CALM Statement on the nationwide Oxytocin for Injection (Pitocin) shortage

By Madeleine Wisner on January 3, 2023 in Updates for all Licensed Midwives

While Licensed Midwives and others attending births in community settings do not induce or augment labor with Pitocin, this medication is carried and utilized in the third and/or fourth stages of labor in community midwifery practices.
Until the Pitocin supply shortage has been resolved, each midwifery practice may need to adjust their practice guidelines and inventory to optimize their use of Pitocin.

California Licensed Midwives are being impacted by the nationwide oxytocin for injection (also known as Pitocin) shortage.

The FDA has issued a notification of a shortage of this medication that could have a significant impact on public health. Two major manufacturers and several small compounding pharmacies currently supply synthetic oxytocin for injection in the United States. On September 23, 2022, one of the major manufacturers reported a manufacturing delay of oxytocin for injection. Most Licensed Midwives in California have now noticed this shortage. The FDA Drug Shortage webpage indicates lack of availability from one manufacturer and limited availability from another manufacturer. It is unknown when manufacturing/stock levels will return to normal.

Key Considerations for Licensed Midwife Practice

There are many differences between birth settings, interventions, tools, medications and provider types, but there is no doubt that having a plan for excessive postpartum bleeding improves outcomes and saves lives.

Licensed Midwives make their own management decisions to address postpartum bleeding based on their training and experience, the training and experience of the other birth attendants, the overall quantity and quality of the bleeding, and considerations for EMS response times and distance to additional emergency services.

The guidelines below offer examples of possible practice changes in prenatal care, labor, birth care, and postpartum care as well as administrative changes California Licensed Midwives may need to make considering the ongoing Pitocin shortage.

For clients who need or desire active management of the third stage of labor, consider the use of an alternative uterotonic such as methylergonovine/Methergine or misoprostol/Cytotec, depending on client risk factors and whether the placenta has yet delivered.

If a client experiences increased bleeding in the immediate postpartum, consider using either methylergonovine or misoprostol, advancing to Pitocin only if these therapies have been already administered.

Consider the use of Tranexamic Acid (TXA) in addition to a first line uterotonic medication in your response to excess third- and fourth-stage bleeding. Tranexamic Acid has been shown to reduce mortality due to postpartum hemorrhage if given within three hours of recognition, regardless of the source of the bleeding.

Midwives with training and experience in therapies outside of the use of medications may include those therapies to their own practice guidelines or protocols.

Care in Pregnancy

Midwives should facilitate informed decision making including sharing information about any shortages in medications, supplies, or devices.

Licensed Midwives already evaluate for and document risk factors for Postpartum Hemorrhage throughout the course of care.

Practices should consider implementing additional measures to identify and counsel clients with risk factors or special considerations for abnormal or excessive bleeding, such as:

Unknown placental location
History of postpartum hemorrhage in a previous pregnancy
Clotting disorders
Prenatal anemia
Client declines medications in the event of a hemorrhage
Client declines blood work during pregnancy
Client declines blood products in the event of a hemorrhage

Midwives should screen and aggressively address severe anemia to reach optimal hematological values especially for clients with other risk factors.

Midwives should provide counseling/education regarding their protocols for a postpartum hemorrhage specific to the planned site of birth.

Care After Postpartum Hemorrhage

Midwives should educate & counsel all clients on warning signs of hemorrhage and when to reach out to their midwife.

Midwives should blood work per their practice guidelines or protocols.

Midwives should consider making alternations to their postpartum follow-up schedule for clients who have had excess bleeding in the third or fourth stage, as they may need earlier or more frequent home visits to assess their physical and emotional recovery.

A difficult birth, blood loss, fluid loss, and/or exhaustion can all impact lactation. Midwives should consider referring the client for IBCLC services or other specialized lactation support if available.

Clients who experienced complications during their delivery may benefit from counseling and support resources. Midwives should consider keeping a resource list of peer support organizations, professional counselors or therapists, and patient organization resources.

Documentation

Midwives should note in the client chart all informed decision making discussions, including those regarding medication shortages, individual client risk factors, or medication substitutions.

Midwives should note in the client chart any use of and rationale for medication substitutions, such as the use of expired medication due to supply shortages.

Supply Management

Midwives should consider keeping expired Pitocin on hand to use with informed consent if unexpired Pitocin is unavailable.

Midwives should consider utilizing a system for procuring medications in bulk with other midwives to reduce waste.

Midwives should consider coordinating with other midwives in region to optimize use of limited supply of oxytocin.

Midwives should plan for additional stores of non-Pitocin antihemorrhagic medications.

Midwives who have training in herbal remedies for excessive postpartum bleeding should keep those items stocked.

Debrief and Peer Review

Following any event that a California Licensed Midwife feels they need to review confidentially, they may consider the free CALM Quality Improvement Program.

This program is available to all CALM members and provides a formal, confidential midwifery peer review.

Modified Medication Management of Excessive Postpartum Bleeding in the Community Setting

The below guideline is one for the medication management of excess bleeding in the third- or fourth-stage of labor in practices where oxytocin for injection (Pitocin) is unavailable or in very short supply.

If third- or fourth-stage PPH requires treatment with medication, administer a first-line uterotonic:
- Methylergonovine (Methergine) 0.2 mg IM
- Consider Misoprostol (Cytotec) 600 mcg orally or 800 mcg sublingually only for patients with asthma or hypertension, or if a temperature controlled environment (such as a cooler or refrigerator) for Methergine is unavailable.
  - Misoprostol is no longer recommended by CMQCC as a first-line uterotonic otherwise due to high rates of side effects, inconsistent efficacy, and late onset of action (specific to rectal administration), however midwives in community settings do report continued utility of this medication by oral, sublingual, and rectal routes.
If bleeding continues, repeat the first-line uterotonic previously used:
- Methylergonovine 0.2 mg IM, or
- Misoprostol 600 mcg orally or 800 mcg sublingually
If bleeding remains excessive and is unresponsive to the first two doses of chosen uterotonic, consider:
- Pitocin 10 units IM if no IV access is available
- IV access if not already in place
IV medications:
- Pitocin 10-30 units in 500 mL normal saline or 20-60 units in 1000 mL normal saline, in a time-limited bolus infusion over 10-15 minutes, followed by maintenance infusion at a lower rate.
- Tranexamic Acid 1 Gram in 10+mL fluid administered over 10 minutes
  - Tranexamic Acid is relatively inexpensive and easy to administer.
  - The shelf life is about 3 years, and it can be stored at room temperature.
  - Tranexamic Acid may be mixed with up to 250mL of most solutions for infusion, such as Normal Saline. This should be mixed at the time of use.
  - A second dose of 1 Gram can be administered 30 minutes after the first dose if excessive bleeding continues.
  - TXA can be administered through the same IV cannula used for IV hydration or uterotonic administration.
  - TXA should not be mixed with solutions containing penicillin or mannitol.
- Volume replacement with Normal Saline or Lactated Ringer’s as indicated

In addition to medications addressing uterine atony, the following may be considered at any point:

Applying external or internal bimanual compression
Investigating for trauma to tissues and prompt repair
Activating EMS
Evaluating for retained placenta, clots, or other tissue
Urinary catheterization

Additional information on Tranexamic Acid (TXA) for Postpartum Hemorrhage

In 2017 the World Health Organization updated their PPH Guidelines to include IV Tranexamic Acid (TXA). Tranexamic Acid is a competitive inhibitor of plasminogen activation and can reduce bleeding by inhibiting the breakdown of fibrinogen and fibrin clots. Therefore, it should not be used in birthing persons with a contraindication to antifibrinolytic therapy (such as a known thromboembolic event, history of coagulopathy, active intravascular clotting, or known hypersensitivity to Tranexamic Acid).

First, TXA is not an initial treatment—abnormal bleeding must be rapidly addressed with uterotonics, surgical repair, and/or transport as indicated. If excessive bleeding continues, the risk of coagulopathy rises, at which time TXA may have an important role.
A delay in the use of TXA appears to reduce its benefit. The benefit appears to decrease by 10% for every 15-minute delay, with no benefit seen after 3 hours.
TXA should be used in all cases of PPH, regardless of whether the bleeding is due to genital tract trauma or other causes.