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Quantifying the Impact of NSAID-associated
Adverse Events

By |June 4, 2017|Iatrogenic Injury, NSAIDs|

Quantifying the Impact of NSAID-associated
Adverse Events

The Chiro.Org Blog


SOURCE:   Am J Manag Care. 2013 (Nov); 19 (14 Suppl): s267–272

Michael Fine, MD

Health Net
736 Kendall Dr
Laguna Beach, CA 92651


Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used among patients experiencing many different types of pain, including inflammatory, acute pain (eg, injury, low back pain, headache, postoperative pain), and chronic pain (eg, rheumatoid arthritis, osteoarthritis).

However, both traditional NSAIDs and second-generation NSAIDs (cyclooxygenase-2 inhibitors) can lead to very expensive and serious adverse events. Gastrointestinal, cardiovascular, and renal complications associated with NSAIDs have been shown to be dose-dependent. In 2005, to help minimize these risks, the US Food and Drug Administration issued a public health advisory stating that “NSAIDs should be administered at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.”

This article reviews the undue clinical and economic burden associated with NSAID-related serious adverse events.


From the FULL TEXT Article:

Introduction

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the cornerstone of pain management in patients who have inflammatory, acute pain (eg, headache, postoperative pain, and orthopedic fractures), and chronic pain (eg, rheumatoid arthritis, osteoarthritis, and gout). [1, 2] Approximately 70% of people 65 years or older use NSAIDs at least once per week, with half of them taking at least 7 doses per week. In 2000, more than 111 million prescriptions were written for NSAIDs in the United States, at an approximate cost of $4.8 billion. [3] The use of NSAIDs is likely to increase even more as the US population continues to age and experience painful conditions that are more common among older adults. [4]

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Regular Use of Medication for Musculoskeletal Pain and Risk of Long-term Sickness Absence: A Prospective Cohort Study Among the General Working Population

By |November 4, 2016|Iatrogenic Injury, Pain Medication|

Regular Use of Medication for Musculoskeletal Pain and Risk of Long-term Sickness Absence: A Prospective Cohort Study Among the General Working Population

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SOURCE:   Eur J Pain. 2016 (Aug 26) [Epub]

E. Sundstrup, M.D. Jakobsen, S.V. Thorsen, L.L. Andersen

National Research Centre for the Working Environment,
Copenhagen, Denmark.

Physical Activity and Human Performance group, SMI,
Department of Health Science and Technology,
Aalborg University, Denmark.


BACKGROUND:   The aim was to determine the prospective association between use of pain medication – due to musculoskeletal pain in the low back, neck/shoulder and hand/wrist – and long-term sickness absence.

METHODS:   Cox-regression analysis was performed to estimate the prospective association between regular use of pain medication and long-term sickness absence (LTSA; at least 6 consecutive weeks) among 9,544 employees from the general working population (Danish Work Environment Cohort Study 2010) and free from LTSA during 2009-2010. The fully adjusted model was controlled for age, gender, body mass index, smoking, leisure physical activity, job group, physical activity at work, psychosocial work environment, pain intensity, mental health and chronic disease.

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Morbidity and Mortality of Major Adult Spinal Surgery

By |January 12, 2016|Iatrogenic Injury|

Morbidity and Mortality of Major Adult Spinal Surgery. A Prospective Cohort Analysis of 942 Consecutive Patients

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SOURCE:   Spine J. 2012 (Jan);   12 (1):   22–34

John T. Street, Brian J. Lenehan, Christian P. DiPaola et. al

Combined Neurosurgical and Orthopedic Spine Program,
Vancouver General Hospital,
818 West 10th Ave.,
Vancouver, British Columbia, Canada


BACKGROUND CONTEXT:   To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center.

PURPOSE:   To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool.

STUDY DESIGN:   Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study.

PATIENT SAMPLE:   All adult patients admitted to the spine service of a quaternary referral center for a 12-month period.

OUTCOME MEASURES:   A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS).

METHODS:   Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded.

RESULTS:   One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission.

The average hospital length of stay was 13.5 days (range, 1-221 days).

  • Eight hundred twenty-two (87%) patients had at least one
    documented complication.

  • Thirty-nine percent of these adversely affected hospital length of stay.
  • There were 14 mortalities during the study period.
  • The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition
    requiring revision and 2.2% blood loss >2 L).

  • The incidence of postoperative complication was 73.5%
    (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological
    deterioration, 3%).

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FDA’s NSAID Panel Nixes Naproxen Safety Claim

By |February 11, 2014|Iatrogenic Injury, NSAIDs, Safety|

FDA’s NSAID Panel Nixes Naproxen Safety Claim

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SOURCE:   MedPage Today ~ 2-11-2014

By John Gever, Deputy Managing Editor, MedPage Today


In 16-9 vote, the FDA advisory committee assessing NSAID safety said the warning label on naproxen should not be changed to suggest it has a better cardiovascular risk profile than other drugs in this class.

Those voting “No” on the question indicated that the current evidence on naproxen’s safety — much of which was indirect, coming from studies in which it served as a comparator to a coxib drug — did not meet the standards necessary to support label statements.

The panel — comprising members of FDA’s arthritis and risk management committees — split more closely on a question about label information on the duration of NSAID treatment that raises cardiovascular safety risks.

Currently, labels for these drugs say that short-term treatment is relatively safe; however, some recent studies have sown doubt. A total of 14 panel members said the current statement should be reconsidered, while 11 voted No.

However, most of those in the latter camp indicated in post-vote discussion that they believed there is no completely safe dosing period.

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Recent Considerations in Nonsteroidal Anti-inflammatory Drug Gastropathy

By |January 16, 2014|Iatrogenic Injury, NSAIDs|

Recent Considerations in Nonsteroidal Anti-inflammatory Drug Gastropathy

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SOURCE:   American Journal of Medicine 1998 (Jul 27);   105 (1B):   31S–38S

Gurkirpal Singh, MD

Department of Medicine, ARAMIS Postmarketing Surveillance Program,
Stanford University of Medicine, Palo Alto, California 94303, USA


Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications (internal bleeding) and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone.

The figures for all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated (and under-reported!).


In the following year the prestigious New England Journal of Medicine published a similar statement:

“It has been estimated conservatively that 16,500 NSAID-related deaths occur among patients with rheumatoid arthritis or osteoarthritis every year in the United States. This figure is similar to the number of deaths from the acquired immunodeficiency syndrome and is considerably greater than the number of deaths from multiple myeloma, asthma, cervical cancer, or Hodgkin’s disease. If deaths from gastrointestinal toxic effects from NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would constitute the 15th most common cause of death in the United States. Yet these toxic effects remain mainly a “silent epidemic,” with many physicians and most patients unaware of the magnitude of the problem.

Furthermore, these mortality statistics do not include deaths ascribed to the use of over-the-counter NSAIDS.”

Another statement that just happened to catch my eye:

On the basis of these conservative figures and ARAMIS data, the annual number of hospitalizations in the United States for serious gastrointestinal complications is estimated to be at least 103,000. At an estimated cost of $15,000 to $20,000 per hospitalization, the annual direct costs of such complications exceed $2 billion. [14]


Thanks to the American Nutrition Association
for access to this picture!

The Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) Post-Marketing Surveillance Program (PMS) has prospectively followed patient status and outcomes, drug side effects, and the economic impact of illness for >11,000 arthritis patients at 8 participating institutions in the United States and Canada.

Analysis of these data indicates that:

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FDA Asks Docs to Limit Acetaminophen in Prescription Meds

By |January 15, 2014|Iatrogenic Injury|

FDA Asks Docs to Limit Acetaminophen in Prescription Meds

The Chiro.Org Blog


SOURCE:   Medscape Medical News ~ January 15, 2014

By Megan Brooks

Freelance writer for Reuters Health


The US Food and Drug Administration (FDA) is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, citing the risk for liver damage.

The action targets prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.

In a statement, the FDA said, “There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury.”

“Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death,” they added.

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