Nalanda Institute of Pharmaceutical Sciences, Siddharth Nagar, Kantepudi, Sattenapalli, Guntur, Andhra Pradesh, India 522438
Medication errors and adverse drug reactions (ADRs) are major threats to patient safety worldwide. Errors may occur at any stage of the medication-use process, including prescribing, dispensing, administration, and monitoring. Many medication-related problems remain unreported, leading to repeated harm and poor safety outcomes. Pharmacovigilance and ADR reporting systems play a vital role in identifying drug-related risks, preventing future incidents, and promoting rational drug use. This review highlights the causes and types of medication errors, their impact on patient safety, and the importance of pharmacovigilance and ADR reporting systems. The role of healthcare professionals, especially pharmacists, in minimizing medication errors and enhancing drug safety is also discussed.
Medication errors are one of the most common health threatening mistakes affecting patient care today. This is apparent by the number of medication error stories a nurse encounters during his or her career.(1)
Deaths resulting from medication errors are not only tragic for patients and their families, but these errors can cause lifelong shame, guilt and depression for the healthcare professionals responsible.
BACKGROUND
Medication therapy is one of the most common interventions in medical practice. However, errors related to medicines account for a substantial proportion of hospital admissions and adverse clinical outcomes. As healthcare delivery becomes more complex with the introduction of newer therapeutic agents, personalized medicine, and polypharmacy, the risk of drug-related harm increases.
Historical Perspective
Historically, drug safety monitoring was reactive, focused on crisis response after harmful effects occurred. The thalidomide disaster in the 1960s emphasized the importance of systematic drug safety surveillance. This led to the establishment of structured pharmacovigilance programs across nations.
Significance of Patient Safety
Patient safety focuses on reducing unnecessary harm associated with healthcare delivery. Medication-related problems represent a leading cause of preventable injury, making safety strategies imperative at both clinical and institutional levels.
Link Between Errors and Pharmacovigilance
Pharmacovigilance complements patient safety efforts by providing continuous evaluation of medicines after marketing. ADR reporting allows signal detection for unknown risks and prevention of medication-related disasters.
MOST COMMON TYPES OF MEDICATION ERRORS
Medication errors can occur at any stage in the medicines use process. Most studies refer to five main types of error, namely those related to prescribing, transcribing, preparation or dispensing, administration, or monitoring. Aronson also noted that errors can occur during the medicine manufacturing process, for example when the packaging is incorrectly labelled or adulterants are introduced.(2)
It is challenging to identify and quantify the most common types of medication errors, as research evidence is limited and many go unnoticed or unreported. However, the literature suggests that prescribing, administration, and monitoring errors are the most frequent.(3) The previously mentioned study on the economic burden of medication errors in England suggested that 54% of errors are made at the point of administration, and 21% during prescribing. These figures, the authors explained, are similar to those reported in the USA and European Union countries.
Fig :1 The most common types of medication errors: 54% of medication errors are made at the point of administration.
Administration errors
Administration errors may include using the incorrect route of administration, giving the drug to the wrong patient, or using the wrong dose or administration rate. The worldwide prevalence of administration errors is around 22%, according to a WHO systematic review.
Case study: In 2016 a 50-year-old woman complained of chest tightness, breathing difficulties, and tremors during a colonoscopy at an Egyptian hospital. Health professionals found she had accidentally received adrenaline (epinephrine) instead of midazolam. A root cause analysis found that ampules of adrenaline and midazolam – which were similar in size, shape, and colour – had mistakenly been placed in the same box by pharmacy staff.(4)
NHS Resolution deals with patient claims and complaints in the NHS. Medication errors resulting in claims are likely to represent the tip of the iceberg. Their analysis of medication error claims over a five-year period (April 2015 – March 2020) found that of 487 claims settled with damages paid, 45% related to administration errors. In 27% of these cases, the wrong dose was given, in 18%, the wrong drug was given, and in 15%, the wrong route of administration was used.(5) The most common medications implicated in these claims were; anticoagulants, antimicrobials, opioids, anticonvulsants, and antidepressants.
Prescribing errors
Prescribing errors account for a high proportion of all medication errors, with the World Health Organization suggesting the error rate may be as high as 53%.(6)
These errors can happen at any part of the prescribing process and include irrational, inappropriate or ineffective prescribing, under and over-prescribing, and medicines that are omitted or delayed.
Case study: Anti-infectives (NHS Resolution, 2022, anti-infectives).(Fig 2)
NHS Resolution received 172 claims relating to errors with the prescription of antibiotics, antivirals, and antifungals between April 2015 and March 2020.(7)
The key causes of the claims were:
Fig:2 prescribing errors
Dispensing error
A dispensing error is a discrepancy betweena prescription and the medicine that thepharmacy delivers to the patient or distributes to the ward on the basis of thisprescription,(8) including the dispensing of amedicine with inferior pharmaceutical or informational quality. (Fig 3)
DISPENSING ERRORS: THE NUMBERS
Fig:3 dispensing errors
Patient Safety pharmacovigilance :
Patient safety is improved through pharmacovigilance, which involves the science and activities of detecting, assessing, understanding, and preventing adverse effects or other medicine-related problems.(9) It is a continuous process that monitors medications after they are approved and marketed to minimize risks and maximize benefits, helping to prevent harm to patients and ensuring the safe use of medicines. Key activities include collecting reports of adverse drug reactions from patients and healthcare professionals, analyzing this data to identify potential safety signals, and implementing preventive measures. (10)
Key aspects of patient safety pharmacovigilance
How Pharmacovigilance Work in Ensuring Patient Safety in Clinical Studies:
Step 1: Data Collection:
Adverse event (AE) reporting is a critical component of pharmacovigilance, enabling the detection and prevention of harmful reactions to medicinal products. Healthcare professionals, patients, and pharmaceutical companies report adverse events to national or international databases, such as the World Health Organization's (WHO) global database, the US Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) and the European Medicines Agency's (EMA) Eudra Vigilance. Spontaneous reporting is a voluntary process where healthcare professionals and patients report adverse events, providing valuable insights into medicinal product safety. This approach, however, may result in underreporting, as not all events are captured.
Step 2: Data Processing:
Data processing is a critical step in pharmacovigilance, ensuring the accuracy and consistency of adverse event (AE) reports. Data entry involves capturing AE reports into databases, such as the US Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) and the European Medicines Agency's (EMA) EudraVigilance. These databases serve as central repositories for AE data, facilitating analysis and signal detection. Following data entry, verification of AE report accuracy and completeness is performed through data validation. This quality control measure ensures the reliability and consistency of the data, preventing errors and inconsistencies that could compromise safety assessments.
Step 3: Signal Detection:
Signal detection in pharmacovigilance involves a multi-step process to identify potential safety concerns. Statistical analysis is the first step, utilizing various methods to identify potential safety signals within adverse event data. These statistical methods enable the identification of potential safety signals, which are then further investigated. Building on statistical analysis, data mining is conducted to analyse large datasets and identify patterns. Once potential safety signals are detected, signal validation verifies their accuracy through manual review, causality assessment, literature review, and external data validation. Expert evaluation of adverse event reports determines causal relationships between medicinal products and adverse events, while literature reviews examine scientific literature for supporting evidence. External data validation compares detected signals with external datasets, ensuring reliability. Signal validation informs regulatory decisions, enhances patient safety, and improves medicinal product development. Effective signal detection enables timely identification of safety concerns, informed regulatory decisions, and enhanced patient safety.
Step 4: Signal Evaluation:
Causality, severity, and risk-benefit assessments are crucial steps in pharmacovigilance, enabling informed decision-making. Causality assessment evaluates the relationship between a medicinal product and an adverse event (AE). This involves determining whether the AE is directly related to the product, a coincidental occurrence, or exacerbated by underlying conditions. Standardized tools, such as the World Health Organization's (WHO) causality assessment criteria and the Naranjo algorithm, guide evaluators. Causality assessment informs signal validation, regulatory actions, and patient safety measures. Severity assessment evaluates the intensity and impact of adverse events. Severity assessment facilitates the prioritization of safety concerns, regulatory decision-making, and risk management strategies. Risk-benefit assessment weighs the benefits of a medicinal product against its risks. Regulatory agencies, like the FDA and EMA, conduct risk-benefit assessments during product approval and post-marketing surveillance. This assessment ensures medicinal products provide overall benefits, minimizing harm.
Adverse drug reactions reporting
Adverse drug reaction (ADR) reporting is the process of submitting information about harmful or unintended responses to a drug. This can be done by healthcare professionals, patients, and pharmaceutical companies, and the reports are submitted to national regulatory bodies like the Indian Pharmacopoeia Commission (IPC) or the U.S. Food and Drug Administration (FDA) MedWatch system. Reporting is done using standardized forms that collect details on the patient, the reaction, and the suspected medication to monitor drug safety.
Adverse drug reactions (ADRs) are a major cause of morbidity and mortality across the world. ADR-related hospitalizations contribute substantially to the economic burden in both developing countries and developed countries. In India, 52810 ADRs were reported between April 2020 to March 2021, of which 28.10% were serious events as per the annual report released in pharmacovigilance program of India (PvPI).As ADRs are an inevitable part of treatment, healthcare professionals (HCPs) are encouraged to identify and spontaneously report individual case safety reports (ISCRs) using a predesigned suspected ADR reporting form. These ISCRs should be reported to the nearest adverse drug reaction monitoring centers (AMC). There are over 300 AMCs spread across the country. These centers receive the adverse events, review them for completeness, perform causality assessments and report to National Coordination Centre (NCC) via online software, Vigiflow for quality and signal review. With gradual increase in number of activities and spread of its work, PvPI has collaborated with several national health programmes and research institutions.
CONCLUSION
Medication errors and adverse drug reactions continue to pose a significant threat to patient safety across healthcare systems worldwide. Errors occurring at different stages of the medication-use process—prescribing, dispensing, administration, and monitoring—lead to preventable patient harm, prolonged hospital stays, increased healthcare costs, and, in severe cases, mortality. This review highlights that despite advances in therapeutic options and healthcare technology, medication-related risks remain a major challenge, emphasizing the need for strong patient safety strategies and effective surveillance systems.Pharmacovigilance plays a central role in identifying, assessing, and preventing medicine-related problems throughout a drug’s life cycle. Through systematic data collection, signal detection, causality assessment, and risk-benefit evaluation, pharmacovigilance ensures that previously unknown or rare adverse effects are recognized and addressed promptly. The integration of pharmacovigilance into routine clinical practice strengthens early warning mechanisms and supports regulatory actions that ultimately improve patient outcomes.Adverse drug reaction (ADR) reporting remains one of the most critical components of pharmacovigilance, yet underreporting continues to be a major limitation. Improving awareness and encouraging active participation of healthcare professionals—especially pharmacists, nurses, and physicians—in reporting systems is essential. In the Indian context, the Pharmacovigilance Programme of India (PvPI) has made notable progress in improving ADR monitoring through an expanding network of ADR Monitoring Centres and the use of digital platforms such as Vigiflow. However, continuous training, institutional support, and a non-punitive reporting culture are required to further strengthen the system. The role of pharmacists is particularly important in medication safety. As medication experts, pharmacists contribute significantly by detecting prescribing errors, ensuring accurate dispensing, counseling patients, and actively participating in ADR monitoring and reporting. Their involvement in multidisciplinary healthcare teams enhances medication safety and promotes rational drug use. IN conclusion, strengthening pharmacovigilance systems and improving ADR reporting practices are essential to reducing medication errors and improving patient safety. A collaborative approach involving healthcare professionals, regulatory authorities, policymakers, and patients is crucial for building a robust safety culture. Continuous education, adoption of technology, and systematic reporting mechanisms will further enhance drug safety and ensure better healthcare outcomes. Effective pharmacovigilance istherefore not merely a regulatory requirement, but a vital component of high-quality patient-centered care.
REFERENCES
K. Malleswari, Dr. D. Rama Brahma Reddy, J. Venkatasiva Reddy, An Overview on Medication Errors and Patient Safety Role of Pharmacovigilance and ADR Reporting, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 12, 3583-3590. https://doi.org/10.5281/zenodo.18047576
10.5281/zenodo.18047576
