the specialist in Hospital Pharmacy must have gained theoretical, scientific and professional knowledge in the field of clinical pharmacy, pharmacotherapy and the use of health technologies, pharmacoeconomics as well as health legislation, with particular reference to the pharmaceutical sector, useful for the performance of the profession within the hospital and territorial pharmaceutical structures of the National Health Service. Specific areas of competence include the management of drugs and medical devices, the production of drugs, including experimental drugs, information and documentation on medicines, supervision of health products, supervision of pharmaceutical operations.
Integrated training objectives (i.e. common core): the student must acquire satisfactory theoretical knowledge and professional competence in the disciplines that contribute to the definition of the Pharmaceutical Area class with particular regard to those included in the SSD Pharmaceutical Chemistry, Applied Technological Pharmaceuticals, Pharmacology, Food Chemistry, Biochemistry, Clinical Pathology and Microbiology and Clinical Microbiology. He must know the aspects of professional responsibility related to the role of pharmacist, the inspiring principles of pharmaceutical legislation and the professional duties connected to it; In addition, they must acquire knowledge regarding the organization of services, the principles underlying the management of pharmaceutical services and the planning of specific interventions related to health. The resident must acquire the knowledge necessary to organize and manage his or her activity as a pharmacist in relation to the characteristics of the structures and the territory in which he or she is required to operate;
Basic educational objectives: the acquisition of knowledge in the biological and medical disciplines related to the human organism, both in normal and pathological conditions that allow the complete evaluation of pharmacotherapy in general, with particular reference to the effectiveness and appropriateness of therapeutic interventions, and the performance of Pharmacovigilance activities, with particular reference to pharmaco-toxicokinetics, to the evaluation of the risk/benefit of the pharmacological treatments, 152 to the interactions between biomolecules and drugs; the acquisition of knowledge of both statistical and statistical-epidemiological methodologies and their application aspects with particular regard to the area of pharmacoepidemiology; the acquisition of specific knowledge in the technological disciplines of medicines, with particular reference to the galenic production of medicines, their control and related plant engineering, according to the principles of good preparation and manufacturing standards; the acquisition of knowledge and in-depth study of the problems inherent in clinical galenics, in particular with regard to the formulation of medicines and the techniques for setting up injectable therapies in personalized unit doses, including radiopharmaceuticals, according to the principles of the rules of good dispensing; the acquisition of knowledge relating to the preparation, manufacture, storage and use of health products (medical, diagnostic and dietary devices); the acquisition of knowledge necessary for the management of medical gases. The educational objectives of the type of School are: the acquisition of specific skills aimed at the research, identification and archiving of biomedical information, clinically relevant, through the use of databases in order to apply the methodologies of EvidenceBased Medicine, Evidence-Based Health Care and Health Technology Assessment (HTA) in the specific field of competence (definition and updating of therapeutic handbooks, participation in the preparation of guidelines and diagnostic and therapeutic pathways in particular areas of therapy, verification of the efficacy, safety, costs of technologies, such as medicines, medical devices and diagnostic material used for health care); the acquisition of knowledge in the field of Clinical Trials, with particular regard to regulatory aspects and evaluation of experimental protocols; the acquisition of knowledge in the field of Clinical Governance: the acquisition of in-depth and integrated knowledge, which allows to obtain, from the structure of the active ingredient and its formulation, specific information to be used in the rational and molecular interpretation of pharmacokinetic and pharmacodynamic processes, both on a pharmacological and toxicological level. This is in order to use, in an appropriate way, the methodologies oriented: to Information and Documentation on drugs and health technologies in general; health education and knowledge of the therapeutic uses of medicines; variability of response in relation to genetic and pathophysiological factors; drug interactions and criteria for defining therapeutic plans. knowledge of the analytical methods applicable to active ingredients and medicines; the acquisition of specific knowledge on nutrition that allows to inform, document and monitor dietary products; the acquisition of knowledge that allows the evaluation of possible interference of drugs on chemical-clinical analyses; knowledge of quality system management, analytical and microbiological quality control techniques and their application to raw materials, packaging and finished products prepared in hospital pharmacies; knowledge of the fundamentals and use of data processing systems and the acquisition of skills, aimed at setting up data collection and analysis processes, through which to achieve the realization of studies of Pharmacoutilization, Pharmacoepidemiology, Pharmacovigilance and Pharmacoeconomics, aimed at monitoring prescription and managing pharmaceutical expenditure; the acquisition of knowledge in the field of artificial nutrition aimed at the evaluation/preparation of personalized therapies of Parenteral and Enteral Nutrition; the acquisition of specific knowledge in the field of oncological therapies and support aimed at the development of oncology pharmacy; the acquisition of specific knowledge in the field of pain therapy; knowledge regarding the national and EU regulations governing the various activities of the pharmaceutical sector. These are similar or supplementary objectives: the specialist in the pharmaceutical area must also: - know the fundamentals in the field of health management, with particular regard to the management of resources; - know the legislative rules governing the health organization, with particular focus on the rules governing pharmaceutical activity; - acquire computer skills, useful for the management of information systems of pharmaceutical services; - know the English language at a level that allows the understanding of international literature and updating. These are compulsory professionalizing activities: the training of the resident must include guided and assisted participation in all the activities that take place at the Hospital and Territorial Pharmaceutical Facilities of the NHS. The following are compulsory professional activities for the achievement of the educational purposes of the Hospital Pharmacy typology: Scientific information and documentation Querying databases and other information sources, finding bibliographic entries, interpreting data from clinical works, systematic reviews, meta-analyses, for at least 100 hours. Passive information activities: 100 hours with the processing of at least 50 answers to specific questions; Active information activities: participation in the development of at least 2 projects with the production of texts aimed at health professionals or patients/citizens; Pharmacovigilance and vigilance of medical devices Participation in the collection, analysis and monitoring of reports of adverse drug reactions, accidents/near misses resulting from the use of medical devices for a total of 200 hours. Management of information flows related to the pharmacovigilance system, such as the spontaneous reporting of ADRs, the national registration system, the main information sites, the national and local alert system: 100 hours. Production of at least 2 informative feed-back reports for doctors and health professionals; Participation in the development of at least one active pharmacovigilance project. Participation in 10 inspections of the pharmaceutical cabinets of the ward. The following are compulsory professional activities in the Hospital Pharmacy: a. Management of drugs and medical devices: - Participation in procurement activities and the preparation of technical specifications for the acquisition of medical materials and in the subsequent phases of product evaluation as part of the purchasing procedures, for a total of at least 80 hours. - Participation in the management activities of the Therapeutic Handbook and the Repertoire of Medical Devices and application of HTA (Health Technology Assessment) principles including the evaluations of at least 10 requests for the inclusion of new drugs and 5 medical devices, for a total of at least 350 hours. - Participation in clinical risk management and prevention of errors in therapy for a total of at least 50 hours. - Counseling activities for the patient during the dispensing of drugs for a total of at least 50 hours. - Participation in at least 6 meetings of the Local Therapeutic Commission and the Medical Device Commissions. - Evaluation of requests for products being distributed, with particular reference to personalized drug prescriptions and management during the distribution phase of personalized requests/prescriptions and narcotic and psychotropic drugs for a total of at least 200 hours. - Participation in the analysis of pharmaceutical prescription activities in the hospital setting with the preparation of at least 3 reports of pharmacouse and/or evaluation of the clinical use of high-tech medical devices. - Monitoring activities aimed at management control for cost centers for a total of at least n. 200 hours and processing of at least 3 reports. - Participation in programming and planning activities, related to the process of defining the company budget, for at least n. 100 hours. b. Clinical Trials: - Participation in the Scientific Secretariat activities of the Ethics Committees. - Evaluation of at least 50 trial protocols, including the methodological evaluation of the study, the evaluation of the documentation necessary for evaluation by the ethics committees, the methods of data entry in the observatory of the Ministry of Health. The protocols must include the following types: drug trials, trials with medical devices and other technologies, epidemiological-observational studies; management of experimental samples (receipt, accounting, monitor visits, return, etc.) for at least 10 trials; - Have assisted in the management of the randomization/preparation of the investigational drug or have made visits to the ward, to verify compliance with Good Clinical Practices, by the investigators for at least one trial; - Have produced at least one example of an ethics committee's activity report, relating to the main indicators of the studies. c. Preparation of medicines in pharmacies according to F.U.: - Planning and production of non-sterile magistral and officinal preparations, including the evaluation of the medical prescription, the technical formulation (feasibility study, choice of materials and preparation methods) and the quality controls to be carried out for at least 100 preparations/batches. - Production of compulsorily sterile magistral preparations, nutritional, antiblastic and supportive therapies, experimental medicines and radiopharmaceuticals, including the evaluation and interpretation of prescription data, the evaluation of the technical feasibility of the preparation, the elaboration of the formulation, the knowledge of the preparation techniques also through the use of automated systems and other dedicated equipment, the verification operations on the finished product provided for by the FU., for at least 350 preparations. - Compilation and archiving of traceability and documentation relating to the activities of the production processes of medical products concerning environments, equipment, raw materials and magistral and officinal preparations, for at least 50 preparations/batches. - Evaluation, planning and, in some cases, execution of checks on environments, equipment and any critical points of the preparation operations, in compliance with the provisions of the FU., for at least n. 20 batches of officinal plants. - Participation in the monitoring activity of patients treated with personalized therapies, including the collection, entry and processing of data, through specific IT procedures, for at least 50 patients/cases and processing of at least 3 analysis reports of the patients treated. - Participation in at least 2 meetings of multidisciplinary commissions and/or working groups such as the Nutritional and Oncology Teams, the Pain-Free Hospital Project, etc., from which consultancy, guidance and verification activities are carried out in specific areas. - Participation in the drafting, review and application of procedures and operating protocols relating to the different phases of the production processes, in accordance with the NBP and the Quality System, for at least n. 2 operating procedures/instructions). These are compulsory professionalizing activities in the field of territorial Pharmaceuticals - Participation in inspection surveillance interventions, relating to the service provided by pharmacies and the trade of medicines, with particular reference to ordinary and extraordinary inspections, trade in veterinary medicines, wholesale distribution of medicines, for at least 10 inspections. - Participation in activities related to the technical controls carried out on the services rendered by pharmacies open to the public, under the conventional NHS regime, with reference to pharmaceutical, prosthetic/supplementary assistance and the tasks assigned to the arbitration commissions provided for by the National Agreement, for at least 100 hours. - Participation in activities related to the provision to users of the NHS of medicines and other health material relating to the areas of continuity of care, ADI, supplementary prosthetic assistance. Monitoring of prescriptions and appropriateness checks, for at least 300 hours. - Participation and/or analysis of the paths concerning the preliminary procedures of the Administrative Acts on the subject of pharmacies and wholesale distribution of medicines, taken by the competent bodies (A.USL, Mayor, Region, Province), for at least n. 50 hours. - Monitoring of prescription data through the querying of databases. Targeted analyses, aimed at verifying the appropriateness of prescribing behaviors in general medicine. Analysis of reports, for at least 300 hours. - Analysis of some examples of the construction and monitoring of objective projects for the improvement of prescription appropriateness and the rationalization of pharmaceutical expenditure in general medicine, for at least n. 200 hours. Finally, the following are compulsory professional activities: - Participation in refresher courses, seminars, demonstrations, conferences and congresses with topics directly relevant to or in any case to complete the training course, accredited by the Ministry of Health for Continuing Medical Education; - Participation in at least one multicenter study, in particular in the field of pharmacoepidemiology and pharmacoeconomics. The student will be able to compete for the diploma after completing the professionalizing activities. As part of the training course, the student will have to learn the scientific bases of the type of School in order to achieve full maturity and professional competence that includes an adequate ability to interpret scientific innovations and critical knowledge that allows him to consciously manage both assistance and his own updating; In this context, participation in meetings, congresses and the production of scientific publications and periods of attendance in qualified Italian and foreign institutions useful for his/her training may be envisaged.
Specialists in the specialization courses of the Pharmaceuticals class, type HOSPITAL PHARMACY, must acquire a total of 240 ECTS.
Therefore, taking into account the specificity of access and the peculiarity of the professional profile to be carried out, the specialization in Hospital Pharmacy, within the pharmaceutical class, is divided into 4 years of course for 240 CFU, of which at least 168 CFU are reserved for professionalizing activities aimed at the maturation of specific professional skills in the context of practical elective activities and internship in Hospital Pharmacy and Territorial Pharmacy. The remaining training activities are divided into basic activities, characterizing activities, related or supplementary activities, elective activities chosen by the student and activities aimed at the final exam. In turn, the activities are divided into homogeneous areas of knowledge characterised by their respective scientific disciplinary sectors. In any case, 70% of the credits present in the characterizing activities are reserved for the specific area corresponding to the professional figure, to which the specialization course is aimed. The teaching regulations of the individual schools determine the fraction of the total time commitment reserved for individual study and/or other individual training activities that must in any case be carried out in the structures of the School, normally reserving 30% for these activities according to the specific objectives of the training. This percentage will vary according to the gradual acquisition of autonomy by the student and will be modulated according to the performance of training activities with a high practical content.
The Postgraduate School of Hospital Pharmacy reserves a number of 15 credits for basic activities.
A number of 195 ECTS are reserved for characterising activities, 15 ECTS for similar or supplementary multidisciplinary activities, and no less than 5 ECTS for other activities.
10 ECTS are reserved for the preparation of the final examination.
The class of PHARMACEUTICALS includes the following type:
- Hospital Pharmacy (access for specialist graduates in Pharmacy and Industrial Pharmacy (Class 14/S), for master's degree graduates in Pharmacy and Industrial Pharmacy (Class LM-13), and for graduates of the old system in Pharmacy and in Pharmaceutical Chemistry and Technology).