Analysis of Outcomes by Extraction Site following Subtotal Colectomy in Ulcerative Colitis: A Retrospective Cohort Study.

BACKGROUND: Ulcerative colitis frequently requires surgery as a definitive management strategy. The colonic specimen can be extracted from various sites including a midline incision, the stoma site, or a Pfannenstiel incision. It is unclear if one extraction site offers improved outcomes and fewer complications. METHODS: A retrospective review of charts obtained of colorectal surgery patients was conducted for all patients with ulcerative colitis who underwent a subtotal colectomy between 2008 and 2016 at a single tertiary care institution. Demographic data and outcomes data including parastomal and incisional hernias, advanced wound/ostomy certified nurse referrals, surgical site infections, reoperations, and readmissions were collected. Univariate and multivariate analyses were completed to detect any significant differences in outcomes between groups based on extraction site (midline incision, stoma site, or Pfannenstiel incision). RESULTS: Univariate analysis did not show any statistical differences between groups in regard to outcomes. Stoma site extraction did not statistically differ from midline extraction in regard to hernias, advanced ostomy referrals, infections, or reoperations, but midline incision extraction did have a lower risk of readmission (OR = 0.56, p = 0.0066). Pfannenstiel extraction had lower risk of incisional hernias (OR = 0.25, p = 0.0002), advanced ostomy referrals (OR = 0.45, p = 0.0164) and readmission (OR = 0.26, p < 0.0001) as compared to stoma site extraction. CONCLUSIONS: While stoma site extraction can be successfully performed for most patients requiring subtotal colectomy for ulcerative colitis, Pfannenstiel extraction leads to the fewest number of complications and provides the most consistent results.

Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants.

The Food and Drug Administration Adverse Event Reporting System (FAERS) is used for postmarketing pharmacovigilance. Our study sought to assess attitudes and usage of the FAERS among gastroenterology nurse practitioners (NPs) and physician assistants (PAs). A survey was administered at the August 2012 Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course, held in Chicago, IL. Of the 128 respondents, 123 (96%) reported a specialty in gastroenterology or hepatology and were included in analysis. Eighty-nine participants were NPs and 32 PAs, whereas 2 did not report their profession. Although 119 (98%) agreed or strongly agreed with the statement that accurately reporting adverse drug reactions is an important process to optimize patient safety, the majority of participants (54% NPs and 81% PAs) were unfamiliar with the FAERS. In addition, only 20% of NPs and 9% of PAs reported learning about the FAERS in NP or PA schooling. Our study shows enthusiasm among gastroenterology NPs and PAs for the reporting of adverse drug reactions, coupled with a lack of familiarity with the FAERS. This presents an opportunity for enhanced education about reporting of adverse drug reactions for gastroenterology NPs and PAs.

Ischaemic colitis in rheumatoid arthritis patients receiving tumour necrosis factor-α inhibitors: an analysis of reports to the US FDA Adverse Event Reporting System.

BACKGROUND: Tumour necrosis factor-α (TNF-α) inhibitors are immunosuppressants, approved for the treatment and maintenance of rheumatoid arthritis (RA). Immunosuppression has been shown to induce ischaemic colitis (IC) in an animal model; however, a relationship between TNF inhibitors and IC has rarely been reported in the published literature. OBJECTIVE: The aim of this study was to better characterize the association between TNF-α inhibitors with IC in RA patients, by analysing adverse event reports submitted to the US FDA Adverse Event Reporting System (AERS) and the published literature. METHODS: The FDA AERS database was searched and we identified all reports between January 2003 and June 2011. The search was limited to an indication of RA, a 'primary suspect' drug of TNF-α inhibitors and a reaction of IC. Full-length reports were obtained and analysed utilizing the Freedom of Information Act. The cases were organized by age, sex, type of TNF-α inhibitor, concomitant drugs and medical co-morbidities. Cases were labelled as definite, probable, possible or doubtful drug-induced adverse events based on the Naranjo Scale. A PubMed search was performed to obtain published literature documenting events of anti-TNF-associated IC. RESULTS: Twelve cases were eliminated because of more likely causes for IC. Thirty-five primary suspect reports of TNF-α inhibitors associated with IC in RA patients were identified in the FDA AERS. Thirteen cases were reported with infliximab, 12 with adalimumab, 7 with etanercept and 3 with certolizumab. The majority of the cases were in females (29/35) and those between the ages of 50 and 65 years (18/35). Use of the Naranjo Scale revealed 17 probable and 18 possible cases of anti-TNF-induced IC. In the literature, one report of IC associated with adalimumab was identified. CONCLUSION: TNF-α inhibitors may be initiating factors or co-factors in the development of IC in RA patients, and further research to determine the mechanism of this association is warranted.

Ischemic colitis with type I interferons used in the treatment of hepatitis C and multiple sclerosis: an evaluation from the food and drug administration adverse event reporting system and review of the literature.

OBJECTIVE: To better characterize the association between type I interferons and ischemic colitis (IC) in patients with the hepatitis C virus (HCV) and multiple sclerosis (MS), by analyzing reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) and the published literature. DATA SOURCES: A total of 2,562,390 reports of adverse events between January 2003 and June 2011 were downloaded from the FDA AERS. A literature review was performed on PubMed (January 1966-August 2012) using the MeSH terms interferon or interferon alfa or interferon beta and ischemic colitis separated by the Boolean operator "and" between the first 3 terms and the last term. Additional literature was identified by conducting a hand search of the reference list of the published literature identified in the initial search. STUDY SELECTION AND DATA EXTRACTION: Cases were restricted to those with an indication of HCV or MS, a primary suspect drug of a type I interferon, and a reaction of IC. Full-length reports were requested and organized by type of interferon, age, sex, concomitant drugs, and comorbidities. The Naranjo probability scale was used to define cases as definite, probable, possible, or doubtful drug-induced adverse events. DATA SYNTHESIS: Type I interferons, including interferon alfa (IFN-α) and interferon beta (IFN-ß), are approved for the treatment of HCV and MS. IFN-α has been shown to induce IC, but a relationship between type I interferons and IC has not been clarified in the medical literature. Fifty-six primary suspect reports of type I interferons associated with IC in patients with HCV or MS were identified from the FDA AERS. Seventeen cases were reported with IFN-α and 39 cases were reported with IFN-ß. The majority of the cases were in females (80%) and those between the ages of 50 and 65 years (52%). The Naranjo probability scale identified 13 probable and 4 possible cases of IFN-α-induced IC, and 19 probable and 20 possible cases of IFN-ß-induced IC. In the literature, 11 cases of IFN-α-induced IC were reported, while there were no reports with IFN-ß. CONCLUSIONS: Our study suggests a possible association between treatment with type I interferons and the development of IC. Further research to determine the mechanism of this association is warranted.