Royal Decree 463/2020 through which the government declared the state of emergency in order to manage the health crisis caused by COVID-19 allowed the Minister of Health to approve any resolution that may be convenient in order to guarantee the protection of persons and the supply of products necessary for the protection of public health.
Order SND/293/2020, published today, and which will remain in force for the duration of the state of emergency, is one of these resolutions. The objective of the order is to facilitate access to hospital medicines, including products which are undergoing clinical trials so that patients who are not in the hospitals may obtain these products outside of the hospital premises. To such effect, the Order foresees that the competent health authorities in the regions are entitled to approve the necessary instructions.
Medicines dispensed in hospitals
Hospital pharmacy services will not dispense an amount higher than the one necessary for two months of treatment, although the Spanish Medicines Agency made reduce this period to one month for products in respect of which this may be considered necessary.
On the other hand, it will also be possible to adopt measures contemplating that the dispensation of these products may be done at the domicile of the patient or outside the premises of the hospital, thus avoiding unnecessary visits of the patients to the hospital.
Medicines used in clinical trials
As regards products that are currently being used in clinical trials, the hospital pharmacy will be allowed to dispense the amount of the product needed to cover a treatment period higher than the ordinary one. Furthermore, the regional authority may also adopt measures so that patients participating in the trial may receive the product in their domiciles. For such purposes, the competent authority may give instructions to the sponsor of the trial ordering it to provide the necessary logistics under the direction of hospital pharmacy services and of the principal investigators.
Hospital used medicines
Finally, regional authorities may also approve measures so that medicines which are normally restricted for use only in hospitals may be administered to patients at their domiciles or outside the premises of the hospital if this is convenient considering the condition of the patients, their pathologies, the characteristics of the product or the epidemiological situation.