Shanghai Medical Institutions In Preparation To Preparation And Supervision Of The Status Quo Analysis

BackgroundDrug refers to the special products used for preventing, treating or diagnosing human diseases. The effective drug administration is essential for ensuring the safe use of drug by common consumers, as well as protecting the public health. The pharmaceutical preparations dispensed by the medical institutions are restricted to those unavailable from the market, however are necessary to the clinical treatment, so that have the features of low demand, short shelf time and few substitutions. Such preparations are required to have fixed formula and should be approved by the provincial authorities in advance. As the crucial supplements for the commercial drug products, the pharmaceutical preparations made by the medical institutions are non-substitutive to clinical treatment. The same as drug, the quality of preparations is directly related to the public benefits and health protection. Shanghai is the most regarded city with rich medical resources, and one of the leading cities in developing the preparations. However, there are few reports on the research and administration for pharmaceutical preparations from medical institutions in Shanghai.ObjectiveThrough the review of history, and the investigation on the status quo of the make-up, application and administration of the pharmaceutical preparations, this research is aimed to identify the weaknesses and issues in the governmental administration, so that can provide countermeasures and recommendations for improvement.MethodThis study is a descriptive research, taking the medical institutions which have been authorized certification for pharmaceutical preparations in Shanghai as the scene. The research is focused on the status quo of pharmaceutical preparations and the governmental administration on preparations during the year 2005 to 2007. The conclusion has been drawn from qualitative analysis and semi-quantitative analysis based on the statistic yearbooks, approval data on preparations, interview data and other related statistical data. Results1. The number of medical institutions involved in dispensing preparations has decreased gradually in recent years and tends to be reasonable.2. The categories and preparation lines have shrunk correspondingly, and become accordant with the position of the preparations.3. The instruments and people for the pharmaceutical preparations in the medical institutions are not satisfying for the administrative requirements.4. The systems of governmental administration and regulations have been initiated yet still under developing and required to be improved continuously.5. The implementation of certification for Good Preparation Practice (GPP) quality system has contributed to the improvement of preparation quality.6. The measures for the contract manufacture of preparations should be reinforced.7 . The post-approval surveillances and re-assessments of pharmaceutical preparations are suggested to initiate urgently in the near future.ConclusionAs the crucial supplements for the commercial drug products, the pharmaceutical preparations have played an important role to promote public health. The number of medical institutions involved in the preparations and the preparation lines have decreased to be more rational, as well as the quality of preparations has been improved as the results of implementing the national law and regulations by the Shanghai Food and Drug Administration (FDA). However, the instruments, people and quality control system in dispensing preparations are not satisfying. The reinforcement on measures for the contract manufacture of preparations is recommended. In addition, the post-approval surveillances and re-assessments are suggested for better administration.