1.2 Importance of safety monitoring of Medicine.pptx

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 (8 th 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/teratogenicity Clinical studies Phase-I 20-50 healthy volunteers to collect preliminary data Phase-II 150-350 subjects with disease to determine safety and dosage recommendation S 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