PATIENT-CENTERED APPROACH TO THE INDIVIDUALIZATION OF PHARMACEUTICAL CARE: THE EXAMPLE OF AMLODIPINE

Abstract

A patient-centered approach to pharmaceutical care involves taking into account not only the clinical indications for the use of a medicinal product, but also the individual needs of the patient, including the required dose, the availability of an appropriate dosage form, and economic factors. Amlodipine was selected as a model medicinal product because certain patient groups, including pediatric, geriatric and frail patients, as well as patients with hepatic impairment, may require a 2.5 mg dose, whereas monocomponent amlodipine products actually available in Ukraine are predominantly presented as 5 mg and 10 mg tablets, creating a need for dose individualization. Additional consideration is required for patients with swallowing difficulties, for whom a standard tablet dosage form may be unsuitable. The aim of the study was to analyze amlodipine medicinal products in tablet form registered in Ukraine with regard to the possibility of dose subdivision and to substantiate the role of the pharmacist in the individualization of pharmaceutical care. Based on the State Register of Medicinal Products of Ukraine, a list of monocomponent amlodipine medicinal products was compiled. Their actual availability and retail prices were assessed using data from tabletki.ua as of September 2026, while tablet characteristics and the possibility of splitting were evaluated according to the approved product information. Thirty-eight marketed amlodipine products in strengths of 5 mg and 10 mg were available in Ukrainian pharmacies; no 2.5 mg strength was identified among the products actually available on the market. Thirty-one of the 38 products (81.6%) were included in the Affordable Medicines reimbursement program. Among 12 brand names of 5 mg amlodipine tablets, halving to obtain a 2.5 mg dose was explicitly permitted in the approved product information for five medicinal products, prohibited for three, while four contained no relevant instructions. For 10 mg tablets, obtaining a 2.5 mg dose by splitting was not provided for in any of the analyzed product information documents. A model assessment of dosing in children under 6 years of age demonstrated limited possibilities for accurately obtaining an individually calculated dose by splitting industrially manufactured tablets. For patients with swallowing difficulties, tablet splitting also does not resolve the issue of dosage-form acceptability. It was established that patient-centered pharmaceutical care in the use of amlodipine should include a comprehensive assessment of the prescribed dose, medicinal product availability, reimbursement conditions, whether tablet splitting is explicitly permitted in the approved product information, and the acceptability of the dosage form for the individual patient. An algorithm for pharmacist actions was proposed, including identification of the need for dose or dosage-form individualization, selection of a medicinal product for which the required splitting is explicitly authorized, counselling on correct tablet splitting and storage of tablet fragments, and, when the required dose or an acceptable dosage form cannot be ensured, referral of the patient to the prescriber to consider an alternative dosage regimen or extemporaneous compounding. This approach supports the role of the pharmacist as an active participant in the individualization of pharmaceutical care and in the practical implementation of patient-centered pharmacotherapy.