Adverse Drug Reactions Notifications Research Articles

Análisis de Reacciones Adversas a Medicamentos por fármacos antipsicóticos en un instituto de salud mexicano

Introduction: Adverse Drug Reactions (ADR) are unwanted clinical or laboratory manifestations that are related to drug use. ADR are common and are associated with significant risk of morbidity, mortality and hospital admissions. Antipsychotics have a reduced therapeutic window, and have been related to the manifestation of a variety of ADR. Objective: To evaluate the pattern of ADRs due to antipsychotic drugs detected in patients treated at the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz between December 2021 and May 2022. Methods: Observational, descriptive, prospective and cross-sectional study of a series of cases. The seriousness, severity, and quality of the information in the notification of the ADR were defined in accordance with NOM-220-SSA1-2016, Installation and Operation of Pharmacovigilance, while causality was determined using the Naranjo algorithm. Results: The incidence of ADRs was 59%, with one or more ADR detected in 52 of the 88 patients who were receiving antipsychotic treatment during the study period. Forty-five percent of the ADR had probable causality and 55% possible; only three ADR were classified as serious as they prolonged the hospital stay and endangered the patient's life. Conclusions: The ADR of the gastrointestinal and endocrine systems were the most incidental, with hyperprolactinemia being the most frequent. Olanzapine and clozapine were the medications that caused the most ADR. It is recommended to promote the culture of notification and follow-up of ADR caused by antipsychotic drugs.

Perfil das notificações de reações adversas a medicamentos antineoplásicos encaminhadas ao programa de farmacovigilância de um hospital universitário em Porto Alegre

Introduction: Pharmacovigilance encompasses a range of crucial activities aimed at detecting, evaluating, comprehending and preventing adverse events, or any other drug-related problems. It is an essential component of health systems, contributing to the evaluation and monitoring of the safety of medication use. Among the relevant activities of Pharmacovigilance, the notifications of adverse drug reactions (ADR) stand out. Due to their narrow therapeutic index, antineoplastic drugs have a high potential for the occurrence of adverse events. Objective: The aim of this study was to globally quantify the antineoplastic ADR spontaneous notifications profile sent to the Pharmacovigilance Program of a university hospital in Porto Alegre. Material and Methods: This is a cross-sectional, descriptive and retrospective study, carried out between 2020 and 2021. This study was approved by the Research Ethics Committee of the aforementioned institution. Results: The hospital's Pharmacovigilance Program spontaneously received 119 and 105 ADR notifications in the years 2020 and 2021, respectively, of which 71 (60%) and 49 (47%), respectively, were related to antineoplastic therapy. A total of 14 different antineoplastic drugs involved in the 2020 and 11 in the 2021 notifications were identified, with emphasis on Oxaliplatin and Paclitaxel. Conclusions: This work highlighted the importance of the Pharmacovigilance Program around antineoplastic chemotherapy, adding safety to the use of drugs in the hospital environment.

Defining the awareness and attitude of the clinicians through pharmacovigilance in Turkey.

Pharmacovigilance (PV) is the activities and scientific studies conducted to detect, evaluate, understand or prevent adverse reactions and other drug-related problems. To define the awareness and experiences of the clinicians on PV and adverse drug reactions (ADRs) in Turkey. The study was cross-sectional and analytical. Data were obtained through a questionnaire. The questionnaire was sent via e-mail. The survey was sent to 2030 physicians and 670 participated. The most appropriate definition of PV was correctly defined by 53.9% of the participants. The most important goal of PV was correctly defined by 54.9% of the participants, and 27.3% of the participants were aware of the Turkish Pharmacovigilance Center. Nonsurgical physicians had better PV knowledge than surgical physicians. A total of 80.9% of the physicians who encountered ADRs, filled in the ADR notification form, and 8.8% received training on how to fill in the form. PV knowledge of the clinicians was not sufficient. Although half of the physicians encountered ADRs, the rates of seeing and filling in the ADR form were low. Few of the physicians followed the current information about PV. The results provide more comprehensive data on PV practices and ADR reporting at a national level.

Causality, Severity, and Avoidability of Adverse Drug Reactions in Hospitalized Children: A Prospective Cohort Study.

Adverse drug reactions are an important cause of morbidity and mortality in all patients. Information regarding adverse drug reactionsin the pediatric age group,especially with regard to the drugs involved and the clinical presentations is scanty. The aim of our study is to determine the incidence of adverse drug reactionsand to study theirfeatures in terms of causality, type, severity, avoidability, drugs implicated and their clinical presentations. The study was carried out on patients admitted to the pediatric ward and the pediatric intensive care unit over a one-year period (January 1, 2013 to December 31, 2013). Patientseither presenting with or developing an adverse drug reactionin the hospital were includedin the study. The incidence rate for adverse drug reactioncausing hospital admission was 1.79% (95% CI 1.48, 2.16) whereas it was 1.23% (95% CI 0.97, 1.53) for children exposed to a drug during their hospital stay. Type B (bizarre or idiosyncratic type) was seen in 114 (62.6%) of the ADRswhereas 53 (29.1%) were of type A (augmented pharmacologic effect). Severe ADRs were seen in 25 (13.7%) of the total ADRs. ADR was responsible for the death of two patients. 15.4% were rated as avoidable. Anti-microbials were the most common group responsible for ADRs (43.4%), followed by drugs acting on the immune system (15.9%) and drugs acting on the nervous system (14.3%). The most common ADRs were metabolic (29.3%) followed by neurological (17.6%). Adverse drug reactionscan occur in a substantial proportion of hospitalized patients with some of them being severe and potentially avoidable. Awareness among physicians should be encouraged regarding monitoring, documentation and notification of adverse drug reactions.

Pharmacist’s Knowledge and Behaviors Toward Pharmacovigilance and Adverse Drug Reactions Reporting Process in Türkiye

Adverse drug reactions (ADRs) increase patient-related morbidity and mortality. Additionally, it is an important public health problem associated with prolonged hospital stay and increasing economic burden. Pharmacovigilance is central to reducing ADRs, so the development and growth of this science is critical to effective and safe clinical practice. The aim of the study was to evaluate the knowledge and behaviors of pharmacists toward pharmacovigilance and spontaneous ADR notifications in Türkiye. The online questionnaire method was used with the pharmacists, whose prior consent was obtained to participate in the study. The survey was uploaded onto Google form. The survey link was distributed electronically to the eligible participants via social media channels. The knowledge of pharmacovigilance practice, ADR reporting compliance rates, reasons for not reporting ADR, and perceptions of the Turkish pharmacists on pharmacovigilance practice were evaluated. Four hundred six pharmacists (45%) agreed to participate in the study, 81.8% of whose correctly defined correctly defined the term pharmacovigilance. 91.6% knew the name of the Turkish Pharmacovigilance Center. Clinical and hospital pharmacists were found to have a more adequate knowledge than community pharmacists (p<0.05). 18.7% of pharmacists stated that they had previously reported ADRs. Most of the pharmacists stated that the most important reason for not reporting ADRs was not knowing how and where spontaneous reporting should be done, a single spontaneous reporting would not make a difference and the report would generate extra work. These results showed that Turkish pharmacists had adequate knowledge about the concept of pharmacovigilance and the spontaneous ADR reporting system. However, they had little experience in reporting. Training programs should continue to increase the knowledge and reporting experience of pharmacists about the reporting process and requirements.

COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal.

Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty®, Spikevax®, Vaxzevria® and Jcovden®. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.

Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit.

Spontaneous reports (SRs) of adverse drug reactions (ADRs) remain the basis of pharmacovigilance systems. The main objective of this study was to evaluate the quality of SRs received by the Pharmacovigilance Unit of Beira Interior, in Central Portugal. The second objective was to identify factors associated with complete SRs. SRs received between 1 January 2017 and 31 October 2019 were analyzed. SR information was classified as “mandatory” or “recommended” criteria. SR were then grouped into three categories (well, slightly, and poorly documented). Association between “well documented” SR and confounding variables was estimated using a multiple logistic regression model. The results showed 22.4% of SRs are “well documented”, and 41.2% are “poorly documented”. Most of the complete SRs correspond to non-serious ADRs (55.8%), with a negative association between complete SRs and serious ADRs (OR = 0.595, [95% CI 0.362–0.977], p = 0.040). There is also a significant association between complete SRs and e-mail notification (OR = 1.876, [95% CI 1.060–3.321], p = 0.002). The results highlight the small amount of SR documentation sent to pharmacovigilance systems. There is an association between non-serious ADRs and complete SRs. These results reinforce the need for training for notification of ADRs and that these SRs include as much information as possible for an effective drug risk management.

Thromboembolism and Oral Contraceptives During the COVID-19 Pandemic: A Disproportionality Analysis Within the Spanish Pharmacovigilance Database.

BackgroundThromboembolic events (TEs) are known to be a severe complication for COVID-19. They are associated with a systemic inflammatory response syndrome with coagulation cascade activation.ObjectiveThe aim of this study was to determine a potential association between the COVID-19 pandemic and the increment of the risk of suspected TEs in women on systemic hormonal contraceptives (SHCs).Patients and MethodsThis study utilised a case/non-case approach in the Spanish Pharmacovigilance Database, which includes more than 290,000 cases of suspected adverse drug reactions (ADRs). The reporting odds ratio (ROR) was calculated during an initial pandemic period in 2020 compared with a pre-pandemic period in 2019 and an additional control period in 2018.ResultsWhile there was a decreased number of ADR notifications for any medications and for any type of ADR in patients on SHCs during the pandemic period, the TE ROR for all SHCs was higher in the 2020 pandemic period [ROR = 11.8 (5.6–24.7)] relative to the pre-pandemic period in 2019 [ROR = 6.3 (3.2–12.5)] and the additional control period in 2018 [ROR = 4.6. (2.1–9.9)]. In contrast, ROR for progestogen-only contraceptives was lower during the pandemic as compared with the two control periods.ConclusionThe reported disproportionality of TEs in women on SHCs rose during the pandemic period. This suggests a potential interaction of the drug (SHC) with COVID-19, which led to an increased risk of TEs in women exposed to both factors. This should be taken into consideration in the context of the COVID-19 pandemic.

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.

Retrospective analysis of adverse drug reactions to anticancer drugs at a tertiary care hospital in South India

Background: Many newer drugs are approved every year for the treatment of cancers. With the limitation of clinical trials data on long-term safety, there is a need for constant monitoring of drugs use in various population. Occurrence of adverse drug reactions (ADRs) due to anticancer drugs is high due to their cytotoxic effects. Aims and Objectives: This study aims to analyze ADR reported due to anticancer drugs in relation to frequency of their occurrence, causality, severity, and preventability. Materials and Methods: This was a retrospective analysis of ADRs due to cancer chemotherapeutic agents that were spontaneously reported between January 2017 and June 2018. Data were collected from the suspected ADR notification forms submitted to ADR Monitoring Centre of the institute. Data were analyzed for type of cancers, medications used, type of ADRs, causality assessment, severity, and preventability. Results: A total of 545 ADRs were reported from 391 cases, with majority in females (65.1%). Breast was more commonly involved cancer (16.62%) and cisplatin was the common individual drug reported to cause ADRs (16.15%). The most common ADR reported was paresthesia (13.03%) followed by diarrhea (12.29%). Causality assessment revealed that most cases were probably related (61.65%). Most of the cases were moderately severe (61.28%) and most of the reported ADRs were not preventable (72.65%). Conclusion: Toxicities due to anticancer drugs can affect different organs. Most of the reported cases in this study are not preventable and of moderately severe. Appropriate use of preventive strategies helps in reduction in the occurrence and severity of ADRs.

Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study.

The inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports.

Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.

Withdrawal of hospital outpatient treatments in severe diseases due to unacceptable toxicity: A retrospective study from the register of patients and treatments.

To retrospectively analyse hospital outpatient treatment (HOT) withdrawal due to unacceptable toxicity at our hospital. Information regarding unacceptable toxicity leading to treatment withdrawal was recorded. HOT interruptions because of unacceptable toxicity were identified from the Register of Patients and Treatments (RPT) (January 2014 to December 2017). Information regarding the demographic and clinical characteristics of patients, adverse drug reactions (ADRs) and drug treatments was retrieved from electronic health records. Causality and previous knowledge of ADRs were assessed according to the Spanish Pharmacovigilance System algorithm. Information regarding HOT risk management plans (RMPs) and their classification as inverted black triangle medicines was obtained from the European Medicines Agency (EMA). HOTs were withdrawn due to unacceptable toxicity in 136 (1.5%) registries corresponding to 135 (1.7%) patients. Fifty-one different HOTs (38.6% of those registered) were involved in 240 ADR/HOT pairs: 24 (47%) were additional monitoring medicines and 37 (72.5%) were EMA RMPs. The most frequent medicines involved in ADRs were lenalidomide (30, 12.5%) (mainly neutropenia, thrombocytopenia and bicytopenia), bevacizumab (19, 7.9%) (mainly venous and pulmonary thromboembolism) and sunitinib (13, 5.4%) (mainly thromboembolic events, diarrhoea and worsening of chronic renal failure). Cytopenia (40, 17.3%), diarrhoea (15, 6.5%), asthenia (9, 3.9%) and neuropathy (6, 2.6%) were the most frequent ADRs. All ADRs were severe, 10 (6 patients) had been poorly described or were unknown and only 9 (5 patients) had been reported by spontaneous notification. Valuable information regarding severe and unknown ADRs was obtained from the RPT. Such registers are useful tools to complement spontaneous ADR notifications.

Adverse drug reactions' reporting in a Mexican hospital.

To summarize the procedure for reporting adverse drug reactions (ADRs) in a Mexican hospital, with the purpose of promoting and facilitating the report of ADRs by the heath team. We outline the relevance of pharmacists in performing these activities in Mexican hospitals. A pharmacovigilance study was carried out following the establishment of the Pharmacovigilance Unit of a Mexican hospital on January 2014 through March 2019. There is an undernotification rate of ADRs, since only 137 ADRs were notified in a five-year period, mostly by biopharmaceutical chemists holding bachelor's degrees that were acting as pharmacists. To improve the safety of medications, it is necessary to improve ADR notifications in Mexico's health system. One important step in this direction is to establish a Pharmacy degree with training for promoting and performing ADR notifications.

A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale.&#x0D; Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail.&#x0D; Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole.&#x0D; Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.

Queixas técnicas e reações adversas a medicamentos notificadas em um hospital regional (Brasil): um estudo transversal

Introdução: Reações adversas e os incidentes associados com medicamentos ocasionam a morte e ameaçam a segurança do paciente. No Brasil, persiste-se uma escassez de dados epidemiológicos e uma abordagem ainda insuficiente. Objetivo: Descrever a frequência e as características das notificações de queixas técnicas e reações adversas a medicamentos (RAM) em um hospital regional. Métodos: Estudo transversal, realizado em um hospital de ensino referência para o noroeste do Estado de São Paulo. Por meio do sistema Notivisa da Anvisa, foram contabilizadas as notificações de RAM e queixas técnicas do período de junho de 2012 a julho de 2014. Excluíram-se as não finalizadas e com dados incompletos. Os casos de RAM foram classificados de acordo com o critério de gravidade, sistema de órgãos afetado e caracterização da classe do fármaco suspeito. Ademais, as características do sexo e da idade dos pacientes envolvidos também foram investigadas. Os dados foram descritos como frequência simples e proporções. Resultados: No total, contabilizaram-se 151 (84,8%) notificações de potenciais RAM e 27 (15,2%) de queixas técnicas. Mulheres (62,9%) com idades entre 26-59 anos (42,4%) foram predominantes entre os pacientes notificados com RAM. A maioria das reações foram distúrbios da pele (33,1%), de gravidade moderada (70,2%), provindas de medicamentos que atuam no sistema nervoso (35,8%). Sobre as queixas técnicas, o extravasamento de líquido do material de acondicionamento foi a ocorrência mais descrita (40,7%). Conclusão: As notificações associadas com medicamentos são recorrentes no âmbito hospitalar e as características relatadas embasam conhecimentos sobre o perfil clínico dos episódios adversos apresentados.

Les études cas–non cas : principe, méthodes, biais et interprétations

Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals. This article describes the principle of the case-non case study, the method of calculating the ROR and its confidence interval, the different modalities of analysis and how to interpret its results with regard to the advantages and limitations of this design.

Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

Studies that evaluate the safety of non-prescription drugs in children remain scarce. The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test. We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p=0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p=0.0006 and p<0.0001, respectively). The frequency of "serious" ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p=0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n=37; 4.2%), tuberculosis vaccine (n=23; 2.6%), aspirin (n=20, 2.3%), and paracetamol (n=17; 1.9%). ADRs from prescription drugs involved asparaginase (n=27; 3.1%), immunoglobulins (n=25; 2.9%), and amoxicillin (n=23; 2.4%). Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen.

A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital

Background: As a part of pharmacovigilance program of India (PvPI) adverse drug reactions (ADRs) are cause of mortality and morbidity in patients unnoticed, which is a part of WHO program for International Drug Safety Monitoring across world. ADRs are considered to be among top 10 causes for mortality. The reason for sex difference in medication response is multi factorial with wide range of aspects like steroid hormones, organ physiology to psychology and socio-cultural factors. The aim was to study on gender related differences in adverse drug reactions in patients attending tertiary care teaching hospital at Nandyal.Methods: ADR cases were collected from multicenter health care units from tertiary care teaching hospital. ADRs were reported in ADR notification forms or yellow form, CDSCO forms are used to report ADR to Regional pharmacovigilance center. Causality assessment of the ADRs was done based on WHO-UMC causality assessment scale using modified Hartwig and Seigel scale.Results: In the 30 ADR reports collected 21 reports (70%) are of female patients and 9 reports (30%) are of male patients. According to WHO-UMC scale 20 (70%) of Adverse drug reactions were falling into PROBABLE, while 10 (30%) ADR’s are CERTAIN. In 21 females, ADR reports were due to 15(76.43%) Antibiotics, 2 (9.52%) NSAID’s, 2 (9.52%) proton pump inhibitors, 2 (9.52%) anti-convulsants. In 9 males, ADR reports were due to 5 (55.5%) Antibiotics, 2 (22.22%) NSAID’s, 2 (22.22%) anti-convulsants.Conclusions: ADRs are the common occurrences but ADR monitoring helps in prevention of morbidity and mortality in patients. The most commonly affected gender is among female patients, as they are more exposed to drugs starting their journey right from the childhood, pregnancy till their adult menopausal stage.

Knowledge, practice, and attitude toward adverse drug reaction reporting among interns at a tertiary health care centre

Background: Adverse drug reactions (ADRs) are an important public health problem in terms of mortality, morbidity as well as costs. However, studies worldwide have shown gross under-reporting with a rate of just 6–10%. Knowledge and attitude of health-care professionals about ADR greatly influence the extent of reporting. Educational interventions such as lectures, CMEs on pharmacovigilance (PvG) have proven to improve the rate of reporting. Hence, this study was conducted among new interns to assess their awareness, attitude, and practice patterns toward ADR reporting. Aims and Objectives: (1) To assess the knowledge and awareness regarding ADR reporting, (2) to assess attitude and practice patterns, and (3) to assess barriers to reporting among interns. Materials and Methods: A validated questionnaire based cross-sectional study was conducted among the medical interns in a tertiary health care center. Data were assessed by frequency, percentage. Statistical analysis was performed using SPSS version 22. Results: Of the 100 interns in the study, more than 80% were aware about who can report an ADR and the type of ADR. 90% knew that ADR can occur with drugs, vaccines and herbal products too. However, 52% did not know about the PvG center or reporting system in the hospital. Only 20% had reported an ADR, the common drug being penicillin. 97% had never filled the ADR notification forms. Conclusion: Knowledge regarding ADRs was found to be adequate with the positive and right attitude toward reporting, but the actual reporting practice was found to be poor and needs to be improved. Hence, it is essential to include lectures on ADR and PvG, hands-on training, CMEs and interactive workshops in the MBBS curriculum, to promote reporting of ADRs, particularly among interns.