Singhal Shubha, Shah Rima B, Piparva Kiran G, Dutta Siddhartha
Department of Pharmacology, AIIMS, Rajkot, Gujarat, India.
J Family Med Prim Care. 2023 Jul;12(7):1399-1405. doi: 10.4103/jfmpc.jfmpc_1883_22. Epub 2023 Jul 14.
Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as per Drug and Cosmetic Rule 1945 and US Food and Drug Administration criteria.
A cross-sectional study was conducted on PIs collected from accessible pharmacy stores. Information provided was recorded as per criteria, and total information adequacy score (IAS) and information deficiency (IDS) score were calculated. The association of factors like single-drug/FDCs, a company of origin Indian/multinational, and route of administration (ROA) with IDS was statistically analyzed.
Of 120 PIs, 60%, 86.66%, and 73% were single-drug, prescription-drug, and drugs by Indian manufacturers, respectively. Most PIs provided generic names, ROA, and indications for use. 85%, 12%, 29.16%, and 3.33% provided information on PIs on the ability to drive, drug-food interactions, drug-drug interactions, and addiction potential, respectively. Lacking area was information on use in pediatrics-geriatrics (30%), excipients (28.3%), preclinical (15.83%), post-surveillance data (18.33%), and approval date (2.5%). There was a statistically significant difference between pharmaceutical score (3.22 vs 4.12), therapeutic score (11.5 vs 13.18), and total IAS (14.78 ± 3.39 vs 17.31 ± 2.33) of Indian and multinational companies. IDS was statistically significantly different in both pharmaceutical and therapeutic categories for single-drug vs FDCs ( = 0.00001), OTC vs prescription drugs ( < 0.05), and Indian vs multinational companies' PIs ( = 0.00001).
Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS.
药品说明书（PIs）向用户和初级保健医生提供有关药品的详细信息，因此信息应准确、可靠，并符合监管指南。本研究旨在根据1945年《药品和化妆品规则》及美国食品药品监督管理局的标准，分析印度市场上现有药品说明书的信息充分性。
对从可及的药店收集的药品说明书进行横断面研究。按照标准记录所提供的信息，并计算总信息充分性得分（IAS）和信息不足得分（IDS）。对单药/复方制剂、原产公司（印度/跨国）以及给药途径（ROA）等因素与IDS之间的关联进行统计学分析。
在120份药品说明书中，分别有60%、86.66%和73%为单药、处方药以及印度制造商生产的药品。大多数药品说明书提供了通用名、给药途径和适应证。分别有85%、12%、29.16%和3.33%的药品说明书提供了关于驾驶能力、药物与食物相互作用、药物与药物相互作用以及成瘾可能性的信息。缺乏的信息领域包括儿科-老年科用药信息（30%）、辅料信息（28.3%）、临床前信息（15.83%）、上市后监测数据（18.33%）以及批准日期信息（2.5%）。印度公司和跨国公司在药学得分（3.22对4.12）、治疗学得分（11.5对13.18）以及总IAS（14.78±3.39对17.31±2.33）方面存在统计学显著差异。在药学和治疗学类别中，单药与复方制剂（P = 0.00001）、非处方药与处方药（P < 0.05）以及印度公司与跨国公司的药品说明书（P = 0.00001）的IDS均存在统计学显著差异。
药品说明书在诸多信息方面存在欠缺，未能提供完整信息，尤其是印度原产的药品说明书，根据客观的IDS来看更是如此。
