Ovarian Hyperstimulation Syndrome

(asked on 6th January 2017) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, how many incidents of hospitalisation due to ovarian hyperstimulation syndrome have been reported to the Human Fertilisation and Embryology Authority (HFEA); and what steps the HFEA is taking to ensure that all suspected serious adverse reactions are reported to the Medicines and Healthcare Products Regulatory Agency.


This question was answered on 16th January 2017

The information on the number of incidents of hospitalisation and adverse incidents due to ovarian hyperstimulation syndrome (OHSS) reported to the Human Fertilisation and Embryology Authority (HFEA) could only be obtained at disproportionate cost.

The HFEA has advised that severe or critical cases of OHSS are treated as adverse incidents. A clinic must submit an incident report to the HFEA whenever it is made aware of a case of OHSS requiring a hospital admission, that has a severity grading of severe or critical. The HFEA would expect the clinic to review the patient’s drug stimulation regime, treatment and predisposing factors for OHSS, and to revise its practice and protocols where appropriate. This review is expected to be submitted to the HFEA within 10 working days from the date the incident was reported. The clinic’s report is reviewed by the Authority’s inspectorate and the clinical governance lead and, where appropriate, further enforcement action may be taken or relevant authorities contacted. Should there be unexpected adverse drug reactions not associated with a particular drug regime, these should be reported to Medicines and Healthcare Products Regulatory Agency (MHRA), by the patient’s clinician, under the MHRA’s Yellow Card scheme.

The Yellow Card scheme enables clinicians to help improve medicines safety by reporting all suspected adverse drug reactions to MHRA. The scheme is focused on healthcare professionals and patients rather than regulatory bodies. The HFEA does not separately report adverse drug reactions to MHRA.

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