Nei giorni scorsi avevamo pubblicato la notizia dell’istituzione del Regolamento sulle Modalità di Accesso Degli Informatori Scientifici del Farmaco” nelle strutture dell’ASP di Messina.
We now reproduce the full document: ASP Messina ISF access regulation and the resolution-1855-DG-23-07-2019-1.pdf
We publish an excerpt below
The ISF must be equipped with an identification card.
Companies interested in carrying out medical-scientific information activities in the Sicilian Region must inform Service 7 "Pharmaceuticals" - Department for Strategic Planning of the Health Department, with regard to the professionals indicated above, as required by DDG n.2528/2013.
Dedicated spaces
The activity of the IS/ISF, within the structures of the ASP of Messina, must be ensured and facilitated by the health departments (Departments, Districts, Hospitals), through the identification of suitable premises (doctors' room, department library, doctor's office), in time slots agreed with the Head of the Unit.
Modalità d’accesso
For access to the ASP structures of Messina, the IS / ISF and / or operators of the companies producing / distributing DM must show their regional identification card, together with which a personal identification document may be requested validity, under penalty of not being able to be received by the personnel concerned.
The methods of access for reception are communicated through specific notices (Annexes 1, 2, 3), to be positioned near the premises identified for this activity, as well as at the entrance of the individual UU.OO. and in any other room deemed useful to ensure maximum visibility for users as well.
As far as pharmacists working at Direct Distribution points are concerned, reception must take place outside the opening hours to the public, by appointment.
Meeting scheduling
The meetings between the Company's professionals with the IS/ISF and all the other operators of the pharmaceutical companies and the manufacturers/suppliers of medical devices (DM) and in vitro diagnostics (IVD) are carried out by appointment according to the procedures established by the Directors of the UU.OO..
The traceability of accesses also allows for the facilitation of on-the-spot checks, aimed at ascertaining compliance with the established time slots.
Tutti gli IS/ISF e gli altri operatori delle Aziende farmaceutiche e delle Aziende produttrici/fornitrici di dispositivi medici (DM) e diagnostici in vitro (IVD) dovranno essere informati circa l’obbligo di annotazione degli accessi nel predetto registro.
Nell’ambito della programmazione degli incontri, si auspica vengano privilegiati incontri collegiali organizzati all’interno della U.O./Dipartimento interessati. Agli incontri possono partecipare le Direzioni di Dipartimento e di Distretto ed eventualmente il Direttore del Dipartimento Farmaceutico e l’Ingegnere Clinico o loro delegati.
Limiti dell’attività degli ISF
The number of individual visits by each ISF/operator of pharmaceutical companies and manufacturers/suppliers of medical devices (DM) and in vitro diagnostics (IVD) to individual medical employees, can be quantified indicatively at a maximum of 5 per year, for each doctor interested in prescribing.
A questo limite è possibile derogare nel caso in cui l’Azienda Farmaceutica oproduttrice/distributrice di DM/IVD abbia necessità di comunicare al medico/professionista nuove e rilevanti informazioni circa l’uso appropriato del proprio prodotto (nuove indicazioni terapeutiche,eventi avversi, etc…), con particolare riferimento a modifiche del Riassunto delle Caratteristiche del Prodotto (RCP), che prevedano nuove indicazioni terapeutiche e/o nuove istruzioni d’uso e/o informazioni sulla sicurezza e sulla farmaco o dispositivo-vigilanza.
IS/ISF cannot carry out any commercial activity at the hospital pharmacy or direct distribution points.
Furthermore, IS/ISF cannot ask the pharmacist for information on the prescribing habits of doctors.
Gli IS/ISF devono svolgere individualmente la loro attività presso i medici/professionisti: lapresenza di capoarea o altre figure professionali non correlate all’attività di informazione scientifica, è ammessa solo per funzioni diverse dall’informazione (ad esempio, tutoraggio professionale,organizzazione e proposizione di eventi formativi, progetti di ricerca, etc…).
In order to avoid the dispersion of resources in the case of information activities on individuals, multidisciplinary meetings are preferable, involving several company professionals, in order to deepen certain aspects or to present new aspects.
Companies that are interested in organizing multidisciplinary meetings must submit a request to the Training and Updating Unit and, for information, to the General Management, by means of the appropriate company form (Annex 6), specifying its object and purpose, to be submitted to the competent evaluation of the same can make use of the opinion of the UOC Hospital Pharmaceutical Assistance / Hospital Pharmacy.
In the event that subjects other than company professionals and IS/ISF duly declared according to these regulations must be present at these meetings, participation must be subject to authorization by the Training and Update Unit, after presentation of the identification and professional data relating to these subjects, who justify their interest.
The Department of Medicine ensures the participation of a pharmacist in the multidisciplinary meetings organized in the Company, in order to guarantee the scientific value and the absence of any form, even indirect, of conflict of interest.
Control and monitoring
The supervisory and control activity envisaged by this regulation is guaranteed by:
- the Directors of the UU.OO. involved who guarantee the application and compliance with this regulation, which process the reports received from the professionals involved, in particular those concerning the access requirements of Specialists to operating theaters and similar health areas;
- the Supervision Directorate / Health District / Department which carries out the supervisory and control activity for the part relating to the hygienic-sanitary aspects, which provides support for the management of the activities relating to the reports received regarding the lack of access requirements;
- The Department of Medicine which carries out supervision, control and support activities regarding the activity of scientific information on drugs, aids and devices;
- The Prevention and Protection Service COU and the Qualified Expert Physicist who carry out surveillance and control activities respectively for risk assessment and for aspects relating to ionizing radiation.
- In order to ensure constant monitoring of the activity of the Pharmaceutical Representatives, pharmaceutical companies must notify the Pharmaceutical Department of the ASP of Messina, on an annual basis, by 31 January of the following year:
- the average annual number of visits made by Pharmaceutical Representatives to healthcare operators who were recipients of the Scientific Information activity during the year.
The Department of Medicines, as the structure in charge of control and supervision, draws up a quarterly report on its supervisory activity, highlighting all the critical issues found and sends it to the Company Management.
All violations of this provision and those relating to Legislative Decree no. 541/92 will be communicated not only to the competent authorities, but also to Service 7 "Pharmaceuticals" - DPS Health Department of the Sicilian Region, the Ministry of Health and the Italian Medicines Agency (AIFA), each for the part of its competence.
The OU Directors/Managers are responsible for the correct application of the provisions of these Regulations in their own OU.
The ASP of Messina supervises the correct application of the provisions contained in these Regulations through a multi-professional work group which will carry out internal and external checks, reporting any cases of violation to the Head of Corruption Prevention and Transparency and to the Health Department.
Confidentiality of information
Non è consentito ad alcun operatore sanitario dipendente o convenzionato del SSR fornire agli ISF o agli altri operatori sopracitati informazioni inerenti gli approvvigionamenti, i consumi dei medicinali e le abitudini prescrittive e d’uso dei prodotti prescritti o utilizzati dai medici inerentil’attività in regime SSN.
Similarly, healthcare professionals are not permitted to provide personal data and/or details of patients to informants, with the exception of what is provided for Specialists on the basis of the instructions provided in the Framework Agreement stipulated pursuant to art. 28 EU Regulation 2016/679.
Anti-corruption legislation and code of conduct
The Companies undertake to respect the Company Code of Conduct, as well as the P.TPCT of the Messina ASP, which can be consulted on the Messina ASP corporate website (www.asp.messina.it) in the "Transparent Administration" section, for the parties competence.
Ed: According to Legislative Decree 196 of the June 30, 2003 (“Privacy Code” – Consolidated Law on Privacy of the Italian Republic), modified from the Legislative Decree 101 of the August 10, 2018 "processing of personal data" means any operation carried out, even without the use of electronic tools, which concerns: the use, consultation, collection,at registration, the organization, storage, processing, modification, extraction, comparison, selection, interconnection, blocking, dissemination, communication, deletion of data, even if not recorded in a database.
Gli elenchi degli ISF, la registrazione delle visite, gli orari di controllo, sono dati personali degli ISF. Gli stessi ISF devono dare il consenso scritto alla tenuta dei loro dati, deve essere inoltre indicato chi detiene questi dati ed il responsabile degli stessi. Deve essere inoltre garantita la sicurezza dei dati, non possono quindi essere esposti alla consultazione di chiunque, men che meno ai funzionari delle aziende per le quali lavorano, ciò costituirebbe un controllo improprio di un’attività per conto di altri. Tutti reati.
The ISF who are not commercial figures are regulated and limited in their activity, all the commercial figures of the pharmaceutical companies instead have free access. A winning strategy!
Related news: Sicily Circular ISF-19302-of-4-3-2019