© Springer Nature Singapore Pte Ltd. 2018
Koushik Lahiri (ed.)A Treatise on Topical Corticosteroids in Dermatologyhttps://doi.org/10.1007/978-981-10-4609-4_1717. Topical Corticosteroid Abuse: Indian Perspective
(1)
Dr. Meghana’s Skin Clinic, JK Chambers, First Floor, Office no 111, Sector-17, Vashi, Navi Mumbai, 400703, India
(2)
Bishen Skin Centre, M-69, Janakpuri, Aligarh, 202001, India
Abstract
Topical steroids (TSs) have been used for decades to treat various dermatological disorders due to their various effects, which have become responsible for the various deleterious side effects. Their free availability in India has made them prone for abuse, increasing the risk of local and systemic side effects.The reasons for TSs abuse varies from wrong prescription, dubious marketing by pharmaceutical companies, free availability as OTC drugs and lack of regulations regarding the manufacturing of irrational combinations.The misuse occurs at various levels such as manufacturing, marketing, prescription, sales and end-use by patients/ laymen. TSs are misused for varied indications like acne, pigmentation, fungal infection, pruritus, and as a cosmetic cream .TSs abuse is more common in the younger generation and dark races. The Indian Association of Dermatologists, Venereologists, and Leprologists (IADVL) has formed a task force against TSs abuse, with main aims like raise public awareness, run media campaigns, form study groups for doctors, highlight the problem in journals, and meet with central and state authorities.
Keywords
Topical steroidsTSs abuseOTC drugsLearning Points
- 1.
Proper education, sensitization, regularization o prescriptions and strict legal rules and actions would go a long way in curbing the TSs abuse menace.
17.1 Introduction
Abuse is inappropriate or excessive use of a drug. In recent years, there has been a dramatic increase in drug abuse. Topical steroids (TSs) which came into existence more than 50 years ago have been used for decades to treat various dermatological disorders. Various effects of TSs like vasoconstrictive, immunosuppressive, antiproliferative, antipruritic, atrophogenic, melanopenic and sex-hormone-like effects lead to rapid response in many dermatoses including infections. But unfortunately these effects have become responsible for the myriad deleterious effects of TSs [1, 2].
Also their free availability over the counter (OTC) without prescription in India has made them prone for abuse, increasing the risk of local and systemic side effects. Betamethasone valerate is the most favored preparation, being popular due to the misconception that it is fairness and anti-acne cream [3].
17.2 Historical Aspects of Steroids
TSs were first introduced in 1951 by Sulzberger. The TS to be introduced was topical hydrocortisone then known as “compound F” [4]. In 1952 Sulzberger and Witten published an article on the effect of topically applied compound F in selected dermatoses [5]. A large number of modifications of the original compound F (hydrocortisone) were discovered in rapid succession. These included fluorohydrocortisone (1955), triamcinolone acetonide (1958), fluocinolone acetonide (1961), betamethasone (1963), clobetasol propionate (1974), clobetasone butyrate (1978), fluticasone (1990), Halobetasone (1990), mometasone (1991) and a host of other molecules. These molecules were of varying potencies as determined by their vasoconstrictive properties [6].
17.3 Reason for Misuse of Steroids
The reasons for rampant TS abuse vary from wrong prescription, dubious marketing by pharmaceutical companies, free availability as OTC drugs (many cosmetic and Ayurvedic products contain unlabeled depigmenting agent and steroids; TSs are available in various irrational combinations) and lack of regulations regarding the manufacturing of irrational combinations [2, 5].
The misuse occurs at various levels such as manufacturing, marketing, prescription, sales and end use by patients and laymen [6].
17.4 Stages at Which Misuse Occurs [6]
- 1.
Manufacturing misuse: Many pharmaceutical companies often market products which they think would be innovative and attractive to the prescriber, to increase their sales. But in the long run such products do more harm than good. Examples include modified Kligman’s formula containing mometasone for melasma, superpotent steroids with enhanced penetration and superpotent steroids for use on scalp.
- 2.
Marketing misuse: TSs are often introduced to non-dermatologists without revealing the true aspects of its appropriate usage and information regarding side effects. Unfortunately such marketing practices may not be strictly illegal, leading to abuse of TSs. Though it is illegal for a practitioner of alternative medicine to prescribe allopathic drugs, there is no legal restriction on promotion and sale of TSs by pharmaceutical companies to such practitioners. Hence TS prescriptions coming from alternative medicine are common in India.
- 3.
Prescription misuse: Prescriptions of TSs by dermatologists may be incomplete with respect to quantity to be used, frequency, site and duration. Prescriptions of non-dermatologists ignore the important aspects like potency, site, duration and indication. Also patients with TS prescriptions tend to repeatedly buy the same drug from chemists against medical advice.
- 4.
Sales misuse: TSs in India most are available at very cheap prices since they come under Drug Control Price Order (DPCO) being sold as over-the-counter (OTC) products unlike the international market. This causes multiple problems:
- a.
Layman can buy any TSs from chemists for any ailment.
- b.
Salespersons at chemist counters are considered equal to doctors by many laypersons who encourage buying of TSs to increase their sales. This results in flooding of society with TSs sold and misused freely without a dermatologist’s prescription.
- a.
- 5.
Misuse by laypersons: Laypersons suffering from various dermatoses tend to apply steroids which are recommended by their friends, neighbors and relatives. Their diseases may also be aggravated on application of steroids. But they do not consult dermatologists initially or even later and continue to use steroids for long time increasing the risk of development of side effects. Another situation where steroids are commonly misused is as fairness cream. Mometasone, hydroquinone and tretinoin containing skin-lightening agent’s usage has become very popular especially in India resulting in their aggressive marketing and prescription not just by dermatologists but all physicians resulting in their widespread abuse [2].
17.5 Indications for Misuse
TSs are misused for varied indications, such as acne, pigmentation, fungal infection, pruritus and as a cosmetic or skin cream for any type of rash [5].
17.6 Commonly Abused Steroids
Betamethasone valerate (0.1%), fluocinolone acetonide (0.1%) and betamethasone dipropionate (0.05%) were the main types of steroid abused [7]. The greatest increase in sales in May 2015 was of Panderm Plus Cream, which contains clobetasol, ornidazole, ofloxacin and terbinafine. A modified and vitiated version of the original triple combination of Kligman’s formula, intended for use in melasma, contains potent topical corticosteroids such as mometasone in addition to hydroquinone and tretinoin, with a brand called Skinlite topping the sales in 2015. With total sales of Rs. 2.74 bn in May 2015, these combinations are available over the counter, even though mometasone can cause severe cutaneous adverse effects. Some combination products are marketed and used as whitening creams but can cause long-term and often permanent side effects [8].
17.7 Population Commonly Abusing Topical Steroids
17.8 Figures on Sales of Topical Steroids
In the Indian market, 1066 brands of TSs are sold. Sale of TSs at the end of December 2013 was 1400 crores, showing an annual growth of 16%. This accounted for 82% of the topical dermatology market, reflecting clearly their popularity. The top-selling combinations contain beclomethasone, neomycin and clotrimazole (sale of Rs. 152 crores in 2013), followed by combination products containing clobetasol, ofloxacin, ornidazole and terbinafine (sale at Rs. 110 crores). According to IMS Health data, most prescriptions for TSs and combinations come from dermatologist followed by general practitioners, obstetrician and gynecologists, pediatricians and physicians [10].
17.9 Magnitude of Steroid Abuse Problem in India
In India all drug combinations are considered new drugs for the first 4 years and therefore need approval from the Drug Controller General of India after safety and efficacy data have been presented. After approval, state licensing authorities allow manufacture and sale throughout the country [8].
By law, steroids, like clobetasol, clobetasone, fluticasone and mometasone, can be sold in India only with a registered medical practitioner’s prescription. All steroids are included in schedule H of the Drugs and Cosmetics Rules 1945, but a footnote confusingly excludes topical preparations and eye ointments from the list. This means that the status of these drugs is interpreted as “over the counter” which needs urgent revision. Moreover, existing laws are poorly implemented. Many of India’s 800,000 pharmacists sell steroid creams without a prescription, ignoring the box warnings [8].
The situation in India is complicated by these factors:
- 1.
The number of dermatologist in India is currently approximately 7500, of which more than 80% of them practice in urban areas. The population is 1.21 billion out of which about 70% live in villages. So the number of dermatologists is few for the Indian population living in rural areas. Because of this, nonphysicians who are not trained treat dermatoses by prescribing TSs [10]. The top prescribers of topical steroids in India, after dermatologists, are general practitioners, gynecologists, pediatricians and consulting physicians [8].
- 2.
Another major concern regarding selling of prescription drugs as non-prescription drugs is the lack of awareness about medication among the general public, particularly in a developing country like India [6].
- 3.
Inadequate regulation of unscrupulous pharmacists by authorities who act as quasi-dermatologists dispensing reasonably priced superpotent topical steroids either alone or in combination to an unsuspecting populace.
- 4.
“Law related to drugs and cosmetics” indicates that TSs are schedule H drugs; that means they have to be sold strictly only after prescription of a registered medical practitioner. Only clobetasol propionate, clobetasone 17-butyrate, fluticasone propionate and mometasone furoate are included in this list. TS combinations are also not included in the list. From the analysis of the affidavit filed in the Supreme Court in November 2013 in a drug pricing case by the All India Drug Action Network and others vs Union of India and others, 99.8% of topical steroids have escaped inclusion in the Drug Price Control Order [8, 10].
17.10 General Side Effects of TSs
General side effects noted with topical corticosteroids include telangiectasia, cutaneous atrophy, striae, hyper-/hypopigmentation, tinea incognito, perioral dermatitis, infantile gluteal granuloma and pyoderma [11].
These are likely to occur when superpotent TSs are used on the face, in body folds and on areas with a thin skin (e.g., genitalia). Children are especially liable to these side effects due to their relatively thin skin.
Hypopigmentation is due to impaired melanocyte function and is especially seen with triamcinolone due to its tendency to aggregate owing to its large molecular size. Atrophic changes can affect both epidermis and dermis. The process starts microscopically within 3–14 days of steroid application. Initially epidermis becomes thin due to reduction in epidermal cell size, which reflects a decreased metabolic activity. After prolonged exposure there is reduction in cell layers, that is, the stratum granulosum disappears and the stratum corneum becomes thin. Synthesis of stratum corneum lipids and keratohyalin granules and formation of corneodesmosomes are suppressed.
Dermal atrophy is caused by decreased fibroblast growth and reduced synthesis of collagen. Intertriginous areas are particularly susceptible due to thinner skin, increased moisture, elevated temperature and partial occlusion provided by the skin in these sites. The atrophy is reversible on stoppage of TS, but the normalization may take months [12].
17.11 Side Effects on Face
Another major aspect of TCs abuse is its cosmetic use in dark skinned, particularly in combination with bleaching creams, to make the skin fair [13]. TS-damaged facies is a newly described entity associated with TS abuse.
17.12 Effects of Steroid Abuse on the Face [1, 7, 12–16]
- 1.
Steroid addiction.Related posts:
Evolution and Development of Topical Corticosteroids
Pros and Cons of Topical Corticosteroids in Lactating Females
Topical Corticosteroids: Pharmacology
Systemic Side Effects of Topical Corticosteroids
Use and Misuse of Topical Corticosteroid in Genital Dermatosis
Topical Corticosteroid Abuse: Southeast Asia Perspective
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