The Academy of Managed Care Pharmacy today reaffirmed its full confidence in the safety and efficacy of generic drug products. AMCP released the following statement in response to an NBC Today Show segment shown May 26 that raises questions about the suitability of switching patients to generic anti-epileptic drugs and the safety of generic pharmaceuticals in general.
“Generic drugs undergo rigorous evaluation by the federal Food and Drug Administration and must demonstrate that they have the identical active ingredients as their brand-name counterparts,” says AMCP Executive Director Judith Cahill. “We have full confidence in the ability of the FDA to ensure that all generics reaching consumers today are of the highest standard, in terms of both safety and efficacy.”
“That said, all medications - both generic and brand drugs - carry risks. Any patient who experiences an adverse event or unexpected side effect when starting on a new prescription should consult with his or her physician or pharmacist right away,” Cahill adds.
AMCP encourages the use of generic drugs as safe, cost-effective alternatives to brand-name products. In addition to interchangeability between a generic drug and its brand-name counterpart, a generic drug may also be safer than a newer medication in the same therapeutic class. Prescription drugs in the same therapeutic class can often be used interchangeably with one another.
Generic drugs, by definition, are versions of products that have been on the market for many years. The longer a drug has been available, the more health care practitioners know about possible side effects and treatment outcome expectations. This may not be true for a newer therapy option. Promotion of generic drugs can not only lower overall prescription drug spending, but could also prevent unnecessary and unknown side effects from newer treatments.
The Today Show segment and a related article in the May issue of Self magazine singled out generic anti-epileptic drugs -- a group of products that have been the target of certain patient advocacy groups. Some older anti-epileptic drugs are considered “narrow therapeutic index” (NTI) drugs, meaning that small variances in blood levels cause changes in the effectiveness or toxicity of that drug. The FDA has said it is aware that certain individuals and groups have expressed concerns about the switching of anti-epileptic drug products, but that it has “no scientific evidence demonstrating a particular problem with this group of products.”
“Further, there are frequently circumstances other than switches that may cause untoward responses,” said Gary Buehler, director of the FDA's Office of Generic Drugs, in a January 2008 letter to the Iowa Pharmacy Association addressing the topic of anti-epileptic drugs.
The FDA has not changed its position as to the safety and efficacy on any generic products, including anti-epileptic drugs.
The Academy of Managed Care Pharmacy (AMCP) is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's 5,700 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. More news and information about AMCP can be obtained on its website, at www.amcp.org.The Academy will observe its 20th anniversary in 2009.
Contacts:
Academy of Managed Care Pharmacy
Neal Learner,703-683-8416
ext. 608
nlearner@amcp.org