Retrospective Study of Pneumonia Patients in a Tertiary Hospital of South India

Published By: Trendz In Medical World, January 2012
http://www.trendz.org/view_article.php?article_id=158


Jeetu Gangil*¹, Dr Prabha Adhikari², Dr Kishore G Sam³

¹Clinical Research Executive, Apothecaries Foundation, New Delhi, India.
E.mail: jeetu.gangil@gmail.com 

²Professor of Medicine, Kasturba Medical Hospital, Mangalore, Karnataka, India

³Lecturer, Department of Pharmacy Practice, College of Pharmacy, Gulf Medical College, Ajman, United Arab Emirates, P.O. Box- 4184

 ABSTRACT

AIMS

This epidemiological survey was done to evaluate the demographic and clinical characteristics of pneumonia patients, antibiotics usage pattern, clinical response to macrolides concomitant therapy, duration of hospitalization and mortality rate due to pneumonia infection.

MATERIAL AND METHODS

The retrospective was conducted at the Kasturba Medical Hospital, Mangalore, Karnataka, India. This study was carried out over eight months from August 2009 to March 2010 and patients enrolled who were admitted for treatment of pneumonia infections and information was recorded in patient case report form on the base of demographic, clinical characteristics of pneumonia patients, antibiotics usage pattern, clinical response to macrolides concomitant therapy, duration of hospitalization and mortality rate.

RESULTS

During the year August 2009 – May 2010, a total of forty five (n= 45) pneumonia cases were admitted in Kasturba Medical Hospital, Mangalore for the treatment of pneumonia. Most of the patients who were admitted in the hospital due to pneumonia disease were male [n=26 (57.8%)] as compare to female [n=19 (42.2%)]. The mean age of these patients were 43±23.0 years. On the basis of radiological findings all patients showed infiltrates suggestive of lobar pneumonia Totally eighteen types of prescription pattern were used to treat these patients. Majority of the antibiotics in prescription used were amino-penicillin (n=7) and third generation of cephalosporin (n=7).A total  of six  prescriptions had a  combination of ‘Azithromycin with third generation cephalosporin’ antibiotic to treat pneumonia.  We reviewed all cases (N=45) of pneumonia infection and we analyzed that median duration of hospitalization stay which  was 8.1±3.7 (range 2-12) days. Seven patients (15%)  expired during  hospitalization.

CONCLUSION

This retrospective studies concluded that macrolides concomitant therapy showed good effect in pneumonia patients as compare to other patients who were not received macrolides concomitant therapy.

Keywords: Pneumonia, Macrolides, Antibiotics, Mortality

INTRODUCTION

What is already known about this subject? 

·         Pneumonia is the sixth leading cause of death in the United States.

·         According to a report by the WHO, India accounts for majority of pneumonia cases among children under the age of five and has the highest death rate in the world.

What this study adds? 

·         The macrolides have long been associated with anti-inflammatory benefits in patients with chronic pulmonary inflammatory disorder.

·         Shorter lengths of hospital stay and lower mortality rates in pneumonia who are treated with macrolides concomitant therapy.

Letter to the editor on "Pharmacovigilance: A worldwide master key for drug safety monitoring: Some additional information"

Dr. Chetana Patel

Department of Pharmacology, Government Medical 

College, Majuragate, Surat, India

Link: http://www.jyoungpharm.in/text.asp?2011/3/2/168/80310

Sir,

I have read the article titled "Pharmacovigilance: A worldwide master key for drug safety monitoring," and I found the topic quite informative and it also included recent updates. So first of all, I congratulate the authors for such a nice compilation. It covers almost all areas; however, I would like to add more information about pharmacovigilance in vaccines. The great challenge here is to convey a proper message to the general public as it is like a double-edged sword. ^[1] Majority of vaccines are administered to vulnerable (children) as well as healthy population that requires strict safety supervision. Therefore, the safety of a vaccination must be more than other pharmacological agents to make it acceptable in general population. ^[2]

According to WHO, the adverse event following immunization (AEFI) is "a medical incident that takes place after an immunization causes concern, and is believed to be caused by the immunization." Vaccines are biological agents given prophylactically to protect target population again specific infection by immunological action. ^[2] Following points favor different pharmacovigilance for vaccines and drugs:

1. Complex vaccine sources

Vaccines are complex biological products, which may include multiple antigens, live organisms, adjuvants, and preservatives. Adverse drug reactions (ADRs) may be due to the administration of live wild viruses, e.g., lymphocyte meningitis after anti-mumps vaccine or may be non-specific, related to a component different from the antigen (aluminum hydroxide involved in the "macrophagic myofasciitis," allergic reactions to neomycin, latex, egg, or gelatin). ^[3]

2. Different modes of causality assessment

There are some issues, which make evaluation of vaccines different from other drugs. Local or immediate adverse reactions, which occur due to administrative error and attenuated virus, can be attributed with a degree of confidence but delayed events are difficult to correlate. They have immunological considerations in addition to pharmacological action and take a long time to respond. ^[3] Criteria commonly used to determine causality such as resolution of the event following treatment discontinuation and the result of rechallenge cannot be used to assess causality of an event occurring after vaccination. ^[4]

3. Difference between reporters and reporting chain

This suggests big communication gap, which requires immediate modification in the current system.

So, it is high time to change the current strategy for pharmacovigilance of vaccines as considerable research is going on for vaccine development in infectious diseases, e.g., HIV, malaria, H1N1, etc. having high patient load. ^[2]

 

References

1.	Jeetu G, Anusha G. Pharmacovigilance: A worldwide master key for drug safety monitoring. J Young Pharma 2010;2:315-20.
2.	Budhiraja S, Akinapelli R. Pharmacovigilance in vaccines. Indian J Pharmacol 2010;42:117.    [PUBMED]
3.	Autret-Leca E, Bensouda-Grimaldi L, Jonville-Bιra AP, Beau-Salinas F.Pharmacovigilance of vaccines. Arch Pediatr 2006;13:175-80.
4.	WHO. Adverse Events Following Immunization (AEFI): Causality Assessment. World Health Organization. [accessed on 2009 Dec 14].

Worldwide Escalation of Indian Pharmaceutical Market: Vision 2020

Author:

Mr. Jeetu Gangil

Manipal College of Pharmaceutical Sciences, Manipal University, Karnataka

• Published By: Pharmanext. 2010; 59-62.

Introduction

In the upcoming era India is expected to be in the group of top 10 pharma markets by 2020. The Indian Pharmaceutical industry is on the threshold of becoming a global pharma hub. To capitalize on this opportunity India needs to build a strong research base. This growth include the marketed product portfolios, R&D pipelines, clinical research, market share data, sales forecasts and competitive landscape of the major players in the Indian pharma market. High-flying players in the Indian pharmaceutical market Like Ranbaxy Laboratories Limited, Cipla Limited, GlaxoSmithKline Pharmaceuticals Limited, Nicholas Piramal India Limited and Zydus Cadila. India is emerging as a competitive outsourcing hub and is playing a major role in the global pharmaceutical industry. Global pharmaceutical companies are establishing long-term relationships with Indian manufacturing companies and contract research providers in India. India emerging as a big global destination for contract manufacturing industry and it is growing at thrice the rate of the global outsourcing market.

Do intellectual property rights and data exclusivity encourage innovation in the pharmaceutical world?

J Gangil¹, G Thunga¹, R Nagaich²

¹ Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India

² Department of Pharmacy Practice, VNS Institute of Pharmacy, Bhopal, Madhya Pradesh, India

ABSTRACT:

Today many countries either fail to provide protection or the protection that they provide falls below the levels required by Trade Related Aspects of Intellectual Property Rights (TRIPS). Data exclusivity is one of the most interesting issues in the current discussion on pharmaceutical intellectual property policy making on the global pitch. Data exclusivity, also known as marketing exclusivity, refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the registration files of a pioneer company to be used to register a therapeutically equivalent generic version of that medicine. Only with a clear understanding of the data exclusivity issue and a concerted effort by governments and industries, such as the pharmaceutical industry, that are required to provide registration data to governments have the assurances that their extensive efforts to research, develop, and bring new, innovative products to market will not be subject to unfair business use. Data exclusivity also plays a key role in the development and marketing of new biologics.

Keywords: Data exclusivity, Intellectual property, Patent
Available at: http://www.sysrevpharm.org/text.asp?2010/1/2/190/75088

Evaluation of Azithromycin As Add On Therapy in Community Acquired Pneumonia Patients; A Pilot Clinical Study

Jeetu Gangil¹, Dr. Prabha Adhikari²*, Dr. Kishore G. Sam¹, Anish Kumar¹, Girish T. ¹

¹Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Manipal University, Karnataka- 576 104

²Research Director, Manipal Acunova, Clinical Research Center of KMC Manipal, Manipal University, Karnataka- 575 001

ABSTRACT:

Objective: The objective of this pilot clinical study was evaluation of efficacy and safety of azithromycin versus placebo in combination with standard antibiotic therapy in Community acquired Pneumonia (CAP) patients.

Materials & Methods: Effectiveness of azithromycin was evaluated at dose 500 mg orally once in a day, for ten days with standard antibiotic therapy cefotaxim 500mg i.v. (t.i.d.) in adult patients who hospitalized for CAP. We selected n = 40 patients and randomized into two groups azithromycin and placebo. We analyzed the effectiveness of concomitant use of azithromycin in CAP patients on the basis of improvement in clinical characteristics, duration of hospitalization and outcomes.

Result; On comparison with the standard therapy, CAP patients who received azithromycin tablet showed a significant reduction in average length of stay in the hospital (Mean ± SD) days for study group and controls, mortality and clinical outcomes. However moderate improvement was observed in clinical characteristics (reduction in Pneumonia scores of study group versus controls) with standard therapy of CAP treatment.

Conclusion: Concomitant administration of azithromycin showed significant benefits in reduction in length of hospital stay and mortality rate when added to standard care. This benefit is independent of its antibiotic activity.

Keywords: Add on therapy, Azithromycin, Community Acquired Pneumonia, Duration of hospitalization

Available at: http://jcpronline.com/final/09781.pdf

Pharmacovigilance: A worldwide master key for drug safety monitoring

Jeetu Gangil, Anusha Gupta¹

Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka,

¹Institute of Professional Studies College of Pharmacy, Gwalior, Madhya Pradesh, India


Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964775/?tool=pmcentrez

ABSTRACT

Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

Key words: Drug safety, Erice declaration, Pharmacovigilance

CLINICAL RESEARCH OPPORTUNITIES IN INDIA: BEYOND THE FUTURE

Jeetu Gangil†*, Anish Kumar*, R.Rajesh*, Girish Thunga*, Sureshwar Pandey*

*Manipal College of Pharmaceutical Sciences, Manipal

Published By: Pharmabuzz. 2009; 8(4): 06-09

Abstract

India is emerging as a global hub for clinical research. According to projections from McKinsey & Company, the Indian clinical research industry could attract US $1.5 billion of revenue from U.S. and European sponsors by 2010, creating a demand for more than 10,000 investigators trained in good clinical practice (GCP) and supported by nearly 50,000 clinical research professionals. The revenue expected to be reaching US $ 20 billion in India till 2015.With increased outsourcing from the U.S. and Europe to India, global pharmaceutical companies and Indian entrepreneurs have set up contract research organizations (CROs) in India. They are attracting highly competent professionals, both in the clinical research profession and the knowledge process outsourcing sector.

Available at: http://www.pharmabuzz.org/cover_article.php?feature_id=42