Archived: World Medical Association Resolution on Therapeutic Substitution

Adopted by the 42nd World Medical Assembly Rancho Mirage, CA., USA, October 1990
and rescinded at the WMA General Assembly, Santiago 2005

• WHEREAS: Therapeutic Substitution is one form of drug substitution. Therapeutic substitution occurs when a pharmacist substitutes a chemically different drug for the drug that the physician actually prescribed. The drug substituted by the pharmacist belongs to the same pharmacologic class and or to the same therapeutic class. However since the two drugs have different chemical structures, potentially adverse outcomes for the patient can occur.
• WHEREAS: Genetic substitution is entirely different from therapeutic substitution. In generic substitution, a generic drug is substituted for a brand name drug. However, both drugs have the same active chemical ingredient, same dosage strength, and same dosage form.
• WHEREAS: The prescription of a drug represents the culmination of a careful deliberative process between physician and patient aimed at the prevention, amelioration or cure of a disease or problem. This deliberative process requires that the physician evaluate a variety of scientific and psychological data including costs and make an individualized choice of therapy for the patient.
• WHEREAS: Physicians have the responsibility for diagnosing the patient’s condition and for the development of a treatment plan, including the prescribing of appropriate drugs and medications.

BE IT RESOLVED that the World Medical Association supports:

1. Individualization of therapy for patients based on a complete clinical database compiled from a comprehensive history, current physical findings, all relevant laboratory data, and psychosocial factors.
2. Maintaining the prescription authority of the physician so that the patient will receive organized, effective care.
3. Requiring the pharmacist to dispense the exact chemical, dose, and dosage form prescribed by the physician.

BE IT FURTHER RESOLVED that the World Medical Association opposes:

1. The concept of therapeutic substitution because it results in prescribing based on incomplete information and, thus may be harmful to patient welfare.
2. Any governmental law or regulation that permits therapeutic substitution.