Friday, October 31, 2008

Daylight Savings Time Ends - set clocks, check stocks

It's time to turn back the clocks, and check your "stocks" (emergency preparedness supplies). This Medical News Today news article gives you the scoop, "Check Your Emergency Preparedness Kits When You Set Your Clocks, Says American Public Health Association Campaign (APHA)." After a tough weather season, we're being prompted to prepare for Winter and any other potential emergencies. Here's what you need to do this weekend . . .

  1. "Get Ready: Set Your Clocks, Check Your Stocks"
  2. Refresh your emergency supplies
  3. Check your batteries in smoke detectors

Additional APHA Resources:

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Wine - For Enjoyment Or Metal Ion Poisoning?!

I love my wine, but I hate it when reports like these come out. This news article posted on Ivanhoe's Medical Breakthroughs, tells us to worry about the metal ion content of wines, "Wines Found Contaminated With Metals." From where I sit, there doesn't appear to be much I can personally do until producers label the metal ion content on the bottle. Until then, I think I'll keep drinking wine the way I do now. Bottoms up! Sante'

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Thursday, October 30, 2008

Medical Devices - A murky 510(k) world?!

"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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FDA Glossary Of Acronyms (free)

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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Wednesday, October 29, 2008

Halloween Safety Alert From The US Product Safety Commission - Costumes, etc.

It's never too late to brush-up on the latest tips on Halloween safety. The US Product Safety Commission publishes this excellent collection of safety tips, "Halloween Safety: Safety Alert." It covers things like, costumes, pedestrian safety, and how to choose safe houses to visit.

Previous posts:
The Health, Drug, Prescription, and GMP Supersite: Halloween Costume Flame Retardants - Caution (video)

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Counterfeiters Can Get Life In Jail

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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Tuesday, October 28, 2008

Log Into Google Health - Patient Assistance - Reduce Drug Costs

Your drugs and medications are way too expensive. Here's one way to cut your costs. Just log into Google Health, then "click on "Explore Online Health Services" in the left column. They can then scroll down and click on "Patient Assistance" and click the "link to profile" button to connect their Google Health profile to the patient assistance programs search from," as reported in this Medical News Today news article, "Google Health Application Helps Users Find Patient Assistance Programs For Medications Using" This is just one of many ways to reduce the costs of your prescriptions, by getting help from these patient assistance programs.

Related Links:
Google Health

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Treat The Flu With Red Wine?!

Flu season is here in full force, so it was fun to see this article in the Wine Spectator magazine, "Red Wine Chemical Cuts Flu Risk - Quercetin reduces susceptibility to influenza, especially after exercise." Although the research was conducted in mice, I'm hopeful that there's some benefit to be found in humans. The research was published in the American Journal of Physiology—Regulatory, Integrative and Comparative Physiology. I got my flu shot several weeks ago and hope to avoid catching the flu. But if I do, know that I'll be swilling some red wine, cheers!

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Monday, October 27, 2008

FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

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 . . .

  1. Pharmaceutical factories in the U.S. get a federal inspection every 2.7 years, on average
  2. It would take U.S. inspectors 13 years to visit each of the 3,249 foreign manufacturing plants that make medications for the American market
  3. The GAO (Government Accountability Office) recommended more surveillance inspections of foreign plants

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Sunday, October 26, 2008

Flash - HIV Drug Treatment Needs To Start Earlier

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 Houston Chronicle news article, "AIDS treatment should start sooner, study finds." If you're interested, I've embedded the video proceedings of the press session of the conference:

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Halloween Costume Flame Retardants - Caution (video)

If you're still shopping for Halloween costumes, consider this. Many costumes are treated with flame retardant chemicals. If this is important to you and your children, then view this MSNBC News video, "Costume Chemical Scrutinized." Be safe and have fun trick or treat'n!

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FDA And Future Nanoscale Drug Regulation

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 . . .

  1. Existing methods for examining traditional-sized products may fall short at the nanoscale level
  2. There's a need to understand the potential benefits and hazards of smaller drug particles
  3. At what size does a drug become a nanoscale product?
  4. Nanoscale drugs are manipulated in ways that may change the chemical and physical properties of a substance, which may alter how the drug functions inside the body

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Saturday, October 25, 2008

Oh No - Stinky Farts Prevent Hypertension

Updated October 9, 2019

The original link broke.

You might also be interested in:

The Stink in Farts Controls Blood Pressure - LiveScience

- - -  original post follows below  - - -

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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Warning - Halloween Decorative Contact Lenses Can Damage Your Eyes!

Bottomline, some non-prescription contact lenses used as Halloween eyewear might result in damage to your eyes. Check out this Medical News Today news article for the full story and 9 "Recommendations for Decorative Contact Lens Wearers from the American Optometric Association" described in, "Consumer Warning: Halloween Eye Wear Accessory May Permanently Damage Eyes." Your eyes and vision are a precious commodity, don't risk them for the sake of looking cool this Halloween.

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Friday, October 24, 2008

Flip Of A Coin Chance Your Doctor Gave You A Placebo (video)

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?

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Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

  1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
  2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
  3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.
Stay tuned, as there's hope the FDA will respond within the next couple of weeks.

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: New FDA Guidance - Residual Solvents in Drug Products

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Thursday, October 23, 2008

Opiates Can Kill Kids!

Nobody wants to see kids hurt! So it's important that you read this CNBC 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 . . .

  1. Don't spill or drop pills, and if you do, it's critical that you pick them all up, so that they're not eaten by your children.
  2. Be sure your painkillers are secure, because one pill is enough to harm or kill.

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Wednesday, October 22, 2008

FDA Creates New Web Page of Drug Safety Information

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 . .

  • Drug Labeling
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder
  • Registries and Clinical Trials
  • Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
  • Latest Safety Information
  • Reporting Problems to the FDA
  • Warnings and Recalls
  • Regulations and Guidance Documents
  • Information about FDA's Drug Safety Oversight Board (DSB)
  • Using Medicines Safely
  • Consumer Articles on Drug Safety
  • General Health Information
  • FDA's Response to the Institute of Medicine's 2006 Report

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Tuesday, October 21, 2008

Is It Safe To Eat The Mushrooms In My Yard? - Probably Not

I just ran across this Chicago Tribune news article, and it made me stop to think, "You asked: Can I eat the mushrooms in my yard?" While the weather here in San Francisco is rather mild and dry, the article reminds me that Fall is in full swing and some places are getting lots of rain. Ripe conditions for mushrooms in the yard. So if you're even tempted to eat those mushrooms, please stop and consider the following main points . . .

  1. Some wild mushrooms are poisonous and possibly deadly
  2. It's very hard to tell which are safe and which are not
  3. Eating poisonous mushrooms can cause vomiting, cramps, bloody diarrhea, seizures and deadly liver damage
  4. If you suspect a mushroom poisoning, call your local poison center for advice

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Monday, October 20, 2008

More FDA 483 Resources - Comments and Pearls from Validation Online

Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the 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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Sunday, October 19, 2008

Caffeine Consumption Does Not Raise Overall Breast Cancer Risk

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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Saturday, October 18, 2008

New FDA Guidance - New Contrast Imaging Indication Considerations

The FDA has just released this new guidance document, "Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (pdf)." To get quickly up to speed on the gist of the guidance, read this commentary posted on the FDA Law Blog, "FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling." In a nutshell, here's what the guidance covers . . .

The guidance describes a process that allows either the imaging drug or imaging device developers to seek approval of medical imaging contrast indications using an already marketed imaging drug or biological product, including radiopharmaceuticals.

1. Device developers should generally submit a marketing application to add a new indication for using an already approved imaging drug under the circumstances described in this guidance.
1a. The data to establish these indications in a device application should include information developed in accordance with FDA existing guidance on Developing Medical Imaging Drug and Biological Products.
1b. For most types of indications as described in this guidance, when submitted to request marketing under a device application, the submission should be a Premarket Application (PMA).

2. Drug or biological product application holders of the already marketed imaging drug or biological product should generally submit an efficacy or labeling supplement, as appropriate, to add labeling for the new indication initially developed under a device application.

3. Device application holders may continue their current practice to request approval or clearance of labeling revisions for any new indications that may be initially approved in a supplement to the NDA for the imaging drug.

4. FDA expects to establish an internal intercenter imaging process to review and evaluate indications to ensure consistency in the development and review of clinical trials to establish the contrast indications that may be in either the drug or device labeling.

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Friday, October 17, 2008

CA Gov Delays e-Pedigree Mandate to 2015

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 . . .

  • Under the new law, a manufacturer must have an epedigree by 2015 for 50 percent of its drugs sold in California. Unit volumes, SKUs or drug product families may define the 50 percent figure.
  • California Gov. Arnold Schwarzenegger has signed legislation that delays the state’s 2009 electronic pedigree mandate for prescription drugs until 2015.

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: CA E-Pedigree - Pedigree and Serialization

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FDA CFSAN - Food Safety and Nutrition Video Library (free)

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:

  1. Food Safety Videos from FDA
  2. Other Videos from CFSAN
  3. Food Safety Videos from FDA/USDA and Partnerships

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Thursday, October 16, 2008

Accelerating the Use of Electronic Prescribing to Improve Health Care

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:

  1. Electronic Prescribing: Becoming Mainstream Practice
  2. A Clinician's Guide to Electronic Prescribing
  3. A Consumer's Guide to Electronic Prescribing
  4. A Guide for Health Care Payers to Improve the Medication Management Process

Related News:
CMS-eRX: Officials Lay Out Cost-Benefit Analysis of E-Prescribing Bonuses
Confab pushes ‘e-prescribing’

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Wednesday, October 15, 2008

EU Says Turn Down MP3 Players Or Risk Hearing Loss

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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Tuesday, October 14, 2008

FDA Launches Food Defense Awareness Training Kit For Employees In The Food Industry

Here's the real news. 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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Monday, October 13, 2008

BPA Linked To Heart Disease And Diabetes (video)

Here we go again! More bad BPA (bisphenol A) news. You've been worrying about BPA exposure to your baby, now worry about BPA causing diseases in adults. Watch this ABC News video, "The Dangers of BPA." Bottomline, try to avoid BPA whenever possible. Avoid plastics with the number 7 in the recycle symbol, and avoid canned foods and beverages lined with an epoxy plastic substance.

Previous Posts:
The Health, Drug, Prescription, and GMP Supersite: Bisphenol A and the FDA - Is it safe or carcinogenic?!

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Sunday, October 12, 2008

Pfizer Caught Manipulating Studies Too

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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Saturday, October 11, 2008

FDA CDRH Online Courses (Free)

Very exciting! Check out these free courses at the CDRH Learn site. Here's why you want to go there . . .
CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) Web page for industry education. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.

CDRH Learn offers training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues.
Expect more training modules to get released, and eventually associated post-tests.

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Friday, October 10, 2008

Cold Meds For Kids - The FDA Weighs In Again

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:

  • Do not give children medications labeled only for adults.
  • Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
  • Choose OTC cough and cold medicines with child-resistant safety caps, when available.
  • Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose.
  • Be very careful if you are giving more than one medicine to a child.
  • Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label.
  • Only use measuring devices that come with the medicine or those specially made for measuring drugs.
  • Understand that using OTC cough and cold medicines does not cure the cold or cough.

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Thursday, October 9, 2008

Choosing A Mouthrinse For Bad Breath

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 . . .

  1. Over the counter mouthrinses actually work
  2. Mouthrinses containing chlorhexidine can cause temporary staining of the tongue and teeth, and also can temporarily alter taste sensations
  3. Chlorhexidine and cetylpyridinium were significantly more effective than placebos in reducing mouth odors
  4. Chlorine dioxide and zinc were more effective in neutralising odor compounds

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Wednesday, October 8, 2008

Cold Meds For Kids - Part 2

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 . . .

  • Parents should never:
    Give adult medicines to a child.
    Give two or more medicines with the same ingredients at the same time.
    Give antihistamines to make a child sleepy.
  • Parents should:
    Give the exact recommended dose, using the measuring device that comes with the medicine.
    Keep OTC medicines out of sight and out of reach.
    Consult their doctor if they have any questions.

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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Tuesday, October 7, 2008

The FDA And Cold Meds For Children (video)

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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Monday, October 6, 2008

Home Medical Testing Kits - Overview and Recommendations (video)

I really like this MSNBC video, "Medical Testing At Home." It provides an introduction to home testing and includes some important tips, such as:

  • Read the label and instructions carefully
  • Use only FDA-approved tests
  • Follow all instructions
  • Keep good testing records
  • Call the 800 number for questions

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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Sunday, October 5, 2008

CA E-Pedigree - Pedigree and Serialization

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:

  1. CA State Board of Pharmacy - California E-Pedigree Law
  2. CA E-Pedigree: Hasta La Vista, 2011 - a blog post by Fein
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Friday, October 3, 2008

170 Diabetes Tips from the ADA

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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Thursday, October 2, 2008

20 Drugs - New FDA Safety Info

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."

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

  1. FDA to Post Quarterly Report of Potential Safety Issues (news release)
  2. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) - links to quarterly reports

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Wednesday, October 1, 2008

More Than 20 Free Tips - Use Your Medications Safely

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 . . .

  1. At Home. For example, make a list of medications you are taking now, or ; any time that your medications change, change your list, too.
  2. In The Hospital. For example, take your medications and the list of your medications with you when you go to the hospital, or ; after your doctor has seen them, send your medications home with your family.
  3. At The Doctor's Office. For example, take your medication list every time you go to your doctor’s office, especially if you see more than one doctor, or ; ask your doctor to explain what is written on any prescription, including the drug name and how often you should take it.
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