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In recent years, the emergence or re-emergence of critical issues in infectious disease and public health has presented new challenges and opportunities for laboratory animal care professionals. The re-emergence of bioterrorism as a threat activity of individuals or small groups has caused a heightened awareness of biosecurity and improved biosafety. The need for animal work involving high-risk or high-consequence pathogens and for arthropod-borne diseases has stimulated renewed interest in animal biosafety matters, particularly for work in containment. Application of these principles to animals retained in outdoor environments has been a consequence of disease eradication programs. The anticipated global eradication of wild poliovirus has prompted the promulgation of new biosafety guidelines for future laboratory and animal work. Increased concern regarding the use of biologically derived toxins and hazardous chemicals has stimulated a new categorization of facility containment based on risk assessment. Recognition that prion disease agents and other high-consequence pathogens require safe handling and thorough destruction during terminal decontamination treatment has led to the development of new biosafety guidelines and technologies. The implementation of these guidelines and technologies will promote state-of-the-art research while minimizing risk to laboratory animals, researchers, and the environment.

Background and aims Over-the-counter codeine products were up-scheduled to prescription only in Australia from February 2018. This trend study aimed to identify changes in codeine supply before and after the February 2018 implementation. Design, setting and cases Time-series regression analysis of monthly medicine supplies in Australia from 2014 to 2018. The February 2018 up-scheduling was pre-specified as the intervention; outlier analysis was used to detect automatically sudden unexpected changes before February 2018. Measurements Per-capita supplies based on national data for pharmaceutical wholesales and population exposure. Weight of supplies in milligrams for low-dose codeine (≤ 15 mg per tablet or ≤ 1.92 mg per ml, originally sold over the counter but up-scheduled after February 2018), high-dose combination codeine (30 mg per tablet, prescription only throughout the study period) and all codeine.Findings Several level shifts in supply occurred during the 5 years, led by one of À4.4% [95% confidence interval (CI) = À6.6 to À2.1%] in high-dose codeine in 2015, followed by shifts in low-dose codeine of À40.0% (CI = À46.9 to À32.3%) and À82.2% (CI = À84.3 to À79.9%), respectively, before and after February 2018. High-dose codeine supply increased by 4.4% (CI = 1.8-7.1%) immediately after up-scheduling. Also detected were transient increases and decreases in 2016 and 2017. Compared with pre-2015 levels, the February 2018 up-scheduling was associated with reductions of 45.7% (CI = 43.2-48.0%) and 89.3% (CI = 87.9-90.6%), respectively, in all and low-dose codeine supply but no change in high-dose codeine supply. The level shifts and transient changes were located around various regulatory activities, including public announcements and expert advisory meetings on up-scheduling. Conclusion Up-scheduling of over-the-counter codeine products in Australia in 2018 appears to have been associated with a near halving of Australia's national codeine supply. The transition occurred in multiple forms and phases.

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