What is OLEsearch.com and how does it help me provide better patient care?
OLEsearch.com is web-based information source that is free for MedEsafe users. OLEsearch (Off-Label Events) gives physicians early warnings of drug complications before the complications are formally reported by the FDA. OLEsearch.com provides up-to-the minute summaries of off-label adverse events, drug recalls, lawsuit alerts, and emerging drug problems. OLEsearch.com does not contain drug product labels or drug interaction lists that are already provided by the PDR. OLEsearch.com is a supplemental resource to keep you better informed about off-label medications.
Unlike the PDR, OLEsearch.com provides up-to-the minute summaries of off-label adverse events, drug recalls, lawsuit alerts, and emerging drug problems. OLEsearch.com does not contain drug product labels or drug interaction lists that are already provided by the PDR. OLEsearch.com is a supplemental resource to keep you better informed about off-label medications.
OLEsearch.com is updated weekly with new drugs added each month to the data base. If a drug you are looking for does not appear in the OLE data base just send an email request and the drug information will be provided to you free of charge.
What does off-label mean?
Off-label means medications prescribed for a use not originally FDA approved including:
- unapproved indications
- unapproved combinations
- for patient populations at an unapproved dose
- in an unapproved format
- outside the approved age group
- longer than the approved interval
- at a different dose schedule
Is there a liability risk for off-label prescribing?
Off-label prescribing creates an inherent liability risk for the physician. Increasing patient safety and reducing your liability risk means you must know about the prescribed medication. Sounds simplistic, but with off-label drugs, physicians often lack critical information about adverse effects, dosage, and route of administration that is provided in product labeling for drugs with approved uses. In selecting an "off-label" use, the physician has an obligation to be familiar with the literature regarding such use. Simply relying on a drug representative’s sales pitch or a reprint of a drug-company provided journal as the basis for prescribing an off-label drug is, in most cases, not sufficient to overcome your legal burden of proof in a malpractice lawsuit.
How Can I Use OLE information in my practice?
Since the safety and efficiency of a drug's off-label use has not been studied or approved by the FDA, it is vitally important, for the safety of your patients, that you become aware of the drug's adverse events. Armed with this knowledge, you can
- include the risks in your informed consent including the fact the drug is an off-label prescription
- prescribe a different drug or
- prescribe the drug for only an FDA-approved use
Click Here to learn more about OLEsearch.com