Legislative Update January 7, 2008

Author: Lynn Rolston

Legislative Update

By Kathy Lynch, Vice President of Government Affairs

in collaboration with

John Cronin, Pharm.D., J.D.

January 7, 2008

Happy New Year!

The 2008 Regular Legislative Session commenced today, January 7^th. 

The Special Session to address health care reform is ongoing.  At this time, the Senate Health Committee is scheduled to hear the health care reform plan promoted by the Governor and the Speaker that was adopted by the Assembly in December.  There are again, many moving parts so this hearing may or may not happen next week.  Governor Schwarzenegger and Assembly Speaker Fabian Nunez have submitted ballot language asking voters to fund their health care reform plan. 

An addition Special Session to address the fiscal emergency is scheduled to be called by the Governor on Thursday, January 10^th – the same day is going to release his proposed 2008-09 proposed budget.  Emergency legislation was supposed to be drafted over the holidays to address the current year shortfall and is scheduled to be introduced immediately upon opening of this additional Special Session.

It is our understanding that all three of the above Sessions will be operating concurrently for the foreseeable future.  At this time, there is no firm time limit on the Special Sessions.

The bill introduction deadline for the 2008 Legislation Session is February 22^nd.  We will post a chart of the bills and CPhA’s positions after review and decisions are made by the CPhA Legislative Committee.

If you have any questions or comments, please contact me at klynch@cpha.com or (916) 779-1400. 

Thank you very much for your continued support!  Happy Holidays! 

Kathy   

HHS is hosting a public summit on January 8, 2008 in Mountain View, California.  The topic is "Wired for Wellness - Advancing 21^st Century Medicine with Electronic Health Records."  To learn more about this summit, click here. 

The recently enacted Food and Drug Administration Amendments Act of 2007 directs the Secretary of Health and Human Services (HHS) to implement a 2004 proposed rule regarding a new adverse event reporting requirement.  The 2004 proposed rule would require medication labeling to include a toll-free number maintained by the Department of HHS for the purpose of receiving reports of drug-related adverse events.  The number must be included on the labeling of prescription and non-prescription drug products.   This proposed rule became effective on January 1, 2008. 

The Secretary of HHS has been directed to implement the labeling statement in a manner "most likely to reach the broadest consumer audience" and to minimize the cost to the pharmacy profession.  The proposed rule would require pharmacists and other authorized dispensers to distribute the side effect statement to consumers with new and refill prescriptions.  Pharmacists would be allowed to select from five options to distribute the side effects statement:

1. On a sticker attached to the unit package, vial, or container of the drug product;
2. On a preprinted pharmacy prescription vial cap;
3. On a separate sheet of paper;
4. In consumer medication information; or
5. In the appropriate FDA-approved Medication Guide that contains the side effects statement. 

Pharmacies can comply with the requirement by including the statement: “Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088” on their prescription labels or consumer information printouts.  As more information about this matter develops, we will pass it on. This regulation is now in effect, but we have heard that FDA will not seek to enforce this new requirement until January 2009.

The next Board of Pharmacy meeting will be on January 23-24, 2008 in San Diego. On January 24^th the Board will be discussing the proposed compounding regulations. The proposed language will impact any pharmacy that does compounding and will impose new requirements on this traditional pharmacy practice.  The regulation language has been in development for several years, with input from CPhA, Kaiser and compounding pharmacists across the State. The full text of the regulation is available at the Board’s website: www.pharmacy.ca.gov/laws_regs/regulations.shtml, under “Pending” regulations, “Beginning with section: 1716.”