Popular Articles

Signostics Receives FDA Clearance For World's Smallest Ultrasound Product
Pioneering medical device company Signostics announced it has secured clearance from the U.S. Food and Drug Administration (FDA) for its palm-sized personal ultrasound device, the "Signos".
generic viagra online
Ohio Supreme Court Restricts Mifepristone Use In State To Scope Of FDA's Approval Letter
In answering two certified questions from the U.S. Court of Appeals for the 6th Circuit, the Ohio State Supreme Court on July 1 declared that a state law regulating the use of mifepristone -- which is used in medication abortion -- bars physicians from prescribing it for off-label use, BNA reports. The court confirmed that doctors who use the drug to induce abortion must do so in compliance with the 49-day gestational limit included in FDA"s 2000 drug approval letter. Doctors also must prescribe the drug in accordance with the protocols and dosage indications included in its FDA-approved labeling.Interpretation of State Law in ContentionThe Ohio General Assembly in 2004 passed a law (Section 2919.123 (A)) that required any health care professional prescribing or dispensing mifepristone to comply with "all provisions of federal law that govern the use" of the drug. The law defines "federal law" as "any law, rule or regulation of the United States or any drug approval letter" from FDA "that governs or regulates the use of" mifepristone for inducing abortion. FDA"s approval letter states that the drug "is indicated for use in the termination of pregnancy (through 49 days" pregnancy) and has no other approved indication for use during pregnancy." In addition, the drug"s label states the recommended dosage and that its use requires three office visits by the patient. Planned Parenthood Southwest Ohio Region challenged the law in district court, arguing that neither FDA"s approval letter nor any other federal provision bans the off-label use of mifespristone to induce abortion beyond 49 days" gestation. The group also argued that the state law was unconstitutionally vague because it did not notify abortion providers in advance regarding which FDA documents were included in the state"s criminal law. In addition, Planned Parenthood said that prohibiting the evidence-based use of the drug would infringe on the rights of women, requiring them to take higher-than-necessary dosages of the drug or to undergo surgical abortions when a noninvasive alternative is available. The district court ruled in favor of Planned Parenthood, saying that the law was void because of vagueness. The state appealed the decision to the 6th Circuit, which then submitted two questions to the state Supreme Court seeking its interpretation of the law.The state Supreme Court ruled that FDA"s drug approval letter is included in the definition of "federal law" and that the state law is not ambiguous, according to BNA. The court said that because the drug approval letter incorporated FDA"s labeling text, Ohio physicians cannot prescribe or provide mifepristone to induce abortion outside of the stipulations of the drug approval letter and approved label. According to BNA, product liability law experts say the ruling will not have an impact outside of mifepristone or the state of Ohio.Case Returns to Appeals CourtRoger Evans of Planned Parenthood Federation of America said that he is not sure if the court"s decision helps or hurts the group"s case. Evans said that the district court declared the law unconstitutional based on an interpretation that the statute operates in the same way the state Supreme Court ruled it does. He noted that there are other possible interpretations of the law that would have solved the constitutional issues at the center of the litigation. However, because those issues were not resolved, the case now returns to the 6th Circuit, which will decide if the statute is constitutional based on the state Supreme Court"s interpretation. If the circuit court agrees with the district court that the statute is unconstitutionally vague, the state of Ohio could seek a U.S. Supreme Court review. If the circuit court finds that the statute is constitutional, the case likely will be sent back to the district court for resolution of some other issues in the case, according to BNA (BNA, 7/6).
News of the day
Malpractice Suits, Other Factors Contribute To Rise In Caesarean Births, Experts Say
Many doctors believe that the increase in caesarean section births in the U.S. over the last decade has been fueled by three main factors -- fear of malpractice lawsuits, a decrease in vaginal births after c-sections and rising rates of obesity -- the St. Petersburg Times reports. According to the Times, 31.8% of U.S. births were c-sections in 2007, compared with 21% a decade earlier, making c-sections the most commonly performed procedure in the nation"s hospitals.A few decades ago, c-section births were relatively rare, representing only 4% of U.S. births in 1965. According to the Times, c-section rates began to increase when it was believed that many cerebral palsy cases were the result of infants being deprived of oxygen during traumatic vaginal deliveries, which led to malpractice suits against doctors. At the same time, advancements in neonatal care and electronic fetal monitoring in recent decades have helped make the procedure safer and therefore more common. Robert Yelverton, a physician and board member of the Florida Obstetric and Gynecologic Society, said that doctors "tend to opt for the method of childbirth most likely to withstand a legal challenge." Whereas doctors in the past were more likely to use techniques such as vacuum extraction or manually turning an infant during a difficult birth, doctors today automatically opt for a c-section, according to Yelverton. According to the Times, one study found that 76% of U.S. obstetricians reported at least one litigation event, with an average award of $2.3 million for negligence in childbirth.An increase in obesity and a decline in VBACs also have driven the rise in c-section births, the Times reports. VBACs have declined from nearly 30% in the 1990s to 7.9% in 2005, which some doctors say is a result of fear of litigation because of the chance for rare but serious complications during birth. Similarly, obesity puts women at an increased risk for gestational diabetes, delivering prematurely or having larger infants, which can make birth more risky, the Times reports. More than one-third of U.S. women of childbearing age are overweight or obese (Martin, St. Petersburg Times, 6/17).
Oncology

Highlights Of Pain Research

Musculoskeletal problems are among the complaints most frequently reported in health interview surveys. Typically around 50 percent of the population report having had musculoskeletal pain in one or more areas for at least one week during the past month. Musculoskeletal disorders are also the most common work-related health problems in the EU: 25 percent of European workers complain of backache and 23 percent of muscular pains. The trend will become even more acute as demographic changes lead to an ageing society. The theme of pain is therefore one of the focuses of the 10th EFORT Congress taking place in Vienna from June 3 to 6, 2009. The Congress is organized by the European Federation of National Associations of Orthopaedics and Traumatology. The following are some highlights of the orthopaedic pain research presented at this scientific event. Shoulder surgery: Greater attention to factors determining quality of life perception "Factors determining quality of life perception (QLP) should be taken into account when planning surgery strategies for different shoulder disorders," according to Dr. Joan Miquel from Barcelona, Spain, speaking at Europe"s largest gathering of orthopaedists. "Age, sex and aetiology of shoulder disorder determine different perceptions of quality of life independently of the shoulder functional scoring." Dr. Miquel said his and his team"s motive for studying 134 patients was to analyze the quality of life in patients affected by different shoulder pathologies and to check how pain and movement influence QLP. Current treatments in shoulder pathology are focused on reducing pain, he said, though it is yet to be established that pain itself is the factor most significantly affecting such patients. The results of their study showed that there were statistically significant differences among age, sex and diagnosis groups. Patients older than age 65 significantly perceived a worse quality of life. Women and patients affected by a degenerative disorder also significantly perceived a worse quality of life. A relationship (linear trend) between movement and quality of life was ascertained. In patients with preserved range of motion, changes in pain perception significantly affected QLP, while changes in pain perception did not affect the QLP of patients with poor range of motion. A predominant effect of external rotation, that is rotation away from the centre of the body, in QLP was observed. Pain during activity, at rest and at night: Do we have to measure it all? The patient alone can provide the information about the most important symptom of musculoskeletal system disease: pain. To assess the pain situation better the symptoms can be measured in routine with the "Pationnaire", a simple tool easy to use and to understand. This instrument allows an objective assessment of pain during activity, at rest and at night. In the end an aggregate score of all three pain categories is calculated. But is that really necessary? Here too, new findings were presented at the EFORT Congress. Dr. Jē¶rg Huber from Switzerland assessed the pain of patients with various degenerative disorders of the musculoskeletal system and evaluated a total of more than 1,000 questionnaires. The results indicated that the degree of pain at rest correlated to a high degree with nocturnal pain. The researcher thus concludes that these two kinds of pain can be asked in one single question. Dr. Huber: "It would suffice, therefore, to inquire about and to document pain during activity and pain at rest/night, thereby facilitating the assessment of the clinical situation." Emergency surgical admissions: Every fifth patient"s regularly prescribed medication overlooked Particularly during hospital emergency cases, "more care and emphasis need to be given to individual drug history when admitting a patient." Presenting the study "Errors in Prescription of Regular Medication in Emergency Surgical Admissions - Clinical Audit," Dr. Amit Sharma of the Luton & Dunstable Hospital in the UK emphasized at the EFORT Congress in Vienna that "the results of our audit are surprising and alarming." In 21% of cases, the admitting doctors failed to prescribe at least one regular medication the patient was dependent on. Missing out on regular medication can have potentially life-threatening effects on patients as well as severe medico-legal implications. The data for this audit was taken from all surgical admissions over an approximately one month period. Prescribed drugs for each patient were checked the morning after admission. If the patient was unable to provide this information, their regular medication list was obtained from the General Practitioner (GP). A total of 71 admissions were studied, 58% were referred from the accident and emergency department (A&E), whereas 34% from the GP/primary care and a small percentage came from referrals from other wards within the hospital. Out of the 71 admissions, 46 patients were receiving at least one regular medication. Dr. Sharma: "From all 71 admissions, 21% of them had at least one error, i.e. at least one regular medication was not prescribed upon admission. Analyzing each co-morbidity individually: 42% of ischemic heart disease (IHD) medication was not prescribed for patients who regularly depended on them; 33% for hypertensive and diabetic medication; 50% for asthmatic and psychiatric medication and 29% for medication for other less serious conditions." Of the errors made, 81% were on patients referred from A&E, while 15% where from patients received from the GP/primary care. Patients referred from the A&E department are generally more unwell than the ones referred from the GP or primary care. Quite often, they are elderly patients on a multitude of drugs that are unable to remember some or all of their medications. Patients admitted out of hours present an added difficulty in that GPs are not available for confirmation of the patient"s regular medication, notes Dr. Sharma. Discussions with a physician reduce pain and improve shoulder function New study results on the influence of physician-patient communications indicate that patients with shoulder disorders have significantly less pain perception following clinical doctor-patient interviews. Patients who had received surgery because of a shoulder disorder perceived significantly better shoulder function and less pain after doctor visits. The conclusion results from a study presented at the EFORT Congress in Vienna by Dr. Carlos Torrens (Barcelona, Spain) on the "Change in Patient Self-evaluation of Pain, Function and Satisfaction Before and After Clinical Visit." The study involved 95 consecutive patients (mean age: 64.18) with varying shoulder problems such as fractures, cuff disorders, instabilities and glenohumeral arthritis. Just under half of the patients had undergone surgery. The objective of the study was to analyze the effect of the doctor-patient interview on the patient"s self-evaluation of his/her pain level as well as the level of function and satisfaction during different shoulder procedures. Before and after the clinical visit, the patients were asked to fill 3 analogical scales related to: the level of shoulder pain; the level of shoulder function; and satisfaction with the procedure. Self-administered questionnaires are commonly used to evaluate functional and satisfaction results of different treatments applied. An analysis of the whole series indicated that there were significant differences between the pain experienced in the shoulder before and after a visit. There were marginally significant differences between the level of function of the shoulder experienced before and after a visit, and there were no differences in satisfaction with the procedure. If the cohort of patients that had received surgery is analyzed separately, significant differences emerge in perceptions of pain and function. Females significantly considered less pain after visits than males; no differences were noted because of age, diagnosis or time elapsed since surgery. No differences were noted with satisfaction, even though patients tend to perceive more satisfaction after a visit. Dr. Torrens concludes that "when planning patient self-evaluation of pain and function, the effect of the clinical visit has to be considered in order to avoid masking results." British pain researcher: "We require improved alternative analgesic regimes following hip arthroscopy" British pain researchers, analyzing the results of post-operative pain measurement of 71 patients, reported at the EFORT Congress that better analgesic regimes are needed after day-case hip arthroscopic surgery. Background: Day-case hip arthroscopic surgery is frequently carried out using an intra-articular depot of local anaesthetic as post-operative analgesia plus additional opiate or oral analgesia as required. Although problems with chondral toxicity caused by prolonged exposure to local anaesthetics have been increasingly recognized, Dr Jonathan Robert Bunn (Craigavon Area Hospital, Northern Ireland, UK) and his team nevertheless set out to evaluate the efficacy of three different hip arthroscopy post-operative analgesic regimes. In particular, they wanted to examine whether or not intra-articular local anaesthetics provided any benefit. Dr Bunn: "There are no previous studies relating to hip arthroscopy post-operative analgesic requirements." He investigated 71 consecutive patients and prospectively audited their post-operative analgesic requirements. Each patient was given one of three alternative post-operative analgesic regimes: Group A received the local anaesthetic Bupivacaine 0.25% 10ml intra-articular and 20ml periportal skin infiltration; group B had Bupivacaine 0.25% 20ml periportal skin infiltration only; and group C had no infiltration. Outcome measures were visual analogue scores (VAS) immediate postoperatively, one hour post-operatively, two hours post-operatively

Pages: [1] 2 


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):