Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers.

AIM: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. METHODS: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. RESULTS: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. CONCLUSION: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.

A study of the free radical scavenging effects of Piper betle leaf extract in patients with vitiligo.

BACKGROUND: Vitiligo is an idiopathic skin disease manifested by depigmented macules. It is characterised by melanocyte destruction, and redox imbalance is proposed to play a contributory role. AIM: The aim of this study was to analyze the effects of an ethanolic extract of Piper betle leaves on the generation of reactive oxygen species in erythrocytes sourced from vitiligo patients. METHODS: The effect of Piper betle on the generation of reactive oxygen species in erythrocytes was measured by flow cytometry in patients with active and stable vitiligo versus healthy controls, using 5-(and-6)-chloromethyl-2'-7'-dichlorodihydrofluorescein diacetate. RESULTS: The generation of reactive oxygen species in erythrocytes was higher in patients with vitiligo (n = 23) compared to healthy controls (n = 18). The geometrical mean fluorescence channel was 23.05 ± 2.11 in patients versus 17.77 ± 1.79 in controls, P = 0.039. The levels of reactive oxygen species were higher in patients with active vitiligo. Treatment of erythrocytes with Piper betle in concentrations of 0.5 and 1.0 µg/ml significantly decreased the baseline levels of reactive oxygen species by 31.7% in healthy controls, and 47.6% and 44.3% in patients with active vitiligo, respectively. Piper betle effectively scavenged hydrogen peroxide, which was evident by a decrease in the geometrical mean fluorescence channel by 52.4% and 62.9% in healthy controls, and 45.0% and 57.0% in patients with active vitiligo. LIMITATIONS: The study had a small sample size. Future studies should focus on evaluation of the antioxidant role of Piper betle at the lesional site. CONCLUSION: This pilot study indicates that patients with active vitiligo demonstrate enhanced generation of reactive oxygen species in erythrocytes, which was significantly reduced following ex vivo treatment with Piper betle.

Let's 'play' with molecular pharmacology.

BACKGROUND: Understanding concepts of molecular mechanisms of drug action involves sequential visualization of physiological processes and drug effects, a task that can be difficult at an undergraduate level. Role-play is a teaching-learning methodology whereby active participation of students as well as clear visualization of the phenomenon is used to convey complex physiological concepts. However, its use in teaching drug action, a process that demands understanding of a second level of complexity over the physiological process, has not been investigated. We hypothesized that role-play can be an effective and well accepted method for teaching molecular pharmacology. METHODS: In an observational study, students were guided to perform a role-play on a selected topic involving drug activity. Students' gain in knowledge was assessed comparing validated pre- and post-test questionnaires as well as class average normalized gain. The acceptance of role-play among undergraduate medical students was evaluated by Likert scale analysis and thematic analysis of their open-ended written responses. RESULTS: Significant improvement in knowledge (P < 0.001) was noted in the pre- to post-test knowledge scores, while a high gain in class average normalized score was evident. In Likert scale analysis, most students (93%) expressed that role-play was an acceptable way of teaching. In a thematic analysis, themes of both strengths and weaknesses of the session emerged. DISCUSSION: Role-play can be effectively utilized while teaching selected topics of molecular pharmacology in undergraduate medical curricula.

Acute and sub-chronic oral toxicity study of black tea in rodents.

OBJECTIVES: Systematic oral toxicity study for black tea (Camellia sinensis), the most commonly consumed variety of tea, is lacking. The present study was undertaken to assess the iron load on black tea (Camellia sinensis) and its safety aspects in animals. MATERIALS AND METHODS: The analysis of iron was done in six tea samples as per American Public Health Association method using flame atomic absorption spectrophotometer. Maximum physical iron-loaded tea sample was identified on black tea sample 2 (BTS-2), and this was further studied for acute and 90-day sub-chronic toxicity following Organisation for Economic Co-operation and Development guidelines. RESULTS: Black tea sample 2 did not show any signs of toxicity or mortality at up to 2 g/kg per oral dose in Swiss albino mice. 90-day toxicity studies in Wistar rats did not reveal any evidence of toxicity at up to 250 mg/kg/day (2.5% infusion of BTS-2) oral dose as exhibited by regular observations, body weight, food consumption, hematology, serum chemistry, organ weights, and histopathology. Further, serum iron, total iron binding capacity, unsaturated iron binding capacity, and ferritin were not altered after 90 days of treatment. Masson trichrome staining and Perls' staining did not reveal any abnormalities in hepatic tissue following 90-day treatment of high iron-loaded BTS-2. CONCLUSIONS: This safety study provides evidence that BTSs, in spite of relatively high iron content, show no significant iron-related toxicity on acute or sub-chronic oral administration in animals.

Antidiabetic effect of seeds of Strychnos potatorum Linn. in a streptozotocin-induced model of diabetes.

The antidiabetic effect of seeds of Strychnos potatorum Linn. was evaluated in a model of diabetes mellitus using streptozotocin (40 mg/kg b.w., i.p.). Changes in fasting blood sugar were estimated periodically for 12 weeks along with weekly measurement of body weight, food and water intake for 4 weeks. The antidiabetic effects were compared with glipizide as the reference hypoglycemic drug. Strychnos potatorum Linn. (100 mg/kg p.o.) significantly reduced fasting blood sugar, the effects being comparable with glipizide (40 mg/kg, p.o.), an established hypoglycemic drug. It also increased body weight along with decreased food and water intake in streptozotocin-induced diabetic rats. Taken together, Strychnos potatorum Linn. shows promise as an effective hypoglycemic compound worthy of future pharmacological investigations.

Stress modulating antioxidant effect of Nardostachys jatamansi.

The rhizomes of Nardostachysjatamansi, the plant commonly known as Jatamansi have been described in Ayurveda for their soothing and sedative action on the central nervous system. In the present study, the anti-stress effect of hydroethanolic extract (70%) of N. jatamansi (NJE) was evaluated in reference to its antioxidant property. Wistar rats were divided into four groups: naive, stressed, and T-200 and T-500 stressed with oral pre-treatment of NJE 200 and 500 mg/kg, respectively. Restraint of rats in metallic chambers for 4 h at 4 degreesC was followed by sacrifice and assessment of stress-induced alterations in biochemical parameters, incidence and severity of ulcers. Lipid peroxidation (LPO) and NO levels in stomach and LPO, NO levels and catalase activity in brain, plasma corticosterone level and adrenal ascorbic acid were measured. In vitro antioxidant activity of NJE was studied by measuring the free radical scavenging activity. NJE showed potent antioxidant activity and significantly reversed the stress-induced elevation of LPO and NO levels and decrease in catalase activity in the brain. It inhibited the incidence of gastric ulcerations and reversed the alterations in biochemical parameters/markers of stress-induced gastric ulceration. NJE also significantly altered stress-induced increase in adrenal and spleen weights and decrease in level of ascorbic acid in adrenal gland. Elevation of plasma corticosterone level was negated dose- dependently. The findings suggest that the NJE possesses significant anti-stress activity, which may be due to its antioxidant activity.

The role of antioxidant properties of Nardostachys jatamansi in alleviation of the symptoms of the chronic fatigue syndrome.

An experimental model of chronic fatigue syndrome (CFS) is utilized for evaluation of antidepressant, anti-stress effects, wherein the rat is forced to swim in water for 15 min/day on 21 consecutive days. Rats were divided into stressed control, stressed plus standard drug (Panax ginseng) and stressed plus 200 and 500 mg/kg of test drug, i.e., Nardostachys jatamansi extract (NJE) given orally. The immobility during each 5 min periods of 0-5, 5-10 and 10-15 min of stress were noted. Similarly the climbing (struggling) behaviour was noted in the above four groups of rats in intervals of 5 min. The locomotor activity and also the anxiety state in animals were evaluated in an elevated plus maze after CFS in all the four groups. There was a significant increase in despair behaviour and anxiety in stressed control animals on successive days of CFS. Locomotor activity gradually decreased in stressed control group. Treatment with NJE (200 and 500 mg/kg) significantly reversed both paradigms. Biochemical analysis showed that CFS significantly increased lipid peroxidation, nitrite and superoxide dismutase levels and decreased catalase level in rat brain. Administration of NJE (200 and 500 mg/kg) tended to normalize both augmented lipid peroxidation, nitrite, superoxide dismutase activities and catalase level significantly. NJE per se has an antioxidant effect. The results indicate that CFS may lead to oxidative stress, which is mitigated by NJE and so its antioxidant property may be responsible for anti-stress effect of NJE.

Drug utilization study in a neonatology unit of a tertiary care hospital in eastern India.

OBJECTIVES: To evaluate the drug prescribing trends in a neonatal intensive care unit (NICU) of a tertiary care hospital in eastern India. METHODS: The study was a prospective study that spanned for a period of 6 months from March 2005 to August 2005. Prescriptions and patient records were reviewed and analyzed using the World Health Organization (WHO) indicators for drug utilization studies. Rationality of drug usage was also evaluated by analyzing the drug prescriptions. RESULTS: A total of 176 neonates were admitted and 21 deaths were noted. The total number of drugs prescribed were 849. The average number of drugs per prescription was 4.8. The intravenous route (92.1%) was the commonest route of drug administration. 79.7% of the drugs were prescribed in generics. 30.2% of the total drugs prescribed were antimicrobials. It was noted that 88.6% of the drugs prescribed were in compliance with the National list of Essential Medicines 2003. CONCLUSION: The common diseases for which the neonates sought admission in the NICU were suspected septicaemia, birth asphyxia, neonatal jaundice and major congenital malformations. As antibiotics were the most frequently used drugs, their usage was analyzed in all cases. It was found to be rational in 84% of suspected septicaemia cases, as the provisional diagnosis on admission was confirmed with subsequent investigations thereby justifying appropriate antibiotic therapy. The diagnosis and treatment of other cases like neonatal jaundice, birth asphyxia, congenital malformations and electrolyte imbalance were rational and treatment was given as per treatment guidelines. Irrational usage of vitamins, nutritional supplements and parenteral fluids was not noted. The absence of the latest National essential list of medicines at the neonatology unit was noted. Secondly an antibiotic usage policy for the unit depending on the local microbial sensitivity pattern should have been in place.