ABSTRACT
Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector. Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3. Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively. Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society.
ABSTRACT
Dengue fever, a mosquito-borne viral infection, causes significant morbidity and has become endemic in the Indian subcontinent. Virus strains currently circulating in many parts of the country are not well studied at the molecular level. In the present study, genetic characterization of virus strains from a dengue outbreak that occurred in and around a tertiary care hospital in Ernakulam, Kerala in the year 2008 has been reported. By reverse transcription polymerase chain reaction (RT-PCR), 37 out of 75 (49.3%) clinically suspected cases were positive for dengue viral RNA. Among these, 21 (56.8%) samples showed concurrent infection with multiple serotypes of the virus. Majority of the combined infections were caused by dengue serotype 2 and 3. Co-infections with type 1 and 2 in two patients, and type 1, 2 and 3 in one patient were also observed. The core-pre-Membrane (CprM) junction nucleotide sequencing and phylogenetic analysis revealed that the type 1 strains were related to the viral strains reported from Delhi-2001 and Gwalior-2002 dengue outbreaks, while the type 2 strains were related to the strains from Gwalior-2001 epidemic. Sequences of type 3 strains did not show clear relation to any of the previous Indian isolates, and in the phylogenetic analysis, they formed a distinct lineage within the Indian type 3 strains. This study indicates hyperendemicity of dengue in the region with the presence of multiple serotypes and high rates of co-infection, and local genomic evolution of the viral strains involved in this outbreak.
ABSTRACT
Introduction and Objectives: ileal conduit urinary diversion following cystoprostatectomy has not been reported by the laparoscopic intrracorporeal technique to date. Herein, we present our technique of laparoscopic ileal conduit following cystoprostatectomy in the porcine model performed in a completely intracorporeal manner. After developing the technique in 5 acute animals, laparoscopic cystoprostatectomy with intracoporeally performed ileal conduit urinary diversion was performed in 10 male survival pigs. A 5-port transperiloneal technique was used. All steps of the technique as applied during open surgery were duplicated intracorporeally, Specifically, cystectomy, isolation of an ileal conduit, restoration of bowel continuity, and mucosa to mucosa, stented bilateral ileoureteral anastomosis were performed with exclusively intracorporeal laparoscopic techniques. Surgery was successful in all 10 study animals without intraoperative or immediate postoperative complications. Blood loss was minimal and operating time 'averaged 290 minutes. An end ileal stoma was formed at the right lower quadrant port site. At euthanasia, renal function was normal in all surviving animals. No ileoureteral anastomotic strictures were noted on pre-euthanasia loopgrams or on post-mortem examination of the anastomotic sites. Laparoscopic ileal conduit urinary diversion .following cystoprostatectomy can be performed completely intracorporeally in the porcine model. Clinical application of this technique is imminent