Assessment of medication discrepancy, medication appropriateness, and cost analysis among patients with pediatric nephrotic syndrome: An ambispective cohort observational study.

BACKGROUND: Nephrotic syndrome (NS) is a commonly encountered chronic kidney disease in pediatric populations, with South Asian children being at high risk and requiring long-term pharmacological management. Thus, identifying medication discrepancies and evaluating the appropriateness of therapy and its economic burden are vital for inpatient management. The aim of the study was to assess medication reconciliation, medication appropriateness, and cost analysis in NS cases. METHODS: An ambispective cohort observational study was carried out with 150 NS patients where medication discrepancies were identified retrospectively and prospectively using the best possible medication history and following up patients correspondingly. Further, the Medication Appropriateness Index and cost variation analysis were used to assess the prescribed therapy and cost analysis, respectively. RESULTS: Out of 150 patients with NS included, 67.3% were male and the mean age was 7.2 years. In total, 36.7% medication discrepancies were found at baseline and 6% discrepancies at follow-up. The majority of discrepancies were unintentional and due to dosing error both at baseline and follow-up. Further, in only 2% of the patients was there inappropriately prescribed medication, and the majority of patients spent between INR (Indian Rupees) 500 and 1000. CONCLUSION: Chronic conditions like NS require continuous monitoring by the specialist pediatric clinical pharmacist, who can contribute significantly by minimizing the medication discrepancies, by assessing the appropriateness of therapy, and lessening the economic burden.

Pharmacists' medication reconciliation interventions during admission and transfer from an emergency department at a tertiary care hospital: a randomized pilot study and evaluation of physician and patient perceptions.

AIM: The study aimed to assess the impact of pharmacist interventions during the transition of care. BACKGROUND: Medication discrepancies can occur at various levels of transition, such as during admission, the transition from emergency to special wards or from special to general wards, and during discharge. Discrepancies can be detected through the process of medication reconciliation. OBJECTIVE: The objective of the study was to compare discrepancies among patients exposed to pharmacist intervention groups and those who were not and assess the perception of healthcare professionals and patients towards integrating pharmacists in the transition care process. METHODS: A pharmacist-led interventional study was conducted for six months on patients above 18 years of age and either sex who were admitted to the emergency department, had chronic diseases, and subsequently transferred to another department (any). The patients were randomized into intervention and control groups. The pharmacist performed a medication reconciliation and medication review to identify discrepancies in every transition in both the groups, and then reported to the treating physician to resolve in the intervention group. RESULTS: Among the 73 patients recruited in the study, 152 discrepancies were identified. The total discrepancies observed in the control and intervention groups were 78 (51.3%) and 74 (48.6%), respectively. The majority, 35.53%, were found during the transition from emergency to special wards. The physician, upon pharmacist recommendations, accepted and resolved 48 discrepancies in the intervention group. The healthcare professional acceptance rate of pharmacist interventions was 64.86%. CONCLUSION: The transitions of care are at risk for errors due to medication discrepancies, and pharmacists could potentially identify and resolve discrepancies. Healthcare professionals and patients reported to be satisfied by the involvement of clinical pharmacists in the healthcare team.

Utilization of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scale for evaluation of quality of life among cancer patients treated with chemotherapy: A hospital-based observational study.

BACKGROUND: In this new era of cancer management, the quality of life (QOL) is given more importance than the quantity of life. QOL evaluation studies are widely used in oncology to assess the patient's performance in different cancer types and treatment modalities. OBJECTIVE: To evaluate cancer patients' QOL after various chemotherapy cycles. METHODS: An observational study was performed on cancer patients receiving chemotherapy in the daycare setting of a South Indian Tertiary Care Hospital for 6 months. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire was employed to study the QOL. RESULTS: Precisely, 102 patients participated in the study, out of which the majority were in the 51 to 60 age group (24%). Female participants (65%) were more. Functional scale domains especially physical ability (P = 0.004), role (P = 0.033), and emotional functioning (P = 0.01) were significantly decreased in patients treated with 4 to 6 chemotherapy cycles. Cognitive ability (P = 0.043) significantly improved in patients treated with more than 6 chemotherapy cycles. Dyspnea (P = 0.036) was significantly increased in patients treated with 4 to 6 chemotherapy cycles and decreased significantly with the further addition of chemotherapy cycles. CONCLUSION: Dyspnea is a commonly observed symptom among cancer patients and is often neglected by physicians. Chronic dyspnea can negatively impact a patient's functional ability. Cancer symptoms such as dyspnea should also be given priority and need appropriate treatment. Based on the findings, further interventions can be made to improve the functional ability of cancer patients. Also, studies can be conducted to correlate with cancer rehabilitation programs to improve functional ability and complete the entire chemotherapy cycle.

Gefitinib induced Pemphigus Vulgaris with PRIDE complex.

Introduction: Pemphigus Vulgaris is a rare, noncommunicable, non-hereditary fatal autoimmune dermatological manifestation in which a painful blister initiates from the oral cavity. PRIDE complex stands for Papulopustules or paronychia, regulatory abnormality of hair and nails, itching, and dryness due to inhibition of EGFR. Both of these mucocutaneous manifestations are rare and are often caused by drugs. Case report: Our case reports 53-year-old patient presented with multiple crusted plaques, multiple hyperpigmented macules to patches, Solitary fluid-filled lesions on several parts of the body, and numerous erosions positive over buccal mucosa on initial follow up which was diagnosed as Pemphigus Vulgaris with PRIDE complex induced by Gefitinib. Management and outcome: The patient was treated with almost all possible treatment options, i.e., both steroids plus adjuvant therapy for pemphigus and antihistaminic, antibiotics, moisturizer, and lotions for PRIDE complex. The patient was initially admitted for infusion of the first dose of rituximab and later for management of flare-up condition and infusion of the second dose of rituximab infusion. Discussion: The complexity of the management of Pemphigus Vulgaris and PRIDE complex demands adequate monitoring of the patient's anti-cancerous therapy by clinical pharmacists, which can impact the clinical outcomes by providing pharmaceutical care and minimize the economic burden.

Health economics and effectiveness analysis of generic anti-diabetic medication from jan aushadhi: An ambispective study in community pharmacy.

BACKGROUND AND AIMS: The pharmacotherapy of diabetes mellitus has a colossal economic burden, which demands cost-effective therapy, as the patients have to be on treatment lifelong. Thus, our study aimed to study cost variation and effectiveness analysis among type 2 diabetic patients. METHODOLOGY: We conducted ambi-spective research for the adult type 2 diabetes patients who underwent substitution of branded anti-diabetic therapy with the generic alternative from "Jan Aushadhi" for more than one month and were not using any other anti-diabetic medicines. RESULTS: Among the monotherapy, glimepiride (2500%) and vildagliptin (20%) were found to have wide and narrow percentage cost variation respectively whereas, metformin Hcl 500 mg plus voglibose 0.2 mg was estimated to have the highest (891.7%), and teneligliptin 20 mg plus metformin 500 mg with the lowest (137.29%) cost variation in case of combined therapy. Similarly, generic substitutions were cost-effective in most patients, whereas the increased cost of brand drugs didn't justify its effectiveness. There was no significant difference between glycated hemoglobin (HbA1c) of brand and generic anti-diabetic drugs (t = 0.774, p = 0.22). CONCLUSION: The adaptation of generic drugs can significantly reduce the economic burden of treatment. Thus, healthcare professionals should promote generic medicines by prescribing & dispensing generic drugs and erasing misconceptions prevailing among patients.

RAPIDIRON: Reducing Anaemia in Pregnancy in India-a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries.

BACKGROUND: Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India's anaemia rate is among the highest in the world with India's National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India's Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. METHODS: This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30-34 weeks' gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 g), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. DISCUSSION: The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2020/09/027730. Registered on 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy.

Application of KW-ANOVA statistics to generate evidence for cytotoxic drug wastage induced financial burden among cancer patients: A clinical pharmacist observation.

BACKGROUND: Very little is known about the effects of drug wastage costs among cancer patients in terms of "financial toxicity" leading to poor health and nonhealth outcomes. But reducing this drug waste is an attractive strategy for cost-cutting with regard to improving the health-related quality of life of the cancer patients. Thus, the objective of the study was to determine drug wastage and to generate evidence for cytotoxic drug waste and financial burden among cancer patients.Methodology: On Ethics Committee approval, a prospective-observational study was conducted in cancer patients. The data were collected in data collection form. Daily monitoring was done to analyze the quantity of drug wastage which was interpreted using KW-ANOVA and further evidence was developed for corrective mitigation strategies applicable to intent drugs. RESULTS: Among 90 patients, 52 patients experienced drug wastage that includes 9 intent drugs which figured out unnecessary monetary units and quantity wastage that range from 80 to 50,000 INR and 10 to 500 mg, respectively. The median price value for cost of drug wastage was 237.30 INR. CONCLUSION: The study generates evidence that concludes the mandatory requirement of implementation of drug wastage mitigation strategies for the drugs expected to cause wastage. Clinical pharmacist extensively contributes in oncology pharmacy practice setting to identify the intent drugs and to abate the drug wastage among medications intending to cause potential increment in drug expenditure among cancer patients on chemotherapy clinical pharmacist.

Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial.

OBJECTIVE: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0. DESIGN: Randomised double-blind placebo-controlled trial. SETTING: Rural southern India. POPULATION: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks. METHODS: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo. MAIN OUTCOME MEASURES: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks. RESULTS: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death. CONCLUSION: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0. TWEETABLE ABSTRACT: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0.

A Comparison of Colorimetric Assessment of Vaginal pH with Nugent Score for the Detection of Bacterial Vaginosis.

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring. Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%. Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity.

Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

OBJECTIVE: Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 µg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. DESIGN: Double-blind randomised controlled trial. SETTING: A teaching hospital: J N Medical College, Belgaum, India. SAMPLE: A cohort of 652 consenting eligible pregnant women admitted to the labour room. METHODS: Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. MAIN OUTCOME MEASURES: Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. RESULTS: The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. CONCLUSION: Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results.