Academy of Managed Care Pharmacy Issues Statement In Support of Generic Drugs To Help Lower Prescription Costs.Business Editors/Health/Medical Writers ALEXANDRIA, Va.--(BUSINESS WIRE)--May 9, 2003 The Academy of Managed Care Pharmacy (AMCP AMCP Academy of Managed Care Pharmacy AMCP Aeronautical Mobile Communications Panel AMCP Association of Managed Care Providers (now Association of Managed Care Dentists) AMCP Army Materiel Command Pamphlet AMCP Army Married Couples Program ) has issued a position statement that reiterates its support of the use of generic drugs generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. to help lower the cost of prescription medications and help restrain the skyrocketing increases in prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, costs. In 2002, the use of generic drugs exceeded 50% of all prescribed medications. AMCP states that generic drugs are clinically equivalent to brand name drugs; they contain the same active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. (s); are of the same dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. ; have the same route of administration; are identical in strength or concentration; and can be expected to have the same effect and safety profile when administered to patients under the conditions specified on the label. AMCP reminds consumers that the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) requires many rigorous tests and procedures to assure that approved generic drugs are interchangeable in·ter·change·a·ble adj. That can be interchanged: interchangeable items of clothing; interchangeable automotive parts. in with their brand name counterparts. The statement further supports legislative and regulatory changes that would accelerate the entrance of generic drugs into the marketplace. Provisions set forth in the Hatch-Waxman Amendments of 1984 to the Federal Food Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. , such as the 30-month stay and the 180-day exclusivity provisions, are susceptible to strategies that can delay the entry of generic drugs into the marketplace for reasons other than safety and efficacy. AMCP believes these provisions must be addressed in order to streamline the generic approval process and allow patients greater access to generic drugs. Judith Cahill, executive director of AMCP notes, "Although AMCP has always supported the use of generic drugs, the Academy's views had previously been contained within our Policy Digest. The issue has now become so dominant in policy debates, we believed it was necessary to create a discrete statement that additionally contained our position on current legislative issues." The position statement can be found on the AMCP website at: http://www.amcp.org/professional_res/position/019.asp The Academy of Managed Care Pharmacy's mission is to empower its members to serve society by using sound medication management principles and strategies to achieve positive patient outcomes. AMCP has more than 4,800 members nationally who provide comprehensive coverage and services to the more than 200 million Americans served by managed care. More news and information about AMCP can be obtained on their website, at www.amcp.org. |
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