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Objectives: Parenteral drug products should be essentially free from visible particulate contamination. To ensure this, every batch produced must be subject to a 100% visual inspection. Monograph 2.9.20 of the European Pharmacopoeia (Ph. Eur.) describes a method for visual inspection of parenteral drug units in front of a black and white panel using a white light source. Nevertheless, several Dutch compounding pharmacies rely on an alternative method for visual inspection by means of polarised light. The objective of this study was to compare the performance of both methods., Methods: Trained technicians in three different hospitals inspected a predetermined set of samples using both methods for visual inspection of parenteral drugs., Results: The results of this study show that the alternative method for visual inspection yields a higher recovery than the Ph. Eur. method, while no significant difference in false positive results was found., Conclusions: Based on these findings, it can be concluded that the alternative method for visual inspection by means of polarised light can very well replace the Ph. Eur. method in pharmacy practice, provided that local validation of the alternative method is performed., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Due to their mechanism of action, most classical cytostatic drugs have carcinogenic, mutagenic and/or reprotoxic properties. Therefore, occupational exposure of healthcare staff to these drugs should be prevented. Our objective was to lay out European legislation on this topic and reflect on the process of revising the European CM-directive. We summarise independent European and Dutch studies, and give a concise set of basic recommendations for safe working with cytotoxic drugs in healthcare facilities., Methods: We were directly involved in the process of revising the CM-directive: first, through an EU commissioned workshop in the Netherlands, and after that by contributing to the pan-European stakeholder symposium. For this aim, we had to gather the relevant study data from the Netherlands and from Europe. We analysed all relevant industry-independent studies and collated a set of basic recommendations., Results: Independent studies show that the development of measures in recent years can lead to a safe work environment. Standardising the cleaning process leads to a significant improvement in environmental contamination in the majority of hospitals. In the Netherlands, exposure of workers was shown to be well beneath the limit value of 0.74 µg cyclophosphamide per week, therefore showing that the measures taken in recent years are adequate., Conclusions: The safety of healthcare workers is of the utmost importance. Current practice in the Netherlands show that measures taken in recent years are adequate. European legislation should be based on independent scientific research and practice. The first goal should be to bring countries with less safe working levels to a higher level instead of introducing measures that only increase healthcare budgets but not healthcare safety., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Some drugs need processing before they can be administered or dispensed. We measured airborne exposure of pharmacy staff to small particles when performing these tasks., Methods: Reconstitution of powdered drugs in vials; crushing, splitting, and counting of tablets; and opening of capsules, using different ventilation strategies, were investigated in five pharmacies after in a worst-case approach. Airborne particulate matter was determined for a range of particles sizes., Results: Mean particle concentrations ranged from not detectable to 1.03 μg/m 3 (<1 μm) and 589.7 μg/m 3 (<10 μm). Dust exhaust made tasks safer. Most hazardous was pouring out tablets from a bulk supply, and least hazardous was reconstitution of a powder for injection., Conclusions: Occupational exposure during routine handling of drugs can occur, but the risks vary greatly with the nature and duration of the tasks., Competing Interests: Conflict of Interest: None declared., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American College of Occupational and Environmental Medicine.)

The global increase of use of oncology drugs combined with the higher costs of these drugs raise the question of how to reduce these costs. One way to reduce the costs is to reduce spillage by extending the beyond-use date by preserving remainders in the vial of (expensive) oncology drugs instead of wasting them. Therefore, we investigated if spikes, instead of the expensive closed-system transfer devices, can be used to extend the beyond-use date of drugs both at room temperature and in the refrigerator during seven days after reconstitution and partial fluid withdrawal of a vial. Six hundred vials containing concentrated tryptic soy broth were reconstituted with 10-mL of sodium chloride 0.9%, after which approximately 3 mL were removed from the vial and discarded using a regular spike for 300 vials and a MicroSpike for the other 300 vials. Subsequently, the vials were stored either at refrigerator temperature or at room temperature for seven days. After seven days, all six hundred vials were transported and incubated at a temperature of 30°C to 35°C for fourteen days. None of the six hundred vials used showed contamination, either punctured with a MicroSpike or with a regular spike, after storage of seven days at room temperature or in the refrigerator and two weeks of incubation. Conclusively, it can be stated that hospital pharmacies play an important role in keeping the high costs of oncology drugs as low as possible. This study shows that using a spike instead of a more expensive closed-system transfer device for preservation of the remainder of oncology drugs will further reduce spillage of expensive drugs resulting in lower healthcare costs., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Many studies into surface contamination of hospital environments have demonstrated that occupational exposure to cytotoxics through the dermal route remains a possible risk. In this study, we assess the actual dermal exposure of the hands of pharmacy technicians and cleaning personnel in a panel of hospitals performing tasks that pose a risk of exposure. We compare the dermal exposure to a tentative limit value for cyclophosphamide. Pharmacy technicians and cleaning personnel were asked for hand rinsing after performance of nine tasks previously identified as posing a risk of occupational exposure. All samples were analyzed for the presence and quantity of eight antineoplastic drugs. By using data on both the frequency of the performance of the tasks and the measured dermal contamination during these tasks, weekly exposure to the marker drug (cyclophosphamide) was calculated. In five Dutch hospitals, 70 hand rinse samples and 8 blanks were collected. These were analyzed and results were used to calculate weekly exposure. The tentative limit value used was 0.74 µg of cyclophosphamide. For cleaning personnel, all results remained below this threshold value. For pharmacy technicians, the compounding itself also remained well below the limit; however, the task involving preparatory work, as well as the checking of compounded drugs, had a 13% chance of exceeding the limit. All of the highest values were found when employees were not wearing gloves on these tasks. Cleaning personnel and pharmacy technicians compounding cytotoxic drugs in our study were sufficiently protected from occupational exposure. In contrast, pharmacy technicians who perform preparatory and finishing tasks (before and after the actual compounding) are not protected enough when they do not wear gloves.

Cytotoxic drugs can be harmful when healthcare workers are exposed to them, because of their carcinogenic, mutagenic and reprotoxic properties. There are many European and national laws and guidelines, plus local protocols that must be complied with, to protect healthcare workers against cytotoxic drugs. In the Netherlands, the current guidelines for hospitals are well structured and have been proven effective. Compliance to these guidelines remains pivotal, and further attempts to improve worker safety should be aimed at established risks, such as contamination on the outside of commercial drug vials. Non-proven and costly extra measures should not be introduced until their effectiveness has been demonstrated through independent research.

Eight Dutch hospital pharmacies took wipe samples of prepared infusion bags containing 5 fluorouracil just before distribution to the wards. The samples were tested with high-performance liquid chromatography and triple quadrupole mass spectroscopy. The limit of detection was 10 ng per swipe. None of the 146 samples had a detectable amount of 5-fluorouracil. The outside of infusion bags containing antineoplastic drugs prepared in these eight Dutch hospital pharmacies were not contaminated and, therefore, were not a risk factor with regard to exposure of hospital workers to antineoplastic drugs., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)