Latelines for March 19, 2001



Pharmacy unites in seeking federal aid to fight R.Ph. shortage

Nine pharmacy organizations are asking for federal help in turning out more R.Ph.s. "The pharmacist shortage in this country is creating a public health crisis," the groups said in a letter to Mitchell Daniels, director of the White House Office of Management & Budget. They pointed out to Daniels that a federal report last year found there were nearly 7,000 R.Ph. vacancies, with no end in sight. The groups suggested that federal funds be included in the 2002 budget Daniels is preparing to help pharmacy schools develop laboratory facilities, install computer-based learning, recruit and retain faculty, and support student loans. AMCP, AACP, ACCP, APhA, ASCP, ASHP, FMI, NACDS, and NCPA signed the letter.

Coalition formed to gain Medicare payment for R.Ph.s

ASHP and ACCP have formed the Pharmacist Provider Coalition to win health-care provider status for R.Ph.s under the Social Security Act, the first step in gaining payment for pharmacist services to Medicare beneficiaries. The groups said they would be educating members of Congress and the public about the key role R.Ph.s play in the safe and effective use of Rxs.


NACDS backs Bush on tax cuts, repeal of ergonomic rules

NACDS has endorsed President Bush's $1.6 trillion tax cut proposal, part of which passed the House earlier this month. CEO Craig Fuller said, "We want the White House to know that we will help them make this plan become reality." The chain store group also applauded the decision by Congress and the President to scrap a new workplace safety rule aimed at preventing repetitive motion injuries and other musculoskeletal disorders. OSHA issued the regulation shortly before former President Clinton left office. Fuller said the rule "lacked credible evidence that its benefits would justify the great costs."

NACDS gains Thompson's ear at HHS on privacy

HHS secretary Tommy Thompson is crediting NACDS CEO Craig L. Fuller for helping him understand why medical privacy rules issued late in the Clinton Administration should be delayed and reexamined. "Fuller told me that the way they currently are written, if you are married and you're too sick to go to the drugstore, you can't send your spouse down to pick up your medicine," Thompson said at a national health summit March 1, sponsored by the U.S. Chamber of Commerce. "I've been governor for 14 years," the former Wisconsin chief executive said. "I don't know where the drugstore is anymore." The rules require a patient to sign an authorization form permitting someone else to pick up the Rx. Fuller and several officials from the chain store industry met with Thompson last month to discuss privacy, a Medicare Rx benefit, and the value of R.Ph. services at community pharmacies.

New Alzheimer's drug approved

The FDA has approved a new acetylcholinesterase inhibitor, Reminyl (galantamine hydrobromide), for the treatment of mild to moderate Alzheimer's disease. The new drug, derived from daffodil bulbs, was shown in clinical trials to improve or stabilize cognitive function. The most common side effects were primarily gastrointestinal in nature, including nausea, vomiting, anorexia, diarrhea, and weight loss. Reminyl will be supplied in 4-mg, 8-mg, and 12-mg tablets and marketed by Janssen Pharmaceutical and Ortho-McNeil.

Abbott completes Knoll purchase

Abbott Laboratories has competed its $6.9 billion acquisition of the Knoll Pharmaceuticals unit of BASF AG, Germany's largest chemical firm. European Union regulators approved the deal, and the 30-day U.S. government review period lapsed without any action. Having agreed to move Knoll out of BASF's building in Mount Olive, N.J., Abbott will decide which of the drug unit's 450 employees at that facility will be relocated or laid off.

DepoCyt returns to market

SkyePharma PLC and its marketing partner Chiron Corp. have received clearance from the FDA to return DepoCyt (cytarabine liposome injection) to the market. It was voluntarily withdrawn in October 1999 when certain batches of the agent did not meet all regulatory specifications. DepoCyt is approved for the treatment of lymphomatous meningitis, a disabling and potentially fatal complication of cancer. The agent is an injectable, sustained-release formulation of the chemotherapeutic drug cytarabine, which uses lipid-based drug delivery technology to extend the dosing interval to once every two weeks as compared with the standard intrathecal chemotherapy dosing of two times per week. This offers the advantage of fewer injections and less frequent hospital visits, according to a company spokesman.

FDA approves Gonal-F Multi-Dose

Serono has received FDA approval to market a new multidose formulation of its infertility drug Gonal-F (follitropin alpha for injection). According to Serono, Gonal-F Multi-Dose 1,200 IU will offer the advantages of flexible dosing and the convenience of one-step drug mixing that produces a ready-to-use solution that can be taken over several days of treatment. Gonal-F Multi-Dose is injected SC. It is used to stimulate ovulation in women undergoing infertility treatment and to stimulate sperm production in men with a rare form of infertility.

Warfarin reaction with vaginal miconazole noted

The FDA is advising women on warfarin to consult with their M.D. or R.Ph. before using an OTC vaginal miconazole product because bleeding or bruising may occur. The agency has asked manufacturers of vaginal creams and suppositories containing miconazole to include that advice on product labels. The interaction of systemically administered miconazole is well established, the FDA noted, but it recently received two adverse event reports indicating abnormal blood-clotting tests in women who used warfarin and vaginal miconazole.

Wyoming requires diabetes coverage

Wyoming has become the 44th state to require that state-regulated health plans cover medically necessary supplies, equipment, and education needed to help beneficiaries control their diabetes. Alabama, Idaho, Montana, North Dakota, Ohio, and Oregon have not enacted such laws, according to the American Diabetes Association.

Public Citizen wants wider probe of Proventil problems

The advocacy group Public Citizen has asked for a full-scale FDA investigation into quality-control problems at a Schering-Plough manufacturing plant in Kenilworth, N.J. The group noted that outside auditors and the FDA's own inspectors found numerous production problems that have led to the recall of 59 million Proventil (albuterol) asthma inhalers in the past 15 months because many lacked the active ingredient. The company said it has committed more than $50 million to upgrade the plant and also will hire more quality-control personnel.

Anesthetic supplies dwindling at some hospitals

Shortages of anesthetic agents and related Rxs used during surgery are at critical levels in some hospitals, the American Society of Anesthesiologists has told the FDA, DEA, and PhRMA. Muscle relaxants, antinausea medications, and local anesthetics also are in short supply, ASA said. The only current shortage of anesthetics the FDA lists on its Web site is for fentanyl, which it attributed to increased demand. ASHP recently posted a specially dedicated page on its Web site ( ) offering information on how to manage Rx shortages.

NCPA seeking answers on PBMs' RxHub project

NCPA has some pointed questions about RxHub, the newly announced joint venture by the nation's three largest PBMs to develop a single electronic standard for transmitting prescriptions. Among them: Will it be open to all patients and pharmacies on equal terms? Will it increase the use of generics? Will there be a ban on sharing of pricing information? Will transaction fees—estimated from 25 cents to $1—be negotiable? Will the exchange be mandatory for all pharmacies or will the PBMs' mail-order facilities be exempt? The PBMs—AdvancePCS, Merck-Medco, and Express Scripts—said the enterprise is not intended to make a profit. The goal is to encourage M.D.s to write Rxs electronically, thereby improving accuracy, increasing safety, and reducing costs, they said Feb. 22. NCPA sent letters to the PBMs Feb. 27 and is waiting to be convinced.


Marina Marketos. Latelines. Drug Topics 2001;6:5.