The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. has announced it will be strengthening opioid addiction and dependence warning labels on patient information leaflets. According to the agency, these labels will make it clear “the medicine is an opioid, which can cause addiction, and that there can be withdrawal symptoms if people stop taking it suddenly.”
Addressing the growing epidemic in the U.K., the Opioid Expert Working Group (EWG) of the Commission on Human Medicines (CHM) drafted recommendations to improve available information for prescribers and patients. The CHM is still committed to disseminating knowledge concerning effectiveness of these drugs for addressing short-term pain while advising on the adverse effects of opioids with long-term use. The guidelines apply specifically to opioids used for non-cancer pain which are either prescribed or sold over the counter in the U.K., including codeine, tramadol, fentanyl, and morphine.
The government’s patient opioid use guidelines suggest the following: “Only take the medicine as directed; Do not increase the dose or take an extra dose; Do not take any other medicines that contain opioids to ‘top up’ your pain relief; Do not take opioid medicines if you are pregnant without health professional advice.” They also include the advice: “If you have any questions about your opioid medicine or side effects, or if you do not understand how to take your medicine, talk to the person who prescribed your opioid medicine or to a pharmacist. Keep talking to them about your pain – there may be different treatments that can help. Do not allow others to take any opioid medicines given to you. Your medicine has been prescribed or specifically recommended for you by your doctor or pharmacist and can be dangerous if taken by other people – it could even cause fatal overdose. Always keep medicines out of sight and reach of children.”
“During discussions with patients, doctors, pharmacists, and nurses would be expected to agree a treatment plan, including the duration of treatment, to minimize the risk of dependency,” a spokesperson for the MHRA said.
Minister for Innovation Lord Bethell added, “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 stated, “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 warning labels. Now, we are strengthening those warning labels to ensure that opioid medicines are supplied with consistent information on how to manage the risk of addiction.”
In February of this year, Dr Cathy Stannard, consultant in pain medicine at NHS Gloucestershire, reported, “What is happening in the U.S. is not happening here in the UK,” referring to data on opioid consumption levels. She added, “The U.S..prescribes nearly four times as much as the UK, and in terms of Europe, we are also low prescribers.” However, the problem still exists, nevertheless, and still needs to be addressed before it gets even worse, according to experts.
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Safety warnings for opioid medicines in UK to be added to labels
Opioid addiction warnings to be strengthened in UK
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