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

ALEXANDRIA, VA – May 31, 2012 – 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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The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, is a 501 C6 organization, representing more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States.

Food Marketing Institute (FMI) conducts programs in public affairs, food safety, research, education and industry relations on behalf of its nearly 1,250 food retail and wholesale member companies in the United States and around the world. FMI’s U.S. members operate more than 25,000 retail food stores and almost 22,000 pharmacies with a combined annual sales volume of nearly $650 billion.  FMI’s retail membership is composed of large multi-store chains, regional firms and independent operators. Its international membership includes 126 companies from more than 65 countries. FMI’s nearly 330 associate members include the supplier partners of its retail and wholesale members.

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 2,100 pharmacists and pharmacist technicians who focus upon the specialty practice of pharmacy compounding.  Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be by manufactured medications.  More than 163,000 patients and prescribers also belong to our organization via the grassroots advocacy group, P2C2 (Patients and Professionals for Customized Care).  IACP's mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare.  Visit www.iacprx.org to learn more and to find a compounding pharmacist near you.

The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies – from regional chains with four stores to national companies.  Chains operate more than 40,000 pharmacies and employ more than 3.5 million employees, including 130,000 pharmacists.  They fill over 2.6 billion prescriptions annually, which is more than 72 percent of annual prescriptions in the United States.  The total economic impact of all retail stores with pharmacies transcends their $900 billion in annual sales.  Every $1 spent in these stores creates a ripple effect of $1.81 in other industries, for a total economic impact of $1.76 trillion, equal to 12 percent of GDP.  For more information about NACDS, visit www.NACDS.org.

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists.  Independent community pharmacists are readily accessible medication experts who can help lower health care spending. They are committed to maximizing the appropriate use of lower-cost generic drugs and reducing the estimated $290 billion that is wasted annually by improper medication use. To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com.