Cross sectional study to assess the awareness of pharmacovigilance among post graduate residents of tertiary care medical college hospital of central India

Background: Pharmacovigilance knowledge and awareness in post graduate student doctors is key factor for proper implementation of PvPI. This study was planned to evaluate the knowledge &awareness of pharmacovigilance in post graduate students in tertiary care centre in Indore.Methods: It was a single point cross sectional questionnaire-based study conducted in a tertiary care Institute MGM Medical College & M.Y. Hospital in the state of Madhya Pradesh at Indore. It was conducted among post graduate student doctors from various clinical departments. Total of 150 questionnaires were distributed, 115 of them were returned back and were analysed.Results: Overall knowledge level was satisfactory. 91.30% knew about ADR while 95% were aware about PVPI. 13% knew about local AMC at Indore while only 4.34% knew global centre for Pharmacovigilance is at Sweden Uppsala. 86.95% thought Med watch as global database for ADR against only 13% knew its Vigibase. 96.50% thought ADR reporting is necessary. 97.40% thought it should be included in UG curriculum. 95.65% had not reported any ADR till date while 86.95% had not seen an ADR form.Conclusions: Post graduate doctors are the prime candidates to impart the importance of pharmacovigilance. The study strongly suggested that there was a great need to create awareness among the post graduate doctors to improve the reporting of ADRs

Assessment of knowledge, attitudes and practice among the post graduate students of dentistry and physiotherapy towards adverse drug reactions reporting and pharmacovigilance at a tertiary care centre at Indore, India

Background: Pharmacovigilance knowledge and training in post graduate student doctors is key factor for proper implementation of PvPI. Often the dentists and physiotherapists who are also one of the main stakeholders for ADR reporting are neglected for training and knowledge regarding pharmacovigilance. This study was planned to evaluate the knowledge and awareness of pharmacovigilance in post graduate students in tertiary care centre in Indore.Methods: It was a single point cross sectional questionnaire-based study conducted in a tertiary care Institute MGM Medical College and M.Y. Hospital in the state of Madhya Pradesh at Indore. It was conducted among post graduate student doctors from dentistry and physiotherapy. Total of 55 questionnaires were distributed, 50 of them were returned back and were analysed.Results: Overall knowledge level was average. 90% knew about ADR while 80% were aware about PVPI. 10% knew about local AMC at Indore while only 04% knew global centre for Pharmacovigilance is at Sweden Uppsala. 88% thought Med watch as global database for ADR against only 12% knew its Vigibase. 90% thought ADR reporting is necessary. 96% thought it should be included in UG curriculum. 98% had not reported any ADR till date while 84% had not seen an ADR form.Conclusions: Post graduate doctors are the prime candidates to impart the importance of pharmacovigilance. The study strongly suggested that there was a great need to create awareness and impart training among the post graduate doctors to improve the reporting of ADRs

A prospective study of adverse drug reactions associated with chemotherapy in patients of carcinoma head and neck in Government Cancer Hospital Indore, India

Background: Adverse drug reactions (ADRs) has become one of the major health issues due to wide use of medications worldwide. Chemotherapy is one of the treatment lines in which multiple drugs are commonly used for long term in cancer patients, are more prone to cause ADR.Methods: Head and neck cancer patients admitted in government cancer hospital, Indore for chemotherapy were included in study for a period of 6 month from March to August 2019. Data from chemotherapy related ADR was obtained either from patient’s case reports or interview of patients, recorded in suspected adverse drug reaction reporting form (version 1.3) of CDSCO and analyzed.Results: During 6 months duration total 126 patients (M:F=108:18) were enrolled in the study, among which 251 ADRs were reported. Majority of ADRs occur in 45-60 years of age group followed by 30-45 years. Paclitaxel, cisplatin, 5-florouracil (5-FU) combinations (45.2%) implicated highest number of ADRs followed by paclitaxel and carboplatin combination (38%). Most common ADR was alopecia and constipation. ADR related mostly with GIT system followed by integumentary, haematological system while CNS was least affected.Conclusions: In this study Ca tongue was most commonly seen head and neck cancer followed by Ca buccal mucosa. Age group 45-60 years were commonly affected. Paclitaxel, cisplatin, 5-FU combination was commonly used regimen and primary cause of ADR. Alopecia and constipation were noted to be most common ADR. Other ADRs reported were mild and easily manageable

Evaluation of the effect of piperine per se and its interaction with ondansetron on haloperidol induced catalepsy in Albino mice

Background: This study aims to evaluate the per se effect of piperine and its interaction with ondansetron on haloperidol induced catalepsy in swiss albino mice.Methods: The piperine crystals were separated from crude extract of Piper nigrum. Catalepsy was induced by haloperidol (1mg/kg, i.p.). Control group received 2% gum acacia (10ml/kg), standard group ondansetron (0.5mg/kg), test group piperine (10mg/kg) and combination group ondansetron plus piperine (0.5mg/kg + 10mg/kg), per oral, respectively. In acute study, drugs were administered only once, one hour prior to the haloperidol administration. Whereas in chronic study, catalepsy was determined on the seventh day of treatment.Results: In acute study, from 60 min onwards after haloperidol administration, ondansetron and ondansetron plus piperine group resulted in significantly lower cataleptic scores than the control treated group. On the other hand, 120 min onwards ondansetron group showed significantly lower cataleptic scores (24.62) as compared to the ondansetron plus piperine group (31.50). In the chronic study, from 60 min onwards, ondansetron and the ondansetron plus piperine resulted in significantly lower cataleptic scores than the control treated group. Also the combination of ondansetron plus piperine was more significantly protective compared to ondansetron alone (P <0.05).Conclusions: Piperine has the potential to be used as a bioenhancer when combined with other drugs which would reduce the dose of drugs and thereby adverse effects. It may act probably by enhancing the bioavailability as well as by inhibiting the metabolic pathways of other drugs

Spectrophotometric assessment of effect of aqueous extract of Aloe vera on rabbit erythrocytes in varying concentrations of saline

Background: Hemolytic disorders are one of the prime reasons for frequent blood transfusions which involves lots of costs and sufferings to the patient. This study was undertaken to determine the effect of water soluble extract of Aloe vera on rabbit erythrocytes in varying concentrations of NaCl from 0.9% (isotonic) to 0.15% (hypotonic).Methods: Aqueous extract of Aloe vera (AVE) 200mg/kg was orally administered to rabbits in the test group while control group was given 1ml of distilled water (DW). Blood was withdrawn from rabbits, centrifuged and suspension in 1ml of normal saline was made. 20 microliter of red blood cells suspension from both control and test groups was added to normal saline of varying concentrations from 0.9% to 0.15% NaCl which were quantitatively analysed for hemolysis by UV spectrophotometer. Data was analysed by unpaired t test and P <0.05 was considered statistically significant.Results: The difference in percentage of hemolysis in both test and control groups was not statistically significant. Therefore, acute administration of water soluble extract of Aloe vera (200mg/kg) did not have protective effect on rabbit erythrocytes against hypotonic solution of normal saline.Conclusions: Aloe vera might be useful for the treatment of oxidative stress-related human disorders by virtue of its antioxidant activity and may have a role in prevention of hemolysis which needs to be explored by further studies

STUDY OF CNS ACTIVITIES OF PIPERINE PERSE AND ITS BIOENHANCING EFFECT ON VARIOUS DRUGS IN EXPERIMENTAL ANIMAL MODELS

Objective: Study of CNS activities of piperine perse and its bio-enhancing effect on various drugs in experimental animal models.Methods: The CNS effects of piperine and its interaction with various drugs were evaluated by maximal electroshock convulsion model, pentobarbitone-induced sleeping time, anxiolytic activity, muscle relaxant activity and antidepressant activity using tail suspension and forced swimming test using standard procedures in experimental animal models. piperine at a dose of 10 and 20 mg/kg orally was used to evaluate CNS activities.Results: The results revealed that piperine perse posses only anticonvulsant activity and other significant CNS effects were not observe. But when it was combined with various drugs piperine increases the effect of the standard drug.Conclusion: Piperine 10 mg/kg has the potential to be used as a bio-enhancing agent when combined with other drugs. Bio-enhancing effect of piperine will decrease the dose of the standard drug, thereby decreasing the risk of their toxicity.Keywords: Piperine, Bio-enhancing, MES, Anxiolytic test, Tail suspension test, Forced swimming test, Motor co-ordination, Righting refle

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P &lt; 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

Background: Detailed, comprehensive, and timely reporting on population health by underlying causes of disability and premature death is crucial to understanding and responding to complex patterns of disease and injury burden over time and across age groups, sexes, and locations. The availability of disease burden estimates can promote evidence-based interventions that enable public health researchers, policy makers, and other professionals to implement strategies that can mitigate diseases. It can also facilitate more rigorous monitoring of progress towards national and international health targets, such as the Sustainable Development Goals. For three decades, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) has filled that need. A global network of collaborators contributed to the production of GBD 2021 by providing, reviewing, and analysing all available data. GBD estimates are updated routinely with additional data and refined analytical methods. GBD 2021 presents, for the first time, estimates of health loss due to the COVID-19 pandemic. Methods: The GBD 2021 disease and injury burden analysis estimated years lived with disability (YLDs), years of life lost (YLLs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries using 100 983 data sources. Data were extracted from vital registration systems, verbal autopsies, censuses, household surveys, disease-specific registries, health service contact data, and other sources. YLDs were calculated by multiplying cause-age-sex-location-year-specific prevalence of sequelae by their respective disability weights, for each disease and injury. YLLs were calculated by multiplying cause-age-sex-location-year-specific deaths by the standard life expectancy at the age that death occurred. DALYs were calculated by summing YLDs and YLLs. HALE estimates were produced using YLDs per capita and age-specific mortality rates by location, age, sex, year, and cause. 95% uncertainty intervals (UIs) were generated for all final estimates as the 2·5th and 97·5th percentiles values of 500 draws. Uncertainty was propagated at each step of the estimation process. Counts and age-standardised rates were calculated globally, for seven super-regions, 21 regions, 204 countries and territories (including 21 countries with subnational locations), and 811 subnational locations, from 1990 to 2021. Here we report data for 2010 to 2021 to highlight trends in disease burden over the past decade and through the first 2 years of the COVID-19 pandemic. Findings: Global DALYs increased from 2·63 billion (95% UI 2·44–2·85) in 2010 to 2·88 billion (2·64–3·15) in 2021 for all causes combined. Much of this increase in the number of DALYs was due to population growth and ageing, as indicated by a decrease in global age-standardised all-cause DALY rates of 14·2% (95% UI 10·7–17·3) between 2010 and 2019. Notably, however, this decrease in rates reversed during the first 2 years of the COVID-19 pandemic, with increases in global age-standardised all-cause DALY rates since 2019 of 4·1% (1·8–6·3) in 2020 and 7·2% (4·7–10·0) in 2021. In 2021, COVID-19 was the leading cause of DALYs globally (212·0 million [198·0–234·5] DALYs), followed by ischaemic heart disease (188·3 million [176·7–198·3]), neonatal disorders (186·3 million [162·3–214·9]), and stroke (160·4 million [148·0–171·7]). However, notable health gains were seen among other leading communicable, maternal, neonatal, and nutritional (CMNN) diseases. Globally between 2010 and 2021, the age-standardised DALY rates for HIV/AIDS decreased by 47·8% (43·3–51·7) and for diarrhoeal diseases decreased by 47·0% (39·9–52·9). Non-communicable diseases contributed 1·73 billion (95% UI 1·54–1·94) DALYs in 2021, with a decrease in age-standardised DALY rates since 2010 of 6·4% (95% UI 3·5–9·5). Between 2010 and 2021, among the 25 leading Level 3 causes, age-standardised DALY rates increased most substantially for anxiety disorders (16·7% [14·0–19·8]), depressive disorders (16·4% [11·9–21·3]), and diabetes (14·0% [10·0–17·4]). Age-standardised DALY rates due to injuries decreased globally by 24·0% (20·7–27·2) between 2010 and 2021, although improvements were not uniform across locations, ages, and sexes. Globally, HALE at birth improved slightly, from 61·3 years (58·6–63·6) in 2010 to 62·2 years (59·4–64·7) in 2021. However, despite this overall increase, HALE decreased by 2·2% (1·6–2·9) between 2019 and 2021. Interpretation: Putting the COVID-19 pandemic in the context of a mutually exclusive and collectively exhaustive list of causes of health loss is crucial to understanding its impact and ensuring that health funding and policy address needs at both local and global levels through cost-effective and evidence-based interventions. A global epidemiological transition remains underway. Our findings suggest that prioritising non-communicable disease prevention and treatment policies, as well as strengthening health systems, continues to be crucially important. The progress on reducing the burden of CMNN diseases must not stall; although global trends are improving, the burden of CMNN diseases remains unacceptably high. Evidence-based interventions will help save the lives of young children and mothers and improve the overall health and economic conditions of societies across the world. Governments and multilateral organisations should prioritise pandemic preparedness planning alongside efforts to reduce the burden of diseases and injuries that will strain resources in the coming decades. Funding: Bill &amp; Melinda Gates Foundation

Cross sectional study to assess the awareness of pharmacovigilance among post graduate residents of tertiary care medical college hospital of central India

Background: Pharmacovigilance knowledge and awareness in post graduate student doctors is key factor for proper implementation of PvPI. This study was planned to evaluate the knowledge &amp;awareness of pharmacovigilance in post graduate students in tertiary care centre in Indore.Methods: It was a single point cross sectional questionnaire-based study conducted in a tertiary care Institute MGM Medical College &amp; M.Y. Hospital in the state of Madhya Pradesh at Indore. It was conducted among post graduate student doctors from various clinical departments. Total of 150 questionnaires were distributed, 115 of them were returned back and were analysed.Results: Overall knowledge level was satisfactory. 91.30% knew about ADR while 95% were aware about PVPI. 13% knew about local AMC at Indore while only 4.34% knew global centre for Pharmacovigilance is at Sweden Uppsala. 86.95% thought Med watch as global database for ADR against only 13% knew its Vigibase. 96.50% thought ADR reporting is necessary. 97.40% thought it should be included in UG curriculum. 95.65% had not reported any ADR till date while 86.95% had not seen an ADR form.Conclusions: Post graduate doctors are the prime candidates to impart the importance of pharmacovigilance. The study strongly suggested that there was a great need to create awareness among the post graduate doctors to improve the reporting of ADRs

Assessment of knowledge, attitudes and practice among the post graduate students of dentistry and physiotherapy towards adverse drug reactions reporting and pharmacovigilance at a tertiary care centre at Indore, India

Background: Pharmacovigilance knowledge and training in post graduate student doctors is key factor for proper implementation of PvPI. Often the dentists and physiotherapists who are also one of the main stakeholders for ADR reporting are neglected for training and knowledge regarding pharmacovigilance. This study was planned to evaluate the knowledge and awareness of pharmacovigilance in post graduate students in tertiary care centre in Indore.Methods: It was a single point cross sectional questionnaire-based study conducted in a tertiary care Institute MGM Medical College and M.Y. Hospital in the state of Madhya Pradesh at Indore. It was conducted among post graduate student doctors from dentistry and physiotherapy. Total of 55 questionnaires were distributed, 50 of them were returned back and were analysed.Results: Overall knowledge level was average. 90% knew about ADR while 80% were aware about PVPI. 10% knew about local AMC at Indore while only 04% knew global centre for Pharmacovigilance is at Sweden Uppsala. 88% thought Med watch as global database for ADR against only 12% knew its Vigibase. 90% thought ADR reporting is necessary. 96% thought it should be included in UG curriculum. 98% had not reported any ADR till date while 84% had not seen an ADR form.Conclusions: Post graduate doctors are the prime candidates to impart the importance of pharmacovigilance. The study strongly suggested that there was a great need to create awareness and impart training among the post graduate doctors to improve the reporting of ADRs