??????????????????????????
?????????????????????????????????????????????????????????????????????????????????FDA??????????????????????
Meeting of the Risk Communication Advisory Committee?2009.2.26-27?
?http://www.fda.gov/AdvisoryCommittees/Calendar/ucm117060.htm
??????????????????????3???????????????????????????CMI?????????????????????????????????????????????????????FDA??????????????????????????????CMI??????????????????
| Consumer Medication Information?CMI? | ??????????????????????????????????????????????????????????FDA??????? |
| Medication Guide?MG? | ????????????????????????????????????????????????????????????? |
| Patient Package Insert?PPI? | ????????FDA??????????????????????????????????????????????????????? |
Consumer Medication Information (CMI)?Questions and Answers
?http://www.fda.gov/cder/news/CMI/QA.htm???????
????????????????????????????????
?????????????? ????2009?2?9??
?http://www.yakugai.gr.jp/attention/attention.php?id=235
?????????????25?????????FDA???????????94%
??World?Report-????????? Credential Vol.2 No.2 P37?
???????
Expert and Consumer Evaluation of Consumer Medication Information?2008??PDF:2410KB?
???????????????????????????????????CMI????????????????????????????????
??????????????????
Prescription Drug Leaflets Need Improvement
???Consumer Update 2008.12.16?
?http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm106950.htm
??????????????????????????????????????????????????????????????????5????????????????????????????????????????????
Food and Drug Administration Risk Communication Advisory Committee February 26-27, 2009 SLIDES????
???????????National Community Pharmacists Association????????????????American Society of Health-System Pharmacists??????????????????????????????????????????(pdf) ?????????????????????Draft Possible Recommendations(pdf)??????????????????
- FDA???????????CMI?MG?PPI?????????????????????standard document for communicating essential information??????????
- ?????????????????????????????????????????????????????
- ???????????????????????�the Drug Facts Box format� ?????????
???�the Drug Facts Box�??????????????????????????DTC???????????????????????????????????????????????????????????????????????????????????
?WEB?�The drug facts box�??????????????? IOM?2006?5???????????Forum on Drug Discovery, Development, and Translation: Workshop–Understanding the Benefits and Risks of Pharmaceuticals?????????????????????Zometa???????????????????????????????????
The Prescription Drug Facts Box:An example using Zometa?PDF5.15MB?
?Presentation. Lisa Schwartz. Drug Forum Workshop 2, May 30-31, 2006.?
??http://www.iom.edu/Object.File/Master/34/923/Schwartz.pdf
?????????2007?????????????????????????????
The drug facts box: providing consumers with simple tabular data on drug benefit and harm.
?Med Decis Making. 2007 Sep-Oct;27(5):655-62. Epub 2007 Sep 14?
http://www.ncbi.nlm.nih.gov/pubmed/17873258
http://mdm.sagepub.com/cgi/reprint/27/5/655
?????????2??Ann Intern Med ??????????????????????�the Drug Facts Box”??????????????????????????????????????????
Communicating Drug Benefits and Harms With a Drug Facts Box: Two Randomized Trials
(Ann Intern Med 2009; 150(8). Early Release 2009.2.17)
?http://www.annals.org/cgi/content/abstract/0000605-200904210-00106v1
?http://www.annals.org/cgi/content/full/0000605-200904210-00106v1
????????????????????????????????????????????????????????????????????????????????????DTC?????????????????????
??????????????????????(pdf) ???????????????????????????????????????????????????????????????????????PPI?????????????????????????????????????????????????�Headline Section�?????????????
Always Read The Leaflet Getting the best information with every medicine
?MHRA 2005??
?http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2018041.pdf
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????
???????????????????????????????????????????????????????????????????????????????????????????????????????
3?7??11:10???5?31???????