Assessment of prescribing pattern of drugs and completeness of prescriptions as per the World Health Organization prescribing indicators in various Indian tertiary care centers: A multicentric study by Rational Use of Medicines Centers-Indian Council of Medical Research network under National Virtual Centre Clinical Pharmacology activity.

OBJECTIVE: The rational use of medicines as per the World Health Organization (WHO) should be practiced globally. However, data regarding the completeness of the prescriptions and their rational use is lacking from developing countries like India. Thus, the aim of this study was to assess the prescribing patterns of drugs and completeness of prescriptions as per WHO core drug use and complementary indicators to provide real-life examples for the Indian Council of Medical Research (ICMR) online prescribing skill course for medical graduates. METHODS: Prescriptions of the patients, fulfilling inclusion criteria, attending Outpatient Departments of various specialties of tertiary care hospitals, were collected by thirteen ICMR Rational use of medicines centers located in tertiary care hospitals, throughout India. Prescriptions were evaluated for rational use of medicines according to the WHO guidelines and for appropriateness as per standard treatment guidelines using a common protocol approved by local Ethics committees. RESULTS: Among 4838 prescriptions, an average of about three drugs (3.34) was prescribed to the patients per prescription. Polypharmacy was noted in 83.05% of prescriptions. Generic drugs were prescribed in 47.58% of the prescriptions. Further, antimicrobials were prescribed in 17.63% of the prescriptions and only 4.98% of prescriptions were with injectables. During the prescription evaluation, 38.65% of the prescriptions were incomplete due to multiple omissions such as dose, duration, and formulation. CONCLUSION: Most of the parameters in the present study were out of the range of WHO-recommended prescribing indicators. Therefore, effective intervention program, like training, for the promotion of rational drug use practice was recommended to improve the prescribing pattern of drugs and the quality of prescriptions all over the country.

Acceptability and feasibility of mini-clinical evaluation exercise as a formative assessment tool for workplace-based assessment for surgical postgraduate students.

BACKGROUND: Despite an increasing emphasis on workplace-based assessment (WPBA) during medical training, the existing assessment system largely relies on summative assessment while formative assessment is less valued. Various tools have been described for WPBA, mini-clinical evaluation exercise (mini-CEX) being one of them. Mini-CEX is well accepted in Western countries, however, reports of its use in India are scarce. We conducted this study to assess acceptability and feasibility of mini-CEX as a formative assessment tool for WPBA of surgical postgraduate students in an Indian setting. METHODS: Faculty members and 2nd year surgical residents were sensitized toward mini-CEX and requisite numbers of exercises were conducted. The difficulties during conduction of these exercises were identified, recorded, and appropriate measures were taken to address them. At the conclusion, the opinion of residents and faculty members regarding their experience with mini-CEX was taken using a questionnaire. The results were analyzed using simple statistical tools. RESULTS: Nine faculty members out of 11 approached participated in the study (81.8%). All 16 2nd year postgraduate surgical residents participated (100%). Sixty mini-CEX were conducted over 7 months. Each resident underwent 3-5 encounters. The mean time taken by the assessor for observation was 12.3 min (8-30 min) while the mean feedback time was 4.2 min (3-10 min). The faculty reported good overall satisfaction with mini-CEX and found it acceptable as a formative assessment tool. Three faculty members (33.3%) reported mini-CEX as more time-consuming while 2 (22.2%) found it difficult to carry the exercises often. All residents accepted mini-CEX and most of them reported good to high satisfaction with the exercises conducted. CONCLUSIONS: Mini-CEX is well accepted by residents and faculty as a formative assessment tool. It is feasible to utilize mini-CEX for WPBA of postgraduate students of surgery.

Efficacy and safety of montelukast add-on therapy in allergic rhinitis.

Allergic rhinitis is a common airways hypersensitivity disease. Histamine and leukotrienes are involved in the pathogenesis of allergic rhinitis. Conventional treatments include topical steroids and antihistamines. Due to the adverse effects of these treatments, new drugs like leukotriene receptor antagonists are being investigated for the treatment of allergic rhinitis. A total of 90 patients suffering from allergic rhinitis were enrolled in this prospective, randomized, controlled study. Patients were divided randomly into three groups of 30 patients each. Group I was administered fluticasone nasal spray (200 µg in each nostril) once a day, Group II was administered fluticasone nasal spray (200 µg in each nostril) plus cetrizine (10 mg) orally once a day and Group III was administered fluticasone nasal spray (200 µg in each nostril) plus montelukast (10 mg) orally once a day. Efficacy was measured based on daytime and nighttime symptom scores. Safety was evaluated on the basis of psychomotor tests, laboratory investigations and subjective assessment. The present study showed that montelukast add-on therapy is as efficacious as conventional therapies in controlling total symptom score, but it is more efficacious in controlling nighttime symptoms. Furthermore, montelukast add-on therapy does not cause psychomotor impairment as observed with cetrizine.

Combination therapy of low-dose atorvastatin and fenofibrate in mixed hyperlipidemia.

Mixed hyperlipidemia is a major cause of coronary artery disease. Monotherapy with statins is considered the gold standard for treatment of mixed hyperlipidemia. But greater benefit may be expected by combination therapy. Combination may allow lower doses of statins and less adverse effects. Hence, this preliminary study was designed to evaluate the efficacy and safety of low-dose atorvastatin in combination with fenofibrate in patients with mixed hyperlipidemia. Ninety patients were assigned into three groups and received atorvastatin (10-40 mg/day) or fenofibrate (160-200 mg/day) or combination of low-dose atorvastatin (5 mg/day) and fenofibrate (160 mg/day). There was a significant decrease in low-density lipoprotein (LDL), triglycerides (TG) and total cholesterol (TC), and a significant increase in high-density lipoprotein (HDL) in all the groups at the end of therapy. Combination therapy produced maximum decrease in LDL, TG and TC, and maximum increase in HDL when compared with monotherapies. No significant difference was reported in safety profile between the two groups. To conclude, the results suggest that combination therapy with low-dose atorvastatin and fenofibrate is more efficacious, with no increase in adverse effects when compared with monotherapies with individual drugs for mixed hyperlipidemia. The results are preliminary and suggestive only, as the study was open and nonrandomized.

A multicentric study to evaluate efficacy and safety of cefetamet pivoxyl in lower respiratory tract infections in Indian patients.

This multicentric, open label, non-comparative study was designed to evaluate the extended spectrum of third generation oral cephalosporin, cefetamet pivoxyl in the treatment of patients with lower respiratory tract infections. This study was conducted among 111 patients with clinical, radiological and bacteriological findings consistent with the diagnosis. After obtaining written informed consent, patients were given cefetamet 500 mg tablet twice a day for 7 days. Cefetamet consistently decreased all clinical signs and symptoms at post-therapy visit. All the treated patients were either cured or improved. Cefetamet was well tolerated with a low incidence of drug related adverse events. The findings of this study indicate that cefetamet pivoxyl was well tolerated and is suitable option for the treatment of patients with lower respiratory tract infection.

Effect of clarithromycin on the pharmacokinetics of carbamazepine in rhesus monkeys.

Clarithromycin, an advanced-generation macrolide antimicrobial, is less prone to drug interactions as compared to erythromycin. Based on two case reports in which increased carbamazepine (CBZ) plasma concentrations were observed in patients receiving clarithromycin, a crossover multiple dose study was designed to find out the pharmacokinetic interaction between CBZ and clarithromycin in rhesus monkeys. CBZ (46 mg/kg/d) was administered to the monkeys alone and along with clarithromycin (20 mg/kg/d). Blood samples were collected from 0-24 h. Plasma concentrations of CBZ were measured by HPLC technique. Pharmacokinetic data revealed an increase in plasma concentrations, AUC(0-24) and t1/2e of CBZ when coadministered with clarithromycin, but the increase was not statistically significant. These findings suggest careful administration and plasma monitoring of CBZ concentrations when coadministered with clarithromycin.

Pharmacokinetics of phenytoin: unaltered by enalapril and amlodipine in rhesus monkeys.

A cross over single and multiple dose study was carried out to find out pharmacokinetic interactions between diphynylhydantoin (DPH) (35 mg/kg, p.o.) and antihypertensives enalapril (1.6 mg/kg; p.o.) and amlodipine (0.4 mg/kg, p.o.) in rhesus monkeys. Neither the plasma concentrations nor the pharmacokinetic parameters of DPH were altered by coadministration of enalapril or amlodipine, suggesting that enalapril and amlodipine can be safely administered to epileptic patients receiving phenytoin.

Antimicrobial prescribing pattern in an Indian tertiary hospital.

550 prescriptions of the indoor patients receiving antimicrobial drugs in the Departments of Internal Medicine, Surgery, Urology and Paediatrics were analysed for drug utilization studies. The prescribing frequency of one antimicrobial per prescription was maximum in Surgery and Urology (52.52%) and Internal Medicine (50.51%) whereas prescribing frequency of two antimicrobials was maximum in Paediatrics (59.9%). In all the departments, quinolones, aminoglycosides, cephalosporins and penicillins were frequently prescribed among which amikacin, ciprofloxacin, cefotaxime and cloxacillin were most preferred drugs, with a general tendency of prescribing newer antimicrobials. In majority of cases selection of antimicrobials was not based on microbiological confirmation. It is suggested that the use of newer and expensive antimicrobials should be kept reserved only for serious and life threatening situations.