title: [Topical chemotherapy for conjunctival tumours - the medical and legal bearings of the case].
abstract: The treatment management of malignant tumours is characterised and limited by specific features of the topographical structure of the eye. The anatomic characteristics of the conjunctival sac, the movable tissue structures and the need to take care of corneal transparency and conjunctival stability are the main concerns of the experts. Clinical studies have revealed adjuvant chemotherapy to have a positive effect as a therapeutic treatment for neoplasia of the conjunctiva and cornea. Although mitomycin and interferon are widely used, there are no phase III studies on local adjuvant chemotherapy (interferon, mitomycin, 5-fluorouracil) that evaluate the proof of effectiveness, potential adverse effects or interactions with other drugs. For this reason, the currently available studies fail to comply with the jurisdiction of the German Federal Social Court. Hence, the Medical Service of the Health Insurance Funds (MDK) regionally does not accept the medical preconditions for reimbursement of the costs in adjuvant local chemotherapy. A doctor's unquestioned acceptance of such an MDK decision could have legal consequences. An off-label use is acceptable by law if there is no alternative treatment available with a higher evidence level that conforms to the medical standard. It is therefore recommendable for the Joint Federal Committee commissions the experts in ophthalmology and oncology on off-label use, to review the scientific evidence regarding adjuvant therapy of malignant tumours of the ocular surface. Only in this way can regional disparities in patient care, and intrusions on the doctor-patient relationship, be avoided.
authors.affiliation: Augenklinik der Universitätsmedizin, Ernst-Moritz-Arndt Universität, Greifswald.
authors.forename: R
authors.initials: R
authors.lastname: Kempin
authors.affiliation: Augenklinik der Universitätsmedizin, Ernst-Moritz-Arndt Universität, Greifswald.
authors.forename: F
authors.initials: F
authors.lastname: Tost
mesh_terms: D060433:Administration, Ophthalmic; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D003230:Conjunctival Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003299:Cooperative Behavior; D005104:Expert Testimony / Q000331:legislation & jurisprudence; D018588:Fee-for-Service Plans / Q000331:legislation & jurisprudence*; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005858:Germany; D054625:Healthcare Disparities / Q000331:legislation & jurisprudence; D006801:Humans; D033183:Interdisciplinary Communication; D007372:Interferons / Q000008:administration & dosage / Q000009:adverse effects; D008318:Malpractice / Q000331:legislation & jurisprudence*; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000331:legislation & jurisprudence
chemical_list: D000970:Antineoplastic Agents; D016685:Mitomycin; D007372:Interferons; D005472:Fluorouracil