Talegaonkar Sushama, Chitlangia Ayushi, Pradhan Varsha, More Supriya, Salunke Smita
School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University (DPSRU), MB Road, New Delhi 110017, India; Society for Paediatric Medicines and Healthcare Initiative, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga East, Mumbai 400 019, India.
Society for Paediatric Medicines and Healthcare Initiative, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga East, Mumbai 400 019, India.
Eur J Pharm Biopharm. 2023 Jun;187:166-174. doi: 10.1016/j.ejpb.2023.03.009. Epub 2023 Mar 23.
Administration devices play a very crucial role in achieving a drug's therapeutic effect. Children are often dosed with oral liquids, but dosing devices don't have the accuracy needed, putting them at risk of inaccurate and suboptimal dosing. The availability and use of administration devices may vary throughout the world. Multiple surveys in UK, Europe and Japan have shown diverging practices by parents/caregivers. The aim of the present investigation was to conduct a larger Pan-India study through a series of workshops to understand the use and challenges of traditional devices and assess the need of innovative administration devices for liquid orals in India.
The methodology used for the workshop was contextual inquiry and survey questionnaire were used to record the responses. Parents for the workshop were recruited by advertising the survey on various social media platforms. Informed consent was taken from the parents or caregivers for their participation in the survey. Workshops were conducted pan India and both middle class and urban worker families in the occupational category were included in the study. During the workshop, the parents were briefed about the background and purpose of the study. Certain global innovative devices such as oral syringes, syringes with pacifiers were shown to the parents. Their views and opinions were taken through survey questionnaire and via interactive sessions. The questions were themed for the interactive session on 1) challenges faced, 2) willingness to use innovative devices and 3) the factors influencing their decision on the use of innovative devices.
Across the four regions (4 metro cities) involved in the study, 271 caregivers agreed to participate in the workshops. 17.7 % administered solid dosage forms, 81.2 % administered liquid dosage form and the remaining 1.1 % opted for others.
Caregivers reported the use of measuring cups (41.4 %) followed by household spoons (25.8 %), droppers (15.3 %), measuring spoons (2.6 %), and other dosing devices (5.5 %) for measuring oral liquids. 8.0 % did not use any of the dosing devices as they were administrating tablets and/or capsules. The ease-of-use score was the highest for the dropper (2.67 ± 0.68) and the lowest for the measuring spoon (2.00 ± 1.00). The reported challenges were categorised into five categories which also influences the preference of using administration devices. This includes device design, user experience and usability, sociocultural factors, such as beliefs, knowledge and education, regulatory, and market/distribution.
The majority of the caregivers (86.7 %) were not aware of any of the innovative devices shown to them. 58.7 % were willing to use it if was recommended by the doctor, 1.5 % of caregivers would use it on pharmacists' recommendation and 37.6 % parents would use it if came along with the medicine. The criteria considered by the parents for use of the innovative devices in the descending order were Doctor's recommendation > Quality > Cost > Packed in medicine > Ease of use > Availability/accessibility. There were no differences observed among the low and high socioeconomic status of caregviers regarding the use of traditional devices, challenges faced and awareness about innovative devices. Overall, the study revealed heterogeneity in the SES for the use of administration devices in the four zones. The association of SES and opinion on the use of administration devices was demonstrated with no statistically significant interaction between caregiver SES and the use of administration devices.
The workshop revealed the prevalence of traditional dosing devices like measuring cups, household spoons among the caregivers. It highlighted key issues with the use of appropriate administration devices for correct and accurate dosing in children that remain unresolved and prevalent in India. This study reflects on the needs of the target community; thus hope will help facilitate the development of locally sustainable solutions to improve the administration of medicines in children in India.
给药装置在实现药物治疗效果方面起着至关重要的作用。儿童通常服用口服液体制剂,但给药装置缺乏所需的准确性,使他们面临剂量不准确和不理想的风险。给药装置的可用性和使用情况在世界各地可能有所不同。英国、欧洲和日本的多项调查显示,家长/照顾者的做法存在差异。本研究的目的是通过一系列研讨会开展一项更大规模的全印度研究,以了解传统装置的使用情况和挑战,并评估印度对口服液体制剂创新给药装置的需求。
研讨会采用的方法是情境调查,并使用调查问卷记录回复。通过在各种社交媒体平台上宣传调查来招募参加研讨会的家长。获得了家长或照顾者参与调查的知情同意书。在全印度举办了研讨会,研究纳入了职业类别中的中产阶级和城市工人家庭。在研讨会上,向家长简要介绍了研究的背景和目的。向家长展示了某些全球创新装置,如口服注射器、带奶嘴的注射器。通过调查问卷和互动环节收集他们的意见和看法。互动环节的问题主题为:1)面临的挑战;2)使用创新装置的意愿;3)影响他们使用创新装置决策的因素。
在参与研究的四个地区(4个大城市),271名照顾者同意参加研讨会。17.7%的人给予固体剂型,81.2%的人给予液体制剂,其余1.1%选择了其他剂型。
照顾者报告在测量口服液体制剂时,使用量杯的比例为41.4%,其次是家用勺子(25.8%)、滴管(15.3%)、量勺(2.6%)和其他给药装置(5.5%)。8.0%的人在给予片剂和/或胶囊时未使用任何给药装置。滴管的易用性得分最高(2.67±0.68),量勺的易用性得分最低(2.00±1.00)。报告的挑战分为五类,这也影响了给药装置的使用偏好。这包括装置设计、用户体验和可用性、社会文化因素,如信仰、知识和教育、监管以及市场/分销。
大多数照顾者(86.7%)对向他们展示的任何创新装置都不了解。58.7%的人表示如果医生推荐就愿意使用,1.5%的照顾者会根据药剂师的建议使用,37.6%的家长会在药品附带创新装置时使用。家长在使用创新装置时考虑的标准从高到低依次为:医生推荐>质量>成本>药品包装内附带>易用性>可获得性/可及性。在照顾者的社会经济地位高低方面,在传统装置的使用、面临的挑战以及对创新装置的认知方面未观察到差异。总体而言,研究揭示了四个地区在给药装置使用方面社会经济地位的异质性。证明了社会经济地位与给药装置使用意见之间的关联,照顾者的社会经济地位与给药装置的使用之间没有统计学上的显著相互作用。
研讨会揭示了照顾者中量杯、家用勺子等传统给药装置的普遍使用情况。它突出了在印度,使用适当给药装置进行儿童正确和准确给药方面仍未解决且普遍存在的关键问题。这项研究反映了目标社区的需求;因此希望将有助于推动开发当地可持续的解决方案,以改善印度儿童的药物给药情况。