Background: Helicobacter pylori, the cause of most peptic ulcer diseases, infects approximately 50% of the population worldwide. Indian data on cost and effectiveness of the standard first-line therapies for H. pylori eradication are scarce. Thus, the present study was aimed at comparing the cost and efficacy of two standard first-line therapies: Regimen I comprising pantoprazole (40 mg) plus amoxicillin (750 mg) plus clarithromycin (500 mg) (PAC) and Regimen II comprising rabeprazole (20 mg) plus amoxicillin (625 mg) plus metronidazole (200 mg) (RAM). Methodology: This prospective, observational, bottom-up study collected demographic, economic, diagnostic, and therapeutic data from 60 H. pylori-positive patients. The study was carried out for 6 months in the Gastroenterology Department of a Tertiary Care Hospital in Hyderabad, Telangana, India. Results: Health-care system perspective was used to account for direct costs. Average cost per patient for complete H. pylori eradication was Rs. 10,221 and Rs. 8568 for Regimen I and Regimen II, respectively. Inpatient cost was considerably higher than the outpatient cost. Diagnostic costs ranked first in direct costs, followed by hospitalization costs, medication costs, and finally, physician's office visit cost. Individual patient's costs difference between two regimens was found to be statistically significant. Overall, Regimen I proved to be more efficacious than Regimen II, but Regimen II proved to be more cost-effective than Regimen I. Furthermore, incremental cost-effectiveness analysis revealed additional cost of Rs. 127 per patient if the patient was treated with Regimen I instead of Regimen II. Conclusion: Our study showed that Regimen II (RAM) was more cost-effective than Regimen I (PAC), but PAC achieved faster H. pylori eradication than RAM. We assume that this study provides local clinical data as to which regimen may be useful in a particular patient. National Level Clinical Trials are required to further ascertain this conclusion.

Aim: Drug–drug interactions (DDIs) are one of the major but preventable cause of adverse drug reaction. Study of prevalence and prediction of DDIs will make the physician easier to provide better patient care and mitigate patient's harm. Hence, the study was planned to evaluate the potential DDIs among medication prescribed to hypertensive patients in our hospital. Materials and Methods: A prospective, cross-sectional study was conducted among the hypertensive patients in medicine (outpatient/inpatient) department over the period of three months in a tertiary care hospital. Adult hypertensive patients of either sex with comorbidities were included in the study. The prescriptions were collected and analyzed for DDI using Medscape interaction checker. Data were analyzed using SPSS (version 16.0) software and expressed in percentage. Pearson's correlation and regression analysis were done. Results: Among 125 patients, 48% were exposed to at least one DDI. Totally 123 DDI were identified and majority of them were significant (85.36%). No serious interactions were identified. Pharmacodynamic and pharmacokinetic drug interactions were found to be 37.39% and 28.76%, respectively. Logistic regression analysis showed advanced male gender and polypharmacy was associated with increased risk of DDI. About 51 interacting pairs of DDI were identified and most frequently occurring pair was amlodipine with atenolol. Aspirin was found to have commonly involved in DDI with enalapril, atenolol, frusemide, spironolactone, carvedilol, and metoprolol. Conclusion: The study highlighted that patients with hypertension are particularly vulnerable to DDI. The comorbidities, advanced age, and polypharmacy are the important factors associated with the occurrence of DDI.

Aims: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). Methods: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey–Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjo's probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. Results: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. Conclusions: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM.

Background: Drug therapy today is remarkably safe and efficacious. Still, some drugs - particularly anticancer drugs - are fraught with numerous adverse drug reactions (ADRs), severely jeopardizing quality of life of cancer patients. Fortunately, most of these ADRs are preventable provided adequate prophylactic drugs are administered along with chemotherapy. Aims: The aim of this study is to assess the pattern and impact of cytoprotective prophylactic drugs on anticancer ADRs in patients receiving cancer chemotherapy. Subjects and Methods: We included 200 patients receiving anticancer therapy for the first time. Patient details and for each cycle: details of baseline investigations, anticancer treatment given, ADRs observed and interventions done to prevent and manage the ADRs were recorded. Preventability and predictability scales were applied to assess the impact of drugs and strategies toward toxicity amelioration. Data were analyzed using descriptive statistics. Results: Adjuvant drugs were administered prophylactically along with anticancer drugs for the prevention of nausea and vomiting, gastritis, immediate allergic reactions, nephrotoxicity, ototoxicity, hemorrhagic cystitis, and other anticipated ADRs. About 94.80% reactions were found to be predictable and 5.20% unpredictable. Maximum reactions (56.47%) were probably preventable. Paracetamol, filgrastim, mucaine, etc., were used to manage a variety of ADRs. Conclusions: Although the predictability of ADRs was almost 95%, we could prevent only about 56% of them. Surprisingly, we have no ADRs that appear definitely preventable. This could be due to less attention being paid to the ADRs that could have been prevented by the appropriate use of prophylactic measures.

Data transparency has been an important aspect of medical research as it helps in enabling evidence-based decisions in medicine which leads to foster trust among the patients and research community alike. Currently, it is one of the key talking points owing to a number of initiatives taken by the pharmaceutical organizations, regulatory bodies, and the other decision enablers of the industry. Thanks to this, there are a number of ways by which a single piece of datum is available through multiple access points, namely, clinical trial disclosures (CTDs), clinical study reports (CSRs), plain language summaries, and scientific publications including abstracts, posters, and manuscripts, to name a few. This may pose a burden of documentation on the pharmaceutical organizations, demanding downsizing of medical writing documents. Since CTDs, CSRs, and other regulatory document are more or less template driven; there may not be much scope to interfere with their structure and submission timings. Scientific publications, on the other hand, provide the flexibility of presenting the clinical data that is typically not dependent on a particular format and timelines. The present paper discusses how the upcoming data transparency initiatives could affect the publication practices across the pharmaceutical industry and what could pharmaceutical companies do to get the maximum benefit out of the data transparency initiatives.

The article discusses conflict of interest (COI) situations and how to manage COI in ethics committee (EC).

In this article in our series on common pitfalls in statistical analysis, we look at some of the attributes of diagnostic tests (i.e., tests which are used to determine whether an individual does or does not have disease). The next article in this series will focus on further issues related to diagnostic tests.

The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which is the ability to assimilate and understand the information presented in the consent form. In India, a unique aspect of the informed consent process is the need for audio-video [AV] recording of the process for vulnerable populations and new chemical entities. The present narrative summates authors' experiences as investigators with A-V recording of the informed consent process as also providing a brief narrative review of relevant literature. It also offers potential solutions for challenges faced during this process.

This document provides updates in regulatory requirements regarding conduct of clinical trials in India.

Background: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016. Aim: This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India. Methodology: A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i.e., individual case safety report (ICSR) management system at NCC, where these unlisted drug-ADR combinations considered and issued as drug safety alerts for further reporting these to NCC, if any detected at healthcare settings during routine clinical practice by healthcare professionals. Results: From July 2011 to June 2017, NCC-PvPI was collated 250,787 ICSRs and contributed to WHO international drug safety database, i.e., VigiBase, from these ICSRs; NCC-PvPI was issued 56 drug safety alerts from March 2016 to June 2017. Conclusion: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.