Search

Environmental monitoring (EM) is the cornerstone for the assurance of sterility during aseptic manufacturing. In this study, the EM quality aspects in the radiopharmaceutical cleanrooms of the University Medical Center Groningen (UMCG), The Netherlands, were evaluated. Hereto, data obtained from EM over the period 2010–2022 were analyzed. The data were sorted according to the Good Manufacturing Practice (GMP) classification of the respective premises with their corresponding limits, and frequencies of excursions were determined per location. The frequency of conducted measurements gradually increased between the start and end of the assessed period. There was a trend of increased action limit excursions observed between 2010–2022. We found that EM in grade A areas appeared to be significantly less compliant with GMP specifications than the combined data from all sampled premises at the facility (p < 0.00001; two-sided Fisher's exact test). A trend was found for reduced action limit excursions for passive air sampling and particle counting, suggesting improved GMP compliance over time for this specific type of EM. The contamination recovery rate (CRR) found for cleanroom conditions, around 10%, was considered sufficient. From this comprehensive data analysis, we learn that, in order to be fully compliant with the requirements set in the recent revision of EU (European Union)-GMP Annex 1 'Manufacture of sterile medicinal products' (in force as of 25 August 2023), strategies to further improve product protection are justified. For example, improved cleaning and disinfection procedures, more efficient working methods as well as optimization of the conditions under which aseptic manufacturing is performed are to be considered. [ABSTRACT FROM AUTHOR]

This study investigated whether and how medication reviews (MRs) conducted by pharmacists and general practitioners (GPs) with patient involvement can be performed on the island of Aruba (Dutch Caribbean). In this mixed-methods pilot study (both qualitative and quantitative), constructive and observational methodologies were combined. Healthcare providers' and patients' views on MRs and aspects of Aruban healthcare and culture relevant to MRs were examined. These insights were used to develop a protocol for conducting and implementing MRs in Aruba. Surveys were distributed and semi-structured interviews were held among Aruban community pharmacists and GPs, and a pilot program was created in which MRs were carried out with four Aruban patients and their GPs. According to the included healthcare providers, the main purpose of MRs is to optimize the patient experience and achieve concordance. Even though pharmacists and GPs consider their partnership equal, they have different views as to who should bear which responsibility in the MR process in matters regarding patient selection and follow-up. Common Aruban themes that were mentioned by the healthcare providers and deemed relevant for conducting MRs included behaviour/culture, healthcare, lifestyle, and therapy compliance. Anamnesis should be concise during the MR, and questions about medication storage, concerns, beliefs, and practical problems, as well as checks for limited health literacy, were considered important. In the pilot, at least three to, maximally, eight pharmacotherapy-related problems (PRPs) were detected per MR consultation, such as an incorrect dosage of acetylsalicylic acid, an inappropriate combination tablet for blood pressure regulation, and the absence of important laboratory values. All patients considered their consultation to be positive and of added value. In addition, it was observed that an MR can potentially generate cost savings. The information obtained from the healthcare providers and patients, together with the basic principles for MRs, as applied in the Netherlands, led to a definitive and promising MR format with practical recommendations for community pharmacists in Aruba: in comparison with the Dutch MR approach, GPs and pharmacists in Aruba could collaborate more on patient selection for MRs and their follow-up, because of their specific knowledge regarding the medications patients are taking chronically (pharmacists), and possible low levels of health literacy (GPs). Taking into account the Aruban culture, pharmacists could ask extra questions during MRs, referring to lifestyle (high prevalence of obesity), readability of medication labels (limited literacy), and herbal product use (Latin American culture). GPs and medical specialists sometimes experience miscommunication regarding the prescription of medication, which means that pharmacists must carefully take into account possible duplicate medications or interactions. [ABSTRACT FROM AUTHOR]

Tea tree (Melaleuca alternifolia) essential oil is widely used as an antiseptic. It mainly consists of monoterpenes with terpinen‐4‐ol as the major constituent. The aim of this study was to review literature on safety data about tea tree oil and to assess its safety by investigating 159 cases of adverse reactions possibly caused by the oil, reported to the World Health Organization (WHO) from December 1987 until September 2021. To extract these data, VigiBase, the WHO global database of individual case safety reports maintained by the Uppsala Monitoring Centre (UMC), was used. All cases were categorized and analysed and 16 serious cases further assessed. It was concluded that tea tree oil should never be administered orally, as it can lead to central nervous system depression and pneumonitis. Applied topically, skin disorders may occur, especially when the oil had been exposed to light or air. This yields monoterpene oxidation products, being potent skin irritants. Tea tree oil stored under appropriate conditions and not exceeding the expiration date should be considered safe to use by non‐vulnerable people for non‐serious inflammatory skin conditions, although the occurrence of adverse reactions such as contact allergies is difficult to predict. [ABSTRACT FROM AUTHOR]