|Year : 2012 | Volume
| Issue : 6 | Page : 704-709
A study to evaluate the price control of antifungal medicines and its practical applicability
Amrita Sil1, Nilay Kanti Das2, Pramit Ghosh3, Pijush Kanti Datta2, Chowdhury Nazrul Islam1, Santanu Kumar Tripathi4
1 Department of Pharmacology, Burdwan Medical College, Burdwan, India
2 Department of Dermatology, Medical College, Kolkata, India
3 Department of Community Medicine, Medical College, Kolkata, India
4 Department of Experimental and Clinical Pharmacology, School of Tropical Medicine, Kolkata, India
|Date of Submission||26-Oct-2011|
|Date of Decision||31-Aug-2012|
|Date of Acceptance||31-Aug-2012|
|Date of Web Publication||8-Nov-2012|
Nilay Kanti Das
Department of Dermatology, Medical College, Kolkata
Source of Support: None, Conflict of Interest: None
Background: Superficial fungal infections are common and treatment imposes economic burden on the patients. Government of India had introduced price control over griseofulvin and tolnaftate in 1995; however, this measure can only benefit the needy if the policy is harmonized with the health-care service provider, that is, dermatologists. The aim of this study was to evaluate the existing Government mechanisms over price control of antifungal medications and its reach to the people-in-need.
Materials and Methods: A questionnaire-based, cross-sectional study was carried out over a period of 6 months. Questionnaire was mailed to members of a state branch of Indian Association of Dermatologists, Venereologists, and Leprologists. Responses reaching investigators within 2 months from the date of mailing were finally analyzed.
Results: Among 93 (41.33%) respondents, only 6 (6.5%) were aware of existing price control over griseofulvin but none about tolnaftate. Thirty-nine (41.9%) respondents were in favor of introducing price control on terbinafine and 42 (45.2%) for itraconazole. The topically preferred antifungals were primarily azoles and terbinafine, while among systemic antifungals, dermatologists mostly preferred fluconazole and terbinafine. The choice of antifungals by the dermatologists matched with the evidence-based dermatology data.
Conclusion: Currently, price-controlled antifungal drugs are less commonly used by practitioners. Although the dermatologists favor price control, the initiative undertaken by the Government has not reached them. This shows the need to bridge the gap between policy makers and health-care service providers to help the ailing population.
Keywords: Antifungal medications, drug price control order, Government of India
|How to cite this article:|
Sil A, Das NK, Ghosh P, Datta PK, Islam CN, Tripathi SK. A study to evaluate the price control of antifungal medicines and its practical applicability. Indian J Pharmacol 2012;44:704-9
|How to cite this URL:|
Sil A, Das NK, Ghosh P, Datta PK, Islam CN, Tripathi SK. A study to evaluate the price control of antifungal medicines and its practical applicability. Indian J Pharmacol [serial online] 2012 [cited 2023 Sep 23];44:704-9. Available from: https://www.ijp-online.com/text.asp?2012/44/6/704/103257
| » Introduction|| |
Superficial fungal infection is a global problem with an estimated 20-25% of the world's population having cutaneous mycoses.  It is also noteworthy that the prevalence of a particular mycosis is influenced by local socioeconomic conditions and cultural practices. The treatment imposes sufficient economic burden on the patient.  Thus, the choice of therapy at times is guided by the financial condition of the patient. Access to low-cost essential medicines would be a crucial prerequisite for addressing this need, as it is known that in India major health-care costs are made from out-of-pocket expenses. The Government of India had introduced price control on two antifungal drugs, namely griseofulvin and tolnaftate, in 1995 (Drug Price Control Order (DPCO), 1995).
With the rise of immunosuppressant diseases in India, for example, HIV-AIDS and diabetes, there has been an upsurge of superficial fungal infections (especially candidal glossitis). These superficial fungal infections are occasionally drug resistant. Also, infections of nails and hair require long-term therapy adding to the cost. Knowledge of changing trends in pattern of superficial fungal infection offers the Governmental and social agencies to reallocate the available health resource to the benefit of mankind. Medical practitioners tend to prescribe the more efficacious and safer antifungals. It is also interesting to know to what extent the drug price influences the prescription pattern. To address the problem, the drugs assigned for treatment of these diseases in the DPCO would have to be reframed or the benefit will be partial.
At present, most of the antifungal drugs are outside price control, and there is wide inexplicable difference between brands in their retail prices. This indicates profiteering by the companies at the cost of the patient. The behavior of drug price that is outside price control provides strong proof that poor, ignorant, choice-less patients are forced to pay out-of-pocket expenditure. Although the previous drug policy formulation made clear its intent to monitor drug prices, certain operational details about which drugs to monitor, tools for monitoring, and definitions of abnormal behavior of prices needed to be more precisely defined.
This study was undertaken with the primary objective of evaluating how far the existing Government price control of antifungal medications is reaching to the consumers by assessing the awareness and opinion of the prescribers. The secondary objectives were to assess the knowledge of antifungal medications in the National List of Essential Medicines (NLEM) of India and to analyze the perceptions and practice with regard to evidence-based medicine. This study was also aimed at determining their perception of the study participants about efficacy, safety, and price of different antifungals and correlating them with the volume of the respective antifungal prescribed.
| » Methods|| |
A questionnaire-based, cross-sectional study was carried out over duration of 6 months starting from April to September 2010. This study was approved by Institutional Ethics Committee. The questionnaire was developed indigenously and the draft questionnaire was subjected to pilot test. Clinical information regarding the various types of superficial fungal infections (namely tinea corporis/cruris, tinea capitis, tinea pedis/manuum, onychomycosis, candidiasis, pityriasis versicolor) was obtained. The study participants were asked to respond on a 10-point scale on the percentage of each infection seen, the preferred mode of therapy (whether topical, systemic, or combination of both used), topical agents, and systemic drugs preferred (with their approximate frequency of use on the same 10-point scale). Also questions were designed regarding the dermatologists' opinion of the efficacy, safety, and price of individual antifungal agents that influence the prescription pattern. Moreover, questions were also asked to elicit their knowledge and attitude about the price control of antifungals. The questionnaire was mailed to all the members of a state branch of Indian Association of Dermatologists, Venereologists, and Leprologists, containing forwarding letter along with self-addressed and self-stamped envelope. The responses reaching the investigators within 2 months from the date of mailing were finally analyzed.
Information regarding evidence-based antifungal prescription pattern was obtained from PUBMED database of the various superficial fungal infections and was compared with the prescription pattern of the study participants and NLEM, India.
To determine the volume of a drug prescribed, the cumulative drug usage score (DUS) was used as described in [Figure 1].
|Figure 1: Formula of calculation of cumulative drug usage score. DUSa can range from 0 to 6|
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Descriptive statistics was expressed in percentage, mean±standard deviation (SD). Analytical statistics was performed using ANOVA and Mann-Whitney tests as applicable. SPSS version 11 was used for statistical analysis, and p<0.05 was considered statistically significant.
| » Results|| |
A total of 93 (41.33%) responses were obtained from 225 questionnaires delivered to the dermatologists. Only six (6.5%) dermatologists were aware of the existing price control over griseofulvin, but none knew that tolnaftate was also price controlled. A majority of them, 78 (83.9%), were of the opinion to introduce price control, and among them, 39 (41.9%) were in favor of introducing the price control on terbinafine and 42 (45.2%) for itraconazole.
The disease load of superficial fungal infection perceived to be encountered in clinical practice, expressed as disease score [dis (xi), [Figure 1]], was found to be maximum for tinea corporis/cruris (dis=0.54±2.58), followed by pityriasis versicolor (dis=0.38±1.85) and candidiasis (dis=0.37±1.78) [Table 1].
The topically preferred antifungals were primarily azoles (DUS=0.70±0.15) and terbinafine (DUS=0.39±0.20), while tolnaftate (DUS=0.08±0.12) was not preferred by the study participants (P value<0.0001, ANOVA test). Use of topical azoles was found to be significantly more than topical terbinafine (P value<0.0001, Mann-Whitney test). Regarding systemic antifungals, dermatologists mostly preferred fluconazole (DUS=0.62±0.16) and terbinafine (DUS=0.40±0.19), while itraconazole (DUS=0.17±0.17) and griseofulvin (DUS=0.16±0.17) were used less frequently (P value<0.0001, ANOVA test). Furthermore, fluconazole was significantly used compared with terbinafine (P value <0.0001, Mann-Whitney test).
Regarding disease-specific drug usage, topical azoles were found to be significantly used than terbinafine in candidiasis (p<0.0001, Mann-Whitney test), pityriasis versicolor (p<0.0001), and tinea corporis/cruris (p=0.0084). No significant difference between use of topical azoles and terbinafine was found in tinea capitis (p=0.5159), onychomycosis (p=0.2700), and tinea pedis/manuum (p=0.3977). However, the DUS indicated that topical agents were less frequently used than systemic antifungals in these conditions. Among the systemic antifungal medications, fluconazole was used more than terbinafine in candidiasis (p<0.0001), pityriasis versicolor (p<0.0001), and onychomycosis (p=0.3709), whereas terbinafine was used more frequently than fluconazole in tinea pedis (p=0.0008), corporis (p=0.0735), and capitis (p=0.2203).
The perception of study participants regarding the drugs' efficacy, side effects, and price, and its influence on the volume of drug use (cumulative DUS) is shown in [Table 2].
|Table 2: Perceptions regarding the determinants that infl uence the drug usage and its relation to the volume of drug used (cumulative drug usage score) in practice|
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The number of participants who does not know (noncommittal) about the efficacy (35.48%), side effects (41.93%), and price (48.38%) of tolnaftate was higher than any other antifungals studied.
The DUS of tolnaftate and griseofulvin was low in noncommittal. On the other hand, the drug was significantly higher in those who thought the price was high in case of topical azoles, and those who were noncommittal of the price for fluconazole (p<0.0001).
The choice of antifungals by the dermatologists was in close harmony with the evidence-based dermatology data [Table 3]. ,,,,,,,,,,,,,,,,,,, A discrepancy was observed between DPCO list and list of essential medicines for fungal infections recommended by WHO and NLEM, India [Table 4].
|Table 3: Comparison of prescription pattern of dermatologists and available evidence from PubMed|
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|Table 4: Comparison of antifungals enlisted in the DPCO with NLEM, India, and WHO model list of essential medicines|
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| » Discussion|| |
The objective of having drug policies was to provide essential medicines of good quality at affordable prices. A list of essential drugs has been included in light of the prevalent public health problems in the country. The "Modifications in Drug Policy 1986" proposed in 1994 included criteria that did not consider the nature of the drug and its use, but were based on the turnover and market share of the manufacturer. Drugs with an annual turnover of more than four crore rupees in which there was either a monopoly situation (one formulator having a greater than 90% share in the market) or evidence of insufficient competition were subjected to price control. These criteria although seemingly objective may not be in tune with the realities of India's vast pharmaceutical market where such monopoly situations are generally the exception rather the rule. Also, based on the same criteria that gave superiority to turnover and market share, a host of drugs whose utility was highly doubtful and some which were clearly outdated and nonessential found their way into the list, at the cost of drugs important for public health, for example, analgin, vitamin E, phenylbutazone, sulphaguanidine, and sulphadimidine. On the other hand, the drug policy based on therapeutic use and public health importance can help developing a much needed beneficial and effective price-controlled drugs.
Clinicians with a public demand for an effective therapy for superficial fungal infections are further challenged with treatment-resistant infections. Although these superficial infections are not life threatening, chronic fungal infections of the skin and nails carry a considerable morbidity. This study highlights that the three most common superficial fungal infections are tinea corporis/cruris, candidiasis, and pityriasis versicolor. Griseofulvin and tolnaftate are effective against dermatophytes with little use against Candida sp., Malassezia furfur. This fact is evident from evidence-based medicine, ,,, as well the DUS obtained in this study. Thus, the present DPCO list fails to address a large fraction of superficial fungal infections. Azoles (both topical and systemic) are most widely used, and considering the wide interbrand variability in price of systemic fluconazole (range Rs. 9.65-37.70 for one 150 mg tablet),  it is desirable that there should be a ceiling on its price so that common man does not suffer unnecessary expenditure because of the ignorance of the practitioners about the price (this study shows 15 of 93 are not sure of the price of fluconazole). This ignorance about the cost of drugs has also been highlighted in a meta-analysis of 24 articles.  The meta-analysis also found that the doctors acknowledge that awareness of cost information would improve their prescription pattern, but they stressed that such information was not accessible. The findings of our study also highlight this unfortunate phenomenon with only 6.5% of dermatologists aware of the existing DPCO. It should never be interpreted that doctors are apathetic about the cost because it was found that 83.9% want price control to be introduced. Thus, there is a gap between administrative agencies and the health-care service providers, which needs to be abridged to make the benefit of price control reach the people-in-need.
Knowledge about a drug has a major impact on its use as evidenced from our study, with tolnaftate having the least DUS because 35.5% were unaware of efficacy, 41.9% unaware of side effects, and 48.4% unaware of price [Table 2]. The low knowledge on this particular antifungal can be explained as an effect of hypothetical drug usage cycle with price control, that is, less promotion by pharmaceuticals leading to decrease use of medication, less focus on the upgrading the knowledge, and decreased use; the vicious cycle continues. The impact of promotion by pharmaceutical companies on the prescription pattern has been previously studied and found to have an influence on higher prescribing frequency, higher costs, or lower prescribing quality.  Hence, it is evident that introducing price control is not the end point of effort to reduce the cost burden of treatment for the Governmental agencies, but they should carry out regular monitoring. It should be ensured that pharmaceutical companies manufacturing those medicines do not shift such medicines in their waste basket leading to decreased availability and usage.
Regarding the future of price control of antifungal medications, the study participants were of the opinion that price control should be introduced for terbinafine (41.9%) and itraconazole (45.2%). Their opinion was found to be in tune with the efficacy of those medications, which was evaluated in light of evidence-based medicine [Table 3].
Efficacy is favored when it comes to the treatment of these chronic morbid infections. Very few dermatologists use tolnaftate (a price control medicine) topically. Griseofulvin, another price-controlled drug, is used by dermatologists only in the treatment of tinea capitis, although terbinafine and itraconazole are favored. Thus, the utility of the present antifungal drugs under price control is questionable and clearly outdated. There is a need to include the more frequently used, effective, and evidence-based antifungals in the DPCO for the benefit of the needy. The dermatologists desired a price control over the antifungals they frequently prescribed, namely itraconazole (among azoles) and systemic and topical terbinafine (among allylamines). The NLEM 2003 represents a selection of the efficacious, safe, and cost-effective medicines for the priority health-care needs of India. Thus, the National list forms a sort of reference list from which the list of drugs to be placed under price control can be drawn. Unfortunately, at present, it is only a guideline and a prescriptive tool and does not accurately reflect the reality of the pattern of drug production, prescription, and drug availability in the country. If the DPCO has the aim of ensuring availability of drugs at reasonable prices, then it has to look beyond NLEM. The reality of the pattern of prescriptions is that most of the drugs prescribed are outside the NLEM [ORG-MARG retail audit of October 2003 stated out of the top-selling 300 brands in the country, only 115 (i.e., only 38%) were drawn out of the NLEM]. The people, therefore, need regulation of prices of drugs outside this list, which means that the alternative drugs to the ones mentioned in the National list also require regulation. It is noted that azoles find its place in the NLEM but not the DPCO. Also there is no representation of allylamines in both the NLEM and DPCO. From our study, we find a need to include a fair representation of the above two therapeutic groups (azoles and allylamines) in the DPCO.
| » Conclusion|| |
The pharmaceutical policy has to balance the public interest with economic interest. Antifungal drugs for the treatment of superficial fungal infections form a part of the DPCO, and from our study, we have found a unanimous consent among dermatology practitioners for the price control of the much used itraconazole and terbinafine. The antifungal drugs included in the present day DPCO, tolnaftate and griseofulvin, are seldom used nowadays.
The new DPCO should base itself firmly on the need to address the priority disease and health-care conditions of Indians and to regulate the market through rigorous monitoring.
It might be suggested that the list to be dynamic and revised periodically. Newer drugs may be introduced, which are either more efficacious, safer, more convenient, or even more expensive, and these may needed to be brought under the monitoring and/or price control list for the benefit of the society at large.
| » Acknowledgment|| |
The authors would like to acknowledge the members of Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), West Bengal branch for their valuable time in responding to the questionnaire. Technical support received from the residents of Department of Dermatology, Medical College, Kolkata is also appreciated.
| » References|| |
|1.||Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses 2008;51 Suppl 4:2-15. |
|2.||DAS S, Goyal R, Bhattacharya SN. Laboratory-based epidemiological study of superficial fungal infections. J Dermatol 2007;34:248-53. |
|3.||Bell-Syer SEM, Hart R, Crawford F, Torgerson DJ, Tyrrell W, Russell I. Oral treatments for fungal infections of the skin of the foot.. Cochrane Database Syst Rev 2002:CD003584. |
|4.||De Keyser P, De Backer M, Massart DL, Westelinck KJ. Two-week oral treatment of tinea pedis, comparing terbinafine (250 mg/day) with itraconazole (100 mg/day): A double-blind, multicentre study. Br J Dermatol 1994;130 Suppl 43:22-5. |
|5.||Kakourou T, Uksal U, European Society for Pediatric Dermatology. Guidelines for the management of tinea capitis in children. Pediatr Dermatol 2010;27:226-8. |
|6.||González U, Seaton T, Bergus G, Jacobson J, Martínez-Monzón C. Systemic antifungal therapy for tinea capitis in children. Cochrane Database Syst Rev 2007;17:CD004685. |
|7.||Fleece D, Gaughan JP, Aronoff SC. Griseofulvin versus terbinafine in the treatment of tinea capitis: A meta-analysis of randomized, clinical trials. Pediatrics 2004;114:1312-5. |
|8.||Foster KW, Friedlander SF, Panzer H, Ghannoum MA, Elewski BE. A randomized controlled trial assessing the efficacy of fluconazole in the treatment of pediatric tinea capitis. J Am Acad Dermatol 2005;53:798-809. |
|9.||Bonifaz A, Saúl A. Comparative study between terbinafine 1% emulsion-gel versus ketoconazole 2% cream in tinea cruris and tinea corporis. Eur J Dermatol 2000;10:107-9. |
|10.||Singal A, Pandhi D, Agrawal S, Das S. Comparative efficacy of topical 1% butenafine and 1% clotrimazole in tinea cruris and tinea corporis: a randomized, double-blind trial. J Dermatolog Treat 2005;16:331-5. |
|11.||Budimulja U, Bramono K, Urip KS, Basuki S, Widodo G , Rapatz G et al. Once daily treatment with terbinafine 1% cream (Lamisil) for one week is effective in the treatment of tinea corporis and cruris. A placebo-controlled study. Mycoses 2001;44:300-6. |
|12.||Boonk W, de Geer D, de Kreek E, Remme J, van Huystee B. Itraconazole in the treatment of tinea corporis and tinea cruris: comparison of two treatment schedules. Mycoses 1998;41:509-14. |
|13.||Rich P, Houpt KR, LaMarca A, Loven KH, Marbury TC, Matheson R, et al. Safety and efficacy of short-duration oral terbinafine for the treatment of tinea corporis or tinea cruris in subjects with HIV infection or diabetes. Cutis 2001;68:15-22. |
|14.||Faergemann J, Mörk NJ, Haglund A, Odegård T. A multicentre (double-blind) comparative study to assess the safety and efficacy of fluconazole and griseofulvin in the treatment of tinea corporis and tinea cruris. Br J Dermatol 1997;136:575-7. |
|15.||Mishra M, Panda P, Tripathy S, Sengupta S, Mishra K. An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis. Indian J Dermatol Venereol Leprol 2005;71:262-6. |
|16.||Bräutigam M, Nolting S, Schopf RE, Weidinger G. Randomised double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection. Seventh Lamisil German Onychomycosis Study Group. BMJ 1995;311:919-22. |
|17.||Evans EG, Sigurgeirsson B. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group. BMJ 1999;318:1031-5. |
|18.||Korting HC, Schäfer-Korting M, Zienicke H, Georgii A, Ollert MW. Treatment of tinea unguium with medium and high doses of ultramicrosize griseofulvin compared with that with itraconazole. Antimicrob Agents Chemother 1993;37:2064-8. |
|19.||Jung EG, Haas PJ, Bräutigam M, Weidinger G. Systemic treatment of skin candidosis: A randomized comparison of terbinafine and ketoconazole. Mycoses 1994;37:361-5. |
|20.||Ferahbas A, Koc AN, Uksal U, Aygen E, Mistik S, Yildiz S. Terbinafine versus itraconazole and fluconazole in the treatment of Vulvovaginal candidiasis. Am J Ther 2006;13:332-6. |
|21.||Faergemann J, Gupta AK, Al Mofadi A, Abanami A, Shareaah AA, Marynissen G. Efficacy of itraconazole in the prophylactic treatment of pityriasis (tinea) versicolor. Arch Dermatol 2002;138:69-73. |
|22.||Faergemann J. In vitro and in vivo activities of ketoconazole and itraconazole against Pityrosporum orbiculare. Antimicrob Agents Chemother 1984;26:773-4. |
|23.||Current index of medical specialities (CIMS). Bangalore, India: CMP Medica India; 2009;106:354-6. |
|24.||Allan GM, Lexchin J, Wiebe N. Physician awareness of drug cost: A systematic review. PLoS Med 2007;4:e283. |
|25.||Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: A systematic review. PLoS Med 2010;7:e1000352. |
[Table 1], [Table 2], [Table 3], [Table 4]
|This article has been cited by|
||A study to evaluate the price control of antifungal medicines and its practical applicability
| ||Sil, A., Das, N.K., Ghosh, P., Islam, C.N., Tripathi, S.K. |
| ||Indian Journal of Pharmacology. 2012; 44(6): 704-709 |