Can they make a complaint against me if I have a complication on administering bebacizumab (Avastin®)?

Menéndez de Lucas, J.A.; Molina Seoane, V.

doi:10.1016/j.oftale.2013.07.001

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"tieneTextoCompleto" => true "saludo" => "Dear Sir," "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "173" "paginaFinal" => "174" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "J.A. Menéndez de Lucas, V. Molina Seoane" "autores" => array:2 [ 0 => array:4 [ "nombre" => "J.A." "apellidos" => "Menéndez de Lucas" "email" => array:1 [ 0 => "jamenendezdelucas@yahoo.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "¿" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "V." "apellidos" => "Molina Seoane" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Oftalmología, Hospital Universitario Montepríncipe, Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "¿Me pueden denunciar si tengo una complicación al administrar un bevacizumab (Avastin®) intravítreo?" ] ] "textoCompleto" => "The question posed in the heading of this letter is in the back of the mind of many ophthalmologists. The answer must necessarily be affirmative. Regardless of whether the hospital management does not attach a lot of importance to this issue, we may find ourselves in a compromised situation as we apply medications with the potential risk of producing severe complications beyond the threshold of the legal procedures for administration of authorized drugs in Spain.Even though the use of drugs for indications that are not included in the technical specifications thereof (off label prescriptions) is a frequent clinical practice for over 20% of conditions routinely treated in our country,<a class="elsevierStyleCrossRef" href="#bib0005">1</a> it is not covered by current legislation. In Spain, the legal framework for administering drugs, in addition to those found in the markets (authorized pharmaceutical specialties) are only 3: drugs used in clinical trials, foreign drugs and compassionate use.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> A few years ago your Journal commented on the impossibility of using bevacizumab (Avastin®) as compassionate use for treating ARMD because a prerequisite is that the physician must consider its use as “indispensable” (Art. 28 RD 223/2004, on regulation of clinical trials), and the use of this drug cannot be considered indispensable due to the existence of an authorized available therapeutic alternative such as ranibizumab (Lucentis®).<a class="elsevierStyleCrossRef" href="#bib0015">3</a>The reassuring words of hospital managers saying that we should not worry about patient complaints because the hospital will handle it can be a consolation provided that the patient claims for damages (administrative lawsuit) but will be futile if the claim is submitted at the criminal court. The latter is used more frequently because it is faster, easier and cheaper for patients. However, it is the worst type of lawsuit for physicians because penal or criminal responsibility is personal (i.e., the patient is not suing the hospital but the physician) and sentences go beyond fines and could involve prison and professional barring.Accordingly, from the medical-legal angle, the current situation is not easy for ophthalmologists. For a number of years we have been requesting the administration to enable some legal procedure to resolve this problem.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> Meanwhile, ophthalmologists are in the disagreeable situation of having within reach an efficient therapeutic drug (bevacizumab) to treat a disease that will most certainly produce severe sequels (ARMD) but not being able to apply it within the law because its intraocular use is not authorized for purely economic reasons. As published elsewhere, we are in the midst of an unequal clash between the economic interests of the pharmaceutical industry and the general interests of society. The public health system has to pay 40 times more for patient treatments with ranibizumab than with bevacizumab (the cost difference per patient and year is of 2330€ compared to 53.31€).<a class="elsevierStyleCrossRef" href="#bib0020">4</a>In 2009 the administration, aware of the problem caused by routine use in clinical practice of drugs for unauthorized applications (frequently due to the lack of commercial interest in performing necessary studies) approved a Royal Decree to regulate the use of drugs under special circumstances (RD 1015/2009, June 19). Chapter 3 of said decree specifically regulates access to drugs for unauthorized applications, and considers it exceptional and limited to situations in which “there is an absence of authorized therapeutic alternatives for a given patient”. The Spanish Medication Agency was assigned the task of drafting usage recommendations for these cases to be taken into account in the preparation of therapeutic protocols in health centers.We must be aware that in the current economic climate, the Spanish public health system “is lacking” financial resources to provide “authorized therapeutic alternatives” (Lucentis®) for the majority of ARMD patients. Even so, at this date we still do not have an official position in contrast with other countries such as Italy, Germany, Austria or Finland where the use of bevacizumab is recommended instead of ranibizumab for treating ARMD.<a class="elsevierStyleCrossRef" href="#bib0020">4</a>We consider that, in the light of recently published studies where both drugs have demonstrated equal efficiency without significant toxicity differences,<a class="elsevierStyleCrossRef" href="#bib0025">5</a> the Spanish Medication Agency should fulfil the task requested by the law and issue the necessary recommendations to resolve this problem. In this way, the ophthalmologists would avoid having to assume unnecessary risks and, more importantly, many patients would obtain access to an available and efficient remedy for treating their disease (Avastin®), which in some cases is being refused purely for legal reasons." 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ISSN: 2173-5794
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Archivos de la Sociedad Española de Oftalmología is the official journal of the Ophthalmology Society of Spain, that has over 4,000 members. It gives priority to the publication of basic, translational and clinic research including reviews, original articles, short communications, editorials, letters to the editor and clinic practice guides related to Ophthalmology and its subspecialties. A small section of the journal is reserved for the most relevant papers presented at the annual Congress of the Society. All manuscripts considered for publication are reviewed by expert examiner peers (double blind). The journal is published monthly and even though its official language is Spanish all articles are translated into English to increase the dissemination of scientific information. At present, Archivos is the only Spanish language Ophthalmology journal indexed in PubMed/MEDLINE in addition to other prestigious international databases such as Scopus.

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Vol. 89. Issue 4.

Pages 173-174 (April 2014)

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