Artificial intelligence in pharmacovigilance - Opportunities and challenges.

Pharmacovigilance (PV) is a data-driven process to identify medicine safety issues at the earliest by processing suspected adverse event (AE) reports and extraction of health data. The PV case processing cycle starts with data collection, data entry, initial checking completeness and validity, coding, medical assessment for causality, expectedness, severity, and seriousness, subsequently submitting report, quality checking followed by data storage and maintenance. This requires a workforce and technical expertise and therefore, is expensive and time-consuming.

Treatment outcome of different antiretroviral drug regimens in HIV-positive pregnant women.

Objective: The objective of the study was to compare the maternal and fetal outcomes of currently preferred tenofovir-based regimen with previous zidovudine-based regimen and also to determine whether the time of starting antiretroviral therapy (ART), whether it can affect the pregnancy and fetal outcome.

Materials And Methods: Pregnant patients prescribed any of the above regimens were followed up every month till delivery and newborns for initial 6 months. Maternal endpoints were body weight, hemoglobin, and CD4 count, whereas fetal endpoints were birth weight, Apgar score, body weight, and HIV status at 6 months.

Pharmacovigilance and assessment of drug safety reports during COVID 19.

The speed and volume of clinical research to discover effective drug against novel corona virus has been remarkable. To address the unmet medical need, the regulations are made flexible and convenient without any relaxation in drug safety reporting. The pharmacovigilance activities, especially adverse event reporting regardless of clinical trials or clinical practice should continue as usual because patient safety is the priority.

Early treatment outcome of bedaquiline plus optimised background regimen in drug resistant tuberculosis patients.

Aims: Bedaquiline (BDQ) has been recently approved for drug resistant tuberculosis with active drug safety monitoring under programmatic condition. The present study was conducted to evaluate safety, tolerability and efficacy of bedaquiline plus optimised background regimen.

Methods: A prospective study was conducted on cohort of pre-extensively drug resistant (XDR) and XDR pulmonary TB patients.

An analysis of the use of antimicrobial agents in outdoor patients of ophthalmology.

Objectives: The study was aimed to analyze commonly used antimicrobials in outdoor patients of ophthalmology department.

Materials And Methods: The study was an observational, cross-sectional study carried out in the Department of Pharmacology and Ophthalmology after approval from the head of departments and Institutional Ethics Committee. All the patients age 18 years and above who were prescribed antimicrobials and gave consent were included in study.

Analysis of Cutaneous Adverse Drug Reactions Reported at the Regional ADR Monitoring Center.

Introduction: Skin is one of the major target organ for adverse drug reactions (ADRs). The incidence of dermatological ADRs among indoor patients in developed countries ranges from 1-3%, whereas in developing countries such as India, it is 2-5%.

Aims: To analyze the clinical spectrum, seriousness, outcome, causality, severity, and preventability of the cutaneous ADRs.

A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients.

Background: Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART).

Materials And Methods: All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used.

An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital.

Objectives: To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients.

Materials And Methods: All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J.

An Evaluation of Efficacy and Safety of Commonly Prescribed Drugs and Effect of These Drugs on Quality of Sleep in Patients Suffering From Zoster-Associated Pain.

This observational, prospective, single-center study was conducted to evaluate the efficacy and safety of commonly prescribed drugs for zoster-associated pain and their impact on quality of sleep at a tertiary care hospital in western India. Patients ≥18 years of age, newly diagnosed with zoster-associated pain were evaluated on days 0, 7, 14, 30, 60, 90, 120, 150, and 180 or until resolution of pain, whichever was earlier, using the Wong Baker FACES Pain Rating Scale, Neuropathic Pain Scale, and Insomnia Severity Index for intensity of pain, quality of pain, and quality of sleep, respectively. A total of 78 patients (46.

Treatment Outcome of Ovulation-inducing Agents in Patients with Anovulatory Infertility: A Prospective, Observational Study.

Objective: To compare different treatment regimens on pregnancy rate and outcome in patients with anovulatory infertility.

Patients And Methods: A prospective observational study was conducted on patients with infertility due to anovulation. Patients treated with clomiphene citrate (CC) 50/100 mg/day from 2 to 6 day of menstrual cycle (MC) ( = 38), short gonadotropin-releasing hormone (GnRH) agonist regimen (leuprolide [0.

Transfusion-related adverse reactions in pediatric and surgical patients at a tertiary care teaching hospital in India.

Background: Use of blood and its components is lifesaving. However, their use is often associated with adverse events.

Objective: To analyze the pattern of adverse reactions associated with transfusion of blood and its components in pediatric and surgical patients at a tertiary care teaching hospital.

Treatment outcome of patients having extensively drug-resistant tuberculosis in Gujarat, India.

Background: To investigate the factors affecting treatment outcome of extensively drug resistant tuberculosis (XDR-TB) in Gujarat, India.

Methods: A prospective, observational study was conducted on patients with XDR TB from January 2012 to October 2016. Details of demography, clinical symptoms, sputum/culture and radiological examination, drug treatment, adverse drug reactions (ADRs) and treatment outcome were recorded in pretested case record form (CRF).

Comparison of Effect of Antidepressants on Psychomotor Functions.

Objective: The comparison of the effect of antidepressants on psychomotor functions in patients with endogenous depression.

Materials And Methods: This prospective interventional study was carried out at a tertiary care teaching hospital on 95 literate patients with newly diagnosed endogenous depression matching inclusion and exclusion criteria. Patients were prescribed either desvenlafaxine (50 mg) or fluoxetine (40 mg) or sertraline (50 mg).

Critical Analysis of Cardiovascular and Central Nervous System Fixed Dose Combinations Available in Indian Market.

Introduction: Fixed Dose Combinations (FDCs) are being increasingly used to improve compliance and achieve greater benefits of the two or more active ingredients given together than the corresponding individual drug components given separately.

Aim: To analyse the rationality of Cardiovascular (CV) and Central Nervous System (CNS) FDCs available in Indian market.

Materials And Methods: CVS and CNS FDCs, enlisted in Indian Drug Review, 2014, were analysed by a pretested validated eight point criteria tool.

A Survey of Knowledge, Attitude, and Practice of Consumers at a Tertiary Care Hospital Regarding the Disposal of Unused Medicines.

Objectives: To evaluate the knowledge, attitude and practice of consumers in India about disposal of unused medicines.

Materials And Methods: A questionnaire comprising 11 questions evaluating the Knowledge (2), Attitude (3) and Practice (6) of unused medicines was prepared and pre validated before administering to 200 consumers of medicines attending the outpatient department of Civil Hospital Ahmedabad, a tertiary care teaching hospital in Western India. Requisite permissions from Institutional Ethics Committee and informed consent were obtained prior to recruiting them for the study.

An analysis of serious adverse drug reactions at a tertiary care teaching hospital.

Objective: The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs) such as clinical presentation, causality, severity, and preventability occurring in a hospital setting.

Materials And Methods: All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J.

A study of medication errors in a tertiary care hospital.

Objective: To determine the nature and types of medication errors (MEs), to evaluate occurrence of drug-drug interactions (DDIs), and assess rationality of prescription orders in a tertiary care teaching hospital.

Materials And Methods: A prospective, observational study was conducted in General Medicine and Pediatric ward of Civil Hospital, Ahmedabad during October 2012 to January 2014. MEs were categorized as prescription error, dispensing error, and administration error (AE).

Evaluation of impact of teaching clinical pharmacology and rational therapeutics to medical undergraduates and interns.

Objectives: To find out the impact of teaching clinical pharmacology and rational therapeutics (CPT) to medical undergraduates (UGs) and interns.

Materials And Methods: This cross-sectional, prospective study was conducted on three UGs batches and interns using two pretested validated structured questionnaires, modified from the work of Tobaiqy et al. The study was approved by the Institutional Ethics Committee.

An evaluation of drug promotional literatures published in scientific medical journals.

Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines.

Materials And Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria.

Treatment outcome of standardized regimen in patients with multidrug resistant tuberculosis.

Objective: To evaluate the treatment outcome of second line drugs used in directly observed treatment, short-course (DOTS)-Plus regimen under Revised National Tuberculosis Control Program (RNTCP).

Materials And Methods: A prospective, observational study was carried out on multidrug resistant tuberculosis (MDR-TB) patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January to December 2009. Demographic details, symptoms, sputum examination and adverse drug reactions were recorded in a case record form.

Early outcome of second line antiretroviral therapy in treatment-experienced human immunodeficiency virus positive patients.

Purpose And Aim: Multi-drug resistance in treatment-experienced human immune deficiency virus (HIV) patients has been a major cause to first line antiretroviral therapy (ART) failure, necessitating a switch to second line therapy. In India, the second line treatment program is still relatively new with little experience and unclear outcomes. It is therefore, critical to assess the clinical, virological and immunological effectiveness and treatment outcome over the 1(st) year of follow-up in the patients' switched to the second line ART at public sector tertiary care center.

Tenofovir induced Fanconi syndrome: a possible pharmacokinetic interaction.

Tenofovir was introduced as a second line drug for the treatment of human immunodeficiency virus (HIV) infection in India in December 2009. Although rare, renal toxicity is a recognized adverse drug reaction (ADR) of this drug, especially when administered with boosted lopinavir-ritonavir. In this case, an HIV positive patient receiving tenofovir based antiretroviral therapy (ART) for last 1 year developed albuminuria, glycosuria and hypophosphatemia.