HSLS Update

DailyMed Web Site

As of November 2005, drug manufacturers are required to provide product labels (package inserts) to the Food and Drug Administration (FDA) in a standardized, electronic format. The idea behind this new label layout is to manage the risks of medication usage, and to reduce medical errors. 

A direct result of this recent FDA requirement is a useful Web site, DailyMed <http://dailymed.nlm.nih.gov>, developed by the FDA and National Library of Medicine to provide up-to-date medication information for consumers and health care professionals.

The uniform product label format includes:
•  Description -- name, route of administration, active ingredients, inactive ingredients, and structural formulas;
•  Clinical pharmacology -- pharmacokinetics and pharmacodynamics;
•  Indications and usage;
•  Contraindications, warnings, precautions such as information for patients, laboratory tests, drug interactions, carcinogenesis, mutagenesis, animal toxicology, and pediatric use, adverse reactions, overdosage;
•  Dosage and administration;
•  How supplied -- marks (words, numbers, and scoring), how to store, and manufacturer’s contact information. 

DailyMed allows users to e-mail, download information, and request an RSS (Really Simple Syndication) feed for notification of drug updates.

 DailyMed also links from each drug page to MedlinePlus, clinical trials, and biochemical data.  The latter link connects to DrugBank, a database combining detailed drug data and comprehensive drug target information. DailyMed also provides a link to the FDA’s MedWatch, where clinicians and the public can report adverse events on any FDA-regulated drug, biologic, medical device, or dietary supplement.  Other DailyMed links lead to a preformulated PubMed search that retrieves all citations, or limits to adverse effects, therapeutic use, pharmacology, or clinical trials related to the drug.

Currently, DailyMed content consists of about 50 newly and recently approved prescription drugs, and drugs approved for new uses. However, since the FDA reviews and approves each label annually, every medication on the market should appear in the database over the next twelve months.

--Linda Hartman