Coroners have renewed a call for a common prescription medicine to be classified as a controlled drug, after a study showed it was detected in one out of every 16 postmortem toxicology tests.
The study raises concerns about the wide availability of pregabalin, including a growing illicit supply, and the potential for serious harm arising from polydrug use, according to researchers at the Royal College of Surgeons in Ireland (RCSI).
Pregabalin, marketed as Lyrica, is licensed in Ireland to treat epilepsy, nerve pain and general anxiety disorders. Reclassifying it as a controlled drug would entail monthly reviews of its prescription.
Doctors working with drug-users have said pregabalin is being accessed by people from multiple sources and then sold on the streets of Dublin – where it is known as the “coffin tablet” – for €1 per 100mg tablet and €3 per 300mg tablet.
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In 2021 pregabalin was the 20th-most-prescribed drug on State drug schemes, according to Health Service Executive figures, with more than 615,000 prescriptions written at a cost of €5.83 million.
It was detected in 6.4 per cent of all postmortem toxicological cases between 2013 and 2020, and 27.8 per cent of cases where heroin or methadone was also found, according to the study.
The growing abuse of pregabalin could lead to it becoming “the new OxyContin,” said Dr Eleanor Fitzgerald, president of the Coroners Society of Ireland. OxyContin, an unrelated prescription opioid medicine, has been blamed for tens of thousands of overdose deaths in the US.
Coroners wrote to the Department of Health last year asking for pregabalin to be made a controlled drug, but the matter was referred to the Health Products Regulatory Authority (HPRA), Dr Fitzgerald said.
The HPRA said that although it was responsible for authorising medicines and for processing controlled drug licences for the department, the department was responsible for controlling substances under the Misuse of Drugs Act 1977.
The department said that while pregabalin was not a controlled drug it is subject to wider regulations on the dispensing of prescriptions.
“The control of any drug by its addition to the schedules of the Misuse of Drugs Acts must have an evidential basis. In this regard, the Department is always prepared to examine evidence in relation to the use of pregabalin to determine the most appropriate course of action to reduce harm caused by the use of the drug,” a spokesman said.
Prescribing of the drug almost doubled between 2010 and 2020, the study says, while the number of seizures involving pregabalin increased from 14 in 2016 to 59 in 2020.
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The study attributes the drug’s growing popularity internationally to increased off-label prescribing for disorders such as chronic back pain, particularly after concern grew about alternatives such as prescription opioids. In other countries, however, studies have shown increases in the prescribing of pregabalin with opioids and benzodiazepines, leading to an increased risk of overdose.
“Although initially considered to have low abuse potential, concern regarding misuse, diversion and dependence is growing.”
The effectiveness of the anti-overdose drug naloxone may be reduced when pregabalin is present along with opioids, the study also suggests.
In 2019 the Medical Council issued advice to all doctors to only prescribe pregabalin when absolutely required. The study says this does not appear to have had an impact on prescribing.
Pregabalin should be prescribed with caution, particularly for patients who are abusing substances, it recommends.
Last year there were 34 reports of suspected adverse reactions involving pregabalin and a related drug, gabapentin, according to the HPRA.
“Generally, the types of reports received for pregabalin and gabapentin align with the known safety profile outlined in their product information,” a spokeswoman said.
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