Analysis of Influential Factors for the Construction of ADR Damage Relief System under MAH System ：Based on the Perspec- tive of Pharmaceutical Manufacturers in Shaanxi Province
- VernacularTitle:MAH制度下构建药品不良反应损害救济体系的影响因素分析——基于陕西省药品生产企业视角
- Author:
Xiayi JIA
1
;
Yanbing ZHU
2
;
Zuoren LIU
1
;
Hongjun HOU
2
;
Shimin YANG
3
Author Information
1. College of Pharmacy，Guangdong Pharmaceutical University，Guangzhou 510006，China
2. Shaanxi Drug Administration，Xi’an 710065，China
3. College of Pharmacy，Xi’an Jiaotong University，Xi’an 710061，China
- Publication Type:Journal Article
- Keywords:
Marketing authorization holder;
ADR damage relief system;
Influential factor;
Pharmaceutical manufacturer
- From:
China Pharmacy
2019;30(20):2746-2751
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under MAH system.
