Pharmacy groups oppose hydrocodone amendment to PDUFA bill
ALEXANDRIA,Va. — Five pharmacy organizations on Thursday wrote 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-W.Va., 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 healthcare 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 and 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 record-keeping, 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 re-authorization legislation, Sen. 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 30. 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 to 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.
NCPA pinpoints three regulations that inhibit job growth among independents
ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday identified three problematic regulations that inhibit job creation.
The Medicare Part B diabetes testing supplies competitive bidding program threatens patient access to these medical necessities, the association noted, and the 340B Drug Discount program also represents a challenge to community pharmacy due to its loose eligibility criteria. Lastly, job creation can be inhibited by the fee-for-service Medicare enrollment/revalidation fees that many pharmacies have to pay twice.
The announcement came in response to a request from Rep. Darrell Issa, R-Calif., chair of the U.S. House Committee on Oversight and Government Reform, who recently contacted 200 business organizations seeking their insight on regulations that hurt job creation.
NCPA’s response letter details “the regulatory burdens faced by independent community pharmacies,” as well as “examples of rules and regulations where a federal agency did not fully and effectively comply with the rulemaking process.”
In addition to pinpointing those problematic regulations, the NCPA offered possible solutions. For example, the NCPA suggested in order to maintain seniors’ access to diabetes testing supplies NCPA supports a permanent exemption for independent community pharmacies as proposed in H.R. 1936, the Medicare Diabetes Access to Care Act that has been sponsored by Reps. Aaron Schock, R-Ill. and Peter Welch, D-Vt. To reform 340B NCPA supports explicitly closing the language loopholes that allows the programs prescriptions to be used for patients other than the intended recipients, which are uninsured and underinsured Americans. And to stop the double billing for Medicare Part B enrollment and revalidation, NCPA suggested that Congress review how the Centers for Medicare and Medicaid Services is interpreting the applicable statute.
Almond Dream gets coconut treatment
MELVILLE, N.Y. — Almond Dream nondairy yogurt has added a new variety to its lineup.
The brand’s new coconut variety features bits of coconut mixed in. The current lineup of Almond Dream nondairy yogurt includes plain, vanilla, strawberry and mixed berry flavors.
"Almond Dream nondairy yogurt has been very well received by customers and has been praised not only for its taste but creamy texture as well. We are excited to expand our flavor selection to include coconut," said Basel Nassar, COO of the Hain refrigerated foods division.