Critical evaluation of promotional drug literature based on the WHO criteria

Background: Pharmaceutical companies use drug promotional literature (DPL) as an important mode to promote their products and it also influences the prescribing behavior of prescribers. However, information provided in promotional literature may be inadequate or misleading which may lead to irrational prescribing. The WHO has provided ethical criteria for medicinal drug promotion. Aims and Objectives: This study was undertaken with the aim to analyze the promotional drug literature for their compliance to the WHO ethical criteria for medicinal drug promotion, 1988. Materials and Methods: A cross-sectional and observational study was carried out to evaluate the extent to which promotional literature collected from private physicians meet the WHO ethical criteria for medicinal drug promotion. A total of 100 promotional literature were evaluated for their fulfillment of the WHO criteria. Results: Information regarding brand name, generic name of drugs, dosage form, therapeutic uses, and active ingredient per dosage form was present in most of the promotional drug literature in the present study. However, the information such as safety profile of drugs, precautions, warnings, and drug interactions was not mentioned in most of the DPLs. Conclusion: The majority of DPLs evaluated in this study did not comply with the WHO guidelines for medical drug promotion. As prescribing behavior of physicians is influenced by promotional literatures, regular training of health professionals and medical students regarding critical analysis of DPLs can help in ethical and rational prescribing.

Hospital-based Surveillance of Rotavirus Diarrhea among Under- five Children in Chandigarh.

In a prospective hospital-based surveillance of 958 under five children admitted with acute gastroenteritis in Chandigarh (May 2011 to July 2012), 239 stool samples were collected. Rotavirus antigen was detected in 18.8% of samples by reverse transcriptase polymerase chain reaction. Genotypes G1P[8] (53.3%), G12P[6] (15.6%) were prevalent, and G3 not detected.

Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance.

The office of the Drugs Controller General (India) vide order dated 19th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.

Cardiovascular involvement in systemic lupus erythematosus: an autopsy study of 27 patients in India.

BACKGROUND: Although cardiovascular disease (CVD) is recognized as a leading cause of death in patients with systemic lupus erythematosus (SLE) in western countries, there is hardly any data regarding Indian subjects with SLE. AIMS: To determine the incidence of cardiac abnormalities and vascular lesions at autopsy and to assess their contribution to the mortality in patients with SLE. SETTINGS AND DESIGN: Retrospective retrieval of reports of autopsies performed on 35 patients with SLE over a 11 year period and analysis of 27 cases with cardiac and/or vascular lesions. MATERIALS AND METHODS: Gross and microscopic features in 27 autopsies were analyzed with special attention to the heart and the vasculature of all organs. Findings were correlated with clinical features and ante-mortem investigations. Their contribution towards mortality was assessed. RESULTS: Valvar lesions were the commonest cardiac lesions noted with non-bacterial thrombotic endocarditis in nine (33.33%), valvar thickening in two (7.41%), Libman-Sacks endocarditis and infective endocarditis in one (3.70%) each. Myocarditis and myocardial scarring were seen in 10 (37.03%) and seven (25.92%) cases, respectively. Fibrinous pericarditis was noted in seven (25.92%). Thromboses/embolism, vasculitis and severe coronary atherosclerosis were seen in nine (33.33%), five (18.52%) and one (3.70%) subjects, respectively. Renal disease [13, 48.14%] and cardiovascular manifestations [8, 29.62%] were the leading causes of death in our patient population. CONCLUSION: CVD contributes significantly to the mortality in patients with SLE in India. It is second only to renal disease in this regard.

Multiple myeloma: treatment options for an incurable disease.

Multiple myeloma remains a challenge for the treating physician, with extremely low complete response rates (5-10%) to conventional induction therapy. High dose therapy with autologous hematopoietic stem cell transplant results in improved response, event-free and overall survival and should be considered the standard of care for patients who are candidates for transplantation. Several newer treatment option are now available.

Thymoma: a pathological study of 50 cases.

BACKGROUND: A combination of epithelial cells and lymphocytes results in a varied histomorphology of thymomas and consequent varied classification systems. AIM: To correlate the Marino and Muller-Hermelink (MMH) classification with the invasive behaviour of thymomas. SETTING AND DESIGN: Retrospective analysis. MATERIALS AND METHOD: Thymomas encountered in the past 21 years were re-classified with the MMH classification and correlated with Masaoka's staging and clinical presentation. RESULTS: The thymomas formed 91% of the primary thymic epithelial tumours. Predominantly cortical thymomas (n=21) and cortical thymomas (n=22) were the common subtypes and 60% and 77% of these, respectively, were in stages II or III. Cystic change, necrosis or haemorrhage played no role in predicting invasive behaviour. Cortical epithelium correlated well with the presence of para-thymic syndromes, especially myasthenia gravis. CONCLUSION: MMH classification is easy to apply. Cortical thymomas in stage I should be followed up for possible recurrence.

Invasive pulmonary aspergillosis: A study of 39 cases at autopsy.

BACKGROUND: Aspergillus is a common cause of invasive mycosis, especially in immunocompromised or immunosuppressed individuals. AIMS: To study the incidence of invasive pulmonary aspergillosis and evaluate the predisposing factors and clinico-pathological manifestations. SETTINGS AND DESIGN: Retrospective analysis of autopsy material from a tertiary care hospital. MATERIAL AND METHODS: All autopsies performed over a 12-year period were reviewed and cases with invasive aspergillosis were analysed with respect to their clinical presentation, predisposing factors, gross and histological features, complications and causes of death. RESULTS: Among a total of 20475 autopsies performed in 12 years, 39 patients (0.19 %) had invasive pulmonary aspergillosis. There were 28 males and 11 females. Their ages ranged from five months to 67 years. Dyspnoea, fever, cough with mucopurulent expectoration, chest pain and haemoptysis were commonly encountered symptoms. Forty-one per cent of the patients had no respiratory symptoms. Fungal aetiology was not entertained clinically in any of the patients. The major underlying conditions were prolonged antibiotic therapy, steroid therapy, and renal transplantation, often associated with underlying lung diseases. Pneumonia, abscesses, vascular thrombosis and infarction were common findings at autopsy. Antecedent tuberculosis, mucormycosis, Pneumocystis carinii pneumonia and Cytomegalovirus infection were also present. In most cases, death was related to extensive pulmonary involvement or fungal dissemination. CONCLUSION: A diagnosis of invasive pulmonary aspergillosis should always be borne in mind whenever one is dealing with recalcitrant lung infections even with subtle immunosuppression. Radiological investigations and serologic markers can be utilised for confirmation and prompt therapy.

Hepatoprotective effect of Himoliv, a polyherbal formulation in rats.

The effect of Himoliv (HV) was evaluated in carbon tetrachloride or paracetamol induced hepatotoxicity in rats. Liver necrosis was produced by administering single dose of either carbon tetrachloride (CCl4, 1 ml/kg, 50% v/v with olive oil, s.c.) or paracetamol (PC, 1 g/kg, p.o.). The liver damage was evidenced by elevated levels of serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT) and serum alkaline phosphatase (ALP) and hepatic thiobarbituric acid reacting substances (TBARS) and superoxide dismutase (SOD). HV pretreatment (0.5 and 1.0 ml/kg, p.o.) significantly (P < 0.001) reduced CCl4 or PC-induced elevations of the levels of SGOT, SGPT, ALP and TBARS, while the reduced concentration of SOD due to CCl4 or PC was reversed. Silymarin (25 mg/ kg, p.o.), a known hepatoprotective drug showed similar results.

Aplasia cubs congenmta associated with meningomyelocoel.

Aplasia cutis congenita is a rare congenital anomaly where skin is missing over part of the body. Most of the cases are present on the scalp. We present a case of ACC where skin was absent over the lumbosacral area. It was associated with meningomyelocoel.

Angiosarcoma of the heart presenting as recurrent cardiac tamponade.

We present an interesting case of angiosarcoma of the heart presenting as recurrent percardial effusion and cardiac tamponade.

Pseudoexstrophy in a female child.

A six-year-old female patient presenting with a swelling in the infraumbilical part of the abdomen, bulging out on straining, was diagnosed to have pseudoexstrophy bladder. The urinary tract was normal. The patient had bifid clitoris. There was no other associated malformation. Surgical repair of abdominal wall defect was done successfully. A new classification of exstrophy variants is proposed.

Intrauterine intussusception--a cause for ileal atresia.

A case of ileal atresia consequent to intrauterine intussusception is reported. The baby presented with features of neonatal intestinal obstruction but signs of peritonitis were absent. The intussusception was discovered on gross examination of distal atretic ileal segment. The case was managed successfully by resection and end to back anastomosis. This case is reported to highlight intrauterine intussusception as one of the causes of ileal atresia.

Choledochal cyst: a 10-year experience.

A retrospective study of 11 cases of choledochal cyst over a period of 10 years is presented. There were 8 females and 3 males in a ratio of 2.67:1. The classical triad of jaundice, mass and abdominal pain was seen in none of our patients. Ultrasonography was diagnostic in 9 out of 11 (80%) patients. Surgical procedures performed were, complete excision of the cyst with Roux en Y hepaticojejunostomy (nine cases), internal drainage of the cyst (one case) and excision of the extrahepatic cyst with Roux en Y hepaticojejunostomy in one case of Type IV choledochal cyst. One patient died in the immediate postoperative period. Others have remained well upto 10 years follow-up. We recommend total cyst excision with hepaticojejunostomy as the treatment of choice.

Cystic lymphangioma with special reference to rare sites.

A 10 year retrospective study of 45 cases of cystic lymphangioma (CL) in children is presented. There were 25 females and 20 males. Age ranged from 6 months to 8 years. Common sites were involved in 38 and rare sites in 7 patients. Rare sites were--gluteal region (1), pelvis (1), retroperitoneum (1), mesentery (2), inguinal region (1) and inguinoscrotal region (1). The clinical presentation included sudden increase in size (25), lump abdomen (3), gluteal abscess (1), abdominal distension (1) and inguinal swelling (2). Diagnosis was established preoperatively in 38 cases, and after surgery and histopathology in 7 cases. Near total or subtotal excision was carried out in all cases. Facial nerve palsy (1) and recurrence (2) were the complications of surgery. The study is presented to highlight the occurrence of the cystic lymphangioma at rare sites to avoid diagnostic errors and unnecessary mutilating surgery.

A Study on Heritability of Pattern Intensity Index and Asymmetry of Digital Dermatoglyphic Pattern Frequency in Muslims of Assam.

The frequency distribution of digital dermatoglyphic patterns was studied in 50 muslim families from Lakshmipur district from Assam. The study revealed asymmetry in the distribution of various patterns on individual digits though bimannual differences were not present. The mean pattern intensify index was found to be 13.54 + 3.76 corresponding to the presence of more number of loops and whorls in the data. Heritability, as calculated from mid parent child regression was found to be 82% indicating the presence of stronger genetic component in the formation of dermatoglyphic patterns. There was significant inter-familial variance suggesting the presence of genetic and environmental factors. The higher values of intra-familial variance also indicate influence of polygenes with additive effects on dermatoglyphic patterns.

Post traumatic bile ascites.

A 4 year old girl with progressive distension of abdomen and previous history of blunt abdominal trauma was found to have bile ascites due to left hepatic duct (LDH) injury. The management with a brief review of literature is discussed below.

Genotoxic Effects On Photocopying Workers : A Statistical Investigation.

Photocopiers are a source of employment for a large number of people. The personnel working with photocopiers are commonly exposed to toners and their by-products during reloading and running of the machines. The main components of these toners are carbon black, styrene, resins, formaldehyde and polycyclic aromatic hydrocarbons (PAHs) and they are known to be genotoxic. For possible genotoxic effects of occupational exposure to photocopying machines, the present study was undertaken on 29 exposed and 26 control subjects. DNA damage war studied on their peripheral blood leukocytes, using comet assay. DNA repair studies were also undertaken on 10 exposed and 10 control subjects. 50 cells per treatment per individual were scored for comet tail length which is an estimate of DNA damage. The control and the exposed groups show clear difference in the mean tail length of the comets and the standard deviations. The scatter in the individual measurements is also high in the exposed group as compared to the control group.