PARADIGM BYTES JUNE 2011

PARADIGM BYTES
Newsletter for Paradigm 97
June 12, 2011

PARADIGM DEFINED:
1) an outstandingly clear or typical example or archetype.2) a philosophical and theoretical framework of a scientific school or discipline within which theories, laws, and generalizations, and the experiments performed in support of them, are formulated.

Our website...... http://paradigm97.blogspot.com/ ; Please copy, paste, and bookmark it.

MISSION STATEMENT
We believe that nurses need each other for support during the "lean and mean" days to help survive them. We offer research results and other ideas to enrich the nursing experience.
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SNIPPETS

If you ever have a patient who is a Quad (SCI), you really need to understand the dangers associated with their condition. I had a patient when I lived in Washington state, who was a new Quad. I arrived one day, his wife and friend were scared to death because he was having a autonomic dysreflexia reaction, and they didn't know what to do. I examined his catheter tubing....and saw that it was crimped. I straightened it out and he immediately became "normal"...his face was no longer reddened and he did not have pain (as such). This was a time to explain all the ramifications of AD and what they needed to know. Since they lived in the mountains, help was a very, very long way away. Patient and caregiver teaching is essential. Please check both links below.ay. The following is more for the family and patient....but educational for anyone.
Autonomic dysreflexia (AD) is a medical problem unique to people with spinal cord injuries (SCI). Although uncommon, it is a serious concern because it can be life threatening and needs immediate attention. If you know what you are looking for, however, it is relatively easy to recognize and treat. But since many health care providers may not be familiar with AD, it is important to understand it yourself and carry a medic alert card.
What is autonomic dysreflexia (AD)?
AD is an abnormal response to a problem in your body—pain, pressure, full bladder or bowel—somewhere below the level of your SCI. Because of the SCI, your body doesn't respond properly to signals that something is wrong. Instead, your body may develop a sudden rise in blood pressure, and this can lead to stroke, seizures or death.
How does AD happen?
AD is usually triggered by something that would cause pain or discomfort in a person without SCI, such as a full bladder, tight clothing or an ingrown toenail. In non-injured individuals, the body reacts to pain by narrowing the blood vessels, and this causes blood pressure to increase. Receptors near your brain and heart receive messages from non-spinal cord pathways (nerves in the sympathetic nervous system) that your blood pressure is getting too high, and your brain responds by sending signals down the spinal cord to slow down the heart beat and relax the blood vessels. As the blood vessels open up and widen, blood pressure goes back down. Meanwhile, pain signals coming through the spinal cord have told the brain there is something wrong, so the individual feels the discomfort and knows to do something about it and remove the source of the pain. ...
http://emedicine.medscape.com/article/322809-overview and http://sci.washington.edu/info/forums/reports/autonomic_dysreflexia.asp
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The following is not really a Snippet......but I think it is very important that all of us become aware of a problem:

Original Research: Tragedy into Policy: A Quantitative Study of Nurses' Attitudes Toward Patient Advocacy Activities.

Black, Lisa M.
AJN The American Journal of Nursing, June 2011,111(6):26-35
Feature Articles

Although the Centers for Disease Control and Prevention (CDC) reports that an estimated 3.2 million Americans are living with chronic hepatitis C, in southern Nevada fewer than four cases of acute hepatitis C are confirmed annually.1, 2 So when six people who had recently undergone endoscopic procedures were diagnosed with acute hepatitis C within a six-month period (July 2007 to December 2007), alarms were sounded.1 Ultimately, more than 62,000 patients who had undergone endoscopic procedures at either of two southern Nevada endoscopy clinics would be notified that they might have been exposed to bloodborne pathogens, including hepatitis B virus, hepatitis C virus (HCV), and HIV, as a result of unsafe injection practices. ... ( I, for one, would have reported it no matter what the consequences would be. )
http://journals.lww.com/ajnonline/Fulltext/2011/06000/Original_Research__Tragedy_into_Policy__A.23.aspx?WT.mc_id=EMxALLx20100222xxFRIEND
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During a discussion on a list serve about stethoscopes, Wendie (whowland1@mac.com) made the following comment:
"This might be a silly addition to the discussion, but I notice this all thetime-- people don't wear the ear plugs properly. They should aim forward towards the point of your nose when they enter your ear canal, because that's the way the ear canal aims; if you wear them so they point straight in to the middle ofyour head or backwards their little openings will be up against soft tissue and you won't hear worth a tinker's dam. I used to spend time every year teaching students that, usually 2nd year by the time I got them, and it was always comical to see their little eyes light up when they realized there was a real reason why they couldn't hear breath sounds or heart sounds, and it wasn't just that they needed to try harder.

This is also one of my small peeves about otherwise good portrayals of nursing on TV-- Nurse Jackie and her colleagues (including that complex beautiful physician she hangs out with) are always hanging their stethoscopes backwards ontheir necks, so when they pull them on, they can't possibly hear through them. You can rotate the vertical axis so it fits you just right. Try". Best, Wendie
Another stethoscope hint: When you are trying to hear the ankle/brachial sounds to assess circulation in the foot, ... tilt the head of the stethoscope up about 45 degrees........works every time.


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FROM THE MEMBERS

This was supposed to have been in a previous Newsletter....I goofed.

ConnieRN2Be1@aol.com writes:

"I graduated from nursing school in May 2005. I have been working in a hospital on a geriatric med-surg floor. it is a specialty unit called an ace (acute care of the elderly) unit. Regular med surg, just specialize with those over the age of 65. I became nationally certified in gerontological nursing and am a geriatric clinical scholar in the hospital". Congratulations, Connie !

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INTERESTING READING

Please remember that the REUTERS articles usually good for only 30 days

The addition of daily azithromycin to standard treatment reduced the frequency of COPD (chronic obstructive pulmonary disease) exacerbations and improved quality of life at 1 year in a large, prospective, randomized, placebo-controlled clinical trial involving more than 1,100 high-risk COPD patients.Use of the macrolide antibiotic was associated with a significantly greater incidence of hearing decrement, although the overall rate was low and Dr. Richard K. Albert reported at an international conference of the American Thoracic Society. ...
http://www.internalmedicinenews.com/newsletter/internal-medicine-news-e-newsletter/singleview40682/daily-azithromycin-cut-acute-copd-exacerbations-in-high-risk-patients/fc603beca5.html
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Study finds need for care after cancer treatment Sixteen percent of 248 patients who survived breast, colorectal, lung or prostate cancer experienced fatigue, 15% had disturbed sleep, 13% suffered cognitive difficulties and 13% reported pain three to five years after their treatment, according to a study presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago. "It seems we haven't come a long way in managing pain despite a lot of medical advances. This is eye-opening. It tells us we need to be better in clinical practice about managing our survivors' pain," said researcher Lynne Wagner. Nurse.com
http://news.nurse.com/article/20110603/NATIONAL02/106060028/-1/frontpage
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This is from BAcello . Thanks Barbara...she writes "There is a link for a free pdf download on the right side of the page....

Synopsis of the National Institute for Health and Clinical Annals of Internal Medicine
... that may precipitate delirium, including cognitive impairment or disorientation, ... pain, poor nutrition, sensory impairment, and sleep
disturbance. http://www.annals.org/content/154/11/746.abstract?aimhp "
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Early detection of Ovarian cancer is key, but what are the symptoms and how is it diagnosed?
(Since) your ovaries lie deep within your pelvis, thus making disease detection tricky. Early screening methods for ovarian cancer have so far proved unreliable, and although routine pelvic exams include a check for anything that feels out of the ordinary, early-stage ovarian tumors easily escape detection because they're difficult to feel. In addition, ovarian cancer has a reputation for being "silent," meaning symptoms tend to be either vague or nonexistent until the disease has spread.
As a result, the vast majority of ovarian cancers are diagnosed when the cancer is in an advanced stage, at which point the chances of survival are significantly reduced. In a comparison of survival rates among women with one of the most common types of ovarian cancer, fewer than 20% of women diagnosed at an advanced stage (stage IV) survived more than 5 years after diagnosis. In contrast, 89% of women diagnosed at the earliest stage (stage I) did survive at least 5 years. ...
http://www.realage.com/check-your-health/womens-health/detecting-ovarian-cancer?click=main_sr&cbr=wn1105_mn&eid=1010637809&memberid=4687812
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Urine culture doubtful in determining etiology of diffuse symptoms among elderly individuals: a cross-sectional study of 32 nursing homes The high prevalence of bacteriuria in elderly individuals makes it difficult to know if a new symptom is related to bacteria in the urine. There are different views concerning this relationship and bacteriuria often leads to antibiotic treatments. The aim of this study was to investigate the relationship between bacteria in the urine and new or increased restlessness, fatigue, confusion, aggressiveness, not being herself / himself, dysuria, urgency and fever in individuals at nursing homes for elderly when statistically considering the high prevalence of asymptomatic bacteriuria in this population. ... http://www.biomedcentral.com/1471-2296/12/36
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The Role Telomeres play in our lives....A new study/ discovery Be sure to read this...really very good info.
The tiny "caps" that keep our chromosomes from fusing together are also providing clues that could eventually lead to the achievement of one our nation's most important public health goals: extending good health well into old age.
To help understand the role telomeres play within the human body, it's useful to review some basic biology. All of the tissues within the human body are made up of individual cells. These cells contain chromosomes within their nuclei. Chromosomes are the packages that hold most of our DNA - the genetic instructions that tell the cell what to do.
To help understand the role telomeres play within the human body, it's useful to review some basic biology. All of the tissues within the human body are made up of individual cells. These cells contain chromosomes within their nuclei. Chromosomes are the packages that hold most of our DNA - the genetic instructions that tell the cell what to do.
Telomeres are repeating DNA sequences at the ends of the chromosomes. They do not contain any genetic instructions; they simply repeat a sequence of DNA over and over. When we are young, the telomeres are very long - they may contain as many as 20,000 base pairs of DNA. ...
http://www.agingresearch.org/content/article/detail/878
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THRIFTY TIP: The federal government will reimburse you for 30 percent of the cost, up to $1,500 for highly efficient insulation. Additionally, low-income households can qualify for an average of $6,500 worth of weatherization improvements to their homes through government programs administered by each state!
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THURSDAY, May 26 (HealthDay News) -- For men with advanced hormone-resistant prostate cancer who have also failed chemotherapy, the new drug Zytiga (abiraterone acetate) along with the steroid prednisone appears to boost survival, researchers report.
Based on data from the ongoing clinical trial, Zytiga was approved by the U.S. Food and Drug Administration in April. It works by inhibiting the production of the male hormone testosterone, which promotes the growth of cancer cells. In this regard, the drug mimics hormone therapy. ... http://www.nlm.nih.gov/medlineplus/news/fullstory_112513.html

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FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers The U.S. Food and Drug Administration Release-- April 22, 2011-- approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Menactra was originally approved in 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm252392.htm
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RANDOM FACTS: New aluminum cans that are manufactured from used beverage containers use 95% less energy than producing
them from virgin materials.
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Each year, Americans throw out enough plastic film to shrink-wrap the entire state of Texas.
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Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication FDA notified consumers, women who participate in breast cancer screening and healthcare professionals that thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. The FDA is concerned that women will believe these misleading claims about thermography and not receive needed mammograms.

Certain facilities, websites, and mobile units are promoting the use of thermography as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming that is a substitute for or superior to mammography. They also claim that thermography can detect pre-cancerous abnormalities and diagnose breast cancer long before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257707.htm

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WHO defers fixing date on destroying live smallpox
(Reuters) - A decision on when to destroy the last known stocks of live smallpox was put off for a further three years at the World Health Organization's annual meeting on Tuesday in the latest stage in a debate that has lasted decades.
The issue had deeply divided the annual World Health Assembly in Geneva, with Iran spearheading opposition to a U.S. and Russian-backed plan to postpone setting a date for destruction for five years.
Iran was at the forefront of countries arguing for the stocks held in Russia and the United States to be destroyed now. ... http://www.reuters.com/article/2011/05/24/us-smallpox-who-idUSTRE74N35T20110524?feedType=nl&feedName=ushealth1100
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(Reuters) - Giving a high dose of niacin to people with heart disease who are already taking a cholesterol-lowering statin does nothing more to prevent heart attacks and strokes, U.S. government researchers said on Thursday.
The findings from a large clinical trial challenge the notion that raising high-density lipoprotein, or HDL, the so-called "good" cholesterol, can further reduce heart risks in people who already have their "bad" cholesterol -- low-density lipoprotein, or LDL -- well under control. ...
http://www.reuters.com/article/2011/05/26/us-heart-niacin-idUSTRE74P4SN20110526?feedType=nl&feedName=ushealth1100
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Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimers disease Full Text BMC Neurology, 05/26/2011 Clinical Article Farlow M et al. – The 23 mg/d dose of donepezil was associated with typical cholinergic adverse events(AEs), particularly gastrointestinal–related AEs, similar to that observed in studies with a dose increase from 5 to 10 mg/d. The good safety and predictable tolerability profile for donepezil 23 mg/d supports its favorable risk/benefit ratio in patients with moderate to severe Alzheimers disease(AD)....
http://www.biomedcentral.com/1471-2377/11/57
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People admitted to the hospital on the weekend are 10 percent more likely to die than those who checked in during the week, according to a new analysis of nearly 30 million people.
Even if 10 percent doesn't sound like much of a difference, when applied to the entire U.S. population it equals an additional tens of thousands of people each year, study author Dr. Rocco Ricciardi of Tufts University Medical School told Reuters Health.
"In other words, an extra 20 to 25 thousand people die each year in the United States because of admission on a weekend," he said ... http://health.yahoo.net/news/s/nm/us_more_hospital_deaths_weekends
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Scientists have found that a gene linked to diabetes and cholesterol is a "master switch" that controls other genes found in fat in the body, and say it should help in the search for treatments for obesity-related diseases.

In a study published in the journal Nature Genetics, the British researchers said that since fat plays an important role in peoples' susceptibility to metabolic diseases like obesity, heart disease and diabetes, the regulating gene could be target for drugs to treat such illnesses. ...
http://www.huffingtonpost.com/2011/05/15/scientists-find-genetic-s_n_862237.html?icid=maing-grid7|main5|dl1|sec3_lnk1|63139 ************************** TRIVIA

The CDC estimates that 3.8 million sport and recreation related concussions happen in the United States each year.
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Sixty percent of sport related injuries occur during practice.
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Eat this fish for a heart healthy life Researchers who recently examined an Eskimo community in Alaska were surprised to find that some of the overweight and obese people in the group didn't have the high, unhealthy levels of triglycerides that usually come with being large. And scientists suspect it's because of the fatty fish they were enjoying.
Fish-Fat Connection
Fatty fish, like salmon, is a rich source of docosahexaenoic (DHA) and eicosapentaenoic acid (EPA) -- two omega-3 fatty acids that have a solid rep for promoting heart health. And these two types of fat appeared to have a protective effect in the overweight and obese Yup'ik Eskimos observed in the study. The Yup'ik Eskimos tend to consume about 20 times more omega-3 fatty acids from fish compared to Americans outside of Alaska. ...

http://www.realage.com/tips/follow-this-heart-healthy-eskimo-diet?eid=1098958000&memberid=4687812
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Pituitary tumors are fairly common. About 1 in 10,000 people get them. They grow slowly, do not spread and are usually not cancerous. The most common type of pituitary tumor produces hormones and disrupts the balance of hormones in your body. This can cause endocrine diseases such as Cushing's syndrome and hyperthyroidism. Symptoms of pituitary tumors include:

Headaches
Vision problems
Nausea and vomiting
Any of the problems caused by the production of too many hormones

Pituitary tumors are usually curable. Treatment is often surgery to remove the tumor. Other options include medicines and radiation. http://www.nlm.nih.gov/medlineplus/pituitarytumors.html
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Continuing Education: Drug Therapy gets personal with genetic profiling
Two patients are admitted to different hospitals for treatment of deep vein thrombosis. One receives warfarin, with the dosage based on her age and weight. The other also is prescribed warfarin, but the treating physician determines the dosage with an algorithm that uses data about the patient’s genetic profile and activity of the cytochrome 2C9 enzyme and the VKORC1 enzyme (vitamin K epoxide reductase complex subunit 1); both enzymes metabolize warfarin.
The first patient suffers several bleeding episodes because her coagulation can’t be stabilized; she requires a transfusion and is hospitalized for 10 days. The second patient remains free from bleeding episodes and is discharged 3 days later. ...
http://www.americannursetoday.com/Article.aspx?id=7814&fid=7770
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Trivia all about Wedding Matters: In the U.S., the bride traditionally walks down the aisle last, after the bridesmaids, groomsmen, flower girl, and ring bearer. In England, the bride is the first down the aisle to emphasize her importance. Another key difference in the wedding precession is in America, the groomsmen walk arm-in-arm with the bridesmaids. British bridesmaids, however, follow the bride without escort, while the groomsmen, known in England as ushers, stand in the front.
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Each wedding party in England typically has bridesmaids around the same age as the bride and groom, but also younger bridesmaids, from ages 10-12. In the U.S., the bridesmaids are usually close friends or family of the bride or groom and are around the same age.
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British women traditionally wear hats—big ones—to weddings. At a Christian ceremony in the U.S., the bride is usually the only person with something on her head. Generally the English weddings take place in the afternoon. After the ceremony, the guests attend a wedding breakfast. There are a couple of theories about the origin of the term wedding breakfast. One theory is that the name comes from the tradition of the bride and groom fasting before the wedding, therefore, the reception would be when
they would break their fast. Another is that the wedding breakfast is the first meal of the couple's married life, just as breakfast is the first meal of the day.
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Pre-wedding bashes are called bachelor and bachelorette parties in the U.S., while in the U.K. they are referred to as stag night or stag weekend for the men and hen night for the women. Britain has more legal restrictions about weddings than America. For example, in England and Wales, couples cannot legally get married outdoors unless the location has been approved by local authority.
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In the U.S., wedding cakes—both the main cake and, in some cases, a groom's cake—are a major part of the reception. In Britain, the dessert is traditionally a fruit cake. The top-tier of the fruit cake is saved for the christening of the couples' first child. The top-tier in the U.S. is saved for the couple's first anniversary.
(Facts courtesy of infoplease.com)
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(Unfortunately, I can not have the entire article presented now. Hopefully, the link will work for you. LET ME KNOW, Please)

Preventing accidental IV infusion of breast milk in neonates
Several years ago, we received a letter from the mother of a hospitalized infant named Zoey who
accidentally received breast milk intravenously (IV) instead of through a nasogastric (NG) feeding tube.
The primary underlying cause of this ... newsletter@ismp.org ISMP Nurse Advise-ERR June 2011 Vol. 9, Issue 6
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RANDOM FACT: A dairy cow produces about 100,000 glasses of milk in it's lifetime.
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Patch cover applied without the medicated patch underneath
CATAPRES-TTS (transdermal therapeutic system) is
a square, tan, reservoirtype adhesive patch that contains cloNIDine, which is used to treat hypertension. These patches,
manufactured by Boehringer Ingelheim, come with an optional white, round, adhesive cover that can be placed over the
drug patch to prevent it from coming loose. Each patch—the tan patch containing cloNIDine and the white cover patch
—come in separate pouches. So, each “dose” typically has two pouches: one pouch with the tan medication patch and ne pouch with the optional cover. ... newsletter@ismp.org ISMP Nurse Advise-ERR June 2011 Vol. 9, Issue 6
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Electronic Cigarettes are no panacea Slender, battery-powered electronic cigarettes look lik the real thing. Some even hava a fake ember that lights up with each puff, but they are smoke-free and don't contain tar, instead, the user inhales vapors emitted by a cartridge of nicotine fluid. Sold online and in shopping malls, "e-cigarettes" come in tempting flavors such as cappuccino, cherry, chocolate, and apple-flavors with special appeal to teens and children.

Although e-cigarettes are touted as being healthier than regular cigarettes, the FDA has serious concerns. In the agency's initial tests, it detected diethylene glycol, a toxic chemical found in antifreeze, along with nitrosamines and other cancer-causing compounds. Substandard manufacturing practices are another concern. In the brands tested, the amount of nicotine in each inhalation varied considerably, and some e-cigarettes labeled "nicotine free" contained low levels of the addictive chemical. The trendy devices are often marketed as a smoking-cessation aid, but public-health experts worry that they might lead to increased nicotine addiction among children.
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RANDOM FACT: In the summer, the amount of water pouring over Niagara Falls each second could fill 13,00 bathtubs.

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HUMOR SECTION

In one of my classes, they were discussing the qualifications to be president of the United States. It was pretty simple - the candidate must be a natural born citizen of at least 35 years of age. However, one girl in the class immediately started in on how unfair was the requirement to be a natural born citizen.

In short, her opinion was that this requirement prevented many capable individuals from becoming president. The class was just taking it in and letting her rant, but everyone's jaw hit the floor when she wrapped up her argument by saying, "What makes a natural born citizen any more qualified to lead this country than one born by C-section?"

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CEU SITES---(CME and CNE)
Those that are-----Free and Otherwise..........

Pay Only $34.99 for a full year of CONTACT HOURS http://www.nursingspectrum.com /

Free CEs http://www.myfreece.com/welcome.asp
https://nursing.advanceweb.com/CE/TestCenter/Main.aspx

This site was sent in by FNPMSN@aol.com (Cindy) http://cmepain.com/ !

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WEBSITES/ LINKS
Always on the lookout for interesting websites / links. Please send them to: RNFrankie@AOL.com.

Back issues of the newsletter are available at: http://www.ismp.org/Newsletters/nursing/backissues.asp.
Robert Hess, RN, PhD, FAAN (856) 424-4270 (610) 805-8635 (cell)
Founder, Forum for Shared Governance info@sharedgovernance.org www.sharedgovernance.org
Decubqueen's website: www.accu-ruler.com

http://www.thebreastcancersite.com/clickToGive/home.faces?siteId=2

http://www.nationalnurse3.blogspot.com/

RNs launch a national safe staffing campaign http://www.1199seiu.org/media/magazine/sept_2007/safe_staffing.cfm
H.R. 2123, The Nurse Staffing Standards for Patient Safety and Quality Care Act of 2007

http://www.washingtonwatch.com/bills/show/110_HR_2123.html

Board Supports Your Right to Refuse An Unsafe Assignment: Nurse Practice Act cites three conditions for patient abandonment http://findarticles.com/p/articles/mi_qa4102/is_200408/ai_n9450263

The Nursing Site http://thenursingsite.com .
http://www.snopes.com

Ten Great Public Health Achievements --- United States, 2001--2010
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6019a5.htm?s_cid=mm6019a5_w
http://www.solutionsoutsidethebox.net/ Raconte's website

http://www.theanimalrescuesite.com/clickToGive/home.faces?siteId=3

National Do Not Call Registry

If you're buying a used car, it is recommended having a mechanic inspect it first. And screen the car's VIN through the free database at carfax.com/flood

This is a sampling of the offers on : Rozalfaro's website: http://www.alfaroteachsmart.com/articles.htm
Critical Thinking is More Than Problem Solving Critical Thinking: Not Usually Rapid Fire
Should Clinical Courses Get a Letter Grade?

Metric conversion calculators and tables for metric conversions
http://www.metric-conversions.org/
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MEDICAL RECALLS
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Simply thick may cause serious bowel condition.FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
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On May 25, 2011, FDA granted tentative approval for a generic formulation of tenofovir disoproxil fumarate tablets, 300 mg under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).
This formulation, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (≥12 years of age and ≥35 kg); and for the treatment of chronic hepatitis B in adults, is manufactured by Strides Arcolab Limited, of Bangalore, India.
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.
This product is a generic version of Viread Tablets, 300 mg, manufactured by Gilead Sciences.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.

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Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm


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Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed
FDA's meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm
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Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
FDA and Aidapak Services notified healthcare professionals and hospital pharmacies of a nationwide recall of multiple repackaged drug products after learning of the potential cross contamination of non-penicillin drug products that were repackaged in the same facility. There is the potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products that could result from using these recalled products.
Please click on the link in the firm press release to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.
Hospitals, Emergency rooms, clinics and other healthcare facilities should stop distributing these products immediately and quarantine the products, and then contact Aidapak Services for return instructions.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257723.htm

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NURSING HINTS CORNER

Catheter care comfort Here is a tip for catheterizing a female patient who has a fractured hip or who finds the dorsal recumbent position uncomfortable.
Turn the patient on her left side in the Sims' position, with the right knee and thigh drawn up, if possible. Place a sterile drape over her buttocks, covering the rectal area. The separate the labia and proceed to catheterize her.
Elderly patients especially, find this position more comfortable than the traditional position. Sonja Feist, RN, MS

Used with permission from 1,001 Nursing Tips & Timesavers, Third Edition, 1997, p.39, Springhouse Corporation/

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ADVERTISEMENTS
from the members
This ad is from Decubqueen (Gerry)..........Accu-RulerAccurate wound measurement designed by nurses, for nurses. Now carrying wound care and first-aid supplies at prices you can afford.Visit us at http://www.accu-ruler.com/.

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NEW MEMBERS

Please send the prospective members' screen names and first names to me: RNFrankie@AOL.com

WELCOME TO:

phutchisonpadron@yahoo.com (Peggy) June 2, 2011

scoggins3@earthlink.net (Joan) June 6, 2011

loreerutherford@yahoo.com (Loree) June 10, 2011

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NOTICE

I attempt to send newsletters to your email addresses on file and if the newsletters are rejected THREE consecutive times, I must then delete the email address until you contact me with an updated email address; I have no way to reach you without a correct email address.... Please send me your new name/address, okay? RNFrankie@AOL.com

Old E-mail Address: aznitern@msn.com
New E-mail Address: aznitern@q.com

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PARADIGM 97 CO-FOUNDERS:
MarGerlach @AOL.com (Marlene) and RNFrankie @AOL.com (Frankie)

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DISCLAIMER: The intent of this PARADIGM BYTES Newsletter is to provide communication and information for our members. Please research the hyperlinks and information provided by our members. The articles and web sites are not personally endorsed by the editors, nor do the articles necessarily reflect the staff's views.

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THOUGHT FOR THE DAY

People grow through experience if they meet life honestly
and courageously. This is how character is built.

--Eleanor Roosevelt (1884 - 1962), My Day



Hope to see you online...or, better yet, write me !.. Frankie
RNFrankie@AOL.com