Patients with Comorbidities: Introduction

In today’s health care industry chronic disease creates the most difficult barriers to successful treatment. This is the cause for a great deal of concern because chronic disease is also the most common medical condition that requires treatment.

Acute ailments have given way to an overwhelming list of chronic diseases and conditions, the most common of which include:

• cancer
• diabetes
• arthritis
• dementia
• fibromyalgia
• HIV/AIDS
• low back pain
• migraine

What vexes clinicians further is the fact that most patients with chronic illness also have comorbidities—conditions that exist at the same time as the primary condition. In isolation, treatment of pain caused by a solitary, defining condition presents the ordinary challenges of effective pain assessment and control, but comorbidities can seriously complicate treatment.

In a 1997 study of hospital patients by the Agency for Healthcare Research and Quality (AHRQ),³⁶ the top five most common comorbidities were:

• hypertension (20.4%)
• fluid and electrolyte disorders (13.6%)
• chronic obstructive lung disease (10.9%)
• diabetes (9.5%)
• irregular heartbeat (6.8%)

This same study found that 54% of hospitalized patients have at least one comorbidity, and about one-third have two or more comorbidities.

Some of the difficulties created by comorbidities are caused by drug-disease interactions and drug-drug interactions.

Drug-disease interactions occur when a person's illness increases the toxicity of a medication, or decreases its effectiveness. Drug-drug interactions result when two or more drugs that are given together create an adverse event.

Drug-drug interactions and polypharmacy
Drug-drug interactions are much more common than drug-disease interactions and include:

• Prescription drug-prescription drug interaction
• Over-the counter (OTC) drug-prescription drug interaction
• Herbal drug-prescription drug interaction

Herbal drug-prescription drug interactions are an area of special concern because estimates are that herbal use in the United States is as high as 40% of the overall population, but only about 20% of them report the use to their physicians. Because herbal drugs, most often referred to as “herbal remedies” can be purchased at health food stores and supermarkets, most people don't think of them as drugs. The table included as Figure 2 lists some of the most commonly used herbal remedies and the interactions they have with common prescription and OTC drugs. Appendix K is an enlarged copy of the table that can be reproduced for distribution to patients.

Another pitfall of treating comorbidities is the possibility of “polypharmacy.” Quite simply, polypharmacy means “many drugs,” and it occurs when a patient is prescribed more medications than are actually necessary. This can easily happen when a patient is seeing more than one physician and/or is being treated for more than one disease.

Figure 3 on the following page is a list of “10 Steps to Reducing Polypharmacy,”³⁷ that was published in “Geriatrics” in July of 1996. It was created using information compiled by J. E. Carlson. Polypharmacy is most prevalent in the elderly, because that segment of the population takes 30% of all drugs prescribed, but these tips are equally beneficial in prescribing medication for all patient populations.

Comorbidities include not only medical disorders, but psychological issues as well. Patients with acute or chronic pain frequently experience severe physical dysfunction. They can no longer do the things that make their lives satisfying. They worry about what the pain means. Not surprising, they often suffer from psychological distress symptoms, including depression, anxiety and/or insomnia. Inability to work and participate in normal household and social activities can have a severe impact on self-esteem. Many chronically ill pain patients withdraw from family and friends.

Do these psychological comorbidities contribute to more recalcitrant chronic pain problems? The unequivocal answer is yes. Sadly, these comorbid conditions are often overlooked and left untreated.

Two other common comorbidities that serve up complex dynamics when managing pain are substance abuse and mental illness. If a patient with legitimate chronic pain is a known substance abuser, how do you meet your obligation to provide the established standard of care without violating controlled substance laws? Or, if he/she is bipolar, is there a possibility of adverse drug-drug or drug-disease interactions? What if the patient is both bipolar and a substance abuser?

Legally and ethically, rising expectations for chronic pain management make competent and thorough care of the “whole” person of paramount importance. Clinicians should not dissect the patient's illnesses into discrete units, to be addressed separately from one another. Instead, they should adopt a model of care that focuses on the complete set of comorbidities, and implement an integrated strategy.

Painful Diseases and Comorbidities
The following statistics for cancer, arthritis and diabetes illustrate the extent of the comorbidities problem.³⁸

Cancer

• Cancer affects an estimated 82 million Americans.
• More than 75% of them have one or more additional chronic conditions.
• 27.4% have 3 or more chronic conditions.

The most common comorbidities affecting cancer patients are:

• Cardiovascular Diseases (including hypertension) 42.3%
• Arthritis 18.2%
• Eye Disorders (including glaucoma) 17.7%
• Mental Illness 12.9%

Arthritis

In 2000, approximately 6.5% of Americans or 16 million people were estimated to have arthritis. The incidence of arthritis sharply increases with age (Less than 1% of Americans under the age of 35 have arthritis) and is more prevalent in females above 45 years.

Only one in six people with arthritis have no other chronic conditions. On average, a person with arthritis has at least 3 other chronic conditions. Comorbidities associated with arthritis also increase with age. The most common comorbid condition for people across all age groups is hypertension (44%). The next most common comorbid conditions are heart disease (20%),high cholesterol (18%) and diabetes (16%).³⁹

Common Comorbidities by Population⁴⁰

• In the 0-17 age group, eye disorders are the most common (and only) comorbidities (52%).
• In the 35-64 age group, hypertension is the number one comorbidity (38%) followed by depression (17%).
• In the 65-74 age group, hypertension is number one (52%) and high cholesterol is number two (23%).
• In the 75+ age group, again, hypertension is number one (51%) followed by heart disease (35%).

Diabetes
(Diabetes affects approximately 20 million Americans). Over 81% of people with diabetes have one or more comorbidities, 34% have three or more co-existing conditions.

The most common comorbidities afflicting people with diabetes are:

• Cardiovascular Diseases (including hypertension) 57.2%
• Arthritis 21.4%
• Eye Disorders (including glaucoma) 19.9%
• Mental Illness 13.5%

Pain Management and Comorbidities: A Thought-Provoker
Consider the following hypothetical case:

Ed Crawford, a 52-year-old white, obese male with diabetes makes an appointment with a new primary care clinic. He complains of severe burning and tingling pain with loss of sensation in the distal lower extremities. He claims the pain has become progressively worse and troublesome over the past few years, and that his previous health care provider never asked about his pain. He also tells you that he is sad all the time, and has frequent crying bouts. He comments that he doesn’t get enough sleep, and wakes up early in the morning, and this is affecting his work performance. He has been given medication for both his pain and depression, but it is not helping. He just seems to be getting worse. You also learn that he is single but has a close relationship with his parents, who live nearby. He tells you that he tries to exercise to lose weight, but he says he is experiencing a lot of pain in his knees which makes it hard to stick with the recommended exercise regimen. You ask about and record the medications he's currently taking. You also inquire about his past and present substance use. He tells you that he drinks 4-5 beers a night to help take the edge off of his pain.

In caring for Ed, the “whole” person:

• What would you want to know about his current pain and depression medication?
• What other comorbidities would you want to test for and include in the treatment program?
• What diagnostic tests would you order?
• What tools would you use to obtain a complete and accurate assessment of this patient’s pain?
• What tools would you use to measure his quality of life?
• What tools would you use to measure this patient's depression? Possible alcohol addiction?
• What therapeutic interventions (pharmacologic and non-pharmacologic) would you suggest to deal with his pain, depression and obesity?
• What other specialists might you consult with or refer this patient to and why?
• What objectives would you set for this man’s treatment success? What time frame would you establish for meeting these objectives?
• How would you monitor and evaluate the success of this patient's treatment program?
• What self-monitoring tools would you suggest this patient use?
• If there are other health care professionals involved in this man’s care, how will you stay informed of all results?
• How would you educate this man on his conditions, use of medications, possible side-effects and how to control them, and consequences of non-compliance?
• How might you involve his parents in helping him with his treatment plan?

Comments:
The fruit basket of comorbidities in the above case may or may not seem believable. Nonetheless, the incidence of painful chronic conditions with coexisting disorders is surprisingly commonplace and demands higher levels of knowledge and skills to provide competent care and avoid potential liability.

Proper use of pain, psychological and quality-of-life assessment instruments is an essential first step in defining treatment parameters and developing a sound pain management program. Examples of a body map and verbal and numeric pain intensity scales are included as Appendixes C, D and E. Many other tools encompassing pain assessment are available in print and online. Some of these are listed in Appendix M.

A multi-disciplinary, multi-modality approach to the treatment of co-existing disorders offers many benefits and is increasingly considered a best practice in pain management programs. While maintaining control of the overall treatment strategy is critical, clinicians are encouraged to consult with other specialists as needed to obtain a more comprehensive evaluation, identify optimal therapeutic strategies, utilize expertise outside the scope of a physician's practice, or respond to a patient's desire for a second opinion. Non-pharmacologic therapies to be considered include behavioral strategies, psychotherapy, coping skills training, relaxation techniques, non-invasive somatic interventions and involvement with a formal pain rehabilitation program.

It is also imperative that clinicians understand possible adverse drug side effects as well as the risk of one drug decreasing the benefit of another drug.

Finally, patient education emerges as a singularly ignored yet critical component of the overall pain treatment plan. Desired treatment outcomes rely on patient knowledge and compliance. While health care providers may have all the best intentions in developing a pain management strategy, their objectives for optimal pain relief and functional restoration may be sabotaged from the get-go due to patient misunderstandings or lack of information. This is especially true in situations involving several chronic disorders. Patients (and family members) should be informed of all aspects of the pain treatment program, and adequate time to do this must be allocated.

Following are some guidelines for ensuring thorough patient education:

• Explain what pain is and the different types of pain
• Review the results of your examination and diagnostic tests
• Explain the treatment options and the risks/benefits
• Review proper use of medication (staying “on the clock”) and possible side effects
• Plan ahead for possible side effects and provide solutions (e.g., for constipation or nausea)
• If opiates are included in the treatment plan, conduct a detailed informed consent discussion and have the patient sign an Informed Consent Form
• Review the tools you want the patient to use in tracking his/her pain relief outcomes
• Explain the treatment objectives and time frame for achieving them
• Ask the patient to check with you or a pharmacist before taking any over-the-counter medications
• Provide the patient with medical education brochures; where available, provide brochures in the patient’s native language (Note: Clinicians are advised to make a record of the brochures given to patients, and to keep a master copy of all brochures distributed in the event of legal action. If brochures are updated, archive the previous version.)
• If there is a language barrier, find out if there is anyone on your staff (or a patient family member) who can help with translation
• Solicit and answer any and all questions

Dealing with Substance Abuse
As a serious comorbidity and potential cause of legal action, addiction (or possible drug diversion) must be identified and planned for in any pain management solution.

A one-year study of patients with non-malignant chronic pain at all emergency departments of Calgary, Canada, revealed why many physicians may hold negative beliefs about patients in chronic pain: Of all patients seen, only 4-5% accounted for one-third of total emergency department visits.

Drug-seeking patients do exist, and unfortunately, they taint clinicians' views of patients suffering from chronic pain. Prescription drug abuse is on the rise in the United States. According to the 1999 National Household Survey on Drug Abuse, an estimated 4 million people - almost 2 percent of the population aged 12 and older - were abusing certain pain relievers. It is no surprise that individuals with known or suspected substance abuse encounter significant barriers to adequate pain treatment.

The first step in competently addressing substance abuse problems is to understand the difference between addiction, pseudoaddiction, tolerance and physical dependence. Following are definitions for each one:

Addiction - A primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm.

Physical Dependence - State of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependence, by itself, does not equate with addiction.

Pseudoaddiction - An iatrogenic syndrome resulting from the misinterpretation of relief-seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief seeking behaviors resolve upon institution of effective analgesic therapy.

Tolerance - A physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect, is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

True addiction is a rare occurrence in patients who receive opioids for a legitimate medical reason with no prior history of drug abuse or addiction. Nonetheless, clinicians treating pain are advised to carefully study and be aware of “red flag” behaviors which potentially signal an addiction or drug diversion problem. In order to protect yourself legally, it is an excellent idea to execute an agreement with the patient that includes a "Pain Contract." Included as Appendix L is a copy of a Pain Contract that can be reproduced. The agreement should clearly outline the conditions under which the health care practitioner is willing to treat the patient and should include:

An Informed Consent form dated and signed by both the patient and the physician. An agreement that specifically states the following:

• Only one physician will prescribe controlled substances.
• Only one pharmacy will fill those prescriptions.
• Patient will notify the physician’s office of any controlled substance prescriptions obtained from another physician during emergency treatment.
• Patient will not make an unauthorized change to the medication schedule.
• Patient will not alter the prescription.
• Patient agrees to submit to urine or blood screens at the doctor's request.
• Patient will not sell or give the opioid to another person.

Following are some tips for assessing and controlling possible substance abuse, and steps to help avoid legal vulnerability:

1. Obtain a thorough patient history including possible or potential illegal drug use or abuse.
2. In writing prescriptions
   • Write out quantity of drug in longhand as well as using a numeral; this makes it impossible for the patient to change the quantity.
   • Do not pre-sign blank or use preprinted prescriptions.
   • Do not provide over-the-phone prescriptions.
   • Remember to mark NO Refills.
   • Do not leave blank prescription pads where patients may have access to them.
   • Do not pre-print your DEA number on prescription pads.
3. Ask yourself these questions:
   • Has the patient's functionality decreased?
   • Do you observe intoxication? Negative affective state?
   • Does the patient fail to bring in unused medications to appointments?
   • Has the patient increased his/her dose without permission?
   • Does the patient ever ask for early prescription renewals? Report lost or stolen prescriptions?
   • Does the patient make surprise visits to the clinic without an appointment? At this surprise visit, does the patient seem distressed?
   • Does the patient miss appointments?
   • Does the patient seek prescriptions from multiple providers?
   • Does the patient make frequent visits to emergency room departments to request drugs?
   • Are there any family reports of overuse/intoxication?
   • Does the patient show an interest in non-pharmaceutical therapies? Comply with them? Report improvement as a result of them?
   • Does the patient request specific pain medications (tell you other treatments "don't work")?
4. Document in the patient's chart all medications prescribed and the rationale; include information about the patient's dependence and your plan for addressing it. Document all other consultations received regarding this patient (pain specialist, psychiatrist, etc.).

If there are violations of the contract, immediately refer the patient to a drug treatment program or dismiss him/her from the practice.

Summary
In the management of pain, patients with comorbidities are considered a special population group. Age, gender, race, and ethnicity do not necessarily categorize this group. The elderly do experience higher comorbidities as a rule, and certain diseases tend to invite greater susceptibility to add-on disorders. Nonetheless, comorbidities make a broad sweep across all patients experiencing pain, sparing neither the young child with cancer nor the African American adult with diabetes.

Clinical dynamics are far more complex and challenging when treating a primary painful condition with comorbidities - particularly when those comorbidities also cause pain. Physicians must be aware of risk factors, underlying disease mechanisms, and potential adverse drug-drug interactions and side effects. They must also be able to evaluate and treat psychosocial disturbances that contribute to and are by-products of pain. The desperate search for chronic pain relief may influence perception of drug-related behavior, and it is vital for health care providers to be astutely aware of the true indicators of addiction.

Protection from liability in all pain management cases - whether with the elderly, children, women, minorities, or patients with comorbidities - relies on a clinician's desire to embrace the entire jigsaw puzzle, legally, ethically, technically, culturally and humanely.

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