Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Faculty of Pharmacy, University of Porto
Masters in Pharmaceutical Sciences
Professional Training Report
Azienda Ospedaliera Universitaria di Sassari (Italy)
January 2019 – April 2019
Diana Sofia Pinheiro Chagas Laranjeira
Co-Tutors: Dr.Antonio Solinas and Dr.Paolo Marchi
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Declaration of Integrity
I, Diana Sofia Pinheiro Chagas Laranjeira, the undersigned, no. 201402955, student of the Master in Pharmaceutical Sciences, of the Faculty of Pharmacy, University of Porto, declare that I have acted with absolute integrity in the elaboration of this document. In this sense, I confirm that I did NOT incurred in plagiarism (act by which an individual, even by default, assumes the authorship of a certain intellectual work or parts of it). I also declare that all the sentences picked out of previous works belonging to other authors were reported or written with new words, and in this case placed citation of the source literature.
Faculty of Pharmacy, University of Porto,6 September 2019
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Abstract
Hospital pharmacists are the specialists of medicines yet, they are not just the ones who give medicines, as the time passes by, pharmacists have an increasingly important role in the health care system which I could observe during my internship that took place in the Ospedale Santissima Anunziata in Sassari, Sardinia, Italy, from January to April of 2019 which makes part of L’Azienda Ospedaliero Universitaria di Sassari.
The hospital pharmacy is divided in three major areas: the logistic area, commonly called MAGA1; the galenic laboratory and the pharmacy for patients in discharge commonly called MAGA6. In these departments everyone has their role so pharmacists, nurses, technicians and the administrative staff work together, following a policy of saving and rationazing resources, to make sure that the medicines are efficiently and safely delivered to the hospital units and patients.
The logistic area is responsible for delivering the medicines, nutrition supplements and medical devices to all the departments of the hospital. I spent one month in MAGA1 where I had analyzed, prepared and delivered the requests made by the hospital sectors. In this department the pharmacist has the responsibility to check the computerized request and must guarantee that the medicines given are the right ones as well as try to overcome any obstacles in the distribution of medicines to the different departments.
The galenic laboratory subdivides in the laboratory of the non-sterile preparations, the laboratory for the preparation of parenteral nutrition and the laboratory for the preparation of cytotoxic drugs. I spent one month in the non-sterile preparations laboratory where I was able to prepare some medicines.
My last month was held on the pharmacy for patients in discharge where the medicines and medical devices are delivered directly to the patients. In this department I could assist the pharmacists in the dispensation of drugs and observe the counseling role of the pharmacist in giving the assistance needed to the patients.
During this tree months I had the opportunity of working in these three departments and learn more about the work of pharmacists in the different fields of work inside the hospital.
With this experience I was able to see the importance of pharmacists as a health professional and drug specialist and acquire not only scientific knowledge but also life experience and another point of view of the pharmacist’s role in the healthcare of the patients.
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Index
Declaration of Integrity ... iii Abstract... iv List of Abbreviations ... vi Index of appendices ... vii 1. Introduction ... 1 2. Logistic area: Maggazzino 1 ... 8 3. Galenic Pharmacy ... 12
3.1 Non-Sterile Laboratory ... 12
4. Farmacia per Pazienti in Dimissione: Magazzino 6 ... 13 Conclusion ... 20 References ... 21 Appendices ... 24
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
List of Abbreviations
ADR- Adverse drug reaction
AIC – Autorizzazione all’Immissione in Commercio
AIFA – Agenzia Italiana del Farmaco
AOs -Aziende Ospedaliere
AOU – Azienda Ospedaliera Universitaria ASL – Azienda Sanitaria Locale
ATC – Anatomical Therapeutic Chemical Code
CHMP- Committee for Medical Products for Human Use CND- National Classification of medical Devices
CTA- Commissione terapeutica aziendale CTF- Chimica e tecnologia farmaceutiche
CTS- Commissione consultiva Tecnico Scientifica dell’AIFA
EMA – European Medicines Agency FUI XIII- Farmacopea Ufficiale Italiana XIII GMDN- Global Medical Device Nomenclature IIZZSS- Istituti Zooprofilattici Sperimentali ISS-Istituto Superiore di Sanità
LEAs- Livelli essenziali di assistenza
MAGA1 – Magazzino 1
MAGA6 – Magazzino 6
NPT- Nutrizione Parenterale Totale
PRAC- Pharmacovigilance Risk Assessment Committee PTR – Prontuario Terapeutico Regionale
ROD- Raggruppamento homogéneo di diagnose
SISaR- Sistema Informativo Sanitario Integrato Regionale project SSN – Servizio Sanitario Nazionale
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
Index of appendices
Appendix 1: Timetable ... 24 Appendix 2: Magazzino 1 ... 26 Appendix 3: Example of AREAS requisition ... 26 Appendix 4: AREAS software ... 28 Appendix 5: Software AREAS, movements in MAGA1 ... 28 Appendix 6:Special requisition for Albumin ... 29 Appendix 7: Ricetta Ministeriale a Ricaldo ... 30 Appendix 8: Stupefacenti e Sostanze Psicotrope Registro di Entrata e Uscita ... 31 Appendix 9: Example of a request and a preparation that is made in the non-sterile Galenic lab ... 33 Appendix 10: Example of Foglio di Lavorazione ... 33 Appendix 11: Example of a “ricetta rossa”, used to acquire medicines in the community pharmacy ... 34 Appendix 12:Example of a ricietta bianca repeatable ... 34 Appendix 13: Example of a ricietta bianca non-repeatable ... 35 Appendix 14: Registration in AIFA ... 37 Appendix 15: Example of a request that demands AIFA registration ... 37 Appendix 16: Registration in AREAS ... 39 Appendix 17: Example of a Tessera Sanitaria ... 40
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
1. Introduction
Italy’s health care system: Servizio Sanitario Nazionale (SSN) is a regionally based national health service that provides universal coverage free of charge when providing the service. In Sardinia about 99% of the hospitals are public while in the rest of Italy 90% are public, so it’s a strong health care system in which only in the north of Italy we can find private hospitals since the north region is richer than the rest of the country.
The National Health Service (SSN), established by the law nº 833 of 1978, provides health care to all citizens without discrepancy between genders, age. residence, income or work and is based on some basic principles such as the public responsibility on protection of health; universality and fairness in the access to health services; globality of coverage, according to the care needs of each person, as provided by the essential levels of assistance and equality of rights throughout the national territory. [1]
Under the Italian Constitution, the management of the health system is mainly exercised by the State and the 20 regions. according to the distribution of competences established by the constitutional charter and by the legislation on the matter, subsequently, there’s a complex distribution of health-care skills. On one hand, state legislation must guarantee the essential levels or benefits relating to civil and social rights throughout the national territory so has the power of setting the essential levels of care: livelli
essenziali di assistenza (LEAs). It’s a free public service to everyone including strangers, for this reason
is called Universalist health care system. According to article 32 of the Italian constitution, health is considered a fundamental right of all the citizens and it’s in the best interest of the community. On the other hand, health protection is part of the competency entrusted to the Regions. Therefore, Regions can legislate on the subject in accordance with the fundamental principles establish by the State having exclusive jurisdiction in the regulation and organization of services and activities that aim the protection of health as well as the criteria for the sponsoring of local health and hospital companies. [1,2]
Based on the constitutional "principle of subsidiarity", the health service is articulated according to different levels of responsibility and government: macrolevel or national level that is managed by the State who has the responsibility of ensuring that all citizens have the right to health through the essential levels of assistance; the microlevel or regional level where the regions have a direct responsibility of implement measures approved by the state and manage the expenditure in order to achieve the Country's health goals. Finally, the local level that is composed by hospitals and other organizations such as the territory department and ASLs.
The National Health Service is composed of many institutions in the different levels such as Il Ministero
della Salute which is the nation organ; institutios and organs of national level: Il istituto Superiore di Sanità (ISS) and Il istituti Zooprofilattici Sperimentali (IIZZSS); authorities and territorial organisms: Regioni e Province autonome and la Aziende Sanitarie Locali., which contribute to the achievement of
the health protection objectives. [1]
Formerly, the Ministry of Health managed the National Health Fund (comprise general taxes and insurance contributions) and was accountable for guaranteeing the resources required to provide the
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
LEAs. However, in 2000, the National Health Fund was replaced by various regional taxes. [3] Part of the cost of the health care system is a specific percentage of PIB-around 7%- so the money attributed to health depends on the population, therefore, is divided equally between regions, but some
regions have a health needs, linked to high prevalence of endemic diseases so if one region needs more funds or spends too much money, has to get it with another taxes.
The multi-annual programming method is vital in the field of health protection and one of the qualifying elements of the National health Service. At the national, the main planning tool is the health care plan called Piano Sanitario Nazionale (PSN) which is prepared based on a proposal from the Minister of health considering the suggestions of the Regions who have one hundred and fifty days from the date of entry to implement the PSN. This plan is published every tree-years and depending on the resources available, public funds are assigned annually to various welfare services through the annual national budget. In PSN are described all the objectives as well as the subjects where the money should be invested in these three years, for example to improve vaccination. Based on this general agenda, the amount of resources to be dedicated by the regions to health care services is annually negotiated with the central government. Furthermore, each region, based on regional taxation, determines annually its own-resource budget for its health care system. Some regions have specific conditions, so can publish and have a specific plan, for example in Sardinia region there is a higher percentage of rare diseases cases, so the circumstances are different from the rest of Italy. [4]
Another Important structure of the national level is l’Agenzia Italiana del Farmaco (AIFA), founded in 2003, is responsible for coordinating all the activities that concern pharmaceuticals such as: public research, monitoring of consumption, pricing and reimbursement policies and monitoring of adverse effects. It is a public institution that operates autonomously, but economically under the direction of the Ministry of Health and the Ministry of Economy. Cooperates with Regions and the main health and pharmaceutical authorities, to promote a good health through medicines, encouraging pharmaceutical research and development as well as making the link with foreign agencies and the European Medicines Agency (EMA). [5,6]
The process of drug registration is guaranteed by AIFA based on the procedures described in European legislation: national, centralized, mutual recognition and decentralized registration. Through these procedures, the Agency, supported on information, ensure traceability, transparency and a timeliness of the entire registration process in order to guarantee an equal pharmaceutical assistance in the national territory as well as rapid access to innovative drugs and drugs for rare diseases.
Moreover, with the AIFA technical scientific commission (CTS) in collaboration with experts from the ISS ensure the quality, safety and efficacy requirements of all medicines through chemical-pharmaceutical, biological, pharmaco-toxicological and clinical evaluations.
In addition, to ensuring the transparency of all processes relating to authorization procedures, it’s used a computerized system from which users can obtain on-line information on the progress of authorization applications. In Italy, approximately 99% of the drugs are authorized by the centralized procedure taken by EMA. [7][8]
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
When the drug is approved by EMA every company must apply for founds to AIFA who make some assessment with the company to establish a price for the drug. The first step is the approval of the health care system for the reimbursing of the drug after that every region has to organize the regional care system in order to deliver the drug to the patient so, this procedure depends on AIFA and the region itself. In addition, AIFA decides which indications approved by EMA are reimbursed. In doing so, determinate if the drug is paid by the national health care or by the patient. For instance, a patient that needs aspirin, the state could pay for the patient with the specific indication as antiaggregant, however if is used for headache the patient has to pay.
The second level-regional level-is ruled by the regions, who have the responsibility of ensuring the delivery of a benefits package through a health management organizations network based on the population called Azienda Sanitaria Locale (ASLs) as well as through public and private hospitals. The regional health departments are responsible for pursuing the objectives established in the national level according to their own political agenda so, the regional level has legislative, executive functions and technical support, as well as evaluation functions. The Regional Health Plan reflects the objectives and targets into financing and organizational measures, considering the regional needs determined by epidemiological studies. This level is different from the first since the regions organize their own regional health care system consequently, it will be different from region to region as the richest ones are generally the most organized owing to the fact that they have more funds to invest in education and in the organization of the health care system and the poorest regions as Sardinia are less organized. Sardinia and other regions with more limitations have a special legislation, so they are called regions “di
statuto speciale”, for example Sardinia is an island so has more problems regarding isolation. [9]
Relating local level, ASLs are responsible for delivering the benefit package by directly providing services or by funding AOs (Aziende Ospedaliere) and private accredited providers. The projects to be performed are defined in the local implementation plan, which should be consistent with the regional health plan. In doing so they became responsible for maintaining the balance between the funding provided by regions and expenditure for services. [3]
There’re two different sources of resources that are invested in founding the hospitals or l’Azienda per
la tutella della Salute (ATS). The ATS is paid according the number of inhabitants of a certain area,
while the hospital is reimbursed by “Raggruppamento Omogeneo di Diagnosi” (ROD). This demands a sequential process in which every day doctors have to register the patients, do the diagnosis and after that, Sardinia region or the ASL of the patient have to pay a specific amount of money for the treatments provided for each pathology. This fund depends on the complexity of the treatment, so the regions have a specific rate table with the cost of each treatment and the hospitals like Sassari and Cagliari hospitals, are paid according to this list, every month after delivering all the data regarding the treatments made in the previously month. This data can be sent to the region by electronic data flows implemented every day with electronic movements manually generated. [3][10]
There’re two different flows: H flow that concerns the drugs that are used and delivered in the hospital departments for hospitalized patients and the F flow which is used for patients discharged, chronic
Faculty of Pharmacy, University of Porto Masters in Pharmaceutical Sciences
patients that use the drug at their own or for drugs used in ambulatory. In the first case, after discharged, the hospital guarantees a month of therapy while in the second case, the patient has a follow-up every month, so the doctor can prescribe the drug with an ambulatory prescription.
The most important difference between these two flows are that the H flow is specific to a department, while the F flow is a more complex flow that concerns twelve situations but only seven of these are managed from AOU pharmacy:
1. medication provided for discharging the patient from hospital (delivery of drugs for the continuation of treatment according to law 405/2001 article 8 letter C); [11]
2. drugs used in outpatient therapies when the cost of the drug is not included. This includes the blood and hemocomponents products and cancer drugs with high cost; [12]
3. medications provided as a result of outpatient specialist examination (delivery of drugs for the continuation of treatment Law 405/2001 article 8 letter C); [11]
4. drugs given in hospital for hemophiliacs when the cost of the drug is not included in the health service provided; [11]
5. high-cost cancer drugs established in the law 26/35 of the 6 July 2010 and any subsequent additions) administered in day care regime; [12]
6. drugs given to chronic patients or patients subject to recurrences for example, patients with cystic fibrosis; [11]
7. medicines included in the personalized plan of treatment for patients with rare diseases (regional law number 160/2004); [13]
Other difference is that in H flow the hospital has to pay for all this expenditure while the F flow is a particular case, in the first instance is the hospital who affords the treatments but then is paid by the ASL where the patient is register. [10][14]
These movements are very important to control the expenditure of the health care system and with these data the regions can made the regional plans since they have information concerning the patients and the pathologies so it’s possible the elaboration of a plan for assistance in the future with the budget that is establish by the regional level for the hospitals and other organizations. [3][15]
The tree levels of the health care system, together, have an important role in pharmacovigilance. Reporting adverse drug reaction (ADR) is a responsibility of several institutions: at the national level there’s AIFA, in the regional level there’s the regional center of pharmacovigilance located in Cagliari and at local level there’s the hospital pharmacists, who works in the hospital or in territory organizations. The Current Italian system of pharmacovigilance is based on Rete Nazionale di Farmacovigilanza (RNF) that is a database managed by AIFA where all the ADRs are sent so professionals who work in this field must have access to this record. Established since November 2001, this network guarantees the collection, management and analysis of reports of ADRs. From 2006, the activities of pharmacovigilance have been strengthened through the rising of a national network linked with the