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AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
REPORTING FROM ACOG 2018
