The Hidden Dangers of Self-Medicating with OTC Drugs

By James Campbell, MD, Guest Columnist

The Centers for Disease Control and Prevention (CDC) recently unveiled guidelines for primary care physicians on the use of opioids for chronic pain. Not surprisingly, the guidelines urge physicians to first try non-pharmacologic and non-opioid treatments before resorting to opioid therapy.

If you’re one of the millions of Americans living with pain on a daily basis, it’s likely you’re not a stranger to over-the-counter (OTC), non-prescription pain medications such as naproxen (brand name Aleve), ibuprofen (Advil and Motrin), aspirin and acetaminophen (Tylenol).

In fact, most of my patients with chronic pain began their quest for relief with a cocktail of OTC pain relievers, muscle relaxants and even alcohol, before seeking professional help and eventually graduating to prescription treatments such as opioids, anti-depressants and anticonvulsants.

While OTC pain medications are generally safe when taken at their recommended doses, it’s all too common for patients to unknowingly put themselves at risk of a fatal accidental overdose or serious drug-drug interactions by mixing OTC pain medications or taking them in combination with prescription treatments for pain or other common health conditions.

Given the sheer magnitude of serious adverse events and fatalities associated with opioids, the hidden, yet preventable dangers of the pain medications on your pharmacy shelves are not often discussed.

Let’s take one of the most common OTC pain relievers: acetaminophen. When used as directed within the advised dosing guidelines, acetaminophen is safe and effective. However, if a person takes more than one medication that contains acetaminophen and exceeds the maximum recommended dose, they may be at risk of serious liver damage.

This happens so often that acetaminophen overdose is the leading cause of calls to poison control centers in the United States -- more than 100,000 instances per year – and are responsible for more than 56,000 emergency room visits.

In fact, in 2011, in an effort to reduce the risk of severe liver injury from acetaminophen overdose, the Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription medications, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule or other dosage unit.

Then in 2014, the FDA recommended that health care professionals discontinue prescribing and dispensing prescription combination products that contain more than 325 mg of acetaminophen.

While the FDA’s efforts may help curb accidental overdose related to prescription medications that contain acetaminophen (Tylenol with codeine, for example), it does little to address the risks of OTC acetaminophen or other OTC pain medications such as ibuprofen, a type of non-steroidal anti-inflammatory drug (NSAID), which can cause gastrointestinal bleeding and injury, and cardiovascular side effects when taken on a chronic basis.

Drug Interactions

In addition to the risk of overdose, people taking multiple OTC and prescription medications for pain and other conditions are also at risk of serious drug-drug interactions. Simply put, any “drug” – whether it be a medicine, vitamin, supplement or even alcohol – that enters your body and alters your natural internal chemistry has the potential to interact or alter the intended effect or unintended side effect of other medications.

Even though most medications are accompanied by warnings about combining them with other drugs, most vitamins and supplements are not -- so, unless you’re a licensed medical professional, it’s virtually impossible to recognize the potential for drug-drug interactions.

If you’re using OTC medications, whether alone or with prescription medications, to cope with pain on a daily basis, here are three precautionary steps you can take to safeguard yourself against the risk of accidental overdose or drug-drug interactions.

1) Recognize that ALL medications, whether OTC or prescription, can cause harm if used improperly, and the fact that some medications are available without a prescription does not mean they are inherently safe. Read the labels that come with your medications. Tylenol, Advil and Vicodin are household names, so it can be easy to overlook their “generic” names (or the active ingredient in each).

For example, the generic name for Tylenol is acetaminophen, while that of Vicodin is acetaminophen hydrocodone. Without close examination of either label, a person taking Vicodin and Tylenol together could be inadvertently exceeding the recommended dosage of acetaminophen.

2) Consult a medical professional before you take more than one medication on a daily basis. If your chronic pain is being treated by a physician, be sure to tell them (even if it’s on your medical history) about any OTC or prescription medications you are currently taking. This includes vitamins and other supplements that may seem harmless, but could interact with your pain medications.

3) If you are independently treating your chronic pain, make a list of all the medications, vitamins and supplements you take on a regular basis and share them with your local pharmacist. Pharmacists can identify potential drug-drug interactions like taking acetaminophen and ibuprofen on a long-term basis, which can result in an increased risk of developing kidney problems.

The American Chronic Pain Association also recommends using the same pharmacy for all your prescriptions, so that the pharmacist can screen health information and current medications to avoid the pitfalls of overdose and drug interactions.

As a neurosurgeon with a special interest in pain for over 30 years, I’m empathetic to the daily struggle that patients face and their desperate quest for relief, seeking anything and everything that can simply make the pain stop.

For the patients who are fighting this seemingly endless battle with pain without the help of a medical professional, I hope I’ve provided some useful information and practical advice to help avoid serious risks associated with self-medicating. However, people living with moderate to severe chronic pain may benefit from a consultation with a licensed pain management specialist, who can help guide you toward steps that will help reduce your pain. 

James Campbell, MD, has spent the last 30 years pioneering efforts to improve the diagnosis and treatment of patients with chronic pain. 

Dr. Campbell is professor emeritus of Neurosurgery at Johns Hopkins University School of Medicine and is the founder of the Johns Hopkins Blaustein Pain Treatment Center - one of the largest pain research centers in the U.S. He is also a former president of the American Pain Society. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Neuropathy More Damaging Than Previously Thought

By Pat Anson, Editor

A tingling, sometimes painful sensation in the hands and feet – the early stages of small fiber neuropathy -- may be more damaging to the peripheral nervous system than previously thought, according to new research published in JAMA Neurology.

A 3-year study by Johns Hopkins neurologists found that patients with small fiber neuropathy showed unexpected deterioration over the entire length of sensory nerve fibers, not just nerve fibers at the surface of the skin.

“I liken small fiber neuropathy to the canary in the coal mine,” says senior author Michael Polydefkis, MD, professor of neurology at the Johns Hopkins University School of Medicine and director of the Cutaneous Nerve Lab. “It signals the beginning of nerve deterioration that with time involves other types of nerve fibers and becomes more apparent and dramatically affects people’s quality of life. The results of this new study add urgency to the need for more screening of those with the condition and faster intervention.”

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Small fiber neuropathy can also be caused by lupus, HIV, Lyme disease, celiac disease or alcoholism.

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can eventually lead to injuries, chronic foot ulcers and even amputations.

Polydefkis and his colleagues found that small fiber nerve damage occurs even in patients with prediabetes, and the early symptoms of burning pain may be less benign than most clinicians think. Routine nerve tests, like nerve conduction, often fail to identify nerve damage because they mostly assess injury to large diameter nerve fibers.

In an effort to measure nerve damage more accurately, Johns Hopkins researchers took small samples of skin — the size of a large freckle — from 52 patients diagnosed with small fiber neuropathy and from 10 healthy controls. Skin samples were taken from the ankle, the lower thigh near the knee and the upper thigh. Three years later, samples from the same area in the same patients were taken for comparison.

Microscopic analysis of the skin samples showed that patients with small fiber neuropathy initially had fewer nerve fibers on the ankle compared to the upper thigh, demonstrating the most nerve damage was further down the leg. But after three years, researchers found that longer nerve fibers were also lost from the lower and upper thighs, something that was not expected.

“We are all taught in medical school that the longest nerves degrade first, and we show that this isn’t always the case,” says lead author Mohammad Khoshnoodi, MD, assistant professor of neurology at Johns Hopkins,

Patients with prediabetes or diabetes had at least 50 percent fewer small nerve fibers in their ankles initially than those participants with an unknown cause for their small fiber neuropathy, indicating these patients started the study with more damage to their small nerve fibers.

The patients with prediabetes continued to have worsening damage to their small nerve fibers over the course of the study, losing about 10 percent of their nerve fiber density each year at all sites tested along the leg. Patients with diabetes also lost similar rates of nerve fibers along the three sites of the leg.

“I expected that people with diabetes would do worse, but I didn’t really expect people with prediabetes to experience a similar rate of degradation of their small nerve fibers,” says Polydefkis.

Researchers caution that their study was small, and that other factors such as high blood sugar, smoking, high blood pressure and high cholesterol, may also have contributed to the decline in nerve fibers.

Should Johns Hopkins be Policing the Nanny State?

By Terri Lewis, Guest Columnist

I was copied a response to the recently issued document, "The Prescription Opioid Epidemic: An Evidence-Based Approach" published by Johns Hopkins Bloomberg School of Public Health. 

The 46-page document is full of pronouncements about what the proper course of action should be to rein in the abuse of opioids by people who experience unrelenting chronic pain on a daily basis.  The document is replete with terms like addict, addiction, surveillance, monitoring,  intervention, adherence, and conformance distributed across seven topical areas, all claiming to address the current evidence for the need to ramp up the nanny state:

#1: Prescribing Guidelines
#2: Prescription Drug Monitoring Programs
#3: Pharmacy Benefit Managers and Pharmacies
#4: Engineering Strategies
#5: Overdose Education and Naloxone Distribution
#6: Addiction Treatment
#7: Community-Based Prevention

Nowhere, does this document even remotely address the fact that the onset of chronic pain is often an iatrogenic event that occurs as the result of medical harm or insufficiently delivered medical care. 

Nowhere, does this document address the financial and practical impact of these pronouncements on the ability of persons who have lost everything to illness to conform to protocols that turn healthcare delivery into a policing activity.

Everywhere, these protocols engender the further victimization, the institutionalization of marginalization, and stigmatization of the chronically ill as unworthy, incapable of protecting themselves, and potentially harmful to themselves and others because of the characteristics of their illness imposed disabilities. 

Every dollar that is proposed for expenditure in this document should be going to research designed to prevent and minimize the impact of chronic pain -- not punish it.  But this document, from a major public health training institution, completely fails to address the prevention and reduction of chronic pain as a public health issue of significant importance, and is focused instead on counting adherence, conformance and compliance activities that will (a) not lead to improved personal outcomes for consumers who live with chronic pain and (b) rob consumers of precious resources with which to live. 

These pronouncements reflect an ignorance of astounding proportion in understanding who persons with chronic pain actually are and the conditions under which they are forced to live.  Who does this document serve?  Who are we trying to protect?  

I am outraged.

And then this.  Into my email came a response to this smug, sanctimonious document from a woman in California who suffers from interstitial cystitis -- acquired through medications she received after treatment for shoulder and spinal injuries at the hands of her medical provider.  It's too good not to share:

To the misguided folk at Johns Hopkins Bloomberg School of Public Health:

This is my contribution to your little Town Hall hand-wringing session.

So, I guess you are jumping on the anti-opiate frenzy bandwagon.  Just another organization that feels compelled to point at anyone who takes opiates, and call us all "addicts" and not even considering those of us who suffer from severe CHRONIC PAIN (the kind That Never Ends) due to circumstances totally beyond our control.  My pain is not caused by any flaw in my character.  People like myself who see our doctors religiously and always take our medication responsibly.  What, are you being financially rewarded by punishing us?  What did we ever do to you?  Or are you just trying to Thin the Herd?  I guess Chronic Pain Patients' Lives DON'T Matter.

I'm talking to you.  I'm one of those people, who suffer from illnesses and or injuries that have already stolen our quality of life away from us, and pain that causes as much, and sometimes more, pain than cancer.  People who suffer from pain that only opiate prescription medication can dull.  And people like you, whom I will never meet, want to take that away from me.  A patient who has NEVER EVER ABUSED HER MEDICATION.  Not ONCE.  I am a 60 year old lady who worked her entire adult life and never once did anything to invite nor cause the condition that causes me terrible TERRIBLE pain.

My pain saga started with chronic tears to both my rotator cuffs, and a herniated cervical spine.  All from a desk job involving typing and mousing and staring at a computer monitor for years and years and years.  This activity has destroyed the tendons in both my shoulders and neck and herniated my spine.  And while that pain was bad enough, I figured it would eventually end.  I never envisioned that the pain would remain after my shoulders were carved up and stitched back together.  It was during my recovery from this surgery, that I began to experience the horrors of an incurable illness known as Interstitial Cystitis.

On bad days it feels like someone is taking a blowtorch to my genitalia.   In fact, Interstitial Cystitis is considered the Third Worst Pain in all of medicine.  Imagine, if you will, the sensation of hot lava being blasted through your bladder, vagina, colon and pelvic parts.  All the time.  Having the urge to urinate every 15 minutes -- or more often than that -- on bad days.  I am basically chained to a toilet.  And because the pain is ALWAYS much worse at night, I suffer from severe insomnia.  It is impossible to fall asleep or stay asleep with pain this bad.  My urologist opined that I would be better off if I suffered from Bladder Cancer, because there is at least a chance of recovery from that illness.

The only FDA authorized treatment for this condition is Elmiron, and it doesn't work on every patient.  In fact, it only works on maybe 25% of patients who suffer from this horrible condition.  It did nothing to help me with any of my symptoms but cause my hair to fall out and raise my liver enzymes to a dangerous level.  That's all our modern medical machine could do for me medically.  They sure as hell cannot cure this illness yet.  The only thing that medicine CAN offer is pain relief.  The only chance in hell I have of ever having a life without this horrible, searing, burning, aching, stabbing pain is if The Good Lord decides to send me into remission.  All a doctor can really do for me to help me is provide me with pain relief.

The only medication I take that takes the edge off of this pain is Norco.  I tried the Fentanyl patch, but it caused me to develop an intestinal blockage.  For obvious reasons, I had to discontinue that medication.  And while I intensely dislike taking ANY medication, I dislike the awful pain worse.  I have NEVER abused my medication.  I never take more than I am prescribed.  I do everything and anything that is asked of me, whether it involves blood tests and/or pissing into a cup.

So why am I going to be punished?  Answer me that question.  I just found out that my pain medication is going to be cut drastically OR terminated at my next visit to my pain doctor, which is this Friday.  It is not being taken away because I have ever abused my medication, or lied, or deceived, or stolen, or sold it.  I can only assume that my pain doctor is just too afraid of the DEA and the paperwork headache.  It will be easier for him to just dump me as a patient, and limit his practice to injections which make him more money anyway.  Well, guess what?  Injections have never done a thing to help my pain, and I have had quite a few.  I have had TENS units, Physical Therapy, Massage and Ultrasound.  I have tried just about everything that exists to reduce the horrendous pain I experience 24/7.  The only medicine with the fewest side effects that helps reduce pain is Norco.

We are a vulnerable part of the population who are being deprived of compassionate and adequate care to help us live our lives with a semblance of normalcy.  We are being punished for the irresponsible actions of people who would be addicted whether or not it was via opioids or anything else.  All of this noise is just that:  NOISE.  Mark my words:  all this brouhaha will not make one iota of difference in the epidemic you speak of.  People who are addicts will always find a way to get high.  That is what addicts do.  However, what your actions WILL do is cause an increase in suicides of people suffering from terrible TERRIBLE pain, who can no longer get medication that enables them to have something resembling a quality of life, and be semi-productive citizens. 

Yes.  The pain of illnesses like mine can and does drive good people to commit suicide if they can't get pain relief.  Or maybe these same people turn to other drugs they would never EVER consider if they received the compassionate care we are all entitled to.  That is what you will see start to happen.  I am sure that some of this surge in heroin use is by people who are in such terrible pain that they are desperate, and their doctors will not help them because of fear of the DEA and organizations like yours.  And then what will happen?  More "meetings" and "studies" and "head-scratching" about the spike in suicides?  How can you be so obtuse?

No one is speaking up about us. No one is helping us.  Chronic pain patients are being marginalized and treated like addicts, when we are not.  We can barely function because pain robs us of the ability to function, and we are already exhausted from this daily fight.  I guess we are easy targets.  Few of us possess the strength to march on numbers in Washington or anywhere else.  I know I couldn't.  I am so ill that I can barely leave my house.

I know what happens to me when I don't take my pain medication:  I experience much more severe pain.  I don't drool, or hallucinate, or stumble, or vomit, or shiver, or do anything but just cry buckets and buckets of tears, and huddle in a corner of my bed in the fetal position with bags of ice stuffed into my underwear to try and numb the horrible, searing pain of this illness.  And I guarantee that if any of you people making these horribly unjust decisions suffered from the condition I suffer from, that you would be begging for drugs to take the pain away.  I'm willing to stake what few dollars I still possess on that fact, because guess what?  This illness has also rendered me destitute and incapable of working at my job.  I can't even sit in a chair very long because of the pain.

So, in summary, what you are doing is KILLING US.  You, and 60 Minutes, and the CDC and the DEA and every other soulless agency that is carping about this.  If I weren't so sick from this horrible illness, and what it has done to my life, I would be laughing because of the incredible stupidity being displayed by a bunch of suits I will never meet.  Dumping every single person who takes opiates into a category you call "addiction" and shoving us off in the same leaky boat.  Yes.  You are killing us.

Name withheld to protect her privacy

For the record, this person also found out last week that her beloved husband of 20 years is in the throes of stage 4 kidney failure as a result of 5 years of treatment from a physician for arthritis -- resulting in an unidentified drug-drug interaction that has, unbeknownst to the physician, destroyed his patient's kidneys because he failed to monitor his patient or pay attention to known drug-drug interactions.

So who needs to be monitoring and surveilling here?  Who?  Does the public really need protection from persons with chronic pain who can barely leave their homes?  Or do persons in pain need protection from the public purveyors of unsound, impractical, and misguided policies? 

God spare us from the nanny state.

Terri Lewis, PhD, is a specialist in Rehabilitation practice and teaches in the field of Allied Health.  She is the daughter and mother of persons who have lived with chronic pain.

This column was reprinted with permission from the author.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study Calls for End to ‘Permissive’ Opioid Prescribing

By Pat Anson, Editor

A major study released by the Johns Hopkins Bloomberg School of Public Health is calling for new guidelines in the prescribing of opioid pain medication, including the repeal of “permissive and lax prescription laws and rules.”

The report also calls for sweeping changes in the way opioid prescriptions are dispensed and monitored, and would encourage insurance companies to provide information to federal regulators about “suspicious” pharmacies, prescribers and patients.

The Johns Hopkins report (which can be seen here) grew out of discussions that began last year at a town hall meeting on prescription opioid abuse hosted by the Bloomberg School and the Clinton Foundation. It was prepared primarily by a group of public health researchers, physicians, law enforcement officials and addiction treatment specialists.  

“A public health response to this crisis must focus on preventing new cases of opioid addiction, early identification of opioid-addicted individuals, and ensuring access to effective opioid addiction treatment, while at the same time continuing to safely meet the needs of patients experiencing pain,” wrote G. Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness at the Bloomberg School.

It is widely recognized that a multi-pronged approach is needed to address the prescription opioid epidemic. A successful response to this problem will target the points along the spectrum of prescription drug production, distribution, prescribing, dispensing, use and treatment that can contribute to abuse; and offer opportunities to intervene for the purpose of preventing and treating misuse, abuse and overdose.”

The report calls on federal and state agencies, state medical boards and medical societies to require "mandatory tracking of pain, mood and function" at every patient visit, as well as patient contracts and urine drug tests.  Patients prescribed high doses of opioids would be required to consult with a pain management specialist.

“It sounds like an aggressive government intrusion into the practice of medicine and is punitive towards providers willing to help people in pain. It certainly is a threat.  Every physician in America should be concerned if these recommendations are adopted,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine.

“I am amazed that one of our finest educational institutions in America failed to address the source of the prescription drug abuse problem in their report.  Not once did the report discuss the lack of safe effective treatments for pain.  They almost totally ignored the needs of people in pain.  Yet it is number one public health problem in America. Their focus was myopic and represents a narrow and prejudicial view of people in pain.”

One of the more controversial recommendations in the report would expand access to prescription drug monitoring programs (PDMPs) to private insurance companies and pharmacy benefit managers (PBMs). Access to those databases, which track prescriptions for opioids and other controlled substances, are currently restricted to regulators, law enforcement and physicians.

"It is a very bad idea to allow law enforcement or even payers to have access to PDMPs without a cause approved by a judge.  This is personal medical information that should be protected," said Webster in an email to Pain News Network.  

Under the Johns Hopkins plan, insurers would be encouraged to report suspicious prescribing activity to federal regulators and the Center for Medicare and Medicaid Services (CMS).

“Allowing managed care plans and PBMs access to PDMP data will improve upon their current controlled substances interventions that have been shown to positively influence controlled substances utilization,” the report states. “All PBMs should provide a list of suspicious pharmacies, prescribers and beneficiaries to the National Benefit Integrity Medicare Drug Integrity Contractor (MEDICs). Using the actionable PBM data they are receiving, MEDICs should be reporting potential providers for removal to the CMS.” 

The report also calls for mandatory use of PDMPs by prescribers and pharmacies, more training for medical students in pain management, expanded federal funding of addiction treatment, and greater access to naloxone, a drug that can reverse the effect of an opioid overdose.

“What’s important about these recommendations is that they cover the entire supply chain, from training doctors to working with pharmacies and the pharmaceuticals themselves, as well as reducing demand by mobilizing communities and treating people addicted to opioids,” said Andrea Gielen, director of the Johns Hopkins Center for Injury Research and Policy at the Bloomberg School and one of the report’s signatories.

“Not only are the recommendations comprehensive, they were developed with input from a wide range of stakeholders, and wherever possible draw from evidence-based research.”

One of the ”stakeholders” and a signatory of the Johns Hopkins report is Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioids. Kolodny, who has collaborated with Dr. Alexander on other prescribing studies, is chief medical officer of Phoenix House, a non-profit that operates a chain of addiction treatment centers. According to a note on PROP's website, "PROP is a program of Phoenix House Foundation."

Kolodny has referred to opioid pain medication as “heroin pills” and has called for expanded access to buprenorphine, a weaker opioid widely used to treat both addiction and pain.

The Johns Hopkins report would greatly expand the use of buprenorphine by ending the 100 patient limit on the number of people that DEA licensed physicians can treat with buprenorphine at any one time. It would also require federally funded addiction treatment programs, such as those offered by Phoenix House, to allow patients access to buprenorphine.

Although praised by Kolodny and many addiction treatment specialists as a tool to wean addicts off opioids, some are fearful buprenorphine is already overprescribed and misused. Addicts have learned they can use buprenorphine to ease their withdrawal symptoms and some consider it more valuable than heroin as a street drug.

"The 100 patient limit is going to be lifted. It is going to create buprenorphine pill mills and increase the abuse of heroin. You will have more doctors getting the DEA exemption as they would not be subject to visit by DEA inspectors checking on the patient limit," said Percy Menzes, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area.

Over three million Americans with opioid addiction have been treated with buprenorphine. According to one estimate, about half of the buprenorphine obtained through legitimate prescriptions is either being diverted or used illicitly.