Coroners want a prescription drug licensed here classified as a controlled drug, after toxicology reports indicated an increase in poisoning deaths linked to its toxicity.
The call by the Coroners Society of Ireland (CSI) for the re-classification of pregabalin is aimed at increasing awareness among GPs and the public about the potential side-effects of long-term use, and the particular risk for users with current, or past, substance-related disorders, Dr Eleanor Fitzgerald, president of the CSI, told The Irish Times.
Pregabalin, marketed as Lyrica, is licensed in Ireland, Europe and the US for use in treating epilepsy, nerve pain and general anxiety disorders.
Unlike the UK and some other countries, pregabalin is not classified in Ireland as a Class C or controlled drug.
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Dr Fitzgerald, a GP, wrote earlier this month to the Health Products Regulatory Authority (HPRA) and the Departments of Justice and Health, calling for pregabalin to be classified as a Class C drug.
The move, endorsed by the council of the CSI, followed presentations concerning the drugs by doctors and health researchers whose expertise includes substance abuse.
The material considered by the CSI included reports from inquests and from the National Drug-Related Deaths Index (NDRDI) indicating increased poisoning deaths here linked to pregabalin toxicity.
The coroners heard pregabalin is being sold, often by people with addiction issues, on the streets of Dublin and other cities where it is known as “coffin tablets” and “buds”.
Various studies have fuelled debate over recent years on pregabalin’s potential to cause addictive behaviours, particularly in people with a history of substance abuse, and have led to calls for doctors to be very careful when prescribing it.
Increasing use
Dr Fitzgerald told The Irish Times the material before the CSI indicated increasing use of pregabalin here and an increasing presence of pregabalin, in combination with other drugs, in toxicology reports.
“Because pregabalin has a fast onset relaxing or sedative effect, that can lead to a potential risk of misuse, especially for those with a history of opioid use,” she said.
Some people experience no difficulty with the drug if it is appropriately prescribed and monitored but the evidence suggested long-term use “may be problematic”, she said.
When a drug is classified as a controlled drug, its prescription must be reviewed on a monthly basis and that would contribute to improved monitoring of its use and effects on patients, she said.
Dr Angela Skuse, medical director of Safety Net, a medical charity providing services to homeless and other marginalised people, was among those who made presentations to the CSI seeking to have pregabalin classified as a controlled drug.
Her concerns about pregabalin include that it is being “abused a lot”, Dr Skuse told The Irish Times.
Pregabalin is being accessed for problems such as back pain by people who do not have back pain; and some are seeking prescriptions for it from multiple sources and then selling it on the streets of Dublin for €1 per 100mg tablet and €3 per 300mg tablet, she said.
This underlines the problems with the absence of a central monitoring system here for prescription medicines, she said.
Pregabalin, according to Dr Skuse, should be a treatment “of last choice” for back pain and sciatica.
Another concern is that pregabalin seems to have addictive potential, with some people appearing to have great difficulty coming off it when the reason for it being prescribed has gone, she said.
A further concern is that pregabalin, when combined with opiates, appears to increase the risk of a fatal overdose, she said.
According to the HSE (Primary Care Reimbursement Service Annual Reports, Statistical Analysis of Claims and Payments 2019), use of pregabalin has increased here and worldwide.
A paper published in 2019 in the journal Drug and Alcohol Dependence, entitled ‘A repeated cross-sectional study of factors associated with pregabalin-positive poisoning deaths in Ireland’, reported almost one in six poisoning deaths here between 2013-2016 were pregabalin-positive poisoning deaths (PPPD).
Gender, opioid misuse and in-treatment for problematic drug use were all factors associated with PPPD, the research found. Toxicology reports showed most of the PPPD deaths involved at least two other central nervous system depressant drugs.
Citing data from the NDRDI, which records all poisoning deaths in the State by drugs and/or alcohol, the researchers noted pregabalin was present in 240 (16 per cent) toxicology reports of 1,489 poisoning deaths, representing a rise from 15 (4.5 per cent) in 2013 to 94 (26 per cent) in 2016. While total poisoning deaths appeared to decrease over the four years, there was an increase in PPPD, up from 18 deaths in 2013 to 94 in 2016. Women were almost three times more likely to experience a PPPD.
The authors recommended enhanced training of prescribers and treatment providers on the potential risks associated with pregabalin, particularly among people who use drugs, and consideration of classifying pregabalin as a controlled drug.
