Isotretinoin is a medication used to treat severe cases of Acne Vulgaris. On 26th April 2023, it was announced new safety measures would be introduced for safe prescription of Isotretinoin. These changes were made official on the 31st October 2023.
In October 2023, the British Association of Dermatologists (BAD) released updated guidelines regarding isotretinoin use in acne patients, notably requiring validation by two independent prescribers for those under 18 and a comprehensive sexual function assessment. We evaluated University Hospitals Birmingham's dermatology department's adherence to these guidelines and then presented our findings on the varying degrees of compliance levels. We also offered recommendations to allow for the improvement of compliance to said guidelines. Our current focus is to re-audit under the same principles to see whether there has been greater adoption of the new guidelines set forth by BAD.
On the 26th April 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that new safety measures would be introduced for the use of Isotretinoin, otherwise known as Roaccutane. These included additional safeguards and oversight for those under 18 years of age, and new warnings for risk of sexual dysfunction.
Following this, on 31st October 2023, the British Association of Dermatologists (BAD) formally updated the guidelines pertaining to the use of isotretinoin in acne patients. They introduced key changes, most notably the need for an agreement by two independent prescribers before isotretinoin can commence in those under the age of 18. Furthermore, a comprehensive assessment of sexual function is now required when starting treatment and on follow up.
We conducted an evaluation of the dermatology department at University Hospitals Birmingham (UHB) to assess their adherence to both previously established national guidelines and the newly release guidelines when treating Acne Vulgaris with isotretinoin.
After conducting such assessments we then presented our findings to the department highlighting the varying degrees of uptake observed across the different guidelines (please see results below). During this presentation we offered several key suggestions with how compliance to the guidelines could be increased across the department.
Our main suggestions were as follows. We advised the adaptation of the existing proformas utilised in acne clinics to include the additional information required by BAD for patients under the age of 18. This includes the documentation of the approved second health care profession that was in agreement regarding the initiation of isotretinoin as well as the date that it was agreed and the rationale for why it was agreed.
Additionally, we also suggested the implementation of screening questions within the proformas, designed to allow for the ongoing assessment of sexual function throughout the patients’ course of Isotretinoin.
Our current focus now is to re-audit under the same principles, paying keen emphasis to whether there has been greater adoption of the new guidelines set forth by BAD. Once again, we will aim to present our results to the UHB department and agree on any necessary points of action, all with the paramount objective of patient safety.
Please check this website for updates on our progress with this re-audit as well as our final results which we aim to release by the end of May.
To investigate compliance with existin and updated national guidelines on the safe use of isotretinoin for patients with a confirmed diagnosis of Acne Vulgaris across the University Hospitals Birmingham (UHB) trust.
These new guidelines include:
> Agreement of 2 independent prescribers for Isotretinoin for those <18 years
> Assessment of sexual dysfunction before starting treatment and on follow up
> Use of new regulatory risk minimisation material
Results show that adherence to previously established guidelines were generally high across the board, however there were underlying deficiencies in the data and clear room for improvement. One quarter of female patients had no evidence of the PPP form in their clinical records. Moreover, one half of patients did not have any evidence of mood being assessed prior to starting treatment. A clear strong point in the data was the monitoring of serum lipids and pregnancy tests, which had extremely high adherence (>98%).
For the new guidelines, adherence was poor. Only 33% of patients under 18 years of age beginning isotretinoin had evidence of 2 independent prescribers. While only 37% had evidence of sexual function being assessed on follow-up. Importantly, similar to mood assessment, there seemed to be no evidence of sexual function being assessed prior to starting treatment. No patients beginning treatment since the release of the new guidelines had evidence of the new regulatory risk minimisation material being used.
Strengths
+ The first round of our audit included a range f patients from different clinics, allowing evaluation of performance across a whole department across 2 hospital sites. This increased the diversity of our data, and allowed evaluation from a wider range of clinicians, including the consultant dermatologists beginning the treatment and also the specialist nurses in the nurse-led follow-up clinics.
Limitations
- Due to time constraints, our window for evaluation is extremely short, as it is 2 months from initial guideline release. The British Association of Dermatologists (BAD) mentioned a 6 month transitional period for dermatology departments to begin adherence to the new guidelines. We will re-audit in May as this is when 6 months will have passed to see re-assess compliance following on from this 6 month cooling period.
- Very small sample size. As a by-product of our small window, our sample size is restricted to a few patients and this may not be representative of a wider patient population, across both the West Midlands and greater England. Our re-audit in May should include a much bigger sample size.
Our findings indicate that the new guidelines are not adequately being followed. We presented out findings to a regional department meeting at Solihull Hospital and made numerous recommendations which we will assess in our re-audit in May 2024.
Our full list of recommendations include:
1. Make it a priority that all 'acknowledgement of PPP information' forms are uploaded to a patient's digital record.
2. Ensure the pre-treatment mood assessment is documented at the start. This could potentially be achieved by including a PHQ-9 section within the "For New Starters Only" proforma.
3. Include the following in the "For New Starters Only" proforma: is the patient <18? Name and approved second approved HCP. Role and place of work. Date agreed. If MDT decision, name of lead MDT clinician and date of meeting.
4. Include in "For New Starters Only" & "Follow Up" Proformas the following to allow for assessment of sexual function:
- Males - have you experienced any erectile dysfunction?
- Females - have you experienced any vulvovaginal dryness/dysfunction?
- Both - have you experienced any decreased libido/orgasm difficulties/genital hypoaesthesia?
5. Begin to use the new risk minimisation forms and ensure they are uploaded to patient notes.
6. Order hard copy materials of Oral Isotretinoin PPP materials and make access links for electronic copies more commonly/easily available for HCPs (train them).
Dr. Daniel Yiu was our supervisor, and provided us with a patient list from clinics in both Solihull Hospital and Good Hope Hospital across our timeframe.
Amman Ahmed and Hamzah Ahmed (4th year medical students) had prominent roles in this first round of this quality improvement project, handling everything independently. Our roles included: