Pharmacy Groups: PDUFA Amendment Threatens Most Vulnerable Patients, Increases Drug Costs



Alexandria, Va. — Five leading pharmacy organizations have written to Members of Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients timely relief from chronic pain, while increasing drug costs.

The letter from the American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores and National Community Pharmacists Association was sent to every U.S. Senator and Representative. At issue is an amendment by Sen. Joe Manchin (D-WV) which 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 groups wrote in their 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 to Schedule III and other prescription drugs, Schedule II medications cannot be prescribed as easily by physicians (and in some states, nurse practitioners) and are more costly for pharmacies to obtain, stock and dispense due to government requirements. Opposition to the Manchin amendment centers around two primary issues: its impact on patient care as well as the pharmacy’s cost of dispensing.

First, the quality of life of patients suffering from chronic pain, particularly long-term care patients, is at risk should the amendment become law. For example, 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 cannot be refilled.

Second, higher pharmacy dispensing costs would result from the amendment, including significantly higher administrative costs, due to recordkeeping, inventory management and storage requirements. For instance, most pharmacies would need larger safes to store the dozens of different 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. Such costs will ultimately be borne by all patients and health plan sponsors.

With a compressed time frame to pass the Prescription Drug User Fee Act (PDUFA) re-authorization legislation, Senator Manchin’s amendment was incorporated without much deliberation into the legislation that passed the Senate on May 24, 2012. The House of Representatives passed their version of the PDUFA bill on May 30th. Lawmakers are expected to reconcile differences between the Senate and House bills shortly.

An NCPA survey of more than 250 community pharmacists conducted May 25-29 backs up the pharmacy groups’ concerns regarding the amendment. Survey participants 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. In addition, to satisfy the more stringent Schedule II conditions, community pharmacists surveyed said they would have to extend staff pharmacist hours, in some cases hire additional pharmacists, and install larger safes.

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