VACCINE SAFETY SURVEILLANCE.pptx

Pharma notes

1. VACCINE SAFETY SURVEILLANCE PRESENTED BY, g. gopi Bachelor of pharmacy – final year

2. VACCINES A complex biological formulation that gives acquired immunity to a particular infectious disease is called vaccine . The process of ingestion of antigenic agents to stimulate an individuals immune system for against particular pathogen is called vaccination . It is one of the most effective way. Vaccine Pharmacovigilance , Detection Assessment Understanding Reporting AEFI

3. VACCINE PROVIDE BY GOVT. OF INDIA Govt. of I ndia is providing vaccination to prevent 7 vaccines preventable diseases namely, Diphtheria Pertussis Tetanus Polio Measles Hepatitis B BCG

4. OTHER VACCINES Pneumococcal vaccine Rotavirus vaccine Hepatitis A MMR Influenza Meningococcal Cholera JE HPV Typhoid Varicella

5. TYPES OF VACCINES

6. COMPONENTS OF VACCINE

7. VACCINE PHARMACOVIGILANCE OBJECTIVES: M inimize negative effect. To promote safe use of vaccines. Detect the adverse event early. To Make sure that healthy people usually receive the vaccines. To ensure that infants and children consume most of the vaccines. To administer the vaccines globally

8. STEPS OF VACCINE PHARMACOVIGILANE

9. VACCINATION FAILURE When the disease occurs in a person despite being vaccinated for it, this is called vaccine failure

10. CAUSES OF VACCINE FAILURE Manufacture Incorrect vaccination timing Vaccine administration method Improper duration of vaccination Poor health status immunosuppression Lack of maintenance inappropriate choice of vaccine Poor vaccine storage ageing Vaccine transportation use of expired vaccine Light exposure genetic resistance

11. AEFI Unfavourable or unintended response CLASSIFICATION

12. CLASSIFICATION OF AEFIs Vaccine Product related Vaccine Q uality related Immunization Error related – Inappropriate vaccine management or administration ( preventable in nature ) Immunization Anxiety related – Anxiety about immunization ( Eg : Vasovagal syncope in an adolescent during immunization) Coincidental Events – Fever occurs at the time of the vaccination

13. TYPES OF AEFI BASED ON SEVERITY COMMON MINOR – local reaction ( fever ) SERIOUS AEFIs – causes hospitalization or significant disability or death SEVERE AEFIs – not minor but do not result in disability or death

14. MINOR REACTION SEVERE REACTION Happen s within few hrs of injection Normally no long term problem is observed Resolved after short period of time Disabling is observed Local reaction Symptoms like pain, swelling or redness at the site of injection Rarely lives threatening Systemic reaction – muscle pain, headache, loss of appetite or fever Seizures or anaphylaxis

15. COMPONENTS OF AEFI DETECTION AND REPORTING - Parents or Health care workers (trained), immunization program manager describe the role and responsibilities of healthcare workers INVESTIGATION – confirm the diagnosis, outcome of adverse event , identify the specification of implicated vaccine , examine operational aspects ( immunization error ) WHO provide key instrument- Aide- M emorie on AEFI investigation provide guidelines Only for Serious reaction ( death, cluster investigation, disability and vaccine product ) CAUSALITY ASSESSMENT OF AEFI – systematic review data of AEFI care reports RISK/BENEFIT ASSESSMENT

16. THANK YOU FOR YOUR ATTENTION