Indian Journal of Pharmacy and Pharmacology

Page No. 5-7

Authors: Avanthi E, Pradeep Kumar L

Objectives: To assess the anxiolytic activity of ROUSVASTATIN in male albino mice. To compare the anxiolytic activity of ROUSVASTATIN with standard drug as diazepam. Materials and Methods: The study was conducted in Pharmacology Dept., JJM medical college. Rousvastatin and Diazepam were dissolved in saline. Control group mice were injected with saline. Drugs and saline were injected intraperitoneally. Results: In elevated plus maze Rousvastatin at dose 30 mg/kg and 50mg/kg increased number of open arm and total arm entries, time spent in open arm and decreased time spent in closed arm. Conclusion: The results suggest that the significant dose-dependent antianxiety activity of Rousvastatin is similar to the behavioural effects of Diazepam.

Page No. 11-15

Authors: Meeta D. Vadher, Kamlesh Patel, D.K.Vadher, Sujal Parkar

Background: The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an appropriate formulation. Aim of this study is to assess the extent of use of drugs that are not licensed (unlicensed) and drugs that are used outside the terms of the product license (off-label). Material and Methods: A prospective study was conducted among 210 pediatric patients attending outpatient and inpatients (ward and pediatric intensive care unit) at tertiary care teaching hospital. Demographic data and complete prescription were noted in the predesigned case record form (CRF). Drugs were classified off-label and unlicensed by using National Formulary of India (NFI). Off-label drugs were classified in regards to their indications by using Anatomical Therapeutic Chemical (ATC) Classification. The proportion was compared using chi-square test for statistical analysis. Results: Out of 1053 drugs, prescribed (42.5%) were off-label drugs and (13.7%) were unlicensed drugs respectively. There was no significant result difference (p>0.05) when the proportion of drug prescribed for outpatients and inpatients. The highest proportion of off-label and unlicensed drugs were prescribed among 0-2 years. Respiratory drug (58.7%) and anti-infective (57.1%) had higher off-label use. The most common reason for off-label use of drugs was dosage of drugs. Conclusion: This study shows high level of prevalence of prescribing off-label and unlicensed drugs outpatients and among 0-2 years hence it is recommended to generate more quality data on the safety and efficacy of off-label and unlicensed drugs to rationalize paediatric pharmacotherapy

Page No. 22-26

Authors: Dharani Devangi R, Rajesh B, Shashirekha CH

Objectives: To assess the difference in cost percentage variation of various brands of oral hypoglycaemic drugs available in single and in combination in Indian market. Materials and Methods: An observational study was carried out using ‘Current index in medical specialities’, ‘reference Rx’, & ‘Indian drug referral’ (July-Oct 2014), where in the difference in the maximum and minimum price of a particular drug, manufactured by different pharmaceutical companies, in the same strength, number and dosage form was compared and the percentage variation in price was calculated. Data is analysed using descriptive statistical analysis. Results: The minimum and maximum percentage price variation for different classes of drugs respectively is as follows: In Single drug therapy, among sulfonylurea group of drugs, Glimepiride (2mg) & Glicazide (80mg) shows maximum and minimum price variation of 730.93% & 165.55% respectively. Among Biguanides & Thiazolidinediones groups, Metformin (500 mg) & Pioglitazone (15mg) show maximum price variation of 402.92% & 483.33% respectively. In α-glucosidases inhibitor group of drugs, Voglibose (0.2mg) shows maximum price variation of 451.28 %. Among newer DPP4 (Dipeptide peptidase 4) inhibitors Vildagliptin (50mg) shows maximum cost variation of 100%. In combination therapies Glimipiride & Pioglitazone combination shows the maximum variation up to 307.7%. Conclusion: The percentage cost variation of different brands of the same drug manufactured in India is very wide and the reason behind marketing a drug should be directed towards maximizing the benefit of therapy and minimizing negative personal and economic consequences.

Page No. 29-33

Authors: Satyajit Samal, Bhabagrahi Rath, Swagatika Pradhan, Smaranika Pattnaik

Objective: To evaluate the wound healing effect of topical formulation of Lantana camara Linn flower water distillate in Wistar rats. Materials and Methods: The water distillate of Lantana camara Linn flowers were made into oil based pro-formulation and tested for the ‘wound healing’ activity on excision and incision wound models in albino rats of Wistar strain. Animals were divided into four groups, containing 6 animals each. Group I (control) received no treatment. Group II animals were treated with 5% w/w Povidone iodine (positive control). Group III & Group IV treated with 5% & 10% ointment prepared from Lantana essential oil. The process of wound healing was observed with naked eye till complete healing of wounds, substantiated with histopathological studies. The wound healing parameters like rate of wound contraction and period of epithelialization were observed for excision model, whereas tensile strength (skin breaking strength) was observed in the incision model. Results were analyzed by using One-way ANOVA followed by Tukey’s multiple comparison test. Results: The degree of contraction of wound, period of epithelialization as well as tensile strength in incision model for different groups were compared and correlated. The test drug showed significant pro-wound healing potential in terms of all the parameters studied as compared to control and standard drug. The histopathological findings also correlated with the observed wound healing. Conclusion: Lantana oil formulation can be better alternative of Povidone iodine, which has some delayed wound healing action. Further research in terms of long term dermal toxicity and determination of active principle of the extract is warranted.

Page No. 38-41

Authors: Vijay M. Motghare, Nikhil H. Dhargawe, Chaitali S. Bajait, Vijay Mahobia, AK Diwan

Objectives: To study prescriptions of patients having oral cavity malignancy on antineoplastic drugs and study adverse drug reaction occurred. Methods: an observational study was carried out in radiotherapy out-patient department in tertiary care teaching institute, Nagpur after approval from Institutional Ethics Committee for 2 months period. In this prospective study, diagnosed cases of oral cavity malignancies were included. Epidemiological data and details of prescribed drugs were recorded. Collected data was analyzed for prescription pattern of antineoplastic drugs and reported adverse drug reactions. Results: Out of 34 enrolled patients, majority were male (73.05%) with mean age 48 ± 13.29. Carcinoma of buccal mucosa (35.2%) was most common. Chemotherapy drugs commonly used were Cisplatin (79.4%), 5-fluorouracil (47%), Paclitaxel (41.1%), Carboplatin (20.5%), Docetaxel (20.5%). Monotherapy (Cisplatin) developed 4.6% ADRs, two drug therapy (Cisplatin+Paclitaxel, Cisplatin+5-fluorouracil, Carboplatin+Paclitaxel) developed 79% ADRs and three drug therapy (Cisplatin+Paclitaxel+5- fluorouracil, Cisplatin+Docetaxel+5-fluorouracil) developed 16.2% ADRs. A total of 43 adverse reactions were reported during this study. Reactions observed were nausea (18.6%), vomiting (18.6%), anorexia (16.2%), alopecia (13.9%), diarrhea (2.3%), constipation (4.6%), weakness (18.6%), insomnia (2.3%), hemoptysis (2.3%) and black nails (2.3%). In Naranjo causality assessment, 62.7% of ADRs were probable and 37.2% were possible. In Hartwig and Siegel scale analysis, most reactions (76.7%) were of “mild” severity, 20.9% of reactions were of “moderate” severity, while 2.3% of reactions were of “severe” severity. Modified Schumock and Thornton criteria indicated that 44% of ADRs as “definitely preventable” and 55.8% of ADRs as “not preventable”. Conclusion: Study concludes that antineoplastic drugs, Cisplatin, Carboplatin, Docetaxel, Paclitaxel and 5-fluorouracil were commonly prescribed. Higher incidence of ADRs was observed with two drug therapy as compared to single drug regimen.

Page No. 45-48

Authors: Shivaprasad Kumbar, Purushotham Krishna

Introduction: Reporting of adverse drug reaction (ADR) is vital activity for the success of pharmacovigilance and healthcare professionals. The doctors play a pivotal role in the success of such activity. The one of the reason for under-reporting of ADR has been lack of training in undergraduate medical curriculum. Therefore, we conducted an exercise to sensitize the undergraduate students (UMS), the future doctors, regarding ADR reporting and analysed their patterns of ADR reporting. Materials & Method: The current study was observational study, conducted at department of Pharmacology, Shri B. M. Patil Medial College & Hospital, BLDE University, Vijayapura, Karnataka. At the beginning of the 5th term (3rd term of Phase-II of MBBS), UMS were given an ADR reporting form, which was designed by department of Pharmacology keeping in 2nd year UMS. This form is different from ‘suspected adverse drug reaction reporting form, available from Central Drugs Standard Control Organization (CDSCO). The form was printed with role number for each student. Each form was duly signed by Head of the department. The students were issued only one form bearing their role number. Immediately after distributing the forms, students were briefed about identifying the ADRs and reporting. Opportunity was also utilized teach the students about pharmacovigilance programme in India and importance of ADR reporting. The students were given a time of 7 days from the issue of ADR form to fill the form. Once student goes to the ward he she has been posted by clinical departments, he she will go through the drugs administered to patients in a ward. He she then go through the textbooks about the medication administered to the patient first, then they were advised to examine the patient for known ADRs from the textbooks. Once they appreciate ADRs in patient and assign it to possible drug, they fill the details in the form given to them. If they don’t find ADR in particular patient, they move on to next patient. Once student identifies an ADR s, he she will write it into the form. The same was cross-checked and signed by Assistant Professor, department of Pharmacology posted in the drug information centre, situated in Shri B. M. Patil Medial College & Hospital, BLDE University, Vijayapura, Karnataka and by Clinical Pharmacist. The form then submitted to the department and were then analysed. The data was analysed by the MS Excel and Graph Pad Prism (Demo) software. After entire exercise was over, students were given feedback about entire activity in the class and an emphasis on ADR, Pharmacovigillance was reinforced. Results: In a class of 116 students, all were issued one ADR forms each. Only 95 students out of 116 returned with duly filled forms and submitted them to the department. Out of 11 students who did not submit the ADR forms, 7 students did not bother to collect the ADR forms, 3 did not write ADR for reasons unknown and one student reported that he lost the ADR form. Students reported a total of 256 ADRs from 95 ADR forms over one week time. Out of these 256 ADRs, there were 33 different types of ADRs were found. A total of 77 drugs reported from these ADR forms. On an average each ADR form had 2.72 ADRs reported per prescription. The average number of drugs per patient, which students have gone through were 2.69. Though there were more than one ADR is reported for each drug, so there were 3.32 ADRs reported per drug being prescribed. Headache (n=61) and Nausea (n=60) followed by and vomiting (n=21) were commonly reported ADRs. Conclusion: The students were interested in the activity but needs prompt guidance from the teaching faculty to correct their mistakes.

Page No. 55-61

Authors: Bharadwaj G, Satyanarayana V, Shabeer D, Vishnu Vardhan G

Background: Alcohol dependence syndrome affects an individual at physiological, behavioral, and cognitive level and include symptoms like withdrawal, tolerance, and craving. Heavy alcohol intake is often associated with many health related and social problems which poses a threat to the society. Recently Baclofen has been used to reduce the symptoms of ADS, and is shown to affect the level of blood glucose in patients receiving it. Objective: The main objective of the study is to find out the effect of baclofen on blood glucose levels in ADS patients during therapy. Methodology: A Prospective interventional study was designed and conducted in patients attending Psychiatry Department30 patients aged between 18 years and 60 years diagnosed with alcohol dependence syndrome (ADS) per ICD-10 criteria are enrolled in the study. Blood glucose levels are checked at baseline, 10th day and at 20th day. Results: Mean fasting blood glucose levels in patients was 87.1 mg/dl on day 0, 103.23mg/dl on day 1, 98.63 mg/dl on day 10 and 95.30 mg/dl on day 20. Mean post prandial blood glucose was 125.5 mg/dl on day 0, 144.57mg/dl on day 1, 137.2 mg/dl on day 10 and 136.6 mg/dl on day 20. Conclusion: Our study shows that Baclofen has a definite role in the levels of glucose, but the mechanism of action of depression in blood glucose levels is still unknown. Further studies are needed to confirm the long term effect of Baclofen on the blood glucose levels.