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The state of Washington is trying to keep Medicaid patients out of pharmacies.
The National Association of Chain Drug Stores (NACDS) is endorsing a congressional effort to crack down on the bulk sale of a cough syrup ingredient sometimes abused as a recreational drug. The bill amends the Federal Food, Drug, and Cosmetic Act by making it a violation for any unfinished dextromethorphan to be possessed, received, or distributed in violation of this Act.
Although the Food and Drug Administration (FDA) has not developed a detailed proposal for a BTC drug class, it held a public meeting in 2007 to explore the public health implications of BTC drug availability.
The use of dextromethorphan as a recreational drug has increased sharply in recent years, according to some studies, with many teenagers obtaining it in its unfinished form — sometimes over the Internet.
The new highlights section must include a concise summary of the scientific information needed for safe and effective use of the agent, including any black box warnings, Cook said.
We had a mandate to make labeling more informative, more accessible, and easier to use. "If changes were necessary, we had to negotiate with manufacturers to get the best wording possible," Walker said.
Clinicians in focus groups told the FDA that it was hard to find specific information on the old narrative-style label. The highlights section must be updated whenever new information becomes available that makes the current label inaccurate, false, or misleading. "The highlight section does not include all of the information you need to use the drug," Cook cautioned.
Inner city and rural pharmacies, which have the higher percentage of Medicaid patients, will be particularly hard hit.”
Pharmacists also want to know whether they must keep a prescription if they believe it to be forged.
“State law also requires the health department to assess the impact on access of any proposed rate changes and consult with stakeholders. We had a mandate to make labeling more informative, more accessible, and easier to use.
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This recent GAO study was made in response to a 1995 report regarding the feasibility of a BTC class of drugs. Additionally, the study did not find an association between the restrictions placed by the study countries on the availability of particular drugs in the sample and the presence of a BTC drug class.
“You have to get the state to realize that what they are doing is hurting patients,” said John Coster, NCPA senior vice president of government affairs. “State law also requires the health department to assess the impact on access of any proposed rate changes and consult with stakeholders. Taken in large doses, it can cause brain damage, seizures, and death.
The state later asked that the temporary order be extended until May 18, when the court will hear arguments for a preliminary injunction. Washington failed on both counts.
Clinicians in focus groups told the FDA that it was hard to find specific information on the old narrative-style label. The MedWatch number is 1-800-FDA-1088; the website URL is http://www.
Pharmacists across the United States struggle to achieve a balance between maximizing legitimate medical use of controlled substances and minimizing the ability of abusers to obtain the drugs.