Trends in Drug Safety assessment during pregnancy

Diego F. Wyszynski, Amgen, spoke at World Drug Safety Congress Americas in April on the current trends in drug safety assessment during pregnancy.

Wyszynski began by looking at pregnancy as a uniquely complex area and looking into how and why it differs from other areas. He discussed:

– Drug use in pregnancy has risen in recent decades due to an increase in prescription medicines

– Pregnancy is a complicated area with risks to both mother and foetus with underlying diseases that can affect both

– Pregnancy sections of drug labelling are often limited

– In pregnancy, allowing for risk is highly dependent on the benefit. Benefit is usually towards the mother whilst the risk is usually to the foetus. The risk could be presented by the disease/condition or the drug used to treat the disease/condition.

– All pregnancies and lactation cases must be reported to regulatory agencies, taking into consideration drug, maternal and foetal factors.

Wyszynski then discussed how companies can start their own pregnancy safety programme. He defines a pregnancy safety programme (PSP) as "A global program that gathers data for all pipeline and marketed products about pregnancy in women who have had exposure to a product prior to conception or during pregnancy. Information is also gathered when a male sexual partner of a pregnant woman has had exposure to a product prior to conception at the time of conception or conception, conception, during the pregnancy."

Trends in Drug Safety assessment during pregnancy

A PSP will:

– Include data on products both in the market place and development

– Be global

– Follow newborns up to the first year

– It may use data from claims or population-based databases as matched unexposed comparators

– Can be established in any type of organisation

– Participation is voluntary and can be withdrawn

The data for the PSP can be sourced from a variety of places, including but not limited to: Clinical trials, pregnancy exposure registries, physician/consumer reports and medical literature. The advantages of the programme can range from its global reach to its cover of adverse events regardless of seriousness. It also has no end point.

The challenges facing a PSP include the fact that it relies on participants to enrol which can lead to a biased sample and relies on global participation.

Wyszynski looked at how to analyse and communicate the data from a PSP. He highlighted the difficulties in analysing data that is complex and that is often a small sample without comparative data. Wyszynski continues by suggesting companies create their own PSP, staffed by medical professionals and lead by a SME. Large databases can provide comparative data.

Communicating pregnancy outcomes can present its own challenges. Labels can often be limited and not provider the user with enough information to make an informed decision, regulations can prevent companies being able to list contact information in order to collect data and not all health care providers are adequately trained to be able to interpret previous outcomes to patients.

Wyszynski concludes the presentation with some suggestions for improvement. He suggests:

– In the US, revise pregnancy and lactation sections of labels and in other regions, consider local regulations.

-Companies should create comprehensive websites for the PSP including easy enrolment

– Market the PSP through leaflets in Doctors' offices and the like.

– Companies should create their own PSUR and DSUR templates

– Reports to be created about the pregnancy and lactation safety programmes to be discussed before the PSUR is submitted.

Dr. Diego Wyszynski is Medical Director and Head of Maternal and Paediatric Safety (MAPS) at Amgen Inc. Trained as a paediatrician in his native Argentina, Diego obtained masters and PhD degrees in Epidemiology from Johns Hopkins University and performed postdoctoral work at the National Institutes of Health. In Boston, Dr. Wyszynski was first Assistant and then Associate Professor of Medicine and Epidemiology at Boston University and a Visiting Lecturer in Paediatrics at Harvard Medical School. Among the many appointments he has held in academia, the most relevant to this Congress is Senior Epidemiologist of the North American Antiepileptic Drug Pregnancy Registry. In Amgen, Diego leads the Pregnancy and Lactation Surveillance Programs, which are comprehensive systems to collect, store, analyze, and communicate data on outcomes associated to drug exposure during pregnancy and lactation. Dr. Wyszynski has published more than 80 articles in the scientific literature and he is the editor of 3 recently published books in the field of birth defects with Oxford University Press.

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