Latelines for June 4, 2001
Vermont Sen. James Jeffords' decision to leave the Republican Party adds another twist to the dormant drug-reimportation law. Jeffords was a prime mover of the legislation and called on President Bush to implement it. President Clinton had signed the measure, then his administration reversed course and decided it could not guarantee the safety of the FDA-approved drugs after they left the United States. During the Presidential campaign, Bush backed the idea. Tommy Thompson, his HHS secretary, had promised a decision on whether to resuscitate the law by June 30. Now, the White House has to calculate whether it wants to smack Jeffords by killing the law or revive it as a gesture to moderate Republican and Democratic supporters.
Jeffords' switch from the GOP to an independent status tilts the previously evenly divided Senate to a one-vote Democratic margin. That gives Democrats committee chairmanships and control of the voting schedule, but its impact on the outcome of legislation is less clear. It does not, for example, seem to make it any more or less likely that Congress will approve a Medicare Rx benefit before the 2002 elections.
Sen. Tim Johnson (D, S.D.) has introduced legislation that would amend the Social Security Act to recognize R.Ph.s as health-care providers, making them eligible to bill Medicare directly for providing patient care services. Currently, they can bill only "incident to" a physician's service at the lowest billing code. Many third-party payers follow Medicare in designing their compensation systems.
An FDA advisory committee has recommended that no labeling changes be made for Cardura (doxazosin mesylate, Pfizer) until more data from an NIH-sponsored clinical trial become available. The alpha-blocker is indicated for hypertension and benign prostatic hyperplasia. Preliminary data from the trial suggested that doxazosin users had 25% more cardiovascular events and were twice as likely to be hospitalized for congestive heart failure than were users of the diuretic chlorthalidone.
Prescription drug coverage for senior citizens may cost three to four times more than coverage for younger Americans, a study by Express Scripts indicates. The PBM analyzed millions of claims from commercially insured individuals and found those age 65 and older used the equivalent of 29 one-month-supply Rxs in 1998, at a cost of about $1,185. The firm suggested that Congress and other policymakers use the data to evaluate the potential cost of Medicare Rx proposals.
In its new policy statement, "Principles of Patient Safety in Pediatrics," the American Academy of Pediatrics (AAP) makes new recommendations on protecting children from medical errors. This was in response to a new study that showed the rate of potential adverse drug events was three times higher in children than adults in a hospital setting. AAP supports expanded efforts to include children in new drug trials. Currently, physicians must estimate the pediatric dosages for many medications, which increases the risk of drug dosage calculation errors. The nation's pediatricians also encouraged the health-care industry to develop and enforce standards for drug packaging and labeling, avoid "sound-alike" and "look-alike" drugs, and set up appropriate responses to problems identified after a drug is on the market.
PCMA's new president is pledging to do a better job of getting the PBM industry's message out. Capitol Hill and the Bush Administration will be the focal points, said LaVarne A. Burton, a former HHS official and Congressional aide, as Congress considers a Medicare Rx benefit. But eight national pharmacy organizations are making it clear to lawmakers and the Administration that they want PBMs to play a limited role. Speaking with a rare unified voice, the members of the newly formed Pharmacy Benefits All Coalition delivered their views to Congressional leaders last month. They want a pharmacy benefit, not a drug benefit; payments to pharmacies and R.Ph.s for services that address the special needs of seniors; and further discussion of proposals to assign PBMs "patient care and cost management tasks."
Three New England states have tapped Virginia-based First Health Services Corp. to provide PBM services for a drug-buying pool. Maine, New Hampshire, and Vermont hope to cut their $387 million Medicaid drug bill by 10%-15% through combined purchases. A number of other states also are exploring cooperative buying arrangements.
Even if Congress doesn't pass Medicare drug benefit legislation, it should make Medicare cover oral cancer therapies, according to a bipartisan group of lawmakers. Otherwise, noted Rep. Deborah Pryce (R, Ohio), Gleevec (imatinib mesylate, Novartis), a leukemia therapy the FDA gave fast-track approval to last month, would not be covered because its dosage form is 100-mg tablets. Medicare currently covers only IV cancer drugs, except for a handful that originated as IVs but later became available in oral dosages.
Pharmacists are cheering the decision by American Pharmaceutical Partners to affix a bar code to all its products. At present, all of APP's products packaged in 50-cc or larger vials carry a bar code. In the future, APP intends to bar-code even its 2-ml vials. The Los Angeles firm believes this technology, which will help reduce drug errors, will probably be demanded by most hospitals down the line.
Drug manufacturers should be required to give local pharmacies the same price they charge their best customers or the average price they get overseas, the union-founded Alliance for Retired Americans (ARA) recommended May 23. Pharmacies and health insurers also should be allowed to reimport U.S.-made drugs, said the organization established by the AFL-CIO to help push passage of Medicare drug benefit legislation. The alliance issued a report, The Profit in Pills, which was highly critical of the industry's pricing practices. PhRMA president Alan F. Holmer responded that ARA had "dredged up tired old accusations left over from last year's election campaign, all of which already have been disproved."
Hospitals can expect to dispense more antirejection drugs for liver transplant patients. That's because HCFA has decided to cover Medicare patients who undergo liver transplants because they suffer from primary hepatocellular carcinoma (HCC). Since 1990, HCFA has paid for liver transplants, but not if the patient had a liver malignancy. Now HCC patients, who account for 80% of liver tumor cases, will be covered if their tumor has not spread to other areas and they meet certain other conditions. HCFA added that it will conduct a study to determine if other types of malignancies should be covered.
To alert consumers of lorazepam and clorazepate that they may have some refund money coming to them, state attorneys general across the country have mailed a packet of information to pharmacy owners and managers. The refunds are a result of a $100 million settlement between Mylan Laboratories and FTC over charges that the drug firm jacked up the prices of these products after cornering the market on the ingredients. The packet includes a display with tear-off slips listing a number consumers can call for information, inserts that can be stapled to bags when lorazepam or clorazepate Rxs are filled, a brochure on the settlement, and legal notices and claim forms. Consumers who paid out of pocket for the drugs between January 1998 and December 1999 could get refunds for up to 70% of their expenditures during this time period. They have until Sept. 29, 2001, to submit their claims.
Sensormatic Electronics Corp. has unveiled a new FDA-approved antitheft capsule label. It is designed to provide dietary supplement and vitamin makers and packagers with an effective source-tagging solution for their products. The capsule label, approved by the FDA for direct food contact, can be easily inserted into bottles, boxes, and other types of packaged goods during manufacturing. This process decreases inventory theft by effectively hiding the antitheft label from view, making it difficult for shoplifters to determine which items are protected against theft.
Telephoned Rxs and other verbal medication orders should be limited to urgent situations when written or electronic means aren't feasible, the National Coordinating Council for Medication Error Reporting & Prevention has recommended. The council also suggested that verbal orders for antineoplastic agents "should not be permitted under any circumstances because of their narrow margin of safety." This is the eighth in a series of recommendations from the 20-organization panel, formed by USP in 1995.
Two new studies supported by the National Heart, Lung, and Blood Institute found that using long-acting beta-agonists (LABs) alone is not as effective as using inhaled corticosteroids (ICSs) in the treatment of adults with mild-to-moderate persistent asthma. The first study showed that patients treated with the LAB alone had almost four times more treatment failures, nearly three times more exacerbations, and significantly greater increases in measures for airway inflammation. However, the second study did show that patients treated regularly with LABs to supplement ICSs were able to substantially reduce the steroid doses without significant loss of asthma control. The two studies appear in the May 23/30 issue of JAMA.
Marina Marketos. Latelines. Drug Topics 2001;11:7.