VIAGRA NEWS

Source: PR-Inside.com

Date: 13-Mar-2007

ALEXANDRIA, Va., March 13 /PRNewswire-USNewswire/ -- Patients requiring the compounding services of their community pharmacist could be left without access to life-saving, patient-specific medications if a draft bill circulating in Congress becomes law. Currently, state laws regulate the creation of specialized medication dosage forms traditionally prepared by pharmacists.

Legislation drafted by Sens. Edward Kennedy (D-Mass.), Pat Roberts (R- Kan.), and Richard Burr (R-N.C.) would usurp long-established state practices and laws regulating pharmacist compounding by handing this responsibility over to the already overburdened Food and Drug Administration (FDA), harming patients through

unnecessary, redundant regulation and leaving many patients no choice but to go without these custom-made medications.

Pharmacist compounding has long been a part of the profession of pharmacy. Today, most medications are mass-produced by pharmaceutical companies, but many patients require custom-made preparations that are prescribed by their physician and compounded by trained pharmacists. Today's pharmacist compounding includes such practices as flavoring a liquid medication for easier consumption by a child, producing medications in a cream or gel format for patients who cannot swallow pills, or making a medicine without a commercially inserted inactive ingredient a patient is allergic to.

These specialized dosage forms of FDA-approved active ingredients are generally unavailable from prescription drug manufacturers and must be custom- prepared by licensed pharmacists. Like any prescription medication, the compounded medication must originate from a physician's prescription for an individual patient and must be specifically written to meet that individual patient's needs.

"Compounding allows a physician and pharmacist to decide a proper course of therapy for a patient without being limited to commercially available drugs/devices," said Bruce Roberts, RPh, executive vice president and CEO of the National Community Pharmacists Association (NCPA). "The main purpose of compounding is to provide a patient's medication in a form that their physician has prescribed to treat their individual condition."

In the time before mass production of drugs by pharmaceutical manufacturers, all medications were compounded by pharmacists.

"The need for this specialized pharmacy service continues to this day," Roberts said, "and pharmacists are trained in compounding safe and effective products that are essential to the health of millions of Americans."

In a briefing Monday for congressional health care staffers, NCPA joined representatives from the International Academy of Compounding Pharmacists, American Pharmacists Association, Pharmacy Compounding Accreditation Board, U.S. Pharmacopeia, and the American Association of Zoo Veterinarians. Central to this discussion was education about the harmful effects of the draft bill.

Compounding pharmacies already face strict regulation from the state boards of pharmacy, which are comprised of pharmacists appointed by the governor. Many state boards of pharmacy also have other health care professionals or consumers who serve on the board. U.S. Pharmacopeia, the official public standards-setting authority for all prescription and over-the- counter medicines, serves as a valuable reference for state boards. Additionally, pharmacies may choose to go thorough voluntary accreditation from the Pharmacy Compounding Accreditation Board.

"Patients would not be well-served by granting the FDA wide discretionary powers to regulate pharmacist compounding," Roberts said. "A better use of the FDA's resources would be to get through the overwhelming backlog of manufactured drugs pending approval."

The courts have repeatedly upheld pharmacists' right to compound despite repeated attempts by the FDA to challenge the activity. In May 2006, U.S. District Judge Robert Junell ruled in Medical Center Pharmacy et al. v. Gonzales et al. that the compounding of ingredients to create a customized drug, in accordance with a valid prescription, does not create a new drug subject to the FDA's approval. In addition, the U.S. Supreme Court has held as unconstitutional FDA's repeated attempts to federalize pharmacist compounding.

The draft bill also would severely restrict interstate distribution of any pharmacist-compounded medicines, a move that would endanger hundreds of thousands of patients served by pharmacies near state borders, "snowbird" patients relying on their hometown pharmacies during the winter, and other rural patients living many miles away from the nearest compounding pharmacy.

"It is important that the ability of pharmacists to help their patients through compounded medications not be diminished and that compounding continue to be recognized as an essential feature of the physician-patient-pharmacist relationship," said NCPA President John Tilley, RPh, a pharmacy owner from Downey, Calif. "The FDA has repeatedly attempted to restrict consumer access to compounded medications for years, in spite of the fact that courts have repeatedly ruled against federal government interference in this traditional, state-regulated part of professional pharmacy practice. Allowing the FDA to interfere with pharmacists' right to compound prescriptions will hurt consumers who rely on these products."

The National Community Pharmacists Association, founded in 1898, represents the nation's community pharmacists, including the owners of more than 24,000 pharmacies. The nation's independent pharmacies, independent pharmacy franchises, and independent chains dispense nearly half of the nation's retail prescription medicines.