Gerhard Fortwengel

A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa.

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.

Symptoms of Poststroke Depression among Stroke Survivors: An Appraisal of Psychiatry Needs and Care during Physiotherapy Rehabilitation

Purpose. To identify stroke survivors with symptoms of poststroke depression and the extent of psychiatry needs and care they have received while on physiotherapy rehabilitation. Participants. Fifty stroke survivors (22 females and 28 males) at the outpatient unit of Physiotherapy Department, University of Nigeria Teaching Hospital, Enugu, who gave their informed consent, were randomly selected. Their age range and mean age were 26–66 years and 54.76 ± 8.79 years, respectively. Method. A multiple case study of 50 stroke survivors for symptoms of poststroke depression was done with Becks Depression Inventory, mini mental status examination tool, and Modified Motor Assessment Scale. The tests were performed independently by the participants except otherwise stated and scored on a scale of 0–6. Data were analyzed using Z-test for proportional significance and chi-square test for determining relationship between variables, at p < 0.05. Results. Twenty-one (42.0%) stroke survivors had symptoms of PSD, which was significantly dependent on duration of stroke (χ 2 = 21.680, df = 6, and p = 0.001), yet none of the participants had a psychiatry review. Conclusions. Symptoms of PSD may be common in cold compared to new cases of stroke and may need psychiatry care while on physiotherapy rehabilitation.

Burden and factors associated with post-stroke depression in East central Nigeria

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.

Knowledge, attitude and practices of antibiotic usage among students from Mumbai University

Discovery of antibiotics is one of the greatest events in the history of medicine which has profound effect on human life, and society as a whole. It helped to manage the devastating disease like plague or do surgeries without a desperate gamble with human life. The death due to meningitis, tuberculosis, malaria, leprosy, septicemia once a common incident, is now under control. Presently, the antibiotic era is threatened by the emergence of high level of antibiotic resistance of important pathogens. Several well-known antibiotics commonly used in healthcare have become ineffective as ABSTRACT

Knowledge and attitude towards epilepsy among pharmacy students from Mumbai university

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.

Regulatory roadmap for nanotechnology based medicines

Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.

First International Conference on Health Research, Hannover, Germany

Editorial to the Special Edition on Clinical Trials, featuring scientific articles presented during 2016 at the First International Conference on Health Research held at the Hochschule Hannover, University of Applied Sciences and Arts, in Hannover, Germany.

Hand Hygiene Practices and Microbial Investigation of Hand Contact Swab among Physiotherapists in an Ebola Endemic Region: Implications for Public Health

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.

Distribution of symptoms of post-stroke depression in relation to some characteristics of the vulnerable patients in socio-cultural context

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.