now have better warning labels about the risk of addiction and dependence. The labels will make it clear that the medicine is an opioid, which can cause addiction, and that there can be withdrawal symptoms if people stop taking it suddenly.
Opioids are known to have a serious risk of dependence and addiction. America has seen a massive opioid crisis in recent years, with these medications being the cause of 46,802 overdose deaths in 2018 according to the Centres for Disease Control and Prevention (CDC). A 2019 report from West Sussex NHS Trust highlighted that the UK is now heading toward a USA-style crisis, with five people dying every day from opioid overdoses.
Mitigating opioid addiction
Following concerns raised about the prescribing rates of opioids in the UK, the Opioid Expert Working Group (EWG) of the Commission on Human Medicines (CHM) developed a set of recommendations to improve information for prescribers and patients and to protect public health. These recommendations were fully supported by CHM and formed the basis of the MHRA’s new warnings.
While the CHM continues to consider opioids as important and effective medicines in the treatment of short-term pain relief, they have advised against their long-term use in the treatment of non-cancer pain, due to the risk of dependence and addiction.
MHRA is also requiring conversations between healthcare professionals and patients to discuss the dangers of opioids in greater details, and will involve agreement of a treatment plan, including how long treatment should last, to help minimise the risk of dependence.
Minister for Innovation Lord Bethell said: “Opioid addiction is a serious and life-threatening issue and people need to be aware of these risks before they take medicines with such a high rate of dependency. It is vital that patients are given the right support and guidance on the dangers of long- term use and the strengthening of these labels is a crucial step forwards in protecting patients and saving lives.”
The MHRA Director of Vigilance and Risk Management of Medicines, Sarah Branch said: “Patient safety is our highest priority and that is why we continually monitor the benefits and risks of opioid medicines. Last year, we announced that opioid-containing medicine packaging must carry warnings. Now, we are strengthening those warnings to ensure that opioid medicines are supplied with consistent information on how to manage the risk of addiction.”
Find information on the risks of opioid addiction in this patient guidance.
Patients experiencing any suspected side effects from opioid medicines can report these via the Yellow Card scheme.