Identifying interventions that improve medication safety & rational use of medicines in India

Material & Methods

This study was conducted jointly at the Division of Discovery and Development Research, Indian Council of Medical Research, from November 2022 to March 2023.

Results

In this study, out of ⁓6000 potential participants contacted in the first survey, 190 (3.8%) participants responded with research ideas. Total of 441 ideas related to SUM and 411 ideas related to RUM were received in this study. Characteristics of responders to survey 1 are provided in Table II. A vast majority (70%) were clinicians, while around 12 per cent of respondents resided outside India. After excluding ideas which were duplicate or unclassifiable, there were finally 122 and 87 unique ideas, in the SUM and RUM domains, respectively (Fig. 1). Of the 209 ideas, 67 were from descriptive research, which was of low priority, while 126 and 16 were from the development and delivery domains, respectively. There were no ideas that were classified as ‘discovery’.

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Fig. 1.

Flowchart of ideas under the SUM and RUM domains.

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Of the 33 stakeholders approached in survey 2, scores for 209 ideas from 27 stakeholders were received. The 15 ideas for SUM (Table III) and RUM (Table IV) that scored the highest RPS per cent are presented along with their criteria-wise scores. All 209 ideas that were scored in survey 2 are available in the supplementary material (Supplementary Materials 1 and 2).

In the SUM domain, the top three research topics focused on testing cost-effective strategies for the improvement of antimicrobial stewardship, safe use of polypharmacy in geriatric patients, and drug take-back policy interventions. In the RUM domain, the top three topics were on testing mobile application-based antimicrobial stewardship interventions, development of diagnostics for antimicrobial resistance, and behavioural interventions to improve rational prescription of antimicrobials in children. Across both domains, 9 out of 30 (30%) topics were related to antimicrobial resistance interventions and stewardship; 5 out of 30 (16%) ideas were related to educational/communication/behavioural interventions, while 3 out of 30 (10%) topics were related to policy/technological interventions. Ideas which had elements of both safe and rational use, were classified into safe or rational domains based on the proposed outcomes. On considering the level of interventions, 7 (23%) topics focused on household/community/primary-care level interventions.In the domain of safe use, the RPS of the top 15 ideas were relatively more clustered, with a range of 87-80, compared to the domain of rational use, where the RPS ranged from 89 to 77. Across both domains, when we analysed individual criterion scores, on an average, ‘innovativeness’ received lower scores while ‘effectiveness’ and ‘applicability’ received higher scores.

Discussion

This research priority-setting exercise was undertaken to help steer the focus of research for the SRUM NTF by identifying and prioritizing a set of research ideas to address issues of unsafe and irrational use of medicines in India. Through this study the aim was to make the data available openly for relevant stakeholders in India to identify and develop interventions to improve safe and rational use of medicines. To our knowledge, this is the first such work from an LMIC and the first such work globally on RUM. This is also the first such work that focuses exclusively on solutions that can improve SRUM. Moreover, this research priority-setting exercise is based on the CHNRI methodology, which is a well-documented systematic process. The main advantage of this methodology is that it is transparent, objective, and replicable. The CHNRI methodology allows policymakers and funding agencies to understand the strengths as well as the weaknesses of every research priority while evaluating against predefined criteria.

The research ideas prioritized in both domains of SRUM reflect real-world challenges faced by a wide range of stakeholders such as clinicians, pharmacologists, policymakers, and researchers. Most of the top 15 ideas scored higher for their applicability and effectiveness, thus reflecting a preference for ideas with higher chances of implementation. Some of these ideas included general solutions to improve SRUM, while a few had a narrow focus on specific solutions addressing a particular issue. While antimicrobial stewardship is identified by policymakers as one of the high-priority health programmes in India, antimicrobial resistance is considered a public health problem²⁷. One of the topics which scored high priority – development of diagnostics for antimicrobial resistance – was recommended to be dropped by the advisory team to avoid duplication of research efforts. Safe use of polypharmacy among the elderly population emerged as a priority in our analysis. It is a key consideration for India, as the country is progressively facing a rapid demographic and epidemiological transition with a significant proportion of elderly suffering from chronic morbidities and on various medications²⁸. Communication/behavioural interventions were also scored high, underlining the crucial role of knowledge and practices of health workers and beneficiaries. Patient medication safety training and training courses for healthcare professionals were also among the top research priorities identified by the WHO exercise¹⁸, thus highlighting that these topics are of universal concern.

In our study, testing the efficacy of technological interventions was also one of the top priorities. The top research ideas for both safe and rational use of medicines address issues that need the involvement of multiple types of stakeholders. Some of the proposed interventions were targeted towards medical doctors, some were targeted at pharmacists, while few were targeted at patients, indicating the importance of multiple stakeholders in ensuring SRUM. Further, many of the top ideas involved interventions that require some degree of systems-level changes, such as health cards/pill cards, fixed-drug combinations for cardiovascular diseases and promoting rational use of antibiotics in intensive care units, among others, thus re-iterating that interventions to improve SRUM effectively will have a greater likelihood of success with the involvement of all levels of the healthcare systems in India. We would like to state here that preparing a list of the top 15 ideas in each domain was based on an arbitrary cut-off and the ideas ranked immediately below the top 15 did not differ greatly in their RPS from the earlier ideas. Further, many of the lower-ranked ideas may have contextual relevance and can be taken up in consultation with stakeholders. The finding that the scores of the top 15 ideas were relatively closely spaced (87-80) in the domain of safe use of medicines are similar to those by the original authors of the CHNRI method²⁹, wherein they state that the collective opinion of experts regarding research ideas, expressed through categorical responses, maximises relatively quickly in terms of identifying the ideas that have the most support. This can occur simply due to the relative nature of scoring in the CHNRI process; alternatively, it can mean that a certain set of ideas were assigned higher values due to a shared belief regarding the perceived benefits of researching these ideas.

These results were then discussed in detail with the advisory team before obtaining inputs during separate meetings from the competent authority of ICMR and other relevant Indian stakeholders (including ISRPT, NRSI, AIDAN, IPC, CDSCO, NIPER, Pharmacy Council of India, Indian Nursing Council and NHSRC). All stakeholders were in general agreement with the prioritized list of research ideas and no changes were required in the list of top 15 research ideas in both SUM and RUM domains.

It is acknowledged that there could be other ways of classifying the ideas received than to group them into different themes. One such method is to group different ideas based on where they fall in the pharmaceutical value chain, highlighting every important link between the manufacturer and the patient³⁰. In this classification, interventions such as improved product labelling will fall under manufacture or regulations, while antimicrobial stewardship will fall under prescribers/pharmacists. Some of the themes that we did not consider relevant for the purpose of this study included intellectual property, substandard medicines, development of new diagnostics/drugs, etc.

Identification of research ideas was carried out by inviting national and international experts identified through publications or relevant networks. Of these, there were only 22 non-Indian responders and 88.9 per cent of all responders had experience working in the LMIC setting. The response rate to survey one, which included the identification of research ideas, was only 3.8 per cent despite two reminders, and this may reflect the need for creating interest and awareness in the domain. Other reasons why the response may have been low were that we reached out to experts through professional networks rather than as individuals, and the response period was only two wks. However, from the responders, we received 209 unique research ideas across the two domains, which is a substantial number. However, we admit that some relevant research ideas may not have been accounted for in this list. Scoring of research ideas, i.e., survey 2, was done only by Indian scorers who could determine whether the idea was contextually relevant for India. Having said this, we understand that India is a country with a heterogeneous health system and substantial inequity in healthcare utilization. With such wide-ranging scenarios, the conclusions of the study may still not be generalizable to all Indian healthcare settings. By engaging with various relevant networks to gather ideas, a serious attempt was made to ensure regional representation and lower selection bias. One of the major limitations of the CHNRI process is that it is driven by expert opinion, which can lead to a bias in the scoring, based on the scorer`s value judgement. Other limitations in this study include those that are inherently associated with the CHNRI methodology, such as the risk of not having achieved saturation of ideas, the possibility of scoring ideas by persons with inadequate expertise in the subject, and poor quality of responses received. In this study, we attempted to mitigate the risk of missing out on important research ideas or inappropriate ranking of ideas as per the prioritization exercise, by discussing the ranked ideas with the TAG members and other relevant national stakeholders. These discussions with subject experts provided some level of independent validity to the prioritization results.

The findings of the research priority-setting exercise will help the ongoing SRUM efforts by highlighting opportunities for research. This may further help translate the priority ideas into research topics and further research questions to answer pressing problems. Suitable partners will be identified to evaluate some of these research questions to eventually help formulate policy recommendations. An interesting finding is that many of the priority ideas found in this study aligned with those of global priority, e.g., safe disposal practices³¹ and enhanced pharmacovigilance have been highlighted as areas of action by WHO¹. Furthermore, the ideas related to the rational use found in this study such as interdisciplinary collaborations, and pharmacy workflow improvements are core components included by WHO to promote rational use of medicines³. Patient engagement, which underlines many of the top research ideas found in this study, also underlines many of the top research priorities reported by the WHO priority exercise on research into safe use of medicines¹⁸. Our findings can initiate various discussions at the national/regional level, which will ultimately help policymakers and practitioners guide their decision-making. Eventually, the NTF is expected to identify policy, technological, or educational interventions that can improve SRUM. Thus, there is a scope in the future for implementing shared solutions based on mutual learning across countries.

Overall, this study has identified and prioritized possible solutions to improve SRUM in India. Further work will entail working closely with development partners in India to translate the identified research ideas into research questions and develop and test solutions that are policy-ready and can be adopted by health systems in India.