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The number of patients prescribed pregabalin in England each year has risen by 23% since April 2019, when prescribing restrictions were imposed as part of its reclassification as a Class C controlled drug, NHS data show.
Data obtained by The Pharmaceutical Journal via a freedom of information request to the NHS Business Services Authority show that the number of patients prescribed pregabalin in primary care in England increased from 669,632 during 2018/2019 to 823,231 in 2023/2024 (see Figure).
Gabapentinoids (pregabalin and gabapentin) — which are used to treat neuropathic pain, seizures and anxiety — were reclassified after the Advisory Council on the Misuse of Drugs raised concerns in 2016 about the risks of “illegal diversion and medicinal misuse”.
The reclassification followed a marked increase in the number of deaths linked to gabapentinoids, which can cause euphoria, sedation and dissociation, making them sought after as a recreational drug. Prior to 2009, there was less than 1 death per year attributed to the drugs; however, in 2015, there were 137 deaths associated with them.
While the growth in patients prescribed pregabalin slowed slightly after reclassification, the NHS data suggest that prescribing has started to climb more steeply again in recent years.
Before reclassification, the number of patients prescribed pregabalin rose from 611,098 in 2017/2018 to 669,632 in 2018/2019, an increase of 10%. Following the reclassification, the number of patients prescribed pregabalin increased from 669,632 in 2018/2019 to 688,431 in 2019/2020, a rise of 3%.
However, between 2022/2023 and 2023/2024, the number of patients prescribed pregabalin has increased by 5% from 786,403 to 823,231.
In contrast, the number of patients prescribed gabapentin in England peaked at 926,071 in 2017/2018 and has since fallen to 799,155 in 2023/2024.
Emma Davies, principal pharmacist for pain, analgesic stewardship and harm reduction at Cwm Taf Morgannwg University Health Board, said the increase in prescribing of gabapentinoids was “somewhat baffling”, particularly because the evidence for their use in the conditions they are commonly prescribed for is “generally poor”.
“Certainly, in pain conditions, only a small subset of people are likely to benefit from taking them,” she added.
Pregabalin is recommended by the National Institute for Health and Care Excellence (NICE) as one of the first-line options for neuropathic pain (except for trigeminal neuralgia) in adults, along with gabapentin, amitriptyline and duloxetine.
However, results of a recent study suggested there was widespread off-label prescribing of pregabalin for non-neuropathic pain — most commonly musculoskeletal conditions, such as low back pain — between 1997 and 2019.
In 2020, NICE advised that pregabalin should not be prescribed for managing sciatica and, in 2021, declared that it should not be prescribed for chronic primary pain.
Davies said the increase in prescribing cannot be explained by the prevalence of the conditions that gabapentinoids are licensed for.
“It is likely that some of the increase is explained by the focus on the harms of opioids and prescribers looking for alternative treatments,” she said.
“Trialling people on gabapentinoids is the only way of discovering who might or might not respond to them. However, the concern is the number of people remaining on them with limited review of effectiveness or in spite of signs of harm being caused.”
Amira Guirguis, chair of the Royal Pharmaceutical Society’s Science and Research Committee, and an expert in novel psychoactive substances, said that individuals with substance use disorders, particularly those with opioid use disorders, have recognised the value of pregabalin owing to its dose-dependent synergistic effects when taken with opioids.
“The demand for … pregabalin is increasing among those individuals and is likely to be used long term and at high doses,” she said.
“We need to enhance prescription drug monitoring, particularly in individuals with histories of psychiatric and substance use disorders. Prescribers need to be vigilant when prescribing gabapentinoids to this patient group.
“Pharmacists are well placed to educate patients and the public and raise awareness about harms related to the diversion of gabapentinoids when used alone or in combination with central nervous system depressants.”
Kamila Hawthorne, chair of the Royal College of GPs, said: “Pregabalin can be an effective drug for some patients. GPs will only prescribe after a full and frank conversation with patients about its risks and benefits, exercising particular caution if patients have a history of substance abuse or are at risk of suicide.”
- This article as amended on 11 June 2024 to correct Emma Davies’s job title
