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ProjTitle.icon P.II.B.6. Safety communication

The general guidance in GVP Module XV on safety communication and communication-related aspects of GVP Module XVI on RMM should be followed, together with the considerations in this section. In addition to the GCC guidance for Presenting the Labeling Information, SPC and PIL. For communication regarding pregnancy for vaccines, SFDA GVP Chapter P.I should be applied too.

GVP Module XV provides an overview of different means of communication and stresses the importance of defining communication objectives. The specific communication objectives discussed for medicines which may be used by women who are of child-bearing potential, planning a pregnancy, or are pregnant or breastfeeding, relate to enabling women and healthcare professionals to take informed therapeutic decisions for preventing negative impact of maternal use of medicines on the child, preventing unnecessary pregnancy terminations, promoting adherence to RMM and supporting informed choices where the wish for a child exists. Communication therefore needs to address the specific information needs of women and healthcare professionals in these different possible clinical scenarios. 

The implementation of RMM in healthcare practice also requires specific communication skills in relation to risks and benefits of medicine use in pregnancy and related uncertainties, which may be more challenging than conveying risks of medicines in other circumstances. RMM targeted at healthcare professionals should provide them with information and tools in such a way that they will be able to effectively inform and discuss risks and RMM with their patients. 

In order to provide for the above communication objectives, marketing authorization holders are encouraged to address, in the product information and any additional RMM such as educational materials targeted at different audiences, the following in appropriate manner if information is available and applicable: 

•  Physiological changes during pregnancy that may result in changes to plasma levels and associated dose-related adverse reactions or under-treatment, either of which could have consequences on the pregnancy outcome through their impact on maternal health;

•  Characterization of the risks of adverse pregnancy outcomes and risks for the child in terms of the nature, severity, seriousness and frequency of potential adverse reactions; 

•  Magnitude of the absolute risks for adverse outcome(s)/reaction(s) as well as the background prevalence of birth/developmental defects in absolute numbers, making comparisons more immediately accessible to patients and healthcare professionals; 

•  Additional RMM, including pregnancy prevention program (PPP) and contraception advice (see P.II.B.7.);

•  Presentation of potential risks of breastfeeding for the child in the light of benefits of breastfeeding itself if breastfeeding is not contraindicated, and advice on dose-reduction, timing of breastfeeding in relation to medicine intake, monitoring and early detection of adverse reactions on the child and when to seek medical advice; 

•  Management of adverse reactions in the child.

Communication should be tailored for addressing female patients and their partners, and healthcare professionals (including in particular general practitioners, pediatricians, obstetricians and gynecologists, midwives, nurses and pharmacists).​

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