Is Your OTC Pain Reliever Going to Kill You?

Although acetaminophen (Tylenol) is heavily marketed for its safety, FDA recommends health care professionals to discontinue prescribing and dispensing drug products with more than 325 mg of acetaminophen due to the high risk of liver injury.  Severe liver injury may occur in patients who:

  • Took more than the prescribed dose of an acetaminophen containing product in a 24 hour period.
  • Took more than one acetaminophen containing product at the same time.
  • Drank alcohol while taking acetaminophen products.

Acetaminophen is widely used as an over the counter pain reliever and fever medication and is often combined with other ingredients such as cough and cold ingredients.  Patients may be unaware that many products (both prescription and OTC) may contain acetaminophen, making it easy to accidentally take too much [1-5]. In fact,  acetaminophen poisoning accounts for approximately one-half of all cases of acute liver failure in the United States and Great Britain[16].

Ibuprofen (Motrin, Advil) is also widely used for pain and inflammation but not without risk.  Ibuprofen carries a black box warning from the FDA regarding the cardiovascular and gastrointestinal risks associated with its use.  Patients taking ibuprofen have an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke. Researchers in Denmark observed a nearly threefold increase in the number of deaths from gastrointestinal bleeding within one year of ibuprofen prescription [14].  The risk of side effects is so high for elderly patients the American Geriatrics Society has recommended that patients over the age of 65 avoid NSAID use if at all possible [6-10].  This real risk was studied by RE Tarone who noted a marked rise in baseline rate of gastrointestinal bleed with advancing age with the large majority of cases occurring among persons age 65 or older.  The average relative increase in risk of gastrointestinal bleeding was found to be fourfold or slightly higher in NSAID users and six fold or higher at heavy prescription levels [15].

NSAID High Risk Groups

Medications such as Tylenol and ibuprofen, which are readily available over-the-counter, are perceived to be safe medications; but research has proven that they are not without risk.  Physicians, payers and patients are requesting a safe more effective alternative to treat pain which becomes increasingly important as the population ages.

Medical foods such as Theramine treat the dietary deficiencies that are associated with pain and inflammation.  Pain reduction is accomplished by moderating responsiveness to noxious stimuli, regulating the transmission of pain signals and controlling inflammation. The use of medical foods has been long standing and there have been no reports of GI bleed in over 10 years on the market.

Two multi-center double-blind clinical trials established the safety and efficacy of Theramine in the treatment of chronic back pain.  In a clinical study comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicate significant reduction in back pain with the administration of Theramine alone, while administration of a low dose NSAID had no appreciable effect on pain.

An important observation by researchers EL Fosbol and L Kober note that, “Individual NSAIDs have different cardiovascular safety that needs to be considered when choosing appropriate treatment.  In particular, rofecoxib and diclofenac were associated with increased cardiovascular mortality and morbidity and should be used with caution in most individuals.  This notion is also valid for healthy individuals and underlines the importance of critical use of NSAID therapy in the general population and also that over-the-counter retail of NSAIDs should be reassessed.”[13]

 

REFERENCES

 

1.  Wolf M; King J; Jacobson K; et al “Risk of Unintentional Overdose with Non-prescription Acetaminophen Products”  J Gen Intern Med 2012 Dec; 27(12): 1587-1593

2.  “Acetaminophen Toxicity in Children” Pediatrics vol. 108 No. 4 Oct. 1 2001

3.  Farrell S; Tarabar A; et al “Acetaminophen Toxicity” Medscape June 24, 2011

4.  Plaisance K “Toxicities of Drugs Used in the Management of Fever” Clinical Infectious Diseases 2000 31 Supp 5: S219-S223

5.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

6.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085282.htm

7.  Pilotto A; Franceschi M; Leandro G; Di Mario F; “NSAID and aspirin use by the elderly in general practice:  effect on gastrointestinal symptoms and therapies:  Drugs Aging 2003; 20(9): 701-10.

8.  Smith SG “Dangers of Non-steroidal Anti-inflammatory drugs in the elderly” Can Fam Physician vol. 35 March 1989

9.  American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

10.  Gurwitz JH; Everitt DE; Monane M; Glynn RJ, Choodnovskiy I; Beaudet MP; Avorn J; “The impact of ibuprofen on the efficacy of antihypertensive treatment with  hydrochlorothiazide in elderly persons” J Gerontol A Biol Sci Med Sci 1996 Mar; 51 (2): M74-9

11.  Shell WE; Charuvastra E; DeWood M; May L; Bullias D; Silver D “ A Double-blind controlled trial of a single dose naproxen and an amino acid medical food Theramine for the treatment of low back pain”  Am J of Ther 2010

12.  Shell WE; Pavlik S; Roth B; Silver M; Breitstein M; May L; Silver D “ Reduction in pain and inflammation associated with chronic low back pain with the use of the medical food Theramine”  Amer J of Ther 2014

13.  Fosbol EL; Kober L; Torp-Pedersen C; Gialason GH “ Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals”  Expert Opin Drug Saf 2010 Nov; 9(6): 893-903

14.  Lipworth L; Friis S; Blot Wj; McLaughlin JK; Mellemkjaer L; Johnsen SP; Norgaard B Olsen JH “ A population based cohort study of mortality among users of ibuprofen in Denmark”  Am J Ther 2004 May-Jun; 11(3): 156-63

15.  Tarone RE; Blot WJ; McLaughlin JK “Nonselective non-aspirin non-steroidal anti-inflammatory drugs and gastrointestinal bleeding:  relative and absolute risk estimates from recent epidemiologic studies”  Am J Ther 2004 Jan-Feb; 11(1): 17-25

The Problem with Prescription Pain Killers

Pain is a big deal. On one level, it’s very useful. It tells us when there’s something wrong, and is pretty efficient at giving us a handy indication when what we’re doing may not be particularly good for us. Those who cannot feel pain [1] suffer from horrendous associated problems, and frequently damage themselves quite badly without being alerted to the fact that they’re doing so by pain. However, unlike a man-made alarm, the body does not come with an ‘off’ switch which one can hit once one’s been made aware of the problem. Chronic pain is a major issue, and one of the most troubling symptoms of a great many medical conditions. It’s a factor which seriously affects people’s lives, and good pain management is recognized as being vital to the all-important quality of life [2] experienced by those needing medical treatment. Having said this, however, it is also being increasingly recognized that the people of North America are becoming dangerously dependent upon prescription painkillers. All too often, we pop a pill when we do not really need to, and plenty of us are relying on prescribed narcotic painkillers when we would undoubtedly be a lot better off with some other method of pain-relief. While there is certainly a place for narcotic painkillers in the management of seriously painful conditions, it needs to be recognized that these drugs do come with a major health warning – and alternatives or avoidance should be the preferred options if at all possible.

Narcotic Painkillers

Opioid painkillers were originally designed for cancer pain and somehow over time have become a first line therapy for many physicians despite the potential for addiction. What may be lesser known, however, are the dangers inherent within these drugs, and the startling scope of America’s dependence upon them. Put simply, opioids such as Vicodin and codeine bind to opioid receptors within the brain, which dulls the brain’s pain response. These receptors are designed to work with the body’s natural opioids – endorphins [3]. Endorphins are released during exercise, and numb pain as well as promoting a feeling of wellbeing, enabling and motivating us to stay on the move and thus potentially to survive for longer. Narcotics fulfil the same role – but in hyper-exaggerated form. Narcotic analgesics swamp our opioid receptors, saturate them to the point where we’re utterly numbed and frequently rather high. They’re very effective as a method of pain relief, but also quite dangerous and are associated with a host of dangerous side effects.

Painkiller Addiction

It’s very easy to develop a taste for opioid painkillers. Why wouldn’t you? They keep pain at bay, and they make you feel good. They’re also, unfortunately, highly addictive. Their very nature means that you’re inclined to seek out more and more – and America’s healthcare system doesn’t exactly discourage you from overdoing it. Big pharmaceutical companies do, after all, stand to make a lot of money from plenty of pill-popping patients. North America has the world’s worst rate of prescription painkiller addiction by a long, long way [4]. Places with nationalized healthcare (in which pharmaceutical companies would have nothing to gain from touting their product to the public) are not in any more pain than the people of America, but they’re far less addicted to painkillers. The solution for someone from the USA to the slightest malady invariably involves popping a pill, while those from other countries are put on courses of pills only when necessary, and given alternative pain-relief methods more often. Each system obviously has its pros and cons – but in this particular case the figures concerning painkiller addiction speak for themselves. More overdose deaths in the USA have been caused by prescription narcotics since 2003 than cocaine and heroin put together – partly (if not wholly) because narcotic prescription rates have increased enormously in this time [5].

An Easy Death

A major issue with opioid painkillers is that they’re not only all too easy to get hold of, and highly addictive – they’re also unpredictable killers. While medical science is pretty good at estimating doses according to body weight and so on, the problem of tolerance is always going to rear its ugly head. The body develops a resistance to opioids over time which means that one must take a higher and higher dose in order to achieve the desired effect. And, at any moment, that dose might prove just too high for the body to cope with. Opioids kill in a number of ways. The most common of these is respiratory depression. This can be reversed – but only if the overdose is low and medical aid arrives quickly [6]. If this is not the case, then the overdoser finds themselves unable to adequately fill their lungs and essentially starves of oxygen. It is far better not to risk this, not to get addicted, and to seek alternatives to narcotic analgesics whenever possible!

[1] Gillian Mahoney, “Meet the Child Who Feels No Pain”, ABC, Oct 2013

[2] Nathanial Katz, “The Impact of Pain Management on Quality Of Life”, Journal of Pain and Symptom Management, Jul 2002

[3] PBS, “Role of endorphins discovered, 1975”

[4] Arnold M. Washington, “America’s Painful Love Affair With Painkillers”, Rehabs

[5] National Safety Council, “Opioid painkillers: How they work and why they can be risky”

[6] Ben Wolford, “Respiratory Depression Reversed In Trials With Drug That Fights Opioid Side Effect”, Medical Daily, Aug 2014

 

Safer Options for Pain Management

Pain is complex and there are several treatment options to choose from depending on the type of pain you are experiencing including medications, therapies and mind-body techniques.  The most common treatment consists of analgesics:  narcotic (opioid) and non-narcotic (non-opioid) analgesics.

Narcotics vs NSAIDS
Primary Differences Between Narcotics and NSAIDs

Narcotic analgesics are derived from or related to opium.  Opioids bind to opioid receptors which are present in many regions of the nervous system and are involved in pain signaling and control.  Opioid analgesics relieve pain by acting directly on the central nervous system.  They block incoming pain signals but also work in other parts of the brain, modulating pain receptors in the nervous system, primarily located in the brain and the spinal cord.

Non-opioid analgesics or NSAIDs work by blocking the production of prostaglandins by inhibiting the cyclooxygenase enzyme and therefore decreasing the formation of pain mediators in the peripheral nervous system.   Non-opioids work more directly on injured or inflamed body tissue. In a basic sense, opioids decrease the brain’s awareness of the pain whereas the non-opioids affect some of the chemical changes that normally take place wherever body tissues are injured or inflamed.

Although non-opioids are often preferred for certain types of chronic pain, they have two serious drawbacks.  The first is the ceiling effect; Non-opioids have an upper limit of pain relief that can be achieved.  Once the upper limit is achieved; increasing the dosage will not provide any further pain relief but may exacerbate side effects.  Opioids on the other hand tend not to have a ceiling.  The more you take, the more pain relief you will get.  The second major drawback of non-opioids is the side effects profile.  The side effects of NSAIDS make it impossible for certain patient populations to use NSAIDs such as those with history of peptic ulcer disease, cardiovascular disease and the elderly. In 2014, the American Academy of Neurology determined that the risks of opioids outweigh the benefits for certain chronic pain conditions.

Treatment of pain with the use of medical foods gives patients a safer option for pain management by approaching pain from a new perspective.  Medical foods treat the nutritional deficiencies that are found in patients with acute and chronic pain.  By restoring an optimal balance between the chemicals in the body, substances called neurotransmitters, that are responsible for transmitting and dampening pain signals, one can better manage pain.

Research has found low levels of the amino acids gluatamate, tryptophan, arginine, serine, and histidine in patients with chronic and acute pain.  The perception of pain can be modified by providing amino acids and nutrient precursors to the key neurotransmitters involved in the pain process. Amino acids are able to cross the blood brain barrier and are necessary to produce the appropriate neurotransmitters needed to reduce pain signals and lower inflammation. Increasing the intake of amino acids and nutrients lead to an increase in neurotransmitter levels [1].

The theory that the body’s need for amino acids and nutrients are modified by a disease has been long recognized and is supported by studies that reflect changes in plasma, urinary and tissue levels of nutrients with modified intakes of these nutrients [2].   There are various reasons for depletion of nutrient levels including diet, metabolic demands and genetics.  The required amount for each patient varies depending on the duration and severity of pain. Addressing the increased demand for amino acids and nutrients is a key component for improving clinical outcomes.

Two double-blind clinical trials compared Theramine, a medical food specially designed to address the increased amino acid and nutrient requirements of pain syndromes, to low dose naproxen and ibuprofen.  In both studies, Theramine showed statistically greater pain relief than either naproxen or ibuprofen.  This was measured by patient report and a reduction in the inflammatory markers C-reactive protein (CRP) and interleukin-6 (IL-6) [3, 4].  Treatment with amino acid precursors was associated with substantial improvement in chronic back pain and a reduction in inflammation.

Pain Reduction with TheramineThe improvement in pain directly correlated with increased amino acid precursors to neurotransmitters in the blood.

Theramine is designed using Targeted Cellular Technology (TCT), which facilitates the uptake and utilization of the neurotransmitters precursors that are used in the modulation of pain.  TCT allows for the production of neurotransmitters from ingestion of smaller amounts of amino acids to elicit the same response as larger amounts, making daily dosing more feasible and reducing the potential for tolerance.

At least 100 million adult Americans suffers from chronic pain, a safe and effective treatment option such as medical foods that do not treat symptoms alone but addresses the distinctive nutritional needs of adults who have different or altered physiologic requirements due to pain is vitally needed.

To date, Theramine has been in clinical use for over 10 years with no report of GI bleed or adverse side effects and the clinical trials of Theramine clearly support the theory that the nutritional management of pain syndromes is a safe and effective treatment for pain.

The Dangers of NSAIDs

The most commonly prescribed drugs for pain are Non-Steroidal Anti-Inflammatory drugs (NSAIDs).  Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 [IMS 2012] and this number does not include NSAIDs that are purchased over the counter.  Although effective in treating pain and inflammation, NSAIDs are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs. Toxic side effects of traditional NSAIDs include:

  • Stomach ulceration and/or bleeding
  • Kidney damage
  • Easy bruising because of loss of platelet function
  • Exacerbation of cardiovascular conditions

Recent studies have also highlighted a higher risk of atrial fibrillation with NSAID use [1] and an increase risk of bleeding and events such as heart attack, stroke or cardiovascular death with the use of NSAIDs in conjunction with antithrombotic therapy [2].

NSAIDs work to reduce pain and inflammation by inhibiting cyclooxygenase, an enzyme.  The action of inhibiting cyclooxygenases, reduces pain and inflammation but is also responsible for many of the side effects of NSAIDs.  This inhibition is problematic because it also inhibits some important functions such as the repair and maintenance of the stomach lining.  This is why stomach ulceration and irritation is so common with the use of NSAIDs.

Inhibition of cyclooxygenase is also associated with reductions in prostaglandin synthesis and is associated with less sodium being excreted in urine and constriction of blood vessels.  This effect of NSAIDs on blood pressure may increase mean arterial pressure by as much as 5 to 6 mm Hg in hypertensive patients.   This consequence may be of particular relevance in patients with preexisting hypertension, edema or congestive heart failure.

One study noted the rate of new-onset hypertension developing in elderly patients for whom nonselective NSAIDs were prescribed was 27% [3]

The extremely high risk of side effects with such commonly used medication resulted in a quest for an analgesic/anti-inflammatory that could provide therapeutic efficacy equivalent to that of traditional NSAIDs but without the gastrotoxicity.

The use of medical foods to treat the dietary deficiencies associated with pain and inflammation has proven to be a safe and effective method for pain control.  Two double-blind, randomized,  trials, which compared Theramine to low dose naproxen and ibuprofen demonstrated statistically significantly reduction in inflammation as measured by inflammatory markers, CRP and IL-6 as well as improvement in low back pain.  Theramine was shown to be an effective pain medication but also an effective anti-inflammatory agent without the risk of gastrointestinal bleeding or other serious side effects.

All of the ingredients in Theramine are GRAS (generally recognized as safe) products and carries no risk of addiction or attenuation.  Theramine has been on the market for 10 years without report of GI bleed or serious adverse side effects.

There are several patient populations that should avoid NSAIDs due to the high risk of side effects.

  • Patients over 65 years of age
  • Previous GI history such as peptic ulcers or previous GI bleed
  • Patients with cardiovascular disease
  • Patients with liver disease
  • Patients with kidney disease
  • Patients on anti-coagulants or low dose aspirin

The cumulative evidence of the danger of NSAIDs is an important reminder that the while NSAIDs can be helpful and at times necessary medications for satisfactory quality of life, use of these medications, particularly among high risk patients must be carefully considered.

 

1.  Gang Liu, MD, PhD, Yu-Peng Yan, MD, Xin-Xin Zheng, MD, Phd, Yan-Lu Xu, MD, Phd, Jie Lu, MD, Ru-Tai Hui, MD, Phd, Xiao-Hong Huang, MD, Phd “Meta-Analysis of Nonsteroidal Anti-Inflammatory Drug Use and Risk of Atrial Fibrillation” The American Journal of Cardiology Nov. 15, 2014 Vol. 114, Iss. 10

2. Anne-Marie Schjerning Olsen, Gunnar H. Gislason, Patricia McGettigan, Emil Fosbøl, Rikke Sørensen, Morten Lock Hansen, Lars Køber, Christian Torp-Pedersen, Morten Lamberts. Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction. JAMA, 2015; 313 (8): 805

3.  Solomon DH, Schneeweiss S, Levin R, Avorn J. “Relationship between COX-2 specific inhibitors and hypertension” Hypertension. 2004; 44: 140–145

Alternatives to Opioid Pain Medications for Injured Workers

Workplace injuries affect approximately 4.1 million Americans annually (1) .  More than half of these injured individuals will have to miss work and receive long-term medical care.  Worker’s compensation plans provide partial wages during the time of injury and recovery period in addition to covering the cost of medical care.  The recent trend among physicians treating work related injuries has been the practice of prescribing high and sometimes dangerous doses of opioid pain medications for extended periods of time.  Data from 2005-2008 in 17 states showed an average number of 1,599 cases requiring narcotics for non-surgical cases, with more than seven work days missed due to injury(2).  Additionally, in an average of 6% of these cases, the narcotics were prescribed for long-term periods of time.  These drugs may include but are not limited to hydrocodone, fentanyl, methadone, and oxycodone.  Approximately 50-90% of injured workers will receive narcotics for chronic pain conditions (3).  Opioid pain medications can have deadly side effects and the increased availability and dosages of these medications can be detrimental to an injured worker and prolong the time it takes to return to work.

Opioid pain medications are the most commonly prescribed medication in the United States(4).  They work to decrease the perception of pain and increase pain threshold.  While these drugs are helpful to decrease overall pain of various injuries and conditions, they are highly addictive and only address a portion of the pain process.  Common side effects may be mild such as constipation and fatigue, however, they have also been linked to more severe side effects including sleep apnea, decreased hormone production, and increased falls and broken bones among the elderly population(4).  Additionally patients taking opioid pain medications for long periods of time can become addicted and experience serious symptoms of withdrawal which include nausea, shaking, chills, and sweating when finishing a course of these medications (5).  Lately there has also been in an increase in drug overdose leading to death.  In a study that observed 10,000 patients who were prescribed opioids for 90 days, 51% experienced at least one overdose, and six individuals died as a result of overdose 6.  In 2008 the number of deaths resulting from overdose reached nearly 15,000 individuals(1).

Increased availability and access to opioid pain medications is one of the main problems leading to addiction and overdose among injured workers.  Some physicians are prescribing these medications to treat acute and long-term pain disorders such as arthritis and musculoskeletal pain.  Oftentimes high doses are prescribed and the dosage continues to increase over time as tolerance to the effects of the medications increases.  Instead of treating the underlying physiological conditions causing the painful condition, opioid pain medications are prescribed to help manage and mask the pain associated with a work related injury. They are prescribed for many reasons, however, a few of the most common are pressure from patients to prescribe a strong medication that will lead to decreased pain, as well as pressure from insurance companies to prescribe the most cost-effective generic pain medications. Patients may experience temporary pain relief while on these medications, however chronic pain may persist long after the injury has healed.

Prescribing high dose opioid pain medications for work related injuries often leads to other injuries and physiologic impairments.  In many cases, patients remain out of work for much longer than individuals who are not prescribed opioids, as they often develop new health conditions and require more medications.  In the study conducted by the Danish Health Interview Survey in 2000 observing 10,434 individuals, patients who were not prescribed opioid pain medications to treat their injuries recovered four times more often than individuals prescribed opioid pain medications(7).  Additionally, in this study patients taking opioid pain medications were shown to have a lower quality of life and higher death risk than those patients managing pain without opioids.

Some patients who are prescribed opioid pain medications, especially long-term, may develop other serious conditions such as obesity, mood disorders, and depression.  An injured worker who is taking medication for a pain condition may not be able to exercise regularly and weight gain is fairly common.  Opioid pain medications can also have an effect on overall mood and quality of life.  If an individual takes these medications long-term it can be very hard to stop taking them.  The patient can experience large amounts of anxiety and depression when decreasing the dosage or attempting to discontinue the medication all together.  Research has found that of the 1.9 million workers claims that were filed between 2007-2008, those who previously had or developed a co-morbidity as a result of injury such as depression, obesity, or hypertension, experienced more costly treatments and often longer treatment plans all together(8).

Work related injuries will continue to be an issue for insurers and employers.  The overprescribing of opioid pain medications in this country must be addressed by physicians, insurance companies, and drug manufacturers.   The conversion of acute pain to chronic pain associated with a work related injury can be managed in a more efficient way that will allow an injured worker to return to work as soon as they are healed without the burden of addiction or other opioid pain medication related side effects.  Theramine can be used as a complimentary or standalone therapy among this vulnerable population and can provide treating physicians with the ability to prescribe the lowest effective dose of an opioid pain medication while addressing the underlying pathology of the pain process.

Theramine is a prescription only medication regulated by the FDA as a medical food. Medical foods are prescription only medications which address the underlying pathology of pain associated with the work related injury or illness.  Theramine is clinically proven to correct amino acid deficiencies associated with chronic pain syndromes, and improve the overall perception of pain(9).  Theramine is designed to manage the increased nutritional requirements associated with acute or chronic pain conditions.  Theramine is a proprietary amino acid formulation that, by providing neurotransmitter precursors, helps stimulate production of neurotransmitters that are often deficient in pain conditions.  The ingredients in Theramine are Generally Recognized as Safe by the FDA, and are specially formulated utilizing a proprietary Targeted Cellular Technology to facilitate the uptake and metabolizing of milligram quantities of amino acids and other nutrients.  There have been no reported adverse side effects associated with the clinical application of over 50 million individual doses of Theramine. The most common side effects associated with amino acid therapies are headache, dry mouth, and upset stomach and are often short term, and can be decreased with increased fluid intake.  Theramine can be administered in conjunction with the lowest effective doses of an opiate or NSAID pain medication without loss of efficacy(10).  Treating work related injuries with Theramine may prove to be one possible medication solution to control pain and help decrease the quantity and dosages of opioid pain medications administered in the United States.

1)      http://www.workers-comp-news.com/injury_stats.php

2)      http://www.wcrinet.org/studies/public/books/WCRI_2012_Annual_Report.pdf

3)      http://ehstoday.com/health/workers-compensation/injured-workers-opiate-addiction-0209/

4)      http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?pagewanted=all

5)      http://www.opiates.com/opiate-withdrawal.html

6)      http://www.crcotp.com/crcotp_featured/even-when-prescribed-opioids-can-cause-addiction-and-overdose.php

7)      A Population-based Cohort Study on Chronic Pain:The Role of Opioids Per Sjøgren, MD, DMSC,* Morten Grønbæk, PhD, Vera Peuckmann, PhD,  and Ola Ekh-+olm, PhDw, Lippincott Williams & Wilkins, 2010.

8)      http://coventrywcs.com/web/groups/public/@cvty_workerscomp_coventrywcs/documents/webcontent/c054910.pdf

9)      Shell WE, Silver D, Charuvastra E, Pavlik S, Bullias D; “Theramine and Ibuprofen for the treatment of chronic low back pain double blind clinical trial”, 2010 Targeted Medical Pharma Inc.

10)   Shell WE et al.; “Theramine and Naproxen for the treatment of low back pain, a double bind clinical trial”; Americal Journal of Therapeutics April,2012.

The Cost of Pain

Pain and the treatment of pain affect every sector of our society with at least 100 million adult Americans reportedly suffering  from common chronic pain conditions, a conservative estimate because it does not include acute pain of children.[1]  The proliferation of pain in the United States has resulted in a sharp increase over the past decade in the overuse of narcotics. The prescribing of narcotics has become a popular option for the treatment of chronic pain associated with back injuries, headaches, arthritis, and fibromyalgia.

Chronic pain takes an enormous personal toll on millions of patients and their families, and leads to increased health care costs. Patients with chronic pain have more hospital admissions, longer hospital stays, and unnecessary trips to the emergency department. Such inefficient and even wasteful treatment for pain is contributing to the rapid rise in health care costs in the United States.

The prevalence of pain has a tremendous impact on business.  A recent report by the Institute of Medicine indicated that the annual value of lost productivity in 2010 dollars ranged between $297.4 billion to $335.5 billion. The value of lost productivity is based on three estimates: days of work missed (ranging from $11.6 to $12.7 billion); hours of work lost (from $95.2 to $96.5 billion); and lower wages (from $190.6 billion to $226.3 billion)[2]. This billion dollar annualized price tag will likely climb as the U.S. population ages.

The cost of pain also includes the cost of treating side effects. The most commonly prescribed drug for pain is Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).  Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 (IMS 2012).  Although effective in treating pain and inflammation, NSAIDs are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs which can lead to costly hospitalizations or death.

A study on the effects of NSAID induced side effects in the elderly reflected the average direct costs of GI side effects per patient-day on NSAIDs were 3.5 times higher than those of a patient-day not on NSAIDs. Seventy percent of the cost was attributed to GI events resulting from NSAID treatment. [3]

NSAIDs Image

Treatment of GI problems alone caused by the use of NSAIDs is estimated to add over 40% to the cost of arthritis care[4]

From the perspective of the healthcare system, minor GI side-effects and prophylactic gastroprotection against NSAID-related side-effects may consume even more healthcare resources than severe events because of their high prevalence.

Opioid use has resulted in increased hospitalizations, increased spending on opioid addiction and increased workplace costs.  The cost of the average lost time claim with long acting opioids is 900% higher than those without the use of opioids. U.S. emergency room visits have also increased.  The number of cases in which an opioid other than heroin was cited as a reason for an emergency room treatment in  2004 was 299,498 and in 2011 was 885,348, an almost 300% increase.[5]

While many assume that increase spending and use of pharmaceuticals for pain has had a positive effect on the overall mitigation of pain, there is little scientific data on the relationship between spending on pharmaceutical agents and pain resolution.  Simply treating the symptoms of pain have not proven to be effective nor cost saving in the long run. However, it is increasingly clear that there may be a positive relationship between the use of non-pharmaceutical interventions with or without the use of pharmaceutical and the resolution of pain.

#medicalfoods #NSAIDs #opiods #sideeffects


[1] IMS Health Data, California Workers’ Compensation Institute

[2] Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC

[3] Br J Clin Pharmacol. 2001 August; 52(2): 185–192. Cost of prescribed NSAID-related gastrointestinal adverse events in elderly patients

[4] Bloom, BS. Direct medical costs of disease and gastrointestinal side effects during treatment for arthritis. Am J Med. 1988; 84(2A): 20-24

[5] IMS Health Data, California Workers’ Compensation Institute

Pain Management without Harmful Side Effects

The reduction and management of pain can involve many approaches: prescription medicines, over the counter medicines, medical foods, cognitive behavioral therapy, physical exercise, surgery, nutritional modification, pain education, massage, biofeedback, music, guided imagery, laughter, distraction, acupuncture, and nerve stimulation.  Two or more approaches combined can have a synergistic or additive effect that is greater than the sum of the parts.  One approach, medical foods, has medicinal value that is just beginning to be understood and can be used as a stand-alone therapy or adjacent treatment for chronic pain.

Due to its’ additive effect and low side-effect profile, Theramine®, a medical foods, can be used with high-risk patients over the age of 65 as an alternative to NSAIDs or narcotics.  Adding Theramine to a pain treatment protocol can lead to a reduction in previously prescribed narcotics and minimize the use of NSAIDs or both.  The ingredients in Theramine are Generally Recognized As Safe (GRAS) by the FDA, have no risk of addiction or adverse GI or cardiovascular side effects.  Reducing the burden of adverse side effects while improving clinical outcomes is critical for the overall patient care and a return to activities of daily living.

Two studies comparing Theramine to a low dose NSAIDs in adults 18 years of age and above found Theramine to be more effective than either naproxen or ibuprofen alone for inflammatory pain.  When Theramine was given in combination with the low dose of either product the results were even more beneficial.  Incorporating the use of Theramine into a clinical pain management protocol, allows physicians the flexibility to use less of a narcotic or NSAID pain reliever and potentially eliminate their use all together.

The two studies comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicates significant reduction in back pain with the administration of Theramine alone, and as an adjunct therapy to a low dose NSAID, while administration of a low dose NSAID had no appreciable effect on pain. The use of Theramine as either a standalone or adjunct therapy can significantly improve pain perception.

Theramine is encapsulated with a patented technology that promotes the rapid cellular uptake and conversion of milligram amounts of amino acids and nutrients into the specific neurotransmitters responsible for modulating pain and inflammation.  This patented technology allows Theramine to be effective without losing efficacy over time.

Two multicenter double blind trials have established the safety and efficacy of Theramine in the treatment of chronic back pain. Pain fell by 63% with administration of Theramine and an NSAID as measured by the Roland- Morris Index (Figure 1), and by 62% as measured by The Oswestry Disability Index.

Pain Scale Graph

Traditional pain medication will always have its place in therapeutic treatment and, if used properly, is very effective.  However, physicians, insurance companies, employers and patients are requesting safer, more effective alternatives to treat pain without harmful and costly side effects. The rapidly increasing population of patients 65 years of age and older is a major concern for both physicians and insurance companies as the pain-related costs to overall U.S. health care expenses are likely to rise proportionally as well. The economic impact of pain is certain, as are the physical, emotional, and social impact for millions of people. Reducing the burden of treating chronic pain is a societal necessity, a medical challenge, and an economic requirement.

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The Rising Healthcare Costs of Pharmaceuticals

Prescription drug use and abuse in the United States, continues to rise at an alarming rate as consumers continue to rely on pharmaceuticals for managing disease symptoms. A recent Mayo Clinic study reports that nearly 70% of all Americans have used at least one prescription drug and more than half receive at least two prescriptions, a percentage that has grown over the last decade. A startling 13% of Americans are on painkilling opiods. Increased prescription writing for pharmaceuticals unfortunately results in more side effects, polypharmacy, fatal overdoses and frequent abuse. According the Centers for Disease Control and Prevention (CDC) The overall impact on healthcare expenditures on prescription drugs reached $259 billion in 2010, and accounted for 12 percent of the total personal health care expenditures and is expected to double over the next decade.

This dramatic increase in prescription drug use can be attributed to a number of factors. For example,  as the average lifespan of people increases so to does the incidence of chronic disease, many of which are conditions requiring more treatments and drugs for longer periods of time; patients expect that they will always receive a prescription when they go to a physician’s office which encourages doctors to overprescribe; hospitals and emergency rooms with little time for alternative treatments, want to help patients by giving them prescriptions to treat them expediently for pain, sleep and other issues; and since women on average visit a doctor more frequently than men do, women are often prescribed a narcotic or anti-anxiety drug more often than most men.

generic pills and bottleIncreased prescribing of drugs unfortunately results in more side effects and even fatal overdoses. According to the CDC, from 1999 to 2010, the number of fatal overdoses has increased fivefold among women and tripled among men. When abuse of prescriptions is considered, the problem can be described as epidemic.  Data from the National Survey on Drug Use and Health (NSDUH) show that nearly one-third of people aged 12 and over whom used drugs for the first time in 2009 began by using a prescription drug non-medically.

These escalations continue to put stress on America’s health care system.  Many studies point to the economic impact associated with the increased use of pharmaceuticals. In a recent study released by the Worker’s Compensation Research Institute, the average cost of treating an injured worker without an opiate is $13,000, compared to an average cost of $117,000 for a patient prescribed a long-acting opiate like OxyContin.  According to the Express Scripts 2012 Workers’ Compensation Drug Trend Report for each dollar spent on abused drugs, an additional $41 is used for associated medical treatment.

It’s no secret that more Americans want medical alternatives without the harmful side effects associated with certain pharmaceuticals.  Consumer demands have shifted away from traditional pharmaceuticals to natural alternatives such as plant based pharmaceuticals and more recently medical foods.  In fact, seventy-one percent of sleep-deprived Americans would rather use other means than pharmaceutical drugs to help them sleep, according to a 2013 Harris interactive Rx Sleep Survey.

In one pharmacoeconomic analysis published in the Journal of Pharmacy Research, it was determined that the actual cost of using the non-opiate pain medication, Theramine®, a prescription medical food with minimal side effects is considerably lower when compared to the total impact of NSAIDs.  Medical foods, once a novelty, are becoming mainstream for a variety of diseases. Since drugs and medical foods work along different pathways in the body, medical foods are often recommended as a complementary or adjunct medication to a reduced dosage of a drug, thereby minimizing the potential of harmful side effects associated with traditional, high dose medications. Medical foods offer an important alternative to traditional pharmaceuticals ultimately improving patient outcomes and reducing healthcare care costs.