Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. The compounded preparations have many special features, such as the rapid/immediate need for the drug, the preparation of several pharmaceutical dosage forms, and the variation of batch sizes and manufacturing processes. Medicinal products prepared in hospital pharmacies may pose additional risks to patients compared to industrial products. These risks with limited evidence of quality, efficacy and microbiological purity can jeopardize patient safety. The aim of this study was to perform a product specific risk assessment of aseptically processed and terminally sterilized products belonging to the manufacturing range of the hospital pharmacy of Turku University Central Hospital. The study material contained 118 different products. The risk assessment was performed with the help of a risk matrix in which various quality and safety risks have been identified and assessed. The risk points obtained from the different areas of risks were multiplied together to obtain total risk points for each product. The products were qualitatively classified according to the total risk points into low-risk, medium-risk and high-risk products. All total parenteral nutrition (TPN) solutions of the study were classified as high-risk products. TPN solution prepared into a syringe without lipids and TPN solution prepared into an EVA bag without lipids had the highest risk points of the study (6561 points). Most of the eye drops (88 %) and patient controlled analgesia (PCA) pumps (68%) belonged to high-risk category. PCA pump containing morphine, clonidine, bupivacaine, ketamine and saline solution (1944 points) and autologous serum eye drops (1296 points) had the highest risk points of these product types. 60 percent of intraocular injections and half of pain products prepared into syringes were scored as high-risk products. Intravitreal bevacizumab had the highest risk points of intraocular injections (972 points). Medium-risk products were mainly different infusions. Infusions containing defibrotide, oxytocin and onasemnogene abeparvovec had the highest risk points in the medium-risk category. Liquid solutions and patient controlled analgesia (PCA) pumps were the second largest group in this category. All products used in allergy testing, all ointments and all inhalation solutions were in the low-risk category. The risk matrix used in the study can be used to identify high-risk compounded preparations in hospital pharmacies. Risk assessment enables targeting quality assurance more effectively to high-risk products. Risk assessment can be used to manage various risks in pharmaceutical compounding and reduce harm to patients. The results obtained in the study cannot be directly generalized to other hospital pharmacies because the products, manufacturing processes and the amounts of different products prepared vary among hospital pharmacies.

Featured Application Accuracy of additively manufactured implants for clinical surgery. Abstract In craniomaxillofacial surgical procedures, an emerging practice adopts the preoperative virtual planning that uses medical imaging (computed tomography), 3D thresholding (segmentation), 3D modeling (digital design), and additive manufacturing (3D printing) for the procurement of an end-use implant. The objective of this case study was to evaluate the cumulative spatial inaccuracies arising from each step of the process chain when various computed tomography protocols and thresholding values were independently changed. A custom-made quality assurance instrument (Phantom) was used to evaluate the medical imaging error. A sus domesticus (domestic pig) head was analyzed to determine the 3D thresholding error. The 3D modeling error was estimated from the computer-aided design software. Finally, the end-use implant was used to evaluate the additive manufacturing error. The results were verified using accurate measurement instruments and techniques. A worst-case cumulative error of 1.7 mm (3.0%) was estimated for one boundary condition and 2.3 mm (4.1%) for two boundary conditions considering the maximum length (56.9 mm) of the end-use implant. Uncertainty from the clinical imaging to the end-use implant was 0.8 mm (1.4%). This study helps practitioners establish and corroborate surgical practices that are within the bounds of an appropriate accuracy for clinical treatment and restoration.

Food and Forest Development Finland (FFD) and Tanzania Horticultural Association (TAHA) have a project called “Quality standards for enhanced market access for smallholder farmers in Tanzania” and it aims to improve Tanzanian smallholder farmers access to GLOBALG.A.P. certification. This master’s thesis study is made as a part of the project and the main aim of this study is to answer the following research questions. “What are the strengths, weaknesses, opportunities and threats of GLOBALG.A.P. certification to smallholder farmers in Tanzania?” and secondly, “What is the cost of certification and do farmers get premium price for certified products?”. This study is carried out as a qualitative case study. Data is sourced from a farmer survey in Tanzania and from an interview with Finnish certification specialists. As theoretical basis, Resource-based theory and the concept of competitive advantage is utilized. Previous studies and literature are also reviewed. Horticulture has an important role in Tanzania’s national economy and demand for fruits and vegetables is increasing. Tanzanian fruit and vegetable production is characterized by small-scale farming, poorly organized farm management and issues with market access and product quality. International export markets, especially in Europe, are demanding quality certification by third party. GLOBALG.A.P. (GAP= Good Agricultural Practice) is the largest agri-food certification scheme and the most demanding certification used in fruit and vegetable production. All big multinational retailers are demanding certification to ensure food safety and sustainability of the production. Getting GLOBALG.A.P. certification is a challenging task for smallholders in developing countries such as Tanzania. Farmer surveys were conducted in three different agricultural areas in Tanzania and over 360 farmers are represented in the results. A SWOT analysis was based on the survey results. Results revealed that smallholders have high expectations for the benefits of certification. Expectations of gaining access to local and global markets and for gaining improved negotiating position are confirmed by previous studies. Group certification is also revealed as a strength, as well as improved farm management skills. According to experts and previous studies, increase in prices is not guaranteed with certification. Instead, a wider customer base and economic benefits compared with non-certified farmers are likely to be achieved. GLOBALG.A.P. certification can be seen as a source of competitive advantage to smallholders. The greatest weaknesses of certification are, according to smallholders, the costs of certification, extra work and expensive investments on their farms. Poor infrastructure raises concerns. As external opportunities smallholders expect to gain higher profits, gains in exports and contracts with buyers. They are aiming towards commercial farming. The threats that worry farmers the most, are issues with re-certification, volatile returns in the markets and losing contracts with buyers due to quality issues.