While tying the idea of paying for value into the historical arc of clinical pharmacy, I came across an interesting thought: Was 1952 a low point for pharmacists’ involvement in patient care? Two historical items suggest the answer to this question may be, “Yes.”
1951 Durham-Humphrey Amendment
First, the 1951 Durham-Humphrey Amendment to the Food, Drug and Cosmetic Act (FDCA), sponsored by two pharmacist-legislators, created distinct classes of pharmaceuticals—drugs that required a prescription and drugs that could be sold over-the-counter. Apparently, the primary focus of the amendment was not to establish this dichotomy but to make legal verbally transmitted prescriptions and prescription refills.[1] The federal enforcement mechanism was through the labeling provisions of the FDCA. If a pharmacist sold a prescription-only product without a prescription, that product would be considered to be misbranded and therefore in violation of the FDCA.
Prior to 1951, unless a drug had strong potential for abuse, there were no strong regulations on what products could or could not be sold without a prescription. Clearly, some regulation prohibiting unregulated sale of dangerous substances, is needed, but the Durham-Humphrey Amendment’s failure to establish a third class of behind-the-counter/pharmacist-only products is an issue the profession is still contending with. The Amendment failed to acknowledge pharmacists’ ability (insofar as it existed in 1951) to effectively oversee the use of medications that would perhaps be too dangerous for OTC sales but did not require assessment from a physician before use. First generation antihistamines are examples of products that would potentially fall into this category.
1952 Code of Ethics
The second historical item is the 1952 Code of Ethics.[2] This notorious document, published by the American Pharmaceutical Association, contains incredible quotes that that today seem beyond antiquated. In the second section of the code, “The Duties of the Pharmacist in his Relations to the Physician”, the Code of Ethics states that:
“[The pharmacist] should never discuss the therapeutic effect of a physician’s prescription with a patron nor disclose details of composition which the physician has withheld, suggesting to the patient that such details can be properly discussed with the prescriber only.”
The 1952 Code of Ethics illuminates a different era in pharmacy practice. The statement above clearly describes the patient-physician dyad, not the patient-pharmacist-physician triad of the current pharmaceutical care era. Indeed, it would be impossible to practice clinical pharmacy under the 1952 Code of Ethics.
Conclusion
The 1951 Durham-Humphrey Amendment missed an opportunity to put into law the pharmacist’s ability to make a difference in patient care through effective medication management. The 1952 Code of Ethics echoed the limitations on pharmacists’ abilities by restricting ethical practice to the dutiful and accurate dispensing of prescription products.
The 1960s witnessed encouragement by the APhA for pharmacists to develop a “patient orientation”, such as that of pharmacy pioneer Eugene White’s innovative office-type pharmacy.[3] The 1960s can be considered the origins of clinical pharmacy, which continued to develop through the 70s and 80s, resulting in the 1984 Nursing Home Reform Act’s mandate that pharmacists review medications for nursing home residents and OBRA 90’s requirement that pharmacists counsel Medicaid beneficiaries on prescriptions. The low point for pharmacists’ clinical practice may have been in 1952, and I am confident that with the current movement towards provider status, the high point is yet to come.
[1] Abood RR. Federal Regulations of Medications: Dispensing. In: Pharmacy Practice and the Law. 5th ed. 2008:113-164.
[2] Code of Ethics of the American Pharmaceutical Association. February, 1952.
[3] Sonnedecker G. Economic and Structural Development. In: Kremers and Urdang’s History of Pharmacy. 4th ed. American Institute of the History of Pharmacy; 1986:290-338.
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