Analysis of Pediatric Medication Information Labelling in 46 Pieces of Package Inserts for Skin External Drugs in Our Hospital / 中国药房

ABSTRACT

OBJECTIVE： To investigate the labelling problems of pediatric medication in the package inserts of skin external drugs in our hospital， and to put forward the suggestions. METHODS： A total of 46 package inserts for skin external medicine were collected from outpatient pharmacy of our hospital during Jan.-Dec. in 2018. Information on pediatric medication， precautions for pediatric medication， pediatric usage and dosage， and pediatric pharmacokinetic labelling in those package inserts was analyzed and summarized according to the types of domestic， imported and joint enterprises， classification of western medicine and Chinese patent medicine and labelling clarity， etc. RESULTS： Among 46 package inserts， 37 western medicines and 9 Chinese patent medicines were included； 31 domestic enterprises， 9 import enterprises and 6 joint ventures were involved. The ratio of pediatric medication， precautions （for pediatric medication）， pediatric usage and dosage， and pediatric pharmacokinetics labelling were 38.7％， 58.1％，  29.0％ and 0 for domestic drugs； 88.9％， 55.6％， 44.4％ and 33.3％ for imported drugs； 33.3％， 83.3％， 16.7％ and 0 for joint venture drugs； 59.5％， 62.2％， 32.4％ and 8.1％ for western medicine； 0， 55.6％， 22.2％ and 0 for Chinese patent medicine. 5 （10.9％） drug package inserts clearly indicated the usage and dosage of children； 12 （26.1％） drug package inserts were clearly labeled for the usage and dosage involving children； 12 （26.1％） drug package inserts were clearly marked to remind children to use under the supervision of doctors and adults； 11 （23.9％） drug package inserts clearly indicated that pediatric medication was not clear and the safety of pediatric medication was not yet established； 1 （2.2％） package insert clearly indicated that children should be cautious and forbidden； 3 （6.5％） package inserts did not involve package insert for pediatric medication； 2 （4.3％） package inserts clearly indicated that the drugs were stored in places not accessible to children. CONCLUSIONS： There are some problems in the package inserts of skin external drugs in our hospital， such as the marked rate of pediatric medication is quite different； the contents of the labels of pediatric medication are ambiguous and pharmacokinetic data is absent； the contents of the package inserts are inconsistent and the patients are not easy to understand professional terms. The standardization， strictness and guidance of drug package inserts for children can be improved by strengthening the supervision and management of drug package inserts by drug regulatory authorities， increasing the research and development of children’s special drugs， increasing the attention of pharmaceutical enterprises to pediatric medication， paying the attention to the revision of standard package inserts， advancing the clinical trials of children， and raising the awareness of safe drug use of patients and users.