Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions.

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were "Certain" whereas Naranjo's algorithm categorized 96.74% of ADRs as "Probable". Cohen's kappa showed a "Minimal" agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments.

Comparison of Glycated Hemoglobin (HbA1c) Values Estimated by High-Performance Liquid Chromatography and Spectrophotometry: A Pilot Study.

Background Invasive blood sample collection followed by high-performance liquid chromatography (HPLC) based analysis is the gold standard for estimating glycated hemoglobin level or HbA1c currently. Spectrophotometry could be an alternative that holds the potential to be translated into a portable, non-invasive device for glycated hemoglobin level estimation. This study compares HbA1c values obtained from HPLC and spectrophotometry. Methods Venous blood samples were collected from both diabetic and non-diabetic participants in a cross-sectional study. The samples were subjected to both HPLC and spectrophotometry-based estimation of HbA1c%. The results obtained were compared, and the relationship between the two estimations were assessed. Results About 15 diabetic and non-diabetic individuals participated in the study and 28 samples were included in the final analysis. The Pearson's correlation coefficient was 0.65 (95% CI, 0.37-0.82), indicating that there was a strong positive association. This was further supported by the findings from linear regression analysis with a p-value of <0.001. Conclusions The positive correlation between the HPLC and spectrophotometric values supports the hypothesis that spectrophotometry could be an alternative to conventional HPLC for the measurement of HbA1c. This needs to be further validated through larger, well-powered studies.

Evaluating the Efficacy and Safety of Tirzepatide on Glycaemic and Non-glycaemic Outcomes in Diabetes: A Systematic Review of Meta-Analyses.

Tirzepatide is a novel once-a-week dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, recently approved for type 2 diabetes mellitus (T2DM) and obesity. A systematic review of the literature published in multiple meta-analyses on Tirzepatide with emphasis on its effect on glycaemic and non-glycaemic parameters was conducted. We systematically searched the electronic databases PubMed and Google Scholar up to August 2023 for meta-analyses that compared Tirzepatide with placebo or active antihyperglycaemic drugs in subjects with T2DM. Various parameters for efficacy and safety, with their point estimates and confidence intervals, such as glycated haemoglobin (HbA1c), fasting serum glucose (FSG), body weight, lipid, and cardiovascular outcomes were assessed. Six meta-analyses fulfilled the pre-specified criteria and were included in the study. In all the studies, Tirzepatide treatment at different doses resulted in a significant reduction in HbA1c and FSG levels along with a significant reduction in weight compared with active control and placebo groups. Tirzepatide significantly reduced levels of triglycerides and increased high-density lipoprotein (HDL) cholesterol, whether used as monotherapy or add-on therapy. The studies suggested the cardiovascular safety of Tirzepatide as there was no increase in major adverse cardiovascular events (MACE). The drug shows lesser hypoglycemia but predominant gastrointestinal adverse effects such as nausea, vomiting, and diarrhoea. In conclusion, Tirzepatide shows superior glycaemic control and weight loss in patients with T2DM with beneficial effects on lipids, without an increased risk of hypoglycemia and cardiovascular events.

Willingness to Pay (WTP) for Newer Treatment Options for Diabetes: A Study Among Patients at a Tertiary Care Centre.

Introduction Type 2 diabetes mellitus (T2DM) poses a substantial burden globally and particularly in India, affecting health, finances, and overall quality of life. The management of this condition relies on lifestyle modifications and advanced pharmacological interventions, with emerging drugs showing promise in areas such as administration, side effects, efficacy, and cardiovascular benefits. However, their market penetration is hindered by high costs. Understanding the target population's expectations and willingness to pay (WTP) for these drugs is crucial. WTP, a key concept in behavioral science, reflects the maximum price consumers are willing to pay for a product, aiding in healthcare cost-effectiveness evaluations. Despite its relevance, only one WTP study has been conducted in the Indian context for diabetes. This study explores WTP for two novel drugs: oral semaglutide and icodec (weekly insulin). Material and methods This observational study, conducted in a diabetes specialty clinic and telemedicine facility in All India Institute of Medical Sciences, Bhopal, India, involved adults (18-80 years) diagnosed with T2DM. Data collection adhered to ethical guidelines, and participants provided written informed consent. Face-to-face interviews were employed to gather socio-economic, demographic, and medical details. Participants estimated their WTP for oral semaglutide and weekly insulin, considering reference ranges for existing antidiabetic treatments. Statistical analyses, including t-tests and analysis of variance, explored sociodemographic and clinical factors influencing WTP. Results Of 105 approached patients, 87 (74.3%) participated. The majority were males (55.2%) with an average age of 57.2 years. The average WTP for oral semaglutide was INR 9.35±5.66 per pill, significantly lower than its market price (INR 315). For weekly insulin (icodec), the WTP was INR 157.25±112.60 per dose. Subgroup analyses revealed no significant correlations based on sociodemographic or clinical parameters. Conclusion This study demonstrated the feasibility of WTP assessments in an Indian outpatient setting, revealing a substantial cost disparity between patients' WTP for oral semaglutide and its market price. The findings underscore the importance of considering WTP in introducing new diabetes medications in India, offering valuable insights for healthcare decision-makers and developers.

A review of real-world evidence on preemptive pharmacogenomic testing for preventing adverse drug reactions: a reality for future health care.

Adverse drug reactions (ADRs) are a significant public health concern and a leading cause of hospitalization; they are estimated to be the fourth leading cause of death and increasing healthcare costs worldwide. Carrying a genetic variant could alter the efficacy and increase the risk of ADRs associated with a drug in a target population for commonly prescribed drugs. The use of pre-emptive pharmacogenetic/omic (PGx) testing can improve drug therapeutic efficacy, safety, and compliance by guiding the selection of drugs and/or dosages. In the present narrative review, we examined the current evidence of pre-emptive PGx testing-based treatment for the prevention of ADRs incidence and hospitalization or emergency department visits due to serious ADRs, thus improving patient safety. We then shared our perspective on the importance of preemptive PGx testing in clinical practice for the safe use of medicines and decreasing healthcare costs.

Assessment of the Practices and Perspectives of Healthcare Providers Towards Utilization of Telemedicine for the Care of Adult Patients With Diabetes Mellitus During the COVID-19 Pandemic in India.

Background and purpose The lockdowns and restrictions enforced periodically during the COVID-19 pandemic posed a serious challenge for non-COVID care, especially in diabetes where telediabetes, the utilization of telemedicine consultations for diabetic care, became more necessary than ever before. Although studies have shed light on the perception of patients, there is a paucity of studies from the perspective of healthcare providers, especially in an Indian context. Moving forward, it is imperative to understand the perspectives of telediabetes providers in this domain. Hence, a nationwide survey was carried out to assess providers' practices and perspectives towards using telemedicine for providing diabetes care in India during the COVID-19 pandemic and beyond. Methods An online questionnaire-based, cross-sectional study was carried out involving diabetes care physicians. The study tool was developed after the identification of broad themes and constructs from published literature, national guidelines, and diabetes experts' recommendations, following which, it was validated by six experts and pilot-tested. An online open survey, hosted on a professional platform, was circulated to internists, endocrinologists, and other diabetes care physicians of various institutions, hospitals, and clinics from both public and private sectors across the country through individual and group emails and various mobile messenger services. Results Out of the 239 doctors who responded to the survey, 195 (81.6%) had provided telediabetes services since the COVID-19 outbreak, and 84.1% were actively providing teleconsultations for diabetes at the time of the survey. The majority of participants (63.2%) were private practitioners. Telediabetes engagement was 3.5 hours per day at the peak of the pandemic and reduced significantly to one hour after the end of the pandemic. Video calling was the most preferred modality for consultation, whereas messaging services were preferred for input from the patients. Printed prescription images followed by text messages were the common modalities for sending treatment advice. The overall perception towards telediabetes was positive (50.1%). Most physicians reported being reasonably and somewhat aware (65.6% and 20.5%, respectively) of telemedicine practice guidelines but were not sure about the extent of compliance. Conclusions Our study sheds light not only on the utilization of telediabetes from physicians' perspectives and practices but also on its acceptability while identifying areas requiring clarity and focus moving forward.

Treatment Cost Along With Pattern of Disease and Therapy in the Intensive Care Unit of a Tertiary Care Teaching Hospital in India.

Background The intensive care unit (ICU) represents an important platform for conducting drug utilization analysis using defined daily dose (DDD)/100 bed-days and the financial burden of treatment as patients are seriously ill and are often suffering from chronic critical illnesses. Therefore, in this study, we evaluated the drug utilization patterns and cost of treatment in the ICU. Methods A retrospective observational analysis of the medical records obtained for the medical ICU of an apex tertiary care teaching hospital in central India was conducted for a period of three years from 2017 to 2019. All the patients admitted to the medical ICU during the study tenure were included in the study. Patients hospitalized in neonatal intensive care unit (NICU), pediatric intensive care unit (PICU), and surgical ICU were excluded from the study. The socio-demographic and clinical data, utilization of different classes of drugs, WHO-Anatomic Therapeutic Chemical (WHO-ATC) classification, DDD/100 bed days, hospital stay, etc. were analyzed. A partial pharmaco-economic analysis of the average cost of admission to patients was done. Results Data from 280 patients was assessed. The mean age was 47 ± 19.18 years and 58% were males. Antibiotics and injections were prescribed to 96% and 97.5% of the patients, respectively, during their ICU stay (median: seven days). Antimicrobial drugs were most frequently prescribed (n=1096, 68%); the most common were beta-lactams and carbapenems, followed by drugs acting on the central nervous system (5%) and cardiovascular system (4.3%). Cefoperazone/sulbactum, ceftriaxone, and piperacillin/tazobactam were the most utilized antibiotics with 8, 16, and 6 DDD/100 bed-days, respectively, while proton pump inhibitors, analgesics, and anti-epileptics were the most frequently prescribed non-antimicrobial drug class. The median cost of treatment per ICU admission was Indian Rupees (INR) 23,347 (IQR 12,552- 65,524). Conclusion Drug utilization assessment provides crucial information for understanding the usage of drugs in the settings of the ICU, and should be conducted regularly to help in the proper planning and implementation of rational drug use. Treatment costs reflect the high economic burden seen in ICU admissions.

A Retrospective Analysis of Dynamic Compression Plating Versus Intramedullary Nailing for the Management of Shaft of Humerus Fractures in an Urban Trauma Care Center.

Introduction There is constant debate regarding the best surgical technique for the fixation of shaft humerus fractures. Intramedullary nailing and dynamic compression plating are the most popular surgical options. Materials and methods In our study, we retrospectively analyze the results of 27 patients with shaft humerus fractures managed with intramedullary nailing (10) and dynamic compression plating (17) at our institute from September 2021 to October 2022. Preoperative clinical assessment sheets, postoperative follow-up sheets, operative notes, anesthesia sheets, and preoperative and follow-up radiographs were analyzed. Reamed antegrade nailing was done in all cases, while dynamic compression plating was done through a posterior approach. Results The operative time of the nailing group was 82.1 ± 7.61 mins, which was significantly lesser (P value <0.05) than that of the plating group, which was 119.59 ± 10.16 mins. The intraoperative blood loss of the patients who were managed with nailing was 71 ± 7.38 mL, which was significantly lesser (P value <0.05) than that of the plating group, which was 130.59 ± 11.44 mL. The patients in both groups had a statistically nonsignificant difference in terms of functional results, which were assessed using Rodriguez-Merchan criteria. Complications were similar in both groups with infection (17.65%), and postoperative radial nerve palsy (11.76%) was more common among the patients undergoing plating, and shoulder impingement(20%) was common among those undergoing nailing. Conclusion This study concluded that both surgical options are similar in the case of functional results. The selection of the surgical method should be as per the surgeon's surgical familiarity and personalized to individual patients.

Status of Hypertension Control in Urban Slums of Central India: A community Health Worker-Based Two-Year Follow-Up.

Background: Hypertension (HTN) is a leading cause of cardiovascular diseases and its control is poor. There is heterogeneity in levels of blood pressure control among various population subgroups. The present study was conducted within the framework of the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS) in India. It aims to estimate the proportion of optimal blood pressure control and identify factors associated with uncontrolled HTN consequent to initial screening. Materials and Methods: We assembled a cohort of individuals with HTN confirmed in a baseline screening in sixteen urban slum clusters of Bhopal (2017-2018). Sixteen accredited social health activists were trained from within these slums. Individuals with HTN were linked to primary care providers and followed up for the next two years. Obtaining optimal blood pressure control (defined as SBP <140 and DBP <90 mm of Hg) was a key outcome. Results: Of a total of 6174 individuals, 1571 (25.4%) had HTN, of which 813 were previously known and 758 were newly detected during the baseline survey. Two-year follow-up was completed for 1177 (74.9%). Blood pressure was optimally controlled in 301 (26%) at baseline and in 442 (38%) individuals at two years (an absolute increase of 12%; 95% CI 10.2-13.9). Older age, physical inactivity, higher body mass index, and newly diagnosed HTN were significantly associated with uncontrolled blood pressure. Conclusion: We found about six of every ten individuals with HTN were on treatment, and about four were optimally controlled. These findings provide a benchmark for NPCDCS, in terms of achievable goals within short periods of follow-up.

Genetic predisposition for the development of lamotrigine-induced Stevens-Johnson syndrome/toxic epidermal necrolysis: a systematic review and meta-analysis.

Studies report an association between the expression of HLA alleles and lamotrigine (LTG)-induced Stevens-Johnson syndrome (SJS). This systematic review and meta-analysis evaluates the association between HLA alleles and LTG-induced SJS in different populations. Two alleles, HLA-B*0702 and HLA-C*0702, were deemed to be protective; five alleles, HLA-B*1502, HLA-B*4403, HLA-A*2402, CYP2C19*2 and HLA-B*38, may play a role in LTG-induced SJS, for which only data studying HLA-B*1502 could be extracted. The pooled odds ratio of 2.88, 95% CI of 1.60-5.17 and p-value of 0.0004 establish the presence of HLA-B*1502 as a major risk factor for the development of LTG-induced SJS/toxic epidermal necrolysis (TEN). Although multiple alleles that may play a role in the development of LTG-induced SJS/TEN were identified, the expression of the risk alleles may be ancestry-specific, and genetic screening is warranted for preventing this life-threatening adverse drug reaction.

Use of baricitinib in treatment of COVID-19: a systematic review.

OBJECTIVE: To assess the role of baricitinib alone or in combination with other therapies as a treatment for patients with COVID-19. METHODS: Systematic literature search was conducted in the WHO COVID-19 coronavirus disease database to find clinical studies on use of baricitinib for treatment of COVID-19 between December 1, 2019 and September 30, 2021. Two independent set of reviewers identified the eligible studies fulfilling the inclusion criteria, relevant data was extracted and a qualitative synthesis of evidence performed. The risk of bias was evaluated with validated tools. RESULTS: A total of 267 articles were found to be eligible after primary screening of titles and abstracts. Following assessment of full texts, 19 studies were finally included for this systematic review, out of which 16 are observational, and 3 are interventional studies. Collating the results from these observational and interventional studies, baricitinib used as add-on to standard therapy, either alone or in combination with other drugs, was found to have favorable outcomes in hospitalized patients with moderate to severe COVID-19. Furthermore, ongoing trials indicate that the drug is being extensively studied across the world for its safety and efficacy in COVID-19. CONCLUSION: Baricitinib significantly improves clinical outcomes in hospitalized patients with COVID-19 pneumonia, and further evidence will establish the drug as a standard treatment among such patients.

An observational multi-centric COVID-19 sequelae study among health care workers.

Background: India has seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any. Methods: This was an observational, multicenter cross-sectional study conducted at eight tertiary care centers. The consenting participants were HCWs between 12 and 52 weeks post discharge after COVID-19 infection. Data on demographics, medical history, clinical features of COVID-19 and various symptoms of COVID sequelae was collected through specific questionnaire. Finding: Mean age of the 679 eligible participants was 31.49 ± 9.54 years. The overall prevalence of COVID sequelae was 30.34%, with fatigue (11.5%) being the most common followed by insomnia (8.5%), difficulty in breathing during activity (6%) and pain in joints (5%). The odds of having any sequelae were significantly higher among participants who had moderate to severe COVID-19 (OR 6.51; 95% CI 3.46-12.23) and lower among males (OR 0.55; 95% CI 0.39-0.76). Besides these, other predictors for having sequelae were age (≥45 years), presence of any comorbidity (especially hypertension and asthma), category of HCW (non-doctors vs doctors) and hospitalisation due to COVID-19. Interpretation: Approximately one-third of the participants experienced COVID sequelae. Severity of COVID illness, female gender, advanced age, co-morbidity were significant risk factors for COVID sequelae. Funding: This work is a part of Indian Council for Medical Research (ICMR)- Rational Use of Medicines network. No additional financial support was received from ICMR to carry out the work, for study materials, medical writing, and APC.

Molnupiravir in COVID-19: A Scoping Review.

BACKGROUND: COVID-19, first detected in Wuhan, China, has evolved into a lifethreatening pandemic spread across six continents, with the global case count being more than 243 million, and mortality over 4.95 million, along with causing significant morbidity. It has initiated an era of research on repurposed drugs such as hydroxychloroquine, lopinavir/ritonavir, corticosteroids, remedesivir, ivermectin, alongside selective antivirals to treat or prevent COVID- 19. Molnupiravir is an orally available emerging antiviral drug considered highly promising for COVID-19. METHODS AND RESULTS: We have performed a scoping review for the use of molnupiravir against SARS-CoV-2 and COVID-19. It acts by inhibiting RNA-dependent RNA polymerase (RdRp), and exhibits broad-spectrum antiviral activity. Preclinical studies have evaluated the therapeutic efficacy as well as prophylactic activity of molnupiravir against SARS CoV-2 in various animal models that include ferrets, hamsters, mice, immunodeficient mice implanted with human lung tissue and cell cultures, in various doses ranging from 5-300 mg/kg, and results have been encouraging. Initial evidence of safety and efficacy from early phase clinical studies has been encouraging too, and recent results from a large phase 3 global trial have shown significant benefits among symptomatic outpatients. Other late-phase clinical trials are still underway with the aim of establishing molnulpiravir as a therapeutic option for COVID-19, particularly for non-hospitalized patients. CONCLUSION AND RELEVANCE: On the basis of the limited evidence available as of now, molnupiravir could prove to be a promising oral therapy, worthy of further exploration of its utility for both treatment and prevention of COVID-19 in humans. Elaborate clinical evaluation is further warranted to confirm whether the results are replicable to the clinical scenario among outpatients to reduce the chance of progression to more severe disease.

Implications and Economic Impact of Applying International Guidelines and Recommendations to the Management of High-Risk Group of Type 2 Diabetes Mellitus Patients in India.

Objectives Sodium-glucose cotransporter-2 (SGLT-2) inhibitors and dipeptidyl peptidase IV (DPP-IV) inhibitors are recommended as preferred add-on oral antidiabetic drugs (OADs) after metformin among type 2 diabetes mellitus (T2DM) patients with atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and chronic kidney disease (CKD). They are generally many folds costlier than other OADs. This is a simulatory analysis to assess the incremental cost escalation and risk reduction with their hypothetical substitution/addition in prescriptions of high-risk patients. Methods A simple simulation of cost-effectiveness analysis was performed using prescriptions of T2DM patients with established cardiovascular (CV) or renal disease or high-risk factors. SGLT-2 and DPP-IV inhibitors with proven benefits/safety were substituted or added in place of other OADs. Increments in treatment costs were calculated, and the anticipated decrease in hazards was extrapolated from cardiovascular outcome trials (CVOTs) and real-world studies. The incremental cost-effectiveness ratios (ICERs) were calculated. Results Prescriptions of 351 patients with a mean age of 58.04 ± 8.67 years were analyzed. The median annual acquisition cost of drug therapy for diabetes per patient was found to be Indian national rupee (INR) 8,964.4 for the original prescriptions when calculated using median retail prices of drugs prescribed for diabetes. Upon substituting one of the SGLT-2 inhibitors for the other OADs in the regimen, the cost increased to INR 12,265 (increase by 36.8%) for dapagliflozin, and INR 26,718 and INR 29,419 (increase by ~200%), respectively, for canagliflozin and empagliflozin. Upon calculating the ICERs, additional cost to prevent one all-cause death with dapagliflozin substitution is INR 660,020-25,384,369; INR 2,223,326 with empagliflozin substitution and INR 8,069,818 with canagliflozin substitution. The ICER for prevention of hospitalization with HF with dapagliflozin substitution is INR 1,320,040-1,435,543; INR 4,010,706 with empagliflozin and INR 5,548,000 with canagliflozin. To prevent a three-point major adverse cardiac event (3P-MACE), INR 2,062,562 would be needed with dapagliflozin substitution, and INR 3,146,861 and INR 3,859,478 with empagliflozin and canagliflozin, respectively. Incremental costs for various outcomes were higher with the addition of SGLT-2 inhibitors and significantly more if substitution with sitagliptin/linagliptin was also done. The numbers needed to treat were calculated too and ranged from 35 to 1,831 for various outcomes and drugs. Conclusion While the recommendations for use of SGLT-2 and DPP-IV inhibitors are adequately backed by evidence from CVOTs and real-world data, the incremental costs per event reduction are quite high for most outcomes in the Indian context. Dapagliflozin, being available as cheaper generic versions, appears to be most effective for most outcomes. Interpretations are subjective in terms of value assigned for preventing a major event.

Patterns of drug therapy, glycemic control, and predictors of escalation - non-escalation of treatment among diabetes outpatients at a tertiary care center.

OBJECTIVES: The study was conducted to assess patterns of prescribed drug therapy and clinical predictors of need for therapy escalation in outpatients with diabetes mellitus (DM). METHODS: This was a prospective cohort study, conducted at an apex tertiary care teaching hospital in central India for a period of 18 months. The demographic, clinical, and treatment details on the baseline and follow up visits were collected from the patients' prescription charts. Glycemic control, adherence, pill burdens along with pattern of antidiabetic therapy escalation, and deescalations were analyzed. RESULTS: A total of 1,711 prescriptions of 925 patients of diabetes with a mean age of 53.81 ± 10.42 years and duration of disease of 9.15 ± 6.3 years were analyzed. Approximately half of the patients (n=450) came for ≥1 follow up visits. Hypertension (59.35%) was the most common comorbidity followed by dyslipidemia and hypothyroidism. The mean total daily drugs and pills per prescription were 4.03 ± 1.71 and 4.17 ± 1.38, respectively. Metformin (30.42%) followed by sulphonylureas (SUs) (21.39%) constituted majority of the AHA's and dual and triple drug therapy regimens were most commonly prescribed. There were improvements in HbA1c, fasting/postprandial/random blood sugar (FBS/PPBS/RBS) as well as adherence to medication, diet, and exercise in the follow up visits. Among patients with follow ups, therapy escalations were found in 31.11% patients, among whom dose was increased in 12.44% and drug was added in 17.28%. Apart from Hb1Ac, FBS, and PPBS levels (p<0.001), characteristics such as age, BMI, duration of diagnosed diabetes, presence of hypertension and dyslipidemia, and daily pill burdens were found to be significantly higher in the therapy escalation group (p<0.05). Inadequate medication adherence increased the relative risk (RR) of therapy escalation by almost two times. CONCLUSIONS: Disease and therapy patterns are reflective of diabetes care as expected at a tertiary care center. Higher BMI, age, pill burden, duration of diabetes, presence of comorbidities, and poor medication adherence may be the predictors of therapy escalation independent of glycemic control and such patients should be more closely monitored.

Bilateral Traumatic Nightstick Fracture of the Ulna - A Rare Case Report and Review of the Literature.

INTRODUCTION: Unilateral isolated ulna fracture secondary to trauma are common but the bilateral nightstick fractures are quite rare in the clinical scenario. These are managed conservatively or surgically depending upon the degree of displacement, location of the fracture, fracture pattern and associated injury to other bones. Proper management of these fractures helps in getting a better outcome. The purpose of the study was to present a case of bilateral traumatic isolated ulna fracture and its management. CASE REPORT: A 33-year-old male presented to the emergency department with complaints of pain and swelling over the dorsum of both forearms with a history of assault with a bamboo stick. The mechanism of the injury was, the patient placed his both the forearms in front of the face as a defense during the assault and sustained injury to both forearms. On examination, the patient had bilateral forearm swelling with tenderness. Bony crepitus was present over both the ulna on palpation. X-ray of both forearms (radius and ulna) revealed the fracture of both right and left ulna without any associated fractures/injuries. The patient was managed surgically with open reduction and internal fixation using a 3.5 mm locking compression plate. At present, 1-year follow-up, the patient is having complete wrist, elbow ROM and supination, pronation without any pain. CONCLUSION: Bilateral traumatic Nightstick fractures of the ulna are rare and this is the first reported case of traumatic bilateral isolated ulna fracture according to author's best knowledge and literature review. Open reduction and stable internal fixation using the principles of fracture fixation along with early mobilization helps in getting better functional outcome and prevents further complications and secondary procedures. This case is unique as it helps in identifying the mode of trauma in medico legal cases like assault in cases of bilateral ulna fracture. The mode and the mechanism of injury are different in this case.

Femur Neck Osteoid Osteoma Managed with Radiofrequency Ablation - A Case Report.

INTRODUCTION: Osteoid osteoma is a benign tumor of bones involving mainly the tubular bones and rarely axial skeletons. The patient mainly complains of night pain in the affected region or the joint nearby. Pain always subsides with analgesics and gradually increased over the period of time. It is mostly missed on the plain radiograph so magnetic resonance imaging or computed tomography (CT) scan are preferred for accurate and early diagnosis of the tumor. CASE REPORT: A 20-year-old male presented with pain in the left hip region which was gradually increased over the period of 6 months and was experiencing pain more in the night, used to relieve on medications. CT scan of the left hip showed the presence of osteoid osteoma of 0.5 cm diameter, which was managed with radiofrequency ablation. Moreover, the patient had pain relief immediately after the procedure. At present 1-year follow-up, the patient is symptomless with no recurrence. CONCLUSION: The neck of femur osteoid osteomas is best managed with radiofrequency ablation as it causes less morbidity to the patient and helps in early return to normal activities with fewer complications as compared to open procedures.

Linkage to primary-care public health facilities for cardiovascular disease prevention: a community-based cohort study from urban slums in India.

OBJECTIVES: Hypertension and diabetes mellitus are important risk factors for cardiovascular diseases (CVDs). Once identified with these conditions, individuals need to be linked to primary healthcare system for initiation of lifestyle modifications, pharmacotherapy and maintenance of therapies to achieve optimal blood pressure and glycaemic control. In the current study, we evaluated predictors and barriers for non-linkage to primary-care public health facilities for CVD risk reduction. METHODS: We conducted a community-based longitudinal study in 16 urban slum clusters in central India. Community health workers (CHWs) in each urban slum cluster screened all adults, aged 30 years or more for hypertension and diabetes, and those positively screened were sought to be linked to urban primary health centres (UPHCs). We performed univariate and multivariate analysis to identify independent predictors for non-linkage to primary-care providers. We conducted in-depth assessment in 10% of all positively screened, to identify key barriers that potentially prevented linkages to primary-care facilities. RESULTS: Of 6174 individuals screened, 1451 (23.5%; 95% CI 22.5 to 24.6) were identified as high risk and required linkage to primary-care facilities. Out of these, 544 (37.5%) were linked to public primary-care facilities and 259 (17.8%) to private providers. Of the remaining, 506 (34.9%) did not get linked to any provider and 142 (9.8%) defaulted after initial linkages (treatment interrupters). On multivariate analysis, as compared with those linked to public primary-care facilities, those who were not linked had age less than 45 years (OR 2.2 (95% CI 1.3 to 3.5)), were in lowest wealth quintile (OR 1.8 (95% CI 1.1 to 2.9), resided beyond a kilometre from UPHC (OR 1.7 (95% CI 1.2 to 2.4) and were engaged late by CHWs (OR 2.6 (95% CI 1.8 to 3.7)). Despite having comparable knowledge level, denial about their risk status and lack of family support were key barriers in this group. CONCLUSIONS: This study demonstrates feasibility of CHW-based strategy in promoting linkages to primary-care facilities.

Pattern of Disease and Therapy for Diabetes along with Impact of Generic Prescribing on Cost of Treatment among Outpatients at a Tertiary Care Facility.

BACKGROUND: India has become the diabetes capital of the world. Analyzing trends in drug prescribing helps in judging rationality of prescriptions in different settings. This study aimed to assess disease and prescribing trends with a special emphasis on evaluating use of metformin, insulin, fixed dose combinations (FDCs), concomitant medications, pill burden, and costs of drug therapy in diabetes. MATERIALS AND METHODS: This was a cross-sectional study in which patients of either sex who attended the diabetes clinic at a tertiary care center over 9 months were included consecutively. Basic demographic profile, clinical, and treatment details on the day of visit were collected from the prescription charts. Drug costs for prescriptions were calculated using generic and median brand prices of formulations using a recognized commercial drug directory and generic price list of the government, respectively. Data were analyzed by using Microsoft Excel and Open Epi online software to compare results with published studies. RESULTS: Average age of diabetics was 53.9 ± 11.8 years and disease duration was 8.13 ± 7.78 years in 336 prescriptions analyzed. Dual drug regimens were seen in 32.7% prescriptions, most commonly metformin and sulfonylureas, followed by triple drug regimens (25%) with inhibition of dipeptidyl peptidase IV (DPP IV) inhibitor. Metformin was prescribed in 95% prescriptions (mean dose 1511 ± 559.87 mg) and insulin in 22.6% prescriptions. Angiotensin receptor blocker (ARBs) and statins were the most commonly prescribed concomitant drugs. One FDC per prescription (median) each for diabetes and comorbidities were prescribed. Daily pill burden was 4.59 ± 2.65 pills. The median monthly cost of drug therapy with branded prescribing was INR 870.43 and INR 393.72 with the use of generics. Inferences drawn by comparison with published data showed variable results for different parameters analyzed. CONCLUSION: Disease pattern was as expected for the region and trends of therapy showed concurrence with rational prescribing. Pill burden and cost of therapy remain high with a significant contribution of comorbidities.

Subtrochanteric Femur Fracture in Monostotic Pagets Disease and its Management - A Case Report and Review of Literature.

INTRODUCTION: Paget disease of bone is a chronic progressive disease of the bone of uncertain etiology, characterized initially by an increase in bone resorption, followed by a disorganized and excessive formation of bone, leading to pain, fractures, and deformities. It can manifest as a monostotic or polyostotic disease. Pathological fracture secondary to Paget's disease requires surgical management. CASE REPORT: A 60-year-old male patient came with complaint of pain and swelling over the left hip for 30 days. The patient had a history of a trivial fall. Radiological investigations were suggestive of pathological subtrochanteric femur fracture with Paget's disease of the left femur. We managed with the long proximal femoral nail (PFN). Histopathological examination confirmed the diagnosis of Paget's disease. At present 1-year follow-up, the patient is having good radiological and functional outcome with no implant failure. CONCLUSION: Subtrochanteric pathological femur fractures in Paget's disease are best managed with the long PFN with good outcome and fewer complications, which help in early mobilization and weight-bearing. Long PFN spans the entire pathologic femur and prevents the secondary fractures.