Adverse Drug Reactions in the Pediatric Population: Findings From the Adverse Drug Reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020).

Background and objective The incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India. Methods This was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis. Results The largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent. Conclusions One-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.

Adverse Drug Reaction (ADR) as a Cause of Hospitalization at a Government Hospital in Saudi Arabia: A Prospective Observational Study.

BACKGROUND: ADRs represent a substantial burden on health care resources worldwide and are considered as one of the leading causes of morbidity and mortality which significantly affects hospitalization rates. However, ADR related hospital admissions are not well explored in Saudi Arabia. OBJECTIVE: The current study aims to evaluate ADR-related admissions at King Saud Hospital, Unaizah, Qassim, Saudi Arabia. METHODS: A prospective, observational study was conducted at King Saud Hospital Unaizah. Over a period of 6 months, patients above 12 years of age who visited the Emergency Department (ED) with an ADR were included in this study. The investigators collected patient data by reviewing the patient's medical records and the ED records for admission. The Naranjo algorithm was used to assess the causality of the suspected ADR, and Hartwig's Severity Assessment Scale was used to assess the severity of the ADR. RESULTS: Out of 4739 admissions to the wards, 38 (0.801%) were related to an ADR. The majority of patients were male (52.6%), with a mean age of ± 49.08 years. The total length of hospital stay was 565 days with a mean of ± 14.87 days. The causality assessment shows that 35 (92.1%) cases were probable ADRs, whereas 3 (7.9%) cases were possible ADRs. Moreover, the severity assessment showed that 6 (15.1%) cases were mild, and 27 (71.1%) and 5 (13.2%) cases were moderate and severe, respectively. In regard to the outcome of patients, most patients recovered after the ADR, and 2 ADRs resulted in the death of the patient. CONCLUSION: Our study shows that ADRs as a cause of hospitalization in Qassim population is considerably low. However, ADRs may contribute to morbidity and mortality and result in a considerable financial burden.

A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials.

Pharmacovigilance is the pharmacological science associated with the detection, understanding and prevention of adverse effects, especially long-term and short-term adverse effects of medicines. In the present day pharmaceutical scenario, where the development and marketing of an ever-growing array of medicines has rendered their safety and therapeutic efficacy key to determining the success of a drug, pharmacovigilance has come about to play a critical and significant part. While pharmacovigilance, as a system, has witnessed considerable progress and evolution in the West, not as much has been accomplished in India. With India now being recognised as a hub of global clinical trials and with an increasing number of clinical trials and clinical research studies being conducted actively, the need for a dynamic pharmacovigilance network with an efficient and prudent operation methodology is felt, now more than ever. This article observes the evolution of the pharmacovigilance system in India, with a fundamental overview of the present system in place and also various schemes and proposals to establish and sustain the same. It also examines the challenges faced in the execution of an effective pharmacovigilance network as well as the future prospects with regards to the Indian market.

Evaluation of the Effects of Case Teaching Method on the Course of Drug Abuse and ADR Monitoring in Pharmacy Master Degree Candidates / 中国药房

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.

Research and Application of the Sentinel Hospital Pharmacovigilance System Based on HIS / 中国药房

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.

Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study.

OBJECTIVES: To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. METHODS: It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo's algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. RESULTS: Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99 %. Male patients experienced majority (68.52 %) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87 %) followed by ceftriaxone (20.31 %). Most (51.56 %) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85 % of ADRs were mild. Majority (87.5 %) of the ADRs were of 'probable' causality category and 96.9 % were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). CONCLUSIONS: Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.

Analysis on ADR monitoring of Chinese medical institutions based-on bibliometric / 药学实践杂志

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 .

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR.

OBJECTIVES: Children are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs. METHODS: Intensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance. RESULTS: Incidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5-6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0-1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal. CONCLUSION: Well premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety.

Improving Monitoring and Reporting of Adverse Drug Reactions (ADRs) in HIV positive patients on Antiretroviral Therapy (ART) in Nigeria.

Under-reporting of ADR may be associated with poor knowledge, attitudes and practices to pharmacovigilance. This study evaluated knowledge, attitudes and practices of healthcare professionals about ADR monitoring and reporting following interventions. This longitudinal study included 36 healthcare professionals participating in ART program in a tertiary hospital. Interventions included group training on pharmacovigilance (PV) and provision of ADR reporting forms amongst others. Assessments were conducted at months 0 and 6 post-interventions using study-specific Likert-type instruments. Mean attitude scores above midpoint of 3.6 on 5-point scale were regarded as positive and below as negative. P<0.05 used to determine statistical significance. Mean age of participants was 36.6 (95%CI, 34.5-38.7) years; 61.1% males; 44.4% doctors, 13.9% pharmacists, 19.4% nurses, 8.3% laboratory scientists, 8.3% record officers and 5.6% welfare officers. None had received training on PV previously. Mean knowledge test score increased from 53.6% (95%CI, 44.6-63.6) at pre-intervention to 77.1% (95%CI, 72.8-81.4) at post-intervention with a mean change of 146.9% (95%CI, 60.5-233.3; p=0.000). Mean rated attitude scores increased from 3.6 (95%CI, 3.4-3.8) at pre-intervention to 4.2 (95%CI, 4.0-4.4) at post-intervention; the difference was statistically significant (p=0.000). 75.8% reported that ADR reporting forms were not readily available at pre-intervention compared to 18.2% at postintervention; 15.2% had reported ADR previously at pre-intervention compared to 69.7% at post-intervention; 12.1% reported providing information regarding ADRs and its management always at pre-intervention compared to 45.5% at post-intervention; these differences were statistically significant (p<0.05). Lack/inadequate knowledge, unavailability of reporting forms and negative attitudes were barriers identified; and addressing them resulted in significant improvement in this setting. Scaling up these interventions to other hospitals can better the situation of under-reporting of ADRs in Nigeria.

Adverse Drug Reactions (ADR) in the inPatients of Medicine Department of a Rural Tertiary Care Teaching Hospital and Influence of Pharmacovigilance in Reporting ADR.

OBJECTIVES: (i) To find the incidence and study various aspects of Adverse Drug Reactions (ADR) in the inpatients of medicine department of Shree Krishna Hospital, a rural tertiary care teaching hospital. (ii) To test the impact of pharmacovigilance in reporting ADR. MATERIAL #ENTITYSTARTX00026; METHODS: A prospective study involving 600 patients admitted to the medical wards and TB & Chest diseases ward over a period of six months and a retrospective analysis of 600 case files for the corresponding period of the previous year were carried out to find the incidence rate of ADR, study various aspects of ADR like causality assessment, drugs frequently causing ADR etc. Suitably structured and pre-tested format was used for compiling the data. RESULTS: In the prospective study, 18 of the 600 patients (3%) developed ADR. A significant number (77.78%) of patients developed ADR between the 3(rd) and 10(th) days of administering the drug/s. As the number of drugs increased, the incidence of ADR also increased. Majority of ADR (72.22%) occurred due to chemotherapeutic agents. 66.67% of ADR involved the gastrointestinal tract. None of the ADR was fatal. Sex of the patients did not influence the incidence rate of ADR. On the other hand, in the retrospective analysis, only ADR were reported in just 6 out of 600 patients (1%). CONCLUSION: The incidence rate of ADR is found to be much lower (3%) than the reported rate (10%-20%). Pharmacovigilance certainly contributes to picking up ADR.

Retrospective Analysis of 266 Adverse Drug Reaction Cases / 药物流行病学杂志

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.

Recoguizing the Importance of ADR Monitoring of Drugs Available on the Market From PPA Event / 中国药房

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.

Development of ADR monitoring System and Its Performance Analysis / 대한의료정보학회지

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.