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Monitoring of medicines for births

07 July 2014

The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.

The most important result of the midterm review of the action plan is the completion of an inspection of the two pharmacies in Denmark that manufacture Misoprostol for labour induction. In connection with the inspection, the two pharmacies were informed that they had several deviations, including lack of validation of the manufacturing process and lack of analysis of the finished product. Our laboratory has analysed the medicines and found that they contain Misoprostol in the reported quantities within the acceptable limits. One pharmacy has decided to stop production. The other pharmacy that only produces the medicine for clinical trials is now correcting the deviations.

We have supervised the company in India which produces Angusta, a medicine that also contains Misoprostol. In this production, only acceptable deviations were found, and the company is expected to obtain a certificate of good manufacturing practice shortly.

Requirements have been implemented as to the reporting of the consumption of Misoprostol manufactured by a pharmacy, and the annual follow-up on the consumption of Angusta is being prepared for reporting in early 2015.

Reporting of adverse reactions is important for the surveillance and medicinal product safety. In November 2013, the Danish Health and Medicines Authority stressed the reporting requirement associated with side effects when using medicine to induce labour and made it mandatory for midwives to report adverse reactions.

The Danish Health and Medicines Authority and the National Agency for Patients' Rights and Complaints have started an analysis of reported side effects and adverse events involving medicines for labour induction. The analysis is expected to be completed after the summer 2014. Likewise, a preliminary study is being made ahead of a major registry study of the safety of medicines for labour induction. The preliminary study is expected to be completed in 2014.

Finally, a major study has been initiated to clarify whether there is a need for a change of practice for the induction of labour at all maternity hospitals in Denmark. The Danish Health and Medicines Authority expects that this work is completed in September 2014.

The work is carried out in collaboration with the Danish Society of Obstetrics and Gynaecology (DSOG), the Danish Association of Midwives, Danish Regions and the Danish State Serum Institute.