RESUMO
Introduction: Package inserts are officially approved documents accompanying the drug which intends to provide information on safety and effectiveness of the product. This information is in accordance to country specific regulatory guidelines. It serves as a source of information to both users and prescribers. Hence the information incorporated has to be optimal to avoid medication errors.Objectives: Evaluate the package inserts for completeness of information according to heading mentioned in Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945.Methods: Package inserts were collected from five pharmacies on request over a duration of 1 month and were analysed for the completeness of information according to Section 6.2 and 6.3 of schedule D of Drug and Cosmetic Rule, 1945. Information if present under the defined header, was scored one and zero if not. Total score ofeach header was calculated by adding the score from the individual package insert.Results: 80 package inserts were included in the study. None of the reviewed package inserts contained all the headers as required by the Drugs and Cosmetics Act. Total 16 headings were evaluated under both Section 6.2 and 6.3, highest value for the presence of heading were 15 out of 16 headers. That shows the best value of compliance was 93.75%.Conclusion: Present study encountered incompleteness of information in the package inserts. It is, therefore recommended that regulatory body should strengthen rules and regulations for the pharmaceutical companies to increase the compliance of adequacy of information in their package inserts to ensure rationale, effective and safe use of medicines
RESUMO
Background: Osteoporosis is a rising health difficulty, which is renowned in both developed and developing countries. It is linked with considerable morbidity and socio-economic burden worldwide. Various factors are responsible for osteoporosis such as race, family history, body weight, estrogen deficiency (menopause), low calcium intake, and many others. The present study was aimed to early prediction and evaluates the prevalence of osteoporosis in postmenopausal women of slum area of Ahmedabad (Raipur and Kalupur). Methods: The prospective, single-center study included 230 postmenopausal women. Baseline demographic characteristics were recorded using standard pre-designed case record form. Eligible patients according to inclusion and exclusion criteria were underwent for dual-energy X-ray absorptiometry (DEXA) scan to measure bone mass density at the lumbar spine, femoral neck, and hip bone. Laboratory investigations such as serum calcium and serum vitamin D were performed according to standard procedure. Prediction for early detection of osteopenia and osteoporosis was evaluated based on T-score (DEXA scan). Results: The overall prevalence of osteopenia and osteoporosis were found 28.69% and 44.34%, respectively. Prevalence of osteoporosis was found higher (50.72%) in study population belongs to age between 51 and 60 years, whereas the prevalence of osteopenia was higher (38.53%) in age group (41-50). In further, normal body mass index was associated with the higher prevalence of osteopenia and osteoporosis. The calcium deficiency, vitamin D deficiency, family history of osteoporosis were found major risk factor associated with osteopenia and osteoporosis (p<0.05). T-score was much lower at femoral neck site (−3.29±0.47) and lumbar spine site (−3.15±0.50) when compared with hip bone (−2.40±0.68). Conclusions: The present study found moderately higher prevalence of osteopenia and osteoporosis among the postmenopausal women from slum area of Ahmedabad. Results revealed that the early measurement of bone mineral density will not only help for early detection, but it will also help for the prevention of osteoporosis.