scholarly journals Assessment of Causality, Preventability and Severity of Cutaneous Adverse Drug Reactions: A Prospective Observational Study

2021 ◽  
pp. 93-97
Author(s):  
Rajesh Hadia ◽  
Sunil Baile ◽  
Dhaval Joshi ◽  
Trupal Rathod
Keyword(s):  
Clinical Trials ◽  
Safety Profile ◽  
Pharmacy Practice ◽  
Clinical History ◽  
Multiple Drug ◽  
Self Medication ◽  
Moderate Severity ◽  
History Of ◽  
Multiple Drug Therapy

Background: All drug regulatory authorities have to ensure the safety, efficacy and quality of all the marketed products. Quality and efficacy can be determined by the data from preclinical and clinical trials. In clinical trials at the pre-marketing stage, it is challenging to identify rare Adverse reactions (ADR) and delayed side effects or effects due to long-term exposure because of lack of follow-up. In this case, pharmacovigilance comes into picture where it plays a significant role in marketed drugs safety profile establishment. Aim: This study helps in safety profile establishment for drugs. Methodology: It was conducted by the Department of pharmacy practice at drug information Centre in collaboration with Department of pharmacology at private multi-specialty Hospital. ADR reporting forms of the Central Drug Standard Control Organization has been used for collecting the data, and this form includes patient demographic details like clinical history, co-morbid conditions like Diabetes mellitus, Hypertension, Asthma, history of any drug allergies etc. were collected. The chance of preventability modified Schumock and Thornton criteria was found to be very less, and it was evident that most of them were not. By using Hartwig et al., scale, the severity of ADRs were of moderate severity. The reason behind this moderate severity was a history of allergy and multiple drug therapy. Result: It was observed that preventability 86% were not preventable whereas 14% were preventable as per Schumock and Thornton scale. In these cases of definitely preventable cases were due to history of reaction upon administration of the same drug. It is advised that in such cases usage of drug alert card is preferred. Conclusion: The major risk factor for the development of ACDR includes self-medication, patients’ lack of awareness regarding the dose and frequency of administration, polypharmacy. This can be avoided by prescribing the required drugs only and by educating     the patients regarding the drugs.

M1897 Long-Term Clinical History of Patients with Severe Reflux Esophagitis: A Four-Month to Eighteen-Year Follow-Up Study

2009 ◽  
Vol 136 (5) ◽  
pp. A-441
Author(s):  
Noriaki Manabe ◽  
Ken Haruma ◽  
Jiro Hata ◽  
Hiroshi Imamura ◽  
Tomoari Kamada ◽  
...  
Keyword(s):  
Reflux Esophagitis ◽  
Clinical History ◽  
Follow Up Study ◽  
History Of

scholarly journals Distonía Periférica Post-Traumática. Reporte De Un Caso.

2019 ◽  
Vol 38 (2) ◽  
Author(s):  
Ana Raquel Goti Polanco ◽  
Fernando Gracia
Keyword(s):  
Spontaneous Recovery ◽  
Clinical History ◽  
Cervical Region ◽  
Multiple Drug ◽  
Number Of Patients ◽  
History Of ◽  
Post Traumatic ◽  
The Right ◽  
Plexus Block ◽  
Possible Cause

<p><strong>[Post-Traumatic Peripheral Dystonia. Report Of A Case]</strong></p><div><br />Resumen<br />Introducción: La distonía es un trastorno del movimiento caracterizado por contracciones musculares relativamente sostenidas que producen posturas anormales y repetitivas. Un pequeño número de pacientes con distonía representan los traumas como posible causa. Caso Clínico: Paciente femenina de 15 años de edad con historia de trauma con objeto contuso en región cervical con pérdida de conocimiento y recuperación espontánea. Inmediatamente refirió dolor cervical posterior. Dos días después, presentó movimientos distónicos en miembro superior derecho (MSD) y se agregaron mioclonías, por lo que se hospitalizó. Se manejó con múltiples esquemas de medicamentos, sin mejoría. Se realizó bloqueo de plexo braquial derecho con mejoría de la sintomatología. Conclusión: Los casos de distonía post-traumática son poco comunes. Se debe considerar al momento de evaluar un traumatismo. La historia clínica es la herramienta más valiosa para llegar al diagnóstico, siempre descartando otras posibles causas.</div><div> </div><div> </div><div>Abstract<br />Introduction: Dystonia is a movement disorder characterized by relatively sustained muscle contractions that produce abnormal and repetitive postures. A small number of patients with dystonia represent traumas as a possible cause. Clinical Case: Female patient of 15 years of age with a history of trauma with blunt object in the cervical region with loss of consciousness and spontaneous recovery. Immediately he reported posterior cervical pain. Two days later, he presented dystonic movements in the right upper limb (MSD) and myoclonus was added, so he was hospitalized. It was managed with multiple drug schemes, without improvement. Right brachial plexus block was performed with improvement of the symptomatology. Conclusion: Cases of post-traumatic dystonia are uncommon. It should be considered when assessing a trauma. The clinical history is the most valuable tool to reach the diagnosis, always discarding other possible causes.</div>

scholarly journals Etiology of Diarrhoea with Reference to Multiple Drug Resistant Enteric Bacterial Pathogens

1970 ◽  
Vol 9 ◽  
pp. 131-138 ◽  
Author(s):  
Sirjana Devi Shrestha ◽  
Sarala Malla ◽  
Shital Raj Basnyat
Keyword(s):  
Nalidixic Acid ◽  
Clinical History ◽  
Multiple Drug ◽  
Enteric Infection ◽  
Drug Resistant ◽  
Salmonella Spp ◽  
Key Words Antibiotics ◽  
Significant Incidence ◽  
Multiple Drug Resistant ◽  
History Of

A total of 340 stool samples were processed and studied from both sexes including all ages of patients. Association of enteropathogens between male and female was not statistically significant. Incidence of diarrhoea (28.23%) as well as prevalence of enteropathogens (34.31%) was found highest in the age group (20-30) years. The highest prevalence of enteropathogens (44.87%) was found in August. Of the total isolated enteropathogens, Vibrio cholerae O1 was observed in 51.96% followed by Shigella (18.6%) and Salmonella (8.82%) and parasites were also detected from 20.58% samples. All isolated V. cholerae O1 were El Tor, Inaba. Among Shigella, majority of isolates were S. flexneri. Among Salmonella, S. typhi, S. typhimurium and Salmonella spp. (polyvalent A-S positive) were identified. Entamoeba histolytica, Girdia lamblia, Ascaris lumbricoides and Trichuris trichiura were isolated among parasites. All isolated (100%) V. cholerae O1 were resistant to nalidixic acid and cotrimoxazole, whereas 68%; 63%; 53%; 37% and 11% Shigella were resistant to nalidixic acid, ampicillin, cotrimoxazol, mecillinam and ciprofloxacin respectively. Similarly, 55.5%; 44.4% and 11.1% Salmonella were resistant to nalidixic acid; ampicillin and cotrimoxazole respectively. All V. cholerae strains, 10 strains of Shigella and 2 strains of Salmonella were found multi drug resistant (MDR). The clinical history of the positive cases revealed that abdominal pain, fever, vomiting, dehydration and nausea were the symptoms of enteric infection. Key words: antibiotics; isolates; enteropathogen; Inaba DOI: 10.3126/njst.v9i0.3176 Nepal Journal of Science and Technology 9 (2008) 131-138

Databases in MS research: pitfalls and promises

1999 ◽  
Vol 5 (4) ◽  
pp. 206-211 ◽  
Author(s):  
Brian G Weinshenker
Keyword(s):  
Clinical Trials ◽  
Natural History ◽  
Patient Information ◽  
Interferon Beta ◽  
Statistical Significance ◽  
Entire Population ◽  
Short Term ◽  
The Past ◽  
History Of

A database is an organized repository of data. Prospective collection of patient information in a database (`databasing') has been attempted by a few consortia of MS investigators over the past 10 years. This approach promises to facilitate epidemiologic research in MS and investigation of the natural history of the disease and how it might be altered by long-term treatments such as interferon beta. Databasing has some advantages over clinical trials in assessing new therapies, primarily because the focus is on long-term effectiveness in an entire population rather than short-term statistical significance in a highly selected population. The limitations of databasing and strategies to overcome these limitations are addressed.

Identifying and Communicating Clinically Meaningful Drug–Drug Interactions

2014 ◽  
Vol 29 (2) ◽  
pp. 110-115 ◽  
Author(s):  
Scott D. Nelson ◽  
Joanne LaFleur ◽  
Emily Hunter ◽  
Melissa Archer ◽  
Carin Steinvoort ◽  
...  
Keyword(s):  
Drug Therapy ◽  
Drug Interactions ◽  
Sleep Disorders ◽  
Systematic Approach ◽  
Pharmacy Practice ◽  
Drug Regimen ◽  
Patient Specific ◽  
Multiple Drug ◽  
Medical Problems ◽  
Multiple Drug Therapy

Objective: Providing care to patients with comorbid medical problems may result in complicated, multiple drug therapy regimens, increasing the risk of clinically meaningful drug–drug interactions (DDIs). The purpose of this article is to describe the prevalence of DDIs and provide examples on how to identify and intervene on DDIs. Methods: We described DDI data from the Utah Drug Regimen Review Center, where adult Medicaid patients were reviewed by pharmacists from 2005 to 2009. Patients were selected by the number of prescriptions filled per month (>7) or having a high RxRisk score. Summary: A total of 8860 patients were reviewed, and 16.6% had at least 1 clinically meaningful DDI. Patients with DDIs were slightly younger (mean age 45.2 vs 48.2), more likely to be female (75.0% vs 68.9%), and had more prescriptions per month (13.4 vs 12.5) compared to patients without ( P < .001). Pharmacodynamic DDIs were more prevalent (80.2%) than pharmacokinetic. Pharmacodynamic DDIs mainly occurred with drugs used to treat psychiatric/seizure/sleep disorders (69.4%) and pain/migraine (56.6%). Pharmacokinetic DDIs mainly occurred with drugs used to treat psychiatric/seizure/sleep disorders (53.2%), cardiovascular diseases (46.3%), and infectious diseases (29.6%). Conclusions: Clinically meaningful DDIs are common in patients with complex medication regimens. A systematic approach for identifying DDIs, determining clinical significance, formulating patient-specific recommendations, and communicating recommendations is important in pharmacy practice.

Long-Term Efficacy and Safety with Deferasirox (Exjade®, ICL670), a Once-Daily Oral Iron Chelator, in Pediatric Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2774-2774 ◽  
Author(s):  
Antonio Piga ◽  
Elliott Vichinsky ◽  
Gian Luca Forni ◽  
Yurdanur Kilinc ◽  
Henry Maseruka ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sexual Development ◽  
Safety Profile ◽  
Pediatric Patients ◽  
Negative Impact ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Old Patients ◽  
Term Efficacy

Abstract Background: Children with transfusion-dependent anemias will usually require lifelong iron chelation therapy. Establishing the long-term efficacy and safety profile of deferasirox is critically important in children. Presented here are cumulative long-term efficacy and safety data from a cohort of children treated with deferasirox in ongoing clinical trials. Methods: Pediatric patients (<16 years old) with β-thalassemia, sickle cell disease or other transfusion-dependent anemias were enrolled in 4 clinical trials and treated for 1 year with deferasirox (studies 106/108) or randomized to either deferasirox or deferoxamine (DFO; 107/109). Study treatment was extended for 4 years (extension phases); patients either continued deferasirox (deferasirox cohort) or crossed over from DFO to deferasirox (crossover cohort). Doses in the extensions were adjusted based on efficacy and safety parameters. Efficacy was monitored via serum ferritin (SF); safety was assessed by the incidence and type of AEs. Growth and sexual development were evaluated every 6 months. Results: 434 patients aged 2–<16 years (n=289 deferasirox cohort; n=145 crossover cohort) entered the extensions. In the deferasirox and crossover cohorts, respectively, 50 and 20 pediatric patients were ≥2–<6 years old, 123 and 69 were 6–<12 years old, and 116 and 56 were ≥12–<16 years old. Patients in the deferasirox cohort have received treatment for a median 3.5 years. Mean (SD) doses were 9.5 (1.6), 19.5 (2.6) and 29.6 (2.5) mg/kg/d in the 5/10, 20 and 30 mg/kg/d groups at month 1, respectively, and 22.9 (7.7), 24.6 (7.6) and 26.3 (9.5) mg/kg/d at month 42. Until month 12, median SF levels were maintained in the 20 mg/kg/d cohort, decreased in the 30 mg/kg/d cohort and increased in the 5/10 mg/kg/d cohort. After dose escalations at month 12, median SF levels fell below baseline at month 42 in all cohorts (Table). 390 (90%) children continue to receive deferasirox. Of 43 discontinuations, 22 were due to AEs. Two deaths, both considered unrelated to treatment, occurred in the deferasirox cohort. The most common drug-related AEs, including vomiting (n=26), nausea (n=25), abdominal pain (n=21), diarrhea (n=19) and mild/moderate skin rash (n=35), occurred mainly in the core phases. There were no significant changes in markers of liver function in the extension phases and no cases of progressive increases in serum creatinine. Physical and sexual development proceeded normally in all children. Conclusions: Over a median period of 3.5 years, treatment with deferasirox provided dose dependent overall reduction in iron burden in transfusion-dependent children, as measured by SF levels. Deferasirox had a manageable safety profile in children, which was similar to that observed in the 1-year core trials. There was no negative impact on growth and sexual development. Median SF values (ng/mL) in children (deferasirox cohort) Initial dose, mg/kg/d Month 5/10 20 30 All n=129 n=89 n=74 n=292 *Dose adjustments Baseline 2126 2504 3491 2420 1 2041 2488 2976 2451 6 2394 2724 2678 2460 12* 2653 2602 2608 2618 18 3037 2480 2271 2771 24 2929 2651 2106 2522 30 2747 2404 2007 2440 36 1967 1916 2008 1970 42 1830 1812 1889 1831

Long-term Efficacy of 2 Year WHO Multiple Drug Therapy (MDT) in Multibacillary (MB) Leprosy Patients

2003 ◽  
Vol 71 (4) ◽  
pp. 308 ◽  
Author(s):  
Roland V. Cellona ◽  
Maria F. V. Balagon ◽  
Eduardo C. dela Cruz ◽  
Jasmin A. Burgos ◽  
Rodolfo M. Abalos ◽  
...  
Keyword(s):  
Drug Therapy ◽  
Multiple Drug ◽  
Term Efficacy ◽  
Leprosy Patients ◽  
Multiple Drug Therapy

Clinical landmarks in chronic otitis media with tympanosclerosis: clinical history may have predictive value in the diagnosis of ossicular chain mobility

2019 ◽  
Vol 133 (11) ◽  
pp. 992-994 ◽  
Author(s):  
A E Dinç ◽  
Y Ç Kumbul
Keyword(s):  
Otitis Media ◽  
Predictive Value ◽  
Disease Duration ◽  
Chronic Otitis Media ◽  
Clinical History ◽  
Ossicular Chain ◽  
Duration Of Symptoms ◽  
Chain Mobility ◽  
History Of

AbstractObjectivesTo evaluate clinical characteristics of tympanosclerosis and to investigate the predictive value of clinical evaluation in diagnosing the ossicular chain status in tympanosclerosis.MethodsThe study included 166 ears operated on for chronic otitis media. Age, gender, duration of symptoms and history of ear drainage were recorded from the patient's file. Details of ossicular mobility were obtained from the operation records.ResultsThere was no difference in age or disease duration between ears with chronic otitis media with or without tympanosclerosis. The ears with chronic otitis media without tympanosclerosis had a higher rate of middle-ear suppuration compared to those with tympanosclerosis (p < 0.001). In chronic otitis media with tympanosclerosis, the ears with a mobile ossicular chain had a higher rate of active drainage in their clinical history compared to ears with a fixed ossicular chain (p = 0.026). Stapes fixation was present mostly in dry ears with tympanosclerosis (p = 0.005).ConclusionChronic otitis media with tympanosclerosis is characterised by the long-term absence of suppurations. The probability of having a fixed ossicular chain or stapes was higher in tympanosclerosis cases with no ear drainage.

Sign in / Sign up

Export Citation Format

Share Document