The Medication package insert is "unclear" and "incomprehensible"? The National Drug Administration is carrying out aging adaptation reform

2023-07-04

The font of the Medication package insert is too small to see clearly? Many elderly people said that they could not see the Medication package insert clearly, which also increased the risk of drug use for elderly people invisibly. In order to optimize the management of Medication package insert, solve the problems such as "unclear" of Medication package insert, and encourage the holders of drug marketing licenses to actively explore, the State Food and Drug Administration organized the drafting of the Work Plan for the Pilot Reform of Medication package insert for Aging (the "Work Plan" for short) and the Guidelines for the Preparation of Medication package insert (Simplified Version) (the "Draft for Comments" for short) The requirements for the format of electronic Medication package insert (full version) (draft for comments) are open to the public for comments. The scope of the Work Plan is applicable to the oral and topical drug preparations of elderly patients. The provincial drug regulatory department of the pilot province will organize 5 to 10 holders within the jurisdiction to participate in the pilot work, and each holder will determine 5 to 10 drugs for the Medication package insert aging reform pilot. In addition, the Work Plan puts forward specific implementation requirements for the preparation of the Medication package insert (simplified version), obtaining the electronic Medication package insert (full version) through the two-dimensional code on the drug package or Medication package insert (simplified version). The Simplified Compilation Guide points out that the instructions should include [drug name], [ingredients], [properties], [indications], [specifications], [usage and dosage], [taboos], [medication for pregnant women and lactating women], [medication for children], [medication for the elderly], [drug abuse and dependence], [Drug overdose], [storage], [marketing license holder], etc. (Reporter Tu Duanyu)

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