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Editorial: Are these still in effect? Part 2
As a continuation of our review of the amendments of the Bill of Rights, I think we need to look specifically at Amendment X where it declares that powers not given to the United States (federal government) are retained by the states. It is my understanding that the states have the power to enact their professional practice laws, establish state boards to govern those practices, establish laws to regulate the practices, etc. Pharmacy practice is established in a state by the professional practice laws. Pharmacy practice is governed by the laws of the state and the regulations enacted by the state boards of pharmacy. The practice of pharmacy includes pharmacy compounding. In fact, when most of the professional practice laws were enacted, the majority of the practice of pharmacy was pharmacy compounding. I don't recall states giving up the professional practice acts to the United States (federal government). Consequently, it is difficult to understand why the U.S. Food and Drug Administration (FDA) becomes involved in pharmacy compounding as long as it is being done under the laws of the states and the pharmacists are in compliance. If not, then it is up to the state boards to correct the situation. It is also unclear as to why the FDA becomes involved in the selection of drugs that can be prescribed by physicians (under their professional practice acts) and prepared/compounded by pharmacists (specifically, domperidone, estriol, etc.)�just a thought!
The Bill of Rights (Amendments VI [6] through X [10])
Amendment VI
In all criminal prosecutions, the accused shall enjoy the right to a speedy and public trial, by an impartial jury of the state and district wherein the crime shall have been committed, which district shall have been previously ascertained by law, and to be informed of the nature and cause of the accusation; to be confronted with the witnesses against him; to have compulsory process for obtaining witnesses in his favor, and to have the assistance of counsel for his defense.
Amendment VII
In suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise reexamined in any court of the United States, than according to the rules of the common law.
Amendment VIII
Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.
Amendment IX
The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.
Amendment X
The powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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Avastin Payments to Increase and Save Patients and the Government Money as Compared to Paying for Lucentis!
Medicare has reversed its plans and now will increase reimbursements to physicians using Genentech's Avastin in patients. The move may cost Genentech money by encouraging more doctors to use Avastin as compared to the more expensive Lucentis.
Both drugs are used to treat patients with macular degeneration, a major cause of blindness. Avastin costs about $50 while Lucentis costs about $2,000 per injection.
Earlier this month, the CMS introduced a measure that would only pay about $7 for Avastin—not enough to cover costs. This would encourage doctors to use the more-expensive Lucentis, which doesn't have such reimbursement restriction, and it is estimated that it could cost the federal government several hundred million dollars annually.
Today, about half of all doctors use Avastin to treat eye disease. The reversal of the decision may increase that number.
http://online.wsj.com/article/SB10001424052748704222704574501771192508500.html?mod=dist_smartbrief
H1N1: Roche to Emphasize Tamiflu Capsule Manufacturing and Depend Upon Compounding Pharmacists to Prepare the Liquid for Children
Because of expected sporadic deliveries of Tamiflu liquid (oral suspension), Roche increased the production of the 75-mg capsules. The reasoning is that the capsules can be used by adults, and they can also be converted to a liquid for children. Doing this, the company says it can make medicine for 25 times the number of children in the same amount of time it would normally take to make liquid version for one child.
Pharmacists have been increasingly compounding this liquid suspension using Tamiflu capsules for several weeks now. Instructions were approved by the FDA in 2006 and are included in the Tamiflu package insert.
Roche has written pharmacists and other healthcare professionals to emphasize that the units of measure written on the prescription for liquid formulations of Tamiflu be consistent with the units of measure on the device used to administer the medicine. The compounding procedure results in a 15-mg/mL suspension, which is different from the commercially available Tamiflu for Oral Suspension, which has a concentration of 12 mg/mL.
http://www.pharmacistelink.com/IVResource/
FDA Using Prescription Data to Track Treatment of H1N1 and Other Flu Viruses
Wolters Kluwer Pharma Solutions, Inc., announced that the FDA is using its prescription data to track the treatment of H1N1 and other influenza viruses. These weekly updates give the FDA the visibility of clusters of patients across the U.S. being treated with the four most popular oral anti-viral prescriptions.
The officials are able to see areas of the country where oral anti-virals are being filled and to identify clusters where high concentrations of usage occur. The data provides the FDA with geographic and demographic information. The data includes detailed breakdowns for each of the four anti-virals, including the ability to track nationally, regionally, and at the state levels. The contract calls for the company to provide two years' prescribing data for each drug to help FDA see historical norms of usage.
http://pharmalive.com/news/index.cfm?articleID=660336&categoryid=43&newsletter=1
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�that as of June 1, 2009, there are 102 colleges and schools of pharmacy with full or candidate status and 10 more schools with precandidate status? This is an increase from 89 schools in 2004 to 112 in June 2009; a 25.8% increase over the past 5 years. Forty schools are private institutions, and 62 are publicly supported universities. There are a reported 425 vacant and/or lost faculty positions for 2007-2008. Of the 425 vacant faculty positions, 53.2% are in clinical pharmacy, 26.4% in pharmaceutical sciences, 9.2% in social and administration sciences, 5.9% in administrative positions, and 5.4% in research and noninstructional areas.
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