Many women use at least 1 medication during pregnancy. In 2015, the Pregnancy and Lactation Labeling Rule (PLLR) was introduced in order to integrate summaries of the risks of using a particular drug or biologic agent during pregnancy and lactation. However, this system is still not used by clinicians. A study sought to determine clinicians’ awareness and use of PLLR and the results were published in The Journal of Allergy and Clinical Immunology.
An online survey was developed by the US Food and Drug Administration in collaboration with the American Academy of Allergy, Asthma & Immunology (AAAAI) and conducted in 2018 with the hope of better understanding clinician use of the PLLR. A total of 184 members of the AAAAI who were part of a randomly selected group chose to participate in the survey. Respondents were 66% male, average age 56 years, part of a single or multi-specialty group practice, and treating an average of 2 pregnant women a month. Clinicians were asked whether they were aware of the introduction of the PLLR. Results showed that only 46% of respondents were aware that the narrative summary of risks had replaced the prior letter system, and almost all clinicians said they continued to use the previous system. Most (71%) cited that they had never referred a pregnant patient to a pregnancy exposure registry, but more than half said they would refer patients in the future. A total of 56% of respondents cited that the narrative summary system was too detailed and unclear compared with the letter-based system.
Despite this, many clinicians did find the new narrative summary labeling helpful. Investigators wrote that the most pressing issue identified by the survey was the fact that the majority of clinician respondents were not aware of the PLLR.
There are some study limitations that may help explain this disparity. Many of the respondents were older and treated mostly non-pregnant patients, as well as working in allergy and immunology specialties. A more diverse sample of respondents may yield different results. In addition, a future survey could be useful in understanding why clinicians continue to use the letter system despite the existence of the PLLR.
According to the investigators, the survey reveals a need to educate clinicians in this specialty area on medication risks in pregnancy going forward. This could be met via increased awareness of the new labeling system or development of a multi-product specialty-specific registry.
Namazy J, Chambers C, Sahin L, et al. Clinicians’ Perspective of The New Pregnancy and Lactation Labeling Final Rule (PLLR): Results from an AAAAI/FDA Survey [published online February 18, 2020]. J Allergy Clin Immunol Prac [published online February 19, 2020]. doi:https://doi.org/10.1016/j.jaip.2020.01.056