National Drug Shortage Research Articles

Treatment of Anticholinergic Delirium with Oral Rivastigmine: A Case Report

BackgroundAnticholinergic toxicity is commonly encountered in the emergency department. However, the availability of physostigmine, a central acetylcholinesterase inhibitor used to reverse anticholinergic delirium, has been significantly limited due to national drug shortages in the United States. Several articles have explored the viability of rivastigmine as an alternative treatment for these patients. Case ReportA 33-year-old male presented to the emergency department after a suspected suicide attempt. The patient was found with an empty bottle of diphenhydramine at the scene. On arrival, he was tachycardic, delirious, with dilated and nonreactive pupils and dry skin. As the clinical picture was highly suggestive of anticholinergic toxicity, the patient was treated with oral rivastigmine at a starting dose of 4.5mg to reverse his anticholinergic delirium. Though requiring a repeat dose, his delirium resolved without recurrence.Why Should an Emergency Physician Be Aware of This? Oral rivastigmine has been successfully applied here and in other case reports to reverse anticholinergic delirium with the benefit of prolonged agitation control. Emergency physicians may consider this medication in consultation with a specialist, with initial doses starting at 4.5 to 6 mg, if encountering anticholinergic delirium when physostigmine is not available.

Implementation of a tier system for IVIG indications to address IVIG shortage at a tertiary care pediatric medical center.

Drug shortages are a common issue that healthcare systems face and can result in adverse health outcomes for patients requiring inferior alternate treatment. The United States recently experienced a national drug shortage of intravenous immunoglobulin (IVIG). Several reported strategies to address the IVIG and other drug shortages have been proposed; however, there is a lack of evidence-based methods for protocol development and implementation. To evaluate the efficacy of introducing a multidisciplinary task force and tier system of indications and to minimize adverse effects during a shortage of IVIG. Faculty members across disciplines with expertise in IVIG use were invited to participate in a task force to address the shortage and ensure adequate supply for emergent indications. A tier system of IVIG indications was established according to the severity of diagnosis, urgency of indication, and quality of supporting evidence. Based on inventory, indications in selected tiers were auto-approved. Orders that could not be automatically approved were escalated for task force review. Overall, there were 342 distinct requests for IVIG during the study period (August 1, 2019 to December 31, 2019). All Tier 1 indications were approved. Of all requests, only 2.6% (9) of requests were denied, none of which resulted in adverse effects based on retrospective chart review. Seven patients who regularly receive IVIG had possible adverse effects due to dose reduction or spacing of treatment; however, each complication was multifactorial and not attributed to the shortage or tier system implementation alone. Implementation of a multidisciplinary task force and tier system to appropriately triage high-priority indications for limited pharmaceutical agents should be considered in health institutions faced with a drug shortage.

Communicating the Crisis: Navigating the Challenges of Chemotherapeutic Drug Shortages with a Patient-Centered Ethical Dialogue Framework

Introduction: The United States finds itself gripped by debilitating drug shortages, thrusting thousands of patients nationwide into a precarious limbo and making the potential delay or cancellation of essential chemotherapy treatments a reality. In June 2023, the situation escalated to encompass a staggering 309 active drug shortages, including twenty-five chemotherapeutics, two of which are carboplatin and cisplatin. Communicating the nuances of a chemotherapy drug shortage to those affected transforms into a multifaceted and delicate endeavor that demands deep-seated empathy, preparation, and understanding. Mastering strategic, patient-centered communication becomes an ethical imperative and valuable skill for all physicians, amplifying the human connection at the heart of medicine. Our multidisciplinary team of specialists developed an ethical communication framework to guide physicians in navigating and discussing the complexities of modern drug shortages with patients. This framework promotes empathetic and informative dialogue with patients, empowering them to understand the situation and actively participate in their care decisions. Through this approach, we aim to foster a partnership between physicians and patients, mitigating anxieties and ensuring patients feel heard and supported throughout this trying period. Method: A multidisciplinary team of specialists convened, including physicians, advanced practice providers from hematology and oncology, and bioethicists. We developed an ethical and theoretical communication framework that will prove beneficial for both physicians and patients. Our framework facilitates compassionate and informed exchanges between healthcare professionals and their patients. Special care was given to consider the patient's background, perspectives, and beliefs. Results: The ethical communication framework for addressing chemotherapeutic shortages demonstrated promising potential for enhancing patient-provider interactions during times of crisis. The framework emphasizes open and transparent communication, facilitating patient understanding of the drug shortage situation and empowering patients to participate in their treatment actively. Conclusion: The developed ethical communication framework offers a patient-centered approach to addressing this crisis, aiming to empower patients with knowledge and understanding while fostering a collaborative decision-making process during crisis communication. By prioritizing empathy, transparency, and patient autonomy, the framework serves as a valuable tool for navigating the complexities of drug shortages and mitigating patient fears when discussing the drug shortage crisis. As the framework continues to be integrated into healthcare systems, ongoing evaluation and tracking of patient outcomes will provide valuable insights into its effectiveness and potential areas for improvement in communicating the crisis. Through strategic and empathetic patient-centered communication, physicians can play a crucial role in supporting patients during the national drug shortage crisis, ensuring that patients' voices are heard and their needs are addressed with compassion and understanding when communicating the crisis.

National Drug Shortages Affect Patient Care.

Navigating record-high, ongoing shortages.

National Drug Shortages – Broken Supply or Broken Chain? It Is Time to End the ‘Race to the Bottom’

Features| June 2023 National Drug Shortages – Broken Supply or Broken Chain? It Is Time to End the ‘Race to the Bottom’ Umar Kamal, MD; Umar Kamal, MD Search for other works by this author on: This Site PubMed Google Scholar Taysir Awad, MD; Taysir Awad, MD Search for other works by this author on: This Site PubMed Google Scholar Beenish Khurshid, BS Beenish Khurshid, BS Search for other works by this author on: This Site PubMed Google Scholar ASA Monitor June 2023, Vol. 87, 22–23. https://doi.org/10.1097/01.ASM.0000938824.54441.3b Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn Email Cite Icon Cite Get Permissions Search Site Citation Umar Kamal, Taysir Awad, Beenish Khurshid; National Drug Shortages – Broken Supply or Broken Chain? It Is Time to End the ‘Race to the Bottom’. ASA Monitor 2023; 87:22–23 doi: https://doi.org/10.1097/01.ASM.0000938824.54441.3b Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll PublicationsASA Monitor Search Advanced Search Topics: medication shortages Albuterol, bupivacaine, hydrocortisone, and dopamine – these are only four of the approximately 260 drugs that have experienced national shortages over the past 12 months (asamonitor.pub/41eZ3Hx; asamonitor.pub/40TNKVa). These scarcities have led to treatment delays, rationing, and, in some cases, changes to therapeutic plans (asamonitor.pub/3mxTgh5). Substitutes and alternative therapies have led to medication errors and patient harm (asamonitor.pub/3UCjdZy). In addition to these direct patient costs, there is a significant financial loss associated with addressing the ongoing shortages. Nationally, hospitals incurred an additional $229.7 million per year in costs between 2011 and 2013 because of more expensive generic replacements for shortage drugs. This figure does not include indirect costs of off-contract purchases, therapeutic alternatives, or additional labor requirements (asamonitor.pub/43wqhuP). This danger to public health and safety is particularly pertinent for anesthesiologists because the growing list of critical, lifesaving medications in short supply is... You do not currently have access to this content.

209 - Incidence of Early Toxicities and Mortality after Four Types of Conditioning Regimens for Autologous Hematopoietic Cell Transplantation in Patients with Lymphoma: Impact of National Drug Shortages in a Resource-Constrained Country

209 - Incidence of Early Toxicities and Mortality after Four Types of Conditioning Regimens for Autologous Hematopoietic Cell Transplantation in Patients with Lymphoma: Impact of National Drug Shortages in a Resource-Constrained Country

National and transnational drug shortages: a quantitative descriptive study of public registers in Europe and the USA

BackgroundDrug shortages are a growing global problem, posing clinical and economic challenges. To understand them better, we conducted an inventory of national public drug shortage registers and their comparability in Europe and the USA.MethodsThe study was based on openly accessible drug shortage notifications published by national drug authorities. These data were obtained from all national data sources mentioned on the European Medicines Agency’s (EMA’s) web page and FDA in the USA. After selection of the countries with comparable data, descriptive statistics were used to present characteristics of the shortages both across countries and within countries for 9 months (January–September) in 2020. We studied whether the shortages that occurred in these countries were the same, and how shortages were distributed by therapeutic uses and formulations. We also investigated price variation between the United States and Finland among drugs in shortage in one formulation category (creams and gels).ResultsFinland, Sweden, Norway, Spain, and the United States had suitable registers and were included. Altogether 5132 shortage reports from Finland (n = 1522), Sweden (n = 890), Norway (n = 800), Spain (n = 814), and the United States (n = 1106) were published during the study period. Of active ingredient level shortages 54% occurred in only one country, and 1% occurred in all five. However, at the country level, where there was one or more shortage notifications in an ATC active ingredient category, 19–41% were in a single country.The distributions by ATC therapeutic class and drug formulation differed substantially between countries, particularly between the USA and European countries. Injectables had a high shortage risk in the USA (57% of all shortages versus 17–31% of all shortages in the European countries). By contrast, shortages in gels and creams occurred only in European data (4–6% of all shortages). In the price comparison, creams and gels in shortage in Finland were 160% more expensive in the USA where these shortages were not detected.ConclusionsPublic drug shortage registers are vital data sources for proactively maintaining and managing a reliable drug supply. However, our study demonstrates that much work remains to standardize the contents and quality of public register data.Shortages may not be solely a consequence of manufacturing disruptions but may reflect other contributing factors in the international drug distribution and supply mechanisms, including price differences and profit margins between national pharmaceutical markets. Data to perform practical and useful international comparisons to understand these shortages are required.

ACE Question

Article| May 2022 ACE Question ASA Monitor May 2022, Vol. 86, 16. https://doi.org/10.1097/01.ASM.0000830808.15004.67 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Facebook Twitter LinkedIn MailTo Cite Icon Cite Get Permissions Search Site Citation ACE Question. ASA Monitor 2022; 86:16 doi: https://doi.org/10.1097/01.ASM.0000830808.15004.67 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll PublicationsASA Monitor Search Advanced Search Topics: anesthesiology continuing education (ace) Due to national drug shortages, your facility is unable to obtain bupivacaine. You are planning a peripheral nerve block, and the only preservative-free local anesthetic available is 1.5% mepivacaine. What would be the MOST likely result of using mepivacaine in comparison to bupivacaine? Mepivacaine is an intermediate-potency amide local anesthetic that can be used for peripheral nerve blockade. It is commonly available in a 1.5% concentration. When compared to longer-duration agents such as bupivacaine, the following differences are commonly noted: The addition of epinephrine (1:200,000) will prolong the action of local anesthetics administered for a peripheral nerve block. The extent of this prolongation is greater with intermediate-acting agents such as mepivacaine than with longer-acting agents such as bupivacaine. Anesthesiology Continuing Education (ACE) is a self-study CME program that covers established medical knowledge in the field of anesthesiology. ACE can help fulfill the CME requirements of MOCA®. To learn... You do not currently have access to this content.

Evaluation of Prolonged Versus Continuous Infusions of Piperacillin/Tazobactam During Shortages of Small Volume Parenteral Solutions

Background: In 2017, a national drug shortage of small volume solutions significantly affected the preparation of intravenous antibiotics. In response, a continuous infusion administration protocol for piperacillin/tazobactam (PIP/TAZ) was implemented. Objective: To compare the outcomes of continuous to prolonged infusions of PIP/TAZ in the setting of drug shortages. Methods: This study is a single-center, retrospective cohort study in a community hospital of patients 18 years and older who received intravenous PIP/TAZ through 2 different dosing strategies of intravenous antibiotics from December 2016 to January 2018. Data were collected for 2 months on patients receiving prolonged infusions of PIP/TAZ prior to November 2017 and for 2 months on patients receiving continuous infusions of PIP/TAZ after November 2017. Results: A total of 90 patients who received PIP/TAZ via either prolonged (n = 47) or continuous infusion (n = 43) were evaluated. There were no differences between the groups in mortality (3 vs 2 deaths, P = 1.00), length of therapy (6 ± 4 vs 6 ± 3 days, P = .86), or length of stay (9 ± 7 vs 8 ± 6 days, P = .47). Additionally, no differences were noted between incidences of thrombocytopenia ( P = .41), Clostridioides difficile infection ( P = .48), acute renal failure ( P = 1.00), seizures ( P = 1.0), or 30-day readmission rates ( P = .27). Conclusions: Administration of continuous infusion PIP/TAZ appears to be a viable mitigation strategy during small volume fluid shortages. Future cost-effectiveness studies may provide information on the financial impact of continuous infusions during costly drug shortages.

Incidence and Outcomes of Heparin-Induced Thrombocytopenia Associated with a Heparin Shortage at a Large Academic Medical Center

Heparin-induced thrombocytopenia (HIT) is a life-threatening complication associated with significant morbidity and mortality in hospitalized patients. The 2019 African swine fever outbreak in China resulted in a critical national shortage of porcine-derived heparin products in the United States. As a result, our institution implemented a multitude of mitigation strategies to reduce heparin utilization by >80% and optimize safe and effective alternative therapies. The aim of this study was to determine whether this change in clinical practice impacted the incidence of HIT and associated outcomes. A single-center, retrospective cohort study was performed on patients admitted to Massachusetts General Hospital who were ≥ 18 years of age and had a positive platelet factor 4 (PF4) drawn between February 2019 and January 2020. Patient demographics, comorbidities, baseline labs, serotonin release assay results, timing and magnitude of platelet count fall, and characteristics of heparinoid and non-heparinoid anticoagulant use were collected from the medical record. Thrombotic and hemorrhagic outcomes were characterized. Seventy-five patients were included in the final analysis, of which 56 (75%) were critically-ill. Baseline characteristics were similar between groups including median age 66.8 years, 49% male, 80% Caucasian. Forty-four (59%) patients underwent surgery, 23 (31%) required continuous renal replacement therapy, and 13 (17%) underwent extracorporeal membrane oxygenation. Incidence of HIT with any exposure to heparinoid product was 0.3% and 0.15% (p=0.002) in the pre-shortage and shortage periods, respectively. In those who received therapeutic dose unfractionated heparin, incidence of HIT was 1.26% and 1.05% (p=0.63) in the pre-shortage and shortage groups, respectively. Thrombotic complications were observed in 19 (41%) patients in the pre-shortage group and 11 (38%) in the post-shortage group (p=0.77). Bleeding events were observed in 8 (17%) and 5 (17%) (p=0.99). We observed a lower incidence of HIT resulting from our institution's efforts to conserve unfractionated heparin supply and utilize alternative anticoagulants during a critical national drug shortage. There were no significant differences in associated thrombotic and bleeding events. Disclosures Rosovsky: Bristol-Myers Squibb, Dova, Janssen, Portola: Consultancy; Bristol-Myers Squibb, Janssen: Research Funding.

Critical Obstetric Patients During the Coronavirus Disease 2019 Pandemic: Operationalizing an Obstetric Intensive Care Unit.

Critical Obstetric Patients During the Coronavirus Disease 2019 Pandemic: Operationalizing an Obstetric Intensive Care Unit.

COVID-19 pandemic: Challenges and solutions from the cardiology pharmacist's perspective.

The recent coronavirus disease 2019 (COVID‐19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) challenges pharmacists worldwide. Alongside other specialized pharmacists, we re‐evaluated daily processes and therapies used to treat COVID‐19 patients within our institutions from a cardiovascular perspective and share what we have learned.To develop a collaborative approach for cardiology issues and concerns in the care of confirmed or suspected COVID‐19 patients by drawing on the experiences of cardiology pharmacists across the country.On March 26, 2020, a conference call was convened composed of 24 cardiology residency‐trained pharmacists (23 actively practicing in cardiology and 1 in critical care) from 16 institutions across the United States to discuss cardiology issues each have encountered with COVID‐19 patients. Discussion centered around providing optimal pharmaceutical care while limiting staff exposure.The collaborative of pharmacists found for the ST‐elevation myocardial infarction patient, many institutions were diverting COVID‐19 rule‐out patients to their Emergency Department (ED). Thrombolytics are an alternative to percutaneous coronary intervention (PCI) allowing for timely treatment of patients and decreased staff exposure. An emergency response grab and go kit includes initial drugs and airway equipment so the patient can be treated and the cart can be left outside the room. Cardiology pharmacists have developed policies and procedures to address monitoring of QT prolonging medications, the use of inhaled prostacyclins, and national drug shortages. Technology has allowed us to practice social distancing, while staying in close contact with our teams, patients, and colleagues and continuing to teach. Residents are engaged in unique decision‐making processes with their preceptors and assist as pharmacist extenders.Cardiology pharmacists are in a unique position to work with other pharmacists and health care professionals to implement safe and effective practice changes during the COVID‐19 pandemic. Ongoing monitoring and adjustments are necessary in rapidly changing times.

Redistribution of short-dated emergency medications as a cost avoidance and drug shortage management strategy.

This study aimed to develop a process to reduce waste through redistribution of short-dated medications in emergency drug boxes and assess associated cost avoidance. Short-dated medication items (defined as those expiring within 4 months) from more than 200 emergency drug boxes located throughout a large academic medical center were collected, sorted, and counted during two 3-month time periods. Medications expiring within 2 weeks were discarded. Remaining short-dated medications were redistributed to satellite pharmacies and the emergency department based on historical utilization patterns. The counts and costs of redistributed medications were collected and totaled. Results were compared between study periods to assess differences in numbers of drugs redistributed and the associated cost avoidance. A total of 4,415 short-dated medication items were collected during the study periods. The medication items associated with the highest cost avoidance were epinephrine 1 mg/mL, 30-mL vial (cost avoidance of $25,764), phenylephrine 10 mg/mL, 1-mL vial (cost avoidance of $8,626), and naloxone 0.4 mg/mL, 1-mL vial (cost avoidance of $5,382). The estimated total annualized cost avoidance was $104,357 for the first period and $144,674 for the second period. Of the 16 unique medications stocked in emergency drug boxes, 12 were in short supply at the institution at the time of the project, and about 67% of the redistributed items were subject to national drug shortages. A process that facilitates appropriate redistribution of short-dated emergency drug box medications can reduce medication waste and lead to substantial cost avoidance.

A Comparison of Etomidate, Ketamine, and Methohexital in Emergency Department Rapid Sequence Intubation.

Rapid sequence intubation (RSI) is routinely used for emergent airway management in the emergency department (ED). It involves the use of induction, and paralytic agents help facilitate endotracheal tube placement. In response to a previous national drug shortage resulting in the use of alternative induction agents for RSI, we describe the effectiveness and safety of ED RSI with ketamine or methohexital compared with etomidate. We conducted a retrospective, single-center observational study from March 1-August 31, 2012 describing RSI with etomidate, ketamine, and methohexital. All adult patients undergoing RSI in the ED who received etomidate prior to its shortage and methohexital or ketamine during the shortage were included. The study included 47, 9, and 26 patients in the etomidate, ketamine, and methohexital groups, respectively. Successful intubation on the first attempt occurred in 74.5%, 55.6%, and 73.1% of the etomidate, ketamine, and methohexital groups, respectively. The mean number of intubation attempts and time to intubation seemed to be similar in all groups. At least three intubation attempts were required in 22.2% and 7.7% of the ketamine and methohexital groups, respectively, compared with none in the etomidate group. Two aspirations were observed in the etomidate group. Methohexital and etomidate had similar rates of successful intubation on the first attempt and seem to be more effective than ketamine. Etomidate may reduce the need for three or more intubation attempts. Larger, prospective studies are needed to determine if ketamine or methohexital are more effective than etomidate for RSI.

National drug shortages worsen during COVID-19 crisis: Proposal for a comprehensive model to monitor and address critical drug shortages.

DisclaimerIn an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Do intravenous fluid substitutions influence methotrexate clearance? An unanticipated impact of an intravenous sodium bicarbonate drug shortage.

National drug shortages of essential medications for childhood cancer have increasingly posed a challenge in the treatment of patients. The efficacy of standardized supportive care practices to avoid treatment-related toxicities may be limited during these drug shortages. High-dose methotrexate (HDMTX) plays a critical role in modern treatment protocols for acute lymphoblastic leukemia and requires stringent supportive care measures to mitigate toxicity. As the result of a national intravenous (IV) sodium bicarbonate shortage, institutional standard HDMTX supportive care guidelines had to be modified. We describe the unanticipated consequences on HDMTX clearance. We performed a retrospective chart review assessing the impact of alternative compositions of IV fluids on the mean 24-h methotrexate levels (Cpss ) of 25 patients receiving 76 total HDMTX infusions at Texas Children's Hospital Cancer Center from March to October 2017. During the sodium bicarbonate drug shortage, all patients received IV hydration consisting of either dextrose 5%, 0.45% normal saline (D5 ½ NS-Group A) or dextrose 5%, 0.2% normal saline (D5 ¼ NS-Group B). Patients receiving a higher total sodium dose demonstrated significantly lower Cpss (25.36 ± 16.6 μMol) compared to patients receiving less sodium (53.9 ± 37.9 μMol; P<.001). Our report shows that in the setting of IV sodium bicarbonate shortage, the composition of hydration IV fluids may affect methotrexate clearance. Patient who received a higher sodium load had a lower 24-h methotrexate level. This demonstrates the potential for unanticipated outcomes resulting from national drug shortages.

Impact of order entry alerts and modifications on doses of intravenous opioids dispensed during a national drug shortage.

To address the intravenous (i.v.) opioid shortage, computer-based alerts and modifications were implemented over 2 phases beginning in August 2017 and February 2018, respectively. A study was conducted to assess the impact of these interventions on dispenses of intermittent doses of i.v. opioids during a national shortage. A retrospective, single-center, pre- and postimplementation study was conducted to compare opioid dispenses from September 2017 through December 2017 (phase 1) and March 2018 through May 2018 (phase 2) with dispenses during the same time periods of the previous year (historical control periods). Dispense data for intermittent doses of i.v. fentanyl, hydromorphone, and morphine and select oral opioids were collected from automated dispensing cabinets (ADCs) located in nonprocedural areas. The primary endpoint was the percentage of total intermittent doses of i.v. and oral opioids that were dispensed for i.v. administration. A subanalysis accounting for unit type was conducted. Key secondary endpoints were the numbers of oral and i.v. opioid dispenses by month. The final analysis included data from 92 ADCs. The percentage of i.v. opioid dispenses significantly decreased, by 9.8% during phase 1 (P < 0.0001) and by 16.8% during phase 2 (P < 0.0001) compared to dispenses during the historical control periods. These decreases were significant across all unit types except pediatric units during phase 1. Average monthly dispenses of i.v. opioids were 49.9% and 74.2% fewer than dispenses during the historical control periods after the phase 1 and phase 2 implementations, respectively. Order entry alerts and modifications significantly decreased dispenses of intermittent doses of i.v. opioids during a national shortage, with demonstrated sustainability of decreases over 7 months.

Addressing Cancer Treatment Shortages in Saudi Arabia: Results of a National Survey and Expert Panel Recommendations.

PURPOSECancer treatment shortages are complex and a persistent problem worldwide. Patients with cancer are most vulnerable to drug shortages, which provides opportunities to examine the extent of the challenge(s) facing Saudi Arabia and to provide recommendations toward mitigating the impact of cancer treatment shortages on patient outcomes.MATERIALS AND METHODSA qualitative methodologic approach was conducted in April 2019 using a validated questionnaire and structured panel discussion for data generation.RESULTSOverall, 55 responses were received from practicing oncology health care professionals (26 pharmacists and 29 physicians). The annual average number of treated patients with cancer per institution was 640 (adults [n = 400] and pediatric [n = 240]). All respondents (100%) reported that cancer treatment shortages constitute a current problem in their center, with an average of 5 (range, 1-9) per month. The panelists recognized 2 fundamental points. First, the definition of cancer drug shortages should be standardized and recognized at the national level. Second, the current system must be improved to ensure proper and efficient use of the current resources. On that basis, the panelists developed 9 recommendations for action.CONCLUSIONCancer drug shortage is a significant problem in all health centers in Saudi Arabia. This study presents challenges that should be addressed at the national level and essential consensus recommendations for a coordinated action developed by a panel of experts to tackle the current national problem of cancer treatment shortages. Implementing these recommendations will provide a blueprint for management of national drug shortages in general and cancer treatment shortages in particular.

Comparison of Neonatal Outcomes With the Use Cefotaxime Versus Ceftazidime in a Neonatal Intensive Care Unit.

There is a national drug shortage of cefotaxime, and ceftazidime is recommended as an alternative to cefotaxime for neonates. This study evaluated culture-positive late-onset sepsis (LOS), multidrug resistant organisms (MDROs), and other neonatal outcomes with the use of ceftazidime compared with cefotaxime in neonates. This was a single-center, retrospective cohort study of neonatal subjects who received at least 24 hours of ceftazidime or cefotaxime between April 1, 2015, and August 1, 2017. Subjects were excluded if they received the alternate antibiotic for more than 24 hours. A total of 101 subjects were included (ceftazidime, n = 58; cefotaxime, n = 43). Median gestational ages were significantly different between groups (28.1 [IQR, 25.0-36.6] weeks versus 32.3 [IQR, 26.9-37.4] in the ceftazidime and cefotaxime groups, respectively, p < 0.05). Results showed a non-statistically significant increased incidence of culture-positive LOS (17.2% versus 2.3%, respectively, adjusted OR 6.51 [95% CI, 0.78-55.23], p = 0.09) and MDRO infections (5.2% versus 0%, respectively, p = 0.26) with the use of ceftazidime compared with cefotaxime. There was a statistically significant increased risk of stage II to III necrotizing enterocolitis (NEC) with the use of ceftazidime (22.4% versus 2.3%, respectively, adjusted OR 9.68 [95% CI, 1.18-79.45], p = 0.04). This study found a statistically significant increase in stage II to III NEC with the use of ceftazidime compared with cefotaxime. There was a higher rate of culture-positive LOS and MDRO infections with ceftazidime, but this was not significant. Further research is warranted to assess the implications ceftazidime use in neonates.

Assessment of Electrolyte Replacement in Critically Ill Patients During a Drug Shortage.

Purpose: The purpose of this study was to determine if national drug shortages of electrolyte replacement products negatively impact patient care. Methods: This study was a single-center, retrospective, observational cohort of adults admitted to the medical, surgical, or trauma intensive care unit (ICU) that were ordered or would have qualified for the general or continuous renal replacement therapy electrolyte replacement protocol (ERP) between April 2017 and August 2018. In October 2017, ERP use was suspended and enteral replacement was promoted due to inability to maintain consistent inventory of intravenous replacement products. The primary objective was to compare the percentage of patient days that at least 1 critically low value of potassium, magnesium, and/or phosphorus existed between protocolized and nonprotocolized electrolyte replacement. Secondary objectives included characterizing the ratio of enteral replacement to duration of critically low electrolyte values during protocolized and nonprotocolized electrolyte replacement. Results: A total of 288 patients were included. The mean percentage of ICU days with low electrolyte levels in the protocolized period was significantly higher than in the nonprotocolized period (21.4% vs 17.5%, P = .0238). There was a negative relationship between the total electrolyte replacement that was given enterally and the percentage of patient days with critically low values indicating that as enteral replacement increased, percentage of days with low values decreased. The association between percentage of enteral replacement and days with critically low electrolyte values was significantly lower in the protocolized period. Conclusion: Intravenous electrolyte replacement product shortages did not result in an increased incidence of critically low electrolyte values. Enteral replacement was associated with a decreased incidence of low electrolyte values.