Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice

Brooke L. Griffin; Rebecca H. Stone; Shareen Y. El-Ibiary; Sarah Westberg; Kayce Shealy; Alicia Forinash; Abigail Yancey; Kathleen Vest; Lamis R. Karaoui; Sally Rafie; Cheryl Horlen; Nicole Lodise; Nicole Cieri-Hutcherson; Sarah McBane; Anahit Simonyan

doi:10.1177/1060028018764447

Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice

Brooke L. Griffin, Rebecca H. Stone, Shareen Y. El-Ibiary, Sarah Westberg, Kayce Shealy, Alicia Forinash, Abigail Yancey, Kathleen Vest, Lamis R. Karaoui, Sally Rafie, Cheryl Horlen, Nicole Lodise, Nicole Cieri-Hutcherson, Sarah McBane, Anahit Simonyan

Pharmacy Clinical Affairs

Research output: Contribution to journal › Review article › peer-review

6 Scopus citations

Abstract

Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.

Original language	English (US)
Pages (from-to)	810-818
Number of pages	9
Journal	Annals of Pharmacotherapy
Volume	52
Issue number	8
DOIs	https://doi.org/10.1177/1060028018764447
State	Published - Aug 1 2018

Bibliographical note

Funding Information:
Effective June 30, 2015, the US Food and Drug Administration (FDA) implemented a new product labeling system for medication safety in pregnancy.1The use of previously assigned pregnancy categories (A, B, C, D, X) is no longer supported by the FDA. The primary rationale for eliminating the pregnancy categories was based on stakeholder feedback to the FDA. In the final rule, it is stated that “the pregnancy categories were confusing and did not accurately and consistently communicate differences in degrees of fetal risk.” In addition, pregnancy categories were heavily relied on but often misinterpreted, without taking into account the underlying information and data.2The 3 new required narrative sections (“Pregnancy,” “Lactation,” and

Publisher Copyright:
© 2018, The Author(s) 2018.

Keywords

lactation/drug effects
pregnancy/drug effects
women’s health

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10.1177/1060028018764447

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Griffin, B. L., Stone, R. H., El-Ibiary, S. Y., Westberg, S., Shealy, K., Forinash, A., Yancey, A., Vest, K., Karaoui, L. R., Rafie, S., Horlen, C., Lodise, N., Cieri-Hutcherson, N., McBane, S., & Simonyan, A. (2018). Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice. Annals of Pharmacotherapy, 52(8), 810-818. https://doi.org/10.1177/1060028018764447

Griffin, BL, Stone, RH, El-Ibiary, SY, Westberg, S, Shealy, K, Forinash, A, Yancey, A, Vest, K, Karaoui, LR, Rafie, S, Horlen, C, Lodise, N, Cieri-Hutcherson, N, McBane, S & Simonyan, A 2018, 'Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice', Annals of Pharmacotherapy, vol. 52, no. 8, pp. 810-818. https://doi.org/10.1177/1060028018764447

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abstract = "Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.",

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note = "Funding Information: Effective June 30, 2015, the US Food and Drug Administration (FDA) implemented a new product labeling system for medication safety in pregnancy.1The use of previously assigned pregnancy categories (A, B, C, D, X) is no longer supported by the FDA. The primary rationale for eliminating the pregnancy categories was based on stakeholder feedback to the FDA. In the final rule, it is stated that “the pregnancy categories were confusing and did not accurately and consistently communicate differences in degrees of fetal risk.” In addition, pregnancy categories were heavily relied on but often misinterpreted, without taking into account the underlying information and data.2The 3 new required narrative sections (“Pregnancy,” “Lactation,” and Publisher Copyright: {\textcopyright} 2018, The Author(s) 2018.",

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AU - Westberg, Sarah

AU - Shealy, Kayce

AU - Forinash, Alicia

AU - Yancey, Abigail

AU - Vest, Kathleen

AU - Karaoui, Lamis R.

AU - Rafie, Sally

AU - Horlen, Cheryl

AU - Lodise, Nicole

AU - Cieri-Hutcherson, Nicole

AU - McBane, Sarah

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N2 - Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.

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Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice

Abstract

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