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Published Online: Monday, December 1, 2008
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Personalized Medicine Will Change FDA Approval Process

In a recent speech to business students at St. John's University, FDA Commissioner Andrew von Eschenbach, MD, said that personalized medicine will lead to changes in clinical trials, the business model for the pharmaceutical industry, and the FDA process for new approvals. Personalized medicine will be able to predict how patients react to specific medications based on their genetic profiles. In the future, clinical trials will seek to determine how medications work in the body and in patients with certain genetic profiles. He explained that more cooperation will be necessary among pharmaceutical, biotechnology, and medical companies. The agency also will have to revise its approval process.


Heart Association Unveils "Heart360"

When patients come to collect their cholesterol and blood pressure (BP) medications or have questions about preventing heart disease, pharmacists can suggest they try an innovative new Web tool from the American Heart Association (AHA)—Heart360—an online cardiovascular wellness center, where patients can enter their BP, cholesterol and glucose numbers, log physical activities, record their weight, and keep a medication diary. The entries are stored online in a secure, passwordprotected system to be charted, compared, and updated to help patients track their progress. A variety of links to relevant AHA content are also available at the site.

"Statistics show millions of people are turning to the Internet for health information," said AHA President Tim Gardner, MD. Powered by Microsoft HealthVault, Heart360 replaces and expands on the AHA's former Blood Pressure Management Center. New users can visit www.heart360.org to set up an account. Previous users of the Blood Pressure Management Center can log in normally, and their data will transfer automatically to Heart360.


Texas Pharmacy School Houses Pharmacy Antiques

The University of the Incarnate Word Feik School of Pharmacy is home to some precious artifacts. The Pharmacy Museum Foundation of Texas is donating an antique collection worth $250,000 to the school.

The inventory includes >4000 antique pieces from the pharmacy industry dated between 1850 and 1950. The pharmacy collection will be in the lobby of the Feik School of Pharmacy.

"It is with the greatest of pleasure and honor that the Feik School of Pharmacy was selected to house and maintain this collection for future generations to study and appreciate. We are glad to have it grace our building and will proudly show it off to the public," said Arcelia Johnson- Fanin, PhD, founding dean of the school of pharmacy.

Bill Walker, chairman of the foundation, collected the items related to Texas pharmacy during his nearly 34 years in pharmaceutical sales. Many of these old drugstores had been in business since the early 1900s and began to disappear with the growth of superstore pharmacies.


More Kids Using Meds, Study Finds

A new study of medication use in children aged 5 to 19 has found increased use of drugs prescribed for several conditions like asthma, depression, and attention-deficit/hyperactivity disorder, with use of type 2 diabetes medications doubling among America's tweens and teens over the 4-year study period (2002-2005).

The study was conducted by researchers from the Saint Louis University School of Medicine, Express Scripts, and the Kansas Health Institute. The findings show that whereas more children are being diagnosed, and doctors are increasingly using medication to treat these conditions, the findings also point to more disease, a trend researchers attribute in large part to the spike in childhood obesity rates.

"Our findings indicate that we, the doctors, are doing a better job of screening children and diagnosing chronic conditions," noted Donna Halloran, MD, MSPH, assistant professor of pediatrics at Saint Louis University School of Medicine. "A great example of this is blood pressure, where there has been a big push to identify and treat children in need." She also noted, however, that, "our findings show that childhood obesity not only has long-term health implications, but also impacts children's immediate health."

Among other findings of the study, appearing in the November 2008 issue of Pediatrics, rates of growth in medication use were higher among girls than boys; although boys still take more medications for chronic conditions, the gap has become narrower. For example, researchers found a 147% increase in type 2 diabetes medication use among girls over the study period, compared with a 39% increase among boys. Another example of a higher increase among girls was seen in antidepressants, where use increased 6.8% among females aged 15 to 19, but declined slightly among males in the same age group.


Association Pledges: "See the Return of NACDS"

The National Association of Chain Drug Stores (NACDS) will use a new theme to drive its member-service philosophy and member communications during the current economic climate: "See the return of NACDS."

As testimony to the value of chain members' involvement and the validity of this theme, the association also announced an analytical model that measures public policy victories and their cost savings for member companies. The analysis shows that the success of 2007 activities saved the NACDS chain members >$4.1 billion in operational costs. To measure the return effectively, the organization's research team developed an analytical model, based on a hypothetical 10-store chain and a 25-store chain.

The 10-store chain saved $1.03 million and the 25-store chain saved $2.9 million. Victories that contributed to those savings:

  • Prevention of federal track-and-trace requirements
  • Change in the approach to National Provider Identifier requirements
  • Delay in the implementation of the Medicaid tamper-resistant paper requirement
  • Maintenance of the TRICARE prescriptions by preventing a transition to mail order for this program

"NACDS works aggressively to create a favorable political and business climate for chain members—in Washington, DC, and in state capitals across the country," said Steven Anderson, IOM, CAE, NACDS president and chief executive officer. "We vigorously advocate for legislation and regulations that benefit our membership and work constantly to amend or defeat legislation that would increase cost or impose unnecessary burdens on chain pharmacies."


New Findings on Zyrtec Rx-to-OTC Switch

A new study of patients using the allergy medication Zyrtec following its switch from prescription to OTC status reveals that the majority of users of the OTC product—84%—moved over from other OTC products, rather than from other Rx products as many had expected. Only 27% of prescription Zyrtec patients "followed the molecule" and switched to Zyrtec OTC.

These findings by researchers at Wolters Kluwer Health and The Nielsen Company go against conventional thinking about the dynamics when a prescription drug switches to OTC. The data show that carryover from a base of prescription Zyrtec users was lower than some expected: of all patients who migrated to Zyrtec OTC from other allergy therapies, only 6% were former prescription Zyrtec users. Another interesting finding: the switch to OTC led to increased spending on allergy medications for some consumers, suggesting that access to OTC may be more important than the cost of the medications.


Many Forces Driving Global Drugs Market

The recently released IMS Global Pharmaceutical and Therapy Forecast provides insights into the industry for 2009, predicting slowing growth in mature markets but higher growth in "pharmerging" markets overseas. The specialty arena is expected to contribute 67% of total market growth.

Overall growth in the global pharmaceutical market is expected to be in the 4.5% to 5.5% range in 2009, a pace similar to 2008, according to the report; in the United States, growth is expected to be 1% to 2% for both 2008 and 2009. Contributing to the slower growth is less-than-expected demand for recently introduced products, as well as the economic climate, which appears to be having an impact on doctor visits and pharmaceutical sales, IMS reports.

The picture for generics is somewhat rosier. IMS predicts generics sales will grow 5% to 7% in 2009, a level similar to 2008, but lower than levels experienced in 2006 and 2007. An additional $24 billion of branded products, including antiepileptics, proton pump inhibitors, and antivirals, will lose their market exclusivity in the top 8 world markets in 2009, contributing to projected generics sales of more than $68 billion next year.


CDC Updates Pneumococcal Vaccine Advice

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recently voted to recommend that adults aged 19 to 64 with asthma receive the pneumococcal vaccine (Pneumovax 23).

Pneumococcal diseases are caused by common bacteria and can lead to potentially serious bacterial infections like pneumonia, meningitis, and bacteremia. ACIP's recommendation is based on study data showing an increased risk of pneumococcal disease among asthma patients.

The ACIP also voted to recommend that smokers aged 19 to 64 receive the vaccine, as well as smoking cessation counseling—marking the first time ACIP has recommended a vaccine specifically for people who smoke. Data show that smokers are approximately 4 times more at risk for pneumococcal disease than nonsmokers.


Study Reveals Treatment Targets for Common Cold

A study published in the online edition of the November 1, 2008, issue of the American Journal of Respiratory and Critical Care Medicine found that at the genomic level, the immune response to human rhinovirus—the most common cold virus—and not the virus by itself, results in common cold symptoms.

The new study identifies several categories of therapeutic targets that could balance the immune response in order to minimize symptoms during a cold and potentially lead to therapies to prevent the infection. In a randomized, placebocontrolled study, the researchers infected 17 participants with rhinovirus 16 and a control group of 18 participants were given a sham inoculation in the form of a nasal saline spray. The researchers then scraped small samples of nasal epithelial cells from the participants. Using a microarray gene technology, the investigators compared the gene expression levels between the infected patients and the control group.

The expression of 6530 genes in infected participants was significantly up-regulated or down-regulated 48 hours after inoculation, compared with genes in the control group. The study included researchers from Procter & Gamble, the University of Calgary, and the University of Virginia.


Pharmacists Educate Patients on FDA Requirements

As 2009 approaches, pharmacists need to be mindful of some new FDA requirements when counseling patients and recommending medications.

The agency has issued a public health advisory on the safe and appropriate use of UCB Inc's Tussionex Pennkinetic Extended-Release Suspension. The prescription medicine contains the narcotic ingredient hydrocodone that controls cough.

Tussionex should not be given to children younger than 6 years old; clinicians should not prescribe and patients should not take the product more often than every 12 hours; clinicians who prescribe and patients who take Tussionex should know the signs of hydrocodone overdose; and patients and parents should use a device designed to accurately measure the cough medicine. UCB has updated the drug's label to reflect that it should not be prescribed or used in children under 6 years old and the need for accurate measurement and dosing.

Another change in pediatric cough and cold medicines is the new labels and packaging to state "do not use" in children younger than 4 years of age. A recent FDA public hearing prompted leading manufacturers of these medicines to voluntarily transition the labeling.

Pharmacists also should reiterate to asthma patients that all metered dose inhalers (MDIs) containing chlorofluorocarbons will no longer be available in the United States at the end of this year. Patients will be switched to newer hydrofluoroalkane-containing MDIs. The switch gives pharmacists the opportunity to educate patients on the new inhaler drugs and proper device technique.




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