A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital

Background: Serious adverse drug reactions (ADRs) cause physical, psychological and economic harm to patients and society. This study was undertaken to understand serious ADRs in a tertiary care hospital and risk factors associated with it.Methods: The serious adverse reactions that occurred over a one-year period were assessed. The serious adverse drug reactions, action taken, outcome, predictability, suspect drug, causality, patient demographics and risk factors for the reaction was collected. Chi-square test was applied for observing relationships of predisposing factors for serious ADRs.Results: Out of a total of 984 reported adverse drug reactions, 94 (9.55%) were serious. Hematological disorders (41.05%) were the common serious ADRs followed by electrolyte disturbances (18.94%). Anticancer agents were the suspect drugs for majority of serious ADRs. Serious ADRs contributed to 39 (0.05%) admissions in the hospital. Recovery occurred in 97.87% of the patients. The causality was possible in 91.48% (n=86) and probable in 8.51% (n=8) of the serious adverse drug reactions. Males, patients even with a single concomitant disease and those with more than 2 concomitant medications were at increased risk (p<0.05) for developing serious ADRs.Conclusions: Serious ADRs are a significant problem in health care. Measures should be taken to detect and treat them at the earliest to reduce suffering of the patient.

The wound healing property of ethanolic extract of Michelia champaca flowers in diabetic rats.

Background: The plant Michelia champaca (MC) is widely used in the treatment of inflammation, constipation, dysmenorrhea, ulcers, wounds, fever, and cough. The aim was to evaluate the wound healing property of ethanolic extract of MC flowers in streptozotocin-induced diabetes in rats. Methods: Wound healing activity was assessed by incision and excision wound models. Five groups of n=6 rats and n=14 rats were used for incision and excision wound models, respectively. Group I rats, non-diabetic control and Group II rats diabetic control, received 1 ml of 0.5% caboxymethylcellolose, which was used to prepare a suspension of ethanolic extracts of MC. Group III, IV and V rats were given MC extract the suspension of 100 mg/kg, 200 mg/kg and 300 mg/kg respectively. Parameters observed were breaking strength of incision wound and wound contraction, epithelialization, hydroxyproline content of excision wound respectively. Results were analyzed using one-way analysis of variance, followed by Tukey’s post-hoc test. Results: Breaking strength, rate of wound contraction and hydroxyproline content were significantly increased, and the period of epithelialization was significantly reduced in Group IV and V rats respectively. Conclusion: Oral administration of ethanolic extract of MC promotes wound healing in diabetic rats. Hence, further study in humans is suggested.

Anticonvulsant activity of gap-junctional blocker carbenoxolone in albino rats.

Background: Gap junctions (GJs) are clusters of channels that connect the interiors of adjoining neurons and mediate electrical/electrotonic coupling by transfer of ions and small molecules. Electrotonic coupling between principal neurons via GJs is increasingly recognized as one of the mechanisms in the pathogenesis of the abnormal neuronal synchrony that occurs during seizures. Carbenoxolone the succinyl ester of glycyrrhetinic acid obtained from liquorice has been shown to have the property of blocking gap junctional intercellular communication. The objectives were to study if carbenoxolone has in-vivo anticonvulsive activity in pentylenetetrazole (PTZ) and maximal electroshock (MES) seizure models and to probe the functional role of GJs in seizures. Methods: Carbenoxolone was tested for anticonvulsive effect in albino rats subjected to seizures by the PTZ and MES at three doses 100 m/kg, 200 m/kg, 300 m/kg. In the PTZ model parameters observed were seizure protection, seizure latency and seizure duration. In the MES model parameters observed were seizure protection and seizure duration. Results: The results showed that the carbenoxolone has anticonvulsant activity in both PTZ and MES induced seizures with better protection in the PTZ induced seizures. In the PTZ model carbenoxolone produced a statistically significant increase in seizure latency, decrease in seizure duration and seizure protection. In the MES model carbenoxolone produced a statistically significant decrease in seizure duration. Conclusions: Carbenoxolone has in-vivo anticonvulsive effect and could be useful in both petitmal (absence) seizures and grand mal (generalized tonic-clonic epilepsy) seizures. The protective effect of carbenoxolone could be due to blockade of GJ channels that mediate electro tonic coupling and thereby prevent the neural synchronization that is characteristic of seizures. The study also supports the view that GJs have a functional role in the electrophysiology of seizures and GJ blockers have potential as a new class of antiepileptic drugs.

Students’ attitude toward didactic lecture versus problem-based learning in pharmacology: a questionnaire based study.

Background: The study was conducted to assess student attitude toward learning by didactic lectures versus problem-based learning (PBL). Methods: A questionnaire containing 11 statements was distributed to the students. Statements ranged from general information on lectures and PBL to benefits of lecture-based learning (LBL) over PBL and vice versa. The students were asked to score each individual statement. The median total scores and median with interquartile range of individual statements was calculated. A comparison between questions that support LBL or PBL was performed. Student t-test was employed to compare the mean scores of different groups. Results: Two hundred and seven students participated in this questionnaire study. The individual median total score was 42 when compared with possible total score of 55. There was a statistically significant (p<0.05) difference between the total score (mean±standard deviation) for the questions related to LBL (3.2391±0.05120) and those related to PBL (4.0640±0.05688). Conclusion: The score for PBL was significantly higher than LBL showing that students liked PBL more than LBL.

Effect of ethanolic extract of plectranthus amboinicus leaf on healing of burn wound in wistar rats.

Objectives: To study the effect of ethanolic extract of the leaf of Plectranthus amboinicus on the healing of burn wounds in wistar rats and compare it with silver sulfadiazine treated group.Materials and Methods: Five groups of rats were used in the study. Partial thickness burn wounds were made on each rat under ketamine anesthesia.The wounds in the five groups of rats were treated topically with petroleum base, silver sulfadiazine,1%, 2% and 3% ointment of ethanolic extract of Plectranthus amboinicus, respectively, once daily for 21 days or till complete healing whichever was earlier. The wound contraction rate and period of epithelization were monitored. Results: The rate of wound contraction was significantly more in Plectranthusamboinicustreated groups in comparison to the control. The mean period of epithelization was significantly decreased in Plectranthus amboinicus treated group when compared to control (P < 0.01) and silver sulfadiazine (P =0.02) treated group. Conclusion: The ethanolic extract of Plectranthusamboinicuspromoted healing of burn wound in wistar rats.

Anxiogenic effect of moxifloxacin in wistar rats.

Objective: The study was carried out toevaluate whether moxifloxacin can cause anxiety in rats.Materials and Methods: Elevated plus maze and open field test were used to assess the anxiogenic activity of moxifloxacin. Four groups of rats were treated orally with distilled water (10 ml/kg), levofloxacin (40 mg/kg) andmoxifloxacin (36 mg/kg and 72 mg/kg), respectively. The time spent, number of entries, rears in the arms of the elevated plus maze and central and peripheral areas in the open fieldwere observed. Results: Moxifloxacin (both doses) significantly increased (P<0.05) the time spent in the closed arms of elevated plus maze and significantly decreased (P<0.05) the time spent in the open arms of the elevated maze and central area in the open field as compared to control. The number of entries in the central area was significantly decreased (P<0.05) in moxifloxacin and levofloxacin treated rats. The number of rearings was significantly decreased (P<0.05) in both arms of the elevated plus maze and peripheral areas of open field in moxifloxacin and levofloxacin treated groups. Conclusion:Moxifloxacin produced anxiogenic activity in wistarrats.

A comparative study of the effect of ondansetron, granisetron and alprazolam on anxiety in wistar rats.

Objective: The study was undertaken to compare the effect of ondansetron, granisetron and alprazolam on anxiety in rats. Materials and Methods: Elevated plus maze and Open field test were used to compare the effect of drugs on anxiety in rats. Six groups of rats were treated with 2% gum acacia orally, alprazolam 0.08mg/kg body weight of the rat orally, ondansetron (0.01mg/kg, 1mg/kg intraperitoneally) and granisetron (0.01mg/kg and 1mg/kg intraperitoneally) respectively. The time spent, number of entries and rears in the arms of the elevated plus maze and central and peripheral areas in the open field test Results: Alprazolam and ondansetron significantly increased (P<0.05) the time spent in open arm of elevated plus maze and central squares in the open field and decreased (P<0.05) the time spent in the closed arm of elevated maze and peripheral squares in the open field as compared to control. There was no significant difference between the effects of alprazolam and ondansetron. Granisetron did not produce any significant effect in any of the models. Conclusion: Ondansetron, but not granisetron, produced anxiolytic activity in rats which was comparable to alprazolam.

Evaluation of antiinflammatory and analgesic activities of alcoholic extract of kaempferia galanga in rats.

Alcoholic extract of Kaempferia galanga was tested for analgesic and antiinflammatory activities in animal models. Three doses, 300 mg/kg, 600 mg/kg and 1200 mg/kg of the plant extract prepared as a suspension in 2 ml of 2% gum acacia were used. Acute and sub acute inflammatory activities were studied in rats by carrageenan induced paw edema and cotton pellet induced granuloma models respectively. In both models, the standard drug used was aspirin 100 mg/kg. Two doses 600 mg/kg and 1200 mg/kg of plant extract exhibited significant (P<0.001) antiinflammatory activity in carrageenan model and cotton pellet granuloma model in comparison to control. Analgesic activity was studied in rats using hot plate and tail-flick models. Codeine 5 mg/kg and vehicle served as standard and control respectively. The two doses of plant extract exhibited significant analgesic activity in tail flick model (P<0.001) and hot plate model (P<0.001) in comparison to control. In conclusion K. galanga possesses antiinflammatory and analgesic activities.