Analysis of information labeling in instructions of antitussive and expectorant drugs in 34 children’s medical institutions / 中国药房

OBJECTIVE To understand the information labeling of children’s medication in the instructions of antitussive and expectorant drugs commonly used in children’s medical institutions， analyze the existing problems， and propose relevant suggestions. METHODS The instructions for 100 antitussive and expectorant drugs commonly used in 20 tertiary children’s hospitals （centers） and 14 maternal and child health hospitals （centers） with regional representativeness in China were collected， and the information labeling of children’s medication in the instructions was investigated and analyzed. RESULTS There were only 7 kinds of antitussive and expectorant drugs for children， and the others were non-specific drugs for children. Among antitussive and expectorant drugs， tablets accounted for 18.00%， injections for 18.00%， and capsules for 4.00%. Among 100 antitussive and expectorant drugs， 72 （72.00%） labeled the usage and dosage for children， 63 （63.00%） labeled the medication items for children， 59 （59.00%） indicated the information of children in the precautions， and pharmacokinetic parameters for children were absent. Compared with imported antitussive and expectorant drugs or the drugs manufactured by joint ventures， there were many missing labeling of medication information for children with Chinese drugs. Among 63 kinds of drug instructions labeled with medication items for children， various instructions information had little guiding significance. CONCLUSIONS There is a lack of labeling in the instructions of antitussive and expectorant drugs for children， and the proportion of special drugs for children remains low. Pediatric drug information in the instructions has little guiding significance for pediatric medication. Relevant departments should further promote the completeness of pediatric medication information in the instructions of antitussive and expectorant drugs to ensure the rational use of children’s medication.

Investigation and Analysis of Medication Information Labeling in 157 Package Inserts of Anticancer Drugs / 中国药房

OBJECTIVE： To investigate and analyze medication information labeling in package inserts of anticancer drugs， and to provide reference for clinical rational use. METHODS： The package inserts of anticancer drugs were collected from drug catalogues of 3 Third Grade Class A hospitals in Nanjin. Common problems of drug package inserts （whether the main contents arweree contradictory or not and whether the contents were fully expressed， etc.）， complete specific labeling items （detailed contents of “ADR” “contraindication” “precautions” and other items）， detailed intravenous injection dispensing guidance （solvent selection， precautions during dispensing， etc.）， package insert labeling difference of drugs with same general name and route of administration were evaluated according to Drug Package Inserts and Label Management Regulation，Regulations for Chemical Drugs and Biological Products for Treatment. RESULTS： A total of 157 package inserts for anticancer drugs were collected and divided into domestic drugs （80 pieces） and imported drugs （77 pieces） according to the source as well as also divided into oral preparation （44 pieces） and injection （113 pieces）. The common problems of package inserts for anticancer drugs contained contradictory main contents， incomplete description， Chinese character errors， missing items and simple description of drug interactions， etc. Compared with domestic or oral anticancer drugs， the labeling rate of each item in the import or injection anticancer drug package inserts was higher， but specific labeling items such as prevention and treatment of vomiting （＜20％） under “precautions” and interference of drugs on clinical tests （＜40％） were lower. The labeling rate of serious ADR after large dose or long-term use was all less than 41％ under the item of “drug overdose” （except for imported drugs）. The labeling rate of intravenous dispensing guidance of imported anticancer drug injection package inserts about preparations was higher than that of domestic ones. There were differences in labeling items as “precautions” （30/56，53.57％）， “pharmacological toxicology” （29/56，51.79％）， “contraindication” （26/56，46.43％） among 56 groups of drug package inserts with same general name and route of administration. CONCLUSIONS： The labeling items for drug package inserts of anticancer drugs need to be further standardized and improved. It is recommended that the relevant departments force pharmaceutical manufacturers to regularly supplement the deficiencies in the package inserts to improve the safety of drug use in clinic.

Analysis of related policies in China and abroad on pediatric off-label drug use / 中国小儿急救医学

The problem of off-label drug use is particularly prominent among children. The main rea-son is that children are not routinely tested in drug clinical trials and lack of medication information in chil-dren′s instructions. In view of this,a number of countries have formulated relevant policies to promote the clinical research of children′s drugs,to improve the information of children′s medication in the instructions, and to standardize the pediatric off-label uses. There are no current laws and regulations related on paediatric off-label drug uses in China,we should learn from the experience of other countries,make laws and regula-tions for pediatrics, implement pediatric drug policy,promote pediatric clinical research data to improve, to guide pediatric drug information more scientificly and sufficiently. Only multi-department cooperation can en-sure children′s safety,rational drug use,and promote the healthy growth of children.

Practice and Enlightenment of Patient Medication Guide in Foreign Countries such as Europe and America / 医药导报

Objective To study and analyze the current situation of patient medication guide in foreign countries, aiming to provide references for the preparation of patient medication guide in China. Methods The current situation of patient medication guide by consulting literatures was mastered. In addition,the design concept of patient medication guide in foreign countries was summarized, the existing problems were analyzed, and the need for improvement was discussed. Results America,Australia,European countries and some Asian countries have developed a mature patient medication guide system under the supervision of the government departments. Patient medication information overseas takes patients ' health literacy into consideration.It employs the concept of information design,focuses on risks and adverse reactions of drugs,and tells patients how to communicate with doctors and pharmacists.At the same time,it has some problems such as improper content and presentation, excessive emphasis on medication risk, not satisfying drug information demand of patients, as well as a lack of medication information for special groups such as the elderly. Conclusion The design,management and practice of patient medication guide in foreign countries set a good example for us.

Readability of the Product Labelling Information of Over-The-Counter Pharmaceuticals in Convenience Store

BACKGROUND: Since November 2012, some of over-the-counter (OTC) medications have been sold in convenience store without pharmacist' s supervision. We purposed to examine if the product labels of OTCs provide sufficient information that is appropriate for consumers who may have low health literacy. METHODS: We compared the difficulty of words that are utilized in pharmaceutical product labels of interest (intervention) with those in the 6th grade textbook (control). Pharmaceutical products of interest were comprised of 13 OTCs which have been sold currently in convenience stores. We grouped words into the 4 levels of difficulty based on the Korean Vocabulary Classification for Education, and statistically tested words frequency in each level between OTCs and control. RESULTS: The 13 OTC labels included lay language (easier or equal to language used in primary school) about 10% less; professional language about 10% more (p < 0.001 in all). Labels for analgesics had the longest and most difficult information, followed by common cold preparations, muscle pain relievers as plaster or cataplasma and digestives. CONCLUSION: The 13 OTC labels might fail to provide appropriate information for safety use by consumers in terms of the difficulty level of words. The improvement of labels of OTC medications and consumer education strategies are called for safety use of OTC medications sold in convenience stores.

Investigation and Analysis of Children Medication Information in 580 Drug Instructions / 中国药房

OBJECTIVE:To provide reference for reasonable and safe use of drugs in children. METHODS:580 prescription drug instructions of chemical drugs and chemical product for treatment were collected from our hospital. Children information stated in drug instruction of exclusive drugs for children and special drugs,and in dosage and usage,clinical trial,pharmacokinetics and other items were all analyzed statistically ratio analysis and sequence analysis. RESULTS:The exclusive drugs for children were few,and major dosage form were injection. The instruction of special drugs were lack of children’s information. Usage and dosage based on monotonous evidence. The pharmacokinetic parameters were incomplete,and there were slender amount of data about chil-dren clinical trials. CONCLUSIONS:The drug instruction of drugs for children are looking blue. It is urgent to standard drug in-struction and complete medication information for children,so as to ensure safe and effective of drug use.

Risk Communication Regarding Drugs:The FDA Strategic Plan for Risk Communication / 薬剤疫学

In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.<br>FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".<br>In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.