ABSTRACT
Background: Empirically chosen antibiotics based on the local resistance pattern of uropathogens remain the principle treatment of urinary tract infections (UTI).Methods: Antibiogram of most frequent uropathogen was determined. Based on the antibiogram result, authors compared effectiveness of drugs recommended for UTI by National centre for disease control (NCDC), India, and assessed age and gender based variability in the effectiveness of these drugs.Results: 1278 urine samples were accounted, of which 405 samples showed significant growth. E. coli was the most common uropathogen (n=146, 36%) followed by enterococcus species (31%) and Klebsiella pneumoniae (10%). Using McNemar’s test authors found that nitrofurantoin (90% sensitivity) was statistically the most effective drug among drugs recommended by NCDC for uncomplicated cystitis. Furthermore, authors used Fisher’s exact test on adults and paediatrics and found that significant difference in effectiveness was observed for nitrofurantoin (p-value <0.001) and cotrimoxazole (p-value 0.034). Using logistic regression, authors found that with age, effectiveness of ciprofloxacin and cotrimoxazole deteriorate significantly (p-value 0.021 and 0.002 respectively). Additionally, authors observed that cotrimoxazole has significantly better efficacy in males compared to females (p-value 0.022).Conclusions: In accordance with present study, nitrofurantoin can be used as first line treatment for uncomplicated cystitis. Age and gender should be considered while prescribing empirical treatment for UTI. Periodic surveillance should be carried out to identify the on-going pattern of antibiogram to update the guideline for empirical therapy.
ABSTRACT
Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs. Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.