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Executive Summary

A Wisconsin therapeutic substitution law enacted in November 1987 is viewed by the state medical society as a "precedent-setting" solution to the issue of the pharmacist's prerogative to alter prescriptions by substituting different products within the same therapeutic class. The key to the Wisconsin law, according to a representative of the Wisconsin State Medical Society, is the restriction of therapeutic substitution to the hospital setting. Signed into law by Governor Tommy Thompson on Nov. 13, the act "resolves the question of whether the practice should be allowed in outpatient settings," Wisconsin State Medical Society General Mamager Thomas Adams maintained in a Feb. 3 letter to "The Pink Sheet." The society believes the new law is the first in any state to decide the question so "clearly," Adams added. The law authorizes therapeutic substitution only in hospitals using a prescribed formulary with the concurrence of the hospital's pharmacy and therapeutics committee, and with the final agreement of the attending physician. The law also stipulates that the state board may not promulgate a rule which would expand the therapeutic alternate drug selection powers of a pharmacist beyond those specified. The Wisconsin solution reflects a policy on therapeutic substitution adopted by the Pharmaceutical Manufacturers Association in the autumn of 1985. The official PMA position acknowledged a role for the pharmacist in therapeutic substitition in hospitals and in-patient settings where there is frequent patient monitoring and where MDs are involved in formulary decisions. PMA supported the Wisconsin legislation. The American Society of Hospital Pharmacists opposed the legislation. At a hearing before the Wisconsin state legislature last spring, ASHP maintained that Wisconsin's regulation permitted therapeutic interchange, not unilateral substitution authority. The society argued that because therapeutic interchange occurs with physician knowledge and consent, it need not be limited to hospital settings. The Wisconsin bill varies significantly from therapeutic substitution efforts in other states such as Washington and California, which authorize independent therapeutic substitution by pharmacists, and Florida, which provides limited prescribing authority. In 1985, a bill to permit therapeutic substitution when authorized by the prescriber passed the Iowa legislature, but was vetoed by the governor. A task force on therapeutic substitution was established jointly in 1986 by the American Pharmaceutical Association and the Pharmaceutical Manufacturers Association. That task force concluded that therapeutic substitution is appropriate only when physicians and pharmacists "interrelate." Passage of the legislation was made possible by "a cooperative effort with the Wisconsin Pharmacy Association and the Wisconsin Pharmacists Association," the medical society representative Adams maintained. PMA supported the Wisconsin bill and worked for its passage. The association argued that legislation was needed to effectively supersede a state regulation that allowed pharmacists to modify drug therapy in nonhospital settings. "The legislation was generated after it was discovered that several managed health care systems, delivering care in the outpatient setting, had obtained protocols from Wisconsin physicians in which the physicians believed they were agreeing to generic substitution, but were in fact agreeing to therapeutic substitution," Adams said. The medical society responded with "a challenge to the administrative rule being used to claim authorization of this practice," and ultimately development of the legislation.

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