A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Hada, N. K.
- Post-Marketing Surveillance Studies on the Paediatric population Associated with Vaccination
Authors
1 Laureate Institute of Pharmacy, Kathog, Hamirpur, Himachal Pradesh, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 6, No 1 (2014), Pagination: 50-58Abstract
The aim of this text is to grasp the requirement of observance and coverage of the adverse events (AEs) related to vaccination throughout the post-marketing surveillance studies (PMS) and analysis of the protection, efficaciousness and adverse events of vaccination data from PMS studies. The data obtained through numerous specialists with moral pointers of medicine vaccination by knowing the severity of AEs. Literature review and survey form were key aspects for the achieving the objectives. The approval for the survey form obtained from ICRI (India). The analysis work would be helpful for the scholars UN agency area unit wanting to recognize the particular state of affairs of vaccination associated adverse events and additionally knowledgeable to induce some necessary facts regarding AEs observance in children's once vaccination. For the health professionals it'd create them tuned in to their role and responsibilities in surveillance system. Parents of such subjects were also informing the way to beware of their children's vaccination schedules and management of delicate adverse drug reaction and events.Aim and Objecive: The aim of the research is to identify the importance of monitoring and reporting of AEs associated with vaccination during the PMS studies and evaluation of the safety, efficacy and adverse events of vaccination by comparing data from PMS studies obtained through various paediatricians with ethical guidelines on paediatric in different countries across the worldwide.
Methodology: Research work has been conducted after an extensive review of literature. With help of questionnaire, a survey among various paediatricians has been conducted. Then data collection on the basis of obtained by these paediatricians has been done. Analysis and compiling of obtained data is done. Results obtained with the help of statistical methods.
Results: Obtained results from the questionnaires survey demonstrate that 70% of paediatricians reported vaccines available for paediatrics are essential, while remaining 30% are not in the favour of all vaccines use and only recommend vaccines according to their experience and NIS (National Immunization Schedule). 60% of paediatricians reported AEs associated with vaccination are mild, 32% reported these AEs moderate, and 8% reported these AEs are severe. Hospitalization is not recommended by any of above paediatricians. 76% of paediatricians prefer treatment for AEs at home only, while 66% are not aware of the any AEs monitoring and reporting system.
Conclusion: Awareness of the AEs monitoring, reporting and management is necessary among the health professionals and parents. Awareness campaign should be conducted to report and management of AEs associated with vaccination in paediatrics. The passive system needs to be getting active so the short comings of passive system will overcome. Common case definitions and guidelines are required globally so uniformity in reporting the ADRs and AEs will be achieved.
References
- Kari S. Lankinen, Satu Pastila, Patrick Olin ; "Vaccinnovigillance in Europe-need for timeliness, standardization and resources"; Bulletin of the World Health Organization; November 2004, 82 (11), Page No. 828-835.
- K.D. Tripathi, "Essentials of Medical Pharmacology"; 5th Edition, Page No. 827-835.
- Standard Operating Procedures for Investigations of Adverse Events Following Immunization"; Department of Family Welfare, Ministry Of Health and Family Welfare, Government of India, Page No. 6-38.
- Kathleen Meister, M.S.,"Vaccination: What Parents Need To Know"; Sep.2003:1-24.
- "Guidelines for Reporting Adverse Events Associated with Vaccine Products"; Feb.2000, Volume 26S1, Page No. 1-22.
- Jan Bonhoeffer, Kartin Kohl, Robert Chen; " The Brighton Collaboration: Addressing The Need For Standardized Case Definitions Of Adverse Events Following Immunization (AEFI)" ; Vaccine 21 (2002) 298-302.
- "The development of standardized Case Definitions and guidelines for Adverse Events Following Immunization" ; Vaccine 25(2005) 5671-5674.
- L. C. Rodrigues and P. G. Smith; " Use of the Case - Control Approach in Vaccine Evaluation: Efficacy and Adverse Effects"; Vol. 21, No. 1, 1999.
- S. Michael Marcy, "Fever as an Adverse Events Following Immunization: Case Definition and Guidelines for Collection, Analysis, and Presentation "Vaccine 22 (2004), 2091-2095.
- Alberto E. Tozzi, " Field Evaluation of Vaccine safety"; Vaccine 22, (2004), 2091-2095
- John Beigel, Floyd Brintly et all; " generalized vaccininia as an Adverse Events Following exposure to Vaccinia Case Definition and Guidelines for collection, Analysis and presentation of immunization safety data" ; Vaccine 25,(2007), 5745-5753.
- Philip Duclos, "Global perspective on vaccine safety"; Vaccine 22 (2004), 2059-2063.
- Robert Menzies 1 and Peter Mc Intyre, "Vaccine Preventable Diseases and Vaccination Policy for Indigenous Populations" Vol. 28, 2006: 71-80.
- "Adverse Drug Reaction Monitoring in Pediatric practice"; Indian Pediatrics Volume 33, December 1996, 993-998.
- Maria Luisa Avila. et all; " Immunology And Tolerability Of Inactivated Flu Vaccine In High Risk And Healthy Children"; Medicina , Volume 67, No 4, 2007, 351-359.
- Sandeep B. Bavdekar, Sunil Karande, "National Pharmacovigillance Program"; Indian Pediatrics, Volume 42, January 17, 2006, 27-32.
- Neil Z. Miller, " The Polio vaccine: A Critical Assessment Of Its Arcane History, Efficacy, And Long- Term Health - Related Consequences"; Volume 1 (2004) 239-251.
- John Beigl, katrin S. Kohl, Lulu Bravo et all; " Rash Including Mucosal Involvement: Case Definition And Guidelines For Collection, Analysis, And Presentation Of Immunization Safety Data"; vaccine 25 (2007) 5697-5706.
- Janie Parrino, MD, and Barney S. Graham, MD, PhD; "Smallpox Vaccines: Past, Present, and Future"; Volume 118, Number 6, 1320-1326.
- Ville Postila, Terhi Kilpi, "Use of Vaccine Surveillance data in the evalution of safety of vaccines"; Vaccine 22 (2004) 2076-2079.
- Katrin S. Kohl, Wikke Walop at all; " swelling at or near injection site: Case definition and Guidelines for Collection, Analysis, and Presentation of Immunization safety data" ; Vaccine 25 (2007) 5858-5874.
- Marc girard, M.D., MSc., "World Health Organization Vaccine Recommendations: Scientific Flaws, or Criminal Misconduct" ; Journal of American Physicians and Surgeons, Volume 11, Number 1, Spring 2006, 22-23.
- Nichols Wood,David Isaacs,"Monitoring Vaccine Reaction in Australia" MJA,Vol;184, No;4
- Journal of American Physicians and Surgeons, Volume 11, Number 1, spring 2006, 8-13.
- Robert T. chen, Evalution of Vaccine safety after the events of 11 September 2001 : role of cohort and case - control studies" ; Vaccines 22 (2004) 2047-2053.
- Reza Imani et al;"Adverse Events Following Measles and Rubella Immunization Campaign in Shahrekord, Iran; 2003-04"; Kuwait medical journal 2007,39 (4): 327-329.
- A.M. Galazka, S. E. Robertson, et all; "Mumps and mumps vaccine: A global review"; Bulletin of the World Health Organization, 1999, 77, 3-14.
- J. Michael Lane, Joel Goldstein,FAAP; "Adverse Events Occuring after Smallpox Vaccination"; Seminars in Pediatric Infectious Diseases, Vol 14, no 3 (July), 2003:189-195.
- Aquasome: A Self-Assembling Supramolecular And Nanoparticulate Carrier System For Bio-Actives
Authors
1 Laureate Institute of Pharmacy, Kathog, Hamirpur, Himachal Pradesh, IN