| Abstract|| |
Topical corticosteroids (TC) have been available for more than six decades during which they have completely changed the face of therapy of dermatological disorders. Despite being the most useful drug for such treatment they are known to produce serious local, systemic and psychological side-effects when overused or misused. Though the drug has been misused sporadically earlier, the menace has become more acute during the last two decades. In India, damaging effects to the human body particularly the skin have been reported regularly during the last decade. The misuse occurs at various levels such as manufacturing, marketing, prescription, sales and end-use by patients and laymen. During the last decade dermatologists in India have been regularly campaigning against such misuse. However, the menace keeps on increasing alarmingly. The need to accelerate the momentum of the campaign against TC misuse has been increasingly felt by dermatologists all over India. This symposium aims to contribute significantly to the campaign against misuse of TC.
Keywords: India, misuse, topical corticosteroids
|How to cite this article:|
Coondoo A. Topical corticosteroid misuse: The Indian Scenario. Indian J Dermatol 2014;59:451-5
What was known?
1. TCs are one of the most useful drugs for the treatment of dermatological disorders if used for the proper indication and duration.
2. Misuse of the drug may lead to local, systemic and psychological disorders.
3. Rampant misuse of the drug is gradually increasing to menacing proportions all over India.
4. Dermatologists have been campaigning against such misuse by conducting clinical studies, publishing articles, campaigning in the social, print and electronic media and also by making efforts to sensitize the authorities at the ministerial level.
5. Such efforts have not yielded much result till date.
| Introduction|| |
The renaissance period of dermato-pharmacology was initiated by Sulzberger and Witten in 1952 when topical corticosteroids (TC) were first introduced as marketable commodities.  They were hailed as a panacea for all ills by physicians and patients and gained rapid popularity. This euphoria was lapped up by the pharmaceutical companies. A large number of modifications of the original Compound F (Hydrocortisone) were discovered in rapid succession. These included Fluorohydrocrtisone (1955); Triamcinolone acetonide (1958); Fluocinolone acetonide (1961); Betamethasone (1963); Clobetasone 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. The availability of such a wide variety of corticosteroids proved to be bane to dermatologists. But after the initial honeymoon period the side-effects of the drugs gradually became discernable.  The problem of side-effects became gradually more acute with rampant and unlimited misuse of the drug particularly by non-dermatologists.  What was once considered to be a magic drug for most diseases in dermatology turned itself into a cause of many ills.
| Topical Corticosteroid Usage|| |
TCs are principally used for their antiinflammatory, antiproliferative and immunosuppressive properties. These properties confer upon them the ability to cure a wide variety of disorders. However, the prescriber must be aware of a number of factors which must be considered before the drug is prescribed. Principal among them are (a) the site of application, (b) the potency of the drug, (c) age of the patient, (d) duration of application, and (d) indication for usage. Faltering on any of these counts can lead to misuse of TC. While application of potent or highly potent TC in children, on the face or for prolonged duration would lead too disastrous consequences, application of lower potency drugs in case of diseases such as plantar psoriasis would also be inappropriate and useless.  Similarly, the combination of TC with other formulations such as antibiotics, antifungals, salicylic acid or retinoids should be used judiciously. This is particularly true about the Kligman's formula or its so-called modified versions available in this country. 
| Topical Corticosteroid Misuse|| |
As discussed earlier inappropriate usage of TC can lead to side-effects some of which such as depigmentation have led to the use of the medication as a "fairness" cream. Some patients may become dependent on the drug and use the drug randomly by purchasing it directly from the chemists who are allowed to sell the drug freely without a dermatologist's prescription. Early reports of TC dependence or addiction were published in 1973 by Burry  and in 1976 by Kligman and Frosch  On the flip side, reports of serious topical and systemic side-effects of these drugs appearing regularly in the literature as well as overkill in campaigns about their rational use have gradually led to a phobia regarding the drug among a section of the population both in India and abroad.  TC phobia is particularly observed among parents of atopic children  and can lead to non-adherence and failure in treatment. 
Misuse of TC may occur at various stages during its journey from the factory to the face. These can be divided into the following.
- Manufacturing misuse: In the rat race for enhancement of sales many pharmaceutical companies market products which they think would be innovative and therefore attractive to the prescriber but which ultimately harm the patient. The so-called modified Kligman's formula containing Mometasone for use in melasma,  superpotent corticosteroids with enhanced penetrability and super potent corticosteroids for the scalp are examples of such unethical products. 
- Marketing misuse: Rampant marketing of TC including superpotent ones to non-dermatologists who may not be fully aware of their mode of usage is said to be practiced quite commonly by salespersons of pharmaceutical companies. Though such marketing may not be strictly illegal it may lead to unwanted consequences since the salesperson would only reveal the rosy side of TC to the practitioner who may not be fully aware of their harmful effects. More alarming is the fact that while it is illegal for a practitioner of alternative medicine to prescribe drugs of modern medicine (e.g. TC) there is no legal restriction on marketing of TC by sales persons to such practitioners. Hence, prescriptions of homeopaths and other alternative medicine specialists containing TC products is not an uncommon sight in India. 
- Prescription misuse: This can be at various levels. Prescriptions of TC by dermatologists may be incomplete with respect to quantity to be used, frequency, site and duration prescriptions of non-dermatologists who do not consider the potency, site, duration and indication (e.g. super potent corticosteroid applied on groin for prolonged period for tinea cruris) are served regularly at sales counters of chemists. With the same prescriptions patients tend to repeatedly buy the same drug from the chemists without bothering to visit the doctor for further advice. 
- Sales misuse: In India most TC are available at throwaway prices since they come under DPCO (Drug Control Price Order). Unlike the international market they are mostly sold as over-the-counter (OTC) products in India. This gives rise to multiple problems. Firstly, any layman can buy any TC from chemists for any ailment. Secondly, there is a concept peculiar to India, where salespersons at chemist counters are considered equal to doctors by many lay persons. This peculiar concept arises from the theory that the salesman knows more about drugs than doctors since they are selling the drug. That such a salesperson knows only the name and price of the drug and nothing more is not taken into account. These salespersons also encourage such a concept principally to increase their sales and, to some extent, for ego satisfaction. The net result is the flooding of society with TC sold and misused freely without a dermatologist's prescription. 
- Misuse by lay persons: The end-point of misuse of TC are the people at large some of whom are patients while some others are victims of the beauty and fairness craze created largely by the merchants of the beauty business. The patients may be suffering from a variety of disorders which may or may not be steroid-responsive. Some of these diseases may also be aggravated on application of steroids. However, many of these patients do not consult dermatologists initially or even later and apply steroids which are recommended by their friends, neighbors and relatives. It is only when their disease is aggravated by steroid application or complications set in either on the short or on the long run that they are forced to visit the dermatologist. As mentioned earlier, another example of misuse is prescription repetition by patients whereby they keep on applying the same steroid cream for months together. The fairness craze ignited to a large extent by cosmetic companies promoting "fairness creams" and by beauty parlors has also led to widespread misuse of topical steroids particularly those containing mid potency steroids in the so-called modified Kligman formula marketed by profit-hungry pharmaceutical companies. This problem of misuse by laymen is compounded by the practice of OTC sale of TC of all potencies. 
| Awareness Campaign in India -What has been Done So Far|| |
Though a few articles on usage of TC were published by Indian authors earlier , the first significant article to focus on the misuse of TC in India was published in the Indian Journal of Dermatology in 2006.  In the same year a thread named 'Topical steroid misuse menace" was initiated in the ACAD_IADVL group of IADVL and a delegation of IADVL led by Dr. Suresh Joshipura, the then President of IADVL and Dr. Koushik Lahiri, the then Hon. General Secretary of IADVL submitted a memorandum on this issue to the Union Minister of Health and to the ministry of chemicals and fertilizers. 
In January 2007 at Chennai, the IADVL Central Council and General Body unanimously passed the following landmark proposal submitted by Dr. Arijit Coondoo and Dr. Koushik Lahiri:
"Stop OTC supply of potent topical steroids"
A major concern for dermatologists in recent years has been the injudicious use of TCs due to unscrupulous selling by chemists not only as prescription but also as non-prescription drugs. Non-prescription (OTC) drugs are medicines that are safe and effective for use without a doctor's prescription. They must be useful for a disease which is mild and easily self-diagnosable. The treatment should be of limited duration. The drug must be unlikely to produce hazardous side-effects or induce addiction. And the product's labeling and instructions should be easy to follow. Even prescription drugs can very often be bought from medical shops without an actual prescription from the doctor. Although there have been moves to ensure the presence of certified pharmacists at medical shops, that seldom happens, with the result that an uninformed customer deals with an uncertified drug seller who does not even know the difference between a prescription and a non-prescription drug. Hence, with both prescription and non-prescription drugs being sold simultaneously, chances of wrong medication cannot be ruled out. 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. This is particularly true about TCs which constitute a large bulk of topical preparations sold from medical shops. While some of these are sold as prescription drugs a large proportion is sold without prescriptions (a) on the advice of the shop assistant at the pharmacy, (b) by the customer himself who may have heard about its good effects from an acquaintance or may be continuing the treatment of a doctor beyond the time limit of the prescription without consulting him. Recently, there is also an unfortunate trend to use corticosteroids of mid and strong potency for the purpose of beautification. TCs particularly the potent ones may produce hazardous side-effects if they are used injudiciously without proper indications or for a prolonged period. These may vary from local effects such as atrophy, striae, telengiectasia, hypertrichosis and acneiform eruptions to more serious systemic side-effects due to HPA axis suppression. Neither the customer nor the drug seller is aware of these hazards, resulting in an alarming rise in the number of patients approaching dermatologists with these side effects which may sometimes be irreversible.
It is therefore proposed that a law should be enacted enforcing immediate ban on the non-prescription sale of TCs. The authorities should also be requested to ensure that such laws are strictly enforced both in "letter and spirit". 
Subsequent to this proposal a number of dermatologists from various parts of India started posting cases of such misuse in the official ACAD_IADVL e-group of IADVL. A few of them came together and decided to conduct a multicentric study on topical steroid dependence and misuse on face in 12 centers all over India. The condition resulting from such misuse and dependence was named topical steroid-dependent facies (TSDF) by Dr. Koushik Lahiri.  This study was conducted from April to July 2008 at 12 centers by Dr. Abir Saraswat (Lucknow), Dr. Koushik Lahiri (Kolkata), Dr. Manas Chatterjee (Pune), Dr. Shyamanta Baruah (Dibrugarh), Dr. Arijit Coondoo (Kolkata), Dr. Asit Mittal (Udaipur), Dr. Saumya Panda (Kolkata), Dr. Muralidhar Rajagopalan (Chennai), Dr. Rajeev Sharma (Aligarh), Dr. Anil Abraham (Bengaluru) Dr. Shyam Verma (Vadodara) and Dr. CR Srinivas (Coimbatore) with Dr. AK Bajaj, Chairperson IADVL Academy of Dermatology and Dr. V K Sharma, President-elect of IADVL as mentors and Dr. S Sacchidanand, President, IADVL as observer. The results were first presented along with a panel discussion involving all members of the group at the National Conference of IADVL at Bengaluru in January 2009 and were later documented and published in 2011. 
The introduction to this landmark article is worth quoting:
"In the Indian market, at least 18 different corticosteroid molecules, ranging in potency and activity from mild to super-potent, are available for topical use on the skin. These molecules are marketed under a variety of brand names by thousands of pharmaceutical companies. At least a few of these formulations are available at every medical store with or without a prescription. The situation is further complicated by the inadequate policing of medicine shops by the authorities, whereby any and every medicine, whether OTC or not, can be sold without any prescription. To prescribe these agents rationally, India has only a little over 6500 qualified dermatologists to cater to a population of over 1.2 billion. Thus, easy availability of TCs and poor access to dermatologists makes the situation in India ripe for their misuse in the community. TC misuse is well known and has been the subject of studies mainly from Africa and other Asian countries. However, even developed countries like the USA are facing this problem. In spite of the widely perceived enormity of the problem, only a single case series has been published on this problem from India. The aim of this study was to ascertain the magnitude, clinical features and demographics of TC misuse on the face in order to raise awareness of this problem in the dermatology community and society at large. In India, it appears that the free availability of all TCs without a prescription has allowed many of these brands to become household names, wherein they are no longer considered drugs at all. Patients are unaware of the risks posed by these products and continue to use them for long periods before seeking help from dermatologists. Even correct prescriptions are misused by getting repeated refills from the chemist. At present, loopholes in our laws allow pharmaceuticals to advertise even clobetasol-containing creams on the television and to sell them as OTC products. As indicated by the data in this study, the problem of TC misuse is already significant, and unless urgent steps are taken on all possible fronts, the situation will only get worse and we may soon be facing an avalanche of these unfortunate patients in our clinics". 
Based on the data in this study the authors recommended that "all healthcare workers need to be sensitized about the dangers of TC misuse, especially on the face and legislation/stronger implementation of existing laws is required to limit public access and advertising of potent TCs". 
During the last few years a number of articles focusing on this issue have been published from India. ,,,,,,,, Case reports of patients suffering from various effects of misuse of TCs have regularly been discussed in ACAD_IADVL. The social media is also being utilized for a similar purpose and dermatologists have been actively posting photographs and discussing this issue in a Facebook group devoted to this issue named "No steroid cream on face without a doctor's prescription". Dermatologists have also discussed this issue off and on in the lay print and electronic medium.
But such efforts have only proved to be a drop of water in the ocean without yielding much result. TC misuse is not only rampant but growing enormously every day. We need a more concerted and organized effort to counter the menace. Recently, as a follow-up of the 2007 resolution passed by the IADVL general body an IADVL taskforce led by Dr. Koushik Lahiri has been set up by Dr. Deepak Parikh, President of IADVL to deal with all aspects of the threat of TC abuse including representations to the government and building up an awareness campaign at all levels. It was wit h the same objective in mind that this first ever symposium on the topic was conceived.
Topical steroids cause both local and systemic side-effects, which are more pronounced on repeated and prolonged applications. While the first article on "Topical steroid damaged skin" by Abraham et al. focuses on the local side-effects, the subsequent article by Dhar et al. draws our attention to the "Systemic side-effects of topical corticosteroids". Apart from the physical side-effects psychological factors also play a major role in topical steroid misuse. This aspect has been appropriately discussed by Ghosh et al. in their article on "Topical corticosteroid addiction and phobia". The final article by Abir Saraswat discusses the "Ethical use of topical corticosteroids".
The movement against misuse of TC is still in its infant stage and needs to be made more effective. To achieve this objective, this symposium was conceived by the journal editor and the symposium editor who, incidentally, had also jointly moved the proposal passed by the IADVL general body more than seven years back. If that proposal kick started a movement among the dermatological academia this symposium is a humble effort on our part to take the movement to the next level.
| References|| |
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What is new?
1. An analysis of the various types of TC misuse in a systematic manner.
2. An enumeration of the various steps taken so far by dermatologists in
India to counter the threat.
3. A compilation of articles published by Indian authors on this subject.