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In this journal, review articles by Hamid et al. [1] and Song et al. [2] emphasized the critical role of pharmacovigilance in ensuring patient safety and minimizing the socioeconomic burden of adverse drug reactions (ADRs). In primary care settings, where various medications are prescribed for both acute and chronic conditions, the risk of encountering ADRs is relatively high. Failure by primary care physicians to adequately suspect and assess these reactions can lead to unnecessary diagnostic procedures and prescriptions, ultimately imposing additional burdens on patients [3].
A key first step in the assessment of ADRs is determining their frequency, which is typically based on data from clinical trials and post-marketing surveillance studies [4,5]. For information on the frequency of ADRs associated with specific medications, physicians can refer to product labels (package inserts) and drug information databases such as UpToDate or the Korean Index of Medical Specialties. Additionally, pharmacovigilance databases maintained by regulatory authorities, including VigiBase by the World Health Organization, the FDA Adverse Event Reporting System in the United States, EudraVigilance by the European Medicines Agency, and the Regional Drug Safety Center by the Korean Ministry of Food and Drug Safety, can also be consulted [1,2]. Classification systems used in these studies are listed in Table 1. These systems help physicians communicate risks to patients in probabilistic terms [4]. Although somewhat peripheral to the main focus of this study, a pragmatic question arises: should physicians routinely inform patients about common ADRs? Proactively informing patients about potential side effects may reduce anxiety, encourage appropriate responses when ADRs occur, support medication adherence, and strengthen therapeutic relationships [6]. However, this approach presents practical challenges, such as additional time and effort required for thorough explanations. Moreover, a nocebo effect could occur, wherein negative expectations may lead to the perception of or worsening of symptoms [7,8]. Consequently, the decision to explain potential ADRs should be guided by the patient’s clinical condition and individual characteristics rather than a rigid, “one-size-fits-all” approach [9,10].
The Naranjo ADR Probability Scale, widely used to assess ADR causality, is regarded by many as one of the more practical and accessible tools available (Table 2) [11,12]. It consists of a standardized 10-item questionnaire, with each response contributing to a total score to categorize the likelihood of causality as definite, probable, possible, or doubtful. In addition, evaluating the timing of symptom onset after drug administration, the time course of symptom resolution following drug discontinuation, and other clinical characteristics in comparison with known typical patterns of ADRs can aid in determining whether the reaction is drug-related [13,14]. Table 3 presents specific examples of typical clinical features of the selected ADRs.
Another important consideration is that ADRs can vary among drugs within the same class [15,16]. A well-documented example is statin-associated muscle symptoms (SAMS). Clinical studies have demonstrated that at equipotent doses for lowering low-density lipoprotein cholesterol, simvastatin and atorvastatin are associated with a higher risk of SAMS compared to pitavastatin, pravastatin, and rosuvastatin [17,18]. These findings suggest that SAMS is influenced not by the class effect of statins, but by the specific pharmacological properties of individual drugs, such as lipophilicity, metabolism, and muscle tissue penetration [17]. This highlights the potential value of switching to statins with a lower risk profile in patients experiencing SAMS.
In the current clinical setting in Korea, practical limitations often lead to a tendency to prescribe additional medications, conduct further tests, or make referrals, rather than considering ADRs as a potential cause of patients’ symptoms or discomfort. However, physicians should always maintain clinical suspicion of ADRs, particularly when initiating a new medication or increasing the dose of an existing medication whenever patients report new or worsening symptoms [19]. This approach can help reduce unnecessary procedures and serve as the first step in identifying potential ADRs, ultimately improving patient safety [2,3]. Furthermore, physicians should engage in ongoing education to stay informed about ADRs commonly encountered in primary care settings. Extensive use of reliable drug safety resources is recommended.
Article Information
Conflict of interest
No potential conflict of interest relevant to this article was reported.
Funding
None.
Data availability
Not applicable.
Author contribution
All the work was done by Ki Dong Ko.
Table 1.
Classification of adverse drug reactions by frequency with common examples
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