Latelines for Dec. 8, 2003
The pharmacy industry had mixed reactions to the Medicare drug benefit legislation, which passed both the House and Senate and is poised for signature by President Bush. NCPA is disappointed because it feels the sweeping legislation gives way too much power to PBMs, putting the viability of community pharmacists at risk. The Pharmacists Provider Coalition, however, applauded the measure because it contains provisions for medication therapy management for seniors, even though it doesn't specify that these services are to be provided by a pharmacist. The coalition consists of seven pharmacy groups: AMCP, AACP, ACCP, APhA, ASCP, ASHP, and the College of Psychiatric and Neurologic Pharmacists. Absent from the coalition are NCPA and NACDS.
Abarelix (Plenaxis, Praecis Pharmaceuticals) has been approved for the treatment of advanced prostate cancer in men who have no alternative therapy (those who have not responded to other hormonal therapies and who refuse surgical castration). Abarelix is a gonadotropin-releasing hormone antagonist. Distribution of the drug will be limited to physicians and hospital pharmacies that agree to the conditions outlined in the Plenaxis PLUS (PLenaxis User Safety) risk management program, because of an increased risk of serious and potentially life-threatening allergic reactions associated with its use. The manufacturer is also establishing educational programs for physicians, hospital pharmacists, and patients about the risks and benefits of abarelix. In addition, Praecis will establish a system that collects and reports adverse events to the FDA.
More than one-third of medication errors that reach patients in hospitals involve senior citizens. Those findings were revealed in USP's fourth annual report summarizing the most recent data collected by MEDMARX, USP's anonymous national medication error reporting database. Some major findings were that 55% of fatal hospital medication errors reported involved seniors, and when medication errors caused harm to seniors, 9.6% were prescribing errors, 7% were wrong route-related errors, and 6.5% were errors that involved the wrong administration technique. According to USP, of the 192,477 med errors documented by MEDMARX, the vast majority were corrected before causing harm to the patient.
The FDA recently approved tadalafil (Cialis, Lilly ICOS) for the treatment of erectile dysfunction. Tadalafil is an oral phosphodiesterase-5 (PDE-5) inhibitor. The drug is set to be in pharmacies this month.
Estradiol/levonorgestrel (Climara Pro, Berlex Laboratories) transdermal system has been approved for the relief of moderate to severe vasomotor symptoms associated with menopause. Climara Pro, a thin, translucent patch, is the first once-per-week, combined hormone therapy to be approved for this indication. The product delivers 0.015 mg per day of levonorgestrel and 0.045 mg per day of estradiol. Climara Pro will be available in pharmacies in January.
At least two pharmacy chains are courting JC Penney for its 2,700 plus Eckerd drugstore chain. CVS and Kohlberg Kravis Roberts & Co., the U.S. private equity funds group, have submitted an initial indication of interest for Penney's Eckerd drugstore chain. Also, Jean Coutu Group, the Canadian drugstore chain, and Blackstone Group LP, a global investment and advisory firm, have paired up to offer an initial indication of interest in Eckerd.
The FDA has approved lansoprazole delayed-release capsules/naproxen tablets (Prevacid NapraPAC, TAP Pharmaceutical) for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer that required the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Prevacid NapraPAC is available as a daily dose of one lansoprazole 15-mg delayed-release capsule and two naproxen tablets of either 375 or 500 mg. Prevacid NapraPAC is the first combination package of an NSAID and a proton pump inhibitor. The product will be available in pharmacies in early 2004.
Voriconazole (Vfend, Pfizer) has been approved by the FDA for the treatment of esophageal candidiasis. Voriconazole was previously approved in the United States for the primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by Scedosporium apiospermum and Fusarium spp.
Evidence-based guidelines designed to improve the diagnosis and management of chronic neuropathic pain were published in the November issue of Archives of Neurology. The new guidelines offer recommendations for first-line pharmacologic therapies based on results from multiple, randomized controlled studies; impact on quality of life; and costs of treatment. Therapies recommended by a panel of pain management experts for the treatment of neuropathic pain include lidocaine patch 5% (Lidoderm, Endo Pharmaceuticals), gabapentin (Neurontin, Pfizer), opioid analgesics, tramadol, and tricyclic antidepressants. The treatment guidelines were made possible by an unrestricted educational grant from Endo Pharmaceuticals to the University of Rochester Office of Professional Education.
ASCO, the American Society of Clinical Oncology, has published updated guidelines for the use of bisphosphonates in women with breast cancer in the Nov. 1 issue of the Journal of Clinical Oncology. The guidelines support initiation of bisphosphonates in women with evidence of bone destruction on advanced imaging studies but not on plain radiographs. However, an abnormal bone scan without evidence of bone destruction is not considered sufficient cause to start bisphosphonates, nor should the presence or absence of bone pain influence the decision to begin bisphosphonates. The guidelines provide an algorithm for patient management to maintain bone health and encourage oncologists and other healthcare professionals to expand their role in the assessment of osteoporosis risk in women with breast cancer.
Abbott Laboratories has issued a Dear Healthcare Professional letter concerning reports of fire or extreme heat in the respiratory circuit of anesthesia machines when sevoflurane (Ultane) is used in conjunction with a desiccated CO2 absorbent, which can result in patient injury. The letter provided suggestions to reduce the risk of occurrence of these adverse events. Abbott, in collaboration with the FDA, is investigating the causative and preventive factors surrounding the issues of fire, extreme heat, and potential breakdown products resulting from the use of sevoflurane and desiccated CO2 absorbents.
Aventis Pharmaceuticals and the FDA updated the labeling for leflunomide (Arava) to reflect postmarketing reports of rare, serious hepatic injury, including cases with fatal outcomes. Most cases occurred within six months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which may predispose patients to infection.
Following a recent announcement by Merck that it would establish fee-based inventory management agreements with wholesalers, Cardinal Health CEO Robert Walter said in a recent conference call, "The past business model that was heavily dependent on inflationary vendor margin opportunities can no longer support the profit growth objective for the industry or for Cardinal Health, and so we move to a new compensation model with more margin predictability and less capital required. The fee for service will likely be different for drugs that require special handling, like controlled substances." A Cardinal spokesman said it is too early to draw any conclusions as to whether this new system will result in higher costs for pharmacies. A McKesson spokesman confirmed that the wholesaler is also evaluating a fee-for-service model, following company CEO John Hammergren's recent teleconference in which he said, "We see clear advantages to moving from a risk-based inventory speculation model to a fee-for-service model."
Barr Laboratories recently held a media briefing in New York City to mark the launch of levonorgestrel/ ethinyl estradiol (Seasonale), the first extended-cycle oral contraceptive (OC) to receive FDA approval. Seasonale reduces the number of menstrual periods to just four per year. Anita Nelson, M.D., and Patricia Sulak, M.D., addressed the audience about the benefits of Seasonale. They agreed that the drug gives women even more freedom and control over their lives than the conventional 21/7 OC regimen and does not pose additional health risks compared with conventional OCs.
The American Gastroenterological Association and APhA have launched a public awareness campaign called REDUCE (Risk Education to Decrease Ulcer Complications and their Effects from NSAIDs). The goal of the campaign is to generate awareness of the serious health risks associated with NSAIDs as called for by the Nonprescription Drugs Advisory Committee. Commonly used pain relievers such as ibuprofen and aspirin, both Rx and OTC strengths, can cause ulcers and severe stomach bleeding that can be fatal. For many people these symptoms can occur without warning. The campaign features a public service TV commercial.
The FDA has given the nod to Schering-Plough's Claritin for OTC relief of hives. The firm announced that new Claritin Hives Relief tablets are the first and only FDA-approved, nondrowsy antihistamine to offer OTC itch relief to adults and children age six and older who suffer from hives. The once-daily formulation will be shipping in February 2004 in 10- and 30-count packages.
The Walgreen Co. settled a lawsuit filed on behalf of a seven-year-old New Mexico boy who allegedly suffered permanent brain damage from a dispensing error involving methadone. Terms of the settlement were not revealed. The deal came after an August mistrial in which evidence that a script purported to account for 60 pills missing from the pharmacy's methadone stock was apparently a forgery. The question of the altered Rx has been referred to law enforcement agencies.
As of the first week of November, AdvancePCS began imposing a 99-cent fee on each Rx claim filed that does not use the NCPDP 5.1 transaction standard mandated by HIPAA. The noncompliance fee should have begun to show up as charges against pharmacy reimbursement by the end of November, according to a spokeswoman for the PBM. The volume of noncompliant Rx claims is about "180,000 weekly," she said. Noting that pharmacies are responsible for HIPAA compliance, NCPA urged its independent pharmacy members to check with their software vendors to be sure they are using version 5.1.
Connecticut pharmacists joined an HHS official and the president of the state Lupus Foundation chapter to warn of the dangers of illegal drug importation at a recent health forum in Hartford. Joined by the president of the ASCP, the groups were speaking out against the pro-importation stance taken by the state's Congressional delegation and some state officials.
The FDA recently approved fluticasone/salmeterol 250/50 mcg (Advair Diskus, GlaxoSmithKline) for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis. This is the first and only product to contain an anti-inflammatory drug and a bronchodilator to improve lung function. Advair Diskus 250/50 is the only dosage approved for this indication. Higher doses are not recommended, as no additional improvement of lung function was observed in clinical trials. Advair Diskus was previously approved for the twice-daily, long-term maintenance treatment of asthma in patients age 12 and older.
At an Ottawa press conference, FDA commissioner Mark McClellan called on Canadian officials to step up enforcement of drug laws to stem illegal and unsafe drug importation into the United States. In response, an assistant deputy health minister said there's no evidence that Canadian laws are being broken and no reason to act against pharmacies engaged in such trade. Regulators from the two countries did sign a memorandum of understanding to share information on investigations of Canadian Internet pharmacies.
The 11th Circuit Court of Appeals vacated a U.S. District Court order certifying a class action antitrust suit by drugstores and wholesalers over generic Hytrin (terazosin HCl). The appeals court sent the case back to the lower court to determine whether some of the wholesalers do not qualify for the class of plaintiffs because they actually profited from keeping a generic version of Hytrin off the market. The suit was filed by Valley Drug Co., Walgreen Co., Drug Mart Pharmacy Corp., Hy-Vee Inc., and Stop & Shop Supermarket Co. against Abbott Laboratories and Geneva Pharmaceuticals over an agreement to keep generic Hytrin off the market.
The Pharmaceutical Care Management Association urged the FDA not to change the structure of NDC numbers as part of the agency's bar-code initiative. In a letter to FDA commissioner Mark McClellan, PCMA outlined the central role of NDC numbers in the internal operations of its member PBMs and in their external communications with payers and pharmacies. PCMA urged the agency to tweak the NDC system to ensure the numbers are unique, to prevent their reuse, and to assign and publish the numbers in advance.
Two University of Maryland School of Pharmacy professors have come up with a way to check the authenticity of drugs in just a few seconds. Using Near-Infrared Spectroscopy, the application creates a unique fingerprint for each drug and even for different batches of the same drug. The fingerprints are then stored in a database that regulators, drug manufacturers, and pharmacists can access to check out suspect drugs. The school has submitted the invention to the FDA Counterfeit Drug Task force for its consideration.
Marina Marketos. Latelines. Drug Topics Dec. 8, 2003;147:9.