About Author
Devansh Mehta,
Founder Director, MarketMavericks Digital OPC PVT. LTD.
And TRM Writer’s LLP, Meerut,
Uttar Pradesh, India. Pin code: 250100.
Abstract
Drug development process is very rigorous and time consuming process. Lot of efforts of scientists is involved in finding out even one effective drug for the benefit of any patient suffering from an ailment. However, the drug development process doesn’t stop even after the launch of the drug in the market. Post-marketing survelliance is also one of the important steps in the development of the drug for any particular disease. And the department which especially focuses on finding drug errors and adverse effects of the drug after its launch, is the Pharmacovigilance. Pharmacovigilance, as the word, signifies, is the process of keeping vigilance over the pharmaceuticals. Adverse events was first highlighted when the thalidomide tragedy occurred in the 1960’s. Since, then lot of institutions world wide worked on finding effective strategies to prevent any such events from its occurrence again anywhere in the world. Hence, this review focuses on the importance of pharmacovigilance in todays time, not only on its significance in our country, I.e. India, but also world wide.
Reference Id : PHARMATUTOR-ART-3022
Pharmacovigilance, is the process of finding out the source, the reason, and the detection as well as assessment of any kind of adverse drug events, or adverse drug reaction with regards to any pharmaceutical drug being sold in the market, for any kind of disease or an ailment. World Health Organization (WHO), and many organizations globally have jotted down specific guidelines, in order to find out any type of adverse drug effects or events in any pharmaceuticals, and make them available as data in the databases being accessible to the professionals and authorities globally. In order to do that, healthcare professionals are educated and trained especially in the field of pharmacovigilance in order to report them effectively and efficiently in the data which is being available to all the authorities globally.
In India, CDSCO, Central Drug standards control organization, is especially responsible for the pharmacovigilance practices in our country. However, the challenge is the availability of enough trained staff to detect and report the adverse effects, in our country.
Also, most of the areas in our country are out of reach like villages and rural population, where effective detection is a challenging task.
However, efforts are being made, to develop national database and awareness among people to report any kind or type of adverse effects, or events with the use of any specific pharmaceutical drug or substances.
The present, government of India, is working hard, in order to develop a national database of around 150 billion people living in India, through various schemes, and awareness programmes.
Pharmacovigilance importance came in limelight when thalidomide tragedy occurred in the 1960 where majority of population became sick on the administration of thalidomide drug.
Since then, WORLD HEALTH ORGANIZATION, has carried out serious guidelines, in the use of drugs, across the world.
The regulatory authorities across the globe are advised on following strict guidelines on reporting effectively any kind of adverse drug effects, or events upon the use of any pharmaceutical agent or substance.
It is important to understand that effective ADR’s reporting is important since, it can save lives of millions of people globally. Also, it helps in governing the drug development process strictly according to the standard guidelines, in order to benefit the people from any drug and get cured from the disease effectively as well as efficiently.
All government organizations, and international healthcare authorities are highly serious in reporting and maintaining the database of drugs so that the errors in the administration are minimized, and the people of any region of the country in the world, do not suffer from inadequate data and information on any drug being administered to the patients suffering from mild to moderate to severe health conditions.
It is important that Pharmacovigilance inspectors, do their respective jobs effectively and efficiently, as only then, a safer world can be made for the people across the world.
India, is not only the Diabetic Capital of the world, but slowly becoming the, Cancer capital of the world. And with this, newer drugs are being launched in the market everyday across the world to cure the diseases having mild to moderate to severe effects on the patients body. So, in such scenarios it is very important to report any kind of Adverse drug effects or events with the use of newer drugs, in order to curb the menace of damaging the health of patients suffering from such diseases not only in India, but globally.
CHALLLENGES and BARRIERS
There are lot of challenges, for the same,
1. Lack of Information
2. Lack of proper guidelines
3. Lack of training
4. Lack of Education
5. Lack of Awareness
6. Language barriers
7. Barriers in the globalized systems
8. Lots of illegal practices and people involved in the same
9. Lack of proper data
10. Lack of proper reporting system in many parts of the world.
Conclusion
Pharmacovigilance is now the need of an hour for every pharmaceutical company in the world, also for every government authorities in the countries globally.
There are many cases in the world, where the non availability of adverse effects of any drug data leads to the life threatening situation not only for the healthcare practitioners but also for the patients.
So, for the safety of the patients, and running the healthcare system across the globe smoothly proper reporting of the events and availability of the data is highly important. We should educate each one of us, for reporting any kind of adverse effects, or events while using any drug and make the world more safer for each one of us.
References
1. World Health Organization. (2018). Pharmacovigilance: Ensuring the Safety of Medicines.
2. International Conference on Harmonisation. (2020). ICH E2E Pharmacovigilance Guidelines.
3. Central Drugs Standard Control Organization. (2021). Overview of the Pharmacovigilance Programme of India.
4. Ghosh, S., et al. (2019). Pharmacovigilance in India: An Overview. Indian Journal of Pharmaceutical Sciences, 81(4), 501-510.
5. Sharma, R., et al. (2020). Advances in Pharmacovigilance: Role of Artificial Intelligence. Drug Safety, 43(7), 635-646.
6. Kaur, P., et al. (2022). The Role of Technology in Improving Pharmacovigilance Practices. Journal of Pharmacovigilance, 10(2), 88-95.
.png)
