Pharmacy gets reprieve in side-effects rules
ALEXANDRIA, Va. —Pharmacy leaders are breathing easier after the Food and Drug Administration agreed last month to postpone a new patient-information mandate.
The National Association of Chain Drug Stores hailed the FDA’s decision, which effectively gives pharmacies some breathing room in their efforts to comply with the regulation.
In an interim final rule published Jan. 3, 2008, in the Federal Register, the FDA reported it will give pharmacies until Jan. 1, 2009, to comply with a requirement to provide patients with an FDA-maintained toll-free number to report drug side effects. Pharmacies also will have to provide patients with a statement to contact their doctors for advice about side effects.
The newly published rules also give pharmacies some flexibility as to how they distribute the side-effects statement to patients.
The original rule, as proposed by the agency, required that information on a medication’s side effects be included in FDA-approved Medication Guides. “We also proposed that the side-effects statement be distributed with each prescription drug product…and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting,” the agency noted.
However, the FDA acknowledged the difficulties pharmacies and other health stakeholders would have implementing the new rule, and said it would hold off on the mandate until Jan. 1, 2009. “The FDA continues to anticipate that affected entities, including manufacturers of drug products, authorized dispensers and pharmacies, will need time to comply with the new requirements,” the agency reported last month. “Therefore…the agency does not intend to take enforcement action with regard to this interim final rule before that date.”
The FDA’s change of course perhaps reflects an improved climate for more effective dialogue between the chain pharmacy organization and federal health agencies. “NACDS worked closely with the FDA on the impact of this rule, and we are very appreciative of the agency’s sensitivity to pharmacies in complying with a measure that would impact the millions of prescriptions they fill each year,” said association president and chief executive officer Steve Anderson. “We look forward to continuing to work with the FDA to help chain pharmacies meet the requirements by next January.
“We also emphasize the need to raise awareness among patients that the toll-free number is for the sole purpose of reporting side effects, and that it provides no mechanism for patients to obtain medical advice,” Anderson added.
Report says Tesco looking at expansion in Chicago
CHICAGO Tesco is looking to roll out Fresh & Easy Neighborhood Markets in the Chicago area, according to a report in the Chicago Sun Times.
The newspaper attributed the report to a “knowledgeable source” and said Tesco could offer the Chicago area something “unique because of its strong offering of prepared foods, packaged perishables and selection of produce, meat and bakery.”
Tesco has not commented on the report and has said it plans to expand on the West Coast in 2008, opening stores in California, Nevada and Arizona. The chain opened its first store in December and plans to have up to 50 Fresh & Stores open by the end of February.
Lubin promoted to Walgreens vp and new second position
DEERFIELD, Ill. Walgreens today promoted Steven Lubin to divisional vice president and the new position of general manager of marketing for non-mainland operations. In his new role, Lubin will ensure the company’s marketing meets the needs of customers in Puerto Rico and Hawaii.
As general manager of marketing for Puerto Rico, Lubin spent the past three years living on the island. He is relocating back to the company’s Deerfield, Ill., headquarters for his new duties.
“Steve was a huge asset in Puerto Rico as we worked to better meet the unique needs of our island customers,” said Walgreens chairman and chief executive officer Jeffrey Rein. “He also was invaluable as we opened our first Hawaii store last year, quickly grasping what Hawaiian customers want in a drug store and working with a Walgreens team to buy from many local vendors. Steve’s a big part of our early, strong success in Honolulu.”
Lubin joined the company in 1970 as a stock clerk in Chicago while attending college. He managed several Chicago-area stores before moving into Walgreens’ purchasing department in 1980. He was promoted to a divisional merchandise manager in 1988 and to general manager of marketing for Puerto Rico in 2004.