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Try this month’s
“MedGuide” Challenge |
As of March 2005, the FDA has approved 31 different Medication Guides, or “MedGuides,” including two that apply to entire medication classes... antidepressants and NSAIDs. These 31 MedGuides affect almost 600 individual product NDC numbers... including over 200 antidepressant NDCs and 300 NSAID NDCs.
With so many products affected, this month’s Challenge is devoted to helping pharmacists recall which patients should receive MedGuides. From the choices below, choose which patients should receive MedGuides? (More than one answer may apply).
A. 14 year old patient refilling their Zoloft;
B. 23 year old female taking Accutane;
C. Male patient filling a new prescription for ibuprofen 800 mg;
D. 45 year old patient with new prescription for trazodone;
E. 8 year old child on Strattera®.
Scroll down for the answer to
this month’s challenge
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VOLUME 10 | NUMBER 3 | MARCH 2006
In This Issue…
Find the latest on Medicare and Medicaid reform at the
Center for Advocacy and Public Affairs
As pharmacies have experienced first hand over the past few months, Medicare has undergone significant changes with the introduction of the new prescription drug benefit... a change which began with Federal legislation (the Medicare Modernization Act) in December of 2003.
Earlier this year, the Federal government passed another piece of legislation that will also greatly impact the practice of pharmacy... the Deficit Reduction Act of 2005, which will lower the amount that pharmacies are reimbursed for most generic Medicaid prescriptions starting in 2007.
Taking these two examples into account, the government’s actions in Washington D.C. are affecting the practice of pharmacy now more than ever. To help pharmacists and others keep up-to-date on the impact of legislation on pharmacy, the National Association of Chain Drug Stores (NACDS) has created the Center for Advocacy and Public Affairs...an online resource containing valuable public policy and advocacy information on Medicare, Medicaid, and more.
The site is designed to help pharmacists and others understand the issues impacting the profession of pharmacy and make them aware of ways to get involved in advocacy efforts on behalf of community pharmacy. Visit www.centerforadvocacyandpublicaffairs.org today!
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Federal law curbing methamphetamine abuse may cause changes in
pseudoephedrine sales restrictions at pharmacies
While approximately 40 states have individually created laws which limit access to pseudoephedrine, the Federal government has recently stepped up its efforts to help reduce methamphetamine abuse... by passing a law which will restrict the sale of cough and cold products nationwide. The new law requires pharmacies to quickly comply with “daily sales limits” and “monthly purchase limits” for all non-prescription products containing pseudoephedrine or ephedrine by April 8, 2006 (see requirements below).
In addition, the law will require pharmacies to keep all products containing pseudoephedrine or ephedrine behind a counter or in a locked cabinet... and all pharmacies must maintain a written or electronic logbook of pseudoephedrine purchases. See below for details on when these requirements go into effect.
Anti-methamphetamine Federal Law requirements*
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Comply by April 8, 2006 |
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3.6 gram daily sales limit |
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9 gram monthly purchase limit** |
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All non-prescription pseudoephedrine and ephedrine must be in blister packaging |
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Comply by September 30, 2006 |
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Placement of products behind a counter or in a locked cabinet |
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Maintaining a written or electronic logbook |
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Photo ID must be shown at purchase |
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Retail staff must be trained |
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*Apply to all single and multi-ingredient products containing pseudoephedrine. Logbook and ID requirements
do not apply to sales of 60 mg or less of pseudoephedrine.
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** Effective date for 9 gram monthly limit may be subject to change |
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Pharmacies must place all products behind a counter or in a locked cabinet by September 30, 2006
While many pharmacies have already placed single-ingredient pseudoephedrine products behind a counter to
comply with individual state laws, the new Federal law applies to all products which contain any form of
pseudoephedrine or ephedrine, including pediatric, multiple-ingredient, and liquid formulations. Although sales
and purchase requirements begin in April as indicated above, the requirement to move pseudoephedrine and
ephedrine behind a counter or into a locked cabinet does not go into effect until September 30, 2006. However,
many pharmacies may choose to comply with all requirements before September 30.
Pharmacies must comply with Federal and individual state requirements
While the restrictions within the Federal law may overlap with many of the individual state laws, pharmacies
will need to comply with these Federal restrictions in addition to any requirements enacted within their state.
To view how your state’s law compares with the Federal requirements, visit www.nacds.org/meth for summaries
of all anti-meth state laws.
Patients may need reinforced education to help understand new restrictions
With additional changes to access of pseudoephedrine coming soon, as a result of the Federal law, some
patients may need some additional explanation as to why these changes are occurring. Indicating a widespread
problem, over 12 million Americans age 12 years and older have tried methamphetamine at least once in their
life (5.2% of the population). Remind patients that the new restrictions are the result of a Federal law aimed
at reducing this statistic… and cleaning up communities where abuse is a problem.
Community pharmacists and pharmacy technicians who complete pseudoephedrine transactions have an opportunity to provide patients with this explanation... and at the same time, assure them that these OTC products
are safe when used properly.
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With access to pseudoephedrine becoming more limited, many patients are trying phenylephrine-based products
With many or all pseudoephedrine products already removed from over the counter shelves, patients are frequently making the switch to reformulated medications now containing phenylephrine which are more readily available. While these formulations have allowed patients to have continuous over-the-counter access to familiar cough and cold products, patients may often be unaware that many of these medications now contain a different decongestant.
Although little data exists that supports clear clinical differences between pseudopehedrine and phenylephrine, patients accustomed to the effects of pseudoephedrine may be experiencing a slight difference in efficacy if switching to a phenylephrine-based product. Pharmacists can help patients by making sure they are aware of the active ingredients contained within the products they purchase... and by reminding them that pseudoephedrine is still available behind the counter. Also, as depicted in the chart below, make sure patients are aware of the difference in dosing between the two decongestants.
Standard dosing of pseudoephedrine and phenylephrine
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Dose |
Frequency |
Maximum Daily Dose |
Pseudoephedrine HCl |
60mg (2 X 30mg tablets)* |
Every 4 to 6 hours |
240mg |
Phenylephrine HCl |
10mg (1 tablet) |
Every 4 hours |
60mg |
*also available in extended release formulations; 120 mg twice daily
Visit www.nacds.org for helpful iPledge resources
With the iPledge risk management program becoming the only way to dispense isotretinoin as of March 1, 2006, pharmacists, patients, and prescribers have all been faced with overcoming some technical challenges which exist within the program. For all users, these technical challenges have often resulted in significant wait times on the iPledge call center (1-866-495-0654).
Specific to pharmacy, three main technical issues are causing the majority of the problems. Here is some clarification and resources which can help pharmacists limit their calls to the iPledge help desk:
• Logging in using the automated phone system: Because of the way the iPledge system was designed, pharmacists logging in over the phone (not on website) must hit a "*" key after each digit. So... if your user name is NCPDP # 1234567, you would enter 1*2*3*4*5*6*7*#. The iPledge system may remove the need to enter the "*" key in the future. Pharmacies should continue using the "*" key unless instructed otherwise on the iPledge IVR system.
• Entering proper NDC number: Some isotretinoin products may be listed in the iPledge system as 10-digit NDC numbers… instead of the standard 11-digit format. If you repeatedly receive the “Please enter the NDC number” message, you may want to try entering the 10-digit format which is listed on the product packaging. Visit www.nacds.org/pharmacypractice for a list of product NDC numbers used in the iPledge system.
• Forgot password function: The iPledge website has an added functionality to their “forgot password” link. Any iPledge-registered pharmacy can now use the “forgot password” link on www.ipledgeprogram.com to have a password sent via email... regardless if they have ever logged into the system.
iPledge Fact Sheet |
| To further help pharmacists with the dispensing process, a one-page iPledge fact sheet outlining the pharmacist’s responsibilities under the program is now available on the NACDS website. Visit www.nacds.org/pharmacypractice to download a copy for posting in your pharmacy… and check out many other iPledge resources. |
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Uniform version of NSAID MedGuides coming to pharmacies in April
By the first week of April, pharmacies can expect to receive an initial shipment of Non-Steroidal Anti-inflammatory Drug (NSAID) MedGuides... to be dispensed to all patients filling new or refill prescriptions for NSAIDs. While pharmacies may have manufacturer-specific MedGuides from this fall, this uniform version of the NSAID MedGuide can be dispensed with any NSAID.
Once they arrive, pharmacies should dispense MedGuides to all patients receiving any prescription NSAID... including combination products, such as Vicoprofen® (hydrocodone/ibuprofen). To view a copy of the NSAID MedGuide, or for more information on MedGuides, visit www.nacds.org/pharmacypractice.  New warning and MedGuide for salmeterol... Pharmacists can expect to see a new warning on the labeling for all inhaled products containing long-acting beta-2-adrenergic agonist, salmeterol. The FDA has also approved a new Medication Guide (Medguide) for these products which will be included within the packaging. Let patients know the new warnings are to alert health care providers and patients that these medications may increase the chance of severe asthma episodes and death when those episodes occur. The new requirements apply to brand-name products Serevent® Diskus® and Advair Diskus®.
Prescribing information gets a new look... Pharmacists may be seeing updated versions of prescribing information for some products. This is the result of an FDA ruling requiring products approved as of June 30, 2006 to include a “highlights” section at the top of the label, a “patient counseling” section at the end, and also a detailed table of contents. While only newly approved products will be required to conform with the new labeling format, the FDA is encouraging the manufacturers of existing products to adapt this new look as well. To view samples of the new labeling, visit www.fda.gov/cder and click on “New Requirement for Prescribing Information.”
Fortovase® (saquinavir) discontinued... The manufacturer of the HIV medication Fortovase (saquinavir) has discontinued the product as of February 15, 2006. Pharmacists that come across prescriptions for Fortovase should contact the prescriber to switch patients to Invirase (saquinavir mesylate)... a similar medication allowing patients to take fewer pills per day or another alternative regimen.
References for information included in The Practice Memo are available by request: practicememo@nacds.org |
Answer to this month’s “MedGuide” Challenge |
If you answered that all patients (A-E)
should be receiving MedGuides with their
prescription, congratulations, you’re correct. Below are brief descriptions for each:
A. All patients, regardless of age, should receive a MedGuide with new and refill antidepressant prescriptions.
B. MedGuides for Accutane are included in the product packaging and should be provided to patients.
C. In April 2006, pharmacists will be provided with MedGuides for patients receiving prescription NSAIDs.
D. Same as “A.”
E. All strengths of Strattera® (atomoxetine) have MedGuides included within the package insert and should be dispensed to patients receiving this medication.
For more information on MedGuides, visit www.nacds.org/pharmacypractice
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
Stefan S. Merlo, Pharm.D.
Editor
Stefan S. Merlo, Pharm.D.
Writer
James Semrad
Contributing Writer/Researcher
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. |
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