Pharmacovigilance in patient safety: Challenges and perspectives

Pharmacovigilance is growing as an important discipline, which plays an important role in patient safety concerning with the drug side effects. It is basically to identify the adverse effects related to drugs. Pharmacovigilance is an ongoing activity. This article is an attempt to prioritize the importance of pharmacovigilance, its important facets, challenges, and perspectives and a thought of a pharmacovigilance (dummy-example) system to establish a wider coverage through enhanced networking and thereby a more sound reporting of the adverse effects.

Prevalence and predictors of self-medication practice among adults residing in the rural field practice area of a tertiary care hospital in Chandigarh

Introduction : Self-medication is a harmful practice. There is a need to document its prevalence and educate people about its numerous dangers. This study assessed the prevalence of self-medication practice and its associated factors among adults. Method: This community based cross-sectional study was conducted among 1090 adults. A simple random sampling technique was used to select the study participants. A pre-tested interview schedule was used to collect data regarding self-medication practice and its associated factors. The data was analysed using Epi-info software for windows (CDC Atlanta). Results: The prevalence of self-medication was 18.6%. The most common symptom for which study participants practised self-medication was fever (58.6%). Previous experience was the most common reason for practising self- medication (59.0%). The bivariate analysis revealed that the self-medication practice was significantly more among those aged 50 years and above and widowed individuals; as compared to their counterparts. Conclusion: Nearly one-fourth of the adults practised self-medication. Interventions should be designed to discourage self-medication practice among adults, with a particular focus on those aged above 50 years and widowed individuals

Humanitarian approach in medicine: A study on clinical empathy among medical students and graduates using the Jefferson Scale of Empathy

BACKGROUND Empathy is one of the pillars of professionalism in the medical field associated with better patient satisfaction and outcome. This study aimed to assess and compare the empathy score with other institutes within and outside India using the Jefferson Scale of Empathy-Student version (JSE-S). METHODS We did a cross-sectional study for undergraduate medical students and interns of Pramukhswami Medical College, Karamsad, for 4 months from October 2019. Voluntary participants completed the JSE-S, an internationally validated 20-item survey questionnaire. RESULTS The mean empathy score of 575 voluntary participants out of 631 was 100.75, with women having higher and significant scores than men (F 102.1 [11.5]; M 98.3 [12.5]; p<0.001). The highest empathy score was observed in the first year (102 [10.8]), which increased and decreased in different years of medical education with a maximum dip in the second year (99.4 [11.5]). The choice of specialty of participants showed a lower significant difference as per the JSE-S score. A lower empathy score was identified among participants compared to medical students studying in international medical institutes. CONCLUSION There is a need to organize workshops with training modules to cater to the empathy aspect of professional care, as a continuous process, starting from the first year till the completion of internship.

Parvovirus B19 Induced Fulminant Liver Failure In Pregnancy: A Rare Incidence

Parvovirus B19 (B19V) is a single-stranded DNA virus of the family Parvoviridae and genus Erythrovirus. Parvovirus B19 infection can present with myriads of clinical diseases and syndromes; liver manifestations and hepatitis are examples of them. The majority of the available literature regarding acute parvovirus B19 induced fulminant hepatic failure has described cases involving children.Acute fulminant liver failure caused by acute parvovirus B19 infection in a pregnant lady is rarely reported in the literature. Here, we report a case of fulminant liver failure in a 28-year-old pregnant lady presenting as a diagnostic dilemma, the etiology of which was eventually detected as acute Parvovirus B19 infection. Since Parvovirus B19 is a potential cause of non-A, non-E fulminant hepatic failure, an early diagnosis is of utmost importance as treatment options are limited

Evaluation of Gender Based Morphological and Morphometric Features of Mental Foramen Using CBCT Radiographs

Back ground: Awareness regarding varied and detailedmorphological and morphometric features of mental foramen isof pivotal importance for orthodontists, cosmetic andreconstructive surgeons etc. for avoidance of any inadvertenttrauma, post-surgical neurovascular complications andmorbidity.Aim: To study gender based differences in variousmorphological and morph metric features of mental foramen.Method: In this study we have selected 800 patients. Thepresent study was carried out on CBCT scans procured fromthe Dental Hospitals in Jaipur, Rajasthan. A detailed study ofmorphometric features of mental foramen along with otherparameters of the mandible was carried out on the coronal,axial and sagittal views of CBCT scans using “CS 3D Imagingv3.5.7”. Patients were divided in groups based on age.Results: No significant relationships between age and genderof the patients (p>0.05) and position of mental foramen on theright and left side. MF-S to be significantly longer in males ascompared to females in Group I whereas in Group III, MF-Swas significantly more in males than females on both the sides(p<0.001).Conclusion: Position 6 is considered to be the least commonposition

A community-based study on awareness of cancer and anticipated barriers in seeking help

Cancer is a leading public health problem worldwide. Contributing factors include lack of awareness regarding cancer and improper help seeking behavior. Objective: To assess the awareness regarding early warning signs of cancer, its risk factors and anticipated barriers in seeking help. Methodology: A community-based cross-sectional study was conducted among 470 study participants. Trained workers administered a standardized tool to respondents after obtaining their informed consent. Epi Info software for windows version 7.2 was used for the analysis. Results: Overall, merely 7.7% (36/470) of the study respondents were aware of all the nine warning signs of cancer. The most commonly known early warning sign of cancer was “unexplained swelling” (58.3%). Further, although majority knew that cigarette smoking is a risk factor for cancer (90.4%), very few were aware about the role of inadequate physical activity (9.3%) and diet devoid of adequate amounts of fruits and vegetables (11.9%). There were few anticipated barriers in seeking help such as embarrassment (13.2%) and difficult to interact with a doctor (7.9%). Conclusion: There was inadequate awareness about cancer but a favorable help-seeking behavior. It is, therefore, recommended that health-care professionals should scale up efforts for disseminating information regarding cancer among the people.

Identification of Polymorphism in Intron 2 of Adiponectin (ADIPOQ) Gene in Indian Sahiwal Cattle

Adiponectin (ADIPOQ) gene regulates the glucose metabolism, insulin sensitivity, fatty acid oxidation, immunity and reproduction. In the present investigation, PCR-RFLP method was conducted to identify the genetic polymorphism in intron 2 region of adiponectin (ADIPOQ) gene in Indian Sahiwal cattle. PCR of intron 2 of ADIPOQ gene fragment produced amplicon of 961 bp which was subsequently digested with RsaI restriction enzyme. The RsaI/PCR-RFLP assay revealed monomorphic pattern only, TT genotype (wild type homozygote) in Sahiwal cattle population which was confirmed by sequencing. The obtained sequences of ADIPOQ after aligning revealed absence of RsaI recognition site GTAC and consequently, the association study with economic traits could not be performed

Fixation of T allele in G>T Polymorphism in Exon 7 Region of Secreted Phosphoprotein 1 (SPP1) Gene in Indian Cattle Breeds

Secreted phosphoprotein 1 (SPP1) is popularly known as osteopontin (OPN), which plays an important role in initiation and maintenance of pregnancy, as well as in the development of the fetus and milk production. In the present study, investigation of G>T polymorphism in exon 7 region of SPP1 gene was undertaken in 147 Sahiwal and Hariana cattle maintained at Livestock Farm Complex (LFC), DUVASU, Mathura using HpyCH4IV/PCR-RFLP assay. Amplification of SPP1 exon 7 region revealed 204 bp product and HpyCH4IV restriction digestion screening showed monomorphic pattern. Only one type of genotype, namely, TT (204 bp) was observed in population. The frequency of TT genotypes was 100% in all screened samples with T allele (1.0). The results revealed that SPP1 T allele seems to be fixed in screened cattle population. Consequently, we could not perform the association study of this substitution with milk production traits

Correlation between Second to Fourth Digit Ratio and Anthropometric Variables Indicative of Cardiovascular Disease

Second to fourth digit ratio (2D:4D) is a sexually dimorphic biometric marker. Regarding indirect evidence, there have been several studies that link the waist-tohip ratio (WHR) with the 2D:4D ratio. If the 2D:4D ratio is associated with testosterone and estrogen levels, it may be correlated with a risk of myocardial infarction (MI). The aim of the present study is to find out the correlation between anthropometric risk factors for cardiovascular disease and the 2D:4D ratio in 250 young females of the state of Haryana in Northern India. The present study was conducted on 250 females of the Haryana population aged between 17 and 35 years old. A series of 8 anthropometric measurements was obtained from the participants: height, weight, 2D:4D ratio, body mass index (BMI), waist circumference (WC), hip circumference (HC), neck circumference (NC), and WHR. The data was collected, tabulated and subjected to statistical computation using SPSS Statistics for Windows, Version 13.0 (SPSS Inc., Chicago, IL, USA). Strong positive associations between the NC and the WHR confirm that both measures are indicative of body fat. Also, a positive correlation between the 2D:4D ratio and the WHR suggests that low androgen levels in women are associated with a greater risk of obesity.Moreover, this result, as well as the positive correlation between 2D:4D ratios and NC, suggest that the digit ratio is indicative for being overweight in women and suggest a predisposition toward cardiovascular disease ­ however, these correlations of body measurements with digit ratios are not significant.

Xanthoma disseminatum.

Xanthoma disseminatum is a rare, benign, normolipemic form of non-Langerhans cell histiocytosis affecting the skin and mucous membranes. The cutaneous manifestations consist of hundreds of papules that are red – brown at first and then become yellowish. The papules symmetrically involve the eyelids, trunk, face and proximal extremities and in flexures and folds, tend quickly to merge, forming soft plaques. It is frequently associated with diabetes insipidus. Biopsy specimens show a mixture of histiocytes, foam cells, and inflammatory cells. Later, foam cells predominate and Touton giant cells are frequently present. This chronic disease has no known established treatment.

Mycosis fungoides: cutaneous T-cell lymphoma.

Mycosis fungoides (MF) is the most common group of cutaneous T-cell lymphomas. It is a rare non-Hodgkin’s lymphoma of mature, skin-homing, clonal, malignant T lymphocytes, usually observed in mid to late adulthood, that initially presents in the skin as patches, plaques, tumors, or generalized erythema (erythroderma) and can involve the lymph nodes and peripheral blood. In this review, we survey the MF literature of the last decade and highlight the major trends.

Evaluation of ‘cattle’ and ‘Indian Bison’ type antigens of Mycobacterium avium subspecies paratuberculosis for diagnosis of Bovine Johne’s Disease using ‘indigenous ELISA’ and AGPT .

Two antigens (‘cattle’ type and ‘Indian Bison’ type) of Mycobacterium avium subspecies paratuberculosis were evaluated for diagnosis of Johne’s disease (JD) in a gaushala (cattle herd). Of the 160 cows of Sahiwal and Hariana breeds screened, 81 (50.6%) tested positive in ELISA and 66 (41.8%) in AGPT test. Using the two antigens, 33.5% tested positive in both the tests while 41.1% tested negative. Exclusively, only 8.2% tested positive in ELISA while 17.1% tested positive in AGPT. Two antigens together detected 58.9% prevalence of MAP in the gaushala. Individually, indigenous ELISA using antigen from native source of MAP proved superior to AGPT in the diagnosis of JD in cows.

Stewart-Treves syndrome: a rare entity.

Stewart-Treves syndrome is a rare, deadly cutaneous angiosarcoma that develops in long - standing chronic lymphedema. Most commonly, this tumor is a result of lymphedema induced by radical mastectomy to treat breast cancer. Stewart-Treves syndrome occurs in 0.5% of patients, who survive mastectomy for more than 5 years. The mean age at appearance of the angiosarcoma is 62 years, and the mean interval between mastectomy and the appearance of the tumor is 10.5 years. The exact pathogenesis is not known so far. On histopathology, vascular channels infiltrate the normal structures in a disorganized fashion, as if trying to line every available tissue space with a layer of endothelial cells. The prognosis is poor as it is very aggressive. Only early diagnosis and prompt radical excision with or without adjuvant radiotherapy, can promote survival.

Spectrum of Papillon–Lefevre syndrome.

Papillon–Lefevre syndrome is an extremely rare autosomal recessive disorder characterized by severe periodontal disease with hyperkeratosis and fissuring of the palms and soles. Periodontitis is severe and destructive affecting both deciduous and permanent dentitions associated with palmo-plantar hyperkeratosis. These manifestations usually appear in childhood between 1 and 4 years of age and deciduous teeth exfoliate within or at the age of six. Permanent teeth erupt normally but soon get affected by periodontal disease. Individual becomes edentulous within teenage. Hyperkeratotic lesions extend to knees and elbows. Some cases have shown inconsistent manifestations such as calcification of falx cerebri and choroid plexus, calcification of the dura, attachment of the tentorium, thumb nail dystrophy and hyperhidrosis.

Patterns of Injuries in Road Traffic Accidents in a Rural Tertiary Hospital.

Road traffic injuries are a major but neglected global public health problem, requiring concerted efforts for effective and sustainable prevention. Of all the systems that people have to deal with on a daily basis, road transport is the most complex and the most dangerous. Objectives: To study the patterns of injuries in the road traffic accidents and days of hospitalization. Materials and Methodology: The study was retrospective record based study and included cases reported and recorded from October 2007 to March 2008. Results: The present study was designed to study the patterns of injuries in RTA (Road Traffic Accidents) in Anand district of Gujarat. The results showed that out of total 423 RTA cases, 327(77.3%) of the victims were males and the rest 96(22.7%) were females. Two wheeler riders and pedestrians form twothird of the total victims. Total 232 fractures were noticed and of these maximum numbers occurred in the lower limb region (53.86%) followed by fractures in the upper limb (24.54%) and 10.77% fractures were in the skull. Abrasions were seen most commonly on lower limbs (34.31%), lacerations were seen mostly on head (41.07%) and internal injuries were noticed more in the head region (31.48%). 74.2% of the victims were hospitalized and the rest 25.8% took treatment at the trauma centre. 51.1% of RTA victims were hospitalized for 1-5 days while patients who did not require hospitalization were 109(25.8%).

Hydroa vacciniforme: a very rare photodermatosis.

Hydroa Vacciniforme (HV) is a rare, acquired and chronic paediatric disorder that is characterized by photosensitivity and recurrent crops of skin lesions on sun-exposed skin, such as the face, ears and hands that heal with vacciniforme scarring. The pathogenesis of HV is unknown. No chromosome abnormality has been identified so far. HV patients have no abnormal laboratory results. The histopathologic features are distinctive and demonstrate intraepidermal multilocular vesicles and cellular necrosis. Most cases remit spontaneously by late adolescence.

Molecular evaluation of a novel missense mutation & an insertional truncating mutation in SUMF1 gene.

Background & objectives: Multiple sulphatase deficiency (MSD) is an autosomal recessive disorder affecting the post translational activation of all enzymes of the sulphatase family. To date, approximately 30 different mutations have been identified in the causative gene, sulfatase modifying factor 1 (SUMF1). We describe here the mutation analysis of a case of MSD. Methods: The proband was a four year old boy with developmental delay followed by neuroregression. He had coarse facies, appendicular hypertonia, truncal ataxia and ichthyosis limited to both lower limbs. Radiographs showed dysostosis multiplex. Clinical suspicion of MSD was confirmed by enzyme analysis of four enzymes of the sulphatase group. Results: The patient was compound heterozygote for a c.451A>G (p.K151E) substitution in exon 3 and a single base insertion mutation (c.690_691 InsT) in exon 5 in the SUMF1 gene. The bioinformatic analysis of the missense mutation revealed no apparent effect on the overall structure. However, the mutated 151-amino acid residue was found to be adjacent to the substrate binding and the active site residues, thereby affecting the substrate binding and/or catalytic activity, resulting in almost complete loss of enzyme function. Conclusions: The two mutations identified in the present case were novel. This is perhaps the first report of an insertion mutation in SUMF1 causing premature truncation of the protein.

Abnormal lipid metabolism in collagen-induced arthritis rat model: In vitro, high resolution NMR spectroscopy based analysis.

Collagen-induced arthritis (CIA) was induced in female Wistar rats by intradermal injection of porcine immunization grade native collagen type II (Chondrex). Development and progression of CIA was monitored by studying histopathological, radiographical and biochemical features of arthritic manifestations in the knee joints, hind limb and blood plasma. In addition, oxidative stress status of arthritic animals was determined by measuring lipid peroxidation and the antioxidant enzymes: catalase, superoxide dismutase and glutathione peroxidase. High resolution proton NMR spectroscopy was employed for the analysis of lipid components in the lipid extracts of the joint tissue and plasma of collagen-induced arthritic and control rats. Triglyceride levels showed significant decreases in plasma (1.7 times) but were unchanged in the joint tissue of CIA rats as compared to control. One-dimensional proton NMR spectra showed a 6.2 times reduction in the quantity of choline-containing phospholipids in the plasma of CIA as compared to control rats. There was a 1.6 times elevation of choline-containing phospholipids in the joint tissue of CIA rats as compared to controls. Induction of arthritis showed a 4.0 times reduction in the level of total cholesterol in the plasma and 1.6 times elevation in the joint tissue of CIA rats as compared to controls. The ratio of saturated fatty acids to unsaturated fatty acids was 1.5 times significantly higher in joint tissue and 2.1 times significantly higher in plasma of CIA rats as compared to controls. The results demonstrated significantly altered lipid patterns in the joint tissue and plasma of collagen-induced arthritic rats as detected by one- and two-dimensional NMR spectroscopy compared with controls.

Introducing Combined Measles, Mumps and Rubella Vaccine in Chandigarh, India: Issues and Concerns.

Cyclical outbreaks of mumps have been noticed across Chandigarh city during winter months. Chandigarh does not provide measles, mumps and rubella (MMR) vaccination in the State immunization schedule. Epidemiological shift in age at diagnosis of mumps was noticed with higher incidence in older children and adults. Increased occurrence of complications can be predicted with this age shift. Silent burden of rubella with serious outcomes in newborns further strengthen the case for MMR vaccine inclusion in routine immunization program of Chandigarh.

Health Seeking Behaviour and MCH Care Practices in Fishermen Community.

Background: All people, whether rural or urban, have their own beliefs and practices concerning health and disease. It is now widely recognized that cultural factors are deeply involved in all affairs of man, including health and sickness. The problem affecting the health of the mother and the child are multi-factorial. Despite current efforts, the health of the mother and the child still constitutes one of the most serious health problems affecting the community, particularly in the developing countries. Objectives: The following study was carried out to find the: i) Health seeking behaviour of mother for illnesses in children; ii) Status of antenatal care and postnatal care amongst women of fishermen community. Materials and Methods: Women of fishermen community in the Macchipura area of Khambat falling in the age group of 15-45 and having at least one child in the age group 1-2 year (above 1year and less than 2 years) were selected for the study. Results and Conclusions: A total of 64(87.6 %) mothers would like to go to a doctor in case of medical needs. 22(30.13%) mothers took ANC. All the 22 mothers were given TT injection as well as Iron folic acid tablets. Blood pressure was measured in 21 women and also the weight was taken in these women. 66 (90.41%) deliveries were conducted by trained dai in that area. Antenatal and postnatal care services need to be strengthened for these fisherwomen. The good thing was that a good proportion of mothers were willing to go to a doctor besides having an inclination to practice the traditional ways.