Off-label drug facts

the primary source for unlabled drug use
  • 547 Pages
  • 0.61 MB
  • English
Fact and Comparisons , St. Louis, Mo
Drugs -- Prescribing -- Handbooks, manuals, etc., Drugs -- Labeling -- Handbooks, manuals,
Statementauthor, Joyce A. Generali ; editor, Dennis J. Cada.
GenreHandbooks, manuals, etc.
ContributionsCada, Dennis J.
LC ClassificationsRM138 .G46 2001
The Physical Object
Paginationxxi, 547, 12 p. (loose-leaf) ;
ID Numbers
Open LibraryOL22473849M
ISBN 10157439083X

This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a publication available from Wolters Kluwer -Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published.

Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by Off-label drug facts book US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a.

Drug companies also use many venues to disseminate information about off-label uses (legally, if ethically questionable), such as providing information to authors of drug compendiums, ghost writing research, providing favorable articles to physicians, publishing preliminary positive findings from research, then not publishing completed negative.

37 rows  provides accurate and independent information on more t. That off-label drug combination had devastating results: Many patients ended up with severe, and potentially deadly, heart valve damage, an outcome that triggered a multi-billion dollar lawsuit. Prevalence of Off -Label use A report showed that for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounted for approximately 21% of prescriptions.

1 The highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%),and antibiotics (41%). Off-label drug use is generally not backed by the level of testing and data that allows FDA approvals. Patients don’t have the guides and warnings that come from FDA-approved labels when using a drug off-label.

Doctors and patients therefore don’t always have enough information about the effects and dangers of the off-label use of the drug. Medications and Off-Label Drugs: Benefit Interpretation Policy (Effective 08/01/) treatment or the study of oncology because the off-label use of such prescription drug has not been approved by the Federal Food and Drug Administration for that indication in one of the.

Off-label Drug Facts. Off-Label Drug Facts assists the healthcare professional in quickly identifying published literature regarding a specific drug use that is not currently approved by the FDA. Includes more than 1, monographs providing off-label drug information for patient populations, indications, route of administration, and dosing.

List the “book” that you are citing (e.g., Drug Facts and Comparisons, Review of Natural Products, Off-Label Drug Facts in the above examples). Make sure to cite the updated date for the specific the drug monograph (or page) Off-label drug facts book on each page (MarchJulyand Author: David Nolfi.

off-label drug facts background, pt population, study design safety, therapeutic considerations, complete evaluation of supporting studies links info from time of FDA approval of the drug to the current evidence and studies or literature.

The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education (CME) exercises, and the media. It is a polarizing term because it can be associated with great benefit or harm to patients.1 In addition, OLDU, along with allegations of pharmaceutical company promotion of OLDU, has been the cause of major lawsuits and historically large out-of-court Cited by: Off-label Drug Facts 1st Edition.

by Joyce A. Generali (Author) › Visit Amazon's Joyce A. Generali Page. Find all the books, read about the author, and more. See search results for this author. Are you an author. Learn about Author Central. Joyce A.

Description Off-label drug facts PDF

Generali Author: Joyce A. Generali. Health Sciences Resource Portal. Health Science Databases. Full-Text Journals. Online Textbooks. Full Database List. Academic Search Complete. Description of this database.

CINAHL Complete. Clinical Pharmacology. Description of this database. Facts and Comparisons eAnswers. Description of this database. Includes drug information through the. The Guide to Off-Label Prescription Drugs: New Uses for FDA-Approved, a unique book in this title, but old edition, if the writer renew, it will be famous book, he collect Evey other use to drugs Read more/5(8).

provides accurate and independent information on more t prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

Data sources include IBM Watson Micromedex (updated 4 May ), Cerner Multum™ (updated 4 May ), Wolters Kluwer™ (updated. Facts On Off-Label Drug Use The term ‘Off-label’ refers to the use of drugs to treat diseases or medical conditions for which they are unintended.

While off-label use may seem appealing for ailments with no known solution, it can potentially harm these users. Off-Label monographs are practitioner-oriented resources intended to aid the health care professional in quickly identifying published literature regarding a specific off-label drug use.

The reader is always directed to the full literature publication for more comprehensive information prior to Author: Wendy Wu. Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration.

Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is generally legal unless it violates ethical guidelines or safety regulations.

On the other hand, knowing that a drug is approved for a specific indication is a reliable indicator that it has passed the rather high bar of evidence for safety and efficacy required by the FDA.

Off label use of medications is not uncommon. A review indicates that 21% of prescriptions are for off-label use. Actually, I thought the number. Facts & Comparisons is a widely used drug resource by pharmacists, pharmacy benefit managers, manufacturers, and academic institutions that contains information on more t prescription medications as well as over-the-counter (OTC) products.

3 The print version, Drug Facts & Comparisons, is organized by therapeutic class and. Off-label drug use is common.

Details Off-label drug facts PDF

Within a group of commonly used medications, roughly 1 in 5 prescriptions were for an off-label use, a report found. Another study found that about 79 percent of children discharged from pediatric hospitals were taking at least one off-label medication.

And a study that Stafford led in showed that of the estimated 21 percent of off-label drug uses in73 percent did not have strong scientific support. To get a drug approved by the FDA, a pharmaceutical company must complete three rounds of testing in human subjects to demonstrate its safety and effectiveness in treating a specific.

Much off-label drug use is considered safe because doctors are familiar with the drug in use and it’s dosing, safety, and post-approval clinical trials for the off-label use. However, as reported in JAMA Internal Medicine, when a drug is used off-label with no strong scientific evidence to back it up, there is a high risk of side effects.

Off-Label Drug Use 2 D.

Download Off-label drug facts FB2

If the drug is not clearly stated to be effective for the off-label indication in one of the above references, the drug will be covered (subject to Limitations and Administrative Guidelines) when the drug: 1. Is for the purpose of treating a medical condition; Size: KB. Frequency of drug prescription increases with age; however the number of off-label medicines use decreases.

The highest proportion of off-label prescription in children occurs in the first two years of life [18,20,22,29,31,].In an outpatient setting in the US, the adjusted probability of receiving at least one off-label prescription in a medical visit was 59% in children’s aged 6 Cited by:   Composed of a number of subsets including Herbal Interaction Facts, Off-label Drug Facts, Drug Identifier, and Review of Natural Products.

HerbMed Maintained by the Alternative Medicine Foundation, this database includes published information on Author: Leena Lalwani.

Off-label drug use is the use of a drug approved by the U.S. Food and Drug Administration (FDA) for other uses or in treatment regimens or patient populations that are not included in approved labeling. The FDA approves drugs or specific indications that are included in the drug's labeling.

Off-label prescriptions are completely legal and are a vital alternative for optimal patient care. But until now, there has been no book to inform and guide patients about off-label uses of drugs.

"The Guide to Off-Label Prescription Drugs provides you with the latest information on more than 1, breakthrough uses for prescription drugs.5/5(1).

Wide off-label use. Before a new drug can be sold in the United States, the FDA must affirm that it is safe and effective for specified uses, which are then described in the medicine's labeling.

Drugs become known for off-label use when publications begin discussing how they can be used for off-label treatment of medical conditions. List. Actiq (oral transmucosal fentanyl citrate), a controlled substance, is used off-label to treat moderate to severe chronic, non-malignant pain even though it is approved in the United States solely for breakthrough pain in cancer patients.Drug Facts and Comparisons: Drug Identifier Facts and Comparisons REMS Immunization Resources IV Compatibility – Trissel's IV Chek Laboratory Values/Body Measurements Manufacturer Index Natural Products Database (e.g., Review of Natural Products) Off-Label Drug Facts Patient Assistance Programs Product AvailabilityAuthor: Matthew P.

Van Cuyk, Jason C. Cooper, James P. New.In November, the agency held a two-day hearing to gather input on whether to give drug and medical-device companies more leeway in promoting off-label use of their products.