Archive for January 4th, 2011

CDC: Updated Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2010-2011 Season

by Paul Rega, MD — published on January 4th, 2011

 

http://www.cdc.gov/flu/professionals/antivirals/avrec_ob2011.htm?s_cid=ccu010311_007

Updated Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2010-2011 Season

December 29, 2010

These recommendations provide guidance for obstetric health care providers in prescribing antiviral medications for treatment and prevention of influenza during the 2010-2011 season. These recommendations are consistent with current recommendations for antiviral treatment from the Advisory Committee on Immunization Practices. In addition, CDC convened a meeting of experts on August 12-13, 2010, to review the evidence and provide input on treatment and prevention of influenza during pregnancy. Experts in the fields of influenza, obstetrics, pediatrics, pharmacy, teratology, maternal-fetal medicine, preventive medicine, public health, emergency response, and others participated in the meeting. Data from the 2009-2010 influenza season showed that women who were treated early with antiviral medications were less likely to be admitted to an intensive care unit and less likely to die (Siston et al., 2010; Louie et al., 2010). In addition, available data suggest that neuraminidase inhibitors (oseltamivir and zanamavir) are not teratogenic (Rasmussen et al., 2009; Tanaka et al., 2009; Greer et al., 2010). These treatment recommendations will be updated as needed.

Treatment

  • Pregnant women are at higher risk for severe complications and death from influenza. Changes in the immune, respiratory, and cardiovascular systems that occur during pregnancy result in pregnant women being more severely affected by certain pathogens, including influenza.
  • Postpartum women, who are in transition to normal immune, cardiac, and respiratory function, should be considered to be at increased risk of influenza-related complications up to 2 weeks postpartum (including following pregnancy loss).
  • Treatment with antiviral medications is recommended for pregnant women or women who are up to 2 weeks postpartum (including following pregnancy loss) with suspected or confirmed influenza and can be taken during any trimester of pregnancy.
  • For treatment of pregnant women or women who are up to 2 weeks postpartum with suspected or confirmed influenza, oseltamivir is currently preferred. The duration of antiviral treatment is 5 days. See Table 1 (below) for dosing information.
  • Hospitalized patients with severe infections (such as those with prolonged infection or who require intensive care unit admission) might require longer treatment courses. Some experts have advocated use of increased (doubled) doses of oseltamivir for some severely ill patients, although there are no published data demonstrating that higher doses are more effective.
  • Oseltamivir and zanamivir are antiviral medications that are FDA approved for treatment of influenza. Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. These medications are “Pregnancy Category CExternal Web Site Icon ” medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. However, the available risk-benefit data indicate that pregnant women with suspected or confirmed influenza should receive prompt antiviral therapy.
  • Treatment should be initiated as early as possible because studies show that treatment initiated early (i.e., within 48 hours of illness onset) is more likely to provide benefit. However, some studies of hospitalized patients with influenza, including an analysis of hospitalized pregnant women, have suggested benefit of antiviral treatment even when treatment was started more than 48 hours after illness onset.
  • Treatment should not wait for laboratory confirmation of influenza because laboratory testing can delay treatment and because a negative rapid test for influenza does not rule out influenza. Pregnant women are considered to be at higher risk of influenza complications by the Advisory Committee on Immunization Practices, and thus, empiric treatment is recommended. Treatment decisions, especially those involving empiric treatments, should be informed by knowledge of influenza activity in the community.
  • At this time, nearly all influenza viruses are susceptible to oseltamivir and zanamivir. However, antiviral treatment regimens might change depending on new antiviral resistance or viral surveillance information.
  • Since rapid access to antiviral medications is important, health care providers who care for pregnant and postpartum (including following pregnancy loss) women should develop methods to ensure that treatment can be started quickly after symptom onset. Actions that will support early treatment initiation include:
    • Informing pregnant and postpartum (including following pregnancy loss) women of signs and symptoms of influenza and the need for early treatment after onset of symptoms. Typical manifestations of influenza include fever, cough, rhinorrhea, sore throat, headache, shortness of breath, and myalgia. Some patients with influenza have vomiting, diarrhea, or conjunctivitis, and some have respiratory symptoms without fever.
    • Ensuring rapid access to telephone consultation and clinical evaluation for pregnant and postpartum (including following pregnancy loss) women
    • Considering empiric treatment of pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) based on telephone contact if hospitalization is not indicated and if this will substantially reduce delay before treatment is initiated
  • Fever in pregnant women should be treated because of the risk that it appears to pose to the fetus. Acetaminophen appears to be the best option for treatment of fever during pregnancy.

Chemoprophylaxis

  • Post-exposure antiviral chemoprophylaxis can be considered for pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) who have had close contact with someone likely to have been infectious with influenza. Close contact, for the purposes of this document, is defined as having cared for or lived with a person who has confirmed, probable, or suspected influenza, or having been in a setting where there was a high likelihood of contact with respiratory droplets and/or body fluids of such a person, including having talked face-to-face with a person with suspected or confirmed influenza illness.
  • The drug of choice for chemoprophylaxis of pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) is less clear. Zanamivir may be the preferable antiviral for chemoprophylaxis of pregnant women because of its limited systemic absorption. However, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems. For these women, oseltamivir is a reasonable alternative. The duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure. See Table 1 (below) for dosing information.
  • Early treatment is an alternative to chemoprophylaxis for some pregnant and postpartum (including following pregnancy loss) women who have had contact with someone likely to have been infectious with influenza. Clinical judgment is an important factor in treatment decisions. Pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) who are given post-exposure chemoprophylaxis should be informed that the chemoprophylaxis lowers but does not eliminate the risk of influenza and that protection stops when the medication course is stopped. Those receiving chemoprophylaxis should be encouraged to seek medical evaluation as soon as they develop a febrile respiratory illness that might indicate influenza.
  • All pregnant women should be counseled about the early signs and symptoms of influenza infection and advised to immediately call for evaluation if clinical signs or symptoms develop while these women are pregnant or are in the first two weeks after delivery or pregnancy loss.

Table 1. Antiviral medication dosing recommendations for treatment or chemoprophylaxis of influenza infection
(Table extracted from IDSA guidelines for seasonal influenza .)
Agent, group Treatment Chemoprophylaxis
Oseltamivir
Adults 75-mg capsule twice daily for 5 days 75-mg capsule once daily for 10 days
Zanamivir
Adults 10 mg (2 inhalations) twice daily for 5 days 10 mg (2 inhalations) once daily for 10 days

References:

Greer LG, Sheffield JS, Rogers VL, Roberts SW, McIntire DD, Wendel GD, Jr. Maternal and neonatal outcomes after antepartum treatment of influenza with antiviral medications. Obstet Gynecol 2010;115:711-6.

Louie JK, Acosta M, Jamieson DJ, Honein MA. Severe 2009 H1N1 influenza in pregnant and postpartum women in California. N Engl J Med 2010;362:27-35.

Rasmussen SA, Jamieson DJ, MacFarlane K, et al. Pandemic influenza and pregnant women: Summary of a meeting of experts. Am J Public Health 2009;99 S248-54.

Siston AM, Rasmussen SA, Honein MA, et al. Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA 2010;303:1517-25.

Tanaka T, Nakajima K, Murashima A, Garcia-Bournissen F, Koren G, Ito S. Safety of neuraminidase inhibitors against novel influenza A (H1N1) in pregnant and breastfeeding women. CMAJ 2009;181:55-8.

Comments Off
categories: Emergency Medicine

US: Nonfatal, Motor Vehicle–Occupant Injuries (2009) and Seat Belt Use (2008) Among Adults

by Paul Rega, MD — published on January 4th, 2011

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0104a1.htm?s_cid=mm59e0104a1_e&source=govdelivery

Vital Signs: Nonfatal, Motor Vehicle–Occupant Injuries (2009) and Seat Belt Use (2008) Among Adults — United States

Early Release

January 4, 2011 / 59(Early Release);1-6

ABSTRACT

Background: Motor vehicle crashes are the leading cause of death in the United States among persons aged 5–34 years. Seat belts have been shown to be the most effective method for reducing injuries among adults in the event of a crash.

Methods: CDC used 2009 data from the National Electronic Injury Surveillance System–All Injury Program (NEISS-AIP) to provide U.S. estimates of the number and rate of nonfatal, motor vehicle–occupant injuries treated in emergency departments among adults aged ≥18 years. In addition, CDC used 2008 data from the Behavioral Risk Factor Surveillance System (BRFSS) to estimate the prevalence of self-reported seat belt use among adults in the United States. Seat belt use was examined further by type of state seat belt enforcement law.

Results: In 2009 in the United States, an estimated 2.3 million adult motor vehicle–occupants had nonfatal injuries treated in emergency departments. The nonfatal, motor vehicle–occupant injury rate declined 15.6% from 1,193.8 per 100,000 population in 2001 to 1,007.5 per 100,000 population in 2009. In 2008, self-reported seat belt use was higher in states with primary enforcement laws (88.2%), compared with states with secondary enforcement laws (79.2%). If the secondary law states had achieved 88.2% seat belt use in 2008, an additional 7.3 million adults would have been belted. From 2002 to 2008, self-reported seat belt use increased overall from 80.5% to 85.0%.

Conclusions: Nonfatal, motor vehicle–occupant injuries treated in emergency departments have declined in recent years but still affect a substantial proportion of the adult U.S. population each year. Self-reported belt use increased from 2002 to 2008, and was higher in states with primary enforcement laws compared with states with secondary enforcement laws.

Implications for Public Health Practice: Seat belt use is a proven method to reduce motor vehicle–occupant injuries, and the results of this analysis demonstrate that states with primary enforcement laws have higher prevalence of self-reported seat belt use. To help reduce the number of motor vehicle–occupant injuries, 19 states without primary enforcement laws should consider enacting them.

Introduction

In addition to being the leading cause of death among U.S. residents aged 5–34 years, motor vehicle–occupant injuries account for approximately 15% of all nonfatal injuries treated in U.S. emergency departments (1). In 2005, the lifetime costs of fatal and nonfatal motor vehicle–occupant injuries were estimated at approximately $70 billion, including costs for medical care, treatment, rehabilitation, and lost productivity (2). Motor vehicles account for approximately 90% of all trips taken in the United States, and the vast majority of persons killed and injured while traveling are occupants of motor vehicles (3). Seat belts, which reduce the risk for fatal injuries from motor vehicle crashes by approximately 45% and serious injuries by approximately 50% (4), are the most effective intervention for protecting motor vehicle occupants (5). Primary seat belt enforcement laws and enhanced enforcement of such laws have been shown to increase the use of seat belts and reduce death rates (6).

For this report, CDC used 2009 data from NEISS-AIP to provide estimates of the number and rate of nonfatal, motor vehicle–occupant injuries treated in emergency departments among adults aged ≥18 years. CDC also used 2008 BRFSS to analyze state-level information regarding self-reported seat belt use. In addition, trends in motor vehicle–occupant injuries and seat belt use were examined over time.

Methods

NEISS-AIP is a collaborative effort of CDC and the Consumer Product Safety Commission, and an extension of the National Electronic Injury Surveillance System (NEISS), which collects detailed data abstracted from medical records of initial emergency department visits for all types and causes of nonfatal injuries and poisonings treated in the United States. NEISS-AIP data are a nationally representative, stratified probability sample taken annually from approximately 66 hospitals with at least six beds and 24-hour emergency department services.

NEISS-AIP data were accessed via CDC’s Web-based Injury Statistics Query and Reporting System (WISQARS) online database, which provides customized reports of injury data (1). Motor vehicle–occupant injuries among adults aged ≥18 years were examined for the period 2001–2009. Nonfatal injury rates were calculated for adult motor vehicle occupants by age group and sex. Bridged race postcensal population estimates from the U.S. Census Bureau were used to calculate injury rates. All injury rates were age-adjusted to the 2000 standard U.S. population. A weighted linear regression was used to analyze the trend in occupant injury rates over time.

BRFSS is an ongoing, state-based, random-digit–dialed telephone survey that collects self-reported data on health-related behaviors and conditions. Data are collected from noninstitutionalized, civilian adults aged ≥18 years in all 50 states, the District of Columbia (DC), and three territories (Guam, Puerto Rico, and U.S. Virgin Islands). In 2008, the median Council of American Survey Research Organizations (CASRO) response rate among states was 53%.

One question on seat belt use is included periodically on the BRFSS survey of each state. Participants are asked “How often do you use seat belts when you drive or ride in a car? Would you say: always, nearly always, sometimes, seldom, never, or don’t know?” For this analysis, only those who responded “always” were categorized as seat belt users. Data were examined for the most recent years available: 2002, 2006, and 2008. The prevalence of always wearing seat belts in 2008 was stratified by type of state seat belt enforcement law (primary or secondary) and reported by sex, age group, race/ethnicity, education level, household income, and residential area. Primary enforcement laws allow police officers to stop drivers and issue tickets solely because occupants are unbelted. Secondary enforcement laws only allow police officers to issue tickets for seat belt violations if drivers have been stopped for violating some other law. In 2008, 26 states, DC, and the three territories had primary laws, 23 states had secondary laws, and one state (New Hampshire) had no seat belt law (7).* For this analysis, New Hampshire was grouped with the secondary law states. The t-test was used to determine the trend in seat belt use during 2002–2008.

Results

In 2009, an estimated 2,317,000 nonfatal, motor vehicle–occupant injuries occurred among adults in the United States. The motor vehicle–occupant age-adjusted injury rate was highest among persons aged 18–24 years (1,939.2 per 100,000 population), followed by persons aged 25–34 years (1,322.4) (Table 1). From 2001 to 2009, the injury rate declined 15.6% (p<0.001) from 1,193.8 injuries per 100,000 population to 1,007.5 (Figure); this decline represents an estimated 231,000 fewer injuries in 2009 compared with 2001. During the same period, the injury rate also declined for men, from 1,137.5 per 100,000 population in 2001 to 906.6 in 2009 (p<0.001) and for women, from 1,246.9 in 2001 to 1,104.2 in 2009 (p<0.001).

In 2008, the overall prevalence of self-reported seat belt use in the United States was 85.0%, a 5.6% increase from 80.5% in 2002 (p<0.001). Significant increases in seat belt use from 2002 were observed both in states with primary enforcement laws (p<0.001) and states with secondary enforcement laws (p<0.001). In 2008, among states, self-reported seat belt use ranged from 59.2% (North Dakota) to 93.7% (Oregon) (Table 2). In 2008, seven states and territories had ≥90% prevalence of seat belt use (Table 2). After Oregon, the highest prevalence of self-reported seat belt use was in California (93.2%), Washington (92.0%), Hawaii (91.4%), Texas (91.1%), Puerto Rico (91.1%), and New Jersey (90.3%) (Table 2). Overall, the prevalence of self-reported seat belt use in states with primary enforcement laws was 88.2%, compared with 79.2% for states with secondary enforcement laws (Table 2). If the states with secondary laws had achieved 88.2% seat belt use in 2008, an additional 7,345,000 adults would have been belted. Although the states with secondary laws represented 35% of the total U.S. adult population, 49% of unbelted adults lived in these states.

Persons in certain sociodemographic categories were less likely to report seat belt use than others, such as men (compared with women), persons aged 18–24 years (compared with all other age groups), residents of rural areas (compared with urban or suburban areas), and whites, blacks, and American Indian/Alaska Natives (compared with Hispanics or Asians/Hawaiian or Pacific Islanders) (Table 3). However, for every sociodemographic category examined, prevalence of self-reported seat belt use was higher among residents of states with primary enforcement laws, compared with residents of states with secondary enforcement laws (Table 3).

Conclusions and Comment

Self-reported seat belt use has continued to increase, reaching a high of 85.0% in 2008, until it is now the social norm among residents of the United States. In contrast, in 1982, only 11% of U.S. residents reported seat belt use (8), and the first state law mandating seat belt use was not passed until 1984. Despite the upward trend, the overall prevalence of self-reported seat belt use among residents of states with secondary enforcement laws trails that among residents of states with primary enforcement laws (79.2% versus 88.2%). If the overall prevalence of seat belt use in states with secondary enforcement laws had matched the higher prevalence in states with primary enforcement laws, an additional 7.3 million adults would have reported seat belt use in 2008. Further, a disproportionate number of adults who did not report seat belt use (49%) lived in states with secondary enforcement laws, which made up 35% of the total U.S. adult population. The higher levels of seat belt use associated with primary enforcement laws have been demonstrated to reduce serious injuries and deaths (6).

This analysis shows that persons in certain sociodemographic categories are less likely than others to use seat belts (e.g., men, young adults, residents of rural areas, and certain racial/ethnic populations). However, even among these persons, self-reported seat belt use was higher among those in states with primary laws. This finding supports previous research that showed that primary enforcement laws can increase seat belt use, even among those persons less likely to use seat belts and more likely to be killed in motor vehicle crashes (9).

From 2001 to 2009, a period during which 14 additional states passed primary seat belt laws, the nonfatal, motor vehicle–occupant injury rate declined. Motor vehicle–occupant fatality rates also declined during this period (10). The results of this report indicate that rates of nonfatal injury declined with age, a finding consistent with earlier findings that drivers aged 16–24 years had the highest rates of crash-related injury and death (10). This report found no significant difference in the nonfatal, motor vehicle–occupant injury rates for men and women. However, crash-related injuries sustained by men tend to be more severe than those for women, leading to a higher case-fatality rate for men (11).

Increases in seat belt use likely have contributed to the observed declines in motor vehicle–occupant injuries. Seat belt use reduces the likelihood of serious injury in a crash by approximately 50% (4). The National Highway Traffic Safety Administration (NHTSA) investigated the long-term trend of declining nonfatal traffic injuries and found that increases in seat belt use were a major factor in the reduction in injuries (12). Other contributing factors included declines in alcohol-impaired driving and improvements in vehicle safety (e.g., air bags and electronic stability control) (12). NHTSA estimates that, in 2009, nearly 450 additional lives would have been saved, 12,000 nonfatal injuries prevented, and $1.6 billion in societal costs saved if all states had primary seat belt enforcement laws (NHTSA, 2009, unpublished data). Many high-income countries in Europe have achieved high levels of seat belt use with primary enforcement laws that cover all vehicle occupants. Front-seat estimates of seat belt use are >90% in France (98%), Sweden (96%), Germany (95%), Netherlands (94%), Norway (93%), and United Kingdom (91%)] (13). Notably, the traffic fatality rate per 100,000 population in the United States is nearly double that of 21 selected European high-income countries (13).

Primary enforcement laws are strongly recommended by the U.S. Task Force on Community Preventive Services to increase seat belt use (6). Other components of seat belt laws also can increase seat belt use. Enhanced enforcement of seat belt laws has been shown to increase seat belt use and reduce injuries and fatalities (6). In addition, NHTSA has estimated that the prevalence of seat belt use in rear seats is nearly 20 percentage points higher in states with laws requiring belt use in all seating positions versus states with laws requiring belt use only in the front seating positions (14).

The findings in this report are subject to at least six limitations. First, NEISS-AIP provides data at the national level but prevents examination of injury estimates by state. The injury estimates reported likely are underestimates of all nonfatal motor vehicle–occupant injuries because NEISS-AIP does not include physician offices, clinics, urgent-care facilities, or any medical facilities other than hospital emergency departments. Additionally, NEISS-AIP does not collect factors that might relate to the injuries, such as seating position, seat belt use, air bag deployment, or whether injuries occurred in states with primary or secondary enforcement laws. Second, 2008 BRFSS was a landline telephone survey, and as such, excluded a small percentage of households with no telephone and approximately 15% of households with wireless telephones only. Third, the BRFSS response rate was only 53%. Fourth, the BRFSS data are self-reported; however, a recent evaluation of self-reported data on seat belt use found little evidence of overestimation of use because of social desirability bias (15). Fifth, the analysis did not consider other components of enforcement laws that might affect seat belt use (e.g., amount of fine, whether all occupants or only those in the front seat are covered, and the length of time law has been in effect). Finally, the data presented from both surveillance systems are cross-sectional and cannot be used to assess causality regarding seat belt enforcement laws, seat belt use, and nonfatal injuries.

To reduce the number of crash-related injuries, all motor vehicle occupants should wear seat belts (or age-appropriate and size-appropriate restraints for children) on every trip. Although primary enforcement laws are a proven strategy for increasing seat belt use and reducing the number of injuries, as of January 2011, 19 states still do not have such laws in effect. States should consider enacting primary enforcement seat belt laws that are vigorously enforced and that cover all motor vehicle occupants of appropriate age and size, regardless of seating position in the vehicle (6,14).

Reported by

LF Beck, MPH, BA West, MPH, Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC.

 

References

  1. CDC. WISQARS (Web-based Injury Statistics Query and Reporting System). Atlanta, GA: US Department of Health and Human Services, CDC; 2010. Available at http://www.cdc.gov/injury/wisqars. Accessed October 12, 2010.
  2. Naumann RB, Dellinger AM, Zaloshnja E, Lawrence BA, Miller TR. Incidence and total lifetime costs of motor vehicle-related fatal and nonfatal injury by road user type, United States, 2005. Traffic Inj Prev 2010;11:353–60.
  3. Beck LF, Dellinger AM, O’Neil ME. Motor vehicle crash injury rates by mode of travel, United States: using exposure-based methods to quantify differences. Am J Epidemiol 2007;166:212–8.
  4. National Highway Traffic Safety Administration. Final regulatory impact analysis amendment to Federal Motor Vehicle Safety Standard 208. Passenger car front seat occupant protection. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 1984. Publication no. DOT-HS-806-572. Available at http://www-nrd.nhtsa.dot.gov/pubs/806572.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  5. National Highway Traffic Safety Administration. Lives saved in 2009 by restraint use and minimum-drinking-age laws. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2010. Publication no. DOT-HS-811-383. Available at http://www-nrd.nhtsa.dot.gov/pubs/811383.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  6. Dinh-Zarr TB, Sleet DA, Shults RA, et al. Reviews of evidence regarding interventions to increase the use of safety belts. Am J Prev Med 2001;21(4 Suppl):48–65.
  7. Insurance Institute for Highway Safety. Safety belt use laws. Arlington, VA: Insurance Institute for Highway Safety; 2010. Available at http://www.iihs.org/laws/safetybeltuse.aspxExternal Web Site Icon. Accessed December 13, 2010.
  8. Williams AF, Wells JK. The role of enforcement programs in increasing seat belt use. J Safety Res 2004;35:175–80.
  9. Beck LF, Shults RA, Mack K, Ryan G. Associations between sociodemographics and safety belt use in states with and without primary enforcement laws. Am J Public Health 2007;97:1619–24.
  10. National Highway Traffic Safety Administration. Traffic safety facts 2008. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2009. Publication no. DOT-HS-811-170. Available at http://www-nrd.nhtsa.dot.gov/pubs/811170.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  11. CDC. Surveillance for fatal and nonfatal injuries—United States, 2001. MMWR 2004;53(No. SS-7).
  12. National Highway Traffic Safety Administration. Trends in non-fatal traffic injuries: 1996–2005. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2008. Publication no. DOT-HS-810-944. Available at http://www-nrd.nhtsa.dot.gov/pubs/810944.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  13. World Health Organization. Global status report on road safety: time for action. Geneva: World Health Organization, 2009. Available at: http://www.who.int/violence_injury_prevention/road_safety_status/2009External Web Site Icon.
  14. National Highway Traffic Safety Administration. Seat belt use in rear seats in 2008. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2009. Publication no. DOT-HS-811-133. Available at http://www-nrd.nhtsa.dot.gov/pubs/811133.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  15. Ibrahimova A. Have self-reported and observed seatbelt use in the United States converged? Presented at the 59th Annual Epidemic Intelligence Service Conference, April 19–23, 2010, Atlanta, GA.

* Arkansas, Florida, Kansas, Minnesota, and Wisconsin subsequently passed primary enforcement laws in 2009 or 2010.

Comments Off
categories: Emergency Medicine

Food Safety Modernization Act: Feds’ Q & A, but no one asks how much it will cost each of us….

by Paul Rega, MD — published on January 4th, 2011

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm238506.htm

Questions and Answers on the Food Safety Modernization Act

 

How big a problem is foodborne illness in this country?

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.  This is a significant public health burden that is largely preventable.

Why is this law needed? 

Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in our approach to food safety.  For example, for the first time, FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain.  Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring.  The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year. 

 

What are the major elements of the law? 

The elements can be divided into five key areas:  

  • Preventive controls- For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.  [Or, we could insert the definition of preventive controls here (it comes from the Consumer Update.]  
  • Inspection and Compliance- The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to   produce safe food; thus, the law specifies how often FDA should inspect food producers.  FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches. 
  • Imported Food Safety-   FDA has new tools to ensure that those imported foods meet US standards and are safe for our consumers.   For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards. 
  • Response- For the first time, FDA will have mandatory recall authority for all food products.  FDA expects that it will only need to invoke this authority infrequently since the food industry  largely honors our requests for voluntary recalls. 
  • Enhanced Partnerships- The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals.  For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials. 

How long will it take before our food system is made safer? 

A long-term process will be needed to build a new food safety system based on prevention.  Congress has established specific implementation dates in the legislation.  Some authorities will go into effect quickly, such as mandatory recall authority, and others require FDA to prepare and issue regulations and  guidance documents.  FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.  

 

Does FDA have sufficient funding to implement the new rule? 

The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented. For example, the inspection schedule in the legislation would increase the burden on FDA’s inspection functions. Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals.

 

How will this law make imported food safer? 

U.S. consumers enjoy the benefit of imported foods from more than 150 countries. The Food Safety Modernization Act (FSMA) gives FDA new tools to ensure that those imported foods meet US standards and are safe for US consumers. New authorities under the Act include:

  • importer accountability – importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety 
  • third party certification – FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with US food safety standards;
  • high risk foods – FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country 
  • Additional resources are directed toward foreign inspections 
  • FDA now has the authority to refuse entry into the US of a food that has refused U.S. inspection.

FDA expects to hold briefings on the new legislation for its colleagues in embassies in Washington, and to brief the World Trade Organization on the new legislation.

How does this Act change the way FDA regulates foods? 

This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.  Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required.  FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues.  Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary.

Comments Off
categories: Emergency Medicine