Assessment of Medication Safety Using Only Dispensing Data.

Purpose of Review: The purpose of this review is to provide an overview of the published studies that have been used to generate evidence on the safety of medicine use when only medication dispensing data are available.

Recent Findings: Medication dispensing databases are increasingly available for research on large populations, particularly in countries that provide universal coverage for medicines. These data are often used for drug utilisation studies to identify inappropriate medicine use at the population level that may be associated with known safety issues. Lack of coded diagnoses, to identify outcomes, and lack of data on confounders can limit use of these data in practice for medication safety assessment. To overcome these issues, studies have exploited the fact that symptoms of adverse effects of medications can be treated with other medications, for example antidepressants to treat depression or oxybutynin to treat urinary incontinence. The challenge of unmeasured confounding has been addressed by implementing self-controlled study designs that use within-person comparisons and provide inherent control for confounding. Prescription sequence symmetry analysis (SSA) is a within-person study design that has been demonstrated as a useful tool for safety signal generation in dispensing data.

Summary: Using medicine initiation as a proxy for the development of adverse events can help to generate evidence of the safety of medicines when only medication dispensing data are available. Careful consideration, however, should be given to the sensitivity and specificity of the proxy medicine for the adverse event and potential for time-varying confounding due to trends in medicine utilisation. Data-mining approaches using dispensing data have the potential to improve safety assessments; however, the challenge of unmeasured confounding with these methods remains to be investigated.