197302
Joint Statement on
Antisubstitution Laws and Regulations
POSITION STATEMENT
Approved by the Board of Trustees, February 1973
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"Policy documents are approved by the APA Assembly and Board of Trustees… These are …position statements that define APA official policy on specific subjects…" -- APA Operations Manual. |
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The American Medical Association asked APA to join other organizations in approving this joint statement. As of the end of March 1973, 11 organizations,1 including APA and AMA, had approved this statement. THE PURPOSE OF THIS statement is to affirm the support of the participating organizations for the laws, regulations, and professional traditions that prohibit the unauthorized substitution of drug products.
Traditionally, physicians, dentists, and pharmacists have worked cooperatively to serve the best interests of patients. Productive cooperation has been achieved through mutual respect, as well as through a common concern for the ideals of public service. This mutual respect has been reflected, in part, by joint support over the years for the adoption and enforcement of laws and regulations specifically prohibiting unauthorized substitution and encouraging joint discussion and selection of the supply source of drug products. The basic principles of medical, dental, and pharmaceutical practice are thus utilized and preserved in the interests of patient welfare.
The antisubstitution laws have not obstructed enhancement of the professional status of pharmacy any more than they have, in and of themselves, guaranteed absolute protection from unsafe drugs or have freed physicians, dentists, and pharmacists from their responsibilities to patients. As a practical matter, however, such laws and regulations encourage interprofessional communications regarding drug product selection and assure each profession of the opportunity to exercise fully its expertise in drug usage to the patients' advantage.
Physicians and dentists should be urged to increase the frequency and regularity of their contacts with pharmacists in selecting quality drug products, recognizing that economies to patients can be improved through such communication and taking into account the patients' needs. The pharmacists' knowledge of the chemical characteristics of drugs, their mode of action, toxic properties, and other characteristics that assist in making drug selection decisions should be utilized to the fullest extent practicable by physicians and dentists in serving their patients.
Since drug product selection entails knowledge derived from clinical experience, the physician's role in product selection remains primary and does not permit delegation of decisions requiring medical judgment. A broader role in therapy will evolve for pharmacists as improved understanding and cooperation between the two professions continue to grow.
There has been no evidence that convincing reasons exist to modify or to repeal existing laws and regulations prohibiting the unauthorized substitution of one drug product for the drug product specified by a prescriber. It is our belief that such laws and regulations merit the joint support of the medical, dental, and pharmaceutical professions and of the pharmaceutical industry.
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1The organizations are; the American College of Obstetricians and Gynecologists, the American College of Physicians, the American Academy of Neurology, the American College of Allergists, the American Dental Association, the American College of Cardiology, the American Academy of Dermatology, the American Academy of Family Physicians, the American Academy of Pediatrics, the American Medical Association, and the American Psychiatric Association.