Sistemas de gestión de calidad en autoridades reguladoras de medicamentos: impacto social / Quality management systems in drugs regulatory authorities: social impact

El presente trabajo tiene como objetivo abordar el impacto que tiene sobre la sociedad el adecuado desempeño de las autoridades reguladoras de medicamentos a partir de la implementación de un sistema de gestión de calidad (SGC) en estas agencias. Para esto, previamente se muestra un análisis del entorno actual en la regulación de medicamentos y de la influencia de la calidad en los sistemas de salud, que han propiciado un incremento en los controles en este sentido.Se exponen los beneficios tanto para el desarrollo de la industria farmacéutica y biotecnológica como para la población, que recibe los productos de éstas, a través de un modelo que relaciona el desempeño de las autoridades reguladoras y el ciclo de mejora que se ilustra en un SGC. Finalmente, se presenta el caso de la autoridad reguladora cubana, que actualmente dispone de un SGC avalado por agencias certificadoras(AU)

The aim of this paper is to illustrate the social impact of drugs regulatory authorities’ procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described(AU)

[Quality management systems in drugs regulatory authorities: social impact]. / Sistemas de gestión de calidad en autoridades reguladoras de medicamentos: impacto social.

The aim of this paper is to illustrate the social impact of drugs regulatory authorities' procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described.

Neonatal administration of high-dose intravenous immunoglobulin in rhesus hemolytic disease.

Our aim was to assess the effectiveness of neonatal treatment of Rh hemolytic disease with high-dose intravenous immunoglobulin (HDIVIG), in reducing neonatal hemolysis. A total of 40 neonates born to isoimmunized Rh negative women were studied. The population was randomized into 2 groups: Group 1 received IVIG 800 mg/kg/day for 3 days, plus phototherapy; and Group 2 received only phototherapy. No significant difference was observed between the groups in the severity of either the antenatal and neonatal disease, mode of delivery, mean birthweight, gestational age at delivery, proportion of preterm deliveries, 1 minute Apgar Score, days of phototherapy, and presence of neonatal cholestasis. Group 1 babies showed a significantly decreased duration of hospitalization, less hemolysis, and a less marked increase in bilirubin levels on the first day of life than Group 2 newborns. Therefore, Group 1 neonates received less treatment with transfusions (exchange-transfusions and/or simple blood treatment with transfusions) than those in Group 2. Our data suggest that the frequency of transfusional therapy can be reduced by combining conventional phototherapy with HDIVIG. Further studies are needed to determine the optimum timing and dosages of neonatal HDIVIG treatment.

Limb salvage therapy for soft tissue sarcomas of the foot.

From 1974 to 1988, 20 patients with soft tissue sarcomas of the foot underwent attempted limb preservation at UCLA. Eighteen patients had localized tumor and two had metastases. Sixteen patients had previously untreated tumors and four patients had experienced 2-4 local recurrences before definitive management. Eleven patients had grade 3 sarcomas and nine had grade 2 sarcomas. Fourteen patients had an excisional biopsy and six had an incisional biopsy. At the time of definitive local treatment, nine patients had palpable tumor ranging from 2-10 cm (median 5 cm). Sixteen patients received sequential preoperative chemotherapy and irradiation followed by attempted conservative resection. Four patients underwent immediate conservative resection followed by postoperative irradiation. Preoperative chemotherapy was administered over 3 days intraarterially, intravenously or by a combination of routes. Fifteen patients received 60-90 mg doxorubicin and one received 120 mg doxorubicin plus 220 mg cisplatinum. Preoperative irradiation was delivered in 350 cGy fractions to total doses of 3500 cGy (one patient), 2800 cGy (8) or 1750 cGy (7). Postoperative irradiation doses were 4140-6480 delivered in 180-200 cGy fractions. Fifteen of 16 preoperatively treated patients had limb salvage surgery. Four of these 15 had positive histopathologic margins and none received postoperative irradiation. One patient required a primary amputation due to gross involvement of the os calcis. Three of four patients undergoing immediate conservative excision had positive margins and one had gross residual disease. Five patients received chemotherapy following local treatment: 3 adjuvantly and 2 for metastatic disease. Follow-up for salvage patients ranged from 6 to 99 months (median 36). Local control was achieved in 17 of 19 (90%). Two patients recurred in-field at 24 and 30 months. Fourteen of 15 preoperatively treated and salvaged patients maintained local control. Three of four managed with excision and postoperative irradiation were controlled. The actuarial local control at 3 years was 83%. One patient recurred in the inguinal lymph nodes and three patients died of metastatic disease. The actuarial survival and relapse-free survival at 3 years were 83% and 63%. Eleven patients developed acute complications and four had late complications. Of 14 patients surviving with local control, function was good or excellent in 86%. No patient has required an amputation for complications or a dysfunctional foot. Limb salvage therapy for a selected patient with a soft tissue sarcoma of the foot can reasonably be expected to result in a high probability of local control and useful function without compromising survival.