| Pharmacy Technician Law Passed in Ohio
Columbus, OH — Ohio Governor Ted Strickland signed legislation known commonly as Emily's Law. The law provides stricter requirements and regulations for pharmacy technicians practicing in the state. Emily's Law (SB 203) was enacted following the death of two-year-old Emily Jerry, which resulted from a chemotherapy medication error caused by a pharmacy technician. The law was passed with the lobbying support of the Houston-based National Pharmacy Technician Association (NPTA). Emily's Law was introduced in the Ohio State Senate by Senator Tim Grendell (R). "Governor Strickland,
Senator Grendell, and the Ohio State Legislature have taken a significant step in protecting citizens of Ohio from preventable medication errors," said Mike Johnston, CPhT, NPTA's chairman and CEO. All pharmacy technicians currently practicing in Ohio will have 210 days from the law's effective date to become compliant. The law requires that pharmacy technicians be at least 18 years old, pass a board-certified competency exam, and register with the Ohio State Board of Pharmacy.
The law also provides new standards on training, education, criminal records, and disciplinary actions.
More Transparency for Imported Drugs Sought by FDA
Washington, DC — In an effort to protect patients against imported counterfeit or tainted drugs, the FDA has launched a pilot program requesting drug manufacturers to voluntarily submit more details about their supply chain so that they can get
their products across U.S. border entry points more quickly. The program is being instituted because more than 80% of active drug ingredients are produced overseas, and there has been an increase in the number of counterfeit or tainted drugs entering the U.S. Under the pilot program, which is scheduled to run for two years, the FDA will choose 100 applicants that can submit up to five drugs to be pre-approved.
No More Giveaways to MDs
New York, NY — Branded pens, notepads, and other popular giveaways by pharmaceutical companies may be a thing of the past. Last month the pharmaceutical industry agreed to a voluntary moratorium on giveaways that are usually imprinted with the name of a drug and/or company's name. The new industry guidelines were proposed by the Pharmaceutical Research and Manufacturers of America, an industry group in
Washington that represents most of the pharmaceutical manufacturers in the U.S. The guidelines also reiterate an earlier suggestion by the association that prohibited more expensive gifts like tickets to sporting events and junkets to resorts. Senators Charles Grassley (R-Iowa) and Herb Kohl (D-Wisconsin) are proposing a law that would require drug and medical device manufacturers to publicly disclose all payments and gifts to doctors exceeding $100, or face stiff penalties as high as
$1 million.
FDA Guidelines on Unapproved Drug Use Draw Criticism
Rockville, MD — The FDA has issued final guidelines on the distribution copies of published articles that refer to unapproved uses, often referred to as "off-label" uses, for drugs and medical devices. According to a
report from Reuters, the guidelines are drawing objections from congressional Democrats and drug-industry critics. The guidelines were adopted before former President Bush left office. While the FDA believes the new guidelines will expand the markets for medicines and medical devices, several legislators believe it undermines the need for pharmaceutical companies to first prove to the FDA that a particular use for a drug is safe and effective. Sidney Wolfe, director of
Public Citizen's Health Research Group, is calling on President Obama to reverse the decision. |