SUBJECT: COVID - 19: temporary provisions for the holding of meetings by the Scientific Representatives of the Drug and the representatives of medical devices at the APSS facilities, the private affiliated facilities, the clinics of General Practitioners and Family Paediatricians and local pharmacies
With note prot. 41059 of 03/10/2020, in order to limit access to the areas dedicated to assistance, the suspension was ordered, except in cases of necessity and urgency, of the meetings held by the Scientific Pharmaceutical Representatives (ISF) and by the representatives of medical devices at all the APSS facilities, the affiliated private facilities, the clinics of general practitioners and family paediatricians and local pharmacies. This suspension was subsequently extended until 15 June next
In light of the current epidemiological situation, the measures adopted at national level and the provisions of the "Guidelines for the reopening of economic and productive activities", approved by the Conference of Regions and Autonomous Provinces on 05/25/2020, it is considered be able to allow the access of the ISFs and representatives of medical devices again, in compliance with the provisions contained herein.
These provisions are in line with the "Measures for the safe resumption of healthcare activities in "phase 2" of the COVID-19 pandemic" set out in the document "Guidelines for the reopening of outpatient and hospital activities in the Autonomous Province of Trento", drawn up by the Working table set up by the Autonomous Province of Trento (prot. PAT/273717 of 19 May 2020).
Access to APSS and affiliated facilities
– even in this phase, all health professionals are recommended to continue to favor "remote" information activities;
– the heads of the Operating Unit (UO)/Service identify the premises, days and time slots to be dedicated to meetings with the ISFs and representatives of medical devices, respecting the following criteria:
– identification of premises located in structures other than hospitalization ones (e.g. polyclinics) – carrying out of meetings at strictly distinct times from visiting hours
– the meetings take place exclusively by appointment previously agreed; there booking is made in a "centralized" manner, through an agenda managed by the secretariat of the UO/Service, avoiding the overlapping of appointments and the simultaneous presence of several ISF/representatives in waiting rooms;
– traces must be kept of all the meetings held, in order to allow for any checks by the Medical Directorate of the facility and the Primary Care Operative Units (UOCP) and to quickly reconstruct, if necessary, the contacts held by the operators with the SFIs/representatives; – visits are currently not permitted with more than one ISF/representative of the same company (e.g. with area manager), even if in training;
– the ISF/representatives are subject to the measures envisaged for access to the structures to which they go; in particular, for the APSS structures, it is necessary to fill in a pre-triage form (downloadable from the website www.apss.tn.it), dated no later than 4 hours before entry. The card is viewed by the triage staff, who also measure the body temperature. Once the triage has been completed, entry is allowed after hand disinfection and after wearing the surgical mask.
– similarly to what is provided for patients, access is allowed no more than 15 minutes before the fixed appointment;
– it is not allowed to stay inside the structure once the meeting has ended;
– the premises where the meetings take place must be ventilated frequently and the interpersonal safety distance of at least 1 meter must be maintained;
– the promiscuous use of objects (e.g. pens, tablets) must be avoided;
– the duration of the meetings must be limited to the time strictly necessary.
Access to the clinics of general practitioners and family paediatricians
– even in this phase, it is recommended to continue to favor "remote" information activities;
– GPs and PdFs identify the days and time slots to be dedicated to meetings with the GPs and representatives of medical devices, bearing in mind that information activities on the drug cannot take place during patient visiting hours;
– the meetings take place exclusively by appointment, previously agreed, avoiding the overlapping of appointments and the simultaneous presence of several ISF/representatives in the waiting rooms;
– traces must be kept of all the meetings held, in order to allow for any checks by the UOCPs and to quickly reconstruct, if necessary, the contacts with the ISFs/representatives;
– visits are currently not permitted with more than one ISF/representative of the same company (e.g. with area manager), even if in training;
– ISFs and representatives of medical devices are subject to the protective measures envisaged for access to the clinics to which they go; they must in any case wear a surgical mask and disinfect their hands before entering the clinic;
– access is allowed no more than 15 minutes before the scheduled appointment;
– it is not allowed to stay once the meeting is over;
– the premises where the meetings take place must be ventilated frequently and the interpersonal safety distance of at least 1 meter must be maintained;
– the promiscuous use of objects (e.g. pens, tablets) must be avoided;
– the duration of the meetings must be limited to the time strictly necessary.
The indications for access are intended, for the applicable aspects, also for private structures and affiliated pharmacies.
For anything not governed by these provisions, please refer to the "Regulation on drug information", approved with Resolution no. 127 of 03/16/2016 and the "Directives for the access of representatives of medical devices to the structures of the Provincial Health Service and for the transfer of free samples", approved with Resolution no. 391 of 09/22/2015.
In particular, it should be remembered that each ISF can carry out a maximum of four individual visits per year for each doctor interested in the prescription, without prejudice to the need to convey information relating to recent changes to the Summary of Product Characteristics (for example, new indications therapeutic) or new, relevant information on the safety of use of the medicinal product.
