Sridhar Sathvik Belagodu, Al-Thamer Sura Saad Faris, Jabbar Riadh
Department of Clinical Pharmacy and Pharmacology, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al-Khaimah, UAE.
Department of Psychiatry, Ibrahim Bin Hamad Obaidallah Hospital, Ras Al-Khaimah, UAE; Department of Psychiatry, RAK Medical and Health Sciences University, Ras Al-Khaimah, UAE.
J Basic Clin Pharm. 2016 Jun;7(3):80-6. doi: 10.4103/0976-0105.183263.
Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, resulting in increased healthcare cost. Association of psychotropic medications with ADRs is common. Pharmacovigilance can play a vital role in alerting the healthcare providers from the possible ADRs and thus protecting the patients receiving psychotropic medications.
To monitor and report the incidence and nature of ADRs in psychiatry outpatient department (OPD).
A prospective observational study was carried out in the psychiatry OPD. All the patients attending psychiatry outpatient and satisfying the inclusion criteria were monitored for ADRs. The causality, severity and preventability assessment of documented ADRs was done. Chi-square test was done to identify the association between ADRs and sociodemographic, disease and treatment-related variables. Paired Student's t-test was carried out to compare the significance difference in the weight of the patients who reported weight gain to psychotropic medications.
The incidence rate of ADR was found to be 10.2%. A total of 112 ADRs were documented. Weight gain 18 (16.07%) followed by somnolence 8 (7.14%) was the most commonly reported ADR. Atypical antipsychotics 37 (33.0%) were the most common class of psychotropic drugs implicated in ADRs. Escitalopram 16 (14.28%) followed by quetiapine 14 (12.5%) were associated with a maximum number of ADRs. No significant association (P > 0.05) documented between demographic and treatment-related variables with number of ADRs.
Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and not preventable type.
药物不良反应(ADR)是发病和死亡的重要原因,导致医疗成本增加。精神药物与ADR的关联很常见。药物警戒在提醒医疗服务提供者注意可能的ADR从而保护接受精神药物治疗的患者方面可以发挥至关重要的作用。
监测并报告精神科门诊(OPD)中ADR的发生率及性质。
在精神科OPD进行了一项前瞻性观察研究。对所有前来精神科门诊就诊且符合纳入标准的患者进行ADR监测。对记录的ADR进行因果关系、严重程度和可预防性评估。采用卡方检验来确定ADR与社会人口统计学、疾病及治疗相关变量之间的关联。采用配对学生t检验来比较报告因精神药物导致体重增加的患者体重的显著差异。
发现ADR的发生率为10.2%。共记录了112例ADR。最常报告的ADR是体重增加18例(16.07%),其次是嗜睡8例(7.14%)。非典型抗精神病药物37例(33.0%)是涉及ADR的最常见精神药物类别。艾司西酞普兰16例(14.28%),其次是喹硫平14例(12.5%),与最多数量的ADR相关。在人口统计学和治疗相关变量与ADR数量之间未发现显著关联(P>0.05)。
研究显示精神科OPD患者中ADR的发生率为中等。研究期间报告的大多数ADR性质轻微且不可预防。