Rationalizing the Use of COVID-19 Questionable Efficacy Drugs in a Low Middle-income Country: A Hospital Tocilizumab Committee Experience.

BACKGROUND: Only corticosteroids have confirmed mortality benefits in coronavirus disease of 2019 (COVID-19). Rational use of costlier drugs with questionable benefits poses a great concern to hospital pharmacies in low middle-income countriesAim: The present study aimed to assess the rational utilization of hospital supply tocilizumab and understand its clinical benefits in hospitalized COVID-19 pneumonia patientsMethods: The Hospital Tocilizumab Committee (HTC) decision support system framework was developed to make patients eligible or ineligible for tocilizumab procurement from the hospital pharmacy. A total of 33 consecutive patients receiving tocilizumab were analyzed retrospectively in the 3-month study period. The records of the inpatient stay of the patients were observed for pulse, blood pressure, respiratory rate (RR), oxygen saturation (SpO2), fraction of inspired oxygen (FiO2) laboratory work-up, hospital stay duration, and mortality benefit, if any. Patients were analyzed as "died," "survived," and "composite" subgroupsResults: The study observed death as a final outcome in 48% of patients. The study observed a significant effect of tocilizumab on C-reactive protein (CRP) (p = 0.02) and ferritin (p = 0.018) levels on a 10-day follow-up when all patients were analyzed together. Rising and declining trends of RR and FiO2 were observed among the "died" (RR, p = 0.02; FiO2, p = 0.03) and survived (RR, p = 0.03; FiO2, p = 0.05) subgroups. The second dose of tocilizumab was received by 88% of survivors as against 50% of patients who died (p = 0.04)Conclusion: Hospital Tocilizumab Committee (HTC) was successfully established to continue the assessment of the costlier drug with uncertain treatment benefits. A repeat dose of tocilizumab may provide a mortality benefit in Asian Indians.

Reporting adverse events of ChAdOx1 nCoV-19 coronavirus vaccine (Recombinant) among the vaccinated healthcare professionals: A cross-sectional survey.

Background & objectives: The safety of the ChAdOx1 nCoV-19 vaccine is a cause of concern for many who have been vaccinated. The people have multiple concerns and fear regarding the adverse events of the vaccine. Thus, this study was undertaken to establish the safety profile of ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) among the healthcare professionals. Methods: This was a descriptive cross-sectional survey. After taking clearance from the institutional ethics committee 1500 healthcare professionals, who had their vaccination in the past two weeks were selected. They were provided with an online survey proforma regarding adverse events following immunization (AEFIs) of COVID-19 vaccine developed using google forms with an informed consent form affixed to it. Results: A total of 1036 individuals participated in the study. The mean and median (inter quartile range) age of the participants was 37.7 ±11.25 and 35 (29-46) yr, respectively. Of these, 52.1 per cent were female, 29.3 per cent were doctors, 33.4 per cent were nurses and 9.5 per cent were paramedical staff. Forty six per cent participants experienced one or more minor AEFIs such as pain, tenderness, redness, etc. at the injection site. Fatigue (31.75%), generalized feeling of unwell (28.57%), muscle pain (23.16%) and fever (21.71%) were the most commonly reported systemic AEFIs followed by headache (20.07%), dizziness (10.03%) and joint pains (15.25%). Most of them experienced these AEFIs within 24 h of the first dose of administration. About 42 per cent of the participants took oral antipyretics/analgesics for managing the AEFIs. Interpretation & conclusions: ChAdOx1 nCoV-19 Corona Virus Vaccine was found to be associated with mild local and systemic AEFIs that were more common after the first dose as compared to the second dose. There adverse events could be dealt with oral over-the-counter medications, with no requirement of hospitalization.

Research versus practice in quality improvement? Understanding how we can bridge the gap.

The gap between implementers and researchers of quality improvement (QI) has hampered the degree and speed of change needed to reduce avoidable suffering and harm in health care. Underlying causes of this gap include differences in goals and incentives, preferred methodologies, level and types of evidence prioritized and targeted audiences. The Salzburg Global Seminar on 'Better Health Care: How do we learn about improvement?' brought together researchers, policy makers, funders, implementers, evaluators from low-, middle- and high-income countries to explore how to increase the impact of QI. In this paper, we describe some of the reasons for this gap and offer suggestions to better bridge the chasm between researchers and implementers. Effectively bridging this gap can increase the generalizability of QI interventions, accelerate the spread of effective approaches while also strengthening the local work of implementers. Increasing the effectiveness of research and work in the field will support the knowledge translation needed to achieve quality Universal Health Coverage and the Sustainable Development Goals.

Quality improvement and emerging global health priorities.

Quality improvement approaches can strengthen action on a range of global health priorities. Quality improvement efforts are uniquely placed to reorient care delivery systems towards integrated people-centred health services and strengthen health systems to achieve Universal Health Coverage (UHC). This article makes the case for addressing shortfalls of previous agendas by articulating the critical role of quality improvement in the Sustainable Development Goal era. Quality improvement can stimulate convergence between health security and health systems; address global health security priorities through participatory quality improvement approaches; and improve health outcomes at all levels of the health system. Entry points for action include the linkage with antimicrobial resistance and the contentious issue of the health of migrants. The work required includes focussed attention on the continuum of national quality policy formulation, implementation and learning; alongside strengthening the measurement-improvement linkage. Quality improvement plays a key role in strengthening health systems to achieve UHC.

Impact of BMI on serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with calcifediol supplementation in young adults: a longitudinal study.

BACKGROUND: High body mass index (BMI) is a risk factor for vitamin D deficiency. The rise in serum 25-hydroxyvitamin D [25(OH)D] concentrations following cholecalciferol supplementation is suboptimal, owing to adipose tissue sequestration and/or volumetric dilution. Calcifediol is a proven potent oral alternative for vitamin D supplementation, but whether BMI adversely affects its efficacy in raising 25(OH)D concentrations, is not well known. MATERIAL AND METHODS: Adults with serum concentrations of 25(OH)D < 30 ng/mL were recruited and stratified as normal, overweight, or obese using WHO criteria. Baseline evaluation included 25(OH)D, parathyroid hormone (PTH), and total 1,25-dihydroxyvitamin D [1,25(OH)2D] based on BMI category (n = 883). A subset of participants was supplemented with 50 µg calcifediol (n = 193) and assessed for the rise in serum concentrations of 25(OH)D at 3- and 6-months following supplementation. RESULTS: Participants were stratified as obese (11.2%), overweight (32.1%), or normal weight (56.7%). There were no significant baseline differences in serum concentrations of 25(OH)D among the groups (13.1 ± 6.4 vs 12.8 ± 6.8 vs 11.6 ± 6.6 ng/mL, p = 0.62). Similarly, PTH or 1,25(OH)2D concentrations were not different among the groups. On follow-up, 25(OH)D concentrations increased in all three groups at 3 and 6 months from baseline. The increase in 25(OH)D was 74.4 ng/mL (IQR 35.3-115.3) in obese, followed by overweight 62.2 ng/mL (18.1-98.7) and normal weight groups 47.1 ng/mL (17.5-89.7) at 3 months. 1,25(OH)2D also increased in all groups, without any significant intergroup differences (p > 0.05). CONCLUSION: BMI does not impede the rise in 25(OH)D concentrations following supplementation with calcifediol in young adults with vitamin D deficiency.

Perception and Attitude of Health Care Personnel Regarding Integration of Nursing Education and Nursing Services for Patient Care at a Tertiary Care Center of Northern India.

This study aims to assess the perception and attitude of health care personnel regarding integration of nursing education and nursing services. Using purposive and stratified random sampling technique, 92 medical faculty, 32 nursing faculty and 346 nursing officers were enrolled. A three-point Likert scale consisting of 15 items and six open ended questions was used to collect the data. Overall, the concept of integration of nursing education and nursing services at their institute was welcomed by 74.4% of health care personnel. Medical faculty (47.8%), nursing faculty (37.5%) and nursing officers (57.5%) scored the concept of integration as very good.

Factors associated with health service satisfaction among people living with HIV/AIDS: a cross sectional study at ART center in Chandigarh, India.

People living with HIV/AIDS (PLHA) while availing anti-retroviral therapy (ART) services face administrative and procedural problems in hospitals which affect their level of satisfaction with service providers. There is very little information available regarding quality of services provided at ART centers in India. Hence this study was conducted between July 2007 and December 2008 at ART Center, Chandigarh to analyse the user's perception about quality of services provided and factors associated with satisfaction level. For this prospective cross-sectional study, 100 PLHA were randomly recruited at ART Center. Exit interviews were conducted with structured questionnaire containing four groups of questions and questions on waiting time and satisfaction level. A scoring system was devised. The satisfaction level was cross matched with group questions. Mean age of 100 PLHA was 36.46 years (SD = 8.46), 22% were females, 55% from rural background and 67% educated above primary level. The mean group scores of four groups of questions were: Information, access and guidance (58.8%), Interaction with service providers (92.96%), Physical facilities (70.85%), Confidentiality, discrimination and grievance redressal (70.31%). Eighty-eight per cent rated satisfaction level as satisfactory or above (30% very satisfactory, 58% satisfactory), 10% indifferent and 2% dissatisfied. Factors found to be associated with satisfaction level were patient provider interaction (p=0.002) [behaviour of staff (p=0.005)], physical facilities (p=0.005) [cleanliness (0.002), drinking water (0.006)], confidentiality (p=0.004), waiting time to meet the doctor (p=0.03) and total time spent in hospital (p < 0.001). Problem areas identified were low availability of signage, low awareness of grievance redressal system, sanitation/toilets, drinking water, waiting time to meet the doctor (mean = 53.3 minutes), and "total time spent in hospital" (mean = 143 minutes). Study provided user's perspective about quality of ART services provided in a tertiary care hospital of India and revealed the factors associated with PLHA satisfaction level. Better quality ART Services can be provided to PLHA by addressing these factors.

Factors associated with the willingness of health care personnel to work during an influenza public health emergency: an integrative review.

INTRODUCTION: The first decade of the 21st century has witnessed three major influenza public health emergencies: (1) the severe acute respiratory syndrome of 2002-2003; (2) the avian flu of 2006; and (3) the 2009 H1N1 pandemic influenza. An effective public health response to an influenza public health emergency depends on the majority of uninfected health care personnel (HCP) continuing to report to work. The purposes of this study were to determine the state of the evidence concerning the willingness of HCP to work during an influenza public health emergency, to identify the gaps for future investigation, and to facilitate evidence-based influenza public health emergency planning. METHODS: A systemic literature review of relevant, peer-reviewed, quantitative, English language studies published from January 1, 2001 through June 30, 2010 was conducted. Search strategies included the Cochrane Library, PubMed, PubMed Central, EBSCO Psychological and Behavioral Sciences Collection, Google Scholar, ancestry searching of citations in relevant publications, and information from individuals with a known interest in the topic. RESULTS: Thirty-two studies met the inclusion criteria. Factors associated with a willingness to work during an influenza public health emergency include: being male, being a doctor or nurse, working in a clinical or emergency department, working full-time, prior influenza education and training, prior experience working during an influenza emergency, the perception of value in response, the belief in duty, the availability of personal protective equipment (PPE), and confidence in one's employer. Factors found to be associated with less willingness were: being female, being in a supportive staff position, working part-time, the peak phase of the influenza emergency, concern for family and loved ones, and personal obligations. Interventions that resulted in the greatest increase in the HCP's willingness to work were preferential access to Tamiflu for the HCP and his/her family, and the provision of a vaccine for the individual and his/her family. CONCLUSIONS: Understanding the factors that contribute to the willingness of HCP to report to work during an influenza public health emergency is critical to emergency planning and preparedness. Information from this review can guide emergency policy makers, planners, and implementers in both understanding and influencing the willingness of HCP to work during an influenza public health emergency.

Physicians' compliance with the National Drug Policy on Malaria in a tertiary teaching hospital, India, from 2010 to 2015: a mixed method study.

Background: National drug policies are formulated to encourage rational use of drugs and to reduce drug resistance. This study assessed physicians' compliance with the National Drug Policy on Malaria at a tertiary care hospital in north India. Methods: This mixed method study extracted data from adult malaria inpatient records of the hospital from 2010-2015, and assessed drug supply at pharmacies. Physicians' practices and perspectives were explored by in-depth interviews. Compliance was assessed by severity, type of species and pregnancy status. Thematic analysis was done for the qualitative data. Results: A total of 247 case files were reviewed. Vivax malaria (41.0%) was more common than falciparum malaria (37.2%). The majority (90.8%) of cases were severe malaria. Overall compliance for use of schizonticidal drug was 73.0% in severe malaria and was only 9.5% in uncomplicated malaria. Compliance for use of gametocidal drug (primaquine) was 15.3%. Schizonticidal drugs were available in all pharmacies except the public one. Primaquine was available in only one. The main themes emerging in the thematic network analysis were physicians' misconceptions, physician-related factors, and hospital-related and drug access factors. Conclusions: The degree of compliance for severe malaria treatment was reasonably good but low for radical cure. Raising knowledge and awareness among health care providers, by using written treatment protocols and continuing medical education would improve compliance.

Isolation of an individual already treated for Ebola: has India gone too far?

A 26-year-old Indian male travelling from Liberia to India after being treated for Ebola Virus Disease (EVD) was isolated at Delhi airport, even though he was symptom-free, because his semen was positive for Ebola virus. His blood, saliva and urine samples had tested negative for Ebola. There is no conclusive evidence of sexual transmission of EVD and the World Health Organisation does not recommend the isolation of convalescent patients whose blood is negative for Ebola virus. The decision of the Indian health authorities to isolate this individual is not only unscientific and excessively precautionary, but also raises various ethical and legal issues related to the potential violation of individual rights. The decision to impose individual restrictions during public health emergencies should be a transparent one that is guided by science, and should follow consultations among the various stakeholders. Further, such restrictions should be imposed only when alternative approaches are not sufficient or effective.

Planning and response to the influenza A (H1N1) pandemic: ethics, equity and justice.

This paper aims to highlight three ethical considerations related to influenza pandemic planning and response: ethical allocation of scarce resources; obligations and duties of healthcare workers to treat patients, and the balance between conflicting individual and community interests. Among these, perhaps the most challenging question facing bioethics is how to allocate scarce, life-saving resources given the devastating social and economic ramifications of a pandemic. In such situations, the identification of clear overall goals for pandemic planning is essential in making difficult choices. The dilemma between the duty to save patients and the right to protect the healthcare personnel's own life and health is a key issue. During the course of a pandemic, civil liberties may also be threatened, requiring limits on individual freedom to protect individuals as well as entire communities. Yet, individual liberty should be restricted with great care, and only when alternative approaches are not effective. Pandemic influenza planning and response should be a cooperative and shared responsibility that balances community and individual interests.

A survey of hand-washing facilities in the outpatient department of a tertiary care teaching hospital in India.

INTRODUCTION: Inadequate hand-washing facilities have been reported as a barrier to hand washing. This study aimed to evaluate the availability and accessibility of hand-washing facilities and supplies of hand-washing agents in the outpatient department (OPD) complex of a tertiary care teaching hospital. METHODOLOGY: A checklist containing 13 variables was prepared and all rooms of direct patient care in the OPD were assessed on one occasion.  RESULTS: Out of 211 rooms surveyed, a hand-washing facility was available in 209 (99.05%) rooms. Among these, 206 (98.56%) sinks were easily accessible and were placed close to users. Almost all sinks (99.5%) had hand-operated taps. Thirty-five (16.75%) sinks had no soap stand, and at 21 (10.5%) sinks, soap stands were found to be broken. At 14 (6.70%) sinks, soap bars were not available, while an antiseptic agent was available at 6 (2.87%) sinks. Four (1.91%) sinks had no towel stand, and at 8 (3.83%) sinks the towel stands were broken. At 43 (20.57%) sinks no towel was available, and at 23 (11%) sinks the towels provided were dirty. No sink drain was found to be blocked. No sink had hand-washing instructions displayed demonstrating the correct technique of hand washing. CONCLUSION: Physical facilities required for hand washing were adequate though not perfect. There is a need to shift from hand-operated taps to non-manual taps and from cloth towels to paper towels. Hospital managers in developing countries should continuously strive to provide the best possible hand-washing facilities within their financial resources.