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FDA tightens oversight of dietary, herbal supplements.
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing regulations to require current good manufacturing practices for dietary supplements. The rule will help ensure that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.
The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. The rule applies to all domestic and foreign companies that manufacture, package, and label supplements for sale in the United States. It requires them to analyze the identity, purity, and strength of all the ingredients that go into their products before the products are distributed. Although the rule does govern manufacturing processes, it does not require manufacturers to prove that the products are safe or effective.
Orthopaedic procedures on increase
A report issued by the U.S. Agency for Healthcare Research and Quality (AHRQ) finds that the number of orthopaedic procedures performed each year in the United States increased by nearly 25 percent during the term of the report, from 822,000 in 1997 to 1.3 million in 2005. Hospital Stays Involving Musculoskeletal Procedures, 1997-2005 also reports the following:
- Women were 60 percent more likely than men to have hip replacements and 70 percent more likely to have knee surgery.
- Spinal fusions were equally likely in both men and women.
- Hospital stays for orthopaedic procedures account for more than 10 percent of all hospital patient care costs.
- Medicare paid the largest share of hospital costs for knee surgery and hip replacements (covering nearly 60 percent of all knee surgeries and 64 percent of all hip replacements), but private insurance was billed for 52 percent of spinal fusions.
Joint Commissions adds anticoagulation prophylaxis to 2008 safety goals.
A new National Patient Safety Goal and a new requirement on anticoagulant therapy will be added in 2008, according to the July issue of The Joint Commission Perspectives. The regulations will be phased in during the year, with full implementation required by January 2009. The new goal requires clinicians to respond rapidly to changes in a patient’s condition, and the new requirement is to “reduce the risk of patient harm with anticoagulation therapy.”
Medical errors affect physicians
A survey published in The Joint Commission Journal on Quality and Patient Safety examines the impact of medical errors on physicians according to five work and life domains. Of 3,171 physician respondents, 2,909 said that they had been involved with “a near miss, minor medical error or serious error.” Of those, 61 percent reported increased anxiety about future errors, 44 percent had experienced a loss of confidence, 42 percent had sleeping difficulties, 42 percent had reduced job satisfaction, and 13 percent experienced damage to their reputation.
Physicians were more likely to be distressed after serious errors when they were dissatisfied with error disclosure to patients, perceived a greater risk of being sued, spent more than 75 percent of their time in clinical practice, or were female.
Just 10 percent of physicians thought that healthcare organizations adequately supported them in coping with error-related stress.
Specialists increasing, but surgeons decreasing
A study by the Center for Studying Health System Change indicates that more men are opting for medical-specialty practices, leaving primary care vulnerable to a shortage of physicians. According to the study, a 40 percent increase in female primary care physicians (1996-97 to 2004-05) has helped offset a 16 percent decline in the number of male primary care physicians.
The study also indicates that the proportion of medical specialists who provide direct patient care for at least 20 hours a week has increased from 32.2 percent to 37.6 percent, but the proportion of surgeons has declined from 28.9 percent to 25.7 percent.
Physicians fail to report self-inflicted injuries
A survey of 699 surgical residents at 17 medical facilities in the United States indicates that nearly all stuck themselves with needles or sharp instruments, but just over half failed to report their injuries. The survey results appeared in the June 28 issue of The New England Journal of Medicine.
During the 5 years of surgical training, respondents experienced an average of eight injuries. Of those who reported their injury, more than half had been stuck while working on a patient at high risk for common, potentially fatal infections. The chief reason for the injury was “being rushed.” Injuries were not reported because reporting would take too much time, could jeopardize career opportunities, or might cause a loss of face among peers.
European study examines computer use in anticoagulation dosages
A study presented at the International Society on Thrombosis and Hemostasis Conference in Geneva, Switzerland, calculated the efficacy of using a computer to determine dosages of blood-thinning drugs.
Researchers analyzed nearly 400,000 international normalized ratio (INR) tests carried out on more than 13,000 patients in 32 medical facilities across the European Union. The tests were divided evenly between manual and computer-assisted dosages. Manual tests were found to give the correct INR 64.7 percent of the time, compared to 65.9 percent for computer-assisted dosage. The number of INR tests that resulted in clinical complications was 7.6 percent lower in all clinical groups with computer-assisted dosage, and the number of clinical events following treatment was significantly lower for computer dosage (6.1 per 100 patient-years compared to 9.1 per 100 patient-years with medical staff dosage).
No more computer-generated fax prescriptions
Under terms of a proposed rule announced by the Centers for Medicare and Medicaid Services (CMS), up to 150,000 physicians nationwide may be required to alter how they send electronic prescriptions to pharmacies. According to Government Health IT, many physicians don’t realize that the software they use to write electronic prescriptions is actually sending a fax to the pharmacy.
Since the rules for e-prescribing took effect in 2006, CMS has allowed an exemption for such computer-generated faxes, but the agency plans to lift that exemption beginning January 1, 2008. One expert states that most electronic medical records systems can send e-prescriptions that meet CMS standards, but many physicians do not use that capability.
Medical liability premiums to increase in New York
The Associated Press reports that New York state regulators have approved a 14 percent increase in medical liability premiums. According to the state Insurance Department, the increase is less than the insurance industry requested, but was necessary to “avoid further financial deterioration of the companies.” A task force formed by the governor will seek ways to control insurance costs, and one consumer group plans to urge that task force to focus on reducing medical errors and correcting industry mismanagement.
Manufacturers lobby to reverse imaging cutbacks
The Associated Press reports that several medical imaging equipment manufacturers are lobbying Congress to overturn Medicare cutbacks that may have contributed to a 20 percent reduction in sales of their products during the first quarter of 2007.
The reductions in reimbursement, which are expected to result in a savings of $2.8 billion over 5 years, were implemented after allegations that some healthcare providers were performing unnecessary tests in order to increase revenue. Industry representatives claim that the cuts have restricted the availability of diagnostics. CMS officials responded that they are monitoring the situation, and pointed out that the reductions do not affect hospitals, where most imaging procedures are performed.
Senators to push for national gift registry
According to an article in the New York Times, Senators Herb Kohl (D-Wis.) and Claire McCaskill (D-Mo.) “would push for legislation that would create a national registry of gifts and payments to doctors by the makers of drugs and medical devices.” The comment came at the end of a hearing by the Special Committee on Aging on ties between industry and physicians.
CMS steps up DME fraud response in California and Florida
According to the Associated Press, the Centers for Medicare and Medicaid Services (CMS) is cracking down on Medicare fraud through a pilot program targeting vendors of durable medical equipment (DME) in Los Angeles and southern Florida. CMS officials are targeting these locations because evidence of high levels of Medicare fraud in these areas exists. Under the terms of the prevention-oriented initiative, about 7,500 DME suppliers will be required to resubmit their applications to do business with the government and then will be subject to stepped-up inspections.