Importance of safety monitoring of Medicine

1. IMPORTANCE OF SAFETY MONITORING OF MEDICINE
NAME : DODTALE MAHESH SHILESIDDHA
ROLL NO : 09
SUBJECT: PHARMACOVIGILANCE
YEAR : FINAL YEAR (8TH SEM)
GUIDED BY,
MRS RESHMA V. PAWAR
ASSOCIATE PROFESSOR,
SPM'S COLLEGE OF PHARMACY,AKLUJ

2. IMPORTANCE OF SAFETY MONITORING OF MEDICINE
• Drug safety monitoring is the process of identifying expected and unexpected adverse reactions resulting from
the use of medicines in the post-marketing phase.
• It is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals or devices can
explored, prevented or minimized.
• Before releasing into the market, a medicine is tested using a limited population ranging from 500 to 5000.
• Once the medicine comes into the market it becomes legally available for consumption by the general
population.
• The population may be children, pregnant women, patients suffering from other diseases and the elderly.

3. • It may be given separately or in combination with other medicines.
• Thus, the drug is taken in different therapeutic situations and physiological conditions.
• It is therefore, very much necessary to observe and record the effectiveness and safety of the
medicine under real-life conditions. A close and effective monitoring is required to assess the
risks associated with the use of medicines.
• In fact adverse effects, interactions with foods or with other medicines and risk factors are to
be noticed only during its real use over the years.

4. FLOW CHART: - DIFFERENT PHASES OF CLINICAL EXAMINATIONS
Pre-clinical Animal
Experiments
Animal
Experiments for
acute toxicity,
organ damage,
dose dependence,
metabolism,
kinetics,
carcinogenicity
mutagenicity/terat
ogenicity
Clinical studies
Phase-I
20-50 healthy
volunteers to collect
preliminary data
Phase-II
150-350 subjects with
disease to determine
safety and dosage
recommendationS
Phase-III
250-4000 more, different
patients groups, to determine
short-term safety and efficacy.
Phase-IV
Post approval studies, to determine
specific safety issues.
Spontaneous
reporting

5. TABLE: EXAMPLES OF SERIOUS ADVERSE REACTIONS
Year Drug Adverse Reactions Remark
1950 Chloramphenicol Aplastic anaemia Still being used
1961 Thalidomide Phocomelia National disaster
1970 Clioquinol SMON After 30 years of use
1970 Diethylstilbestrol Adenocarcinoma Of the cervix In utero exposure
1975 Practolol Oculo-mucocutaneous syndrome 5 years after marketing
1976 Zomepirac Anaphylaxis Withdrawn
1978 Phenformin Lactic acidosis Withdrawn
1980 Ticrynafen Deaths from liver disease Detected after 5 years of suspection
1982 Ticrynafen Hepatitis Withdrawn
1990 Etretinate Birth defect High risk of birth-defect, narrow therapeutic index
1999 Astimizole Arrhythmias Because of interaction with other drugs
2004 Rofecoxib Myocardial infarction Withdrawn
2007 Inhaled insulin Long term safety, high cost Withdrawn in the UK due to poor sales caused by
national restriction on prescribing, doubts over
long term safety.
2010 Rosiglitazone Heart attacks Withdrawn in Europe
2011 Drotrcoginalfa Prowess -shock study Withdrawn by Lily
2012 Rimonabant Depression, risk of suicidal tendencies and
seizures
Withdrawn
2012 Sibutramines Heart related side effects Banned

6. • Thus, a close and effective monitoring is required to assess the risks associated with the use of
medicines.
• This is possible only when all the stake holders extend their hands in the field of pharmacovigilance to
make such collaboration successful. effective and comprehensive systems are required.
• The typical limitations include lack of training, resources, political support, and scientific infrastructure.
For future development of the science and practice of pharmacovigilance, understanding and knowledge
of tackling are essential. In general, the stakeholders who need to collaboratively work are:-
• 1. Government 2. Industry
• 3. Hospitals and academia. 4. Medical and pharmaceutical associations
• 5. Poisons and medicines information centres.
• 6. Health professionals 7. Patients
• 8. Consumers 9. The media 10. World Health Organization

7. REFERENCE :-
• A Book of Pharmacovigilance
By Dr. D.K.Tripathi, Dr. Shiv Shanhar ShuklaDr,Ravindra Pandey
Nirali Prakashan,
First edition, August 2019,
Page no:-1.7 to 1.8