Health And Safety Tips - Before and After A Hurricane

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The FDA has this fantastic collection of free tips and resources if you're potentially affected by a hurricane, "Hurricanes: Health and Safety Before and After a Storm." They offer so many items that I can only skim the surface of what's on the site. Here's the best I can do, here's a listing of the general categories of information they provide . . .

1. Drugs
2. Biological products
3. Food safety
4. Animal health
5. Medical devices
6. And lots of other information sources

Be well, and stay out of harm's way.
 

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The Exemptee Institute
The Designated Representative Institute

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Beware These Poisonous Recipes!

It turns out that there are some published recipes out that will poison you. This very interesting, comprehensive, and educational ABC News article is a good read for novice chefs, "OOPS: Magazines Recall Poisonous Recipes - Confusion Between Spices and Poisonous Herbs Spells Trouble for Cooks." There are a number of reasons why a simple and elegant recipe can become poisonous, either the published recipe got it wrong, or you as the cook will make an error . . .

1. The dose makes the poison. Toxic substances in small amounts don't matter, but if you put too much in, you get poisoned (e.g., cherry pits).
2. Confusing common names. If you misread, or the recipe incorrectly gets an ingredient name wrong, you might end up using a poisonous substitute (e.g., substituting 'grass pea' instead of the common vegetable pea can cause serious damage).
3. Parts matter. Using the wrong part of the plant can be bad for you. (e.g., green parts of rhubarb).

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3 Drug Tips - Plan Ahead Of The Hurricane

Updated September 16, 2020

You might also be interested in:

Preparing Your Medicine Cabinet for an Emergency: A Checklist - CDC.gov

- - -  original post follows below  - - -

If you're in the path of an incoming hurricane, and take prescription medications, then you want to read this, so that you can be prepared in advance. I ran across a news feed that attributed these 3 excellent tips to Walgreens.

1. If you evacuate, get to a safe location first and refill your medication at a pharmacy there. Walgreens says if you have a patient record with them, any Walgreen store in the nation can access it.
2. Take a waterproof bag with your current medication - even if the bottle is empty. The information on the bottle label will help the pharmacist refill your medicine once you arrive at your destination.
3. Keep a written record of your current prescriptions in your valuable papers file. If you're taking several prescription drugs, it's an especially good idea to keep a record of your current dosage and doctor's contact information.

Stay safe and be well.

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New FDA Guidance - Residual Solvents in Drug Products

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This just out from the FDA, a new guidance document entitled, "Guidance for Industry - Residual Solvents in Drug Products Marketed in the United States."  Here's what it's all about . . .

1. How holders of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for compendial drug products should report changes in chemistry, manufacturing, and controls (CMC) specifications to FDA to comply with the USP’s General Chapter <467> "Residual Solvents" and 21 CFR 314.70
2. How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with the new <467> and the Federal Food, Drug, and Cosmetic Act (the Act)

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21st Birthday - Extreme Drinking Binges - 12 drink avg for men

More fuel for the debate on lowering the drinking age to 18. This USA Today news article provides some pretty staggering statistics, "Students mark 21st birthdays with 'extreme' drinking binges." In a nutshell, here are some important takeaways stated in the article . . .

1. College students today celebrate 21st birthdays with an average of 12 drinks for men and 9 for women
2. The University of Texas-Austin research found 78% of students cited ill effects, including hangovers (54%). Of 44% who had blackouts, 22% found out later they had sex, and 22% got in a fight or argument. And 39% didn't know how they got home.
3. Harvard researchers have found more binge drinking at campuses with a strong drinking culture and easy access to alcohol. In Austin, 12 of the 152 students reported 21 or more birthday drinks. At the University of Missouri, a study of 2,518 students published in June found 34% of men and 24% of women had 21 or more.

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September is National Alcohol and Drug Addiction Recovery Month

President Bush just proclaimed it. Join the voices of recovery, during September, the National Alcohol and Drug Addiction Recovery Month (check out this HHS website). There are a number of great resources available to you . . .

1. Recovery Month Kit
2. The Road to Recovery 2008 Public Service Announcements
3. Webcasts
4. . . . and so much more!

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Lower Drinking Age Controversy (video)

I have very mixed views on this. What do you think? Watch this CBS New video, "Advocating Lower Drinking Age." In this video, the Amethyst (i.e., no intoxication) founder and former university president debates the national president of MADD (mothers against drunk driving). Decide for yourself, it's not a simple conversation. In my opinion, any efforts that confer societal benefits should be seriously considered.

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It's Sweltering - 10 Hydration Tips

Updated July 2023:

The original link broke.

You might also be interested in:

10 tips for staying hydrated this summer - Nebraska Medicine - University Health Center

---  the original post follows below  ---

We're in a little heat wave here, so I thought I'd pass this gem along, from The HomeChoice Network, "Ten Easy Tips for Adequate Hydration." The HomeChoice Network is a senior-care service located in the Sandhills area of North Carolina. Although I don't live in NC anymore, seeing this brings back some memories of how hot it can get there in the Summer. In a nutshell, their ten tips are . . .

1. Drink fluids with each meal and snack and throughout the day.
2. Keep a bottle of water within reach. The faucet may be close at hand but how many times do you actually get up to fill your glass?
3. When you travel - by car, plane or train - always carry a bottle of water with you.
4. If you don’t like drinking plain water, add a splash of white grape juice, cranberry juice or black currant concentrate. Or, try a glass of sparking mineral with a slice of lemon.
5. If you deprive your body of fluids because you don’t like the taste of tap water, buy a water pitcher with an activated carbon filter. Always keep a full pitcher in the fridge. (And don’t forget to replace the filter periodically!)
6. Use a water bottle when you exercise. Drink 4oz – 6oz of fluid every 15 minutes.
7. If your physical activity lasts longer than one hour, hydrate with a sports drink such as Gatorade, All Sport or PowerAde.
8. If you drink fruit juice, choose only unsweetened varieties that don’t have sugar added.
9. Keep your coffee intake to a minimum. Ideally aim for no more than two cups per day. Replace unnecessary coffee (and soft drinks) with herbal tea, black tea or green tea. You get much less caffeine, and in the case of black and green teas, plenty of health enhancing antioxidants.
10. Limit your intake of alcoholic beverages to no more than seven per week (women) or nine per week (men). When you drink, drink a glass of water after each alcoholic beverage you’ve consumed.

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Medical Identity Theft Emerging

And you thought you only had to worry about your credit cards and bank accounts. Looks like crooks are also trying to move into the medical identity theft arena. According to Brenda Evans Hart (the federal Health Insurance Portability and Accountability Act privacy officer at Baylor College of Medicine), "I think now it's gone so far as to be part of organized crime for fraud regarding Medicare, Medicaid and regular commercial insurance." Additionally, Hart said. "And of course, that comes out of the taxpayers' pockets as well." Hart is cited in this Houston Chronicle article, "Medical records emerge as latest trend in I.D. theft." The article includes the following tips . . .

Safety Tips From The World Privacy Forum:

1. Review statements from your health insurer. Specifically, look for charges you didn't make.
2. Ask your health care provider or insurer for an accounting or history of disclosures.
3. Watch your credit report for any collection notices for unpaid medical bills.

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21 CFR Part 110 - cGMPs for Food - free online

Get your money's worth for your tax dollars. The FDA publishes these food regulations online on their FDA website, and they're available for free! I'm posting these because of the recent tomato and pepper Salmonella scare, and my recent post on the 'fruitcake of the Shuttle astronauts' FDA warning letter. Here's what you get from the FDA . . .

NOTE:
When you open any of the links below, be sure to look at the upper left portion of the page to see the revision date.

Title 21 -- Food and Drugs
Chapter 1 -- Food and Drug Adminstration
Department of Health and Human Services

SubChapter B -- Food for Human Consumption
Part 110
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

Subpart A--General Provisions
§ 110.3 - Definitions.
§ 110.5 - Current good manufacturing practice.
§ 110.10 - Personnel.
§ 110.19 - Exclusions.

Subpart B--Buildings and Facilities
§ 110.20 - Plant and grounds.
§ 110.35 - Sanitary operations.
§ 110.37 - Sanitary facilities and controls.

Subpart C--Equipment
§ 110.40 - Equipment and utensils.

Subpart D [Reserved]

Subpart E--Production and Process Controls
§ 110.80 - Processes and controls.
§ 110.93 - Warehousing and distribution.

Subpart F [Reserved]

Subpart G--Defect Action Levels
§ 110.110 - Natural or unavoidable defects in food for human use that present no health hazard.

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Internet Ayurvedic Medicines Contain Toxic Metals

It turns out that toxic metals can be found in Ayurvedic medicines sold online, according to a JAMA article, "Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic Medicines Sold via the Internet. (abstract)" Here's what I've learned in doing some reading . . .

1. There are two major types of Ayurvedic medicines: herbal-only and rasa shastra, which is an ancient practice of deliberately combining herbs with metals (e.g., mercury, lead, iron, zinc), minerals (e.g., mica) and gems (e.g., pearl). Rasa shastra experts claim that these medicines are safe and therapeutic when properly prepared and administered.
2. One-fifth of both US-manufactured and Indian-manufactured Ayurvedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic. All metal-containing products exceeded 1 or more standards for acceptable daily intake of toxic metals.
3. The research also collected information about claims of Good Manufacturing Practices (GMPs). Among the metal-containing products, 95% were sold by US Web sites and 75% claimed Good Manufacturing Practices.

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Switch To New Asthma Inhalers Now - To Get Used To Them

Current ("old") inhalers use chlorofluorocarbon (CFC) propellants. Because CFCs damage the ozone layer, the FDA will prohit the sale of CFC inhalers after December 31st, 2008. The "new" inhalers use a new ozone-friendly propellant, hydrofluoroalkanes (HFAs). These new inhalers feel and taste different from the old inhalers. If you haven't made the switch yet, you might want to start making the switch now, so that you can get used to the change. Here are some of the things you'll notice . . .

1. The HFA spray is 'softer' and still delivers the medicine to where it needs to go
2. The drug particles in HFA sprays are smaller and have a better chance of getting into tight airways

The source article from the Boston Globe: "Do the new asthma inhalers work as well as the old ones?" 

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College Students - eccch, dorm room bedbugs! (video)

Gross me out! It's time to go back to school, and to your bedbugs! Watch this CBS News video, "Dorm Room Bedbugs." Watch CBS Videos Online Wishing all you college students a fun, and great bedbug-free time this year. Cheers! 

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What Do You Think Is The Biggest Problem For The FDA?

Vote if you'd like, or just see the results of this Reader's Digest poll. . .

1. View the poll results, "What do you think is the FDA’s biggest problem? (results)"
2. Place your vote for, "What do you think is the FDA’s biggest problem? (vote)"

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Bad Economy Improves Public Health!?

Yeah, it's counterintuitive, as reported in this LA Times news article, "Can a troubled economy actually improve public health? " It's an interesting thought, a poor economy might actually help all of us cut down on risky behaviors, and lead to a potentially healthier population.

I would've imagined that a recession would make us all go out, get stressed, smoke more, and drink harder, etc. But to my surprise, here's what seems to really happen . . .

1. Traffic accidents go down when fewer people are working
2. People drink less. That is to say, people who already drink, do less of it.
3. Healthful living improves.

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Cialis Treats Enlarged Prostate

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Looks like there's another use for this ED (erectile dysfunction) drug, Cialis (also known as tadalifil).

Men, if you have an enlarged prostate, also known as benign prostatic hyperplasia (BPH), Cialis might be able to help you by treating your BPH symptoms, according to this CBS News article, "Impotence Drug Eases Prostate Problems - Study Shows That Popular ED Drug Cialis Lessens Symptoms of Enlarged Prostate."

Not sure if you have BPH? Then read this list of common BPH symptoms . . .

• Having to urinate frequently and urgently
• Having to urinate at night
• A straining sensation while urinating
• Still feeling the urge to urinate or a full bladder even after going to the bathroom
• A weak urine stream

Learn more about BPH (benign prostatic hyperplasia):

1. Dr. Peter Scardino's Prostate Book: The Complete Guide to Overcoming Prostate Cancer, Prostatitis, and BPH (book)

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Is The FDA Sick?

Good question. There's a superb Reader's Digest article on just this subject, "Strong Medicine: What's Ailing the FDA? -Is America's consumer watchdog understaffed, overburdened, ethically challenged or merely misunderstood?" This is an easy read, and very well-written. The article is organized by the following problems and what's being done about them . . .

1. Pressure From the Industry
2. Safety of New Drugs
3. Sloppy Record Keeping
4. Conflicts of Interest
5. Muzzled Experts

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Back-To-School Anxiety - tips for parents and their kids under 8

Updated February 5, 2022

The original link broke.

You can still read about the topic here:

Young Kids and Back-to-School Anxiety: How to Shrink it Down to Size - EmpoweringParents.com

---  the original post follows below  ---

Summer is coming to an end, and it will soon be time to go back to school. It's time to pay attention to back to school mental health. There's an excellent Minti post on this topic, "Young Kids and Back to School Anxiety: How to Shrink it Down to Size." The main point is take away as many unknowns as possible (e.g., preview the playground), and address concerns how certain social situations might he handled (e.g., who to eat lunch with). Amazingly, there are back-to-school anxiety books for children ages 4-8. This Amazon.com carousel contains titles from a list I saw published in the San Francisco Examiner (8/20/08):  

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FDA Warning Letter - Space Shuttle Fruitcake

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Updated March 6, 2019

WSJ put the article behind their subscription wall, and the link to the warning letter has broken.

You might also be interested in:

FDA: Pardon Me, But Your Bakery Warehouse Is Full Of "Rodent Excreta Pellets" - Consumerist

---  original post follows below  ---

This would be amusing if it wasn't so serious. I recommend you read this, and share it during an upcoming GMP training or classroom session. At first, I was slightly amused and drawn to this WSJ article by its headline, "Pay No Attention to the Mice Behind the Pallets." Then I read, and was appalled. Read on and take a gander at the FDA warning letter to Capitol Cake Co. BTW, they've proudly supplied fruitcake for the space shuttle program.

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7 Deadly Sins Of Trainers - free tips

Updated September 13, 2021

Sadly the original link broke.

You might also be interested in:

Adult Learning Principles - Valamis.com

---  the original post follows below  ---

If you're a trainer, take heed! If you train GMPs, GXPs, or some other topic, make sure to avoid these seven deadly sins of training. Rollin Glaser, outlines the sins to avoid in his article, "The Seven Deadly Sins of Trainers." The 7 sins include . . .

1. Inadequate or no planning
2. Ignoring established principles of adult learning
3. Letting video carry the learning
4. Presenting training of low relevance to our participants
5. Staying at too high a level on the ladder of abstraction
6. Forgetting to help participants transfer their learning back to their jobs
7. Settling for "smile" evaluations from our participants

Additional resources on adult learning: The Adult Learner, Sixth Edition: The Definitive Classic in Adult Education and Human Resource Development (Amazon)

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It's Summer - Do You Have Swimmer's Ear?

It's hot out, and you're swimming alot. Now your ears are bothering you. Do you have swimmer's ear? Check out the information at the Mayo Clinic online, "Swimmer's ear."

Hoping all is well with you. And if you have swimmer's ear, you'll have suspected it, checked out what you can do on your own, and have consulted a doctor as needed. Wishing you the best in the remaining days of Summer.

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FDA 483 Inspectional Observations - learn from these examples

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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Hi-Tech Pharmaceuticals - Purported assassination, blackmail plots

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This reads like a TV show. Sadly, it's all too real. You'll want to share this story during your GMP training and classroom teaching. The courtroom charges were conspiring to import and distribute adulterated, mislabeled and unapproved new drugs and to commit mail and wire fraud. Even more outrageous is a mention that the defendants allegedly conspired to murder a U.S. Food and Drug Administration agent and blackmail a former assistant U.S. attorney general.

For the full story, read this MSNBC article, "From diet supplements to illegal Net pharmacy - Ga. firm, 3 execs plead guilty to selling generic prescription drugs online."

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Parents, Get A Clue About Teen Drug and Alcohol Abuse

This just in. It seems that parents are clueless when it comes to their teenagers’ behavior, which contributes to their drug and alcohol abuse. This LA Times article reports the findings of a survey conducted by the National Center on Addiction and Substance Abuse at Columbia University, "Problem parents contribute to teen drug use." The report singles out parents for contributing to drug and alcohol use among kids ages 12 to 17. It states that some parents fail to monitor their children's activities, do not safeguard medications at home that can be used for abuse, and do not set good examples for their kids.

According to the survey:

1. It is easier for teenagers to obtain prescription drugs than beer
2. 42% of teenagers said they can buy marijuana in one day or less
3. 1/4th of teenagers said they know a parent of a classmate or a friend who uses marijuana
4. Of the teenagers surveyed who do drink, almost 30% said their drink of choice was hard liquor mixed with soda or something sweet and 16% said they preferred beer

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It Is August 2008 - Upcoming GMP Public Seminars

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2008 is starting to come to an end. Be sure to send your key personnel to training this year. Here's what I came up with while searching for some GMP-related public seminars during the remainder of the year . . .

1. SkillsPlus International Inc. - Public Seminars

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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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Starting Methadone? It could kill you - You must read this!

This is the first time I've heard about this. If you or someone you know is starting on Methadone, you must read this. Methadone deaths are rising because many physicians don't know how to prescribe or adjust the dosage during the critical first week of methadone treatment. There are so many issues that put new methadone patients at risk, that I won't even try to summarize them here. You're better off reading this well-written NY Times article, "Methadone Rises as a Painkiller With Big Risks." For example, contributing risks include: incorrect initial dosage chart, the unique property of the drug that makes it difficult to monitor and adjust dosages during the start of therapy, an FDA-approved package insert, etc . . .

The article is accompanied by a video clip and excellent multimedia presentation of methadone death statistics.

Additional free resources from the FDA about methadone:
FDA Public Health Advisory - Methadone Use for Pain Control May Result in Death and Life-Threatening Changes in Breathing and Heart Beat - a little dated but still good information

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3 Tips For The Traveling Empowered Patient - this means you!

OK, I must admit I'm a little obsessed with travel health these days. It's mostly because the end of Summer is near, and my vacation is rapidly approaching. Here's another set of health tips for the empowered patient getting ready for a vacation trip, published by CNN, "How to avoid getting sick while traveling overseas." The tips are organized into 3 major themes, and includes some great links to additional resources, such as the CDC, and more . . .

1. Keep your “travel health kit” with you at all times.
2. If you’re worried about the food or water, bring an antibiotic with you
3. Learn about your destination

Previous posts related to healthy travel:

1. The Health, Drug, Prescription, and GMP Supersite: Travelling This Summer? Must read tips! (CDC Traveler's Health Tips)
2. Stay Healthy While Traveling Abroad (FDA Consumer Update)

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11 Percent Cut Back On Prescription Drugs Or Dosage

This isn't a good sign. The NAIC (National Association of Insurance Commissioners) reports that 11% say that they cut back on drugs, or on dosages. More specifically, they cut back on the number of prescription drugs they take, or the dosage of those medications to make the prescription last longer. Read the more detailed NAIC news release, "Weakening U.S. Economy Takes Toll On Americans' Health."

This isn't good at all for a couple of reasons. First the prescriber might mistakenly think that the patient is taking a different dose, and makes it really hard to monitor and adjust the dose for the desired effect. Second, taking too much or too little of a medication can put your health at risk. Third, dropping a medication without telling your prescriber can result in a health problem going untreated, and could affect the proper dosing of the other drugs still being taken.

Previous posts on how to save money on prescription drugs:

1. The Health, Drug, Prescription, and GMP Supersite: Save on Prescription Drugs (video)
2. The Health, Drug, Prescription, and GMP Supersite: 8 Tips - Save Money on Prescription Drugs

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GMP Olympics - an onsite training experience

I couldn't resist. The 2008 Olympics are with us. Well, you don't have to be an athlete to go to the Olympics. I discovered this playful title of a GMP training offering, "GMP Olympics." It sounds like fun, involving forming teams and having some friendly competition around the FDA's good manufacturing practices.

Previous posts about GMP training or games:
The Health, Drug, Prescription, and GMP Supersite: C2EO - A fun GMP training game

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FDA Says Avoid These 27 ED Products

The erectile dysfunction (ED) market is a big one. It turns out there are manufacturers out there that are trying to cash in by selling ED products that contain potentially harmful, or undeclared ingredients, says the FDA in their report, "Buying Fake ED Products Online." The FDA report lists 27 products you might want to avoid. Just recently reported, Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product -Product contains undeclared ingredient that could harm consumers. The reports mention some things that should be considered . . .

1. These products might contain potentially hazardous ingredients that aren't stated on the label
2. These products might interact badly with drugs that a patient is already taking

Additional book reading on erectile dysfunction:
100 Questions & Answers About Erectile Dysfunction, Second Edition (100 Questions & Answers about . . .)

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More Than 90 Free Podcasts - International AIDS Conference 2008

What a treasure trove of free podcasts! If you couldn't make it to Mexico City for the 17th International AIDS Conference, held August 3-8, 2008, then check out this massive collection. Keep reading to see the complete listing of podcasts below . . . Here's some information about the folks making this podcast collection available. The mission of the Kaiser Family Foundation is to provide timely, reliable, and non-partisan information on national health issues to policymakers, the media, and the general public. To advance that mission, the Foundation established kaisernetwork.org in November 2000. KaiserNetwork.org makes the following podcasts, in English, available to you. 

TIP: some of the podcasts start with an introduction in Spanish, then are delivered in English. 

Pedro Cahn, M.D., Ph.D., IAS Conference Co-Chair Late Breaker Track C Rapporteur Summary Session Craig McClure, IAS Executive Director Press Conference: The Role of the AIDS Epidemic in Black America in the Global AIDS Epidemic Reaching Millions - Youth, AIDS and the Digital Age Closing Session Official Press Conference Linda Richter, Ph.D., Executive Director, Child Youth Family & Social Development (South Africa) Friday, August 1 Allyson Leacock, Executive Director, Caribbean Broadcast Media Partnership on HIV/AIDS Luis Soto-Ramirez, M.D., IAS Conference Co-Chair Elisabet Fadul, AIDS 2008 Youth Programme Co-Chair Ceci Connolly, Correspondent, Washington Post Food Security, Nutrition and HIV Regional Session: Middle East and North Africa Late Breaker Track B Session 2 The Future of Microbicides: From Vaginal ART to PREP Plenary Session, Day 4 Understanding the Numbers: from HIV Surveillance to HIV National and Global HIV Burden Estimates MenEngage: Developing a Global Movement to Work with Boys and Men for Gender Equality Plenary: Panel Discussion on the State of the Epidemic Official Press Conference Is Religion a Barrier to HIV Prevention? REAL TIME: New Models of Private Sector Engagement Food Security, Livelihoods and HIV: Challenges and Responses HIV and Human Resources: Competing Priorities or Interconnected Solutions? Opening Press Conference Kevin Fenton, M.D., Ph.D., Director, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention CDC's Kevin Fenton Discusses HIV Incidence in the United States HIV Transmission under ART Scaling up Comprehensive Prevention of Mother-to-child Transmission Programmes: Challenges and Lessons Learned from Adapting Global Recommendations to Country Situation Opening Session Universal Access of TB Services to PLHIV: Harnessing Collaboration and Coordination Zonibel Woods, Programme Manager, Ford Foundation Gregg Gonsalves, AIDS and Rights Alliance for Southern Africa Tachi Yamada, M.D., President, Global Health Program, Bill & Melinda Gates Foundation Regional Session: Sub-Saharan Africa HIV/AIDS and Health System Reform: Achieving Universal Coverage Learning by Doing: Scaling up HIV Operations Research in Resource-Limited Settings Monday, August 4 Reclaiming our Lives: Developing Accountability for Positive (PLHIV) Leadership and our Advocacy Priorities Newer Antiretroviral Agents Women's Rights Equal Women's Lives: Violence Against Women and HIV The Lancet Series on HIV Prevention Travel Restrictions on People Living with HIV: Going Against the Grain of Human Rights and Public Health Prevention Working Group Press Conference Official Press Conference Regional Session: Asia-Pacific Where Are We In Achieving UNGASS Targets? Former President Festus Gontebanye Mogae, Botswana Tuesday, August 5 Phill Wilson, CEO, Black AIDS Institute Mark Dybul, U.S. Global AIDS Coordinator, U.S. Department of State Indigenous People, First Nations and Afrodescendants Confronting HIV/AIDS: Breaking the Silence Regional Session: Latin America Financing for Sustainable National Health Care Looking to the Future--The Epidemic in 2031 and New Directions in AIDS Research Moving from Promises to Actions: Building Global and National Commitment for Evidence-Based Approaches to Addressing Stigma and Discrimination Forgotten Truths, Hidden Realities: Addressing the Dynamics of HIV and MSM in Unfavorable Environments Human Security and HIV Achieving Universal Access for Young People Universal ARV Scale Up: Delivering the Second Wave Beyond Barriers: Disabilities and AIDS Beyond the Orphan Crisis: Findings of the Joint Learning Initiative on Children and HIV/AIDS The New Frontiers of Harm Reduction Late Breaker Track B Session 1 AIDS Ambassadors Strengthening Health Systems Through the AIDS Response Regional Session: Eastern Europe and Central Asia Plenary Session, Day 2 Country-Level Advocacy Initiatives that Support Children and AIDS New Frontiers in HIV Prevention Sciences Best Practices for HIV/AIDS Implementers: Highlights from Kampala IAS 20th Anniversary From Commitment to Action: Implementing Effective Responses on Gender and AIDS New Insights Into HIV Transmission and Pathogenesis Positive Synergies Between Health Systems and Global Health Initiatives Vaccines and Microbicides: Where Do We go from Here? Global Financial Architecture Scaling-up HIV Testing and Counseling: A Human Rights and Public Health Imperative Wednesday, August 6 Globalization, Development and Free Trade Agreements (FTAs) The USA HIV Epidemic in 2008 AIDS Vaccines - 2010 and Beyond: Charting a Course for the Future of AIDS Vaccine Research Official Press Conference Universal Access/Universal Crises/Universal Prices Regional Session: Caribbean - Creative Caribbean Approaches to the HIV Epidemic Human Rights, HIV and Sex Work Policy Male Circumcision: To Cut or Not to Cut Kevin De Cock, M.D., Director of HIV/AIDS Department, World Health Organization Plenary Session, Day 3 Official Press Conference Mobile Populations and Globalization Thursday, August 7 Plenary, Day 5 

Additional reading about HIV/AIDS: The First Year: HIV: An Essential Guide for the Newly Diagnosed (First Year, The) 

Previous posts: The Health, Drug, Prescription, and GMP Supersite: Free Health Resources on KP.org (Kaiser Permanente) 

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FDA Authority Over Tobacco - desperately needed

I was watching this interesting Fox News video, "Tobacco Time," about the effects of smoking on aging. I typically expect to hear how smoking shortens your life. However, this video has a twist, and cites recent National Cancer Institute research, reporting that smoking ages your body 10 years beyond your chronological age.

In any event, while googling for more smoking information, I stumbled across the topic about efforts to put tobacco products under the authority of the FDA. My reading started with this Campaign for Tobacco-Free Kids Special Report, "FDA Authority Over Tobacco - Legislation Will Protect Kids and Save Lives." It frames the issue well, and explains the legislative context. This article has been recently updated, reporting successful passage of legislation in the House, "U.S. House Casts Historic Vote to Protect Kids from Tobacco, Save Lives; Senate Should Act This Year and President Should Sign Bill Into Law." It reports, "this legislation would grant the FDA strong and effective authority over the manufacturing, marketing and sale of tobacco products."

Related to Tobacco Products:

1. The Easy Way to Stop Smoking: Join the Millions Who Have Become Non-Smokers Using Allen Carr's Easyway Method
2. Nicorette Gum

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Earlier Treatment of HIV Warranted in Some Patients

I just heard about this through an ASHP Newslink email, "Earlier Treatment of HIV Warranted in Some Patients." The email summarized the findings in this way, "New guidelines for the treatment of HIV infection in adults address evolving issues in care, such as initiating therapy early in the course of disease in asymptomatic patients. The guidelines, from the International AIDS Society--USA Panel, discuss starting treatment before CD4+ T-cell levels fall to 350 per microliter in patients with certain comorbid conditions or health risk factors. Recommended initial antiretroviral regimens include efavirenz or a ritonavir-boosted protease inhibitor plus two nucleoside reverse-transcriptase inhibitors."

For the full details, read the source JAMA article, "Antiretroviral Treatment of Adult HIV Infection 2008 Recommendations of the International AIDS Society–USA Panel."

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Top Picks - Health Self-Monitoring Kits (video)

If you should be monitoring your blood pressure, or your blood sugars, then you need to watch this. This CBS News video shouts out their top picks for blood pressure monitoring, and blood glucose monitoring, "The Top Self-Monitoring Kits." And the top picks are . . . Their Top Blood Pressure Monitoring Kit:

• Omron Elite 7300W Womens Avanced Blood Pressure Monitor

Their Top Blood Glucose Monitoring Kit:

• One Touch UltraMini Blood Glucose Monitoring System Kit - 1 Ea

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C2EO - A fun GMP training game

• Recommended FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

Updated August 26, 2024:

I believe the FDA cGMP training industry continues to evolve.  It's my sense that there are fewer, and fewer companies offering hardcopy board games for cGMP training.

BTW, the C2EO game is no longer available.

- - -  original post follows below  - - - 

Here's a fun game to use, to make your GMP training fun, C2EO. Watch this video teaser for a flavor of the game, "C2EO - a cGMPs training game." The mantra of the game is, "compliance is the rule, knowledge is profit."

Other resources to make GMP training fun:

1. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!

#FDA #GMP #training #cGMP

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Save on Prescription Drugs (video)

Nice quick set of tips on how to save on prescription drugs, in this Kiplinger video, "Save on Prescription Drugs." . . .



Previous posts:
The Health, Drug, Prescription, and GMP Supersite: 8 Tips - Save Money on Prescription Drugs

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Another Free Pill Identifier - for your smart phone or PDA

A lot of folks are interested in free drug pill identifiers. I just learned about this free software from Epocrates, "Epocrates Rx." I'm not an Epocrates user, and I haven't personally downloaded or used this software. From what I can tell, you can register for a free account, and then download the free "Rx" software.

The free software is designed for use with smart phones and PDAs. What's neat is that the software provides:

1. Pill ID <-- capsules="" drugs="" feature="" identify="" li="" pills="" tablets="" this="" to="" use="">
2. Drug Information
3. Drug Interactions
4. Formulary Information
5. Free Updates

Previous posts on pill identifiers:
The Health, Drug, Prescription, and GMP Supersite: Identify Those Drugs - Handy Pill Identifier

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Digital Drugs - This is a must read!

OK, I just can't pass this one up. I've never heard of this before. Apparently, so-called digital drugs are audio files designed to induce drug-like effects. These audio files are also called idozers or idosers. I guess we should be worried if they really work and people are listening to them on their mp3 players while driving, etc. Read the full, very interesting ABC News article, "Web Delivers New Worry for Parents: Digital Drugs - Reports of Sounds With Drug-Like Effects Have Some Parents Spooked. " After reading this, it all seems plausible, binaural beats mimicking brain wave frequencies. You've got to read this, and decide for yourself. Hmmm, imagine the kid on the bus, looking like he's tripping on acid (LSD).

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2 Hot Summer Podcasts - vacation weight gain, and survive the heat wave

Summer is still on! Checkout these 2 podcasts from the MedicineNet podcast library.

1. Avoiding Vacation Weight Gain. Listen to the the vacation podcast, which explains, "vacations should be an opportunity to re-energize, refresh, and relax -- not an excuse to take a break from health. When planning your vacation, opt for locations that will allow you to engage in physical activities you enjoy. Keep in mind that physical activity is the ticket to enjoying extra calories without weight gain."
2. Surviving A Heat Wave - Without Air Conditioning. Listen to the the heatwave podcast, which explains, "steps to take to keep your cool when it's hot. Avoid alcoholic beverages and caffeine, as both these substances can act as diuretics and promote dehydration."

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Oh Dear! Black henna tattoos can cause blisters, severe allergic reaction!

Updated July 18, 2019

The links in the original post all broke.

You might also be interested in:
https://www.goodhousekeeping.com/beauty/news/a38343/10-year-old-boy-black-henna-reaction/


- - -  original post follows below  - - -

Ecccch! Avoid getting henna tattoo blisters and swelling. This MSNBC article is enlightening, "Henna hazard: Chemical causes ornate allergies - Harsh dye can swell popular tattoos into itchy, blistery swirls and shapes." Just look at the New England Journal of Medicine photo.

The facts are, "true henna is made from harmless plants, black henna uses a chemical called para-phenylenediamine, or PPD, which makes the tattoo dry quickly and last longer."

My opinion. Do yourself a favor, avoid getting black henna tattoos.

More resources about allergic reactions to henna tattoos:

1. Henna Tattoos Can Cause Allergic Contact Dermatitis.: An article from: Family Practice News
2. Henna tattoos tied to bad allergic reactions: an ugly souvenir. (Clinical Rounds).: An article from: Family Practice News

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FDA Salmonella Outbreak Page - it has ALL the info!

Updated April 23, 2024

The original links broke.

You might also be interested in:

Get the Facts about Salmonella - FDA.gov

---  the original post follows below  ---

Look no further! This FDA page on the whole Salmonella outbreak, starts at the very beginning, and lists all the important developments along the way. This page is so good that I'm making it my personal single reference for everything related to the recent Salmonella scare. There are lots of resources on this FDA page, "Salmonella Saintpaul Outbreak." Here's a sample of what you'll find. FAQs, the latest news updates, advice for restarateurs, food handlers, and other, and much, much more . . .

These are some of my selected favorites from the page:

• News Updates
• Frequently Asked Questions
• Photos of jalapeño and Serrano Peppers
• Advice for Retailers, Restaurateurs and Food Service Operators
• Advice for Packers and Shippers of Fresh Produce
• Information About Salmonella

Additional resources about food safety:

• Basic Food Safety DVD

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Are We Weaker Vessels? - Seniors make more MD visits than 10 yrs ago

Food for thought. Are we getting soft? Today's seniors make more visits to the doctor than older people did 10 years ago, reports USA Today, in, "Aging population making more visits to the doctor's." I think this statistic is very telling, "The number of medical visits increased 26% between 1996 and 2006, significantly higher than the 11% population growth during that period." I'll admit, as a 50-something, I'm not very hardy. This should be a wake-up call, and tough look in the mirror for ourselves. More reading on this aging population doctor visits topic:

1. Americans Made Over 1 Billion Hospital and Doctor Visits in 2006 - by the CDC

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Big Brother Is Watching Your Prescription Data

Call it doing business, or be very, very scared. I ran across this Business News Blog post, "Prescription Data Used To Assess Consumers." There's a whole big industry growing that is collecting your prescription records in databases. We all need to monitor this very closely, because although this industry might contribute to better healthcare and savings, the flipside is there are possibly some real concerns about privacy that are outside the umbrella of regulators and lawmakers.

The discussion strikes a chord with me. As with so many things like this, it's possible for errors and incomplete information to get captured in databases. Although well-intentioned, a combination of many circumstances can lead to possible mis-interpretation, and just plain bad unjustifiable decisions and outcomes adversely affecting many consumers. Let's all hope for the best, and be sure to follow this closely.

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FDA Good Move! 50K cap on advisory hearings

Updated July 26, 2016

You might also be interested in this FDA draft guidance:

• 06/2016 Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees (PDF - 947KB)

- -  original post follows below  - -

I like this. This is a good step by the FDA to reduce conflicts of interest by its committees of expert advisers. For complete details, read this FDA news release, "FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees. "

Here's what I like about the changes. The FDA says that the expert advisers will be, "screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations. Today, FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting." If this works as intended, the recommendations coming from Advisory Committees can be expected to be above board, and hopefully completely objective. We can only hope.

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It is Summer - These things will make your sunburn worse!

It's the middle of Summer. Be sure to be careful or you'll burn badly. There are things that can make you more susceptible to a worse sunburn. Check out this CBS News article, "Beware Of Sunburn Boosters - Certain Drugs And Skin Care Products Can Increase Your Sensitivity To The Sun." Bottomline, you need to pay attention to these items that can make a sunburn worse:

1. Diuretics - 'water pills' that help lower your blood pressure
2. Antibiotics - certain kinds like tetracycline, and others
3. Skin Care Products - certain products used to make your wrinkles go away
4. Heart Medications - amiodarone for example
5. Diabetes Medications - glipizide for example
6. NSAIDs (nonsteroidal anti-inflammatory pain drugs) - ibuprofen for example
7. Balsam of Peru - can be found in some perfumed products

Additional resources about sun protection and damage:

1. Sun Protection For Life: Your Guide To A Lifetime Of Healthy & Beautiful Skin
2. What You Really Need to Know about Moles and Melanoma (A Johns Hopkins Press Health Book)

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Gassy Foods - How to avoid them and reduce the gas

Updated Dec 4, 2016

You might also be interested in:


- - -  original post follows - - -

Now for something a little different. I know this might seem funny, but there are times when we've all gotten some very uncomfortable gas. This Fox News health video, "Gassy Foods," describes some top offenders, and some ways to avoid them. I won't spoil it for you, there are some familiar things, and a couple surprising causes of gas . . .

      July 19, 2016: Broken link to the original video has been removed.


Additional items about gas and bloating that might be of interest:

1. Get to Know Your Gut: Everything You Wanted to Know about Burping, Bloating, Candida, Constipation, Food Allergies, Farting, and Poo but Were Afraid to Ask
2. Beano- Food Enzyme Dietary Supplement, 240ct (2 Pack)

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The ConsumerLab Red Yeast Rice Product Review - FDA Enforcement Policy

• Trusted FDA CGMP online training courses and programs by SkillsPlus International Inc.

If you take red yeast rice products, for cholesterol-lowering, then you need to read this post, "ConsumerLab Red Yeast Rice Product Review Creates Potential Safety and Regulatory Problems." It appears that ConsumerLab; Hyman, Phelps & McNamara, P.C.; and the FDA converge to make this a compelling read. As stated in a posted Hyman etal memo, "ConsumerLab.com Red Yeast Rice Product Review Is in Conflict with the Law and FDA Enforcement Policy, Creating Safety Issues for Consumers and Regulatory Issues for Industry," . . . "The ConsumerLab product review of red yeast rice supplements makes incorrect statements about the law and FDA enforcement policy, and creates general confusion about the marketing of red yeast rice products. Most important, the review encourages consumers to purchase dietary supplements with high levels of monacolins that FDA has determined to be unsafe."

I'm perpetually perplexed that these kind of situations continue to exist. There are FDA regulations, and companies are expected to comply with them. I care, because when the regs aren't followed, I as a consumer, might inadvertently pay the adverse consequence.

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