Ahmad Akram, Patel Isha, Balkrishnan Rajesh, Mohanta G P, Manna P K
Department of Pharmacy Practice, Annamalai University, Annamalai Nagar, Tamil Nadu, India.
Perspect Clin Res. 2013 Oct;4(4):204-10. doi: 10.4103/2229-3485.120168.
Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010.
This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists' participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates.
A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012.
Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients.
The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.
药物警戒对于确保药品安全及保护消费者免受其有害影响十分有用。医疗保健专业人员应将药品不良反应（ADR）报告视为其职业义务的一部分，并参与本国现有的药物警戒计划。在印度，国家药物警戒计划于2010年7月重新启动。
开展此项调查以评估印度药剂师的知识、态度和实践情况，旨在探究药剂师参与药品不良反应报告系统的情况，找出报告不足的原因，并确定可采取哪些措施来提高报告率。
采用一份经过预测试的包含33个问题的问卷（10个关于知识的问题、6个关于态度的问题、7个关于实践的问题、7个关于印度药品不良反应报告的未来的问题以及3个关于报告药品不良反应的益处的问题），对印度的药剂师进行横断面调查。该研究于2012年5月至2012年7月的3个月期间进行。
在接受调查的600名参与者中，共收回400份问卷。调查的回复率为67%。95%的回复者了解药品不良反应。90%的参与者对强制执业药剂师报告药品不良反应持积极态度。87.5%的参与者有兴趣参与印度的国家药物警戒计划。47.5%的受访者在其实践中观察到过药品不良反应，37%的人已将其报告给国家药物警戒中心。92%的药剂师认为报告药品不良反应对为患者提供优质护理有极大帮助。
印度药剂师在药品不良反应报告和药物警戒方面的知识、态度和实践情况较差。具有较高资质的药剂师，如拥有药学博士学位的药剂师，其知识、态度和实践情况更好。通过接受额外的药物警戒培训，不同部门工作的印度药剂师可以成为药品不良反应报告系统的一部分。
