2007 Archives
2007 Archives:
Patient Safety
Recent archived links on top:
Hospital Superbugs Now In Nursing Homes And Community "Hospital superbugs that can break down antibiotics are so widespread throughout Europe that doctors increasingly have to use the few remaining drugs that they reserve for emergencies. Now these hospital superbug strains have spread to nursing homes and into the community in Ireland…"
Information for Healthcare Professionals Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) "Certain patients taking desmopressin are at risk for developing severe hyponatremia that can result in seizures and death. Children treated with desmopressin intranasal formulations for primary nocturnal enuresis (PNE) are particularly susceptible to severe hyponatremia and seizures. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia."
3 Common Drugs Trigger Most ER Visits by Seniors "In 2004 and 2005, the blood thinner warfarin, the diabetes drug insulin and the heart drug digoxin caused about 58,000 emergency room visits a year in those 65 and older, the researchers found. The major problem is that it's hard to determine the correct dose for each drug, said study lead author Dr. Daniel Budnitz, a medical officer with the U.S. Centers for Disease Control and Prevention (CDC)."
Computed Tomography (CT) Scan of the Body
Bar Code Technology Could Help Curb Drug Errors at Hospitals "Wu added that errors are so common because the U.S. is a "medication society" in which four out of five residents take at least one drug weekly. One possible solution is using a system in which the drugs are labeled with a bar code that is swiped and run through a computer system that checks the dosage and medication, the Times reports."
CDC: New Respiratory Bug Has Killed 10 "A mutated version of a common cold virus has caused 10 deaths in the last 18 months, U.S. health officials said Thursday. Adenoviruses usually cause respiratory infections that aren't considered lethal. But a new variant has caused at least 140 illnesses in New York, Oregon, Washington and Texas, according to a report issued Thursday by the U.S. Centers for Disease Control and Prevention."
Common MRI poisoning some kidney patients "For most people, dyes based on gadolinium — the magnetic ion blamed for the condition — are safe, said David Seidenwurm, a neuroradiologist with Radiological Associates of Sacramento. But for people with severe kidney problems, the ion can poison the patient by causing collagen to build up in tissues."
MRSA infection (Mayo)
[Corticosteroids and osteoporosis.] (Actas Dermosifiliogr. 2007) "Corticosteroids are the principal cause of secondary osteoporosis due to drug treatment. Doses of more than 5 mg daily and periods of treatment lasting more than 3 months increase the risk of osteoporosis and fragility fractures."
Errors in Cancer Diagnosis: Current Understanding and Future Directions (Journal of Clinical Oncology 2007)
Chemicals Flow Unchecked From China to Drug Market "Pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators, The New York Times has found. Because the chemical companies are not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients. The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine. … China has an estimated 80,000 chemical companies, and the United States Food and Drug Administration does not know how many sell ingredients used in drugs consumed by Americans."
Cholinesterase inhibitors: tremor and exacerbation of Parkinson's disease. (Prescrire Int. 2007) "Tremor and dystonia are known adverse effects of cholinesterase inhibitors. (2) In patients with Parkinson's disease who have cognitive disorders, or in patients with Lewy body dementia, exacerbations of parkinsonism and tremor have been observed during treatment with cholinesterase inhibitors at normal doses."
'Superbug' deaths could surpass AIDS "Researchers found that only about one-quarter involved hospitalized patients. However, more than half were in the health care system — people who had recently had surgery or were on kidney dialysis, for example. Open wounds and exposure to medical equipment are major ways the bug spreads. In recent years, the resistant germ has become more common in hospitals and it has been spreading through prisons, gyms and locker rooms, and in poor urban neighborhoods. … A survey earlier this year suggested that MRSA infections, including noninvasive mild forms, affect 46 out of every 1,000 U.S. hospital and nursing home patients — or as many as 5 percent. These patients are vulnerable because of open wounds and invasive medical equipment that can help the germ spread."
Want to stop superbugs? Clean up hospitals "Clean hands can only go so far in protecting patients from infection if doorknobs, bed rails and even sheets are covered with bacteria and viruses, Dr. Stephanie Dancer of South General Hospital in Glasgow writes in the journal Lancet Infectious Diseases."
5 Diagnoses That Call for a Second Opinion
Before Surgery: Your Top 6 Hospital Risks
Guilty, Afraid, and Alone — Struggling with Medical Error
Patients Should Ask Surgeons About Using Honey To Heal Wounds " 'Honey has a number of properties that make it effective against bacterial growth, including its high sugar content, low moisture content, gluconic acid -- which creates an acidic environment -- and hydrogen peroxide. It has also been shown to reduce inflammation and swelling.' … Studies have suggested that honey should be applied at regular intervals, from hourly to twice daily and that wounds can become sterile in three to 10 days."
Society for Medical Decision Making (How do patients choose the best treatment for their disease?)
Questions on deaths (Australia)
Report Assails F.D.A. Oversight of Clinical Trials "The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed. … Privately financed noncommercial trials have no federal oversight. …While some of the report’s findings surprised ethicists, its conclusion that the agency’s oversight of clinical trials is disorganized and underfinanced has long been known and is, in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines."
Survey Picks 41 Top Hospitals in U.S. "Hospitals in Oakland, Calif., Pittsburgh, Boston, and Seattle were among those singled out by the Leapfrog Group, a group started by corporations and other large employers worried about health care costs. Children's hospitals in Atlanta, Los Angeles, and Detroit were also among top scorers."
OIG Clinical Trial Report (Safety of Clinical Trial Participation Examined)
America's Top Hospitals Are Real Lifesavers "Patients in the top-ranked hospitals in the United States are 71 percent less likely to die than those in the lowest-rated hospitals, according to a new study from the health-care ratings company HealthGrades."
Drug company ties common in med schools "Nearly two-thirds of academic leaders surveyed at U.S. medical schools and teaching hospitals have financial ties to industry, illustrating how pervasive these relationships have become, researchers say. Serving as paid consultants or accepting industry money for free meals and drinks were among the most common practices reported by the heads of academic departments. Drug companies and makers of medical devices often use these connections to influence doctors to use products that aren't necessarily in the patient's best interest, said Eric Campbell, the study's lead author. He is a researcher at Massachusetts General Hospital and Harvard Medical School. … But they are dangerous when doctors are so beholden to the company that they withhold safety concerns or push the newest or most expensive products when they aren't necessarily best for the patient, Kassirer said."
Hormone Therapy for Prostate Cancer Linked to Heart Risks "Prostate cancer patients receiving androgen-deprivation therapy, a common form of hormone treatment proven to slow tumor growth and prolong life, may face a nearly threefold higher risk of dying from heart disease, a new study suggests. The apparent danger results from a drop in testosterone levels that is central to androgen-deprivation therapy's (ADT) effectiveness at curbing prostate cancer, the study authors said. This drop in testosterone can provoke insulin resistance, leading to type 2 diabetes, as well as a gain in body mass, body fat and so-called bad cholesterol. Collectively, this group of problems is called the "metabolic syndrome," a condition long-associated with cardiac complications."
Infant cold medicines pulled for overdose risk "Drugmakers on Thursday voluntarily pulled kids’ cold medicines off the market less than two weeks after the government warned of potential health risks to infants. … Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth’s Dimetapp Decongestant Infant Drops, Novartis’ Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings’ Little Colds Decongestant Plus Cough."
Minn. Psychiatrist Quits Drug Panel "Financial relationships between the drug industry and two panel members, including Simon, came to light when The Associated Press reviewed disclosure records filed by drug companies under a pioneering state law. Eli Lilly & Co. and other drug makers paid Simon more than $350,000 in honoraria and fees while he was serving on the Minnesota Medicaid Drug Formulary Committee. Another adviser who resigned last year got $78,000. The Minnesota Department of Human Services is asking the panel members to sign off on a new policy requiring them to reveal "real or perceived" conflicts of interest, including honoraria, compensation, free travel or other perks from drug companies within the past five years."
Bristol-Myers Squibb Fined Again "Bristol-Myers Squibb is paying the government more than half a billion to settle charges that the company inflated the prices of its drugs, paid kickbacks to doctors and promoted its anti-psychotic drug Abilify for unapproved uses."
Have you been misdiagnosed? "It's a lesson worth learning because misdiagnoses are more common than you might think: A 2005 study in the Journal of the American Medical Association says autopsy studies show doctors are wrong 10 percent to 15 percent of the time."
The diseases we cause: Iatrogenic illness in a department of internal medicine. (Eur J Intern Med. 2007) "Eighteen percent of all iatrogenic disease was severe, 61.9% predictable, 54.5% avoidable, and 59% drug-related."
Hospital Quality Info on Web Can Be Misleading "In looking over six hospital-comparison Web sites, researchers found they produced inconsistent results and used inappropriate or incomplete standards to measure a center's quality, according to the report in the September issue of the Archives of Surgery. "Patients are using the Internet to find health-related quality information, and the information is out there," noted lead researcher Dr. Michael J. Leonardi, from the department of surgery at David Geffen School of Medicine, University of California, Los Angeles. "But the information is inconsistent and varies from Web site to Web site," he said. A lot of Web sites try to rank hospitals, Leonardi said. But because there is no standard way of calculating quality differences, Internet sites come up with different results for the same hospitals, he noted."
Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 (Arch Intern Med. 2007) "Conclusions These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."
Hospital volume and stroke outcome (NEUROLOGY 2007) "Conclusions: High annual hospital volume was consistently associated with lower stroke mortality. Our study encourages further research to determine whether this is due to differences in case mix, more organized care in high-volume facilities, or differences in the performance or in the processes of care among facilities."
MDs Don't Issue Pregnancy, Drugs Warning "Doctors aren't doing a very good job of warning young women to avoid getting pregnant when they're taking prescription drugs that can cause birth defects, a new study suggests. Nearly half of the women taking the medicines didn't get counseling from their doctor about using contraceptives or other birth control measures, University of Pittsburgh Medical Center researchers found in a study of nearly 500,000 women."
Mortality among hospitalized Medicare beneficiaries in the first 2 years following ACGME resident duty hour reform. (JAMA. 2007) "CONCLUSION: The ACGME duty hour reform was not associated with either significant worsening or improvement in mortality for Medicare patients in the first 2 years after implementation."
Schizophrenia, drug companies and the internet. (Soc Sci Med. 2007) "Fifty eight percent of the websites analysed received funding from drug companies. Drug company funded websites were significantly more likely to espouse bio-genetic rather than psycho-social causal explanations, to emphasise medication rather than psycho-social treatments, to portray 'schizophrenia' as a debilitating, devastating and long-term illness, and to link violence to coming off medication. They were neither more nor less likely to describe 'schizophrenics' as violent. These results suggest that the documented influence of the pharmaceutical industry over research, professional organisations, teaching institutions, clinical practice and regulatory bodies may now extend to public promotion, via the internet, of perspectives conducive to maximisation of sales."
How Evidence-Based Are the Recommendations in Evidence-Based Guidelines? (PLOS Medicine) "Editors' Summary: … The recommendations made in different clinical practice guidelines vary, in part because they are based on evidence of varying quality. To help clinicians decide which recommendations to follow, some guidelines indicate the strength of their recommendations by grading them, based on the methods used to collect the underlying evidence. Thus, a randomized clinical trial (RCT)—one in which patients are randomly allocated to different treatments without the patient or clinician knowing the allocation—provides higher-quality evidence than a nonrandomized trial. Similarly, internally valid trials—in which the differences between patient groups are solely due to their different treatments and not to other aspects of the trial—provide high-quality evidence. … Nevertheless, the findings serve to warn clinicians that evidence-based guidelines are not necessarily based on high-quality evidence. In addition, they emphasize the need to make the evidence base underlying guideline recommendations more transparent by using an extended grading system like the CHEP scheme. If this were done, the researchers suggest, it would help clinicians apply guideline recommendations appropriately to their individual patients."
Industry-funded breast cancer trials show more positive results. (Int J Health Serv. 2007)
China Recalls Tainted Leukemia Drugs
Estimating the proportion of young adults on antihypertensive treatment that have been correctly diagnosed. (J Hum Hypertens. 2007) "Because of biological variation in blood pressure, most young adults on treatment for hypertension have been misclassified as hypertensive. Most who have been correctly diagnosed are either clinically obese or have kidney disease."
Getting to see your GP (UK - NHS) "The average appointment slot in general practice is ten minutes - not long when you consider it can take an older person several minutes to get undressed and dressed again. Some people need less than this (a repeat prescription for the contraceptive pill, for example) but many take longer. … People who bring long lists of problems can really slow things down for everybody. If you're someone who hoards medical problems, or if you have lots of symptoms you think are relevant, scribble them all down on a piece of paper. Then - and this is key - hand the list to your GP at the start of the consultation. You can both decide what your priorities are and how much, realistically, can be achieved in ten minutes."
UI Research: Patient-Centered Approach Can Backfire
Why pay for mistakes? "THE ANNOUNCEMENT that Medicare will no longer pay hospitals for "conditions that could reasonably have been prevented" is a loud and, many would say, long-overdue wake-up call for American hospitals. Officials are reflecting the rising indignation of the public at the high rate of harm they experience when hospitalized. People have long been baffled by -- and unforgiving of -- the so-called "never" events: sponges left in patients, surgery on the wrong site, mismatched transfusions, etc. But they also don't think they should fall or get infections or pressure ulcers when they go into a hospital, and they think hospitals have been far too blasé about their responsibilities to prevent harm."
Australia Bans Novartis's Prexige on Liver Worries "Australia's drugs regulator banned the use of Novartis's Prexige because of liver problems in patients using the painkiller, the watchdog said, including two deaths and two liver transplants. … Prexige had initially been seen as a blockbuster seller for Novartis, but analysts' expectations collapsed following the Vioxx withdrawal, and there were doubts whether Prexige would ever win U.S. approval."
Two-month waiting time for cancer treatment nowhere near being met (Scotland NHS) "THE NHS in Scotland is still failing to hit a long-overdue cancer waiting-time target, with large variations across the country. The target for all cancer patients to start treatment within two months of being urgently referred by their GP should have been met by the end of 2005. But new figures yesterday showed that, at the start of this year, the NHS was still well adrift of this target - and moving further away."
Health insurance didn’t keep cancer-stricken California woman solvent (USA health insurance issues) " 'When the illness began ... they were floored,' she said. 'They assumed incorrectly that if you have health insurance that you’re fine and that you’ll get the treatment that you’ll need and not have to mortgage the farm to pay for it.' … 'We see it all the time in our practice,' said William Shernoff, who said insurance companies often leave patients on their own to deal with medical providers who bill too much. 'None of these carriers go out of their way to help these people. They’re just looking after their own interests, and they don’t seem to have any consumer-friendly people out there trying to assist their customers. They take the first opportunity they can to get rid of any problems, especially if it’s going to cost them money.'"
Cancer Patients, Lost in a Maze of Uneven Care "Cancer, more than almost any other disease, can be overwhelmingly complicated to treat. Patients are often stunned to learn that they will need not just one doctor, but at least three: a surgeon and specialists in radiation and chemotherapy. Diagnosis and treatment require a seemingly endless stream of appointments. Doctors do not always agree, and patients may find that at the worst time in their lives, when they are ill, frightened and most vulnerable, they also have to seek second opinions on biopsies and therapy, fight with insurers and sort out complex treatment options. The decisions can be agonizing, in part because the quality of cancer care varies among doctors and hospitals, and it is difficult for even the most educated patients to be sure they are receiving the best treatment."
Direct-to-Consumer Drug Ads Booming Despite Criticisms
Do contaminated dental unit waterlines pose a risk of infection? (J Dent. 2007)
Doctors Urged to Curb Reliance on Beta Blockers "Doctors should stop routinely using beta-blockers to control high blood pressure, said researchers who reviewed dozens of previously published studies and found that other hypertension pills work better and cause fewer side effects. For decades, beta-blockers and diuretics, also known as water pills, constituted the cornerstone of treatment for the 50 million Americans with high blood pressure. But a growing body of medical evidence shows that diuretics and newer blood-pressure medications are superior to beta-blockers at reducing high blood pressure, which can lead to heart attacks and strokes, said researchers whose report appeared Monday in the Journal of the American College of Cardiology."
Expert: Diabetes Drug Should Be Pulled "The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday. Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham. … Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos."
5 operations you don't want to get -- and what to do instead
Swabs in Hand, Hospital Cuts Deadly Infections "The problem of infections in hospitals is growing. MRSA has been a particularly troublesome pathogen since its emergence in the United States in 1968. Resistant to a number of antibiotics, it can cause infections of surgical sites, the urinary tract, the bloodstream and the lungs, leading to extended hospital stays. MRSA can be brought into hospitals by patients who show no symptoms, and it then thrives in settings where immune systems are weakened and where incisions provide inviting ports of entry. It now accounts for 63 percent of hospital staphylococcus infections, up from 22 percent in 1995."
The safety of amiodarone in patients with heart failure. (J Card Fail. 2007) "CONCLUSIONS: Treatment with amiodarone was associated with an increased risk of death from circulatory failure independent of functional class."
Doctors suffer too after making medical errors "Patients are not the only ones harmed by medical errors, according to a survey that found many doctors who make mistakes — and even those who come close — suffer stress, sleep problems and loss of confidence. Job stress related to medical errors potentially could make some doctors prone to depression, quitting or even making additional mistakes, underscoring the need for helping them cope, said Washington University psychologist Amy Waterman, the lead author of the study which was released Wednesday."
Use of Antidepressants and Rates of Hip Bone Loss in Older Women (Arch Intern Med. 2007) "Conclusion Use of SSRIs but not TCAs is associated with an increased rate of bone loss at the hip in this cohort of older women."
U.S. Health Experts Rate Hospitals' Cardiac Care "U.S. health officials have rated the nation's hospitals on their treatment of heart attack and heart failure and found that most meet the national average for quality of care. Scoring 4,700 centers across the country, experts at the Department of Health and Human Services took into account heart-related death rates as well as the mix of patients at each hospital to come up with their findings."
Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? (Nat Clin Pract Nephrol. 2007) "Virtually all neurological morbidity resulting from hospital-acquired hyponatremia has been associated with administration of hypotonic fluids. Multiple prospective studies have shown that 0.9% NaCl is effective prophylaxis against hyponatremia. There is not a single report in the literature of neurological complications resulting from the use of 0.9% NaCl in non-neurosurgical patients. Patients at greatest risk of developing hyponatremic encephalopathy following hypotonic fluid administration are children, premenopausal females, postoperative patients, and those with brain injury or infection, pulmonary disease or hypoxemia. When hyponatremic encephalopathy develops, immediate administration of 3% NaCl is essential."
In Health Care, Cost Isn’t Proof of High Quality "In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates. And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found. … the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care. Expensive medicine may, in fact, be poor medicine. “For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers."
Misleading Ads and How They Hurt Us "The pharmaceutical industry spent much of its $4.2 billion direct-to-consumer advertising budget in 2005 on ads targeting healthy upper-income, middle-aged people. A common underlying message was this: you appear to be healthy, but a deadly heart attack, hip fracture, or other medical catastrophe could occur at any time. Therefore, you should take a prescription drug to prevent such problems. … With such direct-to-consumer ad campaigns, which highlight risk factors and promote screening tests, drug companies move beyond promoting certain pills for treatment of diagnosed conditions to expanding their use in healthy people"
CT Heart Scans Raise Cancer Risk "CT scan coronary angiography (CTCA), a test to determine the presence of heart trouble, can up the risk for cancer, especially for women and younger people. The finding comes from a new study in which doctors sought to estimate lifetime cancer risk from CTCA for particular patients. It suggests that doctors should carefully evaluate which patients are the best candidates for this test. "
Medical standards in 21 states based on local rule, not national standards "Although most patients don’t know it, 21 U.S. states follow some form of an 1880 ruling that says the standard of care physicians must meet by law depends on where the doctor practices, even if, in some cases, it is a small town with only two doctors. … “This can help physicians because it requires patients who file malpractice suits to find expert witnesses who also are familiar with that local standard of care,” she says. “But I have seen a lot of cases of malpractice thrown out because it is often difficult to find physicians in the same community who will serve as expert witnesses against a fellow doctor. “But this has become a double-edged sword for many physicians, because it can inhibit the adaptation of scientific advancement, and means that some doctors who want to practice the best evidence-based medicine are at risk if they do so,” Lewis says."
Nosocomial Infections after Peripheral Arterial Bypass Surgery. (World J Surg. 2007) "RESULTS: A total of 67 infections were diagnosed in association with 607 procedures, yielding an infection ratio of 10.0%. Surgical site infection was the most common (55.2%), followed by urinary tract infection (16.4%), pneumonia (14.9%) and bacteremia (10.4%). Staphylococcus aureus was the most commonly found isolate in surgical site infections (48.6%) and in bacteremia (42.9%). Age, the use of corticosteroids (p = 0.02), and critical ischemia with tissue loss (p = 0.009) could be identified as risk factors for the development of a nosocomial infection. Blood transfusion was a postoperative risk factor for nosocomial infection (p < .0001)."
Patients want 'better NHS data' "Many patients do not know about the performance of their local NHS services, a poll suggests. Nearly a third said they were unaware how their local hospitals and GPs compared to others."
States' "Locality Rule" Hurts Patients "What is considered malpractice in some states may be considered acceptable practice in others. Twenty-one states base physicians' standard of care on a "locality rule," which is based on where they practice as opposed to a nationwide standard of care. "Medicine has increasingly become standardized; we use national standards for board certifications, licensing and medical education in medical schools. The majority of states has adopted a nationwide standard of care. However, many states still follow some version of the locality rule," Michelle Huckaby Lewis, M.D., J.D., lead author of this study told Ivanhoe. … The states that adhere to some form of the locality rule are: Arizona, Virginia, Washington, Idaho, New York, Arkansas, Illinois, Kansas, Maryland, Michigan, Minnesota, Nebraska, North Carolina, North Dakota, Oregon, Tennessee, Colorado, Louisiana, Montana, Pennsylvania and South Dakota."
Association of Low Bone Mineral Density With Selective Serotonin Reuptake Inhibitor Use by Older Men (Arch Intern Med. 2007) "Conclusions In this population of men, BMD was lower among those reporting current SSRI use, but not among users of other antidepressants. Further research is needed to confirm this finding in light of widespread SSRI use and potentially important clinical implications."
FDA Scrutiny Scant In India, China as Drugs Pour Into U.S. "After the pet food scandal that triggered fears over the safety of human and animal foods imported from China, experts say medicines from that country and from India pose a similar risk of being contaminated, counterfeit or simply understrength and ineffective. … Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made here, come from India and China. Within 15 years, they predict, as much as 80 percent of the key ingredients will come from those countries -- which are quickly becoming attractive to brand-name drugmakers, too. William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating."
Hazards of Buying Prescription Drugs Online "Many people are choosing to buy prescription drugs online, but unless they are very careful, this can be a risky undertaking. Drugs bought over the internet can be fake, substandard in potency, unapproved by the FDA, counterfeit, or just plain dangerous."
Safety of aggressive lipid management. (J Am Coll Cardiol. 2007) " … the long-term safety of combination with high-dose statins remains to be established. In order to optimize patient outcomes, clinicians should be aware of specific patient characteristics, such as advancing age, gender, body mass index, or glomerular filtration rate, which predict muscle and hepatic statin toxicity."
Satisfied with your medical care? Don't be "Most people have heard the statistics that we pay ridiculously more for our health than other industrialized countries (twice as much per person as Germany, for example) and that our outcomes are far worse (the U.S. is 45th in the world in life expectancy, according to the Central Intelligence Agency's World Factbook). We hear the numbers about the massive death rates from medical errors in this country. And we all hate rising premiums and co-pays, and fear losing our insurance. ... It is not just a question of extra expense. Cancer patients who suffer the horrible side effects of unneeded chemotherapy often believe their doctor saved their life. How could they know the treatment was unnecessary?"
Sobering new statistics affirm seriousness of hospital infections in U.S. "In a newly released study, the CDC estimates that there are 4.5 hospital infections for every 100 patient admissions and nearly 100,000 deaths from hospital infection. This long awaited assessment, published in the March-April 2007 journal, Public Health Reports (1), is not yet posted to the public on the CDC's website. Consumers Union summarizes the results here. … Estimated number of deaths associated with hospital-acquired infections [caused or contributed to the death]: 98,987. Most patients survive a hospital-acquired infection, but many of the survivors endure years of treatment, multiple surgeries, and permanent disability. This study only analyzed the number of deaths and the specific types of infections with which they were associated: • pneumonia: 35,967 • bloodstream infections: 30,665 • urinary tract infections: 13,088 • surgical site infections: 8,205 • infections of other sites: 11,062 "
VA Hospitals Do Well in Preventing Catheter Infections "The recommendations from the U.S. Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality include: • Maximal sterile barrier precautions for inserting a central venous catheter. This includes sterile gloves and gown, mask, cap, and a large sterile drape. • Chlorhexidine gluconate (2 percent) on the skin as an antiseptic before insertion, rather than povidone iodine or alcohol. • Replacing catheters as needed, rather than every 4 to 7 days. • Using antimicrobial catheters, but only if other precautions don't reduce infection rates."
After Sanctions, Doctors Get Drug Company Pay "Medical ethicists have long argued that doctors who give experimental medicines should be chosen with care. Indeed, the drug industry’s own guidelines for clinical trials state, “Investigators are selected based on qualifications, training, research or clinical expertise in relevant fields.” … The Times’s examination of Minnesota’s trove of records on drug company payments to doctors found that from 1997 to 2005, at least 103 doctors who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment over that period was $1,250; the largest was $479,000. The sanctions by the board ranged from reprimands to demands for retraining to suspension of licenses."
Doctor Says Drug Maker Tried to Quash His Criticism of Avandia "Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients’ risk of heart attacks, and he criticized the company’s marketing, saying it employed “blatant selective manipulation of data” to overstate the drug’s benefits and understate its risks."
Doctors Don't Care for Incentives "According to a new study, pay-for-performance programs at hospitals were not associated with significant improvement in processes of care or outcomes for heart attack patients. Patients are not always receiving the care they deserve. "There have been a couple prominent studies in the past couple of years showing that unfortunately there are often gaps in the care that is delivered and the care that's supposed to be delivered according to evidence-based guidelines," Seth W. Glickman, M.D., M.B.A., and lead author of the study told Ivanhoe."
Posing as pals, drug reps sway doctors' choices "As much as doctors would like to deny it, subtle attention from friendly drug sales representatives can have a big impact on what drugs they prescribe, according to two U.S. studies published on Monday."
Psychiatrists, Children and Drug Industry’s Role "… the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care. Nowhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics. These best-selling drugs, including Risperdal, Seroquel, Zyprexa, Abilify and Geodon, are now being prescribed to more than half a million children in the United States to help parents deal with behavior problems despite profound risks and almost no approved uses for minors. A New York Times analysis of records in Minnesota, the only state that requires public reports of all drug company marketing payments to doctors, provides rare documentation of how financial relationships between doctors and drug makers correspond to the growing use of atypicals in children. From 2000 to 2005, drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesota’s Medicaid program rose more than ninefold. … Such payments could encourage psychiatrists to use drugs in ways that endanger patients’ physical health, said Dr. Steven E. Hyman, the provost of Harvard University and former director of the National Institute of Mental Health. The growing use of atypicals in children is the most troubling example of this, Dr. Hyman said."
Lens Solution Is Pulled Over Link to Infection "Customers were advised to immediately stop using the solution, AMO Complete Moisture Plus Multi-Purpose Solution. The solution, used to clean and store soft contact lenses, is made by Advanced Medical Optics of Santa Ana, Calif. … They should also throw out their current contact lenses and the lens storage case because they may harbor an infection-causing amoeba, officials of the federal Centers for Disease Control and Prevention in Atlanta said. The agency also advised people who have used the product to call an eye doctor if they have experienced eye pain or redness, blurred vision, sensitivity to light, the feeling of something in the eye or excessive tearing."
Patients at high risk of adverse events from intravenous contrast media after computed tomography examination. (Eur J Radiol. 2007) " Prior to examinations using CM, patients should be adequately assessed by obtaining thorough medical histories and using simple screening tests. Studies have demonstrated that patients with a history of asthma, allergy, hyperthyroidism, and previous reaction to CM are at risk for severe reactions to iodinated CM. Renal adverse reactions reportedly occur more frequently in patients with pre-existing chronic kidney disease, especially those with diabetic nephropathy. Patients with congestive heart failure, dehydration, older age, and those who use nephrotoxic medications are also at risk for developing contrast-associated nephropathy. The occurrence of adverse events may be further increased in patients with multiple risk factors."
Amiodarone Therapy for Atrial Rhythm Control: Insights Gained From a Single Center Experience. (J Cardiovasc Electrophysiol. 2007) "Introduction: Amiodarone has been advocated as an effective "long-term" therapy for atrial rhythm control in patients with atrial fibrillation (AF). … The incidence of amiodarone cessation was evaluated at 1, 2, and 3 years and attributed principally to drug inefficacy, intolerance, or toxicity. A gradual diminution in the number of patients on therapy was observed, such that by 3 years, only 45% remained. This was attributable to inefficacy (25%), intolerance (12%), or toxicity (18%). Pulmonary toxicity was surprisingly common, occurring in at least 7% of patients. Conclusions: These data challenge the notion of amiodarone as a reasonable "destination" therapy for AF."
Doctors Reap Millions for Anemia Drugs "Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes."
U.S. Hospital Errors Continue to Rise "Patient safety incidents in U.S. hospitals increased by three percent overall from 2003 to 2005, and the error gap between the nation's best- and worst-performing hospitals remained wide, a report released Monday found. America's top rated centers had 40 percent lower rates of medical errors than the poorest-performing hospitals, the study showed."
What do clinical users know regarding safety of ultrasound during pregnancy? (J Ultrasound Med. 2007) "CONCLUSIONS: Ultrasound end users are poorly informed regarding safety issues during pregnancy. Further efforts in the realm of education and training are needed to improve end user knowledge about the acoustic output of the machines and safety issues."
What everyone needs to know about drug marketing Part 1: Products
What everyone needs to know about drug marketing Part 2: Prices
What everyone needs to know about drug marketing: Part 3 Place, Promotion and Goals
Health care errors affect one in 10 patients - WHO "The nine key points listed by the World Health Organisation (WHO) include double-checking similar-sounding medication names, ensuring patients are correctly identified, and improving hand hygiene to avoid preventable infections."
FDA Issues Safety Alert on Avandia "The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia."
FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers "The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs."
From China to Panama, a Trail of Poisoned Medicine "The syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in some antifreeze. … Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste and other products. … The counterfeit glycerin passed through three trading companies on three continents, yet not one of them tested the syrup to confirm what was on the label. Along the way, a certificate falsely attesting to the purity of the shipment was repeatedly altered, eliminating the name of the manufacturer and previous owner. As a result, traders bought the syrup without knowing where it came from, or who made it. With this information, the traders might have discovered — as The Times did — that the manufacturer was not certified to make pharmaceutical ingredients. An examination of the two poisoning cases last year — in Panama and earlier in China — shows how China’s safety regulations have lagged behind its growing role as low-cost supplier to the world. It also demonstrates how a poorly policed chain of traders in country after country allows counterfeit medicine to contaminate the global market."
CT screening for lung cancer stirs safety, ethics concerns "Radiation exposure from low-dose cancer screening of 2.5 to 9 mGy has been associated with an increase in cancer, according to the authors. Radiation-induced lung cancer is most problematic for patients in their mid-50s, and smokers may be particularly vulnerable. The editorial claimed that repeated CT procedures would significantly increase cancer risk and possibly result in thousands of radiation-induced lung cancers. Furthermore, many chest CT findings are benign, and it appears likely that screening would result in a high number of unnecessary biopsies."
Direct-to-Consumer Advertising in Oncology: A Content Analysis of Print Media "Conclusion: Oncology print DTCA is prevalent in cancer-related, patient-directed magazines, and infrequent in the popular press. The information presented is considerably difficult to read, raising important questions about the appropriateness of direct-to-consumer marketing for oncologic medications."
Does "Evidence-Based Medicine" Diminish the Physician's Role? "Medicine that is based on prevailing opinion results in things, such as double mastectomies for fibrocystic breast disease because a particular surgeon believes that lumpy breasts are a risk for breast cancer, hysterectomies for all postmenopausal women because a gynecologist believes that female reproductive organs past a certain age only serve to breed cancer, or surgery on every case of sciatica because a back surgeon says that that's the best approach. I regret to say that I have seen all of these, always in a small town where one specialist's opinion sets the gold standard of care for his or her field simply because he or she is the only expert available. This is not good medicine by any measure, and yet, it was for the most part how medicine was practiced before the EBM movement became popular."
Risk Factors Affecting In-hospital Mortality in Patients with Nosocomial Infections. (J Formos Med Assoc. 2007) "Conclusion: Measures that prevent the occurrence of NI, such as improving the immunity status of the host, removal of catheters as soon as possible, and implementing an infection control program, could reduce the risk of in-hospital deaths attributable to NI."
Sedative-hypnotic drug products "[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving."
An outbreak of Pseudomonas aeruginosa infection caused by contaminated mouth swabs. (Clin Infect Dis. 2007) "CONCLUSIONS: Contamination of mouth swabs during production caused the largest-ever outbreak of P. aeruginosa infection in Norway. Susceptible patient groups should use only documented quality-controlled, high-level-disinfected products and items in the oropharynx."
Fatal errors more likely on 24-hour call "Their research reveals that first-year medical school graduates who worked five shifts of 24 hours or more during a month were three times more likely to make an error that contributed to a patient's death."
Medical Errors Common in Stroke Care "Of preventable adverse events, 37% were transcription/documentation errors, 23% were due to failure to perform a clinical task, 10% were due to communication/handoff errors between providers, and 10% were due to failed independent checks/wrong calculations."
Patient, protect thyself "Hospitalized patients can expect to experience at least one medication error a day, says the Institute of Medicine, which advises Congress on health policy. Though some mistakes are harmless or quickly corrected, others can be deadly. Forty-four thousand to 98,000 Americans a year die from medical errors. … EIGHT WAYS TO HELP YOU, THE PATIENT: • Bring an advocate. … • Educate yourself.…"
10 Patient Safety Tips for Hospitals
The importance of health literacy "Researchers have found that poor health literacy, which is especially prevalent among the elderly, results in poor adherence to prescription instructions, infrequent use of preventive medical services, increased hospitalizations and visits to the emergency room and worse control of chronic diseases. The consequences are poorer health and greater medical costs."
Top U.S. Hospitals Have 28% Lower Mortality Rate: Study " The top 5 percent of hospitals in the United States have a 28 percent lower death rate than other hospitals in the nation, a new study finds. The analysis, released Jan. 29 by HealthGrades, an independent health care ratings company, also found that patients who have surgery at the top-rated hospitals are about five percent less likely to suffer complications than patients at other hospitals."
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