Uterine Rupture

One of the biggest daily challenges faced by healthcare providers is obtaining accurate diagnostic answers in a timely manner. Clinicians spend years training in physical diagnosis, mastering techniques such as listening to hearts and lungs with a stethoscope, palpating the abdomen, and examining painful joints. THE PROBLEM But even in the most expert hands, these traditional diagnostic methods lack the precision needed, said Dr. Stephen Erickson, a board-certified family medicine physician providing care at Jefferson Healthcare's Townsend Clinic. "To compensate for this, we rely heavily on costly lab tests, time-consuming imaging studies and further interventions to confirm diagnoses," he explained. "In fact, the cost of diagnostic testing in the U.S. healthcare system is staggering. Annual spending on imaging procedures, including expensive X-rays, CTs and MRIs, has been rapidly rising. We're now spending more than $100 billion on these procedures annually. "Beyond the financial burden, these tests often come with long wait times, contributing to delays in patient care, unnecessary hospitalizations and increased anxiety for patients," he continued. "This inefficiency strains healthcare resources and impacts clinical workflows, making timely and accurate decision making even harder to achieve." Point-of-care ultrasound, or POCUS, is helping clinicians overcome many of these challenges, he contended. With the ability to visualize the body at the point of care using a pocket-sized ultrasound, clinicians can streamline the diagnostic process, improve accuracy, and save time and money, he said. "In fact, POCUS has been shown to outperform traditional diagnostic methods in several cases," Erickson noted. "For much of my career, for instance, a suspicion of pneumonia automatically led to ordering a chest X-ray. Today, we know from multiple research studies that lung ultrasound not only provides quicker and less expensive results but is also more sensitive in detecting pneumonia . "POCUS is transforming the diagnostic landscape, empowering clinicians to make faster, more informed decisions, and ultimately improving patient outcomes," he added. PROPOSAL POCUS technology proposes to resolve the problem of diagnostic delays and inaccuracies across many clinical settings, centered on bringing real-time imaging capabilities directly to the bedside. "Traditionally, medical imaging was confined to specialized radiology departments, with doctors often relying on bulky, expensive equipment like ultrasound cards, CT scans, MRIs or X-rays to get a comprehensive view of a patient's internal structures," Erickson said. "This process, while still highly valuable in some cases, can introduce significant delays, especially in time-sensitive emergency scenarios or in rural settings where access to radiology is often limited. "POCUS technology changes this by decentralizing imaging and making it accessible to clinicians outside of the radiology department," he continued. "The handheld nature of POCUS devices enables clinicians to perform targeted, immediate scans at the patient's side, without having to wait for specialized equipment or personnel." POCUS has the ability to provide immediate answers to critical, yes or no, diagnostic questions. For example, in situations where the primary concern is whether a patient is experiencing internal bleeding, a detailed MRI or CT scan may not be immediately necessary. POCUS offers a faster way to detect or rule out such conditions right then and there, he added. "Plus, new devices on the market in the last half decade have even made it possible to image the whole body with a single, all-in-one probe," Erickson noted. "By placing this technology in the hands of emergency room doctors, nurse practitioners and physician assistants, POCUS offered a streamlined solution to reduce dependency on costly and time-consuming imaging studies. "It allowed medical professionals to identify urgent issues – such as pleural effusions, pneumothorax or cardiac tamponade – quickly and confidently, guiding immediate treatment decisions," he continued. "This real-time diagnostic tool, then, was supposed to alleviate the problem by providing a faster and more direct method of assessment, particularly in environments where delays in diagnosis could result in poor patient outcomes or when quick decisions were needed for effective triage." POCUS technology has enabled healthcare providers to bypass traditional bottlenecks in diagnostic processes while still delivering accurate and life-saving information, he added. "By doing so, it promised to enhance workflow efficiency, reduce wait times and potentially lower healthcare costs, all while improving patient care quality," he said. MEETING THE CHALLENGE At Jefferson Healthcare, the integration of POCUS technology began with its deployment in the emergency department, where physicians urgently needed rapid diagnostic capabilities at any time of day. "Initially, ER doctors used POCUS to quickly assess critical conditions such as internal bleeding, lung problems and cardiac function, which helped streamline decision making and guide immediate treatments," Erickson explained. "The benefits of POCUS in providing fast, reliable diagnostics without the delays of traditional imaging soon became apparent, leading other departments to request access to their own devices. "Over time, the body of evidence regarding the usefulness of POCUS has grown ," he continued. "With this, more and more specialties have asked to have their own POCUS device in their department. To name a few common use cases – in the anesthesia department, POCUS is used to improve the precision of nerve blocks and to assess patients preoperatively for conditions like gastric aspiration risk." Obstetricians can use POCUS to monitor fetal well-being and positioning, enhancing both routine assessments and responses to emergent situations. Similarly, in orthopedic, rheumatology and sports medicine, POCUS can be a tool to guide more accurate joint injections and to diagnose tendon or ligament injuries with greater precision. In primary care, physicians use POCUS not only for diagnostics but also as a patient education tool, showing real-time imaging to help patients understand their diagnoses. "While POCUS started as a standalone tool, it eventually became integrated with electronic health records and imaging databases, enabling clinicians to seamlessly document and share findings with other providers," Erickson said. "In our institution, we have Butterfly iQ handheld POCUS devices deployed in each primary care clinic, our infusion center and our pre-anesthesia ward. "We also have cart-based ultrasound machines from multiple manufacturers in various locations in our hospital," he continued. "All POCUS machines are networked with DICOM links to our Epic EHR and PACS servers to allow for more optimal workflow and image accessibility across the continuum of care. We also use Butterfly Compass workflow software for QA review of images coming from any POCUS device across the organization." RESULTS The POCUS technology has proven itself to be a cost-effective diagnostic tool that significantly enhances the physical examination, Erickson reported. "One of the challenges of trying to quantify the success of leveraging POCUS is that it is very difficult to measure the money that was not wasted on excessive testing, or the patients who did not end up in the hospital because their disease was recognized more quickly," he noted. "That said, I think any clinician using POCUS can tell you of cases where this occurred." Erickson offered a few examples of such cases that took place in the past few months. "A patient who came to my office late in the afternoon with symptoms to suggest a blood clot in a leg vein," he explained. "This is potentially dangerous because an untreated blood clot can break off, go to the heart, and cause a deadly embolism. "Traditionally this patient would be sent to the emergency room because I can't get a venous ultrasound exam scheduled quickly enough as an outpatient," he continued. "By doing a POCUS exam at a cost of less than $50, I was able to get my answer, start the right treatment and avoid a $2,000 emergency department bill." Another example: Placement of intrauterine contraceptive devices can be unpredictably painful for some women. "A quick POCUS scan before placing an IUD can screen for anatomic variations that are likely to result in pain or even dangerous complications such as uterine perforation," Erickson said. "And after IUD placement, women are traditionally asked to come back in six weeks for a second pelvic exam to confirm that the IUD remains in its proper location. "It has brought great patient satisfaction to instead perform a quick ultrasound to more accurately confirm IUD position without the patient needing to get undressed," he added. And a final example: An elderly patient who was unable to talk due to a previous stroke was brought in by his spouse because he "just hadn't been acting right." "My physical exam yielded little useful information as to why," Erickson explained. "It was hard to know if he needed extensive testing, or reassurance. POCUS, however, quickly demonstrated new, severe systolic heart failure. He was sent right to the emergency department where further tests confirmed a large, silent heart attack. "I shudder to think about the outcome of that case if I hadn't had my POCUS device," he said. ADVICE FOR OTHERS "My advice for healthcare organizations that may be thinking about bringing in POCUS technology is to start setting up the IT system interfaces early to be ready for expanded POCUS use in the future," Erickson advised. "Many departments may eventually want POCUS, and each may have their own ideas of what is best for them. "But an IT or biomedical department doesn't want to be saddled with trying to manage multiple systems that can't work together," he continued. "Get stakeholders to agree on two or three preferred vendors of ultrasound equipment and take the time to set up the DICOM links to your EHR and PACS. Set up standardized training in these workflows for each new user to make sure proper documentation standards are being followed." These things take time, but they get progressively harder to institute across multiple departments the longer that non-standardized practices have proliferated, he concluded. Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.

Strategic effort aims to bring stable, quality supply to providers and enhanced pricing predictability for critical labor and delivery drug CHARLOTTE, N.C. and DUBLIN, July 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) and Premier, Inc. (NASDAQ: PINC) announced today that Endo's Par Sterile Products business will supply Pitocin® (oxytocin injection, USP) vials through Premier's ProvideGx® and PremierProRx® programs. Pitocin® is used to induce labor in pregnant women. The product is on the World Health Organization's essential medications list and has a history of supply disruptions, which can result in potential health risks to mothers and babies, as well as costly delays in hospital labor and delivery wards. The partnership involves a multifaceted approach seeking to provide stable product supply through adequate safety stock on a long-term basis. "We're pleased to offer Pitocin® injection through the robust and highly reliable ProvideGx® and PremierProRx® supply channels," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "As a long-standing collaborator with Premier, we're proud to join the organization in helping to address drug shortages and serving as a reliable supplier of this labor and delivery product." "This initiative with Endo is yet another step forward to help eliminate drug shortages for our healthcare provider members, create increased market competition and promote more predictable, long-term prices," said Michael J. Alkire, President and CEO of Premier. "Both ProvideGx® and the PremierProRx® private label program are building a more diversified pharmaceutical market designed to create sustainable supply of a drug vital for maternal care and health in the U.S." Guided by health systems with more than 1,600 hospitals across the nation, Premier's ProvideGx® and PremierProRx® programs create long-term committed buying contracts with participating manufacturers—creating a steady demand signal and guaranteed buyer base in exchange for increasing production of generics in shortage, maintaining safety stocks or diversifying supply sources. These programs offer members access to more than 150 drugs that are or have been recently designated as shortage drugs, and have successfully helped resolve 14 drug shortages, resulting in their official delisting from the U.S. Food & Drug Administration's shortage list. With a stable supply of Pitocin®, Premier can continue efforts aimed at addressing factors that impact maternal and infant health outcomes, including the PINC AI™ Perinatal Improvement Collaborative that brings together more than 220 health systems in all 50 states using performance improvement tools and standardized data to measure outcomes and help identify the drivers of maternal mortality and morbidity. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion; In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In fetal distress where delivery is not imminent; Where adequate uterine activity fails to achieve satisfactory progress; Where the uterus is already hyperactive or hypertonic; In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord; In patients with hypersensitivity to the drug. WARNINGS Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital. PRECAUTIONS All patients receiving intravenous oxytocin must be under continuous observation by trained personnel who have a thorough knowledge of the drug and are qualified to identify complications. Electronic fetal monitoring provides the best means for early detection of overdosage. When properly administered, oxytocin should stimulate uterine contractions comparable to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. This fact must be considered by the physician in exercising his judgment regarding patient selection. Oxytocin should not be administered in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, and any condition in which there is a predisposition for uterine rupture, such as previous major surgery on the cervix or uterus including cesarean section, overdistention of the uterus, grand multiparity, or past history of uterine sepsis or of traumatic delivery. The decision can be made only by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor. Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth. When oxytocin is used for induction or reinforcement of already existent labor, patients should be carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug. ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction, postpartum hemorrhage, cardiac arrhythmia, fatal afibrinogenemia, nausea, vomiting, premature ventricular contractions, pelvic hematoma, subarachnoid hemorrhage, hypertensive episodes, and rupture of the uterus. The following adverse reactions have been reported in the fetus or neonate: Due to induced uterine motility: Bradycardia, premature ventricular contractions and other arrhythmias, permanent CNS or brain damage, fetal death, and neonatal seizures have been reported with the use of Pitocin. Due to use of oxytocin in the mother: Low Apgar scores at five minutes, neonatal jaundice, and neonatal retinal hemorrhage. DRUG INTERACTIONS Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia. INDICATIONS AND USAGE Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage. Please click for full Prescribing Information. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About Premier, Inc. Premier, Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,400 U.S. hospitals and health systems and approximately 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier's news and investor sites on ; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier's blog for more information about the company. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Messrs. Sims and Alkire, any statements relating to product supply, reliability, availability or pricing, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect Endo's (the "Company's") current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. View original content to download multimedia: SOURCE Endo International plc Company Codes: NASDAQ-NMS:PINC, OTC-BB:ENDPQ, OTC-PINK:ENDPQ

Medical researchers have reported a significant rise in cases of IFH injuries in recent years, with maternity staff implementing varied approaches and no consensus regarding the definition or training regarding management to help deliver the baby during CB. Over 34% of women in Australia have a caesarean birth, and a significant proportion of these happen in late labour when the fetal head is deep in the mother's pelvis and can be impacted which makes delivering a baby challenging and poses serious risks to both the mother and the baby. It's estimated the baby's head is wedged, known as impacted fetal head (IFH) in around 10% of all emergency caesarean births (CB). This makes it difficult for the doctor to get their hand below the baby's head to deliver it, which leads to longer delivery times. Recent statistics show that while the majority of babies born following IFH sustain minor damage, 2% of these infants die or suffer serious injuries with lifelong consequences.The NHS Resolution report in the UK states that 9% of avoidable brain injuries at birth are caused by impacted fetal head (IFH). Complications for the mother include increased blood loss, an increased risk of infection, bladder and urinary tract damage, uterine tears that require repair and may cause issues in subsequent pregnancies, or even a hysterectomy. While complications for the baby include lacerations and bruising to the head and face, skull fractures, and haemorrhages, there have also been reports of eye injuries. A Scientific Impact Paper published in BJOG: an International Journal of Obstetrics & Gynaecology by the Royal College of Obtsetricians & Gynaecologists in the UK and Professor Annette Briley at Flinders University has reported a significant rise in cases of IFH injuries in recent years, with maternity staff implementing varied approaches and no consensus regarding the definition or training regarding management to help deliver the baby during CB. Approaches to managing this obstetric emergency include having an assistant push the baby's head up during birth, delivering the baby feet first, using an inflatable balloon device (Fetal Pillow) designed to elevate the baby's head, and administering medication to relax the mother's womb. However, this scientific impact paper reviewed the available evidence, concluding there is currently no consensus on the best approach for these risky cases. Various manoeuvres and some devices have been introduced to help with the delivery of the baby in this situation, but to date there is no consensus on which is best for mothers and babies or the training required for staff managing this emergency situation. Most commonly, an assistant is asked to push up from below, although some evidence suggests reverse breech extraction may be associated with better outcomes. A UK-wide survey reported that more than half of obstetric registrars did not feel confident performing reverse breech extraction, and fewer than one in 10 are familiar with the Patwardhan technique. "The aim of this scientific impact paper was to examine all the current available evidence regarding different manoeuvres and devices currently in use to manage IFH, with the results integrated into the findings of a systematic review commissioned by the National Guideline Alliance (UK)," says research co-author and midwife at Flinders University, Dr. Annette Briley. The researchers say key steps need to be taken to improve standards: • High-quality adequately powered RCTs comparing techniques to manage and prevent IFH are required. (Those currently available have significant weaknesses.) • A universally accepted definition of IFH would facilitate future research and education. • Women and their partners need to inform research around the language and management of IFH. • The development and implementation of an evidence-based multi-professional educational package would lead to consistent management of this obstetric emergency. • More research is required around the efficacy and cost-effectiveness of the Fetal Pillow Dr Briley says the data clearly shows that there has been a significant rise in caesarean sections in late labour and associated cases of IFH-related injuries in recent years, and further education is needed to develop consistent management of this obstetric emergency. "We've reviewed the existing evidence on strategies to identify, prevent, and manage the IFH during births to provide guidance and recommendations that improve outcomes for mothers and babies when this potentially serious complication occurs. It's essential that clinicians use the best evidence to inform care for women and babies, including the optimal techniques to reduce the potentially devastating complications associated with IFH." Dr Briley is also part of a research team developing and evaluating the Tydeman tube, an innovative single-use, hollow silicone tube inserted to elevate the baby's head. Its designed to minimise applied pressure to the head and reduce any suction effect once access has been achieved. "A minimal number of Tydeman Tubes have been used clinically; further research in a clinical setting, compared with appropriately trained and executed manual disimpaction, is required to investigate its efficacy and safety before use."