Investigation and Analysis on the Label Information of Package Inserts of Pediatric Applicable Drugs of Our Hospital / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for regulating pediatric clinical drugs. METHODS:Package inserts of pediatric drugs used by the outpatient,inpatient and emergency pharmacies of our hospital during January and March in 2015 were collected. The information about pediatric drugs in the package inserts,including drug name,indications or functions,specification,adminis-tration and dosage,was calculated and analyzed. 815 kinds of drugs applicable to adults and children in our hospital were studied to summarize and analyze the dosage form,specification and dose of pediatric applicable drugs. RESULTS:438 package inserts were collected,including 327 related to chemicals and biologicals among which those imported or produced by sino-foreign joint venture were labeled with more complete information about drug use for children compared to those made in China,and 111 rele-vant to Chinese patent medicines and natural medicines for which there were significantly insufficient information about drug use for children. The applicable drugs with the dosage form for children and those with the specification therefor respectively accounted for 51.17% and 31.65% of the above-mentioned 815 kinds of drugs,and were mainly available as injections,tablets or capsules, granules and oral liquid. The drugs labeled with the dose based on the age group of children such as infant,preschooler,school child and adolescent(1-18 years old)accounted for 61.24% of those with the specification for children,the drugs labeled with the dose for babies (28 d-1 year old) accounted for 26.74% thereof,and the drugs labeled with the dose for neonatus (younger than 28 d)accounted for 12.02% thereof. CONCLUSIONS:The label information and variety of pediatric applicable drugs are marked-ly insufficient. It is suggested that our country should formulate relevant policies,strengthen the development of pediatric drugs and improve the data for clinical use thereof to ensure the safety of clinical use for children.