NABP e-News August 22, 2007

August 22, 2007 12:00 AM

CMS Issues Guidance for Implementation of Tamper-Resistant Prescription Pad Requirements
In a letter distributed August 17, 2007 to state Medicaid directors, the Centers for Medicare and Medicaid Services (CMS) provides details regarding its implementation of certain provisions of the tamper-resistant prescription pad requirement that takes effect October 1, 2007. Described in section 7002(b) of the US Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, the law requires all written, non-electronic prescriptions for Medicaid outpatient medications to be written on tamper-resistant pads in order to be reimbursable by the federal government. In the letter, CMS states that, by October 1, 2007, a “tamper-resistant” pad must have security features designed to prevent at least one of the following transgressions: (1) unauthorized copying of a completed or blank prescription form; or (2) the erasure or modification of information written on the prescription by the prescriber; or (3) the use of counterfeit prescription forms. As of October 1, 2008, however, prescription pads must have security features designed to prevent all three violations. CMS clarifies that the requirement does not apply when a prescription is transmitted electronically, verbally, or by fax; when a managed care entity pays for the prescription; or in most cases when drugs are provided in certain institutional and clinical settings. CMS says it will allow emergency fills with a non-compliant written prescription as long as the prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours.

Second-Quarter Survey Confirms Most Online Pharmacy Spammers Are Illegitimate
Results of a second-quarter survey show that most Internet pharmacies sending unsolicited advertisements via e-mail are not what they claim to be. The survey, released August 20, 2007 by MarkMonitor, a privately held firm that alerts companies if their brand is being abused online, finds that most of the Web sites advertised are selling counterfeit versions of name-brand medications. MarkMonitor also reports that less than half of the sites provide a secure connection to protect customer information and that, in many cases, online pharmacies claiming to be based in the United States or Canada have actually been traced to China, Russia, India, or other countries. MarkMonitor examined 60 million spam e-mails advertising six popular drugs, including name-brand medications for erectile dysfunction, as well as antidepressant and antianxiety drugs. Of the 3,160 online pharmacy businesses advertising via bulk e-mail messages that the firm examined, only four were found to be legitimate. An article appearing August 20, 2007 in BusinessWeek online, which cites the MarkMonitor survey, notes that experts advise consumers buying medications online to purchase them only from pharmacy sites accredited by the NABP Verified Internet Pharmacy Practice Sites^™ (VIPPS^®) program.

Proposed Legislation Aims for More Effective Pain Management
The recently proposed National Pain Care Policy Act of 2007 seeks to eliminate barriers to pain medications for patients who legitimately need them. Representatives Lois Capps of California and Mike Rogers of Michigan introduced the bill (HR 2994) on July 11, 2007. The bill calls on the secretary of Health and Human Services to enter into an agreement with the Institute of Medicine to convene a Conference on Pain Care to increase the recognition of pain as a significant public health problem in the United States; to evaluate the adequacy of assessment, diagnosis, treatment, and management of pain in the general population; and to identify barriers to appropriate pain care. The bill also calls for the establishment of a Pain Consortium at the National Institutes of Health to further research on the causes and treatment of pain, along with a National Pain Care Research Advisory Committee. In addition, the bill provides for comprehensive pain care education and training for health care professionals, and a public awareness campaign on pain management. The bill is posted on the Library of Congress Web site.

Grand Jury Indicts 18 on Racketeering Charges in Connection with Costa Rica-based Online Pharmacy
A federal grand jury in San Diego, CA, indicted 18 people on racketeering and related charges for allegedly operating an illegal Internet pharmacy, the office of US Immigration and Customs Enforcement (ICE) announced in an August 2, 2007 news release. The Costa Rica-based operation generated more than $126 million in gross revenues from the illegal sale of prescription medications to customers in 50 states. The 313-count indictment, returned on July 27, 2007, is the result of a two-year multi-agency investigation led by ICE, targeting an online pharmaceutical distribution network known as Affpower, which operated from August 2004 through June 2006. During this period, Affpower allegedly received more than a million Internet orders for controlled and non-controlled prescription medications from throughout the United States and abroad. The defendants include: three physicians, two pharmacists and one pharmacy operator; an administrator and manager; two recruiters of physicians and pharmacies; a credit card processor; and eight affiliate Web site operators. According to the indictment, Affpower sold controlled and non-controlled prescription medications through numerous affiliated Web sites to customers who did not have an authorized prescription for the drugs they ordered.

Four Additional Facilities Awarded VAWD Accreditation
NABP recently accredited four new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 161 as of August 20, 2007. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• American Medical Distributors, Inc distributes controlled-substance prescription medications. The company received accreditation for its North Amityville, NY facility.
• A.F. Hauser, Inc distributes prescription drugs to physicians, veterinarians, pharmacies, and medical clinics in 35 states. The company received accreditation for its Valparaiso, IN facility.
• Boston Scientific Corporation distributes surgical devices and a limited number of prescription medications. The company received accreditation for its Spencer, IN facility.
• Medline Industries, Inc manufactures and distributes medical products including medical-surgical devices, patient care items, and textiles. The company received accreditation for its Mundelein, IL facility.