31:
117:
334:, 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.
337:
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
175:
The
Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the
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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
112:
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 "patient information leaflet" or "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does state
81:
In the United States, labelling for the healthcare practitioner is called "Prescribing
Information" (PI), and labelling for patients and/or caregivers includes "Medication Guides", "Patient Package Inserts", and "Instructions for Use". In Europe, the technical document is called the
184:, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants, or pH.
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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.
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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.
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In addition to the obvious use of inclusion with medications, Prescribing
Information have been used or provided in other forms. In the United States, the Prescribing Information for thousands of prescription drugs are available at the
200:
and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called
132:(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
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inhalation medication must contain a short warning that excessive use could cause breathing difficulties. The second patient package insert required by the FDA was in 1970, mandating that
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must contain information for the patient about specific risks and benefits. The patient package insert issue was revisited in 1980 and in 1995 without conclusive action being taken.
190:- tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various
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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
521:
160:
302:
Dosage and
Administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children)
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167:) 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.
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233:) and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking
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side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section)
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South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name,
309:(s), strength(s), units in which the dosage form(s) are ordinarily available, identifying features of the dosage form(s) such as the
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upon discovering a problem with a certain car. The list of 1997 drug labelling changes can be found on the FDA's website,
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and
Internet address to encourage more widespread reporting of information regarding suspected adverse events.
194:(studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).
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197:
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74:—the person who will take the drug or give the drug to another person, such as a minor. Inserts for
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be used, for example in patients with other medical conditions such as kidney problems or allergies
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Precautions - explains how to use the medication safely including physical impairments, food (
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Other national or international organizations that regulate medical information include the
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313:(NDC), and special handling and storage conditions (e.g., "Store between 68 and 78°F ")
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288:- provides information regarding whether prolonged use of the medication can cause
140:. The first patient package insert required by the FDA was in 1968, mandating that
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Similar documents attached to the outside of a package are sometimes called
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163:(MHLW). Other country-specific agencies, especially in the case of EU (
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405:"Drug Package Inserts: the Letter of the Law - Packaging Gateway"
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426:"Marketing authorisation - Product-information requirements"
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that provides information about that drug and its use. For
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depicting the package insert as overly long and complicated
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33 Fed. Reg. 9001 (1970) (codified at 21 C.F.R. §310.510)
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33 Fed. Reg. 8812 (1968) (codified at 21 C.F.R. §201.305)
86:" (SmPC), and the document for end-users is called the "
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website, provided by the
National Library of Medicine.
529:, which published SmPCs and Package Leaflets in the UK
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Description - includes the proprietary name (if any),
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Each country or region has their own regulatory body.
211:- lists situations in which the medication should
161:Japanese Ministry of Health, Labour, and Welfare
490:"Home - electronic medicines compendium (emc)"
299:and provides recommended action in such cases
176:product. The other sections are as follows:
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27:Document included in a package of medicine
517:South African Electronic Package Inserts
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152:date of initial product approval; and a
380:Nathan, Joseph P.; Vider, Etty (2015).
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171:Sections of the Prescribing Information
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295:Overdosage - gives the results of an
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218:Warnings - covers possible serious
403:Nadine Vanlaer (August 31, 2006).
84:summary of product characteristics
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146:combined oral contraceptive pills
34:A package insert from 1970, with
535:Drug labels at DailyMed website
527:Electronic Medicines Compendium
522:EMA guidance on preparing SmPC
90:" (PIL) or "package leaflet".
46:is a document included in the
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292:(only included if applicable)
250:Use in specific populations (
305:How Supplied - includes the
130:Food and Drug Administration
76:over-the-counter medications
62:, providing information for
428:. European Medicines Agency
270:of reproductive potential,
108:In the European Union, the
88:patient information leaflet
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541:Drug labels at FDA website
318:Other uses and initiatives
128:In the United States, the
78:are also written plainly.
110:European Medicines Agency
38:brand contraception pills
560:Drug marketing and sales
56:prescription medications
222:that may occur (e.g.,
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188:Clinical Pharmacology
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64:medical professionals
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533:dailymed.nlm.nih.gov
494:www.medicines.org.uk
470:dailymed.nlm.nih.gov
382:"The Package Insert"
101:Responsible agencies
340:European Commission
290:physical dependence
182:nonproprietary name
555:Health informatics
311:National Drug Code
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409:Packaging Gateway
358:Patient education
241:Adverse Reactions
209:Contraindications
70:intended for the
16:(Redirected from
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68:plain language
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307:dosage form
231:grapefruits
198:Indications
549:Categories
499:2021-08-07
475:2021-08-07
466:"DailyMed"
392:(5): 8–10.
364:References
286:Dependence
282:Drug Abuse
52:medication
565:Packaging
432:18 August
276:geriatric
272:pediatric
256:lactation
252:pregnancy
60:technical
386:US Pharm
347:See also
325:DailyMed
297:overdose
243:- lists
122:Roy Doty
95:outserts
72:end-user
264:females
134:recalls
48:package
36:Ovrette
570:Labels
268:males
50:of a
434:2018
284:and
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245:all
213:not
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