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"Thank you for visiting my on-line office. Here you will find information about a number of my initiatives that are important to the people of the District of Columbia. I hope you find this information helpful, and please let me know if I can be of assistance to you."
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September 3, 2010
05:03 am
78° F
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SafeRx Amendment Act of 2008 |
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On January 8, 2008, the Council passed the SafeRx Amendment Act of 2007, innovative legislation designed to protect District residents from several potentially harmful prescription drug marketing practices. The bill also helps to inform patients about the use of prescription drugs for off-label purposes.
The Provisions of SafeRx
The legislation, as passed by the Council, establishes pharmaceutical detailing as a health occupation to be regulated by the Board of Pharmacy. As such, pharmaceutical sales representatives, also known as detailers, must be licensed to practice in the District and are also subject to regulations as promulgated by the Department of Health and the Board of Pharmacy. This requirement made D.C. the first jurisdiction to regulate pharmaceutical detailers as a means to protect patient safety and to increase marketing transparency. In addition, the legislation protects the integrity of the District’s Medication Advisory Committees, such as Medicaid’s Prescription and Therapeutics Committee, by prohibiting pharmaceutical companies from giving gifts or remuneration to Committee members.
The bill also requires physicians to use best efforts to inform patients when a drug is being used for off-label purposes. “Off-label” refers to when a drug is utilized to treat conditions outside of those uses that are FDA approved. While certain off-label uses are actually best practices within medical communities, this provision ensures that patients have all of the information about a drug at his or her disposal when making treatment decisions. Lastly, SafeRx establishes a pharmaceutical education program within the Department of Health to provide prescribers with a broad, balanced range of information on pharmaceuticals, including efficacy and cost-savings, so that they can make the best decisions for patients.
Background
Councilmember Catania introduced SafeRx on September 18, 2007, and the Committee on Health held a public hearing on the legislation on October 18, 2007. Testimony was provided by health care advocates, pharmaceutical industry representatives, members of the community, and the Department of Health.
On November 16, 2007, the Committee on Health marked up the permanent version of the legislation. The Council passed SafeRx on January 8, 2008, and the bill became law on March 26, 2008.
Introduced Version of Bill 17-364
Permanent Version of Bill 17-364
Implementation Update
The Committee on Health held a roundtable on November 13, 2009 to provide an update about the implementation of two of the provisions of the SafeRx Act. In particular, the Committee heard from the Department of Health regarding the licensing of pharmaceutical detailers practicing in the District and from the Alosa Foundation about the performance of the academic detailing program.
As of the roundtable, 1,962 pharmaceutical detailers had been licensed in the District since the implementation of SafeRx. That means there is approximately 1 pharmaceutical detailer for every 2.3 actively practicing physicians in the District.
The academic detailing program as implemented by the Alosa Foundation features just two detailers. In the first six months of the program, the detailers visited almost 370 unique practitioners, or between one-third and one-half of the District’s primary care physicians. The detailers’ first area of focus has been on Type II Diabetes treatment, and they expect to focus on anti-platelet therapy next in the next phase of the program.
For more information about the program, please see the Alosa Foundation PowerPoint presentation.
Also, information about the detailers’ lessons and the D.C. detailing team can be found at www.RxFacts.org. |
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Last Updated ( Monday, 23 November 2009 )
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