Band 4, Heft 3-4 -

Background Carbidopa is a drug mainly used to treat Parkinson’s disease. Associations with levodopa or with levodopa/entacapone are commercialized, but there is no oral formulation of carbidopa alone available in Europe. As carbidopa can also be used as premedication of adult patients for insulinoma diagnosis, it must be compounded as single dose mg capsules. The single dose administration of a magistral preparation implies the compounding of only one capsule, or the loss of consequent quantities of active pharmaceutical ingredient. As an alternative solution, carbidopa capsules could be compounded as batches of hospital preparation. Method With this objective, a stability-indicating dosing method for 200 mg carbidopa capsules was developed. Then, the compounding process was assessed according to the European Pharmacopeia requirements. Finally, the stability of carbidopa capsules stored protected from light at room temperature was studied for one year. Results 200 mg carbidopa capsules compounding process was validated on three independent batches. The beyond use date was fixed at one year. Conclusion Our work confirms that carbidopa 200 mg capsules can be realized in hospital pharmacy and its stability allows the compounding of large batches.

Parenteral nutrition (PN) in the neonatal intensive care unit (NICU) involves a succession of risky processes. The objective was to identify and prioritize the risks associated with PN in order to improve the quality of the pathway. A failure modes, effects, and criticality analysis (FMECA) was used to identify potential PN pathway failure modes. A multidisciplinary working group conducted a functional analysis of the processes, then listed the failure modes (FM). The FM criticality was assessed on a scale from 1 to 5 for occurrence (O), severity (S), and detection (D). The risk priority number (RPN), ranging from 1 to 125, was calculated. The FMECA identified 99 FM (prescription (n=28), preparation (n=48), and administration (n=23)). The median RPN was 12, with scores ranging from 3 to 48. 25 % of the scores had an RPN>21.75. Among them, 12 were associated with prescription FM, 5 were associated with FM related to preparation and 8 were associated with a FM linked to administration. It allowed us to prioritize areas of potential quality improvement for parenteral nutrition of the preterm infant. The results demonstrated the need for the presence of a clinical pharmacist in the NICU to ensure the quality of PN process.

In hospitals, the majority of medication therapy is administered intravenously. Especially, in intensive care units, simultaneous of various injectable drugs is a common practice Drug incompatibilities have been reported to be associated with up to 60 % of all serious and life-threatening adverse drug events. Several databases are used by hospital pharmacists to answer the questions of (in)compatibility of co-administered injectable drugs. The objective of this article is to present the European databases on compatibility and stability of injectable drugs. According to a questionnaire which was sent to the National Hospital Pharmacy Associations of the 28 countries of European Community there are three national databases available in EU countries which are in alphabetical order, Belgium, France and Germany. The Belgian database is dedicated to injectable medications, is updated and distributed annually in French language on a USB key. STABILIS ® is an international database giving information with pictograms translated into 29 languages. This database contains also monographs of non-injectable drugs. The internet-based ADKA STABIL-Datenbank is focused on anticancer drug therapy, listing detailed datasets in German language on stability and compatibility including the references.

Background In the hospital setting, trace contamination with hazardous medications comes primarily from the manipulation of containers used in preparing and administering drugs. However, some traces of medications also come from the excreta of patients. Methods This descriptive exploratory study involved direct observation and discussion. The aim was to map potential contamination associated with handling babies’ excreta through diaper management. The study was conducted at CHU Sainte Justine (Montréal, Québec, Canada), a 500-bed mother and child facility with 38 beds for hematology-oncology and bone marrow transplant. A list of key steps related to the management of diapers by a parent or caregiver on a pediatric unit was established by the investigators. A data collection grid was then developed and reviewed by a member of the research team. Results A total of six diaper changes, by six distinct individuals, were observed in August and September 2019. Transport of a soiled diaper for weighing outside the baby’s room by an additional caregiver was also observed and recorded. In total, 25 individual steps in diaper management and 28 potential failure modes were identified through mapping. Conclusions Changing a baby’s diaper involves many individual steps, which are subject to numerous failure modes that can contribute to contamination with traces of hazardous drugs. A good understanding of these process steps and failure modes is desirable to better train caregivers and parents to reduce trace contamination with hazardous drugs.