Expert Consensus: Time for a Change in the Way We Advise Our Patients to Use Topical Corticosteroids
Topical corticosteroids form the mainstay of treatment for many skin conditions. If used appropriately, they are safe and effective, and side-effects are generally uncommon. Current advice to patients to apply topical corticosteroid preparations ‘sparingly’ or ‘thinly’ contributes to ‘steroid phobia’, increasing the risk of poor clinical response and treatment failure. Such cautionary advice also overlooks the fact that the vast majority of patients are prescribed topical corticosteroids of mild potency for which the evidence suggests that the risk of harm is minimal. In the patient’s mind, the current advice groups all steroids together regardless of their potential for adverse effects. The advice also tends to reinforce an erroneous concern that the risks from topical corticosteroids may be similar to those from systemic corticosteroids. We propose a change to make the pharmacy labelling of topical corticosteroids more accurately reflect the low risk of harm from corticosteroids of low to moderate potency and the importance of applying sufficient medication to achieve a satisfactory clinical response. This change could provide the focus for updated, evidence-based education for healthcare professionals in prescribing of topical corticosteroids and help in the provision of more appropriate advice to patients. We recommend that patients are informed that treatment should not exceed prescribed quantities, and continuing treatment should be under careful medical supervision. We also recommend that topical corticosteroid products include clear ‘fingertip unit’ instructions, preferably with images of a ‘fingertip unit’ and a chart to show the number of units required for specific areas of the body.
Patients with skin conditions such as eczema and psoriasis who are prescribed topical corticosteroids, or combination products that contain them, are typically advised on the packaging to apply the product ‘sparingly’ or ‘thinly’. This guidance is in line with the current British National Formulary (BNF) wording:((British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary 52. Section 13.4: Topical corticosteroids. London: BMJ Publishing Group/RPS Publishing, 2006.)) ‘In order to minimise the side-effects of a topical corticosteroid, it is important to apply it thinly to affected areas only, no more frequently than twice daily, and to use the least potent formulation which is fully effective’.
The BNF warning rightly recognizes the potential for side-effects – notably skin atrophy and adrenal suppression – which have been associated with inappropriate, prolonged and/or excessive use of topical corticosteroids, especially the most potent agents.((British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary 52. Section 13.4: Topical corticosteroids. London: BMJ Publishing Group/RPS Publishing, 2006.)) However, the advice to apply ‘sparingly’ or ‘thinly’ carries with it messages of economy and caution, even danger. Certainly, there is good evidence that patients interpret this warning in a negative way, giving rise to so-called ‘steroid phobia’, with accompanying poor adherence to treatment.((Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol 2000; 141:931–6.)) This, in turn, results in suboptimal clinical effectiveness and, in many cases, places an unnecessary burden on healthcare services.
In an ideal world, dermatologists, dermatology nurses, general practitioners, practice nurses and pharmacists would work together to advise and reinforce information about the correct way to apply topical corticosteroids, and to address concerns about the safety of these highly effective agents. But in the real world, expert advice, even when given, is soon forgotten and the product label is often the only reminder that patients have in front of them when using the medicine.
A meeting of the Dermatology Working Group – supported by an unrestricted grant from LEO Pharma – was set up to address concerns expressed by the Skin Care Campaign about the confusion that exists around the appropriate application of topical steroids – an issue pertinent to the majority of patients being treated for skin conditions. Having reviewed the evidence – or lack of it – concerning the harms of the most commonly prescribed topical corticosteroids, the group considered whether a revision of the advice to healthcare professionals and to patients concerning the appropriate application of these important agents was needed.
It is much less easy to advise patients how to use a topical skin preparation correctly than it is to explain how to take a tablet by mouth. Often the advice given is inadequate, with the result that the patient is left confused – and, in the case of topical corticosteroids, even anxious – about using the preparations that have been prescribed.Few attempts have been made to rationalize advice on applying topical therapy. The method that has gained widest acceptance has been the fingertip unit (FTU). It is over 15 years since this simple tool was devised to help doctors and patients obtain a better understanding of the amount of topical products, such as corticosteroids, they should use on different parts of the body.((Long CC, Finlay AY. The finger-tip unit – a new practical measure. Clin Exp Dermatol 1991; 16:444–7.)) The FTU – the amount of cream or ointment expressed from a 5-mm diameter nozzle, applied from the distal skin-crease to the tip of the patient’s index finger (Figure 1) – can be used to calculate how much product is needed to cover affected areas, such as the face and neck, and hence the quantity which should be prescribed. It has the advantage of automatically correcting for body size: thus one FTU (approximately 500 mg) is sufficient to cover two adult palms and three FTUs should be sufficient for a single application to one arm irrespective of the size of the individual being treated.((British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary 52. Section 13.4: Topical corticosteroids. London: BMJ Publishing Group/RPS Publishing, 2006.))
The FTU is used in some factsheets, such as that produced by Patient UK, to help patients understand how much cream to apply ( Table 1 ).((Patient UK. Fingertip Units for Topical Steroids. 2004. Available at: http://www.patient.co.uk (last accessed 4 December 2007).)) For example, one FTU is recommended for treating the fingers, palm and back of an adult hand, or an entire arm and hand of a 3–6-month-old baby.
|Area of skin to be treated (adults)||Approximate size (in adult hands)||FTUs each dose (adults)|
|A hand and fingers (front and back)||2||1|
|A foot (all over)||4||2|
|Front of chest and abdomen||14||7|
|Back and buttocks||14||7|
|Face and neck||5||2-5|
|An entire arm and hand||8||4|
|An entire leg and foot||16||8|
However, use of FTUs by physicians and awareness of them by patients is not widespread. Making patients aware of the FTU system will not solve the problem entirely, unless it is clearly explained. It is worth spending time to ensure that patients – or parents of children prescribed topical agents – are confident in using it.
Undertreatment is undoubtedly a common cause of low efficacy.((Clement M. Treatment failure in dermatology. Dermatol Pract 1994; July/August:7–9.)) However, even when patients understand how much product they should apply, concerns about drug safety, particularly of corticosteroids, often result in a failure to adhere to recommended dosages. In a U.K. survey of 200 dermatology outpatients with atopic eczema, 72.5% said they were worried about using topical corticosteroids on their own or their child’s skin, and 24% admitted to having been noncompliant with treatment because of these concerns.((Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol 2000; 141:931–6.)) In addition, 9.5% of patients were worried that systemic absorption could affect growth and development. This is despite the fact that the most commonly used topical corticosteroid was hydrocortisone – a mild steroid. Furthermore, nearly a third of patients who used this preparation erroneously classified it as either strong or very strong or alternatively did not know its potency.
Further evidence of the rather poor patient understanding of the topical steroids that they are prescribed comes from another U.K. survey to determine the level of use and knowledge of commonly prescribed agents among parents or carers of 100 children attending paediatric outpatient clinics.((Beattie PE, Lewis-Jones MS. Parental knowledge of topical therapies in the treatment of childhood atopic dermatitis. Clin Exp Dermatol 2003; 28:549–53.)) Eighty-six per cent of patients were using low-potency topical corticosteroids, but only 41% of those who had used hydrocortisone were aware that it was of low potency, and 44% graded it as moderately potent. Of 65 who had used the moderately potent 0.05% clobetasone butyrate, 29% graded it as potent and 12% as weak. Of the 50 patients who had used 0.1% betamethasone valerate, 42% did not grade it as potent.
In the public perception, corticosteroids carry similar risks, regardless of their potency, and typical warnings to restrict the amount of topical preparation that is used, i.e. ‘apply thinly’ or ‘apply sparingly’ serve only to reinforce these concerns.
Despite the deep-rooted concerns of patients (and some physicians) about the safety of topical corticosteroids, there is little evidence of harm when less potent agents are used.
In a systematic review of treatments for atopic eczema, randomized controlled trials of topical corticosteroids that specifically gathered data on skin thinning and suppression of the pituitary–adrenal axis failed to show evidence of harm – although the studies were short term.((Hoare C, Li Wan Po A, Williams H. Systematic review of treatments for atopic eczema. Health Technol Assess 2000; 4:1–191.)) Two longer-term studies on intermittent use of the potent topical steroid, fluticasone, found no evidence of skin thinning after 4 months((van der Meer JB, Glazenburg EJ, Mulder PGH et al. The management of moderate to severe atopic eczema in adults with topical fluticasone propionate. Br J Dermatol 1999; 140:1114–21.))((Hanifin J, Gupta AK, Rajagopalan R. Intermittent dosing of fluticasone propionate cream for reducing the risk of relapse in atopic dermatitis patients. Br J Dermatol 2002; 147:528–37.)) or effects on hypothalamic–pituitary–adrenal (HPA) axis.((Hanifin J, Gupta AK, Rajagopalan R. Intermittent dosing of fluticasone propionate cream for reducing the risk of relapse in atopic dermatitis patients. Br J Dermatol 2002; 147:528–37.)) Nor was any clinically significant skin thinning reported in a third study that compared short bursts of 0.05% fluticasone propionate and prolonged use of 0.1% hydrocortisone butyrate in children with mild or moderate atopic eczema.((Thomas KS, Armstrong S, Avery A et al. Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema. BMJ 2002; 324:1–7.))
In a randomized, double-blind, comparative study of unrestricted continuous use of 1% pimecrolimus cream vs. topical corticosteroids (0.1% triamcinolone acetonide for trunk and limbs, and 1% hydrocortisone for face, neck and intertriginous areas) for 1 year in 658 adults with moderate to severe atopic eczema, 1% of those applying topical corticosteroids developed striae.((Luger TA, Lahfa M, Folster-Holst R et al. Long-term safety and tolerability of pimecrolimus cream 1% and topical corticosteroids in adults with moderate to severe atopic dermatitis. J Dermatol Treat 2004; 15:169–78.))
A retrospective cohort study of 35 children aged 0.7–18.7 years with a median of 6.9 years of corticosteroid treatment for atopic eczema found biochemical evidence of HPA axis suppression (decreased cortisol response) only in those using potent or very potent topical corticosteroids or those who had received corticosteroids from other routes (inhaled, intranasal or oral).((Ellison JA, Patel L, Ray DW et al. Hypothalamic–pituitary–adrenal function and glucocorticoid sensitivity in atopic dermatitis. Pediatrics 2000; 105:794–9.))
Reassuring evidence about the effects of long-term use of corticosteroids on the HPA axis in patients with psoriasis comes from a study of 46 patients randomized to 0.25% desoximetasone or 0.1% betamethasone 17-valerate.((Cornell RC, Stoughton RB. Six month controlled study of effect of desoximetasone and betamethasone 17-valerate on the pituitary–adrenal axis. Br J Dermatol 1981; 105:91–5.)) Patients applied their medication to psoriatic lesions on approximately one-third of their body. Plasma cortisol levels were reduced to below normal levels in nine patients using desoximetasone during the study, but in none of the betamethasone group. Levels returned to normal spontaneously in four of the desoximetasone group. In four other patients, plasma cortisol remained suppressed at the end of 5 months of continuous therapy, but returned to normal within 7 days of stopping treatment. The last patient was lost to follow up, but had a cortisol level close to normal the last time it was measured.
In a 3-week comparative study of 40 patients using 3.5 g of either 0.05% betamethasone dipropionate cream or 0.05% clobetasol-17-propionate ointment for treatment of moderate to severe psoriasis, temporary reversible suppression of the HPA axis (low morning cortisol) was seen in eight patients – three on betamethasone and five on clobetasol.((Katz HI, Hien NT, Prawer SE et al. Superpotent topical steroid treatment of psoriasis vulgaris – clinical efficacy and adrenal function. J Am Acad Dermatol 1987; 16:804–11.))
The advice to patients to use their topical corticosteroids sparingly or to spread them thinly is based largely on concerns related to the use of the most potent steroids. Yet, the vast majority of patients are using milder corticosteroids, for which evidence of adverse effects such as skin atrophy or HPA axis effects is lacking. Even with the more potent corticosteroids, such effects appear to be mild and – in the context of HPA axis suppression – reversible when they are used for limited periods.
If patients are to achieve maximum clinical benefit from topical corticosteroids, they must be encouraged to apply these agents appropriately.
More appropriate advice on product labelling would be ‘apply enough to cover affected areas’. This, together with advice about how often the product should be applied, conveys a simple message about the need for adequate treatment.
Such advice does not encourage indiscriminate use of topical corticosteroids. But it does remove the implied message of danger that goes with the current advice to ‘use sparingly’. In effect, it gives patients permission to use sufficient medication to treat all of the skin that is affected by their condition.
It is acknowledged that patients would still need to be informed that treatment should not exceed prescribed quantities, and continuing treatment should be under careful medical supervision.
We would also suggest that, to facilitate clarity in their use, topical corticosteroid products should include clear ‘fingertip unit’ instructions, preferably with images of a ‘fingertip unit’ and a chart to show the number of units required for specific areas of the body.
With such a change comes a need for improvements in the way doctors, nurses and pharmacists are educated about the efficacy and safety of topical corticosteroids, the differences between agents of different potency, and the importance of giving patients sufficient information to enable them to use their treatment effectively.
The FTU is a useful measure for calculating the amount of topical preparation to apply to each area ( See Table 1 Above ), and could be more widely used in both primary and secondary care to help patients understand doses. Patients could be provided with a personal chart of how much cream to apply and how often, and/or a body chart showing which areas to treat, and with how many FTUs.
|Maximum fingertip units per week|
|How long a prescribed tube of cream/ointment should last|
|Stepping up or stepping down treatment potency|
|Instructions on duration of course of treatment and when to re-treat|
|Realistic goals: e.g. ‘continue until affected skin is completely flat’|
|Time frames for review, if goals not achieved|
|Possible side-effects — what to look out for, when to stop treatment, when to seek advice, etc.|
|Precautions with pregnancy or breast-feeding (if any)|
|Useful local/national support groups (with contact details)|
As the last healthcare professional to see the patient, the pharmacist has a valuable role in reinforcing the message about correct application of topical treatment, given by doctors and nurses, and ensuring that they remember and understand what they have been told. Moreover, the community pharmacist – who usually sees people with long-term conditions more frequently than other healthcare practitioners – is ideally placed to monitor response and provide advice/reminders about correct treatment.
A change to the labelling of topical corticosteroids to encourage patients to use their medication more effectively could improve clinical response and reduce treatment failure. We believe that ‘apply enough to cover affected areas’ is a more positive instruction than ‘apply sparingly’ or ‘apply thinly’– which carries alarmist messages that are likely to contribute to continuing steroid phobia. A change in labeling should provide the focus for educational initiatives to ensure a more multidisciplinary and evidence-based approach to the prescribing of topical products, and greater patient understanding of such issues as potency, dosing, duration and desirable outcomes of topical corticosteroid use.