RESUMEN
A cross sectional pan-India study about use of administration devices for paediatric oral and inhalation medicines was conducted with a diverse pool of participants of various age groups. Via 634 respondents from more than 15 states in India, this study has identified the administration devices commonly used by parents/caregivers for children 0 to 18 years and by children over 10 years. It has provided insights on device ease of use, challenges faced and recommendations to facilitate the correct use of administration devices for paediatric oral and inhalation medicines. Ethics approval (DPSRU-BREC/2020/A/008)) was obtained from the Biomedical Research Ethics Committee of Delhi Pharmaceutical Sciences and Research University. The survey was completed by parents only (n = 514) and jointly by both parents and children (n = 120). The mean age of the child was 7.2 ± 4.96 years. 72% of the respondents reported that an oral medicine had been taken recently, 6.3% reported that an inhaled medicine had been taken and the remaining 21.9% reported that both an oral and inhaled medicine had been taken. The use of measuring cup was most prevalent followed by household spoons. The mean of the score for ease of use was found to be highest 4.6 ± 0.50 for oral syringe and lowest (3.8 ± 0.76) for measuring cups. The majority of them found the oral device easy to use. Difficulties were reported mostly for measuring cups and household spoons and were related to a lack of user instructions and measuring difficulties. The respondents who found the device easy to use had mostly received clear instructions from healthcare professionals. Compared to oral devices, there were very limited responses for inhalation devices (n = 175/634). Nebulisers with facemasks were most frequently used followed by manually actuated Metered dose inhalers with and without spacer. The mean of the ease-of-use score for dry powder inhalers was found to be highest (4.2 ± 0.37) followed by mist inhalers (4.0 ± 0) and manually actuated pressurised metered dose inhalers (4.0 ± 0.71). The nebulisers with facemask were reported to be difficult to use by most of the respondents despite receiving clear instructions from healthcare professionals. The study findings add evidence to the understudied area of user experiences and perspectives on administration devices for oral and inhalation medicines in India. It highlights a need for initiatives to improve the usability, availability, and affordability of administration devices for children in India. Awareness on the importance of proper use of devices needs to be raised and sustained about the existence of affordable administration devices.
RESUMEN
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. TRADITIONAL DEVICES: 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. INNOVATIVE DEVICES: 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. CONCLUSION: 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.