Tamoxifen Pharmacovigilance: Implications for Safe Use in the Future

Abstract

Objective To survey the status of current tamoxifen pharmacovigilance documentation reflecting tamoxifen use in an academic outpatient multispecialty practice in older adults. This data will help provide data to develop improved pharmacovigilance for a growing cohort of older adult users. The data will be utilized by an interdisciplinary team developing new methods of identifying factors for individualized pharmacovigilance in older adults. Design Retrospective chart review to gather descriptive and quantitative data on tamoxifen pharmacovigilance. Setting Multi specialty clinic. Patients 93 patients aged 60 and older. Main Outcome Measures Quantitative report of tamoxifen monitoring as well as descriptive analysis of individual cases. Results We found nineteen cases of serious adverse events possibly related to tamoxifen (thrombi, uterine malignancies). There were fifteen cases with no documentation of pharmacovigilance. All cases had incomplete pharmacovigilance documented. There were two cases of hypercalcemia. There was case of tamoxifen discontinuation due to muscle pain and with chronic muscle pain complaints while receiving tamoxifen. We observed a correlation in older age or high comorbidity burden patients and adverse events patients. Conclusion Some studies direct the important pharmacovigilance towards prevention of thrombi, uterine malignancies, and hypercalcemia; however, it is not easy to identify recommendations for frequency or focus of monitoring to prevent adverse events for individual older adults based on existing recommendations. The data collected and presented in this survey (study) serves to heighten awareness of tamoxifen pharmacovigilance, and as a starting point for the application of machine learning techniques and modeling to identify patients and individual pharmacovigilance recommendations.