Perspectives in Clinical Research最新文献

Purpose/aim: Ethics committees (ECs) have gained much importance since the introduction of the New Drugs and Clinical Trials Rules 2019. The committee report authored by Prof. Ranjit Roy Chaudhury suggested the need for accreditation of Institutional ECs. We aimed to enumerate the registered and accredited ECs across different geographical regions in India and to assess the adequacy of EC standard operating procedures (SOPs).

Materials and methods: Our study was conducted between August and October 2022. The registration status of ECs was obtained from the Central Drugs Standard Control Organization (CDSCO) and Department of Health Research (DHR) websites. Information on accreditation status was obtained from the National Accreditation Board for Hospitals and Healthcare Providers (NABH) website. Registration data were categorized region-wise and available SOPs were collected from respective hospital websites and analyzed for adequacy.

Results: We found that 1400 ECs in India were registered under CDSCO and 952 under DHR. Maharashtra had the largest number of registered ECs. Puducherry, Delhi, and Daman and Diu had the highest density of ECs. Bihar, Himachal Pradesh, and Jharkhand had the lowest. Only 299 ECs had their composition listed, and 111 had SOPs available on their websites. Most ECs lacked SOPs related to reviewing clinical trial agreements, compensation, and dealing with participant complaints.

Conclusion: The advent of the New Drugs and Clinical Trials 2019 has created a definite impetus for increased responsibilities of ECs in India. Yet the registered ECs are not evenly distributed across the country. Moreover, it is disheartening to note that 90% of ECs in the country do not have NABH accreditation. Only a handful of ECs had SOPs posted on their websites.

Introduction: One in every 10 women presents with abnormal vaginal discharge in Gynaecology and Obstetrics Department, with the most common cause being candidiasis. Irrational use of antifungal for treatment of this condition leads to antifungal resistance and increase morbidity.

Materials and methods: This retrospective study was conducted at the Department of Pharmacology in collaboration of Department of Obstetrics and Gynaecology of the private medical college hospital in Kolkata. One hundred and forty outpatient department prescriptions were screened and included in this study from March 2024 to April 2024, and the prescriptions of the previous 6 months were collected.

Results: The average number of drugs per prescription was 1.1. Antifungals were prescribed in 89.3%, out of which only 8.6% were in accordance with the standard treatment guidelines of management of vaginal candidiasis. The dose of the drug was written in 11.5% of the prescriptions while the duration of treatment was written in 84.9% of the prescriptions. The fungal culture and sensitivity testing was documented in only 10.7% of the prescriptions. 29.5% of the prescriptions had the generic name of the medicines whereas the complete diagnosis was written in only 13.7% of the prescriptions.

Conclusion: This study highlights the commonly encountered errors in prescribing of antifungal drugs in a tertiary care teaching hospital. These errors may lead to irrational prescribing of antifungal and development of antifungal resistance in the long run. Active surveillance in the form of regular prescription audit and organizing regular training workshop for the prescribers will improve the prescribing practice.

Introduction: Radiopharmaceuticals (RPs) are used in the diagnosis and management of various cancer and noncancerous conditions. Like those of conventional drugs, the use of RPs may also be associated with the development of various adverse events (AEs). The information obtained from patients about these AEs may empower medical professionals to identify, evaluate, and manage them more efficiently to ensure the safe use of RPs.

Objective: The objective of our study was to assess the type, timing, and frequency of the reported AEs associated with the use of RPs and to establish their causal association as well as to evaluate the outcome of these AEs from the perspective of patients.

Methods: This study was a prospective cohort study conducted on 315 patients who underwent nuclear medicine examination in a tertiary care center for various indications. Relevant data were collected from the participants regarding suspected AEs associated with the use of various RPs. The collected data were objectively analyzed and assessed.

Results: Of 315 patients, 39 (12.3%) developed 59 AEs. All the reported AEs were mild in nature and neither required hospitalization nor caused death of any participants. 37.2% of the reported AEs occurred within 1 h of administration of the RPs and spontaneously resolved within a few hours. Of these 59 AEs, 10 had causal associations (possible or probable) with RPs and were considered adverse drug reaction (ADR). The incidence of ADR in our study was 2.2%.

Conclusion: RPs can cause ADRs though it is less in comparison to conventional drugs. We expect that our study will increase the awareness of AEs associated with the use of RPs among patients and health-care professionals and encourage its reporting.

Background: Pharmacotherapy of chronic kidney disease (CKD) consists of prescribing myriad of drugs such as antihypertensives, antidiabetics, and phosphate binders to delay disease progression and control the comorbidities, resulting in inherent variability in prescriptions. In addition, tendency to self-medicate may further aggravate the condition. Hence, the present study was planned to assess self-medication practices and variability in prescription patterns in CKD patients.

Methodology: A cross-sectional, questionnaire-based study approved by the ethics committee was conducted in CKD patients attending the nephrology outpatient department. The prescription details which included drug name, dosage form, dose, frequency, duration, and dosage instructions were recorded and prescription completeness was checked. To assess the tendency of CKD patients to self-medicate, each patient was administered a prevalidated [Content Validity Ratio (CVR) = 0.76] 8-item questionnaire which had dichotomous responses "Yes" and "No" and was scored as 2 and 0, respectively (total score 16).

Results: Three hundred CKD patients (150 on hemodialysis and 150 nondialysis) yielded 300 prescriptions with 1272 drugs. It was evident that 33% of patients did self-medicate themselves with analgesics, and the mean score (7.81 ± 3.01) of self-medication practices was perceived significantly higher in the nondialysis group (8.41 ± 3.46). The most common classes of drugs prescribed in CKD patients were calcium channel blockers (41%), antidiabetic drugs (39%), diuretics (35%), gastrointestinal drugs (35%), and multivitamins (27%), with the average number of drugs being 5.84 ± 0.51.

Conclusion: Nearly one-third of CKD patients were self-medicating with paracetamol, nonsteroidal anti-inflammatory drugs; more in the nondialysis group emphasizing reinforcement of patient education programs. The most common drugs prescribed were amlodipine, followed by metformin, and the average number of drugs was less in our setting, indicating vigilant dose prescribing in CKD patients.

Aim: The study aimed to determine the incidence of adverse drug reactions (ADRs) among newly diagnosed tuberculosis (TB) patients receiving daily drug regimen with fixed-dose combination treatment under the National Tuberculosis Elimination Program.

Materials and methods: A community-based prospective cohort study was carried out in the Udupi district. Over 12 months, all newly diagnosed TB patients of either gender were included from 63 primary health centers and 6 community health centers, and ADRs were recorded by personal interviews.

Results: A total of 710 patients were enrolled, among whom 453 (63.8%), were males, and 257 (36.2%) were females. Pulmonary TB was diagnosed among 510 (71.8%) and 200 (28.2%) were extrapulmonary cases. During the intensive phase (IP) of treatment, 480 (67.6%) patients reported at least one ADR and 79 (11.1%) experienced two ADRs during IP and 31 (6.5%) had ADRs during the continuation phase. Out of 480, 140 (29.2%) had gastritis, 132 (27.5%) had vomiting, 105 (21.9%) had nausea, 60 (12.5%) had skin rashes, 27 (5.6%) had drug-induced hepatitis, and 16 (3.3%) had vision problems. Among 480 patients with ADRs, 462 (96.3%) had successful treatment outcomes, the remaining 17 patients (3.5%) died, and one (0.2%) had treatment failure.

Conclusions: Adverse events were more common in the 1^st few months of treatment than in subsequent months. All mild-to-moderate ADRs were effectively managed, and most had successful treatment outcomes.

Conventional trial designs are resource and time-intensive. To accelerate the process of testing new interventions, we now have several novel research trial designs. This article focuses on master protocol trials, which allow several therapies to be tested within a single larger trial.

Background: Antibiotics are among the most commonly prescribed drugs. Unnecessary use of antibiotics is particularly concerning because antibiotics may be associated with a number of adverse drug events.

Aim: The study was designed to detect the association between pulmonary embolism and antibiotics by disproportionality analysis in the Food and Drug Administration database of Adverse Event Reporting System (FAERS) using data mining algorithms (DMAs).

Materials and methods: A retrospective case/noncase disproportionality analysis was performed in the FAERS database. This study was based on adverse events (AEs) reported to FAERS from 2004 Q1 to 2022 Q3. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were applied to measure the disproportionality in reporting. A positive signal of increased AE risk was defined as ROR >1, Chi-square >4, PRR R2 with the number of cases >3, and IC >0.

Results: Total AEs in the FAERS database from 2004 Q1 to 2022 Q3 were found to be 26,555,430. Among which 80,809 reports of pulmonary embolism were considered. The same were selected for further analysis which showed that 11 antibiotics were reported for pulmonary embolism. The number of reports for minocycline, chloramphenicol, and moxifloxacin was found to be 113, 14, and 179. A significant potential signal was noted for minocycline (ROR - 2.87, Chi-square - 135.95, IC - 1.22), chloramphenicol (ROR - 3.35, Chi-square - 22.80, IC - 0.77), and moxifloxacin (ROR - 2.08, Chi-square - 99.37, IC - 0.83).

Conclusion: This study found a statistically significant increased risk of reporting pulmonary embolism with minocycline, chloramphenicol, and moxifloxacin, although a causal relation cannot be definitively established.