Pharmacovigilnce

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Pharmacovigilance
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Why do we need Pharmacovigilance?
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Pharmaco Vigilance
Pharmaco (Greek) drug Vigilance (Latin)
to keep awake or alert to keep watch
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However, some adverse
drug reactions (ADRs) are often detected ONLY
after marketing,The study of ADRs is the concern
of the field known as pharmacovigilance
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Definition of Pharmacovigilance

• PV is the science and activities dealing with the
  detection, assessment, understanding and
  prevention of adverse effects of drugs
• It has been widened to include biological
  products, herbals, traditional and complementary
  medicines

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Adverse drug reactions

• ADR is defined as any harm associated with the
  use of given drugs at a normal dosage during
  normal use
• ADRs may occur following a single dose or
  prolonged administration of a drug or result from
  the combination of two or more drugs

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Serious ADR according to the FDAIf the drug
results in one or more of the following

• Death
• Life-threatening
• Hospitalization
• Disability - or permanent change, impairment,
  damage or disruption in the patient's body
  function/structure, physical activities or
  quality of life
• Congenital abnormalities
• Requires intervention to prevent permanent damage

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Why do we need pharmacovigilance?

• Because of Insufficient evidence of safety
• Animal experiments
• Clinical trials prior to marketing
• Limitations of clinical trials
• Number of patients is limited 5000
• Narrow population Specific age and sex
• Narrow indications only those having the
  specific disease studied
• Short duration often no longer than a few weeks

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A lesson from history

• 1959 1961 thalidomide (hypnotic, prevention of
  nausea in pregnancy)
• 20000 cases of Phocomelia (congenital limb
  defects)
• This lead to withdrawal of the drug from the
  market

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Examples of products recalled due to toxicity

• Practolol(selective beta blocker used in the
  emergency treatment of cardiac arrhythmias)
  
  (1975) Sclerosing peritonitis
• ..
• Phenformin(an antidiabetic drug from
  the biguanide class)
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  (1982) Lactic
  acidosis
• .
• Rofecoxib(NSAIDs) (2004)
  cardiovascular effects
• Veralipride (benzamide neuroleptic medicine )
  (2007)Anxiety, depression,
  movement disorders
• ..
• Rosiglitazone
  (2010 ( Increased risk of
  MI and death from CV causes

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Changes that occur from the PV findings include

• Restriction in use
• Changes in the specified dose of the medicine
• Introduction of specific warnings in the product
  information
• Changing the legal status of a medicine, e.g.,
  from over-the-counter to prescription only
• In rare cases, removal of the medicine from the
  market, if the risks of a medicine are found to
  outweigh the benefits

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Establishment of the Egyptian (Pharmacovigilance
Center (EPVC

• December 2009
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• http//epvc.gov.eg

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Yellow Card Scheme

• The Yellow Card Scheme is the UK system for
  collecting information on suspected ADRs
• The Scheme was founded in 1964 after the
  thalidomide disaster
• Essential information to include on a yellow
  card
• Patient details
• Suspected drug
• Suspected reaction
• Reporter details

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What should be reported?

• All suspected reactions including minor ones,
• All serious, unexpected, unusual ADRs,
• Change in frequency of a given reaction,
• All suspected drug-drug, drug-food, drug food
  supplements interactions,
• ADRs associated with drug withdrawal,
• ADRs due to medication errors,
• ADRs due to lack of efficacy or suspected
  pharmaceutical defect

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Who can report?

• Patients, patients relatives or patients careers,
  
• Health care professionals (physicians, dentists,
  pharmacists, radiographers, nurses).
• And reported to the responsible person for the
  PVS

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Thank you