An audit of drug package insert: a survey based study in India

Background: The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. Regulatory requirements for drug package inserts or leaflets vary across nations. United States-Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) amend their regulations governing the content and format of labelling for drug products from time to time. US-FDA has published a revised guideline in the Federal Register of January 2006, which is being followed by pharmaceutical industry of the country.Methods: Around 192 package inserts were collected from pharmacies located at different areas. They were analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.Results: Out of 192 package inserts, most available information in therapeutic indications is Posology and method of administration (97.3%) followed by Contra-indications(93.2%) in pharmaceutical information, it is Special precautions for storage (77%) followed by Shelf life in the medical product as packaged for sale (33.8%).Conclusions: Contents of the package inserts should be complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. Therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945

A 5 year retrospective analysis of adverse drug reactions associated with antimicrobials in a teaching hospital of Andaman and Nicobar islands

Antimicrobials are used widely especially in developing countries, due to the high prevalence of various infectious diseases. Inappropriate use of antimicrobials are associated with adverse drug reactions. The present study was done to analyze the patterns of Adverse Drug Reactions (ADR) due to antimicrobials reported to Adverse Drug Reaction Monitoring Centre (AMC) during the last five years.  This was a 5 year retrospective and cross-sectional study. After collecting demographic details of patients, ADR forms, and ADR associated with the antimicrobial class of drugs, data were analyzed for further details. A total of 877 ADRs, 360 ADRs belonged to the antimicrobial group. When data was analyzed data, it revealed that the majority of ADRs (73.05%) were reported in the adult group, 75.27% of reactions belonged to A category, Ceftriaxone (17.2%) was the most common drug-associated with ADRs, majority of ADRs were related to skin (56.66%), rash (27.5%) was the most common ADR encountered with antimicrobial use, 73.61% reactions were non-serious, 69.44% of ADRs recovered, and 77.77% of ADRs were probable category. Ceftriaxone was responsible for the maximum number of ADRs. The study results provide information regarding the pattern of ADRs associated with antimicrobials, and this might be helpful for improving the awareness of healthcare providers about PvPI and subsequently increase the spontaneous reporting of ADRs

Adverse drug reactions: a retrospective review of hospitalized psychiatric patients at tertiary care hospital

Background: Hospital data based monitoring of ADRs can shed light on their extensiveness and pattern of occurrence. Study is expected to enable us in obtaining information on the incidence and pattern of ADRs in the local population. The objective of this study was to do surveillance, detect incidence of ADR and to analyse the ADRs according to their demographic distribution, reporting, presentations and causality assessment scale.Methods: A retrospective study conducted from January 2011 to December 2014 and psychiatric hospitalized patients were analysed and ADR reports were assessed for probability, severity, psychotropic drugs involved, and preventability.Results: A total number of 101 ADRs were reported in 72 patients. Most common ADR were mainly tremor 14 (13.86%), salivation 11 (10.89%) followed by muscle rigidity 6 (5.94%) and slurring of speech 6 (5.94%). In majority of the instances, it was antipsychotic agents 41 (56.94%) followed by antidepressants 11(15.27%) and mood stabilizers 11 (15.27%). As per causality assessment, 95 (94.05%) cases were ‘possible’ in WHO-UMC criteria and 72 71.28%) cases were ‘possible’ in Naranjo scale respectively. As per Schumock and Thornton preventability assessment, 91(90.09%) of total ADRs were in the not-preventable category. As per Hartwig and seigle’s severity assessment, majority of ADRs 74 (73.26%) were mild in severity.Conclusions: ADRs were most commonly associated with antipsychotic drugs. Developing an on-going ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspecting ADR will help to continue reporting and improving the patient’s safety

Transition metals for the synthesis of glycopolymers and glycopolypeptides

Glycopolymers and glycopolypeptides are an important class of molecules, which can self-assemble to various interesting biohybrid materials. It is envisaged that the glycans impart good immunological response, and the aliphatic or polypeptide backbone can give tertiary structure for the resulting glycopolymers. The major bottleneck in the synthesis of glycopolymers or glycopolypeptides is the access to suitable building blocks and polymerization methods. This review describes methods that have recently been explored for the successful synthesis of many useful glycomonomers that could be polymerized to afford glycopolymers and/or glycopolypeptides. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim

Electronic structure study of the reactivity centres in Ti<SUB>8</SUB>C<SUB>12</SUB> clusters

The reactivity centres of Ti8C12, for the three structures suggested in conformity with experimental observations, are studied by extended Huckel theory, The C2 unit can complex with transition metal fragments such as Pt(PH3)2 with the unusual net result of transferring two electrons to Ti8C12. The metal centre, Ti can accommodate extra two-electron donors like CO. Model systems are used to explain the carbon and metal environment in Ti8C12

Gold-catalyzed glycosidation for the synthesis of trisaccharides by applying the armed–disarmed strategy

The synthesis of oligosaccharides is still a challenging task as there is no universal glycosyl donor for the synthesis of all oligosaccharides. The gold catalysis for glycosidation reactions, in which alkynylated glycosides are used, has emerged as one of the versatile options in this regard. A cleavage of the interglycosidic bond that was thought to be due to the higher reaction temperature and the acidic medium was observed during the synthesis of trisaccharides. In addition, a very little percentage of deprotection of benzyl protecting groups at the C-6 position was observed and no deprotection of benzyl ethers in aliphatic molecules was noticed. In order to overcome this fact, a collection of leaving groups that contain an alkynyl moiety were screened. It was found that 1-ethynylcyclohexanyl (Ech) glycosides are suitable for carrying out the glycosidation at 25 °C in the presence of 5 mol % each of AuCl3 and AgSbF6. Subsequently, Ech-glycosides were observed to be suitable for the synthesis of trisaccharides under gold catalysis conditions