Latelines for July 16, 2001
HHS has released the first in a series of clarifications to federal rules designed to prevent inappropriate disclosure of patients' medical records. Of interest to pharmacists: Private counseling rooms are not required, a friend or relative can pick up a prescription, refill reminders are permitted, and a patient's written consent form is not required to obtain advice on OTCs. As it now stands, the rule does not allow a pharmacist to fill a telephoned Rx unless the patient has provided a written consent. However, HHS secretary Tommy Thompson said he would propose modifications to fix the problem, which will require a formal rule-making procedure. The rules take effect April 14, 2003.
In an effort to curtail the purchase of OTCs used to manufacture methamphetamine, the Washington State Legislature has enacted a bill that includes the following provisions: No pharmacy or other seller may sell, in a single transaction, more than three packages of any products containing ephedrine, pseudoephedrine, or phenylpropanolamine (PPA); no package may contain more than 3 gm of these drugs; no person, not licensed by the department of health, may acquire in any 24-hour period more than the quantities of these drugs listed. Pharmacies, wholesalers, and practitioners are exempt from this restriction. No person may possess more than 15 gm of these substances unless he or she is licensed as noted above.
The FDA does not have the authority to exempt some 4,000 secondary Rx wholesalers from rules that will require them to give customers an extensive "pedigree" identifying the source of the product, which manufacturers and so-called authorized wholesalers are not obligated to provide, the agency has told Congress. A bill pending in the House would require secondary wholesalers to certify the source of their product and drop the pedigree provision. The FDA also told Congress it might amend the same rules that implement the Prescription Drug Marketing Act to permit blood centers that provide limited healthcare services to distribute blood-derivative products.
As part of a continuing effort to improve the content and format of Rx labeling, the FDA is seeking public comment for rules on what studies manufacturers should include in the Clinical Studies section and how to do it in a way that does not cross the line into inappropriate product promotion. The agency also is working on the Pregnancy and Adverse Reaction sections of the labeling.
In another action involving clinical studies, the FDA wants comments on how sponsors of clinical trials for serious or life-threatening diseases should submit information on their projects for inclusion in a publicly accessible NIH databank.
Texas Gov. Rick Perry signed legislation permitting Texas A&M to establish a new pharmacy school on its Kingsville campus. The program will be the fifth pharmacy school in the Lone Star State and the first to serve south Texas. The legislation provides $350,000 in startup funding and $25 million for construction.
After winning a court test that blocks Vermont from using Medicaid Rx rebates to cover more uninsured residents, PhRMA is using the same arguments against Maine. The trade group earlier this month filed suit in federal court against the Centers for Medicare & Medicaid Services to stop the Healthy Maine Prescriptions program. CMS, formerly HCFA, had granted Maine and Vermont federal waivers under Medicaid to fund Rx insurance expansions through manufacturer-required rebates. A federal appeals court last month ruled that CMS did not have the authority to approve the Vermont project (Drug Topics, June 18). In May, a federal appeals court ruled that the Maine Rx Program, an earlier and more far-reaching plan that uses the threat of prior-authorization requirements to force manufacturers to negotiate steep price reductions, could proceed. At PhRMA's request, the court stayed its order until July 31 while the association weighs an appeal to the Supreme Court.
The New Hampshire Board of Pharmacy is requiring Internet and mail-order pharmacies to register with it. The board said it plans to post a list of pharmacies that "offer legitimate and safe prescription medication service" on its Web site.
West Virginia is seeking a PBM to run an Rx-aid program for residents age 60 and older as part of a recently enacted law aimed at reining in Rx spending. The law also requires drug companies to break down their expenditures for R&D, advertising, promotion, marketing, and provider incentives. Another provision requires the state to establish a counterdetailing program to educate prescribers on the relative costs and benefits of various Rxs. In addition, West Virginia is expected later this year to solicit a PBM to work with a coalition it has formed with 14 other states to use their buying power to cut Rx bills and expand coverage.
Debiopharm S.A., a Swiss-based pharmaceutical company, has received FDA approval to market a new formulation of triptorelin pamoate to treat advanced-stage prostate cancer. Joining the already approved one-month controlled-release formulation of triptorelin (Trelstar Depot 3.75 mg) is Trelstar LA 11.25 mg, which delivers triptorelin continuously over a period of three months after intramuscular injection. Studies comparing the two formulations have proven that Trelstar LA is as effective as monthly injections in maintaining castration levels of testosterone. The luteinizing hormone-releasing hormone agonist will be distributed either as a vial alone, containing triptorelin pamoate to be reconstituted in sterile water for injection, or in its DebioClip single-dose delivery system, consisting of a vial containing the active ingredient and a prefilled syringe with 2 ml Sterile Water for Injection.
The FDA has sent a letter to dietary supplement manufacturers recommending they remove from the market products that contain the herbal ingredient comfrey (Symphytum officinale [common comfrey]), S. asperum (prickly comfrey), and S. x uplandicum (Russian comfrey). These plants are a source of pyrrolizidine alkaloids that, if ingested, present a serious health hazard to consumers. Reports in scientific literature associate oral exposure of comfrey and pyrrolizidine alkaloids with the occurrence of veno-occlusive disease in animals. There is also evidence that implicates these substances as carcinogens.
James P. Bradley has been named CEO of RxHub, a controversial plan to electronically transfer prescriptions among physicians, PBMs, and pharmacists. Formerly a senior business development executive with McKessonHBOC, Bradley will put together a management team based in St. Paul for the venture cofounded in February by PBM powerhouses AdvancePCS, Express Scripts, and Merck-Medco. The partners expect RxHub to go live early next year, despite calls by community pharmacy organizations for an FTC investigation.
Micromedex has released enhancements to its UltiMedex product line that flag drug-interaction alerts, check dosages and make recommendations, and link directly to relevant clinical information, including alternative medications. Other options include a tablet and capsule image and imprint database, screening of parenteral medications for physical compatibility, and a Red Book drug product and pricing file. UltiMedex is integrated into clinician order entry and Rx management systems to reduce medication errors and boost productivity, according to the firm based in Greenwood Village, Colo.
Marina Marketos. Latelines. Drug Topics 2001;14:4.