The local medicines body must approve all new prescription drugs using evidence that the medicine is safe and effective for a particular condition. This allows a drug maker to market a drug for the use it was registered for.  While a company is not allowed to market an approved drug for other purposes, the law does let physicians prescribe the medication to treat a condition for which it is not approved.

Are off-label drugs safe?

This is a good question to ask your doctor. Most doctors only prescribe off label when they are confident the medicine will work well for treating a condition. Off-label drugs can help patients when approved treatments aren’t working or when patients have rare conditions that don’t have approved treatments.

Heart medicines, antipsychotics, and antibiotics are commonly prescribed off label. Beta blockers, for example, were first approved for treating high blood pressure but have since been found to be good for treating heart failure and migraines. Some medicines designed to treat depression also are used to treat chronic pain.

Talk with your doctor if you have concerns about any medicine or treatment, particularly if it may be off label.  Here are several questions to ask:

• Is this the approved use of the medicine? You may not know if the use is off label. This question can help you start the conversation with your doctor about your medicines.
• Is the off-label use of this drug likely to be more effective than one approved to treat my illness? This is important because the off-label drug may not be as well tested for your condition.
• What evidence shows that this off-label drug can treat my condition?
• What are the risks and benefits of off-label treatment with this drug?
• Will my health insurance cover off-label treatment with this drug?

http://www.ahrq.gov/consumer/cc/cc042109.htm

This is a picture of the “The Pharmacist’s Oath” taken recently at the South African Pharmacy Council. When last did you say it?