Abstract
Pharmacovigilance (PV), or drug safety, is the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related problems. It plays an essential role in protecting patient safety, improving public health, and ensuring the safe and effective use of medicines. PV involves systematic reporting, evaluation, and monitoring of ADRs through national and international programs such as the Pharmacovigilance Programme of India (PvPI). Hospital pharmacists significantly contribute to pharmacovigilance by identifying, documenting, and reporting ADRs, providing patient counseling, and ensuring rational drug use. Despite its importance, challenges such as underreporting, lack of awareness, and limited resources remain. Strengthening training, using digital tools, increasing patient involvement, and promoting global collaboration are key to improving pharmacovigilance systems in the future.
Keywords
Pharmacovigilance (pv), Adverse Drug Reaction (ADRs), Drug Safety, Hospital Pharmacist, PvPI, ADR Reporting, Patient Safety, VigiBase, Risk Benefit Assessment, Drug Regulation
Introduction
Pharmacovigilance, often known as Drug Safety, can be abbreviated as PV or PhV. The term “pharmacovigilance” comes from the Greek word “pharmakon” meaning “drug” and the Latin word “vigilare,” which means “to keep watch.” [1]. PV is a significant and necessary component of clinical research [2]. The research and practices around the identification, evaluation, comprehension, and avoidance of side effects or other drug-related issues are known as pharmacovigilance. “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem, particularly long term and short-term adverse effects of medicines,” states the World Health Organization. [3]. Pharmacovigilance plays a crucial role in drug regulation, public health programs, and clinical practice. It promotes safe and appropriate drug use by detecting previously unknown adverse drug reactions (ADRs), identifying risk factors for ADR development, and estimating quantitative benefits/risks to improve prescribing. [4]. Pharmacovigilance focuses on adverse drug reactions (ADRs), which are undesirable and unanticipated reactions to drugs used for prevention, diagnosis, treatment, or alteration of physiological functions. [5]. Pharmacovigilance refers to the science and activities involved in detecting, assessing, understanding, and preventing adverse effects or any other drug-related issues [6]. With the increasing use of medicines in various health conditions, ensuring patient safety has become more critical than ever [7]. Pharmacovigilance plays a vital role in identifying previously unknown adverse drug reactions (ADRs), reducing harm to patients, and improving the overall healthcare system [8]. ADR is described as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which warrants prevention or regimen, or withdrawal of the product, and which predicts hazard from future administration” [9].
OBJECTIVES OF PHARMACOVIGILANCE
- Improve patient care and safety when using medications. [10]
- Enhance public health and safety of medications. [11]
- Identify and communicate drug-related issues effectively. [12]
- Assessing the benefits and risks of medicines, while supporting safe and effective use. [13]
- Promote education, clinical training, and effective communication about pharmacovigilance among healthcare workers and the public. [14]
- To enhance patient safety by minimizing risks associated with drug use [15].
- To detect and assess ADRs and take necessary actions [16].
- To improve public health by monitoring drug efficacy and safety [17].
- To educate healthcare professionals and patients on drugrelated risks [18].
Types of Adverse Drug Reactions (ADRs)
Type A (Augmented): Dose-related and predictable.
Type B (Bizarre): Not dose-related and unpredictable.
Type C (Chronic): Occurs during long-term treatment.
Type D (Delayed): Appears after prolonged use or exposure.
Type E (End of use): Occurs after stopping the drug.
Type F (Failure): Lack of therapeutic effect [19], [20].
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Type of reaction
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Description
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A: Dose related
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Exaggerated expected effects from medicines at usual doses
e.g.) bleeding with warfarin, bradycardia with beta-blockers
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B: Idiosyncratic
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Unrelated to pharmacological properties
e.g.) Steven’s Johnsons syndrome with allopurinol
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C: Dose & time related
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Related to cumulative drug use over time
e.g.) adrenal insufficiency with corticosteroids
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D: Delayed
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Apparent only use of medicines after time
e.g.) skin cancers with topical tacrolimus
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E: Withdrawal
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Associated with withdrawal or medication cessation
e.g.) rebound tachycardia with stopping beta-blockers
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F: Failure of therapy
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Associated with unexpected failure of therapy, possibly due to drug interaction
e.g.) St. John’s Wort reducing efficacy of combined oral contraceptives
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G: Genetic
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Associated with irreversible genetic damage
e.g.) phocomelia after thalidomide
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H: Hypersensitivity
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Associated with an immune-mediated response to medicines in a sensitized patient
e.g.) amoxicillin and interstitial nephritis (immune complex)
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ADR Reporting Process:
The pharmacovigilance process involves:
Adverse event reporting is the most prevalent activity related with pharmacovigilance (PV), and it consumes a large amount of resources for drug regulatory bodies (or equivalent government organizations) and drug safety departments in pharmaceutical corporations. [21]. Identifying suspected ADRs by healthcare professionals or patients [22]. Recording the details using ADR reporting forms [23]. Sending the report to regional or national pharmacovigilance centers [24]. Analyzing data and implementing regulatory actions [25]. Adverse event (AE) reporting entails receiving, triaging, data entering, assessing, distributing, reporting (if applicable), and archiving AE data and documentation. [26].AE reporting also gives data to these firms and drug regulatory bodies, which are critical in determining the riskbenefit profile of a medicine. [27].
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Yogita Chaudhari
Corresponding author
Department of Pharmacy, S.N.D College of Pharmacy
Manoj Garad
Co-author
Department of Pharmacy, S.N.D College of Pharmacy
Harshada Bangar
Co-author
Department of Pharmacy, S.N.D College of Pharmacy
Komal Kute
Co-author
Department of Pharmacy, S.N.D College of Pharmacy
Yogita Chaudhari*, Manoj Garad, Harshada Bangar, Komal Kute, Importance in Ensuring Patient Safety, Int. J. Sci. R. Tech., 2025, 2 (11), 564-571. https://doi.org/10.5281/zenodo.17667696
10.5281/zenodo.17667696
