Dataset Information

Trends and uptake of new formulations of controlled-release oxycodone in Canada.

ABSTRACT:

Purpose

This study investigated the impact of changing availability of tamper-deterrent and non-tamper-deterrent oxycodone on prescribing patterns of controlled-release oxycodone across Canada.

Methods

We conducted a population-based, serial cross-sectional study of controlled-release oxycodone dispensing from community pharmacies across Canada between October 2007 and April 2016. We calculated rates of dispensing (tablets per 100 population) and reported the relative market share of generic non-tamper-deterrent controlled-release oxycodone. All analyses were reported nationally and stratified by province.

Results

After the introduction of a tamper-deterrent formulation, the national rate of controlled-release oxycodone dispensing fell by 44.6% (from 26.4 to 14.6 tablets per 100 population from February 2012 to April 2016). Between December 2012 and July 2013, there was moderate uptake of generic non-tamper-deterrent controlled-release oxycodone (968 452 tablets; 16.0% in July 2013), which appeared to have little impact on the overall rate of controlled-release oxycodone dispensing in Canada. However, the uptake of generic non-tamper-deterrent oxycodone varied considerably by province. By April 2016, 55.0% of all controlled-release oxycodone tablets dispensed in Quebec were for the generic formulation. Elsewhere in Canada, this prevalence was less than 30%, ranging between 1.6% (Prince Edward Island) and 26.9% (British Columbia) at the end of our study period.

Conclusions

The changing availability of tamper-deterrent and non-tamper-deterrent formulations of controlled-release oxycodone in Canada has had variable influence on the rate of use of these products across Canada. Future research should explore whether the availability of generic controlled-release oxycodone has led to measurable changes in the safety of oxycodone use in Canada.

SUBMITTER: Gomes T

PROVIDER: S-EPMC5947657 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Publications

Trends and uptake of new formulations of controlled-release oxycodone in Canada.

Gomes Tara T Jain Sonia S Paterson J Michael JM Sketris Ingrid I Caetano Patricia P Henry David D

Pharmacoepidemiology and drug safety 20180123 5

<h4>Purpose</h4>This study investigated the impact of changing availability of tamper-deterrent and non-tamper-deterrent oxycodone on prescribing patterns of controlled-release oxycodone across Canada.<h4>Methods</h4>We conducted a population-based, serial cross-sectional study of controlled-release oxycodone dispensing from community pharmacies across Canada between October 2007 and April 2016. We calculated rates of dispensing (tablets per 100 population) and reported the relative market share ...[more]

PMID: 29359446

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Project description:Controlled-release oxycodone/naloxone (OXN-CR) maintains the effect of opioid-induced analgesia through oxycodone while reducing the occurrence rate of opioid-induced constipation through naloxone. The present study was designed to assess the non-inferiority of OXN-CR to controlled-release oxycodone (OX-CR) for the control of cancer-related pain in Korean patients.In this randomized, open-labeled, parallel-group, phase IV study, we enrolled patients aged 20 years or older with moderate to severe cancer-related pain [numeric rating scale (NRS) pain score ?4] from seven Korean oncology/hematology centers. Patients in the intention-to-treat (ITT) population were randomized (1:1) to OXN-CR or OX-CR groups. OXN-CR was administered starting at 20 mg/10 mg per day and up-titrated to a maximum of 80 mg/40 mg per day for 4 weeks, and OX-CR was administered starting at 20 mg/day and up-titrated to a maximum of 80 mg/day for 4 weeks. The primary efficacy endpoint was the change in NRS pain score from baseline to week 4, with non-inferiority margin of -1.5. Secondary endpoints included analgesic rescue medication intake, patient-reported change in bowel habits, laxative intake, quality of life (QoL), and safety assessments.Of the ITT population comprising 128 patients, 7 with missing primary efficacy data and 4 who violated the eligibility criteria were excluded from the efficacy analysis. At week 4, the mean change in NRS pain scores was not significantly different between the OXN-CR group (n = 58) and the OX-CR group (n = 59) (-1.586 vs. -1.559, P = 0.948). The lower limit of the one-sided 95% confidence interval (-0.776 to 0.830) for the difference exceeded the non-inferiority margin (P < 0.001). The OXN-CR and OX-CR groups did not differ significantly in terms of analgesic rescue medication intake, change in bowel habits, laxative intake, QoL, and safety assessments.OXN-CR was non-inferior to OX-CR in terms of pain reduction after 4 weeks of treatment and had a similar safety profile. Studies in larger populations of Korean patients with cancer-related pain are needed to further investigate the effectiveness of OXN-CR for long-term pain control and constipation alleviation. Trial registration ClinicalTrials.gov NCT01313780, registered March 8, 2011.

Dataset Information

Trends and uptake of new formulations of controlled-release oxycodone in Canada.

Purpose

Methods

Results

Conclusions

Publications

Trends and uptake of new formulations of controlled-release oxycodone in Canada.

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