Pharmacovigilance defination,need,ADR ,PVPI,

1. Pharmacovigilance,Materiovigi
lance and Haemovigilance
Dr Rahul Saini(MBBS,MD,PGDCR)
Associate Professor
Department of Pharmcology
B.P.S ,GMC for women,Khanpur kalan,sonipat
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2. What is Pharmacovigilance?
Pharmacovigilance is derived from two words
Pharmakon- ‘drug’ & Vigilare –’to keep watch’
WHO in 2002 defines Pharmacovigilance as the science and
activities relating to the
• Detection
• Understanding
• Assessment
• Prevention
Of adverse effects of drugs
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3. Need of Pharmacovigilance
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1.HUMANITARIAN CONCERN
-Animal toxicology :not a good predictor for human effects
-Evidence of safety from clinical trials is insufficient
LIMITATIONS (phase 1-3):limited size ,narrow population (age &sex
specific),narrow indications,short duration
2. SAFE USE OF MEDICINES
3.ADRs ARE EXPENSIVE
4.PROMOTING RATIONAL USE OF MEDICINES
5.ETHICAL CONCERN :not reporting is serious reaction is unethical

4. Terminologies used in Pharmacovigilance
Adverse event
Medical occurrence temporally associated with the use of a medicinal
product, but not necessarily cause related
Adverse drug reaction
Any noxious, unintended, and undesired effect of a drug after
its administration :
A. Dose-related (Augmented)
B. Non-dose-related (Bizarre)
C. Dose-related and time-related (Chronic)
D. Time-related (Delayed)
E. Withdrawal (End of use)
F. Failure of therapy (Failure) 4

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6. Examples of Adverse Reactions caused
by drugs on skin
Urticaria Fixed Drug Eruption
Systemic Lupus Erythematosus Rash Dermatitis Lichenoid
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7. Examples of Adverse Reactions caused
by drugs on skin
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Angioedema Steven Johnson Syndrome

8. Examples of Adverse Reactions caused
by drugs on skin
Psoriasis
Acute generalised exanthematous
pustulosis (AGEP)
Drug reaction with
eosinophilia and systemic
symptoms syndrome
(DRESS) 8

9. Some examples of Adverse Events
Adverse event can be:
• Nausea and Vomiting
• Abdominal pain
• Headache
• Fever
• Dizziness
• Constipation
• Diarrhea
• Swelling
• Redness in eye
• Hepatitis
• Seizure
• Polyuria
• Hyperkalemia
• Ototoxicity
• Insomnia
• Palpitation, etc
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10. Terminologies used in Pharmacovigilance
Serious Adverse Drug Reaction
A serious adverse event or reaction is any untoward medical
occurrence that at any dose may result in –
 Death
 Life threatening
 Hospitalisation/Prolonged
 Disability
 Birth defect
 Required intervention to prevent permanent damage
/impairment
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11. Terminologies used in Pharmacovigilance
Dechallenge
• The withdrawal of a drug from a patient usually after an adverse event
or at the end of planned treatment
Rechallenge
• The point at which a drug is given to a patient after its previous
withdrawal
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12. Terminologies used in Pharmacovigilance
Causality Assessment and Causality Assessment Scales
Causality Assessment is defined as the evaluation of the
likelihood that a medicine was the causative agent of an
observed adverse event. Two most common types of
Causality Assessment Scales are:
 WHO- UMC Causality Assessment Scale
 Naranjo ADR Probability Scale
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17. • PvPI was initiated in July, 2010 by CDSCO under the aegis of
Ministry of Health & Family Welfare with AIIMS as National
Coordinating Centre (NCC)
• In April, 2011 NCC was then shifted from the All India Institute of
Medical Sciences (AIIMS), New Delhi to the Indian
Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.)
• Currently 250 ADR monitoring centres (AMCs) including BPS
GMC, Khanpur Kalan for women, Sonepat has been set up under
this Programme
Pharmacovigilance Programme of India (PvPI)
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18. Aims and Scope of PvPI
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19. ADR Monitoring Scheme in India
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20. Software used in Pharmacovigilance-
Vigiflow
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.VigiFlow is a web-based Individual Case Safety Report (ICSR)
management system : use by national-pharmacovigilance
centres of the WHO Programme for International Drug
Monitoring.
It is maintained by the Uppsala Monitoring Centre (UMC) in
Uppsala, Sweden

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22. Pathway of ICSR
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23. Relevance - use of this data!
• Data given by HCPs is entered in Vigiflow [Software for entry of ADR
Data, provided by Director Controller General of India (DCGI), Govt.
of India]
• This data is used for evaluating and improving the safety of
marketed medicines (Long term efficacy)
– Identify previously unrecognised hazards
– Quantify and recognise risk factors
– Take action to promote safer use like withdrawal of medicine from the
market, etc
– Provide optimal information to user
– in
– national drug policy
• This data is also helpful in safeguarding patients from serious ADRs
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24. Methods adopted by PvPI to convey Drug
Alerts to HCPs
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Via text messages Via Mail

25. Methods adopted by PvPI to convey Drug
Alerts to HCPs
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Via Newsletters issued quarterly in a year

26. Some Drug Alerts generated by PvPI
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Drugs Indication Signal/Advice
Cefoperazone
Sulbactam
Bacterial
infections
Acute Generalised Exanthematous
Pustulosis (AGEP)
Meropenem Septicaemia,
febrile
neutropenia,
intraabdominal
and pelvic
infection
Hypokalemia
Piperacillin &
Tazobacam
In the treatment
of lower RTI/UTI
Vision abnormal
Cefipime For serious CRTI,
uncomplicated
and complicated
UTI,
Dermatitis Lichenoid
Amoxicillin Infections Eye irritation

27. Paracetamol induced Baboon Syndrome
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28. Diclofenac induced Nicolau Syndrome
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29. Metoprolol & Glimiperide induced
Lichenoid Drug Eruption
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30. Hydroxyzine induced Bullous Pemphigoid
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31. Amikacin induced
Stevens Johnson Syndrome
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32. Cefepime induced
Dermatitis Lichenoid
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33. Tinidazole , Cabergoline, Cefexime &
Etoricoxib induced Hyper-pigmentation
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34. Triamcinolone induced
Skin Peeling
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35. Sodium Valproate & Amlodipine
induced Psoriasis
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36. Clindamycin & Linagliptin induced
Acute Generalised Exanthematous
Pustulosis (AGEP)
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37. Acetazolamide Induced Drug
Hypersensitivity Syndrome
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38. Inactivated Influenza Vaccine induced
Papulovesicular Exanthem
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39. More Drug Safety Alerts
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Drug Safety Alert
Losartan Burning micturition
Carbamazepine Bruxism
Ambroxol Lacrimation
Dexamethasone Hiccups
Lamivudine Hearing loss
Amoxicillin Eye irritation
Montelukast Tinnitus
Amitriptyline Gingival Discoloration
Quetiapine Gynaecomastia
Allopurinol Uveitis (redness of eyes, pain & blurred vision)
Ceftriaxone Palpitation

40. More Drug Safety Alerts
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Drug Safety Alert
Fluoxetine Urinary retention
Levetiracetam Hypokalemia
Mebeverine Retrosternal pian
Measles rubella vaccination Joint pain one week after administration &
Guillain Barre Syndrome
Deferasirox Osteoporosis
Lurasidon Thrombocytopenia
Amisulpride Tinnitus
Losartan Burning micturition
Crizotinib Pneumonitis and hepatic encephalopathy
Febuxostat Allergic vasculitis

41. Reporting of ADRs & ADEs - Who can
Report?
• Any healthcare professionals including clinicians, dentists,
pharmacists, nurses, counsellors, etc
• Non-healthcare professionals including consumers
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42. Reporting of ADR s & ADEs- What to
Report?
 Any type of suspected ADR: Known, unknown, serious or
non-serious, frequent or rare and regardless of a established
causal relationship caused after administration of
pharmaceutical medicines, vaccines, herbal medicines,
medical device and contrast media
 ADRs associated with drug withdrawals
 All suspected drug-drug, drug-food, drug-food supplement
interactions
 ADRs due to medication errors
 Cases of lack of efficacy Continue….
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43. Reporting of ADRs & ADEs - What to
Report?
 from drug overdose whether accidental or intentional
 from drug abuse / misuse / non-approved use
 in the infant of a nursing mother
 possibly as a result of exposure of the mother or the fetus
during pregnancy
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44. Ways to Report ADRs or ADEs by HCPs to
PvPI
A. Using the ‘Suspected Adverse Drug Reaction Reporting
Form’ (Version 1.2) available on the website of IPC
(www.ipc.gov.in) as well as website of CDSCO
(www.cdsco.nic.in)
B. Via Toll free number -1800 180 3024 (Monday –Friday
between 9.00 a.m. To 5.30 p.m.
C. “ADR Reporting PVPI” app which can be easily installed in
any Android Mobile
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45. Reporting of ADRs & ADEs- How to
Report? For you
Healthcare professionals (HCPs) can report in the following
ways:
A. Use the ‘Suspected Adverse Drug Reaction Reporting Form’
(Version 1.2) available on the website of IPC (www.ipc.gov.in)
as well as website of CDSCO (www.cdsco.nic.in) to report any
ADR or ADE.
B. This form can be submitted to Coordinator or
Pharmacovigilance Associate of AMC (BPS GMC, Khanpur
Kalan, Sonepat) or can be mailed directly to
pvpi.ipcindia@gmail.com or to bps.amc05@gmail.com
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46. ADR Reporting Form for Healthcare
Professionals
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47. Reporting of ADRs & ADEs
Four mandatory elements for valid AE report;
 Identifiable patient (Patient initials, age at the onset of
reaction)
 Suspected drug
 Adverse event (Reaction term and date of onset of
reaction)
 Name of reporter
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48. Data collected in AMC
• Total number of cases reported till April, 2017: 540
• Antibiotics (Cephalosporins), NSAIDS, etc were identified to
precipitate most of the drug reactions
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0
50
100
150
200
250
Organ system affected due to ADRs
3%
97%
Seriousness of the Reaction
Serious Non serious

49. Haemovigilance Programme of India (HvPI)- for
reporting of adverse events due to blood products
• HvPI is a centralized, structured programme with defined
responsibilities launched in India on Dec 10, 2012 by Indian
Pharmacopoeia Commission (IPC), Ministry of Health & Family
Welfare, Government of India
• National Coordinating Centre (NCC) for HvPI is at National
Institute of Biologicals (NIB) , Ministry of Health & Family
Welfare, Government of India
Common Adverse events reported due to blood products:
 Allergic reactions like urticaria, anaphylaxis, etc
 Fever
 Acute lung injury
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51. Materiovigilance Programme of India (MvPI)-
For reporting of adverse effects due to medical
device
Medical Device is defined as an article, instrument, apparatus or
machine that is used in the prevention, diagnosis or treatment of
illness or disease.
E.gs. are implants, lenses, stents, surgical gloves, catheter, etc
• Materiovigilance Program of India (MvPI) has been launched by DCG
(I) on 6th July 2015 at Indian Pharmacopoeia Commission (IPC)
Ghaziabad
• Sree Chitra Tirunal Institute for Medical Sciences & Technology
(SCTIMST), Thiruvananthapuram, shall act as National Collaboration
Centre, National Health System Resource Centre (NHSRC), New Delhi shall
act as Technical Support & Resource Centre and Central Drugs Standard
Control Organisation (CDSCO), New Delhi shall act as regulator
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52. MvPI Poster
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53. Materiovigilance Programme of India
(MvPI)
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55. Examples of ADR reported in our AMC
Phenytoin induced SJS Cefotaxime induced Rash Norfloxacin induced FDE
Aceclofenac/Levoflox-Bullous
Eruption
Antitubercular drugs-
Excoriated skin lesions Septran- FDE

56. Some examples of Adverse Drug
Events/Reactions reported at AMC
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S.No. Drug/Vaccine/Medical device Adverse event/reaction
1. Vancomycin Seizure
2. Diclofenac Cutaneous reactions
3. Sodium valproate, Phenytoin and Diclopara Steven Johnson Syndrome (SJS)
4. Ranitidine and Olanzapine Constipation
5. Buscopan (Hysocine Bromide) Blurring of vision
6. Multivitamin tablets (Supradyn) and
injections
Cutaneous reactions
7. Metronidazole Vomiting , chest pain
8. Tranexamic acid Fever with chills
9. Equirab vaccine Swelling with redness at injection
site and Sleepiness
10. Methotrexate Increased liver enzymes
11. Cannula Thrombophlebitis
12. Propofol Excessive myotonic contractions

57. Exercise to fill ADR Reporting Form
Case Report
• Information was received from healthcare professional regarding a
35 year old male patient whose name is Dheeraj Kumar who
received Vancomycin Hydrochloride and experienced nausea and
fever.
• No information about Relevant medical history. Indication for
Vancomycin Hydrochloride was Respiratory tract infection.
• Therapy began on 3 August, 2015 and was discontinued on 8-
August, 2015.
• Dose regimen was 1 g, i.v. once a day.
• The patient had been experiencing nausea and fever since he
started the therapy on 3 August, 2015.
• The patient recovered from the events on 6-August, 2015.
• No additional information was available at the time of this report.
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58. Thank You
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