0
Dr. Prajeesh Nath E N
PG Dept. of Rasasastra & Bhaishajya Kalpana
Amrita School of Ayurveda
Content
 Etymology and Definition.
 Historical Background.
 Aims of Pharmacovigilance.
 Pharmacovigilance in India.
 ...
Etymology and Definition
Pharmakon
Greek

vigilare
Latin

Drug

to be awake or alert,
to keep watch

• Is the pharmacologi...
Technical terms
 Adverse Drug Reactions(ADRs) - A response to a drug
which is noxious and unintended, and which occurs at...
 Side Effect(SE) - Any unintended effect of a
pharmaceutical product occurring at doses normally
used in human which is r...
 Expected adverse reaction - As opposed to

“unexpected”, an event that is noted in the brochure or
labeling.
 Unexpecte...
Historical Background…
 Thalidomide tragedy (1961)- greatest of all drug

disasters.
 1960 marketed in 46 countries (hyp...
1962
1963
1964
15/1/2014

• Amendment to Federal
Food, drug & Cosmetic Act required both safety & efficacy
data
• British ...
1964-65
1968

1978
15/1/2014

• National ADR reporting
system UK, Australia, New
Zealand, Canada, West
Germany, Sweden.

•...
UMC(Uppsala monitoring centre)
 Uppsala monitoring centre(UMC,Swedan) is a field
name of the WHO collaborating Centre for...
4 common drugs banned in other
countries but not in India
S.N
o

Drug

Use

Reason for ban

Brand name

1

Nimesulide

Pai...
Aims of Pharmacovigilance
 Improve patient care and safety.
 Improve public health and safety.

 To contribute to the a...
15/1/2014

Dr. Prajeesh nath, ASA

13
Pharmacovigilance in India
1986

1997

• ADR monitoring system
for India proposed (12
regional centres)

• India joined WH...
Pharmacovigilance in India
 PV was established since 2003 under the control of

Central Drug Standard Control Association...
 IPGT & RA ,Jamnagar conducted a two days
workshop on 3rd & 4th December 2007, on

“Pharmacovigilance for Ayurvedic Drugs...
National Pharmacovigilance
Programme for ASU (NPP-ASU)
 ASU drugs are considered as safe drugs.
 This perception is like...
 Based on the feed back received from the
meet, National Pharmacovigilance Programme for ASU
drugs was launched on 29th S...
Objectives
 Short-term objectives - To develop the culture of

notification.
 Medium-term objectives - To involve health...
National PV centre

PV Centres in India
IPGT
& RA

N

TVM

Guhwat

BHU

W
NIA

15/1/2014

E

BHU

30 Pheripheral
PV centre...
REPORTING CULTURE

15/1/2014

Dr. Prajeesh nath, ASA

21
WHAT TO REPORT?
 All suspected adverse reactions.
 Lack of effects.

 Resistance.
 Drug interactions.
 Reactions susp...
15/1/2014

Dr. Prajeesh nath, ASA

23
15/1/2014

Dr. Prajeesh nath, ASA

24
WHO CAN REPORT ?
 Any health care professional can report .
 Shall not accept reports from lay members of the

public.
...
WHERE TO REPORT?
Regional
Centre

Hospital

Patient

Health
Professional

National
Centre

Manufacturer

15/1/2014

Dr. Pr...
WHAT HAPPENS TO THE INFORMATION
SUBMITTED ?
 Confidential.
 PPC forward the form to the respective RPC (causality

analy...
RESPONSIBILITIES OF CENTRE'S
 To collect ADR reports.
 To fill in the ADR form properly.
 To forward duly filled in ADR...
 To forward all duly-filled ADR forms as per

pre-determined time line.
 To report all SADRs within 24 Hrs.
 To forward...
15/1/2014

Dr. Prajeesh nath, ASA

30
Ayurvedic concept of PV
 Term PV does not feature in Ayurvedic texts.
 Rational drug use are reccurent themes of Ayurved...


ll(Ca.Su.
15/4)
 Effectiveness of all actions depends on proper
administratoin, Conversely failure is the result of
im...
 Pippali when used properly alleviates dosas,however

their excessive and continous use for long time , leads
to aggravat...
Need of PV for Ayurvedic Medicines
 In ancient times, physicians prepared medicines for

their patients themselves.
 Tod...
Challenges in introducing PV in Ayurveda
 NPP encouraged reporting of all suspected ADRs, But

number of reports related ...
 Signal detection is difficult because of inherent

belief that Ayurvedic medicines are safe.
 Patients often use medici...
Summary and Conclusion
 By incoperating PV, we will be able to prepare

medicines with good efficacy,,quality, safety and...
THANKS
15/1/2014

Dr. Prajeesh nath, ASA

38
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Pharmacovigilance for ASU Drugs

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  • Adverse Event (AE) – A negative experience encountered by an individual during the course of a clinical trail, which may or may not be associated with a drug
  • To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions To improve public health and safety in relation to the use of medicinesTo contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public
  • Perceptive of the importance of Pharmacovigilance,Institute for Post Graduate Teaching and Research In Ayurveda,Jamnagar has already conducted a two days workshop on 3rd &4th December 2007, on “Pharmacovigilance for Ayurvedic Drugs:Scope, Limitations & Methods of Implementation”, funded byWHO, Country Office for India, New Delhi. Based on therecommendations of the workshop, a Pharmacovigilance Cell(PV Cell), first of its kind in India for Ayurveda, has beenestablished and a Reporting Form for Suspected AdverseReactions of Ayurvedic Formulations has been developed anddistributed among the faculty members / research scholars /physicians under intimation to the Department of AYUSH,Ministry of Health and F.W., Govt. of India.
  • To put pharmacovigilance for ASU drugs in proper place in India, formation of a National Pharmacovigilance Centre for ASU Drugs, under the control of Department of AYUSH, is highly essential which would monitor the programme centrally. This programme aims to provide adverse drug reaction data related to various drugs of herbal, mineral, metallic, animal and other origin available in the country.The programme is being coordinated by NPRC-ASU under the guidance of National Pharmacovigilance Consultative Committee for ASU drugs being constituted by Department of AYUSH, Ministry of Health and FW, Govt. of India. The first National Consultative meet of National PharmacovigilanceProgramme for ASU Drugs was organized at Dept. of AYUSH, Ministry of Health & FW, New Delhi on 29th & 30th August 2008, sponsored by WHO, Country Office for India, New Delhi, where the draft protocol was technically reviewed and finalized. The finalized draft was circulated among the experts who attended the meet for their comments and additional inputs, if any. Based on the feed back received, final version of the protocol is prepared and the same is being released as a part of launching of National PharmacovigilanceProgramme.
  • Sponsored and coordinated by the country's National Pharmacovigilance Resource Centre (NPRC) for ASU drugs to establish and manage a data base of ADRs for making uniformed regulatory decisions regarding marketing authorisation of drugs in India for ensuring safety of drugs.
  • Any Health care professionals including, ASU Doctors / Dentists / Nurse / Pharmacistsetc.
  • The reporting on prescribed format will be done to any of the Pharmacovigilancecentres.
  • The information in the form shall be handled inconfidentiality. Peripheral PharmacovigilanceCentresshall forward the form to the respective RegionalPharmacovigilanceCentres who will carry out thecausality analysis. This information shall be forwarded tothe National Pharmacovigilance Resource Centre. Thedata will be statistically analysed and forwarded to theDept. of AYUSH, Govt. of India.
  • To collect ADR reporting To fill in the ADR form properly To forward duly-filled in ADR forms to next higher level centreTo maintain a log of all ADR notification forms (blank or filled) To identify, induce PPC / RPC (with concurrence of NPRC - ASU), provide them with general technical support,coordinate and monitor their functioningTo identify and deploy a pharmacologist for management of pharmacovigilance tasksTo identify and deploy a data manager for data management
  • To carry out (or review) causality analysis of all ADR forms or review such analysis by the RPCTo forward all duly-filled ADR forms as per pre-determined time line i.e. first week of every month Information of all serious ADR's must be conveyed to the NPRC within 2 working days by fax, email, telephone, courier as per stipulated guideline To report all serious adverse reactions within 24 Hrs. To forward periodic reports to next higher centre in first week of every month.To liaison with healthcare professionals order to inculcate / foster the culture of ADR reporting 1. Acknowledge the cooperation of the notifier 2. Share with notifier relevant feedback from higher centres To orgnize and attend training programs/ interactive meetings for all lower level centres Organize the public campaigns
  • , the spirit of PV is vibrant & is emphasized repeatedly in Samhitas.
  • (C.Su. 15/4 – upakalpaneeyamadhyayam)
  • Transcript of "Pharmacovigilance for ASU Drugs"

    1. 1. Dr. Prajeesh Nath E N PG Dept. of Rasasastra & Bhaishajya Kalpana Amrita School of Ayurveda
    2. 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. 3. Etymology and Definition Pharmakon Greek vigilare Latin Drug to 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. 15/1/2014 Dr. Prajeesh nath, ASA 3
    4. 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 Dr. Prajeesh nath, ASA 4
    5. 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 Dr. Prajeesh nath, ASA 5
    6. 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 Dr. Prajeesh nath, ASA 6
    7. 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 Dr. Prajeesh nath, ASA 7
    8. 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” system Dr. Prajeesh nath, ASA 8
    9. 9. 1964-65 1968 1978 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, ASA 9
    10. 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 Dr. Prajeesh nath, ASA 10
    11. 11. 4 common drugs banned in other countries but not in India S.N o Drug Use Reason for ban Brand name 1 Nimesulide Pain killer,Fever Liver failure Nise, Nimulid 2 Phenylprapanolamine Cold & Cough Stroke D’cod, Vicks Action500 3 Quiniodochlor Antidiarrheal Damage to sight Enteroquinol 4 Analgin Pain killer Bone marrow depression Novalgin 15/1/2014 Dr. Prajeesh nath, ASA 11
    12. 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 Dr. Prajeesh nath, ASA 12
    13. 13. 15/1/2014 Dr. Prajeesh nath, ASA 13
    14. 14. Pharmacovigilance in India 1986 1997 • ADR monitoring system for India proposed (12 regional centres) • India joined WHO-ADR monitoring programme (3 centres: AIIMS, KEM, JLN) 2010 2004 – 2008 • Pharmacovigilance programme of India (PvPI) • National PV Prog. (2 Zonal, 5 Regional, 24 Peripheral) overseen by CDSCO 15/1/2014 Dr. Prajeesh nath, ASA 14
    15. 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 Dr. Prajeesh nath, ASA 15
    16. 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 Dr. Prajeesh nath, ASA 16
    17. 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 Dr. Prajeesh nath, ASA 17
    18. 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 recommend informed regulatory interventions, beside communicating risks to healthcare professionals and the public. 15/1/2014 Dr. Prajeesh nath, ASA 18
    19. 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 Dr. Prajeesh nath, ASA 19
    20. 20. National PV centre PV Centres in India IPGT & RA N TVM Guhwat BHU W NIA 15/1/2014 E BHU 30 Pheripheral PV centres S 8 Regional PV centres C CCR AS Dr. Prajeesh nath, ASA Chennai B’lore Bhopal 20
    21. 21. REPORTING CULTURE 15/1/2014 Dr. Prajeesh nath, ASA 21
    22. 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 Dr. Prajeesh nath, ASA 22
    23. 23. 15/1/2014 Dr. Prajeesh nath, ASA 23
    24. 24. 15/1/2014 Dr. Prajeesh nath, ASA 24
    25. 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 Dr. Prajeesh nath, ASA 25
    26. 26. WHERE TO REPORT? Regional Centre Hospital Patient Health Professional National Centre Manufacturer 15/1/2014 Dr. Prajeesh nath, ASA 26
    27. 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 15/1/2014 RPC NPRC Dr. Prajeesh nath, ASA AYUSH 27
    28. 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 Dr. Prajeesh nath, ASA 28
    29. 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 Dr. Prajeesh nath, ASA 29
    30. 30. 15/1/2014 Dr. Prajeesh nath, ASA 30
    31. 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 1. Precaution in manufacture techniques. 2. Time of drug administration. 3. Compliment diet and life style and so on. 15/1/2014 Dr. Prajeesh nath, ASA 31
    32. 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 15/1/2014 Dr. Prajeesh nath, ASA 32
    33. 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 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 .  15/1/2014 f Dr. Prajeesh nath, ASA l ll (Ca. Su. 1/124) 33
    34. 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 Dr. Prajeesh nath, ASA 34
    35. 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 Dr. Prajeesh nath, ASA 35
    36. 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 multiingredient. 15/1/2014 Dr. Prajeesh nath, ASA 36
    37. 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 Dr. Prajeesh nath, ASA 37
    38. 38. THANKS 15/1/2014 Dr. Prajeesh nath, ASA 38
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