Description Of Adverse Drug Reactions Research Articles

A case of rapid avacopan-induced liver injury in pediatric granulomatosis with polyangiitis.

Children with anti-neutrophil cytoplasmic antibody-associated vasculitis benefit immensely from avacopan as it reduces the requirement for steroids. However, descriptions of adverse drug reactions in children are lacking, and the dosage and follow-up intervals are unclear. A 10-year-old boy with initial granulomatosis and polyangiitis presented with diffuse pulmonary hemorrhage. Rituximab and 30mg avacopan were administered twice daily as induction therapy following methylprednisolone pulse therapy. However, sudden liver function test abnormalities were observed on day 31 of avacopan treatment, despite liver enzyme levels being within the normal range 5days earlier. A drug-induced lymphocyte stimulation and various infectious disease tests yielded negative results. Discontinuation of rituximab and avacopan resulted in improved liver function; no change in the Birmingham Vasculitis Activity Score during liver function test abnormalities was observed. Avacopan-associated abnormalities in liver function tests suggest that drug-induced liver injury may occur rapidly in children, and appropriate dosing strategies should be reconsidered.

CRITICAL REVIEW OF BHAVPRAKASH NIGHANTU WITH SPECIAL REFERENCE TO PHARMACOVIGILANCE PERSPECTIVE OF MEDICINAL PLANTS AND ITS PRACTICAL APPLICATION IN THERAPEUTICS

Introduction: Ayurveda is ancient literature for protecting the health of healthy individual and curing the diseased one. With this aim in World-wide Ayurveda has increased in their practice in form of diets, medicine and routines. As increasing use in western countries, it leads to concern of regarding safety of use. There are various publications which raise concern about the safety of Ayurveda medicines. Today Ayurveda is gathering globally attention with regards to therapeutic option to treat various acute, chronic and non-infectious diseases. Though Ayurveda is practiced for centuries, there is a few of systematic documentation regarding adverse drug reactions (ADRs) occurrence after administration of Aushadha and safety of Aushadha (Ayurvedic medicine). For safety and efficacy of Aushadha, systematic documentation related to ADR’s mentioned in different Samhitas. With respect to Bhavpraksha Nighantu mentioned various ADRs with drugs as mention of Aushadha is given amazing.Materials and Methods: Bhavprakasha Nighantu was studied critically to look for description of ADRs in medicinal plants (poisonous drugs were excluded) This ADRs were analysed and presented systemically.Result and Discussion: ADRs aims to achieve qualitative use of drugs and to achieve safety and therapeutic uses to treat with caution. The drugs selected from classics name Bhavprakash Nighantu and their adverse effect with respect to administration of drugs and complication. Use of drugs with safety and prevent ADRs in Ayurvedic medicinesConclusion: For Understanding the safety of use of Ayurvedic medicine is need in today era with the help of Pharmacovigilance study.

Patient's reporting of adverse drug reactions: Which added value in 2023?

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called "patient centricity in pharmacovigilance". Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.

Investigation of the boxed warnings in package inserts of prescription medicines for medical professionals in Japan.

In the Japanese Pharmacists Act, article 25-2, revised in 2013, it states that pharmacists shall provide the necessary information and guidance to the patient based on pharmaceutical knowledge and experience for ensuring the proper use of the medicine dispensed. The package insert is one of the documents to be referred to when providing the information and guidance. The boxed warnings in package inserts that include the precautions and responses are the most significant parts, however, the suitability of boxed warnings for pharmaceutical practice has not been evaluated. The aim of this study was to investigate the boxed warning descriptions in package inserts of prescription medicines for medical professionals in Japan. Package inserts of prescription medicines listed in the Japanese National Health Insurance drug price list on March 1st 2015 were collected one by one by hand from the website of the Japanese Pharmaceuticals and Medical Devices Agency (https://www.pmda.go.jp/english/). Package inserts with boxed warnings were classified according to the Standard Commodity Classification Number of Japan based on the pharmacological activity of each medicine. They were also compiled according to their formulations. The boxed warnings were divided into the precautions and responses parts, and their characteristics were compared among medicines. The number of package inserts found on the website of the Pharmaceuticals and Medical Devices Agency was 15,828. Boxed warnings were present in 8.1% of the package inserts. A description of adverse drug reactions accounted for 74% of all precautions. Most of the precautions were observed in the warning boxes of antineoplastic agents. Blood and lymphatic system disorders were the most common precaution. Responses in the boxed warnings directed toward medical doctors, pharmacists, and other healthcare professionals accounted for 100, 77, and 8% of all package inserts with a boxed warning, respectively. Explanations for patients were the second most frequent response. The majority of boxed warnings request therapeutic contribution by pharmacists, and the descriptions of these explanations and guidance by pharmacists to patients were found to be consistent with the Pharmacists Act.

Adverse drug reactions and correlations with drug-drug interactions: A retrospective study of reports from 2011 to 2020.

Introduction: Adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact on mortality, morbidity, and healthcare costs. Drug–drug interactions (DDIs) are an important contributor to ADRs. Most of the studies focused only on potential DDIs (pDDIs), while the detailed data are limited regarding the ADRs associated with actual DDIs. Methods: This retrospective study evaluated ADRs reported between 2011 and 2020 in a tertiary hospital. The causality and severity of ADRs were evaluated through the Naranjo Algorithm and Hartwig’s scale, respectively. Preventability classification was based on the modified Schoumock and Thornton scale. For ADRs with at least two suspected drugs, pDDIs were identified according to the Lexi-Interact. We further checked whether the ADR description in the reports corresponded to the clinical consequences of the pDDIs. Results: A total of 1,803 ADRs were reported, of which 36.77% ADRs were classified as mild, 43.26% as moderate, and 19.97% as severe. The assessment of causality showed that the distributions of definite, probable, and possible categories were 0.33%, 58.68%, and 40.99%, respectively. A total of 53.97% of ADRs were identified as preventable ADRs, while 46.03% were recognized as unpreventable. The severity of ADRs was significantly correlated with age, the number of suspected drugs and preventability. Antimicrobial agents were the most common implicated pharmacological group, and the most frequently affected system was the gastrointestinal system. Considering individual drugs, aspirin was the most frequently reported drug. Among 573 ADRs with at least two suspected drugs, 105 ADRs were caused by actual DDIs, of which only 59 and 6 ADRs were caused by actual DDIs in category D and X, respectively. The most frequent drugs involved in actual DDIs of category D were aspirin and heparin, with the majority of ADRs being gastrointestinal bleeding. Conclusion: This study analyzed the pattern of ADRs in detail and obtained clinical evidence about ADRs associated with actual DDIs. These findings may be useful to compare patterns between different centers and to design preventive strategies for ADRs. Continuous education and training should be provided for physicians regarding the knowledge and recognition of ADRs associated with DDIs.

Nurses' perspectives of the patient care experience assessment items using importance-performance analysis.

This study aimed to evaluate the importance and performance of hospital nurses for patient experience evaluation items from the perspective of care providers and to identify the items that need improvement. Patient experience includes customized treatment and services that focus on patient satisfaction and needs, with healthcare providers participating as partners. The study was conducted using a cross-sectional survey design, and data were collected on the importance and performance of 15 out of 24 patient experience evaluation items. The sample population consisted of 193 direct care nurses from two hospitals in South Korea. The results showed the items with significant differences in importance and performance ('concentrate here' areas) such as 'description of a drug' (t = 2.26, p = .025), 'listening to patients' (t = 6.64, p < .001), 'description of adverse drug reactions' (t = 10.19, p < .001), 'clean hospital environment' (t= 2.95, p = .004) and 'easy notification of complaints' (t = 8.37, p < .001). The findings highlight the importance of awareness and performance in patient experience evaluation items from the nurses' perspective. While some items were recognized as important but not performing well, others were identified as important and performing well. As identified in this study, nursing managers should strive to develop nursing practice standards and educational programs for nurses to improve patient experiences. It is crucial that these changes are reflected in policies.

Risk Factors Related to Serious Adverse Drug Reactions Reported through Electronic Submission during Hospitalization in Elderly Patients.

BackgroundMany studies have assessed the risk factors for adverse drug reactions (ADRs) in elderly patients. However, most of these studies have focused on risk factors for ADRs, not serious ADRs (s-ADRs). s-ADRs are commonly found in hospitalized patients. s-ADRs warrant imminent but thorough investigations, given their critical impact on patient health. Therefore, this retrospective study aimed to assess the associated risk factors for s-ADRs in elderly hospitalized patients.MethodsIn-patients aged >65 years having ADRs during hospitalization at a university hospital in Korea between 2010 and 2012 were included. Medical professionals spontaneously reported ADRs using an electronic submission system at the study hospital. Further, all descriptions of ADRs were characterized and categorized through the screening of electronic medical records. We compared the characteristics of patients having s-ADRs with those of patients not having s-ADRs.ResultsThere were 353 cases of ADRs, 67 of which were s-ADRs. Patients taking more than eight concomitant drugs showed the highest odds ratio (OR, 11.99; 95% confidence interval [CI], 3.42–42.03). The ratio of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) was also significantly related to s-ADRs (OR, 2.78; 95% CI, 1.33–5.81). The use of antibiotics (OR, 2.39; 95% CI, 1.13–5.02) and antineoplastics (OR, 4.17; 95% CI, 1.09–15.94) were significant risk factors.ConclusionOur findings highlight the importance of polypharmacy. Liver function tests (AST/ALT ratio) must be monitored carefully within high-risk groups for ADRs.

Identifying and Characterizing Serious Adverse Drug Reactions Associated With Drug-Drug Interactions in a Spontaneous Reporting Database.

Background: Drug-drug interactions (DDIs) are an important cause of adverse drug reactions (ADRs). In literature most of studies focus only on potential DDIs, while detailed data on serious ADRs associated with DDIs are limited. Our aim is to identify and characterize serious ADRs caused by DDIs using a spontaneous reporting database. Methods: All serious ADR reports, not related to vaccines and with a “definite”, “probable” or “possible” causality assessment, inserted into the National Pharmacovigilance database from Veneto Region (January 1, 2015 to May 31, 2020) were analyzed. A list of drug pairs was created by selecting the reports containing at least two suspected or concomitant drugs. We verified which drug pairs potentially interacted according to the online version of DRUGDEX® system. For each potential DDI we controlled whether the ADR description in the report corresponded to the interaction effect as described in Micromedex. A detailed characterization of all serious reports containing an occurring DDI was performed. Results: In the study period a total of 31,604 reports of suspected ADRs from the Veneto Region were identified, of which 2,195 serious reports (6.9% of all ADR reports) containing at least two suspected or concomitant drugs were analyzed. We identified 1,208 ADR reports with at least one potential DDI (55.0% of 2,195) and 381 reports (17.4% of 2,195 reports) with an occurring ADR associated with a DDI. The median age of patients and the number of contraindicated or major DDIs were significantly higher in reports with an occurring DDI. Warfarin was the most frequently reported interacting drug and the most common ADRs were gastrointestinal or cerebral hemorrhagic events. The proton pump inhibitors/warfarin, followed by platelet aggregation inhibitors/warfarin were the drug-drug combinations most frequently involved in ADRs caused by DDIs. The highest proportion of fatal reports was observed with platelet aggregation inhibitors/warfarin and antidepressants/warfarin. Conclusion: Our findings showed that about one-third of patients exposed to a potential DDI actually experienced a serious ADR. Furthermore, our study confirms that a spontaneous reporting database could be a valuable resource for identifying and characterizing ADRs caused by DDIs and the drugs leading to serious ADRs and deaths.

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug\u2013drug interactions

Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug–drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients’ demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.

Does spontaneous adverse drug reactions’ reporting differ between different reporters? A study in Toulouse Pharmacovigilance Centre

In France since 2011, report of adverse drug reactions (ADRs) has been extended to patients (and patients' associations) who can declare directly ADRs to their regional pharmacovigilance centre. In pharmacovigilance, informativeness of ADRs reports is important to improve signal's detection. The present study was performed to compare the quality of patients', physicians and community pharmacists' reports. We performed a retrospective study investigating the quality of patients', physicians and community pharmacies' ADRs reported to Toulouse University PharmacoVigilance Centre (TUPVC) from January 2014 to June 2017. We used mandatory and non-mandatory criteria, as defined by European Medicines Agency. Reports' quality was defined as "satisfactory" when more than 90% of items were completed. We also compared reports' quality according to ADRs seriousness and the used reporting tools (email or the mobile app VigiBip®). The number of reports to TUPVC increased between 2014 and 2016 (+51%) for patients and remained stable for pharmacists and physicians. According to the mandatory criteria, quality of the investigated reports was "satisfactory" (more than 90% of the items filled) whatever the reporter and without significant differences between reporters. For the non-mandatory criteria, clinical description of ADRs and ADRs' outcome were only filled over 90%. Significant differences were observed between the different reporters: community pharmacists informed better clinical description, ADR outcome and concomitant drugs versus both patients and physicians. Physicians informed better medical history and biological data whereas patients informed medical history and other aetiologies better than pharmacists and clinical description of ADRs better than physicians. The present study failed to show differences between pharmacies', physicians' and patients' ADRs reports, for the mandatory criteria. However, significant differences were found for non-mandatory criteria with drug data more filled by pharmacists and medical ones more by physicians and patients.

Descriptions of Adverse Drug Reactions Are Less Informative in Forums Than in the French Pharmacovigilance Database but Provide More Unexpected Reactions.

Background: Social media have drawn attention for their potential use in Pharmacovigilance. Recent work showed that it is possible to extract information concerning adverse drug reactions (ADRs) from posts in social media. The main objective of the Vigi4MED project was to evaluate the relevance and quality of the information shared by patients on web forums about drug safety and its potential utility for pharmacovigilance.Methods: After selecting websites of interest, we manually evaluated the relevance of the content of posts for pharmacovigilance related to six drugs (agomelatine, baclofen, duloxetine, exenatide, strontium ranelate, and tetrazepam). We compared forums to the French Pharmacovigilance Database (FPVD) to (1) evaluate whether they contained relevant information to characterize a pharmacovigilance case report (patient’s age and sex; treatment indication, dose and duration; time-to-onset (TTO) and outcome of the ADR, and drug dechallenge and rechallenge) and (2) perform impact analysis (nature, seriousness, unexpectedness, and outcome of the ADR).Results: The cases in the FPVD were significantly more informative than posts in forums for patient description (age, sex), treatment description (dose, duration, TTO), and outcome of the ADR, but the indication for the treatment was more often found in forums. Cases were more often serious in the FPVD than in forums (46% vs. 4%), but forums more often contained an unexpected ADR than the FPVD (24% vs. 17%). Moreover, 197 unexpected ADRs identified in forums were absent from the FPVD and the distribution of the MedDRA System Organ Classes (SOCs) was different between the two data sources.Discussion: This study is the first to evaluate if patients’ posts may qualify as potential and informative case reports that should be stored in a pharmacovigilance database in the same way as case reports submitted by health professionals. The posts were less informative (except for the indication) and focused on less serious ADRs than the FPVD cases, but more unexpected ADRs were presented in forums than in the FPVD and their SOCs were different. Thus, web forums should be considered as a secondary, but complementary source for pharmacovigilance.

Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study

BackgroundTo describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs.MethodsA retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children’s Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness.ResultsWithin 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27–0.61] and 0.47 [0.32–0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33–2.62] and 3.01 [2.07–4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs.ConclusionActive surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children.

A comparative study of adverse drug reactions reported by healthcare professionals and patients in a tertiary care teaching hospital

Background: Adverse drug reactions (ADRs) are one of major health concern affecting population of all ages causing significant morbidity mortality and hospitalization of the patients increasing the economic burden on the society. Monitoring of ADRs is of paramount importance for the continued effective and safe use of medicines. Though they are unavoidable accompaniments of pharmacotherapy, the reporting of ADR is poor and inadequate. Substantial under-reporting and selective reporting of ADRs are the major drawbacks of the commonly followed method of spontaneous reporting by healthcare professionals (HCP). Patient direct reporting of ADR has been incorporated into the pharmacivigilance (PV) system in several countries like USA, Canada, Australia, New Zealand, Denmark, Sweden and the Netherlands. Patient direct reporting of ADR was qualitatively similar to HCP ADR report. Patient reports often had richer narratives than those of HCPs. Patient reports often contained detailed information about the impact of the suspected ADR on the patient’s quality of life. The quality of ADR reported by the patients was similar to the reports by HCP in terms of description of ADRs and its severity. So, present study was taken to evaluate the process of spontaneous reporting of suspected ADR by the patient and compare the quality of ADR reported by Health care professional and Patients.Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine Comparison between spontaneous reporting by healthcare professionals and patient direct reporting of adverse drug reactions was assessed in terms of response rate, pattern of ADR reported, causality by Naranjo s scale, severity by modified Hartwig scale and preventability by using Schumock and Thornton scale. Social, emotional, occupational impact due to ADR and narrative elaboration scores were also compared.Results: Majority of the ADRs were from HCP as compared to patient reporting, indicating that better awareness among HCP about pharmacovigilance Majority of the reactions reported by patient were mild in severity, in contrast majority of ADR reported by HCP were moderate. Comparisons between HCP reporting and patient direct reporting also revealed that majority of ADR in both groups were probably preventable. Qualitative analysis reported ADR showed that majority of ADR reported by HCP had no narration or had scant narration, in contrast to patient direct reporting had very elaborate narration of ADR. Patient who did direct reporting of ADR highlighted more about emotional impact, occupational impact and social impact of ADR occurred to them, when compared to ADRs reported by HCP.Conclusions: Patients were clearly willing to report any adverse drug reactions occurring to them. The evidence indicates that patient reporting of suspected ADRs has more Potential benefits than drawbacks. The results indicate that patient perceptions of potential ADRs are relevant and should be an integral part of ADR reporting system.

An Evaluation of Indian Consumers' Reporting of Suspected Adverse Drug Reactions with a Designated Reporting Form.

The Pharmacovigilance Program of India recently initiated a process for direct patient reporting of Adverse Drug Reactions (ADRs) with a designated form. A survey of 200 patients reporting ADRs filling the form. Forms were analysed for patient data, the suspected medication(s), ADRs and possible causality. 54.3% of respondents provided their contact information; the implicated medicine was mentioned in 60% and the description of ADRs in 80% although 46.2% were not interpretable. The severity of ADRs was mentioned in 73.5%. No responder filled the expiry date component of the implicated modification and a causality assessment from most forms was unclassifiable (57%) or unclassified (26%). Details of concomitant drugs were missing. Missing information was a deterrent in analysing the consumer ADR reports for signal detection. It is recommended that the following fields are highlighted in the form: consumer's initials, address, date suspected reaction started, description of event, name, dose, and the reason for the use the medication as well as its expiry date. These should be mandatory in the existing form and new fields added for weight and height, batch number for vaccines and biological products, de challenge and rechallenge results to the suspected medicine and concomitantly used medicines. To improve the quality of information in the consumer reporting form an awareness campaign is also suggested.

The value of patient reporting to the pharmacovigilance system: a systematic review.

Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting.

Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board "Yahoo! Japan Chiebukuro".

PurposeSpontaneous inquiries about the development of adverse drug reactions (ADRs) to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”. Our aim was to clarify the characteristics related to people’s descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry.MethodsFifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term “Fukusayō” (ADR in Japanese) that were posted from July 2004 to June 2009 were extracted from the site.ResultsAmong 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s). Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525). Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine.ConclusionOur examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms, suspected medicines, and the disease for which the medicine was used. However, they often did not describe the start time when the ADR appeared or when the suspected medicine was started.

Language does not come "in boxes": Assessing discrepancies between adverse drug reactions spontaneous reporting and MedDRA® codes in European Portuguese.

The description of adverse drug reactions (ADRs) by health care professionals (HCPs) can be highly variable. This variation can affect the coding of a reaction with the Medical Dictionary for Regulatory Activities (MedDRA(®)), the gold standard for pharmacovigilance database entries. Ultimately, the strength of a safety signal can be compromised. The objective of this study was to assess: 1) participation of different HCPs in ADR reporting, and 2) variation of language used by HCPs when describing ADRs, and to compare it with the corresponding MedDRA(®) codes. A retrospective content analysis was performed, using the database of spontaneous reports submitted by HCPs in the region of the Southern Pharmacovigilance Unit, Portugal. Data retrieved consisted of the idiomatic description of all ADRs occurring in 2004 (first year of the Unit activity, n=53) and in 2012 (n=350). The agreement between the language used by HCPs and the MedDRA(®) dictionary codes was quantitatively assessed. From a total of 403 spontaneous reports received in the two years, 896 words describing ADRs were collected. HCPs presented different levels of pharmacovigilance participation and ADR idiomatic descriptions, with pharmacists providing the greatest overall contribution. The agreement between the language used in spontaneous reports and the corresponding MedDRA(®) terms varied by HCP background, with nurses presenting the poorer results than medical doctors and pharmacists when considering the dictionary as the gold standard in ADRs' language. Lexical accuracy and semantic variations exist between different HCP groups. These differences may interfere with the strength of a generated safety signal. Clinical and MedDRA(®) terminology training should be targeted to increase not only the frequency, but also the quality of spontaneous reports, in accordance with HCPs' experience and background.

Description of Adverse Drug Reactions in a Multi-specialty Teaching Hospital

Adverse drug reaction (ADRs) monitoring is an ongoing and continuing process used by health care professionals to enhance effective patient care and to improve quality of life. The present study was carried out to monitor the incidence of ADRs in a multispecialty teaching hospital in India. A prospective reporting study was conducted including both in-patient and outpatient departments. The Naranjos Algorithm Scale was used for the casualty assessment and a Modified Hartwig and Siegel Scale was used for the severity assessment. Confirmed ADRs were classified according to the Wills & Brown method. The economic burden of ADRs was also measured by calculating the average cost incurred in treating the ADRs. During the study period, a total of 208 adverse drug events were reported, in which 183 reports from 172 patients were confirmed as ADRs. Out of 183 ADRs, 171 reactions were reported in in-patient departments and the remaining 12 from the outpatient department. Of all the ADRs, 132 (72.1%) reports during the hospital stay and 27.9% of ADR-related admissions were observed. The causality assessments of 92 cases were observed to be probable (50.3%). The severity assessment revealed that mild type (57.8%) reactions were most common. The majority of the reactions were of Type H (119, 65.0%), they were not predictable. In the management of ADRs, the suspected drug was discontinued in 61 (33.3%) cases. An ADR monitoring programme was found to be useful and beneficial to the patients and health care professionals for a better therapeutic outcome.

A pharmacovigilance project in ‘San Giovanni di Dio e Ruggi d’Aragona’ – Salerno University Hospital (Italy): hospital pharmacist in department increases pharmacovigilance activity

Background‘MEREAFaPS Project’ is a pharmacovigilance project started in Italy in 2006 with the aim of introduce pharmacists in Emergency Division to collect data on adverse drug reactions (ADR) admissions. In...

Study of drug utilization pattern of antihyperglycemic agents in a South Indian tertiary care teaching hospital

Objective:To determine the drug utilization pattern of antihyperglycemic agents (AHA) in a tertiary care teaching hospital.Materials and Methods:This was a prospective observational study. All the relevant data were collected and drug utilization pattern of AHA was determined. Direct cost associated with the use of antihyperglycemic medicines was calculated and consumption of the antihyperglycemic medicines was measured as defined daily dose (DDD)/100 bed-days. The adverse drug reactions (ADRs) related to anti-diabetic medicines were monitored.Statistical Analysis Used:Chi square test (χ2), mean±standard deviation.Results:During the study period, 350 patients diagnosed as diabetes mellitus (DM) were admitted. Insulin was prescribed as monotherapy to 81% and to 52% patients during hospital stay and discharge, respectively. Increase in utilization of insulin was recorded in majority of the patients due to presence of co-morbid conditions or resistance to oral hypoglycemic drugs. Use of insulin at the time of discharge decreased significantly (P<0.05) by 29%. Among the oral AHA, combination of glimepiride with metformin was more prevalent during hospital stay and at the time of discharge monotherapy of metformin followed by glimepiride was more prevalent. During hospital stay, cost of AHA was found to be Rs. 95.27 ± 119.03. The total antihyperglycemic drug consumption in the medicine ward during study period was 13.42 DDD/100 bed-days. Fifty ADRs were reported and descriptions of ADRs were found to be only hypoglycemia.Conclusion:The study exhibited a significant increase in the utilization of two drug combination therapies and monotherapy of oral AHA and decrease in the utilization of insulin at the time of discharge.