Pharmacovigilance for ASU Drugs

1. Pharmacovigilance for ASU Drugs 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 . 15/1/2014 Dr. Prajeesh nath, ASA 2

3. 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. Pharmakon vigilare Greek Latin Drug to be awake or alert, to keep watch Etymology and Definition 15/1/2014 3 Dr. Prajeesh nath , ASA

4. Technical terms Adverse Drug Reactions(ADRs) - A response to a drug which is noxious and unintended, and which occurs at doses 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. 15/1/2014 4 Dr. Prajeesh nath, ASA

5. Side Effect(SE) - Any unintended effect of a pharmaceutical product occurring at doses normally used in human which is related to the pharmacological properties 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 event which is fatal, life- threatening, permanently disabling or which results in hospitalisation . 15/1/2014 5 Dr. Prajeesh nath, ASA

6. Expected adverse reaction - As opposed to “unexpected”, 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 15/1/2014 6 Dr. Prajeesh nath, ASA

7. Historical Background … Thalidomide tragedy (1961)- greatest of all drug disasters. 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. 15/1/2014 7 Dr. Prajeesh nath, ASA

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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. 15/1/2014 10 Dr. Prajeesh nath, ASA

11. 4 common drugs banned in other countries but not in India S.No Drug Use Reason for ban Brand name 1 Nimesulide Pain killer,Fever Liver failure Nise , Nimulid 2 Phenylprapanol -amine Cold & Cough Stroke D’cod , Vicks Action500 3 Quiniodochlor Anti-diarrheal Damage to sight Enteroquinol 4 Analgin Pain killer Bone marrow depression Novalgin 15/1/2014 Dr. Prajeesh nath, ASA 11

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. 15/1/2014 12 Dr. Prajeesh nath, ASA

13. Pharmacovigilance in India 15/1/2014 Dr. Prajeesh nath, ASA 13

14. Pharmacovigilance in India 15/1/2014 14 Dr. Prajeesh nath, ASA

15. Pharmacovigilance in India PV was established since 2003 under the control of Central 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 Traditional medicines in PV system and has published guidelines on safety monitoring of herbal medicines in pharmacovigilance systems in 2004. 15/1/2014 15 Dr. Prajeesh nath, ASA

16. IPGT & RA ,Jamnagar conducted a two days workshop on 3rd & 4th December 2007, on “ Pharmacovigilance 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. 15/1/2014 16 Dr. Prajeesh nath, ASA

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. 15/1/2014 17 Dr. Prajeesh nath, ASA

18. Based on the feed back received from the meet, National Pharmacovigilance Programme for ASU drugs was launched on 29 th Sept 2008. The purpose of the programme is to collect and collate data, analyse it and use the inferences to recommend informed regulatory interventions, beside communicating risks to healthcare professionals and the public. 15/1/2014 18 Dr. Prajeesh nath, ASA

19. Objectives Short-term objectives - To develop the culture of notification. Medium-term objectives - To involve healthcare professionals and professional associations in the drug monitoring and information dissemination processes. Long-term objectives - To achieve operational efficiencies that would make NPP for ASU drugs a benchmark for global drug monitoring endeavours . 15/1/2014 19 Dr. Prajeesh nath, ASA

20. PV Centres in India IPGT & RA N BHU BHU S TVM E Guhwat W NIA CCRAS Chennai B’lore C Bhopal National PV centre 8 Regional PV centres 30 Pheripheral PV centres 15/1/2014 20 Dr. Prajeesh nath, ASA

21. REPORTING CULTURE 15/1/2014 21 Dr. Prajeesh nath, ASA

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 15/1/2014 22 Dr. Prajeesh nath, ASA

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25. WHO CAN REPORT ? Any health care professional can report . Shall not accept reports from lay members of the public. 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. 15/1/2014 25 Dr. Prajeesh nath, ASA

26. Patient Health Professional Regional Centre Manufacturer Hospital National Centre WHERE TO REPORT? 15/1/2014 26 Dr. Prajeesh nath, ASA

27. WHAT HAPPENS TO THE INFORMATION SUBMITTED ? Confidential. PPC forward the form to the respective RPC (causality analysis). This information shall be forwarded to the NPRC. The data will be statistically analysed and forwarded to the Dept. of AYUSH PPC RPC NPRC AYUSH 15/1/2014 27 Dr. Prajeesh nath, ASA

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. 15/1/2014 28 Dr. Prajeesh nath, ASA

29. To forward all duly-filled ADR forms as per pre-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. 15/1/2014 29 Dr. Prajeesh nath, ASA

30. Pharmacovigilance in Ayurveda 15/1/2014 30 Dr. Prajeesh nath, ASA

31. Ayurvedic concept of PV Term PV does not feature in Ayurvedic texts. Rational drug use are reccurent themes of Ayurvedic pharmacology(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 Precaution in manufacture techniques. Time of drug administration. Compliment diet and life style and so on. 15/1/2014 31 Dr. Prajeesh nath, ASA

32. सम्य्क्प्रयोगनिमित्ता हि सर्वकर्मणां सिध्दिरिष्टा, व्यापच्चासम्यक्प्रयोगनिमित्ता..... ll ( Ca.Su . 15/4) Effectiveness of all actions depends on proper administratoin , Conversely failure is the result of improper administration. अथ खलु द्रव्याणि नात्युपयुञ्जीताधिकमन्येभ्यो द्रव्येभ्यः, तद्यथा- पिप्पलि, क्षारः, लवणमिति ll (Ca. Vi. 1/15) Of all the substances , one should not resort too much to the 3, Pippali , Kshara , Salt 15/1/2014 32 Dr. Prajeesh nath, ASA

33. Pippali when used properly alleviates dosas,however their excessive and continous use for long time , leads to aggravation of dosas . Kshara is used for पचन, दहन, भेदन purpose but if used excess proves harmful for hair, eyes,heart and sexual ability. Continous use causes आन्ध्य, षाण्ढ्य, खालित्य, पालित्य, ह्रदयापकर्तिन . Lavanam is used as रोचन, पाचन, उपक्लेदन, विस्रंसन , but excess uses produces ग्लानि, शैथिल्य, दौर्बल्य . यथा विषं यथा शस्त्रं यथा f ग्निरशनिर्यथा l तथौषधमविज्ञातं विज्ञातममृतं यथा ll (Ca. Su. 1/124) 15/1/2014 33 Dr. Prajeesh nath, ASA

34. Need of PV for Ayurvedic Medicines In ancient times, physicians prepared medicines for their 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. 15/1/2014 34 Dr. Prajeesh nath, ASA

35. Challenges in introducing PV in Ayurveda NPP encouraged reporting of all suspected ADRs, But number 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. 15/1/2014 35 Dr. Prajeesh nath, ASA

36. Signal detection is difficult because of inherent belief 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 multi-ingredient. 15/1/2014 36 Dr. Prajeesh nath, ASA

37. Summary and Conclusion By incoperating PV, we will be able to prepare medicines with good efficacy,,quality , safety and minimum harmful effect. In all, Pharmacovigilance will promote: Systematic and rational use of medicines Boost confidence for safety. 15/1/2014 37 Dr. Prajeesh nath, ASA

38. THANKS 38 15/1/2014 Dr. Prajeesh nath, ASA