UNDERSTANDING PHARMACOVIGILANCE

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UNDERSTANDING  PHARMACOVIGILANCE
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 PHARMACOVIGILANCE

• The science and activities relating to the
  detection, assessment, understanding and
  prevention of adverse effects or any other
  drug-related problems.
• Recent inclusions to this definition are
  herbals, traditional and complementary medicines,
  blood products, biologicals, medical devices and
  vaccines
• Particularly concerned with ADRs. 

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Pharmacovigilance starts from the clinical stage
and continues throughout the product life cycle
of the drug, mainly divided as Pharmacovigilance
during pre-marketing (that is clinical phase) and
post-marketing.     The process of collection of
such information about a drug begins in phase I
of the clinical trial, before approval of the
drug, and continues even after approval several
post-market safety studies are conducted, with
many made mandatory by drug regulatory agencies
around the world.     The Pharmacovigilance
effort in the India is coordinated by The Indian
Pharmacopoeia Commission and conducted by the
Central Drugs Standard Control Organization
(CDSCO).
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PROCESS IN PHARMACOVIGILANCE
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ADVERSE EVENT

• An adverse event (AE) is any untoward medical
  occurrence in a patient or clinical investigation
  subject administered a pharmaceutical product and
  which does not necessarily have a causal
  relationship with this treatment.
• An adverse event (AE) can therefore be any
  unfavourable and unintended sign (including an
  abnormal laboratory finding), symptom, or disease
  temporally associated with the use of a medicinal
  (investigational) product, whether or not related
  to the medicinal (investigational) product.

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ADVERSE DRUG REACTION

• In the pre-approval clinical experience with a
  new medicinal product or its new usages,
  particularly as the therapeutic dose(s) may not
  be established, all noxious and unintended
  responses to a medicinal product related to any
  dose should be considered adverse drug reactions.
   
• An ADR is a response to a drug which is noxious
  and unintended and which occurs at doses normally
  used in man for prophylaxis, diagnosis, or
  therapy of disease or for modification of
  physiological function

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SERIOUS ADVERSE EVENT  

• A serious adverse event (experience) or reaction
  is any untoward medical occurrence that at any
  dose
• Results in death 
• Is life-threatening
• Requires inpatient hospitalization or
  prolongation of existing hospitalization
• Results in persistent or significant
  disability/incapacity 
• Is a congenital anomaly/birth defect

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AEs-Adverse Events SARS-Serious Adverse
Reactions SAEs-Serious Adverse Events SUSARS-
Suspected Unexpected Serious Adverse
Reactions ARs-Adverse Reactions
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AIM OF PHARMACOVIGILANCE 

• Improve patient care safety in relation to the
  use of medicines all medical paramedical
  interventions.
• Improve public health safety in relation to the
  use of medicines.
• Contribute to the assessment of benefit, harm,
  effectiveness risk of medicines, encouraging
  their safe, rational more effective use.
• Promote understanding, education clinical
  training in pharmacovigilance its effective
  communication to the public.
• Decrease the economic burden of adverse drug
  reactions on the heath care system.

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HISTORY

• PVG in 19th century
• The cowpox vaccination started as early as 1718
  and in spite of claims put forth regarding its
  efficacy and safety, the cowpox vaccination was
  not generally accepted.
• A positive response was only observed after the
  publication of the work of Edward Jenner on
  variolae vaccines in 1798.This process not only
  proved the benefits of the vaccine but also
  demonstrated the safety.
• In 1848 death of a 15 year old girl as a result
  of chloroform anesthesia administered ingrown
  toenail was reported. In response to more deaths
  following chloroform anesthesia Glasgow committee
  was appointed and they concluded that chloroform
  was injurious to the heart and in comparison more
  dangerous than ether

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• PVG in 20th Century
• In 1937 the sulfa compounds were considered the
  miracle drugs as they killed a wide range of
  harmful bacterias.
• One of the manufacturers in 1938 prepared and
  elixir of sulfanilamide by dissolving the drug in
  diethylene glycol. Subsequently 107 people
  including 100 children were killed following use
  of this elixir.
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• In Jun-1938 the federal food drug and cosmetic
  act was signed in USA. The new law required the
  safety testing of new drugs before marketing and
  it became essential that new drug application
  (NDA) incorporates the safety date.

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WHY PHARMACOVIGILANCE IN INDIA?

• The information collected during the
  pre-marketing phase of a medical drug is
  inevitably incomplete with regard to possible
  adverse reactions
• Tests in animals are insufficiently predictive of
  human safety. 
• Patients in clinical trials are selected and
  limited in number, the conditions of use differ
  from those in clinical practice and the duration
  of trials is limited.
• Information about rare but serious adverse
  reactions, chronic toxicity, and use in special
  groups (such as children, the elderly or pregnant
  women) or drug interactions is often incomplete
  or not available.

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WHOs PROGRAMME FOR INTERNATIONAL DRUG
MONITORING 

• As a means of pooling existing data on ADRs,
  WHO's Programme for International Drug Monitoring
  was started in 1968.
• Initially a pilot project in 10 countries with
  established national reporting systems for ADRs,
  the network has since expanded significantly as
  more countries worldwide developed national
  pharmacovigilance centres for the recording of
  ADRs.
• Currently, around 136 countries participate in
  the programme, which is coordinated by WHO
  together with its collaborating centre in
  Uppsala, Sweden .
• The collaborating centre is responsible for
  maintaining the global ADR database, Vigibase.

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Pharmacovigilance industry size witnessed
remarkable developments owing to rising number of
adverse drug reactions, side effects coupled with
potential threats to the consumers. Pharmacovigi
lance was implemented in developed nations
earlier in 1970s, including the U.S. and UK,
following numerous consumer health protection
acts. Increasing number of pharmaceutical
companies, as well as global harmonization
practices will further assist advancements in the
market. Furthermore, emergence of personalized
medicines and rising number of ADRs should spur
industry size in the foreseeable future.
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Indian market held around 22 industry share in
2018. Global pharmaceutical firms have found
India to be a favoured marketplace for clinical
trials due to large clinical research space and
attractive opportunities. Improved compliance
with the international guidelines such as the WHO
Good Clinical Practice (ICH-GCP)/International
Council on Harmonization (ICH) and the rules set
down by the U.S. FDA offers enormous
opportunities for clinical trials in the country.
Increased awareness among public, training of
medical professions and existence of stringent
regulations for reporting of ADRs will thus
accelerate the market progress in the foreseeable
future.
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CAREER OPPORTUNITIES IN PV

• Those seeking a role in drug safety or
  pharmacovigilance should hold a life sciences
  degree or a nursing, pharmacy or medical degree.
• Jobs in drug safety and pharmacovigilance exist
  in both permanent and contract arrangements.
  Temporary agreements can last from three to 12
  months, with many of these positions being for
  drug safety medical writers or interim
  pharmacovigilance physicians.
• Drug safety associates and officers monitor and
  track adverse events and reactions, as well as
  other medically related product information.

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• Senior pharmacovigilance consultants process
  adverse event reports sourced from various
  studies. The information that is gathered is then
  submitted to the regulatory authorities.
• Drug safety managers and directors organise the
  processing and reporting on drug safety reports
  and review trial-related documents in order to
  monitor the drug safety profile of specific
  products.
• Responsible for medical case reviews and
  assessing product safety in clinical trials, drug
  safety physicians work to assess and obtain
  information about the safety of products.

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CAREER IN PHARMACOVIGILANCE

• DRUG SAFETY ASSOCIATE
• SAFETY SURVELLIANCE ASSOCIATE
• PV ASSOCIATE
• DRUG SAFETY OFFICER/MANAGER
• DRUG SAFETY PROJECT MANAGER
• QUALITY ASSOCIATE-DRUG SAFETY
• PHARMACOVIGILANCE OFFICER
• SUBJECT MATTER EXPERT-MEDICAL REVIEWER
• DRUG SAFETY AND MEDICAL AFFAIRS EXECUTIVE
• DRUG SAFETY ANALYST
• DRUG SAFETY SCIENTIST
• MEDICAL WRITER
• DRUG SAFETY PHYSICIAN
• DRUG SAFETY REVIEWER

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