1.Dr. Prajeesh Nath E N PG Dept. of Rasasastra & Bhaishajya Kalpana Amrita School of Ayurveda

2. Content Etymology and Definition. Historical Background. Aims of Pharmacovigilance. Pharmacovigilance in India. National Pharmacovigilance Programme for ASU. Reporting Culture. Ayurvedic concept of PV. Need of PV for Ayurvedic Medicines. Challenges in introducing PV in Ayurveda. 15/1/2014Dr. Prajeesh nath, ASA2 3. Etymology and Definition Pharmakon Greekvigilare LatinDrugto be awake or alert, to keep watch Is the pharmacological science related to the detection,collection,assessment,understanding and prevention of adverse effects particularly long term, short term side effects of medicine.(WHO 2002). Post-Marketing tool. 15/1/2014Dr. Prajeesh nath, ASA3 4. Technical terms Adverse Drug Reactions(ADRs) - A response to a drug which is noxious and unintended, and which occurs atdoses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. Eg. Hypersensitivity rash with intake of guggulu Adverse Event/Experience(AE) - Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment. 15/1/2014Dr. Prajeesh nath, ASA4 5. Side Effect(SE) - Any unintended effect of a pharmaceutical product occurring at doses normally used in human which is related to the pharmacologicalproperties of the drug . Eg. Use of Atropine in oraganophosphorus poisoning achieves therapeutic action by its anticholinergic activity but at same time causes dryness of mouth & dilatation of pupil which is not noxious. Serious Adverse Event (SAE) Any adverse eventwhich is fatal, life- threatening, permanently disabling or which results in hospitalisation. 15/1/2014Dr. Prajeesh nath, ASA5 6. Expected adverse reaction - As opposed tounexpected, an event that is noted in the brochure or labeling. Unexpected adverse reaction - The nature or severity of which is not consistent with the domestic labeling or market authorization, or expected from characteristics of the drug. Signal - Reported information on possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than one single report is required to generate a signal 15/1/2014Dr. Prajeesh nath, ASA6 7. Historical Background Thalidomide tragedy (1961)- greatest of all drugdisasters. 1960 marketed in 46 countries (hypnotic, prevention of nausea in pregnancy) . Tragically the drug proved to be a potent human teratogen that caused major birth defects in an estimated 20,000 children. Phocomelia(Absence of proximal part of limbs) was a characteristic feature. 15/1/2014Dr. Prajeesh nath, ASA7 8. 1962 1963 1964 15/1/2014 Amendment to Federal Food, drug & Cosmetic Act required both safety & efficacy data British Committee on Safety of drug monitoring UK starts yellow cards systemDr. Prajeesh nath, ASA8 9. 1964-65 19681978 15/1/2014 National ADR reporting system UK, Australia, New Zealand, Canada, West Germany, Sweden. WHO: Programme for International Drug Monitoring WHO center moved from Geneva to Uppsala Dr. Prajeesh nath, ASA9 10. UMC(Uppsala monitoring centre) Uppsala monitoring centre(UMC,Swedan) is a field name of the WHO collaborating Centre for International Drug Monitoring. It is responsible for the management of the WHO program for International Drug Monitoring. UMC has >3 million AE case reportes from over 75 countries. The data are supplied by national health authorities Does not review or assess the individual cases put into database, but it does pharmacovigilance analyses and signaling. 15/1/2014Dr. Prajeesh nath, ASA10 11. 4 common drugs banned in other countries but not in India S.N oDrugUseReason for banBrand name1NimesulidePain killer,FeverLiver failureNise, Nimulid2PhenylprapanolamineCold & CoughStrokeDcod, Vicks Action5003QuiniodochlorAntidiarrhealDamage to sightEnteroquinol4AnalginPain killerBone marrow depressionNovalgin15/1/2014Dr. Prajeesh nath, ASA11 12. Aims of Pharmacovigilance Improve patient care and safety. 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. 15/1/2014Dr. Prajeesh nath, ASA12 13. 15/1/2014Dr. Prajeesh nath, ASA13 14. Pharmacovigilance in India 19861997 ADR monitoring system for India proposed (12 regional centres) India joined WHO-ADR monitoring programme (3 centres: AIIMS, KEM, JLN)20102004 2008 Pharmacovigilance programme of India (PvPI) National PV Prog. (2 Zonal, 5 Regional, 24 Peripheral) overseen by CDSCO15/1/2014Dr. Prajeesh nath, ASA14 15. Pharmacovigilance in India PV was established since 2003 under the control ofCentral Drug Standard Control Association(CDSCO) under the aegis of Ministry of H & FW, DGHS (Directorate General of Health Service) New Delhi. WHO emphasized that it should include Traditionalmedicines in PV system and has published guidelineson safety monitoring of herbal medicines in pharmacovigilance systems in 2004.15/1/2014Dr. Prajeesh nath, ASA15 16. IPGT & RA ,Jamnagar conducted a two days workshop on 3rd & 4th December 2007, onPharmacovigilance for Ayurvedic Drugs: Scope, Limitations & Methods of Implementation. Based on the recommendations from the workshop, Pharmacovigilance Cell (PV Cell), has been established . Reporting Form for Suspected ADRs of Ayurvedic Formulations has been developed.15/1/2014Dr. Prajeesh nath, ASA16 17. National Pharmacovigilance Programme for ASU (NPP-ASU) ASU drugs are considered as safe drugs. This perception is likely to change in the light of some recent incidences of ADR during their use. The first National Consultative meet of National Pharmacovigilance Programme for ASU Drugs was organized at Dept. of AYUSH, Ministry of Health &FW, New Delhi on August 2008, sponsored by WHO.15/1/2014Dr. Prajeesh nath, ASA17 18. Based on the feed back received from the meet, National Pharmacovigilance Programme for ASU drugs was launched on 29th Sept 2008. The purpose of the programme is to collect and collate data, analyse it and use the inferences to recommendinformed regulatory interventions, beside communicating risks to healthcare professionals and the public.15/1/2014Dr. Prajeesh nath, ASA18 19. Objectives Short-term objectives - To develop the culture ofnotification. Medium-term objectives - To involve healthcareprofessionals and professional associations in the drug monitoring and information dissemination processes. Long-term objectives - To achieve operational efficienciesthat would make NPP for ASU drugs a benchmark for global drug monitoring endeavours. 15/1/2014Dr. Prajeesh nath, ASA19 20. National PV centrePV Centres in India IPGT & RANTVMGuhwatBHUW NIA15/1/2014EBHU30 Pheripheral PV centresS8 Regional PV centresC CCR ASDr. Prajeesh nath, ASAChennaiBloreBhopal20 21. REPORTING CULTURE15/1/2014Dr. Prajeesh nath, ASA21 22. WHAT TO REPORT? All suspected adverse reactions. Lack of effects. Resistance. Drug interactions. Reactions suspected of causing:a. Death b. Life threatening (real risk of dying) c. Hospitalisation (initial or prolonged) d. Disability (significant, persistent or permanent) e. Congenital anomaly 15/1/2014Dr. Prajeesh nath, ASA22 23. 15/1/2014Dr. Prajeesh nath, ASA23 24. 15/1/2014Dr. Prajeesh nath, ASA24 25. WHO CAN REPORT ? Any health care professional can report . Shall not accept reports from lay members of thepublic. Others can report through the physicians under whom he / she had undergone treatment. Consumer can directly report to the concerned PPC / RPC / nearest health centre or physician regarding the suspected ADR.15/1/2014Dr. Prajeesh nath, ASA25 26. WHERE TO REPORT? Regional CentreHospitalPatientHealth ProfessionalNational CentreManufacturer15/1/2014Dr. Prajeesh nath, ASA26 27. WHAT HAPPENS TO THE INFORMATION SUBMITTED ? Confidential. PPC forward the form to the respective RPC (causalityanalysis). This information shall be forwarded to the NPRC. The data will be statistically analysed and forwarded to the Dept. of AYUSH PPC15/1/2014RPCNPRCDr. Prajeesh nath, ASAAYUSH27 28. RESPONSIBILITIES OF CENTRE'S To collect ADR reports. To fill in the ADR form properly. To forward duly filled in ADR forms to next higher centre. To maintain a log of all ADR notification forms. To provide general technical support,coordinate and monitor the functioning of Centres. To carry out causality analysis of all ADR forms.15/1/2014Dr. Prajeesh nath, ASA28 29. To forward all duly-filled ADR forms as perpre-determined time line. To report all SADRs within 24 Hrs. To forward periodic reports to next higher centre. To orgnize and attend training programs/ interactive meetings for all lower level centres. Organize the public campaigns. 15/1/2014Dr. Prajeesh nath, ASA29 30. 15/1/2014Dr. Prajeesh nath, ASA30 31. Ayurvedic concept of PV Term PV does not feature in Ayurvedic texts. Rational drug use are reccurent themes of Ayurvedicpharmacology(DRB) and therapeutics(chikitsa). Along with descriptions related to actions & benefits of medicines, Ayurvedic pharmacology describes detailed adverse reactions & also how to deal with ways to minimize adverse effect such as 1. Precaution in manufacture techniques. 2. Time of drug administration. 3. Compliment diet and life style and so on. 15/1/2014Dr. Prajeesh nath, ASA31 32. ll(Ca.Su. 15/4) Effectiveness of all actions depends on proper administratoin, Conversely failure is the result of improper administration. -ll (Ca. Vi.1/15) Of all the substances , one should not resort too much to the 3, Pippali, Kshara, Salt 15/1/2014Dr. Prajeesh nath, ASA32 33. Pippali when used properly alleviates dosas,howevertheir excessive and continous use for long time , leads to aggravation of dosas. Kshara is used for purpose but if used excess proves harmful for hair, eyes,heart and sexual ability. Continous use causes . Lavanam is used as , but excess uses produces . 15/1/2014f Dr. Prajeesh nath, ASAl ll (Ca. Su. 1/124) 33 34. Need of PV for Ayurvedic Medicines In ancient times, physicians prepared medicines fortheir patients themselves. Today production and sale of Ayurveda drugs is formalized into a thriving industry. Ayurvedic medicines 1.Classical Ayurvedic formulations 2.Patent and proprietry formulations. This industrialization has brought many challenges about safe use of Ayurvedic medicines. 15/1/2014Dr. Prajeesh nath, ASA34 35. Challenges in introducing PV in Ayurveda NPP encouraged reporting of all suspected ADRs, Butnumber of reports related to Ayurvedic /herbal drugs are abnormally low. Concept & terminologies related to ADR monitoring are not covered in the Ayurvedic curriculum. Methods to study drug safety problems have not evolved adequately in Ayurveda. Information related to medicines are in the form of slokas in the texts, it is not easily available for general public. 15/1/2014Dr. Prajeesh nath, ASA35 36. Signal detection is difficult because of inherentbelief that Ayurvedic medicines are safe. Patients often use medicines from different systems of medicine concomitantly - difficulty in assigning causality. Lack of quality assurance and control in manufacture of Ayurvedic medicine. Most Ayurvedic formulations are multiingredient.15/1/2014Dr. Prajeesh nath, ASA36 37. Summary and Conclusion By incoperating PV, we will be able to preparemedicines with good efficacy,,quality, safety and minimum harmful effect. In all, Pharmacovigilance will promote: Systematic and rational use of medicines Boost confidence for safety.15/1/2014Dr. Prajeesh nath, ASA37 38. THANKS 15/1/2014Dr. Prajeesh nath, ASA38