Bupivacaine Hydrochloride Injection Shortage | Pipeline Medical

Bupivacaine Hydrochloride Injection Shortage: Why? A Detailed Insight

June 22, 2023

Bupivacaine Hydrochloride Injection is currently experiencing a shortage, as listed in the FDA’s drug shortage database as of 20th June 2023. This shortage has significant implications for healthcare providers and patients who rely on this medication for various medical procedures.

The scarcity of Bupivacaine Hydrochloride Injection calls for urgent attention and measures to address the issue effectively. Bupivacaine Hydrochloride Injection is an essential medication widely used in medical practice for its local anesthetic properties.

Importance of Bupivacaine

Bupivacaine is a potent local anesthetic used in medical procedures. It belongs to the amide class of anesthetics and has a complex chemical structure. By binding to sodium channels in nerve cell membranes, Bupivacaine inhibits the conduction of nerve impulses, providing temporary pain relief.

With its high lipid solubility, Bupivacaine effectively penetrates nerve membranes, resulting in a long-lasting anesthetic effect. The importance of Bupivacaine lies in its ability to provide prolonged pain relief by blocking nerve impulses in a specific area.

This enables medical professionals to perform surgeries and procedures with reduced pain and discomfort for patients. It plays a crucial role in ensuring patient comfort during and after medical interventions, making it an indispensable tool in healthcare settings.

Reasons for the shortage of Bupivacaine

The shortage of Bupivacaine hydrochloride injection can be attributed to various factors. The American Society of Health-System Pharmacists (ASHP) published a list of Bupivacaine products affected due to shortage on 18th June 2023. The reasons reported by the ASHP include:

Eugia backorder

Eugia has Bupivacaine on backorder due to a shortage of the active ingredient required for its production. This shortage at the manufacturer’s level has contributed to the overall scarcity of Bupivacaine in the market.

Baxter Discontinuation

Baxter has discontinued the production of 0.75% Bupivacaine in 8.25% dextrose 2 mL ampules since early 2023. This discontinuation has reduced the available supply of this specific formulation of Bupivacaine.

Fresenius Kabi Shortage

Fresenius Kabi faced a shortage of Sensorcaine, a brand of Bupivacaine, due to increased demand for the product. The heightened demand exceeded the company’s production capacity, leading to a shortage in the market.

Hikma Launch

Hikma launched its version of Bupivacaine in November 2021. The introduction of a new product into the market may have created temporary supply disruptions as the company ramped up production and distribution.

Pfizer Manufacturing Delays

Pfizer, one of the major pharmaceutical companies, has experienced manufacturing delays with its Bupivacaine products, leading to shortages. Pfizer also discontinued the production of 0.5% Bupivacaine 30 mL glass ampules in December 2017, further contributing to the overall scarcity of Bupivacaine in the market.

Manufacturing issues

Manufacturing problems at pharmaceutical companies that produce Bupivacaine can lead to a shortage. Issues such as equipment malfunctions, quality control problems, or production delays can disrupt the manufacturing process, resulting in a decreased supply of the medication.

Supply chain disruptions

Disruptions in the supply chain can also contribute to the shortage. This can occur due to challenges in sourcing raw materials or active ingredients required for Bupivacaine production.  Supply chain disruptions may be caused by natural disasters, transportation issues, or geopolitical factors that impact the availability and distribution of medication.

Regulatory issues

Regulatory factors can play a role in the shortage of Bupivacaine. Changes in regulatory requirements, such as updates to manufacturing standards or increased scrutiny by regulatory agencies, can lead to production delays or interruptions. Regulatory actions such as recalls or suspensions of manufacturing licenses can further exacerbate the shortage.

Consequences of shortage of Bupivacaine

The shortage of Bupivacaine hydrochloride injection has resulted in several significant consequences, affecting both healthcare providers and patients. These consequences include:

Delayed or canceled medical procedures

Bupivacaine is a vital medication used for surgical anesthesia and pain management. The shortage has forced healthcare providers to face challenges in acquiring an adequate supply of Bupivacaine, leading to the postponement or cancellation of medical procedures. This delay can have a negative impact on patient care, potentially affecting patient outcomes and causing additional discomfort.

Increased costs for alternative medications

With the scarcity of Bupivacaine, healthcare providers have had to seek alternative medications for local anesthesia and pain relief. These substitutes may come at higher costs, potentially straining healthcare budgets.

Increased expenses can put financial pressure on healthcare systems, hospitals, and patients, affecting overall healthcare affordability.

Potential impact on patient outcomes

Bupivacaine plays a crucial role in managing pain effectively during and after medical procedures. The shortage may result in healthcare providers resorting to alternative medications with different efficacy and safety profiles.

Such substitutions may not provide the same level of pain relief or carry potential risks and side effects. Consequently, patient outcomes could be compromised, with increased discomfort, inadequate pain control, or potential complications.

Potential impact on healthcare providers

The shortage of Bupivacaine hydrochloride injection significantly impacts healthcare providers, creating obstacles in delivering optimal patient care and conducting medical procedures. As a result, healthcare providers are compelled to modify treatment protocols and adjust anesthesia plans in response to the shortage.

This may entail the use of alternative anesthetics, dosage adjustments, or exploration of regional anesthesia techniques to ensure quality care despite the limited availability of Bupivacaine.

Strategies to manage the shortage

In response to the shortage of Bupivacaine hydrochloride injection, healthcare providers have been implementing various strategies to manage the situation effectively. These strategies include:

Alternative agents

Healthcare providers have been exploring the use of alternative local anesthetics to mitigate the impact of the Bupivacaine shortage. As per ASHP, Lidocaine, another amide-type local anesthetic, should be considered a substitute. Although lidocaine has different onset and duration of action compared to Bupivacaine, it can be utilized in certain procedures where its properties are suitable.

Increasing production capacity

Pharmaceutical companies have been working on expanding their production capacity to meet the demand for Bupivacaine. This involves optimizing manufacturing processes, streamlining supply chains, and potentially investing in additional production facilities.

The goal is to enhance production efficiency and ensure a more stable supply of medication to resolve this shortage effectively.

Pipeline Medical In Shortage of Bupivacaine Hydrochloride

Pipeline Medical remains committed to addressing the shortage of Bupivacaine hydrochloride injection and working alongside healthcare providers and manufacturers to find solutions. In this crucial time, our dedicated efforts aim to ensure the availability and accessibility of these essential medications. If you are experiencing challenges with the availability of Bupivacaine, we encourage you to contact Pipeline Medical. Our friendly customer support team is always ready to provide guidance, support, and assistance in navigating through the shortage.

by Kinza Khan
by Kinza Khan

June 22, 2023