Professional Documents
Culture Documents
Presentation pharmacovigilance methods29
Presentation pharmacovigilance methods29
METHODS
Supervised By: Prof.Abhinav Bthateja
Submitted By:Manpreet Kaur Kalsi
B.Pharmacy 8 th Semester
Roll No.: 789563
COMPARATIVE
OBSERVATIONAL
STUDIES
TARGETED
CLINICAL
INVESTIGATION
Passive Surveillance:
◦ Passive surveillance means that no active measures are taken to look for adverse effect other than the
encouragement of health professionals and others to report safety concerns.
◦ Most common form of pharmacovigilance.
◦ Commonly referred as “voluntary reporting”.
• In this method,the adverse events of the newly marketed drugs are reported online by the
health-care professionals.
• Furthermore,during the post-marketing surveillance the pharmaceutical companies
regularly provide health care workers with the safety information of newly launched drug
and ask them to monitor the related adverse events and report them.
• Besides, the representative of the respective pharmaceutical company can directly pay a visit
by informing health care professionals through fax and direct mails.
• This method resembles spontaneous reporting system,as the reporting of adverse events
starts soon after the marketing of the drug .
Active Surveillance:
1.SENTINEL SITES
3.REGISTRIES
COMPARATIVE
OBSERVATIONAL
STUDIES
• Comparative observational studies are the epidemiological methods that are used to
analyse and describe the occurrence of a disease in a population .
• The main objective of observational study is to validate drug safety signals reported from
spontaneous reports or case series.
• It is a survey in which the data of the patients is collected at a focal point by a signal person or a
department Serving as coordinator to obtain accurate information which can be reliable to gather
the data for survey.
• These studies are useful to analyse the disease occurrence at any point of time.
• However the only drawback of cross-sectional study is that it cannot explain the relationship
between drug exposure and the outcome (adverse events).
2.CASE – CONTROL STUDY:
• It is a retrospective study in which patients with particular disease are compared to group who
have no disease but are exposed to the risk factor of the disease.
• This type of study is not only useful to investigate the relevance between the drug exposure and
the outcome,but also to recognise the risk factors of adverse events.
• The risk factors can include medical conditions such as hepatic and renal dysfunction.
• As the patients follow-up is monitored ,exposure to one or more drugs can be known which is
useful to calculate incidence rate of disease or event.
• On the other hand , the disadvantage of cohort study is, it is expensive,may continue for
years as it involves large number of subjects.
TARGETED CLINICAL
INVESTIGATION
DESCRIPTIVE
STUDIES:
• NATURAL HISTORY
OF DISEASE
• DRUG UTILIZATION
STUDY