INTRODUCTION:

The World Health Organization (WHO) defines pharmacovigilance (PV) as the pharmacological science and activities involved with the awareness, understanding, and prevention of adverse drug reactions (ADRs) and any other long- or short-term medical issues. (Figure 1)

Figure 1: Diagrammatic representation of PV

A number of medication-related adverse drug reactions (ADRs) served as the impetus for the early advancements in PV science [1-4]. This led to extensive study on adverse drug reactions in medicine being carried out by the World Health Organization at the same time when PV started. After then, numerous ADRs were found, many of which were evident in the data (Table 1). The sixth leading cause of death in the US is ADR. In England, ADRs caused 1% of all hospital admissions between 1999 and 2008. In some countries, at least 100% of hospital admissions are related to adverse drug reactions. Overall drug fatalities linked to tributed deaths are estimated to be 0.19 percent. a medical facility's inpatients ADRs were shown to be directly connected in about 40% of cases.

Linked to high costs Not only can ADRs increase mortality rates, but they also lower life quality. The value of healthcare, however, rises with morbidity [7]. The PV initiative is managed by the Central Drugs Administration and is overseen by the Indian Pharmacopoeia Commission (IPC). Center for Standard Control Organization (CDSCO) the maximum degree of accountability. Maintaining and improving the PV database, which includes all suspected serious adverse drug reactions (ADRs) to pharmaceuticals observed, is the aim of the IPC. Pharmacovigilance National Coordination Center (NCC) is what IPC does. India's program (PvPI). NCC is a nonprofit company.

Table 1- Examples of serious and unexpected ADE caused due to drugs

S. No.	Drug	Year	Serious and unexpected adverse event
1.	Choloroform (Anaesthetic)	1848	Episode of Ventricular fibrillation and death
2.	Sulphanilamide (Elixir)	1937	Death
3.	Thalidomide	1961	Amelia, phocomelia and dysmelia
4.	Clioquinol	1970	Subacute nephropathy
5.	Ractolol	1975	Sclerosing peritonitis
6.	Benoxaprofen	1982	Nephrotoxicity and cholestatic jaundice
7.	Terfenadine	1997	Torsade de pointes
8.	Rofecoxib	2004	Cardiovascular effects
9.	Veralipride	2007	Anxiety, depression and movement disorders

Figure 2: Coordination of Indian Pharmacopoeia Commission with other organizations

History of Pharmacovigilance Programme in India:

PV is not a novel idea; in the Charak Samhita, written circa 700 BC, it is warned that poorly administered, yet correctly comprehended, medication is poison; moreover, Vagbhattaa physicians represented adverse events, which is why ADRs were delayed. Ayurvedic medications were created in 500 AD. Subsequently, numerous adverse drug reactions were reported. In the annals of contemporary medicine, there exists a group from India. Nevertheless, no systematic effort has been made to assess ADR since the primary try was created in 1989.^3,4

Scope of Pharmacovigilance Programme of India:

Clinical trials are used to vet medications for safety and efficacy before approving and marketing them in the country. These studies typically report comparable ADR. It's possible that certain critical reactions, such those that emerge slowly or don't happen often, are missed in clinical studies. Additionally, medications may not always be utilized in the same way in practice as they are evaluated in the controlled environments of clinical trials. The anticipated benefits of a medication must exceed the associated risks of harmful side effects for it to be deemed safe. Completing a comprehensive safety profile of pharmaceuticals requires an ongoing post-marketing surveillance system, or PV.

Management of Pharmacovigilance Programme of India

Under the direction of the National Scientific Coordinator and supported by several groups such as the Quality Review Committee, Working Group, and Steering Committee, this is being handled by Dr. Gyanendra Nath Singh, the Secretary/Scientific Director.In panels like the Core Training Panel and other country, experts from all over the world participate. Situation of NCC's Current PvPIs the PvPI initiative is still underway. All of India's states and union territories have more than 200 Adverse Drug Monitoring Centers (AMCs).⁴

Reporting of Adverse drug reactions

Health care practitioners and consumers can report suspected adverse drug reactions (ADRs) using the forms accessible on the IPC website. In an effort to remove linguistic barriers from ADR filing, the consumer reporting form is available in 10 vernacular languages: Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam. Calling the PvPI support number (18001803024) on weekdays from 9:00 a.m. to 5:30 p.m. is another way to report ADRs. The Android app has also been developed and made available to the public for ADR reporting while on the go.

Figure 3: Suspected Adverse Drug Reaction Reporting Fo

Aim of Pharmacovigilance Programme of India:

1. Boost patient safety and care when using medications, as well as all other medical and paramedical procedures.

2. Enhance medicine utilization in relation to public health and safety.

3. Assist in the assessment of a medication's advantages, disadvantages, effectiveness, and danger, advocating for its safe, sensible, and efficient (including economical) administration.

4. Increase public understanding of PV by instruction, clinical practice, and effective communication ^[8].

CONCLUSION:

The purpose of India's pharmacovigilance, or adverse drug reaction monitoring and reporting, programs is to find risks related to the use of medications. The present investigation has demonstrated potential interventions, most notably preventable adverse events, that can support safer pharmaceutical use and give medical professionals information. To raise awareness, enhance the standard of patient care and inform the general public. This reason for bringing up the subject again is to inform the public about the importance of reporting adverse drug reactions to their local hospital, ADR monitoring center, or medical professionals. They will immediately notify the authorities about the adverse pharmaceutical response. There is also a toll-free number, 18001803024, an adverse medicine reaction form, email, and other channels including social media.

REFERENCES:

1. "Targeted Pharmacovigilance Study on Antitubercular Drugs in the Department of Pulmonary Medicine at Tertiary Care Teaching Hospital in Rural Area," by Nimesh S and Prem Parkash KA. 1-6 in International Journal of Pharmacovigilance (2019)."Targeted Pharmacovigilance Study on Antitubercular Drugs in the Department of Pulmonary Medicine at Tertiary Care Teaching Hospital in Rural Area," by Nimesh S and Prem Parkash KA. 1-6 in International Journal of Pharmacovigilance (2019).

2. "Pharmacovigilance: An Overview," by Nimesh S and Ashwlayan VD. 1-6 in International Journal of Pharmacovigilance, vol. 3.1, 2018.

3. "Directorate General of Health Services, Ministry of Health and Family Welfare." 3. Central TB Division.

4. India, TB 2006. Report on the status of RNTCP. MFHW, New Delhi, India (2006).

5. The National Library of Medicine of the United States of America. APIs for RxNorm. Obtainable from (2017).

6. Srivastava, S. K. "A comprehensive textbook of medical pharmacology," 1st edition, Chapter 56 (2017) 888, Srivastava, S. K. "A full textbook of medical pharmacology," 1st edition, Chapter 56 (2017) 888, Srivastava

7. The Bio-Medical Waste Management (Amendment) Rules are a set of rules that govern the management of bio-medical waste (2018).

8. "Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients on Highly Active Antiretroviral Therapy Regimens." Mohamed B Elnagar I. 1-12 in International Journal of Pharmacovigilance, Vol. 2.2 (2017).

9. "Selective upper airway stimulation in elderly patients," Zhu Z., et al. 77-81 in Respiratory Medicine 140 (2018).

Received on 22.04.2024 Modified on 07.05.2024

Research J. Science and Tech. 2024; 16(2):159-162.

DOI: 10.52711/2349-2988.2024.00023