April 15, 2024

“Pharmacy of Services”: Simplification Decree expands the range of healthcare and telemedicine services pharmacies can provide

The Italian version of this article has been published on April 9, 2024 on AboutPharma.com, within our bi-monthly column “Digital impact in Life Sciences: Legal Corner”.

The new draft of the Simplification Decree, recently approved by the Council of Ministers, significantly expands the range of services that can be provided by pharmacies as part of the National Health Service. The Simplification Decree amends Legislative Decree 153/2009 on what is known as a “Pharmacy of Services.” This is a local pharmacy with the option to provide health services in addition to dispensing medication.

The Simplification Decree focuses on telemedicine, part of the digitization of healthcare services in which pharmacies are increasingly key players. Article 20 provides a list of healthcare services that can be provided remotely, including “telecertification.” The decree stipulates that an agreement reached at the State-Regions Conference will establish scenarios in which doctors may use telemedicine systems to issue medical certificates to justify absence from work and the methods to be used.[1]

Telemedicine services in pharmacies

The new Simplification Decree expressly allows pharmacists to provide telemedicine services, i.e., various types of services offered remotely using new technologies. The pharmacist performing these services must hold professional qualification to do so and the functional requirements and service levels set out in the national guidelines must be met.

The guidelines approved by the State-Regions Conference on December 17, 2020, mention the potential for pharmacies to provide telemedicine services and note that “appropriate agreements will be evaluated to allow” patients who do not have digital devices for telemedicine at home “to make convenient use of dedicated workstations provided by entities close to their homes,” including pharmacies.

With the approval of the new Simplification Decree, pharmacies take an active role in telemedicine by providing healthcare services in nearby locations. This makes it easier for patients living in situations where such access is problematic to access healthcare services.

The Lombardy Region model

The regional telemedicine model adopted by the Lombardy Region in December 2023[2] reinforced the central role of pharmacies in telemedicine.

Under this model, pharmacies form a network helpful for developing digital and telemedicine services. Pharmacies are widespread throughout the territory, are open for long hours, and have limited wait times. The skills of pharmacists make them particularly well-suited to this role.

Further underscoring the usefulness of this approach, the National Recovery and Resilience Plan (“NRRP”) provides investments in the pharmacy network and enhances the role of pharmacies by allocating funds they can use to purchase patient monitoring devices. Pharmacies will be able to expand their telehealth services as a result.

Based on the Lombardy Region model, the following areas may be integrated into the telemedicine network, on the basis of appropriate strategies established down the line:

  • Telehealth visits: Territorial pharmacies already offer various diagnostic services, such as urgent care, ECG checkups, cardiac testing and/or Holter blood pressure monitors, spirometry, and certain types of blood tests ordered by external public and private healthcare facilities. These are comparable to outpatient specialist services, so they fall under the scope of telehealth visits with electronic reporting fed to an electronic health record.
  • Telemonitoring: Local pharmacies are potential access points for self-sufficient patients who require telemonitoring services. Such pharmacies often have devices—including costly devices and certified class 2 medical devices—at their disposal and can use them in a staffed environment. Telemonitoring services carried out with the support of the pharmacy network shall be periodic as opposed to continuous and shall allow data to be collected and parameters to be transmitted to the regional telemedicine infrastructure. Using the territorial pharmacy network presents an opportunity for self-sufficient patients with chronic health issues to make use of intermittent telemonitoring services. In doing so they would avoid the need to install devices directly in their homes, with consequent savings due to reducing the number of devices and associated logistical services required.
  • Logistical support: In addition to serving as effective pick-up and drop-off points for medical monitoring devices, local pharmacies can provide support services for (i) correct device-patient pairing; and (ii) calibration and verification of devices patients use at home as part of their care and monitoring plans, in order to ensure that devices can operate and communicate with the regional telemedicine infrastructure.

Approval of the new Simplification Decree will strengthen the role pharmacies play as providers of digital services. Pharmacies will have the opportunity to conduct the abovementioned activities at the national level, in addition to doing so under specific regional initiatives like the Lombardy Region initiative.

However, telemedicine services are not the only services covered by the Simplification Decree. The decree is designed to emphasize the central role pharmacies play as healthcare providers at the regional level, where both strictly health-related services and administrative activities may be carried out.

Dispensing medicines and medical devices on behalf of healthcare institutions and primary care doctor and pediatrician selection

The new Simplification Decree allows pharmacies to dispense medicines and medical devices necessary for the treatment of patients at home and in residential and semi-residential care on behalf of healthcare institutions. The new Simplification Decree also allows a citizen to select their primary care doctor or pediatrician directly at a pharmacy. This provision is particularly important for the elderly, who will be able simply to go to a pharmacy and choose a doctor.

Administration of vaccines and diagnostic tests

Another important change is that pharmacies may administer vaccines covered under the National Vaccination Plan for people aged twelve and over. Currently, the only vaccines pharmacies can administer are the flu vaccine and the Covid vaccine for adults. Pharmacies can also carry out diagnostic testing involving the collection of nasal, salivary, and oropharyngeal biological samples. These activities may only be carried out by appropriately trained pharmacists who have completed a specific qualification course organized by the National Institute of Health and who have subsequently completed annual refresher courses. Vaccines may be administered and diagnostic tests conducted in various areas, premises, or facilities, including external spaces that are suitable in health and hygiene terms and where confidentiality can be guaranteed. However, the Simplification Decree expressly states that such an area, premise, or facility must be located in the pharmaceutical district established for the pharmaceutical structure.

Requirements for provision of healthcare services in pharmacies

A pharmacy providing healthcare services on its premises must be authorized by the relevant local health authority, which must ensure that the services:

  • meet hygiene and sanitary requirements;
  • are carried out in the appropriate pharmaceutical premises established for the pharmaceutical structure;
  • take place in a location at least 200 meters from any other pharmacy.

A pharmacy providing healthcare services must identify itself by displaying both the green cross and a sign reading “Pharmacy of Services” on its premises. Citizens must be offered information specifically identifying the owners of pharmacies providing services.

Finally, the Simplification Decree provides that two or more pharmacies owned by different parties may jointly provide the abovementioned healthcare services. The pharmacies may use premises separate from their original premises, subject to the signing of a special network contract. The Simplification Decree also states that prescriptions cannot be collected and medicines and other products cannot be dispensed or sold at these separate premises.

[1] Pursuant to Legislative Decree No. 165/2001 on public employment.

[2] With Resolution of December 4, 2023, number XII/1475.

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