Background: Adverse drug reactions (ADRs) are one of major health concern affecting population of all ages causing significant morbidity mortality and hospitalization of the patients increasing the economic burden on the society. Monitoring of ADRs is of paramount importance for the continued effective and safe use of medicines. Though they are unavoidable accompaniments of pharmacotherapy, the reporting of ADR is poor and inadequate. Substantial under-reporting and selective reporting of ADRs are the major drawbacks of the commonly followed method of spontaneous reporting by healthcare professionals (HCP). Patient direct reporting of ADR has been incorporated into the pharmacivigilance (PV) system in several countries like USA, Canada, Australia, New Zealand, Denmark, Sweden and the Netherlands. Patient direct reporting of ADR was qualitatively similar to HCP ADR report. Patient reports often had richer narratives than those of HCPs. Patient reports often contained detailed information about the impact of the suspected ADR on the patient's quality of life. The quality of ADR reported by the patients was similar to the reports by HCP in terms of description of ADRs and its severity. So, present study was taken to evaluate the process of spontaneous reporting of suspected ADR by the patient and compare the quality of ADR reported by Health care professional and Patients. Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine Comparison between spontaneous reporting by healthcare professionals and patient direct reporting of adverse drug reactions was assessed in terms of response rate, pattern of ADR reported, causality by Naranjo s scale, severity by modified Hartwig scale and preventability by using Schumock and Thornton scale. Social, emotional, occupational impact due to ADR and narrative elaboration scores were also compared. Results: Majority of the ADRs were from HCP as compared to patient reporting, indicating that better awareness among HCP about pharmacovigilance Majority of the reactions reported by patient were mild in severity, in contrast majority of ADR reported by HCP were moderate. Comparisons between HCP reporting and patient direct reporting also revealed that majority of ADR in both groups were probably preventable. Qualitative analysis reported ADR showed that majority of ADR reported by HCP had no narration or had scant narration, in contrast to patient direct reporting had very elaborate narration of ADR. Patient who did direct reporting of ADR highlighted more about emotional impact, occupational impact and social impact of ADR occurred to them, when compared to ADRs reported by HCP. Conclusions: Patients were clearly willing to report any adverse drug reactions occurring to them. The evidence indicates that patient reporting of suspected ADRs has more Potential benefits than drawbacks. The results indicate that patient perceptions of potential ADRs are relevant and should be an integral par...
Background: Skeletal muscle relaxants are the drugs which reduce unwanted spasm without interfering with consciousness and voluntary movements. The centrally acting muscle relaxants like Diazepam, is known to be GABA mimetics and other antiepileptics like Gabapentin and Pregabalin also act through the release of GABA. This study is done to investigate skeletal muscle relaxant property of these drugs in comparison to Diazepam.Methods: T Models used in the experiment are Grip Strength Test, Rota Rod Method, Beam Walk Test, Photoactometer Test. Animals were divided into 6 groups of 6 rats each: Group 1: Control group treated with normal saline (0.1 ml/10gm), Group 2: Standard-15mg/kg of Diazepam, Group 3:T1-60 mg/kg of Gabapentin, Group 4:T2-10 mg/kg of Pregabalin, Group 5:T3-60 mg/kg of Gabapentin+Diazepam, Group 6:T4- 10 mg/kg of Pregabalin+Diazepam. Mean and standard deviation was calculated for each group. One way ANOVA was used for multiple group comparisons followed by post hoc Tukey’s test for statistical significance between the groups.Results: Treatment with the above test drugs produced significant muscle relaxation and caused decreased fall off, sliding time, increase climbing time and decreased locomotor activity in all models indicating motor incoordination. The results obtained from both standard and test groups showed a highly significant difference in muscle relaxation when compared with the control group.Conclusions: The test drugs showed skeletal muscle relaxant property in rats comparable to Diazepam. In view of these results, it can open a new avenue for these drugs to be used as skeletal muscle relaxants after conducting clinical trials.
Background: To evaluate the anti-convulsant activity of ethanolic extract of Moringa oleifera (Drum stick leaves) in seizure induced albino mice and to compare it with standard drug Sodium valproate.Methods: Swiss albino mice of either sex weighing around 25-30g were randomly selected and divided into four groups of six mice each. Group 1: control- treated with gum acacia. Group 2: Standard - Valproic acid 40mg/kg body weight. Group 3: T1- ethanolic extract of Moringa oleifera (150mg/kg). Group 4: T2 - ethanolic extract of Moringa oleifera (300mg/kg). All drugs were administered orally one hour prior to induction of seizure. The anticonvulsant activity was screened using maximal electroshock seizure (MES) model and pentylenetetrazole (PTZ) model.Results: Results were analysed by ANOVA followed by Bonferroni’s post hoc test. Abolition of Tonic hind limb extension was taken as the protective end point against MES induced seizures and prolongation of seizure latency in PTZ model.At both the doses the ethanolic extract of Moringa oleifera significantly (p value <0.05) reduced the duration of hind limb extension in MES test and also significantly (p value <0.05) delayed the onset of clonic seizures in PTZ induced convulsion when compared with control group.Conclusions: On comparing the percentage protection offered by Moringa oleifera leaves against both MES and PTZ model, it possesses significant anticonvulsant activity at both doses, with more efficacy at 300mg/kg BW indicating that the test drug can prove a very promising drug for treatment of epilepsy. Further studies are required for isolation and identification of the active constituent.
Background: Osteoporosis is a chronic disease leading to weakened and porous bones which increases the risk of fractures. It is a treatable condition using drugs like bisphosphonates. There is wide variation in the cost among various brands of bisphosphonates in the Indian market, so the objective of the study was to analyse cost of different brands of bisphosphonates.Methods: Cost of both oral and injectable bisphosphonates in the same strength and dosage forms was obtained from CIMS India (January-April 2019). For oral form of the drug, price was calculated per 10 tablets, for injectable form the price per ampoule or vial was calculated and cost ratio, percentage of cost variation was calculated.Results: 15 different formulations of bisphosphonates were analyzed and it was found that cost ratio is found to be highest with 60 mg of pamidronate injection and lowest with 10 mg alendronate tablet, also pamidronate 60 mg injection has highest percentage of cost variation (9632%) and lowest cost variation is seen with 10 mg alendronate (35%). Cost ratio of 11 formulations was found to be very high which was >2 while percentage of cost variation of 11 formulations was found to be more 100.Conclusions: This study concludes that there is wide variation in cost of various brands of bisphosphonates in India. The huge price variation creates unnecessary burden leading on the patients resulting in noncompliance which increases the risk of morbidity and mortality. Therefore, there is an urgent need to regulate the cost of various formulations of bisphosphonates which will reduce the financial burden on the patients.
Background: Oringaoleifera is a widely used plant with high medicinal value, well known for its pharmacological actions and is used in various conditions. It has been reported to have many biological properties like anti-inflammatory, antimicrobial, antispasmodic, antitumour including antidiabetic activity.Methods: The study was carried out in Wistar albino rats with body weight 150-250gms. Diabetes was induced by injecting Streptozotocin intraperitoneally- dose 55 mg/kg BW. Animals were divided into 5 groups with 6 animals in each group. First group (Control) was given 2% gum acacia. Other 4 groups were induced diabetes by giving Streptozotocin. Diabetic control group received gum acacia (0.5 ml), Standard group received Glibenclamide (0.5mg/kg BW), Test group received Moringaoleifera extract (300mg/kg) and Test+ Standard group receiving combination of Moringaoleifera and glibenclamide at half the above doses. All drugs were given orally for 28 days and blood glucose levels analyzed using Glucometer on Day 0 before drug and on D1, D3, D7, D14, D21, and D28. Data were statistically analyzed by ANOVA and Tukey‘s Post Hoc test.Results: Hypoglycemia produced by Moringaoleifera extract was significant (p<0.001) when compared to diabetic control group from day 7 to day 28. The percent reduction of blood glucose level was 52.9% as compared to Glibenclamide group 61.3%. The combination group also showed significant hypoglycemic activity the percentage reduction being 56.44%.Conclusions: Thus, Moringaoleifera decreased blood glucose level efficaciously as compared to diabetic control group and similar to standard group at p<0.001.
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