Date: 03/09/2023

Zahra Haider, Andrew Proctor, Celia Moss Author Notes

British Journal of Dermatology, Volume 188, Issue 3, March 2023, Pages 427–428, https://doi.org/10.1093/bjd/ljac104

Published: 25 November 2022 Article history

Issue Section: Perspectives

A recent article in the BJD1 drew attention to the worrying gap between patients’ and health professionals’ opinions about the safety of topical corticosteroids (TCs). Dermatologists generally agree that TCs are an effective first-line active treatment for most inflammatory skin disorders, with adverse effects that are well-known and avoidable with correct use. However, patients often hold a different view, with steroid avoidance and ‘steroid phobia’ contributing significantly to poor adherence and treatment failure.2 Public concern about TC safety is magnified by alarming media reports of ‘topical steroid withdrawal’ (TSW), a poorly understood and probably heterogeneous condition attributed to the use of TCs. The Medicines and Healthcare products Regulatory Agency (MHRA) recognized topical steroid withdrawal reactions in new guidance3 issued in September 2021.

Despite the well-known dangers of excessive use of TCs, prescribers may be imprecise about the risks and amounts to use. While the fingertip unit helpfully defines quantities for a single application, the advice given regarding total quantities, duration, relapse after stopping and long-term use is often unclear. TC potency is a key consideration, with misunderstandings resulting in confusion and inconsistent advice. There can be a 100-fold difference between mild and very potent TCs. Furthermore, patients can confuse potency with pharmacological strength, believing for example that 1·0% hydrocortisone (mild) is stronger than 0·1% betamethasone valerate (potent). Most authorities, including the National Institute for Health and Care Excellence (NICE) and the British National Formulary (BNF), use the straightforward WHO classification for TCs: I = mild; II = moderately potent; III = potent; or IV = very potent. Adverse effects are minimized by using the lowest potency that controls the condition. Factors to be considered include disease diagnosis, site and severity, and patient age: for example, a very potent steroid should almost never be used in infantile eczema but may be appropriate for palmoplantar dermatitis or psoriasis in adults.

In this perspective, we propose that all topical steroids should be labelled with their potency level I–IV. Considering its importance, one might expect potency to be clearly stated on the tubes and packaging of TCs, but this is not the case. The prescriber can look up potency class in the BNF or other prescribing tools. However, patients are often given different preparations for different sites and severity: for example, NICE advises4 that children with atopic dermatitis should use mild potency for mild eczema, moderate potency for moderate eczema and potent TCs for severe eczema. Additional steroid–antimicrobial compound preparations (again at different potencies for different sites and severities) result in a confusing collection of different products. It is not unusual for patients to present in the skin clinic with numerous creams and very little idea of which to use where or when.

We reviewed the information on potency, provided by manufacturers, for 24 TCs prescribable in the UK.4 Searching patient information leaflets, we found no indication of potency in 18 of 24 (75%), including, alarmingly, one very potent preparation. We then looked at the summary of product characteristics (SmPC), the standardized legal document agreed between the marketing authorization holder and MHRA to inform healthcare professionals. Potency of TCs should be stated in section 5·1 Pharmacodynamic Properties as WHO Anatomical Therapeutic Chemical (ATC) classification code D07AA/B/C/D, where the fifth character, A–D, corresponds to potency I–IV.5 In six SmPCs, potency was not stated in this section. In a further four, the ATC code was provided but with no explanation or other statement about potency. So, in a total of 10 of 24 (42%) the prescriber would not easily understand potency from the SmPC. In some SmPCs, potency is described in relation to other TCs, rather than stating the potency of the TC itself. The situation is particularly confusing for dilutions, which are usually assigned to the same potency level as the parent product. All in all, it is unsurprising that both patients and prescribers have difficulty in selecting correct potency and that both over- and underuse occur.

The lack of potency information undermines patient understanding and confidence in TCs. There should be clear potency labelling on every package and tube containing topical corticosteroids. This labelling should be standardized across all products. A nonverbal potency grading system should be used, independent of language and literacy level, for example, a simple four-colour banding scheme (Figure 1). Certainly the 4-point scale is imprecise, with several-fold differences in potency between members of the same group, particularly dilutions, but this is no excuse – a ballpark figure is much better than no information. We urge the MHRA to develop and mandate an appropriate solution such as this for all TC preparations.

References

1             Cotter C, Burton T, Proctor A et al.  Topical steroid withdrawal syndrome: time to bridge the gap. Br J Dermatol 2022; 187:780–1.

Google ScholarCrossrefPubMedWorldCat

2             Li AW, Yin ES, Antaya RJ. Topical corticosteroid phobia in atopic dermatitis: a systematic review. JAMA Dermatol 2017; 153:1036–42.

Google ScholarCrossrefPubMedWorldCat

3             Medicines and Healthcare products Regulatory Agency (MHRA). Press release. Long-term continual use of topical steroids linked to skin withdrawal side effects. 15 September 2021. Available at: https://www.gov.uk/government/news/long-term-continual-use-of-topical-steroids-linked-to-skin-withdrawal-side-effects (last accessed 28 November 2022).

4             National Institute for Health and Care Excellence (NICE). Corticosteroids – topical (skin), nose, and eyes. Scenario: Topical treatment. Available at: https://cks.nice.org.uk/topics/corticosteroids-topical-skin-nose-eyes/management/topical-­treatment/#potency (last accessed 28 November 2022).

5             WHO Collaborating Centre for Drug Statistics Methodology. D Dermatologicals. Available at: https://www.whocc.no/atc_ddd_index/?code=D07 (last accessed 28 November 2022).

Conflicts of interest Celia Moss is a trustee and chair of the medical advisory board of the National Eczema Society, and a member of the MHRA GRID Expert Advisory Group. Andrew Proctor is CEO of the National Eczema Society.

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