Bibliometric analysis of drug package insert adaptation for the elderly based on Web of Science / 中国药房

OBJECTIVE To explore the hotspots of aging adaptation of drug package inserts， and to provide evidence for the development of aging adaptation of drug package inserts in China. METHODS The relevant English literature on drug package inserts for the elderly published from 2012 to 2022 was retrieved from Web of Science Core Collection； bibliometric analysis was performed by using VOSviewer and CiteSpace software， to explore research hotspots in this field， and summarize obstacles and solutions for the development of this field. RESULTS & CONCLUSIONS This study collected a total of 335 literature related to the aging adaption of drug package inserts， from 819 research institutions in 51 countries （regions）， involving 2 174 authors. The research development of drug package insert adaptation for the elderly has slowed down in the past decade， and developed countries such as the United States and Japan dominate this field. Authors such as Wolf from Northwestern University in the United States， have the largest number of publications（12 literature）. The research focuses in this field include the risk management of medication for the elderly， the updating of medication information for the elderly in drug package inserts， and the understanding and compliance of the elderly with drug package inserts and their influencing factors. The solutions to related obstacles in the development of aging adaption in drug package inserts include improving the visibility and readability of drug package inserts， filling in the information on elderly medication in drug package inserts， and so on. China can learn from the experiences and methods of other countries， conduct investigations into the influencing factors of elderly package inserts and pharmacokinetic studies based on the characteristics of the Chinese population， and improve the safety of medication for elderly patients in multiple dimensions.

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.

Analysis of Drug Use Labeling for Pregnant and Lactating Women in 762 Drug Package Inserts / 中国药房

OBJECTIVE:To provide reference for drug use labeling for pregnant and lactating women. METHODS:The drug package inserts were collected from Linxi Hospital of Kailuan General Hospital during Jul. 2013-Dec. 2015. The information about drug use labeling for pregnant and lactating women was analyzed statistically. RESULTS:Among 762 drug package inserts,pack-age inserts which were not labeled with or labeled with indefinite drug use information for pregnant and lactating women accounted for 31.89% and 52.76% respectively. Among package inserts of 361 domestic chemical drugs and biological products,339 Chinese patent medicine and 62 imported drug,package inserts which were not labeled or labeled with indefinite drug use information for pregnant and lactating women accounted for 22.99% and 25.21%,44.54% and 88.50%,14.52% and 17.74%,respectively. CON-CLUSIONS:Except for poor drug use labeling for pregnant and lactating women in package inserts package,there still are other problems,such as items listed dispersedly,presentation content not consistent. Compared with imported drugs,the missing informa-tion for pregnant and lactating women are obvious in drug package inserts of domestic chemical drugs and biological products,and severe in those of Chinese patent medicine. It is recommended that drug manufacturers should strengthen drug tracing and monitor-ing after listed,and update and revise related content of package inserts timely;drug administration department should strengthen drug package inserts supervision,and unify and standardize labeled content management of drug use.

Analysis of pregnant and lactating women medication in 490 drug instructions / 中国药学杂志

OBJECTIVE: To investigate the instruction for drug use for pregnant and lactating women and to provide reference for standardizing drug package inserts. METHODS: Four hundred and ninty drug instructions sampled from the pharmacy in our hospital were investigated and analyzed on the part for pregnant and lactating women medication by Provisions for Drug Insert Sheets and Labels, Regulatory Guidelines for the chemicals non-prescription drug, Regulatory Guidelines for chemicals and living creature product and other references. RESULTS: In prescription medicines, The rate of pregnant and lactating women to use the medicine circumstance marked was 53.91%, and that of "not yet clear" or "still have no data" was 13.28%, and the other 32.81% have never carried on to mark. In non-prescription medicines, The rate of pregnant and lactating women to use the medicine circumstance marked was 46.23%, 53.77% have never carried on to mark. CONCLUSION: The contents of pregnant and lactating women medication are far from perfect, Which should draw attention to better management.

Considerations on Unlicensed and Off-Label Drug Uses / 中国药房

OBJECTIVE: To provide reference for dealing with the problems arose from unlicensed and off-label drug uses.METHODS: The rationality of unlicensed and off-label drug uses and the possible problems induced by which were analyzed.RESULTS: The existence of unlicensed and off-label drug used has its rationality,and it also in line with the international practices,but it may cause some problems related to policy,laws and regulations and medication safety etc.CONCLUSION: The concerned department and trade association should attach great importance to unlicensed and off-label drug uses and establish a generally accepted principle and strategies to tackle the problems.

Analysis of 375 Drug Package Inserts on "Drug Use for Pregnant Women" / 中国药房

OBJECTIVE:To investigate the "drug use for pregnant women" in drug package inserts and to provide reference in standarding the drug package inserts.METHODS:375 package inserts of common drugs collected in our hospital were analyzed statistically in terms of the item of "drug use for pregnant women".RESULTS:Among the 375 drug package insert,134 stated "forbidden or contraindicated for pregnant women";51 stated "to be used with caution for pregnant women",40 had indefinite explanation about the drug use for pregnant women,and 23 had no explanation for drug use for pregnant women.CONCLUSIONS:It is advisable for the related department in our country tighten control on the safety of drug package inserts by organizing experts to conduct a regular post-marketing reevaluation on the drugs,urging drug manufactures to timely update the drug package inserts,setting and improving the standard format of drug package inserts to ensure the safety of clinical drug use.

Legal Administration of American Drug Labels and Package Inserts / 中国药房

OBJECTIVE: To provide references for the evolvement of the administration of drug labels and package inserts in China. METHODS: By content analysis in non-contact research, 23 law documents relevant to American drug labels and package inserts were collected from FDA website, of which, 7 were acts, 1 federal regulation and 15 guiding principles RESULTS: The drug labels and package inserts of the prescription drugs and the over-the-counter drugs in US were administrated in classification with an emphasis on the contents and formats. CONCLUSIONS: A set of comprehensive lawful system for drug labels and package inserts has been established in American, from which China should draw experience to ensure the comprehensiveness, objectiveness and accuracy of drug information and guarantee safety and efficacy of drugs.