Indian Journal of Pharmacy and Pharmacology

172-175

Authors: Yasmeen A Maniyar, Dasari Sriraj.

Introduction: The objective of the present study was to evaluate the anti-inflammatory activity of ethanolic extract of vitex negundo flowers (EEVNF) in experimental animals. Methods: Acute toxicity test of extract was done following Organization for Economic co-operation and development guidelines (OECD guidelines). Wistar albino rats of either sex weighing 150-250 grams were used for the study. Animals were randomly grouped into 5 groups consisting of 6 animals each. The in vivo acute anti-inflammatory activity was studied using the Carrageenan induced paw edema method. Normal saline was administered to the first group, diclofenac sodium (25mg/kg body weight{b.w} of rat ) was administered to the second group and doses of 100mg/kg, 200mg/kg and 400mg/kg b.w of rat of EEVNF were administered to the third, fourth and fifth groups respectively. All the drugs were given orally. 0.05ml of 1 % w/v carrageenan was used to induce paw edema. After l hr interval all the animals were given 0.05ml of 1 % w/v carrageenan in normal saline solution into the subplantar aspect of the left hind paw. Right hind paw served as the control for the same animal. The paw volume was measured by using digital plethysmometer by measuring fluid displacement at 1hr, 3hrs & 5hrs after Carrageenan injection. Results: Test drug produced reduction in paw volume which was significant (p<0.05) at 3rd and 5th hr respectively at doses 100mg/kg, 200mg/kg and 400mg/kg b.w of rat when compared to diclofenac sodium. Conclusion: EEVNF has significant anti-inflammatory activity.

184-187

Authors: Dharani Devangi, Shashirekha C.H, Shruthi S L.

troduction: Drugs following administration itself affect the biological rhythm or biological rhythm can affect the drug action. Administration of drugs according to biological rhythm helps in optimization and quantification of the drug effects and thereby aids in potentiation of desired effects while minimizing the undesired effects. Objectives: To study the chronopharmacological relevance to time of drug administration in respiratory disorders in Medicine in-patients at a tertiary care hospital. Methodology: A prospective non- interventional observational study was conducted on Medicine inpatients of a tertiary care hospital to study the relevance of chronopharmacology in respiratory disorders. Patients were included in the study based on inclusion and exclusion criteria. Data was recorded on a predesigned proforma. Results: Theophylline, montelukast, levocetrizine, chlorpheniramine have been administered appropriately at bedtime and prednisolone accordingly in the morning in all the subjects thereby showing 100% relevance. However etophylline was administered according to chronopharmacology in 71% of subjects only. Conclusion: Most of the drugs recorded in the study were administered according to their relevance to circadian rhythm, while only a few drugs are lagging in the trend which needs to be addressed.

192-197

Authors: Pallavi Kulkarni, Alice Kuruvilla, Regina Roy, Indla Ravi.

Introduction: To assess the knowledge, attitude and practice of the interns about rational antibiotic use and antibiotic resistance in a teaching tertiary care hospital. Materials and methods: A cross-sectional questionnaire based study was conducted involving a total of 100 interns. The data was collected in excel sheet and analyzed with descriptive statistics and results expressed as mean and standard deviation, frequencies and percentages. Results: Mean age of the participants was 24±0.71 years, with mean duration of internship 6.9±2.3 months. Sixty percent (n=60) had moderate and 39% (n=39) had good knowledge about rational antibiotic use. Fifty-six percent (n=56) knew the components of rationality, 41% (n=41) had confusion between definitive and empirical therapy. The attitude of the interns was good and positive, 96% (n=96) of them agreed that antibiotic resistance is a serious global health issue, 92% (n=92) were aware of the factors contributing to antibiotics resistance and 82% (n=82) strongly felt the need of a hospital antibiotic policy. Seventy-two percent (n=72) of the interns chose antibiotic based on senior clinicians’ opinion. Seventy-four percent (n-=74) interns opined that Internal medicine postings followed by surgery postings would have a significant role and impact on their prescribing practices. Conclusion: Interns had moderate knowledge and favorable positive attitude, improvisation in the internship curriculum involving multi-modal approach with inclusion of tailored educational interventions like case-based scenarios, group discussions, workshops, continued medical education programmes, sensitization programmes particularly during their major clinical postings, in addition active involvement of the clinicians would ensure more effective training of the future prescribers.

203-206

Authors: Siddamma Amoghimath, Suresha R N, Shruthi S L.

Introduction: The effect of Pyridostigmine on blood glucose levels in euglycemic albino rats through OGTT. Methods: Twelve Swiss albino rats weighing around 150-200gmsof either sex were randomly selected from the central animal facility, and divided into two groups. The control group received distilled water (25ml/kg body wt.), test group received Pyridostigmine (3.6mg/kg/day) for 5 days. All the drugs were given per orally. On the fifth day, following overnight fasting, 1 hour after drug administration OGTT was performed, by administering oral glucose in dose of 0.6gm/kg body weight. The capillary blood glucose level of both the groups were measured at 0, 60 and 150 minutes, by rat tail snipping method using (ACCUCHEK) glucometer. Results: The Capillary Blood Glucose levels of Pyridostigmine group was less when compared to control group at all-time intervals and was statistically significant when compared to control at all the time intervals. Conclusion: Pyridostigmine showed the hypoglycemic activity when given for 5 days orally in euglycemic albino rats through OGTT.

210-214

Authors: Renuka L. Kadam, Vijay M.Motghare, Smita Sontakke, Vijay Mahobia, A.K. Diwan.

Introduction: To study current prescription pattern of drugs and adverse drug reactions (ADRs) in patients of carcinoma breast. Methodology: This observational, cross-sectional study was carried out in Radiotherapy department of a tertiary care teaching hospital for a period of two months. Patients diagnosed with breast carcinoma and attending Radiotherapy department for chemotherapy were included. Prescriptions were analysed and details of drugs prescribed were recorded. Patients were enquired about occurrence of any ADRs and details were recorded. Preventability and severity of ADRs were assessed by modified Schumock and Thornton scale and modified Hartwig and Siegel scale respectively. Results: A total of 70 patients were included in the study. Cyclophosphamide was the most commonly used chemotherapeutic agent (77.14%), followed by Doxorubicin (68.57%) and 5-FU (44.29%). Most commonly prescribed regimen was Cyclophosphamide + 5FU + Doxorubicin followed by Cyclophosphamide + Doxorubicin. Nausea was the most commonly reported ADR followed by alopecia, vomiting and blackening of nails. Maximum ADRs were reported with Cyclophosphamide + Doxorubicin + 5 FU combination followed by Cyclophosphamide + Doxorubicin combination. Out of the total ADRs 60.11% belonged to the category of “definitely preventable” while 74.15% of ADRs were of less severity categorized as “mild level 1” severity. Conclusion: Cyclophosphamide was the most commonly prescribed drug. Highest incidence of ADRs was observed with Cyclophosphamide + Doxorubicin + 5 FU. Inspite of prophylactic antiemetic treatment majority of patients had nausea and vomiting which indicates that more vigorous measures to prevent emesis need to be undertaken since these ADRs of antineoplastic drugs are usually preventable.

120-124

Authors: Gopal Gudsurkar, Pali Rastogi, Pooja Solanki, Shubham Atal.

Objectives: Schizophrenia is a psychotic disorder characterized by hallucinations and delusions. Second generation antipsychotics are frequently used to treat the schizophrenia. As there are no clear-cut Indian guidelines for starting a particular drug for newly diagnosed cases of schizophrenia we decided to find out efficacy and tolerability of olanzapine, risperidone, quetiapine and amisulpride at 4 weeks after the initiation of treatment. Materials and Method: Newly diagnosed cases of schizophrenia of either sex between age group 18 to 65 were recruited;30 cases in each group[N-120, n-30]. Patients were prescribed either of the study drugs in oral tablet form. Efficacy was assessed by comparing baseline [day 0] and week 4scores of PANSS, CGI and GAF score and tolerability was assessed by UKU PERT scale at 4 week. Results: Olanzapine and risperidone statistically significantly reduced total PANSS score than amisulpride and quetiapine (p<0.05).Olanzapine, risperidone and quetiapine reduced PANSS positive sub score significantly than amisulpride (p<0.05).Quetiapine reduced the PANSS negative sub score significantly than amisulpride (p<0.05).Olanzapine and risperidone were slightly better than amisulpride and quetiapine in reducing CGI-S score and improving GAF score. All drugs were equally tolerable at the end of 4 weeks.

130-133

Authors: B. Satya Sree, A. Lakshmana Rao, P. Swathanthra Babu, K. Surya Kiran, K. Vandana.

Various novel quinazolinones and quinazolidine dione derivatives were prepared by using anthranilic acid. Anthranilic acid was synthesized by treating phthalimide with sodium hypobromide solution. The synthesized anthranilic acid was treated with urea, thiourea, acetamide and benzamide to give corresponding titled compounds in good yields. The synthesized compounds were characterized by physical properties and spectral studies (IR, 1H-NMR) and tested for antimicrobial activity.

138-142

Authors: Arati Chikaraddy, Yasmeen Maniyar.

Objectives: Evaluation of Hypoglycemic activity of Extract of bark and leaf of Ficus bengalensis Linn.in alloxan induced diabetic albino rats and comparison with standard antihyperglycemic drug Glibenclamide. Materials and Method: Aqueous extracts of bark and leaf of Ficus bengalensis were evaluated for hypoglycemic activity. Albino rats were divided into six groups of six-animals each. Diabetes was induced by using Alloxan monohydrate (160mg kg.b.wi.p).Control group was treated with normal saline 0.5ml; second group was treated with Glibenclamide 5mg kg as a standard antidiabetic drug. Remaining groups were treated with different doses (150 & 300mg kg.b.w) of bark and leaves of F.bengalensis for a period of 28 days. Fasting glucose level estimated by using Glucometer on days 3, 7, 14, 21 and 28. Results: An Aqueous Extract of F.Benglensis Linn. produced significant reduction in the fasting blood glucose in diabetic rats. At the dose of 300mg/ kg of bark showed significant fall in blood. glucose level as compared to other doses of extract. Post-prandial reduction in the blood glucose levels on day 3 after 3hrs of drug administration was significant (p = 0.007) with bark 300mg as compared to other doses. This is however, highly significant (p = 0.0001) when compared with standard drug Glibenclamide. Conclusions: The current small sample size study shows relevant antidiabetic potential for Ficus bengalensis. Further studies are required to elaborate the antidiabetic activity and mode of hypoglycemic action of Ficus bengalensis.

147-152

Authors: Vikas S. Sharma, Vijay M. Motghare, Ganesh N. Dakhale, Sonali A. Pimpalkhate, Chaitali S. Bajait.

Introduction: The introduction of Highly Active Anti-retroviral Therapy (HAART) has led to significant reduction in AIDS related morbidity & mortality. The majority of drugs available today are costly & have serious adverse effects, undesirable drug interactions & have to be taken lifelong. Though Anti-retroviral Therapy (ART) has increased lifespan of HIV positive patients, adverse drug reactions (ADRs) of this therapy still remains a major concern. Objective: To collect demographic details & to assess incidence & causality of ADRs in HIV positive patients receiving ART. Materials and Method: A retrospective observational study was carried out for a period of 18 months (1st January 2014 to 30th June 2015) at Government Medical College & Hospital, Nagpur. The ADRs reported by physician were collected, analysed & causality assessment was done. Result: Out of 85 patients evaluated, 58 (68.3%) were females. ADRs reported were rash (40.6%), anemia (26.0%), nausea (16.7%), dizziness (6.3%), vomiting (5.2%), gastritis (3.2%), Steven Johnson Syndrome (1.0%) & diarrhoea (1.0%). Out of 96 ADRs reported, 39 (40.6%) were related to skin. Use of Zidovudine + Lamivudine + Nevirapine regimen reported majority of ADRs. Sixty one (67%) regimens were dechallenged, 29 (31.9%) regimens were continued while only 1 (1.1%) regimen was rechallenged. Seventy six (79.2%) ADRs were probable & 1 (1.0%) was definite as assessed by Naranjo’s Causality Assessment Scale. Conclusion: Rash was commonly reported ADR from ART. The findings from study suggests that there is need for intensive monitoring of ADRs in ART centre of Government Medical College & Hospital (GMCH), Nagpur.

161-167

Authors: Santhosh R, Shivashankaramurthy KG, Kiran Lakkol, Gokul CG.

Objectives: To study the antinociceptive effect of promethazine and cetrizine in albino mice and to compare its antinociceptive effect with the standard drug morphine. Lastly to rule out the influence of sedation contributing to antinociceptive action, lorazepam a known sedative was used. Materials and Method: A total of 84 albino mice of either sex were used in the study and were divided into two sets with each set containing 7 groups. Each group in each set contained 6 animals. Group 1 in both sets was administered with Normal saline. Group 2 in both sets was administered with Morphine. Group 3 in both sets was administered with promethazine. Group 4 in both sets was administered with promethazine. Group 5 in both sets was administered with cetrizine. Group 6 in both sets was administered with promethazine + cetirizine. Group 7 in both sets were administered with lorazepam. First set of animals were subjected to Hot plate test and second set of animals were subjected to Tail flick test. Results: Results were evaluated by ANOVA followed by post hoc analysis. Promethazine in both tests in both doses showed significant antinociceptive effect when compared to control. Cetrizine and lorazepam on the other hand did not show significant antinociceptive effect when compared to control. Conclusion: This study shows that promethazine has statistically significant antinociceptive activity when compared to control whereas cetrizine has no antinociceptive effect. Lorazepam did not show antinociceptive effect proving us that antinociceptive effect of promethazine is not due to its sedative properties.

69-71

Authors: VT Annapurna, HV Anuradha, MC Shivamurthy.

Introduction: Esophageal carcinoma (EC) ranks 6th among all cancers in mortality. Gastric carcinoma (GC) is the 2nd most common cancer among men and 3rd most among females in Asia and worldwide. The aetiology in majority of patients was linked to tobacco and alcohol. Usually, treatment regimen followed EC, GEJ (gastroesophageal junction) and gastric carcinoma is DCF regimen as per National Comprehensive Cancer Network guidelines. Objectives: To study the prescribing pattern in esophageal cancer, GEJ cancer & gastric carcinoma in a tertiary care hospital. Materials and Method: A prospective observational study was done for a period of 6 months in both male & female patients diagnosed with EC, GEJ & GC. Prescribing patterns were recorded & analysed. Results and Discussion: Total of 31 patients was included in the study; of which 19, 9 & 3 were diagnosed as EC, GC and GEJ carcinoma respectively. The most common treatment regimen followed were combination of cisplatin+5 fluorouracil+ radiotherapy in EC & GEJ whereas oxaliplatin +5-fluorouracil + leucovorin in GC. Conclusion: In our study, anticancer drugs were prescribed in a combination therapy. In majority of upper gastrointestinal carcinoma patients 5-FU and platinum based combination therapy were used. Dexamethasone, granisetron and ondensetron were used to treat adverse drug reactions of anticancer drugs.

77-82

Authors: SC Darade, PB Patil, RS Kalkotwar.

The most preferred route of administration is oral administration of any dosage form because of its self-medication, exact dose of drug and easily administration but difficulty in swallowing in geriatric patients is one important drawback of this route and mentally disturb patients. To solved this problem disintigration time of oral disintegration tablet is within 30 sec. which is disintegrate in mouth. Piroxicam with camphor as subliming agent combined to form fast dissolving tablet.wet granulation technique is used for preparation of Orodispersible tablets of Piroxicam drug. Camphor was removed from the granules by using vaccum. Then tablet were prepared and expose to vaccum. The tablet formulations were evaluated for Disintegration time, dissolution, hardness, friability, weight variation and thickness.

88-94

Authors: Suvajit Das, Debatri Biswas, Chiranjib Bagchi, Kaushik Mukherjee, Santanu K. Tripathi.

Introduction: Narcotics like morphine or pethidine are neither widely prescribed, nor readily available as analgesic drugs. Availability of fentanyl is relatively easier, but has tolerability issues and dependence liability. In post-operative setting, fentanyl and promethazine are frequently co-administered. This study aimed at determining the analgesic potential of promethazine in suitable mice models and at studying if combining it with fentanyl could produce analgesia comparable to pethidine, while reducing the dose requirement of fentanyl. Materials and Method: Dose escalation studies were done to determine subanalgesic doses of fentanyl and analgesic potential of promethazine. Subsequently, analgesia by promethazine in combination with sub-analgesic fentanyl was compared to that caused by pethidine. Five groups of mice were evaluated before and after analgesic dosing. Group I served as vehicle control, Group II received pethidine, Group III and IV received combination treatments with promethazine and sub- analgesic doses of fentanyl, Group V received fentanyl. Evaluation of analgesia were done by tail flick analgesiometer and formalin test. Results: Formalin test ratings showed equivalent scores in the pethidine group and fentanyl-promethazine combination groups. Tail-flick latency in the fentanyl-promethazine combination groups was significantly increased in comparison to the pethidine group. When promethazine was combined to sub-analgesic fentanyl, Tail-flick latency was also found to be similar to that of full analgesic dose of fentanyl. Conclusion: The study showed that promethazine had notable analgesic activity in mice. When combined to sub-analgesic doses of fentanyl, promethazine produced better analgesia as compared to pethidine. Combining promethazine to fentanyl reduced the dose requirement of fentanyl without compromising the analgesic efficacy.

101-104

Authors: Pradeep Kumar, Meena KN.

Background: the study was conducted to analyze the perceptions regarding self medication of antibiotics among medical students and to determine the practice of antibiotic self-medication among medical students. Methods: This is a cross-sectional, questionnaire-based study which was conducted among the second year, third year and final year medical students of Rajarajeswari Medical College and Hospital, Karnataka. The data obtained was analyzed using descriptive statistics and were expressed in proportions and percentages. Results: Among 341 undergraduates participated in the study, 223(65.39%) were female and 118(34.60%) were male. The prevalence of self-medication among the medical students was 273(81.25%), whereas 63(18.75%) said that they don’t follow or encourage self-medication. The most important indication for antibiotic self-medication was sore throat (60.43) followed by fever (44.68) and diarrhea (39.56). The most common class of antibiotic self-medicated was Penicillin group (46.15%) followed by fluoroquinolones (31.13%). Conclusions: our questionnaire based study reveals a higher prevalence of self-medication of antibiotics among the undergraduate facilitated by easy availability of drugs and information from textbook. The major and important reason for misuse of antibiotics is lack of proper knowledge on antibiotics and antibiotic resistance. It is important to spread the information and knowledge about antibiotic misuse by self-medication and its consequent effects. Hence, incorporating a special course on rational prescription of antibiotics becomes necessary that can emphasizes more on the advantages and disadvantages of self-medication rather than advance of knowledge alone.

110-113

Authors: VM Motghare, MB Nandeshwar, CS Bajait, SA Pimpalkhute, SD Sontakke.

In vivo method of animal testing is the use of non-human animals in experiments. Mice, rats, rabbits, guinea pigs, hamsters and non-human primates are widely used as laboratory animals. In vitro cell culture technique and in silico computer simulation are alternatives to in vivo animal testing. Current limitations on performing experiments with laboratory animals bring about the need for search of alternate tissues for biological testing. Bioassay is an integral part of undergraduate and postgraduate Pharmacology curriculum where various isolated tissues like frog rectus, rat colon, guinea pig ileum etc. were used for which whole animal has to be sacrificed for a small piece of tissue. So, we conducted bioassay of acetylcholine on chicken ileum obtained from chicken sacrificed for food which is easily available from slaughter houses. We found greater height of response and stability with Tyrode solution compared with Ringer Locke solution. We assessed the unknown concentration of acetylcholine by interpolation method of bioassay which we found 82.17% correct of actual concentration of unknown. Isolated chicken ileum is a better option available for conducting isolated tissue experiments considering the restriction with the use of experimental animals under CPCSEA guidelines.

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.