Latelines for Sept. 2, 2002
NACDS will roll out a HIPAA Internet-based training program for community pharmacies now that the final patient privacy rule has been issued. The regulation requires all pharmacies to give employees customized training on the new privacy rule by April 14, 2003. NACDS will offer a basic course for R.Ph.s and techs and one for other personnel who deal with patients or patient records.
Three independent pharmacy buying groups have refused to buy generic drugs from Geneva Pharmaceuticals and intend to replace as many products as possible that are made by Geneva's parent, Novartis Pharmaceuticals. The groups plan to ask the FTC to investigate Geneva's action as restraint of trade. The moves came after Geneva restricted distribution of generic Augmentin (amoxicillin/clavulanate) to certain chains with warehouse systems. The co-ops, Great Lakes Pharmacies, Independent Pharmacies of America, and the Phoenix Pharmacy Group, represent 130 independents.
Meanwhile, GlaxoSmithKline, maker of Augmentin, has filed suits against several generic manufacturers, accusing them of stealing its trade secrets in making their version of the antibiotic. The suits target Novartis; Geneva; Biochemie, supplier of Geneva; as well as Ranbaxy Laboratories and TEVA Pharmaceutical Industriesthe latter two don't have a generic out on the market yet. In response, these companies said they plan to fight the suit.
TEVA Pharmaceutical has agreed to pony up 15% rebates to Missouri for taking part in its SenioRx Program, a Rx drug assistance program for seniors that started in July. However, this concession is good only until next May. TEVA wants the state to reduce its generic rebates to 11%, the same level Medicaid gets. Two other generic drugmakers, Geneva Pharmaceuticals and Mylan Laboratories, are still balking at the 15% rebates.
Escitalopram (Lexapro, Forest Laboratories) has been approved by the FDA for the treatment of major depressive disorder. The drug is a selective serotonin reuptake inhibitor and is a single-isomer version of Forest's citalopram (Celexa). Researchers created escitalopram by reengineering citalopram to remove its inactive isomer. Escitalopram is expected to be in pharmacies by Sept. 5.
The FDA has announced a two-year plan to modernize its good manufacturing practice standards. These are standards the agency uses to inspect drug manufacturers. The program has three goals: to focus on products bearing the greatest potential risk, to ensure the FDA's work does not impede innovation, and to boost consistency in the agency's enforcement of production quality and safety. The FDA would like to use new technology to regulate pharmaceutical product quality. PhRMA approves of this step. However, Public Citizen, a consumer advocacy group, fears the plan would end up using fewer people to protect public health. The new FDA initiative comes at a time when many drugmakers have run into problems with the agency over their manufacturing practices.
Procter & Gamble has received an approvable letter from the FDA for an OTC version of Prilosec. The letter says final FDA clearance will be granted after a study is conducted to make sure consumers understand the drug's labeling. The company expects to begin OTC sales of the drug in the first half of next year.
Beginning in January, Blue Cross & Blue Shield of Illinois will pay R.Ph.s $1 every time they persuade a patient to switch from a brand-name drug to a generic after checking with the prescriber. Trying to rein in drug costs that rose 26% last year to $701 million, the insurer estimated that a high-volume pharmacy could earn $5,000 to $10,000 per quarter. PhRMA protested that the insurer is interfering in the doctor-patient relationship.
Massachusetts state officials charged with setting a pharmacy reimbursement rate for Medicaid have asked drugstores for detailed information on their prescription costs. The state's Division of Health Care Finance & Policy will hold a hearing on the pharmacy reimbursement rate on Sept. 5. The notice for the hearing asks pharmacies for copies of purchase invoices for at least 25 of the most heavily used drugs, as well as any off-invoice discounts in the form of volume discounts, rebates, or credits.
Mary Butler, an 82-year-old retired nurse, is suing CVS for more than $25,000 in damages for a prescription error, which her lawyer claims led to her being hospitalized for one day. The suit, filed in Wayne County Circuit Court in Detroit, claims that instead of a beta-blocker used to treat hypertension, she was given Plendil, a calcium-channel blocker, also used to treat high blood pressure.
An expert panel convened by Children's Hospital of Pittsburgh recommended amoxicillin, especially in higher doses, as first-line treatment of acute otitis media (AOM). However, if the patient has a risk factor for drug resistance or has symptoms for more than three days, the guide calls for Augmentin ES-600 (amoxicillin/clavulanate). Risk factors for developing AOM with drug resistance include patients under age two, children who attend day care, children exposed to antibiotics within the previous three months, and the winter and spring seasons. The experts added that pneumococcal vaccine could reduce AOM episodes, office visits, and tympanostomy tube insertions.
Arthur Bedrosian has been named president of the Lannett Co., succeeding William Farber, who currently serves as chairman of the board of directors. Bedrosian had been the generic manufacturer's v.p. since January.
The Justice Department informed Medco Health Solutions that it is preparing to decide whether to intervene in two whistle-blower lawsuits against the PBM. The letter also offered Merck a chance to respond to issues raised and to notify the government within 30 days on whether it's interested in entering settlement discussions. In response, Merck repeated that its practices comply with all legal requirements and it will reply to the letter and continue to assess the situation.
The Kentucky Pharmacists Association won the right of pharmacies to refuse service to Medicaid patients who have outstanding copayments. The provision is part of an emergency Medicaid regulation that imposed a $1 co-pay as of Aug. 1. A pharmacy must have a provision in its outstanding debt policy stating its right to refuse service and must inform the Medicaid patient with outstanding debt of its intention to refuse service.
Orphan Medical has selected Express Scripts as the exclusive distributor of Xyrem (sodium oxybate), its new drug for cataplexy. Cataplexy is a symptom of narcoleptic patients, who have difficulty staying awake. Orphan Medical explained that it chose Express Scripts' Specialty Distribution Services (SDS) subsidiary because Xyrem is a Schedule III controlled substance with special distribution requirements. Besides providing pharmacy services, SDS will collect patient-registry data, provide reimbursement support, and offer education to patients.
The FDA has approved granisetron (Kytril, Roche), a selective 5-HT3 receptor antagonist, for both the prophylaxis and treatment of postoperative nausea and vomiting (PONV). The recommended dose of granisetron for the prophylaxis and treatment of PONV is 1 mg. The most common adverse events reported in the PONV trials included pain, headache, and fever. Granisetron can be given just prior to or during surgery for PONV prophylaxis or following surgery for PONV treatment. This approval is significant because patients who fail other 5-HT3 receptor antagonists may have success with granisetron. The injectable form of the drug was first approved in 1993 for the treatment of chemotherapy-induced nausea and vomiting. A tablet formulation was approved in 1999 for the treatment of radiation therapy-induced nausea and vomiting.
Latelines. Drug Topics 2002;17:5.