VOLUME 11 | NUMBER 2 | FEBRUARY 2007

 

Try this month's
“Patient’s Fib” Challenge Capsule

Researchers say patients often lie to their caregivers in order to appear to be “good patients.” A study by researchers at Johns Hopkins School of Medicine found a big gap between what patients said and what they did. In the study, the researchers looked at how patients used an inhaler equipped with a device that recorded the date and time of each use. They compared the actual recorded use to what patients said.

Seventy-three percent of patients reported using the inhaler on average three times a day. What percent of the patients actually used the inhaler as they reported?

A. 5%
B. 15%
C. 45%
D. 75%
E. 85%

Scroll down for the answer to this month’s
challenge
In This Issue…
 
 
 
 
 
 

New Free CE: Medicare Part D in 2007

A new CE program developed by the National Association of Chain Drug Stores (NACDS) Foundation outlines pharmacy-specific implications of the Medicare Part D drug benefit in 2007. A variety of changes were made to Medicare for 2007. This CE will catch you up to speed.

The lesson addresses issues and challenges created by Medicare Part D in 2006 and the impact on patients and pharmacists, differing aspects of Medicare Part D plans, and changes to Medicare Part D plans for 2007. Visit the NACDS Foundation’s CE Center at www.nacdsfoundation.org to access this free two credit-hour program.

The National Association of Chain Drug Stores (NACDS) Foundation is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This home study web activity has been assigned a maximum of 2.00 contact hours (0.2 CEU) and the Universal Program Number: 206-000-06-070-H03.

Medication Therapy Management: Training and Techniques for Providing MTM Services in Community Pharmacy. The NACDS Foundation and APhA have teamed up to provide you with a multimedia online and CD-ROM training program created to assist pharmacies and pharmacists in learning how to prepare for and operate MTM services in community pharmacies. For ordering information and to view a demo, visit http://www.nacdsfoundation.org/wmspage.cfm?parm1=1044.

Top Pharmacy Stories of 2006

According to the daily Pharmacotherapy News Network’s (PNN) Pharmacotherapy Line news editors, 2006 was full of door openings and closings for pharmacists and the medications with which they work. Top issues and reflections follow.

1. Medicare Part D: While many complained of defects when Medicare Part D began, services were implemented reasonably well, given the program’s size and complexity. The question remains how much difference MTM will make in pharmacy business models in the long run.

2. Recognition of Pharmacists’ Capabilities: Even as MTM services lagged, several events increased recognition of pharmacists as effective gatekeepers and competent clinical practitioners, including FDA approval of Plan B® in dual-status and moving pseudoephedrine products behind pharmacy counters.

3. New Meds for Diabetes: Building on the clinical acceptance of Byetta®, new agents for diabetes provided clinicians with new ways to counter this epidemic. Januvia™ was launched, and Exubera® inhaled insulin made its debut.

4. New Vaccines: 2006 had a number of new vaccines, including Herpes Zoster (Zostavax®), human papillomavirus (HPV, Gardasil®), and rotavirus vaccines (RotaShield®) being licensed along with a fifth brand of influenza vaccine.

5. New Drugs That Didn’t Make It in 2006: Some promising agents did not make it out of clinical testing. Rimonabant, a cannabinoid blocker for obesity, tests well with hope that clinical data will soon appease FDA reviewers. The HDL cholesterol-raising agent torcetrapib increased mortality in a large Phase III trial causing Pfizer to end development.

6. FDA Shows Its Age: FDA celebrated its 100th anniversary during 2006, and a new commissioner was finally in place, but fundamental changes in how FDA approves and monitors drugs are planned.

7. Drug Efficacy, Safety: With drug safety having been such a focus in late 2004 and 2005, FDA issued dozens of alerts and warnings during 2006.

8. Med Errors: The Institute of Medicine issued another report in its ongoing “Quality Chasm” series. “Preventing Medication Errors” highlighted the roles that pharmacists should play in addressing this vexing problem.

9. Alternative Meds Falter: Studies of herbal agents and other dietary supplements continued to emerge, and the relative ineffectiveness of some popular agents--vitamins/minerals and black cohosh--was exposed.

10. Microbes’ Strength: The age-old battle between man and microbe continued, and methicillin-resistant Staphylococcus aureus seemed to be winning at times.

Visit http://homepage.mac.com/lmposey/PNN/index.html for more details and subscription information.

Updates to iPLEDGE Risk Management Program

The iPLEDGE program is designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA.

Newly released items to the iPLEDGE program that went into effect January 19 include a new login method for the iPLEDGE phone system, new documents available for download from the iPLEDGE website, a "Find a Participating Pharmacy" feature, and a new 11-digit NDC format for use on the automated phone system and website. Visit www.ipledgeprogram.com for more information.


Clopidogrel generic supply wanes; court case began in January

The supply of clopidogrel (generic Plavix®) is reportedly almost entirely gone after Apotex flooded the market with the product during a three-week period in August 2006. In an unprecedented move, Apotex launched the product in early August when the Federal Trade Commission failed to approve an agreement that had been reached between the company, Bristol-Myers Squibb (BMS), and sanofiaventis to delay a generic launch until 2011. Apotex received FDA approval for generic clopidogrel in January 2006 with 180-days of market exclusivity once patent litigation between the company, BMS, and sanofi-aventis was resolved. After the launch, BMS and sanofi-aventis filed for injunctive relief against Apotex, asking the courts to stop the firm from continuing to sell clopidogrel. The courts granted relief on August 31 and further appeals by Apotex failed. The patent infringement litigation case began January 22, 2007, with the outcome unknown at press time. Pharmacists should be alert to helping patients who were switched to the generic product get back on Plavix® and let patients know they may need to work with their insurers to receive coverage.

Cough and cold medicines linked to infant deaths

The FDA is urging caution when administering cough and cold medications to infants younger than two years. A Centers for Disease Control and Prevention (CDC) article in Morbidity and Mortality Weekly in early January reported three infants, ages one to six months, were found dead in their homes. Medical examiners found two of the infants had evidence of respiratory infection. All three infants had what appeared to be high levels of pseudoephedrine in postmortem blood samples and two of the infants had detectable blood levels of dextromethorphan and acetaminophen. Two of the infants had received either an OTC or a prescription product, and the other had received both.

Ask About OTCs

Pharmacists should be sure to ask parents/caregivers about their use of OTC combination medications to avoid the risk for overdose from component duplication. You may recommend single-entity acetaminophen products. As an alternative to cough and cold medication, use of a rubber suction bulb to clear congestion should be considered; secretions can be softened with saline nose drops or a cool-mist humidifier.



More makers of generic Zocor®, Toprol-XL® and Zofran®

Sandoz, Cobalt Pharmaceuticals, Aurobindo Pharma, Zydus Pharmaceuticals, and Perrigo have received FDA approval to market simvastatin (generic Zocor), joining TEVA, Ranbaxy, and Dr. Reddy’s now that the 180-day market exclusivity period has expired.

The launch of generic Toprol-XL was met with an authorized generic by maker AstraZeneca. Eon Labs launched its 25-mg generic version of Toprol-XL in November, and AstraZeneca announced entry of its own authorized generic version of metoprolol succinate with generic producer Par Pharmaceuticals. Sandoz won FDA approval in July 2006 to launch a generic version of the drug. Additional applications to market generic versions in 50-, 100-, and 200-mg doses are pending before the FDA.

Generic firms Barr Pharmaceuticals and Dr. Reddy's Laboratories won FDA approval to market ondansetron, a generic version of GlaxoSmithKline's Zofran ODT indicated for the prevention of nausea and vomiting associated with cancer chemotherapy in December 2006. Barr, through a special agreement between its subsidiary Pliva and Par Pharmaceuticals, will market generic ondansetron orally disintegrating tablets in 4- and 8-mg doses. Dr. Reddy's has been approved to market ondansetron hydrochloride tablets in 4-, 8-, 16-, and 24-mg doses.


President Bush Proposes Health Insurance Changes… President Bush used his State of the Union address on January 23 to propose two ideas to stem the rising cost of health care: tax breaks to help low-income people buy health insurance and tax increases for workers whose health plans cost significantly more than the national average. The concept is that employer provided health insurance, now treated as a fringe benefit exempt from taxation, would no longer be entirely tax-free. Workers could be taxed if their coverage exceeded limits set by the government. The government would also offer a new tax deduction for people buying health insurance on their own.

Another Alzheimer’s Gene Found… A variant gene involved in Alzheimer’s disease has been detected through study of Dominican families. Known as SORL1, the defect allows the protein involved in the disease to be converted into toxic form. Researchers hope that the more Alzheimer-associated genes they find, the more possible targets will emerge both for drugs and for diagnostic tests that can tell who is at risk for the disease. For more information, visit Nature Genetics at http://www.nature.com/ng/index.html.

Answer:

If you answered (B.) that only 15% of the patients were using their inhalers three times a day as they had said, congratulations, you are correct! One way to make patients more comfortable with sharing the truth is by asking a series of nonjudgmental, openended questions. Medication-related examples are “Tell me how you are using the medication,” and “Have you had any side effects?” As patients said in the article, “Just ask me and I’ll tell you.”

The Practice Memo is published by the National Association of Chain Drug Stores (NACDS) Foundation, P.O. Box 1417-D49, Alexandria, VA 22313-1480.
ISSN 1092-4272  
Visit our website at www.nacdsfoundation.org

Phillip L. Schneider
President
Ronna B. Hauser, PharmD
Editor
Marsha K. Millonig, MBA, RPh
Contributing Editor

Through educational and research initiatives, the NACDS Foundation supports programs that advance the chain pharmacy industry for the benefit of the public it serves. In addition to its own initiatives, the NACDS Foundation supports other educational and charitable causes across the country.

References for information included in The Practice Memo are available by request: practicememo@nacds.org.

 

HUMIRA®
(adalimumab) Pen

Prefilled Pen allows for convenient administration in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Rheumatoid arthritis (RA) is an autoimmune disorder that causes inflammation of the joints that may range from mild arthritis to progressive joint destruction and disability. RA patients experience tender, warm and swollen joints in a symmetrical pattern, often disturbing the wrist and finger joints closest to the hand, but other joint areas may be affected.

Early prevention of RA disease progression is of great importance as joint destruction may occur rapidly. RA guidelines, developed in 1996, focused mainly on disease management and drug therapy. Currently, the focus of RA treatment is on early prevention of disease progression. HUMIRA is safe and effective for RA, preventing disease progression and reducing disease activity in patients.


HUMIRA inhibits tumor necrosis factor (TNF) from signaling the release of joint-damaging substances

Adalimumab is a recombinant human monoclonal antibody that binds specifically to tumor necrosis factor (TNF)-alpha, blocking the interaction of cell surface TNF receptors. Cells that cannot recognize TNF do not receive the signal to release joint-damaging substances. Although TNF-alpha is a naturally occurring cytokine involved in normal inflammatory and immune responses, elevated levels are found in the synovial fluid of patients with RA.

 

The Easy-to-Use, Single-Use, Disposable HUMIRA Pen

The HUMIRA Pen is a new one-touch device for the administration of adalimumab. Until now, patients with rheumatoid arthritis had to administer HUMIRA as a subcutaneous injection via a prefilled syringe.The needle of the HUMIRA Pen is invisible during the injection process and has proved less painful.

The recommended dosage regimen for HUMIRA for adult patients with rheumatoid arthritis is 40 mg administered every other week as a subcutaneous injection. It may be used in combination with methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease-modifying antirheumatic drugs (DMARDs). Additionally, HUMIRA is approved for use in patients with psoriatic arthritis and ankylosing spondylitis.

  

Support Program for Patients

myHUMIRA provides a full range of free support services that include reimbursement support, 24/7 nurse support, self injection training at home or in the physician office, free Sharps containers, disease management tools and self injection reminders. Help your patients get coverage for HUMIRA, become comfortable with HUMIRA therapy, sign up for a disease management program, and more! Tell patients to call 1-800-4HUMIRA for more information.

Also indicated for psoriatic arthritis and ankylosing spondylitis

Not only is HUMIRA indicated for rheumatoid arthritis, your patients with psoriatic arthritis and ankylosing spondylitis can also benefit.

  • Psoriatic arthritis is a chronic inflammatory disease of the joints and skin that usually develops between the ages of 30 and 50 in men and women equally. 85% of patients experience skin symptoms before joint symptoms.
  • Ankylosing spondylitis (AS) is a form of arthritis. It primarily affects the joints of the spine and causes inflammation, pain, stiffness, and — in advanced cases — can cause disability and deformity, including a permanent fusing of the spine in a stooped-forward position.

Standard dosing of HUMIRA in these patients is the same as for RA patients, 40 mg administered every other week as a subcutaneous injection.

Important Safety Information

The most serious adalimumab adverse reactions include serious infections (including tuberculosis,invasive fungal infections, and other opportunistic infections), neurologic events, and malignancies. Patients should be closely monitored with complete blood count and liver function tests every three months for the first 12 months of therapy due to rare cases of these reactions.

Patients should be evaluated for tuberculosis infection with a tuberculin skin test prior to therapy with HUMIRA.HUMIRA should not be initiated in patients with active infections, and administration with other immunosuppressants increases the risk of infection. HUMIRA is in pregnancy category B, has not been studied in patients under 18, and should be used with caution in the elderly because of increased risk of infection.The most common adverse reactions associated with HUMIRA include headache, rash, upper respiratory infection, and sinusitis.

Pharmacist counseling tips… help your patients maximize use of their HUMIRA Pen

  • Remove HUMIRA Pen from the refrigerator 15-20 minutes before injection. Have an alcohol swab, gauze or cotton ball, and ice pack ready.
  • Choose an injection site on your thighs or stomach that’s at least 1 inch from previous site and at least 2 inches from navel. Wash hands with soap and water and apply small ice pack to area for 2 to 3 minutes. Wipe the injection site with alcohol swab prior to injection.
  • Hold Pen with gray cap 1 pointed up and examine the window to make sure the solution is clear and colorless. Turn Pen so plum cap 2 is pointed up to make sure the liquid is approximately level with the line visible through the window.
  • Remove caps 1 and 2. IT’S ACTIVATED! Don’t accidentally bump or press plum button or replace cap 2 until the Pen is firmly at your injection site and you are ready to inject.
  • Gently squeeze a sizable area of cleaned skin, place pen at a 90-degree angle flush against the skin, push plum button, hear “click” then maintain pressure and count to 10 seconds. Ensure yellow indicator appears in full view and stops.
  • For additional information on injection site preparation or treatment support, patients can call 1-800-4HUMIRA (1-800-448-6472) or visit www.HUMIRA.com.

Please visit www.HUMIRA.com for full prescribing information.

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