Healthcare professionals must warn patients of opioid dependence risk, advises medicines regulator

The Medicines and Healthcare products Regulatory Agency has advised healthcare professionals to discuss with patients that prolonged use of opioids may lead to drug dependence and addiction.

Opioid pills spilling out of pill bottle

Healthcare professionals should warn patients taking prescribed or over-the-counter opioids of their risk of dependence and addiction, the Medicines and Healthcare products Regulatory Agency (MHRA) has advised.

The warnings should include a plan for how long treatment should last, in an effort to minimise the risk of dependence.

The MHRA’s advice follows recommendations made by the Opioid Expert Working Group of the Commission on Human Medicines (CHM), which convened in February 2019 to discuss the benefits and risks of opioid medicines.

In April 2019, Matt Hancock, the health and social care secretary, announced that — in line with initial recommendations from the working group — any opioid medicine will need to carry a prominent packaging label, warning that the medicine “can cause addiction” and “contains opioid”.

However, in a statement on 23 September 2020, the MHRA said it is taking a “further step” to strengthen these warnings.

Under the new advice, healthcare professionals should “discuss with patients that prolonged use of opioids may lead to drug dependence and addiction, even at therapeutic doses”.

It added that, before treatment is started, a plan should be agreed with the patients “for end of treatment”.

“At the end of treatment, taper dosage slowly to reduce the risk of withdrawal effects associated with sudden cessation of opioids; tapering from a high dose may take weeks or months,” it continued.

In addition to further verbal warnings from healthcare professionals, the MHRA has asked opioid market authorisation holders to add addiction warnings to patient information leaflets.

Emma Davies, advanced pharmacy practitioner in pain management at Cwm Taf Morgannwg University Health Board, told The Pharmaceutical Journal that the MHRA’s advice was “timely and well intentioned”.

“It is vital the public are made aware of the risks of opioid analgesics, not least their limited therapeutic benefit and potential to cause long-term health problems, but also the risk of dependence and misuse,” she said. “The accompanying patient information covers the risks well.”

“As always, however, I am concerned that those most likely to be affected detrimentally by these medicines are also least likely to access the information.”

Davies added that all healthcare professionals should aim “to support people with pain to find alternative ways to live meaningfully and effectively with it”.

“For pharmacists, we have a role in ensuring that where opioids are prescribed, we ensure patients are counselled on the risks and benefits of using them,” she continued.

“Also, we need to support regular reviews to ensure people continue to benefit from using opioid analgesics and support careful reductions in prescribing, when functional benefit is not demonstrated or where harm is being caused.”

Ewan Maule, head of medicines optimisation at Sunderland Clinical Commissioning Group, said: ”It is good to see a centralised effort to raise awareness of the dangers of long term and high dose opioid use. I would like to see greater restriction on access, however, in particular a ban on sales of opioid containing medicines over the counter and the introduction of a defined maximum dose for chronic non-cancer pain.”

He added that the risks associated with opioid prescribing are “a complex, long standing and multifaceted problem and solutions to address this must be complemented by development and funding of other evidence based treatments and interventions”.

”The MHRA opioid warnings on their own are unlikely to reduce opioid use, but if they prompt patients to have conversations with their GP or pharmacist about their use then it may lead on to a positive therapeutic intervention,” he added.

Commenting on the new advice, Sarah Branch, MHRA’s director of vigilance and risk management of medicines, said: “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.”

Last updated
The Pharmaceutical Journal, Healthcare professionals must warn patients of opioid dependence risk, advises medicines regulator;Online:DOI:10.1211/PJ.2020.20208385

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