scholarly journals Pattern of adverse drug reactions and serum level of maintenance lithium treatment in patients with bipolar affective disorder: a cross-sectional study in Eastern Nepal

Author(s):  
Deependra Prasad Sarraf ◽  
Suraj Nepal

<p class="abstract"><strong>Background:</strong> Benefits of lithium maintenance therapy in bipolar affective disorder (BPAD) are restricted by adverse drug reactions (ADRs) and low therapeutic index. The same dose of lithium has sub-therapeutic, therapeutic and supra-therapeutic serum level in different patients. The objective of this study was to describe the pattern of ADR and serum concentration of maintenance dose of lithium in patients with BPAD.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was conducted in patients diagnosed with BPAD and taking lithium monotherapy 900 mg daily at least for 6 months at outpatient department of psychiatry, B. P. Koirala institute of health sciences. Sociodemographic profile and relevant laboratory investigations were recorded on a self-designed proforma. Chi square test, ANOVA test and student’s t test were used for analysing the data at p value &lt;0.05.</p><p class="abstract"><strong>Results:</strong> Out of 123, 64 (52.0%) were female. Serum concentration ranged from 0.31 to 1.51 mmol/l with mean of 0.803 mmol/l and was in therapeutic range in 104 (84.6%) patients. At least one ADR was seen in 81 (65.9%) patients and hand tremor (43.6%) was the commonest ADR. Hypothyroidism and hyperthyroidism were seen in 9 (6.8%) and 6 (4.5%) patients, respectively. Occurrence of ADRs were more in female and was significantly significant (P value &lt;0.05).</p><p class="abstract"><strong>Conclusions:</strong> The serum level of lithium 900 mg/day varied widely and was in therapeutic range in majority of the patients. Prevalence of ADRs was 65.9%. Occurrence of ADRs were significantly more common in female patients and supra-therapeutic serum concentration of lithium. A prospective long-term study should be conducted to validate the study findings.</p>

Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030515
Author(s):  
Junpei Komagamine ◽  
Masaki Kobayashi

ObjectivesFew studies have investigated the prevalence of adverse drug reactions (ADRs) leading to hospitalisation in Japan. The aim of this study was to determine the prevalence of ADRs leading to hospitalisation and to evaluate the preventability of these ADRs in Japan.DesignA single-centre cross-sectional study using electronic medical records.SettingAcute care hospital.ParticipantsAll 1545 consecutive hospital admissions to an internal medicine ward due to acute medical illnesses from April 2017 to May 2018. The median patient age was 79 years (IQR 66–87), and the proportion of women was 47.9%.Outcome measuresThe primary outcome was the proportion of hospitalisations caused by ADRs among all hospitalisations. All suspected cases of ADRs were independently evaluated by two reviewers, and disagreements were resolved by discussion. The causality assessment for ADRs was performed by using the WHO-Uppsala Monitoring Committee criteria. The contribution of ADRs to hospitalisation and their preventability were evaluated based on the Hallas criteria.ResultsOf the 1545 hospitalisations, 153 hospitalisations (9.9%, 95% CI 8.4% to 11.4%) were caused by 200 ADRs. Cardiovascular agents (n=46, 23.0%), antithrombic agents (n=33, 16.5%), psychotropic agents (n=29, 14.5%) and non-steroidal anti-inflammatory drugs (n=24, 12.0%) accounted for approximately two-thirds of all ADRs leading to hospitalisation. Of 153 hospitalisations caused by ADRs, 102 (66.7%) were judged to be preventable.ConclusionsSimilar to other countries, one in every ten hospitalisations is caused by ADRs according to data from an internal medicine ward of a Japanese hospital. Most of these hospitalisations are preventable. Some efforts to minimise hospitalisations caused by ADRs are needed.


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