Successfully reported this slideshow.
Your SlideShare is downloading. ×

Pharmacovigilance - an overview

Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Ad
Loading in …3
×

Check these out next

1 of 17 Ad

Pharmacovigilance - an overview

This Presentation will give you a brief outlook on Pharmacovigilance which will be very useful for every Healthcare professional besides Public awareness.


Pharmacovigilance is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

The obtained information is entered in the drug safety database, analyzed, and assessed by the experts to identify new signals.

Signal: Reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented
previously.

The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of the medicines.



***** Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter.When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness.While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose until the medication was removed from the market in Europe in 1961.The total number of infants affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.Those who survived had limb, eye, urinary tract, and heart problems. ****

This Presentation will give you a brief outlook on Pharmacovigilance which will be very useful for every Healthcare professional besides Public awareness.


Pharmacovigilance is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

The obtained information is entered in the drug safety database, analyzed, and assessed by the experts to identify new signals.

Signal: Reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented
previously.

The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of the medicines.



***** Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter.When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness.While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose until the medication was removed from the market in Europe in 1961.The total number of infants affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.Those who survived had limb, eye, urinary tract, and heart problems. ****

Advertisement
Advertisement

More Related Content

Recently uploaded (20)

Advertisement

Pharmacovigilance - an overview

  1. 1. PHARMACOVIGILANCE Dr.S.S.Shiva Pharmacovigilance Associate ADR monitoring centre Department of Pharmacology AIIMS, Patna an overview
  2. 2. HISTORY - THALIDOMIDE TRAGEDY * PHOCOMELIA* Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter.When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness.While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose until the medication was removed from the market in Europe in 1961.The total number of infants affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.Those who survived had limb, eye, urinary tract, and heart problems.
  3. 3. What is Pharmacovigilance? Pharmacovigilance is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pre-Marketing : Phase 0 Phase 1 Phase 2 Phase 3 Post-Marketing : Phase 4 pharmakon (Greek for drug) and vigilare (Latin for to keep watch) Two types:
  4. 4. 1 Improve patient care and public safety for medical and paramedical interventions. 3 Assess benefit, harm, effectiveness and risk of medicines 5 Encourage safe, rational and (cost-)effective use of medicines 2 Effectively communicate surveillance results to the public.. 4 Promote understanding, education and clinical training in PV. Aims of Pharmacovigilance
  5. 5. What is an Adverse Drug Reaction ? “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” steven johnson syndrome phocomelia Maculopapular drug eruptions Hypoxia Fast Heart rate
  6. 6. Classification of ADRs OTHERS TYPE OF REACTION SEVERITY ONSET OF ACTION Acute : <60mins Sub-acute : 1-24hours latent : > 2days Minor Moderate Severe lethal Type A, B, C, D, E, F Side effects, Secondary effects Toxic effects, Intolerance Idiosyncrasy, Drug allergy Photosensitivity, Drug dependance Drug withdrawal reactions Teratogenicity,Mutagenicity Carcinogenicity, Drug induced disease(latrogenic)
  7. 7. 80% 10% Type of Reaction (Mnemonic) Features A: Dose related (Augmented) Common Related to the pharmacologic action of the drug – exaggerated pharmacologic response Predictable Low mortality B: Non–dose related (Bizarre) Uncommon Not related to the pharmacologic action of the drug Unpredictable High mortality C: Dose related and time related (Chemical) Uncommon Related to the cumulative dose D: Time related (Delayed) Uncommon Usually dose related Occurs or becomes apparent sometime after use of the drug E: Withdrawal (End of use) Uncommon Occurs soon after withdrawal of the drug F: Unexpected failure of therapy (Failure) Common Dose related Often caused by drug interactions
  8. 8. Anticoagulants Nitrates Beta blockers A: Dose related (Augmented) B: Non–dose related (Bizarre) Penicillins Anticonvulsants C: Dose related and time related (Chemical) Paracetamol D: Time related (Delayed) TARDIVE DYSKINESIA TERATOGENECITY HYPERSENSITIVITY Phenytoin Antipsychotics Analgesics E: Withdrawal (End of use) Phenytoin withdrawal steroid withdrawal seizures 90% 10%
  9. 9. company adherence to regulations Why is pharmacovigilance important? Patient safety and continuous vigilance Power and authority Keeping it moving
  10. 10. What does pharmacovigilance do? Benefits of a drug outweigh the risks Ongoing monitoring of drugs Clinical trials may not uncover every possible side effect. Elderly may not be involved in the clinical trial
  11. 11. WHAT to report ? ● Serious or Non-serious ADR ● Known or Unknown ADR ● Frequent or Rare WHO can report ? All healthcare professionals (clinicians, dentists, pharmacists, nurses) Patient/consumers The pharmaceutical companies can also send individual case safety reports for their product to NCC.
  12. 12. Nearest ADR Monitoring Center (AMC) - AIIMS Patna ● Cug no : 8544423488 ● Email id : pharmacology@aiimspatna.org ● You can submit the filled ADR form to AMC, Department of pharmacology, Admin block, AIIMS, patna or can send the details on whatsapp HOW to report adverse drug reactions ? Directly to NCC, IPC Ghaziabad ● pvpi.ipcindia@gmail.com, pvpi@ipcindia.net ● Toll free no. – 1800 180 3024 ● ADR Reporting Android app
  13. 13. What happens to ADR reports ? ● The obtained information is entered in the drug safety database, analyzed, and assessed by the experts to identify new signals. ● Signal: Reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously. ● The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of the medicines.
  14. 14. WHO–UMC CAUSALITY ASSESSMENT SCALE
  15. 15. The following points are considered to prevent ADR : LABORATORY MONITORING
  16. 16. Thank you

×