RESUMO
Objective:This paper aims to analyze the monitoring model of Canadian drug price monitoring mod-el based on the international reference price, and make reference for China. Methods: Through policy analysis and literature research, the system combs the specific Canadian practices of using the international reference prices for the drug price monitoring. Results:For the introduction of new drug prices, Canada uses the international median price comparison test, the highest international price comparison test, the treatment category comparison test and the inter-national treatment category comparison test. For the listed drugs, Canada calculates the international price ratio, and then carries out bilateral comparisons and multilateral comparisons to monitor the prices of drugs already on the mar-ket. At present, Canada has achieved effective monitoring of drug prices, that is to say, the introduction of new drug prices complies with the《Excessive Price Guide》;the patented drugs prices are lower than the designed international price;the price difference between the generic drug and the international level has gradually reduced. Conclusions:The Canadian experience is worth learning, and China should add legislative about drug price monitoring, learn from this experience to identify and monitor the varieties and establish the price monitoring and early warning mechanism with the international reference price as the warning indicator.
RESUMO
Introduction The lack of a terminology to compare medical devices together with the arbitrary and opaque nature of product registration systems are major obstacles to a more informed decision process regarding the use and acquisition of new medical devices. This paper describes the systematization of information to help in the identification of similar cardiovascular implantable devices. Methods The systematization was developed in four stages: definition of the technical attributes of each device group; classification of a sample of devices; implementation of the proposed systematization in Protégé; and evaluation of the application. The systematization dealt with a set of common attributes – indication of use, anatomic location, manufacturer, device model and lifetime; and a set of attributes specific for each type of device. Results The systematization was performed by means of a hierarchy of classes with the respective properties in Protégé, which support three basic functions: data entry, query, and maintenance. 38 queries were designed to allow the identification of similar devices according to their technical characteristics. The users’ evaluation showed that the application fulfilled the requirements to monitor the price of these devices on the market. Conclusions Protégé was a useful tool for the systematization of cardiovascular implantable devices that can be used for the post-market vigilance of medical device safety. To better fulfill this aim, other attributes may be incorporated to better characterize the safety aspects of these devices.