Five pharmacy trade groups have written to Congress to voice their opposition to an amendment to the Food and Drug Administration Safety Innovation Act, saying it could delay patients timely relief from chronic pain and hike drug costs.


Food and Drug Administration Safety Innovation Act, amendment, PDUFA, Prescription Drug User Fee Act, reauthorization legislation, National Community Pharmacists Association, NCPA, National Association of Chain Drug Stores, American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists, Sen. Joe Manchin, hydrocodone, pain relief products, Schedule III, Schedule II, Controlled Substances Act, Schedule II medications, Schedule III medicines, prescription drugs, pharmacy organizations, pharmacy trade groups






































































































































































































































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Pharmacy organizations sound off on PDUFA amendment

June 1st, 2012

ALEXANDRIA, Va. – Five pharmacy trade groups have written to Congress to voice their opposition to an amendment to the Food and Drug Administration Safety Innovation Act, saying it could delay patients timely relief from chronic pain and hike drug costs.

The National Community Pharmacists Association said Thursday that NCPA and the National Association of Chain Drug Stores, American Pharmacists Association, Food Marketing Institute and International Academy of Compounding Pharmacists this week sent a letter to every senator and representative regarding an amendment by Sen. Joe Manchin (D., W.Va.) that changes the classification of common, hydrocodone-containing pain relief products from Schedule III to the more restrictive Schedule II under the Controlled Substances Act.

"We understand the concerns about diversion and abuse of these products and we share these concerns," the pharmacy groups stated in the letter. "Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation's health care costs with no assurance of a reduction in diversion and abuse."

Compared with Schedule III medicines and other prescription drugs, Schedule II medications can't be prescribed as easily by doctors (and in some states, nurse practitioners) and are more expensive for pharmacies to obtain, stock and dispense because government requirements, the pharmacy organizations explained.

They noted that their opposition to the Manchin amendment centers on two key issues: its impact on patient care and the pharmacy's cost of dispensing.

The quality of life of patients suffering from chronic pain — especially long-term care patients — is at risk if the amendment becomes law, according to the groups. For example, they said, prescribers could no longer phone in prescriptions for these products to pharmacies, electronic prescribing of Schedule II medicines is illegal in some states, and these prescriptions can't be refilled.

In addition, higher pharmacy dispensing costs would result from the amendment, including much higher administrative expenses, because of recordkeeping, inventory management and storage requirements. For instance, the groups explained, most pharmacies would need larger safes to store the dozens of dosage forms and strengths of the products covered by the amendment. Some states require that pharmacies do a perpetual inventory count of Schedule II products on a pill-by-pill basis, they pointed out, adding that such costs would ultimately be borne by all patients and health plan sponsors.

The pharmacy organizations contend that with a compressed time frame to pass the Prescription Drug User Fee Act (PDUFA) reauthorization legislation, Sen. Manchin's amendment was incorporated without much deliberation into the legislation that passed the Senate on May 24. The House of Representatives passed its version of the PDUFA bill on May 30. Lawmakers are expected to reconcile differences between the Senate and House bills soon.

An NCPA survey of more than 250 community pharmacists conducted May 25 to 29 backs up the pharmacy groups' concerns regarding the amendment, the association noted. Pharmacists polled overwhelmingly indicated that the proposal would likely delay prescribing and dispensing of these medicines, resulting in needless suffering for patients afflicted by chronic pain, particularly in nursing homes and other long-term care settings, according to NCPA. And to satisfy the more stringent Schedule II conditions, pharmacists surveyed said they would have to extend staff pharmacist hours — in some cases hire additional pharmacists — and install bigger safes.

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