Mia Sivén

Background: Controlled substances are commonly used as analgesics or to treat neurodevelopmental disorders in health care, but they also pose a risk of drug abuse and diversion. Therefore, the distribution and handling of controlled substances are strictly regulated, and hospital pharmacies are required to manage their surveillance in hospital settings. Between 2018 and 2021, a large Finnish academic hospital implemented a new electronic health record system enabling the digitalization of paper-based controlled substance surveillance. By November 2023, the electronic narcotic consumption card (eNCC) had been implemented in 84 wards. Although hundreds of health care professionals (HCPs) use the eNCC daily, our understanding of the user experience (UX) with this process is limited. Objective: This study aimed to characterize UX with the eNCC and compare it across different dosage forms. Additionally, we aimed to assess whether the end user’s professional role, years in practice, and years of electronic health record system use affect UX and how investigations and error corrections in controlled substance surveillance have evolved since the implementation of the eNCC. Methods: An electronic survey was conducted among HCPs working in wards and the hospital pharmacy in May 2024. The survey included background questions, statements using a 5-point Likert scale, and 1 open-ended question. This study was reported in accordance with the CROSS (Consensus-Based Checklist for Reporting of Survey Studies) guidelines. Results: There were 599 respondents (n=522, 87.1% nurses; n=21, 3.5% physicians; n=56, 9.3% pharmacists) to the survey during the 3-week response period. Our main finding was that HCPs preferred the eNCC process; 80.9% (484/598) of respondents disagreed when asked whether they were willing to return to the paper-based process. Additionally, HCPs considered the eNCC to be effortless in daily work for both solid (491/578, 84.9%) and liquid (418/578, 72.3%) dosage forms. However, the eNCC process for solid dosage forms was reported to be more straightforward and faster than that for liquid ones. Both nurses and pharmacists reported conducting more investigations and error corrections immediately after eNCC implementation than during the most recent month. Nevertheless, ward pharmacists performed more investigations and corrections than registered nurses at both specified time points. Conclusions: Most HCPs had rather positive attitudes toward the eNCC, and they preferred it over a paper-based process. This research highlights the importance of understanding the varying levels of interaction with the eNCC among different professional roles.

Background and Objectives Additional risk minimization measures (aRMMs), such as direct healthcare professional communication (DHPC) and risk management plan (RMP) educational materials, are required for certain medicinal products to mitigate the risks associated with their use. This research aimed to assess healthcare professionals’ (HCPs) awareness and experiences of DHPC and RMP educational materials, identify the safety information most valued by HCPs, and determine ways to improve the processes and content of DHPCs and RMP educational materials. Methods An open, anonymous online questionnaire was created and made available to HCPs through their respective professional associations. The Chi-squared test for independence was the primary statistical analysis method used. Content analysis of the open-ended answers was conducted by two independent coders. Results A sample size of 185 HCPs (32 physicians, 50 nurses, 26 MSc pharmacists, and 77 BSc pharmacists) was achieved. HCPs showed limited familiarity with aRMMs, with 45% unsure whether they had received DHPCs, 41% uncertain whether they had used RMP educational materials, and 42% unaware where to check whether a product had RMP educational material. Overall, MSc pharmacists demonstrated the highest awareness of RMP educational materials and DHPCs. In addition, 54% of HCPs felt they received insufficient safety information, and 57% desired further training in pharmacovigilance (PhV). Conclusions This research reinforces and complements our previous findings on the need to enhance PhV awareness and expertise among HCPs, particularly in areas such as adverse drug reaction (ADR) reporting, additional monitoring, DHPCs, and RMP educational material. Future DHPCs and RMP educational materials should be made more distinguishable to effectively capture HCPs’ attention.

The pursuit of targeted therapies for cytokine-dependent diseases has led to the discovery of Janus kinase (JAK) inhibitors, a promising class of drugs. Among them, CPL409116, a selective dual JAK and rho-associated protein kinase inhibitor (ROCK), has demonstrated potential for treating conditions such as pulmonary fibrosis exacerbated by the COVID-19 pandemic. This study investigated the feasibility of delivering CPL409116 via inhalation, with the aim of minimizing the systemic adverse effects associated with oral administration. Two micronization methods, jet milling and spray drying, were assessed for CPL409116, with spray drying chosen for its ability to produce an amorphous form of the compound. Moreover, parameters such as the mixing energy, drug load, and force control agent significantly influenced the fine particle fraction (FPF), a critical parameter for pulmonary drug delivery. This study provides insights into optimizing the formulation parameters to enhance the delivery efficiency of CPL409116 to the lungs, offering potential for improved therapeutic outcomes in cytokine-dependent pulmonary diseases.

The distribution and handling of controlled substances (CSs), i.e., narcotics, is strictly regulated to decrease the risk of abuse and drug diversion. In Finland, hospital pharmacies are mandated to keep records of CS distribution and consumption in healthcare through a labor-intensive paper-based process. After implementing a new electronic health record (EHR) system, a large university hospital started to streamline the process by transferring the CS documentation process from paper to digital format. Although the benefits of digital archiving, surveillance, and consumption monitoring are self-evident from the hospital pharmacy’s perspective the advantages at wards remain less explored. Therefore, our goal was to explore the usability and user experience (UX) of the recently implemented electronic narcotic consumption card (eNCC) solution built into the EHR system, and the related workflows of nurses, pharmacists, and physicians. The field study consisted of two parts and was conducted using observation, interviews, and survey methods in two wards. Our findings suggest that the digitalized process enables reliable real-time documentation of CSs and improves process efficiency, particularly for oral tablets and capsules. Considering diverse end-users’ perspectives is crucial when assessing the practical benefits of newly implemented digital solutions targeted at several healthcare professional groups. This approach enables a broader understanding of UX; supports development efforts, including usability improvements; and facilitates broader implementation. More research is needed to analyze the long-term impacts of the digital CSs’ consumption documentation workflow and surveillance at different healthcare units.

Background Isotretinoin, indicated for severe acne, is a potent teratogen and therefore contraindicated in pregnancy. Thus, the pregnancy prevention program (PPP) for isotretinoin has been introduced. Objectives The aim of this study was to assess the concomitant use of isotretinoin and effective contraception and the rate of potential isotretinoin-exposed pregnancies in females of childbearing age in 2017–2020 in Estonia. In addition, we aimed to evaluate whether compliance with the PPP has improved compared with the previous study conducted in Estonia covering the period of 2012–2016. Methods This retrospective, nationwide study using prescription and healthcare claims data included 2575 females aged 15–45 years who started using isotretinoin between 2017 and 2020. Results For 64.7% of females of childbearing age, no concurrent use of an effective contraceptive was detected while using isotretinoin. A moderately higher contraceptive coverage (35.3%) was observed compared with the previous study (29.7%) (p < 0.001). Complete contraception coverage was highest in females aged 30–39 years with an adjusted OR of 12.8 (p < 0.001) compared with the age group 15–19 years and 2.47 (p < 0.001) compared with the age group 20–29 years. 17 pregnancies coincided with the isotretinoin treatment-related period. The risk for potential isotretinoin-exposed pregnancy was 6.6 (95% CI 3.9–10.5) per 1000 treated females of childbearing age over the 4-year observation period. The risk for potential isotretinoin-exposed pregnancies per 1000 treated females was 1.0 in females aged 15–19 years, 11.6 in females aged 20–29 years, 8.8 in females aged 30–39 years, and 7.4 in females aged 40–45 years (p = 0.009). Conclusion A slight improvement in complete contraceptive coverage during isotretinoin use has not resulted in a decrease in the risk of isotretinoin-exposed pregnancies. The contraceptive usage and risk for pregnancy vary greatly across age groups, suggesting the need for a more targeted approach to improve the effectiveness of the PPP.