Medical Council suggests controls needed on widely used prescription drug

A WORKING GROUP of health experts led by the Medical Council has told the government it should consider reclassifying a widely precribed – and misused – anti-anxiety and pain relief medicine as a controlled drug under the Misuse of Drugs Act.

Pregabalin was implicated in 83 drug deaths in 2021, the most recent year for which figures are available. This represented almost one in four drug deaths, almost all of which also involved other substances. 

It is the 22nd most commonly prescribed drug on state drug payment schemes, with over 54,000 prescriptions in July alone, according to the most recent HSE data. It’s also used for epilepsy.

Some of this legally prescribed pregabalin is traded or resold on the street. 

Prescriptions of controlled drugs usually need to be more frequently reviewed by doctors, and classification as such under the Misuse of Drugs Act is likely to act as a red flag to prescribers to consider alternatives.

The recommendations of the working group on the overprescribing of pregabalin, benzodiazepines and z-drugs have been sent to Colm Burke, the Minister of State responsible for the National Drugs Strategy, The Journal has learned.

The report to the minister warns that reclassification of pregabalin as a controlled drug “may not be enough” in and of itself to tackle the overprescribing problem. Efforts from across the healthcare system will be needed to make such a measure effective, the minister has been told.

The working group involved representatives from the HSE’s addiction and primary care services, the Department of Health, the Irish College of Genral Practitioners, the College of Psychiatrists of Ireland and other healthcare organisations.

Austin O’Carroll, a GP working with people who are homeless, said he believed making pregabalin a controlled substance would make doctors less likely to prescribe it.

“Once something is a controlled drug you know immediately its abuse potential,” O’Carroll said.

He added that most people he sees who have a pregabalin problem are taking it alongside other drugs, although some have a problem with pregabalin alone. Some patients who have been prescribed the drug in hospital for pain, when it comes to coming off it, appear to have developed a dependence.

Garrett McGovern, a GP specialising in addiction at Priority Medical Clinic, said the indicated uses for the drug should be reassessed, and its prescription much more tightly regulated. 

“There’s no doubt that there’s too many prescriptions gone out. I’m not for one minute saying we ban the drug – I have no doubt that this drug has changed people’s lives who are taking it responsibly, and it’s effective – but there’s definitely a worry. Its implication in overdose deaths is very worrying,” McGovern said.

“There’s no doubt that the more prescriptions you have for these things, and the more likely there’s swapping going on on the street.”

McGovern said GPs need a service to which they can refer their patients if they are dependent on prescription drugs such as pregabalin, as the HSE addiction service is geared towards helping people with opioid addiction.

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He added that posession should not be criminalised, as this is something the state should be moving away from since the Citizens’ Assembly on drugs.

‘Growing concern’

Concerns have been raised for several years over the misuse of pregabalin, which is sold under the brand name Lyrica, with The Journal first reporting on the issue in 2017.

Pregabalin is taken by some people in addiction for its sedative properties and because it can enhance the euphoric effects of opiates such as methodone and heroin.

The HSE’s harm reduction information on pregabalin warns that mixing it with benzodiazepines or alcohol can result in drowsiness, sedation, respiratory depression and death.

Almost all the 83 cases in which pregabalin was contributed to person’s drug poisoning death in 2021 involved multiple substances. This was down from 94 pregabalin-related deaths in 2020 – but still almost 500% higher than 2013 (before this date it was not really found in postmortem toxicology reports in Ireland).

Pregabalin was the second most commonly implicated substance in drug deaths among women in 2021, according to Health Research Board figures.

Research by the Royal College of Surgeons in Ireland and the HSE published earlier this year raised concern regarding the “wide availability of pregabalin in Ireland, including a growing illicit supply”.

The researchers highlighted the potential for “serious harm arising from poly-drug use involving pregabalin among people who use heroin or methadone”.

They found that pregabalin prescribing increased annually in the decade to 2020, as did the number of seizures of the drug.

Warning to doctors

The HSE already warns doctors to bear in mind the “street value” of pregabalin when prescribing and monitor for signs that people may be selling or trading it – such as requests for increased doses, early prescriptions or replacing “lost” prescriptions.

The HSE has also urged doctors to monitor patients for signs of abuse, misuse and dependence and to the exercise caution when prescribing to patients with a history of substance abuse.

The HSE said this weekend that it was “aware of increasing levels of prescribing” of pregablin since its introduction in the 1990s to a level now higher than some commonly prescribed benzodiazepenes.

“Although initially considered to have low abuse potential, concern regarding misuse, diversion, and dependence is growing,” the HSE said.

There are longstanding concerns within the Medical Council, with the regulator warning doctors in 2019 that anyone caught overprescribing pregabalin would face disciplinary action. 

However, the Medical Council has also acknowledged the difficulty faced by doctors when faced with demands from some patients – and limited access to counselling and other treatment services.

Figures on the number of disciplinary cases that arose from the 2019 Medical Council prescribing instruction were not available this weekend.

The Coroners’ Society of Ireland has twice called for pregabalin to be controlled, most recently in February. 

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