158 CHAPTER 3: FEDERAL REGULATION OF MEDICATIONS: DISPENSING Nonetheless, Dr. Bi

Question

158 CHAPTER 3: FEDERAL REGULATION OF MEDICATIONS: DISPENSING Nonetheless, Dr. Bill agreed with Dr. Jake that this was the best course of therapy. After 48 hours of dos- ing, the contractions stopped. Shortly thereafter, the patient suffered a heart attack, delivered a healthy baby, and underwent open-heart surgery. The patient subsequently sued both Dr. Bill and Dr. Jake. 1. Did Dr. Bill or Dr. Jake violate the FDCA? 2. If you were Dr. Bill, what would you have done? 3. Should the patient have been told of the risks? Should the patient have been told the drug was being used off-label? 5. When would you not dispense or prescribe a drug for an off-label use? 6. How much evidentiary weight should the labeling be given in the malpractice lawsuit?

Explanation / Answer

Turbutalin is an asthma medication that is commonly used to treat preterm labor. The use of turbutalin sulfate to treat preterm labor is an unapproved or off-label use. Turbutalin or related drugs used to halt the early contractions , but if the drug administered to pregnant women also penetrate to unborn baby where they affect brain development . Hence yes , Dr Bill or Dr Jake violate the FDCA.

By my point of view , this drug should not be used treat pregnant women as it affects the brain development of unborn baby.

From the FDA perspective once the FDA approves drug healthcare provider generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patients.

In such case, the patient or relative must ask healthcare provider that why they are prescribed off label drug and what are the side effects of it on patient.

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