Peter Lapsley: Please tick the box!

Peter LapsleySome things never seem to change. I spent much of the ten years during which I ran the Skin Care Campaign (SCC) explaining patiently to the government and to pharmacists that, where topical treatments for skin diseases are concerned, generic substitution can present serious problems. That was not only the view of the 35 patient organisations the SCC represents; it was strongly supported by dermatology nurse specialists, GPSIs in dermatology and consultant dermatologists.

At 83%, the UK already has one of the highest rates of generic prescribing in the Western world. In an attempt to cut the cost of medicines further, the Government is now consulting interested parties on its proposal to implement Automatic Generic Substitution (AGS) from January 2010. AGS requires pharmacists to dispense a cheaper “Generic Equivalent” product against a branded prescription, unless the prescriber has chosen (and remembered) to tick a special “opt-out” box. This could lead to a situation where a patient’s notes indicate that they are using Brand ‘X’ when the chemist has actually dispensed generic ‘Y’.

AGS poses a particular set of problems for people with skin diseases because the concept of “generic equivalent” assumes that only the active ingredients matter in defining a product. Where topical treatments are concerned, this assumption could scarcely be further from the truth. Here, formulations play a crucial role in determining pharmaco-kinetics, bio-availability, stability, potential for irritation or sensitivity, cosmetic acceptability and overall patient satisfaction and compliance. Examples abound where different formulations with the same concentrations of the same active ingredients behave entirely differently in clinical use in terms of efficacy and side-effects.

It is also well understood by those with a knowledge of dermatology that everyone’s skin behaves differently, often being sensitive to particular excipients. For this reason, the widest possible range of formulations is encouraged – not least by NICE in its guidance on, ‘The management of atopic eczema in children from birth up to the age of 12 years’, which recommend that, “Healthcare professionals should offer children with atopic eczema a choice of unperfumed emollients to use every day for moisturising, washing and bathing. This should be suited to the child’s needs and preferences, and may include a combination of products or one product for all purposes.” The guidance says also that, “Healthcare professionals should offer an alternative emollient if a particular emollient causes irritation or is not acceptable to a child with atopic eczema.”The obvious and incontrovertible implication of this is that, once found, the chosen emollient(s) should be both prescribed and dispensed.

The fact that MIMS publishes a table which lists potential skin sensitisers in emollients is another reflection of their clinical importance. Indeed, the problem of potential skin sensitisers is of such importance that MIMS also have a similar list for topical corticosteroids.

The commonest form of generic substitution in treatments for skin diseases is the replacement of a branded emollient with aqueous cream, which is very inexpensive but was developed as a put-on-and-rinse-off soap substitute, rather than as a put-on-and-leave-on emollient.

In their “Audit of adverse drug reactions to aqueous cream in children with atopic eczema,” Cork M J, Timmins J, Holden C, Carr J, Berry V, Young S, Ward SJ, Tazi-Ahnin, R., (Pharmaceutical Journal, 28 November 2003) reported on an audit of 100 children aged one to 16 years with atopic eczema, carried out in Sheffield in November 2002. it showed that an irritant reaction occurred in over 56 per cent of them when aqueous cream was used as an emollient as compared with only 17 per cent of children using all other emollients.

In a further article entitled ‘Skin Wars’ (Chemist & Druggist 24 July, 2004, p27), Dr Cork explained that it was the surfactant in the water phase that makes the difference – he called it differential partitioning. Aqueous cream is composed of emulsifying ointment 30% in purified water 70%. Sodium lauryl sulphate is present in the emulsifying wax within the emulsifying ointment formulation. However, there is no water in emulsifying ointment, so it does not cause the same problem with cutaneous reactions, despite being in a more concentrated form.

Because excipients vary so greatly, the only way that a particular topical formulation can be defined is by its brand name. With AGS, the patient is liable to be given different formulations on different occasions, leading to inconsistencies in treatment, often determined by the latest deal from competing generic suppliers, rather than by clinical experience and need. There is a real risk that this will cause patient confusion, especially amongst the elderly, and that it will reduce adherence to agreed treatment regimens. That, in turn, will lead both to poor clinical outcomes and  waste.

If the government insists on going ahead with the proposed scheme, responsibility for ensuring that patients get what they need will fall to doctors. It is important that they should understand the issues involved – and keep ticking the boxes.

Declaration of interests: The author is patient editor of the BMJ. He was chief executive of the Skin Care Campaign for ten years until March 2007, is an Honorary Member of the British Association of Dermatologists, an Honorary Member and chairman of Trustees of the Primary Care Dermatology Society, and chairman of the Oversight Committee for the All Party Parliamentary Group on Skin.

  • Dr stephen Kownacki

    This is a significant and worrying change which risks patient safety, in the case of differing availability e.g ciclosporin; patient suffering, especially with dermatological topical products e.g. clobetasone/clobetasol (dermovate/eumovate (or is it the other way round?) or the increased skin irritability with emollient substitution. In addition the confusion for many patients who can cope with a consistent supply but suffer anxiety and/or morbidity through error when each month they may receive a different colour or differently packaged medication.
    If the generic could be identical in colour, shape, consistency, (?taste) and bioavailability then there would be no problem but they are not and thus the Primary Care Dermatology Society (PCDS) opposes the policy of generic substitution. The “tick box” opting out is cumbersome and risky mechanism unless we can negate the whole business by programming our computers to routinely add a tick so that our patients actually receive what we intend and expect and they deserve!

  • Stephen Hayes

    It is generally believed that generic substitution is an ‘easy win’ way to save money without compromising care. I have always had doubts about this, for example the effort involved in making the switch isn’t free, nor is the doctor time spent arguing with patients who won’t buy it. Also, the pharma companies have to survive and develop, and they aren’t stupid, they find ways to recoup their costs on generics and elsewhere. Without Pharma, we don’t have pharmaceuticals, so I have always questioned the extent to which any savings on generics are real rather than apparent.

    But even if cost savings are taken for granted as an unalloyed blessing, sometimes there are bioavailability and other issues which mean that, for example, controlled release medications for cardiac disease, epilepsy, bipolar disorder, and other situations cannot be sustituted without compromising care. This is accepted. How much more is this so then for skin preparations, where the delivery system (the cream or ointment) may be as important as the active drug?

    Dermatology is different. Branded names are important. Who can remember the difference between clobetasol and clobetasone (one is mild, another the most potent steroid) and then there are all the fiddly decimal points. Is it 0.025% or 0.25%? betamethasone valerate in WSP or multi-component cream base?

    Aqueous cream, which as Peter Lapsley mentions is often suggested as an economical alternative to various trusted branded put-on emollients, often stings and causes reactions, I know of no dermatologist who would consider using it for themselves or a family member its OK as a soap substitute). To suggest we use it instead of the range of excellent products which careful design and selection have given front-line dermatology doctors is like saying we should go back to the routine use of tricyclic antidepresseants as they are cheaper than modern agents.

    I once, most uncharitably, remarked to a colleague that what might help get skin care the priority it deserved would be for the prime minister or a family member to get melanoma. ‘No’ he said ‘he should get psoriasis.’

    While wishing neither complaint on anyone, even an interfering, tax-eating, busybody of a politician, as a doctor working in dermatology there is no doubt in my mind that generic substitution of skin care products would lead to worse care for patients, especially those with chronic rashes, and this includes many children and elderly

    Dr Stephen Hayes

    trustee Primary Care Dermatology Society
    GPwSI and Hospital Practitioner in dermatology

  • Dr Helen Frow

    It is imperative that clinicians can continue to prescribe topical therapy in a non-generic way. Different topical preparations vary in their ingredients. They may have preservatives in or other agents that can cause both severe irritation to the patients and also allergic contact sensitivity reactions.
    The prescribing clinician will have crucial information about patients from their records of possible contact allergens, amongst other things. This information may not always be remembered by the patients, and will not be available to the pharmacist. Patients will thus be at risk of adverse reactions to the agents dispensed if it is not the preparation prescribed by the clinician.
    We must also remember that the patients that we are prescribing topical treatments for, have a higher risk of irritation and sensitivity reactions to products because their skin often has a defective barrier function.
    The impact of automatic generic substitutions to cheaper alternatives for dermatology patients should not be underestimated. It will have a significant adverse effect on patient morbidity. I suspect also that after treating the inevitable adverse reactions appropriately with alternative agents, the anticipated cost saving will be negligible.

    Dr Helen Frow
    Hospital Practitioner, Exeter and GPSI Plymouth
    PCDS Committee member

  • Rebecca Penzer

    As a dermatology specialist nurse undertaking an independent and supplementary prescribers course, the issue of AGS gives me grave concern. We have worked long and hard to get health care professionals to think beyond aqueous cream as a suitable emollient. The fact that it could even be considered as a “generic” substitution for other branded products shows a degree of ignorance about the way that emollients work. Emollients are complex substances with specific actions on the skin, these might be anti-inflammatory or anti-pruritic, for example. If evidence is needed of the complexity of moisturisers Loden and Maibach’s and excellent 2000 book “Dry skin and moisturisers- Chemistry and Function” leaves the reader in no doubt as to the diversity of effect of these therapeutic agents. Independent prescribers must be free to work with patients to ensure that the right product(s) is/are selected to enhance concordance with treatment and that means selecting brands.

    A previous commentator mentioned the issue of steroid names and confusion for patients. I agree with this concern wholeheartedly. Patients already have a tough enough job remembering which product goes where and for how long, this will be made more difficult if generic names are used.

    Psychorheology is a term often used in the food industry to describe how food feels in the mouth. It has also been used to describe how patients feel when something is applied to their skin. Because people respond differently to the same product we need to be able to prescribe products that patients know will feel right on their skin.

    Remembering to tick a box may not be that difficult, but on principle we shouldn’t have to.

  • StereoID

    My opinion on the matter is quite different: why whould I pay more for a drug that has the same active substance as a generic drug? Many people today do not realize that they pay huge sums of money just because of a certain brand.