1. If pregabalin is unsuitable for some - or many
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
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?
The information contained in this spreadsheet was taken from: Australian Government, Department of Human Services. Medicare Australia Statistics. Pharmaceutical Benefits Schedule Item Report. Accessed at on 26 March 2019.
PBS Item information
2335X
PREGABALIN
pregabalin 75 mg capsule, 56 (PI, CMI)
2348N
pregabalin 25 mg capsule, 56 (PI, CMI)
2363J
pregabalin 300 mg capsule, 56 (PI, CMI)
2355Y
pregabalin 150 mg capsule, 56 (PI, CMI)

4. …and how many scripts are being dispensed?
Summary of services and benefit for PBS items 2335X, 2348N, 2355Y, 2363J
NSW
VIC
QLD SA WA
TAS
ACT NT
Total
$Benefit
Services
2012/2013
1,785,733
41,783
1,189,395
28,311
1,485,140
35,039
526,124
11,769
728,128
17,051
300,238
7,185
85,300
2,064
12,741
306
6,112,800
143,508
2013/2014
22,792,654
510,825
16,118,716
365,373
17,052,122
371,697
6,194,290
131,746
8,250,047
186,651
3,150,809
70,652
991,355
23,236
240,155
5,368
74,790,148
1,665,548
2014/2015
36,890,348
816,772
27,184,945
608,135
26,873,025
573,598
9,370,981
196,900
12,298,749
276,847
4,716,773
104,064
1,591,456
37,723
354,091
7,800
119,280,369
2,621,839
2015/2016
44,742,804
1,013,925
32,822,399
758,081
33,065,306
719,868
11,522,668
249,453
14,592,827
336,235
5,470,749
123,432
1,880,761
46,485
461,662
10,592
144,559,176
3,258,071
2016/2017
48,727,476
1,108,824
36,657,524
854,603
36,772,205
798,549
12,703,186
276,782
16,439,239
380,341
5,844,087
131,280
2,069,109
51,445
511,291
11,913
159,724,119
3,613,737
2017/2018
42,270,598
1,175,913
30,985,513
890,821
30,580,151
811,471
10,773,426
286,625
13,708,501
387,681
4,669,556
126,799
1,684,258
52,815
453,791
13,179
135,125,794
3,745,304
197,209,614
4,668,042
144,958,493
3,505,324
145,827,949
3,310,222
51,090,676
1,153,275
66,017,491
1,584,806
24,152,212
563,412
8,302,239
213,768
2,033,732
49,158
639,592,406
15,048,007
Difference
40,484,865
1,134,130
29,796,118
862,510
29,095,011
776,432
10,247,302
274,856
12,980,373
370,630
4,369,318
119,614
1,598,958
50,751
441,050
12,873
129,012,994
3,601,796
% increase
2267%
2714%
2505%
3047%
1959%
2216%
1948%
2335%
1783%
2174%
1455%
1665%
1875%
2459%
3462%
4207%
2111%
2510%

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?