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

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Seizure control and complications in patients switching from clobazam to clonazepam due to drug shortage.

BACKGROUND: Antiseizure medication (ASM) shortages are a global problem that have a negative impact on outcomes such as seizure control in patients with epilepsy (PWE). In the case of clobazam (CLB) shortage, there is no study regarding the management strategy. This study aims to investigate the alteration in seizure frequency and the occurrence of side effects in PWE undergoing an abrupt switch from clobazam (CLB) to clonazepam (CLZ), during CLB shortage. MATERIAL AND METHODS: A retrospective study was conducted from electronic health records at our neurology outpatient clinic from January to July 2022. Change in seizure frequency and percentage of CLZ-associated side effects were determined as primary and secondary outcomes, respectively. Potential drug-drug interactions (Level C and above) were evaluated by using Lexicomp Drug Interaction Checker. RESULTS: The analysis included a total of 29 adult patients (15F, median age: 29). The switching ratio was 10 mg CLB for every 1 mg CLZ (10:1). Seizure frequency was higher during the CLZ period compared to the CLB period (p < 0.05), but no status epilepticus cases were observed. All patients exhibited potential drug-drug interactions, leading to reduced CLZ levels in 12 cases. A total of 36 CLZ-associated side effects were identified, with fatigue (19.4 %), drowsiness (16.6 %), and somnolence (13.8 %) being the most prevalent. A positive and strong correlation was found between CLZ dose and the number of side effects (r: 0.556; p: 0.002). CONCLUSION: The abrupt switch from CLB to CLZ was observed to increase seizure frequency without leading to status epilepticus in PWE. CLZ-associated side effects were found to be tolerable despite the abrupt switch. Future studies may explore the effect of alternative switching ratios.

Identifying Medicine Shortages With the Twitter Social Network: Retrospective Observational Study.

BACKGROUND: Early identification is critical for mitigating the impact of medicine shortages on patients. The internet, specifically social media, is an emerging source of health data. OBJECTIVE: This study aimed to explore whether a routine analysis of data from the Twitter social network can detect signals of a medicine shortage and serve as an early warning system and, if so, for which medicines or patient groups. METHODS: Medicine shortages between January 31 and December 1, 2019, were collected from the Dutch pharmacists' society's national catalog Royal Dutch Pharmacists Association (KNMP) Farmanco. Posts on these shortages were collected by searching for the name, the active pharmaceutical ingredient, or the first word of the brand name of the medicines in shortage. Posts were then selected based on relevant keywords that potentially indicated a shortage and the percentage of shortages with at least 1 post was calculated. The first posts per shortage were analyzed for their timing (median number of days, including the IQR) versus the national catalog, also stratified by disease and medicine characteristics. The content of the first post per shortage was analyzed descriptively for its reporting stakeholder and the nature of the post. RESULTS: Of the 341 medicine shortages, 102 (29.9%) were mentioned on Twitter. Of these 102 shortages, 18 (5.3% of the total) were mentioned prior to or simultaneous to publication by KNMP Farmanco. Only 4 (1.2%) of these were mentioned on Twitter more than 14 days before. On average, posts were published with a median delay of 37 (IQR 7-81) days to publication by KNMP Farmanco. Shortages mentioned on Twitter affected a greater number of patients and lasted longer than those that were not mentioned. We could not conclusively relate either the presence or absence on Twitter to a disease area or route of administration of the medicine in shortage. The first posts on the 102 shortages were mainly published by patients (n=51, 50.0%) and health care professionals (n=46, 45.1%). We identified 8 categories of nature of content. Sharing personal experience (n=44, 43.1%) was the most common category. CONCLUSIONS: The Twitter social network is not a suitable early warning system for medicine shortages. Twitter primarily echoes already-known information rather than spreads new information. However, Twitter or potentially any other social media platform provides the opportunity for future qualitative research in the increasingly important field of medicine shortages that investigates how a larger population of patients is affected by shortages.

Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database.

AIM: Drug shortages are a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French National Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, 95% confidence interval [CI] 17.5-27.0%), the cardiovascular system (16.4%, 95% CI 11.9-21.4%) and anti-infectives for systemic use (14.3%, 95% CI 9.7-19.2%) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, 95% CI 18-24%), skin and subcutaneous (14%, 95% CI 11-17%), general (13%, 95% CI 10-17%) and gastrointestinal (8%, 95% CI 5-11%) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (MEs) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasizes the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.

Impact of histamine-2 antagonist shortage on the incidence of hypersensitivity reactions to paclitaxel: a reconsideration of premedication protocols in France (PACLIREACT Study).

PURPOSE: An international shortage of ranitidine led to adjustments in premedication regimens for paclitaxel-based chemotherapy in early October 2019. In this study, we implemented and evaluated an anti-allergic protocol without histamine-2 antagonists (H2As) and aimed to assess the risk of hypersensitivity reactions (HSRs) to the different premedication regimens used. METHODS: We conducted a single-center observational retrospective study of paclitaxel administrations (7173 administrations in 831 patients). Between January 2019 and December 2020, all allergies reported were recorded. A mixed logistic regression model was implemented to predict the risk of allergy at each injection and to account for repeated administration per patient. RESULTS: A total of 27 HSRs occurred in 24 patients. No protective effect was observed for H2A when comparing paclitaxel injections with H2A premedication versus without H2A (OR = 1.12, p = 0.84). There was also no significant difference in risk of HSR for famotidine versus ranitidine (OR = 0.79, p = 0.78). However, the risk of HSRs was significantly lower for paclitaxel injections with corticosteroids than for those without (OR = 0.08, p = 0.03). In addition, the risk of HSR was significantly higher for the first, second, or third paclitaxel injections than for the subsequent injections (OR = 10.1, p < 0.001). CONCLUSION: We did not find substantial evidence of an increased risk of HSR due to the absence of H2A in the premedication protocols for paclitaxel. Thus, in contrary to the existing literature on paclitaxel, our findings support the use of a premedication protocol without H2A.

Shortages of agents used to treat antimuscarinic delirium.

INTRODUCTION: Antimuscarinic delirium (AD), a potentially life-threatening condition frequently encountered by emergency physicians, results from poisoning with antimuscarinic agents. Treatment with physostigmine and benzodiazepines is the mainstay of pharmacotherapy, and use of dexmedetomidine and non-physostigmine centrally-acting acetylcholinesterase inhibitors (cAChEi) such as rivastigmine has also been described. Unfortunately, these medications are subject to drug shortages which negatively impact the ability to provide appropriate pharmacologic treatment of patients with AD. METHODS: Drug shortage data were retrieved from the University of Utah Drug Information Service (UUDIS) database from January 2001 through December 2021. Shortages of first-line agents used to treat AD (physostigmine and parenteral benzodiazepines) and second-line agents (dexmedetomidine and non-physostigmine cAChEi) were examined. Drug class, formulation, route of administration, reason for shortage, shortage duration, generic status, and whether the drug was a single-source product (made by only one manufacturer) were extracted. Shortage overlap and median shortage durations were calculated. RESULTS: Twenty-six shortages impacting drugs used to treat AD were reported to UUDIS from January 1, 2001 to December 31, 2021. Median shortage duration for all medication classes was 6.0 months. Four shortages were unresolved at the end of the study period. The single medication most often on shortage was dexmedetomidine, however benzodiazepines were the most common medication class on shortage. Twenty-five shortages involved parenteral formulations, and one shortage involved the transdermal patch formulation of rivastigmine. The majority (88.5%) of shortages involved generic medications, and 50% of products on shortage were single-source. The most common reported reason for shortage was a manufacturing issue (27%). Shortages were often prolonged and, in 92% of cases, overlapped temporally with other shortages. Shortage frequency and duration increased during the second half of the study period. CONCLUSION: Shortages of agents used in the treatment of AD were common during the study period and affected all agent classes. Shortages were often prolonged and multiple shortages were ongoing at study period end. Multiple concurrent shortages involving different agents occurred, which could hamper substitution as a means of mitigating shortage. Healthcare stakeholders must develop innovative patient- and institution-specific solutions in times of shortage and work to build resilience into the medical product supply chain to minimize future shortages of drugs used for treatment of AD.

How Technical Innovations May Help to Prevent Drug Shortages in Switzerland.

In this work, we investigated the technical feasibility of 'on-demand' production of selected drugs to cover their demand for a time window of 90 days. We focused on two sub-processes 'automated chemical synthesis' and 'formulation in micropellets'  to enable personalized dosing. The production of drugs 'on-demand' is challenging, important, but also attractive. Switzerland could thus gain access to an additional instrument for increasing resilience for supply-critical drugs. The biggest challenge in the case study presented here is the scalability of automated chemical synthesis and the application range of micropellet formulations.

[Evaluation of the organisational and clinical impacts of supply chain problems in a university hospital]. / Évaluation des impacts organisationnels et cliniques des ruptures de médicaments au sein d'un centre hospitalier universitaire.

Drug supply problems are a real public health concern. Despite the implementation of legal measures, this problem is still relevant, with potential clinical, organizational and financial consequences in hospitals. The objective is to evaluate the organizational and clinical impact of supply problems in a hospital. A retrospective study of the supply problems encountered in our institution made it possible to classify them according to different criteria using an algorithm. A mapping of the organizational impact of the resolution of each supply problem according to the internal organization of the medication circuit was developed. The potential clinical impact of each problem identified was assessed using a 4-level scale. Over an 18-month period, 332 supply problems were recorded, 78 % of which were classified as a stock-outs. Over the entire study, 2415 organizational impact points were identified, with 2019 impacts for the pharmacy department and 396 impacts for the healthcare departments. Approximately 90 % of the drugs with a supply problem were drugs of major therapeutic interest. In 49 % of the situations, they have a lesser clinical impact as soon as shortage management is put in place. The characterization of the different management methods has made it possible to systematically identify and predict the impact on the entire medication circuit. The impact on the patient is thus limited if the management of the supply problem is well anticipated by the pharmacist. The pharmacist plays an important role in managing supply problems, but also in providing support to the care services.

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

BACKGROUND: Drug 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. METHODS: The 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). RESULTS: Finland, 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. CONCLUSIONS: Public 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.

Immunoglobulin shortage: Practice modifications and clinical outcomes in a reference centre.

BACKGROUND: Growing numbers of indications for intravenous immunoglobulins (IVIg) in recent years has resulted in an increase in the consumption of these products. A lack of raw material has led to IVIg shortage. The objective of this work was to evaluate the impact of this situation on patient care in one French referral centre considering practice modifications and clinical impact. METHODS: All patients treated with IVIg for chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and myasthenia gravis from October 2017 to October 2018 were included. RESULTS: Out of 142 patients, 111 (78%) had a modification of their IVIg treatment. We noted that 75 (68%) patients had a delay in IVIg treatment, 41 (37%) patients had a decrease in IVIg doses and 31 (28%) experienced IVIg treatment interruption. Thirty percent of patients for whom IVIg treatment was discontinued were switched to other treatments mainly plasma exchange (16%) or corticosteroids (13%). Switches to plasma exchange or corticosteroids were carried out in order to save immunoglobulins for patients who had no other alternatives. Fifty-eight (52%) patients presented a deterioration of their clinical score after IVIg treatment changes including 31 (28%) patients who had a moderate or a clinically significant deterioration. Concerning practice modifications, we noted a substantial though not significant decrease in median IVIg dose for myasthenia gravis and a significant increase in the delay between IVIg courses for chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy (P=0.011 and P=0.018 respectively). CONCLUSION: Our study showed a rather important number of changes in IVIg treatment related to IVIg shortage during the period considered. These changes had a negative impact on the clinical status of some patients.

Impact of the Injectable Opioid Drug Shortage on Analgesia and Sedation Management in the Medical Intensive Care Unit: A Retrospective Cohort Study.

Objectives: The purpose of this study was to assess the impact of the injectable opioid drug shortage on analgesia and sedation management in the medical intensive care unit (MICU). Methods: A single-center, retrospective cohort study was conducted of mechanically ventilated patients during the injectable opioid shortage. Outcomes were compared between a cohort of patients during the intravenous (IV) opioid shortage (01/01/18-03/31/18) and a control cohort (01/01/17-03/31/17). Total IV opioids and alternative sedative administration were assessed. Richmond Agitation Sedation Score (RASS) and Clinical Pain Observation Score (CPOT) assessments were also evaluated. The primary outcome was percentage of RASS within goal. Secondary outcomes included duration of mechanical ventilation, hospital/ICU length of stay, and mortality. Results: One hundred patients were included (50 patients per cohort). In the shortage cohort, 23.2% fewer IV opioids were used (40 501.8 vs 52 713.8 oral morphine equivalents [OME]). No statistical differences were found in percentage of patients within goal RASS between the shortage and control (median 63.7% vs 74.8%; P = .094) or CPOT (median 49.7% vs 47.7%; P = .575). More patients received enteral opioids and propofol on day 1 in the shortage cohort when compared to the control (22% vs 4%; P = .007 and 76% vs 56%; P = .035) but there were no differences in benzodiazepine, dexmedetomidine, or antipsychotic use. No differences in mechanical ventilation, hospital/ICU length of stay, or mortality were found. Conclusions: Use of less IV opioids during the injectable opioid shortage did not affect achievement of goal RASS and CPOT scores or increase prescribing of sedative medications such as benzodiazepines in the MICU.

Impact of Opioid Restrictions During a Critical Drug Shortage Period: Interrupted Time Series for Institutional Opioid Utilization.

OBJECTIVES: This study aimed to evaluate the impact of intravenous opioid product restrictions at an academic medical institution in an urban setting during the time of critical opioid shortages. We assessed the effect of ordering restrictions on inpatient opioid utilization measured by 1) changes in intermittent oral and injectable opioid product administration; 2) changes in total institutional opioid administration; and 3) changes in the utilization of individual restricted opioid agents. METHODS: This study is a single-center retrospective analysis by interrupted time series of institutional opioid utilization from 07/2017 to 06/2018. Utilization was quantified using milligrams of intravenous morphine equivalent administered or dispensed per admitted patient. Restrictions were grouped into 10 distinct phases, which informed the interruptions in linear regression models. RESULTS: Sequential restrictions during the study period led to shifts in use of individual agents but did not have a significant impact on overall total opioid utilization. "Soft" restrictions did not have a direct, statistically significant impact on medication use but did decrease utilization over time. In situations where a product was restricted with a "soft stop" followed by a "hard stop," the "hard stop" directly reduced usage. CONCLUSIONS: Targeted ordering restrictions allowed the institution to redirect drug use according to clinical need without affecting the overall utilization. Clinical decision support led providers to choose therapeutically equivalent alternatives. The demonstrated effect of restrictions will guide institutions in the selection of "hard stop" or "soft stop" restrictions in response to future shortages.

Impact of a cefepime shortage on dosing regimens and outcomes in hospitalized adults with febrile neutropenia.

BACKGROUND: Drug shortages may negatively impact outcomes in hospitalized patients. A cefepime dosing regimen of 1 gram every 6 hours (1 g q6h) has shown to provide similar exposures above target minimum inhibitory concentrations compared to the regimen of 2 g q8h approved by the United States Food and Drug Administration (FDA) for febrile neutropenia. Our objective was to determine if the dosing regimen of 1 g q6h amidst a cefepime shortage is an appropriate alternative for the treatment of febrile neutropenia. METHODS: A retrospective chart review of hospitalized patients who received cefepime for febrile neutropenia over a two-year period was performed. Patients were grouped based on cefepime dosing strategy: 2 g q8h vs. 1 g q6h. The primary objective was to compare time to defervescence after cefepime initiation. Secondary objectives included all-cause 30-day mortality, duration of antibiotic therapy, and inpatient length of stay. RESULTS: Seventy-five patients in each arm were included. There were no differences in baseline age or severity of illness between groups. There was no difference in the primary objective as median time to defervescence was similar between the 2 g q8h and 1 g q6h groups (69.0 vs. 65.3 h: p= 0.67). Additionally, no differences were found in the secondary objectives of all-cause 30-day mortality (10.7% vs. 9.3%: p = 0.79), duration of therapy (80.8 vs. 88.0 h: p = 0.34), or length of stay (9 vs. 7 days: p = 0.50). CONCLUSIONS: Our study identified no differences in clinical outcomes with cefepime 1 g q6h compared to the traditional FDA-approved 2 g q8h regimen for the treatment of febrile neutropenia.

Effects of the cefazolin shortage on the sales, cost, and appropriate use of other antimicrobials.

BACKGROUND: Shortages of antimicrobials lead to treatment failures, increase medical costs, and accelerate the development of antimicrobial resistance. We evaluated the effects of the serious cefazolin shortage in 2019 in Japan on the sales, costs, and appropriate use of other antimicrobials. METHODS: We evaluated monthly defined daily doses/1000 inhabitants/day (DID) values of antimicrobial sales from January 2016 to December 2019 using wholesaler's sales databases. Using 2016-2018 sales data, we generated a prediction model of DID in 2019 under the assumption that the cefazolin shortage did not occur. We then compared the predicted DID and actual DID. Cefazolin, government-recommended alternatives, and government-not-recommended broad-spectrum alternatives were assessed. Antimicrobial groups according to the AWaRe classification were also assessed to evaluate the effect on appropriate antimicrobial use. In addition, we evaluated changes in costs between 9 months before and after the cefazolin shortage. RESULTS: DID values of total antimicrobials increased sharply 1 month before the decrease in cefazolin. Actual DIDs were higher than predicted DIDs for ceftriaxone, flomoxef, clindamycin, cefotiam, piperacillin/tazobactam, and meropenem. Actual DID values were higher than the predicted DID values in the Watch group. The costs of antimicrobials between pre- and post- cefazolin shortage were unchanged. CONCLUSION: The cefazolin shortage brought confusion to the antimicrobial market and led to a setback in the appropriate use of antimicrobials. Early recognition and structures for prompt reactions to antimicrobial shortages are needed. Moreover, development of a system to secure the supply of essential antimicrobials is required.

Community Pharmacy Staff Knowledge, Opinion and Practice toward Drug Shortages in Saudi Arabia.

Drug shortages continue to pose a significant threat to public health and safety. Drug shortages not only worsen patient outcomes, but also significantly burden healthcare systems with additional costs. This study aimed to assess community pharmacy staff knowledge, opinion, and practice toward drug shortages in Saudi Arabia from November 2019 to March 2020. This was a cross-sectional study carried out among 1,008 community pharmacists from Saudi Arabia using a validated, self-administered and Internet-based survey. Analysis was done using chi square and fisher exact tests. Most participants were males (97.2%), less than 30 years old (48.1%), and non-Saudi citizens (94.4%), and 72.0% had good knowledge of drug shortages (score = 4-5). Around 36.0% reported that it takes 1-3 days to receive a response to the shortage report. There was a statistically significant association between the professional level of the community pharmacists and their opinion about reporting drug shortages (P < .05). Most community pharmacies (56.2%) did not receive any notification about drug shortages. In conclusion, most community pharmacists are knowledgeable and have good practice regarding drug shortages, but their opinions about drug shortages differ according to each pharmacy reporting policy.

When Pigs Fly: A Multidisciplinary Approach to Navigating a Critical Heparin Shortage.

A recent outbreak of African swine fever (ASF) in China has claimed the lives of millions of pigs, and although this virus has no health impacts on humans, the disruption of the global pig population has far-reaching negative impacts on economic and pork-derived products, including the creation of the critical drug heparin. The active pharmaceutical ingredient in heparin is derived from pig intestines, and because of the ASF outbreak, the U.S. faces an imminent shortage of heparin. This drug shortage has the potential for profound implications, as heparin is used in a substantial and varied number of medical conditions. In response to notification of the heparin shortage crisis, our institution, Massachusetts General Hospital, activated its Hospital Incident Command System to streamline organization of major stakeholders and oversee operational and clinical activities required to mitigate the potential risks and optimize alternative effective strategies. This article describes the essential elements of our institution's emergency response plan, including detailed clinical algorithms developed by our experts for maximal heparin conservation and waste reduction by promoting safe and effective alternative strategies. Through this practice, we have also identified opportunities to change providers' prescribing and utilization behaviors for the better. As the ASF has not yet been contained and this crisis continues, the strategies and policies employed by our institution can provide a framework for other institutions to tackle this ongoing challenge and future drug shortage crises. IMPLICATIONS FOR PRACTICE: A detailed description of how one institution addressed the current heparin crisis, to support heparin conservation and waste reduction, is provided. The strategies used helped decrease heparin use by 80% in less than 2 months of establishing the task force. This accomplishment can be credited to the development of a task force and strategic plan in which experts and stakeholders were quickly identified, offered a part in the decision-making process, and frequently updated. Furthermore, the response system was dynamic, accessible, and one in which challenges were recognized and acted upon. The key to any crisis management is respect for one another and constant and open communication. Heparin is such a widespread drug that this shortage can potentially affect every patient population and provider. Understanding one's institutional needs and the effect of this crisis on those needs is one of the first steps when developing a strategic plan. Continually evaluating and adjusting that approach in response to the needs of the institution are critical to its success. Moreover, as it did for the authors' institution, a constant appraisal of the strategies can lead to opportunities for improvements in organization and practice that can be sustained well beyond the crisis.

Critical Medication Shortages: Effective Strategies to Maintain Continuous Medication Availability for Emergency Medical Services.

Objective: Critical shortages of generic injectable medications are an ongoing challenge for Emergency Medical Services (EMS) systems. Mitigation strategies have been proposed to address the issue, but a limited amount of data exists quantifying the scope of the problem or describing strategies being used to ensure access to essential medications for prehospital care. In this study, we sought to quantify specific medication shortages and to determine the most frequently employed mitigation strategies to maintain medication availability in a large, regional EMS system. Methods: A survey was distributed to the 30 public advanced life support (ALS) provider agencies in Los Angeles County (LAC) to assess the prevalence of specific medication shortages and types of shortage mitigation strategies implemented. Survey responses were reviewed and presented using descriptive statistics. Results: Survey responses were received from 29 of 30 (97%) provider agencies. All but one of the responding agencies reported being impacted by medication shortages. Strategies to maintain the supply of medications included use of alternative vendors 20/28 (71%), rotating medications from low to high volume units (54%), utilizing expired medication FDA-approved extensions (50%), substituting medications (43%), borrowing medications from the LAC EMS Agency (39%) or other EMS provider agencies (32%), utilizing expired medications with medical director approval (29%), diluting medications to obtain desired concentration (18%), reducing minimum periodic automatic replacement (PAR) levels (14%), and using alternate medication concentrations/formulations (14%). The medications most frequently reported to have shortages included epinephrine (0.1 mg/mL), morphine, dextrose 10%, and normal saline. None of the provider agencies self-reported adverse events due to the shortages. Conclusions: Critical medication shortages remain a problem for many EMS systems. EMS medical directors need to implement multiple mitigation strategies to maintain supply of critical medications for prehospital patient care.

Assessment of dextrose 50 bolus versus dextrose 10 infusion in the management of hyperkalemia in the ED.

INTRODUCTION: Hypoglycemia is a common adverse effect when intravenous (IV) insulin is administered for hyperkalemia. A prolonged infusion of dextrose 10% (D10) may mitigate hypoglycemia compared to dextrose 50% (D50) bolus. Our objective was to evaluate whether D10 infusion is a safe and effective alternative to D50 bolus for hypoglycemia prevention in hyperkalemic patients receiving IV insulin. METHODS: We conducted a retrospective review of patients ≥ 18 years who presented to the emergency department (ED) with hyperkalemia (K+ > 5.5) and received IV insulin and D10 infusion or D50 bolus within 3 h. The primary endpoint was incidence of hypoglycemia, defined as blood glucose (BG) ≤ 70 mg/dL, in the 24 h following IV insulin administration for hyperkalemia. RESULTS: A total of 134 patients were included; 72 in the D50 group and 62 in the D10 group. There was no difference in incidence of hypoglycemia between the D50 and D10 groups (16 [22%] vs. 16 [26%], p = 0.77). Symptomatic hypoglycemia, severe hypoglycemia, and hyperglycemia rates in the D50 and D10 groups were [5 (7%) vs. 2 (3%), p = 0.45], [5 (7%) vs. 1 (2%), p = 0.22], and [34 (47%) vs. 23 (37%), p = 0.31] respectively. Low initial BG was a predictor for developing hypoglycemia. CONCLUSIONS: In our study, D10 infusions appeared to be at least as effective as D50 bolus in preventing hypoglycemia in hyperkalemic patients receiving IV insulin. In context of ongoing D50 injection shortages, D10 infusions should be a therapeutic strategy in this patient population.

Therapeutic alternatives and strategies for drug conservation in the intensive care unit during times of drug shortage: a report of the Ontario COVID-19 ICU Drug Task Force.

During the coronavirus disease (COVID-19) global pandemic, urgent strategies to alleviate shortages are required. Evaluation of the feasibility, practicality, and value of drug conservation strategies and therapeutic alternatives requires a collaborative approach at the provincial level. The Ontario COVID-19 ICU Drug Task Force was directed to create recommendations suggesting drug conservation strategies and therapeutic alternatives for essential drugs at risk of shortage in the intensive care unit during the COVID-19 pandemic. Recommendations were rapidly developed using a modified Delphi method and evaluated on their ease of implementation, feasibility, and supportive evidence. This article describes the recommendations for drug conservation strategies and therapeutic alternatives for drugs at risk of shortage that are commonly used in the care of critically ill patients. Recommendations are identified as preferred and secondary ones that might be less desirable. Although the impetus for generating this document was the COVID-19 pandemic, recommendations should also be applicable for mitigating drug shortages outside of a pandemic. Proposed provincial strategies for drug conservation and therapeutic alternatives may not all be appropriate for every institution. Local implementation will require consultation from end-users and hospital administrators. Competing equipment shortages and available resources should be considered when evaluating the appropriateness of each strategy.

RéSUMé: Pendant la pandémie mondiale du coronavirus (COVID-19), des stratégies urgentes pour réduire les pénuries sont nécessaires. L'évaluation de la faisabilité, de l'aspect pratique et du mérite des stratégies de préservation des médicaments et des alternatives thérapeutiques nécessite une approche collaborative au niveau provincial. Le Groupe de travail ontarien sur les médicaments à l'USI pendant la COVID-19 a reçu comme mandat d'élaborer des recommandations proposant des stratégies de préservation des médicaments et des alternatives thérapeutiques pour les médicaments essentiels utilisés dans les unités de soins intensifs courant un risque de pénurie pendant la pandémie de COVID-19. Des recommandations ont été rapidement élaborées en utilisant une méthode Delphi modifiée, puis évaluées selon leur facilité de mise en œuvre, leur faisabilité et les données probantes les préconisant. Cet article décrit les recommandations quant aux stratégies de préservation des médicaments et aux alternatives thérapeutiques aux médicaments possiblement à risque de pénurie fréquemment utilisés pour les soins des patients en état critique. Les recommandations sont identifiées comme 'à privilégier' ou 'secondaires' si moins souhaitables. Bien que la pandémie de la COVID-19 ait été l'impulsion incitant la création de ce document, ces recommandations devraient également être applicables pour réduire les pénuries de médicaments en contexte normal. Les stratégies provinciales proposées pour la préservation des médicaments et les alternatives thérapeutiques pourraient ne pas être adaptées pour toutes les institutions. La mise en œuvre locale nécessitera la consultation des utilisateurs et des administrateurs hospitaliers. Il faudrait tenir compte des pénuries de matériel concurrentes et des ressources disponibles lors de l'évaluation de la faisabilité de chaque stratégie.

The Drug Shortage Crisis in the United States: Impact on Cancer Pharmaceutical Safety.

Drug shortages pose a significant public health concern in the United States, and cancer drugs are among those most affected. Shortages present serious safety risks for patients and substantial burden on providers and the healthcare system. Multifaceted drivers of this complex problem include manufacturing disruptions, raw material shortages, regulatory issues, market dynamics, and limited financial incentives that reward quality and production of off-patent drugs. Oncology drugs in short supply have resulted in substitution of less effective or more toxic alternatives, medication errors, and treatment delays, and are especially concerning for medications with no adequate substitute. Consequently, patient outcomes such as disease progression and survival have been adversely affected. Furthermore, emerging gray markets have contributed to cost-prohibitive markups and introduction of counterfeit products that compromise patient safety. The Food and Drug Administration plays a key role in preventing and managing pharmaceutical shortages, largely through regulations requiring early notification of manufacturing interruptions. Other proposed strategies similarly target upstream causes and center on reducing regulatory hurdles for manufacturers and increasing incentives for market entry and quality improvement. Despite progress in preventing supply disruptions, continued exploration of underlying systemic drivers remains critical to informing long-term solutions and alleviating the clinical and economic impact of drug shortages.