This document discusses pharmacovigilance for Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines the importance of pharmacovigilance due to past drug safety issues like the thalidomide tragedy. India established a National Pharmacovigilance Program in 2003 to monitor adverse drug reactions to herbal, mineral, and metallic ASU drugs. The program aims to collect data on adverse events and establish definitions and reporting procedures to ensure the safety of ASU drugs as their use increases. It seeks to involve healthcare professionals, define goals for drug monitoring over short, medium, and long terms, and make the program a global benchmark for drug safety.
This document discusses pharmacovigilance for Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines the importance of pharmacovigilance due to past drug safety issues like the thalidomide tragedy. India established a National Pharmacovigilance Program in 2003 to monitor adverse drug reactions to herbal, mineral, and metallic ASU drugs. The program aims to collect data on adverse events and establish definitions and reporting procedures to ensure the safety of ASU drugs as their use increases. It seeks to involve healthcare professionals, define goals for drug monitoring over short, medium, and long terms, and make the program a global benchmark for drug safety.
This document discusses pharmacovigilance for Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines the importance of pharmacovigilance due to past drug safety issues like the thalidomide tragedy. India established a National Pharmacovigilance Program in 2003 to monitor adverse drug reactions to herbal, mineral, and metallic ASU drugs. The program aims to collect data on adverse events and establish definitions and reporting procedures to ensure the safety of ASU drugs as their use increases. It seeks to involve healthcare professionals, define goals for drug monitoring over short, medium, and long terms, and make the program a global benchmark for drug safety.
Dr Vasavi Madurwar PG FINAL BMAM Nagpur INTRODUCTION
Pharmacovigilance also called as drug safety.
Pharmakon ( in greek)------- drug
Vigilare ( in latin )------------to keep watch
Definition:
Pharmacovigilance is the scientific branch which is dedicated to reducing
the risks of the drugs related harm to the patients. It includes the reporting system for the adverse events associated with drug use. IMPORTANCE OF PHARMACOVIGILANCE - PREAMBLE:
● Thalidomide tragedy (1961-62): The greatest of all drug disasters.
● Thalidomide had been introduced and welcomed as a safe hypnotic and antiemetic. It rapidly became popular for the treatment of nausea and vomiting in early pregnancy. ● Tragically the drug proved to be potent human teratogen that caused major birth defects in an estimated 10,000 children. ● Phocomelia was a characteristic feature. OTHER HISTORIC VIOLATIONS:
● Sulfanilamide tragedy: Elixir sulfanilamide was an improperly
prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal, Food and Drug Cosmetic act. ● The thalidomide disaster led in Europe and elsewhere to the establishment of the drug regulatory mechanisms of today. ● These mechanisms require that new drugs shall be licensed by well established regulatory authorities before being introduced in clinical use. ● List of a few licensed medicines withdrawn after marketing for drug safety reasons. 1. Secholex (polidexide) - 1975 2. Zomax - 1983 3. Halcion - 1991 4. Kava Kava - 2001 due to liver toxicity. 5. Vioxx ( rofecoxib) - 2004 due to increased cardiovascular risks. 6. Bextra ( valdecoxib) - 2005 due to Stevens Johnson Syndrome. NEED, SCOPE, AIMS & OBJECTIVES
● Worldwide the hazards of the drugs and medical therapies are
monitored stringently to reduce the patient’s mortality or the untoward, adverse or unwanted effects of the drugs or of therapeutic procedures. ● It is commonly considered that as compared to the modern drugs the Ayurvedic drugs show the less adverse effects or the toxic effects on the human recipients. ● Due to the popularity of the ASU drugs and due to increase in a demand of these drugs from the community the chances of adulteration and malpractice in the manufacturing and distribution are increasing. Commercialization of ASU drugs put forward the issue of safety and efficacy. ● For the regulation of safety and efficacy issue the control and check o the use of ASU drugs through the Pharmacovigilance program was essential. NATIONAL PHARMACOVIGILANCE PROGRAM FOR ASU DRUGS :
● Since 2003, National Pharmacovigilance Program under the control
of Central Drug Standards Control Organization ( CDSCO) is being functioning in India. ● In December 2007, the two days workshop and seminar was organized in Jamnagar on Pharmacovigilance which was funded by WHO. The need to develop the National Pharmacovigilance Centre for ASU drugs was addressed in this seminar to monitor the program centrally. ● This program aims to keep the data of adverse drug reactions of herbal, mineral and metallic products. ● The glossary of terms used like adverse events, adverse effects, side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions etc. was published under the National Pharmacovigilance Program for ASU drugs. 1. Adverse event: Any untoward medical occurrence that may be present during treatment with a pharmaceutical product but which does not necessarily have a casual relationship with the treatment. 2. Adverse reaction: A response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological functions. 4. Expected Adverse reactions: As opposed to “unexpected”, an event that is in the investigation brochure or labelling ( package insert or summary of product characteristics.
5. Unexpected adverse reactions: The nature or severity of which is not
consistent with the domestic labelling or market authorization, or expected from the characteristics of the drugs.
6. Adverse Effects: An adverse effect is an undesirable harmful effect
resulting from a medication or other intervention such as surgery. 7. Side Effects: A side effect, is an effect, whether therapeutic or adverse that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to be beneficial, but unintended, consequences of the use of a drug. 8. Serious Adverse Reactions/ Event: An adverse reaction that results in death , is life threatening , requires hospitalisation or prolongation of existing hospitalisation resulting in persistent or significant disability or incapacity, or birth defect. Goals of the program:
1. Short term: To develop the nature of the notification.
2. Medium term: To involve the health care professionals and professional associations in the drug monitoring and information dissemination processes. 3. Long term: To make this program as a benchmark for the global drug monitoring endeavors. As per the provision of this program any health care professional may report the suspected adverse drug event, but not from the layman or any other person than the health care professional.
The reporting should be submitted in the prescribed format to the
Pharmacovigilance Centre. Confidentiality is assured through this program. THANK YOU !