The MHRA is asking healthcare professionals to give “stronger warnings” on the risks of taking prescribed or OTC medicines containing opioids with patients using them for any condition other than non-cancer pain.
In new measures announced yesterday by the MHRA, any patient taking or planning to take medicines containing opioids is to receive stronger warnings on the risks of dependence and addiction.
These discussions between HCPs and patients should also involve the agreement of a treatment plan including how long treatment should last, in order to reduce the likelihood patients will become dependent on the drugs.
The Government is also requiring manufacturers to place additional warnings on patient information leaflets “to reinforce those warnings,” emphasising that the medicine in question is an opioid and can therefore cause addition and may lead to withdrawal symptoms if suddenly stopped.
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.
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.
“This is a further step forward in helping to promote the safe use of these pain-relieving medicines.”
The new warnings required by the MHRA are based on recommendations drawn up by the opioid expert working group of the Commission on Human Medicine after concerns were raised about the rate of opioid prescribing in the UK.