Knowledge of pharmacovigilance among healthcare professionals and the impact of an educational intervention.

Aim: To determine the knowledge regarding various aspects of pharmacovigilance among doctors and nurses of a tertiary care teaching hospital and to evaluate the effect of an educational intervention. Methods: A cross-sectional study was conducted among doctors and nurses of a tertiary care teaching hospital. The participants attended a one-hour educational session during which the concept of pharmacovigilance, the Pharmacovigilance Program of India, the need for reporting ADRs, and the method of reporting were explained by a subject expert. A 20-item questionnaire was used to assess their knowledge regarding pharmacovigilance before and after an educational session. The pre-post comparisons were done using Wilcoxon's signed-rank test. A p-value less than 0.05 was considered statistically significant. Results: Forty-two doctors and 115 nurses participated in the study. A significant improvement in the participant scores was seen following the educational intervention in both doctors (Z = -5.344, p < 0.001) and nurses (Z = -8.808, p < 0.001). Lack of knowledge/awareness was perceived as the major barrier for ADR reporting among nurses as well as doctors. Conclusion: There is need for education and training among doctors and nurses to enhance their knowledge about drug safety and reporting practices. Educational intervention is likely to improve the knowledge regarding pharmacovigilance, and thereby enhance reporting by healthcare professionals.

Clinical pharmacology and pharmacogenomics for implementation of personalized medicine.

With the aim of integrating clinical pharmacology with pharmacogenomics and providing a platform to gather clinicians, academicians, diagnostic laboratory personnel and scientists from related domains, the International Conference on Clinical Pharmacology and Pharmacogenomics 2023 (ICCPP 2023) was jointly organized by the Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India and the CANSEARCH research platform in Pediatric Oncology and Hematology, University of Geneva, Geneva, Switzerland. The conference was held on 31 August and 1 September 2023, as a continued Indo-Swiss scientific exchange event series. In this report we describe the proceedings of this conference for the benefit of peers who could not attend the conference but are interested in knowing about the scientific program in detail.

Supraglottic Laryngeal Paraganglioma: A Rare Case Report.

Laryngeal paraganglioma is a rare tumor with diagnostic challenge. Many a times it can be confused with laryngeal cancers. CECT and MRI has an important role in its diagnosis. Surgical excision is the treatment of choice. Our case presented with stridor. Emergency tracheostomy was done followed by workup for surgery. Excision of the tumor was done by laryngeal fissure.

A Review of the Safety of Interleukin-17A Inhibitor Secukinumab.

Secukinumab is an anti-interleukin (IL)-17A IgG1-κ monoclonal antibody approved for psoriasis, psoriatic arthritis, and ankylosing spondylitis. Its efficacy is well documented, but the complete safety profile of secukinumab, especially on long-term use, needs to be studied. IL-17 inhibitors increase the risk of infections, especially respiratory tract infections and candidiasis, and inflammatory bowel disease; the causal relationships are well described. However, evidence regarding the other adverse events is scarce, and causal associations between the adverse events and the biologic remain unresolved. This review aims to present a narrative perspective on the safety of secukinumab and identify some key areas where the safety of secukinumab may potentially be useful in understanding the scope of secukinumab therapy and making informed clinical decisions.

Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review.

Numerous COVID-19 vaccines are being administered to people around the world. Adverse events following immunization (AEFI) with COVID-19 vaccines have been reported by health care workers as well as surveillance bodies. A wealth of information on the efficacy and safety of vaccines exists in the literature, and the knowledge in this sector is growing exponentially. A narrative literature review was conducted on sources accessed from PubMed, Google Scholar, and Cochrane Review from March 2021 to July 2021. This review is aimed at describing AEFI associated with currently available COVID-19 vaccines, with an emphasis on narrating probable AEFI, and at assisting in a better understanding of the COVID-19 vaccines.

The Role of Infrahyoid Flap in Tongue Defect Reconstruction Following Tumour Excision.

Carcinoma tongue is one of the commonest cancer of head and neck in India. Various pedicled and free flaps have been used to reconstruct the tongue defect following glossectomies. In this era of free flaps various loco- regional pedicled flaps have been overlooked and infrahyoid flap is one of them. This flap meets the functional and cosmetic acceptance of the tongue defect reconstruction with minimal morbidity to the donor site. This paper presents author's experience of using infrahyoid flap in 10 patients of carcinoma tongue. In all the patient's tongue defect was closed with the infrahyoid flap, in 1 case flap necrosed fully and in 1 partially. Functional outcome and quality of life in all the patients were acceptable.

Antidiabetic effect of bio-enhanced preparation of turmeric in streptozotocin-nicotinamide induced type 2 diabetic Wistar rats.

BACKGROUND: Poor oral bioavailability of curcumin, the active ingredient in turmeric, has limited its therapeutic use in various diseases including diabetes mellitus (DM). OBJECTIVE(S): The present study was aimed at evaluating and comparing the antidiabetic activity as well as pharmacokinetic profile of two turmeric extracts. MATERIALS AND METHODS: Rats were divided into seven groups (n = 6) including Normal control (NC), Diabetic control (DC), two standard control groups- Glibenclamide (GLIB) 5 mg/kg and Metformin (MET) 500 mg/kg, two bio-enhanced turmeric extract (BTE) treated groups (BTE-30 (30 mg/kg), BTE-60 (60 mg/kg)) and one regular turmeric extract treated (RTE) group RTE-30 (30 mg/kg). Treatment was given orally for 30 days. Streptozotocin (60 mg/kg) and Nicotinamide (110 mg/kg) were administered intraperitoneally to induce diabetes. Fasting blood glucose (FBG), oral glucose tolerance test at 60 min and 120 min (OG1 and OG2) were analysed at baseline and at the end of study on Day 29. FBG, fasting serum insulin, and concentration of curcumin and its derivatives present in pancreas were analysed at the end of study on Day 30. RESULTS: Turmeric extract treated groups showed significant (p < 0.05) blood glucose lowering effect, when compared with DC group. FBG, OG1 and OG2 readings were found significantly (p < 0.05) higher in RTE-30 treated group when compared with BTE-30 treated groups. Turmeric extracts showed improved beta-cell function, insulin sensitivity and decreased insulin resistance. BTE-30 had more pancreatic bioavailability of curcumin than RTE-30. CONCLUSION: Turmeric extracts demonstrated an antidiabetic effect in streptozotocin-nicotinamide induced type 2 diabetic Wistar rats. BTE extract was found to be an effective agent as compared to RTE in controlling hyperglycemia.

The Role of Pedicled Latissimus Dorsi Flap in Scalp Defect Reconstruction Following Tumour Excision.

Scalp is a common site for skin tumors mainly squamous cell carcinoma and basal cell carcinoma. It is always challenging to reconstruct the scalp defect following tumor excision. Conventional methods of skin grafting or rotation flap is not always feasible for large scalp defect. This paper presents the author's experience in 3 patients of scalp tumors in which conventional methods were not sufficient to reconstruct the defect, hence pedicled latissimus dorsi flap was used considering the flap size to cover the defect and reach needed for the pedicled flap. In all the 3 cases latissimus dorsi myocutaneous was able to reach the defect site and cover the large scalp defect area; thereby serving as an alternative to free flap which is technically more challenging, skill based and less feasible in normal surgical settings.

Biological tailoring of adjuvant radiotherapy in head and neck and oral malignancies - The potential role of p53 and eIF4E as predictive parameters.

BACKGROUND: Recent advances in radiation technology has allowed to significantly reduce toxicity and improve the efficacy of radical radiotherapy in head and neck and oral squamous cell cancers. Insights into molecular biology of carcinogenesis has opened a window for identifying aggressive clinical situations that may benefit with larger clinical target volume (CTV ) margin, broader levels of nodal coverage, or alternative radiation sensitizers. AIM: To evaluate the potential role of eukaryotic translation initiation factor 4E (elF4E) and p53 as predictive biomarkers in resected margins of head and neck and oral cancers. MATERIAL AND METHODS: Forty patients with oral cancers and 26 patients with head and neck cancers were evaluated for p53 and eIF4E in their negative surgical margins, for pattern of distribution and outcome. RESULTS: In oral cancers, 27 patients (67.5%) were positive for p53 and 10 (25%) for eIF4E in surgically negative margins. For head and neck cancer, the values were 13 (50%) for p53 and 9 (34.6%) for eIF4E. Twelve patients with oral cancers and 8 patients with head and neck cancers had local failure or death. The association with these biomarkers did not achieve statistical significance. However, adjuvant radiotherapy had a significant protective value. It improved median survival from 15 to 21 months in patients positive for p53 (P = 0.018) and from 12 to 20 months (P = 0.03) in those with eIF4E. There was no predictive association of subsite, tumor size, or nodal status. CONCLUSION: The overexpression of p53 and eIF4E in pathologically negative margins may represent a subset of patients who would benefit from early initiation of adjuvant radiation and tailored intensity-modulated radiotherapy (IMRT).

Drug-induced Hemolysis in G6PD Deficiency: an Unusual Presentation of a Common Clinical Condition.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency can present a diagnostic dilemma owing to the varying degrees of disease severity and the wide range of precipitating factors. Here, we report a case of a 56-year-old man who presented with signs and symptoms of heart failure and, during the course of treatment, developed intravascular hemolysis. On investigation, he was found to be G6PD deficient. Following discontinuation of the fixed-dose combination of isosorbide dinitrate and hydralazine, the clinical condition of the patient improved, and there were no further episodes of hemolysis. The case highlights the need for a high degree of suspicion of G6PD deficiency in patients with unexplained signs and symptoms of intravascular hemolysis.

Evaluation of Potential Drug-Drug Interactions with Medications Prescribed to Geriatric Patients in a Tertiary Care Hospital.

BACKGROUND AND OBJECTIVES: The drugs most commonly implicated in major potential interactions are those used in the day-to-day clinical management of elderly patients with chronic diseases. This study is planned to evaluate the profile of drug-drug interactions in the medications prescribed to elderly population and also to identify the possible predictors for potential drug-drug interactions in the elderly. METHODS: This cross-sectional study included patients aged above 60 years with a minimum of two drugs in the prescriptions. Data were collected from medical prescriptions and patients' medical records. The data collected included demographic characteristics such as age, gender, height, weight, educational status, socioeconomic status, medical history, and medications prescribed. The prescriptions were analyzed for the potential drug interactions using Lexi-Interact™ Online, an online software to check drug-drug interactions. RESULTS: A total of 209 patients were included in the study, among them 104 (49.8%) were males and 105 (50.2%) were females. The mean number of medications received was 6.53 ± 2.15 per prescription. Around 138 (66%) patients received more than six medications. The mean number of potential drug interactions seen in the prescription of these patients was 3.17 ± 2.78. Around 18.2% patients had more than five drug interactions. Major drug interactions were observed in 21.42% of cases. Around 3.02% of drug interactions belonged to risk category X, i.e., to be avoided. Logistic regression analysis showed that age above 70 years was associated with the presence of drug interactions. Increased number of medication was independently associated with the occurrence of drug interactions. The presence of drug interactions was not associated with increased number of comorbidities. CONCLUSION: A significant number of potential drug-drug interactions were seen in the prescriptions of elderly patients. Increasing age and polypharmacy were identified as the predictors of potential drug interactions.

Effect of Alternate Nostril Breathing Exercise on Experimentally Induced Anxiety in Healthy Volunteers Using the Simulated Public Speaking Model: A Randomized Controlled Pilot Study.

A randomized controlled pilot study was carried out to determine the effect of a 15-minute practice of ANB exercise on experimentally induced anxiety using the simulated public speaking model in yoga-naïve healthy young adults. Thirty consenting medical students were equally divided into test and control groups. The test group performed alternate nostril breathing exercise for 15 minutes, while the control group sat in a quiet room before participating in the simulated public speaking test (SPST). Visual Analog Mood Scale and Self-Statements during Public Speaking scale were used to measure the mood state at different phases of the SPST. The psychometric scores of both groups were comparable at baseline. Repeated-measures ANOVA showed a significant effect of phase (p < 0.05), but group and gender did not have statistically significant influence on the mean anxiety scores. However, the test group showed a trend towards lower mean scores for the anxiety factor when compared with the control group. Considering the limitations of this pilot study and the trend seen towards lower anxiety in the test group, alternate nostril breathing may have potential anxiolytic effect in acute stressful situations. A study with larger sample size is therefore warranted. This trial is registered with CTRI/2014/03/004460.

Evaluation of polypharmacy and appropriateness of prescription in geriatric patients: A cross-sectional study at a tertiary care hospital.

OBJECTIVES: To assess the polypharmacy and appropriateness of prescriptions in geriatric patients in a tertiary care hospital. METHODS: An observational study was done in geriatric patients (>60 years) of either gender. The data collected from patients included: Socio-demographic data such as age, gender, marital status, educational status, socioeconomic status, occupation, nutritional status, history of alcohol/smoking, exercise history, details of comorbid diseases, medication history, findings of clinical examination etc. In this study, polypharmacy was considered as having 5 or more medications per prescription. Medication appropriateness for each patient was analysed separately based on their medical history and clinical findings by applying medication appropriateness index, screening tool to alert to right treatment (START) and Beers criteria and STOPP criteria. RESULTS: A total of 426 patients, 216 (50.7%) were males and 210 (49.3%) were females. Polypharmacy was present in 282 prescriptions (66.2%). Highest prevalence of polypharmacy was seen in 70-79 years age group compared to the other two groups and it was statistically significant. Out of 426 patients, 36 patients were receiving drugs which were to be avoided as per Beers criteria. Among the total patients, 39 patients were overprescribed as per MAI, 56 patients were under prescribed as per START criteria and 85 out of 426 prescriptions were inappropriate in accordance with beers criteria, stop criteria, start criteria and MAI index. CONCLUSION: Around 66.19% patients were receiving polypharmacy. Significant number of patients were receiving drugs which are to be avoided as well as overprescribed and under prescribed. Inappropriate prescription was seen in a good number of patients.

Incidence of Opportunistic Infections among HIV-Positive Adults on Highly Active Antiretroviral Therapy in a Teaching Hospital, India: Prospective Study.

Oral manifestations in HIV infections are numerous and some of these are acknowledged as being of great importance in the early diagnosis of the disease. Many HIV-associated oral infections occur early in HIV disease, not infrequently as the presenting sign or symptom. Thus, early detection of the associated oral opportunistic infections should, in many cases, result in earlier diagnosis of HIV infection. Cytology, a simple, painless, and inexpensive method, has become a preferred method and was used in our study for early diagnosis of certain lesions. To determine the effect of highly active antiretroviral therapy on incidence rate of opportunistic infections among HIV-positive adults in a teaching hospital in India, a prospective study was conducted and the required sample size was 40. Study participants were selected randomly from the outpatient department of an HIV clinic who were currently on for antiretroviral therapy (ART). Data on age, gender, form of contagion, antiretroviral therapy at the time of review, number of CD4 lymphocytes per milliliter, and viral load were collected. Oral cytologic investigation was carried out and then stained for histopathological examination. A total of 40 individuals were examined and the incidence of opportunistic infections was 66.7% in individuals with CD4 counts less than 200, 55.6% in individuals with CD4 counts of 200 to 499, and 40.0% in individuals with CD4 counts more than 500. The incidence of opportunistic infection was higher in individuals with low CD4 counts in spite of being on ART.

Clinicopathological Profile and Outcomes of Follicular Dendritic Cell Sarcoma of the Head and Neck Region - A Study of 10 Cases with Literature Review.

INTRODUCTION: Follicular Dendritic Cell Sarcomas (FDCS) are rare disorders of the lymph node and soft tissues. Accurate characterization of these neoplasms is important in planning optimal treatment given its potential for recurrence and metastasis. AIM: To analyse the clinicopathological profile and outcomes of a series of 10 cases of follicular dendritic cell sarcoma arising in the head and neck region diagnosed at our regional cancer centre. MATERIALS AND METHODS: A series of 10 cases of FDCS of the head and neck region from the hospital registry of head and neck cancers diagnosed between 2007 and 2013 were collected and analysed retrospectively. Clinical details, pathologic features, immuno-phenotypic profile, treatment approach and outcomes over a period of 5 years were noted. The Recurrence Free Survivals (RFS) of all the patients were recorded. RESULTS: The median age of the patients was 57 years and the mean age was 50.9 years. Male: female ratio was 7:3. In eight of the 10 patients, the tumours were located in the tonsils. All the tumour cells showed diffuse cytoplasmic CD21 and CD23 positivity by IHC. All the 10 cases underwent surgical excision of the tumour and three cases underwent additional neck dissection for cervical lymph node enlargement. All the patients with high grade tumours were uniformly managed with Tri-modality treatment (Surgery followed by radiotherapy and chemotherapy). The overall recurrence rate was 70%. The mean and median recurrence free survival was 39.6 and 44 months, respectively. Two of the three patients who remained recurrence free at the end of the 60 months had low grade tumours. CONCLUSION: Early recognition of follicular dendritic cell sarcomas requires a high index of suspicion and bi-modality or tri-modality treatment may cure a subset of low and high grade tumours respectively and prolong recurrence in a large subset of patients. Surgery is the mainstay and the definitive modality of treatment; the advantages and benefit of adjuvant radiotherapy and chemotherapy are yet to be established. Tri-modality management may have a role in high grade patients which needs to be substantiated in future studies.

PMMC Patch Pharyngoplasty Reconstruction After Laryngectomy: Our Experience at a Regional Cancer Institute.

To evaluate our results of post laryngectomy pharyngeal defect reconstruction by pectoralis major myocutaneous (PMMC) flap. Retrospective analysis of 48 patients who underwent laryngectomy and PMMC patch pharyngeal reconstruction from year 2009 to 2013 was done. Patient and tumor characteristics were noted, CT scan and histopathology reports were reviewed. 46 (95.8 %) patients were male and 2 (4.2 %) were female. Mean age was 57.2 ± 8.5 years and mean postoperative stay was 22.6 ± 12.0 days. Most common complication was pharyngocutaneous fistula, seen in 13 (27.1 %) cases. Postoperative mortality was low (2.1 %). Post surgery rehabilitation in respect to swallowing and tolerance to radiotherapy was satisfactory in most patients. PMMC patch pharnygoplasty is a reliable option for pharyngeal reconstruction with acceptable complication.