Patterns, causality, severity, and preventability of adverse drug reactions: An observational study at a tertiary health-care center

Background: Adverse drug reactions (ADRs) are among the top leading causes of death, adversely affect the quality of life by increasing hospital stay, treatment cost, and morbidity. Spontaneous reporting of ADRs by health-care professionals (HCP) helps in signal detection and enables regulatory agencies to formulate drug use guidelines, issue warnings, or even ban/withdraw the drug from the market. Dissemination of knowledge regarding the patterns of ADRs seen in adverse drug reaction monitoring centers (AMCs) among HCP will enable to promote awareness on ADRs, help in early detection, and encourage them to be more vigilant so as to prevent recurrence of ADRs. Aims and Objectives: We conducted an observational study, with the following objectives. The aim of the study was to determine the pattern of ADRs reported to AMC at PESIMSR, causality assessment, severity score, and preventability. Materials and Methods: We conducted an observational, retrospective, and questionnaire-based study in PESIMSR AMC, Department of Pharmacology. The study period was between January 2016 and December 2016. All ADRs reported to the AMC in the above period were collected by convenient sampling method. Data collected includes patient characteristics such as age, gender, details of the reaction, details regarding suspected drugs, treatment, and outcome of ADR details as outlined in the standard CDSCO ADR notification form. Data were entered in SPSS version 22. Descriptive statistics used and values are expressed in frequency and percentages. Results: A total of 153 cases were taken for analysis. Among them, 52% were males and 48% were females. The incidence of ADRs was higher (26%) among third and fourth decade than other age groups. Most frequent classes of drugs causing ADRs are antibiotics (44%) followed by analgesics (10%) and oral hypoglycemics (6%). The most frequently reported ADRs were cutaneous reactions. According to the WHO scale for causality assessment, 59% were possible ADRs. According to modified Hartwig Seigel’s severity assessment scale, about 16% were assessed as severe reactions. About 39% were probably preventable ADRs as assessed by modified Schummock and Thornton scale. Conclusion: Hospital-based ADR monitoring and reporting programs aim to identify and quantify the risks associated with the use of drugs. This study gives an insight to emphasize the awareness to the health-care providers on vigilant monitoring of ADRs and promptly reporting the same so as to prevent the occurrence of the reactions in vulnerable population.

A retrospective study of adverse drug reactions in a tertiary care center

Background: Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hubballi, Karnataka, India.Methods: This was a retrospective observational study, extending over 6 months (May 2019 to October 2019). A total of 124 cases comprising patients of either sex and age group ranging from 1month to 72 years were studied. The data was collected using CDSCO ADR reporting form. 揘aranjo抯 Assessment Scale� was used for causality assessment and severity assessment was done in accordance with 揌artwig and Siegel scale�.Results: The study showed majority of ADRs were from General Medicine department and affected skin and appendages (59%). Skin rashes 44 (31.7%) were found to be the most commonly reported ADRs most of them were with antimicrobials 67 (54%). After causality assessment 83 (66.9%) of the cases were classified as probable and 41 (33.1%) were classified as possible. Majority of serious ADRs were not preventable in our study.Conclusions: ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended.

Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.

Patterns of adverse drug reactions: a study in a tertiary care

Background: Adverse drug reaction, usually reported by pharmacovigilance, either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the severity of the drug and also if the ADRs are casual, preventable or severe.Methods: A total of 42 patients satisfied the WHO definition of ‘adverse drug reactions’ were included in the study. The demographic details were taken, and the regular physical examination and clinical examination was done for all the patients. The latest drug they were on and the dosage were analyzed and the type of reaction was assessed. The causality, severity and preventability were also assessed.Results: Majority of the ADRs were found in the medicine department, followed pulmonology, obstetrics-gynecology and paediatrics. B-lactams were the major cause of ADRs with 42.2%, followed by NSAIDs with 23.8%, fluoroquinolones with 19% and 9.5% due to antitubercular drugs. 66.7% of the ADRs were mild, 28.6% were moderate and 4.8% were severe. The most common type of ADR were skin rashes (40.5%), urticara (16.7%), headaches (26.2%), insomnia (21.4%), diarrhoea (21.4%), abdominal pain (14.3%) and vomiting (4.8%). Most of the ADRs were evaluated as probably preventable (69%), definitely preventable (26.2%), non preventable (4.8%).Conclusions: Most of the drug reactions are mild and preventable. More health care professionals as well as patients need to be aware of the drug reactions at much early age so as to prevent the condition before it becomes serious.

Reacciones adversas evitables graves por antivirales. Sistema Cubano de Farmacovigilancia, 2008-2017 / Serious adverse reactions avoidable by antivirals. Cuban Pharmacovigilance System, 2008-2017 / Reações adversas severas prevenidas por antivirais. Sistema cubano de farmacovigilancia, 2008-2017 / Réactions indésirables graves évitable par les antiviraux. Systeme cubain de pharmacovigilance, 2008-2017

Resumen Objetivo: Caracterizar las reacciones adversas graves evitables por antivirales presentes en el Sistema Cubano de Farmacovigilancia durante los años 2008 al 2017. Material y métodos: Investigación cuantitativa, observacional y descriptiva; enmarcada dentro de los estudios de farmacovigilancia, con un diseño de serie de casos. El universo conformado por las notificaciones de reacciones adversas graves evitables provocadas estos fármacos. Se utilizaron variables como: reacción adversa identificada, grupo de edad, sexo, fármaco antiviral, frecuencia y causas de evitabilidad. Resultados: Las reacciones adversas evitables graves a los antivirales se comportaron a ritmo irregular que muestra tendencia al incremento. Predominaron en hombres (77.8%) y en adultos (94.4%). Zidovudina (44.4%) y nevirapina (38.9%) muestraron la mayor cantidad de reportes, relacionados con la aparición de anemia y síndrome de Stevens Johnson. Los médicos reportaron el 72.2% de los casos. Las reacciones encontradas se describen como frecuentes. Las interacciones medicamentosas (61.1%) fue la principal causa de evitabilidad. Conclusiones: La caracterización de las reacciones adversas graves evitables a los antivirales permitió identificar que las mismas fueron frecuentes, producidas por antirretrovirales y presentadas hombres adultos; siendo la anemia y síndrome de Stevens Johnson las más frecuentes. Las causas de evitabilidad identificadas con mayor frecuencia responden a errores de la prescripción.

Abstract Object: To characterize the serious adverse reactions avoidable by antivirals present in the Cuban Pharmacovigilance System during the years 2008 to 2017. Materials and methods: Quantitative, observational and descriptive research; framed within the pharmacovigilance studies, with a case series design. The sample conformed by the reports of avoidable serious adverse reactions caused by these drugs. Variables were: identified adverse reaction, age group, sex, antiviral drug, frequency and causes of preventability. Results: Severe avoidable adverse reactions to antivirals were presented at an irregular level that shows a tendency to increase. They predominated in men (77.8%) and in adults (94.4%). Zidovudine (44.4%) and nevirapine (38.9%) showed the highest number of reports, related to the appearance of anemia and Stevens-Johnson syndrome. The doctors reported 72.2% of the cases. The reactions found are described as frequent. Drug interactions (61.1%) was the main cause of preventability. Conclusions: The characterization of the serious adverse reactions avoidable to the antivirals allowed to identify that they were in their majority produced by antiretroviral and occurred mainly in adult men; anemia and Stevens-Johnson syndrome were the most frequent. The causes of preventability identified with greater frequency correspond to errors of the prescription.

Resumo Objetivo: Saracterizar as reações adversas graves evitáveis por antivirais presentes no Sistema Cubano de Farmacovigiláncia durante os anos de 2008 a 2017. Materiais e métodos: Pesquisa quantitativa, observacional e descritiva; enquadrada no ámbito de estudos de farmacovigiláncia, com um desenho de estudos de casos. O universo foi constituido pelos relatórios das notificações de reações adversas graves causadas por esses medicamentos. Foram utilizadas variáveis, tais como: reacjao adversa identificada, grupo etário, sexo, fármaco antiviral, frequência e causas de prevenjao. Resultados: Reações adversas severas preveníveis por antivirais surgem a um ritmo irregular mostrando um aumento crescente. Predominaram em homens (77,8%) e em adultos (94,4%). Zidovudina (44,4%) e nevirapina (38,9%) apresentaram o maior número de relatos, relacionados ao aparecimento de anemia e síndrome de Stevens Johnson. Os médicos relataram 72,2% dos casos. As reações encontradas são descritas como frequentes. As interajoes medicamentosas (61,1%) foram a principal causa da prevenção. Conclusões: A caracterização de reações adversas graves, preveniveis por antivirais permitiram identificar que eram frequentes, produzidos por anti-retrovirais e apresentados em homens adultos; sendo a anemia e a síndrome de Stevens Johnson as mais frequentes. As causas mais frequentemente identificadas de prevenção demonstram erros de prescrição.

Résumé Objectif: Caractériser les effets indésirables graves évitables par les antiviraux présents dans le systéme cubain de pharmacovigilance pendant les années 2008 á 2017. Matériaux et méthodes: Recherche quantitative, observationnelle et descriptive; encadré dans les études de pharmacovigilance, avec une conception de série de cas. L'échantillon était conforme aux rapports d'effets indésirables graves évitables provoqués par ces médicaments. Les variables utilisées étaient réaction indésirable identifiée, groupe d'áge, sexe, médicament antiviral, fréquence et causes de prévention. Résultats: Les réactions indésirables évitables tombes aux antiviraux se sont comportées á un rythme irrégulier qui a tendance á augmenter. Ils prédominaient chez les hommes (77,8%) et chez les adultes (94,4%). La zidovudine (44,4%) et la névirapine (38,9%) présentaient le plus grand nombre de signalements, liés á l'apparition de l'anémie et au syndrome de Stevens-Johnson. Les médecins rapportent 72.2% des cas. Les réactions trouvées sont souvent déclinées. Les interactions médicamenteuses (61,1%) étaient la principale cause évitable. Conclusion: La caractérisation des effets indésirables graves évitables antiviraux a permis d'identifier qu'ils étaient produits principalement par les antirétroviraux et se produisaient principalement chez les hommes adultes; l'anémie et le syndrome de Stevens-Johnson étaient les plus fréquents. Les causes évitables identifiées généralement correspondent á des erreurs de prescription.

A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India

Background: The present study was undertaken to evaluate the incidence and pattern of adverse drug reaction (ADRs), causality, severity and preventability of ADRs.Methods: Data was collected and analyzed with the information such as patients’ demographic details, associated co-morbid conditions and detailed drug related information gathered from ADR reporting forms. World Health Organization (WHO) scale was used for assessing causality, modified Hartwig scale was used for assessing severity and modified Schumock and Thorntons scale were used for assessing preventability of ADRs. Data was analyzed using descriptive statistics.Results: Total 154 ADRs were reported in a period of one year (August 2016- July 2017). Out of 154 ADRs analyzed, 120 (77.9%) were in adults, 33 (21.4%) pediatric and 01 (0.7%) in geriatric patients. The most common ADR recorded was cutaneous reactions (43.5%) and the most common causative class of drugs for the same was found to be antimicrobials (46.7%) followed by non-steroidal anti-inflammatory drugs (15.6%). Causality assessment scale indicated 68.8% ADRs possible and 24% ADRs as probable. Severity assessment revealed that 45.5 % were mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 84.4% of the cases were probably non-preventable.Conclusions: In this study it was found that, most of the ADRs were of possible category with mild to moderate severity and majority being non-preventable. Antimicrobial drugs being the most common offending drug class causing ADRs. Strategies targeting appropriate and cautious use of this class of drugs may benefit in reducing the number of ADRs and therefore the cost involved in the treatment.

A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India

Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.

An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.

A prospective study of adverse drug reactions in a tertiary care teaching hospital

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.

A retrospective analysis of adverse drug reactions reported at a tertiary care hospital in South India

Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.

Comorbidities, potentially dangerous and low therapeutic index medications: factors linked to emergency visits / Comorbidades, medicamentos potencialmente perigosos e de baixo índice terapêutico: fatores associados à busca da emergência hospitalar

Abstract This article aims to investigate the morbidities related to medications, their risk factors and causes detected in patients who seek the Hospital Emergency Service of a University in the South of Brazil. Data collection was based on application of a questionnaire to patients of a minimum age of 18 years, that signing the Term of Free and Informed Consent (TFIC), during the period from October 2013 to March 2014, and analysis of electronic record charts. Cases were evaluated by pharmacists and a doctor to define whether it was a case of medication related morbidity (MRM) and to establish its possible causes. Avoidability of MRM was verified based on criteria previously established in the literature. In total 535 patients were interviewed, and the frequency of MRM was 14.6%, Approximately 45% of MRMs were related to safety in the use of medications, and approximately 50% presented user-related questions as the possible cause. Hospitalization was required in 44.8% of MRM cases; 62.7% of cases were considered avoidable. Presence of chronic disease and use of potentially dangerous medication and low therapeutic index were considered independent factors associated with development of MRM, according to statistical analysis.

Resumo O objetivo deste artigo é investigar as morbidades relacionadas a medicamentos (MRM), os fatores e as causas detectados em pacientes que buscam o serviço de emergência de hospital universitário do sul do Brasil. A coleta de dados baseou-se na aplicação de um questionário aos pacientes com idade mínima de 18 anos, durante o período de outubro de 2013 a março de 2014, e na análise do prontuário eletrônico. Os casos foram avaliados para definir se era um caso de MRM e para estabelecer as suas possíveis causas. A evitabilidade da MRM foi verificada com base em critérios previamente estabelecidos na literatura. No total foram entrevistados 535 pacientes e a frequência de MRM foi de 14,6%. Aproximadamente, 45% das MRMs foram relacionadas com a segurança no uso de medicamentos e cerca de 50% apresentou como possível causa questões relacionadas ao usuário. Houve necessidade de internação em 44,8% dos casos de MRM; 62,7% dos casos foram considerados evitáveis. Presença de doença crônica e utilização de medicamentos potencialmente perigosos e de baixo índice terapêutico foram consideradas fatores associados ao desenvolvimento de MRM.

Preventable readmission to intensive care unit in critically ill cancer patients / 世界急诊医学杂志（英文）

BACKGROUND:Readmission to intensive care unit (ICU) after discharge to ward has been reported to be associated with increased hospital mortality and longer length of stay (LOS). The objective of this study was to investigate whether ICU readmission are preventable in critical y il cancer patients. METHODS:Data of patients who readmitted to intensive care unit (ICU) at National Cancer Center/Cancer Hospital of Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) between January 2013 and November 2016 were retrospectively collected and reviewed. RESULTS:A total of 39 patients were included in the final analysis, and the overall readmission rate between 2013 and 2016 was 1.32％ (39/2,961). Of 39 patients, 32 (82.1％) patients were judged as unpreventable and 7 (17.9％) patients were preventable. There were no significant differences in duration of mechanical ventilation, ICU LOS, hospital LOS, ICU mortality and in-hospital mortality between patients who were unpreventable and preventable. For 24 early readmission patients, 7 (29.2％) patients were preventable and 17 (70.8％) patients were unpreventable. Patients who were late readmission were all unpreventable. There was a trend that patients who were preventable had longer 1-year survival compared with patients who were unpreventable (100％ vs. 66.8％, log rank=1.668, P=0.196). CONCLUSION:Most readmission patients were unpreventable, and all preventable readmissions occurred in early period after discharge to ward. There were no significant differences in short term outcomes and 1-year survival in critically ill cancer patients whose readmissions were preventable or not.

Clinical value of preventative surgical resection in the treatment of extra-hepatic portal vein aneurysm / 中华消化外科杂志

Objective To investigate the clinical value of preventative surgical resection in the treatment of extra-hepatic portal vein aneurysm.Methods The method of retrospective descriptive study was conducted.The clinical data of 1 patient with extra-hepatic portal vein aneurysm who was admitted to the Guangzhou General Hospital of Guangzhou Military Command of PLA in May 2014 were collected.The patient suffered from dull pain in his epigastrium,with no obvious causative factors.The patient recieved abdominal B-ultrasound,CT scans abdominal and superior mesenteric artery,angiographies after admission in May 2014,and was diagnosed as with extra-hepatic portal vein aneurysm.The preventative surgical resection was selected according to the patient's individual health status.Extra-hepatic portal vein aneurysm resection was conducted under the guidance of intraoperative ultrasonography after abdominal exploration.A double-cavity drainage tube was placed in the venturis hole when portal vein aneurysm was dissected and removed.Then the abdomen was closed.The patient received regular perioperative management.The operation time,volume of intraoperative blood loss,time for diet recovery,time of drainage tube removal,postoperative complications,results of laboratory tests,results of imaging findings,healing of incision,time of postoperative discharge from hospital,results of pathologic examination and follow-up were observed.Follow-up using outpatient examination or telephone interview was performed to detect the inspect status of portal vein and inspect recurrence of portal vein aneurysm by abdominal B-ultrasound and CT examinations till December 2014.Results The patient underwent successful extra-hepatic portal vein aneurysm resection.The operation time was 85 minutes and the volume of intraoperative blood loss was around 150 mL.The patient gradually returned to normal diet and self-care ability at postoperative day 3,and the abdominal drainage tube was removed at postoperative day 3.No postoperative complications including hemorrhage,portal vein thrombosis and dysfunction of liver were detected after operation.There were normal levels of blood routine and blood biochemical test.Postoperative B-ultrasound examination showed smooth blood flow in portal vein and the abdominal blood vessel CT angiography presented clear image of the portal vein,with smooth blood flow and normal lumen.The surgical incision recovered very well and the patient was discharged from hospital at postoperative day 9.Results of postopeartive pathologic examination showed that there were cystic-like tissues with simple squamous epithelium cells on the interior,the wall of which consisted of smooth muscle was in accordance of the structure of vein.The patient didn't receive any other special treatment or take medicines postoperatively.The patient had good physical health and can take care of himself during six-month follow-up,without narrow portal vein,recurrence of portal vein aneurysm and other complications.Conclusion Preventative surgical resection is safe and feasible for extra-hepatic portal vein aneurysm,with a good efficacy.

A prospective study of incidence and assessment of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school.

Background: The wide and indiscriminate use of drugs has increased the incidence and the modes of presentation of cutaneous drug reaction. Understanding the nature of ACDRs may help narrow down the search for the offending agent. Aim- The study aimed to evaluate incidence, assessment of causality, severity and preventability of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school. Material and methods: The current survey was executed by the department of Pharmacology in collaboration with Department of Dermatology, MSDS Medical College, Fatehgarh among 7692 patients attending Dermatology OPD during March-December 2014. CDSCO ADR Reporting Form, WHO causality assessment scale, Hartwig and Siegel’s Assessment scale and Modified Schomock and Thronton’s preventability assessment scale were used as study tools. All the doctors, residents, interns and students were encouraged to notify any suspected ACDRs. Patients were screened and recruited if they presented with visible skin lesions suspected to be drug related. As per Modified Schumock and Thornton Scale, 43.5% of ACDRs were ‘Definitely preventable’ followed by ‘Probably preventable’ (30.4%) and ‘Not preventable’ (26.1%). Results: 23 patients (0.3%) were detected to have one or other type of ACDRs. Fixed drug eruption was most common form (34.8%) of ACDRs followed by Acneform eruption and Urticaria in 21.7% and 13% respectively among study subjects. The most common drugs responsible for ACDRs were prednisolone, betamethasone and isoniazid for Fixed drug eruption, while matronidazole, cotrimoxazole and paracetamol for acneform eruption. Antimicrobials, other steroids and NSAIDs were responsible for other spectrum of ACDRs. On assessment of Causality of ACDRs, it was noted that more than half (52.2%) of them fall under probable category. Severity assessment of ACDRs revealed that majority (65.3%) of them was moderate in nature. Conclusion: Awareness on part of the physician can help in timely detection of cutaneous reactions, thereby restricting damage from them. Pharmacovigilance activity is significantly effective in increasing the reporting of ADRs. Study with long-term follow-up and monitoring of the patients with bigger sample size is warranted.

A prospective observational study of adverse drug reactions to antiretroviral therapy: type and risk factors in a tertiary care teaching hospital.

Background: To collect demographic details of patients receiving antiretroviral therapy (ART) and study type of adverse drug reactions (ADRs) and risk factors for ADRs to ART and to assess causality, severity, and preventability assessment of the reported ADRs. Methods: A prospective observational study was conducted for 6 months from January 2012 until June 2012 at ART Center, KR Hospital of Mysore Medical College & Research Institute, Mysore. Data were evaluated for patient demography, risk factors for ADRs, type of ADRs. ADRs were also assessed for their causality, severity, and preventability as per the standard algorithm, using SPSS for windows (version 16.0). Results: Out of 158 patients evaluated, majority were of age group of 21-40 years (66.5%). More number of illiterate patients (55.7%) showed ADRs to ART. Most patients were of CD4 count <250 cells/μl (65.82%). Most common regimen which caused ADRs was zidovudine + lamivudine + nevirapine. Most common type of ADRs was anemia (55.06%) and rash (25.31%). On evaluation of the causality of ADRs, majority were found to be possible (89.24%). The severity assessment showed that most of the patients ADRs were of level 3 (93.05%). The preventability assessment showed that 30.38% patients ADRs were preventable. Conclusion: Identifying risk factors are of crucial importance to optimize the initial choice of ARVs regimen before initiating therapy and to prevent severity and complications caused by ART, thereby improving the quality of care to patients on ART.

Pattern of cutaneous adverse drug reactions due to the use of fixed dose drug combinations.

Background: Fixed dose drug combinations (FDCs) possess a higher risk of causing adverse drug reactions (ADRs) compared to a drug used individually. This study analyzes the pattern of ADRs caused due to the use of FDCs in a tertiary care hospital. Methods: A prospective, spontaneous ADR reporting study was conducted for two years at a tertiary care hospital. ADRs reported due to suspected FDC use were evaluated for causality (WHO-UMC probability scale), severity (adapted Hartwig scale) and avoidability (Modified Hallas J. et al. scale). Results: Of the 29 (96.67%) cutaneous ADRs reported, 19 (63.34%) ADRs were due to irrational FDCs, of which 16 (53.34%) were ‘probable’, 13 (43.34%) were ‘possibly avoidable’ and 13 (43.34%) were ‘mild/level 2’ on the severity scale. Conclusion: Irrational FDCs carry a higher risk of causing cutaneous ADRs. Awareness and regular reporting of such ADRs can help physicians fight the evil of irrational prescribing.

Frecuencia, evitabilidad y consecuencias de los eventos adversos / Frequency, preventability and consequences of adverse events

El presente estudio pretende determinar la frecuencia, evitabilidad y consecuencias de los Eventos Adversos (EA) ocurridos en los servicios de hospitalización basándose en las fichas epidemiológicas e historias clínicas de pacientes que hayan tenido un evento durante este periodo. Como resultados se encontró con mayor frecuencia los Eventos Adversos (EA) son debidos a algún procedimiento (63%): suspensión quirúrgica (38%), seguido de otras complicaciones R/C intervención quirúrgica o procedimiento (13.3%), viéndose mayormente afectada la población masculina (61%), en edades de 10 a 29 años (37%). El servicio donde se presentan más frecuentemente estos eventos es cirugía (52%). Esta problemática produce deterioro físico en un 100% en el paciente, además de aumentar la estancia hospitalaria de 1-2 días (91.7%), siendo el mayor factor causal el tipo de asistencia sanitaria que recibe el paciente. Estos eventos pudieron haber sido evitados en un 74% de los casos. En conclusión el presente estudio mostró que los eventos adversos ocurridos con mayor frecuencia fueron los relacionados con algún procedimiento y/o cuidados, siendo de estos, los más comunes la cancelación de turnos quirúrgicos y quemaduras, erosiones y contusiones (incluyendo fracturas consecuentes) respectivamente. Lo que produjo una prolongación de los días de estancia, lo cual no ocasionó directamente situaciones de gravedad o repercusiones importantes en el estado de salud del paciente; pero la aparición de estos Eventos Adversos (E.A) son completamente prevenibles, puesto que tiene que ver directamente con las prácticas de cuidado impartidas por el personal de salud, que requieren mayor concentración al momento de realizar cualquier procedimiento, si se toman en cuenta las medidas necesarias para garantizar la seguridad del paciente.

This study aims to determine the frequency, preventability and consequences of adverse events (AEs) occurring in hospital services based on epidemiologic and clinical records of patients who have had an event during this period. As a result of this most frequently encountered adverse events (AE) it was found that they were due to procedure (63%)as surgical suspension (38%), followed by other complications R / C surgery or procedure (13.3%). the most affected population are male (61%), aged 10 to 29 years (37%). The service in which these events occur more frequently is surgery (52%). This problem causes physical damage by 100% in the patient, moreover it will increase the hospital stay of 1-2 days (91.7%), it is the largest causing factor the type of health care to the patient. These events could have been avoided in 74% of cases. In conclusion this study showed that adverse events occurred most frequently were related to any procedure and / or care. They were the most common; surgical termination of turns and burns, abrasions and contusions (including resulting fractures) respectively. It produced prolongation of the days of stay, which not directly causes serious situations or significant impact on patient health status, but the occurrence of these adverse events (AEs) are completely preventable, since they are related to the practices of care given by health personnel, who require more concentration when performing any procedure, if one takes into account the measures necessary to ensure patient safety

An epidemiologic study of measles among hospitalized pediatric patients

No abstract available.