Short Report
The impact of OxyContin reformulation at the Sydney Medically Supervised Injecting Centre: Pros and cons

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Introduction

Increases in the prescription of pharmaceutical opioids have coincided with an epidemic of drug overdose in the US, with evidence of similar effects in other jurisdictions including Australia (Dart et al., 2015; Pilgrim, Yafistham, Gaya, Saar, & Drummer, 2015). Oxycodone is implicated in a large number of deaths (Blanch, Pearson, & Haber, 2014; Dhalla et al., 2009; Roxburgh, Bruno, Larance, & Burns, 2011), a significant proportion of which involve intravenous administration of preparations designed for oral administration (Blanch et al., 2014). Injection of pharmaceutical preparations is also associated with increases injecting-related harms (other than blood borne virus risks) including local tissue/vein damage, clots and ischemia; as well as pulmonary inflammation and scarring (Darke, Duflou, & Torok, 2015; Patel et al., 2012). International responses to this issue include doctor and patient education strategies, regulatory changes in the way in which pharmaceuticals are scheduled, prescribed, and dispensed, and the development of tamper-resistant preparations to discourage injecting (Paulozzi et al., 2012, Raffa and Pergolizzi, 2010).

Following similar changes in the United States (US) (2010) and Canada (2012), a tamper-resistant sustained-release oxycodone formulation (hereafter reformulated OxyContin®) was introduced in Australia in April 2014, with the explicit aim of reducing misuse by reducing diversion (Mundipharma Pty Ltd., 2014). Reformulated OxyContin® is harder to crush, cut or chew and more difficult to dissolve in preparation for injecting (Cicero, Ellis, & Surratt, 2012). Early post-marketing surveillance in Australia showed that, following introduction of reformulated OxyContin®, sales of the dose most commonly diverted and injected (80 mg oxycodone) declined; and that among people who inject drugs (PWID), reformulated OxyContin® was among the drugs least commonly injected (Degenhardt et al., 2015). The authors noted that reformulated OxyContin® was not particularly popular among PWID for the purposes of tampering, and its introduction was associated with reductions in injection of OxyContin® with no obvious displacement to other drugs (Degenhardt et al., 2015). These results reflect those of early studies in the US indicating the reformulated product’s lower levels of misuse (Havens, Leukefeld, DeVeaugh-Geiss, Coplan, & Chilcoat, 2014) and attractiveness (Sellers, Perrino, Colucci, & Harris, 2013).

Other US studies have, however, highlighted the potential for shifts in opioid use following the introduction of reformulated OxyContin® (Compton, Jones, & Baldwin, 2016). A pre-post evaluation involving 2566 opioid-dependent people entering treatment documented a substantial decline in the percentage identifying oxycodone as their primary drug (that is, drug used most often and preferred over all others), from 36% before the introduction of reformulated OxyContin® to 13% subsequently. However, oxycodone users did not cease using opioids; rather, patterns of use shifted. Following introduction of reformulated OxyContin®, treatment-seekers were significantly more likely to identify hydromorphone or fentanyl as their primary drug (32% versus 20%); and the proportion reporting recent heroin use almost doubled (Cicero et al., 2012). A study among people seeking drug treatment suggested increases in the use of specific long-acting opioid analgesics after reformulated OxyContin® was introduced, including a relative risk of 1.85 for non-prescription use of buprenorphine. There was, however, no evidence of displacement to heroin use (Cassidy, DasMahapatra, Black, Wieman, & Butler, 2014). There is, nevertheless, expanding evidence to support a direct association between reformulated OxyContin® introduction and increased rates of heroin use (Cicero & Ellis, 2015; Cicero et al., 2012; Coplan, Kale, Sandstrom, Landau, & Chilcoat, 2013).

This study’s objective was to examine the impact of the April 2014 introduction of reformulated OxyContin® on service utilisation (visits to), and the number and type of opioid overdoses occurring onsite, at the Sydney Medically Supervised Injecting Centre (MSIC), currently the sole safer injecting facility in the Southern Hemisphere. Based on previous research (Cicero et al., 2012) and evidence that the reduced availability of one drug may increase the use of others among PWID in Australia (Topp, Day, & Degenhardt, 2003) we hypothesise (i) reformulation will have a displacement effect on drugs injected at MSIC; and (ii) this shift in patterns of drug injection will in turn impact service utilisation and subsequent opioid overdoses.

Section snippets

Setting and data

MSIC is a safer injecting facility where clients can legally inject drugs, including prescription opioids, under the supervision of trained health professionals. MSIC access eligibility criteria include being aged at least 18 years and having a history of injecting drug use. Collecting routine data on drug type injected, MSIC is a unique source of real-time drug trend information.

For each MSIC client visit, a clinical database records drug type that the client intends to inject, and other

Results

The results of models for service visits (total and by drug type) are presented in Table 1, with the raw data series and the smoothed fitted models in Fig. 1. The introduction of reformulated OxyContin® was associated with an estimated 1061 fewer client visits to MSIC per month (95% CI: 195.1–1927.8), representing an 18.3% reduction in average monthly visits relative to the pre-reformulation period. Stratifying client visits by type of drug injected demonstrated that the overall decrease was

Discussion

This study examined patterns of service utilisation and opioid overdoses at the Sydney MSIC following the April 2014 introduction in Australia of reformulated OxyContin®. Client visits to MSIC declined by more than 1000 per month following reformulation. This decrease was largely explained by a reduction in visits to inject oxycodone, a pattern of reduced service utilisation partially offset by increased visits to inject morphine or fentanyl after April 2014. These results are consistent with

Conclusions

Cicero et al. note that Reformulated Oxycontin® may not be the “magic bullet” to solving opioid abuse finding substantial substitution of Oxycontin® with opioids that have higher risk of overdose being used in their patient cohorts following the introduction of Reformulated Oxycontin® (Cicero et al., 2012). Our study replicates this trend towards substitution of OxyContin® with other opioids following the introduction of Reformulated OxyContin® in Australia, with a different population of

Conflict of interests

Professor Dietze reports grants from the Australian National Health and Medical Research Council, the Colonial Foundation Trust, the Australian Government Department of Health and Ageing, the Australian Research Council and Gilead Sciences Inc., during the conduct of this study; grants from Reckitt Benckiser, outside the submitted work.

Contributions

Dr Marianne Jauncey contributed to: conception and design of study, interpretation of data, drafting the manuscript, revising the manuscript critically for important intellectual content and approval of the version of the manuscript to be published.

Dr Michael Livingston contributed to: conception and design of study, analysis and interpretation of data, drafting the manuscript, revising the manuscript, approval of the version of the manuscript to be published.

Dr Allison Salmon contributed to:

Acknowledgements

Dr Libby Topp editorial advice and direction on this paper. Thanks to the clients of Sydney MSIC who consented to information gathered from their visits to the service to be used for research and evaluation purposes.

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