NABP e-News June 27, 2007

June 27, 2007 12:00 am

FDA Seeks Comments on Effectiveness of Medication Guides in Communicating Risks
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is seeking feedback from pharmacy stakeholders on the FDA Medication Guide program. CDER held a public hearing, "Use of Medication Guides to Distribute Drug Risk Information to Patients," on June 12-13, 2007, to assess the effectiveness of Medication Guides in communicating the risks of certain drug and biological products to consumers and identifying Medication Guide distribution challenges and solutions. Among the presenters were manufacturers, distributors, pharmacies, health professionals, and patients. FDA is accepting written and electronic comments until July 12, 2007, on ways to improve communication to patients who receive Medication Guides (Docket number 2007N-0121).

NABP Awards DMEPOS Accreditation to Arizona Home Care
NABP recently announced that Patient CareInfusion dba Arizona Home Care received accreditation through the Association's durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. According to Ridge Smidt, RPh, of Arizona Home Care, the company chose the NABP accreditation program because of its focus on quality patient care and Medicare Part B requirements, as well as the Association's "great customer service, no-nonsense approach, and straight-forward pricing." Pharmacies accredited through the NABP DMEPOS program are doing their part to ensure that Medicare beneficiaries receive the appropriate products, services, and patient care associated with DMEPOS products and will position themselves for participation in the Centers for Medicare and Medicaid Services’ (CMS) competitive bidding process. The news release about the accreditation of Arizona Home Care is posted on the NABP Web site, and more information about the NABP DMEPOS accreditation program is available under Accreditation.

States Adopt Legislation to Tighten Licensing Requirements for Wholesale Distributors

• Colorado: State Bill (SB) 217, Prescription Drug Wholesalers, was signed by the governor on May 25, 2007. The legislation states that, prior to issuing a wholesaler license to an applicant, the Colorado State Board of Pharmacy or a board-approved accreditation body may conduct a physical inspection of the wholesale distribution facility at the business address provided by the applicant. Nothing in this subsection would preclude the board from inspecting a wholesaler.
• Kansas: SB 11 was adopted on May 10, 2007. The legislation provides the Kansas State Board of Pharmacy with the authority to establish more stringent licensing requirements for wholesaler distributors seeking to conduct business in Kansas. It also gives the Board the authority to recognize a third party to inspect and accredit wholesale distributors. While the language does have definitions that relate to the normal distribution channel concept, the bill does not explicitly require pedigrees.

FDA, EC, EMEA Agree to Expand Regulatory Cooperation
FDA, the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several areas. At a meeting June 14-15, 2007, FDA and EU reviewed the past year’s activities under the existing Implementation Plan for the confidentiality arrangement. The goals of the initiative are to promote and protect public health, reduce regulatory burden and costs, and bring innovative products to patients in a timely manner. The initiative also promotes sharing of important safety information about medicinal products among the parties. Building upon previous collaborative achievements in vaccines, oncology, and pharmacogenomics, the agencies agreed to collaborate further in the areas of pediatrics and medicinal products for rare diseases (“orphan drugs”). Furthermore, scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans. Based upon the newly adopted pediatric legislation in the EU, a “Principles of Interactions” document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized.

FDA Clears Computerized Medication Box for US Market
FDA has cleared for marketing the Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients’ use in the home. Essentially a computerized medication box, EMMA can reduce drug identification and dosing errors, and allow health care professionals to monitor patient adherence to medication regimens in an outpatient setting. It may be especially useful for aging patients, as well as those with complex medication regimens such as patients with HIV. Manufactured by INRange Systems in Altoona, PA, EMMA stores prescription medications, emits an audible alert to the patient when the prescribed medications are scheduled to be taken, and releases them onto a delivery tray when activated by the patient at the appropriate time. It uses a Web-based application for a health care professional, such as a doctor or pharmacist, to remotely schedule or adjust a patient's prescribed medications, and provides the health care professional with a history of each time patients access their medications.