Breakthrough infection among healthcare personnel following exposure to COVID-19: Experience after one year of the world's largest vaccination drive.

Context: The COVID-19 vaccination drive globally was supposedly a game-changing event. However, the emerging variants of the virus and waning immunity over time posed new challenges for breakthrough infections. Standing at the frontline of defense against COVID-19, healthcare personnel (HCP) were vulnerable to such infections. Aims: This study estimates i) the vaccine breakthrough infections (VBI) among HCP following exposure to COVID-19 cases, and ii) the mean interval between the second dose of vaccine and laboratory-confirmed SARS-CoV-2 infection. Materials and Methods: A cross-sectional study was conducted including 385 HCP with a history of exposure to COVID-19 cases during January and February 2022. Demographic details and clinical and vaccination history were collected from the test forms and the Web-based hospital management system. Laboratory testing of COVID-19 was carried out by real-time RT-PCR test. Results: The majority of the HCP were males (262; 68.05%) and nurses (180; 46.75%) by occupation. Two doses of vaccines were received by 278 (87.7%) HCP. VBI was confirmed in 185 (66.55%) HCP. No significant difference in VBI between the COVAXIN and COVISHIELD recipients (P = 0.69) was observed. The interval between the second dose and confirmed SARS-CoV-2 infection was significantly higher (P < 0.00001) in COVAXIN recipients (median 228 days) than in COVISHIELD recipients (median 95 days). Conclusions: The incidence of VBI was very high among the HCP, but not statistically different among the COVAXIN and COVISHIELD-recipients. Waning immunity over time suggests boosting immunity with a third dose because of emerging variants.

Hair and Nail-On-Chip for Bioinspired Microfluidic Device Fabrication and Biomarker Detection.

The advent of biosensors has tremendously increased our potential of identifying and solving important problems in various domains, ranging from food safety and environmental analysis, to healthcare and medicine. However, one of the most prominent drawbacks of these technologies, especially in the biomedical field, is to employ conventional samples, such as blood, urine, tissue extracts and other body fluids for analysis, which suffer from the drawbacks of invasiveness, discomfort, and high costs encountered in transportation and storage, thereby hindering these products to be applied for point-of-care testing that has garnered substantial attention in recent years. Therefore, through this review, we emphasize for the first time, the applications of switching over to noninvasive sampling techniques involving hair and nails that not only circumvent most of the aforementioned limitations, but also serve as interesting alternatives in understanding the human physiology involving minimal costs, equipment and human interference when combined with rapidly advancing technologies, such as microfluidics and organ-on-a-chip to achieve miniaturization on an unprecedented scale. The coalescence between these two fields has not only led to the fabrication of novel microdevices involving hair and nails, but also function as robust biosensors for the detection of biomarkers, chemicals, metabolites and nucleic acids through noninvasive sampling. Finally, we have also elucidated a plethora of futuristic innovations that could be incorporated in such devices, such as expanding their applications in nail and hair-based drug delivery, their potential in serving as next-generation wearable sensors and integrating these devices with machine-learning for enhanced automation and decentralization.

Impact of Life Cycle Costing in Procurement of Robotic Track-Based Central Laboratory at Apex Medical Institute in India.

Introduction Life cycle costing is an important management tool that takes into account the implications of planning, acquiring, operating, maintaining, and disposing of an asset during its complete life cycle. A major hindrance to the procurement of expensive equipment in developing countries is the lack of a reliable framework combining and integrating all the equipment life cycle aspects into procurement process. Methods The study was conducted from the data collected from the bids that were received for procurement of two robotic track-based central laboratories which were installed at All India Institute of Medical Sciences (AIIMS), New Delhi. The procurement was done as per the guidelines laid down under General Finance Rules (GFR) 2017 following the two bid systems: technical bid and price/commercial bid. Results A complete financial analysis of the robotic laboratory was done that involved gathering of all the pertinent financial information into one place and then using that data to analyze the feasibility of the bid. The life cycle costs of both the labs were calculated by assuming the life of equipment as 10 years and by factoring in cost of equipment including 5-year warranty, comprehensive maintenance from years 6 to 10, indicative cost of all reagents for 10 years, and indicative cost of all other consumables for 10 years. Conclusion Results showed that the cost of equipment alone should not be the sole predictor of making purchase decisions of equipment. Further research may additionally explore differences between processes being followed in government versus private organizations, as well as national guidelines and subnational practices.

Case report of SARS-CoV-2 with secondary Clostridioides difficile infection.

There has been an overuse of antibiotics in most patients suffering from COVID-19 which predisposes patients to hospital acquired C. difficile Infection (CDI). Also, COVID infection of the gastrointestinal tract also predisposes the patient to CDI. We here present a fatal case of SARS-CoV-2 coinfection with CDI.

Persistence of SARS-CoV-2 in COVID-19 patients during the second wave of the pandemic in India.

INTRODUCTION: India witnessed the catastrophic second wave of COVID-19 during the summer months of 2021. Many patients with non-resolution of symptoms admitted to dedicated COVID-19 treatment centers required prolonged inpatient care which led to the unavailability of beds for other COVID-19 patients. The objective of this study was to determine the duration of SARS-CoV-2 positivity in moderate and severe COVID-19 patients requiring long-term pulmonary care as well as to find out the association between different variables with the persistence of the virus. METHODOLOGY: A retrospective chart review of clinical and laboratory data of patients with moderate and severe COVID-19 between 1st April 2021 and 15th July 2021 admitted for more than 28 days and requiring long-term pulmonary care was carried out at National Cancer Institute, AIIMS, India. SARS-CoV-2 RNA was detected with real-time reverse transcriptase-polymerase chain reaction-based tests. Data from all consecutively included patients satisfying the selection criteria were presented temporally and analyzed by Fisher's exact test (p < 0.05). RESULTS: All 51 patients tested positive for SARS-CoV-2 RNA at the 5th week of initial laboratory confirmation of COVID-19. The majority of the patients (38; 74.5%) remained positive for viral RNA till the 6th week and the median duration of viral positivity was 45 days. The clinical presentation of SARI at admission was significantly higher among patients with viral persistence till the 6th week (p < 0.05). CONCLUSIONS: The median duration of the viral positivity was 45 days and SARI at admission was significantly associated with viral persistence till the 6th week.

Patient Satisfaction Scale for Hospitalized COVID-19 Patients: Development and Psychometric Properties.

Objective: Patients' appraisal of health care delivery system and services during COVID-19 could be an important yardstick for hospital administration and policy makers. The study attempted to develop and test the psychometric properties of a new patient satisfaction scale for COVID-19 patients. Methods: A total of 446 COVID-19-hospitalized COVID-19 patients in a tertiary care designated COVID-19 care hospital constituted the sample. Factor structure of scale was obtained using exploratory factor analysis (EFA). Internal consistency, split-half reliability, and validity (e.g., content, convergent, and divergent) were also evaluated. Results: Item reduction resulted in a 21-item scale consisting of three factors, namely COVID-19-focused treatment facility, COVID-19-appropriate hospital facility, and COVID-19-specific daily needs service facility. It demonstrated excellent internal consistency and reliability (Cronbach's alpha [α]: 0.93; Split-half reliability: 0.90), excellent content validity, and adequate convergent and divergent validity. The scale had no floor effects. Inter-index correlations were significant. To our knowledge: this scale is the first such psychometrically robust self-rated scale for patients' perception about hospital services during COVID-19. Available in both Hindi and English languages, the scale provides a quick measure of patient experience regarding CCOVID-19-specific hospital services.

Clinical features, demography, and predictors of outcomes of SARS-CoV-2 infection at a tertiary care hospital in India: A cohort study.

BACKGROUND: The "second wave" of the COVID-19 pandemic hit India from early April 2021 to June 2021. We describe the clinical features, treatment trends, and baseline laboratory parameters of a cohort of patients with SARS-CoV-2 infection and their association with the outcome. METHODS: This was a retrospective cohort study. Multivariate logistic regression models were fitted to identify clinical and biochemical predictors of developing hypoxia, deterioration during the hospital stay, and death. RESULTS: A total of 2080 patients were included. The case fatality rate was 19.5%. Among the survivors, the median duration of hospital stay was 8 (5-11) days. Out of 853 (42.3%%) of patients who had COVID-19 acute respiratory distress syndrome at presentation, 340 (39.9%) died. Patients aged >45 years had higher odds of death as compared to the 18-44 years age group. Vaccination reduced the odds of death by 40% (odds ratio [OR] [95% confidence interval [CI]]: 0.6 [0.4-0.9], P = 0.032). Patients with hyper inflammation at baseline as suggested by leukocytosis (OR [95% CI]: 2.1 [1.5-3.1], P < 0.001), raised d-dimer >500 mg/dL (OR [95% CI]: 3.2 [2.2-4.7], P < 0.001), and raised C-reactive peptide >0.5 mg/L (OR [95% CI]: 3.7 [2.2-13], P = 0.037) had higher odds of death. Patients who were admitted in the 2nd week had lower odds and those admitted in the 3rd week had higher odds of death. CONCLUSION: This study shows that vaccination status and early admission during the inflammatory phase can change the course of illness of these patients. Improving vaccination rates and early admission of patients with moderate and severe COVID-19 can improve the outcomes.

An intelligent Hybrid Wind-PV farm as a static compensator for overall stability and control of multimachine power system.

The paper demonstrates the potential of a hybrid Wind-PV farm as STATCOM (Static Synchronous Compensator) for damping and control of overall chaotic oscillations in a two-area power system. Kundur's modified system associated with a hybrid Wind-PV farm is simulated in MATLAB to demonstrate the detailed performance assessment of the hybrid farm. A unique controller is deployed to regulate the AC and DC currents of the STATCOM using two PI controllers. A swarm-based hybrid metaheuristic optimizer PSO-BFOA optimally tunes and controls the PI controller parameters. The system is compensated to an optimum level of 85% and exposed to a 3-phase fault. Zero dampings are accompanied by additional disturbances of a 20% change in electric torque and the reference voltage. The disturbances are made to model the worst conditions to examine the rigorous performance of the hybrid Wind-PV​ farm in alleviating the overall chaotic oscillations. The simulation results for the performance assessment in different cases, i.e., without control, with Wind-STATCOM, with PV-STATCOM, and with the hybrid Wind-PV-STATCOM, reveal the potential of the hybrid Wind-PV Farm as STATCOM in alleviating the overall chaotic oscillations.

The Effectiveness of SARS-CoV-2 Vaccination in Preventing Severe Illness and Death - Real-world Data from a Cohort of Patients Hospitalized with COVID-19.

Background: While long-term studies on the correlates of protection, vaccine effectiveness, and enhanced surveillance are awaited for SARS-CoV-2 vaccine, studies on breakthrough infections help understand the nature and course of this illness among vaccinated individuals and guide in public health preparedness. This study aims to compare the differences in the hospitalization outcomes SARS-CoV-2 infection of fully vaccinated individuals with with those of unvaccinated and partially vaccinated individuals. Materials and Methods: Single institution observational cohort study. This study compared the differences in clinical, biochemical parameters and the hospitalization outcomes of 53 fully vaccinated individuals with those of unvaccinated (1464) and partially vaccinated (231) individuals, among a cohort of 2,080 individuals hospitalized with SARS-CoV-2 infection. Descriptive statistics and propensity-score weighted multivariate logistic regression analysis adjusting for clinical and laboratory parameters were used to compare the differences and to identify factors associated with outcomes. Results: Completing the course of vaccination protected individuals from developing severe COVID-19 as evidenced by lower proportions of those with hypoxia, abnormal levels of inflammatory markers, requiring ventilatory support, and death compared to unvaccinated and partially vaccinated individuals. There were no differences in these outcomes among patients who received either vaccine type approved in India. Conclusions: Efforts should be made to improve the vaccination rates as a timely measure to prepare for the upcoming waves of this highly transmissible pandemic. Vaccination rates of the communities may also guide in the planning of the health needs and appropriate use of medical resources.

Low-dose radiation therapy for COVID-19 pneumonia: a pilot study.

OBJECTIVES: The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a pilot trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19. METHODS: From June to Aug 2020, we enrolled 10 patients with COVID-19 having moderate to severe risk disease [National Early Warning Score (NEWS) of ≥5]. Patients were treated as per the standard COVID-19 management guidelines along with LDRT to both lungs with a dose of 70cGy in single fraction. Response assessment was done based on the clinical parameters using the NEWS. RESULTS: All patients completed the prescribed treatment. Nine patients had complete clinical recovery mostly within a period ranging from 3 to 7 days. One patient, who was a known hypertensive, showed clinical deterioration and died 24 days after LDRT. No patients showed the signs of acute radiation toxicity. CONCLUSION: The results of our pilot study suggest that LDRT is feasible in COVID-19 patients having moderate to severe disease. Its clinical efficacy may be tested by conducting randomized controlled trials. ADVANCES IN KNOWLEDGE: LDRT has shown promising results in COVID-19 pneumonia and should be researched further through randomized controlled trials.

Coinfections with Other Respiratory Pathogens among Patients with COVID-19.

Emerging evidence indicates that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected individuals are at an increased risk for coinfections; therefore, physicians need to be cognizant about excluding other treatable respiratory pathogens. Here, we report coinfection with SARS-CoV-2 and other respiratory pathogens in patients admitted to the coronavirus disease (COVID) care facilities of an Indian tertiary care hospital. From June 2020 through January 2021, we tested 191 patients with SARS-CoV-2 for 33 other respiratory pathogens using an fast track diagnostics respiratory pathogen 33 (FTD-33) assay. Additionally, information regarding other relevant respiratory pathogens was collected by reviewing their laboratory data. Overall, 13 pathogens were identified among patients infected with SARS-CoV-2, and 46.6% (89/191) of patients had coinfection with one or more additional pathogens. Bacterial coinfections (41.4% [79/191]) were frequent, with Staphylococcus aureus being the most common, followed by Klebsiella pneumoniae. Coinfections with SARS-CoV-2 and Pneumocystis jirovecii or Legionella pneumophila were also identified. The viral coinfection rate was 7.3%, with human adenovirus and human rhinovirus being the most common. Five patients in our cohort had positive cultures for Acinetobacter baumannii and K. pneumoniae, and two patients had active Mycobacterium tuberculosis infection. In total, 47.1% (90/191) of patients with coinfections were identified. The higher proportion of patients with coinfections in our cohort supports the systemic use of antibiotics in patients with severe SARS-CoV-2 pneumonia with rapid de-escalation based on respiratory PCR/culture results. The timely and simultaneous identification of coinfections can contribute to improved health of COVID-19 patients and enhanced antibiotic stewardship during the pandemic. IMPORTANCE Coinfections in COVID-19 patients may worsen disease outcomes and need further investigation. We found that a higher proportion of patients with COVID-19 were coinfected with one or more additional pathogens. A better understanding of the prevalence of coinfection with other respiratory pathogens in COVID-19 patients and the profile of pathogens can contribute to effective patient management and antibiotic stewardship during the current pandemic.

Mycoplasma pneumoniae co-infection with SARS-CoV-2: A case report.

We report co-infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Mycoplasma pneumoniae in a patient with pneumonia in India. Atypical bacterial pathogens causing community-acquired pneumonia may share similar clinical presentations and radiographic features with SARS-CoV-2 making a thorough differential diagnosis essential. The co-infection of SARS-CoV-2 and M. pneumoniae is infrequently reported in the literature. Broader testing for common respiratory pathogens should be performed in severe COVID-19 cases to rule out other concurrent infections. Early identification of co-existing respiratory pathogens could provide pathogen-directed therapy, and can save patient lives during the ongoing COVID-19 outbreak.

How is surgery included in the Strategic Health Plans of the Pacific, Papua New Guinea and Timor-Leste?

BACKGROUND: Papua New Guinea, Pacific Island nations, and Timor-Leste represent a range of island nations with populations ranging from a few thousand to 8 million. They perform on average about 25% of the Lancet Commission of Global Surgery's target 5000 per 100 000 population and their health workforce have significant deficits of trained surgeons and anaesthetists. This study was conducted to determine how the current national health plans of these nations have included surgery and anaesthesia. METHODS: The most recent (as of December 2018) published national health plans of 10 Pacific Island nations (Cook Islands, Fiji, Nauru, Federated States of Micronesia, Kiribati, Samoa, Solomon Islands, Tonga, Tuvalu and Vanuatu), Papua New Guinea and Timor-Leste were reviewed for content and process, searching for key words and identifying themes related to surgery and anaesthesia. RESULTS: There were 12 national health plans with a combined total of 478 pages. There was limited surgical and/or anaesthesia input within the planning process. Injuries, blindness, cancer and non-communicable diseases were included themes, but the potential role of surgical care in addressing these conditions was not well documented. The need for better information and registries was noted by several nations but possible surgical care delivery or outcome metrics were not included. CONCLUSION: There is limited mention of surgical and anaesthesia care planning within current health plans in the Pacific, PNG and TL. There is a need for greater surgical and anaesthesia engagement in future plans with performance measured against World Health Organization core surgical indicators.

Seroprevalence of antibodies to SARS-CoV-2 in healthcare workers & implications of infection control practice in India.

Background & objectives: Healthcare workers (HCWs) are considered to be at a high risk of contracting COVID-19 infection. Besides, control of nosocomial infections transmitted from HCWs to the patients is also a cause of concern. This study was undertaken to investigate the seroprevalence of antibodies against the SARS-CoV-2 virus among the hospital staff of a tertiary care health facility in north India. Methods: The HCWs were tested for SARS-CoV-2 serology (IgG+IgM) using chemiluminescence immunoassay between June 22 and July 24, 2020. Venous blood (2 ml) was collected and tested for SARS-CoV-2 IgG and IgM antibodies. Results: Of the 3739 HCWs tested, 487 (13%) were positive for total SARS-CoV-2 antibodies. The highest seroprevalence was observed in administrative staff (19.6%) and least in physicians (5.4%). The staff who used public (20%) and hospital transportation (16.9%) showed higher seroprevalence compared to staff using personal transportation (12.4%). No difference was observed between HCWs posted in COVID versus non-COVID areas. All seropositive symptomatic HCWs in our study (53.6%) had mild symptoms, and the remaining 46.4 per cent were asymptomatic. The antibody positivity rate progressively increased from 7.0 per cent in the first week to 18.6 per cent in the fourth week during the study. Interpretation & conclusions: The presence of antibodies to SARS-CoV-2 in a significant number of asymptomatic HCWs, association with the use of public transport, relatively lower seroprevalence compared with the non-HCWs and rising trend during the period of the study highlight the need for serosurveillance, creating awareness for infection control practices including social distancing and study of infection dynamics in the community for effective control of an infectious pandemic.

How to rapidly design and operationalise PPE donning and doffing areas for a COVID-19 care facility: quality improvement initiative.

INTRODUCTION: Effective implementation of standard precautions specific to COVID-19 is a challenge for hospitals within the existing constraints of time and resources. AIM: To rapidly design and operationalise personal protective equipment (PPE) donning and doffing areas required for a COVID-19 care facility. METHODS: Literature review was done to identify all issues pertaining to donning and doffing in terms of Donabedian's structure, process and outcome. Training on donning and doffing was given to hospital staff. Donning and doffing mock drills were held. 5S was used as a tool to set up donning and doffing areas. Instances of donning and doffing were observed for protocol deviations and errors. Plan-do-study-act cycles were conducted every alternate day for 4 weeks. The initiative was reported using Standards for QUality Improvement Reporting Excellence (SQUIRE) guidelines. RESULTS: Best practices in donning and doffing were described. Our study recommends a minimum area of 16 m2 each for donning and doffing rooms. Verbally assisted doffing was found most useful than visual prompts. DISCUSSION: Challenges included sustaining the structure and process of donning and doffing, varied supplies of PPE which altered sequencing of donning and/or doffing, and training non-healthcare workers such as plumbers, electricians and drivers who were required during emergencies in the facility. CONCLUSION: Our study used evidence-based literature and quality improvement (QI) tools to design and operationalise donning and doffing areas with focus on people, task and environment. Our QI will enable healthcare facilities to rapidly prototype donning and doffing areas in a systematic way.

Clinico-demographic profile & hospital outcomes of COVID-19 patients admitted at a tertiary care centre in north India.

BACKGROUND & OBJECTIVES: In December 2019, a novel coronavirus (SARS-CoV-2) emerged in China and rapidly spread globally including India. The characteristic clinical observations and outcomes of this disease (COVID-19) have been reported from different countries. The present study was aimed to describe the clinico-demographic characteristics and in-hospital outcomes of a group of COVID-19 patients in north India. METHODS: This was a prospective, single-centre collection of data regarding epidemiological, demographic, clinical and laboratory parameters, management and outcome of COVID-19 patients admitted in a tertiary care facility in north India. Patient outcomes were recorded as death, discharge and still admitted. RESULTS: Data of 144 patients with COVID-19 were recorded and analyzed. The mean age of the patients was 40.1±13.1 yr, with 93.1 per cent males, and included 10 (6.9%) foreign nationals. Domestic travel to or from affected States (77.1%) and close contact with COVID-19 patients in congregations (82.6%) constituted the most commonly documented exposure. Nine (6.3%) patients were smokers, with a median smoking index of 200. Comorbidities were present in 23 (15.9%) patients, of which diabetes mellitus (n=16; 11.1%) was the most common. A significant proportion of patients had no symptoms (n=64; 44.4%); among the symptomatic, cough (34.7%) was the most common symptom followed by fever (17.4%) and nasal symptoms (2.15%). Majority of the patients were managed with supportive treatment with hydroxychloroquine and azithromycin given on a case-to-case basis. Only five (3.5%) patients required oxygen supplementation, four (2.8%) patients had severe disease requiring intensive care, one required mechanical ventilation and mortality occurred in two (1.4%) patients. The time to reverse transcription-polymerase chain reaction (RT-PCR) negativity was 16-18 days. INTERPRETATION & CONCLUSIONS: In this single-centre study of 144 hospitalized patients with confirmed COVID-19 in north India, the characteristic findings included younger age, high proportion of asymptomatic patients, long time to PCR negativity and low need for intensive care unit care.

How will increasing surgical volume affect mortality in the Pacific, Papua New Guinea and Timor Leste?

BACKGROUND: Nine South Pacific nations, Papua New Guinea and Timor Leste, have collaborated to report and publish their surgical metrics as recommended by the Lancet Commission on Global Surgery (LCoGS). Currently, these countries experience about 750 postoperative deaths per year, representing 1% of crude mortality in the region. Given that more than 400 000 annual procedures are needed in the nine nations to reach the LCoGS target of 5000/100 000, we aimed to calculate the potential contribution of perioperative mortality to national mortality where these procedures are performed. METHODS: We utilized reported surgical metrics with current rates for surgical volume (SV) and perioperative mortality (POMR), as well as World Bank/WHO mortality statistics, to predict the likely impact of surgical scale-up to recommended targets by 2030. We tested correlations between SV and POMR in countries from our region using Pearson's r statistic. Funnel plots were used to evaluate the dataset for outliers. RESULTS: Surgical scale up would result in perioperative mortality contributing on average to 3.3% of all national crude mortality. This prediction assumes POMR stays the same, which is challenging to predict. In our region countries that achieved the LCoGS target (n = 5) had a lower POMR than countries that did not (n = 8). CONCLUSIONS: Surgical volumes in the South Pacific region must increase to meet the LCoGS target. Postoperative mortality as a proportion of all mortality may increase with the surgical scale up, however, the overall number of premature deaths is expected to reduce with better access to timely and safe surgical care.

Real-life Bioequivalence of Tacrolimus in Patients With Living-Related Donor De Novo Renal Transplantation: An Observational Study.

Tacrolimus is a narrow therapeutic index drug. As a result, regulatory agencies worldwide recommend stringent bioequivalence evaluation criteria for approval of generics. Despite this, the professional transplantation societies have raised concerns over the safety and efficacy of generic substitutions. We conducted this pragmatic real-life bioequivalence study to assess the effect of generic substitutions of tacrolimus. This was an observational study including recipients of renal transplantation who were considered for generic medication substitution. Transplanted organs were from living-related donors and were performed at least 1 month before the study. Time of administration of the drug, time of dosing with respect to meals, and time of blood sample collection were controlled; however, the lot number of the generic drugs was not controlled. The participants were allowed to use their usual supplies irrespective of the lot number. Concentration (C0) was quantified by liquid chromatography with tandem mass spectrometry after the generic substitution from ABC brand to XYZ brand. The average C0 ± SD with generic ABC was 11.09 ± 4.26 ng/mL and generic ABC was 9.7 ± 4.12 ng/mL. Though there was no statistically significant difference observed between the concentrations, when the individual patient data was examined, 2 patients were found to have a very high concentration of tacrolimus and at least 7 patients fell below the therapeutic range. These derangements called for retitration with the new generic tacrolimus (40%). The results of our study suggest that generic-to-generic substitutions should be carried out very carefully in a closely observed setting in patients with renal transplants. The strength of our study is that it matched the real clinical practice setting as much as possible unlike a bioequivalence study. Therefore, we recommend repeating C0 at least 3 times over a period of 7 to 10 days with a generic substitution to prevent untoward consequences.