Melanie Walker Chief Executive Officer Australian Injecting and Illicit Drug Users League (AIVL)

1. If pregabalin is unsuitable for some - or many? - people for whom it has been prescribed as an alternative to opioids etc. – what happens next? Melanie Walker Chief Executive Officer Australian Injecting and Illicit Drug Users League (AIVL)

2. So what do we know about Lyrica (pregabalin)? According to www.lyrica.com: IMPORTANT SAFETY INFORMATION LYRICA and LYRICA CR are not for everyone. LYRICA and LYRICA CR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members, or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self-harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop LYRICA or LYRICA CR without first talking to your doctor.

3. …and how many scripts are being dispensed?

4. …and how many scripts are being dispensed?

5. What do we know from ambulance attendances? The rate of pregabalin-related ambulance attendances has increased tenfold since 2012, associated with an increase in the national prescription rate. Patients frequently misused pregabalin with other sedatives, particularly benzodiazepines, and almost 40% of misuse-related events requiring paramedic attendance were suicide attempts. Of the 1201 attendances, 593 (49.3%) were for people who had a history of depression, self-harm, suicidal ideation, suicide attempt, or misuse of alcohol or other drugs that may have contraindicated prescribing pregabalin. Of the five pre-existing conditions that contributed to such histories, the most frequent were a history of depression (485 patients, 40.4%) or a suicide attempt (195, 16.2%). Crossin, R. et al., MJA, Feb 2019

6. Is anyone else worried? At the National Drug and Alcohol Research Centre (NDARC) Symposium in October 2018, Dr Amy Peacock’s presentation on ‘Emerging trends in drug use, harms, and markets: Findings from Drug Trends 2018’ highlighted ‘Increased non prescribed use of other drugs (e.g., pregabalin)’ as being ‘of concern’. Of the sample of people who inject drugs, 16.4% had been prescribed pregabalin and a further 26.6% reported non-prescribed use.

7. Is anyone else worried? Meanwhile, a 2019 Cochrane Review on ‘Pregabalin for neuropathic pain in adults’ found that: Moderate-quality evidence shows that oral pregabalin at doses of 300 mg or 600 mg daily has an important effect on pain in some people with moderate or severe neuropathic pain after shingles, or due to diabetes. Low-quality evidence suggests that oral pregabalin is effective after trauma due to stroke or spinal cord injury. Pregabalin appears not to be effective in neuropathic pain associated with HIV. Very limited evidence is available for neuropathic back pain, neuropathic cancer pain, and some other forms of neuropathic pain.

8. Is anyone else worried? • An investigation by The Age and The Sydney Morning Herald can reveal: • In Victoria, there were 164 overdose deaths linked to the drug between 2013 and 2017, according to coronial data • There have been 88 pregabalin-associated deaths in NSW since 2005, increasing at almost 60 per cent a year • Health authorities have records of six suicides of patients taking the drug • 86,000 Australians who have been prescribed the drug appear to be abusing it, according to one study. Yet many doctors consider it a ‘safe’ medicine to replace opiates. • Pregabalin’s officially listed side effects include depression, blurred vision, confusion, and suicidal thoughts. Yet it is often given to people who have depression or a history of self-harm. • Pregabalin’s use exploded after it was approved as a treatment for nerve pain. But later studies now have some experts fearing it may not work at all for as many as half the conditions it is being prescribed for. • The Age, ‘This popular drug is linked to addiction and suicide. Why do doctors keep prescribing it?’, 18 Dec 2018.

9. Why is AIVL worried? • What is Melanie on about and who has she been talking to? • Service providers • Researchers • People who use drugs and their families and friends

10. For further consideration/discussion • Key messages for service users (e.g. Should service delivery agencies be highlighting the link with depression, suicide and overdose and advising people to talk to their doctor if they have concerns?) • Key messages for clinicians (e.g. What should prescribers be saying to/doing for people for whom pregabalin use may be problematic/have become a concern? What are the implications for withdrawal and pain management?) • Consequential actions for consideration o Who will deliver these key messages to service users and clinicians? o Are there systemic capacity issues in terms of withdrawal services and the broader AOD treatment system that will present barriers for service users and clinicians? o What are the resourcing implications for different stakeholder groups? • Do we need further targeted research to inform the development of responses by different stakeholder groups?