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

The Inpatient Pharmacy (PUI) is an essential component of the healthcare chain within healthcare facilities, some long-term care facilities, and even fire and rescue services. More than 2,500 PUIs are currently authorized in France, demonstrating their central role. They guarantee the quality and safety of the medication and sterile medical device supply chain, carrying out 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 are also major players in pharmacovigilance and materiovigilance, and actively promote the proper use of health products. The rapid evolution of medical practices and the requirements 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, modernizing 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 broadened and clarified the missions of the PUI (Pharmacy Units), notably by introducing new provisions concerning clinical pharmacy and facilitating inter-institutional cooperation for optimized 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.
• Verification of safety devices.
• Preparation (compounded, hospital-based) and reconstitution of medicines.
• Quality control of products.
• 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), enabling the pooling of resources.
• Cosmetic surgery facilities.
• A variety of medical and social care facilities and services, particularly those providing accommodation for elderly and disabled people, as well as specific structures such as "short-stay healthcare beds" and "medicalized accommodation beds".
• Social and medical-social cooperation groups.
• The
  • Sterile compounded preparations.
  • Compounded preparations containing substances hazardous to personnel and the environment.
  • Hospital preparations.
  • Reconstitution of pharmaceutical specialties.
  • 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), which includes the sterilization.
  In addition, a hospital pharmacy is also required to have authorization expressly mentioning the activities of preparing doses of medication for administration, importing investigational medicinal products, and importing preparations made in accordance with good practice standards and originating from the European Union.Hospital pharmacies that carry out these activities with particular risks were required to obtain a new authorization by December 31, 2022 at the latest (a date postponed by one year from the initial date). For those that do not carry out 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 medico-social establishments may be authorized only for the preparation of doses to be administered 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 unit is the cornerstone of its operation, and their functions are detailed in the regulations. Generally speaking, they are responsible for all the missions and activities of the pharmacy unit. This responsibility implies 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 per week. In long-term care facilities, this time spent on-site can be adjusted according to the needs of the residents, down to a minimum of two half-days per week. In the event of absence, the managing pharmacist must be replaced immediately. Exceptionally, 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 fulfill their required working hours and perform their duties daily in each one. 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 a managing pharmacist with pharmacy interns 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 given 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 adapted to the activities of the hospital pharmacy, including for 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 contributing 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 formulate pharmaceutical opinions for the medical team, and to promote patient understanding and adherence to treatment. This proactive approach aims to reduce iatrogenic events, strengthen prescription safety, and control healthcare costs. Decree No. 2019-489 of May 21, 2019, explicitly defines the clinical pharmacy actions that hospital pharmacies are now required to carry out: Clinical pharmaceutical expertise 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 presentation.
• Conducting medication reviews: a comprehensive evaluation of the patient's treatments to identify medication-related problems.
• Developing personalized pharmaceutical plans: these plans are designed in collaboration with the healthcare team, the patient, and, if necessary, their family, to best adapt the therapeutic strategy.
• Pharmaceutical consultations and other therapeutic education activities: the pharmacist informs and advises the patient on the correct use of their medications, their therapeutic goals, the biological monitoring to be performed, and the proper handling of administration devices.
• Developing the therapeutic strategy: aimed at ensuring the relevance and the efficiency 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 master national and international therapeutic strategies and implement local protocols to optimize the use of health products. Access to the patient's file and knowledge of their clinical, biological, and therapeutic data are essential for prescription analysis and treatment optimization. The clinical pharmacist must actively integrate 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, pharmaceutical 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 diagnosis, helps the patient acquire self-care skills, and manages their treatments and their 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 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, comprising several components:

• A priori risk management: This involves identifying and prioritizing potential risks related to the hospital pharmacy's activities (for example, preparation of cytotoxic drugs, management of narcotics, sterilization) before they materialize. Preventive actions are defined, staff are trained in risk analysis (using methods such as FMEA or PRA), and documents specifying immediate corrective actions are implemented.
• Adverse Event Management: An organization is in place for the reporting, recording, and analysis of adverse events. This approach, consistent with the institutional organization, involves root cause analysis, feedback to relevant stakeholders, and the implementation of corrective action plans to prevent recurrence. Computerization of reporting is being pursued to facilitate the process.
• Error Management Related to the Use of Health Products: The pharmacy team is integrated into a specific, often multidisciplinary, organization for analyzing these errors. Training and awareness-raising activities are carried out, and the collection and analysis of errors are ensured according to validated methodologies, such as REMED (Review of Errors related to Medications). The patient is also informed about error prevention.
• Integration into the health vigilance system: Pharmacy units actively participate in pharmacovigilance, materiovigilance, hemovigilance, etc. systems. They are organized to respond to health alerts (from the top down, from the competent authorities or manufacturers) and to report adverse events (from the 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 high media impact, to ensure the continuity of production and dispensing.

In parallel with the GdR (Global Drug Regulation), the evaluation of professional practices (EPP) is mandatory for pharmacists and pharmacy technicians in hospital pharmacies, 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 learned societies and best practices.

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

The hospital pharmacy plays a fundamental role in the logistics of health products, encompassing purchasing, supply, inventory management, and delivery to 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 aegis 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 carried out 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/exits, users, and the degree of urgency. The Pharmacy Unit ensures that the 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 health products are also key elements. Finally, ensuring the comprehensive delivery of health 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 control of numerous products, ensuring their conformity and safety. This field requires rigorous control of the environment and specific processes for each type of product.

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

• Water quality control: The design and maintenance of the treated water production network (softened, reverse osmosis, for hemodialysis) are essential. Physicochemical and microbiological requirements are defined, with maintenance, monitoring, and incident management programs to ensure continuity of 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, with 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/disinfection procedures and frequencies, as well as microbiological, chemical, and radioactive contamination controls, are defined and implemented.
• The waste management system: The management of specific waste (radiopharmaceuticals, chemotherapy) is organized in collaboration with the relevant departments within the institution, with identification of hazardous waste, definition of disposal routes, and monitoring programs.

Medication preparation covers a wide range, including compounded and hospital preparations, investigational drugs, radiopharmaceutical preparations, parenteral nutrition, and cytotoxic drugs. This process includes several key steps:

• The pharmaceutical analysis of a preparation: An essential prerequisite, triggered by the pharmaceutical validation of the prescription. It requires secure transmission of prescriptions and access to the patient file, as well as a thesaurus of preparations and an interface with prescribing software.
• The feasibility analysis of a preparation: After validation of the prescription, the pharmacist assesses the technical and scientific feasibility, identifying the necessary raw materials and medical devices, checking stock levels, and using tools to assist in physicochemical analysis. A procedure for recording "non-feasibility" cases is formalized.
• The preparation: This follows precise operating procedures for each type of preparation, including rules for dressing and protection, management of raw materials and medical devices (identification, release, control), and prevention of cross-contamination and errors. Traceability of products, personnel, and actions is ensured. The 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: Purchase of MDs, technical data sheets specifying processing methods, organization of the circuit for new products and loaned MDs.
• Ensuring customer ownership and preservation of MDs to be sterilized: Staff training, handling in accordance with technical data sheets, appropriate storage, and notification in case of loss or damage.
• Disposal of information regarding the risks of transmission of unconventional transmissible agents (UTAs): Risk detection, information transmission, and adaptation of the process stérilisation.
• La réception en stérilisation: Modalités de prise en charge des DM après utilisation (prédésinfection), définition des responsabilités, traçabilité des étapes et planification des flux.
• Le lavage et le séchage: Procédés (privilégiant les laveurs désinfecteurs), choix des détergents, cycles de lavage, accessoires et contrôles.
• La recomposition des plateaux opératoires et des sets de soins: Organisation, vérification des DM, contrôles de fonctionnalité, lubrification, calage et traçabilité, en collaboration avec les équipes chirurgicales.
• Le conditionnement: Organisation et traçabilité, choix des systèmes d'emballage (sachets, feuilles, conteneurs), techniques de scellage, vérification et maintenance des équipements.
• La stérilisation et la libération des DMS: Définition des procédés (vapeur, basse température), organisation, contrôles avant, pendant et après cycle, formation et habilitation du personnel, application des dates de péremption et traçabilité.
• Le stockage adapté pour les DMS: Organisation et gestion du stock et des conditions de stockage (en stérilisation et dans les unités de soins), gestion des produits périmés et équipements adaptés.

Enfin, les contrôles sont une fonction transversale essentielle:

• Contrôles des matières premières à usage pharmaceutique: Organisation des contrôles à réception, définition des méthodes de prélèvement et de contrôle, traçabilité et gestion des non-conformités.
• Contrôles physico-chimiques et microbiologiques des produits finis: Préparations magistrales et hospitalières, avec des plans de contrôle définis et des résultats validés par le pharmacien.
• Contrôles des eaux pour hémodialyse: Procédures de prélèvement et de contrôle conformes à la pharmacopée européenne, planification et validation des résultats.
• Contrôles des fluides médicaux: Le pharmacien est membre actif de la commission locale de surveillance des gaz (CLSG). Des programmes d'entretien, de surveillance et des méthodologies de prélèvement/analyse sont définis et appliqués, avec traçabilité des travaux et gestion des incidents.

Coopération, sous-traitance, enseignement et recherche : l'évolution des PUI

Les PUI, au-delà de leurs missions internes, sont appelées à jouer un rôle croissant dans des dynamiques de coopération inter-établissements, de sous-traitance d'activités, et de participation active à l'enseignement et à la recherche. Ces évolutions sont clés pour l'optimisation des ressources et l'amélioration continue des soins.

La coopération entre PUI est un enjeu majeur, permettant de mutualiser les activités pharmaceutiques et d'optimiser la prise en charge des patients dans un objectif d'efficience et de sécurité optimale. Une PUI peut assurer des missions et activités pour le compte d'autres PUI, de professionnels de santé ou de laboratoires de biologie médicale, à condition d'être elle-même autorisée à exercer ces missions pour son propre compte. Si une PUI n'est plus en mesure d'exercer certaines de ses missions, elle peut en confier la mise en œuvre à d'autres PUI, l'ARS devant en être informée de cette organisation et de sa durée prévisionnelle.

La sous-traitance est également une modalité d'organisation essentielle pour les PUI. Une PUI peut sous-traiter diverses activités à des personnes morales respectant les bonnes pratiques, notamment:

• La délivrance de gaz à usage médical pour les patients en hospitalisation à domicile (HAD) ou hébergés par un établissement médico-social.
• Les opérations de contrôle relatives aux préparations magistrales, hospitalières et officinales, à un laboratoire sous-traitant agréé, avec un contrat écrit et information de l'ARS.
• La réalisation de préparations (hospitalières, magistrales, radiopharmaceutiques) et la reconstitution de spécialités pharmaceutiques à un établissement pharmaceutique autorisé, également via un contrat écrit soumis à l'avis de l'ARS.Le Référentiel insiste sur la définition claire des rôles de donneur d'ordre et de sous-traitant, l'établissement d'un cahier des charges, de plans d'audits, d'analyses financières, de systèmes d'information sécurisés et l'obtention des autorisations nécessaires.

L'enseignement et la formation constituent une mission importante des PUI. Elles dispensent des enseignements et des formations professionnelles et appliquées aux internes, étudiants, préparateurs en pharmacie hospitalière (PPH) et stagiaires. Les PUI participent à l'élaboration et au suivi des objectifs de formation, organisent les activités hospitalières des apprenants et adaptent les méthodes pédagogiques aux objectifs définis.

La recherche scientifique est un axe de développement stratégique pour les PUI, notamment dans le cadre hospitalo-universitaire. Elles sont encouragées à structurer leurs activités de recherche autour de thématiques clairement identifiées, en lien avec des équipes scientifiques reconnues. La mise en place de méthodes de recherche validées est essentielle, avec des protocoles écrits, des plans expérimentaux définis et une évaluation a priori de la faisabilité des projets. Le respect des exigences éthiques et réglementaires est impératif, impliquant la déclaration des projets aux autorités compétentes (CPP, AFSSAPS), l'obtention des avis ou autorisations nécessaires, le consentement des patients et la conformité à la CNIL pour la gestion des bases de données. Enfin, les PUI soutiennent et organisent la valorisation de la recherche, par des communications, publications scientifiques, brevets et collaborations industrielles, contribuant ainsi à l'avancement des connaissances et à l'amélioration des pratiques. La gestion des essais cliniques, spécifiquement, implique une organisation dédiée au sein de la PUI pour maîtriser le circuit des produits de santé expérimentaux (PSE) et garantir la confidentialité des données.

En définitive, la Pharmacie à Usage Intérieur (PUI) est bien plus qu'un simple service d'approvisionnement. Elle est un acteur multifacette et évolutif de la santé, au carrefour de la logistique, de la clinique, de la qualité, de la gestion des risques, de la coopération et de l'innovation. La refonte réglementaire récente a renforcé son rôle essentiel dans la sécurisation du parcours patient et la promotion du bon usage des produits de santé, tout en lui offrant des outils pour s'adapter aux dynamiques de collaboration et d'excellence. L'engagement de ses pharmaciens et de leurs équipes est fondamental pour garantir des soins de haute qualité et en constante amélioration.

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