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Advances in public health in this first decade of the 21st Century have contributed to a record low death rate in the U.S. and the continuation of a steady downward trend.

From 1999 to 2009, the age-adjusted death rate in the United States declined from 881.9 per 100,000 population to 741.0, a record low.

Contributing factors for the advances in public health include the development of new vaccines, awareness campaigns, health screening, new legislation and preparedness.

Public health scientists at the Centers for Disease Control and Prevention, were asked to nominate noteworthy public health achievements that occurred in the United States during 2001 – 2010. From those nominations, 10 achievements, not ranked in any order, have been identified.

Vaccine-Preventable Diseases

The past decade has seen substantial declines in cases, hospitalizations, deaths, and health-care costs associated with vaccine-preventable diseases. New vaccines were introduced, bringing to 17 the number of diseases targeted by U.S. immunization policy.

A recent economic analysis indicated that vaccination of each U.S. birth cohort with the current childhood immunization schedule prevents approximately 42,000 deaths and 20 million cases of disease, with net savings of nearly $14 billion in direct costs and $69 billion in total societal costs.

Prevention and Control of Infectious Disease

Improvements in state and local public health infrastructure along with innovative and targeted prevention efforts yielded significant progress in controlling infectious diseases. Examples include a 30 percent reduction from 2001 to 2010 in reported U.S. tuberculosis cases and a 58 percent decline from 2001 to 2009 in central line–associated blood stream infections.

Other major advances include the capacity to identify contaminated foods rapidly and accurately and prevent further spread; expanded HIV screening of persons aged 13–64 years, and new blood donor screening for the West Nile virus. To date, such screening has interdicted 3,000 potentially infected U.S. donations, removing them from the blood supply.

Tobacco Control

By 2009, 20.6 percent of adults and 19.5 percent of youths were current smokers, compared with 23.5 percent of adults and 34.8 percent of youths 10 years earlier. However, progress in reducing smoking rates among youths and adults appears to have stalled in recent years.

Although no state had a comprehensive smoke-free law (i.e., prohibit smoking in worksites, restaurants, and bars) in 2000, that number increased to 25 states and the District of Columbia (DC) by 2010, with 16 states enacting comprehensive smoke-free laws following the release of the 2006 Surgeon General’s Report.

In 2009, the largest federal cigarette excise tax increase went into effect, bringing the combined federal and average state excise tax for cigarettes to $2.21 per pack, an increase from $0.76 in 2000. By 2010, FDA had banned flavored cigarettes, established restrictions on youth access, and proposed larger, more effective graphic warning labels that are expected to lead to a significant increase in quit attempts.

Maternal and Infant Health

The past decade has seen significant reductions in the number of infants born with neural tube defects (NTDs) and expansion of screening of newborns for metabolic and other heritable disorders. Mandatory folic acid fortification of cereal grain products labeled as enriched in the United States beginning in 1998 contributed to a 36 percent reduction in NTDs from 1996 to 2006 and prevented an estimated 10,000 NTD-affected pregnancies in the past decade, resulting in a savings of $4.7 billion in direct costs.

Improvements in technology and endorsement of a uniform newborn-screening panel of diseases have led to earlier life-saving treatment and intervention for at least 3,400 additional newborns each year with selected genetic and endocrine disorders. Newborn screening for hearing loss increased from 46.5 percent in 1999 to 96.9 percent in 2008.

Motor Vehicle Safety

Motor vehicle crashes are among the top 10 causes of death for U.S. residents of all ages and the leading cause of death for persons aged 5 to 34 years. In terms of years of potential life lost before age 65, motor vehicle crashes ranked third in 2007, behind only cancer and heart disease.

From 2000 to 2009, the death rate related to motor vehicle travel declined from 14.9 per 100,000 population to 11.0, and the injury rate declined from 1,130 to 722; among children, the number of pedestrian deaths declined by 49 percent, from 475 to 244, and the number of bicyclist deaths declined by 58 percent, from 178 to 74.

These successes largely resulted from safer vehicles, safer roadways, and safer road use. Behavior was improved by protective policies, including effective seat belt and child safety seat legislation; 49 states and the DC have enacted seat belt laws for adults, and all 50 states and DC have enacted legislation that protects children riding in vehicles.

Cardiovascular Disease Prevention

Preliminary data from 2009 indicate that stroke is now the fourth leading cause of death in the United States. During the past decade, the age-adjusted coronary heart disease and stroke death rates declined from 195 to 126 per 100,000 population and from 61.6 to 42.2 per 100,000 population. Factors contributing to these reductions include declines in the prevalence of cardiovascular risk factors such as uncontrolled hypertension, elevated cholesterol, and smoking, and improvements in treatments, medications, and quality of care.

Occupational Safety

Significant progress was made in improving working conditions and reducing the risk for workplace-associated injuries. For example, patient lifting has been a substantial cause of low back injuries among the 1.8 million U.S. health-care workers in nursing care and residential facilities. In the late 1990s, an evaluation of a best practices patient-handling program that included the use of mechanical patient-lifting equipment demonstrated reductions of 66 percent in the rates of workers’ compensation injury claims and lost workdays and documented that the investment in lifting equipment can be recovered in less than 3 years.

The annual cost of farm-associated injuries among youth has been estimated at $1 billion annually. A comprehensive childhood agricultural injury prevention initiative was established to address this problem, resulting in a 56 percent decline in youth farm injury rates from 1998 to 2009.

Cancer Prevention

Evidence-based screening recommendations have been established to reduce mortality from colorectal cancer and female breast and cervical cancer. From 1998 to 2007, colorectal cancer death rates decreased from 25.6 per 100,000 population to 20.0 (2.8 percent per year) for men and from 18.0 per 100,000 to 14.2 (2.7 percent per year) for women. During this same period, smaller declines were noted for breast and cervical cancer death rates (2.2 percent per year and 2.4 percent, respectively).

Childhood Lead Poisoning Prevention

In 2000, childhood lead poisoning remained a major environmental public health problem in the United States, affecting children from all geographic areas and social and economic levels. In 1990, five states had comprehensive lead poisoning prevention laws; by 2010, 23 states had such laws. Findings of the National Health and Nutrition Examination Surveys from 1976 to 1980 to 2003 to 2008 reveal a steep decline, from 88.2 percent to 0.9 percent, in the percentage of children aged 1 to 5 years. The economic benefit of lowering lead levels among children by preventing lead exposure is estimated at $213 billion per year.

Public Health Preparedness and Response

After the international and domestic terrorist actions of 2001 highlighted gaps in the nation’s public health preparedness, tremendous improvements have been made. In the first half of the decade, efforts were focused primarily on expanding the capacity of the public health system to respond (e.g., purchasing supplies and equipment). In the second half of the decade, the focus shifted to improving the laboratory, epidemiology, surveillance, and response capabilities of the public health system.

During the 2009 H1N1 influenza pandemic, these improvements in the ability to develop and implement a coordinated public health response in an emergency facilitated the rapid detection and characterization of the outbreak, deployment of laboratory tests, distribution of personal protective equipment from the Strategic National Stockpile, development of a candidate vaccine virus, and widespread administration of the resulting vaccine. These public health interventions prevented an estimated 5 to 10 million cases, 30,000 hospitalizations, and 1,500 deaths (CDC, unpublished data, 2011).

For more on public health issues, see the library of articles by Daytona Beach personal injury attorney.

Positive comments made by a doctor during the physical examination of a child seen for a viral upper respiratory tract infection can markedly reduce the percentage of patients who receive an inappropriate antibiotic prescription, a new study suggests.

Viruses, which do not respond to antibiotics, cause more than two-thirds of upper respiratory tract infections or URIs, but URIs account for approximately 75 percent of  children’s antibiotic prescriptions.

The researchers report that parents who hear positive comments during their child’s examination, such as “no problem,” in contrast to comments suggesting that there is a “problem” to be concerned about, are less likely to question the doctor’s plan not to use antibiotics to treat the URI.

The researchers analyzed videotapes of 261 patient encounters for viral childhood URI involving 38 California pediatricians in 27 community practices. They found that comments during the physical exam occurred in 71 percent of these visits (61 percent with only “no problem” comments, 10 percent with at least one “problem” comment).

For patient encounters for viral URI, “problem” comments were associated with a 13 percent increase in parents’ questioning of the subsequent no-antibiotic treatment plan compared with visits involving “no problem” comments or no comments during the examination.

Statements ruling out the need for antibiotics were independently associated with a 24 percent boost in parents’ questioning of the treatment plan. Patient visits in which the doctor made any “problem” comments resulted in 27 percent more inappropriate prescriptions of antibiotics than visits in which only “no problem” comments were made.

“Clinicians should consider the consequences of raising parental expectations for an antibiotic with an announcement of a ‘problem’ examination finding, or of being seen to commit themselves to a prescription by the same action,” researchers conclude in the study. In addition to influencing perceptions, ‘no problem’ commentary “may contribute to rapport building by giving insight into the physician’s reasoning about symptoms, and reassuring parents that symptoms are mild.”

The study was funded in part by the Agency for Healthcare Research and Quality and was published in the Patient Education and Counseling Journal.

For more on medical issues, see the library of articles by Daytona Beach medical malpractice and child injury attorney.

Cell phones used by patients and their visitors were twice as likely to contain potentially dangerous bacteria as those of healthcare workers, according to a new study.

A team of researchers from the Department of Medical Microbiology at Inonu University in Malatya, Turkey collected swab samples from three parts of cell phones — the keypad, microphone and ear piece. A total of 200 mobile phones  were cultured for the study, 67 of which belonged to medical employees and 133 to patients, patients’ companions and visitors.

The researchers found that 39.6 percent of the patient group phones and 20.6 percent of healthcare worker phones tested positive for pathogens. Additionally, seven patient phones contained multidrug resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multiply resistant gram-negative organisms, while no HCW phones tested positive for multidrug resistant pathogens.

“The types of bacteria that were found on the patients’ mobile phones and their resistance patterns were very worrisome,” state the authors in a press release. “Some investigators have reported that mobile phones of medical personnel may be a potential source of bacterial pathogens in the hospital setting.

“Our findings suggest that mobile phones of patients, patients’ companions and visitors represent higher risk for nosocomial pathogen colonization than those of healthcare workers. Specific infection control measures may be required for this threat.”

Hospital-acquired infections affect more than 25 percent of admitted patients in developing countries. In U.S. hospitals, they cause 1.7 million infections a year and are associated with approximately 100,000 deaths. It is estimated that one third of these infections could be prevented by adhering to standard infection control guidelines.

While this study is small, the results identify another way dangerous bacteria can get into the hospital. That is why medical experts suggest the following tips:

• Use alcohol-based disinfectant wipes on your cell phone to help prevent the spread of germs
• Wash your hands or use a hand sanitizer whether you’re the patient or a visitor
• Insist on clean hands from all hospital staff.

The study was published in the June issue of the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology.

For more on medical safety issues, see the library of articles by Daytona Beach personal injury attorney.

The U.S. Food and Drug Administration has released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication.

The guidance, titled “Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products,” describes how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for OTC medicines such as liquid pain relievers, cold medicine, cough syrups, and digestion aids.

“Accidental medication overdose in young children is an increasingly common, but preventable public health problem,” said Dr. Karen Weiss, program director for the Center for Drug Evaluation and Research’s Safe Use Initiative, in a press release.

The FDA issued the guidance because of ongoing concerns about the potential accidental drug overdoses that can result from the use of dosage delivery devices with markings that are confusing, unclear or inconsistent with the labeled dosage directions.

Key recommendations in the guidance include:

• Dosage delivery devices should be included for all orally ingested OTC liquid drug products.
• Devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon, or milliliter) that are the same as the units of liquid measure specified in the directions for the product and there should not be any unnecessary markings.
• Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged with.
• Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid product is added to the device.

According to the FDA, parents and caregivers should follow 10 tips when giving medicine to an infant or child:

1. Always read and follow the Drug Facts label on your OTC medicine.
2. Know the ‘active ingredient’ in your child’s medicine.
3. Give the right medicine, in the right amount, to your child.
4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn’t.
5. Use the dosing tool that comes with the medicine, such as a dropper or a dosing cup.
6. Know the difference between a tablespoon and a teaspoon.
7. Know your child’s weight.
8. Prevent a poison emergency by always using a child-resistant cap.
9. Store all medicines in a safe place.
10. Check the medicine three times.

The FDA recommends that anyone with questions about dosage delivery devices or how to measure liquid OTC medicines contact a physician, pharmacist, or other health care professional.

For more on child medical issues, see the library of articles by Daytona Beach child injury attorney.

Young children exposed to a brief, single anesthetic did not show any evidence of adverse long-term effects on the brain, a new study shows.

While past studies in young animals have shown anesthetics cause potential developmental and behavioral changes, this particular study found no evidence of a similar detrimental effect in children.

“Fortunately, our study did not find a relation between neuro-degeneration and anesthesia in young children. The findings should help reassure parents that if their child needs to undergo surgery, a minimal amount of anesthesia does not appear to influence subsequent education achievements later in life,” said Dr. Tom G. Hansen, in a press release. “However, we cannot fully conclude that anesthetics are safe in all cases. More human data need to be collected to exclude effects in more particular domains of neurobehavioral outcome.”

Investigators compared the academic performance of all Danish children born between 1986-1990 who underwent inguinal hernia repair prior to one year of age (2,689 individuals) to a randomly selected sample of 5 percent of the remaining Danish children of the same age (14,575 individuals).

Primary analysis compared the average test scores of participants in adolescence during the ninth grade, adjusting for gender, birth weight, and parents’ age and education, as well as the presence of other congenital malformations.

The study found there was no statistically significant difference in academic performance between the hernia group and the general population sample. Results showed the majority of children who underwent hernia repair in infancy did not show any signs of neurological impairment in adolescence.

“Dr. Hansen’s study is very timely with the recent U.S. Food and Drug Administration’s Anesthetic and Life Support Drugs Advisory Committee meeting,” said Anesthesiology Editor-in-Chief Dr. James C. Eisenach.  “The meeting determined that anesthesiologists must continue to actively pursue investigation in this area of research to fully evaluate potential developmental and behavioral changes in children exposed to anesthesia.”

The results of the study are published in the May issue of Anesthesiology.

For more on child medical issues, see the library of articles by Daytona Beach child injury attorney.

While the length of hospital stay has decreased for patients undergoing hip replacement surgery, a new study shows an increase in the rates of readmission to the hospital and discharge to skilled care facilities.

Average hospital stays after total hip arthroplasty (replacement) has gone from 9 days in 1991 to 3.5 days in 2008, according to analysis of data from Medicare beneficiaries who underwent hip replacement or subsequent follow-up corrective surgery between 1991 and 2008.

That’s both good and bad news for hip replacement patients.

“The good news is you don’t have to stay in the hospital to recover,” said Dr. Peter Cram,  of the University of Iowa’s Roy J. and Lucille A. Carver College of Medicine and lead researcher on the study, in a press release. “The bad news is that you’re not in the hospital while you’re recovering.”

Total hip arthroplasty is a safe and effective therapy for patients with advanced degenerative joint disease. In recent years, there has been a dramatic increase in performance of this procedure both in the United States and abroad.

There is a general assumption that increasing experience with total hip arthroplasty has resulted in improvements in patient outcomes, as has been observed in other procedures, but rigorous empirical data documenting such improvement are limited. This lack of data are striking given that an estimated 280,000 total hip arthroplasty procedures are performed annually at a cost of more than $12 billion, according to background information in the article.

Cram and Yue Li, associate professor of internal medicine at the UI Carver College of Medicine, evaluated the long-term trends in the outcomes of Medicare beneficiaries undergoing primary hip replacement and follow-up corrective surgery and to explore whether reductions in hospital length of stay (LOS) might be associated with increased discharge of patients to postacute care settings, increased readmission rates, or a combination of both outcomes.

The study included data from between 1991 and 2008 on 1,453,493 Medicare Part A beneficiaries who underwent primary total hip arthroplasty and 348,596 who underwent revision total hip arthroplasty.

“In an analysis of 1991-2008 Medicare administrative data, 3 trends were identified. First, we found that despite increasing patient complexity, both unadjusted and adjusted mortality for primary total hip arthroplasty showed substantial improvement over time,” the authors note in the study. “Conversely, our second finding was that for revision total hip arthroplasty, unadjusted mortality appeared to increase modestly but this increase was largely explained by increasing patient complexity. Third and most importantly, marked declines in hospital LOS for both primary and revision total hip arthroplasty seemed to correspond with an increase in the proportion of patients who were discharged to postacute care and an increase in patient readmissions.”

For primary total hip arthroplasty, average hospital LOS decreased from 9.1 days to 3.7 days. After adjustment for patient characteristics, risk-adjusted 30-day mortality over the study period decreased from 0.7 percent to 0.3 percent and 90-day mortality decreased from 1.3 percent to 0.7 percent.

“What we found is that patients are staying in the hospital a much shorter amount of time, patient mortality is increasingly low, but an increasing number of patients are requiring readmission 30 to 90 days after their initial surgery,” Cram said.

The researchers also found that the proportion of primary total hip arthroplasty patients discharged to home decreased from 68 percent in 1991-1992 to 48.2 percent in 2007-2008, while the proportion of patients discharged to skilled or intermediate care increased from 17.8 percent to 34.3 percent. The 30-day all-cause readmission rate decreased from 5.9 percent in 1991-1992 to 4.6 percent in 2001-2002, before increasing to 8.5 percent in 2007-2008. Results were similar for 90-day readmission rates.

“For revision total hip arthroplasty, similar trends were observed in hospital LOS, in-hospital mortality, discharge disposition, and hospital readmission rates,” the authors write.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

Consider the scenario where your doctor has just given you a serious diagnosis or told you he had concerns about your results from a recent medical test.

Carefully listening to your doctor and asking questions about a diagnosis or test results are very important. But just when you should be paying close attention to what your doctor is saying, you may be shocked by the news.

That’s when having a health or patient advocate can help, according to Dr. Carolyn Clancy, director of the U.S. Agency for Healthcare Research and Quality, AHRQ.

A health advocate can be a family member, friend, trusted coworker, or a hired professional who accompanies you to your appointments and asks questions, writes down information, and speaks up for you so you can better understand your illness and get the care you need.

Research shows that quality health care requires taking an active role in decisions about your care. If you’re facing a difficult medical decision, it’s a good idea to bring someone with you who can help focus on your care when you’re not fully up to it.

In a survey of more than 12,000 Medicare beneficiaries, all age 65 or older, researchers found that more than a third of those surveyed reported that they were usually accompanied on visits to their doctors, most often by spouses or adult children, but frequently by other relatives, friends or neighbors.

A notable finding of the study was that the older people who regularly had companions with them stated they liked their doctors more and were more satisfied with the care they received than those who went alone. The companions’ usefulness was most beneficial for people who were especially vulnerable—those who were older, sicker or less educated than the others.

A health advocate can:

• Ask your doctor questions for you.
• Compile or update your medicine list.
• Help you follow your medication regimen and treatment instructions, including asking questions about follow-up care.
• Help arrange transportation.
• Research treatment options, procedures, doctors, and hospitals.
• File paperwork or assist with insurance matters.

Who makes a good health advocate?
A health advocate should be a person who is calm, pays attention to details, and can ask questions and state information clearly. If possible, choose someone who knows you well. Be clear about what kind of help you need and what worries you.

Some professional advocates specialize in researching the best available treatments and can assist you at home or in the hospital. Check to see if your health insurance covers these services.

You can also ask your local hospital staff to recommend a patient advocate. In fact, some hospitals and nursing homes employ advocates who work on patients’ behalf at no charge.

For more on patient safety issues, see the library or articles by Daytona Beach personal injury lawyer.

Surgery can improve eye comfort and quality of life for people with facial paralysis who can’t completely close their eyes, according to a small, new study.

The inability to close the eye can be a devastating result of facial paralysis.

“The resulting loss of corneal protection can lead to exposure keratitis [inflammation of the cornea], corneal ulceration, and potentially permanently vision loss,” said Dr. Douglas K. Henstrom, of Harvard Medical School, Massachusetts Eye and Ear Infirmary, in a press release. “Eyelid weight placement, lower eyelid suspension, and brow ptosis [drooping or sagging of the eyelid] correction are frequently performed to protect the eye.”

Henstrom and colleagues measured and reported the change in quality of life (QOL) after surgery.

The researchers used the Facial Clinimetric Evaluation (FaCE) scale — a patient-based system that measures impairment and disability in facial paralysis and represents a valuable adjunct to traditional physician-graded scales for evaluating QOL issues in patients affected by facial paralysis.

From March 2009 to May 2010, 49 patients with paralytic inability to completely close the eye were treated at the Facial Nerve Center at Massachusetts Eye and Ear Infirmary, Boston. Thirty-seven of the patients completed preoperative and postoperative FaCE surveys.

“Overall QOL, measured by the FaCE instrument, significantly improved following static periocular treatment,” the authors report. “Mean FaCE scores increased from 44.1 to 52.7.”

“Patients also reported a significant decrease in the amount of time their eye felt dry, irritated, or scratchy,” the authors write in the study, published in the March issue of Archives of Facial Plastic Surgery.

Two patients experienced localized cellulitis (a bacterial infection of the skin and tissues beneath the skin) in reaction to the eyelid weight. There was one eyelid weight extrusion.

“In the overall treatment paradigm for patients with facial paralysis, treating the eye using this modality is simple, and not only improves corneal protection but also yields a significant subjective benefit,” the authors conclude.

For more on medical issues, see the library of articles by Daytona Beach personal injury attorney.

Patients who have had a gastric bypass operation take longer to process alcohol, which could lead some to overindulge when drinking.

That is the finding of a new study in the February issue of the “Journal of the American College of Surgeons.”

The results of this unique demonstration of alcohol metabolism changes in gastric bypass patients showed that patients who underwent a Roux-en-Y gastric bypass (RYGB) operation had considerably higher breath alcohol content (BAC) and took significantly more time to return to a sober state after drinking, compared with BAC levels tested prior to having their procedure.

Previous studies have shown that gastric bypass patients often find it difficult adjusting to physical and psychological changes after the procedure. An increased risk of depression, alcoholism, and other substance abuse issues for this patient population led researchers to take a more in-depth look at how these patients metabolize alcohol after the procedure.

“Severe obesity continues to be a public health crisis in the U.S., and bariatric surgery offers a very effective treatment,” said senior author Dr. John M. Morton, associate professor of surgery at Stanford (CA) University, in a press release. “Despite its benefits, we want to raise the potential concern for RYGB patients who continue to drink after their operation because they may tend to overuse alcohol, which can, in turn, lead to weight regain, nutritional deficiencies, and/or alcohol dependence.”

During the study, alcohol metabolism tests were performed on 19 morbidly obese patients before their RYGB operation and then measured again at three and six months post-operation. Patients also reported symptoms experienced when drinking and answered a questionnaire about their drinking habits.

The results showed peak BAC percentage of patients after drinking five ounces of red wine was significantly higher post-operation. BAC was 0.024 percent at pre-operation and 0.059 percent at three months. Tested again at six months post-operation, the patients’ BAC was 0.088 percent which is more than the legal driving limit of .08 percent. Additionally, it took 49 minutes for patients to reach a zero BAC prior to their operation compared with 61 minutes at three months and 88 minutes at six months post-operation.

In other studies, researchers have found that a few gastric bypass patients undergo an addiction transfer where they trade one vice, such as overeating, for another, like over consumption of alcohol or drug use. Additionally, patients who display binge eating behavior prior to their operation have the highest likelihood of postoperative alcoholism.

“RYGB patients need to understand that their body will respond to alcohol differently after their operation and they need to exercise caution if they choose to drink alcohol,” said Dr. Morton. “Our recommendation to all of our RYGB patients is never drink and drive and to limit consumption of alcohol to one standard drink (one 12-oz beer, 5-oz wine, or 2-oz liquor) for every two hours. The key to safeguarding bariatric surgery benefits is to provide appropriate patient education.”

For more on medical safety issues, see the library of articles by Daytona Beach personal injury lawyer.

The U.S. Food and Drug Administration has taken action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.

“Removing these unapproved products from the market will reduce potential risks to consumers,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release.  “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products.”

Companies that have previously listed products subject this recent action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days.  Companies that have not previously listed products subject to this action are expected to stop manufacturing and shipping their products immediately.

Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk.

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

This is the 17th action on a drug class as part of FDA’s Unapproved Drugs Initiative1, which began in June 2006.  The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch2 or by calling 800-332-1088.

For more on patient safety, see the library of articles by Daytona Beach personal injury attorney.