Navigating Drug Shortages in Obstetric Care

Labor and delivery units should preemptively build teams and systems to respond to drug shortages to protect the health and safety of pregnant people.

Abstract

The number of long-duration drug shortages in the United States is increasing annually. These shortages may pose significant risks to patients by compromising or delaying care. They also pose challenges to health care systems by creating operational and financial strain. To minimize the effect on patient care, health care professionals and systems need to establish mechanisms to prepare in advance for drug shortages. In this clinical perspective, we explore the definition of drug shortage, causes of drug shortage, prediction of drug shortage, and potential responses to drug shortage. We additionally review the causes and responses to shortages of five drugs specific to obstetric care. In this era of frequent and unanticipated drug shortages, it is crucial to build the necessary teams and systems to respond to the next drug shortage to protect the health and safety of pregnant people.

Medications are an essential component of health care, and access to medicines is a fundamental human right.¹ In turn, drug shortages pose significant challenges to the health care system and may threaten the health and safety of our patients. Recently, there have been frequent drug shortages in obstetrics, and here we will illustrate the key dynamics of shortages of five important medications: penicillin, oxytocin, nirsevimab (brand name Beyfortus), Rhesus factor D immunoglobulin, and intravenous fluids. These examples were selected because they are essential to routine obstetric care, have been widely reported by professional societies and federal agencies, and together illustrate diverse underlying shortage causes and response strategies.

WHAT IS A DRUG SHORTAGE?

There is a lack of standardized definition for drug shortage.^2,3 The World Health Organization has provided two coexisting definitions. The first defines drug shortage from the perspective of supply and explains that “a ‘shortage’ occurs when the supply of medicines, health products and vaccines identified as essential by the health system is insufficient to meet public health and patient needs.”⁴ The second defines drug shortage from the perspective of demand and explains that “a ‘shortage’ will occur when demand exceeds supply at any point in the supply chain and may ultimately create a ‘stockout’ at the point of appropriate service delivery to the patient if the cause of the shortage cannot be resolved.”⁴ On a more local level, the American Society of Health-System Pharmacists defines drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”⁵ Finally, the U.S. Food and Drug Administration (FDA) defines drug shortage as “a period of time when the demand or projected demand for the drug … exceeds the supply of the drug.”⁶

In terms of current-day trends in the United States, FDA data from 2017 to 2023 demonstrate that the number of new-onset drug shortages is overall decreasing, but the number of drug shortages that are ongoing is increasing (Fig. 1A).⁷ So, for those drugs in shortage, there is a shift toward longer duration of shortage (Fig. 1B).⁷ In 2023, 61% of shortages involved sterile injectables, which is a common formulation on labor and delivery with examples including oxytocin, antibiotics, local anesthetics, parenteral narcotics, and Rhesus factor D immunoglobulin.⁸

Fig. 1. Incidence, prevalence, and duration of drug shortages in the United States. A. Number of new and number of ongoing drug shortages by year from 2017 to 2023. B. Comparison of drug shortage duration between 2019 and 2024. Images reprinted from GAO-25-107110.

Piltch. Drug Shortages in Obstetrics. O&G Open 2026.

WHY DO DRUG SHORTAGES HAPPEN?

Causes of drug shortage can be classified as supply issues, demand issues, or regulatory issues (Fig. 2).^2,5,9–11 The underlying causes of supply, demand, and regulatory issues can be nuanced. For example, business decisions made by manufacturers that could lead to supply shortage may include limited production planning, a merger, or an acquisition. “Just-in-time” inventory is a strategy in which suppliers produce medication to meet the immediate, known demand for the medication but no additional supply. Challenges may occur when the prediction of anticipated need is incorrect. Unexpected increases in demand can occur as a result of epidemics or a new indication identified for a preexisting medication. Natural disasters can play a role in both supply and demand issues by, for example, destroying raw materials, disrupting manufacturing or transportation, or increasing demand unexpectedly. Regulatory issues can include FDA enforcement actions or introduction of stricter quality criteria, which can resultantly lead to changes in supply or demand. Making things more complicated, the underlying cause of drug shortage can be multifactorial and may result from a combination of supply, demand, and regulatory issues. Finally, substantive information on the cause of shortage is often lacking.¹²

Fig. 2. Causes of drug shortages. Drug shortages can occur as a result of supply issues, demand issues, or regulatory issues. FDA, U.S. Food and Drug Administration.

Piltch. Drug Shortages in Obstetrics. O&G Open 2026.

The following five examples that have affected the field of obstetrics illustrate the various causes of drug shortage:

• • Penicillin G: Intravenous penicillin G is the antibiotic of choice for intrapartum group B streptococcus (GBS) prophylaxis.¹³ In 1999, the major manufacturer of penicillin G announced a voluntary recall of all of its penicillin products to address the FDA's regulatory concerns (details of which are not available) at the manufacturing site.¹⁴ This penicillin shortage resulted from a regulatory issue.

• • Oxytocin: Oxytocin is crucial for the induction and augmentation of labor and for the prevention and management of postpartum hemorrhage. In 2022, one of two major manufacturers of oxytocin in the United States reported a manufacturing delay of certain-size vials of oxytocin, although details regarding the cause of delay were not made available.¹⁵ This led the other manufacturer to face increased demand and subsequent depletion of inventory.¹⁶ This shortage ultimately resulted from a supply issue.

• • Nirsevimab (Beyfortus): In 2023, two new products were introduced to prevent respiratory syncytial virus (RSV)–related lower respiratory tract disease in infants through 6 months of age: bivalent recombinant RSV prefusion F protein subunit vaccine (Abrysvo) for the pregnant person or long-acting monoclonal antibody (nirsevimab) for the infant. In this first season, there was a shortage of nirsevimab that the pharmaceutical company attributed to “unprecedented demand … despite an aggressive supply plan built to outperform past pediatric immunization launches.”¹⁷ This shortage resulted from a demand issue.

• • Rhesus factor D immunoglobulin: Rhesus factor D immunoglobulin administration to Rhesus factor D–negative pregnant people has reduced alloimmunization rates from 15% to less than 1%, nearly eliminating the significant perinatal risks associated with Rhesus factor D alloimmunization.¹⁸ In 2023, a Rhesus factor D immunoglobulin shortage was reported that was attributed to a shortage of an active ingredient, manufacturing issues, and plant maintenance requirements.¹⁹ The FDA, the American Society of Health-System Pharmacists, and the companies that produce Rhesus factor D immunoglobulin did not provide an explanation for the anti-D plasma shortage, but plasma donation decreased after the onset of the coronavirus disease 2019 (COVID-19) pandemic, compounded by the fact that it takes up to 12 months for plasma to be processed into shelf-ready plasma-derived medicinal products.²⁰ In addition, two-thirds of the world’s plasma supply comes from the United States. Thus, the Rhesus factor D immunoglobulin shortage resulted from a supply issue.

• • Intravenous fluid: Intravenous fluids are used routinely for maintenance hydration, medication administration, and management of obstetric emergencies such as hemorrhage. In 2024, the manufacturing site that produced 60% of intravenous fluid used in hospitals in the United States was damaged by a hurricane and temporarily halted production.²¹ It took approximately 5 months for the manufacturing site to return to prehurricane production levels.²² The intravenous fluid shortage resulted from a supply issue caused by a natural disaster.

CAN WE PREDICT DRUG SHORTAGES?

Pharmacists and hospitals provide frontline delivery of drugs to patients. Unfortunately, “generally, little or no advanced warning of an impending drug shortage is forthcoming” for hospitals, creating the need to rush to develop a response.¹² Earlier warning of drug shortages would more optimally allow time to devise plans to minimize the effect of drug shortage on patient care.

Certain factors are known to increase the vulnerability of a drug to shortage.^23,24 Medications requiring more complex routes of administration or formulations such as injectable drugs are more prone to shortage as a result of more complex manufacturing processes. Examples include oncology medications, pain medication (eg, morphine), emergency medications (eg, norepinephrine), and intravenous electrolyte solutions.²³ Meanwhile, generic drugs are more prone to shortage because manufacturers have less financial incentive to produce off-patent drugs because of price competition and lower margins, resulting in pressure to cut costs.^25,26 This pressure may lead them to take steps that render the supply of drugs vulnerable to interruption such as offshore manufacturing of active ingredients, use of outdated facilities, overuse of equipment, and cutting corners with respect to quality control measures.²⁶ In addition, the production of generic drugs is frequently concentrated among a few manufacturers at most.^23,26 Any drug (either generic or on patent) produced by a single manufacturer or by a dominant producer with a concentrated market share is vulnerable to shortage: If the manufacturer encounters a production issue or other limits on its output or simply chooses to produce less, no other manufacturer is able to fill the supply gap.

Machine learning has been used to improve the accuracy of demand forecasting in pharmaceuticals.^27–29 Pharmaceutical manufacturers commonly use such tools to plan for production and distribution of medicines, including for just-in-time forecasting, whereas some health systems use these tools to plan for pharmaceutical purchasing as a part of supply chain and pharmaceutical inventory management programs.^27,30 More accurate demand forecasting can help to give lead time to the manufacturer to appropriately match supply and to health systems to better plan for pharmaceutical inventory management. To take this one step further, machine learning has additionally been used to predict drug shortages.^31–33 Predictors included in these various machine learning models included drug therapeutic class, drug dosage form, branded or generic drug availability, number of manufacturers, monthly dispensed data, volume-based procurement, unit price, and day of order. These machine learning models were developed before the recent wave of advances in large-scale generative artificial intelligence models. We anticipate that generative models may augment and enhance predictive tools in the future. Adopting these tools will allow pharmaceutical companies and health systems to better predict changes in supply and demand (including drug shortages) further ahead of time.³⁴

To better predict and prepare for shortage, the field of obstetrics can draw lessons from the preexisting approach to pharmaceutical demand forecasting using the machine learning described previously. First, we need to establish how we predict demand or birth rate in a given geography, which will allow better baseline forecasting of demand for key obstetric medicines. Overall, birth rates are on a steady decline; births per 1,000 women 15–44 years of age decreased from 70.8 in 1990 to 56 in 2020.³⁵ In the United States, initiation of pregnancy attempts peak in September, and fecundability peaks in late fall or early winter, corresponding to peak deliveries in August through October.³⁶ These are more predictable fluctuations in demand. Meanwhile, despite the dramatic increase in abortion restrictions in the United States over the past several years, the monthly abortion rate has increased from 81,400 in 2022 to 97,900 in 2024.³⁷ With this foundational knowledge, we can build approaches that allow us to better characterize predictors of more acute changes in birth rate to preempt the possibility of drug shortage on labor and delivery. We also need to remain actively engaged in regulatory issues that could alter birth rate such as policies influencing access to abortion, fertility care, parental leave, and childcare.³⁸ Finally, we need to begin to use technology tools such as machine learning to enhance demand forecasting and to better predict drug shortages in obstetrics before they appear.

As we begin to adopt more advanced forecasting tools, it will be crucial to consider how best to ensure that they do not exacerbate health inequities. Today, drug shortages already disproportionately affect a variety of groups at risk of receiving lower-quality care, including Medicaid beneficiaries and individuals with disabilities.³⁹ The persistence of maternity care deserts complicates these challenges even further, given how difficult it is for women who live in these communities to access care, let alone receive appropriate medication in the setting of shortage.⁴⁰ If only well-resourced health systems have access to the latest forecasting technologies, it will leave these systems better prepared for drug shortage. The result could be exacerbations of care inequalities by enabling well-resourced health systems to hoard drug supply or to better plan for upcoming shortage in a way that less well-resourced institutions do not have access to. Women in maternity care deserts risk facing not only limited access to care but also limited access to optimal clinical resources when they are able to find care.

In the setting of drug shortage, individual systems can address these challenges by intentionally accounting for potential disparities within the system when adopting new forecasting technologies.⁴¹ In addition, creating systems that allow less well-resourced institutions to have access to forecasting technologies such as the creation of regional information sharing platforms that embed these forecasting technologies can help to ensure more equitable outcomes.^41,42

HOW CAN WE RESPOND TO DRUG SHORTAGES?

Health care systems need to prepare for and be ready to respond to drug shortages (Fig. 3). The American Society of Health-System Pharmacists provides guidelines for the management of drug shortages.^10,43 The process begins before shortage with the preparation phase. Several key infrastructure components must be in place before a drug shortage to ensure readiness to respond in the event of a shortage: a drug shortage team, a resource allocation team, and an established process for approving alternative therapies.⁴³

Fig. 3. Management of drug shortages. This outlines a plan to prepare for drug shortage and then to respond to drug shortage.

Piltch. Drug Shortages in Obstetrics. O&G Open 2026.

The drug shortage team is an interdisciplinary team that may consist of clinical informatics and specifically pharmacy informatics specialists, pharmacists, physicians, and nursing, and they will be the leader of the drug shortage response efforts.^44,45 With the onset of a new drug shortage as identified by public announcements from organizations such as the FDA, notifications from manufacturers, or demand forecasting tools, the drug shortage team will need to initiate the assessment phase. Components of the assessment phase may include validating details of the shortage, identifying the affected patient population and anticipated drug demand, determining current inventory, identifying therapeutic alternatives and their respective inventories, estimating time to effect on the health care organization, and determining the supply of the drug in shortage from alternative sources or of alternative drug products. The resource allocation team may include pharmacists, physicians, nurses, social workers, patient representatives, and representatives from the ethics committee; they will focus on meshing clinical evidence and ethics to guide the prioritization and rationing of medications. Approval of alternative therapies should occur through a timely, multidisciplinary decision-making process following the routine drug-change workflows of the health care system. Alternative therapies can then be incorporated into the drug shortage response plan. The drug shortage team can estimate the effect on patient care and establish a final plan to respond to the drug shortage that details temporary guidelines and procedures and incorporates recommendations from the resource allocation team. The staff then must be informed and educated on the drug shortage and action plan.

In response to our five historical examples of drug shortages affecting obstetrics, professional societies recommended the following approaches:

• • Penicillin G: In response to the intravenous penicillin G shortage, it was recommended to reserve penicillin G for patients in whom an alternative antibiotic was not appropriate.¹⁴ With respect to intrapartum GBS prophylaxis, intravenous ampicillin was identified as an acceptable alternative.¹³ However, intravenous penicillin G was considered preferable because of its narrower spectrum and lower likelihood of inducing resistance.

• • Oxytocin: In the face of oxytocin shortage, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Obstetric Anesthesia and Perinatology provided conservation strategies.^15,16 Interventions for conservation of oxytocin included developing a hierarchy for induction indication (eg, prioritizing medically indicated inductions and limiting or not scheduling elective inductions) and evaluating contraindications to uterotonics as part of postpartum hemorrhage risk evaluation. Those with a contraindication to alternative uterotonics could be prioritized for postpartum oxytocin. Interventions for intrapartum conservation included delineation of the admission criteria for active labor, heavier reliance on prostaglandins and amniotomy, and use of the same intrapartum oxytocin bag for postpartum hemorrhage prophylaxis. Finally, postpartum opportunities for oxytocin conservation included using intramuscular oxytocin for hemorrhage prophylaxis, using an alternative uterotonic for hemorrhage prophylaxis (methylergonovine, 15-methyl prostaglandin F2α, misoprostol), or using a stepwise approach to these alternative uterotonics before administering oxytocin infusion.

• • Nirsevimab (Beyfortus): The nirsevimab shortage affected pediatrics. That said, maternal immunization with Abrysvo and reliance on transplacental passage was the alternative option for infant protection, linking the nirsevimab shortage integrally into routine prenatal care. ACOG, the Society for Maternal-Fetal Medicine (SMFM), and the American Academy of Pediatrics developed a joint statement with guidance on response to the nirsevimab shortage, highlighting the importance of an interdisciplinary team.⁴⁶ ACOG and SMFM encouraged vaccination in pregnancy with Abrysvo in response to the nirsevimab shortage, as opposed to just recommending it as a safe option for neonatal protection. They also encouraged clear documentation of Abrysvo administration in the medical record to avoid unnecessary nirsevimab administration to infants who were already protected. Although this should be routine practice, it was of clear importance during the nirsevimab shortage. Furthermore, the Centers for Disease Control and Prevention provided specific guidance on nirsevimab dosage prioritization to protect those infants at highest risk for severe RSV disease.⁴⁷

• • Rhesus factor D immunoglobulin: ACOG provided multiple Rhesus factor D immunoglobulin prioritization and conservation strategies in response to the Rhesus factor D immunoglobulin shortage. Possible interventions included incorporating paternal Rhesus factor D status, noninvasive prenatal screening for fetal Rhesus factor D status, avoiding Rhesus factor D immunoglobulin administration in Rhesus factor D–sensitized patients, prioritizing postpartum prophylaxis followed by the 28-week antepartum dosage, and confirming neonatal Rhesus factor D status before postpartum Rhesus factor D immunoglobulin administration.⁴⁸ ACOG also now suggests forgoing routine Rhesus factor D testing and Rhesus factor D immunoglobulin prophylaxis in patients undergoing termination of pregnancy or spontaneous abortion before 12 0/7 week of gestation.⁴⁹

• • Intravenous fluid: SMFM provided detailed guidance for management of the intravenous fluid shortage.⁵⁰ Recommended measures for consideration included oral hydration intrapartum and perioperatively when appropriate, interdisciplinary review of protocol for pre-epidural intravenous fluid bolus, review of protocol for amnioinfusion, medications administered orally followed by intravenous push rather than bag or piggyback when possible, use of cefazolin intravenous push for GBS prophylaxis, use of intramuscular oxytocin, and early consideration for mechanical or vacuum-induced tamponade devices in management of uterine atony. SMFM also recommended systems practices such as regularly assessing intravenous fluid use and supply during unit safety huddles, using the electronic medical record to require fluid order renewal, adding automated best-practice advisories, and empowering nursing to evaluate intravenous fluid needs before starting each new bag.

CALL TO ACTION

Drug shortages in obstetrics can occur at any time and may have profound implications. Thus, we need to be prepared to respond rapidly and effectively. It is essential to embark on the preparation phase now. Labor and delivery units can build a drug shortage team that may include pharmacists (including informatics specialists), obstetricians, maternal–fetal medicine specialists, obstetric anesthesiologists, and nursing. Within this team, anticipated roles and responsibilities can be predetermined in advance of the next drug shortage. In settings in which advanced forecasting tools are implemented, team members can be regularly informed by the analytics team who manages forecasting about projected changes in supply and demand that might lead to shortage risk. To prepare for possible shortage of critical labor and delivery medications, preliminary plans addressing possible changes in care delivery, drug alternatives, and patient prioritization can be established. Mechanisms for widespread communication such as email distribution lists should be established so that they can be used for rapid responses to shortages. Drug shortage teams can consider establishing relationships with other nearby health care institutions to facilitate drug sharing plans during times of shortage. Once a new drug shortage is identified, the labor and delivery drug shortage team will be ready to initiate the assessment phase, deftly develop a tailored action plan, and disseminate and enact the action plan.

To support the preparation phase across the country, ACOG and SMFM could develop a committee focused on the management of drug shortage. This could help to build and share potential responses across institutions nationally. Preparation for drug shortages can enable more facile and expeditious responses to new-onset drug shortages and thereby may help to optimize patient care.