Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital

Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type 揂� reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.

The study of awareness and adherence in patients receiving anti-hypertensive drugs: a hospital based study

Background: Hypertension is an important worldwide public health challenge. It has changed from a trivial cause of death and disability to one of the global burden diseases. The biggest obstacle for inadequate therapeutic control of blood pressure is meagre knowledge, poor attitude, inadequate treatment practices and lack of adherence towards antihypertensive treatment. The present study was planned to assess the awareness of hypertension on various aspects and to evaluate treatment adherence in hypertensive patients.Methods: This cross-sectional study was conducted on 100 hypertensive patients of both genders visiting medicine OPD at HIMS, Dehradun over a period of six months. A structured and validated questionnaire was used to assess the knowledge, attitude and practice (KAP) among patients. Morisky 8-Item Medication Adherence Questionnaire was used to assess the adherence towards antihypertensive medications. For statistical analysis Chi square test was used.Results: Out of the 100 patients the median KAP scores were 6(5),5(1) and 10(4) respectively. Most of the subjects had high median scores on attitude but majority of the subjects had low knowledge and self-care practice scores. Further Analysis of data revealed that a poor score in self-care practice was significantly associated to the gender(p<0.004) as well as to the level of education(p<0.006).Only 40% patients were adherent to their medication, this result was statistically associated with the level of education (p<0.00001).Conclusions: Hypertensive patients in our community have good attitude but poor knowledge and self-care practices towards management of hypertension. Patients were also found to be non-adherent to their antihypertensive medications.

Comparative evaluation of levetiracetam and valproic acid as monotherapy on cognitive impairment in patients of epilepsy

Background: Cognitive decline with AEDs (Anti-epileptic drugs) is associated with learning and memory deficits especially in the younger age group. The data regarding the impact of levetiracetam and valproic acid as monotherapy on cognition in epileptic patients is scarce. The present study was done for evaluation of cognitive decline associated with the use of AEDs.Methods: Present study was a prospective study on 60 patients on AEDs for a period of 12 weeks. Patients were enrolled from the Department of Neurology, Swami Rama Himalayan University, Dehradun, Uttarakhand, India and divided into group A (levetiracetam) and group B (valproic acid) with 30 patients in each group. Permission from the institutional ethics committee and written informed consent was taken from all the patients. They were analyzed for cognitive impairment using MMSE and MoCA scales at baseline and 12 weeks.Results: The mean duration of disease was 2.13�1 years and 2.08�1 years and mean age of the patients was 14.67�9 years in group A and 16.20�6 years in group B. GTCS was present in 31 patients (52%) followed by partial seizures in 29 patients (48%). The mean change in the MMSE scores from baseline to 12 weeks was significant in group A 1.30�1 (p value <0.05) and change group B was -0.20�4 not statistically significant. The mean change was observed in MoCA scores from baseline to 12 weeks was significant in both groups A and B by 1.17�1 and -0.70�1 respectively (P value <0.05).Conclusions: Patients on levetiracetam showed cognitive improvement, whereas patients on valproic acid showed a decline in the MMSE and MoCA scores.

Comparative efficacy of pregabalin and baclofen in the rodent chronic constriction injury model of neuropathic pain

Background: Neuropathic pain is associated with prolonged disability and is usually not responsive to conventional analgesics like NSAIDs and opioids. Even the recommended first-line drugs are effective in less than 50% patients. Thus, drugs with different mechanisms of action are needed. Baclofen, a GABA-B agonist has shown benefit in different types of neuropathic pains and is compared against pregabalin.Methods: The sciatic nerve was ligated in 2 groups of 6 rats each as per the chronic constriction injury model of neuropathic pain on day 0. After 14 days the effect of single doses of pregabalin (30mg/kg) and baclofen (5mg/kg) intraperitoneally were assessed over a 2 hours period. Thermal and mechanical hyperalgesia were assessed as measures of neuropathic pain by the hotplate and pin-prick method respectively.Results: Significant thermal and mechanical hyperalgesia was produced 14 days after sciatic nerve ligation in both the groups (p <0.05). Both pregabalin (p <0.001) and baclofen (p <0.01) were effective in decreasing thermal hyperalgesia throughout the two hours study period, but pregabalin was more effective as compared to baclofen (p <0.05) at 30, 60 and 120minutes. Both the drugs produced a significant decrease in mechanical hyperalgesia (p <0.01) throughout the study period. Again, pregabalin was the more effective drug (p <0.05) at all time points.Conclusions: Significant thermal and mechanical hyperalgesia was seen 14 days after sciatic nerve ligation. Both pregabalin and baclofen were effective in reversing the hyperalgesia, but pregabalin was the more effective of the two drugs at all time points.

Antibiotic resistance pattern in intensive care unit of a tertiary care teaching hospital

Background: Antimicrobials are a major class of drugs prescribed in Intensive Care Unit (ICU). Widespread use of empirical antibiotic therapy has facilitated the emergence of drug resistance, since empirical therapy is very often initiated at the outset, even before culture and sensitivity reports are available. The problem of drug resistance is on a rise, therefore, this study was planned to assess the drug resistance and sensitivity patterns of the blood isolates recovered from ICU.Methods: An observational- prospective study was conducted in the Tertiary care teaching hospital over a period of twelve months to assess antibiotic resistance and sensitivity pattern. A total of 104 consecutive patients receiving antibiotics in the ICU and having blood cultures with significant growth were included in the study. Blood sample was collected and after obtaining a culture growth, the identification and antimicrobial sensitivity testing was done.Results: Blood stream infection by Gram-negative bacteria (50.96%) was more common than Gram-positive bacteria (49.04%). Coagulase negative Staphylococci (CoNS) was the predominant single blood culture isolate (35.58%). Klebsiella pneumoniae (13.46%), Escherichia coli (12.50%), Acinetobacter baumannii complex (7.69%) were commonly isolated gram negative organisms. Gram positive isolates were resistant to beta lactams in maximum patients whereas Tigecycline, Linezolid, Daptomycin, Vancomycin, Nitrofurantoin and Teicoplanin were sensitive against them. Common gram negative isolates were sensitive to Colistin and Tigecycline but resistant to most of the antibiotics.Conclusions: A preponderance of gram negative bacteria over gram positive bacteria was noted with a higher degree of resistance to most of the first line antimicrobial agents.

Evaluation of levetiracetam and valproic acid as monotherapy on quality of life in patients of generalized tonic clonic epilepsy

Background: Quality of life plays an important role in patients of epilepsy and is the most neglected part during management. The antiepileptic drugs treatment results in seizure control but adversely affect the quality of life in patients.Methods: An observational analytical study was conducted in the Department of pharmacology with Department of Neurology of Himalayan Institute of Medical Sciences, Dehradun over 12 months. 85 patients fulfilling the inclusion criteria with diagnosis of generalized tonic clonic seizures (GTCS) were enrolled and divided into two groups based on physicians discretion and followed up for 12 weeks. Patients were evaluated for quality of life by QOLIE-10 self administered questionnaire at 0 and 12 weeks, assessed for seizure control and drug related adverse effects.Results: 85 patients were enrolled and divided into two treatment arms as per physician discretion, levetiracetam (41) and valproic acid group (44). Study drugs showed significant improvement in quality of life, levetiracetam showed mean change that was significantly greater than valproic acid (p=0.003) at 12 weeks. Patients who failed to achieve seizure control at 6 weeks were 17% patients in levetiracetam and 20% in valproic acid group, reason being non-adherence which was 17% and 20% respectively. Adverse events recorded with Levetiracetam (10), most common being increased sleep and with valproic acid (18), with most common being increased sleep and weight gain.Conclusions: Levetiracetam treatment resulted in better quality of life, with similar seizure control but decreased number of adverse effect then Valproic acid.

Use of Computer Assisted Learning as an Alternative to Experimental Pharmacology Teaching: Student's Opinion.

To evaluate student opinion on use of CAL in the MBBS 2nd professional experimental practical pharmacology curriculum.Also to get their views on the advantages and disadvantages of using CAL over traditional methods. A cross-sectional questionnaire based study was conducted at HIMS, Dehradun and Uttarakhand. After explaining the purpose of the study, voluntary inform consent was taken from the subjects before the start of the study. Students were instructed on experiments followed by computer simulation of the same. Thereafter avalidated self-designed questionnaire form was duly filled by each respondent.Out of the total 98 students, 88 (90%) of these thought that CAL is an effective method of teaching practical aspects. They also agreed to the fact that CAL should be conducted as an adjuvant to practical classes. Majority of students agreed that using CAL was advantageous to them .CAL is accepted as a welcome change byundergraduate students. However on the other hand practical knowledge of how to do the experiment is lost.

Adverse Drug Reaction Monitoring in Psychiatry Outpatient Department of a Tertiary Care Teaching Hospital.

To study the pattern of adverse drug reactions (ADR) in patients attending psychiatry OPD of a tertiary care teaching hospital. Patients attending psychiatry OPD with ADRs due to drugs prescribed for various psychiatric illnesses over a period of 1year were included in the study. Adverse event history, medication history and other relevant details were entered in the PvPI format. Causality was assessed by WHOUMC criteria. A total of 103 ADRs were reported from 85 prescriptions with a female preponderance. Majority of ADRs (45.7%) were seen with antidepressants as they were the commonly prescribed drugs followed by antipsychotics (33.3%) and others by sedative hypnotics and anticonvulsants. ADRs like somnolence topped the list (21.9%) followed by weight gain (18.4%), akathesia (6.8%) and drug induced restless legs syndrome (RLS) (5.8%). The reported ADRs were assessed for causality and maximum (80.6%) belong to the "possible" category. Maximum ADRs were seen with antidepressants followed by antipsychotics. Sedation and weight gain were the most commonly occurring ADRs.

Comparative evaluation of moderate dose inhalational corticosteroid (ICS) fluticasone with the combination of low dose fluticasone and montelukast in moderate persistent bronchial asthma.

Background: Use of inhaled corticosteroids (ICS) are recommended in all grades of persistent asthma and once the symptoms are stabilized, “stepping down" of steroids is recommended to minimize their unwanted effects with the addition of a second medication with a complimentary mechanism of action. Aims & Objective: In our study a comparison of moderate dose ICS Fluticasone in “stepping down” strategy with combination of low dose Fluticasone with once-daily montelukast were assessed. Materials and Methods: 50 patients with moderate persistent asthma were randomly assigned in study. Initially stabilized on fluticasone propionate (FP) 250 μg twice daily, for four weeks, there after patients were given the medication as per the protocol Group-I (n=25)- fluticasone 250μg BD; Group-II (n=25)- fluticasone125 μg BD + Montelukast 10 mg in night. Patients were then followed up for 12 weeks. The primary efficacy variables were changes in FEV1%, PEFR%, ACS (asthma control symptom) score and asthma quality of life (QOL) score. Results: Changes in lung function at the end of study in Group-I and Group-II respectively as compared to 0 week (baseline) values, FEV1% value (p <0.05, p <0.05), PEFR% value (p <0.01, p <0.05), ACS score (p <0.01, p <0.05), AQOL score (p <0.05, p <0.05). ICS fluticasone 250 μg BD and low dose fluticasone 125 μg BD + Montelukast 10 mg in night are equally efficacious in improving lung functions, asthma symptoms and QOL. Montelukast group was more expensive with fewer adverse events. Conclusion: Moderate dose fluticasone did not show any benefit over combination of low dose fluticasone and Montelukast 10mg in night. Montelukast 10 mg in combination with low dose fluticasone can be an alternative in moderate persistent asthma.

Comparative Efficacy and Tolerability of Sumatriptan, Ergotamine, Naproxen and Rizatriptan in Moderate to Severe Acute Attack of Migraine.

A double-blind, randomized, parallel study was done to compare sumatriptan, ergotamine, naproxen and rizatriptan in 40 outpatients treating a single migraine attack of moderate to severe intensity. Among these groups, significantly more number of patients had headache relief at 2 hours postdose in naproxen and rizatriptan group as compared to ergotamine. Naproxen, rizatriptan and sumatriptan were better than ergotamine in causing freedom from the associated symptoms of nausea, vomiting, photophobia and phonophobia at 2 hour postdose. Naproxen, rizatriptan and sumatriptan were also efficacious in causing functional normalization at 2 hours postdose as compared to ergotamine. The overall results of the study suggest that naproxen is as efficacious as triptan group of drugs but better than ergotamine group in treatment of moderate-severe acute migraine attack. It is more cost effective than triptans and also a well tolerated drug.

Modulation of pain perception by ramipril and losartan in human volunteers.

The angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are a well known entity and have been used in therapeutics for various indications like hypertension, myocardial infarction and CHF. However, there is a renewed interest in these compounds in terms of their effects on pain perception in animals as well as in human beings. They have yielded contradictory results, showing hyperalgesia in some studies but analgesia in others. Hence this study was undertaken to evaluate the effect of Ramipril (an ACE-I) and Losartan (an ARB) on pain perception in human volunteers using cola caps and handcuff of sphygmomanometer. A total of 30 healthy, normotensive individuals with no previous history of intake of analgesics during or 4 weeks prior to the study were selected after an informed consent. The first group received a single dose of placebo, the second group received Ramipril (2.5 mg) & the third group received Losartan (50 mg). Pain perception threshold (the point at which an individual first experiences pain) and the maximum tolerated pain were assessed using the above method. The control group showed no significant changes in pain threshold, but the group receiving either Ramipril or Losartan showed a decline in threshold for maximum tolerated pain. Only Ramipril and not Losartan decreased the pain perception threshold. Our study revealed that single dose treatment of healthy volunteers with Ramipril and Losartan may cause algesia as early as after ingestion of the first dose and further studies are needed to study their long term effects on pain perception.

Doping droops.

Drug abuse is a major concern in the athletic world. The misconception among athletes and their coaches is that when an athlete breaks a record it is due to some "magic ingredient" and not because of training, hard work, mental attitude and championship performance. The personal motivation to win in competitive sports has been intensified by national, political, professional and economic incentives. Under this increased pressure athletes have turned to finding this "magic ingredient". Athlete turns to mechanical (exercise, massage), nutritional (vitamins, minerals), pharmacological (medicines) or gene therapies to have an edge over other players. The World Anti-Doping Agency (WADA) has already asked scientists to help find ways to prevent gene therapy from becoming the newest form of doping. The safety of the life of athletes is compromised with all forms of doping techniques, be it a side effect of a drug or a new technique of gene doping.