Pharmaceutical companies are now free to promote their products directly to nurses

Royal Decree No. 954/2015 on prescription, use and authorisation for dispensing medicinal products and medical devices for human use by nurses

Carmela Losada

Capsulas Nº 167

Background

Royal Decree No. 954/2015 came into force on 24 December 2015. The possibility that nurses may prescribe the use of certain medicinal products was introduced in 2009 as part of the Law on Guarantees and the Rational Use of Medicinal Products and Medical Devices. The aim of the legislator was to provide legal coverage for an activity that was already an everyday routine in hospitals and health centres that had previously not been covered by the Spanish legal system. Therefore, the new Royal Decree represents a regulatory implementation concerning a matter already foreseen in the law.

New powers

Nurses may now prescribe, use and authorise the dispensing of certain medicinal products. For over-the-counter medicinal products, nurses authorised by the Ministry of Health may carry out such actions by means of the corresponding dispensation orders.

Concerning prescription medicinal products, nurses may also perform the above mentioned actions, but only if they have been authorised by the Ministry of Health, if there has been a prescription by a doctor who has previously diagnosed the patient and prescribed the medicinal product and, who has also indicated the clinical nursing guidelines or protocol to be followed by the nurse. It should be noted that doctors, dentists and podiatrists are still the only professionals entitled to prescribe, use and authorise the dispensing of prescription medicinal products.

In short, as regards prescription medicinal products, nurses will only intervene to ensure the continuation of a treatment already started by doctors, dentists and podiatrists. In addition, nurses’ performance will be subject to the protocols and guidelines approved by the Permanent Pharmacy Committee of the Interterritorial Council of the National Health System which is the one responsible for their drafting.

Promotion to nurses

On the other hand, one important change introduced by Royal Decree No. 954/2015 is the ability of companies to promote their medicinal products directly to nurses. Therefore, nurses can now receive information and promotional materials on medicinal products, receive visits from representatives of the companies and accept moderate hospitality offered as part of scientific or professional events.

An open question

Despite of the fact that this Royal Decree represents progress, a number of changes may take place in the near future. The Supreme Court has accepted for consideration several actions against this Royal Decree; and, as a result, all the evidence seems to suggest that the debate on “nurse prescription” remains open.

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