A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol

Stopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies’ professionals in the European Economic Area

Background: The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. Objective: The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Methods: Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. Results: The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). Conclusions: Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient

The evaluation of pharmaceutical pictograms among elderly patients in community pharmacy settings – a multicenter pilot study

Piotr Merks,1,2,* Damian Świeczkowski,3,* Marcin Balcerzak,4 Ewelina Drelich,4 Katarzyna Białoszewska,5 Natalia Cwalina,3 Jerzy Krysinski,1 Miłosz Jaguszewski,3 Annie Pouliot,6 Regis Vaillancourt6 1Department of Pharmaceutical Technology, Collegium Medicum in Bydgoszcz, Nicolaus University in Torun, Bydgoszcz-Torun, Poland; 2Piktorex Sp. z.o.o., Warsaw, Poland; 3First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 4Farenta Polska, Warsaw, Poland; 5Department of Medical Psychology, Medical University of Warsaw, Warsaw, Poland; 6Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada *These authors contributed equally to this work Introduction: The search for new ways to optimize the use of medications by patients has led the pharmaceutical community to promote the idea of introducing pictograms into routine practice. The main intention of pictograms is to ease patient adherence and to reduce potential risks or errors associated with the use of medications. Purpose: To evaluate a series of pharmaceutical pictograms for patient comprehension. Patients and methods: The study was conducted in community pharmacies within a European Union country that belongs to the professional research network. Structured interviews were used to evaluate the pictograms for patient comprehension. This consisted of an assessment of the following: the transparency and translucency of the pictograms, health literacy, and pictogram recall. Participants were also given the opportunity to provide feedback on how to improve the pictograms. The primary endpoint was pictogram comprehension. Secondary outcomes included recall of the pictograms and pictogram translucency. Results: The study included 68 patients with whom face-to-face interviews were performed. Low transparency results (≤25%) and extensive patient feedback in initial interviews led to the withdrawal of certain pictograms (n=15) from the evaluation. Among the pictograms included in the final stage of our research, 22 pictograms (62.8%) obtained an acceptable transparency level ≥66%. All pictograms passed the short-term recall test with positive results. Conclusion: A majority of the designed and modified pictograms reached satisfactory guessability scores. Feedback from patients enabled modification of the pictograms and proved that patients have an important voice in the discussion regarding the design of additional pictograms. Keywords: pharmaceutical pictograms, elderly population, health literacy, community pharmacy, Polan