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Background: Pre-marketing clinical trials can filter only about 50% of the drug reaction. Hence, to prevent the morbidity and mortality due to severe cutaneous reactions early detection, evaluation and monitoring of adverse drug reaction (ADR) especially cutaneous ADR (CADR) are mandatory. Hence, it is imperative that we update our knowledge of the precise nature of ADR which will prevent the reactions as well as to find the offending drug. Aim and Objectives: The aim of the study was to evaluate the pattern of CADR, the suspected drugs and to perform the causality assessment using WHO casualty assessment scale. Materials and Methods: A retrospective descriptive study was done using the data reported to ADR monitoring center in the Department of Pharmacology by the health-care professionals. Suspected CADR was diagnosed by the consultants concerned. The CADRs collected were categorized according to their morphology into maculopapupar rash (MPR), fixed drug eruptions (FDE), urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The causality assessment was done using WHO Causality assessment scale. Results: The mean age was 47.20 + 22.31. The most common CADR reported was Urticaria 65.5% followed MPR 23%, FDE 8.8%, and Steven Johnsons Syndrome 2.2%. Anti-microbial drugs were the most frequent cause of the adverse reactions with Amoxicillin clavulinic acid combination being the most frequent suspected drug producing CADR (13.3%). The WHO causality assessment for majority of CADR was Possible (73.5%). Conclusion: Clinical Patterns of CADRs in this set up have some minor variations when compared to studies done across India. Amoxicillin clavulinic acid is the most common suspected drug in this study which was not frequently reported in other ADR monitoring centers.
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Background: Pharmacovigilance has constantly gained importance in the past 15 years, relating to absolute amount of adverse drug reactions (ADRs) and to the fact that several hospital admissions are due to ADRs. Knowledge of ADRs and practice of pharmacovigilance by healthcare professionals will definitely help to evaluate the quality of pharmacotherapy in hospitals and effectively decrease the occurrence of ADRs. Aims and Objectives: The objectives are as follows: (1) To assess the knowledge, attitude, and practice of health care professionals (HCPs) toward ADR monitoring and (2) to assess the causation of underreporting of ADRs. Materials and Methods: This study was a cross-sectional questionnaire-based study. The questionnaire was distributed to 328 HCPs which included al doctors, nurses and pharmacists serving in ESIC Medical College and Hospital, Kalaburagi. HCPs who did not give consent to fill the questionnaire were excluded from the study. Results: The response rate was 82.92%. In our study, only 25.75% were aware that ADR reporting is to be done by doctors, nurses and pharmacists, and 40.44% felt that ADR reporting should primarily done by doctors alone. Overall participants who knowledge about ADRs and pharmacovigilance were 48.8%. Although 75.7% participants agreed that ADR reporting is important, over 76.5% HCPs felt that reporting ADR would be an obligation. In this study 12.5% HCPs have ever reported ADR despite having experienced one during their clinical practice. Majority of the HCPs had a belief that a single ADR reporting would not change the ADR database; hence, this could be one of the reasons for low rate of reporting ADRs. Conclusion: In our study, though the level of knowledge and attitude toward ADR reporting was adequate among the HCPs, there was poor practice of ADR reporting. Necessary measures to be taken to create awareness among HCPs about Pharmacovigilance Programme in India. They should be trained to spontaneously report ADRs.
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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. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.
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OBJECTIVE:To introduce the research and application of sentinel hospital pharmacovigilance system,and provide technical reference for hospital pharmacovigilance working in China. METHODS:A sentinel hospital pharmacovigilance system based on hospital information system was established,the architecture and functionality were introduced and its effects were ana-lyzed. RESULTS:The sentinel hospital pharmacovigilance system formed by hospital business information management platform and data center. Its main functions included drug data arrangement,the auxiliary reporting of ADR,active monitoring,pharmaco-vigilance information inquiry,monitoring and warning and statistical analysis,which successfully achieved the rapid reporting and active monitoring of hospital ADR. The system had applied in 20 sentinel hospitals,and the ADR reporting quantity was obviously increased after applying the system. Compared with 2015,ADR reporting in a sample sentinel hospital was increased 120.6％ since it used the system in early 2016. Besides,the system had improved the ADR reporting process,operation and input standard for the ADR reporter,shortened the reporting time and improved the efficiency of the reporting staff. CONCLUSIONS:The establish-ment and application of sentinel hospital pharmacovigilance system has greatly improved the hospital ADR monitoring management level,and it is of great significance to further strengthen the pharmaovigilance in China.
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OBJECTIVE:To provide reference for improving the teaching quality of the course of Drug Abuse and ADR Moni-toring in pharmacy master degree candidates. METHODS:In Pharmacy College of Jilin University,traditional teaching method was adopted among pharmacy master degree candidates of grade 2014(n=30,control group);case teaching method was adopted for the course of Drug Abuse and ADR Monitoring among those of grade 2015 (n=32,observation group). The teaching effects were evaluated by questionnaire and examination. RESULTS:Theoretical examination result and case analysis score as well as the rate of excellent case analysis score in observation group were all significantly higher than control group,with statistical signifi-cance (P<0.05). The satisfaction degree of observation group was significantly higher than that of control group in respects of teaching methods,arousing interest in classroom learning,establishing the awareness of safe and rational drug use,with statistical significance (P<0.05). CONCLUSIONS:For the course of Drug Abuse and ADR Monitoring in pharmacy master degree candi-dates,case teaching method improves students'exam results,stimulates students'interest and enthusiasm,promotes the establish-ment of students'safe and rational drug use consciousness and improves teaching quality.
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The present study was conducted to evaluate the spontaneous ADR monitoring in a tertiary care hospital. A total of 150 ADRs reports were collected. The WHO definition of an ADR was adopted. Evaluation of the data was done for various parameters which included types, severity and seriousness of reactions. Naranjo score was used for causality assessment. Overall occurrence of ADRs was more in males. Type A reactions (77%) accounted for majority of the reports. Gastrointestinal system (33%) was the most commonly affected organ system. Antibiotics (32%) were the drug class most commonly involved in ADRs. The suspected drug was withdrawn for the management of the ADR in the majority (82%) of the reports. Upon causality assessment, majority of the ADRs were rated as possible (64%). Mild and moderate reactions accounted for 23 and 65% of ADRs, respectively. The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.
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Objective To discuss the development of ADR monitoring in Chinese medical institutions by the bibliomet-rics .Methods Literatures from CNKI .net ,VIP and Wanfang Database were retrieved ,then to compliant literatures were screened according to inclusion requirements ,and the bibliometric indicators were used to analyze by bibliometric metrology . Results 4079 literatures were screened compliantly .The trend in the annual number of literatures about medical institutions ADR reports was overall upward 1990-2015 .Top 20 of journals covered for 54 .55% of all papers analyzing ADR reports . Distribution of journals published ADR literatures publication showed significant Bradford features .The top six provinces pub-lished cumulative amount ratio close to 50% ,which showed regional distribution of literature .The proportion of published lit-eratures from medical institutions in the prefecture-level cities was the largest (50 .87% ) ,the average of literatures amount in the capital cities was largest ,5 mulriple of the county cities .Pharmacists were the main author group of writing papers which analyzing medical institutions ADR reports ,accounting for 87 .01% .Conclusion The changes in the annual number of litera-tures which analyzed medical institutions ADR reports could reflect the development process of ADR monitoring in China .The level of ADR monitoring research was related to the level of regional economic development .
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Background: Internship is the intermediate period between under-graduation and general practice. The dexterity of health professional relies upon prescribing practices. Clinical pharmacology and therapeutics (CPT) is a crucial discipline for interns to acquire safe and rational prescription of drugs. Cultivating sound knowledge about CPT during under graduation is, henceforth, mandatory. Aims and objectives: 1. To assess whether the undergraduate CPT teaching and internship training had prepared interns adequately for safe and rational prescription. 2. To assess the awareness and reporting of adverse drug reaction (ADR). Methods: 110 interns were enrolled after obtaining informed written consent. A structured questionnaire was given to them including basic demographic information, undergraduate CPT teaching, experience of ADR and any deficiency in the under-graduate CPT teaching. Results: Response rate was 91 % in which 53 were males and 47 females. 81 considered themselves aware of CPT. 56% & 57% interns were able to prescribe drug safely and rationally respectively. Without supervision, they were confident to prescribe antacids (93%), vitamins and minerals (90%), NSAIDS (85%), antihistamines (82%), antibiotics (75%), antiemetics (62%) and antiasthmatics (52%). Only 22% had reported ADR and opined that it could lead to hospitalization (51%), prolonged hospital stay (33%), morbidity (16%) and death (21%). According to interns, the topics where more emphasis needed were ADR, dosage calculation, pediatric and emergency medicine and therapeutic drug monitoring during undergraduate CPT teaching. Conclusion: CPT teaching should be improved at undergraduate level for safe and rational prescribing including ADR monitoring, ADR reporting and dosage calculation.
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The observational and cross section study was conducted in the ADR monitoring centre, department of pharmacology, GMCH. The cutaneous adverse drug reactions (CADR) reported by physician of dermatology department of GMCH were collected and then causality, severity and preventability assessment was done. The results were presented as number and percentage. Acne and erythema was commonly reported CADR in our study. Most of the reported CADRs were possible, definitely preventable and mild in nature. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety.
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Objective:To observe the occurrence of ADRs in a hospital and analyze its correlative factors.Meth- od:131 ADR cases collected in a hospital in 2006 were categorized statistically analyzed.Result:121 of the 131 ADR ca- ses were induced by chemical drugs,and the other 10 cases,induced by the traditional Chinese drugs.In the 121 ADR ca- ses induced by chemical drug,the most were induced by intravenous injection,which occupied 49.62%.Antimicrobial drugs were the first category of drugs to cause ADRs,totaling 77 cases from 42 drugs.ADR most commonly manifested themselves in the injury of skin and appendents,which accounted for 52.89%(64 cases).There were 10 comparatively serious ADR cases.Conclusion:The occurrence of ADRs was related to many factors,such as administration route and drug varieties.ADRs monitoring and publicizing of ADRs knowledge should be strengthened so as to lessen and avoid the occurrence of ADRs.
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AIM: To recognize the importance of ADR monitoring of drugs available on the market from PPA Event. MET- HODS: With reviewing relevant literatures and scanning relevant network stations. we summarlzed the importance of moni- toring ADR of drugs available on the market and signiticance of creating a perfect evaluation mechanisms and systems of ADR monitoring for those drugs. and analysed several method of ADR monitoring and points for attention Finally. we gave several suggestions about enhancing ADR monitoring .RESULTS& CONCLUSION:ADR events can be effectively pre- vented by perfect evaluation mechanisms and ADR monitoring systems of drugs available on the market.
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Problems of Adverse Drug Reaction (ADR) have been regarded as growing social concern in health. The purposes of this study were to analyze current domestic and foreign adverse drug reaction monitoring system and to develop a web-based reporting system and to test its performance. Two university hospitals, one clinic, and six pharmaceutical companies were participated in this pilot project. From March 1 to Oct. 30, 1998, a total of 310 cases were reported fromm the participating two hospitals. Of these, 240 cases were mild(77.42%), 61 cases were moderate(19.68%), and 9 cases were severe cases(2.9%). More ADR cases were report from the outpatients(83.22%) than inpatients. Oral intake was the most common route of administration(74.2%). A future ADR monitoring system was also presented in this paper.