Archive for the 'Emergency Medicine' category

Home Births in the US: Rising or falling?

Home Births in the United States: 1990-2009
After a decline from 1990 to 2004, the percentage of U.S. births that occurred at home increased by 29%, from 0.56% of births in 2004 to 0.72% in 2009.

Cervical Cancer

Cervical Cancer: The Preventable Gynecologic Cancer
Most cases of cervical cancer are easily preventable with regular screening tests and follow-up. It also is highly curable when found and treated early. Now vaccines are available to protect against the most common cause of cervical cancer.

National Wear Red Day®

Wear Red for a Million Hearts
Wear red on February 3, National Wear Red Day®, the first Friday in American Heart Month and learn how to prevent heart disease

Morgellons

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0029908

To Tdap or not to Tdap……

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6103a4.htm?s_cid=mm6103a4_e

Notes from the Field : Use of Tetanus, Diphtheria, and Pertussis Vaccine (Tdap) in an Emergency Department — Arizona, 2009–2010

Weekly

January 27, 2012 / 61(03);55-56Because of an increasing incidence of reported pertussis cases attributed to waning immunity among adults and adolescents, the Advisory Committee on Immunization Practices (ACIP) in 2005 recommended administration of a new, combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) for adolescents and adults aged 11–64 years (1). ACIP recommended that they receive a single dose of Tdap to replace tetanus and diphtheria toxoid vaccine (Td) for booster immunization against tetanus and diphtheria if they had not previously received Tdap. Adults aged ≥65 years were to receive Td according to ACIP recommendations (1). To learn whether these age-specific recommendations were being followed in an emergency department (ED), the charts of a sample of patients receiving tetanus vaccines at a large ED were reviewed.The ED is part of an urban, academic center and has an annual volume of approximately 70,000 patient visits. Patients who received a tetanus booster during September 1, 2009–August 31, 2010, were identified through an inpatient pharmacy database. Orders placed through the computerized physician order entry system were used to determine which form of tetanus vaccine the physician ordered. Nursing documentation was reviewed to determine what vaccine was actually administered because, during the study period, the automated medication dispensary allowed access to both vaccine types when “tetanus” was entered. Records were stratified by month, assigned a random number, randomized by sorting, and then sampled proportional to monthly totals. The proportion of patients receiving the correct vaccine according to ACIP recommendations (Tdap for those aged <65 years and Td for those aged ≥65 years) was calculated.

Of 2,085 tetanus vaccinations administered during the study period, 231 were sampled for study to detect a compliance of 95% (±5%). Of 231 charts reviewed, 19 were excluded because of various deficiencies (mainly missing data). The remaining 212 patients had a median age of 38 years (interquartile range: 24–54 years). Of those 212 patients, 184 (86.8%) were aged <65 years, 145 (68.4%) were male, 75 (35.4%) were trauma patients, and 151 (71.2%) were discharged home from the ED, whereas the remaining 61 (28.8%) were admitted. An emergency physician ordered 185 (87.3%) of the boosters, 170 (80.2%) were given for laceration or abrasion, 22 (10.4%) for a skin infection, and 20 (9.4%) for another indication.

Overall, 75.0% (95% confidence interval [CI] = 69.1%–80.8%) of the patients were managed in accordance with ACIP recommendations (Tdap for patients aged <65 years and Td for patients aged ≥65 years). Among patients aged <65 years, adherence to the ACIP recommendation was 76.1% (CI = 69.9%–82.3%), whereas for those aged ≥65 years, adherence was 67.9% (CI = 49.4%–86.3%). For the 181 patients with both physician orders and nursing documentation, adherence to ACIP guidelines based on nursing documentation was 86.7% (CI = 81.8%–91.7%). For 30 (16.6%) patients, the physician order differed from the vaccine dispensed. Of these, 25 (83.3%) were changed by nursing staff such that the appropriate vaccine (Tdap for those aged <65 years and Td for those aged ≥65 years) was dispensed despite an inappropriate vaccine being ordered. Based on nursing documentation alone, adherence to ACIP guidelines differed significantly by age. Those aged <65 years were appropriately vaccinated with Tdap 89.9% (CI = 85.1%–94.6%) of the time compared with those aged ≥65 years, who were appropriately vaccinated with Td 65.2% (CI = 44.2%–86.3%) of the time.

Overall adherence to ACIP guidelines for proper Tdap and Td administration was 75%. In this study, only patients who received tetanus boosters were studied; thus, data on the number of patients that failed to receive either Tdap or Td when it was indicated for wound management are not available. For patients aged 11–64 years, 76.1% received the ACIP-recommended Tdap vaccine. For adults aged ≥65 years, no licensed Tdap vaccine was available in the United States before 2010. Thus, all patients aged ≥65 years who were given a tetanus booster during the study period should have received Td; however, 32.1% received Tdap in place of the recommended Td. ACIP changed its recommendations in 2010 to recommend that adults aged ≥65 years receive Tdap in place of Td if they are health-care professionals or have close contact with an infant (2). The new guidelines also removed the recommended 2-year interval between tetanus vaccinations; no interval is now required between Td and Tdap vaccination. This study is of a single institution and might not be representative of all EDs. An electronic medical record reminder system for health-care providers might increase adherence to the ACIP guidelines.

References

  1. CDC. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR 2006;55(No. RR-17).
  2. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm
  3. CDC. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR 2011;60:13–5.
  4. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm

MMWR: Gang Homicides

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6103a2.htm?s_cid=mm6103a2_e

Gang Homicides — Five U.S. Cities, 2003–2008

WeeklyJanuary 27, 2012 / 61(03);46-51

 

Gang homicides account for a substantial proportion of homicides among youths in some U.S. cities; however, few surveillance systems collect data with the level of detail necessary to gang homicide prevention strategies. To compare characteristics of gang homicides with nongang homicides, CDC analyzed 2003–2008 data from the National Violent Death Reporting System (NVDRS) for five cities with high levels of gang homicide. This report describes the results of that analysis, which indicated that, consistent with similar previous research, a higher proportion of gang homicides than other homicides involved young adults and adolescents, racial and ethnic minorities, and males. Additionally, the proportion of gang homicides resulting from drug trade/use or with other crimes in progress was consistently low in the five cities, ranging from zero to 25%. Furthermore, this report found that gang homicides were more likely to occur with firearms and in public places, which suggests that gang homicides are quick, retaliatory reactions to ongoing gang-related conflict. These findings provide evidence for the need to prevent gang involvement early in adolescence and to increase youths’ capacity to resolve conflict nonviolently.

NVDRS is an active, state-based surveillance system that collects violent death data from multiple sources, such as death certificates, coroner/medical examiner records, and various law enforcement reports (e.g., police reports and supplementary homicide reports [SHRs]). As of 2008, NVDRS has operated in 17 U.S. states.* This report includes 2003–2008 data from large cities in NVDRS states. Only cities ranked within the 100 largest in the United States were examined because gang problems more frequently occur in large cities (1–2). Cases of gang homicide were defined as homicides reported to have been either precipitated by gang rivalry or activity or perpetrated by a rival gang member on the victim.

Because a city might be served by more than one law enforcement agency and each agency might have its own definition of gang-related crime, this analysis used only data from municipal police departments. Municipal police departments often have a jurisdiction congruent with city limits. Geographic areas matching municipal police jurisdictions were identified by geographic codes (either federal information processing standards or zip codes) for location of injury in NVDRS. U.S. Census Bureau 2000 population estimates were determined for each city using the Law Enforcement Agency Identifiers Crosswalk (3). For each of the 33 eligible large cities, gang homicide counts were averaged for the period 2003–2008 and divided by the population estimates to calculate an average annual gang-related mortality rate. Cities with gang-related mortality rates equal to or greater than one standard deviation above the average were selected for further analyses.

Five cities met the criterion for having a high prevalence of gang homicides: Los Angeles, California; Oklahoma City, Oklahoma; Long Beach, California; Oakland, California; and Newark, New Jersey. In these cities, a total of 856 gang and 2,077 nongang homicides were identified and included in the analyses. Comparisons of the characteristics of gang and nongang homicides were made using Fisher’s exact tests for all the variables except mean age, which required a t-test. The characteristics included basic demographics of the victims, descriptive information on the homicide event, and circumstances precipitating the event.

Gang homicide victims were significantly younger than nongang homicide victims in all five cities (Table 1). Whereas 27%–42% of the gang homicide victims were aged 15–19 years, only 9%–14% of the nongang homicide victims were in this age group. Approximately 80% of all homicide victims were male in each city; however, Los Angeles, Newark, and Oklahoma City still reported significantly higher proportions of male victims in gang homicide incidents compared with nongang homicide incidents. In Los Angeles and Oakland, a significantly higher proportion of gang victims were Hispanic and, in Oklahoma City, a significantly higher proportion of gang victims were non-Hispanic black compared with nongang victims.

In at least three of the five cities, gang homicides were significantly more likely than nongang homicides to occur on a street and involve a firearm (Table 2). More than 90% of gang homicide incidents involved firearms in each city. For nongang homicides, firearms were involved in 57%–86% of the incidents. Gang homicides also were most likely to occur in afternoon/evening hours in the majority of the five cities; however, comparisons were not examined because the data were missing for 23% of nongang homicide incidents. In Los Angeles, Oakland, and Oklahoma City, gang homicides occurred significantly more frequently on weekends than did nongang homicides.

With regard to the circumstances preceding the homicide, drive-by shootings were significantly more likely to contribute to gang homicides than other types of homicide in Los Angeles and Oklahoma City (Table 2). Nearly one quarter of gang homicides in these cities were drive-by shootings, compared with 1%–6% of nongang homicides. A significantly smaller proportion of gang versus nongang homicides were precipitated by another crime in progress in the California cities, ranging from zero to 3% of gang homicides, compared with 9% to 15% of nongang homicides. Further, in Los Angeles and Long Beach, less than 5% of all homicides were associated with known drug trade/use. Although data for Newark and Oklahoma City indicated that 20%–25% of gang homicides involved drug trade/use; Newark was the only city that had a significantly higher proportion of gang versus nongang homicides that involved drug trade/use.

Reported by

Arlen Egley Jr, PhD, National Gang Center, Bur of Justice Assistance and the Office of Juvenile Justice and Delinquency Prevention, US Dept of Justice. J. Logan, PhD, Div of Violence Prevention, National Center for Injury Prevention and Control; Dawn McDaniel, PhD, EIS Officer, CDC. Corresponding contributor: Dawn McDaniel, dawn.mcdaniel@cdc.hhs.gov, 770-488-1593.

Editorial Note

Homicide is the second leading cause of death among persons aged 15–24 years in the United States (4). In some cities, such as Los Angeles and Long Beach, gang homicides account for the majority of homicides in this age group (61% and 69%, respectively). The differences observed in gang versus nongang homicide incidents with regard to victim demographics, place of injury, and the use of drive-by shootings and firearms are consistent with previous reports (5). The finding that gang homicides commonly were not precipitated by drug trade/use or other crimes in progress also is similar to previous research; however, this finding challenges public perceptions on gang homicides (5). The public often has viewed gangs, drug trade/use, crime, and homicides as interconnected factors; however, studies have shown little connection between gang homicides and drug trade/use and crime (5). Gangs and gang members are involved in a variety of high-risk behaviors that sometimes include drug and crime involvement, but gang-related homicides usually are attributed to other circumstances (6). Newark was an exception by having a higher proportion of gang homicides being drug-related. A possible explanation of this divergent finding could be that Newark is experiencing homicides by gangs formed specifically for drug trade. Overall, these findings support a view of gang homicides as retaliatory violence. These incidents most often result when contentious gang members pass each other in public places and a conflict quickly escalates into homicide with the use of firearms and drive-by shootings.

The findings in this report are subject to at least two limitations. First, the accuracy of gang homicide estimates in NVDRS and other surveillance systems is unknown. As a point of reference, CDC compared NVDRS’s gang homicide counts to another independent surveillance system, the National Youth Gang Survey (NYGS). NYGS§ is a nationally representative annual survey of law enforcement agencies, including all large cities (2). Most cities included in this report also had high gang-related mortality rates in NYGS (Figure). Second, the gang homicide case definition can vary by law enforcement agency, which might introduce a misclassification bias. For instance, organized crime gangs, although distinct from youth street gangs are included in some but not all definitions of gang homicide. In addition, some agencies report according to a gang member–based definition (i.e., homicides involving a gang member) whereas others report according to a gang motive–based definition (i.e., the homicide further the goals of a gang) (7).

In conclusion, gang homicides are unique violent events that require prevention strategies aimed specifically at gang processes. Preventing gang joining and increasing youths’ capacity to resolve conflict nonviolently might reduce gang homicides (8). Rigorous evaluation of gang violence prevention programs is limited; however, many promising programs exist (9). In terms of primary prevention, the Prevention Treatment Program, which includes child training in prosocial skills and self-control, has shown reductions in gang affiliation among youths aged 15 years (10). Secondary prevention programs that intervene when youths have been injured by gang violence, such as hospital emergency department intervention programs, might interrupt the retaliatory nature of gang violence and promote youths leaving gangs. Finally, promising tertiary prevention programs for gang-involved youths might include evidence-based programs for delinquent youths that provide family therapy to increase the youths’ capacity to resolve conflict.

Moratorium

January 20, 2012
Scientists to Pause Research on Deadly Strain of Bird Flu
By DENISE GRADY

The scientists who altered a deadly flu virus to make it more contagious have agreed to suspend their research for 60 days to give other international experts time to discuss the work and determine how it can proceed without putting the world at risk of a potentially catastrophic pandemic.

Suspensions of biomedical research are almost unheard of; the only other one in the United States was a moratorium from 1974 to 1976 on some types of recombinant DNA research, because of safety concerns.

A letter explaining the flu decision is being published in two scientific journals, Science and Nature, which also plan to publish reports on the research, but in a redacted form, omitting details that would let other researchers copy the experiments. The letter is signed by the scientists who produced the new, more contagious form of the flu virus, as well as by more than 30 other leading flu researchers.

“We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks,” the letter states. At an international meeting next month in Geneva, participants selected by the World Health Organization will consider what to do next. Dr. Anthony Fauci, head of the National Institutes of Health, said the gathering would “address some of these difficult issues on an international scale instead of something restricted to the United States government.”

The scientists say their work has important public health benefits, but they acknowledge that it has sparked intense public fears that the deadly virus could accidentally leak out of a laboratory, or be stolen by terrorists, and result in a devastating pandemic. A national biosecurity panel in the United States has already taken the unusual step of asking the scientists to keep part of their data secret to prevent others from reproducing their work.

Scientists are split regarding the research, with some praising it as important and urging that it be published, and others saying the experiments are so dangerous that they should never have been done.

The experiments involve a type of bird flu virus known as H5N1, which rarely infects people but is highly deadly when it does. The work, paid for by the National Institutes of Health, was done by two separate research teams, at Erasmus Medical Center in Rotterdam, the Netherlands, and at the University of Wisconsin, Madison.

Ron Fouchier, a virologist who conducted the research at Erasmus Medical Center, explained why he and his colleagues decided to pause the research. “It is unfortunate that we need to take this step to help stop the controversy in the United States,” he said. “I think if this were communicated better in the United States it might not have been needed to do this. In the Netherlands we have been very proactive in communicating to the press, politicians and public, and here we do not have such a heated debate.”

Dr. Fauci said that he had never seen the scientific world so polarized, and that led him to urge the researchers to show good faith and flexibility by declaring the moratorium themselves. A concern “looming in the background,” he said, was that biosecurity experts might overreact and impose excessive restrictions on the research.

“I think it’s important research that needs to go forward,” Dr. Fauci said. “I think we need to get greater input on the conditions in which it goes forward.”

Dr. Fauci and others who support the research say it may help explain how flu viruses that start out in animals adapt to humans and become transmissible, and therefore able to cause pandemics. That information, the researchers say, could help them recognize viruses on the way to developing pandemic potential.

Richard H. Ebright, a molecular biologist at Rutgers, is among those who oppose the research because of its risks, and doubts that it could be used to predict pandemics. He said that a moratorium was a good idea, but that this one did not go far enough. He said that the letter did not acknowledge the need for improved “biosafety, biosecurity and oversight,” and that in any case, 60 days would not be enough time to put the needed safeguards in place. The letter noted a “perceived fear” among the public, Dr. Ebright said, and seemed to suggest that the debate would cool down if people would just let the researchers explain that they had done the experiments safely.

Dr. Ebright said experiments with this virus should be done only in laboratories with the highest biosafety rating, BSL4, not in the “enhanced BSL3” in which the work was actually done.

Dr. Fouchier disagreed. He also said that his center did not have BSL4 labs.

Dr. Fauci said various expert groups, including the Centers for Disease Control and Prevention, had determined that enhanced BSL3 was good enough for bird flu research.

Since 1997, when the H5N1 virus was first identified, about 600 people have been infected, and more than half died — an extraordinarily high death rate. The saving grace of H5N1 is that when people do become infected — nearly always from contact with birds — they almost never transmit the disease to other people. But the virus has persisted in the environment, infecting millions of birds, and scientists have warned that if it mutates to become more contagious in people, disaster could ensue.

But what mutations would make the virus more easily transmissible? And how hard, or easy, would it be for those mutations to occur? Hoping to answer those questions, some researchers began experimenting with bird flu, working with ferrets, which are considered the best model for studying flu, because they contract it and get sick in much the same way that people do. Recently, the teams in Rotterdam and Madison announced that they had produced a form of H5N1 with mutations that allowed it to “go airborne,” meaning that it spread through the air from one ferret to another. Presumably, though not certainly, the virus could spread in the same way among people.

Dr. Fouchier said he was surprised by how easy it was to change the virus into the very form that the world has been dreading. Now, scientists around the world will have to grapple with what to do with Dr. Fouchier’s creation.

The Choking Game

http://www.medicalnewstoday.com/releases/240538.php

Medical News Today

Alarming Number Of Texas Teens Playing The Choking Game

“……The study was based on a survey completed by 837 students at a Texas university. Among the findings were:

  • 16% percent of students reported having played the game; 72% reportedly played the game more than once
  • Males were more likely to have played than females
  • The average age when students first played the game was 14
  • 90% of those who played the game first heard about it from peers
  • Most students reported that others were present when they first played the game
  • Curiosity about the effects of the Choking Game was a primary motivation for playing the game
  • Learning about the potential dangers in engaging in this activity served as a deterrent for the majority of non-participants. …”

Minor TBI + Coumadin: What to do??????

http://pubget.com/paper/22244878?title=Management+of+Minor+Head+Injury+in+Patients+Receiving+Oral+Anticoagulant+Therapy%3A+A+Prospective+Study+of+a+24-Hour+Observation+Protocol

Management of Minor Head Injury in Patients Receiving Oral Anticoagulant Therapy: A Prospective Study of a 24-Hour Observation Protocol

Ann Emerg Med  () (2012) PMID 22244878
 
“…. For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk.”

Headphone-Wearing Pedestrians: Beware!!!!!!

Deaths of Headphone-Wearing Pedestrians Increase, Study Finds

January 16, 2012, 6:52 PM EST

By Trista Kelley

Jan. 16 (Bloomberg) — “The number of headphone-wearing pedestrians seriously injured or killed near roadways and railways has tripled in six years, according to a U.S. study.

The number of cases rose from 16 in 2004-2005 to 47 in 2010-2011, according to the research published today in the online journal Injury Prevention. Thirty-four of the 116 total cases in the study specifically mention horns or sirens being sounded before the victims were struck…..”

Postneonatal Mortality Among Alaska Native babies

Postneonatal Mortality Among Alaska Native Infants — Alaska, 1989–2009

Weekly

January 13, 2012 / 61(01);1-5

“Alaska’s postneonatal mortality rate of 3.4 deaths per 1,000 live births during 2006–2008 was 48% higher than the 2007 U.S. rate of 2.3 per 1,000 (1,2). Among American Indian/Alaska Native (AI/AN) infants, the Alaska rate of 8.0 per 1,000 was 70% higher than the U.S. rate of 4.7. The Alaska Division of Public Health analyzed a linked birth-infant death file for 1989–2009 to examine temporal trends in postneonatal mortality in Alaska, specifically in the Alaska Native (AN) population. Overall and non-Alaska Native (non-AN) rates declined during the entire period, but no significant trends in AN-specific mortality were apparent. Infant mortality review committee findings indicated a decline during 1992–2007 among all postneonatal deaths attributed to sudden infant death syndrome (SIDS) or sudden unexplained infant death (SUID), but not for other causes. Lack of progress in reducing postneonatal mortality, particularly among AN infants, indicates a need for renewed emphasis within the Alaska health-care community. Current initiatives to reduce preventable causes of postneonatal mortality should be evaluated and successful models more widely implemented.

The Alaska Bureau of Vital Statistics provided an electronic file with linked records for the 222,317 recorded live births and 821 postneonatal deaths among infants aged 28–364 days born to Alaska residents during 1989–2009. Potential risk factors for infant mortality that might be determined from information included on birth certificates were identified through prior research and literature review. Those risk factors included infant birth weight and gestational age; maternal race, years of education, age, and prenatal cigarette, smokeless tobacco, and alcohol use; and a composite variable reflecting maternal marital status and presence of a father’s name on the birth certificate (1,3). Race was categorized as AN, which included all indigenous groups, or non-AN, based on mother’s race. ……”

Low-dose steroids

Dabigatran & The Risk of Acute Coronary Events

Uchino K, Hernandez A “Dabigatran association with higher risk of acute coronary events” Arch Intern Med 2012; DOI: 10.1001/archinternmed.2011.1666.

ONLINE FIRST
Dabigatran Association With Higher Risk of Acute Coronary Events

Meta-analysis of Noninferiority Randomized Controlled Trials

Ken Uchino, MD; Adrian V. Hernandez, MD, Phd

Arch Intern Med. Published online January 9, 2012. doi:10.1001/archinternmed.2011.1666

http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.1666

Conclusions Dabigatran is associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against different controls. Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran.

They sure don’t make opiates like they used to…..

http://www.fda.gov/Drugs/DrugSafety/ucm286226.htm

FDA Public Health Advisory on Certain Opiate Products Made for Endo Pharmaceuticals

FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.  Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product.  This could result in a stray pill of one medicine ending up in the bottle of another product.  The likelihood of this occurring in medication dispensed to patients is estimated to be low. 

Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists.  Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.  Nonetheless, to ensure continued patient safety and access to these needed medicines, FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same.  FDA and Endo are providing instructions on how to identify an incorrect tablet in these medicines.

Opiates are potent medications used to alleviate pain and are available only by prescription.  The following Endo Pharmaceutical products1 disclaimer icon 2may be affected by the packaging problem (see also www.endo.com3):

  • Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets CII
  • Opana® (oxymorphone hydrochloride) CII
  • Oxymorphone hydrochloride Tablets CII
  • PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • ENDOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • MORPHINE SULFATE Extended-Release Tablets CII
  • ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

The likelihood of finding a wrong tablet in an opiate pain medication dispensed to patients is low and patients should not be unduly alarmed.  For medications already in homes and pharmacies, there are simple steps (see links below) that patients and healthcare professionals can take to identify whether they have any affected products.

Patients should follow the instructions provided by FDA4 and Endo5 disclaimer icon 6and look carefully at all of the pills in their pain medicine bottle.  For any questions, patients should contact Endo Pharmaceuticals at1-800-462-3636 or ask their pharmacist or doctor for additional help in identifying whether there are any problems with their medication.  

When dispensing a medication, pharmacists should perform a visual inspection according to the instructions provided by FDA7.

FDA is actively working with Novartis and Endo to address the manufacturing problems.  Due to the problems that occurred when these products were packaged and labeled at the manufacturer, tablets from one product may have carried over into packaging of another product. 

In the coming weeks we expect there will be periods of shortages for these products.  FDA is working with Endo and Novartis to minimize the degree of impact.  The degree of shortage will depend upon how quickly safeguards can be put in place to prevent this manufacturing issue from happening in the future and how soon manufacturing can be re-started.

Novartis has initiated a consumer level recall of the other non-opiate products made at their Lincoln, Nebraska manufacturing facility out of an abundance of caution for these other products.  Please see the Novartis Press Release8 for more information.

FDA will update the public if this situation changes and more information is available.

Bath Salts Epidemic in Maine

http://www.ems1.com/medical-clinical/articles/1216507-Maine-medical-center-develops-bath-salts-protocol/

EMS1

Maine medical center develops bath salts protocol

Hospitals from around the state that want to send bath salts patients who are in severe crisis to EMMC for specialized care also may have to temporarily paralyze them for the trip

By Nok-Noi Ricker
Bangor Daily news