The International Society for Bipolar Disorders (ISBD) consensus guidelines for the safety monitoring of bipolar disorder treatments

Abstract

Objectives: Safety monitoring is an important aspect of bipolar disorder treatment, as mood‐stabilising medications have potentially serious side effects, some of which may also aggravate existing medical comorbidities. This paper sets out the International Society for Bipolar Disorders (ISBD) guidelines for the safety monitoring of widely used agents in the treatment of bipolar disorder. These guidelines aim to provide recommendations that take into consideration the balance between safety and cost‐effectiveness, to highlight iatrogenic and preventive clinical issues, and to facilitate the broad implementation of therapeutic safety monitoring as a standard component of treatment for bipolar disorder. Methods: These guidelines were developed by an ISBD workgroup, headed by the senior author (MB), through an iterative process of serial consensus‐based revisions. After this, feedback from a multidisciplinary group of health professionals on the applicability of these guidelines was sought to develop the final recommendations. Results: General safety monitoring recommendations for all bipolar disorder patients receiving treatment and specific monitoring recommendations for individual agents are outlined. Conclusions: These guidelines are derived from evolving and often indirect data, with minimal empirical cost‐effectiveness data available to provide guidance. These guidelines will therefore need to be modified to adapt to different clinical settings and health resources. Clinical acumen and vigilance remain critical ingredients for safe treatment practice.

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

“…In particular, when lithium is used in this population, lithium level and renal monitoring should occur at least every 3‐6 months, as well as 5‐7 days following a lithium dose adjustment or adjustment of non‐steroidal anti‐inflammatory drugs (NSAIDs), antiontensin II receptor blockers (ARBs), angiotensin‐converting enzyme inhibitors (ACEIs), or thiazide diuretic dosing 652. Special consideration also needs to be given to dose selection.…”

“…For more detail, readers are referred to comprehensive guidelines for safety monitoring in BD 652. In women of childbearing age, pregnancy should be ruled out, and they should be counselled about the possibility of lamotrigine and carbamazepine affecting the efficacy of oral contraceptives before initiating pharmacotherapy.…”

“…Lithium use is associated with a two‐fold higher risk of chronic kidney disease in older adults (>66 years) 822. While the overall risk for progressive renal failure is low, plasma creatinine concentrations and ideally estimated glomerular filtration rate (eGFR) for these patients should be measured at least every 3‐6 months 652. Since 37% of patients aged >70 years have an eGFR <60 mL/min per 1.73 m 2 ,823 a strict eGFR cut‐off for lithium discontinuation is difficult.…”

Applying the World Health Organization Mental Health Action Plan to evaluate policy on addressing co-occurrence of physical and mental illnesses in Australia

“…Screening and monitoring protocols and guidelines are available in Australia 45,46,54,70,75,77,94 (see Table 2) and overseas. 47 Further, although screening is important, this should be followed by effective, evidence-based interventions. 61 People experiencing mental illnesses other than psychosis, such as anxiety, depression and trauma, encounter heightened rates of a range of physical health problems and chronic diseases, such as CVD.…”

“…Recent developments include: local cross-sector initiatives for specific areas such as dental care, 39,40 change of diet, physical activity 41,42 and smoking; 43,44 identification and management of cardiovascular or cardiometabolic disorders; 31,45,46 and assistance in accessing GPs and effective GP-consumer consultations. 47 Several of these programs for improving services, and studies for ascertaining service needs, have been funded by government at either federal or state level. 39,48 Randomised controlled trials have been conducted for smoking 49 and diet, 50 and several lifestyle programs have been evaluated using other methods.…”