The nurse is caring for a client with migraine headaches. The client asks why she has been prescribed a medication for seizures. Which legislation allows drug companies to share off-label drug use information with healthcare practitioners to allow such a prescription to occur?
1. Therapeutic Products Programme
2. Food and Drugs Act
3. Prescription Drug User Fee Act
4. Health Products and Food Branch
3
Rationale 1: The Therapeutic Products Programme is a piece of Canadian legislation to ensure safety of that country's medications and drugs.
Rationale 2: The Food and Drugs Act is a piece of Canadian legislation to ensure safety of that country's medications and drugs.
Rationale 3: The FDA Modernization Act reauthorized the Prescription Drug User Fee Act, which allows drug companies to give healthcare practitioners information about non–FDA-approved tests of certain drugs. When a drug provides benefits for treatment of a different problem than that for which it was originally prescribed, the drug company is allowed to share accurate information with other physicians about the drug's "unapproved" but effective use in treating that other condition.
Rationale 4: The Health Products and Food Branch is a piece of Canadian legislation to ensure safety of that country's medications and drugs.
Global Rationale: The FDA Modernization Act reauthorized the Prescription Drug User Fee Act, which allows drug companies to give healthcare practitioners information about non–FDA-approved tests of certain drugs. When a drug provides benefits for treatment of a different problem than that for which it was originally prescribed, the drug company is allowed to share accurate information with other physicians about the drug's "unapproved" but effective use in treating that other condition. The Therapeutic Products Programme is a piece of Canadian legislation to ensure safety of that country's medications and drugs. The Food and Drugs Act is a piece of Canadian legislation to ensure safety of that country's medications and drugs. The Health Products and Food Branch is a piece of Canadian legislation to ensure safety of that country's medications and drugs.
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