Aizpurua-Arruti Xabier, Benrimoj Shalom Charlie I, Goyenechea Estibaliz, Isla Arantxa, Oñatibia-Astibia Ainhoa, Malet-Larrea Amaia, Gastelurrutia Miguel Ángel, Cuevas Olatz, Rodríguez-Castejón Julen, Domingo-Echaburu Saioa, Solinís María Ángeles, García Montserrat, Del Pozo-Rodríguez Ana
Official Pharmacist Association of Gipuzkoa, Donostia / San Sebastián, Spain.
Pharmacy Practice Research Group, PharmaNanoGene Group, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.
Integr Pharm Res Pract. 2024 Jul 29;13:115-125. doi: 10.2147/IPRP.S466129. eCollection 2024.
Additional monitoring (AM) medicines include (i) medicines containing a new active substance; (ii) biological medicines; (iii) medicines with conditional approval or authorized in special situations; (iv) medicines which require further studies; (v) medicines that have specific requirements regarding the reporting of suspected adverse drug reactions (ADRs). When AM medicines are marketed, their most common ADRs are known, but safety information is limited because relatively rare ADRs are often not detected in clinical trials. Their AM status warrants real-world studies to identify other safety issues; however, such studies are lacking. Correct use and adherence to dosage regimen by patients are key factors for the evaluation of the safety and efficacy of medicines. The objective of this work was assessing the impact on safety, adherence, use and knowledge (U&K) about medicines and patient's quality of life (QOL), of community pharmacist (CP)-led interventions in a new service focused on AM medicines targeted at three prevalent chronic diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease and cardiovascular disease.
A prospective interventional cohort study was conducted with a 6-month follow-up in 27 community pharmacies (145 patients). Safety, adherence to treatment, patient U&K and QOL were assessed at follow-up visits (months 0, 3 and 6).
The number of detected ADRs was 163 with 41 patients referred to the doctor. At baseline, 24.1% of the patients were non-adherent, mainly due to unintentional causes. After six months and 130 interventions by CPs on adherence, a significant reduction to lower than 5.8% was achieved. The inadequate U&K of medicines also decreased, from 47.6% to 7.9% after 182 interventions. Also, the patient's QOL improved.
A new patient-centered pharmacy service provides some evidence on the important role of CP in assisting the proper and safe use of AM medicines, improving patient health outcomes.
附加监测（AM）药品包括：（i）含有新活性物质的药品；（ii）生物制品；（iii）有条件批准或在特殊情况下获批的药品；（iv）需要进一步研究的药品；（v）对疑似药品不良反应（ADR）报告有特定要求的药品。当AM药品上市时，其最常见的ADR是已知的，但由于相对罕见的ADR在临床试验中往往未被检测到，所以安全信息有限。它们的AM状态需要开展真实世界研究以识别其他安全问题；然而，此类研究尚缺。患者正确使用药品并遵守给药方案是评估药品安全性和有效性的关键因素。本研究的目的是评估社区药师（CP）主导的干预措施，在一项针对2型糖尿病、慢性阻塞性肺疾病和心血管疾病这三种常见慢性病的新的AM药品服务中，对药品安全性、依从性、使用和知识（U&K）以及患者生活质量（QOL）的影响。
开展了一项前瞻性干预队列研究，在27家社区药房对145名患者进行为期6个月的随访。在随访就诊时（第0、3和6个月）评估安全性、治疗依从性、患者的U&K和QOL。
共检测到163例ADR，41名患者转诊至医生处。基线时，24.1%的患者不依从，主要原因是无意因素。在CP进行了130次关于依从性的干预措施6个月后，不依从率显著降至5.8%以下。药品知识掌握不足的情况也有所减少，在182次干预措施后，从不依从率的47.6%降至7.9%。此外，患者的QOL有所改善。
一项新的以患者为中心的药房服务为CP在协助正确、安全使用AM药品、改善患者健康结局方面的重要作用提供了一些证据。
