Changes To The Rules On Prescribing And Dispensing Medicines And Healthcare Products

• Published date: 11 September 2023
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Law Firm: PLMJ
• Author: Mr Eduardo Nogueira Pinto, Ricardo Rocha and Tiago Linhares Carneiro

As part of the measures to improve access to medicines, Ministerial Order 263/2023 of 17 August introduced changes to the rules for prescribing and dispensing medicines and healthcare products. These changes are aimed at facilitating access for clinically stabilised patients with chronic diseases to the long-term medication they need, by avoiding the need for these patients to go to the health centre just to renew their prescriptions.

As a result, the following will now be possible:

In each act of prescribing through paperless prescription:

In the case of certain medicines intended for long-term treatment¹, the number of packs necessary to ensure treatment for 12 months may be prescribed;

In the case of certain medicines intended for short or medium-term treatment², prescriptions may contain a higher number of packs than permitted³, provided that the prescription is justified by the dosage or by a prolonged absence from the country. The reasons must also be recorded in the patient's medical record and the quantities must be appropriate and adapted to the dosage and duration of treatment.

The pharmacy may dispense other packs of the prescribed medicine with an equivalent pharmaceutical form and/or dosage in situations of shortage with a high impact on public health, identified by INFARMED, I.P. (the Portuguese National Authority for Medicines and Healthcare Products).

These changes to the rules on prescribing and dispensing medicines are accompanied by measures to monitor patient compliance and the safety and efficacy of treatments:

the prescribing doctor now has access, at the time of the prescription, to the history of prescriptions and dispensations made to the patient;

the pharmacist has access, with the patient's consent, to all prescriptions issued or dispensed in the previous 12 months;

pharmacies are only allowed to dispense the number of packs necessary to ensure the patient's treatment for 2 months, so that patients can be monitored and advised by pharmacists at regular intervals for the duration of the prescription⁴...