Personal Injury Law

Prescribing Drugs for Off-Label Use

By John A. Day

Many of us know that  doctors prescribe drugs for uses other than those approved by the FDA. 

This article discusses off-label drug prescribing and suggests that physicians who prescribe a drug for an off-label use follow the following steps to obtain informed consent:

• a statement that the off-label use is an 'experimental use' so all the possible side effects and complications are not known;
• a list of the common and/or known risks and complications with use of the medication;
• a statement that the details of the treatment have been fully explained in lay terms or in terms that are easily understood by the patient;
• a statement that no guarantees about the results of the medication are given; and
• a statement that the patient is not required to take the medication.

Read the entire article here.

Full post as published by Day on Torts on April 22, 2009 (boomark / email).