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Other News
MPA Winter C.E. Conference Photos Available Online
Toll-Free Number for Reporting Adverse Events on Labeling
Part D Reference Guide for Pharmacists
American Heart Association Guidelines
Pharmacy Coloring and Activity Book
Pharmacists Share Tips for Successful MTM Programs
NCPDP Announces NPIs on HCIdea Database
Transitioning into a New Part D Plan
Emergency Immunization Rules Approved, Effective Nov. 3
Other Items of Interest
MPA Winter C.E. Conference Photos Available Online
Click hereto view a slideshow of photos from MPA's 2008 Winter C.E. Conference held in Branson, Mo.
Toll-Free Number for Reporting Adverse Events on Labeling
The FDA has issued an interim final rule regarding the reporting of Adverse Events, under the Food and Drug Administration Amendment Act of 2007 (FDAAA). The interim final rule went into effect January 1, 2008, but will not be enforced until January 1, 2009.
This extended time frame allows manufacturers, authorized dispensers, and pharmacies time to comply with the regulation and for the FDA to conduct research on the wording of the side effects statement.
The regulation requires two steps.
1) The following statement to be placed on all prescription products. “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” (see note below)
2) Side effect statements are required to be issued with the prescription, in one or more ways; on a sticker attached to the package unit, vial, or container, on a preprinted pharmacy prescription vial cap, on a separate sheet of paper, in consumer medication information, or an appropriate FDA approved Medication Guide; this excludes inpatient hospital or other inpatient health care settings. The format of the statement should be no smaller than 6 points (1 point = 0.0138) and the under paragraphs be no smaller than 10 points. This rule does not apply to packaging which includes a toll free number through which consumers can report complaints to the manufacturer or distributor of the drug, such as some OTC products.
Please note, the FDA is continuing to conduct research on the wording for the side effects statement. Once this research is complete, the FDA will consider the comments made as well as the data from the research into consideration on whether to finalize the interim final rule or to publish a final rule that would amend the interim rule.
Part D Reference Guide for Pharmacists
The 2007 Pharmacy Reference Document is available in PDF format by clicking here.
American Heart Association Guidelines
Changes contained in the 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care are summarized and now available online in PDF format by clicking here.
Pharmacy Coloring and Activity Book
In response to a recent member request, MPA has developed a 14-page downloadable pharmacy coloring and activity book for children. The book is available online in PDF format by clicking here.
Pharmacists Share Tips for Successful MTM Programs
By Reid Paul
Drug Topics, 10/22/07
All right, so you get it: medication therapy management (MTM) is a great new opportunity. But how do you get started and how do you do it successfully? Recently, the American Pharmacists Association (APhA) and the National Association of Chain Drug Stores (NACDS) held a two-day conference in Philadelphia aimed at addressing these questions.
Whereas, in the past, conferences and sessions have sought to introduce the concept of MTM to pharmacists and encourage them to get involved, this conference focused on the best practices from successful MTM programs. Independent, chain and clinic pharmacists discussed what has worked and what has not in the MTM programs they have developed. Click here to read the 10 key take-aways from the conference, according to the speakers.
NCPDP Announces NPIs on HCIdea Database
NCPDP, 11/1/07 - The National Council for Prescription Drug Programs (NCPDP), the pharmacy industry standards development organization, announced that the National Provider Identifier (NPI) is now available on the HCIdea™ database as of Nov. 1, 2007.
This database, with over 1.3 million prescribers, is designed by pharmacists specifically for the pharmacy services sector of the health care industry. All NPIs come from CMS, the "source of truth" for prescriber NPIs. NCPDP has married this data with other HCIdea prescriber information including DEAs, state license numbers, specialties, phones and multiple practice locations. (more...)
Transitioning into a New Part D Plan
A key objective during the open enrollment period (which ends on December 31, 2007) is to help people in Medicare understand their health care and prescription drug plan options. As people have selected new plans or as they have been reassigned to a new plan for 2008, we want to make sure that both you – our partner – and Medicare consumers are aware of some new publications that have been developed to assist those who may be transitioning into a new Part D plan.
Pharmacy Counter Tips
Plan enrollment paperwork continues to be processed as quickly as possible. If a person with Medicare needs a prescription filled before they have received their new plan ID card, there are other items they can bring with them to pharmacy to assure they will be able to get the medicines they need. A new consumer tip sheet, CMS publication: 11343, Quick Tips for People with Medicare: Using Your New Medicare Drug Coverage, is now available here.
Additional Resources
Additional resources available to assist you in your outreach and support to Medicare consumers in your community include:
- CMS publication: 11246-P, Information Partners Can Use on Repayment of Premiums and Copayments Paid Out-of-Pocket available here.
- CMS publication: 11112, Medicare Prescription Drug Coverage: How to File a Grievance, Request a Coverage Determination or File an Appeal in English and Spanish available here.
- CMS publication: 11259-P, Handling Medicare Part D Prescription Drug Plan Complaints available here.
Continued LIS Outreach
- As a reminder in your continued and future outreach – if you come across someone who may qualify for the extra help, they can still apply, and if they qualify, enroll in a prescription drug plan anytime throughout the year. CMS has developed an easy-to-understand brochure outlining the value and process to apply for the extra help. You can obtain copies of these publications and other resources for outreach to people who may qualify for extra help in our LIS Outreach Toolkit available here.
Emergency Immunization Rules Approved, Effective Nov. 3
Earlier this month, the emergency rules for administration of influenza immunizations were approved and are now posted on the Secretary of State's Web site. They are effective Nov. 3, 2007. Click here to view the emergency rules.
The Board of Pharmacy currently has created a form that pharmacists must complete and send to the Board office prior to administering viral influenza vaccines per protocol. Click here to view and print the form.
Other Items of Interest
DISCLAIMER: THE MISSOURI PHARMACY ASSOCIATION IS NOT RESPONSIBLE IN ANY MANNER FOR LINKS OR LINKED CONTENT ON WEBSITES OWNED OR CONTROLLED BY OTHERS. WE PROVIDE ANY LINKS ONLY AS CONVENIENCE AND NOT AS A RECOMMENDATION OR ENDORSEMENT OF THE LINKED CONTENT.
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