Ethical use of topical corticosteroids.

Dermatologists rely very heavily on corticosteroids for treating many common dermatoses. Concerns about their incorrect use are widely expressed both in lay public and specialist discourse. From the point of view of medical ethics, issues of autonomy, beneficence and non-maleficence are all raised frequently when we prescribe topical corticosteroids to our patients. We need to be aware of situations when conflicts between these issues arise and have a clear thought process about resolving them. This can only be achieved if we have a thorough understanding of the skin disease being treated coupled with expertise in the use of the varied potencies and available dosage forms of topical corticosteroids. A good understanding of human psychology and effective communication is also needed to use these agents optimally.

What was known?

Topical corticosteroids are powerful agents that need careful handling for safe and effective use.

Misuse of these agents by doctors and patients is rampant in our country and much of the world.

Introduction

Topical corticosteroids (TC) are probably the most important therapeutic agents in dermatology. They have antipruritic, anti-inflammatory, anti-proliferative and pigment-lightening activity on the skin.[1] This wide-ranging activity profile leads to their frequent use in dermatology prescriptions. A recent prescription audit from a dermatology OPD revealed that close to 30% of all prescriptions contained a TC.[2] An important reason for such widespread use is their ability to produce rapid alleviation of unpleasant signs and symptoms on the skin. Symptoms such as itch, stinging and tenderness are rapidly relieved regardless of the cause, as are redness, scaling and hyperpigmentation. Unfortunately, this “improvement” may be short-lived and can be followed by worsening of the original condition if TCs are not used correctly or used in conditions where they are not indicated at all.

The natural instinct of every physician is to give rapid relief to a patient who is distressed and TCs are ideally suited for such a role. However, this instinct needs to be tempered with caution. This is because TCs are highly susceptible to misuse by patients, pharmacists and physicians themselves as several studies have shown.[345] If not properly counseled, patients may not return for a follow-up and may continue to use the TC for prolonged periods. Such improper use can have devastating consequences, both local and systemic, in the long run.[6] It is therefore essential that we develop a clear understanding of the ethics of TC prescribing so that they are used optimally for the benefit of our patients.

In our country, easy availability of mild to superpotent TCs even without a prescription coupled with rampant sharing of TCs by patients has created a situation where they seem to be more misused then used correctly.[34] On the other hand, steroid phobia is becoming increasingly common in the internet-savvy population in the cities creating new problems in prescription of TCs.[7] In this backdrop, ethical and careful prescription of these powerful agents is the need of the hour.

What are The Ethical Issues That are Relevant to Topical Corticosteroid Use?

Many ethical issues impinge on the physician prescribing TCs to a patient. Awareness of these issues is essential so that pitfalls can be avoided and a good doctor-patient relationship be established. The most important issues are mentioned below.

Autonomy: This refers to respect for the individuals’ right to make informed decisions about their personal matters. In other words, the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex.) This is in contrast to the older paternalistic style of medicine where patients were simply advised on what to take without any discussion of alternatives, risk vs. benefit etc., With regards to TCs, this law applies when we are faced with a steroid-phobic patient. In this situation, “soft paternalism”[8] is often a good approach whereby such a patient should be counseled about the potential benefits of TC use, the harm that can be caused by non-use and how common adverse effects can be avoided. However, they should also be informed about alternative therapies e.g. topical calcineurin inhibitors or calcipotriol and their efficacy vis-à-vis TCs. After this, whatever their ultimate decision be, it should be respected.

Non-maleficence: This is the principle of primum non nocere (first, do no harm). There are important ramifications of this principle in a TC prescription. A common scenario where non-maleficence needs to be remembered is a patient who is obsessed with a fair complexion and asks for a TC prescription which he/she may have heard about from a friend. It is absolutely essential to avoid the temptation to give in to the patient's request in this situation. Non-maleficence also becomes relevant when we are dealing with an undiagnosed rash and a demanding, distressed patient. Several studies have been reported on the misuse of TCs, especially on the face[349] where the initial prescription was given for an undiagnosed facial rash which then led to prolonged misuse of TCs leading to considerable morbidity. In such a scenario, pending a diagnosis, TCs should be avoided and relief given with safer options like topical antipruritics and oral antihistamines. In the absence of a clear diagnosis and treatment plan, a physician should not hesitate to refer a patient to a senior colleague or an expert instead of using TCs to suppress unpleasant symptoms indefinitely.

Beneficence vs. autonomy: This kind of conflict occurs when patients disagree with recommendations that doctors believe are in the patients’ best interest. An appropriate example would be a patient with widespread eczema who is applying potent TCs over a large area leading to adverse effects.[10] The appropriate approach in such a situation would be to start a systemic steroid-sparing drug like azathioprine and gradually taper the TC. However, many patients are scared of systemic immunosuppressives and resist such treatment. Appropriate counseling about the dangers of potent TC use over large areas along with laboratory demonstration of adrenal suppression etc., will be needed to convince the patient.

In fact, effective communication is the key to resolving almost all ethical dilemmas faced by a physician prescribing TCs. Not only doctor-patient, but communication between doctors of different specialties and between doctors and society in general is essential in resolving these ethical issues. This is discussed in greater detail in later sections (vide infra).

What are The Parameters of Proper Use of Topical Corticosteroids?

Correct use of TCs is predicated on the fulfilling of the following conditions:

The right diagnosis: There are relatively few conditions where there is good evidence of efficacy of TCs. Various eczemas, psoriasis, lichen planus, immunobullous diseases in their localized form, skin manifestations of collagen vascular diseases like lupus erythematosus or dermatomyositis are the best established indications. Other conditions where careful, short-term use may be warranted are superficial fungal or bacterial infections associated with significant inflammation, localized itch of any origin and certain idiopathic diseases characterized by dermal inflammation e.g. superficial variants of pyoderma gangrenosum. In the absence of a diagnosis, it is very important to avoid TC use so that conditions like tinea incognito and Majocchi's granuloma are not produced.[11] If a patient is already applying TC thereby obscuring the clinical features of a disease, an appropriate treatment-free interval should be given after explaining to the patient that his/her symptoms may flare up temporarily, to facilitate a diagnosis.

The right molecule and delivery system: Since they were first introduced in the early 1950s, TCs have grown tremendously as a class and today, more than 20 different molecules of varying potency are available worldwide, ranging from mild to superpotent. In addition, there are varying concentrations and dosage forms available, namely creams, gels, lotions, ointments, foams, muco-adherent gels, aerosols and tapes. It is important for the prescriber to be familiar with at least a few of the molecules, preferably of differing potencies.[12] The characteristics of the various dosage forms should also be thoroughly understood so that the correct drug in the correct vehicle can be given in a particular situation. Although it is generally good to err on the side of caution when prescribing TCs, in many situations, it is better to prescribe a more potent molecule to control the disease quickly and stop treatment fast instead of prolonged treatment with a mild formulation. This is especially true of self-limited conditions like acute irritant dermatitis, paederous dermatitis etc.

The right patient: The age, sex and occupation of the patient play an important role in determining TC use. Very young and very old patients have impaired epidermal barrier function and relatively thinner skin. In addition, infants have a very high surface area to weight ratio that can lead to disproportionately high systemic absorption from topical application.[13] Women who do housework often have damaged skin due to frequent wet-dry cycling. This creates the need for more frequent application, as do certain occupations involving manual labor. Other factors like the anatomical location and extent of the disease also dictate which formulation is optimal. Thin skin areas like eyelids, face and scrotum need milder products than back, palms and soles. Widespread dermatoses demand easily spreadable dosage forms and milder potencies to guard against undesirable systemic absorption.[14] Cosmetic considerations are paramount when TCs are applied on the face or other visible parts and creams, gels and lotions are preferred here due to their elegance. Intertriginous areas are particularly susceptible to stronger than expected effect due to the occlusion and maceration of the skin and therefore we should err on the side of caution when deciding the potency on these sites.[15]

The right amount, frequency and duration: Perhaps the commonest omission in a TC prescription is advice regarding the right amount to be applied in a particular situation. In this regard, the Fingertip Unit (FTU) devised by Long and Finlay[16] is the simplest way to explain to the patient how much TC is to be applied. An FTU is the amount of ointment that occupies the space from the fingertip to the first skin crease when squeezed out of a 5 mm nozzle. This amount was found to be 0.5 g for most adult-sized hands. This amount is enough to cover a palm-sized area on the skin in the case of creams and about 20% more with ointments due to their increased spreadability. Standard recommendations have been developed to guide how many FTUs are required to cover particular anatomical areas.[17] This should be clearly conveyed to the patient to prevent over- or underuse.

The frequency of application is dependent on patient factors such as site and occupation. Hands and feet often need twice or thrice a day application due to the propensity of being rubbed off. Otherwise, most experts agree that once daily application is optimal for all other sites since more frequent application has shown no added benefit[1819] and adherence is also expected to be higher with this regimen.

The duration of treatment needs to be clearly told to the patient orally as well as in writing and he/she should also be apprised of the dangers of overuse at this point. In general, a follow-up visit should be planned after 2 to 4 weeks to review the progress and institute the exit strategy.

The right “exit strategy”: It is extremely important to have a clear plan in mind about tapering and stopping TC use after adequate control/remission has been achieved. Except for self-limiting conditions, TC use is often needed for extended periods, much longer than recommended safe durations. This can be done safely by tapering down to progressively less potent preparations or instituting alternate-day or weekends-only treatment.[20] Emollients and/or steroid-sparing drugs like calcineurin inhibitors are prescribed on TC-free days. Finding the right exit strategy can involve a lot of empiricism but is a worthwhile skill to learn for every physician.

Focusing on prevention and modifiable factors: In many conditions, lasting remission or cure is only achievable if preventive actions are taken or behavioral modifications are done. TCs can only give temporary relief in these situations. Recurrent irritant hand dermatitis, pseudofolliculitis barbae and intertrigo are good examples of these conditions. Physicians should ensure that the quick relief provided by TCs does not make them complacent about tackling deeper issues.[13] They should explain to the patients that relief will be transient if preventive actions like skin protection and moisturizing (hand eczema), changing shaving habits (pseudofolliculitis barbae) and keeping the skin dry, losing weight and wearing loose natural fabrics (intertrigo) are not done.

Being aware of corticosteroid allergy: Many times we are faced with a patient who does not show the desired improvement even if appropriate TC is being used. At other times, control is achieved, only to lead to episodes of increased disease activity which are controlled with increasingly higher potency corticosteroids. In these situations, we should be aware of the possibility of contact dermatitis to topical corticosteroids.[2122] This can happen both due to the preservatives/other excipients or the active molecule per se. In these cases, appropriate patch testing followed by prescription of an allergen-free product should be done.

Effective communication: Involving and informing the patient at every step of diagnosis and treatment is the key to using TCs safely, ethically and effectively. A few scenarios are presented below to exemplify this point.

Patients often self-treat themselves with over-the-counter TCs before coming to the physician, altering the appearance of the skin and making diagnosis difficult.[23] In such a situation, it behooves us to explain the situation to the patient and withdraw all TCs while relevant investigations are done. Even if no investigations are done, a steroid-free interval often renders the disease recognizable, allowing proper treatment to be started.

Patients often neglect to come for follow-up when asked to, either due to financial constraints such as loss of wages/inability to pay re-visit fees or simply due to negligence. To minimize the chances of adverse effects of TC, partial control of the treatment should be handed over to the patient, thus making them partners in their well-being, not just the recipients of instructions. To this end, they can be told at which point they should start alternate day treatment, introduce a calcineurin inhibitor or switch over to a milder TC. With this, they should also be told the warning signs of common adverse effects like folliculitis which would necessitate a re-visit immediately.

Many patients are unsure how long it would take for the effect of TCs to start and therefore either become anxious too quickly or continue to use an ineffective TC preparation till the next scheduled visit. To avoid this, patients should be clearly told approximately how long it would take for the beneficial effects of the TC to “kick in”. They should be counseled to walk in if they are not feeling substantially better at this point.

Corticosteroid phobia is an increasingly common problem in urban and internet-savvy patients.[7] A lot of counseling and reassurance is needed if these patients or their dependents are not to be denied the benefits of TCs. They also need to be told about the non-TC options available and their relative efficacy. If they still choose not to use TCs, their choice should be respected and an appropriate regimen devised.

Conclusion

Today, both patients and physicians contribute to the issues associated with rational and ethical use of topical corticosteroids. Patients are prone to misuse them due to their unrestricted availability and poor awareness about their adverse effects. A smaller but growing section of patients is gravitating toward the other extreme, i.e. an unwarranted fear of topical corticosteroids largely driven by an alarmist media. Dermatologists who number about 7000 in our country are grossly insufficient to care for our vast population and are consequently overworked and often lack the time and skills to counsel the patients regarding safe use. Other specialists and general practitioners who probably see more dermatology patients than dermatologists suffer from grossly inadequate dermatology training. Therefore, it is imperative that increased awareness about ethical use of these agents is created amongst all caregivers so that they are used to their fullest extent and with maximum safety for the benefit of humanity.

What is new?

Ethical conflicts are common when prescribing topical corticosteroids and we need to be aware of them to avoid pitfalls.

Examples of various clinical scenarios are used to exemplify common issues in topical corticosteroid prescriptions.

Practical pointers are given to help physicians use these agents in the best possible manner i.e. maximizing efficacy and minimizing adverse effects.