Deblistering: A new frontier for the “pharmacy of services”
The note on “the preparation of personalized packaging to improve therapeutic adherence of patients” released on February 3 by the Regione Lombardia (“Note”) sets a milestone in Italy for deblistering, which could soon become a standard service provided by Italian pharmacies as it already is provided by pharmacies in many other countries around the world.
The Note defines “deblistering” as a “service aimed at the preparation of personalized packaging of medicines” and specifies that “it is totally charged to the patient, and consists of a pharmacist in a pharmacy unpacking a previously purchased industrial medicine and repackaging the same in customized doses for a patient to take, based on a doctor’s prescription.” The repackaging activity consists of preparing a blister pack containing all the dosage units of the different medicines that the patient takes during one week of therapy. It is possible to prepare blister packs for up to 30 days of therapy, with certain exceptions.
The legal grounds for the introduction of this service are found in Article 1 paragraph 462 of Law No. 160 of December 27, 2019 (Budget Law 2020), which provides for “the possibility of using at pharmacies, in cooperation with chosen general practitioners and pediatricians and in any case in compliance with medical prescriptions, customized medicine access service.” This service is quite new to Italy, which therefore does not yet have an adequate regulatory framework in place for it. Consequently, a series of issues, some of them potentially critical, must be considered.
The Lombardia Note
According to the Note issued by the Regione Lombardia, deblistering is subject to the following conditions:
- pharmacies shall inform the appropriate local health authority (ATS) in advance of starting their activity;
- pharmacies must prepare suitable procedures to guarantee correct performance of deblistering, with particular attention to staff training and with regard to the use of any automated systems, the availability of human resources, the characteristics of the premises, work areas, any additional equipment, and so on;
- deblistering may be performed inside the pharmacy or outside the pharmacy but in the relevant ATS territory, and the spaces used must be similar to those of a galenic laboratory, as provided by the Good Pharmacy Practice Rules outlined in the Official Pharmacopoeia XII edition (Ministerial Decree of December 3, 2008);
- pharmacists shall maintain technical data sheets where they record the characteristics and suitability of the material handled; and
- pharmacists shall prepare and have patients sign a document authorizing the pharmacy to process their previously purchased medicines, so that deblistering can take place.
Finally, it is important to point out that deblistering is the prerogative of the pharmacist, as a health professional. If pharmacists are unable to perform this service, they must supervise the activity performed by others and shall be responsible for the preparation procedures.
A key principle of the regulation
As correctly stated in the Note, it is essential that the medicines be previously purchased by the patients. This is fundamental in order to classify the activity carried out by pharmacists as a post-sale service directly addressed to patients and not a form of medicine distribution. In this case, the patient will buy an industrial medicine and will then ask the pharmacist to prepare a personalized blister pack, shaped to the patient’s specific treatment needs according to the treatment plan provided by a doctor and submitted to the pharmacist by the patient.
As confirmation, when the blister pack is collected/delivered, all empty packages bearing the lot number and expiry date of each medicine and the relevant package leaflets will be returned to the patient. The blister pack prepared by the pharmacy will also indicate storage method and dosage schedule.
In carrying out this service, the pharmacist will be performing medication-handling activity subject to Recommendation No. 19 of the Ministry of Health (on the handling of solid oral pharmaceutical forms). In addition, the pharmacist will be permitted to divide solid pharmaceutical forms only if required by the Summary of Product Characteristics (SPC).
A new opportunity for the “pharmacy of services”
Deblistering certainly represents a significant step forward for the “pharmacy of services.” In fact, this type of service is obviously key to therapeutic adherence, especially for certain types of patients.
Therefore, the Note of the Regione Lombardia expressly provides that, with an eye to improving the therapeutic adherence of chronic patients by guaranteeing that the service is available region-wide, personalized preparation of therapy can also be offered to public and private regional pharmacies that have not activated this service. In this case, an appropriate procedure as well as proper contractual arrangements are required to regulate the relationship between pharmacies and sharing obligations and responsibilities (covering, among other things, transport and delivery of blister packs).
Personalized medicine preparation service can be offered not only to individual citizens/patients requiring ongoing therapies, but also to other public and private healthcare facilities. When personalized medication service is provided to a healthcare facility, the facility itself will provide the pharmacist with prescriptions for the individual patient’s daily therapies for a maximum of one month.
Therefore, opportunities are being created for pharmacies in the Regione Lombardia: the opportunity to equip their structures (including with automated elements) in order to offer deblistering services not only to their own patients, but also to external structures (other pharmacies and healthcare facilities).