The Opioid Timebomb: Victory for the Standard with addiction warnings set to be put on painkiller packaging

You can read our full Opioid Timebomb investigation with enhanced digital content at standard.co.uk/opioids
Matt Writtle

Addiction warnings are set to appear on the packaging of prescription opioids for the first time after the Standard’s groundbreaking investigation.

In the past week the Standard has reported on Britain’s rising dependency on the drugs, which in 90 per cent of cases do not relieve chronic pain. Despite this, prescriptions in England have risen 80 per cent in 10 years.

The Standard also highlighted the fact that none of the five strongest opioids — fentanyl, morphine sulfate, buprenorphine, oxycodone or tramadol — had an explicit addiction warning on its packaging.

In the US, these drugs are required by law to contain boxed warnings in bold capital letters stating their “risk of addiction”.

We exposed the contrasting approach of Britain’s Medicines and Healthcare Products Regulatory Agency, which did not even require drug firms to warn explicitly of the risk in the information leaflet inside the packet.

It is now looking at putting “prominent” warnings on the outside of oral opioid painkiller packets, with clearer wording on the leaflet.

Roger Knaggs, associate professor in clinical pharmacy practice at Nottingham University, said: “This is a very big change in the stance of the MHRA and I don’t think it would have happened without the Evening Standard.

“We in the industry have been trying to get the MHRA to listen to us about the harms of prescription opioids for a very, very long time but with no success and you have managed to achieve this in five days. Your investigation made a compelling argument and I am thrilled they have listened to it.”

June Raine, the MHRA’s director of vigilance and risk management of medicines, said: “We are actively reviewing how we can make sure the strong warnings on opioid medicines are consistent, clear and represent the known risks of tolerance and dependence/addiction.

"We will be looking at including a prominent addiction warning on the outside of opioid packaging as well as stronger, clearer wording on the patient information leaflet.

“Patient safety is our highest priority and we assess all patient information leaflets to make sure they are clear, concise, and accurately convey all warnings on a medicine and we are always looking to do better.”

The MHRA said “the Evening Standard investigation has played a part in further strengthening concerns about the issue”. It said its review is “likely to take some months”.

Cathy Stannard, a top opioid expert, said: “This constructive and flexible response from the regulator is welcome. We need to share everything we know about harms and benefits of medicines to support patients in making informed choices about their treatment.”

The Standard also exposed how opioid packaging and patient information leaflets do not warn patients about the limited effectiveness of the drugs in tackling chronic pain.

The MHRA had said it was a matter for GPs to discuss with patients. Asked if the new warnings would include effectiveness, it said: “We will be looking specifically at warnings concerning addiction and all oral opioid medicines will be in scope.”

After we revealed that almost no inpatient drug addiction treatment centres were left in London other than private clinics, several written questions were put down in Parliament.

Lord Hunt of Kings Heath, a Labour peer, asked if the Government had plans to provide a network of support for people affected by dependence on prescribed drugs.

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