June 13, 2012

Unintended Consequences Could Result From
Reclassifying Hydrocodone

Alexandria, VAMoving hydrocodone products to schedule II will not only create barriers for patients who legitimately need pain relief but also will increase health care costs without much benefit, according to five leading pharmacy associations who oppose an amendment to the Food and Drug Administration Safety Innovation Act.

In letters to all members of Congress, the American Pharmacists Association, the Food Marketing Institute, the International Academy of Compounding Pharmacists, the National Association of Chain Drug Stores, and the National Community Pharmacists Association asked senators and representatives to oppose the amendment by Sen. Joe Manchin (D-WV) to change 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 write. "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."

Schedule II medications cannot be prescribed as easily and are more costly for pharmacies to obtain, stock and dispense due to government requirements, the groups argue.

The letters point out that prescribers would no longer be able to phone-in prescriptions for hydrocodone products and would also not be able to prescribe the drugs electronically in some states. Refills also would be problematic, resulting in delays for patients who need the medications, especially those who live in areas remote from their physicians.

Pharmacists also would bear higher dispensing costs because of recordkeeping, inventory management, and storage requirements. An example, according to the groups, would be the need for larger safes to store a myriad of different dosage forms and strengths of the products covered under the amendment. Expenses would be even greater in states that require pharmacies to do a perpetual inventory count of schedule II products on a pill-by-pill basis.

In an NCPA survey done at the end of May, respondents strongly indicated that the proposal would likely delay prescribing and dispensing of hydrocodone products. The community pharmacists surveyed said they would have to extend staff pharmacists’ hours, possibly requiring additional hiring, and install larger safes to comply with the new requirements for hydrocodone pain medications.

Time is running out to block the amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization legislation. The Senate passed PDUFA with the amendment on May 24. The House of Representatives passed its version of the PDUFA bill on May 30, and the two legislatives bodies are in the process of reconciling their versions for final approval before sending the law to President Obama for signature.

The Manchin amendment, cosponsored by Sens. Mark Kirk (R-IL), Kirsten Gillibrand (D-NY), Chuck Schumer (D-NY), and Jay Rockefeller (D-WV), is designed to make it harder for painkillers to be misused or abused. In addition to the more stringent requirements for prescriptions and storage, fines and penalties would be increased for traffickers.

“The amendment that passed last night with unanimous bipartisan support is a good step toward reaching their dream, and I offer my heartfelt thanks to my colleagues on behalf of all the people in West Virginia who’ve been affected by prescription drug abuse,” Manchin said in a press release shortly after the bill’s passage.

The pharmacy groups point out in their letters that better strategies exist to combat drug diversion and that “states can act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances,” without a change in federal law.

U.S. Pharmacist Social Connect