scholarly journals 743. Evaluation of Adverse Drug Reactions due to Common β-Lactam Therapies Among Patients Enrolled in an Outpatient Parenteral Antimicrobial Therapy (OPAT) Program

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S332-S332
Author(s):  
Erin Mays ◽  
Alan C Kinlaw ◽  
Michael J Swartwood ◽  
Renae A Boerneke ◽  
Claire E Farel ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Therapy ◽  
Medical Center ◽  
Drug Reactions ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Diabetic Foot Infections ◽  
Kaplan Meier ◽  
Average Patient ◽  
Estimated Risk ◽  
Treatment Changes

Abstract Background The UNC Medical Center Outpatient Parenteral Antimicrobial Therapy (OPAT) program was started in 2015 to provide multidisciplinary monitoring and management of patients discharged on parenteral antimicrobials. Laboratory abnormalities and adverse drug reactions (ADRs) are potential complications of OPAT that may result in readmission and treatment changes. The purpose of this study was to evaluate the time to first ADR for OPAT patients treated with BL therapies for diabetic foot infections (DFI) and osteomyelitis (OM). Methods This was a retrospective cohort study of patients enrolled in the UNC OPAT program between January 2015 and September 2018 for treatment of DFI or OM. Included patients received one of the following BL: cefepime, ceftriaxone, ertapenem, meropenem, and piperacillin/tazobactam. The primary outcome was time to first ADR during OPAT. Secondary outcomes were estimation of risk of ADR during OPAT for each medication; and ADR types and frequencies observed among patients treated with BL alone or with concomitant vancomycin or daptomycin. Results In this cohort, 178 OPAT patients received 193 OPAT courses, for a median duration of 42 days (IQR 38–50). The average patient age was 55 years, and 68% were male. Ertapenem was the most commonly prescribed BL (76 courses, 39%), followed by ceftriaxone (29, 15%), cefepime, (41, 21%), piperacillin/tazobactam (30, 16%) and meropenem (17, 9%). Approximately 40% (76) patients received concomitant vancomycin. ADR was documented in 48 patients (27%) and 56 courses of therapy (29%). Kaplan–Meier-estimated risk of at least one ADR in the first 8 weeks of therapy was 38.7% (95% CI 29.1% to 48.2%). ADR resulted in 32 therapy changes and 8 readmissions. Conclusion More than one-third of patients treated with BL for treatment of DFI and/or OM are at risk of ADR within 8 weeks. ADR commonly resulted in treatment changes, and possible hospital readmission. BL therapy is associated with significant ADR risk, and careful selection and monitoring is essential for optimal patient safety during OPAT. Disclosures All authors: No reported disclosures.

scholarly journals Adverse Drug Reactions Among Patients Enrolled in an Outpatient Parenteral Antimicrobial Therapy (OPAT) Program 2015–2016 at UNC Medical Center

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S341-S341
Author(s):  
Vahini Chundi ◽  
Anh Eichholz ◽  
Onyeka Nwankwo ◽  
Alan Kinlaw ◽  
Wesley Kufel ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Medical Center ◽  
Critical Role ◽  
Drug Reactions ◽  
Health Records ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Initial Cohort ◽  
Recorded Data ◽  
Antimicrobial Regimen

Abstract Background The UNC Medical Center OPAT program was started in 2015 to provide multidisciplinary monitoring and management of patients discharged on parenteral antimicrobials. We examined characteristics of incident adverse drug reactions (ADRs) observed in our initial cohort of OPAT patients. Methods We abstracted electronic health records for the first 250 patients enrolled in the OPAT program. 223 patients with sufficient recorded data for entire OPAT course were included in the analysis. ADRs meeting criteria as detailed in Table 1 were collected and further stratified by antimicrobial regimen. Results 57 patients (26%) experienced at least one ADR during OPAT therapy. The frequency of specific ADRs associated with OPAT therapies are provided in Figure 1. Β-lactam regimens were most frequently associated with liver dysfunction, while combinations of β-lactams and vancomycin were associated with kidney dysfunction. Median days on OPAT regimen was 19 days (IQR: 10–29) for patients who experienced an ADR compared with 39 (IQR: 30–44) for patients who did not experience an ADR. Conclusion ADRs were most commonly observed within the first three weeks of therapy, particularly for patients receiving vancomycin and a β-lactam antimicrobial in combination. These results underscore the critical role of a multidisciplinary team in providing laboratory monitoring and response to abnormal results for OPAT patients. In addition, closer monitoring within the first three weeks of therapy may provide opportunities for regimen changes or dose adjustment to avoid toxicities. Disclosures All authors: No reported disclosures.

scholarly journals 1925. Vancomycin Treatment and Time to Adverse Drug Reactions During Outpatient Parenteral Antimicrobial Therapy (OPAT)

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S554-S554
Author(s):  
Asajah Duncan ◽  
Alan Kinlaw ◽  
Vahini Chundi ◽  
Claire Farel ◽  
Ashley Marx ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Therapy ◽  
Drug Reactions ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Vancomycin Treatment

scholarly journals 604. Factors Associated with Adverse Drug Reactions Leading to Discontinuation of Vancomycin in Outpatient Parenteral Antimicrobial Therapy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S364-S364
Author(s):  
Josh McDonald ◽  
Russell J Benefield ◽  
Laura Certain
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Therapy ◽  
Plasma Concentrations ◽  
The United States ◽  
High Rate ◽  
Unplanned Readmission ◽  
Drug Reactions ◽  
Research Support ◽  
Outpatient Parenteral Antimicrobial Therapy

Abstract Background Over 250,000 patients receive outpatient parenteral antimicrobial therapy (OPAT) in the United States each year. Vancomycin is commonly used in OPAT but has a high rate of discontinuations due to adverse drug reactions (ADRs). Being able to predict the occurrence of these ADRs and assess their impact could improve the overall quality of OPAT services when utilizing vancomycin. Methods This was a retrospective chart review of all adult University of Utah Health (UUH) patients who received vancomycin OPAT and had planned follow-up with UUH infectious disease (ID) providers between October 25, 2018 and July 31, 2019. Patients were excluded if they were less than 18 years of age, pregnant, did not have planned follow up with UUH ID physicians, or were on any form of renal replacement therapy. The primary outcome assessed was discontinuation of vancomycin due to ADR, as documented by the ID provider. Type of ADR leading to discontinuation and 30-day unplanned readmission were also assessed. Results One hundred fifty-eight patients met inclusion criteria (n=158). The mean age of patients was 55 years with a median Charlson comorbidity score of 3. Most patients utilized a non-UUH infusion service (116, 73% vs 42, 27%) and utilized vancomycin as their sole antibiotic (83, 53%). The majority of patients were being treated for orthopedic infections (78, 49%). Twenty-eight patients discontinued vancomycin OPAT due to an ADR (18%). The most common ADR leading to discontinuation was acute kidney injury (10, 36%). Variables associated with ADRs leading to discontinuation included utilization of UUH home infusion services (54% vs 21%, P < 0.001) and initial vancomycin plasma concentrations obtained less than 7 days after discharge (92% vs 71%, P < 0.001). The overall 30 day readmission rate was 10% and the rate among patients who experienced an ADR leading to discontinuation was higher than those who did not (25% vs 8%, P < 0.001). Conclusion The overall rate of discontinuation of vancomycin OPAT due to ADR in the UUH population is similar to what has been described in previous literature. The higher rate of unplanned readmission in the population of patients who experienced ADRs warrants further study. The results of this study will be utilized for future quality improvement interventions at our institution. Disclosures Russell J. Benefield, PharmD, Merck and Co (Grant/Research Support)Paratek Pharmaceuticals (Grant/Research Support)Rempex Pharmaceuticals (Grant/Research Support)

The Incidence and Nature of Adverse Reactions during Intravenous Acetylcysteine Therapy for Acetaminophen Overdose

2000 ◽  
Vol 16 (2) ◽  
pp. 47-49 ◽  
Author(s):  
Matitiahu Lifshitz ◽  
Perez Kornmehl ◽  
Haim Reuveni
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Medical Center ◽  
Clinical Manifestations ◽  
Cost Benefit ◽  
Maculopapular Rash ◽  
Oral Formulation ◽  
Drug Reactions ◽  
Acetaminophen Overdose ◽  
History Of

Objective: To determine the incidence of adverse drug reactions in patients with acetaminophen overdose following administration of intravenous acetylcysteine, and to evaluate the cost-benefit ratio of intravenous compared with oral acetylcysteine therapy. Methods: The incidence of adverse drug reactions to intravenous acetylcysteine therapy was studied retrospectively in all patients with acetaminophen overdose who were admitted to Soroka University Medical Center, Beer-Sheva, Israel, from 1994 to 1998. Data were obtained from hospital records. All patients were treated with a 20-hour intravenous regimen according to the Prescott protocol. Special attention was paid to the clinical manifestations of adverse reactions, time of onset, and history of patient allergy and asthma. Cost of therapy (drug prices, hospital per diems) for intravenous versus oral acetylcysteine administration was evaluated in accordance with average rates prevailing in Israel in December 1998. Results: Ninety-two patients, 32 adolescents aged 12–18 years (mean ± SD 14.2 ± 1.9) and 60 adults aged 18–52 years (28.2 ± 3.2), were treated with intravenous acetylcysteine for acetaminophen overdose during the study period. Three patients (3.2%) developed adverse reactions: one adult presented with a maculopapular rash and pruritus, and two adolescents developed mild urticaria; no other adverse reactions were reported. All adverse reactions occurred during administration of the loading dose, 15–20 minutes after initiation of therapy. The reactions subsided a few hours after the acetylcysteine infusion was stopped and did not require antiallergy therapy. None of the three patients had a history of allergy. The 20-hour intravenous acetylcysteine protocol is approximately three times less expensive than the recommended oral regimen in terms of drug cost and length of hospitalization. Conclusions: Intravenous acetylcysteine is a relatively safe antidote for acetaminophen poisoning. The incidence rate of adverse reactions is low, and they are mild and easily controlled by termination of the infusion. We recommend intravenous acetylcysteine therapy, particularly for patients with vomiting caused by the acetaminophen overdose or by oral acetylcysteine therapy. The 20-hour intravenous acetylcysteine therapy has a cost-benefit advantage over oral therapy; however, the oral formulation is not approved by the FDA.

The Safety of Midline Catheters for Intravenous Therapy at a Large Academic Medical Center

2019 ◽  
Vol 54 (3) ◽  
pp. 232-238 ◽  
Author(s):  
Hangil Seo ◽  
Diana Altshuler ◽  
Yanina Dubrovskaya ◽  
Mark E. Nunnally ◽  
Catherine Nunn ◽  
...  
Keyword(s):  
Antimicrobial Therapy ◽  
Medical Center ◽  
Academic Medical Center ◽  
Tertiary Care ◽  
Intravenous Therapy ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Medication Therapy ◽  
Academic Medical ◽  
Outpatient Group ◽  
Days Of Therapy

Background: Midline catheters (MCs) have arisen as alternatives to peripherally inserted central catheters (PICCs) for both general intravenous therapy and extended outpatient parenteral therapy. However, there is a lack of data concerning the safety of medication therapy through midline for extended durations. Objective: The purpose of this study is to evaluate the safety of MCs for extended intravenous use. Methods: This was a retrospective cohort study evaluating patients who received intravenous therapy through an MC at a tertiary care academic medical center. The primary end point was the incidence of composite catheter-related adverse events that included local events, catheter dislodgment, infiltration, catheter occlusion, catheter-related venous thromboembolism, extravasation, and line-associated infection. Results: A total of 82 MC placements and 50 PICC placements were included; 50 MCs were for outpatient parenteral antimicrobial therapy, and 32 were for inpatient intravenous use. There were 21 complications per 1000 catheter-days in the outpatient group and 7 complications per 1000 catheter-days in the PICC group ( P = 0.91). The median time to complication in both groups was 8 days. The antimicrobial classes commonly associated with complications were cephalosporins, carbapenems, and penicillins. Conclusion and Relevance: Our results suggest that intravenous therapy with MCs is generally safe for prolonged courses that do not exceed 14 days as compared with PICC lines, which can be placed for months. There is still limited evidence for the use of MCs between 14 and 28 days of therapy. This study can help guide our selection of intravenous catheters for the purpose of outpatient antimicrobial therapy.

scholarly journals Potential Cost Avoidance of Adverse Drug Reactions Prevention in Outpatient Pharmacy Department Ramathibodi Hospital Thailand

2017 ◽  
Vol 1 (3) ◽  
pp. 136-144
Author(s):  
Nia Kurnia Sholihat ◽  
Wasin Chimsawat
Keyword(s):  
Adverse Drug Reactions ◽  
Diagnosis Related Groups ◽  
Medical Center ◽  
Hospital Setting ◽  
Drug Reactions ◽  
Potential Cost ◽  
Real Cost ◽  
Cost Avoidance ◽  
Pharmacy Department ◽  
Retrospective Database

Pharmacists’ intervention in hospital setting is very beneficial both in patients’ clinical outcomeand economic aspect, in terms of cost avoidance due to adverse drug reactions. This study was conductedto calculate cost avoidance of adverse drug reactions (ADR) prevention in outpatient pharmacydepartment in Ramathibodi Hospital Thailand. A retrospective database review of hospital pharmacyinterventions preventing adverse drug reaction was conducted at second floor pharmacy unit, Somdech-PhraDebaratana Medical Center, Ramathibodi hospital between 1 July 2013 and 31 December 2013. Potentialcost avoidance of ADR was calculated using diagnosis-related groups (DRG’s) data. Results showedthat the detection of ADR was 0.239%. The most frequent ADR came from Penicillin group was accountedfor 32.4% of total case. The estimated cost avoidance generated during July-December 2013 was ThaiBaht (THB) 592,320 to THB 1,257,428 (USD 19,278 to USD 40,925, value 2013). It can be concludedthat hospital pharmacists positively impacted on economic benefit of patients by providing ADR detection.More complete data are needed to get a better results of a real cost avoidance of ADR prevention.

Exploration of associations between adverse drug reactions and clinical outcomes in anlotinib treatment against medullary thyroid carcinoma (MTC): A subgroup analysis based on the ALTER01031 trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18518-e18518
Author(s):  
Yihebali Chi ◽  
Ming Gao ◽  
Pingzhang Tang ◽  
Xiangqian Zheng ◽  
Zhengang Xu ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Clinical Outcomes ◽  
Adverse Drug Reactions ◽  
Survival Benefit ◽  
Positive Association ◽  
Drug Reactions ◽  
Kaplan Meier ◽  
Hand Foot Syndrome ◽  
Dose Reductions ◽  
Clinical Trial Information

e18518 Background: Anlotinib demonstrated favorable efficacy in a randomized, placebo-controlled phase 2b trial (ALTER01031, NCT02586350) for MTC which was published in 2019 ASCO annual meeting. Similar with other anti-angiogenesis drugs, hand-foot syndrome (HFS), hypertension and proteinuria were the major adverse drug reactions (ADRs) observed in this trial. We explored the association between common ADRs and the clinical outcomes with anlotinib in this subanalysis. Methods: Patients in the anlotinib group of ALTER01031 were divided into different groups according to the development of ADRs including HFS, hypertension or proteinuria. Kaplan-Meier method was used to estimate median PFS (mPFS) for patients in different groups. The mPFS for patients with or without dose reduction were also evaluated. Results: A total of 62 patients received anlotinib in ALTER 01031. HFS of any grade was observed in 39 patients with a mPFS of 28.5 months, which was longer than in those without HFS (14.0 months, P = 0.079). The hazard ratio for progression was 0.540 (95% CI 0.252, 1.158) although statistical difference was not reached. Similarly, more survival benefit was also observed in 29 and 38 patients who experienced hypertension and proteinuria, with mPFS of 28.5 months and 22.4 months respectively. While the mPFS for patients without corresponding ADRs were only 17.0 months (HR = 0.648 [95% CI 0.320, 1.314], P = 0.237) and 14.0 months (HR = 0.738 [95% CI 0.331, 1.65], P = 0.421). Median PFS had not been reached in 20 patients with dose reduction while was recorded as 17.0 months in those without (HR = 0.707 [95% CI 0.335, 1.496], P = 0.392). Conclusions: This analysis indicated a trend of greater PFS benefit for MTC patients treated with anlotinib who experienced HFS, hypertension or proteinuria although no statistical differences were observed. A possible positive association was also observed between dose reductions and better clinical outcomes. Clinical trial information: NCT02586350.

Use of Computer Drug-Drug Interaction Program for Detection of Adverse Drug Reactions and Related Therapeutic Problems

1979 ◽  
Vol 13 (12) ◽  
pp. 774-777 ◽  
Author(s):  
Jerry C. Hood ◽  
Jon R. Miller
Keyword(s):  
Drug Interaction ◽  
Adverse Drug Reactions ◽  
Basic Concept ◽  
Medical Center ◽  
Clinical Services ◽  
Potential Drug ◽  
Drug Reactions ◽  
Therapeutic Implications ◽  
Causative Agents ◽  
Clinically Significant

Pharmacies currently using computers to detect drug-drug interactions may not be fully utilizing the computers' programs. Potential drug-disease interactions and some potential adverse drug reactions not traditionally defined as interactions can be detected by extending the basic concept of cross-referencing. For example, certain clinically important ADRs are readily detected by cross-referencing drugs which are often used to treat the results of specific ADRs with certain causative agents. The potential therapeutic implications of such a system when restricted to clinically significant ADRs can be readily appreciated, especially in situations where the pharmacist's time in patient-care areas is limited. This concept is currently being practiced at Bayfront Medical Center, and has added a new dimension to the clinical services provided by the pharmacy. It seems likely that detection of therapeutic situations in this manner may be appropriate in other hospital settings.

Evaluation of Outpatient Parenteral Antimicrobial Therapy at a Veterans Affairs Hospital

2015 ◽  
Vol 36 (9) ◽  
pp. 1103-1105 ◽  
Author(s):  
Emily Sydnor Spivak ◽  
Brian Kendall ◽  
Patricia Orlando ◽  
Christian Perez ◽  
Marina De Amorim ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Antimicrobial Stewardship ◽  
Antimicrobial Therapy ◽  
Medical Center ◽  
Veterans Affairs ◽  
Infect Control Hosp ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Infectious Diseases Consultation

We reviewed outpatient parenteral antimicrobial therapy at a Veterans Affairs Medical Center to identify opportunities for antimicrobial stewardship intervention. A definite or possible modification would have been recommended in 60% of courses. Forty-one percent of outpatient parenteral antimicrobial therapy courses were potentially avoidable, including 22% involving infectious diseases consultation.Infect. Control Hosp. Epidemiol. 2015;36(9):1103–1105

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