Pharmacovigilance (PV), or the science of drug safety, is a continuous, systematic discipline dedicated to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.

It is an essential component of the entire drug lifecycle, beginning during the earliest stages of clinical development and continuing throughout the many years a medication is available for patient use. The core goal is to improve patient care and safety in relation to the use of medicines and, consequently, improve public health.

Limitations of Clinical Trials and the Need for Real-World Surveillance

The necessity for robust PV systems arises from the intrinsic limitations of pre-approval clinical trials. These studies, while rigorous, are conducted on a relatively small number of highly selected patients under controlled conditions and for a finite duration. This structure means they cannot comprehensively capture several critical safety issues:

• Rarity of Events: Very rare adverse drug reactions may not…

Ranil Jayawardena 1,2,✉, Priyanga Ranasinghe 3, Himansa Ranawaka 1, Nishadi Gamage 3, Dilshani Dissanayake 1, Anoop Misra 4

https://pmc.ncbi.nlm.nih.gov/articles/PMC7336946/

J Family Med Prim Care. 2022 Feb; 11(2): 720–727.

Published online 2022 Feb 16. doi: 10.4103/jfmpc.jfmpc_1662_21

Estevao C. The role of yoga in inflammatory markers. Brain Behav Immun Health. 2022 Feb 1;20:100421. doi: 10.1016/j.bbih.2022.100421. PMID: 35199049; PMCID: PMC8842003.

www.ncbi.nlm.nih.gov

Yoga is an ancient system for integrating the mind, body, and spirit. In the hatha yoga ashtanga tradition (the eight limb Patanjali Yoga), three of the limbs are meditation, breathwork (pranayama) and physical postures (asana), which are widely practised ...

Kwok JYY, Kwan JCY, Auyeung M, Mok VCT, Chan HYL. The effects of yoga versus stretching and resistance training exercises on psychological distress for people with mild-to-moderate Parkinson's disease: study prxotocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):509. doi: 10.1186/s13063-017-2223-x. PMID: 29096672; PMCID: PMC5667474.

www.ncbi.nlm.nih.gov

Psychological distress is prevalent among people with Parkinson’s disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quality of life (HRQoL). The under-recognition ...

Mohammad, Ashu, Thakur, Priyanka, Kumar, Rakesh, Kaur, Sharanpreet, Saini, Reena V. and Saini, Adesh K.. "Biological markers for the effects of yoga as a complementary and alternative medicine" Journal of Complementary and Integrative Medicine, vol. 16, no. 1, 2019, pp. 20180094.

https://doi.org/10.1515/jcim-2018-0094

www.degruyter.com

From the last few decades, there are increasing incidences of disorders like premature aging, cardiovascular disease, multiple sclerosis, fibromyalgia, and Alzheimer’s disease In addition to medication, researchers have found that yoga, a mind-body therapy, can be used as an alternative medicine. Yoga combines specific physical postures, breathing techniques, relaxation and meditation that improve mental and physical health of the body. The purpose of this review is to collate the research evidences claiming health benefits of performing traditional yogic practices. What are the biological and other reliable indicators to suggest that doing asanas, pranayama, and meditation could reduce or treat wide range of life style disorders are discussed. Importantly, these indicators are otherwise used to assess the severity of disorders. In many of the study it has been shown that yoga improves the redox health of body whose imbalance has been well proven to cause many health complications. The impact of yoga on neurodegenerative diseases have revealed that it reverses memory loss, reduce anxiety, depression and stress, the biological indicators of disease. However, most studies have several limitations and therefore further research into yoga is needed to validate these findings.

Legault Z, Znaty A, Smith S, Boudrias MH. Yoga Interventions Used for the Rehabilitation of Stroke, Parkinson's Disease, and Multiple Sclerosis: A Scoping Review of Clinical Research. J Altern Complement Med. 2021 Dec;27(12):1023-1057. doi: 10.1089/acm.2021.0003. Epub 2021 Jun 29. PMID: 34185577.

pubmed.ncbi.nlm.nih.gov

<span><b><i>Objectives:</i></b> The current body of literature was reviewed to compile and describe yoga interventions that have been applied in clinical research and neurologic rehabilitation settings with patients affected by stroke, Parkinson's disease (PD), and multiple sclerosis (MS). <b><i>Design:</i></b></span> …

Chetry D, Telles S, Balkrishna A. A PubMed-Based Exploration of the Course of Yoga Research from 1948 to 2020. Int J Yoga Therap. 2021 Jan 1;31(1):Article_22. doi: 10.17761/2021-D-21-00017. PMID: 34727183.

pubmed.ncbi.nlm.nih.gov

Yoga research citations from 1948 to 2020 in PubMed were filtered and sorted in 10-year intervals to explore the occurrence and time frame of change in (1) the focus of research; (2) the number of randomized controlled trials (RCTs), systematic reviews (SRs), and meta-analyses (MAs); (3) health cond …

Sullivan MB, Erb M, Schmalzl L, Moonaz S, Noggle Taylor J, Porges SW. Yoga Therapy and Polyvagal Theory: The Convergence of Traditional Wisdom and Contemporary Neuroscience for Self-Regulation and Resilience. Front Hum Neurosci. 2018 Feb 27;12:67. doi: 10.3389/fnhum.2018.00067. PMID: 29535617; PMCID: PMC5835127.

www.ncbi.nlm.nih.gov

Yoga therapy is a newly emerging, self-regulating complementary and integrative healthcare (CIH) practice. It is growing in its professionalization, recognition and utilization with a demonstrated commitment to setting practice standards, educational ...