Appendix C. Detail on criteria for audit of the use of tacrolimus and pimecrolimus for atopic eczema

Appendix C. Detail on criteria for audit of the use of tacrolimus and pimecrolimus for atopic eczema

Possible objectives for an audit

An audit could be carried out to ensure that pimecrolimus and tacrolimus are prescribed appropriately.

Possible patients to be included in the audit

An audit could be carried out on all children and adults seen for atopic eczema in a reasonable period for audit, for example, 6 months.

Measures that could be used as a basis for an audit

The measures that could be used in an audit of the appropriateness of prescription of tacrolimus and pimecrolimus for atopic eczema are as follows.

Criterion

Standard

Exception

Definition of terms

1. Topical tacrolimus or pimecrolimus are prescribed for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity

0% of people with atopic eczema

None

The diagnosis of atopic eczema is established by the individual having an itchy skin condition in the last 12 months, plus three or more of the following criteria: history of flexural involvement (that is, affecting the bends of the elbow or behind the knees); history of a generally dry skin; personal history of other atopic disease (in children under 4 years, history of atopic disease in a first-degree relative may be included); visible flexural dermatitis as defined by a photographic protocol; and onset below the age of 2 years (not used in children under 4 years).

Clinicians will need to agree locally on how to identify people with mild atopic eczema for audit purposes.

2. Topical tacrolimus is considered, within its licensed indications, as an option for the second-line treatment of moderate or severe atopic eczema in adults and children aged 2 years and over in the following circumstances:

a. the individual's atopic eczema has not been controlled by topical corticosteroids and

b. there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy

100% of adults and children aged 2 years and older with moderate or severe atopic eczema that has not been controlled by topical corticosteroids and where there is a serious risk of important adverse effects from further topical corticosteroid use

None

Clinicians will need to agree locally on how to identify people with moderate or severe atopic eczema and how to document that topical tacrolimus has been considered, within its licensed indications, as an option, for audit purposes.

'Atopic eczema that has not been controlled by topical corticosteroids' refers to disease that has not shown a satisfactory clinical response to adequate use of the maximum strength and potency that is appropriate for the patient's age and the area being treated. Clinicians will need to agree locally on what constitutes adequate use of appropriate potency topical corticosteroids, for audit purposes, but anxiety around topical corticosteroid use alone should not be considered an indication for treatment with tacrolimus.

Irreversible skin atrophy includes telangiectasia, increased transparency and shininess of the skin and the appearance of striae.

3. Pimecrolimus is considered, within its licensed indications, as an option for the second-line treatment of moderate atopic eczema on the face or neck in children aged 2 to 16 years in the following circumstances:

a. the child's facial atopic eczema has not been controlled by topical corticosteroids and

b. there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy

100% of children aged 2 to 16 years with moderate atopic eczema on the face or neck that has not been controlled by topical corticosteroids and where there is a serious risk of important adverse effects from further topical corticosteroid use

None

See above for definitions.

4. Treatment with tacrolimus or pimecrolimus is initiated only by a physician with a special interest and experience in dermatology

100% of people who are prescribed tacrolimus or pimecrolimus

None

'A physician with a special interest and experience in dermatology' can be a physician or a general practitioner.

5. Treatment with tacrolimus or pimecrolimus is initiated only after careful discussion between the prescribing physician and the patient of the potential risks and benefits of all appropriate second-line treatment options

100% of people who are prescribed tacrolimus or pimecrolimus

None

Clinicians will need to agree locally on how the discussion with the patient is documented, for audit purposes.

Risks of topical tacrolimus include side effects such as a burning or tingling sensation, pruritus, erythema, folliculitis, herpes simplex, acne, increased sensitivity to hot and cold, alcohol intolerance and lymphadenopathy. Risks of pimecrolimus include side effects such as a burning sensation, pruritus, erythema, skin infections (including folliculitis, herpes simplex and zoster, impetigo and molluscum contagiosum), papilloma (rarely) and local reactions such as pain, paraesthesia, peeling, dryness, oedema and worsening of eczema.

The discussion should make clear to the patient that the potential long-term adverse effects of topical tacrolimus or pimecrolimus are not yet known and that it is possible that topical immunomodulators might increase the risk of skin malignancy in the long-term. Second-line treatment options, in addition to tacrolimus and pimecrolimus, include systemic corticosteroids, phototherapy and systemic use of immunosuppressants such as ciclosporin. Clinicians will need to agree locally on the risks and benefits of second-line treatment options that are discussed with the patient, for audit purposes.

Calculation of compliance

Compliance (%) with each measure described in the table above is calculated as follows.

Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed

x 100

Number of patients to whom the measure applies

Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.