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Conchita Tros de Illarduya , Professor of the School of Pharmacy, University of Navarra , Spain
Let us train good pharmaceutical professionals
As professor in Pharmacy I thought it appropriate to make a consideration about the inconsistency in the information being provided to the patient-user of the postcoital morning-after pill (PDD), administered without prescription (previously required) after the change of status as of September 28, 2009, with the additional fact that it can be dispensed to minors under 16 years of age. This inconsistency has materialized in a leaflet edited and distributed by the Ministry of Health to pharmacies, in order to be given to people requesting the PDD pill.
Regarding the information provided on a drug, the following points should be made: firstly, and as defined in Law 29/2006, of 26 July, on guarantees and rational use of drugs and health products (Article 15), "the package leaflet of a drug must reflect the authorized conditions of use for the drug and synthesize the essential scientific information for health professionals. The package leaflet shall be prepared from agreement with the contents of the label and shall provide patients with sufficient information on the identification of the medicinal product, employment, administration, adverse effects..." Secondly, and in the same Law (article 19) it is indicated that "those drugs containing substances whose activity and adverse reactions need to be studied in more detail, must be subject to medical prescription".
With this in mind, it should be noted that the technical data sheets of the two commercial forms of PDD (Postinor and Norlevo) detail the following:
In the case of Postinor: it is not recommended for employment in girls. Very limited data available in females under 16 years of age. The precise mechanism of action is not known. In the case of Norlevo, it is also specified that its mechanism of action is not known. In the same way, the package insert corresponding to both specialties states that the mechanism of action of the active ingredient (Levonorgestrel) is not known. It seems clear, therefore, that according to the information contained in the technical data sheets and the corresponding package inserts, the mechanism of action of the active ingredient is not known, there is a possibility of adverse effects and its use is not indicated in minors under 16 years of age, even less in an indiscriminate and uncontrolled manner.
Well, in the aforementioned brochure published by the Ministry of Health and distributed to pharmacies, it is emphatically stated (text in capital letters and bold letters) that PDD is not abortive, assuming that the mechanism of action is known. Furthermore, the brochure specifies that the adverse effects are infrequent, weak and disappear quickly. With these data in view, it is not surprising to find some reactions, not only from pharmaceutical professionals, but also from pharmacy students themselves, who do not understand that the scientific rigor that is presupposed in the information provided to the patient has been ignored in this way.
Our profession deserves to be valued, but much depends on what we, community pharmacists, hospital pharmacists and teachers, as well as future professionals (current students), do. We should not lose sight of the fact that, if it is important what current professionals transmit, it is no less important what political and health institutions do as well. The future of the profession depends, among other things, on what we transmit to future pharmacists in the classroom and on our ability to involve them in the social responsibility of correct patient information and care.