A Comparison of Histamine Receptor Antagonists Versus Proton Pump Inhibitor Gastrointestinal Ulcer Prophylaxis in Kidney Transplant Recipients.

INTRODUCTION: There are several different agents that can be used for gastrointestinal (GI) ulcer prophylaxis in posttransplant recipients, such as histamine-2 receptor antagonists (H2RA) or proton pump inhibitors (PPIs). RESEARCH QUESTION: This study was conducted to compare the incidence of adverse kidney events in transplant recipients who received prophylaxis with H2RAs or PPIs. DESIGN: This retrospective study included all kidney transplant recipients from 3 transplant centers who were transplanted in 2009 through 2011. The primary objective was to compare the incidence of adverse events posttransplant, defined as the incidence of pneumonia, Clostridium difficile, hip fractures, GI bleeding, cytomegalovirus, organ rejection, and bacteremia. RESULTS: A total of 211 patients were included in the study; of which 35 were included in the PPI group and 176 were included in the H2RA group. There were no significant differences between groups in regard to incidence of GI bleeding events or other adverse events. DISCUSSION: These findings suggest there is a low incidence of GI ulcers and upper GI bleeding events after kidney transplantation with the use of H2RAs or PPIs. Additionally, there are similar rates of adverse events when comparing H2RAs versus PPIs for GI ulcer prophylaxis.

Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients.

BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. RESULTS: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. CONCLUSION: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).

Listeria monocytogenes bacteremia in a pancreas transplant recipient.

We report a case of Listeria monocytogenes bacteremia in a patient 12 years after his pancreas transplant, during which time he received a steroid-free immunosuppressive regimen. To our knowledge, there are no reported cases describing L monocytogenes bacteremia after pancreas transplant. In addition, although typically identified as a complication shortly after transplant or after treatment for organ rejection, this case demonstrates that it is still possible for a patient to develop a L monocytogenes infection far removed from transplant.

Hyperuricemia and gout in solid-organ transplant: update in pharmacological management.

Hyperuricemia is a common comorbid condition experienced by up to 28% of kidney transplant recipients. These patients are at elevated risk of acute flare-ups of gout because of transplant-specific risk factors such as impaired renal function, chronic contributing pharmacotherapy (eg, calcineurin inhibitors, diuretics), and associated comorbid conditions. After transplant, treatment is often complicated by drug-drug interactions, renal impairment, and toxic effects of drugs with the use of first-line recommended agents. A number of therapeutic options remain available for transplant recipients, including dose modifications of historic agents and newer pharmacotherapeutic options. Notably, the Kidney Disease Improving Global Outcomes guidelines address the management of hyperuricemia and gout, but these guidelines were last published in 2009, and new data and treatment options have emerged since then. The management of hyperuricemia and acute and chronic gout is described, including the use of novel agents including urate oxidases, interleukin 1 inhibitors, and human urate transporter 1 inhibitors and alternative immunosuppressive therapy strategies.

Duration of prophylaxis against fungal infection in kidney transplant recipients.

OBJECTIVE: To compare the efficacy of 2 strategies that use nystatin to prevent thrush and Candida esophagitis in kidney transplant recipients. METHODS: A retrospective chart review was conducted of adult kidney transplant recipients at our center, where the protocol for prophylaxis against fungal infection was changed in March 2013. Before the protocol change, kidney transplant recipients received nystatin for 1 month (before group) and after the change they received nystatin for the duration of admission (after group). The primary outcome measure was the incidence of thrush and Candida esophagitis within 3 months after transplant. Analyses were conducted on all kidney transplant recipients (intention to treat) and on only those kidney transplant recipients who received at least 1 dose of nystatin (modified intention to treat). Additional data collected included the duration of nystatin and immunosuppression regimens. The Student t test and Fisher exact test were used to calculate P values for continuous and categorical data. RESULTS: A total of 84 kidney transplant recipients, 42 in each cohort, were included in the analysis. The groups did not differ significantly at baseline. Nystatin was administered for a mean of 29 days in the before group and 5.74 days in the after group. Overall, 3 kidney transplant recipients (4%), all from the after group, experienced an episode of thrush and no patients experienced Candida esophagitis. Two recipients who experienced thrush did not receive any nystatin. CONCLUSIONS: Limiting the administration of nystatin to the duration of admission after transplant may be sufficient for prophylaxis of fungal infections in kidney transplant recipients.

National trends in prescription drug expenditures and projections for 2024.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2024 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2024 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, endocrine drugs, generics, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2024 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2023, overall pharmaceutical expenditures in the US grew 13.6% compared to 2022, for a total of $722.5 billion. Utilization (a 6.5% increase), new drugs (a 4.2% increase) and price (a 2.9% increase) drove this increase. Semaglutide was the top drug in 2023, followed by adalimumab and apixaban. Drug expenditures were $37.1 billion (a 1.1% decrease) and $135.7 billion (a 15.0% increase) in nonfederal hospitals and clinics, respectively. In clinics, increased utilization drove growth, with a small impact from price and new products. In nonfederal hospitals, a drop in utilization led the decrease in expenditures, with price and new drugs modestly contributing to growth in spending. Several new drugs that will influence spending are expected to be approved in 2024. Specialty, endocrine, and cancer drugs will continue to drive expenditures. CONCLUSION: For 2024, we expect overall prescription drug spending to rise by 10.0% to 12.0%, whereas in clinics and hospitals we anticipate an 11.0% to 13.0% increase and a 0% to 2.0% increase, respectively, compared to 2023. These national estimates of future pharmaceutical expenditure growth may not be representative of any health system because of the myriad of local factors that influence actual spending.

A guide to understanding and implementing risk evaluation and mitigation strategies in organ transplantation.

OBJECTIVE: To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena. DATA SOURCES AND EXTRACTION: A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated. DATA SYNTHESIS: REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use). CONCLUSION: REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.

Risk evaluation and mitigation strategies: a focus on belatacept.

OBJECTIVE: To review the elements and components of the risk evaluation and mitigation strategies (REMS) for the costimulation blocker belatacept and associated implications for health care providers working with transplant recipients. DATA SOURCES AND EXTRACTION: The MEDLINE and EMBASE databases (January 1990 to March 2012) were searched by using risk evaluation and mitigation strategies, REMS, belatacept, and organ transplant as search terms (individual organs were also searched). Retrieved articles were supplemented with analysis of information obtained from the Federal Register, the Food and Drug Administration, and the manufacturer of belatacept. DATA SYNTHESIS: REMS are risk-management strategies implemented to ensure that a product's benefits outweigh its known safety risks. Although belatacept offers a novel strategy in maintenance immunosuppression and was associated with superior renal function compared with cyclosporine in phase 2 and 3 trials, belatacept is also associated with increased risk of posttransplant lymphoproliferative disorder and central nervous system infections. The Food and Drug Administration required development of a REMS program as part of belatacept's approval process to ensure safe and appropriate use of the medication and optimization of its risk-benefit profile. CONCLUSION: Elements of the belatacept REMS include a medication guide that must be dispensed with each infusion and a communication plan. In the management of a complex population of patients, it is essential that those who care for transplant recipients, and patients, recognize the implications of potential and known risks of belatacept. The REMS program aims to facilitate careful selection and education of patients and vigilant monitoring.

National trends in prescription drug expenditures and projections for 2023.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2023 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2023 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, diabetes medications, generics, COVID-19 pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2023 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2022, overall pharmaceutical expenditures in the US grew 9.4% compared to 2021, for a total of $633.5 billion. Utilization (a 5.9% increase), price (a 1.7% increase) and new drugs (a 1.8% increase) drove this increase. Adalimumab was the top-selling drug in 2022, followed by semaglutide and apixaban. Drug expenditures were $37.2 billion (a 5.9% decrease) and $116.9 billion (a 10.4% increase) in nonfederal hospitals and clinics, respectively. In clinics, new products and increased utilization growth drove growth, with a small impact from price changes. In nonfederal hospitals, a drop in utilization led to a decrease in expenditures, with price changes and new drugs contributing to growth in spending. Several new drugs that will influence spending have been or are expected to be approved in 2023. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2023, we expect overall prescription drug spending to rise by 6.0% to 8.0%, whereas in clinics and hospitals we anticipate increases of 8.0% to 10.0% and 1.0% to 3.0%, respectively, compared to 2022. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Treatment of adenovirus hepatitis with cidofovir in a pediatric liver transplant recipient.

AdV hepatitis is a rarely reported complication after pediatric liver transplantation that is associated with high rates of morbidity, mortality and graft failure. Successful treatment of AdV relies on early diagnosis of disease by quantitative PCR measurement of adenoviral DNA in blood and histological evidence in tissue biopsy. Pharmacologic treatment largely consists of antiviral therapy with CDV, an acyclic nucleoside phosphonate analog and reduction in immunosuppression. This report describes a case of AdV hepatitis in a pediatric liver transplant recipient successfully treated with a modified, renal sparing dosing of CDV.

Expanding the Role of the Pharmacist: Immunoglobulin Therapy and Disease Management in Neuromuscular Disorders.

Immunoglobulin G (IgG) is a commonly used treatment for chronic neuromuscular disorders (NMDs), such as chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. IgG therapy has also shown promise in treating other NMDs including myasthenia gravis, polymyositis, and dermatomyositis. IgG is administered as either intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg), with SCIg use becoming more popular due to the treatment burden associated with IVIg. IVIg requires regular venous access; long infusions (typically 4-6 hours); and can result in systemic adverse events (AEs) for some patients. In contrast, SCIg can be self-administered at home with shorter infusions (approximately 1 hour) and fewer systemic AEs. As patient care shifts toward home-based settings, the role of the pharmacist is paramount in providing a continuation of care and acting as the bridge between patient and clinic. Pharmacists with a good understanding of current recommendations, dosing strategies, and administration routes for IgG therapy are best placed to support patients. The aims of this review are to highlight the evidence supporting IgG therapy in the treatment of NMDs and provide practical information on patient management and IVIg/SCIg dosing in order to guide pharmacists on optimizing clinical outcomes and patient care.

Implementing and Optimizing Biosimilar Use at Mayo Clinic.

OBJECTIVE: To determine whether the formation of a multidisciplinary team, pharmacist-led therapeutic interchange, and streamlined electronic health record optimization improved biosimilar adoption throughout Mayo Clinic. PATIENTS AND METHODS: The project focused on the use of reference products and biosimilars for 5 biologics-bevacizumab, epoetin alfa, filgrastim, rituximab, and trastuzumab-at all Mayo Clinic locations. Pharmaceutical wholesale purchase histories of those reference products and biosimilars were assessed from September 1, 2020, through August 31, 2021, and compared with data from September 1, 2019, through August 31, 2020. Formulary decisions were implemented across 5 biologics for most ordering pathways on September 1, 2020. Pharmaceutical purchased drug units and expenditures were tracked at 3-month intervals for conversion to formulary-preferred contracted biosimilars. RESULTS: In the final postimplementation period, the absolute percentage increase of formulary-preferred biosimilars was 69% for bevacizumab, 63% for epoetin alfa, 80% for filgrastim, 79% for rituximab, and 72% for trastuzumab. Pharmaceutical line item savings in the 12-month postimplementation period totaled $23.1 million across all 5 biologics. CONCLUSION: Creation of a multidisciplinary team to implement formulary-preferred contracted biosimilars led to the adoption of biosimilars throughout Mayo Clinic with considerable pharmaceutical line item savings.

National trends in prescription drug expenditures and projections for 2022.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2022 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2022 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, COVID-19 pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2022 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2021, overall pharmaceutical expenditures in the US grew 7.7% compared to 2020, for a total of $576.9 billion. Utilization (a 4.8% increase), price (a 1.9% increase) and new drugs (a 1.1% increase) drove this increase. Adalimumab was the top drug in terms of overall expenditures in 2021, followed by apixaban and dulaglutide. Drug expenditures were $39.6 billion (a 8.4% increase) and $105.0 billion (a 7.7% increase) in nonfederal hospitals and in clinics, respectively. In clinics and hospitals, new products and increased utilization growth drove growth, with decreasing prices for both sectors acting as an expense restraint. Several new drugs that are likely to influence spending are expected to be approved in 2022. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2022, we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 7.0% to 9.0% and 3.0% to 5.0%, respectively, compared to 2021. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

National trends in prescription drug expenditures and projections for 2021.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Significant sirolimus and dronedarone interaction in a kidney transplant recipient.

OBJECTIVE: To report the potential clinically significant pharmacokinetic interaction between sirolimus and dronedarone. CASE SUMMARY: A 67-year-old man status post-kidney transplant in 2004 was maintained on an immunosuppressive regimen consisting of sirolimus, mycophenolate mofetil, and prednisone. He had been maintained for more than 1 year on a stable dose of sirolimus (5 mg/day), with concentrations ranging between 5 and 13.5 ng/mL. The patient was admitted to the hospital with a complaint of bloody diarrhea; shortly after admission, he developed atrial fibrillation for which dronedarone 400 mg twice daily was initiated. Sirolimus concentrations obtained 3 days after initiation of dronedarone revealed a trough concentration that was increased by more than 3-fold (38.6 ng/mL) from his baseline trough concentration. After sirolimus was held for 6 days, the trough concentration was 7.8 ng/mL. The dosage was reduced to 1 mg/day; there was no need for further adjustment. DISCUSSION: While the potential for an interaction between sirolimus and dronedarone is listed in the package insert of dronedarone, there are no documented reports of this interaction in the peer-reviewed literature. Since sirolimus is a narrow therapeutic index medication, information about the severity and magnitude of the interaction with dronedarone may help clinicians avoid therapeutic misadventures when this combination is employed. Our case clearly demonstrates a significant pharmacokinetic interaction between sirolimus and dronedarone. The Horn Drug Interaction Probability Scale indicates that the occurrence of an interaction between sirolimus and dronedarone in our case is probable. CONCLUSIONS: Due to the potential for sirolimus toxicity and excessive immunosuppression, the concurrent use of dronedarone and sirolimus should be avoided when possible. If concurrent administration cannot be avoided, we suggest close monitoring and a 50-75% dose reduction of sirolimus prior to dronedarone initiation.

Optimizing the correct timing of vancomycin level collection utilizing a vancomycin medication administration record (MAR) level order.

OBJECTIVE: Vancomycin, a commonly used antimicrobial, has a narrow therapeutic index; therefore, Therapeutic Drug Monitoring (TDM) is required. Although the Electronic Medical Record (EMR) may improve patient care, without appropriate optimization, it can contribute to incorrectly drawn vancomycin levels. For medication administration, nurses utilize the Medication Administration Record (MAR) for medication administration documentation and medication workflow guidance. Therefore, we hypothesized creating a MAR level order which would be incorporated into this already established medication workflow may improve the rate of correctly drawn vancomycin levels. MATERIALS AND METHODS: This was a multicenter, retrospective, pre-and post-intervention study which evaluated the effect of a Medication Administration Record (MAR) level order within the EMR on the correct timing of vancomycin level collection. Vancomycin levels were classified into pre-and post-intervention groups. The primary endpoint was the rate of incorrectly drawn levels, defined as a level being drawn early, a level being drawn late, a level drawn while infusing, or a missed level. RESULTS: A total of 1353 vancomycin levels were assessed, and 628 levels met inclusion criteria. Of the levels eligible for inclusion, 331 were in the pre-intervention period and 297 were in the post-intervention period. Levels in the post-intervention group utilizing the vancomycin MAR level order were less likely to be missed or drawn at an incorrect time (11.1 % vs 36 %, P < 0.01) and were less likely to require rescheduling (3.4 % vs 8.5 %, P < 0.01). CONCLUSION: Utilization of a vancomycin MAR level order was associated with a significant decrease in incorrectly drawn vancomycin levels.

National trends in prescription drug expenditures and projections for 2020.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2020 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2020 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for specialty drugs, biosimilars, and diabetes medications. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2020 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2019, overall US pharmaceutical expenditures grew 5.4% compared to 2018, for a total of $507.9 billion. This increase was driven to similar degrees by prices, utilization, and new drugs. Adalimumab was the top drug in US expenditures in 2019, followed by apixaban and insulin glargine. Drug expenditures were $36.9 billion (a 1.5% increase from 2018) and $90.3 billion (an 11.8% increase from 2018) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals growth was driven by new products and price increases. Several new drugs that will likely influence spending are expected to be approved in 2020. Specialty and cancer drugs will continue to drive expenditures. CONCLUSION: For 2020 we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 9.0% to 11.0% and 2.0% to 4.0%, respectively, compared to 2019. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

National trends in prescription drug expenditures and projections for 2019.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2019 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2018 were obtained from the IQVIA National Sales Perspectives database and analyzed. New drug approvals, patent expirations, and other factors that may influence drug spending in hospitals and clinics in 2019 were also reviewed. Expenditure projections for 2019 for nonfederal hospitals, clinics, and overall (all sectors) were made through a combination of quantitative analyses and expert opinion. RESULTS: U.S. prescription sales in calendar year 2018 totaled $476.2 billion, a 5.5% increase from 2017 spending. The top 3 drugs by expenditures were adalimumab ($19.1 billion), insulin glargine ($9.3 billion), and etanercept ($8.0 billion). Prescription expenditures in nonfederal hospitals totaled $35.8 billion, a 4.8% increase from 2017. Expenditures in clinics in 2018 increased by 13.0% to $80.5 billion. The increase in spending in nonfederal hospitals was largely driven by new products and increased utilization of existing products. The list of the top 25 drugs by expenditures in nonfederal hospitals and clinics was dominated by specialty drugs. CONCLUSION: We predict continued moderate growth of 4-6% in overall drug expenditures (across the entire U.S. market). We expect the clinic sector to continue to experience high (11-13%) growth in drug spending in 2019. Finally, for nonfederal hospitals we anticipate growth in the range of 3-5%. These estimates are at the national level. Health-system pharmacy leaders should carefully examine local drug utilization patterns to determine their own organization's anticipated spending in 2019.

Review and drug therapy implications of glucose-6-phosphate dehydrogenase deficiency.

PURPOSE: The pathophysiology, diagnosis, and medication-use implications of glucose-6-phosphate dehydrogenase (G6PD) deficiency, the most common enzyme deficiency in humans, are reviewed. SUMMARY: Originally identified as favism in patients who experienced hemolysis after ingestion of fava beans, G6PD deficiency results from an X-linked chromosomal mutation that leads to reduced activity of the enzyme responsible for the final step of the pentose phosphate pathway, through which reduced nicotinamide adenine dinucleotide phosphate required for protection of cells from oxidative stress is produced. G6PD deficiency affects about 400 million people worldwide. Diagnosis of G6PD can be made through detection of enzymatic activity (by spectrophotometric testing, fluorescence testing, or formazan-based spot testing) or molecular analysis to detect known mutations of the gene encoding G6PD. Most individuals with G6PD deficiency are asymptomatic throughout life. Symptoms of acute hemolysis associated with G6PD deficiency include anemia, fatigue, back or abdominal pain, jaundice, and hemoglobinuria. The most common precipitators of oxidative stress and hemolysis in G6PD deficiency include medication use and infection. CONCLUSION: G6PD deficiency should be considered in patients who experience acute hemolysis after exposure to known oxidative medications, infection, or ingestion of fava beans. A diagnosis of G6PD deficiency is most often made through enzymatic activity detection, but molecular analysis may be required in females heterozygous for the disorder. When clinically feasible, rasburicase, primaquine, dapsone, pegloticase, and methylene blue should not be used until a G6PD diagnostic test has been performed.