Pharmacovigilance is one of the most significant and interesting concept of the Pharmacy field. The word Pharmacovigilance is derived from two different words i.e. "PHARMAKON" (a Greek word) meaning "Medicinal Substance" and "VIGILIA" (a Latin word) meaning "to keep watch".
WHO defines it as " the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/ vaccine related problem." Meaning, it is all about collecting the safety data of the marketed drugs, managing them and analyzing any suspected information for the risk-benefit ratio.
HISTORY
There is a long history behind the development of this concept, which will be discussed here in the subsequent paragraphs.
1. In Jan 29, 1848, a young girl, from England, died after she got operated for removing an infected toe-nail. The reason behind the death was not known.
• This incident didn't raise any concern among the authorities until similar kind of deaths occurred in different parts of the country.
• Lancet established a committee to find out the reasons behind those deaths. This committee invested whole scenario and they mentioned in their report, in 1898, that the reason behind those deaths was Chloroform, an anesthesia which was given to the patients before operating on them.
2. On Jan 30, 1906, U. S. Federal Food &Drug Act was passed which stated that the drug must be pure and free from any kind of contamination.
3. Another incident occurred in 1937 in USA where 107 people died after consuming Sulphanilamide elixir which contained Diethylene Glycol as the solvent.
• Earlier, manufacturer were not aware about the toxicity of the solvent, which means that they haven't tested the safety of the ingredients, being used in the preparation of the elixir.
4. To prevent such incidences from occurring in future, Federal Food, Drug & Cosmetic Act was constituted in 1938. Under this act, it became mandatory to prove the safety and efficacy of medicine before marketing it.
5. In 1961, another huge disaster occurred and the culprit was the marketed drug named Thalidomide which was used as anti-emetic medication among the pregnant women.
• Later on, it was found that the women, who consumed Thalidomide, gave birth to handicapped children i.e. neonates were born with limb deformities. Moreover, one report mentioned that only 40% of the children were able to survive.
• This tragedy brought into light many problems and loop-holes in the system of Pharmacovigilance like the reliability of animal testing, necessity of monitoring the drug after marketing, and many more.
• While looking for the solutions for those problems, many changes were made to the system of surveillance. In fact, it ultimately changed the objective and system of Pharmacovigilance program.
6. In 1964, Yellow Card system was launched in UK in order to initiate spontaneous reporting of adverse drug reactions.
7. In 1968, WHO initiated a program for International Drug Monitoring. Initially, only 10 countries were the member of this program.
• Afterwards, this program was moved to Uppsala, Sweden in 1978 and it was named as Uppsala Monitoring Center (UMC).
• Presently, UMC has 104 official members and 33 associate members from all around the world.
• It performs the task of collecting, managing and analyzing the drug safety data from all around the world.
• UMC has created a database named " VIGIBASE". It contains all the data regarding the adverse drug reactions which are sent by the member countries. Currently, it contains 3.7 million Individual Case Safety Reports from all over the world.
Lets have a look at the history and development of Pharmacovigilance program in India:
1. In 1968, a ADR monitoring system was established in India.
2. India joined WHO International Drug Monitoring program in 1997.
3. In 2004, National Pharmacovigilance Program came into existence under which 2 zonal, 5 regional and 24 peripheral centers were established for collecting ADR related data.
4. In 2010, CDSCO initiated Pharmacovigilance Program of India (PvPI).
• AIIMS, New Delhi, was the National Coordinating Center (NCC) for collecting, storing and monitoring ADRs.
• Later on, it was shifted to Indian Pharmacopoeia Commission (IPC), Ghaziabad on 15th April, 2011.
• Presently, there are 250 ADR monitoring Centers in all over India, established in Government and non- government hospitals, TB treatment centers, ART centers, Corporate hospitals, Army hospitals, District hospitals and Municipal hospitals.
• An ADR reporting form has also been prepared which could be used by any person who thinks that he/she has encountered any ADR.
• A web based Individual Case Safety Report (ICSR) management system has been designed for storing the ADR data. It is named as "VIGIFLOW". It could be used by pharmaceutical companies and CROs for monitoring their ICSR.
SPECIFIC AIMS
• Improve public health and safety wherever medicines, vaccines or medical devices are concerned.
• Contribute to the assessment of risk-benefit ratio of the marketed medicines and thereby encouraging the safety of patients.
• Promote understanding, education and clinical training in Pharmacovigilance and its effective communication to the public.
OBJECTIVES
• To quantify previously recognized ADRs.
• To identify unrecognized ADRs.
• To evaluate effectiveness of medicines among the population.
• To reduce mortality and morbidity rate associated with ADRs.
This was all about the history, aim and objectives of Pharmacovigilance. It could be clearly seen that it is a very important concept and people need to have knowledge about it. Not only knowledge, but they should even practice Pharmacovigilance wherever needed.
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