Uppsala Monitoring Centre Research Articles

Liver Injury in People With HIV on Antituberculosis and/or Antiretroviral Therapy-Assessing Causality Using the Updated Roussel Uclaf Causality Assessment Method.

We compared performance of the Roussel Uclaf Causality Assessment Method (RUCAM) with multidisciplinary expert panel review in identifying a drug-induced liver injury (DILI) due to antituberculosis therapy (ATT) and/or antiretroviral therapy (ART). Cases were drawn from a prospective registry of hospitalised adults with suspected DILI due to ATT and/or ART in Cape Town, South Africa. Participants had to fulfil American Thoracic Society criteria for ATT interruption (alanine transaminase [ALT] ≥5 times upper limit of normal [ULN]/ALT ≥3 times [ULN] and symptomatic). Causality assessment by expert panel review served as reference standard. The panel ranked potentially implicated drugs as certain, probable, possible or unlikely causes guided by World Health Organization Uppsala Monitoring Centre criteria. The RUCAM was performed for each potentially implicated drug. We calculated sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause for liver injury. We included 48 participants. All were people with HIV (PWH). Twenty-seven were on concomitant ART and ATT, with a median of six potentially hepatotoxic drugs per case. Sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause of liver injury compared with expert panel review was 7% and 100% respectively. Implicated drugs (times ranked probable/certain by panel) were isoniazid (18/0), pyrazinamide (17/0), rifampicin (15/1), efavirenz (6/4) and lopinavir/ritonavir (1/0). PWH with liver injury received multiple potentially implicated drugs, which may increase liver injury risk and complicate causality assessment. Compared with expert panel review, the RUCAM had low sensitivity in detecting probable or certain drug causes of liver injury.

Safety of herbal medicine in the postpartum period of a Korean Medicine hospital and postpartum care centre: protocol of a registry study (SAFEHERE-PC)

IntroductionHerbal medicines (HMs) are commonly used during the postpartum period in South Korea. However, the safety concerns associated with these medicines remain unresolved. This study aims to establish a registry...

Adverse Drug Reactions: A Retrospective Analysis from the ADR Monitoring Centre at a Tertiary Care Hospital

Background: Adverse Drug Reactions (ADRs) present significant challenges in healthcare, necessitating vigilant monitoring and analysis to enhance medication safety protocols. This retrospective study aimed to analyse ADRs reported at an Adverse Drug Reactions Monitoring Centre (AMC) to understand prevalence, patterns, and characteristics of ADRs. Methods: Retrospective data from January to December 2023 were collected from the AMC at Vaishampayan Memorial Medical College, Solapur. A total of 282 ADR reports were analysed for frequency, severity, implicated medications, patient demographics, and associated clinical factors. Causality assessment was performed using the WHO- Uppsala Monitoring Centre scale. Results: The majority of ADRs were associated with the oral route of drug administration (79.43%), and most were categorized as minor severity (68.44%) and probable causality (91.84%). Common ADR symptoms included vomiting (9.55%) and rash (9.22%). Antimicrobial agents were the most suspected drugs causing ADRs (17.38%). The study revealed discrepancies in ADR reporting patterns and highlighted the importance of pharmacovigilance in capturing and addressing ADR occurrences. Conclusion: Our study provides valuable insights into the prevalence, patterns, and characteristics of ADRs, emphasizing the need for continued surveillance and reporting to promote patient safety and improve healthcare outcomes. Strategies to improve ADR reporting and enhance medication safety protocols are warranted to optimize patient care.

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

Pharmacovigilance: Past, Present and Future

Pharmacovigilance is a field now everyone in healthcare industry is well aware of. Pharmacovigilance study ensure that the medicine consumed by patient is effective enough to be sell in market and having less harm as compared to its benefit. Historically the medicine safety was not the prime focus during approval of medicine but some unforeseen events happened in past emphasized the need of stringent rules and regulation on drug research and approval process. Though many events happened in past which harmed the mankind seriously but thalidomide was the biggest tragedy happened and turning to be the stepping stone of modern pharmacovigilance. Many countries like USA, Japan and UK realized the importance of pharmacovigilance to ensure patient safety and took serious steps to regularize the drug development process. At collaborative level also many countries come forward to strengthen pharmacovigilance. World health organization (WHO)-Uppsala Monitoring Centre, Council for International Organizations of Medical Science (CIOMS), International council on harmonization (ICH) and Good Pharmacovigilance Practice (GVP) are the bodies which lay down stringent rules and regulations on drug development process and primarily focused on drug safety. Now pharmacovigilance come long a way since its inception back in history, and modern pharmacovigilance is not remains limited to only check effectiveness and safety of medicine but its ensuring the patient safety. It uses many advance tools and trends for effective pharmacovigilance process and to dig more and more safety data related to medicine which finally uses to ensure patient safety.

Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were “Certain” whereas Naranjo's algorithm categorized 96.74% of ADRs as “Probable”. Cohen's kappa showed a “Minimal” agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments.

Pharmacovigilance: A Necessary Tool for Drug Safety Monitoring Globally

Pharmacovigilance, which is like a parasol to define the procedures for monitoring and analysing adverse drug reactions (ADRs), is a crucial part of efficient clinical practise, public health initiatives, and drug control systems. The volume of data processed has increased as a result of the rise in reported adverse drug reactions (ADRs), and understanding pharmacovigilance requires a high degree of skill in order to quickly identify medication hazards and defend the product against an unwarranted removal. An impartial method of evaluation would strengthen the present global network of pharmacovigilance centres, which is managed by the Uppsala Monitoring Centre. This would take into account contentious and significant medication safety problems that might have a negative impact on public health across international borders. Pharmacovigilance has recently focused mostly on identifying previously unrecognised or poorly understood adverse medication occurrences. Pharmacovigilance is a crucial and essential component of clinical research, and it is now expanding in many nations. However, with the turn of the millennium, pharmacovigilance confronts enormous hurdles in aspect of improving safety and monitoring of medications. Today, several pharmacovigilance centres are engaged for drug safety monitoring in this global arena. In this overview, we'll talk about medication safety, the function of international pharmacovigilance centres, the advantages and drawbacks of pharmacovigilance, and how it may be used in the future by the healthcare industry.
 Keywords: Drug safety, Adverse drug reaction, Drug Monitoring, Erice declaration, pharmacovigilance

Delayed Diagnosis of Vasopressor-induced Symmetrical Peripheral Gangrene in Septic Shock Patient

Vasopressors are powerful vasoconstrictors used in critically ill patients to raise blood pressure after volume resuscitation attempts fail. These medications, while lifesaving, carry the risk of severe and under-reported side effects, digital ischemia, and gangrene due to decreased digital perfusion. We here present a case of vasopressin-induced digital gangrene in a female patient who underwent elective surgery for nephrolithiasis without any pre-existing peripheral vascular disease or smoking. The patient developed bilateral upper and lower limb symmetrical acronecrosis. The causality assessment as per the World Health Organisation – Uppsala Monitoring Centre scale was suggestive of a “Possible adverse” event. The patient denied surgical intervention, eventually developed multiorgan failure, and died of cardiopulmonary arrest. Although lifesaving, vasopressors due to alpha constricting activity can cause severe limb ischemia with dreadful consequences. These drugs should be used judiciously with careful monitoring and tapering as soon as possible when the condition improves. The consequences could be dreadful if timely surgical intervention and measures are not taken.

Pharmacovigilance: Safeguarding Vision

Pharmacovigilance defined by the World Health Organization as 'the science and activities relating todetection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge of drug's adverse reactions can be increased by various means, including spontaneous reporting; intensive 1monitoring and database studies.Thalidomide was marketed in 1957 and was considered harmless for use in pregnancy by the 1manufacturer. However, its use during pregnancy led to development of abnormal fetal and limb 2 deformities in 46 countries world wide. The thalidomide tragedy served as a catalyst for the formation of Uppsala Monitoring Centre (UMC) as the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. UMC operates the technical and scientific aspects of the WHO' sworld wide 3 pharma covigilance network. Reports from adverse drug reactions (ADRs) are stored in a global database (VigiBase) and can be used by health professionals to evaluate the associations between various medications and associated ADRs. Drug Regulatory Authority of Pakistan (DRAP), established Pakistan National Pharmacovigilance Centre (PNPC) in 2015, under the division of Pharmacy Services to provide a basic framework for the implementation of pharmacovigilance programme of Pakistan at provincial and national 4 level. National data (VigiFlow) is directly connected to WHO Global Database (VigiBase).

Global burden of vaccine-associated alopecia, 1979-2023: a comprehensive analysis of the international pharmacovigilance database.

While global concern over vaccine-associated alopecia has been gradually increasing, it has also been reported that alopecia, classified as an autoimmune disease, can manifest as an immune-related side-effect caused by vaccinations. However, comprehensive research on vaccine-associated alopecia has been limited. Therefore, we carried out a comprehensive analysis using information from VigiBase (1979–2023) from more than 156 countries, managed by the WHO and the Uppsala Monitoring Centre. Thus, this global pharmacovigilance study of vaccine-associated alopecia, encompassing all age and sex groups, provides international and comprehensive evidence that substantiates the overall real-world impact of vaccines.

Pattern of Adverse Drug Reactions at a Tertiary Care Hospital, Kerala, India: A Cross-sectional Study

Introduction: With the rising use of medications, Adverse Drug Reactions (ADRs) have emerged as a significant public health issue. Therefore, establishing a robust pharmacovigilance system across the nation has become imperative. The present study focussed to analyse the trends and frequency of ADRs to enhance the safety of drug prescriptions and ensure public health protection. Aim: To assess the pattern of adverse effects, drugs implicated, causality, severity, and outcomes of ADRs reported to the ADR monitoring centre in the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India. Materials and Methods: This was a cross-sectional study in which 262 ADRs reported to the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India from May 2022 to April 2023 were analysed for patient demographics, drug and ADR characteristics, and the outcomes of the ADR. Causality and severity assessments of these ADRs were performed using the World Health Organisation (WHO)-Uppsala Monitoring Centre (UMC) scale and the modified Hartwig and Siegel’s scale, respectively. Data were tabulated using Microsoft Excel and expressed as mean, standard deviation, frequency, and percentage as appropriate, with the help of descriptive statistics using Epi Info 7 software. Results: A total of 262 ADRs were analysed. The mean age of the patients was 47.4±20.1 years. The majority were females 160 (61.1%). The intravenous route was the most common route involved in ADRs 158 (59.8%), followed by the oral route 91 (34.5%). Skin reactions accounted for more than half of the ADRs 151 (53.2%), followed by blood dyscrasias 48 (16.9%). Antibiotics were the most common group of implicated drugs 124 (44.9%), followed by anticancer drugs 43 (15.6%) and antitubercular drugs 34 (12.3%). Among antibiotics, cephalosporins (36.3%) were the most frequently encountered, followed by penicillins (30.6%). A total of 148 patients (56.5%) had recovered by the day of reporting, 146 (55.7%) ADRs were found to be ‘possible’ using the WHO-UMC causality scale, and 144 (54.9%) ADRs were classified as moderate severity. Conclusion: The study identified a widespread occurrence of ADRs, some of which increased healthcare costs due to prolonged hospital stays. The high incidence of ADRs from antimicrobials is concerning, as it contributes to antimicrobial resistance. This underscores the urgent need for prudent antimicrobial usage. The present study emphasises the importance of ADR reporting among healthcare workers and the necessity for hospitals to establish ADR reporting strategies for optimal patient care.

Oral Anti-Coagulant (Acitrom) Induced Coagulopathy - A Case Report

The major complication of oral anticoagulants is bleeding. Acitrom Acenocoumarol an oral anticoagulant is similar to Warfarin but has a longer half-life with fewer interactions. To reduce the risk of these complications the Prothrombin time PT ndash usually expressed as the International Normalized Ratio INR is used to monitor the degree of Acenocoumarol or coumarin-associated anticoagulation. In our study a 50 year old male patient presented with a complaint of ecchymosis over abdomen and thigh and hematuria since five days. The patient was on T. Acitrom 4 mg with a history of open-heart surgery 20 years back. On analyzing the subjective and objective evidences the condition was diagnosed as lsquoAcitrom Induced Coagulopathyrsquo which was confirmed using WHO-UMC Uppsala Monitoring Centre Causality Assessment Scale Naranjo Scale Score and Karch and Lasagna scale.

Regulatory Authority in Pharmacovigilance

Abstract: Based on their Gross National Income (GNI) per capita, the World Bank has categorized 80 economies as HighIncome. Global pharmacovigilance rules are primarily driven by three major regulatory stakeholders: the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA). This article's goal is to provide an overview of pharmacovigilance systems and procedures in high-income nations, especially those that are also International Conference on Harmonization (ICH) members. Every high-income nation is a part of the WHO PIDM. Medication safety precautions are directly correlated with a nation's income level. The 10 intrepid members of the Uppsala Monitoring Center are from affluent nations and were among the first to act following the thalidomide catastrophe, establishing drug appraisal committees, launching ADR reporting forms, and implementing safety protocols. Although VigiBase is accessible, several nations have their own databases for data management and analysis, such as the FDA Adverse Event Reporting System, the French pharmacovigilance database, the EU's Eudravigilance system, and Canada's Vigilance online database. Strong pharmacovigilance systems are present in all high-income nations. The two international leaders in pharmacovigilance are the USFDA and EMA. The majority of wealthy nations adhere to EMA regulations. The degree of affluence in a nation directly affects the safety of medicines.

Accuracy in patient-reported adverse drug reactions and their recognition: a mixed-methods study.

The causality assessment tool can be utilized to assist patients in identifying adverse drug reactions (ADRs). To evaluate the accuracy of the causality assessment tool for patients identifying ADRs compared to assessments made by pharmacists, and to explore how patients recall and recognize symptoms as ADRs. Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with patients who had experienced ADRs in the past year at a tertiary care hospital in Thailand. Out of 769 questionnaires, 716 were returned and 622 of these were both valid and had at least one ADR (86.8%). Classification of patient-reported symptoms using the causality assessment tool found 12 (1.9%) highly-probable ADRs, 399 (64.1%) probable ADRs, 207 (33.3%) possible ADRs, and 4 (0.6%) that were not classified as ADRs. There was fair agreement between patient-assessed and pharmacist-assessed causality classifications using the Naranjo algorithm (K = 0.268) and the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria (K = 0.373). The timing relationship between the occurrence of symptoms and administration of a suspected drug was the most frequently mentioned reason that patients gave for recalling and recognizing suspected ADRs. Promoting the causality assessment tool for use by patients in collaboration with healthcare professionals is likely to enhance patients' ability to correctly identify ADRs and ultimately contribute to increased medication safety.

Epidemiology of adverse drug reactions to antihypertensive, antithrombotic and antidiabetic medications among adult inpatients at a National Referral Hospital, Uganda

ABSTRACT Introduction Treatment for hypertension, thrombosis and type 2 diabetes mellitus is long term and usually requires a combination of drugs which increases the risk of adverse drug reactions (ADRs). This study aimed to establish the prevalence at admission, incidence during hospitalization and characteristics of ADRs linked to antihypertensive, antithrombotic and antidiabetic drugs among adult inpatients in Uganda. Methods We conducted a secondary analysis of data from a previously assembled prospective cohort study in Uganda’s Mulago National Referral Hospital. We reviewed the files of inpatients who received antihypertensive, antithrombotic and/or antidiabetic medications prior to and/or during hospitalization. The modified Schumock and Thornton Preventability Scale, the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events and the World Health Organization – Uppsala Monitoring Centre seriousness criteria were used to characterize the ADRs. Results More than a quarter (27%, 42/155) of the inpatients experienced an ADR at admission or during hospitalization. The point prevalence of ADRs at admission was 8% (13/155) and the incidence of ADRs during hospitalization was 23% (36/155). Forty-one percent (35/86) of the ADRs were serious and the majority (59%, 51/86) were preventable. Conclusion One in 13 inpatients experienced an ADR on admission and one in four experienced an ADR that developed during hospitalization. Clinicians ought to prescribe medicines with lower ADR risk profile for cardiovascular and/or diabetic patients whenever possible.

A risk of serious anaphylatic reactions to asthma biologics: a pharmacovigilance study based on a global real-world database

Asthma is a chronic inflammatory condition that affects the lung airways. Chronic use of oral glucocorticoids in patients with severe asthma is associated with several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, reslizumab, and dupilumab) have been developed as alternative therapies for the treatment of asthma. In this study, we aimed to evaluate the risk of anaphylactic reactions associated with these five biologics based on a large global database. We utilized individual case reports from the Uppsala Monitoring Center from January 1968 to December 29, 2019. A disproportionality analysis was performed over all drugs and monoclonal antibodies. Anaphylactic reactions were defined according to the "anaphylactic reaction” of the standardized MedDRA queries. Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated positive signals related to anaphylactic reactions over all drugs and monoclonal antibodies. Reslizumab, which represented only 315 cases of all AEs, requires more reports to determine its association with anaphylactic reactions. More anaphylactic reactions have been identified than are known, and most cases (96.2%) are reported to be serious. Our findings indicate that omalizumab, benralizumab, and mepolizumab for asthma treatment are associated with a high risk of anaphylactic reactions; thus, more careful monitoring in the post-administration period is recommended.

Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Teaching Hospital in North India: A Retrospective Study.

Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. This is an observational, retrospectiveand non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

Evaluation of Cutaneous Adverse Drug Reactions Reported in a Teaching Hospital of Coastal Andhra

Adverse drug reactions (ADR) can be manifested in different forms, among these cutaneous adverse drug reactions (CADRs) are the commonest. They have been steadily gaining importance and constitute a major proportion of all ADRs. As available data on CADRs is very less, more research is required to have reliable data, hence the current study was undertaken. This prospective study was carried out to evaluate the age and gender distribution, presenting complaints, spectrum of CADRs, causative drugs, causality, severity, and outcomes in patients with or suspected CADRs attending the department of Dermatology of Konaseema Institute of Medical Sciences & Research Foundation Hospital between January 2014 and June 2015. In cooperation with the Dermatologist, patients’ reactions were analyzed based on morphology, and laboratory investigations. Causality was assessed as per the World Health Organization- Uppsala Monitoring Centre (WHO-UMC)causality assessment scale. Modified Hartwig and Siegel Scale was used for the severity assessment of reactions. CADRs occurred most commonly in the 31-40 years age group (32%) with no sign of the difference in both sexes. The most common complaint of CADRs by the patients was skin rash (42%) anddiagnoses were Erythematous drug eruption (ERDE) and Fixed drug eruption (FDE) (28%). The commonest causative drug categories were antimicrobials (52%) and Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (24%).Among antimicrobials, ciprofloxacin, and in NSAIDs, diclofenac were the commonest causative drugs. In causality, majority of the cases were under possible category(42%). Most of the reactions were mild (46%), and moderate (46%) in severity. The majority of the cases showed good recovery without any mortality or disability. The limitations of this study were the relatively small sample size, inability to confirm the particular causative drug in majority of the patients. Future research should focus on the genetic factors concerning to CADRs and molecular-level evaluation should be done for a better understanding of the pathophysiology of various ADRs.

Comparison of Pharmacovigilance and Herbovigilance Regulatory Guidelines at the Global level

Pharmacovigilance is the most cutting-edge technology in the medical field, the most advanced technologies in the medical field. It focuses on identifying, evaluating, analyzing, and preventing pharmacological side effects based on identification evaluation analysis and prevention of pharmacological side effects based on long-term and short-term drug exposure. Through the monitoring of drug safety, pharmacovigilance science seeks to enhance patient safety and population welfare. Every nation has regulatory organizations examining case reporting data and examines case reporting data and actual drug-related toxicological concerns. All adverse international unfavourable events in the country are centred at Uppsala Monitoring Centre (UMC). UMC determines judgments based on their investigation connected to numerous aspects of every case report, from Herbovigilance to the Pharmacovigilance drug program. The World Health Organization (WHO) was assisted by UMC when making worldwide decision-making on a global scale.

Monitoring of adverse drug reactions in individuals with type 2 diabetes mellitus receiving oral hypoglycemic agents

Background: This study intends to ascertain the prevalence and overall burden of various adverse drug reactions (ADRs) driven by oral antidiabetics for treating type II diabetes mellitus (T2DM) in India. Methods: Patients with T2DM taking oral antidiabetic medications participated in prospective observational research. Data collection used the pretested format by the Indian pharmacovigilance program to record the history of drugs suspected to be responsible for ADRs. The causality evaluation is according to the guidelines of the Uppsala Monitoring Center and the World Health Organization. Results: This study included 424 patients with established diabetes. Female patients showed a non-significant higher percentage of ADRs (p = 0.059). Naranjo’s assessment recorded 51 suspected ADRs with significant (p = 0.042) categorical differences in casualty. According to ADR severity, there was a significant (p = 0.048) difference between moderate 8.25% (n = 35) and mild 3.80% (n = 16); however, none of the ADRs showed severity. Metformin caused abdominal discomfort, itching, and rashes, accounting for 4.95% (n = 21) of all reported adverse reactions. Gliclazide and glimepiride induced hypoglycemia, itch, and rashes, 1.65% (n = 7), abdominal pain, 1.18% (n = 5), flatulence caused by acarbose, abdominal discomfort caused by pioglitazone, and pedal edema caused by pioglitazone 1.18% (n = 5). Conclusion: ADRs due to oral antidiabetic agents are a frequent problem. Therefore, active pharmacovigilance is essential for risk identification, management, and establishing a robust antidiabetic drug ADR database.