Safety and Tolerability of More than Six Days of Tedizolid Treatment.

Tedizolid has demonstrated its efficacy and safety in clinical trials; however, data concerning its tolerability in long-term treatments are scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid. A multicentric retrospective study of patients who received tedizolid for more than 6 days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data. The World Health Organization causality categories were used to discern AEs that were probably associated with tedizolid. Eighty-one patients, treated with tedizolid 200 mg once daily for a median (interquartile range [IQR]) duration of 28 (14 to 59) days, were included; 36 (44.4%) had previously received linezolid. The most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%). The most common indications were off-label, including prosthetic joint infections, osteomyelitis, and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) developed anemia, and 6 developed thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17 to 58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF), the rate of myelotoxicity was 17.4%, and only 8.7% had to stop tedizolid; 20 out of 22 with previous linezolid-associated toxicity had no AE. Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a history of linezolid-associated toxicity.

Pharmaceutical humanitarian assistance in the establishment of a drug compounding laboratory in a refugee camp.

In 1992 Medicus Mundi Mediterrània and the Sahrawi Arab Democratic Republic spearheaded a cooperation project to set up a small  drug compounding laboratory in the Sahrawi refugee camps located in the desert town of Rabouni (Algeria's Tindouf province). The goal of the  project was to build a drug compounding facility, create a training center  for local staff, and ensure local production of medicines in cases of  inadequate supply.With the help of external experts and of multiple public and private organizations and institutions, a small compounding laboratory was established with separate work areas, similar to the lines of the  laboratories found in Spanish hospitals. The laboratory now has a stable team of 10-12 pharmacy technicians led by a pharmacist. In the  last 25 years, 40 Sahrawis have been trained through internships in  hospital pharmacy departments abroad, visits to drug compounding labs in other countries, tutoring, and ongoing training programs. Products that  can be compounded in the laboratory include capsules, oral solutions,  creams and ointments, topical solutions, eye drops, and sterile irrigation  and lavage solutions. Over fifty different formulations of varying degrees of complexity have been prepared. One of the most significant challenges, given the political situation and the geographical environment, has been  the procurement and transportation of the active ingredients and the packaging materials/equipment required for the compounding process. After 25 years of continuous work, this project is now a reality thanks to the effort and direct involvement of the Sahrawi people. The experience gained in the last few years has shown the importance of coordinating drug preparation with local prescribing physicians, as well as having quality standards and facilities with homologated low complexity basic equipment that allows, in other areas that is required, the replication of this model.

En 1992, Medicus Mundi Mediterrània y la República Árabe Saharaui Democrática iniciaron un proyecto de cooperación para el  establecimiento de un pequeño laboratorio de producción de  medicamentos en los campamentos de refugiados del pueblo saharaui,  situado en pleno desierto del Sahara, concretamente en Rabuni, Tindouf  (Argelia). Los objetivos del proyecto fueron establecer una estructura e  instalaciones que permitieran la elaboración de medicamentos, crear un  centro de formación de personal local y facilitar cierta capacidad de  producción en situaciones de crisis o emergencia ante la falta de  medicamentos.Mediante el asesoramiento externo y la ayuda de múltiples organizaciones, instituciones y entidades privadas, se construyó un  pequeño laboratorio de características similares al que teníamos en los  hospitales españoles, con áreas diferenciadas de trabajo. El laboratorio  dispone de un equipo humano estable de 10-12 técnicos superiores de  farmacia dirigidos por un farmacéutico.A lo largo de estos 25 años se han formado y capacitado 40 saharauis, a través de estancias externas en servicios de farmacia, visitas a  laboratorios de producción de otros países, tutorización de farmacéuticos y cursos de formación continuada. Se han incluido varias líneas de  producción de medicamentos como: cápsulas, soluciones orales, cremas y  pomadas, soluciones tópicas, colirios, soluciones de irrigación y lavado  estériles. Se han elaborado más de 50 formulaciones distintas, todas ellas de diferente grado de complejidad. Una de las limitaciones más relevantes, por la situación y entorno, fue y sigue siendo la adquisición y envío de materia prima, material de acondicionamiento y/o equipos, necesarios en  cualquier proceso de elaboración. Después de estos 25 años de trabajo  continuado se evidencia la realidad de este proyecto, fruto del esfuerzo e  implicación del pueblo saharaui. La experiencia adquirida en estos años  plantea la extrema necesidad de coordinar las actividades de elaboración  con los equipos médicos y/o prescriptores de la zona, así como disponer  de estándares de calidad e instalaciones con equipos básicos homologados y de baja complejidad, que faciliten la replicación del modelo en distintos ámbitos y/o zonas de actuación.

Cooperación farmacéutica en el establecimiento de un laboratorio de producción de medicamentos en un campamento de refugiados / Pharmaceutical humanitarian assistance in the establishment of a drug compounding laboratory in a refugee camp

En 1992, Medicus Mundi Mediterrània y la República Árabe SaharauiDemocrática iniciaron un proyecto de cooperación para el establecimientode un pequeño laboratorio de producción de medicamentos en los campamentos de refugiados del pueblo saharaui, situado en pleno desiertodel Sahara, concretamente en Rabuni, Tindouf (Argelia). Los objetivos delproyecto fueron establecer una estructura e instalaciones que permitieran laelaboración de medicamentos, crear un centro de formación de personallocal y facilitar cierta capacidad de producción en situaciones de crisis oemergencia ante la falta de medicamentos.Mediante el asesoramiento externo y la ayuda de múltiples organizaciones, instituciones y entidades privadas, se construyó un pequeño laboratoriode características similares al que teníamos en los hospitales españoles, conáreas diferenciadas de trabajo. El laboratorio dispone de un equipo humanoestable de 10-12 técnicos superiores de farmacia dirigidos por un farmacéutico. (AU)

In 1992 Medicus Mundi Mediterrània and the Sahrawi Arab Democratic Republic spearheaded a cooperation project to set up a small drugcompounding laboratory in the Sahrawi refugee camps located in thedesert town of Rabouni (Algeria’s Tindouf province). The goal of the project was to build a drug compounding facility, create a training center forlocal staff, and ensure local production of medicines in cases of inadequate supply.With the help of external experts and of multiple public and privateorganizations and institutions, a small compounding laboratory wasestablished with separate work areas, similar to the lines of the laboratories found in Spanish hospitals. The laboratory now has a stableteam of 10-12 pharmacy technicians led by a pharmacist. In the last 25years, 40 Sahrawis have been trained through internships in hospitalpharmacy departments abroad, visits to drug compounding labs in other countries, tutoring, and ongoing training programs. Products that can becompounded in the laboratory include capsules, oral solutions, creamsand ointments, topical solutions, eye drops, and sterile irrigation andlavage solutions. (AU)