Aim:The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.Materials and Methods:A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.Results:At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students.Conclusion:UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.

P-glycoprotein (P-gp) is a 170 kDa membrane-bound protein, an energy-dependent efflux trans porter driven by ATP hydrolysis. It is responsible for multidrug resistance of many drugs. Physi ologically, it is involved in limiting the harmful exposure of toxins, drugs, and xenobiotics to the body by extruding them out of cells. It is increasingly recognized to play an important modulat ing role in the pharmacokinetic properties of many clinically important therapeutic agents and because of its importance in pharmacokinetics, its screening has to be incorporated into the drug discovery process. The modulation of drug transporters through inhibition or induction by various drugs or herbs can lead to significant drug-drug or drug-herb interactions by affecting various pharmacokinetic parameters of the drug. In addition, genetic polymorphism of P-gp has also been reported, which may affect drug disposition, produce variable drug effects, and may change disease risk susceptibility. As drug interactions and genetic polymorphism are important factors to be considered during drug development, P-gp may have an impact on drug develop ment in future.

Background & objectives:Drug-induced diseases (DIDs) are well known but least studied. Data on DIDs from India are not available. Hence, this retrospective cross-sectional study was undertaken using suspected adverse drug reaction (ADR) data collected form Pharmacovigilance Programme of India (PvPI) to evaluate profile of DIDs over two years, in a tertiary care teaching hospital from north India.Methods:The suspected ADRs in the form of DID were evaluated for drug and disease related variables and were classified in terms of causality.Results:DID rate was 38.80 per cent. Mean duration of developing DIDs was 26.05 ± 9.6 days; 25.16 per cent had more than one co-morbid condition. Geriatric population (53.99%) accounted for maximum DIDs followed by adult (37.79%) and paediatric (8.21%). Maximum events were probable (93.98%) followed by possible (6.04%). All DIDs required intervention. Gastritis (7.43%), diarrhoea (5.92%), anaemia (4.79%), hypotension (2.77%), hepatic dysfunction (2.69%), hypertension (1.51%), myalgia (1.05%), and renal dysfunction (1.01%) were some of the DIDs. Anti tubercular treatment (ATT), anti retroviral treatment (ART), ceftriaxone injection, steroids, non-steroidal anti-inflammatory drugs, antimicrobials and anticancer drugs were found as commonly offending drugs.Interpretation & conclusions:Our findings show that DIDs are a significant health problem in our country, which need more attention.

Aim and Objective:To evaluate prevalence of Vitamin D deficiency and establish any correlation between diabetes and vitamin D deficiency among postmenopausal women.Materials and Methods:The 25-hydroxy vitamin D [25 (OH) D] concentrations were measured by competitive in-vitro quantitative immunoassay. The subjects were classified as vitamin D-deficient, insufficient or sufficient on the basis of 25 (OH) D concentrations of < 20 ng/mL, 20–30 ng/mL or > 30 ng/mL respectively. The apparently normal postmenopausal women (PMW) were subjected to fasting blood sugar levels to analyse any correlation between vitamin D deficiency and diabetes.Results:Vitamin D deficiency was observed in 53.35% of the population, 19.48% had insufficiency and 26.83% had adequate Vitamin D levels. In 12.14% of the study population fasting blood glucose was > 110 mg/dl and rest of the subjects were between the normal range which is 70–110mg/dl. Correlation between raised blood sugar levels and Vitamin D deficiency among PMW was non-significant (P = 0.324).Conclusion:High prevalence of vitamin D deficiency exists among apparently healthy Indian PMW. However, the current study failed to show any statistical correlation between vitamin D deficiency and existence of diabetes, which may be due to small sample size.

Aim:The aim of the following study is to evaluate adherence and compliance of postmenopausal osteoporotic patients for different regimens of bisphosphonates (BP).Materials and Methods:A prospective observational randomized comparative 1 year study was undertaken to evaluate the adherence/compliance rates of most commonly prescribed daily alendronate (ALN), weekly risedronate (RIS) and monthly ibandronate (IBN) BP regimens.Results:Nearly 40% was the 1 year adherence rate with BP and 41.33% of non-compliance. Whereas, 8.66% was interrupted compliance rate and 6% switched over to other anti-osteoporotic treatment. The three treatment arm did not vary significantly. However, numerically maximum adherence rate of 56% was recorded in monthly BP regimen followed by weekly (36%) and daily regimen (32%). Medication possession rate confirmed on a follow-up visit was maximum with monthly regimen as 84.61% followed by daily (62.5%) and weekly (61.11%) respectively. Average time in days for non-adherence was 48, 56 and 92 day with daily ALN, weekly RIS and monthly IBN regimen respectively. Age, mean age at menopause, demographical profile failed to influence the adherence. Concomitant treatment for co-morbid condition (57.14%), unawareness about osteoporosis (OP) (50%), cost of treatment (45.33%), belief that drugs is for their general disability (39.28%), physician's failure to stress the need and necessary calcium + vitamin D daily requirement (23.80%) each were the most prevalent factors responsible for non-adherence. Intolerance and adverse drug reactions were responsible for only 13.09% and 11.90% of non-adherence.Conclusion:Treatment compliance is poor with daily ALN, weekly RIS and monthly IBN regimen along with calcium and vitamin D3 in Indian paramedical workers suffering OP.