Thoughts and resources about health, drugs and prescriptions, and how they are affected by GMPs (FDA Good Manufacturing Practices) and other regulations.
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:
Guidance for FDA Staff and IndustryMarketed Unapproved Drugs —Compliance Policy Guide
FDA cracking down on unapproved prescription drugs.(Practice Trends)(Food and Drug Administration): An article from: Internal Medicine News
Serious Problems With Generic Drug Makers In U.S. Continue To Be Discovered
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. "
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!
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."
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.
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."
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.
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."
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.
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:
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.
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:
So it could be Salmonella on Jalapenos! Read these additional resources on Salmonella. View this CBS news video, "Jalapeno Warning In Effect "
OK, so you're tired of hearing about tomatoes, peppers, and Salmonella. Then you should do some more reading about Salmonella food poisoning with these resources:
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.
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.
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
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)
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
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
CFR Parts 210, 211 and 11 Pocket Guide
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
Successfully Validating ERP Systems (and other large, configurable applications)
Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
Part 11 risk assessment 'not an alternative' to compliance with predicate rules.(Electronic records): An article from: Validation Times
Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1stbooks Library (Series).)
Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt
Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
You can still watch the video, using the link below.
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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:
Get enough sleep - if you don't, hormonal imbalances can increase your appetite.
Get enough fiber in your diet - fiber swells and makes you feel full.
Drink water - drink when you're thirsty, and avoid the calories of drinks containing sugar.
Try to avoid chronic stress - if you don't, your body is likely to store more fuel, in the form of weight.
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.
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.
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!
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.
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).
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!
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!
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).
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:
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.
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.
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.
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 International 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:
First, the game needs to be content focused.
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!
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:
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!
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:
Shop around and ask for the lowest price.
Consider generics.
Consider a therapeutically similar drug.
Beware of prescription drugs advertised to consumers.
Don't skip doses or reduce the amount of prescription drugs you're supposed to take to make medication last longer.
Learn if you qualify for special, low cost drug programs operated by governmental agencies, drug companies, insurance companies, or others.
Purchase a greater quantity of medication at one time.
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.
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!
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.
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."
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!
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!!!!
You might also be interested in:
'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."
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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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.
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.
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.
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.
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.
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
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.
SkillsPlus International Inc. is the ONLY training provider approved by the California State Board of Pharmacy to offer California Designated Representative training programs for wholesalers, 3PL, and reverse distributors. Nearly 10,000 students have taken our state license-related training courses!
CA Designated Rep 3PL Course
California Designated Representative 3PL Online Training Course.
California HMDR Exemptee license online training certification class for home medical device retailers. Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. We've added something new, closed captioning. Students can read what the course instructor is teaching. Nearly 10,000 students have taken our state license-related training courses! This feature helps ESL (English as a second language) students, and hard of hearing students. #2024 #2025 #2026
CGMP Online Training Courses
Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses
GMP Trainer Courses
GMP Trainer Awareness, Certification, and Master Trainer Courses
Root Cause Analysis - cGMP Training
cGMP Training - Online Self-Study Course - Root Cause - Investigation Reports
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