词条 | Medication package insert |
释义 |
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly.[1][2] In the US the document is called "prescribing information" or the "package insert" (PI) and layperson's document is called the "patient package insert" (PPI).[1] In Europe the technical document is called the "summary of product characteristics" and the document for end-users is called the "package leaflet".[3] Responsible agenciesEach country or region has their own regulatory body. In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied with the product is aimed at end-users.[3] In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car. The list of 1997 drug labelling changes can be found on the FDA's website, here. The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.[4]{{primary-inline|date=August 2018}} The second patient package insert required by the FDA was in 1970, mandating that combined oral contraceptive pills must contain information for the patient about specific risks and benefits.[5]{{primary-inline|date=August 2018}} The patient package insert issue was revisited in 1980 and in 1995 without conclusive action being taken.[https://web.archive.org/web/20060905155817/http://leda.law.harvard.edu/leda/data/85/bschuman.rtf] Finally, in January 2006, the FDA released a major revision to the patient package insert guidelines, the first in 25 years. The new requirements include a section called Highlights which summarizes the most important information about benefits and risks; a Table of Contents for easy reference; the date of initial product approval; and a toll-free number and Internet address to encourage more widespread reporting of information regarding suspected adverse events. Other national or international organizations that regulate medical information include the Japanese Ministry of Health, Labour, and Welfare (MHLW). Other country-specific agencies, especially in the case of EU (European Union) countries and candidates, plus countries of South America and many in Asia and the Far East, rely heavily on the work of these three primary regulators.{{cn|date=August 2018}} Sections of a package insertPackage inserts follow a standard format for every medication and include the same types of information. Different manufacturers may have different titles for their sections, however, to make them easier for the average person to read and comprehend—for example, instead of "Contraindications" the section may be headed, "Who should not take this medication?" The first thing listed is usually the brand name and generic name of the product. The other sections are as follows:
Other uses and initiativesIn addition to the obvious use of inclusion with medications, package inserts have been used or provided in other forms. In the United States, the package inserts for thousands of prescription medicines are available at the DailyMed website, provided by the National Library of Medicine: http://dailymed.nlm.nih.gov South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name, generic name, and classification, and Canada is working on a similar capability. The UK-based electronic Medicines Compendium provides freely available online access to both Patient Information Leaflets (intended for consumers) and Summary of Product Characteristics (aimed at healthcare professionals) for products available in the UK. Patient information is, understandably, usually generated initially in the native language of the country where the product is being developed. This leads to inconsistency in format, terminology, tone, and content. PILLS (Patient Information Language Localisation System) is a one-year effort by the European Commission to produce a prototype tool which will support the creation of various kinds of medical documentation simultaneously in multiple languages, by storing the information in a database and allowing a variety of forms and languages of output. See also
References1. ^1 {{cite journal |last1=Nathan |first1=Joseph P. |last2=Vider |first2=Etty |title=The Package Insert |journal=US Pharm. |date=2015 |volume=40 |issue=5 |pages=8-10. |url=https://www.uspharmacist.com/article/the-package-insert |language=en}} 2. ^{{cite news |last1=Nadine Vanlaer |title=Drug Package Inserts: the Letter of the Law - Packaging Gateway |url=https://www.packaging-gateway.com/features/feature755/ |work=Packaging Gateway |date=August 31, 2006}} 3. ^1 {{cite web |title=Marketing authorisation - Product-information requirements |url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000199.jsp&mid=WC0b01ac0580022bb3 |publisher=European Medicines Agency |accessdate=18 August 2018 |language=en}} 4. ^33 Fed. Reg. 8812 (1968) (codified at 21 C.F.R. §201.305) 5. ^33 Fed. Reg. 9001 (1970) (codified at 21 C.F.R. §310.510) External links
4 : Health informatics|Pharmaceutical industry|Packaging|Labels |
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