The Pharmacy for Internal Use (PUI): an essential pillar of healthcare safety in a healthcare facility
The Pharmacy for Internal Use (PUI) is an essential component of the care chain within healthcare facilities, certain medico-social establishments and even fire and rescue services. More than 2,500 PUI are currently authorized in France, testifying to their central role. They guarantee the quality and safety of the drug and sterile medical device circuit, ensuring various missions ranging from the management of health products to dispensing, including preparation and control. Beyond these logistical and technical functions, PUIs 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 hospitals has led to a profound overhaul of the regulatory framework governing the PUI. Initiated by the law of January 26, 2016, on the modernization of our healthcare system, this overhaul took concrete form in ordinance n°2016-1729 of December 15, 2016, and decree n°2019-489 of May 21, 2019. These texts have broadened and clarified the missions of the PUI, in particular by introducing new provisions concerning clinical pharmacy and by facilitating inter-hospital 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 bases 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 PUIs, the rules of practice for pharmacists, and above all, the missions and activities that they are authorized to carry out.
The core missions of the PUI are diverse and cover the entire health product circuit within the facilities where they are located. These include:
- Management of health products (medications, products, items under pharmaceutical monopoly, sterile medical devices).
- Supplying these products.
- The verification of safety devices.
- The preparation (compounded, hospital) and reconstitution of drugs.
- The quality control of products.
- The holding and evaluation of health products.
- The dispensing of sterile drugs and medical devices.
In addition to these traditional missions, the modernized regulatory framework has emphasized the development of clinical pharmacy, which includes actions aimed at improving the safety, relevance, and efficiency of the use of health products, in close collaboration with the care team and the patient. The PUI (pharmaceutical compounding units) are also required to actively contribute to pharmacovigilance (monitoring of adverse drug effects) and materiovigilance (monitoring of incidents related to medical devices).
The Hospital Pharmacy Reference Framework, developed by the French Society of Clinical Pharmacy (SFPC) in partnership with the High Authority for Health (HAS), provides a detailed framework for improving professional practices and their efficiency, focusing on the therapeutic management of the patient. This document, structured in seven chapters, addresses in depth the policy and management of PUIs, their operational management, quality and risk management, purchasing and logistics, clinical pharmacy, preparation and control, as well as teaching and research. It emphasizes the importance of integrating the rational use of health products and a health-economic approach in the strategic orientations of the PUI.
Authorized hospitals and specific activities of the PUI (pharmaceutical compounding unit)
The decree relating to the PUI (internal pharmacy use) specified the list of hospitals, structures or organizations authorized to have a PUI. This list is exhaustive and reflects the diversity of care and service contexts requiring internal pharmaceutical support. Among them are:
- Traditional healthcare facilities.
- Military hospitals and the National Institution for Disabled Veterans.
- Health cooperation groups (GCS), enabling the pooling of resources.
- Cosmetic surgery facilities.
- A variety ofmedico-social establishments and services, notably those providing accommodation for the elderly and disabled, as well as specific structures such as "beds halte soins santé" and "lits d'accueil médicalisés".
- Social and medico-social cooperation groups.
- The fire and rescue services, including the Marseille Naval Fire Battalion and the Paris Fire Brigade.
- The Central Pharmacy of the Armed Forces.
Certain activities carried out by the PUI are considered to involve particular risks and therefore require a specific authorization issued by the Regional Health Agency (ARS) for a period of seven years (initially five years, modified by ordinance No. 2020-1407). These activities include:
- The sterile compounded preparations.
- The compounded preparations containing hazardous substances for staff and the environment.
- The hospital preparations.
- Reconstitution of pharmaceutical specialties.
- The appropriate formulation of innovative therapy drugs prepared on an ad hoc basis.
- The preparation of radiopharmaceuticals.
- The preparation of investigational medicinal products.
- The preparation of sterile medical devices (MD), which includes sterilization.
In addition, a PUI is also required to have an authorization expressly mentioning the activities of preparation of doses of drugs to be administered, the import of experimental drugs, and the import of preparations made in accordance with good practice standards and from the European Union.
The PUIs that carry out these activities with particular risks had to obtain a new authorization no later than December 31, 2022 (date postponed by one year compared to the initial date). For those that do not carry out risky activities but were already authorized under the old regulations, a new authorization is required before December 31, 2024. The decree also introduces specificities, for example, the PUIs of medico-social establishments can only be authorized for the preparation of doses to be administered and magistral preparations, while aesthetic surgery facilities can also carry out the preparation of sterile MDs.
The key role of the managing pharmacist and the pharmacy team
The pharmacist in charge of managing the PUI (Pharmacy for Internal Use) is the cornerstone of its operation, the functions of which are detailed in the regulations. They are, in general, responsible for all missions and activities of the PUI. This responsibility implies hierarchical authority over the personnel assigned to the PUI, as well as the direction and supervision of the work of interns and pharmacy students.
The pharmacist manager's presence is also regulated: it cannot be less than the equivalent of five half-days per week. In medico-social establishments, this presence time can be adjusted according to the needs of the people accommodated, down to a minimum of two half-days per week. In case of absence, the pharmacist manager must be replaced. The same pharmacist can exceptionally manage several hospital pharmacies (PUI), up to two (or three if they are in medico-social establishments), provided that they can respect their presence time and perform their missions daily in each of them. The status of the pharmacist manager varies according to the type of establishment: they can perform the functions of head of department or head of an internal pharmacy structure in public hospitals, or be a salaried pharmacist bound by a management contract in private hospitals.
The PUI team is also subject to strict requirements in terms of qualifications and training. The conditions for replacing a pharmacist working in a PUI or a managing pharmacist by pharmacy interns are specified: the intern must have validated five semesters in each of the four mandatory areas of his training model. A certificate valid for one year, issued by the president of the 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 duration of four months per year, and one month per replacement, requiring the signature of an agreement with the hospital.
The Hospital Pharmacy Reference Framework highlights the need to ensure the recruitment of necessary personnel, with qualifications and skills adapted to the activities of the PUI, including for permanent pharmaceutical cover. The initial and continuing training of personnel is essential, integrating mandatory training and its renewal. Regular evaluation of acquired knowledge and skills is also planned. The PUI must be actively involved in the management of occupational risks for all its personnel, identifying at-risk positions, organizing medical surveillance, and analyzing incidents to propose preventive and corrective actions.
Clinical pharmacy: at the heart of the patient's therapeutic management
Clinical pharmacy is a rapidly expanding discipline, essential to the modernization of patient care. It is defined as any action by the pharmacist contributing to the security, relevance and efficiency of the use of health products, in close collaboration with the other members of the care team and involving the patient. The main objective is to optimize therapeutic choices, dispensing and administration of medicines, to formulate pharmaceutical opinions for the medical team, and to promote understanding and adherence to treatment by the patient. This proactive approach aims to reduce iatrogenic accidents, strengthen the safety of prescriptions and control the costs of care.
Decree No. 2019-489 of May 21, 2019 explicitly defines the clinical pharmacy actions that the PUI are now required to carry out:
- Clinical pharmaceutical expertise of prescriptions: it involves an in-depth analysis of prescriptions (drugs, products, sterile medical devices) to guarantee the therapeutic follow-up of patients. This includes verification of dosage, drug interactions, administration rates, physico-chemical incompatibilities, and adequacy with the commercial presentation.
- The performance of medication reviews: a comprehensive assessment of the patient's treatments to identify drug-related problems.
- Development of personalized pharmaceutical plans: these plans are designed in collaboration with the care team, the patient and, if necessary, his or her entourage, to best adapt the therapeutic strategy.
- Pharmaceutical interviews and other therapeutic education actions: the pharmacist informs and advises the patient on the correct use of their medications, their therapeutic objectives, the biological monitoring to be carried out, and the correct handling of administration devices.
- Development of the therapeutic strategy: aimed at ensuring the relevance and efficiency of prescriptions, as well as improving the administration of drugs.
The role of the clinical pharmacist is also detailed in the Hospital Pharmacy Reference Framework. 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 into medical and paramedical teams, participating in multidisciplinary consultation meetings (RCP), medical staff meetings, and service visits to propose the optimization of drug 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 manage their treatments and their side effects.
Quality and risk management: a priority for hospital pharmacies
Quality and risk management (QRM) is at the heart of the concerns of the PUI, and is part of a broader institutional approach to continuous improvement of the safety of care. The PUI are required to define a policy for improving the quality and safety of their pharmaceutical services, in line with the strategic orientations of the healthcare facility. This policy aims to promote a quality culture among PUI staff through awareness and training activities and the implementation of approaches to improving pharmaceutical practices (APP). Rigorous quality document management, consistent with that of the establishment, is also essential to formalize processes and ensure the traceability of information.
Risk management within the Pharmaceutical Unit is a continuous and systematic process, comprising several components:
- A priori risk management: This involves identifying and prioritizing the potential risks associated with the activities of the PUI (e.g., preparation of cytotoxic drugs, management of narcotics, sterilization) before they occur. Prevention actions are defined, staff are trained in risk analysis (using methods such as FMEA or PRA), and documents specifying immediate corrective actions are put in place.
- Management of adverse events: An organization is in place for the declaration, recording, and analysis of adverse events that have occurred. This approach, consistent with the institutional organization, involves an analysis of the causes, feedback to the actors concerned, and the implementation of corrective action plans to prevent their recurrence. The computerization of the declaration is sought to facilitate the process.
- Management of errors related to the use of health products: The pharmacy team is integrated into a specific organization for the analysis of these errors, often multidisciplinary. Training and awareness actions are carried out, and the collection and analysis of errors are ensured according to validated methodologies, such as REMED (Review of Medication-Related Errors). The patient is also informed about error prevention.
- Integration into the health vigilance organization: The hospital pharmacies actively participate in pharmacovigilance, materiovigilance, hemovigilance, etc. systems. They are organized to respond to health alerts (descending, from competent authorities or manufacturers) and to report adverse events (ascending), with specific procedures for product recall, quarantine, and destruction.
- Crisis management: The pharmacy team is integrated into the hospital's emergency plans (e.g., mass casualty plan, nuclear, radiological, biological, chemical risks – CBRN, flu epidemic). Staff are trained in the management of these situations, including those with high media impact, to ensure continuity of production and dispensing.
In parallel with the GdR, the evaluation of professional practices (EPP) is an obligation for pharmacists and pharmacy technicians in hospital pharmacies, integrated into the continuing professional development (CPD) system. The PUI promote EPP to improve the relevance of care and pharmaceutical practice indicators, based on the work of learned societies and best practices.
From purchase to dispensing: the logistics of health products in the hospital pharmacy
The PUI (Pharmacy for Internal Use) 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 health product purchasing policy is defined in consultation with the needs of patients and under the aegis of the Commission on Medicines and Sterile Medical Devices (CMDMS). It integrates a medico-economic and benefit/risk approach to optimize choices. The Reference Framework specifies that the analysis of needs is carried out by the CMDMS, and the purchasing actors must have specialized training (pharmaceutical, economic, legal). The product selection criteria are defined by a group of experts and include technical (unit packaging), economic and associated aspects (supplier services, logistical conditions, sustainable economy). Contracts are established with suppliers, and their follow-up is rigorous.
Supplying the PUI with health products requires precise mapping and forecasting. This involves keeping up-to-date references by product and by supplier, consulting consumption histories, and assessing future needs with users. Storage rules are defined taking into account the characteristics of the products (antidotes, health plans, cold chain), volumes, and usage rates. The organization and planning of supply are crucial, with the definition of requirements (delivery locations/times), supply and reception rules adapted to the specificity of the products (emergency, stock, out-of-stock, consignment stock, blood-derived drugs – MD, implantable medical devices – DMI). Stock safety thresholds are established, and specific procedures manage reception incidents.
The optimization of stock management is a major challenge. A stock management policy is defined within the PUI, with clear objectives (average stock, safety stock, replenishment method). The mapping of products takes into account the number of entries/exits, users, and the degree of urgency. The PUI ensures that the implementation zones (reception, mass storage, detailed storage, shipping) are clearly defined and that the management rules by nature and category of products are applied. Regular inventories are carried out to assess the stock level, analyze movements, and remove expired, deteriorated, or obsolete products. The management of emergency trolleys and the procedure for returning health products are also key elements.
Finally, ensuring the overall 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 in care units is organized by the PUI, with the definition and revision of allocations, supply rates, and stock management and storage protocols. Controlling the overall delivery circuit involves analyzing and validating requests before delivery, using delivery notes and suitable containers to guarantee the integrity and traceability of products, as well as setting up specific circuits for sensitive products (cold chain, emergencies).
Preparation and control of sterile drugs and medical devices
PUIs are centers of expertise for the preparation and control of many products, guaranteeing their conformity and safety. This field requires rigorous mastery of the environment and specific processes for each type of product.
Environmental control is fundamental, especially for the preparation of sterile medications 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 (CAZ), particulate (ISO cleanliness classes) and microbiological requirements are established. Air treatment systems (units, hoods, isolators) are subject to regular maintenance and monitoring programs, with checks for pressure, temperature, humidity, and biocontamination.
- Surface control: All types of surfaces (worktops, walls, floors, ceilings) in the Pharmaceutical Unit's activity sectors must meet defined characteristics. Cleaning/disinfection procedures and frequencies, as well as microbiological, chemical, or non-radioactive contamination controls, are defined and applied.
- The organization of the waste circuit: The management of specific waste (radiopharmacy, chemotherapy) is organized in collaboration with the competent structures of the hospital, with identification of hazardous waste, definition of disposal circuits, and monitoring programs.
The preparation of medicines covers a wide range, including compounded and hospital preparations, investigational medicinal products, 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 preparations thesaurus and interfacing with prescription 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, verifying stocks, and using tools to aid in physico-chemical analysis. A procedure for recording "non-feasibilities" is formalized.
- The execution of a preparation: It follows precise operating procedures for each type of preparation, including dressing and protection rules, management of raw materials and MDs (identification, release, control), and prevention of cross-contamination and errors. The traceability of products, actors and actions is ensured.
- The release and delivery of a preparation: The quarantine and release procedures (parametric or not, with release controls) are defined. The pharmacist proceeds with the release after checking the preparation sheet and compliance. Non-compliant preparations are recorded. Information on proper use and storage conditions is provided, and monitoring of expirations and returns is ensured.
The preparation of sterile medical devices (SMD) 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 MDs on loan.
- Ensuring client property and preserving medical devices to be sterilized: Staff training, handling in accordance with technical data sheets, appropriate storage, and information in the event of loss or damage.
- The provision of information relating to the risks of transmission of non-conventional transmissible agents (NCTA): Risk detection, information transmission, 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/
