Magazine article Drug Topics

Mandatory Generic Substitution Continues to Be Questioned

Magazine article Drug Topics

Mandatory Generic Substitution Continues to Be Questioned

Article excerpt

Mandatory generic substitution, often through legislated preferred drug lists, is part of state efforts to reduce Medicaid costs. But an increasing number of states are requiring physician and patient approval before drug substitution is allowed.

"We are seeing a growing trend to require physician or patient approval of certain generic substitutions, primarily for epilepsy (drugs)," said Carmen Catizone, R.Ph., D.Ph., executive director of the National Association of Boards of Pharmacy. "It's being pushed by the Epilepsy Foundation and some transplant organizations. And some pressure is coming from the manufacturers."

Two drug classes are under particular scrutiny with regard to mandatory substitution-anti-epilepsy drugs (AEDs) and immunosuppressant drugs used for transplant patients. Recently concerns have been raised about antiarrhythmic drugs. Some states are also fine-tuning their Medicaid preferred drug lists for treatment of mental illnesses, AIDS, and cancer.

Although most of the legislative proposals or action related to requiring pharmacists to proactively seek physician or patient approval for generic substitution has centered on AEDs, professional organizations and patient advocates for other medical conditions are seeking similar measures. Of particular concern are the "narrow therapeutic ranges" (reflected in very specific dosing requirements) of many of the immunosuppressants used by transplant and cancer patients.

For example, the National Kidney Foundation has repeatedly expressed concern that generic bioequivalency is lacking for many of the immunosuppressants. The American Heart Association has expressed similar concerns about the antiarrhythmic drugs used in tachyarrhythmia management. And so have some cancer and AIDS patient advocacy groups.

However, the primary area of concern for state legislatures is AEDs, said Richard Cauchi, program director, health program at the National Conference of State Legislatures. "AEDs are where most of the legislative action remains," he said. "The whole area of mandatory generic substitutions remains contentious. Occasionally bills are passed on both sides of the issue. There's been a lot of lobbying."

The American Academy of Neurology (AAN) joined die Epilepsy Foundation last year in actively seeking state legislation that would disallow generic substitution of AEDs "without the full knowledge and consent of both the treating physician and the patient," according to a recent position statement. …

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