Adherence to oral anticoagulants in patients with non-valvular atrial fibrillation: the role of patients' characteristics and out-of-pocket payments.

BACKGROUND: Recent practice guidelines favor direct oral anticoagulants (DOACs) over warfarin for primary stroke prevention in patients with non-valvular atrial fibrillation (NVAF). However, challenges persist in Iraq's private pharmaceutical sector. DOACs have been sold at high and inconsistent retail prices and lack insurance coverage, leading to significant out-of-pocket (OOP) costs. The objective of this study is to investigate the impact of OOP costs on oral anticoagulants (OAC) adherence among NVAF patients. RESEARCH DESIGN AND METHODS: This multicenter cross-sectional study interviewed 359 eligible patients attending three private cardiology clinics within Iraq's southern region from December 2022 to February 2023. The 8-item Morisky Adherence Scale evaluated patient adherence. Statistical analyses, including descriptive analysis, ANOVA, and chi-square. p < 0.05 was considered statistically significant. RESULTS: The most frequently prescribed OAC were DOACs (62.8%). Patient adherence level to OAC was chiefly medium (54.6%) with no significant difference in adherence based on OAC type. Patient adherence was significantly associated with monthly income (p = 0.001), number of daily pills (p = 0.006), and OACs' average monthly cost (p = 0.011). CONCLUSION: Addressing the issue of cost-related non-adherence to OACs requires multiple actions. These include ensuring comprehensive health insurance coverage for OACs, increasing the use of affordable generic alternatives, and establishing effective cost-related discussions between healthcare providers and patients.

The Length of Hospital Stay of Patients with Venous Thromboembolism: A Cross-Sectional Study from Jordan.

Background and Objectives: Venous thromboembolism is one of the leading causes of mortality and disability worldwide. Treatment with anticoagulation therapy is essential and requires a delicate approach to select the most appropriate option to improve patient outcomes, including the length of hospital stay (LOS). The aim of this study was to determine the LOS among patients with acute onset of VTE in several public hospitals in Jordan. Materials and Methods: In this study, we recruited hospitalized patients with a confirmed diagnosis of VTE. We reviewed the electronic medical records and charts of VTE admitted patients in addition to a detailed survey to collect the patients' self-reported data. Hospital LOS was categorized into three levels: 1-3 days, 4-6 days, and ≥7 days. An ordered logistic regression model was used to study the significant predictors of LOS. Results: A total of 317 VTE patients were recruited, with 52.4% of them were male and 35.3% aged between 50 and 69 years. Most patients had a deep vein thrombosis (DVT) diagnosis (84.2%), and most of the VTE cases were admitted for the first-time (64.6%). The majority of the patients were smokers (57.2%), overweight/obese (66.3%), and hypertensive (59%). Most of the VTE patients received Warfarin overlapped with low molecular weight heparins as their treatment regimen (>70%). Almost half of the admitted VTE patients (45%) were hospitalized for at least 7 days. Longer LOS was significantly associated with hypertension. Conclusions: We recommend using therapies that have been proven to reduce hospital LOS, such as non-vitamin K antagonist oral anticoagulants or direct oral anticoagulants, to treat VTE patients in Jordan. Additionally, preventing and controlling comorbidities such as hypertension is essential.

Willingness to pay for COVID-19 vaccines: Applying the health belief model.

BACKGROUND: To date, there is no effective treatment for COVID-19. Vaccines are effective and safe strategies to control the pandemic. OBJECTIVE: To measure consumers' maximum willingness to pay (WTP) for COVID-19 vaccines in Jordan and to identify the predictors of WTP. METHOD: An online survey was used to collect data related to sociodemographic factors and constructs from the Health Belief Model (HBM). The contingent valuation method using the payment card approach was used, whereby the respondents were asked to choose their maximum WTP value from a range of 5-200 Jordanian Dinar (JOD). The maximum WTP values were then categorized into several groups, and an ordered logistic model was used to generate adjusted odds ratios and estimate the significant predictors of maximum WTP. RESULTS: A total of 3116 respondents completed the survey. More than half of the sample were not willing to pay out of pocket for the vaccine (57%). Among the respondents who were willing to pay any amount above zero, the mean maximum WTP was 28.1 JOD (39.63 USD), and the median WTP was 20 JOD (28.21 USD). The significant predictors of higher WTP values were being of younger age, higher income, being a healthcare provider, having one or more chronic diseases, previous history of receiving the seasonal influenza vaccine, having a family member/friend who has died from the COVID-19, lower perceived risk of the vaccine, higher perceived benefits of the vaccine, and having been recommended to get the vaccine. CONCLUSION: It is recommended to continue providing the vaccine free of charge to increase its uptake. Educational campaigns should focus on refuting myths related to the vaccine and promoting the benefits of receiving the vaccine in slowing the spread of the pandemic, and improving the economy. Healthcare providers' recommendations have the potential to increase WTP for the vaccine.

Assessment of the relationship between COVID-19 risk perception and vaccine acceptance: a cross-sectional study in Jordan.

BACKGROUND: In the absence of definitive treatment, vaccination against COVID-19 emerged as an effective solution to the spread of the pandemic. This study aimed to investigate the factors impacting the rates of COVID-19 vaccine acceptance in Jordan, in addition to examining the relationship between COVID-19 risk perception and vaccine acceptance among the Jordanian population. METHODS: This cross-sectional study was conducted among a sample of adults (aged ≥18) residing in Jordan. Data were collected using an online questionnaire disseminated using social media platforms between December 2nd and December 29th, 2020. RESULTS: A total of 2,268 (72.3%) participants demonstrated willingness to receive the COVID-19 vaccine. The mean COVID-19 risk perception score among the participants was 4.65 out of 10 (median 5; IQR 3-6). Higher risk perception scores were significantly associated with being female (p = .001), young (p < .001), or a smoker (p = .005). A significant positive correlation was identified between COVID-19 vaccine acceptance and risk perception scores (OR = 1.319, 95%, CI = 1.261-1.380, p < .001). Moreover, male participants (75%, OR = 1.220, 95% CI = 1.007-1.479, p = .043), participants aged 18-24 years (78.1%, OR = 1.635, 95% CI = 1.189-2.246, p = .002), and participants with children aged under 18 years (73.9%, OR = 1.210, 95% CI = 1.010-1.450, p = .039) were more willing than their counterparts to get vaccinated. CONCLUSION: COVID-19 risk perception and certain sociodemographic characteristics (i.e., being male, being young, and having children aged under 18 years) were found to be significantly associated with vaccine acceptance. Policymakers are recommended to develop public educational campaigns to enhance people's trust in and willingness to take the COVID-19 vaccine.

Faculty Members' Perceptions and Attitudes Towards Anti-Plagiarism Detection Tools: Applying the Theory of Planned Behavior.

OBJECTIVE: To evaluate predictors of the use of anti-plagiarism detection tools (APTs) in higher education institutions. METHODS: An online survey based on the theory of planned behavior was sent to members of science faculties in Jordan. Multivariate Logistic regression was conducted to determine predictors of previous use of APTs, and multivariate linear regression to predict future intentions. RESULTS: A total of 173 faculty members completed the survey, with 78.13% indicating previous APTs use. Turnitin® (43%) and Ithenticate® (32.8%) were the most commonly used APTs. These tools were mainly used to evaluate papers before sending them to journals (65.5%) and to detect plagiarism in theses/dissertations (50.4%). Predictors of previous use were academic rank (p = 0.02) and perceived understanding of APT use (p = 0.043). Intentions for future use were predicted by attitudes (p < 0.001) and perceived behavioral control (p = 0.036). CONCLUSION: The theory of planned behavior successfully predicted intentions to use APTs. The use of APTs should be encouraged to all faculty members and students.

The Association Between e-Health Literacy and Willingness to Deprescribe Among Patients with Chronic Diseases: A Cross-Sectional Study from Jordan.

Background: Deprescribing refers to the partnered discontinuation of chronic medications to limit the negative impacts of polypharmacy. Polymedicated patients play a key role in the success of deprescribing efforts. eHealth literacy reflects patients' ability to appraise electronically available health-related information to make informed health care decisions, which partly reflect their desire to deprescribe. Objectives: The current study aimed to explore the relationship between eHealth literacy and willingness to deprescribe among patients with chronic diseases. Additionally, the predictors of willingness to deprescribe were examined. Materials and Methods: This cross-sectional study was conducted among adult patients with chronic diseases in Jordan. An online questionnaire comprising two validated tools, namely the Electronic Health Literacy Scale (eHEALS) and the Revised Patients' Attitudes Toward Deprescribing (rPATD) Questionnaire, was used for data collection. The questionnaire targeted adult patients with chronic medical conditions in Jordan and was posted to social media portals, following a convenience sampling technique. Results: A total of 719 responses were recorded and included in the final analysis. Participants with higher levels of eHealth literacy were more willing to get their medications deprescribed, as indicated by the perceived use of unneeded medications (p = 0.042). Meanwhile, participants with low levels of eHealth literacy were more likely to report fear of missing out on the potential benefits of deprescribed medications (p = 0.003). Other items that were commonly agreed upon by both the low and high eHealth literacy groups, respectively, included desire for dose reduction (p < 0.001, p < 0.001), belief in the lack of effectiveness of some prescribed medications (p < 0.001, p < 0.001), and fear of precipitating side effects (p = 0.001, p = 0.007). Conclusions: The present study highlighted the relationship between eHealth literacy and a number of items reflecting willingness to deprescribe, and these indicators can be used to guide future deprescribing efforts among eligible patients.

Association between Charlson Comorbidity Index and polypharmacy: a retrospective database study from Jordan.

OBJECTIVES: Polypharmacy is usually associated with duplication of therapy, unnecessary medications and adverse drug reactions. Therefore, it is crucial to study the factors that increase the risk of polypharmacy. The objective of this study was to assess the risk factors for polypharmacy (i.e. the concomitant use of at least five medications) with a special focus on comorbidity in Jordan. METHODS: Using a retrospective cross-sectional study design, medical records of patients (age ≥55 years), which covered slightly over one-fourth of the population, found in a national electronic healthcare database from 2018 to 2019 were retrieved. Polypharmacy, the main outcome, was defined as the current use of at least five medications (the patient should have at least one chronic condition, one medication refill and continuous use of the medication for at least 30 days). Comorbidity, the main exposure, was summarized using the Charlson Comorbidity Index (CCI). Potential predictors of polypharmacy were examined using a multivariable logistic regression analysis. KEY FINDINGS: An eligible sample of 113 834 individuals (mean age 68 years, 51.5% female) were included in the analysis, of whom 38% met the polypharmacy definition (28% were categorized as having major [5-9 medications] and 10.2% exhibited excessive polypharmacy [≥10 medications]). Approximately, 20% of the patients had a CCI of ≥1. The most significant predictors of polypharmacy were a CCI score between 3 and 4 (adjusted odds ratio [AOR] = 5.89; 95% CI, 5.10 to 6.80; P < 0.001), gender (AOR = 0.86; 95% CI, 0.82 to 0.86; P < 0.001), and age ≥75 years (AOR = 1.62; 95% CI, 1.57 to 1.67; P < 0.001). CONCLUSIONS: Polypharmacy is common among patients in Jordan. Comorbidity is positively, independently and strongly related to polypharmacy. Identifying groups who are at the greatest risk for polypharmacy can help optimize patients' treatment, which can lead to better outcomes and improved quality of life.

Pharmacists' Perspectives on Providing the Influenza Vaccine in Community Pharmacies: A Qualitative Study.

PURPOSE: The objective of this study was to explore community pharmacists' views on providing influenza vaccine administration services in community pharmacies in Jordan. METHODS: The current study is a cross-sectional exploratory study conducted using semi-structured telephone interviews. The semi-structured interview schedule was developed by the researchers and comprised open-ended questions aligned with the study objectives. The telephone interviews were recorded and fully transcribed, and the transcripts were quantitatively coded following a generic qualitative approach. RESULTS: A total of 19 pharmacists took part in this study. Eight participants (42.1%) reported that they had administered the influenza vaccine during their practice. The three overarching themes which described the participating pharmacists' views towards providing influenza vaccine administration services in community pharmacies were benefits, enablers, and barriers. The reported benefits included enhanced therapeutic relationships with patients and increased patient accessibility to vaccines. The majority of the participants indicated that they would be more willing to provide influenza vaccine administration if they received the support they needed from the Jordan Pharmacists Association, third-party insurance companies, and drug stores. Further, from the participants' perspectives, the main barriers to this change in practice were physicians, regulations, and lack of sufficient training. CONCLUSION: Overall, the participating pharmacists had positive attitudes towards administering the influenza vaccine in community pharmacies. The participants highlighted the need for support from regulatory bodies and stakeholders to change the current scope of practice in Jordan. Moreover, the study highlighted the need to incorporate vaccine administration in the curricula used to train new pharmacy graduates.

A case-based learning exercise to increase students' understanding of the pharmacist's role in public health interventions for individual patients.

INTRODUCTION: The purpose of this study was to evaluate whether a public health (PH) micro-level case-based learning exercise increased pharmacy students' self-perceived understanding and confidence in their role as PH pharmacists. METHODS: Three PH micro-level case-based learning exercises in community pharmacy settings were developed and integrated into the third professional year PH course. Students enrolled in the PH course from January 2012 - May 2015 completed a pre- and post-activity survey consisting of 22 statements with Likert scale responses. Survey questions were grouped into domains: perceptions of pharmacist roles (ROLES) in PH, confidence in ability to identify and address PH problems (CONF), pharmacist impact on improving PH outcomes for patients with human immunodeficiency virus (IMPACT-HIV), diabetes (IMPACT-DM), or alcoholism (IMPACT-AL), perceiving pharmacists as role models in PH (MODEL), and whether PH is beyond the scope of pharmacy practice (SCOPE). Within each domain, paired t-tests were performed on summated scores (pre- vs. post-, alpha = 0.05). RESULTS: Both surveys were completed by 271 of 336 students (80.7%). Baseline scores were lowest in the CONF and MODEL domains. The activity resulted in significant changes in 21 out of 24 survey questions. Significantly higher scores were found for domains of ROLES (+1.22), CONF (+1.60), IMPACT-HIV (+0.65), IMPACT-DM (+0.42), IMPACT-AL (+0.70), and MODEL (+1.50). Cronbach's alpha ranged from 0.73 to 0.93 for each domain. CONCLUSION: A PH case-based learning session increased students' scores on a pre- and post-activity survey regarding PH challenges at the micro-level. The activity improved students' perceptions and confidence in providing PH interventions.

The prevalence and severity of potential drug-drug interactions among adult polypharmacy patients at outpatient clinics in Jordan.

OBJECTIVE: To assess the prevalence of potential drug-drug interactions (pDDIs) among polypharmacy patients in Jordan using Lexicomp®. Additionally, this study aims to categorize and rate the identified pDDIs according to interaction risk, severity, and reliability. METHODS: A descriptive cross-sectional study was conducted at six different hospitals representing different public health sectors in Jordan (ministry of health, royal medical services, and university-affiliated hospitals). Polypharmacy patients from outpatient clinics (e.g., cardiology,& and internal medicine) were identified, recruited, and interviewed by clinical pharmacists. pDDIs were assessed using the Lexicomp® mobile application and classified according to interaction risk rating, severity, and reliability rating. Furthermore, the prevalence of pDDIs across chronic medical conditions was assessed. P-value <0.05 was considered as significant. RESULTS: A total of 801 patients with polypharmacy were identified. The average number of drugs per patient was 6.6 ± 1.96, with an average of 4.2 ± 3.0 pDDIs per patient. Potential drug-drug interactions were detected in 769 patients (96%), with a total of 3359 interactions. Blood pressure lowering agents were involved in 39.9% of the pDDIs. Cardiovascular system drugs contributed to the largest share of pDDIs (46.6%). While diuretics had the major share of interactions among cardiovascular system drugs (16.2%), drugs used in diabetes had the highest share across all groups (17.1%). The majority of pDDIs were of "C" risk rating with a moderate interaction severity, whilst 1.6% of pDDIs could have been avoided in the first place as the concurrent administration of these agents is contraindicated (i.e., risk rating X). Patients with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, gout, and chronic kidney disease were associated with the highest number of potential drug-drug interactions. CONCLUSION: Our study showed that 96% of polypharmacy patients at outpatient clinics have at least one pDDI. Almost half of the detected interactions involved cardiovascular medications. The majority of these pDDIs had moderate severity, with no more than 10% of the interactions requiring therapy modification.

Analysis of prevalence, risk factors, and potential costs of unnecessary drug therapy in patients with chronic diseases at the outpatient setting.

Background: Patients with chronic diseases require long-term use of medications and are at risk for prescription of unnecessary drugs.Objective: To determine the prevalence, risk factors, and costs associated with unnecessary drugs in patients with chronic diseases at outpatient settings.Methods: Clinical and demographic data, unnecessary drug therapy and prices of drugs were obtained from 2,677 patients from the outpatient setting of six major hospitals in Jordan. Multivariate logistic regression was used to determine risk factors associated with unnecessary drug therapy.Results: A total of 936 unncessary medications were identified with an average of one unnecessary medication per every three patients. Monthly costs of unnecessary medications, at the national level, were estimated to range between JD 438,930.24 [(618,821.41 USD) (payer's perspective)] and JD 744,765.5 [(1,050,000.19 USD) (patient's perspective)]. Unnecessary drug was associated with cardiac catheterization (adjusted odds ratio [AOR] = 1.29, 95% CI: 1.01-1.71, p = 0.041), increased number of medications (AOR = 3.11, 95% CI: 2.51-3.86, p < 0.001), and inadequate knowledge/understanding of drug use (AOR = 2.4, 95% CI: 1.24-4.64, p = 0.009).Conclusion: Unnecessary drug therapy is common in the outpatient setting. Identified risk factors should be specifically targeted to reduce its burden.

Prevalence and risk factors of anaemia among ever-married women in Jordan.

BACKGROUND: Anaemia is associated with poor health outcomes and is considered a serious public health problem particularly in low- and middle-income countries. Specific subgroups are at higher risk of anaemia, such as women of reproductive age. AIMS: This study examined the prevalence and risk factors of anaemia among ever-married women in Jordan using a secondary analysis of the Jordan Population and Family Health Survey. METHODS: This is a secondary analysis of data from a nationally representative sample of ever-married women aged 15-49 years that were tested for haemoglobin levels in the 2012 JPFHS. Anaemia was categorized according to the WHO criteria. Univariate and multivariate logistic regression analyses were used to investigate risk factors associated with anaemia. RESULTS: The prevalence of any anaemia was 37.3%; specifically, 20% had mild anaemia (haemoglobin 11.0-11.9 g/dl), 16.3% had moderate anaemia (hemoglobin 8.0-10.9 g/dl) and 1% had severe anaemia (haemoglobin < 8.0 g/dl). Factors that were associated with anaemia in the multivariate regression included urban women (P = 0.01), living in the north (P = 0.014) or south regions (P = 0.013) of Jordan, having multiple children (P < 0.001), being pregnant (P < 0.01), and using IUD as a contraceptive method (P < 0.001). CONCLUSIONS: A high prevalence of anaemia among ever-married women of reproductive age in Jordan was noticed. The results emphasize the importance of urgent public health interventions to prevent anaemia in Jordan, particularly among high-risk subgroups.

Relationships Between Social/Emotional Support and Quality of Life, Depression and Disability in Patients With Chronic Obstructive Pulmonary Disease: An Analysis Based on Propensity Score Matching.

BACKGROUND: Patients with chronic obstructive pulmonary diseases (COPD) suffer from impaired Health-Related Quality of Life (HRQoL). Having an adequate social/emotional support may improve the quality of life of COPD patients. OBJECTIVE: To study the relationships between social/emotional support and HRQoL, depression and disability among patients with COPD. METHODS: We applied a propensity score model using data from a large U.S. population-based health survey to match COPD patients who reported rarely/never receiving social/emotional support with those who received that support. Social/emotional support and all dependent variables were dichotomized into yes/no responses. For HRQoL domains, number of days of poor physical or mental health and activity limitations, "yes" indicated ≥14 unhealthy days in the last 30 days. McNemar's test was used to compare the matched groups. RESULTS: Social/emotional support was rarely/never received by 37% of responders. Standardized differences between matched groups, after propensity score matching, were less than 10% indicating successful matching. COPD patients who rarely/never receive social/emotional support were more likely to report: depression (n = 321 pairs, odds ratio (OR) = 2.2, 95% confidence interval (CI): 1.56-3.14, p < .001), ≥14 poor mental HRQoL days (n = 310 pairs, OR = 3.12, 95% CI: 2.1-4.73, p < .001) and ≥14 poor physical HRQoL days (n = 307 pairs, OR = 1.5, 95% CI: 1.06-2.13, p = .02). There were no significant differences in general health, disability, or activity limitations. CONCLUSION: Among COPD patients, lower levels of social/emotional support are associated with depression and deterioration of mental and physical HRQoL. The importance of social/emotional support should be emphasized by policy makers, healthcare providers, and family members, to improve functioning among COPD patients.

The impact of a theory-based web-intervention on the intention to use prescription drugs for non-medical purposes among college students: a randomized controlled trial.

The non-medical use of prescription drugs (NMUPD) among college students is escalating at an alarming rate. A limited number of studies have utilized a theoretical framework to influence this behavior. To utilize the reasoned-action approach theory to design and evaluate a web-based intervention to influence students' attitudes, perceived norms (PNs), perceived behavioral control (PBC) and intentions toward NMUPD. Using a two-group post-test only controlled trial, students were randomized to view either a general health website or a web-based intervention focused on NMUPD. The intervention was presented in multiple sections to address each component of the reasoned-action approach. Subsequently, respondents completed a web-survey. Independent t-tests were used to compare responses between the two groups. Of 391 respondents, 112 (28.9%) students indicated previous NMUPD. The intervention group had significantly (P = 0.04) more negative attitudes toward NMUPD. No significant differences were found in PNs (P = 0.11), PBC (P = 0.68) or intentions to NMUPD (P = 0.97). The intervention was successful in changing attitudes toward NMUPD. Targeting the intervention toward college students regardless of previous experiences of NMUPD might have led to insufficiency of the intervention to influence intentions. Additional research is needed to improve the intervention dissemination and utilization.

Influenza vaccination for patients with chronic obstructive pulmonary disease: Implications for pharmacists.

BACKGROUND: Influenza virus is responsible for substantial morbidity and mortality. Specific populations are at higher risk for exacerbations from influenza virus, such as patients with chronic obstructive pulmonary disease (COPD). Influenza vaccination coverage among COPD patients is low. Pharmacists can improve influenza vaccination among COPD patients by recognizing factors that influence vaccination and addressing these factors. OBJECTIVES: To (1) determine the recent influenza vaccination coverage among patients with COPD, (2) identify factors that were associated with immunization, and (3) interpret the results based upon Andersen's healthcare utilization model. METHODS: The 2012 Behavioral Risk Factor Surveillance System (BRFSS) was accessed for the study. Among respondents age ≥ 25 years with COPD, presence of influenza vaccination was captured along with demographic, provider, insurance, and clinical variables. Weighted multiple logistic regression was used to identify significant factors associated with receiving influenza vaccination. The findings were interpreted according to predisposing, enabling, and need factors relevant to Anderson's model. RESULTS: Influenza vaccination rate was 53% among COPD patients. Older age was a significant predisposing factor that increased vaccination (adjusted odds ratio [AOR] = 2.4; 95% CI:2.02-2.88). Predisposing factors that decreased vaccination were being Black or Hispanic (AOR = 0.72, 95% CI:0.59-0.86, and AOR = 0.78, 95% CI:0.61-0.98 respectively), and being a non smoker (former and never smokers had higher vaccination rates [AOR = 1.53, 95% CI = 1.3-1.72, and AOR = 1.36, 95% CI = 1.19-1.55 respectively]). Significant enabling factors included having health insurance (AOR = 1.68, 95% CI = 1.37-2.06), a primary physician (AOR = 1.63, 95% CI = 1.30-2.02), and the ability to see a physician regardless of cost (AOR = 1.33, 95% CI = 1.17-1.52). Significant need factors included the presence of comorbidities such as asthma (AOR = 1.18, 95% CI = 1.1-1.3), or diabetes (AOR = 1.36, 95% CI = 1.20-1.53), activity limitation (AOR = 1.16, 95% CI = 1.04-1.29), and having the last medical checkup within less than one year (AOR = 1.49, 95% CI = 1.31-1.70). CONCLUSION: Influenza vaccination coverage among COPD patients is far below the Healthy People 2020 national goal. Several predisposing, enabling, and need factors influenced vaccination rate among COPD patients. Pharmacists can improve vaccination rate among COPD patients by recognizing these influencing factors and by acting as advocates, counselors, and administrators of influenza vaccine. Ultimately, with the collaborative efforts of other healthcare providers and public health initiatives, pharmacists can help achieve Healthy People 2020 objectives related to influenza vaccination.

Hepatotoxicity with Vismodegib: An MD Anderson Cancer Center and Research on Adverse Drug Events and Reports Project.

BACKGROUND: On 30 January 2012, the US FDA approved vismodegib (Erivedge®, Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma. OBJECTIVE: Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers. METHODS: FAERS was searched for reports dated 1 January 2009 through 31 December 2015 using terms including hedgehog pathway and vismodegib and hepatic-related terms such as liver, jaundice, and hepatitis, among others. Disproportionality analyses with estimates of proportional reporting ratio and empirical Bayesian geometric mean were conducted. A comprehensive literature review was conducted, and the clinical databases at the University of Texas MD Anderson Cancer Center and Robert H. Lurie Comprehensive Cancer Center of Northwestern University were searched. RESULTS: Two cases of severe liver dysfunction were published (Common Terminology Criteria for Adverse Events [CTCAE] class III), and 94 reports of adverse events (AEs) were detected in FAERS, 35 of which were serious AEs. Safety notifications related to hepatotoxicity have not been issued by the manufacturer or the FDA, although vismodegib is listed in LiverTox and the European Medicines Agency website. CONCLUSION: We identified a detectable safety signal for hepatotoxicity for vismodegib within 4 years of FDA approval. Vismodegib should be used in patients with severe liver disease only after careful consideration, and concomitant hepatotoxic medications should be avoided. Rapid dissemination of such safety concerns is expected to result in fewer serious hepatotoxic AEs and more optimal outcomes for patients with cancer receiving vismodegib.

Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration's adverse event reporting system.

OBJECTIVE: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDA's Adverse Event Reporting System (FAERS). METHODS: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95% confidence intervals (CI). RESULTS: There were 2495 FAERs reports of tendon rupture associated with currently approved FQs. Most FAERS reports were associated with levofloxacin (n = 1555) followed by ciprofloxacin (n = 606) and moxifloxacin (n = 230). Signal detection results for FQs were as follows: levofloxacin (EBGM = 55.2, 95% CI = 52.3 - 58.0), ciprofloxacin (EBGM = 20.0, 95% CI = 18.2 - 21.6), moxifloxacin (EBGM = 13.3, 95% CI = 11.7 - 15.1), norfloxacin (EBGM = 9.6, 95% CI = 6.5 - 13.5), ofloxacin (EBGM = 8.2, 95%CI = 6.3 - 10.2) and gemifloxacin (EBGM = 1.9, 95% CI = 0.7 - 4.5). The mean age of affected individuals was 59.6 ± 5.1 years. Corticosteroids were administered concomitantly with FQs in 21.2% of cases. CONCLUSION: As noted in boxed warnings, FQ use is associated with increased tendon rupture risk. Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.

Anaphylaxis associated with gadolinium-based contrast agents: data from the Food and Drug Administration's Adverse Event Reporting System and review of case reports in the literature.

OBJECTIVES: To summarize reports of anaphylaxis associated with gadolinium-based contrast agents (GBCAs) reported to the Food and Drug Administrations Adverse Event Reporting System (FAERS), examine the safety signals of anaphylaxis from GBCAs, and perform a literature review of relevant case reports. METHODS: FAERS (1/1988-8/2012) was searched using groups of preferred event terms for anaphylaxis combined with all drug names for GBCAs Signal detection involved determination of proportional reporting ratios (PRRs) and empirical Bayes geometric means (EBGM). Published case reports were identified through a Medline search (1/1988-7/2013). RESULTS: There were 614 GBCA FAERS reports of anaphylaxis, resulting in a safety signal (PRR = 6.2, 95% confidence interval (CI) = 5.7 - 6.7; EBGM = 5.1 CI = 5.6 - 6.6). Among GBCAs, 43% were associated with gadopentetate dimeglumine (PRR = 4.9, CI = 4.3 - 5.5; EBGM = 4.8, CI = 4.3 - 5.4), 29% with gadobenate dimeglumine (PRR = 17.5, CI = 15.2 - 20.2; EBGM = 17.1, CI = 14.6 - 19.8) , and 17% with gadoteridol (PRR = 5.7, CI = 4.7 - 6.8; EBGM = 5.6, CI = 4.6 - 56.7). There were 14 anaphylaxis case reports in the literature. CONCLUSIONS: GBCAs used as medical imaging agents, can cause life-threatening or fatal anaphylaxis. There were differences in disproportionality of reporting between between agents. Although differences in numbers of reports of anaphylaxis reflect relative utilization rates of the various agents, disproportionality analyses (PRR, EBGM) disclose significant safety signals of anaphylaxis associated with most GBCAs.