Workplace Deaths Rise

Work is getting more dangerous in the US. The US Bureau of Labor Statistics reports, there were 5,250 fatal work injuries recorded in the United States in 2018, a 2 percent increase from the 5,147 in 2017. 

Noise Induced Health Threats

Excessive noise that has dominated the workplace throughout time is now associated as causing a plethora of serious health conditions. A recent article in the New York Magazine by David Owen focusses on occupational induced noise pollution and the ailments it affects.

New Opioid Prescription Regulations

Attorney General Gurbir S. Grewal and the New Jersey Division of Consumer Affairs, together with the New Jersey Coordinator for Addiction Responses and Enforcement Strategies ("NJ CARES"), today announced a series of regulatory actions that will advance the State’s battle to end the opioid epidemic, including proposed rules that will expand access to the prevention and treatment of opioid use disorder through telemedicine.

The Oklahoma Opioid Settlement: A Promising Impact on Workers’ Compensation

The first major settlement in the nation’s massive litigation effort against the manufacturers of opioids may present an outline of how the effort will affect workers’ compensation programs throughout the United States. The settlement outlines a substantial contribution to assist those individuals negatively affected by opioid addiction. 

The Oklahoma Attorney general yesterday announced an historical settlement in the pending state’s opioid litigation. Attorney General Mike Hunter and Oklahoma State University leaders  announced an historic settlement with Purdue Pharma that will establish a nearly $200 million endowment at the Oklahoma State University’s Center for Wellness and Recovery, which will go toward treating the ongoing addiction epidemic nationwide. 

“‘The addiction crisis facing our state and nation is a clear and present danger,’ Attorney General Hunter said. ‘Last year alone, out of the more than 3,000 Oklahomans admitted to the hospital for a non-fatal overdose, 80 percent involved a prescription opioid medication. Additionally, nearly 50 percent of Oklahomans who died from a drug overdose in 2018 were attributed to a pharmaceutical drug. Deploying the money from this settlement immediately allows us to decisively treat addiction illness and save lives.” 

Joseph F. Rice, Esq., of Motley Rice LLC, co-lead counsel and a member of the Plaintiffs’ Executive Committee for the National Prescription Opiate Multidistrict Litigation, coordinated in the Northern District of Ohio, commented, “This is a significant step in the effort of the governmental entities around the country to address the opioid epidemic. Purdue Pharma and the Sackler family, by entering into this settlement, have taken a step forward to address what has been alleged as decades of misinformation, inappropriate marketing and efforts to grow the use of opioids, some of the most addictive narcotic drugs in our society.” 

The US Centers for Disease Control [CDC] has reported that from 1999-2017 almost 400,000 people died from an overdose involving any opioids, including prescription and illicit opioids. On the average, 130 Americans dies every day from an opioid overdose. 

Treatment of work related injuries and the resulting pain have produced an epidemic of opioid related addiction and fatalities. The CDC issued guidelines in 2016 for the prescription of opioids. New safety warnings were also added to all prescription opioid medications. State laws were enacted to add restrictions and limitation on opioid prescriptions. The NJ Attorney General has filed a lawsuit against a subsidiary of NJ based Johnson and Johnson seeking reimbursement for workers' compensation costs resulting from deceptive opioid advertising. At least 33 states have sued the opioid manufacturers. This is a significant action as Johnson and Johnson is a major player in New Jersey's economy. 

An unintended consequence of the restrictions placed on the prescription of opioids has been the inability of injured workers to obtain adequate pain relief. Suicide rates have increased, John Heubusch, a cancer patient, writing in the Washington Post stated, “ We have reached the point where doctors believe the next prescription they write for opioids to treat chronic pain might be their last. In my own case, I’ve had to undergo countless unsuccessful procedures and near superhuman efforts to be granted barely enough medication to try to live a normal life. Even those doctors with the courage to prescribe them for chronic pain sufferers are finding the hurdles established by federal and state reporting requirements so onerous that they are simply turning patients away.”…..”Opioid prescriptions have shrunk substantially, but Washington’s goal now is to cut their number by a further one-third. In a bitter irony, opioid overdose deaths continue to hover at an all-time high. Many chronic pain patients, denied prescriptions, are self-medicating on the street, using synthetic drugs such as fentanyl, 50 times more powerful than heroin. There, danger and overdose lurk around every corner. Even worse, some who have lost all hope for pain relief are choosing to end their pain by ending it all. The risk of suicide among patients with chronic pain is twice that of those without it." 

The Oklahoma settlement is an staring effort to the resolution of the opioid epidemic and the its consequences. Hopefully, this will bring those responsible for the opioid problem to the table to discuss sensible solutions so that injured workers’ can be provided medical care to relieve their pain without resulting addiction and death. This promising future would economically benefit employers, workers’ compensation insurance companies, and public entities that medically treat workplace injuries. All stakeholders involved in the workers’ compensation system hopefully can look to a more promising future.

See also:
New York Sues Sackler Family Members and Drug Distributors (NY Times 3/29/2019)
New York State 1st Amended Complaint (3/28/2019)

….

Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thomson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thomson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  has been representing injured workers and their families who have suffered occupational accidents and illnesses.

Updated: 3/29/2019

State of NJ Sues a NJ Based Opioid Manufacturer Seeking Reimbursement of Workers' Compensation Costs

The NJ Attorney General has filed a lawsuit against a subsidiary of NJ based Johnson and Johnson seeking reimbursement for workers' compensation costs resulting from deceptive opioid advertising. This is a significant action as Johnson and Johnson is a major player in New Jersey's economy.

Massachusetts Sues Purdue Pharma for Illegally Marketing Opioids and Profiting From Opioid Epidemic

More than 670 Massachusetts Residents Prescribed Purdue Opioids Died from Opioid-Related Overdoses since 2009; Purdue Sales Reps Made 150,000 Visits to Medical Offices Since 2008, Sold 70 Million Doses Generating $500 Million in Revenue

Attorney General Maura Healey sued Purdue Pharma L.P. and Purdue Pharma Inc. (Purdue) for misleading prescribers and consumers about the addiction and health risks of their opioids, including OxyContin, to get more people to take these drugs, at higher and more dangerous doses, and for longer periods of time to increase the companies’ profits.

Opioid Epidemic: Walgreens to Pay $5.5 Million Over Alleged Overcharges for Prescription Drugs

Walgreens Overcharged for Drugs Covered by State Workers’ Compensation System. A Settlement was entered into with Massachusetts Attorney General's’ Office to fund programs that address the Opioid Epidemic.

Opioid Litigation: Anticipated Positive Impact on Workers' Compensation Systems

The increase, in both the number of settlements and magnitude of opioid lawsuits being filed, is anticipated having a positive outcome on workers' compensation systems that have suffered the burden of opioid addiction and death in epidemic proportions.

USDOT to Test for Additional Drugs

The Department of Transportation is amending its drug-testing program regulation to add hydrocodone, hydromorphone, oxymorphone, and oxycodone to its drug-testing panel; add methylenedioxyamphetamine as an initial test analyte; and remove methylenedioxyethylamphetamine as a confirmatory test analyte. The revision of the drug-testing panel harmonizes DOT regulations with the revised HHS Mandatory Guidelines established by the U.S. Department of Health and Human Services for Federal drug-testing programs for urine testing. This final rule clarifies certain existing drug-testing program provisions and definitions, makes technical amendments, and removes the requirement for employers and Consortium/Third Party Administrators to submit blind specimens.

The Consequences of TrumpMedical 2016–25: Price Increases, Aging Push Sector To 20 Percent Of Economy

Workers' Compensation medical expenses mirror some of the national health care projections. An aging workforce and the increased longevity of the population impacts overall all costs. Furthermore as the Affordable Healthcare Act's repeal has been anticipated by the Republican Administration, medical care costs are anticipated to spiral. The draft release of the Republican proposal for a new national medical care system is now being revealed.

Directly and indirectly, workers' compensation coverage will feel the impact. For chronic condition denials, pre-existing condition denials and occupational disease denials, the safety net of Medicaid will be diminished and the workers' compensation system will again be the primary target for payment and litigation will increase logarithmically.

Some medicines are just not for sick people: Fluoroquinolone

Obtaining fast and effective medical treatment after suffering and occupational accident or injury is important. Receiving the improper medication can made outcomes a lot worse The FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections and warns about disabling side effects that can occur together.

New safety warnings also added to all prescription opioid medications

FDA
(Photo credit: Wikipedia)

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death. New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use.

NJ Judge Orders Psychotherapy Sessions In Conjunction With Pain Management

A NJ Workers' Compensation Judge Ordered the continuation of medical services to an injured worker who has been struggling for years because of chronic knee pain depression and anxiety despite the objection of the employer who sought to terminate care. The Judge Philip A. Tornetta, Administrative Supervisory  Judge of Compensation, adopted an innovative approach  in attempt to reduce or eliminated prescribed drugs including, "Oxycontin for her knee  pain, Lexapro for depression and Xanax, which helps her sleep."

Workers’ Compensation and the Cancer Moonshot 2020

Official portrait of Vice President of the United States . (Photo credit: Wikipedia)

An exciting initiative, Cancer Moonshot 2020, is under underway establishing a coalition, of academics and insurers to work together to find a cure for cancer by the year 2020. Historically too many occupational exposures have resulted in the development of cancer. Participation by the entire workers’ compensation system in this new venture would create an exciting opportunity to advance worker health, reduce costs and strengthen the social remedial benefit program.

Should Workers' Compensation Be In The Wellness Business?

A recent study indicate that wellness programs are exceptionally important. Employers and workers' compensation insurance companies would be wise to follow this initiative.

One out of every four dollars employers pay for health care is tied to unhealthy lifestyle choices or conditions like smoking, stress and obesity, despite the fact that most large employers have workplace wellness programs.

CDC Reports Increases in Drug and Opioid Overdose Deaths in US 2000-2014

Workers' Compensation has experienced the consequences of the national epidemic of drug and opioid deaths. The issue continues to be reported and addressed at the national levels. Unfortunately employers and workers' compensation insurance companies, as cost cost containment item, continue to use this information to merely restrict drug benefits to injured workers while not meeting the real challenge of the epidemic.

The United States is experiencing an epidemic of drug overdose (poisoning) deaths. Since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). CDC analyzed recent multiple cause-of-death mortality data to examine current trends and characteristics of drug overdose deaths, including the types of opioids associated with drug overdose deaths. During 2014, a total of 47,055 drug overdose deaths occurred in the United States, representing a 1-year increase of 6.5%, from 13.8 per 100,000 persons in 2013 to 14.7 per 100,000 persons in 2014. The rate of drug overdose deaths increased significantly for both sexes, persons aged 25–44 years and ≥55 years, non-Hispanic whites and non-Hispanic blacks, and in the Northeastern, Midwestern, and Southern regions of the United States. Rates of opioid overdose deaths also increased significantly, from 7.9 per 100,000 in 2013 to 9.0 per 100,000 in 2014, a 14% increase. Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as "prescription" opioid overdoses (1). Between 2013 and 2014, the age-adjusted rate of death involving methadone remained unchanged; however, the age-adjusted rate of death involving natural and semisynthetic opioid pain relievers, heroin, and synthetic opioids, other than methadone (e.g., fentanyl) increased 9%, 26%, and 80%, respectively. The sharp increase in deaths involving synthetic opioids, other than methadone, in 2014 coincided with law enforcement reports of increased availability of illicitly manufactured fentanyl, a synthetic opioid; however, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl in death certificate data. These findings indicate that the opioid overdose epidemic is worsening. There is a need for continued action to prevent opioid abuse, dependence, and death, improve treatment capacity for opioid use disorders, and reduce the supply of illicit opioids, particularly heroin and illicit fentanyl.

The National Vital Statistics System multiple cause-of-death mortality files were used to identify drug overdose deaths.* Drug overdose deaths were classified using the International Classification of Disease, Tenth Revision (ICD-10), based on the ICD-10 underlying cause-of-death codes X40–44 (unintentional), X60–64 (suicide), X85 (homicide), or Y10–Y14 (undetermined intent) (2). Among the deaths with drug overdose as the underlying cause, the type of opioid involved is indicated by the following ICD-10 multiple cause-of-death codes: opioids (T40.0, T40.1, T40.2, T40.3, T40.4, or T40.6); natural and semisynthetic opioids (T40.2); methadone (T40.3); synthetic opioids, other than methadone (T40.4); and heroin (T40.1). Some deaths involve more than one type of opioid; these deaths were included in the rates for each category (e.g., a death involving both a synthetic opioid and heroin would be included in the rates for synthetic opioid deaths and in the rates for heroin deaths). Age-adjusted death rates were calculated by applying age-specific death rates to the 2000 U.S standard population age distribution (3). Significance testing was based on the z-test at a significance level of 0.05.

During 2014, 47,055 drug overdose deaths occurred in the United States. Since 2000, the age-adjusted drug overdose death rate has more than doubled, from 6.2 per 100,000 persons in 2000 to 14.7 per 100,000 in 2014 (Figure 1). The overall number and rate of drug overdose deaths increased significantly from 2013 to 2014, with an additional 3,073 deaths occurring in 2014 (Table), resulting in a 6.5% increase in the age-adjusted rate. From 2013 to 2014, statistically significant increases in drug overdose death rates were seen for both males and females, persons aged 25–34 years, 35–44 years, 55–64 years, and ≥65 years; non-Hispanic whites and non-Hispanic blacks; and residents in the Northeast, Midwest and South Census Regions (Table). In 2014, the five states with the highest rates of drug overdose deaths were West Virginia (35.5 deaths per 100,000), New Mexico (27.3), New Hampshire (26.2), Kentucky (24.7) and Ohio(24.6).† States with statistically significant increases in the rate of drug overdose deaths from 2013 to 2014 included Alabama, Georgia, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Mexico, North Dakota, Ohio, Pennsylvania, and Virginia.

In 2014, 61% (28,647, data not shown) of drug overdose deaths involved some type of opioid, including heroin. The age-adjusted rate of drug overdose deaths involving opioids increased significantly from 2000 to 2014, increasing 14% from 2013 (7.9 per 100,000) to 2014 (9.0) (Figure 1). From 2013 to 2014, the largest increase in the rate of drug overdose deaths involved synthetic opioids, other than methadone (e.g., fentanyl and tramadol), which nearly doubled from 1.0 per 100,000 to 1.8 per 100,000 (Figure 2). Heroin overdose death rates increased by 26% from 2013 to 2014 and have more than tripled since 2010, from 1.0 per 100,000 in 2010 to 3.4 per 100,000 in 2014 (Figure 2). In 2014, the rate of drug overdose deaths involving natural and semisynthetic opioids (e.g., morphine, oxycodone, and hydrocodone), 3.8 per 100,000, was the highest among opioid overdose deaths, and increased 9% from 3.5 per 100,000 in 2013. The rate of drug overdose deaths involving methadone, a synthetic opioid classified separately from other synthetic opioids, was similar in 2013 and 2014.

Discussion

More persons died from drug overdoses in the United States in 2014 than during any previous year on record. From 2000 to 2014 nearly half a million persons in the United States have died from drug overdoses. In 2014, there were approximately one and a half times more drug overdose deaths in the United States than deaths from motor vehicle crashes (4). Opioids, primarily prescription pain relievers and heroin, are the main drugs associated with overdose deaths. In 2014, opioids were involved in 28,647 deaths, or 61% of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000. The 2014 data demonstrate that the United States' opioid overdose epidemic includes two distinct but interrelated trends: a 15-year increase in overdose deaths involving prescription opioid pain relievers and a recent surge in illicit opioid overdose deaths, driven largely by heroin.

Natural and semisynthetic opioids, which include the most commonly prescribed opioid pain relievers, oxycodone and hydrocodone, continue to be involved in more overdose deaths than any other opioid type. Although this category of opioid drug overdose death had declined in 2012 compared with 2011, and had held steady in 2013, there was a 9% increase in 2014.

Drug overdose deaths involving heroin continued to climb sharply, with heroin overdoses more than tripling in 4 years. This increase mirrors large increases in heroin use across the country (5) and has been shown to be closely tied to opioid pain reliever misuse and dependence. Past misuse of prescription opioids is the strongest risk factor for heroin initiation and use, specifically among persons who report past-year dependence or abuse (5). The increased availability of heroin, combined with its relatively low price (compared with diverted prescription opioids) and high purity appear to be major drivers of the upward trend in heroin use and overdose (6).

The rate of drug overdose deaths involving synthetic opioids nearly doubled between 2013 and 2014. This category includes both prescription synthetic opioids (e.g., fentanyl and tramadol) and non-pharmaceutical fentanyl manufactured in illegal laboratories (illicit fentanyl). Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl. Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl (7), although this cannot be confirmed with mortality data. For example, five jurisdictions (Florida, Maryland, Maine, Ohio, and Philadelphia, Pennsylvania) that reported sharp increases in illicit fentanyl seizures, and screened persons who died from a suspected drug overdose for fentanyl, detected similarly sharp increases in fentanyl-relateddeaths (7).§ Finally, illicit fentanyl is often combined with heroin or sold as heroin. Illicit fentanyl might be contributing to recent increases in drug overdose deaths involving heroin. Therefore, increases in illicit fentanyl-associated deaths might represent an emerging and troubling feature of the rise in illicit opioid overdoses that has been driven by heroin.

The findings in this report are subject to at least three limitations. First, several factors related to death investigation might affect estimates of death rates involving specific drugs. At autopsy, toxicological laboratory tests might be performed to determine the type of drugs present; however, the substances tested for and circumstances under which the tests are performed vary by jurisdiction. Second, in 2013 and 2014, 22% and 19% of drug overdose deaths, respectively, did not include information on the death certificate about the specific types of drugs involved. The percent of overdose deaths with specific drugs identified on the death certificate varies widely by state. Some of these deaths might have involved opioids. This increase in the reporting of specific drugs in 2014 might have contributed to some of the observed increases in drug overdose death rates involving different types of opioids from 2013 to 2014. Finally, some heroin deaths might be misclassified as morphine because morphine and heroin are metabolized similarly (8), which might result in an underreporting of heroin overdose deaths.

To reverse the epidemic of opioid drug overdose deaths and prevent opioid-related morbidity, efforts to improve safer prescribing of prescription opioids must be intensified. Opioid pain reliever prescribing has quadrupled since 1999 and has increased in parallel with overdoses involving the most commonly used opioid pain relievers (1). CDC has developed a draft guideline for the prescribing of opioids for chronic pain to address this need.¶

In addition, efforts are needed to protect persons already dependent on opioids from overdose and other harms. This includes expanding access to and use of naloxone (a safe and effective antidote for all opioid-related overdoses)** and increasing access to medication-assisted treatment, in combination with behavioral therapies (9). Efforts to ensure access to integrated prevention services, including access to syringe service programs when available, is also an important consideration to prevent the spread of hepatitis C virus and human immunodeficiency virus infections from injection drug use.

Public health agencies, medical examiners and coroners, and law enforcement agencies can work collaboratively to improve detection of outbreaks of drug overdose deaths involving illicit opioids (including heroin and illicit fentanyl) through improved investigation and testing as well as reporting and monitoring of specific drugs, and facilitate a rapid and effective response that can address this emerging threat to public health and safety (7). Efforts are needed to distinguish the drugs contributing to overdoses to better understand this trend.

1Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC.

Corresponding author: Rose A. Rudd, rvr2@cdc.gov, 770-488-3712.

References

1. Paulozzi LJ, Jones C, Mack K, Rudd R. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep 2011;60:1487–92.
2. Bergen G, Chen LH, Warner M, Fingerhut LA. Injury in the United States: 2007 chartbook. Hyattsville, MD: National Center for Health Statistics; 2008 Available at http://www.cdc.gov/nchs/data/misc/injury2007.pdf .
3. Murphy SL, Xu JQ, Kochanek KD. Deaths: final data for 2010. National vital statistics reports. Hyattsville, MD: National Center for Health Statistics; 2013. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_04.pdf .
4. CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2015. Available athttp://wonder.cdc.gov.
5. Jones CM, Logan J, Gladden RM, Bohm MK. Vital signs: demographic and substance use trends among heroin users—United States, 2002–2013. MMWR Morb Mortal Wkly Rep 2015;64:719–25.
6. Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The changing face of heroin use in the United States: a retrospective analysis of the past fifty years. JAMA Psychiatry 2014;71:821–6.
7. CDC. Increases in fentanyl drug confiscations and fentanyl-related overdose fatalities. HAN Health Advisory. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. Available at http://emergency.cdc.gov/han/han00384.asp.
8. Davis GG. Complete republication: National Association of Medical Examiners position paper: recommendations for the investigation, diagnosis, and certification of deaths related to opioid drugs. J Med Toxicol 2014;10:100–6.
9. Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies—tackling the opioid-overdose epidemic. N Engl J Med 2014;370:2063–6.

Rose A. Rudd, MSPH1; Noah Aleshire, JD1; Jon E. Zibbell, PhD1; R. Matthew Gladden, PhD1

* Additional information available at http://www.cdc.gov/nchs/nvss/mortality_public_use_data.htm.

† Additional information available at http://www.cdc.gov/drugoverdose/data/statedeaths.html.

§ Additional information available at http://pub.lucidpress.com/NDEWSFentanyl/.

¶ Additional information available at http://www.cdc.gov/drugoverdose/prescribing/guideline.html.

** Additional information available at https://store.samhsa.gov/shin/content/SMA13-4742/Overdose_Toolkit_2014_Jan.pdf .

FDA Strengthens NSAIDs Warnings: Chance of Heart Attack & Stroke

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. 

Based on the FDA's comprehensive review of new safety information, it is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on the FDA's review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
• The risk appears greater at higher doses.

It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

There is an increased risk of heart failure with NSAID use.

In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.
Patients and health care professionals should remain alert for heart-related side effects the
entire time that NSAIDs are being taken. The FDA urges you to report side effects involving
NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA”
box at the bottom of the page.

Facts about non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs are a class of medicines available by prescription and over-the-counter
(OTC). They are some of the most commonly used pain medicines.
• NSAIDs are used to treat pain and fever from medical conditions such as arthritis,
menstrual cramps, headaches, colds, and the flu.
• Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
See Table 1 for a list of non-aspirin NSAIDs.
Additional Information for Patients and Consumers
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance
of a heart attack or stroke, either of which can lead to death. There are a large
number of studies that support this finding, with varying estimates of how much
the risk is increased, depending on the drugs and the doses studied. These serious
side effects can occur as early as the first weeks of using an NSAID and the risk
may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the
shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
• Chest pain
• Shortness of breath or trouble breathing
• Sudden weakness or numbness in one part or side of the body
• Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep,
so it is important to read the labels and avoid taking multiple medicines that
contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke
should know that some NSAIDs, including those in over-the-counter (OTC)
products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It
explains the risks associated with the use of the medicine. You may access
Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care
professional or pharmacist if you have questions or concerns about NSAIDs or
which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the
information in the "Contact FDA" box at the bottom of this page.
Additional Information for Health Care Professionals
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular thrombotic events, including myocardial infarction
and stroke, either of which can be fatal. There are a large number of studies that
support this finding, with varying estimates of how much the risk is increased.
Estimates of increased risk range from 10 percent to 50 percent or more,
depending on the drugs and the doses studied. This risk may occur as early as the
first weeks of treatment and may increase with duration of use.
• Remain alert for the development of cardiovascular adverse events throughout the
patient’s entire treatment course, even in the absence of previous cardiovascular
symptoms.
• Inform patients to seek medical attention immediately if they experience
symptoms of heart attack or stroke such as chest pain, shortness of breath or
trouble breathing, sudden weakness or numbness in one part or side of the body,
or sudden slurred speech.
• Encourage patients to read the Medication Guide for prescription NSAIDs and the
Drug Facts label for over-the-counter (OTC) NSAIDs.
• Based on available data, it is unclear whether the risk for cardiovascular
thrombotic events is similar for all non-aspirin NSAIDs.
• The increase in cardiovascular thrombotic risk has been observed most
consistently at higher doses.
• The relative increase in serious cardiovascular thrombotic events over baseline
conferred by NSAID use appears to be similar in those with and without known 
cardiovascular disease or risk factors for cardiovascular disease. However,
patients with known cardiovascular disease or risk factors had a higher absolute
incidence of serious cardiovascular thrombotic events due to their increased
baseline rate.
• To minimize the risk for an adverse cardiovascular event in patients treated with
an NSAID, prescribe the lowest effective dose for the shortest duration possible.
• Some NSAIDs, including those in OTC products such as ibuprofen and naproxen,
can interfere with the antiplatelet action of low dose aspirin used for
cardioprotection by blocking aspirin’s irreversible COX-1 inhibition.
• Report adverse events involving NSAIDs to the FDA MedWatch program, using
the information in the "Contact FDA" box at the bottom of this page.

Data Summary
FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper
gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs),
conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the
Clinical Trial Service and Epidemiological Studies Units at Oxford University.2

We also reviewed observational studies and other scientific publications in the medical literature.1

The findings of these studies were discussed at a joint meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee held on
February 10-11, 2014 (for complete safety reviews, background information, and minutes
of this meeting, click here).

Based on the FDA's  comprehensive review and the recommendations from the advisory committees, we are requiring label changes to reflect the following conclusions:
• A large number of studies support the finding that NSAIDs cause an increased
risk of serious cardiovascular thrombotic events, with varying estimates of how
much the risk is increased. Estimates of increased relative risk range from 10
percent to 50 percent or more, depending on the drugs and the doses studied.
• Several observational studies found a significant cardiovascular risk within days
to weeks of NSAID initiation. Some data also showed a higher risk with longer
NSAID treatment.
• There are observational data indicating that the thrombotic cardiovascular risk
from NSAID use is dose-related. There is also some evidence of this doseresponse
effect from clinical trials of celecoxib.
• Some observational studies and the CNT meta-analysis suggested that naproxen
may have a lower risk for cardiovascular thrombotic events compared to the other
NSAIDs; however, the observational studies and the indirect comparisons used in
the meta-analysis to assess the risk of the nonselective NSAIDs have limitations
that affect their interpretability. The variability in patients’ risk factors,
comorbidities, concomitant medications and drug interactions, doses being used,
duration of treatment, etc., also need to be taken into consideration to make valid 
comparisons. Importantly, these studies were not designed to demonstrate
superior safety of one NSAID compared to another.
• There is evidence of an increased cardiovascular risk from NSAID use by
apparently healthy patients. Data from the CNT meta-analysis, individual
randomized controlled trials, and observational studies showed that the relative
increase in cardiovascular thrombotic events over baseline conferred by NSAID
use appears to be similar in those with and without known cardiovascular disease
or risk factors for cardiovascular disease. However, patients with known
cardiovascular disease or risk factors had a higher absolute incidence of excess
cardiovascular thrombotic events due to their increased baseline rate.
• The CNT meta-analysis demonstrated an approximately two-fold increase in
hospitalizations for heart failure with use of both COX-2 selective and
nonselective NSAIDs. In a Danish National Registry study of patients with heart
failure, NSAID use increased the risk of myocardial infarction, hospitalization for
heart failure, and death.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen
or Naproxen (PRECISION) trial, is a large, ongoing randomized safety trial comparing
cardiovascular event rates among patients with high cardiovascular risk who are
randomized to celecoxib, naproxen, or ibuprofen. This trial was also discussed at the
February 2014 Advisory Committee meeting and is expected to provide additional safety
information. 

Table 1. List of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
Generic name Brand name(s)

• celecoxib Celebrex
• diclofenac Cambia, Cataflam, Dyloject, Flector,
• Pennsaid, Solaraze, Voltaren, Voltaren-XR,
• Zipsor, Zorvolex, Arthrotec (combination
• with misoprostol)
• diflunisal No brand name currently marketed
• etodolac No brand name currently marketed
• fenoprofen Nalfon
• flurbiprofen Ansaid
• ibuprofen* Advil, Caldolor, Children’s Advil,
• Children’s Elixsure IB, Children’s Motrin,
• Ibu-Tab, Ibuprohm, Motrin IB, Motrin
• Migraine Pain, Profen, Tab-Profen, Duexis
• (combination with famotidine), Reprexain
• (combination with hydrocodone),
• Vicoprofen (combination with
• hydrocodone)
• indomethacin Indocin, Tivorbex
• ketoprofen No brand name currently marketed
• ketorolac Sprix
• mefenamic acid Ponstel
• meloxicam Mobic
• nabumetone No brand name currently marketed
• naproxen* Aleve, Anaprox, Anaprox DS, ECNaprosyn,
• Naprelan, Naprosyn, Treximet
• (combination with sumatriptan), Vimovo
• (combination with esomeprazole)
• oxaprozin Daypro
• piroxicam Feldene
• sulindac Clinoril
• tolmetin No brand name currently marketed *There are many over-the-counter (OTC) products that contain this medicine.

References

1. Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing
Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee. Available
from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.

….

Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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Look Who Is Prescribing What

As part of the Administration’s goals of better, care, smarter spending, and healthier people, the Centers for Medicare & Medicaid Services announced the availability of new, privacy-protected data on Medicare Part D prescription drugs prescribed by physicians and other health care professionals in 2013. This data shows which prescription drugs were prescribed to Medicare Part D beneficiaries by which practitioners.

“This transparency will give patients, researchers, and providers access to information that will help shape the future of our nation’s health for the better,” said acting CMS Administrator Andy Slavitt. “Beneficiaries’ personal information is not available; however, it’s important for consumers, their providers, researchers, and other stakeholders to know how many prescription drugs are prescribed and how much they cost the health care system, so that they can better understand how the Medicare Part D program delivers care.”

The new data set contains information from over one million distinct health care providers who collectively prescribed approximately $103 billion in prescription drugs and supplies paid under the Part D program. The data characterizes the individual prescribing patterns of health providers that participate in Medicare Part D for over 3,000 distinct drug products. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed, which include original prescriptions and any refills, and the total drug cost paid by beneficiaries, Part D plans, and other sources.

CMS created the new data set using drug claim information submitted by Medicare Advantage Prescription Drug plans and stand-alone Prescription Drug Plans. With this data, it will be possible to conduct a wide array of prescription drug analyses that compare drug use and costs for specific providers, brand versus generic drug prescribing rates, and to make geographic comparisons at the state level.

The Administration has set measurable goals and a timeline to move Medicare toward paying providers based on the quality, rather than the quantity, of care they give patients. This is part of a wide set of initiatives to achieve better care, smarter spending and healthier people through our health care system. Open sharing of data securely, timely and more broadly supports insight and innovation in health care delivery.

Today’s Part D prescriber data availability adds to the unprecedented information previously released on services and procedures provided to Medicare beneficiaries, including hospital charge data on common impatient and outpatient services as well as utilization and payment information for physicians and other healthcare professionals. In addition, under the Qualified Entity (QE) program, CMS releases Medicare data to approved entities for the purposes of producing public performance reports on physicians, hospitals, and other providers. To date, CMS has certified 11 regional QEs and one national QE.

To view a fact sheet on the Medicare Part D prescriber data, visit: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-D-Prescriber.html

Updated: May 15, 2015

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Synchromed II Implantable Infusion Pump Systems: FDA Consent Decree To Limit Use

Medtronic, Inc. cited for manufacturing violations

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufacture.

The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe us

The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.

Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

The FDA first approved the Synchromed II Implantable Infusion Pump Systems in 2004, and first identified problems with the manufacture of these pumps in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients.

Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s Neuromodulation facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians. Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Budget Changes To Medicare, HHS Programs Would Garner $399 Billion In 10 Years

The Obama Administration is making a concerted effort to lower medical costs through budgetary restrictions. It is unknown whether this is really meant to merely reduce service or establish greater efficiency. The CMS program is the model for the majority workers' compensation medical cost schedules. Today's post was shared by Kaiser Health News and comes from kaiserhealthnews.org

President Barack Obama (Photo credit: Wikipedia) President Barack Obama's budget request includes proposals that would increase spending for some Medicare beneficiaries, including co-payments for new Medicare beneficiaries who receive home health care services and a surcharge on premiums for new beneficiaries who buy private insurance to supplement Medicare. The budget also calls on the federal government to use its buying power to negotiate drug prices. The New York Times: Budget Plan Sees Savings In Changes To Medicare In his new budget, President Obama proposed on Monday to squeeze $399 billion over the next 10 years out of Medicare, Medicaid and other programs run by the Department of Health and Human Services. Under the proposals, many Medicare beneficiaries would have to pay more for their care and coverage. The president would, for example, introduce a co-payment for new Medicare beneficiaries who receive home health care services, and he would collect $4 billion over 10 years by imposing a surcharge on premiums for new beneficiaries who buy generous private insurance to supplement Medicare. (Pear, 2/2) The Wall Street Journal: Obama Health Budget Calls For Authority To Negotiate Drug Prices The Obama administration’s fiscal 2016 budget request calls for allowing the government to negotiate the price of prescription drugs and giving regulators new funding to fight Ebola. The Department of Health and Human Services request proposes a budget authority of about $1.09 trillion for fiscal 2016, up from $1.04...

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Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

Found on

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