Analysis of adverse drug reactions of imatinib in chronic myeloid leukemia patients: An Eastern Indian experience.

BACKGROUND: Imatinib mesylate is the cornerstone therapy in the management of chronic myeloid leukemia (CML). Monitoring of adverse drug reactions (ADRs) of imatinib in our patients is very important to ensure their safety. Aims and Objectives: The current study aims to monitor ADRs encountered in CML patients in the chronic phase with imatinib (400 mg/day). MATERIALS AND METHODS: This prospective, observational study was conducted from November 2011 to May 2015 on 310 patients presented to the Departments of Clinical Hematology and Pharmacology of SCB MCH, Cuttack, diagnosed with CML at chronic phase. Collected ADRs were entered in the ADR reporting form (PvPI) and were analyzed for causality and severity. RESULTS: Anemia was the most common hematological ADR, whereas hyperpigmentation and nausea were the most common nonhematological ADRs reported. Maximum ADRs were mild to moderate and required no change in the treatment course. CONCLUSION: The study revealed that imatinib mesylate, a well tolerated drug, has very few cases of severe ADRs in Indian patients at the chronic stable phase of CML.

Effectiveness of Deferasirox in Pediatric Thalassemia Patients: Experience from a Tertiary Care Hospital of Odisha.

BACKGROUND AND OBJECTIVES: Patients with beta-thalassemia require lifelong blood transfusions, leading to chronic iron overload, which can lead to growth retardation, as well as hinder sexual development during the adolescent period and dysfunction of organs such as heart, pancreas, and endocrine glands. These patients are in need of lifelong transfusion therapy and hence lifelong iron chelation therapy as well. Hence, this study was aimed to assess the effectiveness of deferasirox for iron chelation in pediatric thalassemia cases in a tertiary care hospital of Eastern India. SUBJECTS AND METHODS: This prospective, observational, hospital-based study was conducted from June 2015 to December 2016. Two hundred and fifty patients were assessed for eligibility, of which 174 were included. Effectiveness of deferasirox was observed by measuring serum ferritin levels which were monitored at the end of every 3 months till 1 year. We also evaluated the compliance with deferasirox therapy in the same study cohort. RESULTS: The serum ferritin level reduced significantly at the end of 12 months in comparison to baseline (P = 0.04). There was a mean absolute decrease in serum ferritin only in the dose range of 21-30 mg/kg/day. Approximately 90% of the patients had 100% compliance with deferasirox therapy. CONCLUSIONS: Deferasirox is an effective iron chelator when started at an optimum time and with optimum dose. At least 1 year of deferasirox therapy is needed for a significant lowering of serum ferritin levels of pediatric thalassemia patients on multiple blood transfusions.

Pricing and components analysis of some key essential pediatric medicine in Odisha state.

OBJECTIVE: Study highlighting prices, i.e., the patients actually pay at ground level is important for interventions such as alternate procurement schemes or to expedite regulatory assessment of essential medicines for children. The present study was undertaken to study pricing and component analysis of few key essential medicines in Odisha state. METHODOLOGY: Six child-specific medicines of different formulations were selected based on use in different disease condition and having widest pricing variation. Data were collected, entered, and analyzed in the price components data collection form of the World Health Organization-Health Action International (WHO-HAI) 2007 Workbook version 5 - Part II provided as part of the WHO/HAI methodology. The analysis includes the cumulative percent markup, total cumulative percent markup, and percent contribution of individual components to the final medicine price in both public and private sector of Odisha state. RESULTS: Add-on costs such as taxes, wholesale, and retail markups contribute substantially to the final price of medicines in private sector, particularly for branded-generic products. The largest contributor to add-on costs is at the level of retailer shop. CONCLUSION: Policy should be framed to achieve a greater transparency and uniformity of the pricing of medicines at different health sectors of Odisha.

Effect of Atorvastatin on Glycaemic Parameters in Normoglycaemic and Prediabetic Subjects: A Prospective, Panel Study.

INTRODUCTION: Type 2 diabetes is associated with obesity and dyslipidemia, which are risk factor for cardiovascular disease. With recent FDA approved indications for statins being widened because of its lipid lowering and pleiotropic effects, statins are currently amongst the most widely used drugs in patients with or without diabetes. Although cardiovascular risk is reduced by statin therapy, its association with the development of diabetes is disputed. AIM: This study was conducted to evaluate the effect of Atorvastatin on glycaemic status of normoglycaemic and prediabetic individuals. MATERIALS AND METHODS: An observational, prospective panel study was conducted on 75 subjects who were on Atorvastatin therapy. After baseline data collection and investigations, subjects were recruited depending on their glycaemic status into three groups: normoglycaemic, Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) group. Atorvastatin therapy was continued and the subjects were followed every 6 months up to 18 months. At every follow up all glycaemic parameters were evaluated and subjects were assessed for continuation of statin therapy, dosing schedule and possible adverse drug reactions. RESULT: All three groups as a whole, irrespective of dose of Atrovastatin therapy, showed a statistically significant (p<0.0001) increase in all glycaemic parameters. In normoglycaemic group with low dose Atorvastatin, there was no significant change in 2-hour Post Prandial Blood Sugar (PPBS) but change in HbA1c% (p=0.0004) and FBS (p<0.0001) was significant, whereas, with high dose, changes in 2-hr PPBS and HbA1c % were significant from 6 months onwards. In IFG group, both with low and high dose of Atorvastatin, there was significant change in all glycaemic parameters from 12 months onwards. In case of IGT, especially with high dose Atorvastatin, significant changes were evident from 6 months onwards. CONCLUSION: Atorvastatin therapy especially with higher dose was found to be associated with glucose intolerance in normoglycaemics and also caused progression towards diabetes in prediabetic individuals.

L-asparaginase-induced abnormality in plasma glucose level in patients of acute lymphoblastic leukemia admitted to a tertiary care hospital of Odisha.

OBJECTIVES: The objective of this study was to evaluate any abnormal change in plasma glucose levels in patients treated with L-asparaginase (L-Asp)-based chemotherapy regimen in patients of acute lymphoblastic leukemia (ALL). MATERIALS AND METHODS: This retrospective, hospital-based study was conducted in patients of ALL, admitted to the Clinical Haematology Department of a tertiary care hospital of Odisha from August 2014 to July 2015. Indoor records of 146 patients on multi-centered protocol-841 were evaluated for any alteration in plasma glucose level, time of onset of hypo/hyperglycemia, and persistence of plasma glucose alteration. RESULTS: Twenty-one percent of patients showed abnormal plasma glucose level. Most of these patients developed hypoglycemia and were of lower age group. Most of these patients developed hypoglycemia and were of lower age group, whereas a majority of higher age group patients developed hyperglycemia. In majority of the cases, abnormal glucose developed after three doses of L-Asp. Hypoglycemia subsided whereas hyperglycemia persisted till the end of our observation period. CONCLUSIONS: L-Asp produces more incidences of hypoglycemia than hyperglycemia in a good number of ALL patients towards which clinicians should be more vigilant. However, hyperglycemia persists for a longer duration than hypoglycemia.

High dose Intravenous Anti-D Immune Globulin is More Effective and Safe in Indian Paediatric Patients of Immune Thrombocytopenic Purpura.

INTRODUCTION: Immune Thrombocytopenia (ITP) is characterised by an autoimmune antibody-mediated destruction of platelets and impaired platelet production. Few controlled trials exist to guide management of patients with ITP in Indian scenario for which patients require an individualized approach. Anti-D (Rho (D) immune globulin) at a higher dose can prove to be a cost effective and safe alternative for Indian patients with ITP. AIM: To compare the safety and efficacy of higher dose (75µg/kg) intravenous Anti-D immune globulin against the standard dose of 50µg/kg for the management of ITP in Indian patients. MATERIALS AND METHODS: One hundred and sixty four children with newly diagnosed ITP between 4-14 years were randomly selected for inclusion and were treated with 50µg/kg (standard dose) or 75µg /kg (higher dose) of Anti-D to compare the efficacy and safety of higher dose intravenous anti-D immune globulin. Efficacy of Anti-D was measured in terms of rate of response and median time to response for increase in platelet counts. Any adverse event was noted. A decrease in haemoglobin concentration suggested accompanying haemolysis. RESULTS: Seventy one out of 84 patients treated with Anti-D at 75µg/kg produced complete response (85%) with median time of response being 2.5 days. On the contrary, 45 patients (70%) patients treated with 50µg/kg had complete response. However, there was no significant increase in haemolysis with higher dose. A significant correlation was found between dose and peak increase in platelet count measured at 7th day following administration. However, there was no relationship between the decrease in haemoglobin and the dose given, or between the increase in platelet count and fall in haemoglobin. CONCLUSION: A 75µg/kg dose of Anti-D is more effective with acceptable side effect in comparison to 50µg dose for treatment of newly diagnosed Indian patients of ITP.

Pricing and availability of some essential child specific medicines in Odisha.

OBJECTIVES: Continuous availability of affordable medicines in appropriate formulations is essential to reduce morbidity and mortality in children. Odisha an eastern Indian state records very high mortality of children. The study aims at documenting the availability and prices paid for purchasing essential child-specific medicines. MATERIALS AND METHODS: The survey of 34 essential medicines was conducted in six randomly selected districts of Odisha. Data were collected from medicine outlets of the public, private, and other sector (Nongovernmental Organization [NGO]/mission sectors) of six randomly selected districts, using WHO/Health Action International medicine price collection methodology. For each medicine surveyed, data were collected on the highest and lowest-priced formulations available in each facility. RESULTS: Both public sector and other sector health facilities procure only one brand of medicines, mean percentage availability of medicines being 17% and 21.8%, respectively. In the private sector, the mean percentage availability of the high and lowest-priced medicines for a particular drug product was 10.8% and 38.5%, respectively. The public sector procurement price is 48% lower than international reference prices. In the private sector, high-priced, and low-priced products are sold at 1.83 and 1.46 times the international reference price, respectively. Substantial price variation was observed for some medicines across individual outlets. Medicines were found to cost 2.08 times their international reference price in NGO/mission sector facilities. CONCLUSIONS: The availability of children's medicines in public sector facilities of Odisha state is poor. Medicines for children cost relatively high in both private and NGO sectors compared to the international reference price. The availability medicines should be improved on an urgent basis to improve access of medicines for children of Odisha.

Information Education and Communication can Improve Adherence to Artemether-Lumefantrine Combination in Patients of Uncomplicated Falciparum Malaria.

BACKGROUND: Early diagnosis and prompt treatment with Artemisinin combination therapy (ACT) is vital to improve mortality in Falciparum Malaria. Information education and communication (IEC) is a strong tool that can improve drug adherence. AIM: To explore if IEC in the form of designed drug bags with verbal communication can improve ACT adherence in Falciparum Malaria patients. MATERIALS AND METHODS: A prospective, interventional, controlled study was conducted in OPD patients of both SCB Medical college, Cuttack and district headquarter hospital Cuttack district of Odisha. IEC material in the form of well designed drug bag and verbal communication was used for intervention. Control group received ACT combinations but were not given IEC. RESULTS: Adherence to IEC was significantly higher (81%) in patients receiving IEC compared to controlled patients not receiving IEC. Educational status and the geographical area of the patient were found out to affect adherence to IEC to a significant extent. CONCLUSION: IEC in the form of designed drug bags, supplemented by verbal communication can improve ACT adherence in Falciparum Malaria.

Nonadherence to anti-HIV medication is associated with higher level of anxiety: Experience from a tertiary care hospital of Odisha.

AIM: To correlate the level of anxiety with nonadherence to antiretroviral medication. MATERIALS AND METHODS: This observational, cross-sectional, hospital-based study was conducted in 78 patients attending antiretroviral therapy (ART) center of a tertiary care hospital of Odisha. The study duration was 6 months. Patients were designated as nonadherent by referring to the white card. Utilization of ART drugs and adverse drug reactions were included in a predesigned format. The anxiety level of all included patients was scored as per Hamilton Anxiety Rating Scale. Mean anxiety score of the adherent group was compared with that of the nonadherent group. Possible causes of nonadherence leading to high anxiety level were evaluated. RESULTS: 46% of patients in the nonadherent group had very severe, 17% had moderate to severe, 28% had mild to moderate and 9% had a mild level of anxiety. In the adherent group, however, mild to moderate level of anxiety was observed only in 10% patients. CONCLUSIONS: Anxiety is associated with sub-optimal medication adherence in HIV infected patients.

Adverse drug reaction monitoring of antidepressants in the psychiatry outpatients department of a tertiary care teaching hospital.

BACKGROUND AND INTRODUCTION: Depression is a prevalent mental disorder and the 4(th) leading cause of disability in the world as per the World Health Organization (WHO). The adverse Drug Reactions (ADRs) to antidepressants are common and they can lead to a non compliance or even a discontinuation of the therapy. This study entitled us to monitor the ADR profile of the antidepressants in a tertiary care teaching hospital. PATIENTS AND METHODS: A longitudinal, observational study was conducted in the Outpatients Department of Psychiatry in S.C.B. Medical College and Hospital l in collaboration with the I.M.S and SUM Hospital. A total of 160 cases were studied for ADRs by using a predesigned CDSCO form. The patients who were on TCAs, SSRIs and newer antidepressants (SNRIs/NDRIs) were assessed by doing physical examinations, neurological examinations and relevant lab tests. The causalities were assessed by the criteria of the WHO-UMC. The analysis of ADRs was done by using the Chi square test. RESULTS: Among the 160 patients who took antidepressants, 26.87% reported ADRs, with at least one possible causality.None were labeled as certain, as a rechallenge was not performed.ADRs were mostly observed in polytherapy (14.37%) and with antidepressants like TCAs (58.84%). CONCLUSIONS: Agitation, anxiety and insomnia were the common ADRs which were associated with the use of antidepressants. This study offers a representative profile of the ADRs which can be expected in the Psychiatry Outpatients Department and due care must be taken to avoid these ADRs.

Lenalidomide induced intrahepatic cholestasis in newly diagnosed patients of multiple myeloma.

The chemotherapeutic regimen melphalan, prednisolone, and thalidomide (MPT) is the standard of care for symptomatic multiple myeloma patients who are not eligible for high dose chemotherapy followed by autologous stem cell therapy. Lenalidomide, a newer thalidomide derivative, is 300 times more potent than thalidomide. Combined therapy using melphalan, prednisolone, and lenalidomide (MPL) is very effective with many advantages. We report here one rare adverse effect, i.e., intrahepatic cholestasis related to lenalidomide, in two patients out of a total of 65 newly diagnosed cases of multiple myeloma receiving MPL regimen in our series. As the use of lenalidomide will increase in the future for multiple myeloma and other diseases, clinicians should be aware of this entity.