All News

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.

Despite better tools, decreased time to Food & Drug Administration approval, and an unbelievable figure for 2006 projected pharmaceutical sales-$321.1 billion-the payoff for drug innovation in the United States has been lagging. Over the past 10 years, there has been an annual average of only 10 to 15 new molecular entities (NMEs) to receive a nod from the FDA through fast-track approval, and only five through the regular approval process. This was the news coming from the 2006 Annual Meeting of the American College of Clinical Pharmacy (ACCP), held in St. Louis in October.

Peak and trough serum levels should be measured for patients on vancomycin, right? Well, sort of. According to Sharon See, Pharm.D., BCPS, associate clinical professor at St. John's University College of Pharmacy in New York, only trough levels are necessary. And in most cases, no levels are needed at all. That was one medical myth that was exploded at the recent American College of Clinical Pharmacy (ACCP) annual meeting in St. Louis in October.

New molecular entities on the horizon for the treatment of osteoporosis face a tough row to hoe in their quest for approval from the Food & Drug Administration. That was the subject of a presentation at the 2006 Annual Meeting of the American College of Clinical Pharmacy (ACCP), held in October in St. Louis.

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.

The Centers for Disease Control & Prevention (CDC) estimates that 1.25 million Americans are chronically infected with hepatitis B virus (HBV). Now a new, oral, once-daily treatment has been approved by the Food & Drug Administration and is indicated for the treatment of the illness in adult patients with both evidence of viral replication and either persistent elevations in serum aminotransferases or histologically active disease.

The long-delayed drug pedigree regulations announced by the Food & Drug Administration in mid-November have evoked a storm of criticism and lawsuits. No one is objecting to the FDA's stated goal of reducing drug diversion and counterfeits, but the cure may be worse than the disease.

CMS has issued a final rule on four conditions hospitals must satisfy to participate in Medicare and Medicaid. Three of them are drug related. They involve authenticating verbal orders, securing medications, and completing postanesthesia evaluations. The new requirements call for verbal orders to be authenticated promptly by the prescriber or another practitioner responsible for the patient's care, Schedule II through V drugs to be kept locked within a secure area with access by authorized personnel only, and a postanesthesia evaluation to be documented within 48 hours after patient surgery. Published in the Nov. 27 Federal Register, the new rules go into effect on Jan. 26.

A new software version for managing orders and calculations for total parenteral nutrition (TPN) compounding was released by Baxa Corp. in August. The company supplies about 70% of the nation's hospitals with automated TPN compounding products.

Protocolized Care for Early Septic Shock (ProCESS), a new multicenter research consortium, is beginning a large-scale study to determine whether specific interventions can halt the progression to severe sepsis or septic shock. Every year, about 750,000 people in the United States are affected with severe sepsis and about 200,000 people die from it. Sepsis is a syndrome characterized by a systemic response to infection that can rapidly lead to death. It is the leading cause of death in noncoronary intensive care units.

Arformoterol (Brovana, Sepracor) inhalation solution, 15 mcg, is the first inhaled long-acting beta2-adrenergic agonist to be approved for use with a nebulizer. It was approved for long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The company plans to launch the product during the second quarter of 2007.

Over the years, long-term use of immunosuppressive medications has shown that they reduce morbidity and mortality in transplant patients. One of physicians' challenges is to balance the risk of organ rejection caused by underimmunosuppression with the risk of drug toxicity, secondary infections, and posttransplant lymphoproliferative disorders caused by overimmunosuppressing the patient.

Several dozen neuropsychiatrists and others, at a recent meeting in Washington, D.C., emphasized the need for a national postmarketing surveillance system for drugs. But how will the country move to such a system?

NeoFax recently released an updated version of software for the preparation of total parenteral nutrition solutions for neonatal infants. Named WebApp, the software's data are based on what company officials say is the most widely used neonatal drug manual in the world- NeoFax: A Manual of Drugs Used in Neonatal Care-first published nearly 20 years ago.

A new software version for managing orders and calculations for total parenteral nutrition (TPN) compounding was released by Baxa Corp. in August. The company supplies about 70% of the nation's hospitals with automated TPN compounding products.

New legislation in California takes hospital reporting of serious medication errors to a new and very public level. Signed by the governor in late September, the law requires all hospital medical errors posing serious harm, including medication errors, to be posted on the state Department of Health Services' Web site. The Web site must include a description of the error, any corrective steps taken by the hospital or the state, and the name of the facility.

Suppose you were able to evaluate a hospital based on how well it has implemented quality and safety initiatives. The Leapfrog Group set out to do just that when it commissioned a survey to establish a national rating system that offers a broad assessment of a hospital's quality and safety. Fifty-nine hospitals have been named to Leapfrog's top hospitals list based on data from its survey.

Fungal infections are on the increase, but not for all the usual reasons. Increasing rates of bacterial and viral infections are due in large part to growing resistance to antimicrobials, but fungi and antifungals are different.

The International Society for Heart & Lung Transplantation (ISHLT) has released the first international guidelines for managing heart failure (HF) patients prior to heart transplantation. HF is a serious condition in which the heart is unable to pump blood at a rate sufficient to meet the needs of the body. "The new guidelines will enhance the effectiveness of patient care, optimize patient outcomes, and improve overall cost by focusing resources on the most effective strategies," said Mariell Jessup, M.D., ISHLT task force chair and professor of medicine at the University of Pennsylvania Medical Center.

A 20-year-old patient, T.C., managed in your hospital's asthma clinic has recently been diagnosed with paroxysmal supraventricular tachycardia (SVT). To control his asthma, T.C. uses a fluticasone 250 mcg/salmeterol 50 mcg inhaler (Advair Diskus, GlaxoSmithKline) regularly plus an albuterol inhaler as needed. T.C.'s physician suspects the beta agonists used to control asthma could be a factor in T.C.'s episodes of SVT. He requests a pharmacist consult about how best to deal with the asthma to prevent episodes of heart arrhythmia. What do you suggest?

Diabetes is undertreated among inpatients, especially acute care patients, sometimes with devastating results. "Blood glucose levels are too often not treated as intensively as other medical conditions among floor patients," said Almut G. Winterstein, Ph.D., assistant professor of pharmacy health care administration at the University of Florida College of Pharmacy. "If hospitals made a more aggressive effort, it could save quite a significant number of lives."

Dasatinib (Sprycel, Bristol-Myers Squibb) is a new tyrosine kinase inhibitor for chronic myelogenous leukemia (CML). The Food & Drug Administration approved the drug in June, and now the National Comprehensive Cancer Network (NCCN) has added dasatinib to its CML guidelines.

Drug-eluting stents (DESs) greatly reduce the chances of restenosis, a gradual growth of abnormal cells within the stent. However, the results of a new study reveal that DESs may also put patients at a higher risk for a sudden and potentially fatal thrombosis.

The Food & Drug Administration recently approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioids for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the first tablet formulation of the opioid fentanyl. It is also the first new medication approved for the treatment of breakthrough pain in opioid-tolerant patients with cancer since 1998.

At most large tertiary care hospitals and academic medical centers, around-the-clock pharmacy service is relatively common. But in some small and rural hospitals, 24-hour, seven-day-a-week pharmacy coverage is not economically feasible or practical. How are pharmacy services provided in those facilities? And how do health-system pharmacists feel about a Joint Commission on Accreditation of Healthcare Organizations proposal that would require all hospital pharmacies to provide 24/7 service?

Catalyst Rx ... HealthTrans ... MedImpact ... Navitus Health Solutions.... These pharmacy benefit managers may not be household names yet, but they are shaking up the PBM market.

In 2005, over 3.4 billion prescriptions were filled-a jump of 59% since 1995. This good news comes from the National Association of Chain Drug Stores Foundation's recently released 2006 Chain Pharmacy Industry Profile.

Pharmacists Planning Service Inc. (PPSI) has submitted a citizen's petition to the Food & Drug Administration to regulate the labeling and packaging of acetaminophen/APAP-containing products so that the label states, "Contains acetaminophen. Do not take with any other acetaminophen/ APAP." PPSI is also asking that no more than 50 tablets be sold in a bottle and that the FDA mandate a MedGuide.