Examinando por Materia "Decretos"

Mostrando 1 - 2 de 2

Acceso abierto
Análisis fisicoquímico en condiciones normales y de estabilidad acelerada de amoxicilina tabletas recubiertas de fiable y dudosa procedencia en el Cercado de Lima, diciembre de 2012
(Universidad Privada Norbert Wiener, 2013) Santiago Valverde, Frank Eleazar; Torres Aguirre, Milagros Jacqueline; Chávez Fernández, Ana María
The increasing commercialization of adulterated medicines and the lack of adequate regulatory control in the Peruvian pharmaceutical market represent a risk to patient health. This study aimed to contribute to the control and sanitary surveillance of amoxicillin film-coated tablets. Amoxicillin was selected as the study sample because it is classified as an essential medicine. Three main aspects were evaluated. First, the origin of the medicines was analyzed using checklists based on Supreme Decrees No. 014-2011/SA and No. 016-2011/SA. Second, the physicochemical properties of medicines from both reliable and questionable sources were assessed according to the Amoxicillin Tablets monograph and general chapters <905> and <1151> of the United States Pharmacopeia (USP 35). Third, the stability behavior of amoxicillin was evaluated under partial accelerated stability conditions following Health Directive No. 031-MINSA/DIGEMID. The results showed that the sample from a reliable source complied with all requirements of the Supreme Decrees. Questionable source samples 2 and 3 met the requirements of Supreme Decree No. 016-2011/SA, while sample 1 did not. Furthermore, the establishments from which questionable samples were collected failed to comply with Supreme Decree No. 014-2011/SA. All samples, however, complied with USP 35 acceptance criteria and the national directive regarding physicochemical quality and stability. In conclusion, although amoxicillin marketed in both pharmaceutical and non-pharmaceutical establishments met physicochemical quality standards and demonstrated stability under accelerated conditions, non-pharmaceutical establishments failed to comply with current Peruvian regulatory requirements.
Acceso abierto
Analizar los dispositivos médicos rechazados en el centro quirúrgico de la Clínica Vesalio en base a sus principios, normas, criterios y exigencias básicas, de acuerdo al Decreto Supremo N.° 016-2011/SA-2012
(Universidad Privada Norbert Wiener, 2013) Béjar Delgado, Giovanni Jefferson; Chunga Guzmán, Josefa Eduviges; Llatas Gonzales, Yvonne Magali
This research describes the regulatory conditions in Peru, with greater detail regarding medical devices, with the purpose of identifying those that were rejected in the surgical center of Clínica Vesalio, based on their regulations, criteria, and basic requirements, according to Supreme Decree No. 016-2011/SA, during the year 2012. The rejected medical devices were identified through surveys applied to surgeons and scrub nurses. These rejected medical devices were identified in the surgical center of Clínica Vesalio. The most frequent were the adult urine collection bag, with 33.33%; the two-way Foley catheter, with 26.67%; the gauze sponge, with 23.33%; and surgical gloves, with 16.67%. Likewise, the reasons for rejection were identified. The most frequent was poor quality, with 33.33%, followed by fragility (23.33%); packaging that does not ensure adequate sterility (16.66%); non-compliance with shelf life (16.66%); and finally, non-hermetic sealing, with 10%.