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Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients.

ABSTRACT: INTRODUCTION:Current evidence indicates an alarming increase in topical steroid (TS) misuse in India. Data regarding the magnitude and characteristics of this problem in rural India, where 68% of the population resides, are insufficient. This study analyses the magnitude, causes, characteristics and consequences of TS misuse in rural India. It also examines the association between TS misuse and patients' perception of skin disease. METHODS:A mixed-method observational study was conducted among the attendees of the dermatology outpatient department in a rural North Indian hospital. Those with a history of TS misuse were analysed for behaviour patterns and outcome. RESULTS:Out of 723 patients, 213 (29.2%) misused TS. Clobetasol propionate (58.2%) was most commonly misused. Seventy brands of inappropriate fixed drug combination steroid creams were recovered from the patients. Pharmacists and local healers together contributed to 78% of the sources for steroid misuse. Almost 58% of participants perceived their skin conditions to be allergic reactions to food, when in fact 70.1% were tinea, 10% scabies and 9% acne. Eighty per cent of the respondents having tinea had tinea incognito and 97% had extensive lesions. Eighty-five per cent of the participants with scabies had atypical lesions and 80% with acne had steroid rosacea or aggravation of acne. The median expenditure incurred in purchasing these potentially harmful steroid creams was Rs 1000 (US$14.1, equivalent to 3 days' wages of a labourer). CONCLUSION:Steroid misuse is a problem of epidemic proportion in rural India. This practice is changing the profile of many common and infective skin conditions, which portends diagnostic dilemmas and therapeutic challenges for clinicians. Misconceptions about skin disease drive the public to seek 'quick fixes' from non-allopathic providers who have unrestricted access to potent steroids. There is an urgent need to tighten regulatory controls over the manufacturing, sale and prescription of irrational TS combinations.

SUBMITTER: Thomas M

PROVIDER: S-EPMC7239529 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients.

Thomas Molly M Wong Celestine C CC Anderson Pam P Grills Nathan N

BMJ open 20200518 5

<h4>Introduction</h4>Current evidence indicates an alarming increase in topical steroid (TS) misuse in India. Data regarding the magnitude and characteristics of this problem in rural India, where 68% of the population resides, are insufficient. This study analyses the magnitude, causes, characteristics and consequences of TS misuse in rural India. It also examines the association between TS misuse and patients' perception of skin disease.<h4>Methods</h4>A mixed-method observational study was co ...[more]

PMID: 32430446

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Project description:ImportanceDuring the last decade, increases in drug prices for commonly prescribed dermatologic medications have outpaced the rate of inflation, national health care growth, and reimbursements. Among nondermatologic medications, studies have shown a role for robust generic market competition in reducing drug prices. The association between competition and the costs of topical dermatologic generic drugs has not been evaluated.ObjectiveTo characterize the association between changes in drug price and the number of US Food and Drug Administration (FDA)-approved manufacturers among the most commonly used topical dermatologic generic products.Design, setting, and participantsThis retrospective cost analysis of the most commonly prescribed topical dermatologic generic drugs used cumulative annual claims data from the Medicare Part D Prescriber Public User File to identify 597 dermatologist-prescribed drugs with more than 10 claims. The number of manufacturers and the price per unit were identified from the FDA Orange Book and the National Average Drug Acquisition Cost (NADAC) database, respectively, for 2013 through 2016. Drugs that were nondermatologic, were not topically administered, were missing NADAC data, were lacking a generic formulation, or had fewer than 400 claims were excluded.Main outcomes and measuresPrimary outcomes included per-unit drug price and number of FDA-approved manufacturers. Pricing measures were adjusted for inflation and are reported in 2016 dollars.ResultsThe present analysis included 116 topical dermatologic generic formulations, representing 70.5% of the total Medicare Part D dermatologist-coded claims from 2015. Drug formulations with 1 to 2 manufacturers during the study period sustained a median percentage increase in price of 12.7%, whereas those with more than 6 manufacturers had a median percentage decrease in price of 20.5%. Formulations with 1 to 2 manufacturers had a 20.6%, 19.5%, and 33.2% higher percentage increase in price than those with 3 to 4 manufacturers, 5 to 6 manufacturers, and more than 6 manufacturers, respectively. There was a statistically significant inverse association between the percentage change in drug price and median number of manufacturers (Spearman correlation coefficient, -0.26; P = .005).Conclusions and relevanceThe negative association between the change in drug price and the median number of manufacturers of generic topical dermatologic drugs indicates a role for market competition in controlling the costs of generic drug prices within dermatology. These findings support policies that facilitate robust market competition among topical dermatologic generic drugs produced by a limited number of manufacturers.

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Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients.

Publications

Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients.

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