scholarly journals Longitudinal analysis of safety and medication adherence of patients in the Fingolimod patient support program: a real-world observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Aline Bourdin ◽  
Marie Paule Schneider ◽  
Isabella Locatelli ◽  
Myriam Schluep ◽  
Olivier Bugnon ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medication Adherence ◽  
Real World ◽  
Safety Data ◽  
Support Program ◽  
Patient Support ◽  
Patient Support Program ◽  
Dose Monitoring ◽  
Real World Evidence ◽  
Patient Reported

AbstractThe Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).

Active postmarketing surveillance: Results from a manufacturer's patient support program for patients under treatment with the first biosimilar trastuzumab (MYL-1401O) approved in Brazil.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14000-e14000
Author(s):  
Allisson Monteiro da Silva ◽  
Gislaine Villarta Capeleti Dib ◽  
Emanuela Lopez Fernandes Saraiva ◽  
Thais Tiemi Watanabe ◽  
Jaqueline Amália de Paulo
Keyword(s):  
Safety Data ◽  
The Body ◽  
Support Program ◽  
High Tech ◽  
Patient Support ◽  
Female Patients ◽  
Related Data ◽  
Patient Support Program ◽  
Her2 Breast Cancer ◽  
Phone Calls

e14000 Background: The development of biosimilars is increasing around the world, and facilitates patient’s access to these high-tech therapies. Active pharmacovigilance is considered one of the main tools for monitoring the safety of biologics and biosimilars, especially in post marketing. In 2017, trastuzumab (MYL-1401O) became the first trastuzumab biosimilar approved in Brazil. A program to support patients under trastuzumab (MYL-14010) treatment was sponsored by the manufacturer in order to closely monitor adverse events (AE). Methods: This is a prospective observational study based in data from a manufacturer’s patient support program. Patient diagnosed with initial or advanced HER2+ breast cancer (BC) and HER2+ gastric cancer (GC) who received prescription for trastuzumab (MYL-1401O) were invited to participate. They are followed by periodical phone calls after each infusion and up to 3 months after the last infusion of trastuzumab. Treatment related data and AEs were collected. Results: A total of 21 female patients with HER2+ BC receiving trastuzumab (MYL-14010) were enrolled in the program between May 2018 and January 2019. 16 (76,2%) out of these patients with median age 52 years (range 33 to 76) reported 101 AEs (all-causality): 94 (93,1%) non-serious (73 expected / 21 unexpected) and 7 (6,9%) serious (5 expected / 2 unexpected). Considering all unexpected AEs causality assessment was unlikely in 47,8% AEs. The most frequently reported AEs according SOC (system organ classification) were general disorders and administration site conditions (18,8%), nervous system disorders (14,9%) and gastrointestinal disorders (14,9%). The most reported symptoms were nausea, asthenia, infusion reactions, paresthesias and pain in the body. Conclusions: Safety data for biosimilar trastuzumab (MYL-1401O) is consistent with original trastuzumab in female patients with HER2+ BC. Most of the reported AEs were non-serious (93,1%) and expected (77,2%). No new safety signals were detected.

scholarly journals Implementation and Effectiveness of an Interprofessional Support Program for Patients with Type 2 Diabetes in Swiss Primary Care: A Study Protocol

Pharmacy ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 106
Author(s):  
Noura Bawab ◽  
Joanna C. Moullin ◽  
Clémence Perraudin ◽  
Olivier Bugnon
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Large Scale ◽  
Quantitative Methods ◽  
Implementation Process ◽  
Support Program ◽  
Patient Support ◽  
Patient Support Program ◽  
Patient Reported

This research protocol illustrates the use of implementation science to support the development, dissemination and integration in primary care of effective and sustainable collaborative pharmacy services for chronic care management. The objective is to evaluate the implementation and the effectiveness of a pharmacist-led patient support program including regular motivational interviews; medication adherence, patient-reported outcomes, and clinical outcomes monitoring; and interactions with physicians, for patients with type 2 diabetes taking at least one oral antidiabetic medication in the French-speaking part of Switzerland. This is a prospective, multi-centered, observational, cohort study using a hybrid design to assess the patient support program. The evaluation includes three levels of analysis: (1) the implementation strategies, (2) the overall implementation process, and (3) the effectiveness of the program. Qualitative and quantitative methods are used, and outcomes are assessed at each stage of the implementation process: exploration, preparation, operation, and sustainability. This research project will provide key insights into the processes of implementing patient support programs on a large scale and adapting the traditional community pharmacy practices towards the delivery of person-centered and collaborative services.

scholarly journals Real‐world persistence with liraglutide 3.0 mg for weight management and the SaxendaCare® patient support program

2020 ◽  
Vol 6 (4) ◽  
pp. 382-389
Author(s):  
Sean Wharton ◽  
Christiane L Haase ◽  
Elham Kamran ◽  
Aiden Liu ◽  
Johanna Mancini ◽  
...  
Keyword(s):  
Weight Management ◽  
Real World ◽  
Support Program ◽  
Patient Support ◽  
Patient Support Program
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