An audit on consent process for ocrelizumab in Lancashire Teaching Hospital NHS Foundation Trust
Authors: J Wall, M Maskery, M Arthur, R Tanveer
Consenting prior to first ocrelizumab infusion is a mandatory step. Consenting should include explaining purpose of treatment, the risks associated with the treatment, the risk of not having the treatment and explaining alternative treatments. We use a generic trust consent form for ocrelizumab consenting where the neurology registrar would document the discussion with the patient including the risks of the treatment. Variation has been observed in the information regarding risk of treatment provided to patients. We decided to perform an audit on the consent process of ocrelizumab in Lancashire Teaching Hospital NHS Foundaiton Trust to access gaps in the process and how to improve them.
The aim of the audit was to evaluate variations in information/ risks discussed during the consenting process for ocrelizumab. We would then take steps to improve the quality of the information provided during the consent process.
Case notes of 10 patients who had received ocrelizumab in the last 18 months and had scanned consent form available in the electronic patient record were identified for the audit. No previous audits of this category could be identified. We set a high standard for the audit. We agreed that common risks (minor infections, minor infusion reactions) and serious risks (immunosuppression and risk of serious infections, anaphylaxis/ serious infusion reaction, PML, foetal malformation, malignancy risks) must be discussed during the consenting process and achieve 100% compliance.
A wide variation in the information provided to patients regarding risk of treatment was observed. Common risks (risk/ presence on consent form) analysis revealed: URTI (2/10), nasopharyngitis 0/10), flu like illness (2/10), Hepatitis B reactivation (1/10), Herpes infection (0/10), gastroenteritis 0/10), skin infection (0/10) hypotension (0/10), blood abnormalities (5/10), minor infusion reactions 7/10) were discussed. Of the serious risks (risk/ presence on consent form) analysis revealed immunosuppression (5/10), serious infection (10/10), anaphylaxis/ serious infusion reaction (10/10), PML (8/10), foetal malformation (4/10), malignancy risk (5/10) were discussed. One of the consent form had illegible informations. Kidney and liver failure was mentioned in 2 forms which had no evidence from clinical trials.
This audit demonstrates wide variation in the information provided to patients during consenting for ocrelizumab in our trust. This could be rectified through use of treatment-specific consent form where the common and serious risks of treatment are available to refer to and explain to patients by consenting clinician. This audit was presented in local and trust clinical governance meeting and a proposal was made to develop treatment specific consent forms to assist consenting doctor. Based on the findings of this audit we also developed treatment specific consent form for natalizumab and fingolimod. We hope this process will reduce the variance in the information provided during the consenting process.
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