Pain is one of the greatest deterrents to pursuing wellness and obtaining an improved, happy healthspan. This analgesic’s (APFD) position in the market: to fill the void and challenge any current topical or oral analgesic, in safety, efficacy, and value.

Some of this information is expanded, updated, and repeated under the section "For Your Patient."

Pain is a significant public health problem and is clearly a major contributor to escalating healthcare costs. It has been poorly addressed and barely discussed. The CDC reports that one third of all adults in the U.S. will experience severe chronic pain in their lifetime. Five 5% children, thirty-eight 38% adolescents are a part of the thirty-nine 39% of those with chronic pain that are diagnosed with high-impact chronic pain. Chronic pain affects vastly more Americans than any other health condition—over one hundred million, plus the additional twenty-five million experiencing short-term acute pain. The costs society is  roughly $635 billion annually. Seven-in-ten Americans feel that pain research and management should be among the medical profession’s top priorities. Pain treatment is important because pain adversely affects quality of life, mentally, physically, emotionally, economically, and has an increased mortality risk. Suicide rates due to chronic pain are above 10.2%. Thirty 30% of adults in the United States have experienced pain lasting more than six-months, with chronic pain being the leading cause of disability worldwide. Patients receiving medication or a procedure for chronic pain, report only 25 to 30 % relief. Nearly half of American adults have received a prescription pain medication, in the past month, and about half of patients receiving prescription medications are also taking OTCs, which can be hazardous, if mixed, especially for the elderly.    Analgesics are by far the most popular class of OTC medication. Over 60% of pain sufferers self-medicate. Children and the elderly receive inadequate pain treatment; women are more likely to have pain disorders than men, and pregnant women are typically excluded from pain management trials.

In the U.S., with pain medications Vioxx and Bextra having been removed from the market, and Celebrex and other oral anti-inflammatory medications coming under increased scrutiny, as more serious side-effects and drug interactions are increasingly found in their profile. What is available to effectively fill this void? Even the popular OTC products, like Aleve, Advil, Motrin, etc., have come into question, with regards to safety associated with long term use, especially in the elderly and pregnant women. Then there are narcotics, which add respiratory distress, hallucinations, dizziness/drowsiness, headache, fatigue, constipation, addiction, and long-term loss of normal body dopamine response. Along with narcotics, other analgesics and biologics, we can add more side-effects: nausea/vomiting, agitation, paranoia, neuropathological dysfunction, personality pathology, constipation, GI bleed, cardiovascular events with an increased chance of heart attack, edema, kidney or liver failure, VTE, cancer, death, etc.  A list of pain solutions and their use with APFD can be found under "For Your Patient."

Aspirin is the standard by which all other analgesic/anti-inflammatory, anti-pyritic medications are measured. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that works similar to other NSAIDs, but is also an antiplatelet that suppresses the normal functioning of platelets. It is used to treat pain, fever, and inflammation. It is sometimes used after a heart attack, to decreases the risk of death; sometimes used long-term to help prevent heart attacks, ischemic strokes, and blood clots in people at high risk, also a prevention strategy for certain diabetic conditions; and it may decrease the risk of certain types of cancer, particularly colorectal cancer.

In 1897, scientists at Bayer began studying acetylsalicylic acid and, by 1899, Bayer had named the drug Aspirin and was selling it around the world. Aspirin is one of the most widely used medications globally, with an estimated 50 to 120 billion pills being consumed each year. Aspirin works by inhibiting the activity of the enzyme cyclooxygenase (COX), which leads to the formation of prostaglandins (PGs) that cause inflammation, swelling, pain, and fever. The positive effects typically begin within 30 minutes.
Aspirin is an effective anti-inflammatory and can be used for any pain or inflammatory conditions. Dosages, which can be significant, may have side-effects that are limiting factors. Aspirin should not be taken by anyone with a history of stomach or intestinal bleeding, a bleeding disorder such as hemophilia; if one has ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID; and it should be discontinued by mothers in late stages of pregnancy (this is true for all NSAIDs). Aspirin can also pass into breast milk. It should not be used in combination with other NSAIDs. It should not be given to children or teenagers with fever, flu symptoms, or chicken pox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition, in these children. A physician should be contacted by anyone taking regular doses of aspirin, if any of these side-effects occur: black, bloody, or tarry stools; coughing up blood or vomit that looks like coffee grounds; severe nausea, vomiting, or stomach pain; fever lasting longer than 3 days; swelling, or pain lasting longer than 10 days; hearing problems, ringing ears.
Help protect the stomach by using enteric coated aspirin and take with food.
Adding APFD can help lower effective dose of aspirin and avoid some side-effects.

The other NSAIDs are particularly important in the control of pain and inflammation. Use of nonsteroidal anti-inflammatory drugs (NSAIDs), for over 3 months, can be associated with rates of gastric ulceration between 15% and 35%, although many of these ulcers may not be clinically significant. The elevated risk for cardiovascular events associated with NSAIDs, recently prompted the US Food and Drug Administration to issue a stronger warning regarding these drugs. It is stated that if taken regularly, NSAIDs can be expected to add seven to eight cardiovascular events per 1000 patient-years among adults, with moderate cardiovascular risk, and there is greater risk associated with the use of NSAIDs among patients with known cardiovascular disease. A recent study published in BMJ demonstrated a 60% increase in the 30-day risk for intracranial hemorrhage in individuals taking antidepressants plus NSAIDs vs antidepressants alone. Chances of VTE is increased in patients treated with diclofenac, ibuprofen, and rofecoxib, but not naproxen. Besides the usual patient education that would be provided with regular long-term  NSAID treatment, liver enzymes should be checked periodically. NSAIDs may be used in combination with other OTC medications, so reading ingredient labels is very important. Other drug interactions also need to be assessed.

FDA has issued a recommendation for pregnant women to avoid use of NSAIDs at 20 weeks or later. APFD is safe alone or in addition to use with NSAIDs.

A good overview of NSAIDs: Medscape CME: Update on NSAIDs: Translating Pharmacology into Practice. Authors: Dominick J. Angiolillo, MD, PhD Professor of Medicine, Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.

Acetaminophen has recently earned a black box warning, from the FDA, because of the association of its use with increased liver disease and failure. One-half of the acute liver failures are caused by drugs, and 80% of these being caused by acetaminophen. Most of the cases are intentional overdoses, but a substantial minority of patients having significant liver toxicity due to acetaminophen have misused the medication without realizing it. Acetaminophen (weak COX-1 and COX-2 inhibitor, but targets COX-3 and an indirect activation of ECS CB1). Another recent study showed the maternal use of acetaminophen demonstrates a possible increased risk of ADHD, in their children.
Improved pain control, at lower doses, can be achieved by adding APFD.

Gabapentin (with new warnings), tricyclic antidepressants, serotonin reuptake inhibitors, pregabalin, clonidine are also used as part of a pain management “cocktail.”

Lidocaine helps prevent conduction of pain, by blocking voltage-gated sodium channels, within the neuronal cell membrane. The transdermal patch may not be appropriate for patients with diffuse or poorly localized pain. Even at the higher prescription dosage, there has been a lack of efficacy data.

Capsaicin interacts with sensory afferents, through the vanilloid receptors, depletes substance P and also induces cellular degeneration in the skin. There is limited evidence supporting efficacy, 63% of patients report erythema, and 42% pain at application site. A clinical trial showed capsaicin ineffective, for TMJ.

Opioids, one of the most commonly prescribed and effective medication for pain,  works by binding to opioid receptors at the level of damaged tissue, interacting with the nociceptors to prevent pain signal transduction. Some of their adverse effects have been widely discussed, make the news headlines, and are said to be responsible for more than one death every thirty-minutes, though the largest numbers come from illegally obtained opioids and designer combinations.
Opioids, one of the most commonly prescribed and effective medication for pain, works by binding to opioid receptors at the level of damaged tissue, interacting with the nociceptors to prevent pain signal transduction. Some of their adverse effects have been widely discussed, make the news headlines, and are said to be responsible for more than one death every thirty-minutes, though the largest numbers come from illegally obtained opioids and designer combinations.
Chronic pain treatment may lead to the necessity of prescribing long-term opioids. First, an assessment of realistic goals, appropriateness, and your expectations, should be set. Because of the serious risks with inappropriate opioid use, the CDC has published guidelines in the use of opioids for chronic pain and recommends urine drug screening for patients using opioids. This is not particularly easy, and many pain sufferers who require opioids may be left with untreated pain and a diminishing quality of life.
Common opioids like codeine, hydrocodone, methadone, oxycodone, and tramadol are metabolized by the CYP2D6 enzyme. Difference in the metabolism of these drugs has a philosophical and functional impact on their efficacy and side effects. Ultrarapid metabolizers have shown more analgesia compared to normal metabolizers. Poor metabolizers show less analgesia. This makes the choice of opioid and use of these analgesics very important when dosing and maintaining a patient on opioids.
Some of the problems seen with long-term opioid use: tolerance, addiction, abuse, respiratory depression, dizziness, drowsiness, constipation, nausea, vomiting, itching, depression/suicide. Other adverse problems produce poor mental, psychological and physiological outcomes; some adversely affect other disease states (respiratory, cardiac, decreased immune function); there are drug interactions, withdrawal; long-lasting loss of normal body dopamine response, death. Respiratory depression being the most severe and life-threatening adverse effect.
APFD is a safe treatment adjunct that can help limit pain or deal with breakthrough pain, and can be used with a decreasing dose schedule or in a MAT program

Omega-3 polyunsaturated fatty acids have demonstrated, in studies, that oral intake from pharmaceutical-grade fish oil supplements results in pain reduction. This can be an alternative treatment that reduces inflammation and reduces pain, when NSAIDs and other prescription pain medication cannot be taken, due to extreme adverse medical events. Because of the “blood-thinning” effects of omega-3 fatty acids, patients should be advised to stop such supplements, as well as herbal products with ginkgo, curcumin and ginger, two weeks prior to any surgery, dental work, and invasive procedures. APFD is a reliable addition for pain relief.

Medical marijuana/cannabis: the cannabis species has shown over one hundred cannabinoid compounds. The two most recognized cannabinoids are delta-9-tetrahydrocannabinol (delta-9-THC), and less potent delta-8-tetrahydrocannabinol (delta-8-THC) the psychoactive, and the non-psychoactive cannabidiol (CBD). There have been two cannabinoid receptors identified, CB1 in the central nervous system and CB2 in cells and organs enabling outlying responses. Some marijuana properties show relaxation, sedation, boosted sociability, distorted assessment of time, an amplified appetite for sweets and fatty foods, and an enjoyable “buzz.” With the push for the growing approval of marijuana, as a medicine and a legal intoxicant, pharmacists will see an increasing number of patients using marijuana, for a wide range of conditions, but particularly for pain. The elderly seem to be the most vulnerable, to the sales pitch and adverse effects.

Only a minority of States have pharmacists dispensing medical marijuana and no role in recreational marijuana. The risk of interactions, adverse effects, and poor adherence to prescribed therapies is a concern. Pharmacists should monitor CYP2C9, CYP2C19, and CYP3A4 inhibitors that cannabinoids affect. Pharmacists should educate patients regarding  the possibilities of adverse effects. Beyond drug interactions, some adverse effects of marijuana are: diminished short-term memory; impaired motor skills and driving abilities; depression, psychotic behavior and reduced cognitive function with high dose chronic use; dry mouth; tachycardia, palpitations, hypertension and other cardiovascular incidents; reduced immune system capabilities, uncontrolled hyperemesis (which can sometimes controlled with haloperidol); bronchitis and other unknown effects on the lungs. Increased hospitalizations have been seen.
The FDA still places marijuana under schedule 1 category. There are several marijuana derived prescription products on the market, for nausea and seizures, which are no longer schedule 1. The medical research in the uses of active components of marijuana will be bringing more legitimate synthetic compounds, that address direct pharmacodynamic targets within the endocannabinoid system, through legal FDA channels.
Marijuana is mostly smoked, but also put in edible and topical forms. Oral and topical are less effective. Consistent strains and pure CBD products are difficult to obtain.. Also, we should understand  that the clinical evidence for efficacy, for the conditions for which cannabis/CBD is used, has been seen as limited and inconsistent, and has provided inadequate verifiable results.

Along with APFD for pain, additional non-pharmacological pain management methods to include are: cognitive-behavioral therapy, physiotherapy, massage and self-massage, braces, supports, peripheral nerve stimulation, acceptance and commitment therapy, relaxation therapy, acupuncture, exercise activities that improve function and mood and decrease pain. The last choice would be surgery. Patients can look to paintoolkit.org, for more information.
Harvard University has put together a booklet on pain relief without drugs or surgery, plus other important information, which can be found at:
https://www.health.harvard.edu/special-health-reports/pain-relief-natural-and-alternative-remedies-without-drugs-or-surgery
Topical analgesics, like APFD, are considered a non-drug approach.

Pain is untreated or undertreated in half of all pain patients. In these patients there has been seen an increase in mental health issues and personality disorders due to uncontrolled pain. In treated patients, 70% still have pain. There are even larger numbers of pain sufferers, if one looks at those who are silent about their pain and not counted. A lot of this silent group exists because of fear: from physicians regarding oversight (there is registration of patients on opioid pain management); fear of side-effects and addiction (especially with those who may have their job impacted or impaired); and some the high costs of medical care and medication. The government has reported that the number of overdose deaths from powerful painkillers has more than tripled over a decade—a trend the nation's top health official called an epidemic. Pain medications led to the deaths of almost 15,000 people in 2008. We know that these numbers are always miscalculated, and deaths that are indirectly due to medication usage are not counted. Prescription painkillers, such as Oxycodone, Vicodin, Fentanyl, morphine, and methadone are a part of the group of medications leading to overdose deaths. No doubt, it is the illegally obtained drugs, namely fentanyl and heroin that head the list, as the cause of overdose deaths. The number of deaths is now stated to be over one hundred thousand yearly, from drug overdoses. The elderly are the most vulnerable to accidental drug mortalities.

When pain is not relieved, the mixing of medications, OTC and/or prescription, has led to other serious problems, drug interactions, and deaths. Some current options/solutions being proposed do not help the pain sufferer and, in many cases, has led to the misuse problem and the rising use of heroin and other illegal drug combinations. This is a complex problem needing solutions outside the pharmaceutical industry.
APFD is focused on assisting the millions suffering from acute and chronic pain by offering an effective product, and by helping them become better acquainted with multimodal options available to manage their pain and limit the need to be pushed into seeking illegal drugs for their pain.

Because pain is underestimated and undertreated, individuals, so afflicted, are faced with the unfortunate choices of continuing to suffer or take medications that may negatively impact their health. People older than seventy-five who visit the hospital emergency, with complaints of pain, are about 20 percent less likely to have their pain treated than are middle-aged patients, according to studies. There is also post-op pain which is addressed in hospitals, but after patients are discharged, pain is not well managed.

A Pain Free Day with Copper PowerRx is a product that has been shown to effectively aid in the relief of pain; helps eliminate many of the problems/hazards of other pain management options; provides a safe first-line or adjunct treatment for pain sufferers; offers clinical evidence to support confidence in recommending the product to patients, as an effective addition throughout their pain management treatments.
The only issues arising with APFD during the clinical trial and subsequent patient use, was allergy to salicylates. Though no other problems have appeared, outside of salicylate sensitivity, persons allergic to NSAIDs, pregnant women, children, patients with Wilson’s disease, should avoid use without consulting a physician. Product safety has not been studied in children, persons with chronic respiratory disease, or angioedema, though persons in these groups have used APFD. Do not use on sensitive areas. Wash hands after application. If redness, rash, or skin irritation develops in areas the cream has been applied, discontinue use immediately. Consult physician for any painful condition that persists longer than 14 days.



 

 

 




What is left to stop pain?
There have not been any recent safe and effective pain management treatments, and some current choices can have intense side-effect profiles, may not be totally effective, and can be cost prohibitive. Healthcare costs continue to escalate, so treatment options are important to a very large and diverse population of pain sufferers. Consider integrating APFD throughout all pain treatments, as a viable option to improve outcomes