Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies

Effects of Early Versus Late Amniotomy on maternal and fetal outcomes in low risk induced pregnancies following cervical ripening for labour induction: A Randomized control trial

INTRODUCTION: Induction of labour (IOL) is a common obstetrical procedure done in pregnancy when continuing the pregnancy has more risks to the mother or fetus than benefits. The common indications for IOL are maternal medical complications like hypertension, diabetes, connective tissue disorders and fetal indications are intrauterine growth restriction, Oligohydramnios and non-reassuring fetal status. Most low risk pregnancies between 40 weeks to 41 weeks are induced if they have not got spontaneous labor according to Obstetrician’s discretion. The induction rate in pregnancy is 9.6% globally and in more developed countries the induction rate is more having maximum of 35%. The induction rate in CMC is 40%. The cervix is assessed with BISHOP score to assess the possibility of vaginal delivery. The women with unfavorable BISHOP score are given ripening agents for 12 hours prior to induction of labour. The induction of labour not only doubles the caesarean rate but also increases infection rate and labour related other maternal and fetal complications. So, induction of labour is done only when it is indicated. In indicated women measures are taken to minimize the maternal and fetal complications like minimizing the pelvic examination, retaining the amniotic membrane till late in labour and using the Cardiotocograph (CTG) for fetal monitoring. Studies have shown the early amniotomy in spontaneous labour reduces the duration of labour and thereby reducing the infective morbidity to the mother and the baby without increasing the caesarean rate. OBJECTIVES: To assess whether late amniotomy reduce the rate of caesarean delivery in comparison with early amniotomy in low risk pregnant women who undergo induction of labour. METHODS: In the present randomized controlled trial, low risk induced women with singleton pregnancies presenting at a tertiary teaching hospital in South India between June, 2018, and August 2019, were randomized in a 1:1 ratio to undergo early amniotomy or late amniotomy. The primary outcome was the rate of Caesarean section. Per-protocol analyses were performed and the LSCS rate was compared between the groups of patients. RESULTS: There were 225 patients randomized to each group. In early amniotomy group, 63 women underwent LSCS whereas in late amniotomy group, only 42 women underwent LSCS (P value of 0.0193). CONCLUSION: Early Amniotomy was associated with increased LSCS rate in early amniotomy (Amniotomy along with oxytocin augmentation) when compared to delayed amniotomy group (amniotomy after 6 hours of oxytocin augmentation) in low risk induced women. • This study showed increased LSCS rate in early amniotomy (Amniotomy along with oxytocin augmentation) when compared to delayed amniotomy group (amniotomy after 6 hours of oxytocin augmentation), which is statistically significant with P value of 0.0193. • This study also showed a smaller number of NRFS as indication of LSCS in late amniotomy when compared to early amniotomy group. There was statistically significant difference in NRFS as an indication of LSCS between the two groups, P value: 0.0383. • There was more category III NRFS who delivered by LSCS in early amniotomy group compared to late amniotomy group with P value of 0.0143. • We also found that duration of labour was slightly less (1 hour) in early amniotomy group compared to late amniotomy group. Which is significant- 0.049. • The Amount of oxytocin required was less in early amniotomy group. Which is significant with P value of 0.001. • Maternal complications like chorioamnionitis, PPH, Postpartum fever, postpartum endometritis and fetal outcomes like sepsis, asphyxia, low APGAR score showed no significant difference among both groups

A pharmacovigilance study of antiretroviral therapy in HIV positive out patients at a tertiary care teaching hospital

Background: Anti-Retroviral Therapy regimen (ART) is the only treatment option for treating the HIV positive patients for improving the immune system by increasing the CD4 cells. But eventually these medications lead to development of some Adverse Drug Reactions (ADRs) in seropositive patients under treatment.Methods: A prospective observational study was conducted for 6 months from March to August 2018 at ART Centre, Sri Venkateswara Ramnarayan Ruya Government General Hospital (SVRRGGH), Tirupati.Results: Out of 216 ADRs identified, majority where identified in females (54.35%). Most common regimen caused ADR was tenofovir+ lamivudine+ efavirenz (TLE) (55.55%). Data were analysed using the chi-square test were P-value was found to be 0.0024. Majority of ADRs were found in patients of age group between 31-35years was found to be 45 (20.83%) followed by age group between 41-45years was found to be 40 (18.51%). Most of the ADRs were related to central nervous system (27.31%) followed by metabolic disorders (26.38%), hematologic system (23.14%), gastrointestinal system (12.96%), dermatologic system (9.25%), renal system (0.46%) and musculoskeletal system (0.46%). On evaluation of WHO-UMC causality of ADRs, majority were found to be possible (78.7%). The Hartwig and Siegel’s severity assessment scale showed that most of the ADRs were mild (64.42%). The Schumock and Thornton preventability scale showed that 50.92% patients ADRs were probably preventable.Conclusions: As most of the ADRs were observed in patients receiving TLE regimen. So, patients receiving TLE regimen need intensive monitoring. Doctors, nurses, pharmacist must focus on early detection and prevention of ADRs, based on their severity

A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana

Background: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.ng

BIG DATA ANALYTICS IN PHARMACOVIGILANCE - A GLOBAL TREND

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India

Seroprevalence of transfusion transmitted infections in voluntary and replacement blood donors in a tertiary care hospital blood bank of Anantapur, Andhra Pradesh, India: 5 years retrospective study

Background: Critical part of transfusion is effective screening of TTI, to reduce the risk of transmission is as safe as possible. The present study has undertaken to focus on seroprevalence of TTIs among both voluntary and replacement donors and also to project epidemiological data of TTIs in this community.Methods: This is a retrospective study conducted from January 2014 to December 2018. All blood samples collected from donors were screened for HIV, HBV, HCV, Syphilis and malaria according to blood bank policy. Before drawing blood, donors were asked to fill pre structured Blood bank questionnaire and consent form.Results: In this present 5-year study, total number of blood donor population was 54937, among them voluntary donors were 33891 and replacement donors were 21046. Out of 33891 voluntary donors, 33486(98.8%) were males and remaining 405(1.19%) were females. All replacement donors (21046) were males. The seroprevalence of HBV was highest, 1.82% (1003/54937) followed by HCV 0.31% (175/54937) in all the donors. The seropositivity for HIV is 0.23% (129/54937), for syphilis 0.04% (24/54937) and for malaria 0.01% (6/54937).Conclusions: National blood transfusion policy should be strengthening the standards and quality of screening across the country. For blood screening, resources and appropriate screening assays must be available at all health centres

REFRIGERANT RECOVERY UNIT

In this project we are fabricating the Refrigerant Recovery unit. It is a simple unit which is used for recovery the refrigerants in refrigeration system and air conditioning systems. It is used to recover the refrigerants and other refrigerants also. The refrigerant or gas which is stored in recovery unit is reusable. The refrigerants are very hazardous and harmful. Due to concerns about environmental pollution caused by the release of refrigerants into the environment, and ozone layer depletion due to choro-for a carbons present in the refrigerant gas so, we use recovery unit to recover that gases when any Leakages or repairs occur in refrigeration system and Air conditioning system. We know that refrigerants are very cost .so, we use recovery unit to store the refrigerants in recovery cylinder and we reuse it. It is very is useful in central AC plants (Air handing units and fan coil units) in industries. In future international Refrigeration society banned the present refrigerants in that time recovery unit is so useful to recover that refrigerants or gases .It is very useful to protect our Atmosphere and Environment

Maximizing Resource Efficiency using Task Scheduling in Cloud

Considering the growing use of cloud computing and the want for best use of resources within the cloud, and attention to users that get services they use supported their pay-as-you-go basis, there ought to be a faster approach for users to decrease the user's waiting time and task's waiting time. The main purpose of this paper is to provide comparison between various task scheduling algorithms hence gives better understanding as to which algorithms aids better in maximizing resource efficiency and also enhance security by giving various layers of security. There are many scheduling algorithms within the world. In this paper, we have selected a few better working algorithms along the traditional max-min and min-min algorithms and also the security is enhanced using ECC encryption.

Facts and Treatment of Bullous Pemphigoid: A Review

Bullous pemphigoid (a type of pemphigoid) is an autoimmune pruritic skin disease that typically occurs in people aged over 60, that may involve the formation of blisters (bullae) in the space between the epidermal and dermal skin layers. It is classified as a type II hypersensitivity reaction, which involves formation of anti-hemidesmosome antibodies, causing a loss of keratinocytes to basement membrane adhesion. Pemphigus and bullous pemphigoid are autoantibody-mediated blistering skin diseases. In pemphigus, keratinocytes in epidermis and mucous membranes lose cell-cell adhesion, and in pemphigoid, the basal keratinocytes lose adhesion to the basement membrane. Pemphigus lesions are mediated directly by the autoantibodies, whereas the autoantibodies in pemphigoid fix complement and mediate inflammation. In both diseases, the autoantigens have been cloned and characterized; pemphigus antigens are desmogleins (cell adhesion molecules in desmosomes), and pemphigoid antigens are found in hemidesmosomes (which mediate adhesion to the basement membrane). This knowledge has enabled diagnostic testing for these diseases by enzyme-linked immunosorbent assays and dissection of various pathophysiological mechanisms, including direct inhibition of cell adhesion, antibody-induced internalization of antigen, and cell signaling. Understanding these mechanisms of disease has led to rational targeted therapeutic strategies

<span style="font-size:15.0pt;color:black;mso-bidi-font-weight:bold" lang="EN-US">Antioxidant activity of <i>Hedychium</i> <i>spicatum</i> Buch.- Ham. rhizomes </span>

354-358The different extracts of Hedychium spicatum Buch.-Ham. (Zingiberaceae) were evaluated for antioxidant activity by 1, 1-diphenyl-2-picrylhydrazyl (DPPH) radical scavenging activity and reducing power determination method. Total phenol and total flavonoid content in each extracts were also determined. Gallic acid and ascorbic acid were used as reference standards. They exhibited strong antioxidant DPPH radical scavenging activity with IC50 value of 0.43, 259.1, 386.7, 414.3, 77.01 and 51.54 μg/mL for gallic acid, petroleum ether, benzene, chloroform, methanol and aqueous extracts of rhizomes of H. spicatum, respectively. The absorbance for reducing power was found to be 0.540, 0.036, 0.042, 0.046, 0.050 and 0.072 for ascorbic acid, petroleum ether, benzene, chloroform, methanol and aqueous extracts of rhizomes of H. spicatum, respectively. Total phenol content was found to be 13, 33, 24, 32 and 35 mg equivalent to gallic acid per gram of petroleum ether, benzene, chloroform, methanol and aqueous extracts of rhizomes of H. spicatum, respectively. Total flavonoid content was found to be 4.6, 7, 7.5, 34.5 and 40 mg equivalent to rutin per gram of petroleum ether, benzene, chloroform, methanol and aqueous extracts of rhizomes of H. spicatum, respectively. The strongest antioxidant activity of the methanol and aqueous extracts could be due to the presence of flavonoids and phenols