In the last ten years and, even more, since the spread of the Covid-19 pandemic, the central role has increased 
of pharmacies in the patient care process enhanced by the approval of Legislative Decree number 153/2009 and by the subsequent implementing documents which have laid and consolidated the foundations for the provision of new services by pharmacies within the National Health Service .
It is in this context that the recent initiative of the Lombardy Region fits into "the adherence of patients to medical therapies". The institution set up a working group which last February 3 adopted a guideline act to regulate the performance of theunpacking of industrial medicines already owned by the patients (i.e. already purchased by the latter) and repackaging by the pharmacists in the pharmacy, in personalized doses. All precisely to facilitate the assumption of therapy on the basis of the dosage previously identified by the doctor. The Lombardy Region has thus regulated a service, also known as the "deblistering" service, which had already found a development in the practice of some pharmacies in Italy, to respond to a very felt need and which is proving to be particularly virtuous in terms of adherence therapeutic and with positive effects also in terms of effectiveness of pharmaceutical expenditure.
The regulatory bases and regional guidelines
The legitimacy of the preparation of personalized therapies today finds its regulatory foundation in the Budget Law for the year 2020 which, in introducing a new provision in article 1 of Legislative Decree 153/2009, provides, "in order to favor the care of chronic patients and contribute to the efficiency of the network of services” the possibility “to use at pharmacies, in collaboration with general practitioners and paediatricians of free choice and in any case in compliance with medical prescriptions , of a personalized access service to medicines”.
The absence of a detailed implementing rule which expressly regulates the "deblistering" activity has led the Lombardy Region to confirm, through the approval of the aforementioned policy document and in order to overcome any discrepancies on the territory, the legitimacy of the conduct of this service by pharmacies. The document approved by the Lombard working group gave important and shareable indications on the implementation methods of this innovative service, as an activity that has been brought back within the context of the competences of pharmacies in the field of galenic preparations.
Moreover, it was possible to reach a similar conclusion also thanks to the contribution of decisions of the administrative justice: in the past, the Council of State in fact ruled favorably on the possibility for pharmacists to unpack industrial medicinal specialties to be used in the preparation of galenic medicines. Therefore, if nothing prevents the performance of this depackaging activity for the use of active ingredients in the production of masterful preparations, all the more reason there must be no doubts about the competence of the pharmacist in carrying out the "deblistering" service for patients , when he limits himself to unpacking the medicinal specialties, on the basis of the specific indications received from the doctors, without even intervening on the content of the same through a specific manipulative activity.
The requirements for carrying out the service
The work carried out by the Lombard working group offers the starting point for analyzing the ways in which pharmacies can today be considered legitimized to carry out the service of setting up personalized therapies for patients, with the dutiful clarification that the latter can be achieved limited to the dispensing of solid oral pharmaceutical forms that can be repackaged in unit doses.
The assimilation to the galenic activity
From the assimilation of "deblistering" to the galenic activity it follows that, for the performance of this service, compliance with the Standards of good preparation (Nbp) envisaged for the production of galenic medicinal products must be guaranteed and, in order to prevent any disputes regarding possible alteration of the drug due to the unpacking of the primary packaging, it is not excluded that pharmacies will have to equip themselves with sterile rooms ("clean rooms"), where they can carry out this activity in compliance with the good manufacturing standards for medicines (Gmp) . The Lombardy Region has established the obligation to notify the competent local health authority of the start of this activity, since a specific procedure must be prepared, which certifies the training of personnel, the type and methods of use of the automated system and the characteristics of the premises. For this reason, in compliance with the Nbp, it should be remembered that the employee in charge of the galenic laboratory must have the necessary qualifications and skills (degree in pharmacy or Ctf), even if he/she may be able to make use of cleaning personnel, staff technician and trainees. However, the latter will be able to carry out the simpler and more repetitive parts of the pharmacist preparation, which do not involve the assumption of responsibility, as these activities must always be carried out under the direct supervision, vigilance and responsibility of the pharmacist.
The procedures have already been defined
On this point, the Lombard guidelines, in addition to having recalled that the "deblistering" activity is "a prerogative of the pharmacist, as an expert health professional of the drug", provide that the pharmacy "prepares a suitable procedure, kept at the same , to ensure the proper performance of the activity in question, paying particular attention to staff training, especially as regards the use of the automated system, the availability of human resources, the characteristics of the premises which must be in the territory of the competent Ats, similar to those of a pharmaceutical laboratory".
In terms of the premises intended for the performance of this service, from the same regional note, it can be deduced that they must fall within the area of competence of the health authority responsible for supervising the pharmacy, even though they may not be physically connected to the pharmacy itself . On this point, the Lombardy Region has aligned itself with a recent orientation of the Council of State which has endorsed the location of part of the galenic laboratory of a pharmacy in rooms not adjacent to the premises intended for sale to the public, with the clarification that what is relevant is that they are under the supervision and control of the director of the pharmacy or his delegate.
Given that the setting up of personalized therapies, as seen, presupposes the unpacking not only of the secondary packaging, but also of the primary one, the Lombardy Region has framed this type of service performed by the pharmacist in the context of drug handling activities, believing that it is also permitted, where necessary, to divide of solid oral pharmaceutical forms, if permitted by the Summary of Product Characteristics (SmPC), with the recommendation that attention be paid to the case where the tablets do not show any dividing lines.
The act of regional guidance has thus regulated an activity of primary importance for patients to the extent that it allows the preparation of a personalized treatment plan, with a consequent improvement in the therapeutic adherence of chronic patients. In order to ensure maximum diffusion at a territorial level, it has been established that this service can also be offered to public or private pharmacies that do not have the possibility to activate it, having allowed its extension also to patients in nursing homes and health facilities public and private.
Related news: Legislative Decree 3 October 2009, n. 153
LAW 27 December 2019, n. 160 paragraphs 401 - 500
