Information adequacy of medicine package inserts in India: A critical evaluation.

OBJECTIVES: Package inserts (PIs) are used by physicians and other health-care providers as ready source of approved prescribing information. In India, they are subject to statutory regulations that specify the information to be provided under various headings. Uniformity of PIs with optimal level of information is desirable, the absence of which may lead to medication errors. This observational study aimed to evaluate the information adequacy and accuracy of PIs available in the Indian market. MATERIALS AND METHODS: PIs of drugs marketed in India, and approved by United States Food and Drug Administration, were collected from various retail pharmacies through purposive sampling. The adequacy and accuracy of the information in each PI were evaluated with the help of a 25-item checklist prepared as per stipulations mentioned in statutory guidelines. Each required item of information was scored 1 if present and appropriate or 0 if absent or deemed incomplete or inaccurate. A total information adequacy score (IAS), with maximum value 25, was thereby calculated. RESULTS: From the total 135 PIs analyzed, the median IAS was 17 (interquartile range 15-19). Deficiencies were observed under important headings. For example, "references" were mentioned in only 6.67% and "date of last updating" in only 19.26% of PIs. Other notable shortcomings were in "disposal" (not mentioned in 92.59%), "effects on ability to drive and use machines" (76.30%), "pharmaceutical incompatibilities" (66.67%), "shelf life" (62.96%), "excipients" (60.00%), and "overdose" (17.78%) information. Information on "generic name," "composition," and "indications" were however provided by all (100%) PIs. CONCLUSIONS: The information provided by PIs in India being inadequate, may not be able to serve as a reliable source of information.

Use of concept map as a reinforcement tool in undergraduate curriculum: An analytical study.

INTRODUCTION: Ever-expanding medical literature demands successful amalgamation of huge information and clinical practice for budding doctors. This study aimed to find the effectiveness of the concept map, a novel method of teaching to improve performance among undergraduate pharmacology students. METHODS: The undergraduate medical students pursuing pharmacology in 2017-18 in our institute was divided into two groups after stratified randomization based on the last semester grades. After a session of didactic lecture on 'Drugs affecting Calcium Metabolism' and a pre-test, one group was taught using traditional tutorial methods and another group using the concept map method. Finally, a post-test was taken and feedback received from the intervention group. RESULTS: A significant improvement of student performance was found in both groups using validated questionnaire from pre-test to post-test. There was no significant difference in the percentage of improvement between the groups. This finding was consistent in both Low scorers and High scorers of the previous semester examination. Students found the new method better in terms of understanding the concept and interactivity. CONCLUSIONS: Concept mapping encourages the students to actively participate and get a comprehensive and accurate overview of the topic, but the improvement in performance in the test was not evident.

Implementation of a confidential helpline for men having sex with men in India.

BACKGROUND: In India, men who have sex with men (MSM) often face physical violence and harassment from police and the general society. Many MSM may not openly disclose their sexual identity, especially if they are married to women and have families. Due to pervasive stigma and discrimination, human immunodeficiency virus (HIV) prevention programs are unable to reach many MSM effectively. OBJECTIVE: The objective of this paper was to describe the design, operations, and monitoring of the Sahaay helpline, a mHealth intervention for the MSM population of India. METHODS: We established the "Sahaay" mHealth intervention in 2013; a MSM-dedicated helpline whose main goal was to increase access to comprehensive, community-based HIV prevention services and improve knowledge, attitudes, and behaviors of MSM towards HIV and sexually transmitted infections (STI) in three states of India (Chhattisgarh, Delhi, and Maharashtra). The helpline provided a 24x7 confidential and easy to use interactive voice response system (IVRS) to callers. IVRS function was monitored through an online dashboard of indicators. The system also provided real-time reporting on callers and services provided. RESULTS: The helpline received more than 100,000 calls from 39,800 callers during the first nine months of operation. The helpline maintained an operational uptime of 99.81% (6450/6462 hours); and answered more than 81.33% (83,050/102,115) of all calls. More than three-fourths of the calls came between 9:00 am-12:00 pm. The most successful promotional activity was "interpersonal communication" (reported by 70.05%, 27,880/39,800, of the callers). Nearly three-fourths of the callers self-identified as MSM, including 17.05% (6786/39,800) as rural MSM and 5.03% (2001/39,800) as a married MSM. Most callers (93.10%, 37,055/39,800) requested information, while some (27.01%, 10,750/39,800) requested counseling on HIV/acquired immune deficiency syndrome (AIDS), STIs, and other health and nonhealth issues. There were 38.97% (15,509/39,800) of the callers that were provided contacts of different HIV/AIDS referral services. Many MSM clients reported increased self-esteem in dealing with their sexual identity and disclosing the same with their family and spouse; and an increase in HIV/AIDS risk-reduction behaviors like consistent condom use and HIV testing. CONCLUSIONS: National HIV/AIDS prevention interventions for MSM in India should consider scaling-up this helpline service across the country. The helpline may serve as an important mechanism for accessing hard-to-reach MSM, and thus improving HIV prevention programing.

Black tea (Camellia sinensis) decoction shows immunomodulatory properties on an experimental animal model and in human peripheral mononuclear cells.

BACKGROUND: Black tea (Camellia sinensis) has been used as a daily beverage for time immemorial. Immunomodulatory effects of tea are recognized as it stimulates the proliferation of cultured human peripheral blood mononuclear cells. Anti-inflammatory effects of tea have also been depicted in the available literature. Therefore, we designed this study to examine the potential immunemodulatory and anti-inflammatory activities of black tea in a rat model and in human peripheral mononuclear cells. AIMS: The purpose of the study was to determine (1) evaluation of anti-inflammatory effects of black tea on rats, (2) evaluation of immunemodulator effects of black tea on rats, and (3) evaluation of immunemodulator effects of black tea on human peripheral mononuclear cells. MATERIALS AND METHODS: Black tea decoction (10% and 20%) was prepared. Acute anti-inflammatory activity of tea decoction was evaluated using carrageenan and dextran whereas chronic anti-inflammatory (Immunomodulatory) effects were evaluated in a complete Freunds' adjuvant-induced arthritis model. Immunostimulatory role was evaluated in cultured human (in vitro) peripheral mononuclear cells (T-lymphocytes) by using methyl thioazolyl tetrazolium (MTT) and Trypan blue assay. STUDY DESIGN: An experimental study was designed. RESULTS: Black tea decoction (10% and 20%) strength has shown significant anti-inflammatory effects (64.8% and 77% reduction, respectively), on carrageenan-induced acute inflammatory models (rat paw edema) which can be comparable with the standard drug indomethacin (89.1%). In a chronic anti-inflammatory model, black tea decoction (10% and 20%) has shown significant suppressive effects on rat paw edema (38.56% and 69.53%) observed on 21(st) day. Lymphoproliferative action of tea was evaluated on human peripheral mononuclear cells using an MTT assay where the number of living cells were expressed in terms of optical density at 570 nm. An experiment has shown that black tea increases the maximum number of T-lymphocytes at 72 h with a maximum strength of 20%. Maximum number of viable cells (T-lymphocytes) was observed with black tea at 20% strength at 72 h. The results were expressed as mean ± SD, and the significance was evaluated by Student's t-test versus control, with P < 0.05 implying significance. CONCLUSIONS: Taken together, our data indicate that black tea has potential anti-inflammatory and immunomodulatory action and this corroborates with the current trend of tea being promoted as a 'health drink'.

Rapid analysis of the DNA-binding specificities of transcription factors with DNA microarrays.

We developed a new DNA microarray-based technology, called protein binding microarrays (PBMs), that allows rapid, high-throughput characterization of the in vitro DNA binding-site sequence specificities of transcription factors in a single day. Using PBMs, we identified the DNA binding-site sequence specificities of the yeast transcription factors Abf1, Rap1 and Mig1. Comparison of these proteins' in vitro binding sites with their in vivo binding sites indicates that PBM-derived sequence specificities can accurately reflect in vivo DNA sequence specificities. In addition to previously identified targets, Abf1, Rap1 and Mig1 bound to 107, 90 and 75 putative new target intergenic regions, respectively, many of which were upstream of previously uncharacterized open reading frames. Comparative sequence analysis indicated that many of these newly identified sites are highly conserved across five sequenced sensu stricto yeast species and, therefore, are probably functional in vivo binding sites that may be used in a condition-specific manner. Similar PBM experiments should be useful in identifying new cis regulatory elements and transcriptional regulatory networks in various genomes.