Thursday, July 31, 2008

Are Your Teens Abusing Drugs? - 4 Tips

If you have a child in the household, you need to read on.  Read the Partnership for a Drug-Free America Fact Sheet, "Preventing Teen Abuse of Prescription Drugs - Fact Sheet. "

In a nutshell, according to the IndyStar:

  1. Monitor the prescriptions you have in your home
  2. Secure your medicines
  3. Dispose of old prescriptions
  4. Communicate and set a good example for your child
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FDA Seizes Millions Worth of Unapproved New Drugs

Updated January 31, 2021

Links in the original post broke.

People also ask about:

- - -  original post follows below  - - -

This makes me think twice. The FDA and US Marshals caught this one though, "Federal Agents Seize more than $24 Million in Unapproved New Drugs Products made after the FDA required an end to production." As a consumer, I wonder how many manufacturers simply ignore the regulations and get away with it. As a GMP trainer, this situation makes another good example to add to your gmp training war stories. Additional FDA-related resources related to this post:
  1. Guidance for FDA Staff and IndustryMarketed Unapproved Drugs —Compliance Policy Guide
  2. FDA cracking down on unapproved prescription drugs.(Practice Trends)(Food and Drug Administration): An article from: Internal Medicine News
  3. Serious Problems With Generic Drug Makers In U.S. Continue To Be Discovered

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Wednesday, July 30, 2008

3 Alzheimer Headlines -- Promising Drug - Men - Statins

Updated July 26, 2021

Links in the original post broke.

You might also be interested in:

---  the original post follows below  ---

Alzheimer's is in the news. Follow this triple play of news. Methylene blue (Rember) shows promise, "New Alzheimer's drug shows early promise." "A milder type of mental decline that often precedes Alzheimer’s disease is alarmingly more common than has been believed, and in men more than women," as reported in this article," ‘Pre-Alzheimer’s’ rising, especially in men - Report: A million older Americans slide into mild mental decline each year." "Statin users were about half as likely to develop dementia, or to have cognitive impairment without dementia, as those who did not use statins," reports, "Statins Linked To Lower Dementia Risk. " 

Tuesday, July 29, 2008

Medical Myths - fun reading about serious things

I take things too seriously, so I'm offering up something a little lighter, and more fun than my usual. This NY Times article makes for some interesting reading about things that potentially can be deadly serious, "Health 'Facts' You Only Thought You Knew. " How about: 1) poison ivy is contagious?!, 2) don't swim after eating?!, 3) natural is safer than man-made?!, 4) and much more! 



Monday, July 28, 2008

Deadly Overdose At Home - Especially alcohol and opioid painkillers

Updated February 14, 2021

Links in the original post broke.

- - -  the original  post follows below  - - -

The biggest risk seems to be mixing alcohol and opioid painkillers (e.g., codeine, morphine). This reflects the growing use of these kinds of painkillers in the home. This Bloomberg article frames the situation nicely, "Drug, Alcohol Mix Increases Medication Error Deaths (Update1). " If you want the research publication information, read this abstract, published in the Archives of Internal Medicine, "A Steep Increase in Domestic Fatal Medication Errors With Use of Alcohol and/or Street Drugs." Bottomline, "findings suggest that a shift in the location of medication consumption from clinical to domestic settings is linked to a steep increase in FMEs [fatal medication errors]. It may now be possible to reduce FMEs by focusing not only on clinical settings but also on domestic settings." 

Sunday, July 27, 2008

21 CFR Part 11 - Masking Real Data For Testing

Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.

Prior 21 CFR Part 11 Posts:
The Health, Drug, Prescription, and GMP Supersite: Resource List - FDA Part 11 - Electronic Records and Signatures

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Saturday, July 26, 2008

Salmonella - Peppers? Tomatoes? Both? - It is not so clear

Bottomline, it still isn't so clear which vegetable, or who, or where is to blame. If you read this article, it becomes clear that we really don't know for sure what's going on. In the end it could be something far more complex than just blaming peppers from Mexico. For more details, read this Washington Post article, "FDA Officials Narrow Salmonella Warning To Mexican Peppers." 


Gardasil, the HPV Vaccine, Is Safe, Says FDA and CDC

Updated November 11, 2020.

It's good news to hear that an approved vaccine, Gardasil (the vaccine against HPV, Human Papilloma Virus) is still safe to use, as reported in this Reuters news article, "US FDA, CDC back Merck's Gardasil shot as safe." The Reuters article covers the highlights, and is more readable than the more detailed information made available by the FDA, "Information from CDC and FDA on the Safety of Gardasil Vaccine.

Bottomline, Gardasil continues to be safe and effective to use. If this applies to you or your children, then consider this and get vaccinated, this vaccine prevents infection with the types of HPV that cause most cases of cervical cancer and genital warts. 

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Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
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Alert - Granite Countertops - They are HOT - Radiation and Radon Risk

Hmmm. If you have granite countertops, or are thinking about upgrading to one, then think again. You might be exposing yourself and your family to uranium radiation and radon gas. Both can endanger your health. Read this Houston Chronicle article, "Be wary of granite that glows." As one poster says, "You can't take anything for granite these days." 


Friday, July 25, 2008

FDA Guidance Documents - FDA Current Thinking (free)

Updated October 23, 2020

The original post had a lot of hyperlinks. Many of them broke and made the original post unusable. Therefore, I deleted it.

You might also be interested in:

Guidances - an FDA.gov webpage



-------

FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.


SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Women - Mammograms can be more comfortable with lidocaine gel

Women, be more comfortable, read this article, "Lidocaine Gel Could Make Mammograms More Comfortable." The lidocaine gel was far better than taking ibuprofen (e.g., Motrin), or acetaminophen (e.g., Tylenol).

More recommended information about mammograms:

  1. Breast Cancer: Early Detection
  2. BARING YOUR BREAST: Mammograms: A Positive Experience
  3. Mammograms and Mastectomies: Facing Them With Humor and Prayer

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Travelling This Summer? Must read tips! (CDC Traveler's Health Tips)

Summer is in full swing. Make sure you're thinking about your travel health, go to this CDC page of traveler's health information and travel health resources by the CDC. When travelling outside of the country, it's important to pay attention to many aspects of staying safe and healthy. Be sure to educate yourself about the potential health dangers and preventions, and get vaccinated as appropriate to prevent coming down with a disease due to your trip.


Thursday, July 24, 2008

FDA Will Exempt Phase 1 Drugs from GMP Regulations

Good article on FDANews, "FDA Moves Forward With Exempting Phase I Drugs From GMPs." In the article, the agency is cited and says, "FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.”

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!












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SkillsPlus Intl Info Blog
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Pharmaceutical Site Closings - Shocking Statistics

This Pharmalot blog posting by Ed Silverman is eye-opening to me, "And The Next Pharma Plant To Close Will Be . . ." The blog states, "Since January 2007, a total of 77 industry sites employing more than 14,000 people were either closed or have been put on notice, according to Industrial Info Resources, a research firm." Here's what I take away. Some plants could easily re-open in a matter of weeks. Others, "are tainted by the very factors that targeted them for closure. Aging facilities and equipment coupled with stringent FDA regulations place a particular burden on reopening the doors anytime soon." Bottomline, if your company is acquiring one of these plants, you'll want to know if there were pre-existing FDA GMP issues. Good luck if you are a prospective successor. 

Wednesday, July 23, 2008

Stay Healthy While Traveling Abroad (FDA Consumer Update)

Updated October 13, 2021

All the links in the original post broke.

You can still read about these topics here:

---  the original post follows below  ---

Summer is in high season, so take care while traveling. This FDA Consumer Update is excellent, "Stay Healthy While Traveling Abroad." This update addresses basic health, drug, and medication issues you might want to consider in the following major topics:
  1. Before You Go
  2. Tips for the Trip
  3. While in Developing Countries
  4. Illnesses to Avoid
  5. When You Return

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Tuesday, July 22, 2008

Monday, July 21, 2008

Pets Taking Human Prescription Drugs (video)

Updated May 2, 2023

You might also be interested in:


- - -


Updated 12/9/2022

Sorry. The original link broke.

You might also be interested in:

---  the original post follows below  ---

This is an interesting MSNBC news video about our pets taking prescription drugs for people (humans), "Are you taking same drugs as your pet?"

Sunday, July 20, 2008

It Is Not OK To Abusively Cancel Health Insurance

Are you 1 of about 14 million Americans that have an 'individual policy' that could be potentially affected by this? Read the full LA Times article, "California fines two health plans $13 million."

In California, some folks carrying individual health insurance coverage had their policies terminated by health insurers after they became ill. As a result, some people landed in situations where they lost their homes and businesses. California state authorities are watching for abusive practices and have stepped in over time to smooth things over. The good thing is now everyone is watching. Health insurers will need to be more careful, and people with coverage who become sick have hope that their coverage won't be unfairly canceled.

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Resource List - FDA Part 11 - Electronic Records and Signatures

Updated May 7, 2021

So many links broke.

You can still learn more about Part 11 here:

Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry | FDA.gov

---  the original post follows below  ---

One big list of resources for The FDA Regulations on Part 11, Electronic Records and Electronic Signatures. Useful for getting up to speed, answering questions, and to prepare for classroom training.

  1. GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD
  2. Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
  3. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
  4. Pharmaceutical Computer Validation Introduction 5 Users: GMP (Good Manufacturing Practices) Training Introduction to Meet FDA Regulations in the Use of ... on Computer System Validation and Part 11
  5. CFR Parts 210, 211 and 11 Pocket Guide
  6. Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11
  7. Successfully Validating ERP Systems (and other large, configurable applications)
  8. Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
  9. Part 11 risk assessment 'not an alternative' to compliance with predicate rules.(Electronic records): An article from: Validation Times
  10. Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
  11. 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
  12. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1stbooks Library (Series).)
  13. Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt
  14. Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

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Saturday, July 19, 2008

4 Easy Weight Loss Tips (video)

Updated March 12, 2022

One of the links broke.

You can still watch the video, using the link below.

---  the original post follows below  ---

Follow these 4 easy tips to lose weight. For more details watch this CBS News Video, "Serious About Slimming Down," or read this accompanying article, "Surprising Secrets Of Slimming Down." If you don't have time to view the video, or read the article, here's the bottomline:

  1. Get enough sleep - if you don't, hormonal imbalances can increase your appetite.
  2. Get enough fiber in your diet - fiber swells and makes you feel full.
  3. Drink water - drink when you're thirsty, and avoid the calories of drinks containing sugar.
  4. Try to avoid chronic stress - if you don't, your body is likely to store more fuel, in the form of weight.

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Survey says! Men, you need to tell your doctor about your erectile dysfunction (ED)

Cialis product photo from Lilly.com
Men, tell your doctor about your erectile dysfunction (ED). Your ED might be a warning that you might have other potentially serious health conditions. Read this article for in-depth details, "The ED Conversation Dilemma: Forty Percent Of Men With ED Don't Talk To Their Doctor, Survey Finds." It's important for men to discuss ED with a health professional for two reasons. First, to find out if there are other serious medical conditions that require treatment or attention. Second, erectile dysfuntion (ED) can be treated with medications such as Cialis (tadalafil). If you think you're reading about yourself, I recommend you strongly consider sharing your ED with your doctor.

Do some more reading, and learn more about ED:
100 Questions & Answers About Erectile Dysfunction, Second Edition (100 Questions & Answers about . . .)

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4 Free Articles on GMP Training

GMP Resources

Updated August 29, 2017
The original links are no longer available.

You might also be interested in:
ISPE GMP Resources

- -  original post follows below  - -

Enhance your GMP training skills. Read these four free articles on GMP training from the GMP Institute (a division of ISPE). These are wonderful quick hits on improving GMP training.

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Friday, July 18, 2008

Caffeine - Overdose? It's in lots of drinks! (video)

It's possible to poison yourself with too much caffeine! Caffeine is in coffee, tea, soda, energy drinks, and many other drinks and beverages. Don't end up in the ER (emergency room)! Watch this CBS New Video, "When Caffeine Becomes Toxic."


Caffeine is in so many beverages. Watch yourself by monitoring and figuring out what's in your drink. Pay attention to how it's making you feel. Happy and safe drinking to you!

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GMP News Sources - updated list for free

Updated March 22, 2022

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. This list is provided to you for free.

Biospace Newsfeeds - Biotech and Pharmaceutical News
BioWorld Online - the worldwide biotechnology news and information source
European Compliance Academy Newsfeeds (2022)
FDA WebView - the internet's fastest FDA news center
GMP Trends - an online and printed GMP information source
Health, Drug, Prescription, GMP Supersite - reference additional news sources on the Blog List
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

You might also be interested in the Health & FDA-related news, that displays on this blog's Blog List (just scroll down the left sidebar of this blog).

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Thursday, July 17, 2008

Tomatoes - Yes! Jalapenos, Serranos - uhh, no. (video)

Yay! This latest CBS News Video, "FDA Lifts Tomato Warning," says it's safe to eat tomatoes, and it's still time to be cautious about Jalapeno and Serrano peppers (because of the Salmonella scare). 


 

Well, I'm ready to start eating my tomatoes in salads, on hamburgers, and with pasta. But you know what? I'm still going to be a little leery and sheepish about fresh jalapeno and serrano peppers. And definitely I'll be cautious about salsas. Here's to good summer eating! 

Prior blog posts: 

Free GMP Training Tip - Your Homework Is To Sleep Before Class

Here's a fun GMP or general classroom training tip! As the trainer, assign this homework assignment before class or training. Apparently, "Sleeping Soundly Provides Memory Boost." The results of the study suggest that sleeping appears to be a great way to help the brain process new information. So help your students and yourselves to get the most out of the training experience. Tell students to get a good night's sleep before class!

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Wednesday, July 16, 2008

Menthol in Cigarettes - Cig makers might've played you! (video)

View the MSNBC video above or read this NY Times article, "Study Finds Manipulation of Menthol Levels." If you smoke, or you've started to, you might be getting manipulated. More specifically, a just published study from Harvard states that cigarette manufacturers might be, "manipulating sensory elements of cigarettes to promote initiation and dependence." If you need help to stop smoking (smoking cessation), here's a good place to start, Smoking and Tobacco Use -How To Quit (on the CDC website). 

Free GMP Tip - Post Customer Pictures

An excellent blogpost GMP tip by GMP Training Systems, Inc., "GMP Tips - Keep Your GMP Awareness HIGH." Bottomline, you want to make sure your drug and device manufacturing employees are reminded of who they're working for, their customers! Put up customer picture reminders, and they'll have to be more aware, and proud of who they're really serving.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

You might also be interested in the following cGMP basics training course:


If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!












SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 


Tuesday, July 15, 2008

Pregnant? - Avoid Nuts!? (video)



If you're pregnant or know someone who is, you'll want to view this CBS News Video, "Should Moms-To-Be Nix Nuts?" This report suggests that eating nuts during pregnancy may increase your child's risk for wheezing or asthma.

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No Prescription Needed - Rogue Pharmacy Sites

Updated December 14, 2023

The original links broke.

You might also be interested in:

---  the original post follows below  ---

No Prescription Needed

This CBS News video article is shocking! Based on the findings of, "You've Got Drugs. V" The bottomline, the study found hundreds of different Web sites offered controlled drugs for sale, but only a few were certified as legitimate Internet pharmacies. The remaining vast majority were called "rogue sites" because users could get controlled drugs online without a proper prescription.

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Monday, July 14, 2008

Free FDA Compliance Library (Immel Resources LLC - Pharmaceutical, Medical Device, Biologics and Related Industries)

This is a great FDA Free Compliance Library of free resources by Immel Resources LLC (Regulatory Compliance, Quality Assurance and Training for the Pharmaceutical, Medical Device, Biologics and Related Industries). I ran across this while doing some research on GMP training resources. This Compliance Library offers resources that are suggested for use in your classes or meeting. 

2 Free GMP Training Tips - Make It Fun!

Updated August 31, 2021

Unfortunately the original has broken.

---  the original post follows below  ---

Free GMP Training Tips

Teaching GMP (Good Manufacturing Practices) training is hard enough as it is, so be sure to make it fun! Don't be a talking head during your classroom or training sessions. Keep your 'students' engaged. Including games and fun activities during your training will go a long way. The good folks at SkillsPlus Internationl Inc share this great free tip (PDF), "Increase Classroom Success through the Fun of Games." If you don't have enough time to read this, then here are the highlights:
  1. First, the game needs to be content focused.
  2. Second, the game needs to relate directly to the organization.
For games to be fun and create the energy needed for learning, prizes are a
valuable asset. No need to go hog-wild. Simple inexpensive prizes will do. Happy training!

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#FDA #GMP #cGMP #training #course #class

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Sunday, July 13, 2008

Identify Those Drugs - Handy Pill Identifier

At some time, we've all needed to try and identify a pill, tablet, capsule, or medication that somehow got separated from the original bottle. Or maybe you found some drugs that aren't even yours. The clues you need are:

  1. Imprints, marks, or shapes on the drug. Drugs.com has a drug imprint lookup page.
  2. Shape of the drug
  3. Color of the drug
  4. A guess of the name of the drug can help too

Now you need to turn your clues into some possible matches. Drugs.com offers a Pill Identification Wizard. You simply provide some of the clues mentioned above, and with any luck you're shown a list of possible matches with photos (if they're available) and drug manufacturers. Drugs.com quite responsibly adds, "As a general rule, we should all periodically check our medicine cabinets for any expired, re-bottled, or unidentified pills. The safest bet is to keep all medications in their original bottles or packets, with pertinent labeling and instructions attached, to avoid confusion and mistakes." Be safe, be well!

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Saturday, July 12, 2008

8 Tips - Save Money on Prescription Drugs

Updated July 31, 2021


The original link broke.

Read more about the topic here:
7 ways to save cash on prescription drugs - Harvard Health

---  original post follows below  ---

I was checking out some information at the California Board of Pharmacy site, reading about the Designated Representative (Exemptee) license. The CA Board of Pharmacy has some great consumer-oriented resources.

Their Tips to Save You Money When Buying Prescription Drugs caught my eye. In a nutshell:
  1. Shop around and ask for the lowest price.
  2. Consider generics.
  3. Consider a therapeutically similar drug.
  4. Beware of prescription drugs advertised to consumers.
  5. Don't skip doses or reduce the amount of prescription drugs you're supposed to take to make medication last longer.
  6. Learn if you qualify for special, low cost drug programs operated by governmental agencies, drug companies, insurance companies, or others.
  7. Purchase a greater quantity of medication at one time.
  8. Keep a list of all medication you take.
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Wow! This New Home TeleHealth Device Brings The Future Closer


The future keeps getting closer. I never knew Intel had a hand in the home health care management arena for folks with chronic medical conditions. The FDA just approved their Intel Personal Health System. This is really exciting for me to read because over the last couple of decades, health care systems have attempted to connect to patients in their home via telemedicine or video devices with various degrees of success. What's going to be really important is how these kind of devices will get integrated with what will become the power players in the personal health record space. What I mean is, offerings like Google Health, and Microsoft HealthVault.

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Thursday, July 10, 2008

Summer Sunscreens - Yours Might Not Work!

www.YouTube.com


A local newspaper article alarmed me, and lead me to this recent report on sunscreens, Sunscreen Summary — What Works and What's Safe. This summary from the Environmental Working Group (a non-profit in Washington DC), says that 4 out of 5 sunscreens offer inadequate protection against harmful rays or could contain harmful chemicals. What's interesting is that when a new sunscreen is marketed, the FDA asks manufacturers to show that it prevents sunburn, but the FDA doesn't require clinical trials verifying the prevention of melanoma or other forms of skin cancer. At the heart of this is, for a long time, "UVB [ultraviolet B] was thought to be the primary carcinogen in the sunlight, but what is happening now is that UVA is being viewed as a melanoma carcinogen," says Edward Gorham, an assistant professor at Moores Cancer Center at UC San Diego. It's probably no longer good enough to block just UVB, and to make sure your sunscreen blocks UVA too!

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Wednesday, July 9, 2008

Mercury-Containing Dental Fillings - Health and Environmental Concerns

www.YouTube.com

Dental amalgam. You might also know these as mercury containing dental fillings. I've got them, you've got them, we've all got them. Yesterday there was a bit of a brouhaha over them in a hearing in Washington DC, Dental Industry Gets An Earful On Mercury. The hearing considered whether dentists should be required to keep pieces of fillings from getting into public wastewater, using special equipment. In any event, the hearing created opportunities for legislators to attack the dental industry on the purported health risks of having mercury-containing fillings in your mouth, and the ramifications of mercury getting into wastewater. If you're interested in the health risk aspect of this, I recommend this page on the FDA's website, Questions and Answers on Dental Amalgam. On a personal closing note, I rotted my teeth on childhood candy, resulting in amalgams in all my teeth; thankfully now, I have a mouthful of caps and crowns, and only one remaining amalgam.

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Tuesday, July 8, 2008

Ouch! Black Box, Black Eye. Watch Out For These Antibotics.

Updated March 19, 2022

The original link broke.

You can still read about the same topic here:

---  the original post follows below  ---

 

Increased risk of tendinitis and tendon rupture - It's tough to be a drug company, and it's tough to be a patient taking medications. The FDA just released this alert, Information for Health Professionals - Fluoroquinolone Antimicrobial Drugs. So, if you're taking any of the following: Cipro, Proquin, Factive, Levaquin, Avelox, Noroxin, Floxin, or their myriad generically named brethren, then you should read the FDA release. This class of drugs just earned a black box warning, which means patients and prescribers should pay more attention to this unwanted effect. It's worth repeating the main thrust of the alert, "Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug." 

Lasik - Pretty Safe . . . AND . . .

Updated October 28, 2022

You might also be interested in:

---  the original post follows below  ---

 

OK, so I'm a holdout. I should have Lasik eye surgery, and get perfect vision. Reading articles like this one, Look closely before you seek 20/20, allows me to rationalize why I shouldn't get it done. Honestly, this is actually a well-written story. Lasik has gotten better over the years, and a very small percentage of folks end up with problems. I especially like the fact that more ophthalmologists are getting Lasik. That tells me that the technology and advancements have finally matured. Don't let me hold you back, think about getting Lasik! 

Monday, July 7, 2008

Bargain With Doctors (& others) - Get a Discount!

Updated Dec 9, 2016:

Links in the original post didn't age well.   You might also be interested in:


- - original post follows below - -

Really radical! Bargain with your doctor (and others!). Don't just accept the price they're charging. This article makes you think twice about paying the sticker price. Do yourself a favor and ask for or suggest a discount. The suggestions and phrasing techniques are really helpful. Everything is so expensive on a budget these days. Bargain yourself to a 40% discount! If you don't ask, you won't get!!!!

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Sunday, July 6, 2008

Magic Mushrooms - Finally Legit?!

Updated Dec 9, 2016

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'MAGIC MUSHROOMS' COULD SOOTHE ANXIETY AND DEPRESSION, DOCTORS SAY (ABC13 News): "Doctors with NYU and John Hopkins performed independent tests with the illegal ingredient psilocybin and found it helped cancer patients relax and eased signs of depression and anxiety in 80% of the patients studied. In some cases - the effects lasted months."

- -  original post follows below  - -

Interesting findings from a Johns Hopkins study, Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. The ramifications of this study are best summarized in this LA Times news article, A medical use for magic mushrooms. The findings in someway support what many have already known for years, shrooms can cause profound mystical experiences, and the spiritual effects can last more than a year. I'm excited about the mentions of studying the effects in treating drug dependence, and treating people with cancer. Have a good 'trip' this summer!

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Saturday, July 5, 2008

Drink Red Wine - Live Longer !?


This is such a fun topic for me, and this fountain of youth article is a fun read. I love to drink red wine, and sure, who wouldn't want to live longer! I'm staying optimistic that the animal studies suggesting that red wine or a substance in it, resveratrol, can really contribute to longevity. It might be a very long time until we really know for sure. But heck, I'm all for drinking more red wine for now. Bottoms up! Cheers!

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Wine Lovers Dishwasher Magnet

Watermelon Acts Like Viagra?!

Updated November 18, 2020

The video link and hyperlinks broke.

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Can watermelon help with erectile dysfunction? - Medical News Today

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I just read this news article about watermelon acting like Viagra and wondered how many folks are going to run out this fourth of July weekend to see if watermelon really works like Viagra. I think the timing of this article is somewhat amusing because now people are joking about having a different kind of fireworks over this holiday weekend. I can't wait to see the follow-up threads on what other foods contain the same ingredient in watermelon. Before I close, this takes me back several years, thinking about what used to be taught in pharmacy schools, the coursework of pharmacognosy. Pharmacognosy is the study of natural products (ie, plant, animal, organism, or mineral in nature) used as drugs or for the preparation of drugs. I've often wondered when this class should be added back to the standard pharmacy school curriculum.

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Food Scare - Was Tomatoes, Might Be JalapeƱos and More

 


In the latest update to the Salmonella tomato story, the blame is starting to shift to other food items that are commonly eaten with tomatoes. It's an interesting twist as tomatoes are no longer seen as the prime suspect for Salmonella. The latest culprits now include jalapeƱo peppers, cilantro, Serrano peppers, and salsas. The FDA and CDC teams continue their investigation to find the source of Salmonella. For more background, read the previous post: FDA Announces Progress in Its Protection Plan. As for me, no more tomatoes, peppers, cilantro, or salsa for now. I'm hoping the investigative teams discover the root cause, and identify the food handling deviations leading to the Salmonella contamination. 

Friday, July 4, 2008

FDA Unveils Food Protection Plan

In the FDA's news release two days ago, they report progress in helping to keep Americans enjoying one of the safest food supplies in the world. The FDA lists their accomplishments to date, in the areas of prevention, intervention, and response. I imagine this update was released given the fact that many of us keep asking ourselves whether it's safe to eat tomatoes. As a personal health and safety issue, though I've not stopped eating tomatoes, I worry about when I might run into and eat a Salmonella tainted tomato and get sick.

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Free Health Resources on KP.org (Kaiser Permanente)

Updated March 18, 2018

Several links in the original post have broken.

You might also be interested in Kaiser Permanente's Health and Wellness resources

- -   original post follows below  - -

I still can't get over my excitement about Kaiser Permanente (KP) piloting a personal health record feed to Microsoft HealthVault (a HealthNews news article). Here's what this means, if the pilot is successful. KP members will be able to have all their Kaiser health information, like lab results, doctor visit summaries, allergies, medications, and more, fed from Kaiser to the MS HealthVault. Once the health info is in HealthVault, it means the member can access this whenever they want, and it's essentially portable. This is important as we hurtle forward towards adopting and implementing national standards for having portable health records. I'm eager to hear how this pilot progresses.

While I'm at it, I should mention that Kaiser Permanente has an excellent website: http://www.kp.org/ It gets a lot of awards, and though some features are hidden behind a secure sign-on, a lot of free KP.org resources can be used, even if you're not a member. Check out their drug, natural medicine, and health encyclopedias, health tools, etc. For more free online health resources, check out Most Popular and Top Ranked Online Health Resources.

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Thursday, July 3, 2008

Google Health versus Microsoft HealthVault

Watch as these two giants go toe-to-toe to create new tools to help you manage your very own personal online health information via the web. It's worth paying attention to the efforts between Microsoft and Kaiser Permanente.

Google Health - securely store & manage your health information online
Microsoft HealthVault - puts you in control of your health information
Microsoft HealthVault and Kaiser Permanente to try health-records sharing (news article)

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Job Opportunities in the GMP and Health Sector

Updated March 4, 2022

As you can imagine, this 2008 posts just didn't age well.  Sorry.

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---  the original post follows below  ---

Pursue this list of jobs, and job hunting resources. Plan your career in the health, drug, and regulated industries (e.g., GMP, drug manufacturing) or look for your next job, consulting engagement, or opportunity amongst these job hunting links. Getting one of these jobs can put you in a place to influence, guide, and support ethical research and manufacturing of medical devices and drugs. 
  • Bio Jobs - blog of biopharmaceutical jobs, tools, many topics
  • Careers with i3global - the company of specialists
  • cGMP Job Listings - by job-hunt.org
  • Executive Recruitment Services - by Med Exec Intl. Jobs in clinical research, QA, medical affairs, regulatory affairs
  • GMP Consultancy Opportunities from MasterControl
  • GMP Job Listings - by CareerBuilder
  • GMP Job Listings - by CareerJet
  • GMP Job Listings - by Juju 
  • GMP Job Listings - by MySpace
  • GMP Job Listings - by SimplyHired
  • GXP Job Listings - by GXP Recruiters
  • i3 Pharma Resourcing - pharmaceutical personnel placement
  • RegulatoryOpenings.com - Regulatory, QA, Clinical, and Medical Writing openings & jobs

GMP News Sources

Updated February 20, 2021

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. 
Biospace Newsfeeds - Biotech and Pharmaceutical News
BioWorld Online - the worldwide biotechnology news and information source
FDA WebView - the internet's fastest FDA news center
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

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