A critical appraisal of medication package inserts
Journal Title: International Journal of Pharmacological Research - Year 2015, Vol 5, Issue 10
Abstract
Introduction: Package Inserts (PIs) refers to officially specified document that accompanies a drug for relevant, updated and unbiased information for rational drug use based on regulatory guidelines as per section 6.2 and 6.3 of schedule D of Indian Drug and cosmetic Act 1945. But some studies had shown non-uniformity with suboptimal level of informations which frequently can lead to medication errors. Hence this study was conducted to evaluate the completeness of PIs. Aim: To critically evaluate package inserts of allopathic medicines. Material and Methods: 100 allopathic drug PIs were collected from pharmacies in Rohtak and were checked for the presence of each heading as per schedule D criteria, followed by scrutiny of the information included under the heading. Indian guidelines were also compared with US FDA guidelines for PIs. Scoring of package inserts: The informations were evaluated for completeness and scored as 1 if present otherwise scored as zero for no information or partial information. Scores for each heading were calculated by totaling the scores of all the package inserts. The total scores were expressed as absolute numbers and percentages. Results: On an average PIs analyzed for the completeness of the criteria scored 10 (Mean SD = 9.732.48) out of 16. Absence of common layout and headings caused inconvenience. In comparison to US FDA guidelines it lacked, disclaimer statement, boxed warning, revision date, approval date, toll-free number etc. Conclusion: PIs dont seem to be serving effectively because of multiple deficiencies like completeness, uniformity, absence of headings.
Authors and Affiliations
Pranjit Narzaree, M. C. Gupta
Keywords
Related Articles
- EP ID EP434577
- DOI 10.7439/ijpr.v5i10.2473
- Views 74
- Downloads 0
Effect of menstrual cycle phase on glucose kinetics in healthy women & women with premenstrual symptoms
Objective: To compare the blood glucose levels during the two phases of the menstrual cycle between healthy women and patients with premenstrual syndrome (PMS). Methods: From January of 2012 to the August of 2013, a des...
Antimicrobial drugs usage in a tertiary care hospital A descriptive study
Background: Emergence of resistant organisms is alarmingly high all over the world. Irrational and inappropriate prescription of antimicrobials is the major contributing factor for developing drug resistance in addition...
An in-vitro studies on green synthesis of gold nanoparticles against pathogens and cancer cells
Nanotechnology is a most promising field for generating new applications in medicine. It is imperative to integrate nanoscience and medicine. The present investigation is highly warranted to through more light upon the g...
Efficacy and safety of oral vitamin D (cholecalciferol) supplement therapy in Stage I primary hypertension; a prospective, randomized, double-blind, placebo controlled, clinical trial in a tertiary care hospital in central India
Introduction: Hypertension is one of the most common cardiovascular disorders. Almost all targets in its therapy are exploited and there is a growing need to search for newer targets. Vitamin D is gaining increasing atte...
Water extract of Osmanthus Fragrans attenuates TGF-?1-induced lung cellular fibrosis in human lung fibroblasts cells
Introduction: Idiopathic interstitial pneumonia, also known as idiopathic pulmonary fibrosis, is a type of diffuse parenchymal lung disease of unknown etiology. Osmanthus Fragrans, referred to as sweet olives, possesses...