scholarly journals More than skin deep. Ten year follow-up of delayed cutaneous adverse drug reactions (CADR)

2016 ◽  
Vol 82 (4) ◽  
pp. 1040-1047 ◽  
Author(s):  
Linda Velta Graudins ◽  
Jenny Ly ◽  
Jason Trubiano ◽  
Ar Kar Aung
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions

scholarly journals The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study

Drug Safety ◽  
2018 ◽  
Vol 41 (8) ◽  
pp. 753-765 ◽  
Author(s):  
Helen Byomire Ndagije ◽  
Victoria Nambasa ◽  
Leonard Manirakiza ◽  
Donna Kusemererwa ◽  
Dan Kajungu ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Health Facilities ◽  
Drug Reactions ◽  
Antimalarial Treatment ◽  
Follow Up Study

scholarly journals Time to onset in statistical signal detection revisited: A follow‐up study in long‐term onset adverse drug reactions

2019 ◽  
Vol 28 (10) ◽  
pp. 1283-1289
Author(s):  
Joep H.G. Scholl ◽  
Florence P.A.M. Hunsel ◽  
Eelko Hak ◽  
Eugène P. Puijenbroek
Keyword(s):  
Signal Detection ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Follow Up Study ◽  
Statistical Signal Detection ◽  
Time To Onset

scholarly journals Follow-up of suspected ocular adverse drug reactions

2009 ◽  
Vol 88 (7) ◽  
pp. e279-e280 ◽  
Author(s):  
Gordon A. Reeks ◽  
Ghee S. Ang
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions

scholarly journals The spectrum of adverse drug reactions in a multidisciplinary kidney clinic

2019 ◽  
Vol 9 (1) ◽  
pp. 61-67
Author(s):  
Shaima Al-Bader ◽  
Shaikha Al-Bader ◽  
Kamel El-Reshaid
Keyword(s):  
Adverse Drug Reactions ◽  
Kidney Diseases ◽  
Immunosuppressive Treatment ◽  
Drug Side Effects ◽  
Drug Reactions ◽  
Drug Compliance ◽  
Chronic Kidney Diseases ◽  
The Past ◽  
Morbid Conditions

Introduction: Data on adverse drug-reactions (ADR) in the medical field are rare. Objective: To report on the pattern of such problem in a multidisciplinary kidney clinic Patients and Methods: Medical records of patients were reviewed retrospectively for such phenomenon in the past 6 years Results: A total of 4834 patients were included for analysis.   The unit is responsible for a large proportion of patients with acute and chronic kidney diseases of diverse etiologies and multiple co-morbid conditions.  Acute and maintenance dialysis as well as immunosuppressive treatment for idiopathic glomerulopathy and autoimmune systemic diseases were common practice.  Results: A total of 70044 ADR were diagnosed in 4438 patients.  Most patients were adults (39+14) and had median follow up of 38 months. Nearly half of the ADR were due to drug-side effects while idiosyncrasy accounted for 1.2%.  The former is due to misuse/abuse of medications while the latter is due to genetic, co-morbid conditions or synergetic between 2 drugs or a drug and disease.  Details of drugs ADR are outlined with their respective prevalence.  Our study indicates the need for careful auditing of patient’s response during follow up to improve their drug-compliance. Keywords: adverse drug reaction, allergy, medical clinic, kidney disease.

scholarly journals Management and outcomes of real-world use of non-vitamin-K oral anticoagulants (NOACs) in patients with atrial fibrillation: experience of a dedicated NOAC clinic

2019 ◽  
Vol 27 (12) ◽  
pp. 605-612 ◽  
Author(s):  
A. J. W. M. de Veer ◽  
N. Bennaghmouch ◽  
M. C. E. F. Wijffels ◽  
J. M. ten Berg
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Drug Reactions ◽  
Vitamin K ◽  
Real World ◽  
Oral Anticoagulants ◽  
Daily Practice ◽  
Drug Reactions ◽  
Real World Data ◽  
First Choice

Abstract Background Current guidelines recommend non-vitamin‑K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF). The use of drugs in a clinical trial setting differs from that in real-world populations. Real-world data are important to accrue more heterogeneous patient populations with respect to co-morbidities and co-medication use. The aim of this study was to evaluate the use of NOACs in daily practice in a large tertiary hospital in the Netherlands. Methods A single-centre prospective study was conducted among all patients with AF using a NOAC in the St. Antonius Hospital between 2013 and June 2017. The outcomes were the rates of any bleeding, stroke/transient ischaemic attack, mortality, discontinuation rate and adverse drug reactions. Results In total, 799 patients were enrolled with a mean follow-up of 1.7 years. Mean age was 69.8 (SD ± 11) and 61.2% were male. Mean CHA2DS2-VASc score was 2.8 (SD ± 1.6) and mean HAS-BLED score was 1.4 (SD ± 0.9). Bleeding occurred in 6.0, major bleeding in 1.8, stroke in 1.2 patients per 100 patient-years, and 87 patients (10.9%) died during the follow-up period. Adverse drug reactions were reported by 59 patients (7.4%). Finally, 249 patients (31.2%) reported a temporary interruption and 132 (16.5%) permanent discontinuation of NOAC treatment, of whom 33 (25%) patients switched to a vitamin‑K antagonist. Conclusions We observed low rates of bleeding and adverse drug reactions. However, rates of mortality and discontinuation were relatively high. These results could possibly be explained by the real-world nature of the data including higher-risk patients.

scholarly journals A retrospective study of Adverse Drug Reactions in a tertiary care centre

2018 ◽  
Vol 7 (7) ◽  
pp. 1339
Author(s):  
V. J. Ambika Abhishake ◽  
S. Basalingappa ◽  
Arun Gopi ◽  
More Pankaj Daulat
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Unintended Effects ◽  
Age Group ◽  
Test Results ◽  
Drug Reactions ◽  
Tertiary Care Centre ◽  
Common System ◽  
Males And Females

Background: Adverse drug reactions (ADRs) are a major concern in present day clinical practice. They are inevitable consequences of drug therapy; as no pharmacotherapeutic agent is completely free from noxious and unintended effects. They are major contributors for morbidity, mortality and hospitalization of the patients increasing the economic burden on the society and uncertainty in clinical outcomes.Methods: This was a retrospective observational study, extending over 6 months (September 2016 to February 2017). A total of 290 cases were studied, excluding the geriatric age group. The data was collected using CDSCO ADR reporting form. A comparison of ADR between males and females was made; based on the organ system affected and the category of drug using “proportion test”.Results: The study showed the ADR incidence was equal in both sexes (≈50%). It was observed that majority ADRs were from gastro intestinal system (39%) followed by CNS (20%) and skin and soft tissue (14%). Constipation was found to be the most common of the reported ADRs (18%) followed by vomiting (9%) and diarrhoea (8%).Conclusions: ADRs are a major cause of morbidity worldwide. Several studies; including the present one, has shown GIT to be the most common system affected. Frequency of ADRs can be reduced by careful follow up and a robust hospital based pharmacovigilance setup.

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)

scholarly journals Impact assessment of pharmacovigilance-related educational intervention on nursing students’ knowledge, attitude and practice: A pre-post study

2019 ◽  
Vol 9 (6) ◽  
pp. 98 ◽  
Author(s):  
Subish Palaian ◽  
Mohamed Izham Mohamed Ibrahim ◽  
Pranaya Mishra ◽  
Pathiyil Ravi Shankar
Keyword(s):  
Nursing Students ◽  
Adverse Drug Reactions ◽  
Test Group ◽  
Knowledge Score ◽  
Rank Test ◽  
Control Group ◽  
Drug Reactions ◽  
Total N ◽  
The Impact

Objective: This study evaluated the impact of a pharmacovigilance education module for nursing students.Methods: In this prospective, pre-post interventional study, the 2nd year diploma in Nursing students (n = 38) were the ‘test’ group (who received intervention), and the 1st and 3rd year students were the control group (n = 78); total n = 116.  Knowledge Attitude Practice (KAP) responses were taken at baseline (0 day), 30 days, 90 days and 180 days from both the groups. Improvements in the KAP scores following the intervention was analyzed using Wilcoxon signed rank test at alpha = .05, and the feedback was obtained using a ‘Likert scale’ having 20 questions; maximum possible score was 100.Results: The median (IQR) overall baseline scores of knowledge were 11 (10-12), the attitude/practice scores were 22 (20.25-22.00) and the total scores was 32.5 (31-34); the maximum possible score was 40. Almost all (n = 113; 97.4%) of them felt adverse drug reactions reporting was necessary and were interested in learning about adverse drug reactions. The baseline KAP scores were significantly higher among the second- and third-year students compared to the first year (p < .001). Upon intervention, a significant improvement was seen in knowledge scores between the baseline and first follow-up (p = .018) and between second and third follow-up (p = .001) in the test group. The median (IQR) feedback score was 85 (80.7-88.2).Conclusions: Students had better attitude/practice scores, but a poor knowledge score at baseline. This study confirmed the feasibility of conducting a pharmacovigilance module for nursing students in Nepal.

scholarly journals 136. Impact of an OPAT Pharmacist on Guideline Adherence and Clinical Outcomes

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S83-S84
Author(s):  
Alice Lin ◽  
Trisha S Nakasone ◽  
Nancy N Nguyen ◽  
Catherine Yang
Keyword(s):  
Antibiotic Therapy ◽  
Adverse Drug Reactions ◽  
Guideline Adherence ◽  
Clinical Cure ◽  
Pharmacist Intervention ◽  
Laboratory Monitoring ◽  
Drug Reactions ◽  
Cure Rates ◽  
The Impact

Abstract Background Outpatient parenteral antibiotic therapy (OPAT) provides select patients a cost-effective alternative to completing intravenous (IV) antibiotic therapy outside the hospital. The Infectious Diseases Society of America (IDSA) OPAT practice guidelines and handbook recommend weekly laboratory monitoring and timely follow-up for OPAT patients. An analysis at VA Palo Alto Healthcare System (VAPAHCS) conducted prior to pharmacist involvement demonstrated that IDSA recommendations were not routinely followed, leading to a clinical cure rate of 62.7%. This led to the implementation of an OPAT pharmacist in 2019. This analysis aims to determine the impact of a pharmacist-managed OPAT program at VAPAHCS. Methods This comparative, retrospective analysis included patients who received OPAT at VAPAHCS between October 1, 2019 and September 30, 2020 and those who received OPAT in a prior analysis. Primary outcomes included rates of adherence to IDSA recommendations on follow-up visits and weekly lab monitoring during OPAT. Secondary outcomes included rates of clinical cure, 90-day readmission, and adverse events or complications. Data was analyzed using Fisher’s exact test and independent t-test. Results This analysis included 74 patients and 76 total OPAT episodes. Bacteremia was the most common diagnosis (n=35, 38.0%), and the most common organism was methicillin-susceptible Staphylococcus aureus (MSSA) (n=23, 29.9%). With respect to guideline adherence pre- and post- pharmacist-managed OPAT, 31.3% versus 93.4% of patients had follow-up within 7 to 14 days of discharge (p&lt; 0.001). Rates of weekly lab monitoring of CBC, BMP, and LFTs pre-pharmacist were 63.2%, 63.3%, and 49.5%, respectively, compared to post-pharmacist rates of 93.0%, 92.1%, and 83.6%, respectively. Clinical cure rates were 62.7% pre-pharmacist and 89.6% post-pharmacist (p&lt; 0.001). More adverse drug reactions were identified in the post-pharmacist period, of which 30% required pharmacist intervention. Figure 1. Weekly Laboratory Monitoring of Antimicrobials (%) Figure 2. Adherence to IDSA Guideline Follow-up Recommendation Figure 3. Rates of Clinical Cure Conclusion Pharmacist involvement in OPAT significantly increased IDSA guideline adherence to lab monitoring and follow-up visits, and clinical cure rates. Identification of adverse drug reactions prompting pharmacist intervention further highlights the importance of follow-up in OPAT patients. Disclosures All Authors: No reported disclosures

scholarly journals Adverse Drug Reactions Associated with Anthracyclinebased Chemotherapy in Mexican Cancer Pediatric Patients: Cohort Study

2020 ◽  
Vol 2 (2) ◽  
pp. 9-17
Author(s):  
Jessica Liliana Vargas Neri ◽  
Osvaldo Daniel Castelán Martínez ◽  
Gilberto Castañeda Hernández ◽  
Felipe Rodríguez Islas ◽  
Miguel Ángel Palomo Colli ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Drug Reactions ◽  
Pediatric Patients ◽  
Causality Analysis ◽  
Drug Reactions ◽  
First Line ◽  
Pediatric Hospitals ◽  
Temporary Suspension ◽  
The Mean

Introduction. Adverse drug reactions (ADR) are an important cause of illnesses and death in cancer pediatric patients. Anthracyclines are drugs used as the first-line treatment for this disease. It is necessary to apply different pharmacovigilance strategies to know the incidence, causality, and evaluation of an ADR prevention processes. The objective of this cohort study was evaluating the incidence, severity, and causality of ADRs associated with anthracycline-based chemotherapy in Mexican pediatric patients. Material and Methods. A retrospective cohort study was conducted in two pediatric institutions in Mexico. All ADRs were identified and analyzed according to pharmacovigilance guidelines. Ninety-nine patients were included in this study, 92 % had at least one ADR associated with chemotherapy. Results. A total of 718 AR were found, 354 (49.3 %) were associated, by causality analysis, as probable and definite with anthracycline-based chemotherapy. The reaction with the highest incidence was febrile neutropenia (67.7 %). The mean ADR associated with anthracycline-based chemotherapy per patient was 4 ADR / patient. Most ADRs were severe, involving hospitalization, treatment and temporary suspension of chemotherapy. Conclusions.The incidence of ADRs associated with anthracycline-based chemotherapy is high and most require monitoring and follow-up, so increasing awareness of the safety of these medications provides relevance to implement pharmacovigilance actions in pediatric hospitals.

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