Safety profile of the most ordered medications for breastfeeding patients in the emergency department

Authors: Courtney Premer, MD, PhD; Kelsea Caruso, PharmD

Journal: American Journal of Emergency Medicine, 2024, Volume 80, Issue 1–7

Type of Study: Retrospective Safety Analysis

DOI: 10.1016/j.ajem.2024.02.042

Quick Reference Summary

The majority (66%) of commonly ordered emergency department (ED) medications are safe for breastfeeding patients, with 21% being likely safe and only 3% recommended to avoid. Analgesics, antibiotics, system-based medications, and supplements/electrolytes predominantly fall into safe categories, minimizing the need for pumping and dumping.

An evidence-based algorithm was developed to guide ED physicians in prescribing medications to breastfeeding patients, ensuring continued breastfeeding without compromising patient care.

Core Clinical Question

In breastfeeding patients presenting to the emergency department (Population), are the most commonly ordered medications (Intervention) safe for continued breastfeeding compared to recommending pumping and dumping (Comparison) based on safety profiles and compatibility (Outcome)?

Background

Disease or Condition Overview:

Breastfeeding is the optimal nutrition for infants, recommended exclusively for six months by the American Academy of Pediatrics (AAP).

Prior Data on the Topic:

Only 27% of women in the U.S. continue breastfeeding at 6 months, dropping to 12.3% by 12 months due to various challenges.

Physicians often lack formal education regarding lactation, contributing to early cessation.

Current Standard of Care:

Emergency Medicine (EM) physicians frequently advise pumping and dumping milk when prescribing medications due to perceived safety risks.

Knowledge Gaps Addressed by Study:

Limited comprehensive safety analyses of commonly ordered ED medications for breastfeeding patients.

Need for evidence-based guidelines to support continued breastfeeding during ED treatment.

Study Rationale:

To evaluate the safety profiles of the most commonly ordered ED medications and provide an algorithm to aid EM physicians in treating breastfeeding patients without unnecessary disruptions to breastfeeding.

Methods Summary

Study Design:

Retrospective safety analysis of medication orders.

Setting and Time Period:

Tertiary care academic medical center in a large urban area, serving a diverse and multiracial population, from January 1, 2018, to December 31, 2022.

Population Characteristics:

Female patients aged 15 to 50 years presenting to the ED with common chief complaints related to postpartum complications.

Inclusion/Exclusion Criteria:

Included: Top 100 most ordered medications for breastfeeding patients based on ED prescriptions.

Excluded: Contrast agents (e.g., perfluorotrien, gadobutrol), fluid boluses (e.g., lactated ringers, sodium chloride), tetanus, diphtheria, and pertussis (tDAP) vaccine, and duplicative medications.

Intervention Details:

Not applicable (observational study).

Control/Comparison Group Details:

Not applicable.

Primary and Secondary Outcomes:

Primary: Safety profiles of the most commonly ordered medications categorized as safe, likely safe, or avoid.

Secondary: Development of a treatment algorithm for breastfeeding patients in the ED.

Statistical Analysis Approach:

Medications were categorized based on safety information from LactMed®, InfantRisk Application, and PubMed®.

Sample Size Calculations:

Not applicable.

Ethics and Funding Information:

Ethics: Approved by institutional review board (implied).

Funding: None. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Detailed Results

Participant Flow and Demographics:

Total Doses Analyzed: 145,960 doses across 90 medications.

Exclusions: 19,916 doses were excluded based on criteria.

Primary Outcome Results:

Outcome	Intervention Group	Control Group	Difference (95% CI)	P-value
Analgesics Safe	54% Completely Safe	-	-	-
Antibiotics Safe	70% Completely Safe	-	-	-
System-based Medications Safe	89% Cardiovascular Safe 78% Endocrine Safe 89% GI Safe 72% Neurology Safe 100% Respiratory Safe	-	-	-
Supplements and Electrolytes Safe	100% Safe	-	-	-

Statistical Significance:

All safety categorizations were based on existing literature and database classifications; specific statistical significance values were not reported.

Effect Sizes & Confidence Intervals:

Not applicable as the study was descriptive in nature.

Secondary Outcome Results:

Development of a treatment algorithm: Provided to guide EM physicians in prescribing safe medications without necessitating pumping and dumping.

Subgroup Analyses:

None reported.

Adverse Events/Safety Data:

Minimal adverse events associated with recommended safe medications. Specific contraindications noted for certain medications (e.g., dicyclomine should be avoided).

Figures:

Figures 1-5: Included detailed tables and pie charts categorizing medication safety profiles and the treatment algorithm (not reproduced here).

Authors' Conclusions

Primary Conclusions:

The majority of medications utilized in the ED are compatible with breastfeeding, reducing the need to advise pumping and dumping.

Authors' Interpretation of Results:

Safe alternative medications are readily available, allowing continued breastfeeding without compromising patient care in acute settings.

Clinical Implications Stated by Authors:

EM physicians can confidently prescribe safe medications to breastfeeding patients, fostering the continuation of breastfeeding.

Future Research Recommendations:

Validation of the treatment algorithm in diverse clinical settings and exploration of medication safety in broader populations.

Literature Review

A. Previous Studies and Meta-Analyses:

Li et al., 2003: Prevalence of breastfeeding in the U.S., highlighting low continuation rates [Pediatrics. 2003;111(Suppl_1):1198–201].

Premer et al., 2024: Current study assessing safety profiles of ED medications.

Palmer et al., 2018: Tramadol use in breastfeeding, supporting safety over more potent opioids [Arch Dis Child. 2018;103(12):1110–3].

B. Contrasting Methodological Quality:

Previous studies predominantly small sample sizes or case reports, whereas this study analyzed a large dataset of 145,960 doses, enhancing internal validity.

C. Comparisons with Guidelines:

American Academy of Pediatrics (AAP), 2022: Recommends exclusive breastfeeding for six months [Pediatrics. 2022;150(1):e2022057988].

World Health Organization (WHO), 2016: Guidelines on preventing and treating maternal peripartum infections [World Health Organization; 2016].

D. This Trial's Contribution:

Provides a comprehensive safety analysis of commonly ordered ED medications for breastfeeding patients, filling a significant knowledge gap and offering a practical algorithm for clinical use.

Critical Analysis

A. Strengths:

• Comprehensive Dataset: Analysis of 145,960 doses across 90 medications enhances the reliability of safety categorizations.
• Use of Multiple Databases: Integration of LactMed®, InfantRisk Application, and PubMed® ensures thorough safety assessments.
• Practical Application: Development of a user-friendly treatment algorithm aids in immediate clinical decision-making.

B. Limitations:

• Single-Site Study: Conducted at one tertiary care academic medical center, limiting generalizability to other settings.
• Retrospective Design: Potential for unmeasured confounders and reliance on accurate medical records.
• Exclusion of Chronic Medication Use: The algorithm does not account for patients on long-term medications prior to their ED visit.
• Limited Subgroup Analysis: Lack of detailed analysis based on specific patient demographics or comorbidities.

C. Literature Context:

• Alignment with Previous Research: Confirms findings from smaller studies that most ED medications are safe for breastfeeding.
• Integration with Guidelines: Supports AAP and WHO recommendations by facilitating continued breastfeeding through safe medication use.
• Fills Knowledge Gaps: Provides empirical evidence and practical tools lacking in previous literature.

Clinical Application

Findings Indicate:

Continued breastfeeding is largely safe while administering most ED medications, reducing unnecessary disruptions.

Applicable Scenarios:

Postpartum women requiring acute care in the ED can be treated without advising pumping and dumping, using the provided algorithm.

Implementation Considerations:

Training EM physicians on the use of the safety algorithm to ensure consistent application.

Integration with Existing Evidence:

Reinforces current breastfeeding guidelines by ensuring medication safety, thereby supporting overall public health objectives.

How To Use This Info In Practice

EM physicians should utilize the provided safety algorithm to guide medication prescriptions for breastfeeding patients, enabling continued breastfeeding without compromising patient care.

Notes for Clarity

No Conflicts of Interest: The authors declared none.

Funding Sources: This research did not receive any specific funding.

Areas of Uncertainty: Limited generalizability due to single-site study; further research needed in diverse settings.

Implementation Barriers: Potential lack of awareness or training on the new algorithm among EM physicians.

Confidence Intervals: Not applicable as the study was descriptive.

Number Needed to Treat/Harm: Not applicable.