Tomato Flu ( Pooja R. Mundhe)

How to cure tomato flu by using IBUPROFEN...

1. B Pharm Final Year (SEM VII) C ourse structure and contents for PRACTICE SCHOOL (BP706PS) DOMAIN-18 PHARMACOVIGILANCE TOMATO FLU

2. A Review Article By: Pooja Ram Mundhe Final Year B Pharmacy (2052811823002) Guided By: Prof.Kalyani Dhavale

3. INDEX Abstract Introduction Clinical research Good clinical practices Concept of pharmacovigilance ICH Guidelines Selection of drug class

4. Abstract- Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines . The importance of pharmacovigilance is withdrawl the regulatory agencies, media; consumers have become more aware about the benefit and risks of medicines. “An adverse event is defined as any un toward medical occurrence that may present during treatment with a drug but which does not necessarily have a relationship with its use.” “An adverse drug reaction is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in human for prophylaxis, diagnosis, therapy or modification of physiological function.”

5. Introduction- It is derived from pharmakon (Greek word drug) vigilar ( latin word) observer as such pharmacovigilance heavily focused on ADR. pharmacovigilance is system to monitor the safety and effectiveness of medicines and other pharmaceutical products. A century long history of many tragic events has played. A critical role in shaping the present day drug development structure and processes none more so than those concerned with pharmacovigilance As per WHO- Pharmacovigilance as science and activities relating to the detection, assessment, understanding and prevention of adverse effect or any other possible drug related problems.

6. Clinical research- Definition Research in which people, or data or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.

7. Phases of clinical trial-

8. Function of DCGI-(drug controller general of India) and CDSCO ( central drug standard control organisation)- . Permission to conduct clinical trials with new drug . .Import license for clinical trial .Approval for conducting clinical trial with medical devices. .Testing of new drug

9. Good clinical practices- Objectives and scope of ICH GCP- .To reduce cost of research work duplication .To achieve greater harmonisation worldwide to ensure that safe effective and high quality medicines .To maintain and formulate guidelines on quality safety and efficacy based regulations for patient benefits 2                          

10. Scope of ICH GCP- .Basis for the conduct of clinical trial .Harmonisation between the member states in entire EU ( Europian Union) .Rules for protection of personal data .protection of human rights

11. Protocol for clinical trial- .Title page(general info) .Objective or purpose .Selection of subject .Treatment of subject .Assessment of efficacy .Assessment of safety

12. Concept of Pharmacovigilance- pharmacovigilance- Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem

13. Objective of pharmacovigilance- .To improve patient care and safety .To improve public health and safety .To contribute to the assessment of benefit, harm, effectiveness and risk of medicines .To promote understanding, education and clinical training

14. Objective of pharmacovigilance programme of India ( PvPI )- .support the CDSCO for formulating safety related regulatory decisions for medicines .communicate findings with all key stakeholder .create a national centre of excellence at par with global drug safety monitoring standards

15. International conference on harmonisation(ICH)-E2e Guidelines- elements of pharmacovigilance safety specification- .summery of identified risk of the drug .potential for important unidentified risk .populations potentially at risk .situation that h

16. Identification and risk including drug drug interaction and drug food interaction Drug drug interaction . cyclosporine and rifampin – loss of immunosuppressive effect .amiodarone and haloperidol – may cause arrhythmias .sirolimus and clarithromycin – nephrotoxicity

17. Drug Food interaction . aspirin and milk – stomach upset .caffeine and food – rapid heart beat .benzodiazepine and grape fruit – inhibit drug metabolism .oxycodone and alcohol – cause coma or asthma

18. Selection of drug class

19. - What is tomato flu - How its spread - Symptoms - Treatment

20. What is tomato flu It is a viral disease that starts with rashes, Blisters or ulcers in the mouth it firstly shown in kerala It mainly occurs in children below 9 year. How its spread Virus spread mainly by droplets when people with flu cough, sneeze, talk, shearing food

21. Symptom Mild fever Rashes Pain in Joint Poor appetites Nausea Vomiting Blisters on tongue, gums Treatment No specific treatment Its not a life threatening disease Self limiting disease

22. Selection of drug Ibuprofen - NSAID Mechanism of action

23. Pharmacological effect Ibuprofen works on the chemical pathway for pain it means it act as analgesic It reduce the ability of our body to make prostaglandins it means it act as anti-inflammatory Side effect Headache Dizziness Nausea Diarrhea Constipation Heart burn

24. Contraindication Asthma Hypertensive patients Heart attack Pregnancy Kidney disease

25. Assessment of ADR As per Naranjo’s Algorithm 63% of adverse drug reaction were possible and 36% were probable The severity assessment should that 72% of adverse effect were mild and that 27% were moderate

26. As tomato fever is a new among all the types of flu, still its spread, cause, treatments are all similar to dengue and chikungunya. So, as this study concludes that most aren’t aware of this fever, still they know that isolation is first step. As during recent pandemic everyone has learned about hygiene which is a crucial factor for this fever. Preventing infected child from sharing toys, clothes, food is one of the leading prevention. Drug repurposing is one of the most efficacious approach to ensure public safety. As no antiviral drugs or vaccine are available for prevention of tomato flu. Monitoring and follow up is needed for better understanding the potential treatment. So we can use drugs like Ibuprofen, acetaminophen, etc. Conclusion:

27. Reference’s - Joel M. Gelfand, Megan H. Noe, in Comprehensive Dermatologic Drug Therapy (Fourth Edition), 2021 World health organisation (Regulation and Prequalification) Creswell, J.W. (2008). Educational research: Planning, conducting, and evaluating quantitative and qualitative research (3rd). Upper Saddle River, NJ: Prentice Hall. 2008, p. 300. ISBN 0-13-613550-1 FDA Page last updated 27 October 2014 Investigational New Drug (IND) Application US Food and Drug Administration. 4 January 2018. Retrieved 17 August 2020. https://medicaldialogues.in/mdtv/medicine/videos/the-tomato-flu-97964 - https://en.wikipedia.org/wiki/Tomato_fever - https://www.narayanahealth.org/blog/tomato-flu/

28. THANK YOU