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"Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax," reports this New York Times news article, "Quickly Vetted, Treatment Is Offered to Patients." In general, the 510(k) process is intended to be a quick-review process that promotes innovation, and that most new devices improve upon an existing device so there is rarely is a need for full review.
Read the article for yourself. Some controversial issues are raised that you might be interested learning about. You be the judge.
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It can be really hard to remember all the acronyms. The FDA does its best to make quite a number of free resources available. Do you know what MAB stands for, or what PERV is? Check out the FDA Glossary of Acronyms (it's free!).
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Big Pharma has been calling for the passage of the Prioritizing Resources and Organization for Intellectual Property Act of 2007 (PRO IP) which strengthens the US court’s power to punish those convicted of counterfeiting. Well, President George W Bush just signed the bill, so now counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual. For more information, read this InPharmaTechnologist news article, "Counterfeiters can get life in jail under new US Act."
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The numbers are pretty startling. It seems as though the FDA doesn't inspect domestic drug plants too often, but worse, they inspect foreign plants even less. Get the complete details in this Chicago Tribune news article, "FDA scrutiny of foreign drug plants knocked - GAO report finds huge gap in inspections." Here are some quick highlights . . .
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Fresh from the ICAAC & IDSA meeting in Washington, DC. In a nutshell, recent findings suggest that HIV drug therapy should be started earlier, reports this short The Spokesman-Review news article, "AIDS treatment should start sooner, study finds."
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The future is here. The FDA is starting to wrestle with how to regulate the burgeoning area of nanoscale drug development. This is pretty fascinating and interesting stuff as reported in this American Society of Health-System Pharmacists (ASHP) news article, "FDA Gathers Information For Plans To Regulate Nanoscale Drugs." Here are a couple of things I found interesting . . .
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Updated October 9, 2019
The original link broke.
You might also be interested in:
The Stink in Farts Controls Blood Pressure - LiveScience
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Uh-oh. The future could be very smelly. This research in mice shows that hydrogen sulfide gas might help regulate blood pressure and have the potential to treat high blood pressure. Hydrogen sulfide smells like rotten eggs. The finding in mice might also apply to humans. Find out more in this MSNBC New article, "Stinky farts may help regulate blood pressure - Gas relaxes the blood vessels to prevent hypertension in mice, study finds."
Sorry, the weekend is near, and I couldn't resist posting this one :)
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A recent report says that doctors prescribe placebos regularly. Watch this MSNBC News video for the quick story, "Half of U.S. doctors often use placebos." I have mixed feelings about this. The majority of physicians didn't tell their patients about it, and thought that the practice was ethical. This is food for thought. Are we weaker vessels these days? Are there other "ethical" practices going on?
Nobody wants to see kids hurt! So it's important that you read this NBC News article to avoid such a situation, "Prescription opiates and kids: One pill can kill - Glut of drugs fuels reports of poisonings among very young children." Oxycontin and other opiates can poison your kids. Here are some things you need to do . . .
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Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs, "Postmarket Drug Safety Information for Patients and Providers." On this page you'll find many resources organized in the following categories . .
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Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the Validation-Online.net website. In particular, there's a nice collection of "cGMP FDA 483 COMMENTS." Here you'll find over 100 FDA 483 topics that cover a 483 issue with associated comments, tips, and recommendations. Validation Online says, "Some of the problems listed below cost companies million of dollars to find and rectify."
Previous FDA 483 Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA 483 Inspectional Observations - learn from these examples
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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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This should come as some relief to those who drink caffeinated beverages. For a quick overview, read this Washington Post news article, "Caffeine Consumption Doesn't Raise Overall Breast Cancer Risk." The article reports the findings of a study published in the Archives of Internal Medicine, "Caffeine Consumption and the Risk of Breast Cancer in a Large Prospective Cohort of Women (abstract)." Here's the bottomline reported by the investigators . . .
Conclusions. These data show no overall association between caffeine consumption and breast cancer risk. The possibility of increased risk in women with benign breast disease or for tumors that are estrogen and progesterone receptor negative or larger than 2 cm warrants further study.
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Here's the latest update on the CA e-Pedigree situation, as reported in this The MQN Weekly Bulletin news brief, "Schwarzenegger Terminates 2009 ePedigree Deadline." Here are the main points . . .
Previous Posts: The Health, Drug, Prescription, and GMP Supersite: CA E-Pedigree - Pedigree and Serialization
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This is a wonderful free library of videos, offered by the US FDA's Center for Food Safety and Applied Nutrition (CFSAN). There are more than 24 videos listed on this page, categorized as follows:
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Updated July 9, 2020
The original post didn't age well.
You might also be interested in this journal article from about the same timeframe, 2009:
Interoperable Electronic Prescribing In The United States: A Progress Report
The adoption of e-prescribing has started to accelerate, but its use is not yet as widespread as policymakers want it to be. (Health Affairs)
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How appropriate for October, which is National Pharmacy Month! There's an effort to help the U.S. health care system transition from a largely paper-based system of prescribing to electronic prescribing, in order to support more effective medication management. The eHealth Initiative in collaboration with the Center for Improving Medication Management, offers a series of guides and reports have been issued over the last several months to support the effective adoption of e-prescribing to drive improvements in the quality, safety and effectiveness of health care:
I think this makes a lot of sense. I take the bus and train to work, and pass a lot of folks listening to an MP3 player. Guess what, I can hear their tunes only too well, too! Seems to me most of these players are putting out some decibels. So the European Union (EU) in some wisdom has set out to reduce the volume put out by MP3 players. Read the full story in this Boston Globe news article, "EU tells music lovers to turn down MP3 players."
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The FDA launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. Food industry management will use the FIRST tool kit as part of ongoing employee food defense training programs, "Employees FIRST - Food Defense Awareness for front-line food industry workers."
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I'm really disgusted and disappointed. Pfizer now joins the ranks of Merck, and Schering-Plough (both recently criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries) for purportedly manipulating the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses. For more details, read this NY Times news article, "Experts Conclude Pfizer Manipulated Studies."
I'm particularly irritated given the recent drop in the stock market. Corporations and entities need to be held accountable, especially when the American populace takes it on the chin.
Previous posts:
The Health, Drug, Prescription, and GMP Supersite: Merck - Pharma Gone Bad
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This is probably my last post on this subject, yet a worthy close to this thread. If you've been following this issue you'll want to read this FDA statement, "FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children."
In a nutshell, there are still a lot of issues that need to get resolved. In the meantime, here's the abbreviated version of what the FDA recommends:
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Nobody wants bad breath. Nobody wants to endure somebody else's bad breath. This Medical News Today article, "Combatting Bad Breath: Mouthrinses Work, But Some Cause Temporary Staining" gives some advice and cautions in choosing products to buy. Here are the takeaways . . .
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Looks like the pharmaceutical industry is coming out with some strong recommendations. Read this MSNBC news article, "Drug companies: No cold meds for kids under 4."
They recommend . . .
These suggestions seem pretty reasonable, all things considered.
Previous post:
The Health, Drug, Prescription, and GMP Supersite: The FDA And Cold Meds For Children (video)
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The FDA stance is interesting. Instead of banning kids' cold medicines, they've chosen the "lesser of two evils" position. That is, the FDA fears that if they ban cold meds for kids (which are believed to be ineffective), parents will give adult-strength cold meds to children making the whole situation worse.
Check out this MSNBC news video to get the quick story about this, "FDA Rejects Ban On Kids' Cold Meds. "
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I really like this MSNBC video, "Medical Testing At Home." It provides an introduction to home testing and includes some important tips, such as:
I was surprised by the breadth of tests available, for example, blood pressure, blood sugar, drugs of abuse, cholesterol, fertility, etc. In some cases, brand recommendations are made.
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In Why California (Still) Matters, a podcast interview of Adam Fein offers a quick overview of key issues regarding supply chain security, compliance costs, state versus federal legislation, and data ownership issues. This podcast nicely frames the issues before you dive deeper into the specifics surrounding California's e-Pedigree legislation.
The CA e-Pedigree situation is getting complicated as the state's serialized e-pedigree law implementation deadline is shifting from 2011 to 2015 in order to give folks affected by the law some additional time to implement electronic technology to track the distribution of drugs within the state.
Additional Resources:
Updated July 13, 2020
You might also be interested in resources from the ADA. Find what you need:
https://www.diabetes.org/resources
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Managing diabetes isn't easy. Now you can get the latest advice from the experts. What to Expect When You Have Diabetes helps you get through all your questions. The book is skewed towards type 2 diabetes, because this is the type most diabetics have. The book is formatted in a question and answer format for easy understanding. For example, "Is diabetes a dangerous disease? - Should I tell my boss and coworkers that I have diabetes?" This book is authored by The American Diabetes Association, the nation's leading voluntary health organization supporting diabetes research, information, and advocacy.
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The FDA began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). Here are the results of their very first quarterly report, Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008.
The FDA list is a bare-bones compilation naming 20 medications and the potential issue for each. This Reuter's news article provides a little more information about the 20 drugs, and is a little easier to digest, "FACTBOX: Drugs on U.S. FDA list for possible risks."
Bottomline
As stated in the FDA news release, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research."
Additional Information Sources
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I like to keep an eye out for superbly written drug resources. This is a wonderful collection of more than 20 tips on safe medication use from the Institute for Safe Medication Practices (ISMP), "General Advice on Safe Medication Use." The tips are categorized in the following way . . .
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