[Discussion about risk and management of Chinese patent medicine with double identity].

Chinese patent medicine with double identity was a special phenomenon, and many preparations not only were prescription drugs but also over the counter ( OTC) drugs, which brought a lot of trouble. Based on statistics of list of OTC medicines of CFDA, related varieties, route of administration and functions of these drugs were searched. The causes of insufficient were analyzed and the potential risk was investigated. To ensure the safety of drug usage for the patient, risk management system should be set up by improving the technical requirements for registration, improving the drug labels and manuals, playing the role of pharmacists in pharmacy services and raising awareness of doctor and patient for these drugs.