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Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Background: India has the third largest HIV epidemic in the world. The Indian epidemic is characterized by low levels in the general population and elevated concentrations among high-risk groups. The present study was planned to determine the awareness of HIV among students from Mumbai University.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 199 agreed to participate (males: 132; females: 67). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Study participants had high knowledge (86%) and attitude score (87%). There was no significant difference between males and female participants for attitude and knowledge, except for one question regarding knowledge about HIV transmission via breastfeeding to child.
Conclusions: Present study showed that there are no misconceptions or negative attitudes regarding HIV among students. A longitudinal study with a larger sample size across India is recommended for further investigation.
A study to assess the knowledge and attitude towards HIV of pharmacy students from Mumbai university
(2020)
Background: India is the biggest HIV epidemic in the world. The role of a pharmacist is pivotal in educating the general masses. The aim of the study was to determine the knowledge and attitude of pharmacy students from University of Mumbai.
Methods: A cross-sectional study was conducted in University of Mumbai during February-March 2020. Therein, 307 students (214: females and 94: males) participated in the study. The questionnaire was distributed in the classroom and data was collected by means of Google-forms. Furthermore, the data was analysed using IBM SPSS version 23.
Results: The participants demonstrated good knowledge (84%) and attitude (76%) score. With respect to knowledge score, no significant difference was observed except for responses of two questions, aim of the antiretroviral therapy (ART) and Avoidance of sexual intercourse can decrease the risk of HIV. With respect to attitude score, Volunteering to work at an institute for the welfare of HIV patients showed a significant difference.
Conclusion: The current study showed that there were no misconceptions or negative attitude regarding HIV among the students. However, a study with greater sample size must be conducted across India for further investigation.
Background: Immunization is the most cost-effective intervention for infectious diseases which are the major cause of morbidity and mortality worldwide. There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India. Objectives: Present study explored the adult vaccination status and influence of income and education of parents on adult vaccination status in university students from Mumbai, India.
Methods: On the basis of the eligibility criterion 149 students were selected for the present study. A total of 8 vaccines namely Tdap/DTP, Varicella, MMR, Influenza, Pneumococcal, Hepatitis A, Hepatitis B and Meningococcal were included in this study for all the respondents. In addition to these vaccines, Human Papilloma Virus vaccine was also included for female respondents.
Results: There were total of 149 (75 male and 74 females) respondents with the mean age of 21.5 years. The top 3 immunizations were Td/Tdap (97.3%), MMR (66.4%) and Hepatitis B (55%) among the respondents. Only 4 (5.5%) female respondents have been immunized against the HPV. Conclusions: Td/Tdap (97.3%) and MMR (66.4%) coverage was in line with the recommendations. For all the other vaccines the coverage was low varying from 5.5% to 35.4%. The vaccination coverage was better in respondents with higher educated and higher income parents. We suggest that patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.
Immunization is the most cost-effective intervention for infectious diseases, which are the major cause of morbidity and mortality worldwide. Vaccines not only protect the individual who is vaccinated but also reduce the burden of infectious vaccine-preventable diseases for the entire community.
1 Adult vaccination is very important given that >25% of mortality is due to infectious diseases.
2 There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India.
The drugs we use to treat any condition – from an innocuous cough to a life-threatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. In recent years there has been a clear shift in clinical trial sites from core developed countries like USA, European countries to developing countries like India, China, South American countries. This shift is related to challenges and opportunities like costs of trials, recruitment issues, and regulatory challenges in developed vs. developing countries. Developing countries and developed countries have their unique disease burden patterns based on various parameters like but not limited to age, health care facilities, health insurance, sanitary conditions, environmental issues, education, nutrition
and GDP. Previous studies have reported that many of the important global diseases are not much explored in clinical trials and many published clinical trials have very less international health relevance. This study was aimed at finding the correlation between disease burdens, number of clinical trials done and trial success rates. We compared 2005 - 2010 Global Burden of Disease data for Germany, India and number of clinical trials from clinicaltrials.gov database done in the same period. Our findings indicated that there was a good correlation between the disease burden and clinical trials for Germany in 2005 and 2010. For India in 2005 there was a moderate positive correlation, 2010 data showed the improvement in India in terms of match between disease burden and clinical trials. But careful observation of the data shows still a need for more trials on Communicable, maternal, neonatal and nutritional disorders.
Background: Pharmacovigilance (PV); also known as drug safety surveillance, is the science of enhancing patient care and patient safety regarding the use of medicines by collecting, monitoring, assessing, and evaluating information from healthcare providers and patients. Pharmacists are pivotal players in adverse drug event (ADE) monitoring and reporting. However, most pharmacists are unaware or not knowledgeable about the guidelines used by their respective countries’ drug regulatory bodies. It is the need of the hour to train pharmacy students on the concept of pharmacovigilance.
Methods: A cross-sectional study was carried out among pharmacy students from Mumbai University, India during May-June 2017. On the basis of the eligibility criterion 352 students were selected for the present study. Four hundred students were approached to participate in the study of which 201 agreed to participate (males: 179; females: 173). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Overall pharmacovigilance knowledge (44%) and perception (58%) was low among the participants of the present study. Seventy four percent of the participants felt that adverse drug reaction (ADR) reporting should be made compulsory for healthcare professionals. And only 21% agreed that the topic of Pharmacovigilance is well covered in pharmacy curriculum.
Conclusions: Pharmacy council of India, pharmacy teacher’s association and respective pharmacy college should take necessary steps to increase the knowledge and create awareness regarding pharmacovigilance and adverse drug reaction reporting among pharmacy students.
A systematic review of the literature on survey questionnaires to assess self-medication practices
(2017)
Self-medication is of great public health importance as it often bypasses regulatory mechanisms to assure quality of health care. Nevertheless there are no established standards on how to assess self-medication. We therefore intended to systematically retrieve questionnaires and survey tools used to capture self-medication, with the aim to identify the scope of information investigated in this context and commonalities between the tools. We conducted a systematic review of the literature on questionnaires used for self-medication assessment by searching PubMed and Web of Science databases using the combinations of following keywords; self-medication, self-prescription, non-prescription, questionnaire. Truncation was used to ensure retrieval of all possible variations of search terms. The search was limited to articles published between 1st January 2000 and 31st December 2015, human studies and English language. Duplicate and irrelevant studies were excluded from the final review. A total of 158 studies were included in the review. Studies were from diverse geographical locations, most of the studies were from Nigeria 16 (10.1%) followed by India 10 (6.3%) and Iran 8 (5%). Forty-three studies (27.2%) focused on antibiotic self-medication. Majority of the studies (106; 67%) were done with adult populations. The components addressed by the questionnaires covered: reasons for self-medications in 147 (93%) studies, purchasing source in 136 (86%) studies, medical conditions to be treated in 153 (96.8%) studies, adverse events in 67 (42.4%) studies, use of prescribing information in 24 (15.1%) studies and antibiotic resistance awareness in 20 (46.5%) antibiotic studies. For 74 (46.8%) studies, survey questionnaires were self-administered and most studies (57; 36%) were done at homes of respondents. Thirty-seven (23.4%) studies did not report any recall period for self-medication practices. Study response rates varied from 17.9% to 100%, and while validity of the study questionnaire was reported for 100 (63.3%) studies, 15 (9.5%) studies reported reliability test of the study questionnaire. There is a large variety of questionnaires being used for investigating self-medication practices making comparability and meta-analyses very difficult. It is desirable to have a basic set of standardized survey questions on this topic to make available for future research groups in this field.
Objective: To determine the burden and factors associated with post-stroke depression in East central Nigeria.
Method: We carried out this cross-sectional study of 50 stroke survivors (mean age=54.8 ± 8.8 years), at the physiotherapy Department of the University of Nigeria Teaching Hospital, Enugu. Data were collected using Becks Depression Inventory , it was analyzed using Z-scores, Chi-square test and univariate logistic regression.
Results: PSD was more common in females (45.45%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%). Self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (p=0.03), and was related to the risk ofOR3.7 (95% CI 1.1-12.0 )
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease.1 India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India.2 Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized.
Background: Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease. India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India. Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized. The present study assesses the cost-effectiveness of antidiabetic drugs in patients with T2DM from Mumbai, India.
Methods: A prospective cross-sectional study was performed to assess the cost-effectiveness of antidiabetic drugs in patients with T2DM. Face-to-face interviews were conducted by using a validated questionnaire in a total of 152 (76 males, 76 females) patients with T2DM from F-North Ward, Mumbai, India. Cost-effectiveness was determined on the basis of cost of antidiabetic drug/s, efficacy, adverse drug reactions, safety of administration, frequency of administration, and bioavailability.
Results: For treatment of T2DM in non-obese participants, Glimepiride+Pioglitazone costed least (`3.7) per unit of effectiveness followed by Glimepiride (`6.6), Gliclazide (`8.1), Repaglinide (`24.5), and Vildagliptin (`45.2). For treatment of T2DM in obese participants, Metformin cost least (` 6.7) per unit of effectiveness followed by Glimepiride + Metformin (`5.9) and Repaglinide (`24.5).
Conclusions: In case of non-obese participants, cost effectiveness and prescribed treatments did not show a match, while for obese participants prescribed treatments were in line with cost effectiveness.
Hypertension is a serious global public health problem. It accounts for 10% of all deaths in India and is the leading noncommunicable disease.1 Recent studies have shown that the prevalence of hypertension is 25% in urban and 10% in rural people in India.2 It exerts a substantial public health burden on cardiovascular health status and health care systems in India.3 Antihypertensive treatment effectively reduces hypertension-related morbidity and mortality.1 The cost of medications has always been a barrier to effective treatment.
The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are classified into 1 of 3 categories in the order of increasing risk: Class I, Class II, and Class III.1 Medical devices are distinguished from drugs for regulatory purposes based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.
Objective: To determine the distribution of symptoms of post-stroke depression (PSD) in relation to some predisposing factors in an African population.
Relevance: Environment is a key determinant of behavior, and varied socio-cultural contexts must have implications for modifiable characteristics (age, duration of the stroke, marital status, type of employment, gender, the location of cerebral lesion and complications) of individuals vulnerable to PSD, which may be targeted to enhance recovery.
Method: This was a cross-sectional observational study of 50 (22 females and 28 males) stroke survivors (mean age=54.76±8.79 years), at the physiotherapy department, the University of Nigeria teaching hospital, Enugu, selected using convenience sampling technique. Data were collected using Becks Depression Inventory and analyzed using Z-score, Chi-square test and univariate logistic regression, at p<0.05.
Results: PSD was more prevalent in females (45.45%); young(100%); middle-age(60%) adults(27-36/47-56 years respectively); living with spouse (45%); left cerebral lesions (40.74%); complications(45%); cold case >3 years(47.05%); self-employed and unemployed (66.67%), respectively. Age was significantly associated with depression (χ2 =4.92,df=1,p=0.03), and was related to the risk of PSD (3.7[1.1-12.0], p=0.03, φ = +0.31, φ2=0.1).
Conclusion: Age could be a risk factor for PSD, which was more prevalent in the elderly than young/middle-age adults, female gender, left cerebral lesion, complications, cold case; those living with a spouse, self-employed and unemployed.
Background: Foodstuff traders operating from warehouses (FTFW) are potentially exposed to dangerous rodenticides/pesticides that may have adverse effects on cardiopulmonary function. Methods: 50 consenting male foodstuff traders, comprising 15 traders (21–63 years) operating outside warehouses and 35 FTFW (20–64 years), were randomly recruited at Ogbete Market, Enugu, in a cross-sectional observational study of spirometric and electrocardiographic parameters. 17 FTFW (21–57 years) participated in focus group discussions. Qualitative and quantitative data were analysed thematically and with independent t-test and Pearson correlation coefficient at p < 0.05, respectively. Results: Most FTFW experienced respiratory symptoms, especially dry cough (97,1%) and wheezing (31.4%) with significant reductions in forced vital capacity (FVC) (t = -2.654; p = 0.011), forced expiratory volume in one second (FEV1) (t = -2.240; p = 0.030), maximum expiratory flow rate (FEF200-1200) (t = -1.148; p = -0.047), and forced end-expiratory flow (FEF25-75) (t = -1.11; p = 0.007). The maximum mid-expiratory flow (FEF25-75) was marginally decreased (p > 0.05) with a significantly prolonged (p < 0.05) QTc interval. Conclusion: Allergic response was evident in the FTFW. Significant decrease in FVC may negatively impact lung flow rates and explains the marginal decrease in FEF25-75, which implies a relative limitation in airflow of peripheral/distal airways and elastic recoil of the lungs. This is consistent with obstructive pulmonary disease; a significant decrease in FEF75-85/FEV1 supports this conclusion. Significant decrease in FEF200-1200 indicates abnormalities in the large airways/larynx just as significantly prolonged ventricular repolarization suggests cardiac arrhythmias.
Background: Hand hygiene practices (HHP), as a critical component of infection prevention/control, were investigated among physiotherapists in an Ebola endemic region.
Method: A standardized instrument was administered to 44 randomly selected physiotherapists (23 males and 21 females), from three tertiary hospitals in Enugu, Nigeria. Fifteen participants (aged 22–59 years) participated in focus group discussions (FGDs) and comprised 19 participants in a subsequent laboratory study. After treatment, the palms/fingers of physiotherapists were swabbed and cultured, then incubated aerobically overnight at 37°C, and examined for microbial growths. An antibiogram of the bacterial isolates was obtained.
Results: The majority (34/77.3%) of physiotherapists were aware of the HHP protocol, yet only 15/44.1% rated self-compliance at 71–100%. FGDs identified forgetfulness/inadequate HHP materials/infrastructure as the major barriers to HHP. Staphylococcus aureus were the most prevalent organisms, prior to (8/53.33%) and after (4/26.67%) HPP, while Pseudomonas spp. were acquired thereafter. E. coli were the most antibiotic resistant microbes but were completely removed after HHP. Ciprofloxacin and streptomycin were the most effective antibiotics.
Conclusion: Poor implementation of HPP was observed due to inadequate materials/infrastructure/poor behavioral orientation. Possibly, some HPP materials were contaminated; hence, new microbes were acquired. Since HPP removed the most antibiotic resistant microbes, it might be more effective in infection control than antibiotic medication.
The present investigation was conducted to investigate the in-vitro activity of ethanolic extract of roots of Centaurea behens by using DPPH radical scavenging activity, nitric oxide radical scavenging activity, hydrogen peroxide radical scavenging activity, hydroxyl radical. Result suggests that the extract possess significant antioxidant activity as compared to the standard ascorbic acid and thus further in vivo investigation is required to evaluate the medicinal significance of the extract which can be used for assessing the possible therapeutic importance of the drug.
Malnutrition, nutritional deficiency, or undernutrition is an imbalanced nutritional status resulting from insufficient intake of nutrients to meet normal physiologic requirements. Malnutrition in childhood has both short-term consequences and long-term consequences on mental and physical health as well as the overall health development of children. Of all regions in the world, the Asia and the Pacific region has achieved the fastest rate of economic growth. There is no evidence that this rapid economic growth translates into a decline in malnutrition of children in Asian countries such as India.
Background: Epilepsy is a chronic disorder of the brain that affects people worldwide. The overall prevalence (3.0-11.9 / 1,000) and incidence (0.2-0.6/1,000) of epilepsy in India are comparable to the rates of high-income countries. The high prevalence of negative attitudes towards epilepsy has been highlighted by several studies. Pharmacy students represent a better-educated section of society regarding drugs and have the potential to create awareness, and influence attitudes towards the disease. Thus, it is important that they have the appropriate and updated knowledge and appropriate attitude towards epilepsy and antiepileptic drugs. Objective of the present study was to determine the Mumbai University pharmacy student’s awareness about epilepsy, so as to know the kind of education and awareness strategies that would be applicable to them.
Methods: A cross-sectional study was carried out among students from Mumbai University, India during May-June 2017. Two hundred and fifty students were approached to participate in the study of which 213 agreed to participate (males: 107; females: 106). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23.
Results: Response rate for this study was 85.2% (213/250). Ninety six percent (204/213) of the participants had heard or read about epilepsy. Overall knowledge was poor (40.2%) and attitude was fair (75.3%). None of the participants were aware about recent research regarding hereditary nature of epilepsy. Only 2 (0.98%) students were aware how to perform the first aid in epilepsy. Only 6.8% participants felt that epileptics should participate in sports.
Conclusions: The findings of this study show that, even with extensive curriculum covering diseases, drugs and relevant laws of land, the knowledge and attitude scores were low. There is a need to have focused education and campaigns to increase the knowledge and attitude towards epilepsy.
Knowledge and attitude towards voluntary blood donation among students from Mumbai University
(2018)
Background: Blood is scarce; its demand far outweighs the supply. In addition to limited supply, the issue of safety especially with regard to the risk of transfusion transmissible infection is also an issue of utmost concern especially in the developing countries. Blood transfusion services in India have gained special significance in recent years and forms a vital part of national health care system. Voluntary Non-Remunerated Blood Donation (VNRBD) is the safest of all types of blood donations. One of the potential sources that can be tapped for blood donation is the young and physically fit students from educational institutions across India. Methods: A cross-sectional study was carried out among students from Mumbai University, India during May–June 2017. Two hundred and fifty students were approached to participate in the study of which 201 agreed to participate (males: 104; females: 97). Pretested questionnaire was distributed and collected data was analyzed using IBM SPSS version 23. Results: High number of participants agreed about encouraging general public about voluntary blood donation (96%; 193/201), lack of awareness about VBD in general public (82%; 164/201). But not a single participant was able to respond to the knowledge part of the questionnaire with 100% accuracy. Almost all the participants had correct knowledge about blood groups (98%; 196/201) and blood matching need (195/201; 97%). Conclusions: Participants showed good attitude but demonstrated poor knowledge about voluntary blood donation. Details about blood donation should be incorporated in the undergraduate curriculum and periodic awareness programs should be organized for students.