The Inpatient Pharmacy (PUI): A Key Pillar of Patient Safety in Healthcare Facilities

The Inpatient Pharmacy (PUI) is an essential component of the healthcare system within healthcare facilities, certain long-term care facilities, and even fire and rescue services. More than 2,500 PUIs are currently authorized in France, underscoring their central role. They ensure the quality and safety of the medication and sterile medical device supply chain, performing a variety of tasks ranging from the management of health products to dispensing, including preparation and quality control. Beyond these logistical and technical functions, hospital pharmacies also play a major role in pharmacovigilance and materiovigilance, and actively promote the proper use of healthcare products. The rapid evolution of medical practices and the need for cooperation between institutions have led to a profound overhaul of the regulatory framework governing hospital pharmacies. Initiated by the law of January 26, 2016, which modernized our healthcare system, this overhaul was implemented by Ordinance No. 2016-1729 of December 15, 2016, and Decree No. 2019-489 of May 21, 2019. These texts expanded and clarified the missions of the PUI (Pharmacy Units), notably by introducing new provisions concerning clinical pharmacy and facilitating inter-institutional cooperation to optimize pharmaceutical care. The regulatory framework and fundamental missions of the PUI: The operation and organization of the PUI are governed by strict legislation, the foundations of which have been modernized to adapt to the current challenges of the healthcare system. Decree No. 2019-489 of May 21, 2019 is the key implementing text that redefines the conditions for the establishment and operation of hospital pharmacies, the rules of practice for pharmacists, and above all, the missions and activities they are authorized to perform. The fundamental missions of hospital pharmacies are multifaceted and cover the entire supply chain of healthcare products within the facilities where they are located. These include, in particular:

• Management of health products (medicines, products, items subject to the pharmaceutical monopoly, sterile medical devices).
• Supply of these products.
• Inspection of safety devices.
• Preparation (compounded, hospital-based) and reconstitution of medications.
• Product quality control.
• Holding and evaluation of health products.
• Dispensing of medicines and sterile medical devices.

• Traditional healthcare facilities.
• Military hospitals and the National Institution for Disabled Veterans.
• Healthcare cooperation groups (GCS), which facilitate the pooling of resources.
• Cosmetic surgery facilities.
• A variety of medical and social care facilities and services, particularly those providing housing for the elderly and people with disabilities, as well as specific types of facilities such as "short-stay healthcare beds" and "medicalized housing beds".
• Social and medical-social cooperation groups.
• The
  • Sterile compounded preparations.
  • Compounded preparations containing substances that are hazardous to personnel and the environment.
  • Hospital preparations.
  • Reconstitution of pharmaceutical preparations.
  • Appropriate formulation of advanced therapy medicinal products prepared on an ad hoc basis.
  • Preparation of radiopharmaceuticals.
  • Preparation of investigational medicinal products.
  • Preparation of sterile medical devices (MDs), including sterilization.
  In addition, a hospital pharmacy is also required to have authorization that specifically lists the activities of preparing doses of medication for administration, importing investigational medicinal products, and importing preparations manufactured in accordance with good manufacturing practices and originating in the European Union.Hospital pharmacies that engage in these high-risk activities were required to obtain a new authorization by December 31, 2022 no later than (a date postponed by one year from the original date). For those that do not engage in high-risk activities but were already authorized under the old regulations, a new authorization is required before December 31, 2024. The decree also introduces specific provisions; for example, hospital pharmacies in medical-social facilities may be authorized only to prepare doses for administration and compounded medications, while cosmetic surgery facilities may also prepare sterile medical devices. height="auto" loading="lazy">The Key Role of the Managing Pharmacist and the Team in the Pharmacy UnitThe pharmacist in charge of managing the pharmacy department is the cornerstone of its operations, and their functions are outlined in the regulations. Generally speaking, they are responsible for all the duties and activities of the pharmacy unit. This responsibility entails hierarchical authority over the staff assigned to the pharmacy unit, as well as the direction and supervision of the work of pharmacy interns and students. The managing pharmacist’s time spent on-site is also regulated: it cannot be less than the equivalent of five half-days a week. In long-term care facilities, the amount of time spent on-site can be adjusted to meet the residents' needs, down to a minimum of two half-days a week. In the event of absence, the managing pharmacist must be replaced immediately. In exceptional cases, a single pharmacist may manage several hospital pharmacies—up to two (or three if they are part of a healthcare or social care facility)—provided they can meet their required working hours and perform their duties daily at each location. The managing pharmacist’s status varies depending on the type of facility: in public institutions, they may serve as a department head or head of an internal pharmacy unit, while in private institutions, they may be a salaried pharmacist bound by a management contract. The hospital pharmacy team is also subject to strict qualification and training requirements. The conditions for replacing a pharmacist working in a hospital pharmacy or as a managing pharmacist with pharmacy interns The following requirements are specified: the intern must have completed five semesters in each of the four mandatory areas of their training program. A certificate valid for one year, issued by the president of the National Council of the Order of Pharmacists, must be provided to the hospital director and the managing pharmacist. The replacement of a managing pharmacist by an intern is limited to a maximum of four months per year, and to one month per replacement, requiring the signing of an agreement with the hospital. The Hospital Pharmacy Reference Framework highlights the need to ensure the recruitment of the necessary staff, with qualifications and skills tailored to the activities of the hospital pharmacy, including on-call pharmacy services. Initial and ongoing staff training is essential, including mandatory training and its renewal. Regular assessment of acquired skills and competencies is also planned. The Pharmacy Unit (PUI) must be actively involved in occupational risk management for all its staff, identifying high-risk positions, organizing medical monitoring, and analyzing incidents to propose preventive and corrective actions. Clinical pharmacy: at the heart of patient therapeutic care. Clinical pharmacy is a rapidly expanding discipline, essential to modernizing patient care. It is defined as any action by the pharmacist that contributes to the safety, appropriateness, and efficiency of the use of health products, in close collaboration with other members of the healthcare team and involving the patient. The main objective is to optimize therapeutic choices, medication dispensing and administration, to provide pharmaceutical advice to the medical team, and to promote patient understanding and adherence to treatment. This proactive approach aims to reduce iatrogenic events, enhance prescription safety, and control healthcare costs. Decree No. 2019-489 of May 21, 2019, explicitly defines the clinical pharmacy activities that hospital pharmacies are now required to perform: Clinical pharmaceutical review of prescriptions: this involves a thorough analysis of prescriptions (medications, products, sterile medical devices) to ensure therapeutic monitoring of patients. This includes verifying dosage, drug interactions, administration schedules, physicochemical incompatibilities, and suitability for the commercial form.
• Conducting medication reviews: a comprehensive assessment of a patient's treatments to identify medication-related issues.
• Developing personalized treatment plans: these plans are designed in collaboration with the healthcare team, the patient, and, if necessary, their family, to best tailor the treatment strategy.
• Pharmaceutical consultations and other therapeutic education activities: the pharmacist informs and advises the patient on the correct use of their medications, their treatment goals, the necessary clinical monitoring, and the proper use of administration devices.
• Developing the treatment strategy: aimed at ensuring the appropriateness and effectiveness of prescriptions, as well as improving medication administration.

The role of the clinical pharmacist is also detailed in the Hospital Pharmacy Reference Guide. They must be well-versed in national and international therapeutic strategies and implement local protocols to optimize the use of healthcare products. Access to the patient’s medical record and knowledge of their clinical, biological, and therapeutic data are essential for prescription analysis and treatment optimization. The clinical pharmacist must actively collaborate with medical and paramedical teams, participating in multidisciplinary team meetings (MTMs), medical staff meetings, and ward rounds to propose optimizations for medication therapies and sterile medical devices. Finally, the pharmacist’s involvement in patient therapeutic education (PTE) is recognized as an essential component of comprehensive care. The pharmacist, specifically trained in PTE, contributes to the educational assessment, helps the patient acquire self-care skills, and manages their treatments and side effects. Quality and Risk Management: A Priority for Hospital Pharmacy Units (HPUs) Quality and Risk Management (RRM) is central to the concerns of HPUs, as part of a broader institutional approach to the continuous improvement of patient safety. Pharmacy units are required to define a policy for improving the quality and safety of their pharmaceutical services, consistent with the strategic directions of the healthcare facility. This policy aims to promote a culture of quality among pharmacy unit staff through awareness and training initiatives and the implementation of pharmaceutical practice improvement processes. Rigorous quality document management, consistent with that of the institution, is also essential to formalize processes and ensure the traceability of information.

Risk management within the hospital pharmacy is a continuous and systematic process that consists of several components:

• Proactive risk management: This involves identifying and prioritizing potential risks associated with the hospital pharmacy’s activities (such as the preparation of cytotoxic drugs, the management of controlled substances, and sterilization) before they occur. Preventive measures are established, staff are trained in risk analysis (using methods such as FMEA or PRA), and procedures specifying immediate corrective actions are implemented.
• Adverse Event Management: A system is in place for the reporting, recording, and analysis of adverse events. This approach, consistent with the institutional structure, involves root cause analysis, feedback to relevant stakeholders, and the implementation of corrective action plans to prevent recurrence. Efforts are underway to computerize the reporting process to streamline it.
• Error Management Related to the Use of Health Products: The pharmacy team is part of a dedicated, often multidisciplinary, organization responsible for analyzing these errors. Training and awareness-raising activities are conducted, and the collection and analysis of errors are carried out using validated methodologies, such as REMED (Review of Errors related to Medications). Patients are also informed about error prevention.
• Integration into the health surveillance system: Pharmacy units actively participate in pharmacovigilance, medical device vigilance, and hemovigilance systems. They are organized to respond to health alerts (top-down, from the competent authorities or manufacturers) and to report adverse events (bottom-up), with specific procedures for product recalls, quarantine, and destruction.
• Crisis management: The pharmacy team is integrated into the institution’s emergency plans (e.g., hospital emergency plan, nuclear, radiological, biological, and chemical risks—CBRN, influenza epidemic). Staff are trained to manage these situations, including those with significant media attention, to ensure the continuity of production and dispensing.

In addition to the GdR (Global Drug Regulation), the evaluation of professional practices (EPP) is mandatory for pharmacists and pharmacy technicians in hospital pharmacies and is integrated into the continuing professional development (CPD) system. Hospital pharmacies promote EPP to improve the appropriateness of care and pharmaceutical practice indicators, drawing on the work of professional societies and best practices.

From purchasing to dispensing: the logistics of healthcare products in hospital pharmacies

The hospital pharmacy plays a fundamental role in the logistics of healthcare products, encompassing purchasing, supply, inventory management, and delivery to patient care units. This complex process is governed by principles of efficiency, safety, and regulatory compliance. The healthcare product procurement policy is defined in consultation with patient needs and under the auspices of the Commission for Medicines and Sterile Medical Devices (CMDMS). It incorporates a medico-economic and benefit-risk approach to optimize choices. The Reference Framework specifies that the needs analysis is conducted by the CMDMS, and procurement stakeholders must have specialized training (pharmaceutical, economic, legal). Product selection criteria are defined by a group of experts and include technical aspects (unit packaging), economic aspects, and related factors (supplier services, logistics conditions, sustainability). Contracts are established with suppliers, and their monitoring is rigorous. The supply of healthcare products to the Pharmacy Unit (PUI) requires precise mapping and forecasting. This involves maintaining up-to-date reference data for each product and supplier, reviewing consumption history, and assessing future needs with users. Storage rules are defined taking into account product characteristics (antidotes, hygiene protocols, cold chain), volumes, and usage patterns. Supply organization and planning are crucial, including defining requirements (delivery locations/times) and establishing supply and receiving rules adapted to the specific nature of the products (emergency, stock, out-of-stock, consignment, blood products, implantable medical devices). Stock safety thresholds are established, and specific procedures manage receiving incidents. Optimizing stock management is a major challenge. A stock management policy is defined within the Pharmacy Unit (PUI), with clear objectives (average stock, safety stock, replenishment method). Product mapping takes into account the number of entries and exits, users, and the degree of urgency. The Pharmacy Unit ensures that storage areas (receiving, bulk storage, retail storage, shipping) are clearly defined and that management rules by product type and category are applied. Regular inventories are conducted to assess stock levels, analyze movements, and remove expired, damaged, or obsolete products. The management of emergency carts and the procedure for returning healthcare products are also key elements. Finally, ensuring the comprehensive delivery of healthcare products to care units is an essential mission. This includes organizing requests from care units, assessing needs, planning requests, and implementing supply procedures for emergencies and exceptional requests. The management of health products within care units is organized by the Pharmacy Unit, including defining and reviewing allocations, supply schedules, and stock management and storage protocols. Mastering the entire delivery process involves analyzing and validating requests before delivery, using delivery slips and appropriate containers to guarantee product integrity and traceability, and implementing specific procedures for sensitive products (cold chain, emergencies).

Preparation and Control of Sterile Medicines and Medical Devices

Pharmacy Units (PUIs) are centers of expertise for the preparation and quality control of a wide range of products, ensuring their compliance and safety. This field requires strict environmental controls and specific processes tailored to each type of product.

Control of the environment is essential, particularly for the preparation of sterile medicines and medical devices. This includes:

• Water quality control: The design and maintenance of the treated water distribution system (softened water, reverse osmosis, and water for hemodialysis) are essential. Physicochemical and microbiological requirements are established, along with maintenance, monitoring, and incident management programs to ensure uninterrupted production.
• Air quality control: For controlled atmosphere zones (CAZs), particulate (ISO cleanliness classes) and microbiological requirements are established. Air handling systems (central units, fume hoods, isolators) are subject to regular maintenance and monitoring programs, including checks of pressure, temperature, humidity, and biocontamination. Surface control: All types of surfaces (worktops, walls, floors, ceilings) in the PUI’s areas of activity must meet defined characteristics. Cleaning and disinfection procedures and frequencies, as well as controls for microbiological, chemical, and radioactive contamination, are defined and implemented.
• The waste management system: The management of specific types of waste (radiopharmaceuticals, chemotherapy) is organized in collaboration with the relevant departments within the institution, including the identification of hazardous waste, the determination of disposal methods, and monitoring programs.

Medication preparation encompasses a wide range of products, including compounded and hospital-prepared medications, investigational drugs, radiopharmaceuticals, parenteral nutrition, and cytotoxic drugs. This process involves several key steps:

• The pharmaceutical analysis of a medication: An essential prerequisite, driven by the pharmaceutical validation of the prescription. It requires secure transmission of prescriptions and access to the patient record, as well as a medication database and an interface with prescribing software.
• Feasibility analysis of a compounding: After validating the prescription, the pharmacist assesses the technical and scientific feasibility of the compounding, identifies the necessary raw materials and medical devices, checks inventory levels, and uses tools to assist with physicochemical analysis. A procedure for documenting cases deemed "non-feasible" is established.
• Preparation: This process follows precise operating procedures for each type of preparation, including guidelines for personal protective equipment, management of raw materials and medical devices (identification, release, and control), and prevention of cross-contamination and errors. Traceability of products, personnel, and actions is ensured. Release and dispensing of a preparation: Quarantine and release procedures (parametric or non-parametric, with release controls) are defined. The pharmacist releases the preparation after verifying its conformity with the preparation record. Non-conforming preparations are recorded. Information on proper use and storage conditions is provided, and expiration dates and returns are monitored.

The preparation of sterile medical devices (SMDs) is a critical process that includes:

• Control of input elements: Procurement of master data, technical data sheets specifying processing methods, and organization of the workflow for new products and borrowed master data.
• Ensuring that customers take responsibility for and properly store medical devices to be sterilized: staff training, handling in accordance with technical data sheets, proper storage, and notification in the event of loss or damage.
• Disposal of information regarding the risks of transmission of unconventional transmissible agents (UTAs): Risk detection, information sharing, and adaptation of the sterilization process.
• Reception in sterilization: Procedures for handling MDs after use (pre-disinfection), definition of responsibilities, traceability of steps and flow planning.
• Washing and drying: Procedures (giving preference to washer-disinfectors), choice of detergents, washing cycles, accessories, and controls.
• Reconfiguration of operating room setups and surgical sets: Organization, verification of medical devices, functionality checks, lubrication, calibration, and traceability, in collaboration with surgical teams.
• Conditioning: Organization and traceability, choice of packaging systems (bags, sheets, containers), sealing techniques, verification and maintenance of equipment.
• Sterilization and release of medical devices: Definition of processes (steam, low temperature), organization, controls before, during and after the cycle, training and qualification of personnel, application of expiry dates and traceability.
• Appropriate storage for medical devices: Organization and management of stock and storage conditions (in sterilization and in care units), management of expired products and adapted equipment.

Finally, controls are an essential cross-functional function:

• Controls of raw materials for pharmaceutical use: Organization of controls upon receipt, definition of sampling and control methods, traceability, and non-compliance management.
• Physico-chemical and microbiological controls of finished products: Compounded and hospital preparations, with defined control plans and results validated by the pharmacist.
• Water controls for hemodialysis: Sampling and control procedures compliant with the European Pharmacopoeia, planning and validation of results.
• Medical fluid controls: The pharmacist is an active member of the local gas monitoring committee (CLSG). Maintenance, monitoring programs, and sampling/analysis methodologies are defined and applied, with traceability of work and incident management.

Cooperation, subcontracting, teaching and research: the evolution of the PUI

PUIs, beyond their internal missions, are called upon to play an increasing role in dynamics of inter-hospital cooperation, outsourcing of activities, and active participation in teaching and research. These evolutions are key to optimizing resources and continuously improving care.

Cooperation between hospital pharmacies is a major issue, allowing for the pooling of pharmaceutical activities and optimizing patient care with the goal of optimal efficiency and safety. A hospital pharmacy can perform missions and activities on behalf of other hospital pharmacies, healthcare professionals, or medical biology laboratories, provided that it is itself authorized to perform these missions on its own behalf. If a hospital pharmacy is no longer able to perform some of its missions, it may entrust the implementation to other hospital pharmacies, with the Regional Health Agency (ARS) being informed of this organization and its planned duration.

Subcontracting is also an essential organizational modality for hospital pharmacies. A hospital pharmacy may subcontract various activities to legal entities that comply with good practices, including:

• The delivery of medical gases for patients in home hospitalization or housed in a medical-social hospital.
• The control operations relating to magistral, hospital and pharmacy preparations, to an approved subcontracting laboratory, with a written contract and information from the ARS.
• The performance of preparations (hospital, compounded, radiopharmaceutical) and the reconstitution of pharmaceutical specialties to an authorized pharmaceutical establishment, also via a written contract subject to the opinion of the Regional Health Agency (ARS). The Reference Framework insists on the clear definition of the roles of principal and subcontractor, the establishment of specifications, audit plans, financial analyses, secure information systems and the obtaining of the necessary authorizations.

Teaching and training are an important mission of the PUI. They provide professional and applied teaching and training to interns, students, hospital pharmacy technicians (PPH) and trainees. The PUI participate in the development and monitoring of training objectives, organize the hospital activities of learners and adapt teaching methods to the defined objectives.

Scientific research is a strategic development focus for hospital pharmacies (PUI), particularly within the hospital-university framework. They are encouraged to structure their research activities around clearly identified themes, in conjunction with recognized scientific teams. The implementation of validated research methods is essential, with written protocols, defined experimental plans, and an a priori assessment of project feasibility. Compliance with ethical and regulatory requirements is imperative, involving the declaration of projects to the competent authorities (CPP, AFSSAPS), obtaining the necessary opinions or authorizations, patient consent, and compliance with the CNIL for database management. Finally, hospital pharmacies support and organize the valorization of research, through communications, scientific publications, patents, and industrial collaborations, thereby contributing to the advancement of knowledge and the improvement of practices. The management of clinical trials, specifically, involves a dedicated organization within the hospital pharmacy to control the circuit of experimental health products (PSE) and ensure data confidentiality.

Ultimately, the Pharmacy for Internal Use (PUI) is more than just a supply service. It is a multifaceted and evolving healthcare entity at the crossroads of logistics, clinical practice, quality, risk management, cooperation, and innovation. Recent regulatory reforms have reinforced its essential role in securing the patient pathway and promoting the appropriate use of health products, while providing it with tools to adapt to collaborative and excellence-driven dynamics. The commitment of its pharmacists and their teams is fundamental to ensuring high-quality and continuously improving care.

Sources

https://www.omedit-paysdelaloire.fr/contrats-et-financement/obligations-reglementaires/

https://sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/pharmacie-a-usage-interieur-pui/article/pharmacie-a-usage-interieur-pui

https://sfpc.eu/wp-content/uploads/2020/10/Re%CC%81fe%CC%81rentiel-de-Pharmacie-Hospitalie%CC%80re.pdf