A cross-sectional observational study to assess awareness of pharmacovigilance among interns of a teaching medical institute in western Maharashtra

Background: Adverse Drug reaction (ADR) is one of the most serious health problems and remains an important cause behind treatment non-adherence and treatment failure. Voluntary reporting of ADRs is fundamental basis of Pharmacovigilance and Drug safety. However, underreporting of ADRs remains hindrance to Pharmacovigilance practice. Hence the present study was conducted to assess awareness regarding Pharmacovigilance in Interns.Methods: A cross-sectional questionnaire-based survey was conducted in Interns at tertiary care hospital of Western Maharashtra.Results: Questionnaire was analyzed at the Response Rate of 87.5%. Interns were having good knowledge (52.42%) and practices (50%) about Pharmacovigilance. Majority of interns (85.75%) possess correct attitude towards Pharmacovigilance. All the interns (100%) are of opinion that it is important to report the ADRs. Majority of the interns (97.60%) suggest that it should be mandatory to have an ADR reporting center in each institute. Most of them (59.52%) feel that there should be some incentive to report an ADR and 90.47% of Interns want to get trained in ADR reporting.Conclusions: Awareness and Practice of Pharmacovigilance can be improved by proper training of interns about ADR reporting. We strongly recommend the introduction of ADR reporting in the internship orientation program

Comparative study of hyperbaric 0.5% bupivacaine and hyperbaric 0.5% bupivacaine with low dose dexmedetomidine in spinal anaesthesia

Background: Spinal anaesthesia remains one of the basic techniques in the arsenal of modern anaesthesiology despite the waxing and waning of its popularity over last 100 years since its introduction into clinical practice.It avoids biochemical and metabolic changes consequent to the stress of general anesthesia for surgery as well as provides near optimal conditions for surgery. In present study, we tried to study effectiveness of intrathecal 0.5% heavy bupivacaine alone with Dexmedetomidine as an adjuvant to intrathecal 0.5% heavy bupivacaine for lower limb and lower abdominal surgeries.Methods: The present study was conducted in the department of anaesthesiology from December 2011 to September 2013.This study was a prospective, randomised controlled, single blind, study conducted in 100 patients of ASA grade I and II undergoing elective surgeries under spinal anaesthesia. The patients were divided randomly into two groups, containing 50 patients in each group. Dosages of drugs selected are divided as Group B: Patients received 3 ml of 0.5% hyperbaric bupivacaine (15mg) and Group BD: Patients received 3 ml of 0.5% hyperbaric bupivacaine (15mg) plus 10 µg Dexmedetomidine. Spinal block characteristics, Mean arterial pressure, Mean pulse rate, sedation and side effects were studied during intra-operative and postoperative period.Results: It was found from present study that in Dexmedetomidine group time to reach T10 sensory blockade and complete motor blockade was earlier and a higher level of sensory blockade compared to control group achieved. Duration of sensory, motor blockade and duration of analgesia was significantly prolonged in the Dexmedetomidine group compared to the control group. Hemodynamic parameters were preserved both intra-operatively and postoperatively. However there were a small percentage of patients who developed hypotension and bradycardia which were easily managed without any untoward effect. Hence Dexmedetomidine is a better neuraxial adjuvant for providing early onset of sensory and motor blockade, prolonged sensory blockade and post operative analgesia and adequate sedation.Conclusions: Intrathecal low dose Dexmedetomidine in a dose of 10µg along with 0.5% hyperbaric bupivacaine is an addition into anaesthesiologist's armamentarium for spinal anaesthesia in patients undergoing elective lower abdominal and lower limb surgeries

Knowledge, attitude and practice of adverse drug reaction reporting among teaching and nonteaching hospital physicians

Background: Knowledge, attitude and practice (KAP) analysis may provide insight into the reasons associated with reporting of adverse drug reaction. Therefore study was carried out to investigate knowledge, attitude and practice of adverse drug reaction reporting and identify factors affecting reporting of adverse drug reactions among physicians in a teaching (THPs) and non-teaching hospital/s (NTHPs).Methods: This was a questionnaire based cross sectional study. 6 items on knowledge, 3 on attitude and 1 on practice were scored and mean KAP score calculated. The score was graded as: 0-5 low, 6-8 moderate, 9-10 high. Factors influencing reporting of ADRs were studied. Chi square and student’s unpaired t test were used to study statistical significance intergroup.Results: Out of 102, 61 were THPs and 41 NTHPs. KAP scores were similar in both groups. Both groups believed in reporting all ADRs to new and old drugs. Most did not know where to obtain a form/ if an ADR monitoring centre existed in town. Most were ready to report an ADR to ADR monitoring centre while very few had actually reported. Most were unaware how and where to report. THPs seemed more concerned about being considered negligent in duty and had difficulties identifying ADRs correctly.Conclusions: Groups had moderate knowledge, attitude and practice (KAP) score but there is scope for improvement. Attitude to reporting is positive. Concerns regarding blame for negligence in duty, difficulty in identifying ADRs, how and where to report exist. There is a need to create awareness among physicians and address these factors

End tidal CO2 level (PETCO2) during laparoscopic surgery: comparison between spinal anaesthesia and general anaesthesia

Background: Laparoscopy is a procedure which involves insufflations of the abdomen by a gas, so that endoscope can visualise intra abdominal content without being in direct contact with viscera or tissues. Its advantages are small incisions, less pain, less postoperative ileus, short hospital stay compared to traditional open method. Monitoring of end tidal carbon dioxide (PETCO2) and hemodynamics is very necessary during Laparoscopy surgery. This study is conducted to find out effects of CO2 insufflation on parameters like PETCO2, Mean arterial pulse pressure, SPO2 under spinal anaesthesia and general anaesthesia in ASA I and ASA II patients.Methods: The present study was conducted in the department of anaesthesiology from December 2014 to September 2015.This study was a prospective, randomized controlled, single blind. Each group consisted of 30 patients having Group A and Group B as patient undergoing laparoscopic surgery under Spinal anaesthesia and General anaesthesia respectively. Preoperatively patients in Group A (Spinal anaesthesia) given inj. Midazolam 0.3mg/kg IM 45 before surgery and Group B (General anaesthesia) inj. pentazocin 0.3mg/kg, inj. promethazine 0.5mg/kg, inj. Glycopyrrolate 0.004 mg/kg IM 45 before surgery. In operation theatre, intra operative pulseoximetre, ECG, SPO2, Heart rate (HR), Mean arterial pulse pressure and PETCO2 monitoring done. Amount of CO2 insufflated noted.Results: It was found from present study that in both group there was significant progressive rise in PETCO2 after CO2 insufflation, with peak at 30 min and thereafter plateau till the end of procedure (avg. duration 45-60 min). In group A i.e. laparoscopic surgery under spinal anaesthesia with (spontaneous respiration) the rise in PETCO2 was significant as compared to the group B i.e. laparoscopic surgery under general anaesthesia with controlled ventilation. The heart rate increased after CO2 insufflation in both the group, but it was significant in group A. The increase in SBP, DBP, MAP were less in group A as compared to group B. SPO2 showed no significant changes and it remained above 97% in all patients throughout surgery. All values come to baseline 15 min after insufflation.Conclusions: From the present study it can be concluded that balanced general anaesthesia using IPPV with moderate hyperventilation, as the preferred anaesthetic technique for laparoscopic surgery

A Study of drug utilization and clinical outcomes in indoor patients of hypertensive disorders of pregnancy

Background: Hypertensive disorders of pregnancy are an important determinant of drug use during pregnancy. The aim of study was to assess the clinical outcome and evaluate drug utilization according to WHO core drug prescribing indicators in hypertensive disorders of pregnancy.Methods: This prospective, observational study in a tertiary care hospital was conducted in 150 pregnant women with hypertensive disorders of pregnancy from January 2014 and December 2014 who fulfilled the inclusion criteria. Antepartum and intrapartum care and the maternal and perinatal outcome were noted. The data was analyzed to evaluate clinical outcome and drug utilization according to WHO core drug use indicators.Results: Gestational hypertension was most common among hypertensive disorders of pregnancy seen in 62/150 (41.3%) women. The most common symptom was headache (48%) while sign noted was edema (69%). A total of 66% women had preterm delivery and 42% babies weighed less than 2.5 kg. Average number of drugs per encounter was 9.7. Percentage of drugs prescribed by generic name and from essential drug list was 64% and 79% respectively. The most commonly used drugs were vitamins and minerals prescribed in 100% patients followed by antihypertensive drugs (92%). The most common antihypertensive used were calcium channel blockers and anticonvulsant was magnesium sulphate.Conclusions: There was increased maternal and perinatal morbidity and operative intervention among pregnant women with hypertensive disorders of pregnancy. Most of the drugs were used appropriately and were in accordance with standard guidelines. The important problems identified were inappropriate use of antimicrobials, use of sublingual nifedipine and use of brand names in 1/4th of prescriptions.

Comparison of cardiovascular safety of escitalopram and sertraline based on electrocardiographic alterations: a pharmacovigilance study

Background: Escitalopram and sertraline are the most commonly prescribed antidepressant drugs, belongs to SSRI class. Both the drugs are long been considered as free from cardiovascular adverse effects. Recently number of studies reported potential association between these drugs and pronounced cardiovascular adverse effects. ECG changes like prolongation of QT interval are frequently used as markers for the increased risk of a fatal cardiac arrhythmia. The potential cardiovascular adverse reaction profile of both these drugs is little studied in Indian rural population.Methods: This was a 6 weeks prospective open label observational study carried out in a drug naive 209 patients receiving either escitalopram (n=106) or sertraline (n=103). ECG parameters like heart rate, RR interval, PQ/PR interval, QRS duration and QTc interval, were obtained directly from the digital machine recordings, additionally the QT interval was measured manually with the help of caliper. Statistical analysis was done by using Statistical software SPSS 17.0.Results: Out of 209 drugs naive patients, 12 from escitalopram group and 10 patients from Sertraline were lost to follow-up. Hence ECG recordings of the remaining 94 patients under escitalopram group, 93 patients under sertraline group were used for study analysis. The ECG alterations caused by the escitalopram were compared with that caused by sertraline. It was observed that the differences between the ECG alterations caused by either of escitalopram or sertraline were statistically non-significant.Conclusions: It was concluded, at therapeutic doses neither of the drugs have the potential risk of drug induced arrhythmias, throughout the study. 

A cross-sectional observational study to assess awareness of pharmacovigilance among interns of a teaching medical institute in western Maharashtra

Background: Adverse Drug reaction (ADR) is one of the most serious health problems and remains an important cause behind treatment non-adherence and treatment failure. Voluntary reporting of ADRs is fundamental basis of Pharmacovigilance and Drug safety. However, underreporting of ADRs remains hindrance to Pharmacovigilance practice. Hence the present study was conducted to assess awareness regarding Pharmacovigilance in Interns.Methods: A cross-sectional questionnaire-based survey was conducted in Interns at tertiary care hospital of Western Maharashtra.Results: Questionnaire was analyzed at the Response Rate of 87.5%. Interns were having good knowledge (52.42%) and practices (50%) about Pharmacovigilance. Majority of interns (85.75%) possess correct attitude towards Pharmacovigilance. All the interns (100%) are of opinion that it is important to report the ADRs. Majority of the interns (97.60%) suggest that it should be mandatory to have an ADR reporting center in each institute. Most of them (59.52%) feel that there should be some incentive to report an ADR and 90.47% of Interns want to get trained in ADR reporting.Conclusions: Awareness and Practice of Pharmacovigilance can be improved by proper training of interns about ADR reporting. We strongly recommend the introduction of ADR reporting in the internship orientation program