Objective Valproate has undergone significant changes in labeling to the boxed warnings associated with it. This review will analyze evidence regarding the valproate-boxed warnings for teratogenicity, hepatotoxicity, and pancreatitis, with a particular emphasis on the fetal risk. Data Sources A review of Pubmed, Cochrane Central Register, Google Scholar, manufacturer websites, and product labeling was performed from 1963 to February 2022, using the following search terms: valproate, valproic acid, depakote, teratogenicity, birth defects, fetal risk, hepatotoxicity, and pancreatitis. Relevant English-language studies and those conduced in humans were considered. Product labeling was also reviewed. Data Synthesis There is a significant fetal risk following in utero valproate exposure (risk of malformation development: 8.6% in 360 women in North America). Current labeling in the United States recommends co-prescribing effective contraception for women of childbearing age. The risk of hepatotoxicity and pancreatitis is much lower in the general population (1/20 000 and 1/40 000 patients, respectively) compared with those patients with certain risk factors who are taking valproate (1/500). Conclusions Overstated monitoring recommendations for the potential risk of hepatotoxicity and pancreatitis distracts from a much more common and severe risk of fetal harm. Clinicians must be diligent about discussing this risk with patients and documenting when this discussion occurs. Changes to the current recommendations for monitoring of the boxed warnings associated with valproate therapy should be considered, such as more stringent monitoring requirements for the inherent fetal risk. This could be accomplished through a Risk Evaluation and Mitigation Strategy program or through institution-based policies and procedures. In addition, monitoring recommendations for the risk of hepatotoxicity and pancreatitis should account for contributing risk factors.
Introduction: People who identify as transgender experience a significant amount of mental health concerns compared to the general population. Gender health programs offer the opportunity to provide comprehensive care for this highly stigmatized population, with the potential for psychiatric pharmacists to assist other providers and serve this need. This study aimed to evaluate the number and type of interventions made by a psychiatric pharmacist within a gender health program. Methods: A retrospective review of the electronic medical record was conducted analyzing mental health visits completed by psychiatric pharmacists within the Gender Health Program between May 1, 2020 and December 31, 2021. The primary outcome was number and type of interventions, defined as medication adjustments, laboratory monitoring, and completion of prior authorizations. Secondary outcomes included a description of medication regimens, number and type of patient education provided, and referrals to other healthcare professionals. Key subgroup analyses consisted of number of interventions based on gender identity, race identity, and insurance status.Results: There were a total of 152 appointments among 93 patients. Sixty-one patients (66%) received at least one intervention [median (interquartile range, IQR) of 2 (2, 4)], which occurred across 81 pharmacist appointments (53%). Psychotropic medications were adjusted at 79 appointments (97%), with primarily medication initiations. Patient education was completed and documented at 102 appointments with a median (IQR) of 2 (1, 2) topics discussed per appointment. There was a statistically significant difference found between transmen and transwomen on number of interventions [31 (67%) vs 15 (45%), P = 0.048]. Conclusion:The pharmacist in this study had the opportunity to bridge gaps in access to care to healthcare providers by initiating and managing medications, providing thorough education, and referring patients to further resources. This study affirms the accessibility and role of a psychiatric pharmacist on the interdisciplinary team
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