Table 1
The Patient's Laboratory Data Before Copper Was Omitted From Parenteral Nutrition (PN), at the Time When Copper Deficiency Was Diagnosed, and 2 Months After Copper Repletion Was Started
Source publication
Recently, drug shortages in the United States have affected multiple components of the parenteral nutrition (PN) solution. A 62-year-old patient with systemic sclerosis who was dependent on home PN due to intestinal dysmotility developed anemia and leukopenia approximately 4 months after parenteral copper was withheld from her PN solution due to dr...
Citations
... 45 Copper deficiency associated with symptomatic anemia and leukopenia developed in an adult with intestinal dysmotility after receiving PN without copper for a 4-month period. 46 All cited case reports were noted to be associated with national product shortages of multi-trace element preparations. In some cases, certain individual trace element components were added, but not all were available. ...
Product shortages related to the components of parenteral nutrition (PN) therapy have been well described over the past decade. The situation has more recently worsened and expanded globally because of the impact the COVID-19 pandemic has placed on supply chain issues and workforce demand. The impact of enteral nutrition (EN) product shortages is less well documented when compared with PN, and development of management strategies is often left up to the discretion of individual providers. The recent crisis in infant formula supply has heightened the national awareness of how a nutrition support product shortage can significantly impact patient safety. This review provides a historical perspective of PN and EN product shortages to gain insight into the lessons learned and applies this to strategies for managing current and future product shortages. Strategies for managing PN and EN shortages can best succeed if they are tailored to address aspects that are unique to the inpatient and outpatient care setting. In addition, patients who transition between care settings are vulnerable to harm related to product shortages if measures are not in place to communicate and address these shortages. Teamwork and communication within an organization and among key stakeholders are necessary to develop processes that aim to minimize patient harm related to product shortages.
... In response to such challenges, the American Society for Parenteral and Enteral Nutrition (ASPEN), along with the American Society of Health-System Pharmacists (ASHP) and the Food and Drug Administration (FDA), developed guidelines on the reporting, monitoring, and alternative repletion of ETEs during times of shortage. [33][34][35][36] Consequently, several recent cases related to the clinical signs and symptoms of ETE deficiency were published on patients receiving prolonged HPN owing to shortages of parenteral Zn, [37][38][39][40][41] Cu, 38,42 or Se. 43,44 A national ASPEN survey in 2012 captured subjective information on the influence of nutrition product shortages, with approximately 70% of responders confirming that such shortages "interfere with the ability to meet patient micronutrient needs." ...
Background: Recent data on the prevalence of essential trace element (ETE)
deficiencies in home parenteral nutrition (HPN) patients are scarce. We investigated
whether ETE deficiencies are still an important issue for HPN patients
and whether the prevalence of such deficiencies may be influenced by nationwide
drug shortages.
Methods: We conducted a single-institution, retrospective analysis from 2006
to 2015 of hospitalized HPN patients who continued PN during and in between
hospitalizations. In subgroup analysis, patients were dichotomized as those with
HPN duration <1 vs ≥1 year. Zinc (Zn), copper (Cu), and selenium (Se) levels
were abstracted for patients over the study period. Prevalence of ETE deficiency
was compared using chi-squared test for patients hospitalized during nonshortage
vs shortage (2011–2014) periods.
Results: Ninety-six patients were included in the analysis. Prevalence of ETE
deficiency during nonshortage vs shortage periods was 48% vs 54% (Zn), 15% vs
21% (Cu), and 24% vs 48% (Se; P = .01), respectively. When comparing patients
who received HPN <1 year vs ≥1 year, the prevalence of Se deficiency doubled
during shortage in both subgroups (24% to 42% vs 26% to 49%); and Cu deficiency
tripled during shortage period in the group receiving HPN ≥1 year (5% to 16%).
Conclusion: ETE deficiency is prevalent in hospitalized HPN patients and was
exacerbated during nationwide shortages of parenteral supplements. Statistical
significance may be limited by small sample size. Future studies are needed to
determine optimal ETE supplementation strategies for minimizing the impacts
of nationwide drug shortages on HPN patients.
... As publicações com foco nas consequências do desabastecimento, diferentemente das pertencentes às demais categorias, são em sua maioria estudos empíricos, com apenas uma exceção (RUKTANONCHAI et al., 2014). 1 São citadas como consequências: a substituição para terapias menos eficazes e mais tóxicas aos pacientes (BECKER et al., 2013;KEHL et al., 2015;KOSAREK et al., 2011); maiores custos (BIBLE et al., 2014;DORSEY et al., 2009;HAVRILESKY et al., 2012;HAYES et al., 2014;McLAUGHLIN et al., 2013;RALLS et al., 2012); piora de parâmetros bioquímicos (CORRIGAN; KIRBY, 2012;DAVIS;JAVID;HORSLEN, 2014;PRAMYOTHIN et al., 2013); atraso em ensaios clínicos (SALAZAR et al., 2015) e aumento na taxa de eventos adversos (HALL et al., 2013;HOLCOMBE, 2012;McLAUGHLIN et al., 2013;SHETH et al., 2005;WUERZ;BOW;SEFTEL, 2013); e piores desfechos clínicos devido à suspensão da terapia (RUKTANONCHAI et al., 2014). Em contraste com esses resultados, oito artigos não encontraram diferenças importantes ou, inclusive, observaram melhores desfechos clínicos de pacientes na suspensão do tratamento ou redução da dose da terapia (DEROMA et al., 2012;GOLDBLATT et al., 2011;HUGHES;GOSWAMI;MORRIS, 2015;ROBERTS et al., 2012;STOREY et al., 2016;THOMA et al., 2014;TOLIA et al., 2014). ...
Resumo O desabastecimento de medicamentos já é considerado um problema de saúde pública e representa um obstáculo importante para a garantia do acesso a eles e, consequentemente, do direito à saúde. Sendo assim, com o intuito de compreender melhor esse fenômeno, este artigo buscou identificar, descrever e caracterizar as publicações científicas da saúde que versam sobre o tema de desabastecimento de medicamentos e identificar as lacunas de pesquisa. Para tanto, realizou-se revisão narrativa da literatura científica na base de dados PubMed. Os resultados foram selecionados de acordo com o título e resumo, e os dados foram extraídos do texto completo. Além de uma análise quantitativa, também foi realizada uma síntese qualitativa dos estudos, explicitando as principais causas, estratégias de enfrentamento, discussões conceituais e a descrição do problema contido nas publicações incluídas. Foram analisados 98 artigos, a maioria foi publicada a partir do ano de 2011, nos EUA, citando diversos medicamentos e com o foco na descrição do problema. Os resultados deste estudo sugerem a contemporaneidade do problema, o uso da literatura científica como denúncia e a falta de estudos sobre o tema em países de baixa e média renda e que se voltem a compreender suas causas.
... ISMP has provided several safe practice recommendations, in part based upon these and other reported errors: 45 50 and anemia and leukopenia in patients receiving long-term PN. 51 Mainstream media have also highlighted the devastating effects of PN-related shortages on patients, especially in children (e.g., "Children are Dying" article in The Washingtonian in 2013). 52 Of the 683 respondents to an ASPEN survey, PN-related medication shortages interfered with the ability to meet patient micronutrient (70% of respondents) or macronutrient (47% respondents) needs, and directly affected patient outcome (16% respondents). ...
Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow. © 2018 American Society of Health-System Pharmacists Inc, American Society for Parenteral and Enteral Nutrition, and the Academy of Nutrition and Dietetics
... 48 There have been several very serious and tragic outcomes, including patient deaths, as a result of PN-related shortages, including contamination of compounded amino acid products during an amino acid shortage, 49 selenium deficiency in pediatric patients with intestinal failure, 50 and anemia and leukopenia in patients receiving long-term PN. 51 Mainstream media have also highlighted the devastating effects of PN-related shortages on patients, especially in children (e.g., "Children are Dying" article in The Washingtonian in 2013 52 ). Of the 683 respondents to an ASPEN survey, PN-related medication shortages interfered with the ability to meet patient micronutrient needs (70% of respondents) and macronutrient needs (47% of respondents) and directly affected patient outcome (16% of respondents). ...
Parenteral nutrition (PN) is a complex therapeutic modality provided to neonates, children, and adults for various indications. Surveys have shown that current electronic health record (EHR) systems are in need of functionality enhancement for safe and optimal delivery of PN. This is a consensus statement from the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists outlining some of the key challenges to prescribing, order review/verification, compounding, and administration of PN using EHRs today and is a call to action for clinicians and vendors to optimize their EHRs regarding the PN build and workflow.
... 48 There have been several very serious and tragic outcomes, including patient deaths, as a result of PN-related shortages, including 50 and anemia and leukopenia in patients receiving long-term PN. 51 Mainstream media have also highlighted the devastating effects of PN-related shortages on patients, especially in children (e.g., "Children are Dying" article in The Washingtonian in 2013). 52 Of the 683 respondents to an ASPEN survey, PN-related medication shortages interfered with the ability to meet patient micronutrient (70% of respondents) or macronutrient (47% respondents) needs, and directly affected patient outcome (16% respondents). ...
... Trace elements are very important in parenteral nutrition, although the deficiency of some of them manifest after many months, or even years, of administration of PN deprived of an individual element. This, however, does not concern the deficiency of zinc and copper, which manifest as early as within the first weeks of nutrition and are of a great clinical importance [50]. The demand during the period of disease, stress, and after injury is difficult to establish because the majority of recommendations concerning the supply are based on the demand calculated for a healthy individual. ...
Introduction: Parenteral nutrition (PN) therapy may be effective only provided that the organism is supplied with all the indispensable components. In clinical practice, the treatment of an undernourished patient requires the introduction of substitution of various nutrients, including such elements as copper and zinc.
Aim of the research: An evaluation of the effectiveness of copper and zinc supplementation in patients receiving short-term parenteral nutrition therapy – lasting up to 10 days, and long-term therapy – for more than 10 days.
Material and methods: The study was conducted in the Clinical Department of Surgery at the Regional Polyclinical Hospital in Kielce. Two study groups were distinguished: group 1 – PN with supplementation up to 10 days, into which were qualified 35 patients (16 females and 19 males; median age 66 years); group 2 – PN with supplementation lasting for more than 10 days, into which were qualified 34 patients (15 females and 19 males, median age 59 years), and two control groups. Control group 1 were 20 healthy individuals selected at random from among the medical staff. Control group 2 were patients qualified for planned surgical procedure of gallbladder removal. In order to evaluate the concentration of copper and zinc in patients in the study groups, venous blood was collected prior to the introduction of nutrition, and within 7-day intervals during the parenteral nutrition.
Results: No statistically significant differences were observed between the concentrations of zinc in the blood of patients in study groups 1 and 2. This means that, irrespective of the time of measurement, the zinc concentration in blood was similar. In study group 1, the mean concentration of copper was higher in the measurement performed after 7 days of PN (88.48 µg/dl), compared to the measurement prior to PN (82.45 µg/dl) (p = 0.028). The lowest mean concentration of copper in blood in study group 2 was observed in the measurement prior to the introduction of PN (71.17 µg/dl) and, at the same time, it was lower than the measurements performed after 14 (98.16 µg/dl), 21 (96.33 µg/dl), and 28 (100.03 µg/dl) days. A significant increase in the concentration of copper and zinc was observed after 14 days of PN.
Conclusions: based on the results of the analysis performed, it was found that zinc and copper administration in standard PN doses is sufficient. The concentration of copper remains within reference values; however, it is higher after PN therapy.
... 12,16 At the same time, more reports of patients developing clinical micronutrient deficiencies associated with IV drug shortages have been published in the past 2 years. [17][18][19][20][21][22] It is unclear how many and how often these businesses compete with hospitals, medical clinics, and home infusion companies for the same distributors in ordering and stockpiling these FDA-approved prescription medications. With the continued challenge of IV fluid, electrolyte, and micronutrient shortages we are facing in patient care, there are still no rules, regulations, or even incentives for putting patients' benefits ahead of business interests and corporate profits. ...
... 12,16 At the same time, more reports of patients developing clinical micronutrient deficiencies associated with IV drug shortages have been published in the past 2 years. [17][18][19][20][21][22] It is unclear how many and how often these businesses compete with hospitals, medical clinics, and home infusion companies for the same distributors in ordering and stockpiling these FDA-approved prescription medications. With the continued challenge of IV fluid, electrolyte, and micronutrient shortages we are facing in patient care, there are still no rules, regulations, or even incentives for putting patients' benefits ahead of business interests and corporate profits. ...
... Reports of harm due to shortages of nutrition products include severe dermatitis related to zinc deficiency in premature infants, 26 selenium deficiency in pediatric patients, 27 and anemia and leukopenia in an adult patient due to a shortage of trace elements. 28 Critical nutrients, such as amino acids, vitamins, lipids, and trace elements, are rationed for patients receiving both short-and long-term parenteral nutrition. 29 Shortages of chemotherapy agents delay treatment, result in inferior outcomes, lead to omitted or reduced doses, adversely affect clinical trials, require rationing or substitutions not supported by evidence, and may affect potential cures for patients. ...
National tracking of drug shortages began in 2001. However, a significant increase in the number of shortages began in late 2009, with numbers reaching what many have termed crisis level. The typical drug in short supply is a generic product administered by injection. Common classes of drugs affected by shortages include anesthesia medications, antibiotics, pain medications, nutrition and electrolyte products, and chemotherapy agents. The economic and clinical effects of drug shortages are significant. The financial effect of drug shortages is estimated to be hundreds of millions of dollars annually for health systems across the United States. Clinically, patients have been harmed by the lack of drugs or inferior alternatives, resulting in more than 15 documented deaths. Drug shortages occur for a variety of reasons. Generic injectable drugs are particularly susceptible to drug shortages because there are few manufacturers of these products and all manufacturers are running at full capacity. In addition, some manufacturers have had production problems, resulting in poor quality product. Although many suppliers are working to upgrade facilities and add additional manufacturing lines, these activities take time. A number of stakeholder organizations have been involved in meetings to further determine the causes and effects of drug shortages. A new law was enacted in July 2012 that granted the Food and Drug Administration additional tools to address the drug shortage crisis. The future of drug shortages is unknown, but there are hopeful indications that quality improvements and additional capacity may decrease the number of drug shortages in the years to come.
