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INTRODUCTION
Topical Corticosteroids (TCs) play a crucial role in dermatology, as primary treatments for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. These medications are categorized into different potency levels and provide relief by suppressing inflammation and modulating immune responses (Ference and Last, 2009). While TCs have proven effective in managing various dermatological disorders, their inappropriate use, often stemming from misconceptions about their safety and efficacy, has led to widespread misuse and an increase in Adverse Drug Reactions (ADRs) (Kang et al., 2020). The misuse of TCs has become a global concern, with studies indicating that patients frequently use high-potency TCs without proper medical supervision. This improper usage can result in serious dermatological complications, including skin atrophy, telangiectasia, and steroid dependence (Dey, 2014). In certain regions, pharmacists struggle to adhere to regulatory guidelines, especially where the Over-the-Counter (OTC) availability of TCs is common. Unregulated access often contributes to misuse and exacerbates the risks associated with prolonged or inappropriate steroid application (Shakeel et al., 2021).
India struggles with the rational use of TCs because of gaps in regulatory enforcement (Marripalli et al., 2023). Additionally, the lack of widespread patient education further complicates the issue (Lee et al., 2019). Studies have revealed that many pharmacists and physicians are not adequately informed about the risks associated with TCs, leading to inconsistent prescribing and dispensing practices. Additionally, economic and social pressures often influence how pharmacists dispense these medications, sometimes resulting in unsupervised and inappropriate TC usage. In low-resource settings, patients frequently bypass healthcare protocols, using TCs for unapproved conditions such as cosmetic purposes, further aggravating the problem (Sharma et al., 2017).
To address these challenges, it is critical to understand the current prescribing practices, perceptions, and barriers faced by healthcare professionals in ensuring the rational use of TCs.
The objective of the study was to investigate the knowledge, practices, and perceptions of community pharmacists and physicians regarding TCs usage. This study seeks to explore these aspects in Kannur District, Kerala (India), through Focus Group Discussions (FGDs) with community pharmacists and physicians. The research aims to generate valuable insights into TC usage trends and highlight areas where intervention is necessary to curb misuse. By contributing to the growing body of evidence on TC application, the findings can support targeted strategies for improving dermatological healthcare practices in similar settings. Ultimately, ensuring the proper and responsible use of TCs requires stronger regulatory frameworks, enhanced awareness among healthcare providers, and comprehensive patient education. A collaborative effort between dermatologists, pharmacists, and policymakers can lead to more effective interventions, mitigating the adverse effects associated with TC misuse and improving patient outcomes.
MATERIALS AND METHODS
Study Design
This study employed a qualitative design using FGDs to explore the perspectives of community pharmacists and physicians. The FGDs were guided by a structured protocol developed based on insights from prior research and local healthcare challenges (Hennink, 2014). The FGD guidelines were meticulously designed to facilitate comprehensive discussions among physicians and pharmacists regarding TCs usage. Two separate guidelines were developed, each tailored to the distinct professional roles and practices of the target groups. The physician guidelines focused on prescribing patterns, ADRs, and patient education, while the pharmacist guidelines addressed dispensing practices, regulatory compliance, and counselling approaches.
To ensure clarity, relevance, and alignment with study objectives, the FGD guidelines underwent a rigorous validation process. A panel of five experts from each professional group - physicians and pharmacists - were consulted to evaluate the content of their respective guidelines. These experts were selected based on their clinical experience and familiarity with TCs. They assessed the guides for relevance, clarity, and appropriateness using a structured evaluation framework. The validation process employed the Content Validity Index (CVI) and Content Validity Ratio (CVR) as metrics to quantify the consensus among experts (Ebadi et al., 2017). For each question in the guidelines, experts rated its essentiality. The CVR was calculated using the formula:
Where ne is the number of experts indicating the question as “essential”, and N is the total number of experts.
A critical value of 0.99 was used, as recommended for panels of five experts (Nguyen et al., 2025). Both FGD guidelines achieved a CVR of 1.0 for all items, indicating unanimous agreement on their essentiality. The CVI, calculated as the mean CVR across all questions, was also 1.0 for both guides, demonstrating their robust content validity.
The validated guides were subsequently piloted in preliminary discussions to ensure practical applicability. Feedback from these sessions affirmed the guides’ ability to elicit meaningful insights, establishing them as effective tools for exploring the knowledge, practices, and perceptions of TCs among healthcare professionals. This validation process underscores the methodological rigor applied in the study to ensure data reliability and relevance.
Study Setting and Ethical Approval
The study was conducted in Kannur District, Kerala (India), a region characterized by a mix of urban and rural healthcare settings. FGDs were held in a government teaching hospital, Kannur, a tertiary care institution that serves as a central hub for medical education and patient care in the district. This venue provided a neutral and accessible location for participants, ensuring a conducive environment for open discussions. The setting enabled the inclusion of diverse perspectives from community pharmacists and physicians, reflecting the varied healthcare delivery dynamics of the district. The ethical approval was obtained from the Institutional Ethics Committee with approval number IEC/29/2022/GMCK and the study was registered in the Clinical Trials Registry-India (CTRI/2023/05053287). The participants were provided with written informed consent. Confidentiality was maintained throughout the study, with data anonymized during transcription and analysis.
Participant Selection
Eight participants were selected for each focus group including registered physicians and pharmacists in Kannur District, Kerala. Inclusion criteria ensured that participants held active registration with medical or pharmacy councils and provided informed consent to participate. Physicians were primarily drawn from dermatology and general medicine departments of tertiary care facilities at Kannur district, while pharmacists included from community pharmacy settings to capture diverse perspectives.
The selection process aimed to balance expertise and practical experience, ensuring meaningful contributions to the study objectives. Once identified, potential participants were contacted and briefed on the study's purpose, methodology, and confidentiality protocols. Individuals who expressed willingness and provided written consent were included in the final focus group composition.
FGD Procedure
Two separate FGDs were conducted: one with eight community pharmacists and another with eight physicians. Each session lasted 50-60 min. Each focus group was facilitated by a moderator who was an expert in the respective field. The moderators were tasked with fostering open, unbiased discussions while ensuring adherence to the FGD guide. Discussions were audio and video recorded with participants’ consent. A semi-structured interview guide was used, focusing on themes such as knowledge of TC classifications, adverse effects, prescribing and dispensing practices, and patient education (Flick, 2014).
Data Analysis
The recorded discussions were transcribed verbatim and analyzed using thematic analysis. Initial coding was performed independently by two researchers to identify key themes and subthemes. Discrepancies were resolved through consensus discussions, ensuring comprehensive coverage of the data.
RESULTS
The findings from the FGDs are categorized into four major thematic insight: Knowledge-practice gap, Irrational use of TCs, Lack of Diligence, and Confront the challenges. These themes encapsulate the key insights shared by physicians and pharmacists regarding the use of TCs in Kannur District, Kerala (Table 1). Key insight of FGD is illustrated in Figure 1.
| Theme | Subtheme | Formulated Meanings |
|---|---|---|
| Knowledge-Practice Gap | Physician | |
| Insufficient in-service education among interns and general practitioners | “While many cases involve referrals to dermatologists, some patients insist on receiving prescriptions directly from their general practitioners. Unfortunately, a significant number of these prescriptions involve combination products that contain topical steroids.” (G1R8 and G1R3) “Triple combination products containing steroids are commonly prescribed by general practitioners. However, there is a challenge: these practitioners sometimes prescribe topical corticosteroid combinations and in certain cases, for fungal infections.” (G1R5). | |
| Pharmacist | ||
| Inadequate training-In dispensing and counselling, time constraints | “As part of our continuing medical education, we have actively participated in various training programs. However, it is worth noting that we have not encountered any specific programs that focus on the rational use and adverse effects of TCs.” (G2R8). | |
| Irrational use of TCsMajor misuse exists among patient | Physician | |
| Frequent misuse - A significant concernRelated Problems Development of resistanceMasking of clinical presentationDelayed diagnosis | “High-potency steroids were commonly used by patients inappropriately on their own. They may use these medications for a few days or even continuously. This may lead to the development of resistance and, in some cases, mask the clinical presentation, which leads to delayed diagnosis.” (G1R6 and G1R7)“Tinea incognito was observed in some patients, which was obviously due to the continuous use of TCs.” (G1R4). | |
| Pharmacist | ||
| Frequent requests for refills based on old prescriptions or used tubes and often without valid prescriptions. | “Patients often bring in their previously used tubes of topical corticosteroid preparations, seeking a refill.” (G2R6) “Additionally, some patients arrive with old prescriptions either from their own medical history or from family members.” (G2R4) “Patients may request TCs based on the symptoms they experience, such as itching, redness, or inflammation related to their skin conditions. However, caution should be exercised when individual responses to medications vary. However, they insisted on dispensing medication.” (G2R7). | |
| Market competition and economic stress | “In many instances, management representatives are present in private retail pharmacies, actively promoting business. Given the abundance of pharmacies, patients can easily obtain the same medications from other sources. The profits of private retail pharmacies remain a significant concern.” (G2R5). | |
| Lack of diligence | Physician | |
| Patient insistence on self-medication | “While many cases involve referrals to dermatologists, some patients insist on receiving prescriptions directly from their general practitioners. Unfortunately, a significant number of these prescriptions involve combination products that contain topical steroids.” (G1R8). | |
| Pharmacist | ||
| Meeting customer demand | “In certain cases, we dispense TCs based on old prescriptions. However, when such requests are declined, patients often do not return for further medicine purchases, resulting in reduced sales.” (G2R1). | |
| Confront the challenge | Physician | |
| Addressing a major challenge in the healthcare system | “Despite resource limitations in peripheral areas, there is room for more rational prescription practices. In the future, regulatory changes will address these issues and improve the prescription practices.” (G1R3). | |
| Continuing Medical Education (CME) | “Among dermatologists, there are CMEs and conferences specifically dedicated to TCs use. In the dermatology department, we typically have at least one session that focuses on TCs use.” (G1R1) “In other departments, there exists a knowledge gap. To address this issue, awareness programs are essential, especially for students, interns, and postgraduates.” (G1R2). | |
| Pharmacist | ||
| Strict enforcement of regulations | “To overcome the above limitations, the regulation must be strictly enforced, or stringent amendments to the D&C rule may be beneficial.” (G2R3). | |
| Comprehensive education and training programs | “As part of our CME, we have actively participated in various training programs. However, it is worth noting that we have not encountered any specific programs that focus on the rational use and adverse effects of TCs.” (G2R4). “To address this knowledge gap, I recommend incorporating training sessions specifically dedicated to TCs use.” (G2R2). |
Theme 1: Knowledge-Practice Gap
In physicians’ perspective, they demonstrated a strong foundational understanding of TCs, particularly their classifications, potency, and the importance of application site specificity. They highlighted the need for tailored prescriptions, emphasizing that the potency and type of corticosteroid must align with the lesion type and location. For example, mild corticosteroids such as hydrocortisone acetate were recommended for sensitive areas like the face, while potent options like clobetasol propionate were reserved for more severe conditions (Zvidzayi et al., 2021). Despite this knowledge, physicians admitted that time constraints often limited their ability to educate patients about the safe use of TCs, including the importance of adhering to prescribed dosages and application durations.
As per pharmacists’ perspectives, they acknowledged their familiarity with the Drugs and Cosmetics (D&C) Act, which mandates prescription-only dispensing of TCs (Govt of India, n.d.). However, they admitted to facing challenges in consistently following these regulations due to market competition and customer expectations. A significant knowledge gap was evident in their limited understanding of ADRs associated with long-term TC use. Pharmacists also reported relying heavily on online resources and product inserts for drug information, reflecting inadequate training in this domain. Many pharmacists expressed a lack of confidence in counseling patients, especially regarding the identification and prevention of ADRs.
Theme 2: Irrational Use of Topical Corticosteroids
Misuse by Patients
Both physicians and pharmacists identified widespread misuse of TCs among patients. Patients often used high-potency steroids without prescriptions for non-medical purposes, such as skin whitening or to alleviate itching caused by fungal infections. Frequently used preparations include clobetasol, mometasone, and fluticasone, as well as combinations like Miconazole with Clobetasol propionate, Beclomethasone with Clotrimazole, Beclomethasone with Neomycin and Clotrimazole, and Betamethasone with Gentamicin. These practices were largely driven by misconceptions about the safety of topical applications, with many patients perceiving TCs as harmless remedies for skin conditions. Physicians noted that leftover medications from previous prescriptions or those borrowed from family members were frequently misused, exacerbating the problem.
Dispensing Challenges
Pharmacists revealed that patients often demanded TCs based on symptoms rather than medical advice. Common scenarios included presenting previously used tubes for refills or citing old prescriptions. In some cases, patients procured these medications on the advice of beauticians for cosmetic benefits. This underscores the influential role of informal advice in the widespread misuse of topical corticosteroids. Pharmacists reported feeling pressured to dispense such medications to retain customer loyalty, even when doing so violated regulations.
Impact of Irrational Use
The irrational use of TCs has led to serious medical complications, including the masking of clinical symptoms, delayed diagnoses, and the development of resistant fungal infections. Repeated use of topical corticosteroids can alter and mask the clinical presentation of dermatophytic infections like tinea incognito, complicating diagnosis and delaying appropriate treatment. Physicians emphasized that such practices often result in patients presenting with advanced or complicated conditions that are more challenging to treat.
Commonly Reported ADRs
Physicians and pharmacists collectively identified several ADRs associated with inappropriate or prolonged TC use. These included skin atrophy, hypopigmentation, telangiectasia, acneiform eruptions, and striae. Previous studies have reported similar findings, documenting ADRs associated with topical corticosteroids, including tinea incognito, acneiform eruptions, cutaneous atrophy, rosacea, hypopigmentation, telangiectasia, irritant contact dermatitis, striae, perioral dermatitis, and hypertrichosis. Severe cases, such as steroid-induced glaucoma and systemic absorption leading to endocrine effects, were also reported in patients who used TCs on sensitive areas like the eyelids or over large body surfaces for extended periods.
Theme 3: Lack of Diligence
This theme encapsulates instances where healthcare professionals, both physicians and pharmacists, demonstrated lapses in professional rigor, often influenced by patient pressure or commercial considerations. The findings reveal that such lapses may inadvertently contribute to irrational drug use, particularly in the context of topical corticosteroids.
In physician’s perspective some general practitioners were reported to prescribe combination products containing topical steroids without dermatological consultation, primarily due to patient insistence. As one respondent noted, despite the availability of referral pathways, patients often demand immediate prescriptions, leading to potentially inappropriate medication choices. Pharmacists acknowledged dispensing topical corticosteroids based on outdated prescriptions, citing customer retention and sales pressures. One participant highlighted that refusal to meet such demands often resulted in loss of clientele, indicating a tension between ethical dispensing practices and commercial viability.
Theme 4: Confront the Challenges
Awareness and Management
Pharmacists admitted to limited training in recognizing and managing ADRs. Most reported referring patients with suspected ADRs to dermatologists rather than addressing the issues themselves. Physicians, on the other hand, highlighted the need for vigilance in monitoring long-term TC users and ensuring timely interventions to mitigate risks. A notable ADR reported by both groups was tinea incognito, a fungal infection altered in appearance due to inappropriate TC use, which often complicates diagnosis and treatment.
Role of Education
Both groups agreed that increasing awareness about the potential risks of TCs among patients and healthcare providers is essential. Physicians advocated for incorporating ADR management training into Continuing Medical Education (CME) programs, while pharmacists suggested the inclusion of ADR reporting protocols, rational use and adverse effects of TCs in their professional education.
Regulatory Enforcement
Participants highlighted significant challenges in enforcing prescription-only regulations for TCs. Pharmacists pointed out that economic pressures and market competition often compelled them to compromise on regulatory adherence. Many expressed the need for stricter monitoring and penalties for violations to curb OTC sales of TCs.
Economic and Social Pressures
Pharmacists reported that economic pressures from private retail pharmacy management often prioritized business goals over adherence to ethical dispensing practices. Physicians noted that such pressures also influenced general practitioners in peripheral areas, who sometimes prescribed TC combinations without proper indications to meet patient demands.
Education and Training Gaps
A lack of comprehensive training programs on TC usage and ADR management was identified as a critical barrier. While dermatologists reported attending specialized CMEs on TCs, such opportunities were scarce for general practitioners and pharmacists. Participants emphasized the need for targeted training programs that address the specific roles and challenges faced by each professional group.
Collaboration and Communication
Both groups acknowledged the importance of improving collaboration between physicians and pharmacists. Physicians suggested creating standardized protocols for TC usage and patient education, while pharmacists advocated for regular inter-professional meetings to align practices and messaging.
DISCUSSION
This study delves into the multidimensional challenges surrounding the rational use of TCs among healthcare providers and patients in Kannur District, Kerala. By examining the insights from physicians and pharmacists, several critical issues have been identified, including gaps in knowledge application, misuse by patients, the prevalence of ADRs, and systemic barriers to optimal TC usage. These findings underscore the need for targeted interventions to enhance TC-related practices and policies. While physicians possess a solid understanding of TC classifications, potency, and appropriate applications, this knowledge does not consistently translate into effective patient education. Many physicians acknowledged the constraints imposed by their busy schedules, which limit their ability to provide detailed counseling. Consequently, patients often remain unaware of the potential risks of inappropriate TC use, contributing to overuse, misuse, or prolonged application beyond prescribed durations (Alamri and Al Satti, 2024). Similar findings were observed in a previously conducted study, where the misuse of Betamethasone Valerate, combinations of clobetasol propionate with antifungals and antibiotics, Clobetasol, Mometasone Furoate, Fluticasone Propionate, and Halobetasol was reported (Mahar et al., 2016).
Pharmacists, as frontline healthcare providers, face additional challenges. Their knowledge of TCs, though sufficient to guide basic dispensing practices, is often inadequate for addressing complex issues like ADR identification or counseling on appropriate usage. A reliance on online resources and product labels, rather than formal training, highlights a critical gap in professional development. The limited engagement of pharmacists in direct patient education further weakens their role in mitigating TC misuse (Pathak et al., 2023). Pharmacists frequently encounter patients requesting refills based on old prescriptions or presenting partially used tubes. In some cases, patients obtain TCs on the advice of non-medical sources, such as beauticians or social media advertisements. Similar findings were observed in a previous study, which revealed that a significant proportion of patients (59.3%) using topical corticosteroids on their faces had received recommendations from non-physician sources such as friends, relatives, pharmacists, and beauticians (Saraswat, 2018).
A major finding of this study is the pervasive misuse of TCs among patients. The inappropriate application of high-potency corticosteroids for cosmetic purposes, such as skin whitening, reflects a dangerous lack of awareness about the associated risks. Patients often assume that topical medications are inherently safe, leading to their use without medical guidance. This behaviour is exacerbated by easy access to TCs without prescriptions. Pharmacists frequently encounter patients requesting refills based on old prescriptions or presenting partially used tubes. These practices not only increase the likelihood of ADRs but also complicate the diagnosis and treatment of underlying conditions. The role of pharmacists in curbing TC misuse is hindered by economic pressures and competitive business environments. Many pharmacists feel compelled to accommodate patient demands to retain their customer base, even if it conflicts with regulatory requirements. Addressing this issue requires balancing ethical dispensing practices with economic realities (Sheth and Nair, 2021).
The irrational use of TCs has significant clinical implications, leading to adverse effects that complicate diagnosis and treatment. A major concern is the masking of clinical symptoms, particularly in dermatophytic infections like tinea incognito, where inappropriate steroid use alters the infection’s appearance, making timely and accurate diagnosis difficult. A previous study by Dhaher et al., also have the similar findings (Dhaher, 2020). This often results in delayed treatment, allowing the condition to progress unchecked, sometimes leading to more severe or resistant infections. Physicians emphasized that patients who misuse high-potency corticosteroids without medical guidance frequently present with advanced or atypical dermatological conditions, requiring more intensive therapeutic interventions. Addressing these challenges requires stricter regulations on TC distribution, improved patient awareness, and enhanced physician-pharmacist collaboration to mitigate misuse and promote rational prescribing practices.
The study identified numerous ADRs resulting from inappropriate or prolonged TC use, including skin atrophy, telangiectasia, and hypopigmentation. Previous studies have documented similar ADRs associated with TCs (Meena et al., 2017). Physicians and pharmacists both reported severe cases, such as tinea incognito and steroid-induced glaucoma, highlighting the far-reaching consequences of misuse. Despite recognizing these risks, pharmacists rarely receive training in ADR identification or management. Most refer patients with suspected ADRs to physicians, missing an opportunity to contribute directly to patient care. Physicians, while better equipped to manage ADRs, stressed the need for continuous education to remain updated on emerging best practices.
Inadequate reporting of ADRs further complicates efforts to address this issue. A structured framework for ADR reporting and management, integrated into pharmacy and medical education, could empower healthcare providers to play a more proactive role in mitigating the impact of TC misuse. Challenges, including regulatory laxity and economic pressures, significantly influence TC usage practices. The enforcement of prescription-only policies for TCs remains inconsistent, enabling their OTC availability. This undermines efforts to promote rational use and exacerbates the misuse problem. Economic pressures on pharmacists, particularly those in private retail settings, create an environment where business priorities often override ethical considerations. Physicians noted similar challenges in peripheral areas, where resource constraints and patient demands lead to suboptimal prescribing practices. Collaboration between physicians and pharmacists is another critical area requiring attention. The lack of standardized protocols for TC prescribing and dispensing contributes to inconsistent practices and messaging. Regular inter-professional communication and training sessions could address this gap, ensuring a more unified approach to patient care.
CONCLUSION
This study underscores the pressing need to address gaps in the knowledge and practices of community pharmacists and physicians regarding TCs. While healthcare providers demonstrate substantial knowledge of TCs, challenges such as economic pressures, regulatory laxity, and patient misconceptions hinder their ability to promote rational use. Enhanced education, stricter regulations, and collaborative efforts are imperative to mitigate misuse and improve patient outcomes. These findings provide a foundation for designing interventions to ensure the safe and effective use of TCs in similar settings.