HOSPITAL RETURNS: 10-DAY TIME LIMIT IS "UNREASONABLY SHORT,"
HOSPITAL RETURNS: 10-DAY TIME LIMIT IS "UNREASONABLY SHORT," the American Pharmaceutical Association maintained in Dec. 2 comments on an FDA proposal to allow wholesalers to resell drugs returned by hospitals within 10 days after delivery. "APhA submits that 10 days is an arbitrary and unreasonably short time to permit returns," the association's Senior VP and Chief Operating Officer Joan Zaro Saah, PhD, stated. APhA's comments are in response to FDA's Nov. 3 guidance letter, which updates FDA's tentative interpretation of the drug diversion bill. FDA's new interpretation of the bill allows drug wholesalers to resell drugs returned by health care entities when the returns are due to order or shipment error, and when the entities return the shipments within 10 days after receipt and notify the manufacturer of the return. FDA's Nov. 3 update "gives no explanation of how 10 days has been determined to be a `reasonable time,' Saah wrote. "A 10-day limit does not take into account the delays that can be encountered by hospital pharmacies in discovering order and delivery mistakes and simple overstocks. In addition, there is not sufficient reason to prohibit returns of drug products that are not misordered or misfilled," APhA argued. Furthermore, FDA's position to date does not allow "legitimate returns to wholesalers of oversupplied drug products caused by change of patient population, those nearing expiration or other reasons besides misfill or misorder," Saah noted. "There is no statutory authority for different treatment of misfills and misorders from simple oversupplies," she contended. "If the FDA recognizes statutory authority for returns of misfills and misorders to wholesalers," then the agency "also has the basis to recognize the statutory authority for other legitimate returns." In separate comments, The American Society of Hospital Pharmacists contended that "FDA's updated policy places an onerous administrative burden on hospital pharmacists and will result in substantial costs due to FDA's restrictions on returns and wholesalers' reluctance to receive and/or allow credit for returns." The agency should permit unrestricted returns, ASHP General Counsel Robert Greenburg suggested in a Nov. 11 memorandum, urging members to send FDA cost estimates for compliance with the new policy. Several hospitals have submitted widely disparate cost estimates to FDA. Lake Region Hospital and Nursing Home in Fergus Falls, Minn. told the agency in Nov. 19 comments that the proposal would require expenditures of "up to $25,000" in computer programming, form development, and cataloging supplier names and addresses. "Postage alone would cost over $250 per week," assuming 15-20 letters per week, Pharmacy Director Gerald Peterson maintained. Buyer/Inventory Controller Judith Boudreaux of Cincinnati, Ohio's Bethesda Hospitals, Inc. reported in Nov. 21 comments that since July her "time and paperwork involved in taking care of outdates and returns has doubled, as it is very difficult to coordinate all the various return policies from all the pharmaceutical companies." In Nov. 18 comments, St. Joseph Hospital & Health Care Center Pharmacy Services Director Lee Simon estimated labor costs at $2,558.40 plus $80 in postage and handling per hospital pharmacy technician, assuming 10% of technician time will be spent on compliance with the new policy. Therefore, "the aggregate annual cost for 6,000 hospitals will be $15.8 mil.," Simon said. Veterans Administration Pharmacy Service Chief W.B. Breuninger commented on Nov. 21 that V-A's "cost of implementing" the law "would approximate $2,000 per year."
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