As of Jan. 1, 2026, the PIC/S regulations will officially come into effect. Although certain aspects of the Belgian legislation are currently still in a gray area, many hospital pharmacies have already started the necessary preparations to (partially) comply with the standards.
The transition to the new way of working requires significant investments: in infrastructure, training, consumables, adapted software as well as additional time commitment - resulting in an increased need for extra staff (FTE). More and more hospitals are therefore actively seeking forms of cooperation, both within their own network and beyond.
Such cooperation requires thorough preparation at several levels:
- Strategic level: creating the climate of trust for good cooperation. Typically, the following questions are answered: Are we all convinced of the business case? What is the governance structure of the central cleanroom? What financial commitment do we expect from each partner?
- Tactical level: preparing the collaboration. Which team prepares the collaboration? How does this team report? At what level will cooperation take place, who will be involved?
- Operational level: what will the clean room look like? How many devices will we need? How big will the cleanroom be? When do physicians need to validate prescriptions? When will preparations be delivered? How much will a preparation cost and how will these costs be accounted for?
Tip #1: Data, data, data
The preparation data is the starting point for evaluating cleanroomoperations . Collect the data from all participating hospitals and clean it up so that the data can be the starting point for analyses. Below we provide some guidelines:
- The vision of working in the cleanroom impacts the data: Will we prepare mabs separately? What is definition of a high-risk mab? What is definition of a sterile preparation? Collect each category separately: cytotoxicpreparations, high-risk mabs,non- high-risk mabs, sterile preparations, non-sterile preparations. Designate preparations with a specific chemical and/or biological character such as phages so that they can be easily retrieved .
- Consider the scope of the data: What data do you need? What will happen in the clean room and what won't? What about outsourced preparations?
- Standardize the data: Use substance names to easily derive the numbers of molecules across hospitals.
- Agree on preparations: In what way do we include samples? In what way do we handle studies? Which preparations should be split based on the method of administration (subcutaneous, IV, pump, etc.)? What batch sizes do we want to use for certain types of (stock) preparations?
- Think about which analyses should be done so that the data are complete from the start (minimum: campus level, preparation date, molecule description, dose, sample, study).
- Most hospitals are familiar with the principle of dose banding. Within a collaboration, there must be an agreement on applied dose banding methodology and effective preparation of doses: In which infusion? What is the stability (is it at room temperature or refrigerator), What doses are offered? In what diluent? Agree with the physicians on how this new way of working will be validated and evaluate at the software level how this can be prescribed efficiently and safely.
When the data areavailable in a workable format , they can be analyzed. We recommend starting with the analyses below :
- Stock analyses: "By linking the consumptions per dose band to stability data, it can be determined which preparations can be prepared in stock (batch) and what the optimal batch sizes are in this regard. Based on this, a hospital can determine a stock strategy (which preparations are prepared in stock, where are they stored, in which type of system, ...). Preparing in stock is more efficient than preparing the day before or the day itself, which benefits the cost price per preparation. Thanks to simulations (and general knowledge of pharmacists), it is also possible to evaluate the best way to produce: once a week, once a month,...
- Number of devices needed: After determining the inventory strategy and the way of working, the number of devices can be derived. The number of devices is the result of various strategic decisions (such as opening hours, growth rates, share of stock preparations, share of ad hoc preparations, ...) and determines the area required .
Tip 2: Models as a basis for decisions
Within a partnership it is essential to make clear and supported agreements. These agreements always result from strategic choices, in which the financial impact also plays an important role. Simulation models offer a valuable tool for this: they make it possible to evaluate different scenarios in an efficient and well-founded manner. One of the basic models used here is the calculation of the production cost per preparation.
This cost is influenced by various factors, such as the opening hours of the cleanroom, the deployment of FTEs, the number of devices, the area required, any construction costs and associated operating costs, and so on. For decision makers, these insights provide a crucial basis for defining the operational framework of the cleanroom.
Moreover, the cost per preparation also helps determine which types of preparations are best performed in the cleanroom, and which, if any, can be organized externally or in another way.
Tip 3: Hospital pharmacists are the experts, but working according to PIC/S standards is challenging
Cross-hospital collaboration between pharmacists is always valuable. Professional associations such as the VZA are strongly committed to sharing knowledge about the new PIC/S standards Due to the high workload in many hospital pharmacies, however, it is not evident to follow up on each topic individually. Make use of the power of cooperation: organize targeted and efficient consultation moments, divide the preparatory work, build a culture of trust in each other's expertise and determine who will delve into which topic. Make use of existing expertise, both as input for modeling and as a sounding board when evaluating results.
In addition, consider targeted working visits to pharmacies that already operate (partially) in compliance with PIC/S standards. Such visits not only provide valuable insights into the practical application of the guidelines, but also strengthen the network needed to develop one's own strategy within the context of a still partly unclear regulatory environment.
Collaboration across hospitals undoubtedly presents challenges, but at the same time offers significant advantages - especially in a context where the workload within most pharmacies is high. This does presuppose a clear and supported framework within which such cooperation takes shape.
