Knowledge and attitude of the medical and dental residents about the availability of globally discarded drugs in India - An evaluative study

INTRODUCTION

The principal objective of the drugs and their formulations is to prevent and treat illnesses or diseases; from such medications, only a few medicines are considered vital and life-saving, while others continue to serve as substitutes. The prevalence of diseases is steadily rising in the current circumstances, and the major preliminary concern of pharmaceutical manufacturers, doctors, and other healthcare professionals is to ensure the quality of medications with definite therapeutic benefits and minimal adverse side effects.^[1-4] When a specific drug causes a significant adverse impact in a large-scale population, the adverse effects are tracked by pharmacovigilance; when the risk surpasses the advantage, it is suggested that the country withdraws the substance.^[5] Drugs banned in other countries are still available in India, there are various reasons for the availability of globally discarded drugs in India,^[1] the primary reason is the lack of awareness among medical professionals. The lack of comprehensive adverse drug reaction (ADR) information on these pharmaceuticals is another significant factor contributing to their availability. In the current context, it is considered important to educate and create awareness among physicians and other healthcare professionals about the significant side effects of drugs that are prohibited. This current study is a multi-centric knowledge and attitude survey conducted among the medical resident (MR) and dental resident (DR) in an academic set-up. This contemporary survey is intended to assess the knowledge and attitude among the MRs and DRs in various medical and dental colleges in Tamil Nadu regarding the availability and use of drugs that have been globally discarded but are still accessible in India. The key objectives include assessing the knowledge and attitude concerning (1) globally discarded drugs, (2) to assess the level of awareness among DRs and MRs, (3) regarding drugs that have been globally discarded but still are available in India, (4) reason for banned drugs in other countries, (5) intervention regarding improvement of drug safety.

MATERIALS AND METHODS

This current cross-sectional study was conducted online to explore the awareness of dental and MRs posted in various dental and medical colleges in India toward the availability of globally banned drugs in India using cross-adapted questionnaires between March 2024 and August 2024 following the Institutional Review Board’s Ethical Committee approval (no: 398/IRB-IBSEC/SIST). WhatsApp groups were created and the admins of each group in the various medical and dental colleges in India helped distribute the questionnaire invitation for survey participation. Before the start of the main study, the created questionnaire was verified for its rationality and credibility in the minor group of respondents (n = 30). Validity was established using face-to-face discussion, and a good response was elicited. A set of 18 multiple-choice questions was formulated based on the literature review. 2 experts in oral medicine and radiology, 1 expert from general medicine and pharmacology, and 2 experts in public health dentistry assessed the content authenticity of the generated questionnaire. The revised set of 18 questions was based on the knowledge of the dental and MRs regarding this subject. Inclusion criteria included interested participants working in several departments in various medical and dental colleges in Chennai, Tamil Nadu. Participants not willing to participate in the study were excluded from the study. Descriptive statistics were performed using the Statistical Package for the Social Sciences software IBM Corporation (New York, USA).

RESULTS

Final data included the response from 100 residents – Bachelor of Medicine, Bachelor of Surgery (MBBS) [n = 43], Bachelor of Dental Surgery (BDS) [n = 57], posted in several departments in various medical and dental colleges in Chennai, Tamil Nadu. Among the study population, 38.0% were males and 62.0% were females [Graph 1].

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Graph 1:

Knowledge and practice-related responses of the study population. ADR: Adverse drug reporting, MBBS: Bachelor of Medicine, Bachelor of Surgery, BDS: Bachelor of Dental Surgery.

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Around 93.0% of MRs and 80.7% of DR were aware that some globally banned drugs are available in India. On questions assessing their knowledge of drug availability and practice of prescription, 69.8% of MR and 68.4% of DR have prescribed paracetamol formulations fixed dose combination (FDC) for fever and pain. Most of the participants, 44.2% of MR and 50.9% of DR were not aware that metamizole is a globally withdrawn drug, and those who were aware that metamizole is globally withdrawn stated that the reason was due to the adverse effect of agranulocytosis and bone marrow depression. Majority of the participants from the study population 46.5% of MR and 57.9% of DR have not been prescribed. Nimesulide in their practice as they are aware that the drug is globally withdrawn, both MR and DR are similarly aware that nimesulide is withdrawn globally with a statistically significant value of 0.044* (P-value). Among the participants 53.5% of MR and 52.6% of DR were not aware that the nitrofurazone cream is withdrawn globally, most of the population 46.5% of MR and 57.9% of DR are not aware that practolol is still available in India. On evaluating the difference in knowledge regarding globally discarded drugs availability in India among MR and DR, no difference in knowledge and awareness was elicited [Table 1].

Around 62.8% of MR and 43.9% of DR perception regarding primary source of information about pharmaceutical drugs is from heathcare professionals. Majority of the participants from both the groups are aware of the term adverse drug reporting but the majority of the study population are unaware that ADR reporting system exists in India. Around 44.2% of MR and 29.8% of DR perception regarding the reason for the availability of globally banned drugs in India was due to the under-reporting of ADR. Most of the participants in both the groups are aware that Drug Technical Advisory Board is a final authority in imposing a ban on drugs in India. Around 39.5% of MR and 35.1% of DR perceive that creating awareness about ADR reporting among healthcare professionals and patient could impart drug safety in India. Majority of the participants from both the groups perceive that creating awareness and educating regarding the risk associated with drugs could be done to prevent the availability of banned drugs in India [Graphs 1 and 2, Table 2].

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Graph 2:

Knowledge and attitude-related responses of the study population. ADR: Adverse drug reaction, MBBS: Bachelor of Medicine, Bachelor of Surgery, BDS: Bachelor of Dental Surgery.

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DISCUSSION

Most of the medications have the potential of inducing adverse side effects and there is always a risk, which is reserved when a specific medication is recommended. When considering whether to continue or stop a specific medication in a population, the level of risk must be considered in addition to the projected therapeutic benefit.^[6] There are several reasons behind the prevalence of globally discarded drugs in India: (a) Unawareness among healthcare professionals, (b) under-reporting of ADR, (c) non-availability of appropriate drugs at right time and their high-cost, (d) regulatory status of drugs in India,^[1,4,7] etc. The regulations in India concerning the marketing and accreditation of pharmaceuticals are not properly defined. Despite lacking the legislative authority, state drug controllers (SDCs) can and do provide certificates for the approval and marketing of novel combinations. Drugs that have been approved by one SDC can be traded or sold in any state in the nation; however, neither the Drug Controller General of India (DCGI) nor other SDCs have approved them.^[1,4,6]

Based on our current knowledge, surveys regarding the awareness among healthcare professionals about the availability of globally banned drugs in India are very limited. This cross-sectional study has been carried out to evaluate the knowledge and attitude of MRs and DRs regarding the availability of globally banned drugs in India because these population are the future professionals going to carry the torch forward and this is the first study exploring the knowledge and attitude among MRs and DRs regarding this subject. In this study, the majority of the participants are aware that globally discarded drugs are available in India but they are not aware about the medications that are banned globally. On evaluating the difference in knowledge regarding globally discarded drugs availability in India among MR and DR, no difference was elicited. The majority of study participants in both categories are aware of the term “adverse drug reporting;” however, they are unaware of persistence of ADR reporting system in India. Despite their perception regarding the reason for the availability of globally banned drugs in India is due to the under-reporting of ADR and also, they believe that creating awareness about ADR reporting among healthcare professionals and patient could impart drug safety in India.

To collect data on ADRs across the nation, the Ministry of Health and Family Welfare established the National Pharmacovigilance Program (NPP) at AIIMS, New Delhi, in 2010. Healthcare professionals intended reporting of ADRs are regarded as the cornerstone of ADR management. Reports can be typically sent either verbally through letter or through electronically through online portal to the relevant organization. The NPP includes a national coordinating center that uses a VigiFlow software interface operated by the Uppsala Monitoring Centre to gather ADR data about the cause, problem, and personnel involved in an adverse drug event from various pharmacovigilance centers across the nation.^[5] In India, the organization for reporting ADR is the Indian Pharmacopoeia Commission.^[1] Creating awareness regarding ADR reporting and familiarizing reporting methods for patients will immensely increase the reporting of cases. A synchronized verification process can be executed to authorize that the ADRs conveyed by the patients are potentially associated with using a particular drug.^[8] Strengths include the novelty of the study as well as the study addressing a relevant and concerning issue. Limitations of the study include the small number of participants, need for future research to expand its scope, improve statistical analysis, and assessing real-world prescribing behaviors.

CONCLUSION

The participants are aware that globally discarded drugs are available in India but they are not aware of the medications that are banned globally. There was no discernible difference between MR and DR when it came to their understanding of the availability of globally discarded medications in India. Despite this, their perception regarding the reason for the availability of globally banned drugs in India is due to the under-reporting of ADR. Overall, this study underscores the urgent need for comprehensive efforts to improve drug safety in India. This includes not only educating healthcare professionals but also strengthening the regulatory framework and ADR reporting systems to protect public health. The implementation of required ADR reporting, as in industrialized nations, and the involvement of all categories of healthcare personnel can enhance the efficacy of a pharmacovigilance system.