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The American Thoracic Society (ATS) recently issued a statement on the hepatotoxicity of antituberculosis medications. The statement, which appeared in the Oct. 15 issue of the American Journal of Respiratory and Critical Care Medicine, addresses the growing incidence of drug-induced liver injury (DILI) by tuberculosis medications.

Many agents are in development to fight resistance to Gleevec (imatinib, Novartis) in patients with chronic myeloid leukemia (CML). That was one of the issues highlighted at the recent meeting of the American Society of Hematology (ASH), held in Orlando, Fla. The meeting drew 20,000 attendees seeking news of improved treatments for blood cancer.

Last fall, the Infectious Diseases Society of America (IDSA) released updated guidelines for the diagnosis and treatment of Lyme disease. (See Drug Topics, Nov. 20, 2006, "Updated Lyme disease guide clarifies confusion".) Approximately one month later, Connecticut attorney general Richard Blumenthal issued a Civil Investigative Demand (CID) to look into possible antitrust violations by IDSA in connection with exclusionary conduct and monopolization in the development of its Lyme disease guidelines.

The Food & Drug Administration recently approved paliperidone (Invega, Janssen, L.P.), an atypical antipsychotic, for the treatment of schizophrenia, a disease that affects more than two million Americans. It is the first new treatment for schizophrenia to be approved since 2003.

House Democrats to push for Medicare drug negotiation

Maalox is a well-recognized brand name that healthcare professionals associate with nonprescription or OTC antacid drug products containing the active ingredients aluminum hydroxide, magnesium hydroxide, and simethicone. However, the Food & Drug Administration wants to alert healthcare professionals that Maalox Total Stomach Relief (an OTC upset stomach reliever/antidiarrheal drug product) contains the active ingredient bismuth subsalicylate.

CMS issued new rules governing Medicaid reimbursement on Dec. 22 that would cut more than $8 billion in Medicaid prescription generic drug reimbursements over a five-year period. Reimbursement for brand-name drugs would not be impacted, but CMS estimates it will reduce reimbursements for generics by $800 million in 2007 alone.

Pharmacists who want to opt out of the traditional career path should keep an eye on Thomas Menighan in Gaithersburg, Md. The former pharmacy owner and onetime American Pharmacists Association president created a new specialty. His current company, SynTegra, audits drug manufacturers, wholesalers, and other links in the pharmaceutical supply chain.

South Carolina officials looking to reduce costs in the state Medicaid program have tapped pharmacists to help in the effort by improving drug selection and adherence. The South Carolina Department of Health & Human Services is offering a $1.98 million grant to the South Carolina College of Pharmacy (SCCP) to implement the program, which will focus on Medicaid patients diagnosed with mental health disorders, HIV/AIDS, or cancer.

With traumatic brain injury (TBI), the first question we often ask is, Will the patient recover? Beyond concerns about cognitive function and disability, little is generally known about the milestones and setbacks patients encounter while recovering from a TBI.

State and federal authorities are increasingly cracking down on pharmacies for fraud, waste, and abuse

For too long now, many technicians have been trained in programs that just don't meet quality standards. Pharmacists know about this, but many people outside the profession don't. At its midyear meeting in Anaheim, Calif., Henri Manasse, executive VP and CEO of ASHP, made known his intention to expose this "dirty little secret" to state legislators and the public.

It is probably safe to say that pharmaceutical manufacturers as a group approached the implementation of Medicare Part D with mixed feelings. Although the benefit is seen as likely to increase access to medication among those eligible, large government programs run the risk of concentrating purchasing power, thereby lowering prices and decreasing profits over time. Early indicators remain mixed.

It's hard enough to get an employer and labor union to sit at the table, but what happens when you add pharmacists, a wholesaler, and a pharmacy benefit administrator to the mix? For Aerospace Contractors Trust (ACT) union members working at Jacobs Engineering, the answer is a transparent pharmacy benefit plan that seeks to strengthen the tie between healthcare providers and patients, providing low-cost coverage, while at the same time supporting local pharmacy businesses.

We're at the bottom of the healthcare funnel, whether we like it or not. Being at the front line, we see many patients who have been marginalized by our society, our culture, and our medical system. They're simply not equipped to navigate through the complexities of the healthcare scheme.

Last June the Food & Drug Administration approved a new vaccine, Gardasil (Merck & Co.), which studies show to be highly effective against major types of human papillomavirus (HPV). Now comes the hard part: actually getting it to girls and women.

Deaths associated with opioid use have been on the rise in Washington State. In Seattle and surrounding King County, for example, opioid-related deaths increased by 40% between 2003 and 2004, according to Caleb Banta-Green, MPH, MSW, a research scientist for the Alcohol & Drug Abuse Institute at the University of Washington. Banta-Green reported that the increase in opioid-related deaths coincided with an increased rate of opioid prescriptions for the treatment of chronic pain.

In a unanimous vote, a Food & Drug Administration advisory group has recommended modifying antidepressant labels to include new information on the risk of suicidality in young adults.

No longer just for drinking, green tea is now part of an ointment used for the topical treatment of genital warts. The Food & Drug Administration recently approved the new therapy for both external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years of age and older. Called Veregen, the Rx botanical was developed by German company MediGene. It contains 15% kunecatechins, a defined green tea extract.

Until now, pharmacy faculty authoring continuing education programs had only to disclose if they had any conflicts of interest to program participants. However, under new standards the Accreditation Council for Pharmacy Education (ACPE) is planning to implement this year, CE authors will also have to resolve any conflicts in order for their programs to pass muster. Conflicts can be resolved by requiring the CE content to be reviewed by a committee beforehand or presenting both pro and con sides to any given debate.

The Centers for Medicare & Medicaid Services recently selected 11 national organizations to accredit suppliers of DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) under Medicare Part B.

This past April, methylphenidate (Daytrana, Shire) was approved as a transdermal drug delivery system (TD-DDS) for the treatment of attention deficit hyperactivity disorder. And many more patches are on the horizon. Novartis is seeking Food & Drug Administration approval for its rivastigmine (Exelon) patch to aid in the treatment of Alzheimer's disease. Researchers in the United Kingdom are working on a TD-DDS to deliver synthetic cannabinoids for use as antiemetics and appetite stimulants in patients with AIDS and cancer.

An expert panel convened by the Alzheimer?s Drug Discovery Foundation recently released consensus recommendations on the treatment of Alzheimer?s disease and related dementias (ADRD) in managed care. The guidelines were published as a supplement to the American Journal of Geriatric Pharmacotherapy.

Consultant pharmacists are busy preparing to implement the Centers for Medicare & Medicaid Services' newly revised survey guidance for Pharmacy Services and Unnecessary Medications (F-Tags 329, 425, 428 and 431) in Appendix PP of the State Operations Manual (SOM). CMS released the revised guidelines on Sept. 15, with the changes scheduled to become effective on Dec. 18. They represent the first substantive changes in these sections in nearly seven years.

According to the U.S. Census Bureau, every 31 seconds a limited-English speaker enters the United States. For the approximately 48 million residents who speak a language other than English at home, that language barrier looms large when they visit an emergency room or are admitted to a hospital.