INTRODUCTION:

Over-the-counter (OTC) or non-prescription medications refer to drugs that a patient can purchase without a prescription from a registered medical practitioner.¹In a developing country like India, patients often buy medications directly from the pharmacist on advise of friends/relatives, bypassing the Doctor. In rural areas, this practice is very common especially for Dermatological conditions due to non availability of Dermatologists. Also, due to the easy availability of general practitioners and Doctors practising alternative systems of medicine, patients may consult them for skin diseases. These doctors, due to their limited knowledge about Dermatology and Dermatological therapeutics, prescribe creams containing various combinations of steroids, antifungals and antibiotics. Almost all skin conditions including fungal infections, acne, pigmentation etc are treated by non-Dermatologists. This not only results in ineffective treatment and cutaneous adverse effects but also drug resistance. We conducted this study to find the pattern of usage and implications of inappropriate use of topical drugs suggested by non-Dermatologists to treat skin disorders as there are only a few studies which have highlighted this problem in rural India.

MATERIALS AND METHODS:

This cross-sectional observational study was conducted at a rural tertiary care hospital in South India over 6 months between November 2020 and April 2021. Institutional Ethics committee approval was obtained. Patients giving written informed consent to participate in the study were included. Patients not willing to participate in the study were excluded. In case of children, the history was taken from their parents or guardians and included in the study after taking their consent. All patients presenting to Dermatology OPD with a history of applying topical medications for skin disorders on the advice/suggestion of non-Dermatologists were recruited in the study. A detailed history regarding demographic variables, details of the topical drug including brand name and composition, the indication for which it was used, duration of usage, source of advice/prescription like pharmacists, friends, family members and non-Dermatologist Doctors like general physicians, Doctors practising alternative systems of medicine was obtained. Patients were asked about their knowledge and potential side effects of prolonged use of such drugs. A thorough general physical examination was conducted. Cutaneous examination was conducted to look for side effects like erythema, telangiectasia, atrophy, hyperpigmentation, hypopigmentation, hypertrichosis, alteration in morphology of original lesion. Awareness of the patients about topical steroids and their adverse affects was assessed. The data collected was entered into MS excel 2007 software. For descriptive analysis, the categorical variables were analysed by using percentages.

RESULTS:

In our study, out of 100 patients included, there were 46 males and 54 females. Male:female ratio was 1:1.17. The youngest patient was a 9-month-old male infant and the oldest was a 70-year-old elderly male. Maximum patients were in the age group of 21-30 years (23%) followed by 31-40 years (22%) as in table 1. Housewives (23%), students (31%) farmers (18%) were the the ones who used these medications the most (Table 2). The most common indication for which these medications were used was Dermatophytosis (29%) followed by melasma (21%), acne (16%) as shown in table 3. Most of the patients used the creams for less than a month (53%) as in table 4. The common adverse effects encountered due to use of these topical drugs were itching in 20(17.86%) patients, burning sensation in 15(13.39%) patients as shown in table 5. Most of the patients reported multiple adverse effects (Table 5). Most of the patients used topical drugs on the advice of pharmacists (36%) followed by friends/relatives (29%) as shown in table 6.

Topical agents (figure 1) used included corticosteroids (26%), antifungals (10%), antibacterials (8%), retinoids (2%), combination creams (35%) and others (19%). Antifungal brands (figure 2) that were most commonly prescribed included SZ HH cream (Sertaconazole) and KZ cream (Ketoconazole). Antibacterial agents (figure 3) included Acnestar gel (clindamycin). Corticosteroid creams (figure 4) included Betnovate (Betamethasone), Elocon cream (Mometasone). Retinoid brands (Figure 5) such as A-ret gel and AP gel were also prescribed Among combination creams (figure 6), the most common ones were Panderm-plus and Dermi-5. Other topical agents (figure 7) such as Sapat lotion (Salicylic acid), Calosoft lotion (Calamine) and Picon cream (Pimecrolimus) were also prescribed. With respect to the awareness of the patients regarding side effects of prolonged use of topical steroids, we found that 97% of them were not aware of steroids or their side effects.

Table 1: Age of presentation

Age group	Percentage (%)
0-10 years	9
11-20 years	18
21-30 years	23
31-40 years	22
41-50 years	17
51-60 years	7
61-70 years	4

Table 2: Occupation

Occupation	Percentage (%)
Farmers	18
Housewives	23
Students	31
Teachers	4
Labourers	9
Others	15
Total	100

Table 3: Indications

Indications (Skin conditions For which creams were used)	Patients (%)
Dermatophytosis	29
Melasma	21
Acne	16
Pityriasis alba	7
Eczema	6
Pityriasis versicolor	5
Seborrheic dermatitis	3
Psoriasis	2
Papular urticaria	2
Scabies	2
Acanthosis nigricans	1
Atopic dermatitis	1
Candidal balanoposthitis	1
Fairness	1
Folliculitis	1
Furuncle	1
PIH	1
Total	100

Table 4: Duration of application

Duration of use	Patients (%)
< 1 month	53
1 - 6 months	41
> 6 months	3
> 1 year	3
Total	100

Table 5: Adverse effects due to topical medications

Adverse effects	Patients (Number)	Patients (%)
Itching	20	17.86
Burning sensation	15	13.39
Photosensitivity	14	12.50
Hyperpigmentation	12	10.71
Acne	10	8.93
Alteration in existing lesion	9	8.04
Hypopigmentation	6	5.36
Erythema	5	4.46
Irritant contact dermatitis	5	4.46
Telangiectasia	4	3.57
Aggravation of lesion	4	3.57
Allergic contact dermatitis	3	2.68
Hypertrichosis	3	2.68
Pain	1	0.89
Striae	1	0.89

Table 6: Source of prescription

Source	Patients (%)
Pharmacists	36
Friends/Relatives	29
General practitioners	27
Other specialists	5
Ayurvedic Doctors	2
Self	1
Total	100

Figure 1: Topical medications used

Figure 2: Antifungal brands prescribed

Figure 3: Antibacterial brands

Figure 4: Corticosteroids brands

Figure 5: Topical Retinoid brands

Figure 6: Combination creams prescribed

Figure 7: Other topical agents used

Figure 8: Hypertrichosis (hairs) over cheeks due to corticosteroid abuse

Figure 9: Acneform eruptions

Figure 10: Exogenous ochronosis due to Hydroquinone

Figure 11: Tinea incognito in an infant

Figure 12: Stria rubra due to prolonged steroid application for Tinea corporis

Figure 13: Irritant contact dermatitis due to Sapat lotion (Salicylic acid)

DISCUSSION:

According to the US Food and Drug Administration, more than 300,000 over-the-counter (non-prescription) drug products are available in the market.^1,2According to Health Care Financing Administration (HFCA) 6 out of 10 drugs which are purchased are OTC medications.³ In rural Maharashtra, the prevalence of self-medication was 81.5%.⁴In some urban areas of Delhi the prevalence was found to be 92.8%.³ According to drug laws in India, self-medication is permitted for OTC drugs. However, there is no specific list of OTC drugs for reference.⁵ These drugs, both oral and topical can be bought without the prescription of Registered Medical Practitioner. Many studies have been done to determine the pattern of prescription of OTC drugs with respect to oral medications. However the exact prevalence of topical drugs prescribed or suggested by non-Dermatologists in India is unknown. In rural areas patients tend to self treat their skin diseases by buying medicines directly from pharmacy, due to non-availability of Dermatologists. In conditions like vitiligo (white patches), where a lot of stigma is attached to the disease, patients may not consult a Doctor and try to self-medicate. In villages and smaller towns, skin diseases are treated by general practitioners and AYUSH Doctors. This has led to several cutaneous side effects and antifungal resistance. This prompted us to conduct this study to find implications of this OTC drugs. In our study, a characteristic female preponderance was seen (M:F= 1:1.17). This was similar to a study by Birudala R et al (male:female = 1:1.79).¹The obsession of Indian people towards achieving fair skin and the self conscious nature of females are the reasons for females outnumbering males. In contrast, a study of Meena S et al showed a male preponderance with a M:F ratio of 1.7:1.⁶

The age of patients in our study ranged between 9 months and 70 years. Commonest age group found was 21-30 years (23%). This was in concordance with a study by Bains P et al (21-30 years - 49%) and Chauhan A et al (20-39 years - 66.7%).^7,8 However Machanda K et al found maximum cases in the 11 - 20 year age group (55%). Most individuals in India get married in the age group of 21 - 30 years. Therefore this age-group is more conscious of their appearance and complexion. Consequently this subset of population especially young women buy these medications as fairness creams or to self-treat acne or facial pigmentation, thus leading to increased incidence in this age group.⁹ Farmers, House wives and students were the major chunk of population who misused these drugs. The study being conducted in rural area explains the large number of farmer population.

In our study, the most common indication for OTC abuse was Dermatophytosis (29%) followed by melasma (21%) and acne (16%). This was in concordance with Meena S et al who also found Dermatophytosis (52.54%) as the most common indication.³ In contrast, other authors found acne to be the most common indication for abusel.^1,10,11 Few studoes found Melasma was the most common skin condition for topical OTC drug abuse.^12,13Our study consisted of patients from rural area, who are predominantly engaged in agriculture. Hence there is a high incidence of fungal infections especially Dermatophytosis. Melasma occurring over the face leads to cosmetic disfigurement especially among the young women. Since women were also predominantly involved in agriculture in this part of the country, the excessive sun exposure aggravates the pigmentation. Therefore this was the found to be the second most common indication for misuse.

In our study, majority of the patients (53%) misused these drugs for less than a month, 41% used it for 1 to 6 months, 3% for 6 months to 1 year, 3% patients used them for more than one year. In a study by Nagesh TS et al majority of the patients (62.5%) used the medications for 1 to 3 months.¹⁴ A study by Swaroop MR et al reported that a maximum patients (29%) misused the medications for more than 1 year (29%).¹⁵

The source of prescription was mainly from pharmacists (36%) followed by friends/relatives (29%) and general practitioners (27%). Two studies, one from Kerala and one from Hyderabad also reported the major source of prescription to be pharmacists (36.39% and 35.71% respectively).^16,17 These two studies however included all drugs, not restricting to topical medications. Due to paucity of Dermatologists in rural areas, patients consult Pharmacists, general physicians and AYUSH Doctors for skin problems. Pharmacists usually dispense creams containing a combination of potent steroid, antifungal, antibiotics, antihelminthics etc in various concentrations. It is seen that the subjective opinions of patients about a trademark or brand following the satisfaction, interest, trust, sense of pride enables a good patient pharmacist relationship and helps in the repurchase of medications and their repeated usage.¹⁸ Similarly, allopathy general practitioners prescribe these drugs. Studies by Chohan SN et al (64%), Brar KB et al (51%) found that majority patients were advised by their friends.^10,19Rathore I reported that the major source of information was pharmacists (12.1%) and major source of supply as pharmacy (52%).²⁰We found that all pharmacological categories of topical drugs were prescribed including corticosteroids, antifungals, antibacterials, keratolytics, retinoids and creams containing different combinations of the above agents. In our study, Betamethasone valerate 0.1% cream was the most commonly misused topical steroid and Betnovate was the most common brand name prescribed/suggested. Swaroop MR et al also reported Betamethasone valerate 0.1% cream was the most commonly misused topical steroid and Betnovate was the most common brand.¹⁵ Nagesh TS et al also reported Betnovate as the commonest brand abused.¹⁴ Contrary to our finding, Meena S et al found clobetasol propionate 0.05% was most commonly misused.⁶

One of the aims of our study was determining the adverse effects of misuse of topical OTC drugs. Most common averse effects reported by our patients were itching, burning sensation over face, photosensitivity, hyperpigmentation and acne. Nagesh TS et al reported acne, pigmentation redness, itching and burning.¹⁴ In contrast, Chohan SN et al found facial erythema (redness) in 51.8%.¹⁰ In our study, redness on face, burning sensation, photosensitivity, irritation were present in those who applied potent steroid creams like Betnovate (Betamethasone), Clonate (Clobetasol) and retinoids like A-Ret gel (Tretinoin), AP gel (Adapalene) and triple combination creams (containing Hydroquinone, tretinoin, mometasone/fluocinolone) like Skin lite, Skin shine for long duration over face. The tretinoin in these creams causes thinning of skin leading to irritation, redness and photosensitivity. The steroid component is responsible for atrophy, telangiectasia, post inflammatory hypopigmentation. Heavy metals and Parabens (p-hydroxybenzoates) which are the esters of para-hydroxybenzoic acids are commonly used as preservatives in pharmaceutical products and cosmetics which may cause allergic contact dermatitis.^21,22 Acne patients are usually suggested clindamycin gels (Acnestar) and retinoids (AP gel, A-ret) irrespective of the grade of acne and without regard to sensitivity of patient’s skin. Due to lack of knowledge about the mode of application and precautions to be taken while applying, like short contact therapy in case of retinoids, patients apply them according to their whims and fancies resulting in the above side effects. Patients who ask for fairness creams or for the treatment for dark spots on face in Pharmacies are given triple combination creams. Initially there will be an apparent improvement in complexion due to the redness on face which occurs due to thinning of skin, giving a false sense of fairness. This motivates the patient to continue using these creams as ‘fairness’ creams. Eventually patients end up with side effects like hyperpigmentation, hypertrichosis (figure 8), acneform eruptions (figure 9) and exogenous ochronosis (figure 10). Patients with fungal infections were prescribed antifungals like sertaconazole (SZ HH, Setrabet) by general physicians. However, due to incorrect method application, treatment is ineffective. Patients treated with steroid creams for Tinea, presented with alteration in the morphology of lesions also called Tinea incognito (figure 11). Lesions improve quickly due to the anti inflammatory effect of steroid, only to reappear once the patient stops applying it. He then resumes the application and the cycle continues. This long term use of steroids leads to atrophy or thinning of skin, striae or stretch marks (figure 12), telangiectasia.²³ Rampant use of steroids for fungal infections has given rise to anti-fungal resistance and is now an epidemic of sorts. Some patients were advised Sapat lotion (Salicylic acid) for tinea leading to irritant contact dermatitis (figure 13).

Regarding awareness among patients about side effects of steroid and OTC drugs, we found majority of the patients (97%) were not familiar of a category of drugs called steroids nor were they aware of their potential side effects. They were also unaware that the non subsidence of their skin condition despite prolonged usage was because of the steroid present in these drugs. This is the primary reason for steroid creams being misused.

In the US, OTC products fall into one or more US Food and Drug Administration (FDA) categories. Each category has unique set of regulations. The FDA website (www.fda.gov/cosmetics) contains comprehensive and up-to-date information about categorisation, safety and regulation of these products. However no such regulation is prevalent in our country leading to widespread misuse of drugs.²⁴Many authors even support complete ban on sale of drugs by pharmacies without a valid Doctors prescription.²⁰

CONCLUSION:

Pharmacists are professionals in health care, especially in pharmacy. Their role is not only to dispense drugs, but also help patients by promoting rational use of drugs and involve themselves in health promotion and public health practices.¹⁸ However many Pharmacists dispense topical steroids without advising the patients regarding their long term side effects. Hence Pharmacists have to be sensitized regarding the same. To curb this practice of dispensing topical drugs without a Dermatologist’s prescription, strict regulations with regard to sale of topical drugs should be brought about by the Government. Drugs have to be sold only on production of a valid prescription from a qualified Medical practitioner. There is also an urgent need to sensitise non-dermatologists and AYUSH practitioners about these serious side effects and antifungal resistance that can occur. Even when Dermatologists prescribe topical steroids or triple combination creams, patients have to be clearly advised about the exact quantity and duration of usage. In addition to this, drugs with irrational combination have to be totally banned. Although this has happened to some extent in case of oral medications, it is yet to come into effect in case of topical medications. Only with the active participation of various stake holders including Doctors, patients, pharmacists, Government and the society as a whole, this problem can be solved. Strength of this study is that the topic is unique and not many studies are done as regarding this aspect. One of the limitations of this study is the small sample size and limited to a small geographical area. Therefore studies with larger sample size are required to confirm the findings of this study.

ACKNOWLEDGEMENT:

• Financial or Other Competing Interests: None

• Was informed consent obtained from the patients: Yes

• For any images presented appropriate consent has been obtained from the patients: Yes

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Received on 23.10.2022 Modified on 18.04.2023

Research J. Pharm. and Tech 2024; 17(4):1491-1497.

DOI: 10.52711/0974-360X.2024.00236