P030 Quality improvement project on awareness in patients to stop teratogenic disease-modifying anti-rheumatic drugs (DMARDs) while planning pregnancy and need for highly effective contraception
Authors: Khan Fahd A 
Published: April 2022

Abstract

Background/Aims
The MHRA (Medicines and Healthcare Products Regulatory Agency) published guidelines in February 2018 on highly effective contraception (injectable/IUCD/partner vasectomy) for women of childbearing age consuming potentially teratogenic DMARDs (disease-modifying anti-rheumatic drugs) which might result in increased risk of birth defects. Objective: A quality improvement project was carried out in the rheumatology department at James Cook University Hospital, Middlesbrough to assess patient awareness of the potential teratogenicity of the DMARDS like methotrexate, leflunomide and mycophenolate mofetil and need for highly effective contraception to avoid foetal complications.

Methods
A spot audit was carried out from June to September 2019, through patient questionnaires to assess awareness in women of childbearing age (15- 45 years) about the potential teratogenic effects of these DMARDs and the need for highly effective contraception. Following this audit more tailored consent forms were introduced in February 2020 to increase awareness of potential teratogenicity at initiation of DMARDs with robust counselling. Subsequent to this we carried out quality improvement project to accumulate similar data between June and September 2021.

Results
Data were collected from 43 patients during the spot and 27 patients during the second cycle. 88% patients were on methotrexate, 9% on MMF, 2% on leflunomide and 2% on multiple DMARDS during the first audit compared to 66.6% on methotrexate, 16.6% on leflunomide and 6% on MMF during the second cycle. It was very positive to see 74% of patients reporting increased awareness about potential teratogenicity of the DMARDS gained through counselling compared to the 37% previously. 90% of the patients were aware to stop these DMARDs when planning pregnancy compared to the 88% previously. We achieved 100% awareness that the medication should be stopped in pregnancy compared to 90% previously. Rates of contraception use were comparable across cycles - 54% during the first cycle and 56.7% during the second. Of patients using contraception, 33.3% were using highly effective contraception the first cycle which improved to 37% during the second cycle. Nearly 44.4% patients were not on any contraception. Reasons why contraception was not used was not explored which was beyond remit of this project. Since this is a significant proportion there is certainly a need for further assessment and analysis.

Conclusion
Overall this quality improvement project has highlighted the need for robust counselling as well as structured and informative consent forms to improve the awareness of teratogenicity with certain DMARDs therapy in woman of childbearing age. In spite of increased awareness of the teratogenicity of these DMARD 44.4% patients were not on any form of contraception. There is definitely room for improvement in effectively disseminating information regarding highly effective form of contraception to prevent inadvertent exposure during pregnancy which may result in foetal birth defects.

Disclosure
F.A. Khan: None.