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The Food & Drug Administration recently approved exenatide (Byetta, Eli Lilly/Amylin Pharmaceuticals) as adjunctive therapy to improve glycemic control in those with Type 2 diabetes who are taking metformin, a sulfonylurea, or a combination of both. Exenatide is a synthetic analog of a peptide found in the saliva of the Gila monster, a poisonous lizard. The drug is currently available in pharmacies.

To help pharmacies meet the legislatively mandated goal of providing useful written consumer medication information (CMI) to patients by 2006, the FDA has issued a draft guidance. The guidance gives recommendations not only on what drug information should be provided to consumers, but also in what sequence, type size, etc. If pharmacies' voluntary CMI efforts fail to meet FDA standards by next year, the agency could resort to a mandatory approach. For more information, refer to the May 26 Federal Register or click on www.fda.gov/cder/guidance/index.htm.

Distributors of diverted drugs indicted

Consultant pharmacists can find plenty to like about Medicare Part D. The new prescription benefit that debuts next Jan. 1 is still provoking questions, but the overall impact on long-term care (LTC) pharmacy seems to be positive. "There are several very positive aspects in medication management and prescription drug plans [PDPs] for both long-term care pharmacy and long-term care pharmacists," said Tom Clark, director of policy and advocacy for the American Society of Consultant Pharmacists.

In 2002, with data supplied by the British National Health Service, newspapers in England began publishing the names of hospitals with high infection rates. By 2004, every hospital in Great Britain was required to display its infection rate in a prominent place where patients could see it.

Pharmacists are gaining new support in the organ transplantation world. UNOS, the United Network for Organ Sharing, is encouraging all transplant centers to include at least one clinical R.Ph. on each transplant team. UNOS coordinates organ donation and transplantation specialists nationwide.

Scios Inc., a Johnson & Johnson company, has changed its package labeling to add data about deaths associated with its heart failure drug nesiritide (Natrecor) after studies in prominent medical journals raised questions about an increased risk of fatal renal problems. The Food & Drug Administration-approved label change, which stops short of an outright warning, indicated that in clinical trials 5.3% of the patients treated with nesiritide died, compared with 4.3% who took other agents, including diuretics and intravenous nitroglycerin. However, the new label states that the data might not be statistically significant because of the small number of patients involved.

Does your state require the reporting of medication errors? If the answer is No, get ready for a change. Twenty-three states, including California, Florida, New York, and other major hospital population centers, already mandate med-error reports. Another six states are actively considering legislation, according to on-line publisher NETSCAN, based in Falls Church, Va.

Innovative supermarket pharmacy programs can persuade customers filling prescriptions to shop the whole store. Results of a study, formulated by the Educational Foundation of the General Merchandise Distributors Council (GMDC), were presented at the Food Marketing Institute's 18th Annual Supermarket Pharmacy Conference in New Orleans.

Attempts continue unabated in the courts and state legislatures this year to make the dealings of pharmacy benefit managers more transparent, to make the organizations personally liable as "fiduciaries" under the Employee Retirement Income Security Act (ERISA), or to otherwise regulate them.

The Centers for Medicare & Medicaid Services is designing a comprehensive Medicare information Web site for pharmacists, as well as a pharmacy kit. The agency will also be sharing more information through continuing education and special pharmacist outreach events.

If a vote were held tomorrow on whether to unionize their workplace, 18% of nonunion staff pharmacists would say Yes, according to a six-state study by researchers at Midwestern University Chicago College of Pharmacy.

The American College of Physicians (ACP) recently issued guidelines for the management of obesity. Prepared by ACP's clinical efficacy assessment subcommittee, the paper was published in the April 5 issue of Annals of Internal Medicine.

New evidence-based guidelines for the treatment of cancer pain were presented at the 24th Annual Scientific Meeting of the American Pain Society (APS) in Boston last month. The meeting was designed to help clinicians and patients better control the pain associated with the disease. According to APS, approximately 1.2 million people are diagnosed with cancer each year. While effective treatment for pain exists, studies have reported significant undertreatment.

How do we improve medication-error rates? Indeed, how do we even set up systems to know whether med-error rates are improving? Should reporting of errors be voluntary or mandatory? And should agencies that receive such reports give the public information on them?

You might see specialty pharmacies compete tooth and nail under a new Medicare Part B program proposed by the Centers for Medicare & Medicaid Services. Under the proposal, physicians can continue buying Part B drugs on their own. Under this scenario, their reimbursement switches from average wholesale price (AWP) minus 5% to average sales price (ASP) plus 6%. Or physicians can opt into a competitive acquisition program (CAP).

Pharmacists who want to transfer their licenses to another state can now download the application directly from the Web site of the National Association of Boards of Pharmacy.

This month a jury in the Circuit Court for the Sixth Judicial Circuit in Champaign County, Ill., is expected to hear a countersuit that was filed by Bruce Kelle, R.Ph., against Albertson's, doing business as Osco, for sign-on bonus breaches.

Will pharmacies see more drug shortages and price increases as a result of a new way of doing business for wholesalers? That's what some experts have warned.

The administrator of the Centers for Medicare & Medicaid Services, Mark McClellan, is in a big hurry. A telltale sign is the rapid-fire way in which he spoke before pharmacists at the American Pharmacists Association annual meeting in Orlando last month. McClellan knows there are still many plans to be laid in the remaining months before Medicare Part D can be rolled out next January. But on schedule it will be, he vowed repeatedly at APhA's opening general session.

The National Home Infusion Association (NHIA) held an audio conference recently to alert home infusion providers to the challenges they may face when the new Medicare Part D prescription drug benefit is implemented on Jan. 1, 2006.

Medco Health Solutions, one of the nation's largest pharmacy benefit managers, has joined forces with the University of Medicine & Dentistry of New Jersey (UMDNJ) to study major public health issues and their effects on prescription utilization and healthcare costs.

You might see specialty pharmacies compete tooth and nail under a new Medicare Part B program proposed by the Centers for Medicare & Medicaid Services. Under the proposal, physicians can continue buying Part B drugs on their own. Under this scenario, their reimbursement switches from average wholesale price (AWP) minus 5% to average sales price (ASP) plus 6%. Or physicians can opt into a competitive acquisition program (CAP).

A California hospital recently lost its accreditation from the Joint Commission on Accreditation of Healthcare Organizations, and another one is at risk of losing it. In both cases, medication-related problems accounted for part of the reason for their predicament. Their experience could signal a tougher approach by JCAHO.

Health-system pharmacists are taking a wait-and-see attitude about proposed rule changes for hospitals' conditions of participation (CoPs) in Medicare that were announced recently by the Centers for Medicare & Medicaid Services. When the feds first proposed these rules eight years ago, it provoked a firestorm of protest from R.Ph.s.

For the third year in a row, a record number of pharmacists had their licenses transferred to other states in 2004, according to an annual year-end review by the National Association of Boards of Pharmacy.

Sensing that the time has come for the profession to take responsibility for policing what many view as a pharmacist"s cherished prerogative—compounding—Kenneth Baker has accepted the job of implementing a way for compounding pharmacies to earn a stamp of approval from the Pharmacy Compounding Accreditation Board (PCAB).

One percent of the world's population has rheumatoid arthritis, accounting for more than nine million physician visits and 250,000 hospitalizations in the United States annually. Abatacept, the first in a new class of agents called selective T-cell co-stimulation modulators, is in development by Bristol-Myers Squibb for the treatment of this joint disease.