A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR扴.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo抯, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software抯 are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

Cross sectional study on prevalence and medication adherence of hypertension and diabetes in a tertiary care hospital in Karimnagar, India

Background: The study aimed to assess the prevalence of Hypertension (HTN), Diabetes mellitus(DM) and other diseases along with comorbid conditions, disease complications and also to assess medication adherence in a tertiary hospital in Karimnagar, Telangana, India.Methods: A Cross sectional study is performed by analysing a total of 500 patient抯 individual case safety reports (ICSR). Prevalence of Hypertension and Diabetes along with most prescribed drugs are analysed. Medication adherence is analysed by using Morisky Medication adherence questionnaire scale (MMAS-4).Results: Patients with past history of DM, HTN and other diseases which was found to be 245 (49%) patients. Patients with highest disease prevalence were found to be with HTN (56.73%), DM (31.83%) followed by other diseases like asthma (8.57%), Cerebrovascular accident (4.89%) etc., Total of 66 Patients were ruled out with comorbid diseases. Patients with HTN+DM (47) were found to be highest followed by DM+HTN+CVA (4). MMAS-4 revealed 208 patients were using medication out of 245 patients with previous history. According to MMAS-4 most of the patients were with medium adherence (76). Prevalent drug used for HTN include Amlodipine and for DM Telmisartan+Hydrochlorthiazide.Conclusions: The study revealed that almost half of the admitted patients were with HTN and DM. The patients were counselled properly to adhere strictly to the prescription. Medication adherence to HTN and DM was found to be good in this study. Since the disease complications were also ruled out, the health care professionals are recommended to spread awareness on DM and HTN and disease management in order to control disease and improve health outcomes.

First case series of emerging Rickettsial neonatal sepsis identified by polymerase chain reaction-based deoxyribonucleic acid sequencing.

Purpose: To detect and identify the aetiological agent in the peripheral blood from the cases of neonatal sepsis. Materials and Methods: Four neonates from geographically different regions of South India presented with signs of neonatal sepsis and all the routine clinical and laboratory investigations were performed. Blood culture by Bac T Alert 3D was negative. To establish the aetiology, polymerase chain reaction (PCR) for eubacterial genome and subsequent amplifi cation with Gram positive and Gram negative primers were performed followed by deoxyribonucleic acid (DNA) sequencing. Results: PCR for the detection of eubacterial genome was positive in all the four neonates and further amplifi cation with designed Gram positive and Gram negative primers revealed the presence of Gram negative bacteria. The amplicons were identifi ed as Orientia tsutsugamushi in three neonates and Coxiella burnetti in the other neonate. Multalin analysis was done to further characterise the strain variation among the three strains. Conclusion: PCR-based DNA sequencing is a rapid and reliable diagnostic tool to identify the aetiological agents of neonatal sepsis. This is the fi rst case series of emerging Rickettsial neonatal sepsis in India.

Prevention of no flow/slow reflow phenomenon in primary PCI by Nicorandil.

AIM: To investigate the efficacy of Nicorandil in preventing no-flow/slow reflow phenomenon in patients with acute myocardial infarction undergoing primary PCI. MATERIALS AND METHODS: From September 2004 to October 2005, 29 patients underwent a primary percutaneous coronary intervention and stenting with nicor-andil as a protocol drug at a dose of 1 mg/hour - this drug was titrated upwards to maximum tolerated dose, with a 2 mg intracoronary bolus given after balloon inflation during PCI. LAD was the infarct related artery in 62% of cases. 72.4% of them had a TIMI thrombus grade of 5. The corrected TIMI frame count following primary percutaneous intervention in the Nicorandil arm was 19.54 + 8.7. None of the patients had a no flow or slow reflow phenomenon with this protocol. One patient developed a subacute stent thrombosis necessitating a revascularization. At a mean follow up of 251 +/- 96.7% days, MACE was not reported in the other patients. Thirty four patients underwent a primary percutaneous coronary intervention and stenting without nicorandil as an adjuvant drug. Some of these patients were retrospectively assessed. They have been followed up for 285.4 +/- 264.6 days. LAD was the infarct related artery in 61.8% of cases while 79.5% of them had a TIMI thrombus grade of 5. The corrected TIMI frame count in this group was 23.9 +/- 17.5 (p <0.56). MACE was reported in 5 of these patients. The mean TIMI frame count for these 5 patients was 40.5 +/- 29.2. Glycoprotein IIb/IIIa receptor inhibitors were given to all patients in both groups. The choice of the agent used was left to the discretion of the operator. CONCLUSION: Nicorandil prevents no-flow/slow reflow phenomenon in patients undergoing primary PCI for acute myocardial infarction. This is shown by a lower corrected TIMI frame count in the nicorandil arm (p < 0.56). Reduction in the incidence of no-flow/slow reflow phenomenon translates into a lower MACE. The drug is safe and does not require intensive monitoring. It must be started early and electively in patients undergoing a primary PCI as a strategy to prevent no-flow rather than to treat this phenomenon.

Cutaneous zygomycosis: necrotising fascitis due to Saksenaea vasiformis.

Saksenaea vasiformis is an emerging human pathogen, most often associated with cutaneous or subcutaneous lesions following trauma. This is the report of a case of subcutaneous zygomycosis from which Saksenaea vasiformis was isolated on culture. As the patient developed acute interstitial nephritis, amphotericin B could not be administered in full dose. Surgical debridement was carried out, but the patient deteriorated gradually and died. To the best of our knowledge, this is the first reported case of Zygomycosis due to Saksenaea vasiformis from Visakhapatnam.