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W-36: Prescribers’ Perception of the PLLR When Making Clinical Decisions for Patients with Chronic Respiratory Conditions

Poster Presenter

Victoria Quang

Post-Doctoral Fellow
Rutgers University/Ernest Mario School of Pharmacy
United States

Objectives

The objective of this study is to evaluate the prescribers’ perception of the Pregnancy and Lactation Labeling Rule (PLLR), when making clinical decisions for patients with chronic respiratory conditions.

Method

Healthcare providers were asked to participate and complete an observational, prospective, online questionnaire comprised of 10 survey questions. Surveys were analyzed using descriptive statistics. The study was approved by the Rutgers University Institutional Review Board (IRB).

Results

Approximately 48,000 healthcare providers (HCPs) were electronically contacted using a product listserv to request their participation in this study. The survey is still active, but preliminary data show that 65 HCPs consented to participate. Two study participants dropped out due to unknown reasons resulting in 63 HCPs who met the inclusion criteria of being licensed prescribers making clinical decisions for patients with chronic respiratory conditions (e.g. asthma, COPD, bronchitis, emphysema). Of these 63 licensed prescribers, the majority (54%), have been practicing for = 20 years in the ambulatory care setting (70%) caring for adults = 18 years old (89%). Thirty-six percent of licensed prescribers are aware of the Pregnancy and Lactation Labeling Rule (PLLR). When evaluating the usefulness of the PLLR, the percentage of licensed prescribers that find the PLLR to be useful when prescribing and counseling is 20% (10/49) and 22% (11/49), respectively. With regards to the PLLR changes, “restructuring and renaming of section 8.1 and 8.2 to pregnancy and lactation” has the most positive impact, while the “addition of the clinical considerations subheading” has the least positive impact. Additional PLLR changes licensed prescribers (n=52) would like to see include the “addition of information regarding discontinuation of therapy during pregnancy” (52%), “reordering of the current pregnancy and lactation subsections” (25%), “other” (11%), “non-active metabolites in breast milk within the risk summary” (8%), and “pregnancy registry initiation date” (4%).

Conclusion

The Pregnancy and Lactation Labeling Rule (PLLR) has sparked conversation surrounding its effectiveness in the years following its release in December 2014. While this study confirms that the PLLR has positively impacted licensed prescribers when making clinical decisions for patients with chronic respiratory conditions, there is still room for future updates to this rule. When looking prospectively, many licensed prescribers would like to see more information regarding the discontinuation of therapy during pregnancy to fulfill the lack of information surrounding this topic. Others would prefer a less complicated system for prescribers to consider a medication within seconds. Furthermore, this study shows that many licensed prescribers are still unaware of the PLLR. As it stands now, the PLLR is a helpful rule that should be more widely known by licensed prescribers. More outreach initiatives are needed by the Food and Drug Administration (FDA) to educate the healthcare community about drug labeling rules and its guidance. As new drugs are being approved, the PLLR will continue to be utilized when developing US Prescribing Information (USPI) and HCPs should be well versed in this information to help make more informed clinical decisions for their patients.