美国药典2021通则17.pdfVIP

Printed on: Mon Aug 09 2021, 06:35:19 PM Official Status: Currently Official on 09-Aug-2021 DocId: 1_GUID-46BF6E02-E3E3-492E-A344-8194C8ACC17F_1_en-US (EST) Printed by: Nguyen Nhan Official Date: Official as of 01-Aug-2016 Document Type: GENERAL CHAPTER @2021 USPC 1 á17ñ PRESCRIPTION CONTAINER LABELING INTRODUCTION This chapter applies to labeling instructions and information on prescription containers that are directly dispensed to the patient to promote better patient understanding. These standards do not apply when a prescription drug will be administered to a patient by licensed personnel who are acting within their scope of practice. Medication misuse has resulted in more than 1 million adverse drug events per year in the United States. Patients’ best source (and often only source) of information regarding the medications they have been prescribed is on the prescription container label. Although other written information and oral counseling may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These obligations include giving patients the essential information they will need to understand how to safely and appropriately use the medication and how to adhere to the prescribed medication regimen. Inadequate understanding of prescription directions for use and auxiliary information provided on dispensed containers is widespread. Studies have found that 46% of patients misunderstood one or more dosage instructions, and 56% misunderstood one or more auxiliary warnings. The problem of misunderstanding is particularly com