The view of experts on initiatives to be undertaken to promote equity in the access to orphan drugs and specialised care for rare diseases in Spain: A Delphi consensus.

OBJECTIVES: To reach a consensus amongst experts on the most feasible actions to be undertaken to facilitate patient access to specialised care and orphan drugs (OD) in the public health sector in Spain. METHODS: Two Delphi rounds were completed. The questionnaire was based on a literature review and 2 focus groups. Agreement was sought on the desire (D) and prognosis (P) for the implementation within the next 5 years, on a 5-point Likert scale. Consensus was reached when ≥75% participants chose agreement (1-2) or disagreement options (4-5). RESULTS: 82 experts on rare disease (RD) participated. Agreement on the D and P was reached in 66.07% statements: OD pricing review [absence of clinical effectiveness (D:85.37%; P:85.90%), target population increase (D:79.27%; P:91.03%)]; reference team definition of referral protocols and clinical practice guidelines (D: 97.56%; P: 89.74%); and a unified, usable, etiology-based registry (D:97.56%; P:84.62%). D and P assessment diverged in 32.14% items: creation of a specific funding system for OD (D: 97.56%; P: 60.25%); and a network of medical teams to coordinate the care of RD patients (D: 99%; P: 62%). CONCLUSIONS: The results have shown the need to promote dialogue between stakeholders, introduce European recommendation to national and regional Spanish policies and set up priorities and undertake actions to drive relevant changes in current medical practice in managing RD patients.

The antibiotic resistance pattern of conjunctival bacteria: a key for designing a cataract surgery prophylaxis.

PURPOSE: To assess the prevalence of the antibiotics resistant conjunctival bacteria in order to adapt our cataract surgery prophylaxis to the new prophylaxis techniques. METHODS: Observational prospective study of preoperative conjunctival cultures of consecutive patients undergoing cataract surgery during a year. Patients having eye surgical prophylaxis in the previous 6 months were excluded. The aerobiosis and microaerobiosis incubation lasted 2 and 7 days, respectively. Three profiles of identification and antibiotics sensibility tests were used. The data recorded on the Autoscan4 were exported to a Microsoft Access database. Statistical calculations were carried out with the Epidat program, 3.1 version. RESULTS: Of 4391 microbes isolated, 94.2% bacteria were Gram-positive and 5.3% Gram-negative. In the 1940 selected patients, their prevalence was coagulase-negative Staphylococci (CNS) 88.3%, Diphtheroids 58.1%, Propionibacteria 31%, Streptococci 23.1%, Staphylococcus aureus 10.2%, Haemophilus plus Gram-negative diplococci 7.5%, other Gram-negative rods 4.5%, Enterococci 2%. The Enterococci-Staphylococci profile was the most resistant (erythromycin 47.4%, methicillin 42.8%, ciprofloxacin 23.1%, tetracycline 18.4%, gentamicin 15.7%, levofloxacin 15.1%, tobramycin 14.8%, ..., chloramphenicol 3.7%, rifampicin 1.6%, and fusidic-acid 0.6%). The typical respiratory bacteria remained sensitive to chloramphenicol and beta-lactams. Other Gram-negative rods were sensitive to aminoglucosides, quinolones, and certain beta-lactams. CONCLUSIONS: None of the antibiotics tested here, including cefuroxime and levofloxacin, was active against the whole isolated conjunctival bacteria of our patients. On the basis of our resistance patterns and other prophylaxes effects, two phases of local prophylaxis are suggested: first, eliminating Staphylococci and respiratory bacteria with rifampicin or chloramphenicol, preoperatively; second, giving levofloxacin from 1 h before surgery until 6 days afterwards.