Padma Gm Rao

Antihepatotoxic effect of grape seed oil in rat

OBJECTIVES: To study the effect of oral administration of grape seed oil (GSO) against carbontetrachloride (CCl4)-induced hepatotoxicity in rats. METHODS: Liver damage was induced in male Wistar rats (150-250 g) by administering CCl4 (0.5 ml/kg, i.p.) once per day for 7 days and the extent of damage was studied by assessing biochemical parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) in serum and concentrations of malondialdehyde (MDA), hydroperoxides, glutathione (GSH), catalase (CAT), superoxide dismutase (SOD), and total protein (TP) in liver. The effect of co-administration of GSO (3.7 g/kg, orally) on the above parameters was further investigated and compared with a vitamin E (100 mg/kg, orally) treated group. Histopatholgical studies of the experimental animals were also done. RESULTS: Oral administration of GSO (3.7 g/kg, body weight orally) for 7 days resulted in a significant reduction in serum AST, ALT, and ALP levels and liver MDA and hydroperoxides and significant improvement in glutathione, SOD, CAT, and TP, when compared with CCl4 damaged rats. The antioxidant effect of GSO at 3.7 g/kg for 7 days was found to be comparable with vitamin E (100 mg/kg, orally) in CCl4-treated rats. Profound fatty degeneration, fibrosis, and necrosis observed in the hepatic architecture of CCl4-treated rats were found to acquire near - normalcy in drug co-administered rats. CONCLUSION: The GSO has protected the liver from CCl4 damage. Probable mechanism of action may be due to the protection against oxidative damage produced by CCl4.

Poisoning severity score, APACHE II and GCS: effective clinical indices for estimating severity and predicting outcome of acute organophosphorus and carbamate poisoning

Self-poisoning with organophosphorus (OP) compounds is a major cause of morbidity and mortality across South Asian countries. To develop uniform and effective management guidelines, the severity of acute OP poisoning should be assessed through scientific methods and a clinical database should be maintained. A prospective descriptive survey was carried out to assess the utility of severity scales in predicting the outcome of 71 organophosphate (OP) and carbamate poisoning patients admitted during a one year period at the Kasturba Hospital, Manipal, India. The Glasgow coma scale (GCS) scores, acute physiology and chronic health evaluation II (APACHE II) scores, predicted mortality rate (PMR) and Poisoning severity score (PSS) were estimated within 24h of admission. Significant correlation (P<0.05) between PSS and GCS and APACHE II and PMR scores were observed with the PSS scores predicting mortality significantly (P< or =0.001). A total of 84.5% patients improved after treatment while 8.5% of the patients were discharged with severe morbidity. The mortality rate was 7.0%. Suicidal poisoning was observed to be the major cause (80.2%), while other reasons attributed were occupational (9.1%), accidental (6.6%), homicidal (1.6%) and unknown (2.5%) reasons. This study highlights the application of clinical indices like GCS, APACHE, PMR and severity scores in predicting mortality and may be considered for planning standard treatment guidelines.

Cost of Adverse Drug Reactions in a South Indian Tertiary Care Teaching Hospital

In India, very few reports on the cost of adverse drug reactions (ADRs) are available. There is a need to study this aspect of health care in order to understand the economic burden imposed by ADRs. The aim of the current work was to study the costs associated with documented ADRs in a tertiary care teaching hospital. This study was conducted in medical wards of a south Indian tertiary care teaching hospital over a 6‐month period. The study protocol was assessed and approved by the institutional ethics committee. A total of 317 ADRs from 246 patients were identified during the study period. The present study used an intensive monitoring method to detect ADRs and assessed an incidence of 32.7% adverse reactions in the monitored group. The causality, severity, predictability, and preventability of the documented ADRs were assessed. The total cost to the hospital due to ADRs was found to be Rs. 1,567,397 (US

Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

36 451). The average cost per patient hospitalized with an ADR was Rs. 4,945 (US

Drug safety reports on complementary and alternative medicines (ayurvedic and homeopathic medicines) by a spontaneous reporting program in a tertiary care hospital.

115). The cost per reaction was found to be higher in the Indian context, as the per capita annual expenditure on health in this country is around US

Adverse drug reactions to fluoroquinolone antibiotics - Analysis of reports received in a tertiary care hospital

109.

Evaluation of a Drug Information Service in a South Indian Teaching Hospital

The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the adverse drug reactions were also studied. Adverse drug reactions were also assessed for causality, using Naranjos scale, severity, and preventability, using Hartwig et al. scale. Adverse drug reaction attributes to 77% of the hospital visit. Incidence of reported cutaneous adverse drug reactions, were 2.85%. Majority of the adverse drug reactions (96%) were of type B. Antibiotics (30%), were the common class of drugs, causing a cutaneous adverse drug reactions. Maximum number of adverse drug reactions were due to Acetaminophen, Amoxicillin, antitubercular drugs, and Phenytoin. Most of the adverse drug reactions were managed by withdrawal of drug (81%), and 58% patients were recovered from the reaction. Naranjos scale classifies, 29 as probable, 21 as possible, and 3 as definite adverse drug reactions. Most of the adverse drug reactions were of moderate severity, however 13 adverse drug reactions were severe. All the adverse drug reactions were probably preventable on extreme caution.

Development of hospital formulary for a tertiary care teaching hospital in south India

OBJECTIVES The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs. DESIGN A targeted approach was taken in increasing the ADR reporting to CAM in a tertiary care hospital in South India. Suspected ADRs to CAM spontaneously reported over a period of 24 months were selected for evaluation. Reported ADRs were evaluated for patient demographics, reaction and drug characteristics, causality, severity, and outcome. RESULTS A total of 12 ADRs to CAM were reported, which included 9 to Ayurvedic and 3 to homeopathic medicines, which accounted for 1.5% of the ADRs reported to the ADR reporting unit. ADR resulted in hospitalization in 5 patients. The system organ class most commonly involved included skin and appendage disorders (58.3%). Only four of the reactions were previously reported in the literature. The mean time for onset of the ADR after the administration of the drug was 27.8 +/- 36.1 days. The suspected drug was withdrawn in all the reports that resulted in recovery, with mean time for recovery 5.9 +/- 3.6 days. The majority (66.6%) were moderate in severity and 2 were severe in nature. On causality assessment, 6 were probable in nature and the remaining were possible. CONCLUSIONS Even though there were fewer ADRs reported by this spontaneous reporting system, it gave valuable information regarding the potential for adverse effects with these agents. The study has reinstated the potential role of spontaneous reporting in identifying lesser reported ADRs, including those to CAM. Such hospital-based programs can contribute much in increasing the safety-related data of these agents.

Frontline defense against the next pandemic: Antivirals for avian flu

Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4% of the total ADRs reported in the ADR reporting unit and 30.2% of all reports to antibacterials. Type A reactions (58.8%) accounted for majority and more were described to be common (48.8%) in the literature. Levofloxacin (48.8%) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5%) and the most frequently reported reaction was skin rash (21.3%). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8%) for management of the reactions, while additional treatment was instituted in 50% of the reactions. More of the reactions were probable (52.5%) in nature on causality assessment and were of moderate (72.5%) severity. Many (23.8%) of the reactions were deemed to be preventable on evaluation. Drug-drug and drug-disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our eval- uation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications.

Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital

To evaluate the service provided by a drug information centre in a teaching hospital in Manipal, India.