Do Health Care Providers Trust Product Monograph Information Regarding Use of Vaccines in Pregnancy? A Qualitative Study

Inactivated influenza vaccines (IIVs) are recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet unresolved safety concerns among healthcare providers and patients pose a potential barrier to vaccine acceptance. One way that safety information is communicated is in the "vaccine product monographs" that present information about approved indications, contraindications, warnings, and precautions. Publicly available online, these monographs are developed by the vaccine manufacturers for use by healthcare professionals in making prescribing decisions and in counselling patients about a product's risks and benefits.

Previously, these researchers conducted a survey with 141 health professionals from 49 low-, middle-, and high-income countries to determine the effects of product monograph language statements on their perceptions of the safety of IIVs and their recommendations for use in pregnancy. The quantitative results, published elsewhere, demonstrated that healthcare providers perceived the safety of the vaccine differently, depending on which of 3 product monograph statements they read, with fewer than half rating the vaccine as safe. Many respondents provided additional comments regarding product monograph language. The present qualitative analysis of those comments sought to identify themes and suggestions for improving product monograph language.

Healthcare providers from all 6 World Health Organization (WHO) regions were recruited at 2 international health conferences and from teaching programmes in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. They were asked to read the product monograph excerpts for 3 licensed IIVs: (i) "safety and effectiveness in pregnancy is not established [and it should be used] only if clearly needed"; (ii) "use only following the advice of a health care professional, based on consideration of the benefits and risks to the mother and the foetus"; and (iii) "use only from the 2nd pregnancy trimester onwards [limiting use throughout pregnancy to women] at risk of complications of infection."

Respondents were then asked to indicate their perception of the safety of the vaccine described in the statement. Some respondents stated they would only feel comfortable administering a vaccine if safety could be assured. They called for more research into vaccine safety in pregnancy while acknowledging the difficulties associated with such investigation.

They were also asked to provide comments about product monograph information regarding vaccine use in pregnancy. The principal theme was lack of trust in product monograph content and vaccine manufacturers. Respondents described product monograph statements as "ambiguous", non-specific, and lacking essential information. Several respondents stated that product monographs are not up to date with current evidence. Some respondents expressed a view that product monograph content is restricted by vaccine manufacturers who are "protecting themselves against litigation". Respondents indicated they were more inclined to trust organisations such as the WHO for vaccine information and guidance, rather than the product monograph.

Respondents expressed a desire for more informative, clearly worded product monographs that provide guidance for vaccine use, suggesting that healthcare providers want product monographs to include detailed information about the safety and effectiveness of the vaccine in pregnancy. Comments by respondents that product monographs should be understandable to a layperson highlight the challenges of revising the product monographs.

The researchers offer various suggestions and describe their own action in this area. With support from the Public Health Agency of Canada, in collaboration with the Society of Obstetricians and Gynaecologists of Canada, the researchers have adopted an interdisciplinary approach to develop product monograph language that they hope will inform efforts to standardise product monograph language for vaccines with similar safety profiles and levels of evidence in Canada and abroad. From their perspective, this "will be an important first step to improve the product monographs and increase trust among Canadian health care providers in vaccines recommended in pregnancy."