Effectiveness of mepolizumab in patients with severe eosinophilic asthma: results from real-world clinical practice in Finland.

OBJECTIVES: Mepolizumab treatment provides clinical benefits for patients with severe eosinophilic asthma in randomized controlled trials. However, real-world data for patients in Finland are lacking. METHODS: This retrospective, non-interventional, chart review study included patients with severe eosinophilic asthma ≥18 years of age initiating mepolizumab between January 1, 2016 and January 31, 2019 at three investigational sites in Finland. Patient characteristics during the 12 months prior to mepolizumab initiation (baseline) were recorded and primary and secondary endpoints included changes from baseline in disease outcomes during follow-up (up to 24 months following mepolizumab initiation). Exploratory endpoints included association between patient characteristics and exacerbation frequency/annual cumulative oral corticosteroid (OCS) dose. RESULTS: Overall, 51 patients were included (mean 17.8 months follow-up). At baseline, patients had a mean (standard deviation) blood eosinophil count of 550 (410) cells/µL; impaired lung function and health-related quality of life; poor symptom control; frequent exacerbations (2.78/year); and 90% were using OCS (mean: 9.80 mg/day). At the last follow-up visit, reductions from baseline in blood eosinophil count (84%) and fractional exhaled nitric oxide (26%) were observed, as were improvements in Asthma Quality of Life Questionnaire score (36%) and Asthma Control Test score (34%). Reductions in the mean number of annual exacerbations (82%) and mean daily OCS dose (39%) were also seen; reductions were observed even after adjustment for several patient baseline characteristics. CONCLUSIONS: Results are consistent with previous randomized clinical trials, indicating that Finnish patients experience clinically relevant improvements when treated with mepolizumab in real-world clinical practice.

Medication Counselling on Unlicensed Medicines Should Be Improved - Results from a Finnish Survey for Patients and Pharmacy Staff.

Background: Finnish authorities have published specific instructions for prescribing, handling, and dispensing unlicensed medicines and for the associated communication with patients. However, there is a clear research gap concerning the quality of medication counselling given by doctors and especially pharmacists to patients who are prescribed unlicensed medicines. The success of such counselling was studied with a survey for both pharmacy staff and patients. Methods: The survey was conducted in 2022 with two electronic semi-structured questionnaires, one for patients (or caregivers of underaged patients) purchasing medicines with special or fixed-term special permits from community pharmacies in Finland and one for the pharmacy staff dispensing such medication. Results: In all, 49% of the 389 pharmacists did not know if the prescribing doctor had given any counselling to the patient, and 52% of the pharmacists had not given any counselling to the patient themselves. Still, 51% of the pharmacists considered that the patient had received sufficient medication counselling. Almost every one of the 36 patients expressed that they had received medication counselling, 61% of them from the prescribing doctor and 53% from a pharmacist. Conclusion: Medication counselling on unlicensed medicines should be improved to ensure their safe and effective use. This survey revealed that many patients did not receive any such medication counselling as required by the Finnish Medicines Decree.

If patients need medicines that are not available in their own country, they can be treated with unlicensed medicines imported from abroad.Community pharmacies deliver tens of thousands of packages of unlicensed medicines yearly in Finland, and we wanted to find out whether patients receive appropriate information about their use.We contacted pharmacy staff and patients using unlicensed medicines and conducted an electronic survey to ask about their experiences on whether patients receive sufficient information on these medicines.Almost every patient participating the survey felt that they had received counselling on their unlicensed medication, more often from a doctor than a pharmacist, despite most of the pharmacist responding to this survey had a lot of work experience and dispensed these medicines regularly.Patients have the right to receive supporting information to ensure the effectiveness and safety of their medication, and pharmacists have a crucial role in ensuring this.Based on this study, we suggest that pharmaceutical companies and authorities should provide reliable supporting material on the use of unlicensed medicines for doctors, pharmacists, and patients, bearing in mind the respective information needs of these groups.

Identification of metabolites of fosinopril produced by human and rat liver microsomes with liquid chromatography-mass spectrometry.

Metabolic profiles of prodrug fosinopril and pharmacologically active metabolite fosinoprilat were studied using human or rat liver microsomes and S9 fractions. Metabolites were identified by ultra high-performance liquid chromatography/quadrupole time-of-flight mass spectrometry (UHPLC/Q-TOF-MS) using electrospray ionization in the positive and negative ion mode. They were characterized by accurate MS and MS/MS spectra and based on their different fragmentation pathways. With human liver microsomes fosinopril was metabolized via hydroxylation, glucuronidation, and hydrolysis to fosinoprilat. As expected the main metabolite was fosinoprilat and it was further hydroxylated and glucuronidated. However, these metabolites were not detected after incubation of fosinoprilat with human liver microsomes, indicating that metabolic reactions occur in sequence and fosinopril is hydrolyzed after glucuronidation or hydroxylation. With the developed UHPLC/Q-TOF-MS method once or twice hydroxylated fosinopril metabolites were detected for the first time and different regioisomers were separated. It was observed that the hydrolysis of fosinopril to fosinoprilat was more efficient with rat than with human liver microsomes, and therefore more hydroxylated fosinoprilat metabolites were detected when rat liver microsomes were used. Glucuronidation of fosinopril was not observed with rat liver microsomes.