Adverse Drug Reactions and Pharmacovigilance

Abstract

The discovery of a new drug usually takes 10-15 years. Within this time period, the candidate drug is thoroughly screened for its beneficial as well as side effects. But the side, adverse or toxic effects cannot be detected to a full scale due to some special reasons. The beneficial effects and toxicity of new drugs and vaccines are usually studied by “Clinical trials”, which are divided into four categories ranging from clinical trial phases I to IV. During clinical trial phase-III, about 4,000-10,000 patients are involved and after passing this phase, the drug is allowed to enter into the global market. Then, billions of people, including those who were excluded in phase-III, may be administered with this drug. It is worthy to mention that these 4,000-10,000 patients may not show many of the side effects or toxic actions. The undetected adverse drug reactions (ADRs) are studied in clinical trial phase-IV, which is also known as post market surveillance. For this reason, the ADRs are compared with the tip of the iceberg, as it indicates the minor part of a major event. This phenomenon gave birth to a new branch of the pharmacology known as Pharmacovigilance.

Pattern of anti-epileptic medications nonadherence and associated factors at ambulatory clinic of Jimma Medical Center, Southwestern Ethiopia: A prospective observational study

“…Adverse drug reaction is the response to a drug that can be noxious or unintended and occurs at the normal doses used in humans for prophylaxis, diagnosis, or treatment. 29 …”

Pharmacovigilance practices in South Asian Association for Regional Cooperation countries: the need for collaboration

“…Seventy-nine children died after taking the spurious drug. The ban on the tainted product by the regulators helped in the reduction of new cases of renal failure and admission to hospitals [42,43] In 2009 another paracetamol catastrophe hit Bangladesh where 28 children died of diethylene glycol toxicity [44] .…”

Predicting Drug-Drug Interactions Using Knowledge Graphs

“…Currently, drug developers rely on clinical trials to detect unknown DDIs, whilst pharmacists and doctors depend on a textbook, such as the British National Formulary (BNF), when they are unsure of a known DDI. Amran et al [3] reported that less than 50% of ADRs are usually detected during these trials since these are very labourintensive, time-consuming, and expensive, whilst the remaining ADRs are first-hand experienced by patients during the post-marketing surveillance, known as Pharma-coVigilance (PV). Therefore, a platform that can predict potential DDIs, and serve as a reference point to known and potentially dangerous DDIs is essential for healthcare professionals to prescribe safe medications to patients, to provide better and safer healthcare [4].…”