POST-MARKETING PASSIVE SURVEILLANCE OFBIVALENT AND QUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINES

Objective: Cervical cancer and other Human papillomavirus associated malignancies might be prevented by Human papillomavirus vaccines namely Gardasil® (HPV4) - quadrivalent (Merck) and Cervarix™ (HPV2) - bivalent (GlaxoSmithKline) which are marketed internationally. The aim of this study is to analyze vaccines adverse events reporting system (VAERS) which is used for post-marketing passive surveillance (PMS) of licensed vaccines.Methods: We searched and analyzed reports of adverse events associated with HPV 2 and HPV4 vaccines from Vaccine Adverse Event Reporting System (VAERS). In United States, between the year2006-2013, total 24, 719 adverse events were reported after taking HPV2 and HPV4 vaccines. For HPV2 vaccine, we searched for reports from October 2009 to December 2013 and for HPV4 vaccine, we searched for reports from October 2006 to December 2013.Results: For HPV4 vaccine during 2006-2013, total 24, 460 adverse events and 84 deaths were reported while for HPV2 vaccine during 2009-2013, total 259 adverse events and 3 deaths were reported. Even after proper route of HPV vaccinesadministration i. e. intramuscular 13, 287 adverse events have been reported for HPV4 while 259 adverse events have been reported for HPV2 vaccine. The most frequently recorded adverse events due to HPV4 vaccine were found to be within the year 2006-2013 which included rash (2306 cases) followed by injection site erythrema (2245 cases) and pyrexia (2142 cases). However, adverse events recorded for HPV2 vaccine were within the period 2009-2013 which included dizziness (37 cases) followed by headache (34 cases) and malaise (19 cases).Conclusion: In future ongoing HPV vaccines safety surveillance and further studies may shed light on some of the hypothesized associations

Utilization pattern of antiepileptic drugs and their adverse effects in tertiary healthcare and teaching hospital

Background: Epilepsy is the most common neurological condition with 65 million cases of active epilepsy found worldwide. The incidence is approximately 0.3 - 0.5% in different world populations with a prevalence rate of five to ten per thousand people. The aim of the present study was to evaluate the prescriptions according to WHO/INRUD drug use indicators and to study the adverse effects to antiepileptic drugs (AEDs).Methods: A cross sectional survey based observational study of 1year duration was conducted at tertiary healthcare hospital. Prescription data of patients (n=361) with Epilepsy from Neurology department was analysed using WHO indicators. The demographic data, type of seizures, AEDs prescribed and adverse drug reactions (ADRs) reported by the patients were recorded. Statistical analysis was done using Microsoft excel 2013.Results: A total of 593 AEDs were prescribed to 361 patients. Average number of AEDs prescribed per prescription was 1.65±0.78 (S.D) with only 02% of newer AEDs. Generalized Tonic Clonic (GTC) was the most common seizure with 55.68%. Phenytoin (32%) was commonly prescribed followed by valproate for GTCS. Carbamazepine was commonly prescribed for partial seizures. Out of 15 ADR cases that has been recorded, phenytoin (73%) was associated with most ADRs followed by valproate (20%). 53% patients were on Monotherapy, 31% on dual drug therapy.Conclusions: Older AEDs are still commonly prescribed drugs. Prescription of newer AEDs to be encouraged, as study revealed majority of adverse effects to drugs like phenytoin and valproate. Study concludes the need of creating awareness of reporting of adverse event to AEDs, in treating physician

Carbamazepine induced Stevens Johnson Syndrome: a case report from a tertiary care hospital

Stevens Johnson Syndrome is a rare but life-threatening skin disease and Carbamazepine is considered as one of the most common cause. The reported frequency of serious Carbamazepine hypersensitivity reaction is between 1/1000 and 1/10000 new exposures to the drug. Here, we report a case of a 40 year old female patient, who developed multiple ulcerative lesions all over the body three days after starting treatment with Carbamazepine for Trigeminal Neuralgia. (Worldwide Unique Number- 2017-58502 and AMC Report Number- BJGMC-Pune/Nov-2017/BBG-1860) Stevens Johnson Syndrome was diagnosed. Carbamazepine was withdrawn, and the patient was treated with topical and intravenous antibiotics. A biopsy was done which confirmed the diagnosis of Stevens Johnson Syndrome

A survey on the knowledge, attitude, and practices about antibiotic usage and resistance among homeopathic general practitioners

Background: Antimicrobial resistance(AMR) is an urgent and serious global health problem, demanding considerable attention from health care providers(HCPs) all over the world. The threat is progressing rapidly and intensifying with time. Therefore study was conducted to assess the knowledge, attitude and practices of Homeopathic HCPs about antibiotic usage and resistance(ABR).Methods: Cross-sectional, observational study. The data was collected from 75 Homeopathic HCPs practicing in Maharashtra with prior informed consent. Questionnaire based study whose responses were assessed by using five point Likert scale and analysed by using appropriate descriptive statistics.Results: 68(90.67%) respondents agreed that antibiotics are overused in India and 70(93.33%) of them facing ABR in their daily practices. Only 62(82.7%) of them were aware of the fact that bacteria are not responsible for causing colds and flu. 33(44%) believe that skipping one or two doses of antibiotic does not contribute to ABR. Only 23(30.67%) knew drug schedule H correctly. 22(29.33%) opined that antibiotics should be discontinued if patient develops mild gastrointestinal side effects. Only 28(37.33%) reads patient information leaflet(PIL) and counsel patients accordingly. 28(38.67%) feel that they don’t have enough sources of antibiotic information and 35(46.67%) find it difficult to select appropriate antibiotic.Conclusions: Most of HCPs were aware of rising issue antibiotic resistance. However, their knowledge, attitude and practices were found to be a matter of some concern. Educational intervention can be introduced to bring about behaviour changes regarding rational antibiotics prescribing. Government should take initiative against overt antibiotic promotional advertisements and to curb over the counter(OTC) sell of antibiotics

Study of the pattern of adverse events following immunization of children in a tertiary care hospital

Background: Success of an immunization programme depends upon awareness regarding usefulness and safety of vaccines. Widespread information on vaccine safety is very essential. Objective of study was to analyze pattern of Adverse Events Following Immunization (AEFI) in children.Methods: Prospective, observational study was carried out at immunization OPD of B. J. Government Medical College and Sassoon General hospital, Pune, where children receiving routine immunization were analyzed & followed up through telephonic survey of parents. Vaccine Adverse Event Reporting System (VAERS) form was used to record AEFI.Results: Total 1206 children, aged 0-6 years, received total of 3179 vaccine doses. 22.71% AEFI were reported. Most common AEFI per 1000 doses of all vaccinations was Fever, seen in less than 9 months of age group (84.67%). DPT vaccine was most common vaccine associated with AEFI and maximum (37.8%) adverse events were seen with 1st dose of DPT.Conclusions: Reporting of AEFI with regular analysis and feedback should be an integral part of immunization programs

Screening of N-Benzoyl Isoserine Methyl Ester (N-bime) for anti-inflammatory analgesic activity and toxicity profile in animals

Background: Pain and inflammation are the basic processes involved in the pathogenesis of many diseases. Non-steroidal anti-inflammatory drugs are often used to treat rheumatic diseases. The study compound N-Benzoyl Isoserine Methyl Ester (N-bime) is a newly synthesized propionic acid derivative by National Chemical Laboratory, Pune. Since the biological data of this compound is not available, the present study has been planned to screen this compound for anti-inflammatory, analgesic activity and its toxicity profile in animals.Methods: Single dose toxicity study was carried out in rats. Anti-inflammatory activity was tested by Rat Hind Paw Oedema and Cotton Pellet Implantation method. For Analgesic activity, Acetic acid induced writhing and Tail Pinch method was used. Yeast induced Pyrexia was used for evaluation of anti-pyretic activity. Ibuprofen was the positive control. Data are presented as mean±SEM. Statistical analysis was performed by analysis of variance and students unpaired‘t’ test.Results: The test compound N-bime did not show any apparent adverse effects or mortality in the dose range 1mg - 500mg / 100gm body weight in animals. It showed better anti-inflammatory actions in higher doses as compared to Ibuprofen (p˂ 0.05). In acetic acid induced writhing test N-bime offered better protection against writhes, than Ibuprofen. But, both failed to demonstrate analgesic activity in the Tail Pinch method. N-bime showed a gradual decrease in temperature in the anti-pyretic test (P<0.001).Conclusions: The present study indicates that N-bime does possess anti-inflammatory, analgesic and weak anti-pyretic properties like the NSAIDs. It has proved to be safe in the dose range of 1mg - 500mg / 100gm body weight in rats and mice

COMPARISON OF POST-LICENSURE SAFETY SURVEILLANCE OF BIVALENT AND QUADRIVALENT HUMAN PAPILLOMAVIRUS VACCINES IN HEALTHY MUMBAI WOMEN

Objective: This study is the first comprehensive effort after HPV vaccine controversy in INDIA to compare two HPV vaccines without vaccine manufacturers funding in single, randomized, well-defined population of healthy married women aged 18-25 years using identical methodology for assessment.Methods: The study protocol was approved by an institutional ethical review committee and registered in Clinical trial registry of INDIA prior to subject recruitment. Total 77 women were screened but 69 were randomized to receive either HPV2 or HPV4 vaccines.Results: According to the present study, both HPV vaccines were well tolerated without any serious vaccine-related adverse event. Adverse drug reactions reported for both HPV vaccinations were 22 (35.48%) after the ï¬rst dose, 7 (12.05%) after the second dose and 11 (25%) after the third dose. After bivalent and quadrivalent HPV vaccination, 29 and 11 adverse drug events were recorded within seven days after any HPV vaccine dose respectively. Most frequently reported solicited local symptom from both groups was34 injection site pain which was mild in intensity.Conclusion: Both HPV vaccines appear to be safe, HPV4 being more cost-effective. However, large scale post-marketing studies are needed in view of amount of disease burden.Â

An assessment of pattern of adverse drug reactions of cardiovascular drugs in a tertiary care institute

Background: Cardiovascular disease is very prevalent in India. So, use of cardiovascular drugs is also more. So, it is very important to keep watch on adverse drug reactions. Aim of this study was to assess the pattern of adverse drug reactions (ADRs) reported with cardiovascular drugs in a tertiary care institute.Methods: The study was carried out in medicine department of a tertiary care hospital over a period of one year. Each ADR was analysed for demographic data, causality, relationship between frequency of ADRs and the number of drugs used etc. In statistical analysis Microsoft excel 2013, SPSS software was used.Results: A total of 136 patients, 58 (43%) men and 78 (57%) women, using cardiovascular medications reported ADRs during the entire study period. Total 168 ADRs were reported out of which, Amlodipine (causing headache and edema feet) was the most common drug with 51 (30.3%) ADR’s followed by Enalapril, Aspirin and Isosorbide Dinitrate with 37 (22%), 24 (14.2%), 23 (13.6%) ADRs respectively. Most common ADR was headache (due to amlodipine and Isosorbide di nitrate) affecting 38 (22.62%) cases followed by dry cough 37 (22.02%) cases, edema feet 36 (21.43%), gastritis 24 (14.29%) and 10 (5.95%) of nausea.Conclusions: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines are mostly used as multidrug therapy and always prone for ADRs

Comparison of conventional and sustained-release formulation of metformin in type 2 diabetics

Background: To investigate the effects of metformin sustained-release (MSR) compared with metformin immediate-release (MIR) on glycaemic control, blood pressure, lipid profile and metabolic parameters like weight, waist circumference in type 2 diabetes.Methods: A prospective, randomized, double blind study was conducted at tertiary healthcare and teaching hospital at Pune, Maharashtra. After obtaining institutional ethical committee approval and written informed consent, 40 newly diagnosed type 2 diabetic patient were randomly assigned to receive metformin immediate release formulation (MIR) 500 mg once 1 week and then twice daily and metformin sustained release formulation (MSR) 500 mg once 1 week and  then 1000mg once daily for 18 weeks. Fasting and post prandial blood glucose level (BGL), HbA1c, blood pressure, lipid profile, weight and waist circumference, were recorded at the start and end of study.Results: Both MIR and MSR significantly decreased fasting; post prandial BGL and HbA1c at 18 weeks. But no significant difference was seen between two groups. Study did not show any effect on blood pressure and on lipid profile. Both formulations decreased obesity as evident by significant reduction in weight and waist circumference. All patients tolerated both formulations of metformin. Though overall incidences of adverse effects are less with sustained release formulation, difference was not significant between two groups.Conclusions: To conclude, both metformin immediate release and sustained release formulations achieved comparable glycaemic control and sustained release formulation would be as effective as immediate release formulation with advantage of being reduce daily intake of tablets