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“Phasing Out Categories & Phasing in the Pregnancy & Lactation Labeling Rule “

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HealthTrust presents…”Phasing Out Categories & Phasing in the Pregnancy & Lactation Labeling Rule ”

Despite being approved and published by the FDA in 2015, the Pregnancy and Lactation Labeling Rule (PLLR) is still not recognized by many pharmacists and instead, the pregnancy categories are still being utilized. “Pregnancy category C” medications are defined as those that either have potential adverse effects shown in animal reproduction studies, or they have no adequate and well-controlled studies in animals or humans. This blurs the line between medications being unsafe for use in pregnancy and not having any available data which limits the use of important medications that may be safe for use in this patient population. This session will introduce the Pregnancy and Lactation Labeling Rule (PLLR) and how it could potentially contribute to the decision-making process when considering whether or not to administer certain high-risk medications to pregnant patients. The speaker will explain why pregnancy categories are no longer used and how the new PLLR provides a structured approach to labeling. Available data that weighs the risks and benefits of administering medications in pregnancy will also be discussed.

Learning Objectives for  Pharmacists  |  At the end of this session, participants should be able to:

  1. Compare previous pregnancy categories to the new Pregnancy and Lactation Labeling Rule (PLLR)
  2. Describe the new addition of reproductive potential to pregnancy guidelines
  3. Apply the PLLR in making clinical recommendations and decisions in situations where it was previously unclear within former pregnancy categories

Learning Objectives for Pharmacy Technicians |  At the end of this session, participants should be able to:

  1. Explain the current components of the Pregnancy and Lactation Labeling Rule (PLLR)
  2. Recall the different subsections of pregnancy, lactation and reproductive potential that are now required on medication labels


Su Jin Cho, PharmD  | PGY-1 Drug Information Pharmacy Resident  |  Robert Wood Johnson University Hospital

Target Audience: Pharmacists & Pharmacy Techs

Continuing Education Information: 1.0 contact hours approved for Pharmacists and Pharmacy Technicians. Belmont University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The ACPE Universal Activity Numbers for this activity are 0863-9999-19-036-L04-P and 0863-9999-19-036-L04-T . The activity will provide 1 hour (.1 CEUs) of continuing education credit to pharmacists and pharmacy technicians who attend the webinar and complete the online evaluation.

Note about CE credit: If you plan to obtain credit, stay until the end of the presentation to receive the verification code you will need to obtain your continuing education credit. A reminder that CE credit is individual. No group credit is available. Each person must register for this session and attend the webinar for 40 minutes or longer in order to receive an email after the event with instructions on how to apply for continuing education credit. Please do not share the code or forward the email you receive to others who did not actually attend the program. If they are not able to be verified on our webinar provider reports and registration list they will not receive credit. Also, please note: If you are joining only by phone, you will not be eligible for credit. You must also log in and join the visual portion of the webinar to be part of our CE provider-required reporting.