Jennifer Namazy1, Christina Chambers2, Leyla Sahin3, Tamara Johnson3, Miriam Dinatale3, Brian Lappin4, Michael Schatz5. 1. Allergy and Immunology, Scripps Clinic, La Jolla, Calif. Electronic address: janamazy@mac.com. 2. Department of Pediatrics, University of California San Diego, La Jolla, Calif. 3. Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, Office of New Drugs, Food and Drug Administration, Silver Spring, Md. 4. Office of Communications, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md. 5. Department of Allergy, Kaiser Permanente Medical Center, San Diego, Calif.
Abstract
BACKGROUND: On June 30, 2015, the US Food and Drug Administration (FDA) began implementation of the Pregnancy and Lactation Labeling Rule (PLLR), which replaced the pregnancy letter category system (A, B, C, D, and X) with integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The letter category system, first established in 1979, was regarded as overly simplistic and misinterpreted as a grading system. The PLLR labeling format was created to improve the presentation of available data on use of the drug during pregnancy and/or lactation. OBJECTIVE: To survey clinician awareness, assessment, and use of this new labeling format. METHODS: In January 2018, an online survey, developed in collaboration between the American Academy of Allergy, Asthma & Immunology and the FDA, was sent to a random sample of the US membership of the American Academy of Allergy, Asthma & Immunology. The survey content consisted of questions addressing the following: demographic characteristics, awareness and use of the PLLR, and value and understanding of the PLLR format on the basis of an example of the "Pregnancy" subsection of labeling. RESULTS: Of the 1500 members who received the survey via an email, 184 (12%) completed the survey. Respondents had a mean age of 56 years and treated on average 2 pregnant women per month. Less than half (46%) of the respondents were aware that the pregnancy letter category system was replaced with a narrative summary. After reading the example, most of the respondents (68%) did not feel that the narrative summary was concise. However, 71% of the respondents found the background risk and disease-associated risk information helpful. Most of the respondents (95%) continued to use the pregnancy letter category system to make prescribing decisions. CONCLUSIONS: These survey results suggest that the PLLR format was not known by most prescribers and that the pregnancy letter category format is continuing to be used despite significant flaws in the old system. However, the survey did not address why prescribers were continuing to rely on the pregnancy letter category system. Whether this is due to the PLLR format itself or the lack of quality data to inform the safe use of medications in pregnancy cannot be determined from these survey results. The FDA will use these survey results to refine the communication of pregnancy safety information in labeling and will expand outreach efforts to educate health care providers in the new labeling system.
BACKGROUND: On June 30, 2015, the US Food and Drug Administration (FDA) began implementation of the Pregnancy and Lactation Labeling Rule (PLLR), which replaced the pregnancy letter category system (A, B, C, D, and X) with integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The letter category system, first established in 1979, was regarded as overly simplistic and misinterpreted as a grading system. The PLLR labeling format was created to improve the presentation of available data on use of the drug during pregnancy and/or lactation. OBJECTIVE: To survey clinician awareness, assessment, and use of this new labeling format. METHODS: In January 2018, an online survey, developed in collaboration between the American Academy of Allergy, Asthma & Immunology and the FDA, was sent to a random sample of the US membership of the American Academy of Allergy, Asthma & Immunology. The survey content consisted of questions addressing the following: demographic characteristics, awareness and use of the PLLR, and value and understanding of the PLLR format on the basis of an example of the "Pregnancy" subsection of labeling. RESULTS: Of the 1500 members who received the survey via an email, 184 (12%) completed the survey. Respondents had a mean age of 56 years and treated on average 2 pregnant women per month. Less than half (46%) of the respondents were aware that the pregnancy letter category system was replaced with a narrative summary. After reading the example, most of the respondents (68%) did not feel that the narrative summary was concise. However, 71% of the respondents found the background risk and disease-associated risk information helpful. Most of the respondents (95%) continued to use the pregnancy letter category system to make prescribing decisions. CONCLUSIONS: These survey results suggest that the PLLR format was not known by most prescribers and that the pregnancy letter category format is continuing to be used despite significant flaws in the old system. However, the survey did not address why prescribers were continuing to rely on the pregnancy letter category system. Whether this is due to the PLLR format itself or the lack of quality data to inform the safe use of medications in pregnancy cannot be determined from these survey results. The FDA will use these survey results to refine the communication of pregnancy safety information in labeling and will expand outreach efforts to educate health care providers in the new labeling system.
Authors: Helen W Sullivan; Claudia Squire; Kathryn J Aikin; Janice Tzeng; Kate Ferriola-Bruckenstein; Eric Brodsky; Ann Marie Trentacosti; Mihaela Johnson Journal: Res Social Adm Pharm Date: 2021-08-01